UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒ QUARTERLY REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarter ended September 30, 2024
☐ TRANSITION REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission file number: 001-38762
BiomX Inc.
(Exact Name of Registrant as Specified in Its Charter)
Delaware | | 82-3364020 |
(State or other jurisdiction of
incorporation or organization) | | (I.R.S. Employer
Identification No.) |
22 Einstein St., Floor 4, Ness Ziona, Israel | | 7414003 |
(Address of principal executive offices) | | (Zip Code) |
Registrant’s telephone number, including
area code: +972 723942377
Securities registered pursuant to Section 12(b)
of the Act:
Title of each class | | Trading Symbol(s) | | Name of each exchange on which registered |
Common stock, $0.0001 par value | | PHGE | | NYSE American |
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes
☒ No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
| Emerging growth company | ☐ |
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The number of shares outstanding of the Registrant’s shares of
Common Stock as of November 12, 2024 was 18,176,602.
BIOMX INC.
FORM 10-Q FOR THE QUARTER ENDED SEPTEMBER 30,
2024
TABLE OF CONTENTS
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING
INFORMATION
This Quarterly Report on Form
10-Q, or the Quarterly Report, includes “forward-looking statements” within the meaning of the Private Securities Litigation
Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange
Act of 1934, as amended, or the Exchange Act, and other securities laws. The statements contained herein that are not purely historical,
are forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions,
assumptions and other statements that are not historical facts. Words or phrases such as “anticipate,” “believe,”
“continue,” “estimate,” “expect,” “intend,” “may,” “ongoing,”
“plan,” “potential,” “predict,” “project,” “will” or similar words or phrases,
or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily
mean that a statement is not forward-looking. For example, we are making forward-looking statements when we discuss our business strategy
and plans, our clinical and pre-clinical development program, including timing, milestones and the design thereof, including acceptance
of regulatory agencies of such design, the potential opportunities for and benefits of the BacteriOphage Lead to Treatment, or BOLT, platform,
the potential of our product candidates and the sufficiency of financial resources and financial needs and ability to continue as a going
concern. However, you should understand that these statements are not guarantees of performance or results, and there are a number of
risks, uncertainties and other important factors that could cause our actual results to differ materially from those expressed in the
forward-looking statements, including, among others:
|
● |
the ability to generate revenues, and raise sufficient financing to meet working capital requirements; |
|
● |
the integration of the operations of Adaptive Phage Therapeutics LLC, a Delaware limited liability company, or APT, into the Company; |
|
● |
the unpredictable timing and cost associated with our approach to developing product candidates using phage technology; |
|
● |
political, economic and military instability in the State of Israel, and in particular, the war in Gaza and Lebanon, additional potential conflicts with other middle eastern countries and the continuation of the proposed judicial and other legislation reform by the Israeli government; |
|
● |
political and economic instability, including, without limitation, due to natural disasters or other catastrophic events, such as the Russian invasion of Ukraine and world sanctions on Russia, Belarus, and related parties, terrorist attacks, hurricanes, fire, floods, pollution and earthquakes; |
|
● |
obtaining U.S. Food and Drug Administration, or FDA, acceptance of any non-U.S. clinical trials of product candidates; |
|
● |
our ability to enroll patients in clinical trials and achieve anticipated development milestones when expected; |
|
● |
the ability to pursue and effectively develop new product opportunities and acquisitions and to obtain value from such product opportunities and acquisitions; |
|
● |
penalties and market withdrawal associated with any unanticipated problems with product candidates and failure to comply with labeling and other restrictions; |
|
● |
general economic conditions, our current low stock price and other factors on our operations, the continuity of our business, including our preclinical and clinical trials, and our ability to raise additional capital; |
|
|
|
|
● |
expenses associated with compliance with ongoing regulatory obligations and successful continuing regulatory review; |
|
● |
market acceptance of our product candidates and ability to identify or discover additional product candidates; |
|
● |
our ability to obtain high titers for specific phage cocktails necessary for preclinical and clinical testing; |
|
● |
the availability of specialty raw materials and global supply chain challenges; |
|
● |
the ability of our product candidates to demonstrate requisite, safety and efficacy for drug products, or safety, purity and potency for biologics without causing adverse effects; |
|
● |
the success of expected future advanced clinical trials of our product candidates; |
|
● |
our ability to obtain required regulatory approvals; |
|
● |
our ability to maintain compliance with the continued listing standards of the NYSE American; |
|
● |
delays in developing manufacturing processes for our product candidates; |
|
● |
competition from similar technologies, products that are more effective, safer or more affordable than our product candidates or products that obtain marketing approval before our product candidates; |
|
● |
the impact of unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives on our ability to sell product candidates or therapies profitably; |
|
● |
protection of our intellectual property rights and compliance with the terms and conditions of current and future licenses with third parties; |
|
● |
infringement on the intellectual property rights of third parties and claims for remuneration or royalties for assigned service invention rights; |
|
● |
our ability to acquire, in-license or use proprietary rights held by third parties necessary to our product candidates or future development candidates; |
|
● |
ethical, legal and social concerns about synthetic biology and genetic engineering that may adversely affect market acceptance of our product candidates; |
|
● |
reliance on third-party collaborators; |
|
● |
our ability to attract and retain key employees or to enforce the terms of noncompetition agreements with employees; |
|
● |
the failure to comply with applicable laws and regulations other than drug manufacturing compliance; and |
|
● |
potential security breaches, including cybersecurity incidents. |
For a detailed discussion
of these and other risks, uncertainties and factors, see Part I, Item 1A “Risk Factors” of our Annual Report on Form 10-K
for the year ended December 31, 2023 and Part II, Item 1A “Risk Factors” of our Quarterly Report on Form 10-Q for the quarter
ended June 30, 2024 and of this Quarterly Report. All forward-looking statements contained in this Quarterly Report speak only as of the
date hereof. Except as required by law, we are under no duty to (and expressly disclaim any such obligation to) update or revise any of
the forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this Quarterly Report.
Comparisons of results between current and prior periods are not intended to express any future trends, or indications of future performance,
and should be viewed only as historical data.
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
INDEX TO FINANCIAL STATEMENTS
BIOMX INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(USD in thousands, except share and per share data)
(unaudited)
| |
As of | |
| |
September 30, 2024 | | |
December 31, 2023 | |
ASSETS | |
| | |
| |
| |
| | |
| |
Current assets | |
| | |
| |
| |
| | |
| |
Cash and cash equivalents | |
| 23,537 | | |
| 14,907 | |
Restricted cash | |
| 1,114 | | |
| 957 | |
Other current assets | |
| 3,665 | | |
| 1,768 | |
Total current assets | |
| 28,316 | | |
| 17,632 | |
| |
| | | |
| | |
Non-current assets | |
| | | |
| | |
Other assets | |
| 96 | | |
| - | |
Operating lease right-of-use assets | |
| 9,700 | | |
| 3,495 | |
Property and equipment, net | |
| 6,581 | | |
| 3,902 | |
In-process Research and development (“IPR&D”) assets | |
| 15,287 | | |
| - | |
Total non-current assets | |
| 31,664 | | |
| 7,397 | |
| |
| 59,980 | | |
| 25,029 | |
The accompanying notes are an integral part
of these unaudited condensed consolidated financial statements.
BIOMX INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(USD in thousands, except share and per share data)
(unaudited)
| |
As of | |
| |
September 30, 2024 | | |
December 31, 2023 | |
| |
| | |
| |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | |
| |
| |
| | |
| |
Current liabilities | |
| | |
| |
Trade accounts payable | |
| 2,779 | | |
| 1,381 | |
Current portion of lease liabilities | |
| 1,096 | | |
| 666 | |
Other accounts payable | |
| 5,069 | | |
| 3,344 | |
Current portion of long-term debt | |
| - | | |
| 5,785 | |
Total current liabilities | |
| 8,944 | | |
| 11,176 | |
| |
| | | |
| | |
Non-current liabilities | |
| | | |
| | |
Contract liability | |
| - | | |
| 1,976 | |
Long-term debt, net of current portion | |
| - | | |
| 5,402 | |
Operating lease liabilities, net of current portion | |
| 8,651 | | |
| 3,239 | |
Other liabilities | |
| 161 | | |
| 155 | |
Private Placement Warrants | |
| 4,328 | | |
| - | |
Total non-current liabilities | |
| 13,140 | | |
| 10,772 | |
| |
| | | |
| | |
Commitments and Contingencies (Note 7) | |
| | | |
| | |
| |
| | | |
| | |
Stockholders’ equity | |
| | | |
| | |
| |
| | | |
| | |
Preferred Stock, $0.0001 par value; Authorized – 1,000,000 shares as of September 30, 2024 and December 31, 2023. Issued and outstanding- 147,735 as of September 30, 2024. No shares issued and outstanding as of December 31, 2023. | |
| 18,645 | | |
| - | |
Common Stock, $0.0001 par value; Authorized – 750,000,000 shares as of September 30, 2024 and 120,000,000 shares as of December 31, 2023. Issued and outstanding- 18,176,602 shares as of September 30, 2024 and 4,723,320 shares as of December 31, 2023. (*) | |
| 6 | | |
| 3 | |
| |
| | | |
| | |
Additional paid in capital | |
| 185,429 | | |
| 166,048 | |
Accumulated deficit | |
| (166,184 | ) | |
| (162,970 | ) |
Total stockholders’ equity | |
| 37,896 | | |
| 3,081 | |
| |
| 59,980 | | |
| 25,029 | |
The accompanying notes are an integral part
of these unaudited condensed consolidated financial statements.
BIOMX INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(USD in thousands, except share and per share data)
(unaudited)
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Research and development (“R&D”) expenses, net | |
| 7,279 | | |
| 5,641 | | |
| 18,281 | | |
| 14,023 | |
General and administrative expenses | |
| 3,248 | | |
| 2,154 | | |
| 8,756 | | |
| 6,053 | |
Goodwill impairment | |
| 801 | | |
| - | | |
| 801 | | |
| - | |
Operating loss | |
| 11,328 | | |
| 7,795 | | |
| 27,838 | | |
| 20,076 | |
| |
| | | |
| | | |
| | | |
| | |
Other income | |
| (84 | ) | |
| (89 | ) | |
| (2,189 | ) | |
| (270 | ) |
Interest expenses | |
| 5 | | |
| 574 | | |
| 868 | | |
| 1,884 | |
Income from change in fair value of Private Placement Warrants | |
| (20,559 | ) | |
| - | | |
| (24,417 | ) | |
| - | |
Finance expense (income), net | |
| (332 | ) | |
| (382 | ) | |
| 1,104 | | |
| (1,034 | ) |
Loss (income) before tax | |
| (9,642 | ) | |
| 7,898 | | |
| 3,204 | | |
| 20,656 | |
| |
| | | |
| | | |
| | | |
| | |
Tax expenses | |
| - | | |
| 8 | | |
| 10 | | |
| 22 | |
| |
| | | |
| | | |
| | | |
| | |
Net loss (income) | |
| (9,642 | ) | |
| 7,906 | | |
| 3,214 | | |
| 20,678 | |
| |
| | | |
| | | |
| | | |
| | |
Basic loss (earnings) per share of Common Stock (*) | |
| (0.31 | ) | |
| 1.30 | | |
| 0.32 | | |
| 4.29 | |
Diluted loss (earnings) per share of Common Stock (*) | |
| (0.31 | ) | |
| 1.30 | | |
| 2.45 | | |
| 4.29 | |
| |
| | | |
| | | |
| | | |
| | |
Weighted average number of shares used in computing basic loss (earnings) per share of Common Stock | |
| 16,366,122 | | |
| 6,058,774 | | |
| 9,944,267 | | |
| 4,819,658 | |
Weighted average number of shares used in computing diluted
loss (earnings) per share of Common Stock | |
| 16,387,633 | | |
| 6,058,774 | | |
| 11,294,880 | | |
| 4,819,658 | |
The accompanying notes are an integral part
of these unaudited condensed consolidated financial statements.
BIOMX INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
REDEEMABLE CONVERTIBLE
PREFERRED SHARES AND IN STOCKHOLDERS’ EQUITY
(CAPITAL DEFICIENCY)
(USD in thousands, except share and per share data)
(unaudited)
| |
Redeemable
Convertible
Preferred
Shares | |
| |
Redeemable
Convertible
Preferred
Shares | | |
Common Stock
(****) | | |
Additional
Paid-in | | |
Accumulated | | |
Total
Stockholders’
Equity
(Capital | |
| |
Shares | | |
Amount | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Deficiency) | |
Balance as of January 1, 2024 | |
| - | | |
| - | |
| |
| - | | |
| - | | |
| 4,723,320 | | |
| 3 | | |
| 166,048 | | |
| (162,970 | ) | |
| 3,081 | |
| |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of Common Stock, Merger Warrants and Redeemable Convertible Preferred Shares upon the APT acquisition, net of issuance cost (***) | |
| 40,470 | | |
| 12,561 | |
| |
| - | | |
| - | | |
| 916,497 | | |
| 1 | | |
| 3,227 | | |
| - | | |
| 3,228 | |
Exercise of Pre-Funded Warrants into shares of Common Stock (**) | |
| | | |
| | |
| |
| - | | |
| - | | |
| 477,827 | | |
| * | | |
| 5 | | |
| - | | |
| 5 | |
Issuance of Common Stock under At the Market Sales Agreement, net of $1 issuance costs (**) | |
| | | |
| | |
| |
| - | | |
| - | | |
| 7,518 | | |
| * | | |
| 19 | | |
| - | | |
| 19 | |
Stock-based compensation expenses | |
| | | |
| | |
| |
| - | | |
| - | | |
| - | | |
| - | | |
| 909 | | |
| - | | |
| 909 | |
Issuance of Redeemable Convertible Preferred Shares upon March 2024 PIPE, net of issuance costs (**) | |
| 216,417 | | |
| 19,859 | |
| |
| - | | |
| - | | |
| - | | |
| - | | |
| 541 | | |
| | | |
| 541 | |
Net loss | |
| | | |
| | |
| |
| - | | |
| - | | |
| - | | |
| - | | |
| | | |
| (17,327 | ) | |
| (17,327 | ) |
Balance as of March 31, 2024 | |
| 256,887 | | |
| 32,420 | |
| |
| - | | |
| - | | |
| 6,125,162 | | |
| 4 | | |
| 170,749 | | |
| (180,297 | ) | |
| (9,544 | ) |
| |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Exercise of Pre-Funded Warrants into shares of Common Stock (**) | |
| | | |
| | |
| |
| - | | |
| - | | |
| 980,811 | | |
| 1 | | |
| - | | |
| - | | |
| 1 | |
Stock-based compensation expenses | |
| | | |
| | |
| |
| - | | |
| - | | |
| - | | |
| | | |
| 77 | | |
| - | | |
| 77 | |
Reclassification of Redeemable convertible preferred Shares to equity | |
| (256,887 | ) | |
| (32,420 | ) |
| |
| 256,887 | | |
| 32,420 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 32,420 | |
Net income | |
| | | |
| | |
| |
| - | | |
| - | | |
| | | |
| | | |
| | | |
| 4,471 | | |
| 4,471 | |
Balance as of June 30, 2024 | |
| - | | |
| - | |
| |
| 256,887 | | |
| 32,420 | | |
| 7,105,973 | | |
| 5 | | |
| 170,826 | | |
| (175,826 | ) | |
| 27,425 | |
| |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Redeemable Convertible Preferred Shares conversion into shares of Common Stock | |
| | | |
| | |
| |
| (109,152 | ) | |
| (13,775 | ) | |
| 10,915,200 | | |
| 1 | | |
| 13,774 | | |
| | | |
| - | |
Issuance of Common Stock upon restricted stock units (“RSU”) vesting | |
| - | | |
| - | |
| |
| | | |
| | | |
| 155,429 | | |
| * | | |
| - | | |
| - | | |
| * | |
Stock-based compensation expenses | |
| | | |
| | |
| |
| - | | |
| - | | |
| - | | |
| - | | |
| 829 | | |
| - | | |
| 829 | |
Net income | |
| | | |
| | |
| |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 9,642 | | |
| 9,642 | |
Balance as of September 30, 2024 | |
| - | | |
| - | |
| |
| 147,735 | | |
| 18,645 | | |
| 18,176,602 | | |
| 6 | | |
| 185,429 | | |
| (166,184 | ) | |
| 37,896 | |
The accompanying notes are an integral part
of these unaudited condensed consolidated financial statements.
BIOMX INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
REDEEMABLE CONVERTIBLE
PREFERRED SHARES AND IN STOCKHOLDERS’ EQUITY
(CAPITAL DEFICIENCY)
(USD in thousands, except share and per share data)
(unaudited)
| |
Common Stock (***) | | |
Additional Paid-in | | |
Accumulated | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| |
Balance as of January 1, 2023 | |
| 3,122,987 | | |
| 2 | | |
| 157,838 | | |
| (136,801 | ) | |
| 21,039 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of Common Stock and warrants under February 2023 PIPE, net of $176 issuance costs (**) | |
| 319,950 | | |
| * | | |
| 1,293 | | |
| - | | |
| 1,293 | |
Stock-based compensation expenses | |
| - | | |
| - | | |
| 175 | | |
| - | | |
| 175 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (6,361 | ) | |
| (6,361 | ) |
Balance as of March 31, 2023 | |
| 3,442,937 | | |
| 2 | | |
| 159,306 | | |
| (143,162 | ) | |
| 16,146 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of Common Stock and warrants under February 2023 PIPE, net of $157 issuance costs (**) | |
| 1,279,796 | | |
| 1 | | |
| 5,858 | | |
| | | |
| 5,859 | |
Stock-based compensation expenses | |
| - | | |
| - | | |
| 271 | | |
| | | |
| 271 | |
Net loss | |
| | | |
| | | |
| | | |
| (6,411 | ) | |
| (6,411 | ) |
Balance as of June 30, 2023 | |
| 4,722,733 | | |
| 3 | | |
| 165,435 | | |
| (149,573 | ) | |
| 15,865 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation expenses | |
| - | | |
| - | | |
| 195 | | |
| - | | |
| 195 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (7,906 | ) | |
| (7,906 | ) |
Balance as of September 30, 2023 | |
| 4,722,733 | | |
| 3 | | |
| 165,630 | | |
| (157,479 | ) | |
| 8,154 | |
(**) |
See Note 10A. |
(***) |
All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split as discussed in Note 10A. |
The accompanying notes are an integral part
of these unaudited condensed consolidated financial statements.
BIOMX INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(USD in thousands, except share and per share data)
(unaudited)
| |
For the Nine Months Ended September 30, | |
| |
2024 | | |
2023 | |
CASH FLOWS – OPERATING ACTIVITIES | |
| | |
| |
Net loss | |
| (3,214 | ) | |
| (20,678 | ) |
| |
| | | |
| | |
Adjustments required to reconcile cash flows used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 882 | | |
| 659 | |
Stock-based compensation | |
| 1,083 | | |
| 641 | |
Amortization of debt issuance costs | |
| - | | |
| 453 | |
Finance income, net | |
| (478 | ) | |
| (293 | ) |
Revaluation of contingent consideration | |
| 6 | | |
| (40 | ) |
Income from change in fair value of Private Placement Warrants | |
| (24,417 | ) | |
| - | |
Private Placement Warrants issuance cost | |
| 732 | | |
| - | |
Change in contract liability | |
| (1,976 | ) | |
| - | |
Loss from sale and disposal of fixed assets, net | |
| 145 | | |
| - | |
Goodwill impairment | |
| 801 | | |
| - | |
| |
| | | |
| | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Other current and non-current assets | |
| (213 | ) | |
| 679 | |
Trade accounts payable | |
| (2,691 | ) | |
| 241 | |
Other accounts payable | |
| (1,169 | ) | |
| 3,354 | |
Net change in operating leases | |
| (181 | ) | |
| (60 | ) |
Net cash used in operating activities | |
| (30,690 | ) | |
| (15,044 | ) |
| |
| | | |
| | |
CASH FLOWS – INVESTING ACTIVITIES | |
| | | |
| | |
Cash and restricted cash acquired from the APT acquisition | |
| 663 | | |
| - | |
Proceeds from short-term deposits | |
| - | | |
| 2,000 | |
Proceeds from sale of property and equipment | |
| 72 | | |
| - | |
Purchases of property and equipment | |
| (19 | ) | |
| (43 | ) |
Net cash provided by investing activities | |
| 716 | | |
| 1,957 | |
| |
| | | |
| | |
CASH FLOWS – FINANCING ACTIVITIES | |
| | | |
| | |
Issuance of Private Placement Warrants under March 2024 PIPE | |
| 28,745 | | |
| - | |
Issuance of Redeemable Convertible Preferred Shares under March 2024 PIPE | |
| 21,269 | | |
| - | |
March 2024 PIPE issuance costs | |
| (507 | ) | |
| - | |
Issuance costs from February 2023 PIPE | |
| - | | |
| (333 | ) |
Issuance of Common Stock and Warrants under February 2023 PIPE | |
| - | | |
| 7,485 | |
Pre-Funded Warrants exercise | |
| 6 | | |
| - | |
Issuance of Common Stock under Open Market Sales Agreement, net of issuance costs | |
| 19 | | |
| - | |
Issuance cost from the APT acquisition | |
| (13 | ) | |
| - | |
Repayment of long-term debt | |
| (10,747 | ) | |
| (2,929 | ) |
Net cash provided by financing activities | |
| 38,772 | | |
| 4,223 | |
| |
| | | |
| | |
Increase (decrease) in cash and cash equivalents and restricted cash | |
| 8,798 | | |
| (8,864 | ) |
Effect of exchange rate changes on cash and cash equivalents and restricted cash | |
| (11 | ) | |
| (37 | ) |
Cash and cash equivalents and restricted cash at the beginning of the period | |
| 15,864 | | |
| 32,294 | |
Cash and cash equivalents and restricted cash at the end of the period | |
| 24,651 | | |
| 23,393 | |
| |
| | | |
| | |
RECONCILIATION OF AMOUNTS ON CONSOLIDATED BALANCE SHEETS | |
| | | |
| | |
Cash and cash equivalents | |
| 23,537 | | |
| 22,450 | |
Restricted cash | |
| 1,114 | | |
| 943 | |
Total cash and cash equivalents and restricted cash | |
| 24,651 | | |
| 23,393 | |
| |
| | | |
| | |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: | |
| | | |
| | |
Cash paid for interest | |
| 1,437 | | |
| 1,455 | |
Taxes paid | |
| 10 | | |
| 50 | |
| |
| | | |
| | |
SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | |
| | | |
| | |
Property and equipment purchases included in accounts payable and Trade payable | |
| 11 | | |
| 5 | |
Issuance cost from March 2024 PIPE | |
| 1,685 | | |
| - | |
Issuance of Common Stock under the APT acquisition | |
| 3,041 | | |
| - | |
Issuance of Redeemable Convertible Preferred Shares under the APT acquisition | |
| 12,610 | | |
| - | |
Issuance of Merger Warrants under the APT acquisition | |
| 200 | | |
| - | |
Redeemable Convertible Preferred Shares conversion into shares of Common Stock | |
| 13,774 | | |
| - | |
The accompanying notes are an integral part
of these unaudited condensed consolidated financial statements.
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 1 – GENERAL
BiomX Inc. (individually, and together
with its subsidiaries, BiomX Ltd. (“BiomX Israel”), RondinX Ltd. and Adaptive Phage Therapeutics LLC, (“APT”),
the “Company” or “BiomX”) was incorporated in 2017. The Company’s shares of Common Stock are traded on the
NYSE American under the symbol PHGE. The Company’s units, consisting of one share of Common Stock and one warrant to purchase one-half
of a share of Common Stock (“Units”), were traded on the NYSE American under the symbol PHGE.U until a mandatory unit separation
of the units became effective on October 25, 2024. Certain warrants were quoted on OTC Pink under the symbol “PHGEW” and expired
on October 28, 2024.
BiomX is developing both natural and
engineered phage cocktails designed to target and destroy harmful bacteria in chronic diseases, focusing its efforts, at this point, on
cystic fibrosis and on diabetic foot osteomyelitis. BiomX discovers and validates proprietary bacterial targets and customizes phage compositions
against these targets. The Company’s headquarters are located in Ness Ziona, Israel.
On March 6, 2024, the Company entered
into an agreement and plan of merger (the “Merger Agreement”) with APT and certain other parties, as a result of which APT
became a wholly-owned subsidiary of the Company (the “Acquisition”), as further described below. Additionally, on March 15,
2024, concurrently with the consummation of the Acquisition, the Company consummated a private placement (the “March 2024 PIPE”)
with certain investors pursuant to which such investors purchased an aggregate of 216,417 shares of the Company’s Series X non-voting
convertible preferred share, par value $0.0001 per share (the “Redeemable Convertible Preferred Shares”), with each share
of Redeemable Convertible Preferred Shares being convertible into 100 shares of the Company’s Common Stock, after giving effect
to the Reverse Split (as defined below), and warrants (the “Private Placement Warrants”) to purchase up to an aggregate of
10,820,850 shares of the Company’s Common Stock, for aggregate gross proceeds of approximately $50,000. See Note 1D for further
information regarding the Acquisition and the conversion of the Redeemable Convertible Preferred Shares.
On August 8, 2024, the Board of Directors
approved a 1-for-10 reverse stock split of the Company’s shares of Common Stock (the “Reverse Split”), effective on
August 26, 2024. See Note 10A for further information.
|
B. |
The war with Hamas and Hezbollah |
On October 7, 2023, an unprecedented
attack was launched against Israel by terrorists from the Hamas terrorist organization that infiltrated Israel’s southern border
from the Gaza Strip and in other areas within the state of Israel attacking civilians and military targets while simultaneously launching
extensive rocket attacks on the Israeli population. These attacks resulted in extensive deaths, injuries and kidnapping of civilians and
soldiers. In response, the Security Cabinet of the State of Israel declared war against Hamas and a military campaign against these terrorist
organizations commenced in parallel to their continued rocket and terror attacks. In addition, Hezbollah, an Islamist terrorist group
that controls large portions of southern Lebanon, has attacked military and civilian targets in Northern Israel, to which Israel has responded.
Moreover, Iran recently launched a direct attack on Israel involving hundreds of drones and missiles and has threatened to continue to
attack Israel and is widely believed to be developing nuclear weapons. Iran is also believed to have a strong influence among extremist
groups in the region, such as Hamas in Gaza, Hezbollah in Lebanon, the Houthi movement in Yemen and various rebel militia groups in Syria
and Iraq. Such clashes may escalate in the future into a greater regional conflict.
To date, the State of Israel continues
to be at war with Hamas and Hezbollah and in an armed conflict with Iran and its rebel militia groups.
BiomX headquarters are located in Ness
Ziona, Israel; as well as most of its operations. In addition, most of the key employees and officers are residents of Israel. Accordingly,
political, economic and military conditions in Israel and the surrounding region may directly affect its business.
While a few employees of the Company
were called to reserve duty in the Israel Defense Forces, the ongoing war with Hamas and Hezbollah has not, since its inception, materially
impacted BiomX’s business or operations. Furthermore, BiomX does not expect any delays to its programs as a result of the situation.
However, at this time, it is not possible to predict the intensity or duration of Israel’s war against Hamas and Hezbollah, nor
predict how this war will ultimately affect BiomX business and operations or Israel’s economy in general.
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 1 – GENERAL (Cont.)
As of September 30, 2024, the Company has an accumulated deficit of
$166,184 and has incurred significant losses and negative cash flows from operations. These are expected to continue in the foreseeable
future. The Company plans to continue to fund its ongoing operations, as well as other development activities relating to additional product
candidates, through issuance of debt and/or equity securities, loans, and government grants. Management believes that its current funds
are not sufficient to fund its operations for at least one year from the issuance date of these financial statements. Increased research
and development, clinical, or operating expenses may require additional funding or expense postponement. The Company’s ability to
raise capital is subject to market conditions and other aspects, which may affect the terms and availability of such funding. These factors
raise substantial doubt about the Company’s ability to continue as a going concern. The unaudited condensed consolidated financial
statements have been prepared on a going concern basis and do not include any adjustments that may result from the outcome of such circumstances.
On March 6, 2024, the Company, entered
into the Merger Agreement with BTX Merger Sub I, Inc., a Delaware corporation and a wholly owned subsidiary of the Company (“First
Merger Sub”), BTX Merger Sub II, LLC, a Delaware limited liability company and wholly owned subsidiary of the Company (“Second
Merger Sub”), and APT. Pursuant to the Merger Agreement, First Merger Sub merged with and into APT, with APT being the surviving
corporation and becoming a wholly owned subsidiary of the Company (the “First Merger”). Immediately following the First Merger,
APT merged with and into Second Merger Sub, pursuant to which Second Merger Sub was the surviving entity. APT was a U.S.-based privately
held, clinical-stage biotechnology company pioneering the development of phage-based therapies to combat bacterial infection. As a result
of the Acquisition, the Company is expected to have a pipeline that includes two Phase 2 assets each aimed at treating serious infections
with unmet medical needs.
On March 15, 2024, the effective date of the Acquisition (the “Closing
Date”), APT’s former stockholders were issued an aggregate of 916,497 shares of the Company’s Common Stock, 40,470 Redeemable
Convertible Preferred Shares and Warrants to purchase up to an aggregate of 216,650 shares of the Company Common Stock (“Merger
Warrants”). Each share of Redeemable Convertible Preferred Shares is convertible into an aggregate of 100 shares, after giving effect
to the Reverse Split of Common Stock. The Merger Warrants will be exercisable at any time after the date of the receipt of BiomX
stockholder approval at an exercise price of $50.00 per share and will expire on January 28, 2027. In the event the Redeemable Convertible
Preferred Shares are not converted by the earlier to occur of (i) the time that meeting of BiomX stockholders is ultimately concluded
or (ii) five months after the initial issuance of the Redeemable Convertible Preferred Shares, the Company may be required to pay to each
holder of the Redeemable Convertible Preferred Shares an amount in cash equal to the fair value of the Redeemable Convertible Preferred
Shares. On July 9, 2024, the Company’s stockholders approved the conversion of the Redeemable Convertible Preferred Shares into
shares of Common Stock and the issuance of shares of Common Stock upon the exercise of the Merger Warrants.
The Redeemable Convertible Preferred
Shares are entitled to receive dividends on shares of the Redeemable Convertible Preferred Shares equal to, on an as-if-converted-to Common-Stock
basis, and in the same form as, dividends actually paid on shares of the Common Stock. Except as otherwise required by law or with respect
to the Redeemable Convertible Preferred Shares protective provisions set forth in the Company’s Certificate of Designations, the
Redeemable Convertible Preferred Shares does not have voting rights.
At the Closing Date, the Redeemable Convertible Preferred Shares were
classified as temporary equity in accordance with the provisions of ASC 480-10-S99, as they included clauses that could constitute redemption
clauses that were subject to the Company’s stockholder approval and outside of the Company’s control. On June 17, 2024, the
Company filed a definitive Proxy Statement on Schedule 14A with respect to a meeting of stockholders to approve, among other things, the
conversion of the Redeemable Convertible Preferred Shares into shares of Common Stock. In addition, the majority of the Company’s
stockholders signed a binding support agreement that contained their commitment to vote in favor or deliver a written consent regarding
any stockholders’ matter in the stockholders’ meeting which took place on July 9, 2024. These circumstances led the Company
to determine that the Redeemable Convertible Preferred Shares meet the definition of permanent equity as the Company is able to control
the redemption. Therefore, the Redeemable Convertible Preferred Shares were reclassified as equity. On July 15, 2024, 109,152 Redeemable
Convertible Preferred Shares that were issued under the Acquisition and the March 2024 PIPE were converted into 10,915,200 shares of the
Company’s Common Stock according to beneficial ownership limitations set by certain investors.
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 1 – GENERAL (Cont.)
The Merger Warrants are classified
as equity, as they are indexed to the Company’s own shares and meet the classification requirements for stockholders’ equity
classification under ASC 815-40.
Concurrently with the consummation
of the Acquisition, the Company entered into a securities purchase agreement with certain investors, for aggregate gross proceeds of $50,000.
See Note 10A for further information.
Immediately following the Acquisition,
and without taking into account the PIPE Preferred Shares and the Private Placement Warrants as defined and described in Note 10A, the
Company’s stockholders prior to the Acquisition owned approximately 55% of the Company and APT’s stockholders prior to the
Acquisition owned approximately 45% of the Company on a diluted basis.
The Acquisition was accounted for in
accordance with Accounting Standards Codification (“ASC”) Topic 805, “Business Combinations,” using the acquisition
method of accounting. The Company was identified as the accounting acquirer, based on the evaluation of the following facts and circumstances:
|
● |
Pursuant to the Merger Agreement, the post-Acquisition board of directors of the Company consisted of seven directors, out of which the Company designated four board seats, with the Company’s chair of the board prior to the Acquisition continuing in his position, i.e. the majority of the post-closing board was designated by the Company. |
|
● |
The Chief Executive Officer and the majority of management roles are held by individuals who were affiliated with the Company prior to the Acquisition. |
The Acquisition-related transaction
costs are accounted for as expenses in the period in which the costs are incurred. The Company incurred transaction costs of $874 during
the nine months ended September 30, 2024, which were included in general and administrative expenses in the condensed consolidated statements
of operations.
Purchase Price Allocation
The following sets forth the fair value
of acquired identifiable assets and assumed liabilities of APT, after considering measurement period adjustment as described
below, which includes adjustments to reflect the fair value of intangible assets acquired as of March 15, 2024:
| |
Amounts | |
Cash and cash equivalents | |
| 509 | |
Restricted cash | |
| 154 | |
Other current assets | |
| 1,780 | |
Property, plant and equipment | |
| 3,748 | |
Operating lease right-of-use asset | |
| 7,953 | |
IPR&D assets and Goodwill | |
| 16,088 | |
Total assets | |
| 30,232 | |
| |
| | |
Trade accounts payable | |
| (3,667 | ) |
Other accounts payable | |
| (2,895 | ) |
Operating lease liability | |
| (7,819 | ) |
Total liabilities | |
| (14,381 | ) |
Total consideration | |
| 15,851 | |
The fair value estimate for all identifiable
assets and liabilities assumed is based on assumptions that market participants would use in pricing an asset, based on the most advantageous
market for the asset (i.e., its highest and best use).
The Company recognized intangible assets
related to the Acquisition, which consist of IPR&D valued at $15,287 using the Multi-Period Excess Earnings Method valuation method
and of goodwill valued at $501. The goodwill is primarily attributed to the expected synergies from combining the operations of APT with
the Company’s operations and to the assembled workforce of APT. The IPR&D is considered indefinite lived until the completion
or abandonment of the associated research and development efforts. Upon successful completion of the project, IPR&D assets are reclassified
to developed technology and amortized over their estimated useful lives
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 1 – GENERAL (Cont.)
During the three months ended September
30, 2024, the Company made measurement period adjustment to the purchase price allocation, which resulted in an increase to goodwill of
$300. The increase resulted from a provision for a contingency not provided in the initial Purchase Price Allocation, following a
term sheet for a settlement agreement between APT and Oyster Point Pharma, Inc. (“Oyster”) in connection with the Collaboration
and Option Agreement signed in May 2021 as discussed in Note 7A. The fair value of assets acquired and liabilities assumed have been finalized.
During the three months ended September 30, 2024, the Company recorded goodwill impairment in the amount of $801. See note 12 for further
information.
These intangible assets are classified
as Level 3 measurements within the fair value hierarchy.
The following table summarizes the
fair value of the consideration transferred to APT shareholders for the Acquisition:
| |
Amounts | |
Common Stock | |
| 3,041 | |
Redeemable Convertible Preferred Shares | |
| 12,610 | |
Merger Warrants | |
| 200 | |
| |
| 15,851 | |
The fair value of shares of Common
Stock issued by the Company was determined using the Company’s closing trading price on the Closing Date adjusted by a discount
for lack of marketability (“DLOM”) of 9.4% as a registration statement was filed within 45 days. The fair value of Redeemable
Convertible Preferred Shares was determined using the Company’s closing trading price on the Closing Date adjusted by a DLOM of
14.9% as the conversion of the Redeemable Convertible Preferred Shares to shares of Common Stock was subject to the stockholder approval,
which was obtained on July 9, 2024. The Company determined the fair value of the Merger Warrants using the Black-Scholes model as of the
Closing Date. The main assumptions used are as follows:
Underlying value of Common Stock ($) | |
| 0.37 | |
Exercise price ($) | |
| 5.0 | |
Expected volatility (%) | |
| 117.7 | |
Expected terms (years) | |
| 2.87 | |
Risk-free interest rate (%) | |
| 4.5 | |
The actual APT net loss included in
the Company’s condensed consolidated statements of operations for the nine months ended September 30, 2024, is as follows:
| |
September 30, 2024 | |
Net loss attributable to APT | |
| 5,884 | |
The unaudited pro forma financial information
below summarizes the combined results of operations for BiomX Inc. (including its wholly owned subsidiaries, BiomX Ltd. and RondinX Ltd.)
and APT. The unaudited pro forma financial information includes adjustments to reflect certain business combination effects, including:
acquisition-related costs incurred by both parties and reversal of certain costs incurred by BiomX Inc. which would not have been incurred
had the acquisition occurred on January 1, 2023. The unaudited pro forma financial information as presented below is for informational
purposes only and is not necessarily indicative of the results of operations that would have been achieved if the Acquisition had taken
place at the beginning of fiscal 2023.
The following unaudited table provides
certain pro forma financial information for the Company as if the Acquisition occurred on January 1, 2023:
| |
September 30, 2024* | |
Net loss | |
| 2,698 | |
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES
| A. | Unaudited Condensed Financial Statements |
The accompanying unaudited condensed
consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”)
for condensed financial information. They do not include all the information and footnotes required by GAAP for complete financial statements.
In the opinion of management, all adjustments considered necessary for a fair statement have been included (consisting only of normal
recurring adjustments except as otherwise discussed).
The financial information contained
in this report should be read in conjunction with the annual financial statements included in the Company’s Annual Report on Form
10-K for the fiscal year ended December 31, 2023, that the Company filed with the U.S. Securities and Exchange Commission (the “SEC”)
on April 4, 2024. The year-end balance sheet data was derived from the audited consolidated financial statements as of December 31, 2023.
| B. | Principles of Consolidation |
The condensed consolidated financial
statements include the accounts of the Company and its subsidiaries. Intercompany balances and transactions have been eliminated upon
consolidation.
| C. | Use of Estimates in the Preparation of Financial Statements |
The preparation of financial statements in conformity with GAAP requires
management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets
and liabilities in the financial statements and the amounts of expenses during the reported years. The most significant estimates in the
Company’s financial statements relate to accruals for research and development expenses, valuation of stock-based compensation awards,
purchase price allocation related to the Acquisition and the Private Placement Warrants fair value revaluation; estimates used in the
IPR&D impairment assessment for calculating the fair value of the Company’s assets by using discounted cash flow incorporate
the Company’s estimated post-tax weighted average cost of capital, amounts and timing of projected future cash flows that are influenced
by the expected outcome of research and development activities, the probability of success and timing in gaining regulatory approval,
size of the potential market and the Company’s specific market share. These estimates and assumptions are based on current facts,
future expectations, and various other factors believed to be reasonable under the circumstances, the results of which form the basis
for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from
other sources. Actual results may differ materially and adversely from these estimates.
The full extent to which Israel’s
war with Hamas and Hezbollah may directly or indirectly impact the Company’s business, results of operations and financial condition
will depend on future developments that are uncertain, as well as the economic impact on local, regional, national and international markets.
The Company allocates the fair value
of consideration transferred in a business combination to the assets acquired, liabilities assumed based on their fair values at the acquisition
date. Acquisition-related expenses are recognized separately from the business combination and are expensed as incurred. The excess of
the fair value of the consideration transferred over the fair value of the assets acquired, liabilities assumed in the acquired business
is recorded as goodwill. The fair value of the consideration transferred included equity securities. The allocation of the consideration
transferred in certain cases may be subject to revision based on the final determination of fair values during the measurement period,
which may be up to one year from the acquisition date. The cumulative impact of revisions during the measurement period is recognized
in the reporting period in which the revisions are identified. The Company includes the results of operations of the businesses that it
has acquired in its consolidated results prospectively from the respective dates of Acquisition.
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES (Cont.)
When the Company issues freestanding
instruments, it first analyzes the provisions of ASC 480, “Distinguishing Liabilities From Equity” (“ASC 480”)
in order to determine whether the instrument should be classified as a liability, with subsequent changes in fair value recognized in
the consolidated statements of operations in each period. If the instrument is not within the scope of ASC 480, the Company further analyzes
the provisions of ASC 815-10 in order to determine whether the instrument is considered indexed to the entity’s own stock and qualifies
for classification within equity.
When the Company issues preferred shares,
it first considers the provisions of ASC 480, in order to determine whether the preferred shares should be classified as a liability.
If the instrument is not within the scope of ASC 480, the Company further analyzes the instrument’s characteristics in order to
determine whether it should be classified within temporary equity (mezzanine) or within permanent equity in accordance with the provisions
of ASC 480-10-S99. The Company reassesses the classification of a contract over its own equity under the guidance above at each balance
sheet date. If classification changes as a result of events during the reporting period, the Company reclassifies the contract as of the
date of the event that caused the reclassification. See Note 1D regarding the reclassification of the Redeemable Convertible Preferred
Shares.
When the Company issues warrants, it
first considers the provisions of ASC 815-40, “Contracts in Entity’s Own Equity” (“ASC 815-40”) in order
to determine whether the warrants should be classified as equity. Equity classification is permitted when warrants are indexed to the
Company’s own shares and meet the classification requirements for stockholders’ equity classification under ASC 815-40. If
the warrants are not within the scope of ASC 815-40, the Company accounts for the warrants in accordance with the guidance contained in
Accounting Standards Codification 815 (“ASC 815”), “Derivatives and Hedging”, under which the warrants do not
meet the criteria for equity treatment and must be recorded as derivative liabilities. Accordingly, the Company classifies the Private
Placement Warrants as liabilities at their fair value and adjusts the warrants to fair value at each reporting period. This liability
is subject to re-measurement at each balance sheet date until the warrants are exercised or expire, and any change in fair value is recognized
in the condensed consolidated statements of operations. See Note 10A for further information regarding the Private Placement Warrants.
| F. | Basic and diluted loss (earnings) per share |
Basic loss (earnings) per share is
computed by dividing net loss (income) by the weighted average number of shares of Common Stock outstanding during the period, fully vested
warrants with no exercise price for the Company’s Common Stock and fully vested Pre-Funded Warrants for the Company’s Common
Stock at an exercise price of $0.001 per share, as the Company considers these shares to be exercised for little to no additional consideration.
The calculation excludes shares of Common Stock purchased by the Company and held as treasury shares. Diluted loss (income) per share
is computed by dividing net loss by the weighted average number of shares of Common Stock outstanding during the period, plus the number
of shares of Common Stock that would have been outstanding if all potentially dilutive shares of Common Stock had been issued, using the
treasury stock and if-converted method, in accordance with ASC 260-10, “Earnings per Share.”
The Company computes net loss (income)
per share using the two-class method required for participating securities. The two-class method requires income available to common stockholders
for the period to be allocated between shares of Common Stock and participating securities based upon their respective rights to receive
dividends as if all income for the period had been distributed. The Company considers its Redeemable Convertible Preferred Shares to be
participating securities as the holders of the Redeemable Convertible Preferred Shares would be entitled to dividends that would be distributed
to the holders of Common Stock, on a pro-rata basis assuming conversion of all Redeemable Convertible Preferred Shares into shares of
Common Stock. These participating securities do not contractually require the holders of such shares to participate in the Company’s
losses. As such, net loss for the periods presented was not allocated to the Company’s participating securities.
Goodwill
Goodwill reflects the excess of the
consideration transferred at the business combination date over the fair values of the identifiable net assets acquired. Goodwill is an
asset representing the future economic benefits arising from other assets acquired in a business combination that are not individually
identified and separately recognized. The primary items that generate goodwill include the value of the synergies between the acquired
company and the Company and the acquired assembled workforce, neither of which qualifies for recognition as an intangible asset. ASC 350,
“Intangibles—Goodwill and Other” allows an entity to first assess qualitative factors to determine whether a
quantitative goodwill impairment test is necessary. Further testing is only required if the entity determines, based on the qualitative
assessment, that it is more likely than not that the fair value is less than its carrying amount. Otherwise, no further impairment testing
is required.
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES (Cont.)
The Company’s goodwill is tested
for impairment at least on an annual basis, on the last day of the third quarter of the fiscal year and whenever events or changes in
circumstances indicate the carrying value of a reporting unit may not be recoverable. When necessary, the Company records charges for
impairments of goodwill for the amount by which the carrying amount of the respective reporting unit exceeds its fair value. However,
the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. During the three months ended September
30, 2024, the Company recorded goodwill impairment in the amount of $801. See note 12 for further information.
Intangible assets
IPR&D assets acquired in a business combination are recognized
at fair value as of the acquisition date and subsequently accounted for as indefinite-lived intangible assets until completion or abandonment
of the associated R&D efforts. Indefinite-lived intangible assets are reviewed for impairment at least annually, on the last day of
the third quarter of the fiscal year or whenever there is an indication that the asset may be impaired.
| H. | Recent Accounting Standards |
Recently issued accounting pronouncements,
not yet adopted
In December 2023, the Financial Accounting
Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-09 “Income Taxes (Topic 740): Improvements
to Income Tax Disclosures” (“ASU 2023-09”). This guidance is intended to enhance the transparency and decision-usefulness
of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily through
changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S. and in foreign jurisdictions. ASU 2023-09 is
effective for fiscal years beginning after December 15, 2024 on a prospective basis, with the option to apply the standard retrospectively.
Early adoption is permitted. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated
financial statements disclosures.
In November 2023, the FASB issued ASU
2023-07 “Segment Reporting: Improvements to Reportable Segment Disclosures” (“ASU 2023-07”). This guidance expands
public entities’ segment disclosures primarily by requiring disclosure of significant segment expenses that are regularly provided
to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of
its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets that are currently
required annually. Public entities with a single reportable segment are required to provide the new disclosures and all the disclosures
required under ASC 280, “Segment Reporting”. The guidance is effective for fiscal years beginning after December 15, 2023,
and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The amendments are required
to be applied retrospectively to all prior periods presented in an entity’s financial statements. The Company is currently evaluating
this guidance to determine the impact it may have on its consolidated financial statements disclosures.
NOTE 3 – FAIR VALUE OF FINANCIAL INSTRUMENTS
The Company accounts for financial
instruments in accordance with ASC 820, “Fair Value Measurements and Disclosures” (“ASC 820”). ASC 820 establishes
a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest
priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority
to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy under ASC 820 are described below:
Level 1 – Unadjusted quoted prices
in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities.
Level 2 – Quoted prices in non-active
markets or in active markets for similar assets or liabilities, observable inputs other than quoted prices, and inputs that are not directly
observable but are corroborated by observable market data.
Level 3 – Prices or valuations
that require inputs that are both significant to the fair value measurement and unobservable.
There were no changes in the fair value
hierarchy levelling during the nine months ended September 30, 2024 and year ended December 31, 2023.
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 3 – FAIR VALUE OF FINANCIAL INSTRUMENTS (Cont.)
The following table summarizes the
fair value of our financial assets and liabilities that were accounted for at fair value on a recurring basis, by level within the fair
value hierarchy:
| |
September 30, 2024 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Fair Value | |
Assets: | |
| | |
| | |
| | |
| |
Cash equivalents: | |
| | |
| | |
| | |
| |
Money market funds | |
| 20,325 | | |
| - | | |
| - | | |
| 20,325 | |
Foreign exchange contracts receivable | |
| - | | |
| 15 | | |
| - | | |
| 15 | |
| |
| 20,325 | | |
| 15 | | |
| - | | |
| 20,340 | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Contingent consideration | |
| - | | |
| - | | |
| 161 | | |
| 161 | |
Private Placement Warrants | |
| - | | |
| - | | |
| 4,328 | | |
| 4,328 | |
| |
| - | | |
| - | | |
| 4,489 | | |
| 4,489 | |
| |
December 31, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Fair Value | |
Assets: | |
| | |
| | |
| | |
| |
Cash equivalents: | |
| | |
| | |
| | |
| |
Money market funds | |
| 11,377 | | |
| - | | |
| - | | |
| 11,377 | |
Foreign exchange contracts receivable | |
| | | |
| 256 | | |
| - | | |
| 256 | |
| |
| 11,377 | | |
| 256 | | |
| - | | |
| 11,633 | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Contingent consideration | |
| - | | |
| - | | |
| 155 | | |
| 155 | |
| |
| - | | |
| - | | |
| 155 | | |
| 155 | |
The changes in the fair value of the
Company’s Level 3 financial liabilities, which are measured on a recurring basis are as follows:
| |
Nine Months Ended September 30, 2024 | | |
Nine Months Ended September 30, 2023 | |
Beginning balance | |
- | | |
- | |
Private Placement Warrants | |
| 28,745 | | |
| - | |
Change in fair value | |
| (24,417 | ) | |
| - | |
Ending balance | |
| 4,328 | | |
| - | |
Financial instruments with carrying
values approximating fair value include cash and cash equivalents, restricted cash, short-term deposits, other current assets, trade accounts
payable and other accounts payable, due to their short-term nature.
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 3 – FAIR VALUE OF FINANCIAL INSTRUMENTS
(Cont.)
The Company determined the fair value
of the liabilities for the contingent consideration based on a probability of discounted cash flow analysis. This fair value measurement
is based on significant unobservable inputs in the market and thus represents a Level 3 measurement within the fair value hierarchy. The
fair value of the contingent consideration is based on several factors, such as: the attainment of future clinical, developmental, regulatory,
commercial and strategic milestones relating to product candidates for treatment of primary sclerosing cholangitis. The discount rate
applied ranged from 3.84% to 4.52%. The contingent consideration is evaluated quarterly, or more frequently, if circumstances dictate.
Changes in the fair value of contingent consideration are recorded in consolidated statements of operations. Significant changes in unobservable
inputs, mainly the probability of success and cash flows projected, could result in material changes to the contingent consideration liability.
Changes in contingent consideration for the nine and three months ended September 30, 2024 and September 30, 2023, resulted from the passage
of time and discount rate revaluation.
The Company uses foreign exchange contracts
(mainly option and forward contracts) to hedge cash flows from currency exposure. These foreign exchange contracts are not designated
as hedging instruments for accounting purposes. In connection with these foreign exchange contracts, the Company recognizes gains or losses
that offset the revaluation of the cash flows also recorded under financial expenses (income), net in the condensed consolidated statements
of operations. As of September 30, 2024, the Company had outstanding foreign exchange contracts for the exchange of USD to NIS in the
amount of approximately $3,410 with a fair value asset of $15. As of December 31, 2023, the Company had outstanding foreign exchange contracts
for the exchange of USD to NIS in the amount of approximately $4,136 with a fair value asset of $256.
The Company determined the fair value
of the liabilities for the Private Placement Warrants using the Black-Scholes model, a Level 3 measurement, within the fair value hierarchy.
The main assumptions used are as follows:
| |
September 30, 2024 | | |
December 31, 2023 | |
Underlying value of Common Stock ($) | |
| 1.02 | | |
| - | |
Exercise price ($) | |
| 2.31 | | |
| - | |
Expected volatility (%) | |
| 117.6 | | |
| - | |
Expected terms (years) | |
| 1.75 | | |
| - | |
Risk-free interest rate (%) | |
| 3.6 | | |
| - | |
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 4 – OTHER CURRENT ASSETS
| |
September 30,
2024 | | |
December 31, 2023 | |
Government institutions | |
| 84 | | |
| 66 | |
Prepaid insurance | |
| 1,165 | | |
| 505 | |
Other prepaid expenses | |
| 574 | | |
| 128 | |
Grants receivable | |
| 950 | | |
| 574 | |
Other | |
| 892 | | |
| 495 | |
Other current assets | |
| 3,665 | | |
| 1,768 | |
NOTE 5 – OTHER ACCOUNTS PAYABLE
| |
September 30,
2024 | | |
December 31, 2023 | |
Employees and related institutions | |
| 956 | | |
| 1,852 | |
Accrued expenses | |
| 3,421 | | |
| 1,289 | |
Government institutions | |
| 622 | | |
| 175 | |
Prepaid sublease income | |
| - | | |
| 28 | |
Severance related to former employees of APT | |
| 70 | | |
| - | |
| |
| 5,069 | | |
| 3,344 | |
NOTE 6 – LEASES
On August 9, 2019, APT entered into
a lease agreement (the “Lease Agreement”) with ARE-708 Quince Orchard, LLC (the “Landlord”), for office and lab
spaces in Gaithersburg, Maryland starting on September 1, 2019. Over the course of years, APT and the Landlord amended the Lease Agreement
in order to expand the square footage and to extend the lease period until November 28, 2034. The agreement included 49,625 square feet
of area. The monthly lease payments under the lease agreement were approximately $255. On March 5, 2024, in connection with the Acquisition,
APT and the Landlord, signed an amendment to the lease agreement. Pursuant to the amendment, the leased area will be decreased to 25,894
square feet (the “Remaining Area”), effective as of December 31, 2024. Following the amendment, the revised monthly lease
payments are approximately $134. In exchange, APT was required to pay a relinquished premises fee in an amount equal to $1,500 within
10 business days following March 15, 2024 (the “Amendment Effective Date”). In addition, the Company issued the Landlord warrants
(the “Landlord Warrants”) to purchase up to an aggregate of 25,000 shares of the Company’s Common Stock at an exercise
price of $50.00 per share. The Landlord Warrants became exercisable from the date of the receipt of BiomX stockholder approval, which
was obtained on July 9, 2024, and will expire on January 28, 2027. The amendment also included a one-time option to early terminate the
lease agreement on February 28, 2029 with respect to the Remaining Area under certain terms. The execution of the early termination will
require APT to pay a termination fee of $3,000.
APT accounted for the decreased leased
area and the termination option as a modification as it continues to use the area for a period of time after the termination. The modification
occurred before the Acquisition as APT signed the amendment before the Closing Date but was contingent upon the Acquisition. The operating
lease right-of-use assets and operating lease liabilities contemplate the termination option.
Lease expenses recorded in the condensed
statements of operations were $2,543 and $995 for the nine and three months ended September 30, 2024, respectively, and $488 and $161
for the nine and three months ended September 30, 2023, respectively.
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 7 – COMMITMENTS AND CONTINGENCIES
| A. | In May 2021, APT entered into a Collaboration and Option Agreement
(the “Oyster Agreement”) with Oyster, a wholly owned subsidiary of Viatris Inc., to collaborate on the use of APT’s
proprietary phage technology for the treatment of certain ophthalmic diseases. Upon execution of the Agreement, Oyster paid an upfront
payment of $500 to APT, a portion of which APT claims it has spent in the course of performing its obligations under the Oyster Agreement.
In April 2022 and September 2023, APT received letters from Oyster and Viatris Inc. raising concerns about APT’s actions, including
allegations that APT had breached the Oyster Agreement. APT and Oyster have agreed to settle their dispute related to the Oyster Agreement,
including the allegations described in the letters, and to terminate the Oyster Agreement under a term sheet (the “Term Sheet”).
Under the terms of the Term Sheet, APT and Oyster will sign a final settlement agreement, which will include a payment of $300 from APT
to Oyster. As of September 30, 2024, the final settlement agreement had not yet been signed. The Company has recorded a provision of $300
as other accounts payable in the condensed consolidated balance sheets. |
| | |
| B. | In August 2021, the Israeli Innovation Authority (“IIA”) approved an application that supports upgrading the Company’s manufacturing capabilities for an aggregate budget of NIS 5,737 (approximately $1,778). The IIA committed to fund 50% of the approved budget. The program was for the period beginning July 2021 through June 2022. The program does not bear royalties. Through September 30, 2024, the Company received NIS 1,912 (approximately $577) from the IIA with respect to this program. In March 2022, the IIA approved an application for a total budget of NIS 13,004 (approximately $4,094) in relation to the Company’s cystic fibrosis product candidate. The IIA committed to fund 30% of the approved budget. The program was for the period beginning January 2022 through December 2022. Through September 30, 2024, the Company received NIS 1,365 (approximately $395) from the IIA with respect to this program. In March 2023, the IIA approved an application for a total budget of NIS 11,283 (approximately $3,164) in relation to the Company’s cystic fibrosis product candidate. The IIA committed to fund 30% of the approved budget. The program was for the period beginning January 2023 through December 2023. Through September 30, 2024, the Company received NIS 2,783 (approximately $768) from the IIA with respect to this program. |
According to the agreement with the IIA, excluding the August 2021 program, BiomX Israel will pay royalties of 3% to 3.5% of future sales up to an amount equal to the accumulated grant received including annual interest of LIBOR linked to the USD. Starting January 2024, the IIA has notified that the interest has changed to the 12-month Secured Overnight Financing Rate (“SOFR”) as published on the first trading day of each calendar year. BiomX Israel may be required to pay additional royalties upon the occurrence of certain events as determined by the IIA, that are within the control of BiomX Israel. No such events have occurred or were probable of occurrence as of the balance sheet date with respect to these royalties. Repayment of the grant is contingent upon the successful completion of the BiomX Israel’s R&D programs and generating sales. BiomX Israel has no obligation to repay these grants if the R&D program fails, is unsuccessful or aborted or if no sales are generated. The Company had not yet generated sales as of September 30, 2024; therefore, no liability was recorded in these condensed consolidated financial statements. IIA grants are recorded as a reduction of R&D expenses, net. Through September 30, 2024, total grants approved from the IIA aggregated to approximately $9,353 (NIS 32,068). Through September 30, 2024, the Company had received an aggregate amount of $8,003 (NIS 27,423) in the form of grants from the IIA. Total grants subject to royalties’ payments aggregated to approximately $7,413. As of September 30, 2024, BiomX Israel had a contingent obligation to the IIA in the amount of approximately $8,250 including annual interest of SOFR applicable to dollar deposits. |
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 7 – COMMITMENTS AND CONTINGENCIES (Cont.)
| C. | On June 23, 2022, BiomX Israel entered into a research collaboration agreement with Boehringer Ingelheim International GmbH (“BI”) for a collaboration to identify biomarkers for Inflammatory Bowel Disease. Under the agreement, BiomX Israel is eligible to receive fees totaling $1,411 to cover costs to be incurred by BiomX Israel in conducting the research plan under the collaboration. The fees were paid in four installments according to certain activities under the agreement. In December 2023, the Company completed its obligations with respect to this agreement and the last installment of $211 was received on January 18, 2024. The consideration was recorded as a reduction of R&D expenses, net in the condensed consolidated statements of operations according to the input model method on a cost-to-cost basis. |
NOTE 8 - U.S. GOVERNMENT CONTRACTS AND GRANTS
In 2019, APT entered into a Base Agreement
and Research Project Award (collectively, the “Agreement”) with the U.S. Army Medical Research Acquisition Activity (“USAMRAA”)
and the U.S. Army Medical Research & Development Command (“USAMRDC”) to advance personalized phage therapy from niche
to broad use. Awards under the Agreement are intended to lay the groundwork for rapid advancement of personalized phage therapy to commercialization
for the variety of clinical indications and bacterial pathogens representing un-met needs with a focus on infections with significant
military relevance. The competitive award was granted by USAMRAA and USAMRDC in collaboration with the Medical Technology Enterprise Consortium
(“MTEC”), a 501(c)(3) biomedical technology consortium working in partnership with the U.S. Department of Defense. Since Agreement
inception, APT entered into certain modifications to the Agreement to include additional activities and perform pre-clinical activities
to advance the Diabetic Foot Osteomyelitis (“DFO”) clinical program. Under the Agreement, MTEC reimburses APT for approved
costs as incurred that are based upon the achievement of certain milestones up to a contract value of $36,214. In September 2024, the
Agreement was amended to extend the period of performance to continue and complete the pre-clinical activities for the DFO clinical program,
which increased the total contract value to $39,081. In conjunction with this Agreement, APT is subject to an assessment fee of an amount
equal up to 3% of the total funded value of the research project award which should be paid by the Company upon signing the agreement
or the modifications. For the period between the Acquisition and September 30, 2024, the Company received grants of $2,895 from MTEC with
respect to the cost reimbursement contract. During the nine and three months ended September 30, 2024, the Company recorded $1,802 and
$849 as a reduction of R&D expenses, net, respectively. The remainder of the consideration the Company is entitled to receive is recorded
as other current assets in the condensed consolidated financial statements. See Note 14B for information regarding grants received subsequent
to the financial statement date.
NOTE 9 – LONG-TERM DEBT
On August 16, 2021 (the “Closing
Date”), the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with Hercules Capital, Inc. (“Hercules”),
with respect to a venture debt facility. Under the Loan Agreement, $15,000 was advanced to the Company on the date the Loan Agreement
was executed. The Company was required to make interest only payments through March 1, 2023, and started to then repay the principal balance
and interest in equal monthly installments through September 1, 2025.
The Loan Agreement provided that the
Company could prepay advances under the Loan Agreement, in whole or in part, at any time subject to a prepayment charge equal to 1.0%
after 24 months but prior to 36 months following the Closing Date. Upon prepayment or repayment of all or any of the term loans under
the Term Loan Facility, the Company was required to pay an end of term charge (“End of Term Charge”) equal to 6.55% of the
total aggregate amount of the term loans being prepaid or repaid. On March 19, 2024, the Company prepaid the entire balance under the
Term Loan Facility in a total of $10,428. The prepayment included the End of Term Charge of $983 and accrued interest of $69. The Company
received from Hercules a waiver regarding the prepayment charge that should have been 1% out of the prepaid principal amount that equals
to $94.
Interest expense relating to the term
loan, which is included in interest expense in the condensed statements of operations was $850 for the nine months ended September 30,
2024. No interest expense was recognized in connection with the term loan for the three months ended September 30, 2024. Interest expense
for the nine and three months ended September 30, 2023, was $1,884 and $574, respectively.
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 10 – STOCKHOLDERS EQUITY
| A. | Share Capital: Reverse Stock Split: On July 9, 2024, the Company’s stockholders approved a reverse stock split at a ratio within a range of 1-for-5 and 1-for-10 at such time as the Board of Directors shall determine, in its sole discretion, at any time before July 9, 2025. On August 8, 2024, the Board of Directors approved a 1-for-10 Reverse Stock Split of the Company’s shares of Common Stock (the “Reverse Stock Split”). On August 20, 2024, the Company filed the Certificate of Amendment
with the Delaware Secretary of State to effect the Reverse Stock Split, which became effective on August 26, 2024 (the “Effective
Date”). The Company’s Common Stock began trading on a Reverse Stock Split adjusted basis on the NYSE American at the opening
of the markets on the Effective Date. As a result of the Reverse Stock Split, the number of shares of Common Stock outstanding was reduced from 178,958,447 shares to 18,021,173 shares. No fractional shares of Common Stock or Units were issued in connection with the Reverse Stock Split. Stockholders of the Company who otherwise were entitled to receive fractional shares or Units, because they held a number of shares or Units, as applicable, not evenly divisible by the Reverse Stock Split ratio were automatically entitled to receive an additional fraction of a share of the Common Stock or Unit, as applicable, to round up to the next whole share. As a result, 125,328 shares of Common Stock were issued. The Reverse Stock Split did not change the par value of the Common Stock nor the authorized number of shares of Common Stock, preferred stock or any series of preferred stock. Unless otherwise indicated, all amounts of issued and outstanding stock contained in the accompanying condensed consolidated financial statements have been adjusted to reflect the 1-for-10 Reverse Stock Split for all prior periods presented. Proportional adjustments were also made to shares underlying outstanding equity awards, warrants and Redeemable Convertible Preferred Shares, and to the number of shares issued and issuable under the Company’s stock incentive plans and certain existing agreements. Authorized shares of common stock: On July 9, 2024, the Company’s stockholders approved increasing the number of authorized shares of Common Stock from 120,000,000 shares, par value $0.0001 per share, to 750,000,000 shares, par value $0.0001 per share. Preferred Stock: The Company is authorized to issue 1,000,000 shares of preferred stock with a par value of $0.0001 per share with such designation, rights and preferences as may be determined from time to time by the Company’s Board of Directors (the “Board”). On March 15, 2024, the Company issued 40,470 and 216,417 Redeemable
Convertible Preferred Shares, par value $0.0001 per share, as part of the Acquisition and the March 2024 PIPE, respectively. On July 15,
2024, 109,152 Redeemable Convertible Preferred Shares were converted into 10,915,200 shares of the Company’s Common Stock. |
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 10 – STOCKHOLDERS EQUITY (Cont.)
Private Investment in Public Equity:
On February 22, 2023, the Company entered
into a Securities Purchase Agreement to issue and sell an aggregate of 1,599,746 shares of its Common Stock and 1,461,072 pre-funded warrants
(the “Pre-Funded Warrants”) at a price of $2.45 per share and $2.44 per Pre-Funded Warrant in a private placement (the “February
2023 PIPE”). The net proceeds from the PIPE were approximately $7,152, after deducting issuance costs of $333. During the nine months
ended September 30, 2024, 533,031 Pre-Funded Warrants were exercised into 533,031 shares of Common Stock for total consideration of $6
at an exercise price of $0.01 per share of Common Stock, and 928,041 Pre-Funded Warrants were exercised into 925,607 shares of Common
Stock through cashless mechanism with no consideration. As of September 30, 2024, there are no outstanding Pre-Funded Warrants.
On March 15, 2024, in connection with
the Acquisition, the Company issued to APT’s former stockholders 916,497 shares of the Company’s Common Stock, 40,470 Redeemable
Convertible Preferred Shares and Merger Warrants to purchase up to an aggregate of 216,650 shares of the Company Common Stock. See Note
1D for further information.
Concurrently with the consummation of
the Acquisition as described in Note 1D, the Company entered into the March 2024 PIPE, pursuant to which such investors purchased an aggregate
of 216,417 Redeemable Convertible Preferred Shares (“PIPE Preferred Shares”) and Private Placement Warrants to purchase up
to an aggregate of 10,820,850 shares of the Company’s Common Stock, at a combined price of $231.10 per share. The PIPE Preferred
Shares and the Private Placement Warrants were issued in a private placement pursuant to an exemption from registration requirements under
the Securities Act for aggregate gross proceeds of $50,000. Each Private Placement Warrant’s exercise price equals to $2.31, subject
to customary adjustments for stock dividends, stock splits, reclassifications and the like, became exercisable from the date of the receipt
of BiomX stockholder approval, which was obtained on July 9, 2024, and will expire on July 9, 2026. Under certain circumstances, the Company
may be required to pay to each holder of the Private Placement Warrants (i) an amount in cash equal to the holder’s total purchase
price for the shares of Common Stock purchased (the “Buy-In Price”) or credit such holder’s balance account with the
Depository Trust Company (“DTC”) for such shares of Common Stock shall terminate, or (ii) promptly honor its obligation to
deliver to such holder a certificate or certificates representing such shares of Common Stock or credit such holder’s balance account
with DTC, as applicable, and pay cash to such holder in an amount equal to the excess (if any) of the Buy-In Price over the product of
(A) such number of shares of Common Stock, times (B) Weighted Average Price (as defined in the Private Placement Warrant) on the trading
day immediately preceding the exercise date.
The Company accounted for the Private
Placement Warrants as liabilities as the Private Placement Warrants are not considered indexed to the entity’s own stock based on
the provision of ASC 815. The Private Placement Warrants will be measured at fair value at inception and in subsequent reporting periods
with changes in fair value recognized in the condensed consolidated statements.
The terms of the PIPE Preferred Shares
are substantially the same as those of the Redeemable Convertible Preferred Shares issued under the Acquisition and were accounted for
as temporary equity at the issuance date and were reclassified as equity. See Note 1D for further information. On July 15, 2024, 109,152
Redeemable Convertible Preferred Shares that were issued under the Acquisition and the March 2024 PIPE were converted into 10,915,200
shares of the Company’s Common Stock according to beneficial ownership limitations set by certain investors.
In connection therewith, the Company issued
warrants to purchase shares of the Company’s Common Stock to the Placement Agents (the “Agents Warrants”). See Note
10B for further information.
The Company allocated the total consideration
from the issuance of the 2024 March PIPE first to the fair value of the Private Placement Warrants and then to the PIPE Preferred Shares.
The Company had transaction costs of approximately $3,317 out of which $1,273 is Stock-Based Compensation due to issuance of the Agents
Warrants. The transaction costs were allocated in the same manner as the consideration. Issuance costs which were allocated to the PIPE
Preferred Shares were $1,410 and deducted from Redeemable Convertible Preferred Shares, and issuance costs that were allocated to the
Private Placement Warrants were $1,907 and were expensed immediately.
At-the-Market
Sales Agreement:
In December 2023, pursuant to a registration
statement on Form S-3 declared effective by the SEC on January 2, 2024, the Company entered an At the Market Offering Agreement with H.C.
Wainwright & Co., LLC (“Wainwright”), pursuant to which the Company may issue and sell shares of Common Stock having an
aggregate offering price of up to $7,500 from time to time through Wainwright. During the nine months ended September 30, 2024, the Company
sold 7,518 shares of Common Stock under this agreement, at an average price of $2.71 per share, raising aggregate net proceeds of approximately
$19, after deducting an aggregate commission of $1.
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 10 – STOCKHOLDERS EQUITY (Cont.)
Warrants:
As of September 30, 2024, the Company
had the following outstanding warrants to purchase Common Stock issued to stockholders:
Warrant | | Issuance Date | | Expiration Date | | Exercise Price Per Share | | | Number of Shares of Common Stock Underlying Warrants | |
Public Warrants | | IPO (December 13, 2018) | | October 28, 2024 | | | 115.00 | | | | 350,000 | |
2021 Registered Direct Offering Warrants | | SPA (July 28, 2021) | | January 28, 2027 | | | 50.00 | | | | 281,251 | |
Merger Warrants | | March 15, 2024 | | January 28, 2027 | | | 50.00 | | | | 216,650 | |
Private Placement Warrants | | March 15, 2024 | | July 9, 2026 | | | 2.31 | | | | 10,820,850 | |
Agents Warrants | | March 15, 2024 | | July 9, 2026 | | | 2.31 | | | | 952,381 | |
| | | | | | | | | | | 12,621,132 | |
|
B. |
Stock-based Compensation: |
On March 15, 2024, the Company issued Agents Warrants to purchase up
to an aggregate of 952,381 shares of the Company’s Common Stock to the Placement Agents in connection with the March 2024 PIPE.
The exercise price of the Agents Warrants is $2.31 per share and they became exercisable at any time after the date of the receipt of
BiomX stockholder approval, which was obtained on July 9, 2024, and will expire on July 9, 2026.
The Company accounted for the Agents Warrants
under the scope of ASC 718-10 “Stock-Based Payment”, (“ASC 718-10”), and treated them as issuance costs of the
March 2024 PIPE as the Company considers these Warrants as consideration for receipt of Private Placement Services.
The Company determined the fair value
of the Agents Warrants using the Black-Scholes model as of March 5, 2024. The main assumptions used are as follows:
Underlying value of Common Stock ($) | | | 2.31 | |
Exercise price ($) | | | 2.31 | |
Expected volatility (%) | | | 100.6 | |
Expected terms (years) | | | 2.32 | |
Risk-free interest rate (%) | | | 4.4 | |
On July 9, 2024, the Company’s stockholders
approved increasing the number of shares of Common Stock under the Company’s 2019 Omnibus Long-Term Incentive Plan (the “2019
Plan”) to be equal to 15% of the total number of fully-diluted shares of Common Stock outstanding as of the approval date, or 7,800,000
shares.
On September 16, 2024, the Company granted
155,429 RSUs to four senior officers and one service provider. The RSUs were fully vested and issued on the grant date and are not subject
to continued service to the Company. The RSUs’ fair value is the Company’s stock closing price as of the grant date, which
was $0.99. As of September 30, 2024, the Company has no unvested RSUs.
On July 11, 2024, the Board of Directors
approved the grant of 1,567,795 options to 51 employees, six senior officers and seven directors under the 2019 Plan, without consideration.
Options were granted at an exercise price of $3.63 per share with a vesting period of four years. Directors and senior officers are entitled
to full acceleration of their unvested options upon the occurrence of both a change in control of the Company and the end of their engagement
with the Company.
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 10 – STOCKHOLDERS EQUITY (Cont.)
| A summary of options granted to purchase the Company’s Common Stock under the Company’s share option plans is as follows: |
| | For the Nine Months Ended September 30, 2024 | |
| | Number of Options | | | Weighted Average Exercise Price | | | Aggregate Intrinsic Value | |
Outstanding at the beginning of period | | | 528,112 | | | | 5.41 | | | | 72 | |
Granted | | | 1,567,795 | | | | 3.63 | | | | | |
Forfeited | | | (26,808 | ) | | | 3.96 | | | | | |
Expired | | | (6,449 | ) | | | 4.58 | | | | | |
Exercised | | | - | | | | - | | | | | |
Outstanding at the end of period | | | 2,062,650 | | | | 4.08 | | | | 22 | |
Exercisable at the end of period | | | 351,109 | | | | 5.79 | | | | | |
Weighted average remaining contractual life of outstanding options – years as of September 30, 2024 | | | 8.85 | | | | | | | | | |
Warrants:
As of September 30, 2024, the Company
had the following outstanding compensation related warrants to purchase Common Stock:
Warrant | | Issuance Date | | Expiration Date | | | Exercise Price Per Share | | | Number of Shares of Common Stock Underlying Warrants | |
Private Warrants issued to scientific founders | | November 27, 2017 | | | - | | | | - | | | | 298 | |
Landlord Warrants* | | March 15, 2024 | | | January 28, 2027 | | | | 50.00 | | | | 25,000 | |
| | | | | | | | | | | | | 25,298 | |
| The following table sets forth the total stock-based payment expenses resulting from options granted, included in the statements of operations: |
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development expenses, net | |
| 273 | | |
| 31 | | |
| 336 | | |
| 202 | |
General and administrative | |
| 556 | | |
| 164 | | |
| 747 | | |
| 439 | |
| |
| 829 | | |
| 195 | | |
| 1,083 | | |
| 641 | |
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 11 – BASIC AND DILUTED LOSS (EARNINGS) PER SHARE
Basic loss (earnings) per share is
computed on the basis of the net loss (income) for the period divided by the weighted average number of shares of Common Stock outstanding
during the period, fully vested warrants with no exercise price for the Company’s Common Stock and fully vested Pre-Funded Warrants
for the Company’s Common Stock at an exercise price of $0.001 per share, as the Company considers these shares to be exercised for
little to no additional consideration.
Diluted loss per share is based upon
the weighted average number of shares of Common Stock and of potential shares of Common Stock outstanding when dilutive. Potential shares
of Common Stock equivalents include outstanding stock options and warrants, which are included under the treasury stock method when dilutive.
The calculation of diluted loss per
share for the nine and three months ended September 30, 2024 and September 30, 2023, does not include the shares underlying
the following financial instruments because their effect would be anti-dilutive:
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Options | |
| 2,041,139 | | |
| 591,034 | | |
| 2,062,650 | | |
| 591,034 | |
Warrants | |
| 12,646,132 | | |
| 921,251 | | |
| 1,825,281 | | |
| 921,251 | |
Contingent shares | |
| 200,000 | | |
| 400,000 | | |
| 200,000 | | |
| 400,000 | |
Redeemable Convertible Preferred Shares | |
| 14,773,500 | | |
| - | | |
| 14,773,500 | | |
| - | |
The following table presents the computation
of basic and diluted loss (earnings) per share:
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Basic loss (earnings) per share of common stock | |
| | |
| | |
| | |
| |
Numerator: | |
| | |
| | |
| | |
| |
Net loss (income) | |
| (9,642 | ) | |
| 7,906 | | |
| 3,214 | | |
| 20,678 | |
Amount allocated to Redeemable Convertible Preferred Shares | |
| (4,575 | ) | |
| - | | |
| - | | |
| - | |
Net loss (income) attributable to shares of common stock | |
| (5,067 | ) | |
| 7,906 | | |
| 3,214 | | |
| 20,678 | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Number of shares of common stock outstanding | |
| 16,365,824 | | |
| 4,597,403 | | |
| 9,943,968 | | |
| 3,951,624 | |
Number of shares upon Pre-Funded Warrants exercise | |
| - | | |
| 1,461,073 | | |
| - | | |
| 867,736 | |
Number of shares upon Fully vested Warrants exercise | |
| 298 | | |
| 298 | | |
| 298 | | |
| 298 | |
Total weighted-average number of shares of common stock, shares upon Pre-Funded Warrants and Fully vested Warrants exercise used in computing basic loss (earnings) per share | |
| 16,366,122 | | |
| 6,058,774 | | |
| 9,944,267 | | |
| 4,819,658 | |
Basic loss (earnings) per share of common stock | |
| (0.31 | ) | |
| 1.30 | | |
| 0.32 | | |
| 4.29 | |
| |
| | | |
| | | |
| | | |
| | |
Diluted net loss per share of common stock | |
| | | |
| | | |
| | | |
| | |
Numerator: | |
| | | |
| | | |
| | | |
| | |
Net loss (income) | |
| (9,642 | ) | |
| 7,906 | | |
| 3,214 | | |
| 20,678 | |
Change in fair value of Private Placement Warrants | |
| - | | |
| - | | |
| 24,417 | | |
| - | |
Diluted net loss | |
| (9,642 | ) | |
| 7,906 | | |
| 27,631 | | |
| 20,678 | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted-average number of shares of common stock outstanding | |
| 16,366,122 | | |
| 6,058,774 | | |
| 9,944,267 | | |
| 4,819,658 | |
Private Placement Warrants | |
| - | | |
| - | | |
| 1,350,613 | | |
| - | |
Options | |
| 21,511 | | |
| - | | |
| - | | |
| - | |
Total weighted-average number of shares of common stock outstanding, after giving effect to dilutive securities | |
| 16,387,633 | | |
| 6,058,774 | | |
| 11,294,880 | | |
| 4,819,658 | |
Diluted net loss per share of common stock | |
| (0.31 | ) | |
| 1.30 | | |
| 2.45 | | |
| 4.29 | |
BIOMX
INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(USD and NIS in thousands, except share and per
share data)
(unaudited)
NOTE 12 – GOODWILL
Following the APT Acquisition, the Company
recognized goodwill valued at $801 after adjustment made during the measurement period as described in Note 1D above. In the third quarter
of 2024, the Company experienced a decline in its stock price resulting in its market capitalization being less than the Company’s
stockholders’ equity. Thus, the Company performed quantitative assessments of the Company’s goodwill. The assessments utilizes
the Company’s market capitalization plus an appropriate control premium. Market capitalization is determined by multiplying the
outstanding number of shares of Common Stock by the Company’s stock price. The control premium is determined by utilizing publicly
available data from studies for similar transactions of public companies. As a result of this assessment, the Company recorded a goodwill
impairment of $801 during the three and nine months ended September 30, 2024.
NOTE 13 – EVENTS DURING THE PERIOD
In October 2021, the Company entered into
a Stock Purchase Agreement with a subsidiary of Maruho Co. Ltd., (“Maruho”), pursuant to which the Company issued to Maruho
shares of Common Stock of the Company and granted Maruho a right of first offer to license its atopic dermatitis product candidate, BX005,
in Japan. The right of first offer was supposed to commence following the availability of results from the Phase 1/2 study which were
expected in 2022. Part of the consideration paid under the agreements, equal to the grant date fair value of the shares issued to Maruho
was attributed to the issuance of shares. The remainder of $1,976 was attributed to a contract liability, to be recognized as other income,
at a point in time, once the clinical trials related to the product candidate are completed. In April 2024, following the Acquisition,
the Company decided to pause the development of BX005. As a result, the parties agreed that the right of first offer to license BX005
is no longer applicable. As a result, the Company reversed the full amount of the contract liability and recognized $1,976 as Other Income
in the condensed consolidated statements of operations.
NOTE 14 – SUBSEQUENT EVENTS
| a. | On October 15, 2024, the Company announced that effective October 25, 2024, the Company’s Units
will be mandatorily separated and the Units will no longer trade on the NYSE American. In the separation, Unit-holders received shares
of Common Stock and warrants underlying their units, which warrants expired on October 28, 2024. The Common Stock continues to trade on
the NYSE American under the symbol “PHGE” with the other existing shares of the Company’s Common Stock. |
| b. | On October 17, 2024, the Company received a payment of $600 from MTEC in connection with the Agreement
for reimbursement of approved costs. See Note 8 for further information. |
Item 2. Management’s Discussion and Analysis
of Financial Condition and Results of Operations
References in this Quarterly
Report to “the Company”, “BiomX”, “we”, “us” or “our”, mean BiomX Inc. and
its consolidated subsidiaries unless otherwise expressly stated or the context indicates otherwise.
The following discussion and
analysis of our financial condition and results of operations should be read in conjunction with our financial statements and the notes
thereto contained elsewhere in this Quarterly Report. The analysis of the financial condition and results of operations includes Adaptive
Phage Therapeutics LLC, a Delaware limited liability company (formerly Adaptive Phage Therapeutics Inc., a Delaware corporation), or APT,
from the date that we acquired it on March 15, 2024. Certain information contained in the discussion and analysis set forth below includes
forward-looking statements that involve risks and uncertainties. Our actual results may differ materially from those discussed in any
forward-looking statement because of various factors discussed in this Quarterly Report and in our other filings with the U.S. Securities
and Exchange Commission, or the SEC.
General
We are a clinical stage product
discovery company developing products using both natural and engineered phage technologies designed to target and kill specific harmful
bacteria associated with chronic diseases, such as cystic fibrosis, or CF and diabetic foot osteomyelitis, or DFO. Bacteriophage or phage
are bacterial, species-specific, strain-limited viruses that infect, amplify and kill the target bacteria and are considered inert to
mammalian cells. By utilizing proprietary combinations of naturally occurring phage and by creating novel phage using synthetic biology,
we develop phage-based therapies intended to address both large-market and orphan diseases.
Based on the urgency of treating
the infection (whether acute or chronic), the susceptibility of the target bacteria to phage (e.g. the ability to identify a phage cocktail
that would target a broad range of bacterial strains) and other considerations, we offer two phage-based product types:
| (1) | Fixed
cocktail therapy – in this approach a single product containing a fixed number of selected phage is developed to cover a wide range
of bacterial strains, thus allowing treatment of broad patient populations with the same product. Fixed cocktails are developed using
our proprietary BOLT platform, in which high throughput screening, directed evolution, and bioinformatic approaches are leveraged to
produce an optimal phage cocktail. |
|
(2) |
Personalized therapy – in this approach a large library of phage is developed, of which a single optimal phage is personally matched to treat specific patients. Matching optimal phage with patients is carried out using a proprietary phage susceptibility testing, where multiple considerations are analyzed simultaneously – allowing for an efficient screen of the phage library while maintaining short turnaround times. |
In our therapeutic programs,
we focus on using phage therapy to target specific strains of pathogenic bacteria that are associated with diseases. Our phage-based product
candidates are developed utilizing our proprietary research and development platform named BOLT. The BOLT platform is unique, employing
cutting edge methodologies and capabilities across disciplines including computational biology, microbiology, synthetic engineering of
phage and their production bacterial hosts, bioanalytical assay development, manufacturing and formulation, to allow agile and efficient
development of natural or engineered phage combinations, or cocktails. The cocktail contains phage with complementary features and is
optimized for multiple characteristics such as broad target host range, ability to prevent resistance, biofilm penetration, stability
and ease of manufacturing.
Our goal is to develop multiple
products based on the ability of phage to precisely target harmful bacteria and on our ability to screen, identify and combine different
phage, both naturally occurring and created using synthetic engineering, to develop these treatments.
On March 6, 2024, we entered
into a merger agreement with APT and certain other parties, as a result of which APT became our wholly-owned subsidiary, effective as
of March 15, 2024, or the Acquisition. The Acquisition was structured as a stock-for-stock transaction whereby all outstanding equity
interests of APT were exchanged in a merger for an aggregate of 9,164,968 shares of BiomX common stock, 40,470 shares of Series X Preferred
Stock, or Redeemable Convertible Preferred Shares, convertible upon stockholder approval into 4,047,000 shares of BiomX common stock,
and warrants, or the Merger Warrants, exercisable for 216,650 shares of BiomX common stock. Upon the consummation of the Acquisition,
a successor-in-interest of APT became a wholly-owned subsidiary of BiomX. The Merger Warrants are exercisable at any time after July 9,
2024 at an exercise price of $50.00 per share and will expire on January 28, 2027.
Concurrently with the consummation
of the Acquisition, we entered into a securities purchase agreement, or the March 2024 PIPE, with certain investors, pursuant to which
such investors purchased an aggregate of 216,417 Redeemable Convertible Preferred Shares and warrants to purchase up to an aggregate of
10,820,850 shares of Common Stock, or the Private Placement Warrants, for aggregate gross proceeds of approximately $50 million.
Immediately following the
Acquisition, and without taking into account the Redeemable Convertible Preferred Shares issued in the March 2024 PIPE, and assuming conversion
of all of the Redeemable Convertible Preferred Shares into Common Stock, our stockholders (including holders of the Pre-Funded Warrants,
as defined below) prior to the Acquisition owned approximately 55% of the share capital of the Company and APT’s stockholders prior
to the Acquisition owned approximately 45% of the share capital of the Company.
On July 9, 2024, the stockholder
approved, among other things, the conversion of 256,887 Redeemable Convertible Preferred Shares into up to 25,688,700 shares of Common
stock. Subsequently, on July 15, 2024, 109,152 Redeemable Convertible Preferred Shares were converted into 10,915,200 shares of Common
Stock according to beneficial ownership limitations set by certain investors.
On July 9, 2024, the Company’s
stockholders approved a reverse stock split at a ratio within a range of 1-for-5 and 1-for-10 at such time as the Board of
Directors shall determine, in its sole discretion, at any time before July 9, 2025. On August 8, 2024, the Board of Directors approved
a 1-for-10 Reverse Stock Split of the Company’s shares of Common Stock, or the Reverse Stock Split. On August 20, 2024, the Company
filed the Certificate of Amendment with the Delaware Secretary of State to effect the Reverse Split, which became effective on August
26, 2024, or the Effective Date. The Company’s common stock began trading on a Reverse Stock Split-adjusted basis on the NYSE American
at the open of the markets on the Effective Date. Unless otherwise indicated, all issued and outstanding shares amounts in this Quarterly
Report on Form 10-Q have been adjusted to reflect the Reverse Stock Split for all periods presented. Proportional adjustments
also were made to shares underlying outstanding equity awards, warrants and Redeemable Convertible Preferred Shares, and to the number
of shares issued and issuable under the Company’s stock incentive plans and certain existing agreements.
Clinical and Pre-Clinical Developments
Ongoing Programs
Cystic Fibrosis
BX004 is our therapeutic phage
product candidate under development for chronic pulmonary infections caused by Pseudomonas aeruginosa, or P. aeruginosa, a main
contributor to morbidity and mortality in patients with CF. Enhanced resistance to antibiotics develops, particularly in CF patients,
due to extensive drug use consisting of prolonged and repeated broad-spectrum antibiotic courses often beginning in childhood, and leading
to the appearance of multidrug-resistant strains. In preclinical in vitro studies, BX004 was shown to be active against antibiotic resistant
strains of P. aeruginosa and demonstrated the ability to penetrate biofilm, an assemblage of surface-associated microbial cells enclosed
in an extracellular polymeric substance and one of the leading causes for antibiotic resistance.
The Phase 1b/2a trial in CF
patients with chronic respiratory infections caused by P. aeruginosa. is comprised of two parts. The study design is based on recommendations
from the Cystic Fibrosis Therapeutic Development Network.
In February 2023, we
announced positive results from Part 1 of the Phase 1b/2a trial evaluating BX004. Part 1 evaluated the safety, tolerability, pharmacokinetics,
and microbiologic activity of BX004 over a 7-day ascending treatment period in nine CF patients (7 on BX004, 2 on placebo) with chronic
P. aeruginosa pulmonary infection in a single ascending dose and multiple dose design.
Results from Part 1 of the
Phase 1b/2a trial included the following findings: No safety events related to treatment with BX004 occurred; Mean P. aeruginosa colony
forming units, at Day 15 (compared to baseline): -1.42 log (BX004) vs. -0.28 log (placebo). This reduction was seen on top of standard
of care inhaled antibiotics; Phage were detected in all patients treated with BX004 during the dosing period, including in several patients
up to Day 15 (one week after end of therapy); no phage were detected in patients receiving placebo; there was no evidence of treatment-related
resistance to BX004 during or after treatment, compared to placebo; and as expected due to the short duration of treatment, there was
no detectable effect on % predicted forced expiratory volume in 1 second, or FEV1.
In November 2023, we announced
positive topline results from Part 2 of the Phase 1b/2a trial evaluating BX004. The objectives of Part 2 of the Phase 1b/2a trial were
to evaluate the safety and tolerability of BX004 in a larger number of CF patients dosed for a longer treatment duration than Part 1 of
the study. In Part 2, 34 CF patients were randomized in a 2:1 ratio with 23 CF patients receiving BX004 and 11 patients receiving placebo
via nebulization twice daily for 10 days.
Highlights from the Part 2
data of the Phase 1b/2a study included:
| ● | Study
drug was safe and well-tolerated, with no related SAEs (serious adverse events) or related APEs (acute pulmonary exacerbations) to study
drug. |
|
● |
In the BX004 arm, 3 out of 21 (14.3%) patients converted to sputum culture negative for P. aeruginosa after 10 days of treatment (including 2 patients after 4 days) compared to 0 out of 10 (0%) in the placebo arm (In patients that had quantitative colony-forming unit levels at study baseline). |
|
● |
BX004 vs. placebo showed a clinical effect in a predefined subgroup of patients with reduced baseline lung function (FEV1<70%). Difference between groups at Day 17: relative FEV1 improvement of 5.67% (change from baseline +1.46 vs. -4.21) and +8.87 points in CFQR respiratory symptom scale (change from baseline +2.52 vs. -6.35). |
In August 2023, the FDA granted
BX004 Fast Track designation for the treatment of chronic respiratory infections caused by P. aeruginosa bacterial strains in patients
with CF. In addition, in December 2023, BX004 received orphan drug designation from the FDA.
BiomX expects to initiate
a randomized, double blind, placebo-controlled, multi-center Phase 2b study in CF patients with chronic P. aeruginosa pulmonary
infections in the fourth quarter of 2024. The study is designed to enroll approximately 60 patients randomized at a 2:1 ratio to BX004
or placebo. Treatment is expected to be administered via inhalation twice daily for a duration of 8 weeks. The study is designed to monitor
the safety and tolerability of BX004 and is designed to demonstrate improvement in microbiological reduction of P. aeruginosa
burden and evaluation of effects on clinical parameters such as lung function measured by FEV1 and patient reported outcomes. During the
third quarter of 2024, we experienced manufacturing delays for BX004. As a result of these delays, study results are now expected in the
first half of 2026.
BX211 – Treatment of Diabetic Foot Osteomyelitis,
or DFO
BX211 is a personalized phage
therapy for the treatment of DFO associated with Staphylococcus aureus, or S. aureus, a bacterium associated with the development and
exacerbation of inflammation in atopic dermatitis. The personalized phage treatment tailors a specific phage selected from a proprietary
phage-bank according to the specific strain of S. aureus biopsied and isolated from each patient. DFO is a bacterial infection of the
bone that usually develops from an infected foot ulcer and is a leading cause of amputation in patients with diabetes. We believe that
scientific literature demonstrating the potential benefit in treating osteomyelitis using phage in animal models as well as numerous successful
compassionate cases using phage therapy to treat DFO patient support our approach of using phage therapy to treat DFO.
The ongoing randomized, double-blind,
placebo-controlled, multi-center Phase 2 trial investigating the safety, tolerability, and efficacy of BX211 for subjects with DFO associated
with S. aureus has finished enrollment for a randomized at a 2:1 ratio to BX211 or placebo. BX211 or placebo is designed to be administered
weekly, by topical and IV route at week 1 and by the topical route only at each of weeks 2-12. Over the 12-week treatment period, all
subjects are expected to continue to be treated in accordance with standard of care which will include antibiotic treatment as appropriate.
A first readout of study topline results is expected at week 13 evaluating healing of the wound associated with osteomyelitis, followed
by a second readout at week 52 evaluating amputation rates and resolution of osteomyelitis based on X-ray, clinical assessments, and established
biomarkers (Erythrocyte Sedimentation Rate and C-Reactive Protein). These readouts are expected in the first quarter of 2025 and the first
quarter of 2026, respectively.
Non-CF Bronchiectasis, or NCFB
Chronic P. aeruginosa infections
in NCFB patients are a main contributor to morbidity and mortality in this disease. Pending positive data of BX004 in our cystic fibrosis
Phase 2B study, we expect to look to initiate studies into NCFB as an additional indication for BX004.
National Institutes of Health, or NIH, study
in Cystic Fibrosis
We are supporting a study
conducted by the NIH and The Antibacterial Resistance Leadership Group targeting P. Aeruginosa infections in CF patients under
FDA emergency Investigational New Drug allowance. Phase 1b/2, multi-centered, randomized, double-blind, placebo-controlled trial is assessing
the safety and microbiological activity of a single IV dose of bacteriophage therapy in cystic fibrosis subjects colonized with P. aeruginosa.
Programs on hold
Prosthetic Joint Infections, or PJI
Our personalized phage therapy
for treating PJI targets multiple bacterial organisms such as Staphylococcus aureus, Staphylococcus epidermidis and Enterococcus faecium.
This treatment was granted Orphan-drug designation by the FDA in July 2020. As of the date of this Quarterly Report, we have paused development
efforts of this program due to prioritizing resources towards our CF and DFO programs, and we cannot provide guidance on resuming its
development.
Discontinued programs
BX005 – Treatment of Atopic Dermatitis,
or AD
BX005 is our topical phage
product candidate targeting S. aureus. S. aureus is more abundant on the skin of AD patients than on the skin of healthy individuals
and on lesional skin than non-lesional skin. It also increases in abundance, becoming the dominant bacteria, when patients experience
flares. By reducing the load of S. aureus, BX005 is designed to shift the skin microbiome composition to its ‘pre-flare’
state and potentially provide a clinical benefit. In preclinical in vitro studies, BX005 was shown to eradicate over 90% of strains,
including antibiotic resistant strains, from a panel of S. aureus strains (120 strains isolated from skin of subjects from the
U.S. and Europe). On April 8, 2022, the FDA approved the Company’s IND application for BX005.
In 2024, we discontinued
the development of BX005, choosing instead to focus our resources on our Cystic Fibrosis and DFO programs.
Consolidated Results of Operations
Comparison of the Three Months Ended September
30, 2024 and 2023
The following table summarizes
our consolidated results of operations for the three months ended September 30, 2024 and 2023:
| |
Three Months ended September 30, | |
| |
2024 | | |
2023 | |
| |
USD in thousands | |
Research and development (“R&D”) expenses, net | |
| 7,279 | | |
| 5,641 | |
General and administrative expenses | |
| 3,248 | | |
| 2,154 | |
Goodwill impairment | |
| 801 | | |
| - | |
Operating loss | |
| 11,328 | | |
| 7,795 | |
Other income | |
| (84 | ) | |
| (89 | ) |
Interest expenses | |
| 5 | | |
| 574 | |
Income from change in fair value of Private Placement Warrants | |
| 20,559 | ) | |
| - | |
Finance income, net | |
| (332 | ) | |
| (382 | ) |
Loss (income) before tax | |
| (9,642 | ) | |
| 7,898 | |
Tax expenses | |
| - | | |
| 8 | |
Net loss (income) | |
| 9,642 | | |
| 7,906 | |
Basic loss (income) per share of Common Stock | |
| (0.31 | ) | |
| 1.30 | |
Diluted loss (income) per share of Common Stock | |
| (0.31 | ) | |
| 1.30 | |
Weighted average number of shares of Common Stock outstanding, basic | |
| 16,366,122 | | |
| 6,058,774 | |
Weighted average number of shares of Common Stock outstanding, diluted | |
| 16,387,633 | | |
| 6,058,774 | |
R&D expenses, net (net
of grants received from the Israel Innovation Authority (“IIA”) and the Medical Technology Enterprise Consortium (“MTEC”),
and consideration from research collaborations) were $7.3 million for the three months ended September 30, 2024, compared to $5.6 million
for same period in 2023. The increase of $1.7 million, or 30%, is primarily due to the following factors:
| ● | preparations
for Phase 2b in the clinical trial of our CF product candidate, BX004, |
|
● |
an increase in expenses relating to the clinical trial of our DFO product candidate, BX211; and |
|
● |
an increase in rent and related expenses following the APT Acquisition. |
The increase was partly offset
by higher grants received. During the three months ended September 30, 2024, the Company recorded $0.9 million of MTEC grants, compared
to $0.2 million of IIA grants recorded in the same period in 2023.
General and administrative
expenses were $3.2 million for the three months ended September 30, 2024, compared to $2.2 million for the three months ended September
30, 2023. The increase of $1.0 million, or 45%, is primarily attributed to a full quarter consolidation of expenses following the Acquisition,
incorporating the combined workforce, increased professional services, and additional subcontractor expenses.
Goodwill impairment was
$0.8 million for the three months ended September 30, 2024, following an impairment of the Company’s goodwill that resulted from
the Acquisition. The Company’s market capitalization as of September 30, 2024, was lower in comparison to its stockholders’
equity and triggered an impairment assessment that concluded that the entire goodwill should be impaired.
Other income was $0.1 million
for each of the three months ended September 30, 2024 and September 30, 2023 and consisted proceeds from a sublease agreement for a portion
of our office space in Ness Ziona, Israel.
Interest expenses were $5,000
for the three months ended September 30, 2024, compared to $574,000 for the three months ended September 30, 2023. The decrease of $569,000,
or 99%, is due to repayment of the loan under the Loan and Security Agreement, or the Hercules Loan Agreement, with Hercules Capital,
Inc., or Hercules, in March 2024.
Income from change in fair
value of Private Placement Warrants reflects the revaluation that resulted from the accounting of the Private Placement Warrants issued
under the March 2024 PIPE.
There was no material change
to Finance income that impacted earnings for the three months ended September 30, 2024 compared to the three months ended September 30,
2023.
Basic and diluted earnings
per share of Common Stock was $0.31 for the three months ended September 30, 2024, compared to loss per share of $1.30 for the three months
ended September 30, 2023. The increase of $1.61 resulted from the revaluation of the Private Placement Warrants. Such increase was partly
offset due to share issuances as part of the Acquisition and the Redeemable Convertible Preferred Shares’ conversion into shares
of Common Stock.
Comparison of the Nine Months Ended September
30, 2024 and 2023
The following table summarizes
our consolidated results of operations for the nine months ended September 30, 2024 and 2023:
| |
Nine Months ended September 30, | |
| |
2024 | | |
2023 | |
| |
USD in thousands | |
R&D expenses, net | |
| 18,281 | | |
| 14,023 | |
General and administrative expenses | |
| 8,756 | | |
| 6,053 | |
Goodwill impairment | |
| 801 | | |
| - | |
Operating loss | |
| 27,838 | | |
| 20,076 | |
Other income | |
| (2,189 | ) | |
| (270 | ) |
Interest expenses | |
| 868 | | |
| 1,884 | |
Income from change in fair value of Private Placement Warrants | |
| (24,417 | ) | |
| - | |
Finance expense (income), net | |
| 1,104 | | |
| (1,034 | ) |
Loss before tax | |
| 3,204 | | |
| 20,656 | |
Tax expenses | |
| 10 | | |
| 22 | |
Net loss | |
| 2,214 | | |
| 20,678 | |
Basic loss per share of Common Stock | |
| 0.32 | | |
| 4.29 | |
Diluted loss per share of Common Stock | |
| 2.45 | | |
| 4.29 | |
Weighted average number of shares used in computing basic loss (earnings) per share of Common Stock | |
| 9,944,267 | | |
| 4,819,658 | |
Weighted average number of shares used in computing
diluted loss (earnings) per share of Common Stock | |
| 11,294,880 | | |
| 4,819,658 | |
R&D expenses, net (net
of grants received from IIA and MTEC, and consideration from research collaborations) were $18.3 million for the nine months ended September
30, 2024, compared to $14.0 million for the nine months ended September 30, 2023. The increase of $4.3 million, or 31%, is primarily due
to the following factors:
| ● | Increased
expenses relating to the clinical trial of our DFO product candidate, BX211; and |
| ● | Increased
expenses relating to the combined workforce and rent expenses following the Acquisition |
Such increase was partly offset
by completing the enrollment and follow-up period of patients in the clinical trial of our CF product candidate, BX004. During the nine
months ended September 30, 2024, the Company recorded $1.8 million of MTEC grants, compared to $1.3 million of IIA grants for the same
period in 2023.
General and administrative expenses were $8.8 million for the nine
months ended September 30, 2024, compared to $6.1 million for the same period in 2023. The increase of $2.7 million, or 44%, is primarily
due to issuance costs and legal services expenses related to the Acquisition and the March 2024 PIPE agreement. as well as due to increased
salaries and related expenses resulting from the combined workforce following the Acquisition.
Goodwill impairment was $0.8 million for the nine months ended September
30, 2024, following an impairment of the Company’s goodwill resulted from the Acquisition. The Company’s market capitalization
as of September 30, 2024, was lower in comparison to its stockholders’ equity and triggered an impairment assessment that concluded
that the entire goodwill should be impaired.
Other income was $2.2 million
for the nine months ended September 30, 2024, compared to $0.3 million for the nine months ended September 30, 2023. The increase of $1.9
million, or 633%, is primarily due to the reversion of the contract liability associated with the Company’s AD program which has
been paused.
Interest expenses were $0.9
million for the nine months ended September 30, 2024, compared to $1.9 million for the nine months ended September 30, 2023. The decrease
of $1.0 million, or 53%, is due to the repayment of the loan under the Loan and Security Agreement in March 2024.
Income from change in fair
value of Private Placement Warrants reflects the revaluation that resulted from the accounting of the Private Placement Warrants issued
under the March 2024 PIPE.
Finance expenses, net were
$1.1 million for the nine months ended September 30, 2024, compared to Finance income, net of $1.0 million for the nine months ended September
30, 2023. The increase of $2.1 million resulted mainly from the Private Placement Warrants transaction costs.
Basic loss per share of Common
Stock was $0.27 for the nine months ended September 30, 2024, compared to $4.29 for the nine months ended September 30, 2023. The decrease
in loss per share of $4.02, or 94%, is primarily attributable to an increase in outstanding shares resulting from the share issuance as
part of the Acquisition and the Redeemable Convertible Preferred Shares’ conversion into shares of Common Stock. In addition, the
income resulting from the Private Placement Warrants revaluation has led to a decreased net loss.
Diluted loss per share of
Common Stock was $2.45 for the nine months ended September 30, 2024, compared to diluted loss per share of $4.29 for the nine months ended
September 30, 2023. The decrease of $1.84 resulted from the increased number of potential shares of Common Stock that would have been
issued upon exercises of the Private Placement Warrants from the March 2024 PIPE.
Liquidity and Capital Resources
We believe our cash and cash equivalents and short-term deposits on
hand will be sufficient to meet our working capital and capital expenditure requirements into the fourth quarter of 2025. We currently
plan to continue to focus primarily on the development of BX004, our product candidate for treating CF and BX211, our product candidate
for treating DFO. Although we recently completed the 2024 March PIPE, in the future we will likely require or desire additional funds
to support our operating expenses and capital requirements. Accordingly, we are implementing cost cutting measures, and exploring and
expect to further explore, raising such additional funds through public or private equity, debt financing, loans, government or other
grants or collaborative agreements or from other sources, as well as under the 2023 ATM Agreement discussed below. If we are unable to
obtain adequate financing or financing on terms satisfactory to us, when we require it, our ability to continue to grow or support our
business and to respond to business challenges could be significantly limited. If there are increases in operating costs for facilities
expansion, research and development and clinical activity, we will need to use mitigating actions such as to seek additional financing
or postpone expenses that are not based on firm commitments. If certain disruptions due to, for instance, the war with Hamas and Hezbollah,
or Israeli political instability persists and deepens, we could experience an inability to access additional capital, which could in the
future negatively affect our capacity to support our operating expenses and capital requirements. As a result of these factors, management
believes that there is substantial doubt as to the Company’s ability to continue as a going concern.
Cash Flows
The following table summarizes
our sources and uses of cash for the nine months ended September 30, 2024 and 2023:
| |
Nine Months Ended September 30, | |
| |
2024 | | |
2023 | |
| |
USD in thousands | |
Net cash used in operating activities | |
| (30,690 | ) | |
| (15,044 | ) |
Net cash provided by investing activities | |
| 716 | | |
| 1,957 | |
Net cash provided by financing activities | |
| 38,772 | | |
| 4,223 | |
Net increase (decrease) in cash and cash equivalents | |
| 8,798 | | |
| (8,864 | ) |
Effect of exchange rate changes on cash and cash equivalents and restricted cash | |
| (11 | ) | |
| (37 | ) |
Operating Activities
Net cash used in operating
activities for the nine months ended September 30, 2024 was $30.7 million, primarily driven by our R&D, general and administrative
expenses, as well as changes in our operating assets and liabilities of $4.0 million, offset by non-cash charges of $23.5 million.
Non-cash charges for the nine months ended September 30, 2024 consisted primarily of income from change in fair value of the Private Placement
Warrants of $24.4 million and income from change in contract liability in amount of $2.0 million resulting from pausing the Company’s
AD program. Additionally, there were depreciation and amortization expenses of $0.9 million, Private Placement Warrants issuance costs
of $0.7 million and Goodwill impairment of $0.8 million. Net changes in our operating assets and liabilities consisted primarily of a
decrease in trade account payable of $2.7 million, as well as a decrease in other accounts payable of $0.9 million and a decrease in other
current and non-current assets of $0.2 million.
Net cash used in operating
activities for the nine months ended September 30, 2023 was $15.0 million primarily due to a net loss of $20.7 million, mostly due to
our R&D and general and administrative expenses, and due to changes in our operating assets and liabilities of $4.2 million, offset
by non-cash charges of $1.4 million. Non-cash charges for the nine months ended September 30, 2023 consisted primarily of depreciation
and amortization expenses of $0.7 million, stock-based compensation expenses of $0.6 million and amortization of debt issuance costs
of $0.4 million, partly offset by finance income of $0.3 million. Net changes in our operating assets and liabilities consisted primarily
of an increase in other accounts payable of $3.3 million, due to expenses related to conducting the clinical trial of our CF product
candidate, BX004, and an increase in trade account payables of $0.2 million, partially offset by a decrease in other current assets in
the amount of $0.7 million.
Investing Activities
During the nine months ended
September 30, 2024, net cash provided by investing activities was $0.7 million, mainly consisting of cash and restricted cash acquired
from the Acquisition.
During the nine months ended
September 30, 2023, net cash provided by investing activities was $2.0 million, mainly consisting of proceeds from short-term deposits
of $2.0 million.
We have invested, and plan
to continue to invest, our existing cash in short-term investments in accordance with our investment policy. These investments may include
money market funds and investment securities consisting of U.S. Treasury notes, and high quality, marketable debt instruments of corporations
and government sponsored enterprises. We use foreign exchange contracts (mainly options and forward contracts) to hedge balance sheet
items from currency exposure. These foreign exchange contracts are not designated as hedging instruments for accounting purposes. In connection
with these foreign exchange contracts, we record gains or losses that offset the revaluation of the balance sheet items under financial
income, net in our condensed consolidated statements of operations. As of September 30, 2024, we had outstanding foreign exchange
contracts for the exchange of USD to NIS in the amount of approximately $3.4 million with a fair value asset of $15,000. As of September
30, 2023, we had outstanding foreign exchange contracts for the exchange of USD to NIS in the amount of approximately $3.8 million with
a fair value of $33,000.
Financing Activities
During the nine months ended
September 30, 2024, net cash provided by financing activities was $39.0 million, mainly consisting of the issuance of Redeemable Convertible
Preferred Shares and the Private Placement Warrants in the March 2024 PIPE in the amount of $20.8 million, net of issuance costs and $28.7
million, respectively. This was partially offset by the prepayment of the long-term debt in the amount of $10.7 million under the Hercules
Loan Agreement.
During the nine months ended
September 30, 2023, net cash provided by financing activities was $4.2 million, mainly consisting of the issuance of Common Stock under
the Securities Purchase Agreement we entered into in February 2023, of $7.2 million net of issuance costs, partially offset by the repayment
of long-term debt of $2.9 million under the Hercules Loan Agreement.
Under the Hercules Loan Agreement,
Hercules provided the Company with access to a term loan with an aggregate principal amount of up to $30 million, or the Term Loan Facility,
available in three tranches, subject to certain terms and conditions. The first tranche of $15 million was advanced to us on the date
the Hercules Loan Agreement was executed. The conditions for the second and third tranches were not reached and have expired. We were
required to make interest only payments through March 1, 2023, and started to then repay the principal balance and interest in equal monthly
installments. Interest on the Hercules Loan accrues at a per annum rate equal to the greater of (i) the Prime Rate as reported in The
Wall Street Journal plus 5.70% and (ii) 8.95%. On March 19, 2024, the Company prepaid all the term loan under the Term Loan Facility in
a total of $10,428,000. The prepayment included an end of term charge of $983,000 and accrued interest of $69,000. The Company received
a waiver regarding the prepayment charge that should have been 1% out of the prepaid principal amount, equaling $94,000.
On December 7, 2023, we filed
a shelf registration statement on Form S-3, which was declared effective by the SEC on January 2, 2024. In addition, on December 7, 2023,
we entered into an At the Market Offering Agreement, or the 2023 ATM Agreement, with H.C. Wainwright & Co., LLC, or Wainwright, with
Wainwright as manager, pursuant to which we may issue and sell shares of our Common Stock having an aggregate offering price of up to
$7.5 million from time to time through Wainwright. We are not obligated to make any sales of Common Stock under the 2023 ATM Agreement.
From January 1, 2024 through November 12, 2024, we issued 7,518 shares of Common Stock pursuant to the 2023 ATM Agreement for aggregate
gross proceeds of $19 thousand.
On March 15, 2024, concurrently
with the consummation of the Acquisition, we consummated the March 2024 PIPE with existing and new investors, resulting in aggregate gross
proceeds of approximately $50 million, in which the investors purchased (i) an aggregate of 216,417 Redeemable Convertible Preferred Shares,
convertible upon stockholder approval, which was obtained on July 9, 2024, into an aggregate of up to 21,641,700 shares of BiomX common
stock, and (ii) the Private Placement Warrants, to purchase up to an aggregate of 10,820,850 shares of BiomX common stock, at a combined
purchase price of $231.10 per share of Series X Preferred Stock and an accompanying Private Placement Warrant to purchase 50 shares of
BiomX common stock. The Private Placement Warrants are exercisable at an exercise price of $2.311 per share and will expire on July 9,
2026.
During the nine months ended
September 30, 2024, 533,031 Pre-Funded Warrants were exercised into 533,031 shares of Common Stock for total consideration of $6,000 at
an exercise price of $0.01 per share of Common Stock, and 928,041 Pre-Funded Warrants were exercised into 925,607 shares of Common Stock
through cashless mechanism with no consideration. As of September 30, 2024, there are no outstanding Pre-Funded Warrants.
Outlook
We have accumulated a deficit
of $166.2 million since our inception. To date, we have not generated revenue from our operations, and we do not expect to generate any
significant revenues from sales of products in the next twelve months. Our cash needs may increase in the foreseeable future. We expect
to generate revenues from the sale of licenses to use our technology or products, but in the short and medium terms any amounts generated
are unlikely to exceed our costs of operations. According to our estimates and based on our current operating plans, our liquidity resources
as of September 30, 2024, which consisted primarily of cash, cash equivalents, short-term deposits and restricted cash of approximately
$24.7 million will be sufficient to fund our operations into the fourth quarter of 2025.
Consistent with our ongoing
R&D activities, we expect to continue to incur additional losses in the foreseeable future. To the extent we require funds above our
existing liquidity resources in the medium and long term, we plan to fund our operations, as well as other development activities relating
to additional product candidates, through future issuances of public or private equity, including under our 2023 ATM Agreement, issuance
of debt securities, loans, and possibly additional grants from the IIA or other government or non-profit institutions. Our ability to
raise additional capital in the equity and debt markets is dependent on a number of factors including, but not limited to, the market
demand for our securities, which itself is subject to a number of development and business risks and uncertainties, as well as the uncertainty
that we would be able to raise such additional capital at a price or on terms that are favorable to us.
Item 3. Quantitative and Qualitative Disclosures
About Market Risk
As a smaller reporting company,
we are not required to make disclosures under this Item.
Item 4. Controls and Procedures
We maintain disclosure controls
and procedures (as that term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) that are designed to ensure that information
required to be disclosed by us in our Exchange Act reports is recorded, processed, summarized, and reported within the time periods specified
in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal
executive officer and principal financial officer or persons performing similar functions, as appropriate to allow timely decisions regarding
required disclosure.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation
of our principal executive officer and principal financial officer, conducted an evaluation, as of the end of the period covered by this
Quarterly Report, of the effectiveness of our disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e)
under the Exchange Act. Based on this evaluation, our principal executive officer and principal financial officer have concluded that
our disclosure controls and procedures were effective as of September 30, 2024.
Changes in Internal Control over Financial
Reporting
There has been no change in
our internal control over financial reporting, as that term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, during
the quarter ended September 30, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control
over financial reporting.
PART II - OTHER INFORMATION
Item 1A. Risk Factors
In
addition to the other information set forth in this report, you should carefully consider the factors discussed in Part I, “Item
1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 and in Part II, “Item 1A.
Risk Factors” in our Quarterly Report on Form 10-Q for the second quarter ended June 30, 2024, which could materially affect our
business, financial condition or future results.
There
have been no material changes from the risk factors previously disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31,
2023, filed with the SEC on April 4, 2024, and in our Quarterly report on Form 10-Q for the quarter ended June 30, 2024, filed with the
SEC on August 14, 2024, except as noted below.
Risks Related to Our Operations in Israel
Our research and development
and other significant operations are located in Israel, and, therefore, our results may be adversely affected by political, economic and
military instability in Israel, including the recent war with Hamas, Hezbollah and other terrorist organizations in the Middle East.
Our executive offices and
research and development facilities are located in Israel. In addition, the majority of our key employees and all of our officers are
residents of Israel. Accordingly, political, geopolitical, economic and military conditions in Israel may directly affect our business.
Since the establishment of the State of Israel in 1948, several armed conflicts have taken place between Israel and its neighboring Arab
countries, the Hamas (an Islamist terrorist militia and political group that controls the Gaza strip), the Hezbollah (an Islamist terrorist
militia and political group based in Lebanon) and other terrorist organizations active in the region. These conflicts have involved missile
strikes, drone strikes, hostile infiltrations and terrorism against civilian targets in various parts of Israel, which have negatively
affected business conditions in Israel. Any hostilities involving Israel or the interruption or curtailment of trade between Israel and
its trading partners could negatively affect business conditions in Israel in general and our business in particular, and adversely affect
our product development, operations and results of operations.
In October 2023, Hamas terrorists
infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Hamas
also launched extensive rocket attacks on Israeli population and industrial centers located along Israel’s border with the Gaza
Strip and in other areas within the State of Israel. These attacks resulted in extensive deaths, injuries and kidnapping of civilians
and soldiers. Following the attack, Israel’s security cabinet declared war against Hamas and a military campaign against these terrorist
organizations commenced in parallel to their continued rocket and terror attacks. In addition, since the commencement of these events,
there have been continued hostilities along Israel’s northern border with Lebanon (with the Hezbollah terror organization) and southern
border (with the Houthi movement in Yemen, as described below). In April 2024 and September 2024, Israel experienced direct attacks from
Iran, involving hundreds of drones and missiles launched towards various parts of the country, mostly targeting military bases. The Israeli
defense systems, aided by international allies, successfully intercepted most of these attacks, minimizing physical damage and casualties.
Such incidents contribute to regional instability and could potentially escalate into broader conflicts with Iran and its proxies in the
Middle East, affecting Israel’s political and trade relations, especially with neighboring countries and global allies. The situation
remains fluid, and the potential for further escalation exists.
In
connection with the Israeli security cabinet’s declaration of war against Hamas and possible hostilities with other organizations,
several hundred thousand Israeli military reservists were drafted to perform immediate military service, including 6 employees, none of
whom are management or key employees, who were called up for reserve service, of which 4 have since returned to work full time and their
pre-war military reserve duty. So long as the war continues,
our personnel may be called up for reserve service, whether for extended periods or periodically for short-term periods. Military service
call ups that result in absences of personnel for extended periods of time may materially and adversely affect our business, prospects,
financial condition and results of operations.
Since the war broke out on
October 7, 2023, our operations have not been adversely affected by this situation, and we have not experienced disruptions to our business
operations. As such, our product and business development activities remain on track. However, the intensity and duration of Israel’s
current war against Hamas is difficult to predict at this stage, as are such war’s economic implications on our business and operations
and on Israel’s economy in general. If the war extends for a long period of time or expands to other fronts, such as Lebanon, Syria
and the West Bank, our operations may be adversely affected.
Any armed conflicts, terrorist
activities or political instability in the region could adversely affect business conditions, could harm our results of operations and
the market price of our Common Stock, and could make it more difficult for us to raise capital.
Our commercial insurance does
not cover losses that may occur as a result of an event associated with the security situation in the Middle East. Although the Israeli
government has in the past covered the reinstatement value of certain damages that were caused by terrorist attacks or acts of war, we
cannot assure you that this government coverage will be maintained or, if maintained, will be sufficient to compensate us fully for damages
incurred. Any losses or damages incurred by us could have a material adverse effect on our business.
Finally, political conditions
within Israel may affect our operations. Israel has held five general elections between 2019 and 2022, and prior to October 2023, the
Israeli government pursued extensive changes to Israel’s judicial system, which sparked extensive political debate and unrest. To
date, these initiatives have been substantially put on hold. Actual or perceived political instability in Israel or any negative changes
in the political environment, may individually or in the aggregate adversely affect the Israeli economy and, in turn, our business, financial
condition, results of operations and growth prospects.
Item 6. Exhibits
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
|
BIOMX INC. |
|
|
|
Date: November 14, 2024 |
By: |
/s/ Jonathan Solomon |
|
Name: |
Jonathan Solomon |
|
Title: |
Chief Executive Officer |
|
|
(Principal Executive Officer) |
|
|
|
Date: November 14, 2024 |
By: |
/s/ Marina Wolfson |
|
Name: |
Marina Wolfson |
|
Title: |
Chief Financial Officer |
|
|
(Principal Financial Officer and
Principal Accounting Officer) |
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Exhibit 3.1
BIOMX INC.
COMPOSITE CERTIFICATE OF INCORPORATION
INCORPORATING:
Amended and Restated Certificate of Incorporation
filed December 13, 2018
Certificate of Amendment of Certificate of Incorporation
filed October 28, 2019
Certificate of Amendment of Certificate of Incorporation
filed August 31, 2022
Certificate of Amendment of Certificate of Incorporation
filed July 9, 2024
Certificate of Amendment of Certificate of Incorporation
filed August 20, 2024
AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION
OF
BIOMX INC.
Pursuant to Section 245 of the
Delaware General Corporation Law
FIRST:1
The name of the corporation is BiomX Inc. (hereinafter called the “Corporation”).
SECOND:
The registered office of the Corporation is to be located at 850 New Burton Road, Suite 201, in the City of Dover, in the County
of Kent, 19904. The name of its registered agent at that address is Cogency Global Inc.
THIRD:
The purpose of the Corporation is to engage in any lawful act or activity for which corporations may be organized under the General
Corporation Law of Delaware (“GCL”).
FOURTH:
The name and mailing address of the incorporator is: Jaszick Maldonado, c/o Loeb & Loeb LLP, 345 Park Avenue, New York NY 10154.
FIFTH:2
The total number of shares of all classes of capital stock which the Corporation shall have authority to issue is 751,000,000, of which
750,000,000 shares shall be common stock, par value $.0001 per share (“Common Stock”) and 1,000,000 shares shall be preferred
stock, par value $.0001 per share (“Preferred Stock”). Subject to this Certificate of Amendment becoming effective pursuant
to the General Corporation Law of the State of Delaware, at 12:01 a.m. on August 26, 2024 (the “Effective Time”), the shares
of Common Stock issued and outstanding or held in treasury immediately prior to the Effective Time (the “Old Common Stock”)
shall be reclassified as and converted into a different number of shares of Common Stock (the “New Common Stock”) such that
each ten shares of Old Common Stock shall, at the Effective Time, be automatically reclassified as and converted into one share of New
Common Stock (the “Reverse Stock Split”). From and after the Effective Time, certificates representing the Old Common Stock
shall represent the number of whole shares of New Common Stock into which such Old Common Stock shall have been reclassified pursuant
to this Certificate of Amendment. No fractional shares of Common Stock shall be issued as a result of the Reverse Stock Split. Fractional
share resulting from the Reverse Stock Split will be rounded up to the next whole share.
A. Preferred Stock. The Board
of Directors is expressly granted authority to issue shares of the Preferred Stock, in one or more series, and to fix for each such series
such voting powers, full or limited, and such designations, preferences and relative, participating, optional or other special rights
and such qualifications, limitations or restrictions thereof as shall be stated and expressed in the resolution or resolutions adopted
by the Board of Directors providing for the issue of such series (a “Preferred Stock Designation”) and as may be permitted
by the GCL. The number of authorized shares of Preferred Stock may be increased or decreased (but not below the number of shares thereof
then outstanding) by the affirmative vote of the holders of a majority of the voting power of all of the then outstanding shares of the
capital stock of the Corporation entitled to vote generally in the election of directors, voting together as a single class, without a
separate vote of the holders of the Preferred Stock, or any series thereof, unless a vote of any such holders is required pursuant to
any Preferred Stock Designation.
B. Common Stock. Except as otherwise
required by law or as otherwise provided in any Preferred Stock Designation, the holders of the Common Stock shall exclusively possess
all voting power and each share of Common Stock shall have one vote.
| 1 | This provision has been revised to reflect changes effectuated
by the Certificate of Amendment filed October 28, 2019. |
| 2 | This provision has been revised to reflect changes effectuated
by the Certificate of Amendment filed August 20, 2024. |
SIXTH:
This Article Sixth shall apply during the period commencing upon the filing of this Certificate of Incorporation and terminating
upon the consummation of any “Business Combination” (as defined below). A “Business Combination” shall mean any
merger, capital stock exchange, asset acquisition, stock purchase, recapitalization, reorganization or other similar business combination
involving the Corporation and one or more businesses or entities (“Target Business”), or entering into contractual arrangements
that give the Corporation control over such a Target Business, and, if the Corporation is then listed on a national securities exchange,
the Target Business has a fair market value equal to at least 80% of the balance in the Trust Fund (defined below), less any taxes payable
on interest earned, at the time of signing a definitive agreement in connection with the initial Business Combination. “IPO Shares”
shall mean the shares sold pursuant to the registration statement on Form S-1 (“Registration Statement”) filed with the Securities
and Exchange Commission (“Commission”) in connection with the Corporation’s initial public offering (“IPO”).
The “fair market value” for purposes of this Article Sixth will be determined by the Board of Directors of the Corporation
based upon one or more standards generally accepted by the financial community (such as actual and potential sales, earnings, cash flow
and/or book value). If the Board of Directors is unable to independently determine the fair market value of the Target Business, the Corporation
will obtain an opinion from an independent investment banking firm, or another independent entity that commonly renders valuation opinions,
with respect to the satisfaction of such criteria.
A. Prior to the consummation of a Business
Combination, the Corporation shall either (i) submit any Business Combination to its holders of Common Stock for approval (“Proxy
Solicitation”) pursuant to the proxy rules promulgated under the Securities Exchange Act of 1934, as amended (“Exchange Act”),
or (ii) provide its holders of IPO Shares with the opportunity to sell their shares to the Corporation by means of a tender offer (“Tender
Offer”).
B. If the Corporation engages in a Proxy
Solicitation with respect to a Business Combination, the Corporation will consummate the Business Combination only if a majority of the
then outstanding shares of Common Stock present and entitled to vote at the meeting to approve the Business Combination are voted for
the approval of such Business Combination.
C. In the event that a Business Combination
is consummated by the Corporation or the Corporation holds a vote of its stockholders to amend its Certificate of Incorporation, any holder
of IPO Shares who (i) voted on the proposal to approve such Business Combination or amend the Certificate of Incorporation, whether such
holder voted in favor or against such Business Combination or amendment, and followed the procedures contained in the proxy materials
to perfect the holder’s right to convert the holder’s IPO Shares into cash, if any, or (ii) tendered the holder’s IPO
Shares as specified in the tender offer materials therefore, shall be entitled to receive the Conversion Price (as defined below) in exchange
for the holder’s IPO Shares. The Corporation shall, promptly after consummation of the Business Combination or the filing of the
amendment to the Certificate of Incorporation with the Secretary of State of the State of Delaware, convert such shares into cash at a
per share price equal to the quotient determined by dividing (i) the amount then held in the Trust Fund (as defined below) less any income
taxes owed on such funds but not yet paid, calculated as of two business days prior to the consummation of the Business Combination or
the filing of the amendment, as applicable, by (ii) the total number of IPO Shares then outstanding (such price being referred to as the
“Conversion Price”). “Trust Fund” shall mean the trust account established by the Corporation at the consummation
of its IPO and into which the amount specified in Registration Statement is deposited. Notwithstanding the foregoing, a holder of IPO
Shares, together with any affiliate of his or any other person with whom he is acting in concert or as a “group” (within the
meaning of Section 13(d)(3) of the Exchange Act) (“Group”) with, will be restricted from demanding conversion in connection
with a proposed Business Combination with respect to 20.0% or more of the IPO Shares. Accordingly, all IPO Shares beneficially owned by
such holder or any other person with whom such holder is acting in concert or as a Group with in excess of 20.0% or more of the IPO Shares
will remain outstanding following consummation of such Business Combination in the name of the stockholder and not be converted.
D. The Corporation will not consummate
any Business Combination unless it has net tangible assets of at least $5,000,001 upon consummation of such Business Combination.
E. In the event that the Corporation
does not consummate a Business Combination by 24 months from the consummation of the IPO (such date being referred to as the “Termination
Date”), the Corporation shall (i) cease all operations except for the purposes of winding up, (ii) as promptly as reasonably possible
but not more than ten business days thereafter redeem 100% of the IPO Shares for cash for a redemption price per share as described below
(which redemption will completely extinguish such holders’ rights as stockholders, including the right to receive further liquidation
distributions, if any), and (iii) as promptly as reasonably possible following such redemption, subject to approval of the Corporation’s
then stockholders and subject to the requirements of the GCL, including the adoption of a resolution by the Board of Directors pursuant
to Section 275(a) of the GCL finding the dissolution of the Corporation advisable and the provision of such notices as are required by
said Section 275(a) of the GCL, dissolve and liquidate the balance of the Corporation’s net assets to its remaining stockholders,
as part of the Corporation’s plan of dissolution and liquidation, subject (in the case of (ii) and (iii) above) to the Corporation’s
obligations under the GCL to provide for claims of creditors and other requirements of applicable law. In such event, the per-share redemption
price shall be equal to a pro rata share of the Trust Account plus any pro rata interest earned on the funds held in the Trust Account
and not previously released to the Corporation for its working capital requirements or necessary to pay its taxes divided by the total
number of IPO Shares then outstanding.
F. A holder of IPO Shares shall only
be entitled to receive distributions from the Trust Fund in the event (i) he demands conversion of his shares in accordance with paragraph
C above or (ii) that the Corporation has not consummated a Business Combination by the Termination Date as described in paragraph E above.
In no other circumstances shall a holder of IPO Shares have any right or interest of any kind in or to the Trust Fund.
G. Prior to a Business Combination, the
Board of Directors may not issue (i) any shares of Common Stock or any securities convertible into Common Stock; or (ii) any securities
which participate in or are otherwise entitled in any manner to any of the proceeds in the Trust Fund or which vote as a class with the
Common Stock on a Business Combination.
SEVENTH:3
The following provisions are inserted for the management of the business and for the conduct of the affairs of the Corporation, and for
further definition, limitation and regulation of the powers of the Corporation and of its directors and stockholders:
A. Election of directors need not be by ballot
unless the by-laws of the Corporation so provide.
B. The Board of Directors shall have
the power, without the assent or vote of the stockholders, to make, alter, amend, change, add to or repeal the by-laws of the Corporation
as provided in the by-laws of the Corporation.
C. The directors in their discretion
may submit any contract or act for approval or ratification at any annual meeting of the stockholders or at any meeting of the stockholders
called for the purpose of considering any such act or contract, and any contract or act that shall be approved or be ratified by the vote
of the holders of a majority of the stock of the Corporation which is represented in person or by proxy at such meeting and entitled to
vote thereat (provided that a lawful quorum of stockholders be there represented in person or by proxy) shall be as valid and binding
upon the Corporation and upon all the stockholders as though it had been approved or ratified by every stockholder of the Corporation,
whether or not the contract or act would otherwise be open to legal attack because of directors’ interests, or for any other reason.
D. In addition to the powers and authorities
hereinbefore or by statute expressly conferred upon them, the directors are hereby empowered to exercise all such powers and do all such
acts and things as may be exercised or done by the Corporation; subject, nevertheless, to the provisions of the statutes of Delaware,
of this Amended and Restated Certificate of Incorporation, and to any bylaws from time to time made by the stockholders; provided, however,
that no bylaw so made shall invalidate any prior act of the directors which would have been valid if such bylaws had not been made.
| 3 | This provision has been revised to reflect changes effectuated
by the Certificate of Amendment filed October 28, 2019. |
E. The Board of Directors shall be divided
into three classes: Class I, Class II and Class III. The number of directors in each class shall be fixed exclusively by the Board of
Directors and shall be as nearly equal as possible. Following the filing of the amendment to the certificate of incorporation including
this provision, the entire Board of Directors will be elected at the first Annual Meeting of Stockholders. At such first Annual Meeting
of Stockholders, the directors in Class I shall be elected for a term expiring at the second Annual Meeting of Stockholders, the directors
in Class II shall be elected for a term expiring at the third Annual Meeting of Stockholders and the directors in Class III shall be elected
for a term expiring at the fourth Annual Meeting of Stockholders. Commencing at the second Annual Meeting of Stockholders following the
filing of the amendment to the certificate of incorporation including this provision, and at each annual meeting thereafter, directors
elected to succeed those directors whose terms expire shall be elected for a term of office to expire at the third succeeding annual meeting
of stockholders after their election. Except as the GCL may otherwise require, in the interim between annual meetings of stockholders
or special meetings of stockholders called for the election of directors and/or the removal of one or more directors and the filling of
any vacancy in that connection, newly created directorships and any vacancies in the Board of Directors, including unfilled vacancies
resulting from the removal of directors for cause, may be filled only by the vote of a majority of the remaining directors then in office,
although less than a quorum (as defined in the Corporation’s bylaws), or by the sole remaining director. All directors shall hold
office until the expiration of their respective terms of office and until their successors shall have been elected and qualified. A director
elected to fill a vacancy resulting from the death, resignation or removal of a director shall serve for the remainder of the full term
of the director whose death, resignation or removal shall have created such vacancy and until his successor shall have been elected and
qualified.
EIGHTH:
A. A director of the Corporation shall
not be personally liable to the Corporation or its stockholders for monetary damages for breach of fiduciary duty as a director, except
for liability (i) for any breach of the director’s duty of loyalty to the Corporation or its stockholders, (ii) for acts or omissions
not in good faith or which involve intentional misconduct or a knowing violation of law, (iii) under Section 174 of the GCL, or (iv) for
any transaction from which the director derived an improper personal benefit. If the GCL is amended to authorize corporate action further
eliminating or limiting the personal liability of directors, then the liability of a director of the Corporation shall be eliminated or
limited to the fullest extent permitted by the GCL, as so amended. Any repeal or modification of this paragraph A by the stockholders
of the Corporation shall not adversely affect any right or protection of a director of the Corporation with respect to events occurring
prior to the time of such repeal or modification.
B. The Corporation, to the full extent
permitted by Section 145 of the GCL, as amended from time to time, shall indemnify all persons whom it may indemnify pursuant thereto.
Expenses (including attorneys’ fees) incurred by an officer or director in defending any civil, criminal, administrative, or investigative
action, suit or proceeding for which such officer or director may be entitled to indemnification hereunder shall be paid by the Corporation
in advance of the final disposition of such action, suit or proceeding upon receipt of an undertaking by or on behalf of such director
or officer to repay such amount if it shall ultimately be determined that he is not entitled to be indemnified by the Corporation as authorized
hereby.
C. Notwithstanding the foregoing provisions
of this Article Eighth, no indemnification nor advancement of expenses will extend to any claims made by the Company’s officers
and directors to cover any loss that such individuals may sustain as a result of such individuals’ agreement to pay debts and obligations
to target businesses or vendors or other entities that are owed money by the Corporation for services rendered or contracted for or products
sold to the Corporation, as described in the Registration Statement.
NINTH:
Whenever a compromise or arrangement is proposed between this Corporation and its creditors or any class of them and/or between
this Corporation and its stockholders or any class of them, any court of equitable jurisdiction within the State of Delaware may, on the
application in a summary way of this Corporation or of any creditor or stockholder thereof or on the application of any receiver or receivers
appointed for this Corporation under Section 291 of Title 8 of the Delaware Code or on the application of trustees in dissolution or of
any receiver or receivers appointed for this Corporation under Section 279 of Title 8 of the Delaware Code order a meeting of the creditors
or class of creditors, and/or of the stockholders or class of stockholders of this Corporation, as the case may be, to be summoned in
such manner as the said court directs. If a majority in number representing three fourths in value of the creditors or class of creditors,
and/or of the stockholders or class of stockholders of this Corporation, as the case may be, agree to any compromise or arrangement and
to any reorganization of this Corporation as a consequence of such compromise or arrangement, the said compromise or arrangement and the
said reorganization shall, if sanctioned by the court to which the said application has been made, be binding on all the creditors or
class of creditors, and/or on all the stockholders or class of stockholders, of this Corporation, as the case may be, and also on this
Corporation.
4
Exhibit 3.2
BIOMX INC.
COMPOSITE CERTIFICATE OF INCORPORATION
INCORPORATING:
Amended and Restated Certificate of Incorporation
filed December 13, 2018
Certificate of Amendment of Certificate of Incorporation
filed October 28, 2019
Certificate of Amendment of Certificate of Incorporation
filed August 31, 2022
Certificate of Amendment of Certificate of Incorporation
filed July 9, 2024
Certificate of Amendment of Certificate of Incorporation
filed August 20, 2024
AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION
OF
BIOMX INC.
Pursuant to Section 245 of the
Delaware General Corporation Law
FIRST:1
The name of the corporation is BiomX Inc. (hereinafter called the “Corporation”).
SECOND:
The registered office of the Corporation is to be located at 850 New Burton Road, Suite 201, in the City of Dover, in the County
of Kent, 19904. The name of its registered agent at that address is Cogency Global Inc.
THIRD:
The purpose of the Corporation is to engage in any lawful act or activity for which corporations may be organized under the General
Corporation Law of Delaware (“GCL”).
FOURTH:
The name and mailing address of the incorporator is: Jaszick Maldonado, c/o Loeb & Loeb LLP, 345 Park Avenue, New York NY 10154.
FIFTH:2
The total number of shares of all classes of capital stock which the Corporation shall have authority to issue is
751,000,000, of which 750,000,000 shares shall be common stock, par value $.0001 per share (“Common Stock”) and 1,000,000
shares shall be preferred stock, par value $.0001 per share (“Preferred Stock”). Subject
to this Certificate of Amendment becoming effective pursuant to the General Corporation Law of the State of Delaware, at 12:01 a.m. on
August 26, 2024 (the “Effective Time”), the shares of Common Stock issued and outstanding or held in treasury immediately
prior to the Effective Time (the “Old Common Stock”) shall be reclassified as and converted into a different number of shares
of Common Stock (the “New Common Stock”) such that each ten shares of Old Common Stock shall, at the Effective Time, be automatically
reclassified as and converted into one share of New Common Stock (the “Reverse Stock Split”). From and after the Effective
Time, certificates representing the Old Common Stock shall represent the number of whole shares of New Common Stock into which such Old
Common Stock shall have been reclassified pursuant to this Certificate of Amendment. No fractional shares of Common Stock shall be issued
as a result of the Reverse Stock Split. Fractional share resulting from the Reverse Stock Split will be rounded up to the next whole
share.
A. Preferred Stock. The Board
of Directors is expressly granted authority to issue shares of the Preferred Stock, in one or more series, and to fix for each such series
such voting powers, full or limited, and such designations, preferences and relative, participating, optional or other special rights
and such qualifications, limitations or restrictions thereof as shall be stated and expressed in the resolution or resolutions adopted
by the Board of Directors providing for the issue of such series (a “Preferred Stock Designation”) and as may be permitted
by the GCL. The number of authorized shares of Preferred Stock may be increased or decreased (but not below the number of shares thereof
then outstanding) by the affirmative vote of the holders of a majority of the voting power of all of the then outstanding shares of the
capital stock of the Corporation entitled to vote generally in the election of directors, voting together as a single class, without a
separate vote of the holders of the Preferred Stock, or any series thereof, unless a vote of any such holders is required pursuant to
any Preferred Stock Designation.
B. Common Stock. Except as otherwise
required by law or as otherwise provided in any Preferred Stock Designation, the holders of the Common Stock shall exclusively possess
all voting power and each share of Common Stock shall have one vote.
| 1 | This provision has been revised to reflect changes effectuated
by the Certificate of Amendment filed October 28, 2019. |
| 2 | This
provision has been revised to reflect changes effectuated by the Certificate of Amendment filed July August 920,
2024. |
SIXTH:
This Article Sixth shall apply during the period commencing upon the filing of this Certificate of Incorporation and terminating
upon the consummation of any “Business Combination” (as defined below). A “Business Combination” shall mean any
merger, capital stock exchange, asset acquisition, stock purchase, recapitalization, reorganization or other similar business combination
involving the Corporation and one or more businesses or entities (“Target Business”), or entering into contractual arrangements
that give the Corporation control over such a Target Business, and, if the Corporation is then listed on a national securities exchange,
the Target Business has a fair market value equal to at least 80% of the balance in the Trust Fund (defined below), less any taxes payable
on interest earned, at the time of signing a definitive agreement in connection with the initial Business Combination. “IPO Shares”
shall mean the shares sold pursuant to the registration statement on Form S-1 (“Registration Statement”) filed with the Securities
and Exchange Commission (“Commission”) in connection with the Corporation’s initial public offering (“IPO”).
The “fair market value” for purposes of this Article Sixth will be determined by the Board of Directors of the Corporation
based upon one or more standards generally accepted by the financial community (such as actual and potential sales, earnings, cash flow
and/or book value). If the Board of Directors is unable to independently determine the fair market value of the Target Business, the Corporation
will obtain an opinion from an independent investment banking firm, or another independent entity that commonly renders valuation opinions,
with respect to the satisfaction of such criteria.
A. Prior to the consummation of a Business
Combination, the Corporation shall either (i) submit any Business Combination to its holders of Common Stock for approval (“Proxy
Solicitation”) pursuant to the proxy rules promulgated under the Securities Exchange Act of 1934, as amended (“Exchange Act”),
or (ii) provide its holders of IPO Shares with the opportunity to sell their shares to the Corporation by means of a tender offer (“Tender
Offer”).
B. If the Corporation engages in a Proxy
Solicitation with respect to a Business Combination, the Corporation will consummate the Business Combination only if a majority of the
then outstanding shares of Common Stock present and entitled to vote at the meeting to approve the Business Combination are voted for
the approval of such Business Combination.
C. In the event that a Business Combination
is consummated by the Corporation or the Corporation holds a vote of its stockholders to amend its Certificate of Incorporation, any holder
of IPO Shares who (i) voted on the proposal to approve such Business Combination or amend the Certificate of Incorporation, whether such
holder voted in favor or against such Business Combination or amendment, and followed the procedures contained in the proxy materials
to perfect the holder’s right to convert the holder’s IPO Shares into cash, if any, or (ii) tendered the holder’s IPO
Shares as specified in the tender offer materials therefore, shall be entitled to receive the Conversion Price (as defined below) in exchange
for the holder’s IPO Shares. The Corporation shall, promptly after consummation of the Business Combination or the filing of the
amendment to the Certificate of Incorporation with the Secretary of State of the State of Delaware, convert such shares into cash at a
per share price equal to the quotient determined by dividing (i) the amount then held in the Trust Fund (as defined below) less any income
taxes owed on such funds but not yet paid, calculated as of two business days prior to the consummation of the Business Combination or
the filing of the amendment, as applicable, by (ii) the total number of IPO Shares then outstanding (such price being referred to as the
“Conversion Price”). “Trust Fund” shall mean the trust account established by the Corporation at the consummation
of its IPO and into which the amount specified in Registration Statement is deposited. Notwithstanding the foregoing, a holder of IPO
Shares, together with any affiliate of his or any other person with whom he is acting in concert or as a “group” (within the
meaning of Section 13(d)(3) of the Exchange Act) (“Group”) with, will be restricted from demanding conversion in connection
with a proposed Business Combination with respect to 20.0% or more of the IPO Shares. Accordingly, all IPO Shares beneficially owned by
such holder or any other person with whom such holder is acting in concert or as a Group with in excess of 20.0% or more of the IPO Shares
will remain outstanding following consummation of such Business Combination in the name of the stockholder and not be converted.
D. The Corporation will not consummate
any Business Combination unless it has net tangible assets of at least $5,000,001 upon consummation of such Business Combination.
E. In the event that the Corporation
does not consummate a Business Combination by 24 months from the consummation of the IPO (such date being referred to as the “Termination
Date”), the Corporation shall (i) cease all operations except for the purposes of winding up, (ii) as promptly as reasonably possible
but not more than ten business days thereafter redeem 100% of the IPO Shares for cash for a redemption price per share as described below
(which redemption will completely extinguish such holders’ rights as stockholders, including the right to receive further liquidation
distributions, if any), and (iii) as promptly as reasonably possible following such redemption, subject to approval of the Corporation’s
then stockholders and subject to the requirements of the GCL, including the adoption of a resolution by the Board of Directors pursuant
to Section 275(a) of the GCL finding the dissolution of the Corporation advisable and the provision of such notices as are required by
said Section 275(a) of the GCL, dissolve and liquidate the balance of the Corporation’s net assets to its remaining stockholders,
as part of the Corporation’s plan of dissolution and liquidation, subject (in the case of (ii) and (iii) above) to the Corporation’s
obligations under the GCL to provide for claims of creditors and other requirements of applicable law. In such event, the per-share redemption
price shall be equal to a pro rata share of the Trust Account plus any pro rata interest earned on the funds held in the Trust Account
and not previously released to the Corporation for its working capital requirements or necessary to pay its taxes divided by the total
number of IPO Shares then outstanding.
F. A holder of IPO Shares shall only
be entitled to receive distributions from the Trust Fund in the event (i) he demands conversion of his shares in accordance with paragraph
C above or (ii) that the Corporation has not consummated a Business Combination by the Termination Date as described in paragraph E above.
In no other circumstances shall a holder of IPO Shares have any right or interest of any kind in or to the Trust Fund.
G. Prior to a Business Combination, the
Board of Directors may not issue (i) any shares of Common Stock or any securities convertible into Common Stock; or (ii) any securities
which participate in or are otherwise entitled in any manner to any of the proceeds in the Trust Fund or which vote as a class with the
Common Stock on a Business Combination.
SEVENTH:3
The following provisions are inserted for the management of the business and for the conduct of the affairs of the Corporation, and for
further definition, limitation and regulation of the powers of the Corporation and of its directors and stockholders:
A. Election of directors need not be by ballot
unless the by-laws of the Corporation so provide.
B. The Board of Directors shall have
the power, without the assent or vote of the stockholders, to make, alter, amend, change, add to or repeal the by-laws of the Corporation
as provided in the by-laws of the Corporation.
C. The directors in their discretion
may submit any contract or act for approval or ratification at any annual meeting of the stockholders or at any meeting of the stockholders
called for the purpose of considering any such act or contract, and any contract or act that shall be approved or be ratified by the vote
of the holders of a majority of the stock of the Corporation which is represented in person or by proxy at such meeting and entitled to
vote thereat (provided that a lawful quorum of stockholders be there represented in person or by proxy) shall be as valid and binding
upon the Corporation and upon all the stockholders as though it had been approved or ratified by every stockholder of the Corporation,
whether or not the contract or act would otherwise be open to legal attack because of directors’ interests, or for any other reason.
D. In addition to the powers and authorities
hereinbefore or by statute expressly conferred upon them, the directors are hereby empowered to exercise all such powers and do all such
acts and things as may be exercised or done by the Corporation; subject, nevertheless, to the provisions of the statutes of Delaware,
of this Amended and Restated Certificate of Incorporation, and to any bylaws from time to time made by the stockholders; provided, however,
that no bylaw so made shall invalidate any prior act of the directors which would have been valid if such bylaws had not been made.
| 3 | This provision has been revised to reflect changes effectuated
by the Certificate of Amendment filed October 28, 2019. |
E. The Board of Directors shall be divided
into three classes: Class I, Class II and Class III. The number of directors in each class shall be fixed exclusively by the Board of
Directors and shall be as nearly equal as possible. Following the filing of the amendment to the certificate of incorporation including
this provision, the entire Board of Directors will be elected at the first Annual Meeting of Stockholders. At such first Annual Meeting
of Stockholders, the directors in Class I shall be elected for a term expiring at the second Annual Meeting of Stockholders, the directors
in Class II shall be elected for a term expiring at the third Annual Meeting of Stockholders and the directors in Class III shall be elected
for a term expiring at the fourth Annual Meeting of Stockholders. Commencing at the second Annual Meeting of Stockholders following the
filing of the amendment to the certificate of incorporation including this provision, and at each annual meeting thereafter, directors
elected to succeed those directors whose terms expire shall be elected for a term of office to expire at the third succeeding annual meeting
of stockholders after their election. Except as the GCL may otherwise require, in the interim between annual meetings of stockholders
or special meetings of stockholders called for the election of directors and/or the removal of one or more directors and the filling of
any vacancy in that connection, newly created directorships and any vacancies in the Board of Directors, including unfilled vacancies
resulting from the removal of directors for cause, may be filled only by the vote of a majority of the remaining directors then in office,
although less than a quorum (as defined in the Corporation’s bylaws), or by the sole remaining director. All directors shall hold
office until the expiration of their respective terms of office and until their successors shall have been elected and qualified. A director
elected to fill a vacancy resulting from the death, resignation or removal of a director shall serve for the remainder of the full term
of the director whose death, resignation or removal shall have created such vacancy and until his successor shall have been elected and
qualified.
EIGHTH:
A. A director of the Corporation shall
not be personally liable to the Corporation or its stockholders for monetary damages for breach of fiduciary duty as a director, except
for liability (i) for any breach of the director’s duty of loyalty to the Corporation or its stockholders, (ii) for acts or omissions
not in good faith or which involve intentional misconduct or a knowing violation of law, (iii) under Section 174 of the GCL, or (iv) for
any transaction from which the director derived an improper personal benefit. If the GCL is amended to authorize corporate action further
eliminating or limiting the personal liability of directors, then the liability of a director of the Corporation shall be eliminated or
limited to the fullest extent permitted by the GCL, as so amended. Any repeal or modification of this paragraph A by the stockholders
of the Corporation shall not adversely affect any right or protection of a director of the Corporation with respect to events occurring
prior to the time of such repeal or modification.
B. The Corporation, to the full extent
permitted by Section 145 of the GCL, as amended from time to time, shall indemnify all persons whom it may indemnify pursuant thereto.
Expenses (including attorneys’ fees) incurred by an officer or director in defending any civil, criminal, administrative, or investigative
action, suit or proceeding for which such officer or director may be entitled to indemnification hereunder shall be paid by the Corporation
in advance of the final disposition of such action, suit or proceeding upon receipt of an undertaking by or on behalf of such director
or officer to repay such amount if it shall ultimately be determined that he is not entitled to be indemnified by the Corporation as authorized
hereby.
C. Notwithstanding the foregoing provisions
of this Article Eighth, no indemnification nor advancement of expenses will extend to any claims made by the Company’s officers
and directors to cover any loss that such individuals may sustain as a result of such individuals’ agreement to pay debts and obligations
to target businesses or vendors or other entities that are owed money by the Corporation for services rendered or contracted for or products
sold to the Corporation, as described in the Registration Statement.
NINTH:
Whenever a compromise or arrangement is proposed between this Corporation and its creditors or any class of them and/or between
this Corporation and its stockholders or any class of them, any court of equitable jurisdiction within the State of Delaware may, on the
application in a summary way of this Corporation or of any creditor or stockholder thereof or on the application of any receiver or receivers
appointed for this Corporation under Section 291 of Title 8 of the Delaware Code or on the application of trustees in dissolution or of
any receiver or receivers appointed for this Corporation under Section 279 of Title 8 of the Delaware Code order a meeting of the creditors
or class of creditors, and/or of the stockholders or class of stockholders of this Corporation, as the case may be, to be summoned in
such manner as the said court directs. If a majority in number representing three fourths in value of the creditors or class of creditors,
and/or of the stockholders or class of stockholders of this Corporation, as the case may be, agree to any compromise or arrangement and
to any reorganization of this Corporation as a consequence of such compromise or arrangement, the said compromise or arrangement and the
said reorganization shall, if sanctioned by the court to which the said application has been made, be binding on all the creditors or
class of creditors, and/or on all the stockholders or class of stockholders, of this Corporation, as the case may be, and also on this
Corporation.
4
Exhibit 10.1
BIOMX INC.
2019 OMNIBUS LONG-TERM INCENTIVE PLAN
Restricted Stock Unit Agreement
This Restricted Stock Unit Agreement and the associated
grant award information (the “Customizing Information”), which Customizing Information is provided in written form or
is available in electronic form from the recordkeeper for the BiomX Inc. 2019 Omnibus Long-Term Incentive Plan (including any appendices
and addendums thereto), as amended and in effect from time to time (the “Plan”), is made as of the date shown as the “Grant
Date” in the Customizing Information (the “Grant Date”) by and between BiomX Inc., a Delaware corporation (the “Company”),
and the individual identified in the Customizing Information (the “Recipient”). This instrument and the Customizing Information
are collectively referred to as the “Restricted Stock Unit Agreement.”
WITNESSETH THAT:
WHEREAS, the Company has instituted the Plan; and
WHEREAS, the Administrator has authorized the grant
of restricted stock units (“RSUs”) with respect to the Company’s Stock upon the terms and conditions set forth below
and pursuant to the Plan, a copy of which is incorporated herein; and
WHEREAS, the Recipient acknowledges that he or
she has carefully read this Restricted Stock Unit Agreement and agrees, as provided in Section 17(a) below, that the terms and conditions
of the Restricted Stock Unit Agreement reflect the entire understanding between himself or herself and the Company regarding this RSU
award (and the Recipient has not relied upon any statement or promise other than the terms and conditions of the Restricted Stock Unit
Agreement with respect to this RSU award);
NOW, THEREFORE, in consideration of the premises
and the mutual covenants and agreements herein contained and for other good and valuable consideration the receipt and adequacy of which
are hereby acknowledged, the Company and the Recipient agree as follows.
1. Grant.
Subject to the terms of the Plan and this Restricted Stock Unit Agreement, the Company hereby grants to the Recipient that number of RSUs
equal to the corresponding number of shares of the Company’s Stock (the “Underlying Shares”) shown in the Customizing
Information under “Restricted Stock Units Granted.”
2. Vesting.
(a) In
General. If the Recipient remains in an employment, contractual or other service relationship with the Company (“Relationship”)
as of a “Vesting Date,” as specified in the Customizing Information, and the Recipient as of such date is not in violation
of any confidentiality, inventions, non-solicitation and/or non-competition agreement with the Company (each to the extent not otherwise
prohibited under applicable state law), all or a portion, as applicable (the “Incremental Amount,” as specified in the Customizing
Information), of the RSUs shall vest on such date. For the avoidance of doubt, except as otherwise provided pursuant to the terms of the
Plan and Section 2(c), if the Recipient’s Relationship with the Company is terminated by the Company or by the Recipient for any
reason, whether voluntarily or involuntarily, no RSUs granted pursuant to this Restricted Stock Unit Agreement shall vest under any circumstances
on and after the date of such termination.
(b) Change
in Control. In the event of a Change in Control, the Company, or the entity that is the surviving
entity or successor to the Company following such transaction, may elect to: (i) continue this RSU subject to the terms of this Restricted
Stock Unit Agreement and the Plan and subject to such adjustments, if any, by the Administrator as permitted by Section 3.2 of the Plan;
or (ii) accelerate vesting of this RSU and terminate this RSU in exchange for a cash payment. In the event that the Company or its successor
chooses to terminate this RSU upon a Change in Control, the Recipient shall be entitled to a payment within thirty (30) days of such Change
in Control.
(c) Administrator
Discretion. In the event the Relationship is terminated for any reason (whether voluntary or involuntary), (i) the Recipient’s
right to vest in the RSU will, except as provided otherwise explicitly in this Section 2 or as provided by the Administrator, terminate
as of the date of the termination of the Relationship (and will not be extended by any notice period mandated under local law) and (ii)
the Administrator shall have the exclusive discretion to determine when the Relationship has terminated for purposes of this RSU (including
when the Recipient is no longer considered to be providing active service while on a leave of absence).
(d) Special
Definitions. For purposes of this Section 2, the term “Company” refers to the Company and its Related Companies.
3. Dividends.
If so provided in the Customizing Information under “Dividend Equivalent Units”, a Recipient shall be credited with dividend
equivalents equal to the dividends the Recipient would have received if the Recipient had been the actual record owner of the Underlying
Shares on each dividend record date on or after the Grant Date and through the date the Recipient receives a settlement pursuant to Section
4 below (the “Dividend Equivalent”). If a dividend on the Stock is payable wholly or partially in Stock, the Dividend Equivalent
representing that portion shall be in the form of additional RSUs, credited on a one-for-one basis. If a dividend on the Stock is payable
wholly or partially in cash, the Dividend Equivalent representing that portion shall also be in the form of cash and a Recipient shall
be treated as being credited with any cash dividends, without earnings, until settlement pursuant to Section 4 below. If a dividend on
Stock is payable wholly or partially in other than cash or Stock, the Administrator may, in its discretion, provide for such Dividend
Equivalents with respect to that portion as it deems appropriate under the circumstances. Dividend Equivalents shall be subject to the
same terms and conditions as the RSUs originally awarded pursuant to this Restricted Stock Unit Agreement, and they shall vest (or, if
applicable, be forfeited) as if they had been granted at the same time as the original RSU. Dividend Equivalents representing the cash
portion of a dividend on Stock shall be settled in cash.
4. Delivery
of Underlying Shares or Cash Settlement. With respect to any RSUs that become vested RSUs as of a Vesting Date pursuant to Section
2, the Company shall issue and deliver to the Recipient as soon as practicable following the applicable Vesting Date (a) the number of
Underlying Shares equal to the number of RSUs vesting on that date or an amount of cash equal to the Fair Market Value, as defined in
the Plan, of such Underlying Shares as of that date (or such later delivery date, if applicable) and (b) the amount (and in the form)
due with respect to any Dividend Equivalents applicable to such Underlying Shares. Whether Underlying Shares, or the cash value thereof,
shall be issued or paid at settlement shall be determined based on the “Form of Settlement” specified in the Customizing Information.
To the extent
the vesting of any RSUs occurs during a “blackout” period wherein certain employees, including the Recipient, are precluded
from selling Stock, the Administrator retains the right, in its sole discretion, to defer the delivery of the Underlying Shares; provided,
however, that the Administrator shall not exercise its right to defer the Recipient’s receipt of the Underlying Shares if the Stock
is specifically covered by a Rule 10b5-1 trading plan of the Recipient that causes the Stock to be exempt from any applicable blackout
period then in effect. In the event the receipt of any shares of Stock is deferred hereunder due to the existence of a blackout period,
the shares shall be issued to the Recipient on the first day following the termination of the blackout period; provided, however, that
in no event shall the issuance of the shares be deferred later than the fifteenth day of the third month following the close of the year
in which the Underlying Shares otherwise would have been issued.
Any shares issued pursuant to this Restricted Stock
Unit Agreement shall be issued, without issue or transfer tax, by (i) delivering a stock certificate or certificates for such shares out
of theretofore authorized but unissued shares or treasury shares of its Stock as the Company may elect or (ii) issuance of shares of its
Stock in book entry form; provided, however, that the time of such delivery may be postponed by the Company for such period as may be
required for it with reasonable diligence to comply with any applicable requirements of law. Notwithstanding the preceding provisions
of this Section 4, delivery of Underlying Shares shall be made, or the amount of cash equivalent thereto shall be paid, only if the required
purchase price designated as the “Purchase Price” shown in the Customizing Information per underlying RSU is paid to the Company
by means of payment acceptable to the Company in accordance with the terms of the Plan. If the Recipient fails to pay for or accept delivery
of all of the shares, the right to shares of Stock provided pursuant to this RSU may be terminated by the Company.
5. Withholding
Taxes. The Recipient hereby agrees, as a condition of this award, to provide to the Company (or a Related Company employing the Recipient,
as applicable) an amount sufficient to satisfy the Company’s and/or Related Company’s obligation to withhold any and all federal,
state, local or provincial income tax, social security, social insurance, payroll tax, fringe benefits tax, payment on account or other
tax-related items or statutory withholdings related to the Recipient’s participation in the Plan (the “Withholding Amount”),
if any, by (a) authorizing the Company and/or any Related Company employing the Recipient, as applicable, to withhold the Withholding
Amount from the Recipient’s cash compensation, (b) remitting the Withholding Amount to the Company (or a Related Company employing
the Recipient, as applicable) in cash or (c) delivering to the Company stock certificates registered in his or her name representing shares
of Company Stock legally and beneficially owned by him or her, fully vested and free of all liens, claims, and encumbrances of every kind,
duly endorsed or accompanied by stock powers duly endorsed by the record holder of the Company Stock represented by such certificates;
provided, however, that to the extent that the Withholding Amount is not provided by one or a combination of such methods, the Company
may at its election withhold from the Underlying Shares and any Dividend Equivalents that would otherwise be delivered that number of
shares (and/or cash) having a Fair Market Value on the date of vesting sufficient to eliminate any deficiency in the Withholding Amount.
Regardless of any action that the Company and/or Related Company takes with respect to any or all federal, state, local or provincial
income tax, social security, social insurance, payroll tax, fringe benefits tax, payment on account or other tax-related items or statutory
withholdings related to the Recipient’s participation in the Plan, the Recipient acknowledges that he or she, and not the Company
and/or any Related Company, has the ultimate liability for any such items. Further, if the Recipient becomes subject to tax in more than
one jurisdiction between the Grant Date and the date of any relevant taxable or tax withholding event, the Recipient acknowledges that
the Company and/or Related Company may be required to withhold or account for such tax-related items in more than one jurisdiction.
6. Non-assignability
of RSUs and Dividend Equivalents. RSUs and any Dividend Equivalents shall not be assignable or transferable by the Recipient except
by will or by the laws of descent and distribution or as permitted by the Administrator in its discretion pursuant to the terms of the
Plan. During the life of the Recipient, delivery of shares of Stock or payment of cash as settlement of RSUs and any Dividend Equivalents
shall be made only to the Recipient, to a conservator or guardian duly appointed for the Recipient by reason of the Recipient’s
incapacity or to the person appointed by the Recipient in a durable power of attorney acceptable to the Company’s counsel.
7. Compliance
with Securities Act; Lock-Up Agreement. The Company shall not be obligated to sell or issue any Underlying Shares or other securities
in settlement of RSUs and any Dividend Equivalents hereunder unless the shares of Stock or other securities are at that time effectively
registered or exempt from registration under the Securities Act and applicable state or provincial securities laws. In the event shares
or other securities shall be issued that shall not be so registered, the Recipient hereby represents, warrants and agrees that the Recipient
will receive such shares or other securities for investment and not with a view to their resale or distribution, and will execute an appropriate
investment letter satisfactory to the Company and its counsel. The Recipient further hereby agrees that as a condition to the settlement
of RSUs and any Dividend Equivalents, if requested by the Company, the Recipient will execute an agreement in a form acceptable to the
Company to the effect that the Underlying Shares shall be subject to any underwriter’s or similar lock-up agreement in connection
with an offering of any securities of the Company that may from time to time apply to shares held by officers and directors of the Company,
and such agreement or a successor agreement must be in full force and effect.
8. Addendum.
Notwithstanding any provisions in this Restricted Stock Unit Agreement, this RSU award shall, in the case of a Recipient subject to tax,
working and/or residing in Israel, also be subject to any special terms and conditions set forth in Appendix A to this Restricted Stock
Unit Agreement.
9. Legends.
The Recipient hereby acknowledges that the stock certificate or certificates (or entries in the case of book entry form) evidencing shares
of Stock or other securities issued pursuant to any settlement of an RSU or any Dividend Equivalent hereunder may bear a legend (or provide
a restriction) setting forth the restrictions on their transferability described in Section 7 hereof, if such restrictions are then in
effect.
10. Rights
as Stockholder. The Recipient shall have no rights as a stockholder with respect to any RSUs, Dividend Equivalents or Underlying Shares
until the date of issuance of a stock certificate (or appropriate entry is made in the case of book entry form) for Underlying Shares
and any Dividend Equivalents. Except as provided by Section 3, no adjustment shall be made for any rights for which the record date is
prior to the date such stock certificate is issued (or appropriate entry is made in the case of book entry form), except to the extent
the Administrator so provides, pursuant to the terms of the Plan and upon such terms and conditions it may establish.
11. Effect
Upon Employment and Performance of Services. Nothing in this Restricted Stock Unit Agreement or the Plan shall be construed to impose
any obligation upon the Company or any Related Company to employ or utilize the services of the Recipient or to retain the Recipient in
its employ or to engage or retain the services of the Recipient.
12. Time
for Acceptance. Unless the Recipient shall evidence acceptance of this Restricted Stock Unit Agreement by electronic or other means
prescribed by the Administrator within sixty (60) days after its delivery, the RSUs and any Dividend Equivalents shall be null and void
(unless waived by the Administrator).
13. Section
409A of the Internal Revenue Code. The RSUs and any Dividend Equivalents granted hereunder are intended to avoid the potential adverse
tax consequences to the Recipient of Section 409A of the Code and the Administrator may make such modifications to this Restricted Stock
Unit Agreement as it deems necessary or advisable to avoid such adverse tax consequences. If and to the extent that the RSUs and any Dividend
Equivalents are subject to Section 409A, in addition to the provisions of Section 9.13 of the Plan, any payment upon termination of the
Relationship shall be made only upon a “separation from service” under Section 409A, and the Recipient may not directly or
indirectly designate the calendar year of a payment.
14. Electronic
Delivery. The Company may, in its sole discretion, decide to deliver any documents related to current or future participation in the
Plan by electronic means. The Recipient consents to receive such documents by electronic delivery and agrees to participate in the Plan
through an on-line or electronic system established and maintained by the Company or a third party designated by the Company.
15. Company
Policies. This RSU shall be subject to any applicable clawback or recoupment policies, share trading policies, and other policies
that may be implemented by the Board from time to time, in accordance with applicable law.
16. Nature
of Award. By accepting this RSU, the Recipient acknowledges, understands and agrees that:
(a) the
Plan is established voluntarily by the Company, is discretionary in nature and may be modified, amended, suspended or terminated by the
Company at any time, to the extent permitted by the Plan and this Restricted Stock Unit Agreement;
(b) the
grant of this RSU is voluntary and occasional and does not create any contractual or other right to receive future awards under the Plan
or benefits in lieu of Plan awards, even if RSUs or other Plan awards have been granted in the past;
(c) all
decisions with respect to future RSU awards will be at the sole discretion of the Administrator;
(d) he
or she is voluntarily participating in the Plan;
(e) the
future value of the Underlying Shares is unknown and cannot be predicted with certainty; and
(f) the
Company shall not be liable for any foreign exchange rate fluctuation between the Recipient’s local currency and the United States
dollar that may affect the value of this RSU or any amounts due pursuant to the settlement of the RSU or the subsequent sale of any Underlying
Shares acquired upon settlement.
17. General
Provisions.
(a) Amendment;
Waivers. This Restricted Stock Unit Agreement, including the Plan, contains the full and complete understanding and agreement of the
parties hereto as to the subject matter hereof, and except as otherwise permitted by the express terms of the Plan and this Restricted
Stock Unit Agreement and applicable law, it may not be modified or amended nor may any provision hereof be waived without a further written
agreement duly signed by each of the parties; provided, however, that a modification or amendment that does not materially diminish the
rights of the Recipient hereunder, as they may exist immediately before the effective date of the modification or amendment, shall be
effective upon written notice of its provisions to the Recipient, to the extent permitted by applicable law. The waiver by either of the
parties hereto of any provision hereof in any instance shall not operate as a waiver of any other provision hereof or in any other instance.
The Recipient shall have the right to receive, upon request, a written confirmation from the Company of the Customizing Information.
(b) Binding
Effect. This Restricted Stock Unit Agreement shall inure to the benefit of and be binding upon the parties hereto and their respective
heirs, executors, administrators, representatives, successors and assigns.
(c) Fractional RSUs, Underlying
Shares and Dividend Equivalents. All fractional Underlying Shares and any Dividend Equivalents settled in Stock resulting from the
application of the Vesting Schedule or the adjustment provisions contained in the Plan shall be rounded down to the nearest whole share.
If cash in lieu of Underlying Shares is delivered at settlement, or any Dividend Equivalents are settled in cash, the amount paid
shall be rounded down to the nearest penny.
(d) Governing
Law. This Restricted Stock Unit Agreement shall be governed by and construed in accordance with the laws of the State of Delaware,
without regard to the principles of conflicts of law.
(e) Construction.
This Restricted Stock Unit Agreement is to be construed in accordance with the terms of the Plan. In case of any conflict between the
Plan and this Restricted Stock Unit Agreement, the Plan shall control. The titles of the sections of this Restricted Stock Unit Agreement
and of the Plan are included for convenience only and shall not be construed as modifying or affecting their provisions. The masculine
gender shall include both sexes; the singular shall include the plural and the plural the singular unless the context otherwise requires.
Capitalized terms not defined herein shall have the meanings given to them in the Plan.
(f) Language.
If the Recipient receives this Restricted Stock Unit Agreement, or any other document related to this RSU and/or the Plan translated into
a language other than English and if the meaning of the translated version is different than the English version, the English version
will control.
(g) Data
Privacy.
| (i) | The Recipient hereby explicitly and unambiguously consents to the collection, use and transfer, in electronic or other form, of the
Recipient’s personal data as described in this Restricted Stock Unit Agreement by and among, as applicable, his or her employer,
the Company and its subsidiaries for the exclusive purpose of implementing, administering and managing the Recipient’s participation
in the Plan. |
| (ii) | The Recipient understands that his or her employer, the Company and its subsidiaries, as applicable, hold certain personal information
about the Recipient regarding his or her employment, the nature and amount of the Recipient’s compensation and the fact and conditions
of the Recipient’s participation in the Plan, including, but not limited to, the Recipient’s name, home address, telephone
number and e-mail address, date of birth, social insurance number or other identification number, salary, nationality, job title, any
shares of stock or directorships held in the Company and its subsidiaries, details of all options, awards or any other entitlement to
shares of stock awarded, canceled, exercised, vested, unvested or outstanding in the Recipient’s favor, for the purpose of implementing,
administering and managing the Plan (the “Data”). |
| (iii) | The Recipient understands that the Data may be transferred to any third parties assisting in the implementation, administration and
management of the Plan, that these third parties may be located in the Recipient’s country, or elsewhere, and that the third party’s
country may have different data privacy laws and protections than the Recipient’s country. The Recipient understands that the Recipient
may request a list with the names and addresses of any potential recipients of the Data by contacting his or her local human resources
representative. The Recipient authorizes the recipients to receive, possess, use, retain and transfer the Data, in electronic or other
form, for the purposes of implementing, administering and managing the Recipient’s participation in the Plan, including any requisite
transfer of such Data as may be required to a broker or other third party. The Recipient understands that the Data will be held only as
long as is necessary to implement, administer and manage Recipient’s participation in the Plan. The Recipient understands that he
or she may, at any time, view the Data, request additional information about the storage and processing of the Data, require any necessary
amendments to the Data or refuse or withdraw the consents herein, in any case without cost, by contacting in writing the Recipient’s
local human resources representative. The Recipient understands, however, that refusing or withdrawing his or her consent may affect the
Recipient’s ability to participate in the Plan. For more information on the consequences of refusal to consent or withdrawal of
consent, the Recipient understands that the Recipient may contact his or her local human resources representative. |
(h) Notices.
Any notice in connection with this Restricted Stock Unit Agreement shall be deemed to have been properly delivered if it is delivered
in the form specified by the Administrator as follows:
|
To the Recipient: |
Last address provided to the Company |
|
|
|
|
To the Company: |
BiomX Inc. |
|
|
22 Einstein Street, 4th Floor |
|
|
Ness Ziona, Israel 7414003 |
|
|
Attn: Chief Financial Officer |
(i) Version
Number. This document is Version 1 of the BiomX Inc. 2019 Omnibus Long-Term Incentive Plan Restricted Stock Unit Agreement.
APPENDIX
A
BIOMX INC.
2019 OMNIBUS LONG-TERM INCENTIVE PLAN
Restricted Stock Unit Agreement
FOR
Israeli PARTICIPANTS
Terms and Conditions
This Appendix A includes additional terms and conditions that govern
the RSU award to Recipient under the Plan if Recipient is subject to tax, works, and/or resides, in Israel.
This Appendix A forms part of the Restricted Stock Unit Agreement.
Any capitalized term used in this Appendix A without definition will have the meaning ascribed to it in the Restricted Stock Unit Agreement
or the Plan, as applicable.
If Recipient is a citizen or resident of a jurisdiction, or is considered
resident of a jurisdiction, other than Israel, or Recipient transfers employment and/or residency from Israel after the Grant Date, the
Company will, in its sole discretion, determine to what extent the additional terms and conditions included herein will apply to Recipient
under these circumstances.
Notifications
This Appendix A also includes information relating to securities laws,
exchange control, foreign asset/account reporting requirements, and other issues of which Recipient should be aware with respect to Recipient’s
participation in the Plan. The information is based on the securities, exchange control, and other laws in effect in Israel as of July
2024. Such laws are often complex and change frequently. As a result, Recipient should not rely on the information herein as the only
source of information relating to the consequences of Recipient’s participation in the Plan because the information may be out of
date at the time that Recipient vests in the RSUs or sells Underlying Shares acquired pursuant to this RSU award.
In addition, the information is general in nature and may not apply
to Recipient’s particular situation, and the Company is not in a position to assure Recipient of any particular result. Accordingly,
Recipient should seek appropriate professional advice as to how the relevant laws in Israel may apply to Recipient’s situation.
Finally, if Recipient is a citizen or resident of a jurisdiction, or
is considered resident of a jurisdiction, other than Israel, or Recipient transfers employment and/or residency from Israel after the
Grant Date, the information contained herein may not apply to Recipient in the same manner.
Terms and Conditions
Nature of Award. By accepting this RSU award, Recipient understands
and agrees that the RSUs are offered subject to and in accordance with the Israeli Appendix to the Plan and the RSU is intended to be
a 102 Capital Gain Track Award (as defined in the Israeli Appendix). A copy of the Israeli Appendix is attached hereto as Exhibit
A. Notwithstanding the foregoing, the Company does not undertake to maintain the qualified status of this RSU award and Recipient
acknowledges that Recipient will not be entitled to damages of any kind if the RSU award becomes disqualified and no longer qualifies
as a 102 Capital Gain Track Award. In the event of any inconsistencies between the Israeli Appendix, the Restricted Stock Unit Agreement
and/or the Plan, the terms of the Israeli Appendix will govern.
Further, to the extent requested by the Company or an Affiliate, Recipient
agrees to execute any letter or other agreement in connection with the grant of this RSU award or any future RSUs granted under the Israeli
Appendix. If Recipient fails to comply with such request, the RSU may not qualify as a 102 Capital Gain Track Award.
Terms of RSUs. Certain specific terms of the RSU granted under
this Agreement are set forth in Exhibit B attached hereto. Notwithstanding anything to the contrary, this RSU award shall
not be settled in cash nor shall the Recipient be entitled to Dividend Equivalent Units.
Trust Arrangement. Recipient acknowledges and agrees that any
Underlying Shares issued upon vesting of this RSU award will be registered under the name of the Company’s designated trustee in
Israel, Altshare Trusts Ltd. (the “Trustee”) and for the benefit of the Recipient, in accordance with the terms of the trust
agreement between the Company and the Trustee (the “Trust Agreement,” a copy of which is attached hereto as Exhibit C).
Recipient further agrees that such Underlying Shares will be subject to the Required Holding Period (as defined in the Israeli Appendix),
which shall be 24 months from the Grant Date. The Company may, in its sole discretion, replace the Trustee from time to time and instruct
the transfer of all RSUs and Underlying Shares held and/or administered by such Trustee at such time to its successor and the provisions
of this Restricted Stock Unit Agreement shall apply to the new Trustee mutatis mutandis. The Company may replace, amend, cancel
or renew the Trust Agreement at any time, at its sole discretion. By accepting this RSU award, the Recipient hereby confirms that he or
she read the provisions of the Trust Agreement and that the terms and conditions thereof are hereby agreed and acknowledged and the Recipient
hereby agrees to be bound by, and comply with, the provisions of the Trust Agreement. The Recipient hereby confirms that he or she is
aware that the Underlying Shares may be held by a global stock plan administrator other than the Trustee, and that funds from the sale
or other disposition of such Underlying Shares will be transferred to an account in the name of the Trustee who shall transfer the funds
to the Recipient only after withholding any applicable Israeli taxes as required by law.
Restriction on Sale. Recipient acknowledges that any Underlying
Shares may not be sold prior to the expiration of the Required Holding Period in order to qualify for tax treatment under the 102 Capital
Gain Track. Accordingly, Recipient shall not dispose of (or request the Trustee to dispose of) any such Underlying Shares prior to the
expiration of the Required Holding Period, other than as permitted by applicable law. For purposes of Israeli tax provisions, “dispose”
shall mean any sale, transfer or other disposal of the Underlying Shares by Recipient (including by means of an instruction by Recipient
to the designated broker) or the Trustee, including a release of such Underlying Shares from the Trustee to Recipient.
Tax Obligations. The following provision supplements Section
5 of the Agreement.
The Recipient hereby acknowledges that he or she is familiar with the
provisions of Section 102 of the Israeli Income Tax Ordinance (New Version), 5721- 1961 (the “Israeli Income Tax Ordinance”)
and the regulations and rules promulgated thereunder, including without limitation, the tax implications applicable to this RSU award.
The fair market value of the RSUs on the Grant Date (as computed in
accordance with the provisions relating to the 102 Capital Gain Track) shall be subject to taxation in Israel in accordance with ordinary
income tax principles. Moreover, in the event that Recipient disposes of any Underlying Shares prior to the expiration of the Required
Holding Period, Recipient acknowledges and agrees that any additional gains from the sale of such Underlying Shares will not qualify for
tax treatment under the 102 Capital Gain Track and will be subject to taxation in Israel in accordance with ordinary income tax principles,
and any sanctions under Section 102 with respect thereto shall be borne solely by the Recipient. Further, the Recipient acknowledges and
agrees that Recipient will be liable for the Company’s or an Affiliates’ component of payments to the Israeli National Insurance
Institute (to the extent such payments by the Company or Affiliate are required).
The Recipient agrees that he or she shall not sell or release from
trust any Underlying Shares issued upon vesting under Section 102, or any shares received subsequently following any realization of rights,
including without limitation, bonus shares and dividend equivalents, until the lapse of the Restricted Holding Period.
Recipient further agrees that the Trustee may act on behalf of the
Company or its Affiliates, as applicable, to satisfy any obligation to withhold tax-related items applicable to the Recipient in connection
with the RSUs granted under the Israeli Appendix.
The following provisions apply if Recipient was not an Israeli tax
resident when the RSUs were granted or if the RSUs do not qualify as a 102 Capital Gain Track Award –
Non-Trustee Award. This RSU award is subject to the Plan and
is not made pursuant to Sections 102(b)(2) and (3) of the Israeli Income Tax Ordinance and, in particular, is not eligible to benefit
from the capital gains track described in subsection (b)(2) and (3) thereof. To facilitate compliance with tax requirements in Israel,
the Recipient acknowledges and agrees that the Company may require that any Underlying Shares be held with the Company’s designated
broker appointed under the Plan or another designee or that such Underlying Shares be sold at any such time specified by the Company.
Notifications
Securities Law Information. This RSU award does not constitute
a public offering under the Israeli Securities Law, 1968.
Exhibits. Exhibits A–C attached hereto shall be considered
an integral part of Appendix A and the Restricted Stock Unit Agreement.
BIOMX INC.
2019 OMNIBUS LONG-TERM INCENTIVE PLAN
EXHIBITS TO CUSTOMIZING INFORMATION FOR ISRAELI
RECIPIENTS
Exhibit A: |
Israeli Appendix to the BiomX Inc. 2019 Omnibus Long-Term Incentive Plan |
|
|
Exhibit B: |
Terms of RSUs |
|
|
Exhibit C: |
Trust Agreement |
EXHIBIT A
ISRAELI APPENDIX TO THE BIOMX, INC., 2019 OMNIBUS
LONG-TERM EQUITY INCENTIVE PLAN
EXHIBIT B
TERMS OF RSUs
Recipient’s Name and Address
|
|
[FIRST NAME]
[LAST NAME] |
|
|
[ADDRESS] |
|
|
[ZIP CODE] |
Type
of Award |
|
RSU |
Designation |
|
☐ Section
102 – Capital Gains Tax Track
☐ Section
102 – Non-Trustee Tax Track
☐ Section
3(i) |
Number
of Restricted Stock Units |
|
As
set forth in the Customizing Information |
Grant
Date |
|
As
set forth in the Customizing Information |
Vesting
Commencement Date |
|
As
set forth in the Customizing Information |
Vesting
Schedule |
|
As
set forth in the Customizing Information |
EXHIBIT C
Trust Agreement
Exhibit 31.1
CERTIFICATION
PURSUANT TO RULE 13a-14(a)
UNDER THE SECURITIES EXCHANGE ACT OF 1934
I, Jonathan Solomon, certify that:
1. I have reviewed this Quarterly Report on
Form 10-Q of BiomX Inc.;
2. Based on my knowledge,
this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements
made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge,
the financial statements, and other financial information included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s
other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange
Act Rules 13a-15(e) and 15d-15(e)) for the registrant and internal control over financial reporting (as defined in Exchange Act Rules
13(a)-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure
controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared;
(b) Designed such internal
control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes
in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness
of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this
report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most
recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or
is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s
other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to
the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent
functions):
(a) All significant deficiencies
and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely
affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether
or not material, that involves management or other employees who have a significant role in the registrant’s internal control over
financial reporting.
Date: November 14, 2024 |
/s/ Jonathan Solomon |
|
Jonathan Solomon |
|
Chief Executive Officer |
|
(Principal executive officer) |
Exhibit 31.2
CERTIFICATION
PURSUANT TO RULE 13a-14(a)
UNDER THE SECURITIES EXCHANGE ACT OF 1934
I, Marina Wolfson, certify that:
1. I have reviewed this Quarterly Report on
Form 10-Q of BiomX Inc.;
2. Based on my knowledge,
this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements
made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge,
the financial statements, and other financial information included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s
other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange
Act Rules 13a-15(e) and 15d-15(e)) for the registrant and internal control over financial reporting (as defined in Exchange Act Rules
13(a)-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure
controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared;
(b) Designed such internal
control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes
in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness
of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this
report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most
recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or
is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s
other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to
the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent
functions):
(a) All significant deficiencies
and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely
affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether
or not material, that involves management or other employees who have a significant role in the registrant’s internal control over
financial reporting.
Date: November 14, 2024 |
/s/ Marina Wolfson |
|
Marina Wolfson |
|
Chief Financial Officer |
|
(Principal financial officer) |
Exhibit 32
CERTIFICATION PURSUANT
TO
18 U.S.C. SECTION 1350
In connection with the
Quarterly Report of BiomX Inc. (the “Company”) on Form 10-Q for the quarter ended September 30, 2024 as filed with the Securities
and Exchange Commission (the “Quarterly Report”), each of the undersigned, in the capacities and on the dates indicated below,
hereby certifies pursuant to 18 U.S.C. Section 1350, that, to his or her knowledge:
| 1. | The Quarterly Report fully complies
with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
| 2. | The information contained in the
Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: November 14, 2024 |
/s/ Jonathan Solomon |
|
Jonathan Solomon |
|
Chief Executive Officer |
|
(Principal executive officer) |
Date: November 14, 2024 |
/s/ Marina Wolfson |
|
Marina Wolfson |
|
Chief Financial Officer |
|
(Principal financial officer) |
v3.24.3
Document And Entity Information - shares
|
9 Months Ended |
|
Sep. 30, 2024 |
Nov. 12, 2024 |
Document Information Line Items |
|
|
Entity Registrant Name |
BiomX Inc.
|
|
Trading Symbol |
PHGE
|
|
Document Type |
10-Q
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity Common Stock, Shares Outstanding |
|
18,176,602
|
Amendment Flag |
false
|
|
Entity Central Index Key |
0001739174
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Document Period End Date |
Sep. 30, 2024
|
|
Document Fiscal Year Focus |
2024
|
|
Document Fiscal Period Focus |
Q3
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
false
|
|
Entity Shell Company |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Entity File Number |
001-38762
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Tax Identification Number |
82-3364020
|
|
Entity Address, Address Line One |
22 Einstein St.,
|
|
Entity Address, Address Line Two |
Floor 4
|
|
Entity Address, City or Town |
Ness Ziona
|
|
Entity Address, Country |
IL
|
|
Entity Address, Postal Zip Code |
7414003
|
|
City Area Code |
+972
|
|
Local Phone Number |
723942377
|
|
Title of 12(b) Security |
Common stock, $0.0001 par value
|
|
Security Exchange Name |
NYSE
|
|
Entity Interactive Data Current |
Yes
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v3.24.3
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
Current assets |
|
|
|
Cash and cash equivalents |
|
$ 23,537
|
$ 14,907
|
Restricted cash |
|
1,114
|
957
|
Other current assets |
|
3,665
|
1,768
|
Total current assets |
|
28,316
|
17,632
|
Non-current assets |
|
|
|
Other assets |
|
96
|
|
Operating lease right-of-use assets |
|
9,700
|
3,495
|
Property and equipment, net |
|
6,581
|
3,902
|
In-process Research and development (“IPR&D”) assets |
|
15,287
|
|
Total non-current assets |
|
31,664
|
7,397
|
Total Assets |
|
59,980
|
25,029
|
Current liabilities |
|
|
|
Trade accounts payable |
|
2,779
|
1,381
|
Current portion of lease liabilities |
|
1,096
|
666
|
Other accounts payable |
|
5,069
|
3,344
|
Current portion of long-term debt |
|
|
5,785
|
Total current liabilities |
|
8,944
|
11,176
|
Non-current liabilities |
|
|
|
Contract liability |
|
|
1,976
|
Long-term debt, net of current portion |
|
|
5,402
|
Operating lease liabilities, net of current portion |
|
8,651
|
3,239
|
Other liabilities |
|
161
|
155
|
Private Placement Warrants |
|
4,328
|
|
Total non-current liabilities |
|
13,140
|
10,772
|
Commitments and Contingencies (Note 7) |
|
|
|
Stockholders’ equity |
|
|
|
Preferred Stock, $0.0001 par value; Authorized – 1,000,000 shares as of September 30, 2024 and December 31, 2023. Issued and outstanding- 147,735 as of September 30, 2024. No shares issued and outstanding as of December 31, 2023. |
|
18,645
|
|
Common Stock, $0.0001 par value; Authorized – 750,000,000 shares as of September 30, 2024 and 120,000,000 shares as of December 31, 2023. Issued and outstanding- 18,176,602 shares as of September 30, 2024 and 4,723,320 shares as of December 31, 2023. |
[1] |
6
|
3
|
Additional paid in capital |
|
185,429
|
166,048
|
Accumulated deficit |
|
(166,184)
|
(162,970)
|
Total stockholders’ equity |
|
37,896
|
3,081
|
Total liabilities and stockholders’ equity |
|
$ 59,980
|
$ 25,029
|
|
|
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v3.24.3
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares
|
Sep. 30, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
|
Preferred stock, par value (in Dollars per share) |
|
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
|
1,000,000
|
1,000,000
|
Preferred stock, shares issued |
|
147,735
|
|
Preferred stock, shares outstanding |
|
147,735
|
|
Common stock, par value (in Dollars per share) |
[1] |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
[1] |
750,000,000
|
120,000,000
|
Common stock, shares issued |
[1] |
18,176,602
|
4,723,320
|
Common stock, shares outstanding |
[1] |
18,176,602
|
4,723,320
|
|
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.3
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
|
Research and development (“R&D”) expenses, net |
|
$ 7,279
|
$ 5,641
|
$ 18,281
|
$ 14,023
|
General and administrative expenses |
|
3,248
|
2,154
|
8,756
|
6,053
|
Goodwill impairment |
|
801
|
|
801
|
|
Operating loss |
|
11,328
|
7,795
|
27,838
|
20,076
|
Other income |
|
(84)
|
(89)
|
(2,189)
|
(270)
|
Interest expenses |
|
5
|
574
|
868
|
1,884
|
Income from change in fair value of Private Placement Warrants |
|
(20,559)
|
|
(24,417)
|
|
Finance expense (income), net |
|
(332)
|
(382)
|
1,104
|
(1,034)
|
Loss (income) before tax |
|
(9,642)
|
7,898
|
3,204
|
20,656
|
Tax expenses |
|
|
8
|
10
|
22
|
Net loss (income) |
|
$ (9,642)
|
$ 7,906
|
$ 3,214
|
$ 20,678
|
Basic loss (earnings) per share of Common Stock (in Dollars per share) |
[1] |
$ (0.31)
|
$ 1.3
|
$ 0.32
|
$ 4.29
|
Diluted loss (earnings) per share of Common Stock (in Dollars per share) |
[1] |
$ (0.31)
|
$ 1.3
|
$ 2.45
|
$ 4.29
|
Weighted average number of shares used in computing basic loss (earnings) per share of Common Stock (in Shares) |
|
16,366,122
|
6,058,774
|
9,944,267
|
4,819,658
|
Weighted average number of shares used in computing diluted loss per share of Common Stock (in Shares) |
|
16,387,633
|
6,058,774
|
11,294,880
|
4,819,658
|
|
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.24.3
Condensed Consolidated Statements of Changes in Redeemable Convertible Preferred Shares and in Stockholders’ Equity (Capital Deficiency) (Unaudited) - USD ($) $ in Thousands |
Preferred Shares
Redeemable Convertible
|
Preferred Shares
Redeemable Convertible
|
Common Stock |
Additional Paid-in Capital |
Accumulated Deficit |
Total |
Balance at Dec. 31, 2022 |
|
|
|
$ 2
|
[1] |
$ 157,838
|
$ (136,801)
|
$ 21,039
|
|
Balance (in Shares) at Dec. 31, 2022 |
[1] |
|
|
3,122,987
|
|
|
|
|
|
Issuance of Common Stock and warrants under February 2023 PIPE, net of issuance costs |
[3] |
|
|
|
[1],[2] |
1,293
|
|
1,293
|
|
Issuance of Common Stock and warrants under February 2023 PIPE, net of issuance costs (in Shares) |
[1],[3] |
|
|
319,950
|
|
|
|
|
|
Stock-based compensation expenses |
|
|
|
|
[1] |
175
|
|
175
|
|
Stock-based compensation expenses (in Shares) |
[1] |
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
|
|
|
|
(6,361)
|
(6,361)
|
|
Balance at Mar. 31, 2023 |
|
|
|
$ 2
|
[1] |
159,306
|
(143,162)
|
16,146
|
|
Balance (in Shares) at Mar. 31, 2023 |
[1] |
|
|
3,442,937
|
|
|
|
|
|
Balance at Dec. 31, 2022 |
|
|
|
$ 2
|
[1] |
157,838
|
(136,801)
|
21,039
|
|
Balance (in Shares) at Dec. 31, 2022 |
[1] |
|
|
3,122,987
|
|
|
|
|
|
Net income (loss) |
|
|
|
|
|
|
|
(20,678)
|
|
Balance at Sep. 30, 2023 |
|
|
|
$ 3
|
[1] |
165,630
|
(157,479)
|
8,154
|
|
Balance (in Shares) at Sep. 30, 2023 |
[1] |
|
|
4,722,733
|
|
|
|
|
|
Balance at Mar. 31, 2023 |
|
|
|
$ 2
|
[1] |
159,306
|
(143,162)
|
16,146
|
|
Balance (in Shares) at Mar. 31, 2023 |
[1] |
|
|
3,442,937
|
|
|
|
|
|
Issuance of Common Stock and warrants under February 2023 PIPE, net of issuance costs |
[3] |
|
|
$ 1
|
[1] |
5,858
|
|
5,859
|
|
Issuance of Common Stock and warrants under February 2023 PIPE, net of issuance costs (in Shares) |
[1],[3] |
|
|
1,279,796
|
|
|
|
|
|
Stock-based compensation expenses |
|
|
|
|
[1] |
271
|
|
271
|
|
Stock-based compensation expenses (in Shares) |
[1] |
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
|
|
|
|
(6,411)
|
(6,411)
|
|
Balance at Jun. 30, 2023 |
|
|
|
$ 3
|
[1] |
165,435
|
(149,573)
|
15,865
|
|
Balance (in Shares) at Jun. 30, 2023 |
[1] |
|
|
4,722,733
|
|
|
|
|
|
Stock-based compensation expenses |
|
|
|
|
[1] |
195
|
|
195
|
|
Stock-based compensation expenses (in Shares) |
[1] |
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
|
|
|
|
(7,906)
|
(7,906)
|
|
Balance at Sep. 30, 2023 |
|
|
|
$ 3
|
[1] |
165,630
|
(157,479)
|
8,154
|
|
Balance (in Shares) at Sep. 30, 2023 |
[1] |
|
|
4,722,733
|
|
|
|
|
|
Balance at Dec. 31, 2023 |
|
|
|
$ 3
|
[1] |
166,048
|
(162,970)
|
3,081
|
|
Balance (in Shares) at Dec. 31, 2023 |
|
|
|
4,723,320
|
[1] |
|
|
|
|
Issuance of Common Stock, Merger Warrants and Redeemable Convertible Preferred Shares upon the APT acquisition, net of issuance cost |
[4] |
$ 12,561
|
|
$ 1
|
[1] |
3,227
|
|
3,228
|
|
Issuance of Common Stock, Merger Warrants and Redeemable Convertible Preferred Shares upon the APT acquisition, net of issuance cost (in Shares) |
[4] |
40,470
|
|
916,497
|
[1] |
|
|
|
|
Exercise of Pre-Funded Warrants into shares of Common Stock |
[3] |
|
|
|
[1],[2] |
5
|
|
5
|
|
Exercise of Pre-Funded Warrants into shares of Common Stock (in Shares) |
[3] |
|
|
477,827
|
[1] |
|
|
|
|
Issuance of Common Stock under At the Market Sales Agreement, net of $1 issuance costs |
[3] |
|
|
|
[1],[2] |
19
|
|
19
|
|
Issuance of Common Stock under At the Market Sales Agreement, net of $1 issuance costs (in Shares) |
[3] |
|
|
7,518
|
[1] |
|
|
|
|
Stock-based compensation expenses |
|
|
|
|
[1] |
909
|
|
909
|
|
Stock-based compensation expenses (in Shares) |
|
|
|
|
|
|
|
|
|
Issuance of Redeemable Convertible Preferred Shares upon March 2024 PIPE, net of issuance costs |
[3] |
$ 19,859
|
|
|
[1] |
541
|
|
541
|
|
Issuance of Redeemable Convertible Preferred Shares upon March 2024 PIPE, net of issuance costs (in Shares) |
[3] |
216,417
|
|
|
[1] |
|
|
|
|
Net income (loss) |
|
|
|
|
|
|
(17,327)
|
(17,327)
|
|
Balance at Mar. 31, 2024 |
|
$ 32,420
|
|
$ 4
|
[1] |
170,749
|
(180,297)
|
(9,544)
|
|
Balance (in Shares) at Mar. 31, 2024 |
|
256,887
|
|
6,125,162
|
[1] |
|
|
|
|
Balance at Dec. 31, 2023 |
|
|
|
$ 3
|
[1] |
166,048
|
(162,970)
|
3,081
|
|
Balance (in Shares) at Dec. 31, 2023 |
|
|
|
4,723,320
|
[1] |
|
|
|
|
Net income (loss) |
|
|
|
|
|
|
|
(3,214)
|
|
Balance at Sep. 30, 2024 |
|
|
$ 18,645
|
$ 6
|
[1] |
185,429
|
(166,184)
|
37,896
|
|
Balance (in Shares) at Sep. 30, 2024 |
|
|
147,735
|
18,176,602
|
[1] |
|
|
|
|
Balance at Mar. 31, 2024 |
|
$ 32,420
|
|
$ 4
|
[1] |
170,749
|
(180,297)
|
(9,544)
|
|
Balance (in Shares) at Mar. 31, 2024 |
|
256,887
|
|
6,125,162
|
[1] |
|
|
|
|
Exercise of Pre-Funded Warrants into shares of Common Stock |
[3] |
|
|
$ 1
|
[1] |
|
|
1
|
|
Exercise of Pre-Funded Warrants into shares of Common Stock (in Shares) |
[3] |
|
|
980,811
|
[1] |
|
|
|
|
Reclassification of Redeemable convertible preferred Shares to equity |
|
$ (32,420)
|
$ 32,420
|
|
[1] |
|
|
32,420
|
|
Reclassification of Redeemable convertible preferred Shares to equity (in Shares) |
|
(256,887)
|
256,887
|
|
[1] |
|
|
|
|
Stock-based compensation expenses |
|
|
|
|
|
77
|
|
77
|
|
Stock-based compensation expenses (in Shares) |
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
|
|
|
|
4,471
|
4,471
|
|
Balance at Jun. 30, 2024 |
|
|
$ 32,420
|
$ 5
|
[1] |
170,826
|
(175,826)
|
27,425
|
|
Balance (in Shares) at Jun. 30, 2024 |
|
|
256,887
|
7,105,973
|
[1] |
|
|
|
|
Redeemable Convertible Preferred Shares conversion into shares of Common Stock |
|
|
$ (13,775)
|
$ 1
|
[1] |
13,774
|
|
|
|
Redeemable Convertible Preferred Shares conversion into shares of Common Stock (in Shares) |
|
|
(109,152)
|
10,915,200
|
[1] |
|
|
|
|
Issuance of Common Stock upon restricted stock units (“RSU”) vesting |
|
|
|
|
[1],[2] |
|
|
|
[2] |
Issuance of Common Stock upon restricted stock units (“RSU”) vesting (in Shares) |
|
|
|
155,429
|
[1] |
|
|
|
|
Stock-based compensation expenses |
|
|
|
|
[1] |
829
|
|
829
|
|
Stock-based compensation expenses (in Shares) |
|
|
|
|
[1] |
|
|
|
|
Net income (loss) |
|
|
|
|
|
|
9,642
|
9,642
|
|
Balance at Sep. 30, 2024 |
|
|
$ 18,645
|
$ 6
|
[1] |
$ 185,429
|
$ (166,184)
|
$ 37,896
|
|
Balance (in Shares) at Sep. 30, 2024 |
|
|
147,735
|
18,176,602
|
[1] |
|
|
|
|
|
|
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v3.24.3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
CASH FLOWS – OPERATING ACTIVITIES |
|
|
Net loss |
$ (3,214)
|
$ (20,678)
|
Adjustments required to reconcile cash flows used in operating activities: |
|
|
Depreciation and amortization |
882
|
659
|
Stock-based compensation |
1,083
|
641
|
Amortization of debt issuance costs |
|
453
|
Finance income, net |
(478)
|
(293)
|
Revaluation of contingent consideration |
6
|
(40)
|
Income from change in fair value of Private Placement Warrants |
(24,417)
|
|
Private Placement Warrants issuance cost |
732
|
|
Change in contract liability |
(1,976)
|
|
Loss from sale and disposal of fixed assets, net |
145
|
|
Goodwill impairment |
801
|
|
Changes in operating assets and liabilities: |
|
|
Other current and non-current assets |
(213)
|
679
|
Trade accounts payable |
(2,691)
|
241
|
Other accounts payable |
(1,169)
|
3,354
|
Net change in operating leases |
(181)
|
(60)
|
Net cash used in operating activities |
(30,690)
|
(15,044)
|
CASH FLOWS – INVESTING ACTIVITIES |
|
|
Cash and restricted cash acquired from the APT acquisition |
663
|
|
Proceeds from short-term deposits |
|
2,000
|
Proceeds from sale of property and equipment |
72
|
|
Purchases of property and equipment |
(19)
|
(43)
|
Net cash provided by investing activities |
716
|
1,957
|
CASH FLOWS – FINANCING ACTIVITIES |
|
|
Issuance of Private Placement Warrants under March 2024 PIPE |
28,745
|
|
Issuance of Redeemable Convertible Preferred Shares under March 2024 PIPE |
21,269
|
|
March 2024 PIPE issuance costs |
(507)
|
|
Issuance costs from February 2023 PIPE |
|
(333)
|
Issuance of Common Stock and Warrants under February 2023 PIPE |
|
7,485
|
Pre-Funded Warrants exercise |
6
|
|
Issuance of Common Stock under Open Market Sales Agreement, net of issuance costs |
19
|
|
Issuance cost from the APT acquisition |
(13)
|
|
Repayment of long-term debt |
(10,747)
|
(2,929)
|
Net cash provided by financing activities |
38,772
|
4,223
|
Increase (decrease) in cash and cash equivalents and restricted cash |
8,798
|
(8,864)
|
Effect of exchange rate changes on cash and cash equivalents and restricted cash |
(11)
|
(37)
|
Cash and cash equivalents and restricted cash at the beginning of the period |
15,864
|
32,294
|
Cash and cash equivalents and restricted cash at the end of the period |
24,651
|
23,393
|
RECONCILIATION OF AMOUNTS ON CONSOLIDATED BALANCE SHEETS |
|
|
Cash and cash equivalents |
23,537
|
22,450
|
Restricted cash |
1,114
|
943
|
Total cash and cash equivalents and restricted cash |
24,651
|
23,393
|
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: |
|
|
Cash paid for interest |
1,437
|
1,455
|
Taxes paid |
10
|
50
|
SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES: |
|
|
Property and equipment purchases included in accounts payable and Trade payable |
11
|
5
|
Issuance cost from March 2024 PIPE |
1,685
|
|
Issuance of Common Stock under the APT acquisition |
3,041
|
|
Issuance of Redeemable Convertible Preferred Shares under the APT acquisition |
12,610
|
|
Issuance of Merger Warrants under the APT acquisition |
200
|
|
Redeemable Convertible Preferred Shares conversion into shares of Common Stock |
$ 13,774
|
|
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v3.24.3
General
|
9 Months Ended |
Sep. 30, 2024 |
General [Abstract] |
|
GENERAL |
NOTE 1 – GENERAL
BiomX Inc. (individually, and together
with its subsidiaries, BiomX Ltd. (“BiomX Israel”), RondinX Ltd. and Adaptive Phage Therapeutics LLC, (“APT”),
the “Company” or “BiomX”) was incorporated in 2017. The Company’s shares of Common Stock are traded on the
NYSE American under the symbol PHGE. The Company’s units, consisting of one share of Common Stock and one warrant to purchase one-half
of a share of Common Stock (“Units”), were traded on the NYSE American under the symbol PHGE.U until a mandatory unit separation
of the units became effective on October 25, 2024. Certain warrants were quoted on OTC Pink under the symbol “PHGEW” and expired
on October 28, 2024.
BiomX is developing both natural and
engineered phage cocktails designed to target and destroy harmful bacteria in chronic diseases, focusing its efforts, at this point, on
cystic fibrosis and on diabetic foot osteomyelitis. BiomX discovers and validates proprietary bacterial targets and customizes phage compositions
against these targets. The Company’s headquarters are located in Ness Ziona, Israel.
On March 6, 2024, the Company entered
into an agreement and plan of merger (the “Merger Agreement”) with APT and certain other parties, as a result of which APT
became a wholly-owned subsidiary of the Company (the “Acquisition”), as further described below. Additionally, on March 15,
2024, concurrently with the consummation of the Acquisition, the Company consummated a private placement (the “March 2024 PIPE”)
with certain investors pursuant to which such investors purchased an aggregate of 216,417 shares of the Company’s Series X non-voting
convertible preferred share, par value $0.0001 per share (the “Redeemable Convertible Preferred Shares”), with each share
of Redeemable Convertible Preferred Shares being convertible into 100 shares of the Company’s Common Stock, after giving effect
to the Reverse Split (as defined below), and warrants (the “Private Placement Warrants”) to purchase up to an aggregate of
10,820,850 shares of the Company’s Common Stock, for aggregate gross proceeds of approximately $50,000. See Note 1D for further
information regarding the Acquisition and the conversion of the Redeemable Convertible Preferred Shares.
On August 8, 2024, the Board of Directors
approved a 1-for-10 reverse stock split of the Company’s shares of Common Stock (the “Reverse Split”), effective on
August 26, 2024. See Note 10A for further information.
|
B. |
The war with Hamas and Hezbollah |
On October 7, 2023, an unprecedented
attack was launched against Israel by terrorists from the Hamas terrorist organization that infiltrated Israel’s southern border
from the Gaza Strip and in other areas within the state of Israel attacking civilians and military targets while simultaneously launching
extensive rocket attacks on the Israeli population. These attacks resulted in extensive deaths, injuries and kidnapping of civilians and
soldiers. In response, the Security Cabinet of the State of Israel declared war against Hamas and a military campaign against these terrorist
organizations commenced in parallel to their continued rocket and terror attacks. In addition, Hezbollah, an Islamist terrorist group
that controls large portions of southern Lebanon, has attacked military and civilian targets in Northern Israel, to which Israel has responded.
Moreover, Iran recently launched a direct attack on Israel involving hundreds of drones and missiles and has threatened to continue to
attack Israel and is widely believed to be developing nuclear weapons. Iran is also believed to have a strong influence among extremist
groups in the region, such as Hamas in Gaza, Hezbollah in Lebanon, the Houthi movement in Yemen and various rebel militia groups in Syria
and Iraq. Such clashes may escalate in the future into a greater regional conflict.
To date, the State of Israel continues
to be at war with Hamas and Hezbollah and in an armed conflict with Iran and its rebel militia groups.
BiomX headquarters are located in Ness
Ziona, Israel; as well as most of its operations. In addition, most of the key employees and officers are residents of Israel. Accordingly,
political, economic and military conditions in Israel and the surrounding region may directly affect its business.
While a few employees of the Company
were called to reserve duty in the Israel Defense Forces, the ongoing war with Hamas and Hezbollah has not, since its inception, materially
impacted BiomX’s business or operations. Furthermore, BiomX does not expect any delays to its programs as a result of the situation.
However, at this time, it is not possible to predict the intensity or duration of Israel’s war against Hamas and Hezbollah, nor
predict how this war will ultimately affect BiomX business and operations or Israel’s economy in general.
As of September 30, 2024, the Company has an accumulated deficit of
$166,184 and has incurred significant losses and negative cash flows from operations. These are expected to continue in the foreseeable
future. The Company plans to continue to fund its ongoing operations, as well as other development activities relating to additional product
candidates, through issuance of debt and/or equity securities, loans, and government grants. Management believes that its current funds
are not sufficient to fund its operations for at least one year from the issuance date of these financial statements. Increased research
and development, clinical, or operating expenses may require additional funding or expense postponement. The Company’s ability to
raise capital is subject to market conditions and other aspects, which may affect the terms and availability of such funding. These factors
raise substantial doubt about the Company’s ability to continue as a going concern. The unaudited condensed consolidated financial
statements have been prepared on a going concern basis and do not include any adjustments that may result from the outcome of such circumstances.
On March 6, 2024, the Company, entered
into the Merger Agreement with BTX Merger Sub I, Inc., a Delaware corporation and a wholly owned subsidiary of the Company (“First
Merger Sub”), BTX Merger Sub II, LLC, a Delaware limited liability company and wholly owned subsidiary of the Company (“Second
Merger Sub”), and APT. Pursuant to the Merger Agreement, First Merger Sub merged with and into APT, with APT being the surviving
corporation and becoming a wholly owned subsidiary of the Company (the “First Merger”). Immediately following the First Merger,
APT merged with and into Second Merger Sub, pursuant to which Second Merger Sub was the surviving entity. APT was a U.S.-based privately
held, clinical-stage biotechnology company pioneering the development of phage-based therapies to combat bacterial infection. As a result
of the Acquisition, the Company is expected to have a pipeline that includes two Phase 2 assets each aimed at treating serious infections
with unmet medical needs.
On March 15, 2024, the effective date of the Acquisition (the “Closing
Date”), APT’s former stockholders were issued an aggregate of 916,497 shares of the Company’s Common Stock, 40,470 Redeemable
Convertible Preferred Shares and Warrants to purchase up to an aggregate of 216,650 shares of the Company Common Stock (“Merger
Warrants”). Each share of Redeemable Convertible Preferred Shares is convertible into an aggregate of 100 shares, after giving effect
to the Reverse Split of Common Stock. The Merger Warrants will be exercisable at any time after the date of the receipt of BiomX
stockholder approval at an exercise price of $50.00 per share and will expire on January 28, 2027. In the event the Redeemable Convertible
Preferred Shares are not converted by the earlier to occur of (i) the time that meeting of BiomX stockholders is ultimately concluded
or (ii) five months after the initial issuance of the Redeemable Convertible Preferred Shares, the Company may be required to pay to each
holder of the Redeemable Convertible Preferred Shares an amount in cash equal to the fair value of the Redeemable Convertible Preferred
Shares. On July 9, 2024, the Company’s stockholders approved the conversion of the Redeemable Convertible Preferred Shares into
shares of Common Stock and the issuance of shares of Common Stock upon the exercise of the Merger Warrants.
The Redeemable Convertible Preferred
Shares are entitled to receive dividends on shares of the Redeemable Convertible Preferred Shares equal to, on an as-if-converted-to Common-Stock
basis, and in the same form as, dividends actually paid on shares of the Common Stock. Except as otherwise required by law or with respect
to the Redeemable Convertible Preferred Shares protective provisions set forth in the Company’s Certificate of Designations, the
Redeemable Convertible Preferred Shares does not have voting rights.
At the Closing Date, the Redeemable Convertible Preferred Shares were
classified as temporary equity in accordance with the provisions of ASC 480-10-S99, as they included clauses that could constitute redemption
clauses that were subject to the Company’s stockholder approval and outside of the Company’s control. On June 17, 2024, the
Company filed a definitive Proxy Statement on Schedule 14A with respect to a meeting of stockholders to approve, among other things, the
conversion of the Redeemable Convertible Preferred Shares into shares of Common Stock. In addition, the majority of the Company’s
stockholders signed a binding support agreement that contained their commitment to vote in favor or deliver a written consent regarding
any stockholders’ matter in the stockholders’ meeting which took place on July 9, 2024. These circumstances led the Company
to determine that the Redeemable Convertible Preferred Shares meet the definition of permanent equity as the Company is able to control
the redemption. Therefore, the Redeemable Convertible Preferred Shares were reclassified as equity. On July 15, 2024, 109,152 Redeemable
Convertible Preferred Shares that were issued under the Acquisition and the March 2024 PIPE were converted into 10,915,200 shares of the
Company’s Common Stock according to beneficial ownership limitations set by certain investors. The Merger Warrants are classified
as equity, as they are indexed to the Company’s own shares and meet the classification requirements for stockholders’ equity
classification under ASC 815-40.
Concurrently with the consummation
of the Acquisition, the Company entered into a securities purchase agreement with certain investors, for aggregate gross proceeds of $50,000.
See Note 10A for further information.
Immediately following the Acquisition,
and without taking into account the PIPE Preferred Shares and the Private Placement Warrants as defined and described in Note 10A, the
Company’s stockholders prior to the Acquisition owned approximately 55% of the Company and APT’s stockholders prior to the
Acquisition owned approximately 45% of the Company on a diluted basis.
The Acquisition was accounted for in
accordance with Accounting Standards Codification (“ASC”) Topic 805, “Business Combinations,” using the acquisition
method of accounting. The Company was identified as the accounting acquirer, based on the evaluation of the following facts and circumstances:
|
● |
Pursuant to the Merger Agreement, the post-Acquisition board of directors of the Company consisted of seven directors, out of which the Company designated four board seats, with the Company’s chair of the board prior to the Acquisition continuing in his position, i.e. the majority of the post-closing board was designated by the Company. |
|
● |
The Chief Executive Officer and the majority of management roles are held by individuals who were affiliated with the Company prior to the Acquisition. |
The Acquisition-related transaction
costs are accounted for as expenses in the period in which the costs are incurred. The Company incurred transaction costs of $874 during
the nine months ended September 30, 2024, which were included in general and administrative expenses in the condensed consolidated statements
of operations.
Purchase Price Allocation
The following sets forth the fair value
of acquired identifiable assets and assumed liabilities of APT, after considering measurement period adjustment as described
below, which includes adjustments to reflect the fair value of intangible assets acquired as of March 15, 2024:
| |
Amounts | |
Cash and cash equivalents | |
| 509 | |
Restricted cash | |
| 154 | |
Other current assets | |
| 1,780 | |
Property, plant and equipment | |
| 3,748 | |
Operating lease right-of-use asset | |
| 7,953 | |
IPR&D assets and Goodwill | |
| 16,088 | |
Total assets | |
| 30,232 | |
| |
| | |
Trade accounts payable | |
| (3,667 | ) |
Other accounts payable | |
| (2,895 | ) |
Operating lease liability | |
| (7,819 | ) |
Total liabilities | |
| (14,381 | ) |
Total consideration | |
| 15,851 | |
The fair value estimate for all identifiable
assets and liabilities assumed is based on assumptions that market participants would use in pricing an asset, based on the most advantageous
market for the asset (i.e., its highest and best use).
The Company recognized intangible assets
related to the Acquisition, which consist of IPR&D valued at $15,287 using the Multi-Period Excess Earnings Method valuation method
and of goodwill valued at $501. The goodwill is primarily attributed to the expected synergies from combining the operations of APT with
the Company’s operations and to the assembled workforce of APT. The IPR&D is considered indefinite lived until the completion
or abandonment of the associated research and development efforts. Upon successful completion of the project, IPR&D assets are reclassified
to developed technology and amortized over their estimated useful lives During the three months ended September
30, 2024, the Company made measurement period adjustment to the purchase price allocation, which resulted in an increase to goodwill of
$300. The increase resulted from a provision for a contingency not provided in the initial Purchase Price Allocation, following a
term sheet for a settlement agreement between APT and Oyster Point Pharma, Inc. (“Oyster”) in connection with the Collaboration
and Option Agreement signed in May 2021 as discussed in Note 7A. The fair value of assets acquired and liabilities assumed have been finalized.
During the three months ended September 30, 2024, the Company recorded goodwill impairment in the amount of $801. See note 12 for further
information.
These intangible assets are classified
as Level 3 measurements within the fair value hierarchy.
The following table summarizes the
fair value of the consideration transferred to APT shareholders for the Acquisition:
| |
Amounts | |
Common Stock | |
| 3,041 | |
Redeemable Convertible Preferred Shares | |
| 12,610 | |
Merger Warrants | |
| 200 | |
| |
| 15,851 | |
The fair value of shares of Common
Stock issued by the Company was determined using the Company’s closing trading price on the Closing Date adjusted by a discount
for lack of marketability (“DLOM”) of 9.4% as a registration statement was filed within 45 days. The fair value of Redeemable
Convertible Preferred Shares was determined using the Company’s closing trading price on the Closing Date adjusted by a DLOM of
14.9% as the conversion of the Redeemable Convertible Preferred Shares to shares of Common Stock was subject to the stockholder approval,
which was obtained on July 9, 2024. The Company determined the fair value of the Merger Warrants using the Black-Scholes model as of the
Closing Date. The main assumptions used are as follows:
Underlying value of Common Stock ($) | |
| 0.37 | |
Exercise price ($) | |
| 5.0 | |
Expected volatility (%) | |
| 117.7 | |
Expected terms (years) | |
| 2.87 | |
Risk-free interest rate (%) | |
| 4.5 | |
The actual APT net loss included in
the Company’s condensed consolidated statements of operations for the nine months ended September 30, 2024, is as follows:
| |
September 30, 2024 | |
Net loss attributable to APT | |
| 5,884 | |
The unaudited pro forma financial information
below summarizes the combined results of operations for BiomX Inc. (including its wholly owned subsidiaries, BiomX Ltd. and RondinX Ltd.)
and APT. The unaudited pro forma financial information includes adjustments to reflect certain business combination effects, including:
acquisition-related costs incurred by both parties and reversal of certain costs incurred by BiomX Inc. which would not have been incurred
had the acquisition occurred on January 1, 2023. The unaudited pro forma financial information as presented below is for informational
purposes only and is not necessarily indicative of the results of operations that would have been achieved if the Acquisition had taken
place at the beginning of fiscal 2023.
The following unaudited table provides
certain pro forma financial information for the Company as if the Acquisition occurred on January 1, 2023:
| |
September 30, 2024* | |
Net loss | |
| 2,698 | |
| * | The pro forma amounts above are derived from historical numbers of the Company and APT. |
|
X |
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v3.24.3
Significant Accounting Policies
|
9 Months Ended |
Sep. 30, 2024 |
Significant Accounting Policies [Abstract] |
|
SIGNIFICANT ACCOUNTING POLICIES |
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES
| A. | Unaudited Condensed Financial Statements |
The accompanying unaudited condensed
consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”)
for condensed financial information. They do not include all the information and footnotes required by GAAP for complete financial statements.
In the opinion of management, all adjustments considered necessary for a fair statement have been included (consisting only of normal
recurring adjustments except as otherwise discussed).
The financial information contained
in this report should be read in conjunction with the annual financial statements included in the Company’s Annual Report on Form
10-K for the fiscal year ended December 31, 2023, that the Company filed with the U.S. Securities and Exchange Commission (the “SEC”)
on April 4, 2024. The year-end balance sheet data was derived from the audited consolidated financial statements as of December 31, 2023.
| B. | Principles of Consolidation |
The condensed consolidated financial
statements include the accounts of the Company and its subsidiaries. Intercompany balances and transactions have been eliminated upon
consolidation.
| C. | Use of Estimates in the Preparation of Financial Statements |
The preparation of financial statements in conformity with GAAP requires
management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets
and liabilities in the financial statements and the amounts of expenses during the reported years. The most significant estimates in the
Company’s financial statements relate to accruals for research and development expenses, valuation of stock-based compensation awards,
purchase price allocation related to the Acquisition and the Private Placement Warrants fair value revaluation; estimates used in the
IPR&D impairment assessment for calculating the fair value of the Company’s assets by using discounted cash flow incorporate
the Company’s estimated post-tax weighted average cost of capital, amounts and timing of projected future cash flows that are influenced
by the expected outcome of research and development activities, the probability of success and timing in gaining regulatory approval,
size of the potential market and the Company’s specific market share. These estimates and assumptions are based on current facts,
future expectations, and various other factors believed to be reasonable under the circumstances, the results of which form the basis
for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from
other sources. Actual results may differ materially and adversely from these estimates.
The full extent to which Israel’s
war with Hamas and Hezbollah may directly or indirectly impact the Company’s business, results of operations and financial condition
will depend on future developments that are uncertain, as well as the economic impact on local, regional, national and international markets.
The Company allocates the fair value
of consideration transferred in a business combination to the assets acquired, liabilities assumed based on their fair values at the acquisition
date. Acquisition-related expenses are recognized separately from the business combination and are expensed as incurred. The excess of
the fair value of the consideration transferred over the fair value of the assets acquired, liabilities assumed in the acquired business
is recorded as goodwill. The fair value of the consideration transferred included equity securities. The allocation of the consideration
transferred in certain cases may be subject to revision based on the final determination of fair values during the measurement period,
which may be up to one year from the acquisition date. The cumulative impact of revisions during the measurement period is recognized
in the reporting period in which the revisions are identified. The Company includes the results of operations of the businesses that it
has acquired in its consolidated results prospectively from the respective dates of Acquisition.
When the Company issues freestanding
instruments, it first analyzes the provisions of ASC 480, “Distinguishing Liabilities From Equity” (“ASC 480”)
in order to determine whether the instrument should be classified as a liability, with subsequent changes in fair value recognized in
the consolidated statements of operations in each period. If the instrument is not within the scope of ASC 480, the Company further analyzes
the provisions of ASC 815-10 in order to determine whether the instrument is considered indexed to the entity’s own stock and qualifies
for classification within equity.
When the Company issues preferred shares,
it first considers the provisions of ASC 480, in order to determine whether the preferred shares should be classified as a liability.
If the instrument is not within the scope of ASC 480, the Company further analyzes the instrument’s characteristics in order to
determine whether it should be classified within temporary equity (mezzanine) or within permanent equity in accordance with the provisions
of ASC 480-10-S99. The Company reassesses the classification of a contract over its own equity under the guidance above at each balance
sheet date. If classification changes as a result of events during the reporting period, the Company reclassifies the contract as of the
date of the event that caused the reclassification. See Note 1D regarding the reclassification of the Redeemable Convertible Preferred
Shares.
When the Company issues warrants, it
first considers the provisions of ASC 815-40, “Contracts in Entity’s Own Equity” (“ASC 815-40”) in order
to determine whether the warrants should be classified as equity. Equity classification is permitted when warrants are indexed to the
Company’s own shares and meet the classification requirements for stockholders’ equity classification under ASC 815-40. If
the warrants are not within the scope of ASC 815-40, the Company accounts for the warrants in accordance with the guidance contained in
Accounting Standards Codification 815 (“ASC 815”), “Derivatives and Hedging”, under which the warrants do not
meet the criteria for equity treatment and must be recorded as derivative liabilities. Accordingly, the Company classifies the Private
Placement Warrants as liabilities at their fair value and adjusts the warrants to fair value at each reporting period. This liability
is subject to re-measurement at each balance sheet date until the warrants are exercised or expire, and any change in fair value is recognized
in the condensed consolidated statements of operations. See Note 10A for further information regarding the Private Placement Warrants.
| F. | Basic and diluted loss (earnings) per share |
Basic loss (earnings) per share is
computed by dividing net loss (income) by the weighted average number of shares of Common Stock outstanding during the period, fully vested
warrants with no exercise price for the Company’s Common Stock and fully vested Pre-Funded Warrants for the Company’s Common
Stock at an exercise price of $0.001 per share, as the Company considers these shares to be exercised for little to no additional consideration.
The calculation excludes shares of Common Stock purchased by the Company and held as treasury shares. Diluted loss (income) per share
is computed by dividing net loss by the weighted average number of shares of Common Stock outstanding during the period, plus the number
of shares of Common Stock that would have been outstanding if all potentially dilutive shares of Common Stock had been issued, using the
treasury stock and if-converted method, in accordance with ASC 260-10, “Earnings per Share.”
The Company computes net loss (income)
per share using the two-class method required for participating securities. The two-class method requires income available to common stockholders
for the period to be allocated between shares of Common Stock and participating securities based upon their respective rights to receive
dividends as if all income for the period had been distributed. The Company considers its Redeemable Convertible Preferred Shares to be
participating securities as the holders of the Redeemable Convertible Preferred Shares would be entitled to dividends that would be distributed
to the holders of Common Stock, on a pro-rata basis assuming conversion of all Redeemable Convertible Preferred Shares into shares of
Common Stock. These participating securities do not contractually require the holders of such shares to participate in the Company’s
losses. As such, net loss for the periods presented was not allocated to the Company’s participating securities.
Goodwill
Goodwill reflects the excess of the
consideration transferred at the business combination date over the fair values of the identifiable net assets acquired. Goodwill is an
asset representing the future economic benefits arising from other assets acquired in a business combination that are not individually
identified and separately recognized. The primary items that generate goodwill include the value of the synergies between the acquired
company and the Company and the acquired assembled workforce, neither of which qualifies for recognition as an intangible asset. ASC 350,
“Intangibles—Goodwill and Other” allows an entity to first assess qualitative factors to determine whether a
quantitative goodwill impairment test is necessary. Further testing is only required if the entity determines, based on the qualitative
assessment, that it is more likely than not that the fair value is less than its carrying amount. Otherwise, no further impairment testing
is required. The Company’s goodwill is tested
for impairment at least on an annual basis, on the last day of the third quarter of the fiscal year and whenever events or changes in
circumstances indicate the carrying value of a reporting unit may not be recoverable. When necessary, the Company records charges for
impairments of goodwill for the amount by which the carrying amount of the respective reporting unit exceeds its fair value. However,
the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. During the three months ended September
30, 2024, the Company recorded goodwill impairment in the amount of $801. See note 12 for further information.
Intangible assets
IPR&D assets acquired in a business combination are recognized
at fair value as of the acquisition date and subsequently accounted for as indefinite-lived intangible assets until completion or abandonment
of the associated R&D efforts. Indefinite-lived intangible assets are reviewed for impairment at least annually, on the last day of
the third quarter of the fiscal year or whenever there is an indication that the asset may be impaired.
| H. | Recent Accounting Standards |
Recently issued accounting pronouncements,
not yet adopted
In December 2023, the Financial Accounting
Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-09 “Income Taxes (Topic 740): Improvements
to Income Tax Disclosures” (“ASU 2023-09”). This guidance is intended to enhance the transparency and decision-usefulness
of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily through
changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S. and in foreign jurisdictions. ASU 2023-09 is
effective for fiscal years beginning after December 15, 2024 on a prospective basis, with the option to apply the standard retrospectively.
Early adoption is permitted. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated
financial statements disclosures.
In November 2023, the FASB issued ASU
2023-07 “Segment Reporting: Improvements to Reportable Segment Disclosures” (“ASU 2023-07”). This guidance expands
public entities’ segment disclosures primarily by requiring disclosure of significant segment expenses that are regularly provided
to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of
its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets that are currently
required annually. Public entities with a single reportable segment are required to provide the new disclosures and all the disclosures
required under ASC 280, “Segment Reporting”. The guidance is effective for fiscal years beginning after December 15, 2023,
and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The amendments are required
to be applied retrospectively to all prior periods presented in an entity’s financial statements. The Company is currently evaluating
this guidance to determine the impact it may have on its consolidated financial statements disclosures.
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v3.24.3
Fair Value of Financial Instruments
|
9 Months Ended |
Sep. 30, 2024 |
Fair Value of Financial Instruments [Abstract] |
|
FAIR VALUE OF FINANCIAL INSTRUMENTS |
NOTE 3 – FAIR VALUE OF FINANCIAL INSTRUMENTS
The Company accounts for financial
instruments in accordance with ASC 820, “Fair Value Measurements and Disclosures” (“ASC 820”). ASC 820 establishes
a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest
priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority
to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy under ASC 820 are described below:
Level 1 – Unadjusted quoted prices
in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities.
Level 2 – Quoted prices in non-active
markets or in active markets for similar assets or liabilities, observable inputs other than quoted prices, and inputs that are not directly
observable but are corroborated by observable market data.
Level 3 – Prices or valuations
that require inputs that are both significant to the fair value measurement and unobservable.
There were no changes in the fair value
hierarchy levelling during the nine months ended September 30, 2024 and year ended December 31, 2023. The following table summarizes the
fair value of our financial assets and liabilities that were accounted for at fair value on a recurring basis, by level within the fair
value hierarchy:
| |
September 30, 2024 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Fair Value | |
Assets: | |
| | |
| | |
| | |
| |
Cash equivalents: | |
| | |
| | |
| | |
| |
Money market funds | |
| 20,325 | | |
| - | | |
| - | | |
| 20,325 | |
Foreign exchange contracts receivable | |
| - | | |
| 15 | | |
| - | | |
| 15 | |
| |
| 20,325 | | |
| 15 | | |
| - | | |
| 20,340 | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Contingent consideration | |
| - | | |
| - | | |
| 161 | | |
| 161 | |
Private Placement Warrants | |
| - | | |
| - | | |
| 4,328 | | |
| 4,328 | |
| |
| - | | |
| - | | |
| 4,489 | | |
| 4,489 | |
| |
December 31, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Fair Value | |
Assets: | |
| | |
| | |
| | |
| |
Cash equivalents: | |
| | |
| | |
| | |
| |
Money market funds | |
| 11,377 | | |
| - | | |
| - | | |
| 11,377 | |
Foreign exchange contracts receivable | |
| | | |
| 256 | | |
| - | | |
| 256 | |
| |
| 11,377 | | |
| 256 | | |
| - | | |
| 11,633 | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Contingent consideration | |
| - | | |
| - | | |
| 155 | | |
| 155 | |
| |
| - | | |
| - | | |
| 155 | | |
| 155 | |
The changes in the fair value of the
Company’s Level 3 financial liabilities, which are measured on a recurring basis are as follows:
| |
Nine Months Ended September 30, 2024 | | |
Nine Months Ended September 30, 2023 | |
Beginning balance | |
- | | |
- | |
Private Placement Warrants | |
| 28,745 | | |
| - | |
Change in fair value | |
| (24,417 | ) | |
| - | |
Ending balance | |
| 4,328 | | |
| - | |
Financial instruments with carrying
values approximating fair value include cash and cash equivalents, restricted cash, short-term deposits, other current assets, trade accounts
payable and other accounts payable, due to their short-term nature. The Company determined the fair value
of the liabilities for the contingent consideration based on a probability of discounted cash flow analysis. This fair value measurement
is based on significant unobservable inputs in the market and thus represents a Level 3 measurement within the fair value hierarchy. The
fair value of the contingent consideration is based on several factors, such as: the attainment of future clinical, developmental, regulatory,
commercial and strategic milestones relating to product candidates for treatment of primary sclerosing cholangitis. The discount rate
applied ranged from 3.84% to 4.52%. The contingent consideration is evaluated quarterly, or more frequently, if circumstances dictate.
Changes in the fair value of contingent consideration are recorded in consolidated statements of operations. Significant changes in unobservable
inputs, mainly the probability of success and cash flows projected, could result in material changes to the contingent consideration liability.
Changes in contingent consideration for the nine and three months ended September 30, 2024 and September 30, 2023, resulted from the passage
of time and discount rate revaluation.
The Company uses foreign exchange contracts
(mainly option and forward contracts) to hedge cash flows from currency exposure. These foreign exchange contracts are not designated
as hedging instruments for accounting purposes. In connection with these foreign exchange contracts, the Company recognizes gains or losses
that offset the revaluation of the cash flows also recorded under financial expenses (income), net in the condensed consolidated statements
of operations. As of September 30, 2024, the Company had outstanding foreign exchange contracts for the exchange of USD to NIS in the
amount of approximately $3,410 with a fair value asset of $15. As of December 31, 2023, the Company had outstanding foreign exchange contracts
for the exchange of USD to NIS in the amount of approximately $4,136 with a fair value asset of $256.
The Company determined the fair value
of the liabilities for the Private Placement Warrants using the Black-Scholes model, a Level 3 measurement, within the fair value hierarchy.
The main assumptions used are as follows:
| |
September 30, 2024 | | |
December 31, 2023 | |
Underlying value of Common Stock ($) | |
| 1.02 | | |
| - | |
Exercise price ($) | |
| 2.31 | | |
| - | |
Expected volatility (%) | |
| 117.6 | | |
| - | |
Expected terms (years) | |
| 1.75 | | |
| - | |
Risk-free interest rate (%) | |
| 3.6 | | |
| - | |
|
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v3.24.3
Other Current Assets
|
9 Months Ended |
Sep. 30, 2024 |
Other Current Assets [Abstract] |
|
OTHER CURRENT ASSETS |
NOTE 4 – OTHER CURRENT ASSETS
| |
September 30,
2024 | | |
December 31, 2023 | |
Government institutions | |
| 84 | | |
| 66 | |
Prepaid insurance | |
| 1,165 | | |
| 505 | |
Other prepaid expenses | |
| 574 | | |
| 128 | |
Grants receivable | |
| 950 | | |
| 574 | |
Other | |
| 892 | | |
| 495 | |
Other current assets | |
| 3,665 | | |
| 1,768 | |
|
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v3.24.3
Other Accounts Payable
|
9 Months Ended |
Sep. 30, 2024 |
Other Accounts Payable [Abstract] |
|
OTHER ACCOUNTS PAYABLE |
NOTE 5 – OTHER ACCOUNTS PAYABLE
| |
September 30,
2024 | | |
December 31, 2023 | |
Employees and related institutions | |
| 956 | | |
| 1,852 | |
Accrued expenses | |
| 3,421 | | |
| 1,289 | |
Government institutions | |
| 622 | | |
| 175 | |
Prepaid sublease income | |
| - | | |
| 28 | |
Severance related to former employees of APT | |
| 70 | | |
| - | |
| |
| 5,069 | | |
| 3,344 | |
|
X |
- DefinitionThe entire disclosure for accounts payable, accrued expenses, and other liabilities that are classified as current at the end of the reporting period.
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v3.24.3
Leases
|
9 Months Ended |
Sep. 30, 2024 |
Leases [Abstract] |
|
LEASES |
NOTE 6 – LEASES
On August 9, 2019, APT entered into
a lease agreement (the “Lease Agreement”) with ARE-708 Quince Orchard, LLC (the “Landlord”), for office and lab
spaces in Gaithersburg, Maryland starting on September 1, 2019. Over the course of years, APT and the Landlord amended the Lease Agreement
in order to expand the square footage and to extend the lease period until November 28, 2034. The agreement included 49,625 square feet
of area. The monthly lease payments under the lease agreement were approximately $255. On March 5, 2024, in connection with the Acquisition,
APT and the Landlord, signed an amendment to the lease agreement. Pursuant to the amendment, the leased area will be decreased to 25,894
square feet (the “Remaining Area”), effective as of December 31, 2024. Following the amendment, the revised monthly lease
payments are approximately $134. In exchange, APT was required to pay a relinquished premises fee in an amount equal to $1,500 within
10 business days following March 15, 2024 (the “Amendment Effective Date”). In addition, the Company issued the Landlord warrants
(the “Landlord Warrants”) to purchase up to an aggregate of 25,000 shares of the Company’s Common Stock at an exercise
price of $50.00 per share. The Landlord Warrants became exercisable from the date of the receipt of BiomX stockholder approval, which
was obtained on July 9, 2024, and will expire on January 28, 2027. The amendment also included a one-time option to early terminate the
lease agreement on February 28, 2029 with respect to the Remaining Area under certain terms. The execution of the early termination will
require APT to pay a termination fee of $3,000.
APT accounted for the decreased leased
area and the termination option as a modification as it continues to use the area for a period of time after the termination. The modification
occurred before the Acquisition as APT signed the amendment before the Closing Date but was contingent upon the Acquisition. The operating
lease right-of-use assets and operating lease liabilities contemplate the termination option.
Lease expenses recorded in the condensed
statements of operations were $2,543 and $995 for the nine and three months ended September 30, 2024, respectively, and $488 and $161
for the nine and three months ended September 30, 2023, respectively.
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v3.24.3
Commitments and Contingencies
|
9 Months Ended |
Sep. 30, 2024 |
Commitments and Contingencies [Abstract] |
|
COMMITMENTS AND CONTINGENCIES |
NOTE 7 – COMMITMENTS AND CONTINGENCIES
| A. | In May 2021, APT entered into a Collaboration and Option Agreement
(the “Oyster Agreement”) with Oyster, a wholly owned subsidiary of Viatris Inc., to collaborate on the use of APT’s
proprietary phage technology for the treatment of certain ophthalmic diseases. Upon execution of the Agreement, Oyster paid an upfront
payment of $500 to APT, a portion of which APT claims it has spent in the course of performing its obligations under the Oyster Agreement.
In April 2022 and September 2023, APT received letters from Oyster and Viatris Inc. raising concerns about APT’s actions, including
allegations that APT had breached the Oyster Agreement. APT and Oyster have agreed to settle their dispute related to the Oyster Agreement,
including the allegations described in the letters, and to terminate the Oyster Agreement under a term sheet (the “Term Sheet”).
Under the terms of the Term Sheet, APT and Oyster will sign a final settlement agreement, which will include a payment of $300 from APT
to Oyster. As of September 30, 2024, the final settlement agreement had not yet been signed. The Company has recorded a provision of $300
as other accounts payable in the condensed consolidated balance sheets. | | | | | B. | In August 2021, the Israeli Innovation Authority (“IIA”) approved an application that supports upgrading the Company’s manufacturing capabilities for an aggregate budget of NIS 5,737 (approximately $1,778). The IIA committed to fund 50% of the approved budget. The program was for the period beginning July 2021 through June 2022. The program does not bear royalties. Through September 30, 2024, the Company received NIS 1,912 (approximately $577) from the IIA with respect to this program. In March 2022, the IIA approved an application for a total budget of NIS 13,004 (approximately $4,094) in relation to the Company’s cystic fibrosis product candidate. The IIA committed to fund 30% of the approved budget. The program was for the period beginning January 2022 through December 2022. Through September 30, 2024, the Company received NIS 1,365 (approximately $395) from the IIA with respect to this program. In March 2023, the IIA approved an application for a total budget of NIS 11,283 (approximately $3,164) in relation to the Company’s cystic fibrosis product candidate. The IIA committed to fund 30% of the approved budget. The program was for the period beginning January 2023 through December 2023. Through September 30, 2024, the Company received NIS 2,783 (approximately $768) from the IIA with respect to this program. |
According to the agreement with the IIA, excluding the August 2021 program, BiomX Israel will pay royalties of 3% to 3.5% of future sales up to an amount equal to the accumulated grant received including annual interest of LIBOR linked to the USD. Starting January 2024, the IIA has notified that the interest has changed to the 12-month Secured Overnight Financing Rate (“SOFR”) as published on the first trading day of each calendar year. BiomX Israel may be required to pay additional royalties upon the occurrence of certain events as determined by the IIA, that are within the control of BiomX Israel. No such events have occurred or were probable of occurrence as of the balance sheet date with respect to these royalties. Repayment of the grant is contingent upon the successful completion of the BiomX Israel’s R&D programs and generating sales. BiomX Israel has no obligation to repay these grants if the R&D program fails, is unsuccessful or aborted or if no sales are generated. The Company had not yet generated sales as of September 30, 2024; therefore, no liability was recorded in these condensed consolidated financial statements. IIA grants are recorded as a reduction of R&D expenses, net. Through September 30, 2024, total grants approved from the IIA aggregated to approximately $9,353 (NIS 32,068). Through September 30, 2024, the Company had received an aggregate amount of $8,003 (NIS 27,423) in the form of grants from the IIA. Total grants subject to royalties’ payments aggregated to approximately $7,413. As of September 30, 2024, BiomX Israel had a contingent obligation to the IIA in the amount of approximately $8,250 including annual interest of SOFR applicable to dollar deposits. | | C. | On June 23, 2022, BiomX Israel entered into a research collaboration agreement with Boehringer Ingelheim International GmbH (“BI”) for a collaboration to identify biomarkers for Inflammatory Bowel Disease. Under the agreement, BiomX Israel is eligible to receive fees totaling $1,411 to cover costs to be incurred by BiomX Israel in conducting the research plan under the collaboration. The fees were paid in four installments according to certain activities under the agreement. In December 2023, the Company completed its obligations with respect to this agreement and the last installment of $211 was received on January 18, 2024. The consideration was recorded as a reduction of R&D expenses, net in the condensed consolidated statements of operations according to the input model method on a cost-to-cost basis. |
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v3.24.3
U.S. Government Contracts and Grants
|
9 Months Ended |
Sep. 30, 2024 |
U.S. Government Contracts and Grants [Abstract] |
|
U.S. GOVERNMENT CONTRACTS AND GRANTS |
NOTE 8 - U.S. GOVERNMENT CONTRACTS AND GRANTS
In 2019, APT entered into a Base Agreement
and Research Project Award (collectively, the “Agreement”) with the U.S. Army Medical Research Acquisition Activity (“USAMRAA”)
and the U.S. Army Medical Research & Development Command (“USAMRDC”) to advance personalized phage therapy from niche
to broad use. Awards under the Agreement are intended to lay the groundwork for rapid advancement of personalized phage therapy to commercialization
for the variety of clinical indications and bacterial pathogens representing un-met needs with a focus on infections with significant
military relevance. The competitive award was granted by USAMRAA and USAMRDC in collaboration with the Medical Technology Enterprise Consortium
(“MTEC”), a 501(c)(3) biomedical technology consortium working in partnership with the U.S. Department of Defense. Since Agreement
inception, APT entered into certain modifications to the Agreement to include additional activities and perform pre-clinical activities
to advance the Diabetic Foot Osteomyelitis (“DFO”) clinical program. Under the Agreement, MTEC reimburses APT for approved
costs as incurred that are based upon the achievement of certain milestones up to a contract value of $36,214. In September 2024, the
Agreement was amended to extend the period of performance to continue and complete the pre-clinical activities for the DFO clinical program,
which increased the total contract value to $39,081. In conjunction with this Agreement, APT is subject to an assessment fee of an amount
equal up to 3% of the total funded value of the research project award which should be paid by the Company upon signing the agreement
or the modifications. For the period between the Acquisition and September 30, 2024, the Company received grants of $2,895 from MTEC with
respect to the cost reimbursement contract. During the nine and three months ended September 30, 2024, the Company recorded $1,802 and
$849 as a reduction of R&D expenses, net, respectively. The remainder of the consideration the Company is entitled to receive is recorded
as other current assets in the condensed consolidated financial statements. See Note 14B for information regarding grants received subsequent
to the financial statement date.
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v3.24.3
Long-Term Debt
|
9 Months Ended |
Sep. 30, 2024 |
Long-Term Debt [Abstract] |
|
LONG-TERM DEBT |
NOTE 9 – LONG-TERM DEBT
On August 16, 2021 (the “Closing
Date”), the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with Hercules Capital, Inc. (“Hercules”),
with respect to a venture debt facility. Under the Loan Agreement, $15,000 was advanced to the Company on the date the Loan Agreement
was executed. The Company was required to make interest only payments through March 1, 2023, and started to then repay the principal balance
and interest in equal monthly installments through September 1, 2025.
The Loan Agreement provided that the
Company could prepay advances under the Loan Agreement, in whole or in part, at any time subject to a prepayment charge equal to 1.0%
after 24 months but prior to 36 months following the Closing Date. Upon prepayment or repayment of all or any of the term loans under
the Term Loan Facility, the Company was required to pay an end of term charge (“End of Term Charge”) equal to 6.55% of the
total aggregate amount of the term loans being prepaid or repaid. On March 19, 2024, the Company prepaid the entire balance under the
Term Loan Facility in a total of $10,428. The prepayment included the End of Term Charge of $983 and accrued interest of $69. The Company
received from Hercules a waiver regarding the prepayment charge that should have been 1% out of the prepaid principal amount that equals
to $94.
Interest expense relating to the term
loan, which is included in interest expense in the condensed statements of operations was $850 for the nine months ended September 30,
2024. No interest expense was recognized in connection with the term loan for the three months ended September 30, 2024. Interest expense
for the nine and three months ended September 30, 2023, was $1,884 and $574, respectively.
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v3.24.3
Stockholders Equity
|
9 Months Ended |
Sep. 30, 2024 |
Stockholders Equity [Abstract] |
|
STOCKHOLDERS EQUITY |
NOTE 10 – STOCKHOLDERS EQUITY
| A. | Share Capital: Reverse Stock Split: On July 9, 2024, the Company’s stockholders approved a reverse stock split at a ratio within a range of 1-for-5 and 1-for-10 at such time as the Board of Directors shall determine, in its sole discretion, at any time before July 9, 2025. On August 8, 2024, the Board of Directors approved a 1-for-10 Reverse Stock Split of the Company’s shares of Common Stock (the “Reverse Stock Split”). On August 20, 2024, the Company filed the Certificate of Amendment
with the Delaware Secretary of State to effect the Reverse Stock Split, which became effective on August 26, 2024 (the “Effective
Date”). The Company’s Common Stock began trading on a Reverse Stock Split adjusted basis on the NYSE American at the opening
of the markets on the Effective Date. As a result of the Reverse Stock Split, the number of shares of Common Stock outstanding was reduced from 178,958,447 shares to 18,021,173 shares. No fractional shares of Common Stock or Units were issued in connection with the Reverse Stock Split. Stockholders of the Company who otherwise were entitled to receive fractional shares or Units, because they held a number of shares or Units, as applicable, not evenly divisible by the Reverse Stock Split ratio were automatically entitled to receive an additional fraction of a share of the Common Stock or Unit, as applicable, to round up to the next whole share. As a result, 125,328 shares of Common Stock were issued. The Reverse Stock Split did not change the par value of the Common Stock nor the authorized number of shares of Common Stock, preferred stock or any series of preferred stock. Unless otherwise indicated, all amounts of issued and outstanding stock contained in the accompanying condensed consolidated financial statements have been adjusted to reflect the 1-for-10 Reverse Stock Split for all prior periods presented. Proportional adjustments were also made to shares underlying outstanding equity awards, warrants and Redeemable Convertible Preferred Shares, and to the number of shares issued and issuable under the Company’s stock incentive plans and certain existing agreements. Authorized shares of common stock: On July 9, 2024, the Company’s stockholders approved increasing the number of authorized shares of Common Stock from 120,000,000 shares, par value $0.0001 per share, to 750,000,000 shares, par value $0.0001 per share. Preferred Stock: The Company is authorized to issue 1,000,000 shares of preferred stock with a par value of $0.0001 per share with such designation, rights and preferences as may be determined from time to time by the Company’s Board of Directors (the “Board”). On March 15, 2024, the Company issued 40,470 and 216,417 Redeemable
Convertible Preferred Shares, par value $0.0001 per share, as part of the Acquisition and the March 2024 PIPE, respectively. On July 15,
2024, 109,152 Redeemable Convertible Preferred Shares were converted into 10,915,200 shares of the Company’s Common Stock. | Private Investment in Public Equity:
On February 22, 2023, the Company entered
into a Securities Purchase Agreement to issue and sell an aggregate of 1,599,746 shares of its Common Stock and 1,461,072 pre-funded warrants
(the “Pre-Funded Warrants”) at a price of $2.45 per share and $2.44 per Pre-Funded Warrant in a private placement (the “February
2023 PIPE”). The net proceeds from the PIPE were approximately $7,152, after deducting issuance costs of $333. During the nine months
ended September 30, 2024, 533,031 Pre-Funded Warrants were exercised into 533,031 shares of Common Stock for total consideration of $6
at an exercise price of $0.01 per share of Common Stock, and 928,041 Pre-Funded Warrants were exercised into 925,607 shares of Common
Stock through cashless mechanism with no consideration. As of September 30, 2024, there are no outstanding Pre-Funded Warrants.
On March 15, 2024, in connection with
the Acquisition, the Company issued to APT’s former stockholders 916,497 shares of the Company’s Common Stock, 40,470 Redeemable
Convertible Preferred Shares and Merger Warrants to purchase up to an aggregate of 216,650 shares of the Company Common Stock. See Note
1D for further information.
Concurrently with the consummation of
the Acquisition as described in Note 1D, the Company entered into the March 2024 PIPE, pursuant to which such investors purchased an aggregate
of 216,417 Redeemable Convertible Preferred Shares (“PIPE Preferred Shares”) and Private Placement Warrants to purchase up
to an aggregate of 10,820,850 shares of the Company’s Common Stock, at a combined price of $231.10 per share. The PIPE Preferred
Shares and the Private Placement Warrants were issued in a private placement pursuant to an exemption from registration requirements under
the Securities Act for aggregate gross proceeds of $50,000. Each Private Placement Warrant’s exercise price equals to $2.31, subject
to customary adjustments for stock dividends, stock splits, reclassifications and the like, became exercisable from the date of the receipt
of BiomX stockholder approval, which was obtained on July 9, 2024, and will expire on July 9, 2026. Under certain circumstances, the Company
may be required to pay to each holder of the Private Placement Warrants (i) an amount in cash equal to the holder’s total purchase
price for the shares of Common Stock purchased (the “Buy-In Price”) or credit such holder’s balance account with the
Depository Trust Company (“DTC”) for such shares of Common Stock shall terminate, or (ii) promptly honor its obligation to
deliver to such holder a certificate or certificates representing such shares of Common Stock or credit such holder’s balance account
with DTC, as applicable, and pay cash to such holder in an amount equal to the excess (if any) of the Buy-In Price over the product of
(A) such number of shares of Common Stock, times (B) Weighted Average Price (as defined in the Private Placement Warrant) on the trading
day immediately preceding the exercise date.
The Company accounted for the Private
Placement Warrants as liabilities as the Private Placement Warrants are not considered indexed to the entity’s own stock based on
the provision of ASC 815. The Private Placement Warrants will be measured at fair value at inception and in subsequent reporting periods
with changes in fair value recognized in the condensed consolidated statements.
The terms of the PIPE Preferred Shares
are substantially the same as those of the Redeemable Convertible Preferred Shares issued under the Acquisition and were accounted for
as temporary equity at the issuance date and were reclassified as equity. See Note 1D for further information. On July 15, 2024, 109,152
Redeemable Convertible Preferred Shares that were issued under the Acquisition and the March 2024 PIPE were converted into 10,915,200
shares of the Company’s Common Stock according to beneficial ownership limitations set by certain investors.
In connection therewith, the Company issued
warrants to purchase shares of the Company’s Common Stock to the Placement Agents (the “Agents Warrants”). See Note
10B for further information.
The Company allocated the total consideration
from the issuance of the 2024 March PIPE first to the fair value of the Private Placement Warrants and then to the PIPE Preferred Shares.
The Company had transaction costs of approximately $3,317 out of which $1,273 is Stock-Based Compensation due to issuance of the Agents
Warrants. The transaction costs were allocated in the same manner as the consideration. Issuance costs which were allocated to the PIPE
Preferred Shares were $1,410 and deducted from Redeemable Convertible Preferred Shares, and issuance costs that were allocated to the
Private Placement Warrants were $1,907 and were expensed immediately.
At-the-Market
Sales Agreement:
In December 2023, pursuant to a registration
statement on Form S-3 declared effective by the SEC on January 2, 2024, the Company entered an At the Market Offering Agreement with H.C.
Wainwright & Co., LLC (“Wainwright”), pursuant to which the Company may issue and sell shares of Common Stock having an
aggregate offering price of up to $7,500 from time to time through Wainwright. During the nine months ended September 30, 2024, the Company
sold 7,518 shares of Common Stock under this agreement, at an average price of $2.71 per share, raising aggregate net proceeds of approximately
$19, after deducting an aggregate commission of $1. Warrants:
As of September 30, 2024, the Company
had the following outstanding warrants to purchase Common Stock issued to stockholders:
Warrant | | Issuance Date | | Expiration Date | | Exercise Price Per Share | | | Number of Shares of Common Stock Underlying Warrants | | Public Warrants | | IPO (December 13, 2018) | | October 28, 2024 | | | 115.00 | | | | 350,000 | | 2021 Registered Direct Offering Warrants | | SPA (July 28, 2021) | | January 28, 2027 | | | 50.00 | | | | 281,251 | | Merger Warrants | | March 15, 2024 | | January 28, 2027 | | | 50.00 | | | | 216,650 | | Private Placement Warrants | | March 15, 2024 | | July 9, 2026 | | | 2.31 | | | | 10,820,850 | | Agents Warrants | | March 15, 2024 | | July 9, 2026 | | | 2.31 | | | | 952,381 | | | | | | | | | | | | | 12,621,132 | |
|
B. |
Stock-based Compensation: |
On March 15, 2024, the Company issued Agents Warrants to purchase up
to an aggregate of 952,381 shares of the Company’s Common Stock to the Placement Agents in connection with the March 2024 PIPE.
The exercise price of the Agents Warrants is $2.31 per share and they became exercisable at any time after the date of the receipt of
BiomX stockholder approval, which was obtained on July 9, 2024, and will expire on July 9, 2026.
The Company accounted for the Agents Warrants
under the scope of ASC 718-10 “Stock-Based Payment”, (“ASC 718-10”), and treated them as issuance costs of the
March 2024 PIPE as the Company considers these Warrants as consideration for receipt of Private Placement Services.
The Company determined the fair value
of the Agents Warrants using the Black-Scholes model as of March 5, 2024. The main assumptions used are as follows:
Underlying value of Common Stock ($) | | | 2.31 | | Exercise price ($) | | | 2.31 | | Expected volatility (%) | | | 100.6 | | Expected terms (years) | | | 2.32 | | Risk-free interest rate (%) | | | 4.4 | |
On July 9, 2024, the Company’s stockholders
approved increasing the number of shares of Common Stock under the Company’s 2019 Omnibus Long-Term Incentive Plan (the “2019
Plan”) to be equal to 15% of the total number of fully-diluted shares of Common Stock outstanding as of the approval date, or 7,800,000
shares.
On September 16, 2024, the Company granted
155,429 RSUs to four senior officers and one service provider. The RSUs were fully vested and issued on the grant date and are not subject
to continued service to the Company. The RSUs’ fair value is the Company’s stock closing price as of the grant date, which
was $0.99. As of September 30, 2024, the Company has no unvested RSUs.
On July 11, 2024, the Board of Directors
approved the grant of 1,567,795 options to 51 employees, six senior officers and seven directors under the 2019 Plan, without consideration.
Options were granted at an exercise price of $3.63 per share with a vesting period of four years. Directors and senior officers are entitled
to full acceleration of their unvested options upon the occurrence of both a change in control of the Company and the end of their engagement
with the Company. | A summary of options granted to purchase the Company’s Common Stock under the Company’s share option plans is as follows: |
| | For the Nine Months Ended September 30, 2024 | | | | Number of Options | | | Weighted Average Exercise Price | | | Aggregate Intrinsic Value | | Outstanding at the beginning of period | | | 528,112 | | | | 5.41 | | | | 72 | | Granted | | | 1,567,795 | | | | 3.63 | | | | | | Forfeited | | | (26,808 | ) | | | 3.96 | | | | | | Expired | | | (6,449 | ) | | | 4.58 | | | | | | Exercised | | | - | | | | - | | | | | | Outstanding at the end of period | | | 2,062,650 | | | | 4.08 | | | | 22 | | Exercisable at the end of period | | | 351,109 | | | | 5.79 | | | | | | Weighted average remaining contractual life of outstanding options – years as of September 30, 2024 | | | 8.85 | | | | | | | | | |
Warrants:
As of September 30, 2024, the Company
had the following outstanding compensation related warrants to purchase Common Stock:
Warrant | | Issuance Date | | Expiration Date | | | Exercise Price Per Share | | | Number of Shares of Common Stock Underlying Warrants | | Private Warrants issued to scientific founders | | November 27, 2017 | | | - | | | | - | | | | 298 | | Landlord Warrants* | | March 15, 2024 | | | January 28, 2027 | | | | 50.00 | | | | 25,000 | | | | | | | | | | | | | | | 25,298 | |
| The following table sets forth the total stock-based payment expenses resulting from options granted, included in the statements of operations: |
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development expenses, net | |
| 273 | | |
| 31 | | |
| 336 | | |
| 202 | |
General and administrative | |
| 556 | | |
| 164 | | |
| 747 | | |
| 439 | |
| |
| 829 | | |
| 195 | | |
| 1,083 | | |
| 641 | |
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v3.24.3
Basic and Diluted Loss (Earnings) Per Share
|
9 Months Ended |
Sep. 30, 2024 |
Basic and Diluted Loss (Earnings) Per Share [Abstract] |
|
BASIC AND DILUTED LOSS (EARNINGS) PER SHARE |
NOTE 11 – BASIC AND DILUTED LOSS (EARNINGS) PER SHARE
Basic loss (earnings) per share is
computed on the basis of the net loss (income) for the period divided by the weighted average number of shares of Common Stock outstanding
during the period, fully vested warrants with no exercise price for the Company’s Common Stock and fully vested Pre-Funded Warrants
for the Company’s Common Stock at an exercise price of $0.001 per share, as the Company considers these shares to be exercised for
little to no additional consideration.
Diluted loss per share is based upon
the weighted average number of shares of Common Stock and of potential shares of Common Stock outstanding when dilutive. Potential shares
of Common Stock equivalents include outstanding stock options and warrants, which are included under the treasury stock method when dilutive.
The calculation of diluted loss per
share for the nine and three months ended September 30, 2024 and September 30, 2023, does not include the shares underlying
the following financial instruments because their effect would be anti-dilutive:
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Options | |
| 2,041,139 | | |
| 591,034 | | |
| 2,062,650 | | |
| 591,034 | |
Warrants | |
| 12,646,132 | | |
| 921,251 | | |
| 1,825,281 | | |
| 921,251 | |
Contingent shares | |
| 200,000 | | |
| 400,000 | | |
| 200,000 | | |
| 400,000 | |
Redeemable Convertible Preferred Shares | |
| 14,773,500 | | |
| - | | |
| 14,773,500 | | |
| - | |
The following table presents the computation
of basic and diluted loss (earnings) per share:
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Basic loss (earnings) per share of common stock | |
| | |
| | |
| | |
| |
Numerator: | |
| | |
| | |
| | |
| |
Net loss (income) | |
| (9,642 | ) | |
| 7,906 | | |
| 3,214 | | |
| 20,678 | |
Amount allocated to Redeemable Convertible Preferred Shares | |
| (4,575 | ) | |
| - | | |
| - | | |
| - | |
Net loss (income) attributable to shares of common stock | |
| (5,067 | ) | |
| 7,906 | | |
| 3,214 | | |
| 20,678 | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Number of shares of common stock outstanding | |
| 16,365,824 | | |
| 4,597,403 | | |
| 9,943,968 | | |
| 3,951,624 | |
Number of shares upon Pre-Funded Warrants exercise | |
| - | | |
| 1,461,073 | | |
| - | | |
| 867,736 | |
Number of shares upon Fully vested Warrants exercise | |
| 298 | | |
| 298 | | |
| 298 | | |
| 298 | |
Total weighted-average number of shares of common stock, shares upon Pre-Funded Warrants and Fully vested Warrants exercise used in computing basic loss (earnings) per share | |
| 16,366,122 | | |
| 6,058,774 | | |
| 9,944,267 | | |
| 4,819,658 | |
Basic loss (earnings) per share of common stock | |
| (0.31 | ) | |
| 1.30 | | |
| 0.32 | | |
| 4.29 | |
| |
| | | |
| | | |
| | | |
| | |
Diluted net loss per share of common stock | |
| | | |
| | | |
| | | |
| | |
Numerator: | |
| | | |
| | | |
| | | |
| | |
Net loss (income) | |
| (9,642 | ) | |
| 7,906 | | |
| 3,214 | | |
| 20,678 | |
Change in fair value of Private Placement Warrants | |
| - | | |
| - | | |
| 24,417 | | |
| - | |
Diluted net loss | |
| (9,642 | ) | |
| 7,906 | | |
| 27,631 | | |
| 20,678 | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted-average number of shares of common stock outstanding | |
| 16,366,122 | | |
| 6,058,774 | | |
| 9,944,267 | | |
| 4,819,658 | |
Private Placement Warrants | |
| - | | |
| - | | |
| 1,350,613 | | |
| - | |
Options | |
| 21,511 | | |
| - | | |
| - | | |
| - | |
Total weighted-average number of shares of common stock outstanding, after giving effect to dilutive securities | |
| 16,387,633 | | |
| 6,058,774 | | |
| 11,294,880 | | |
| 4,819,658 | |
Diluted net loss per share of common stock | |
| (0.31 | ) | |
| 1.30 | | |
| 2.45 | | |
| 4.29 | |
|
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v3.24.3
Goodwill
|
9 Months Ended |
Sep. 30, 2024 |
Goodwill [Abstract] |
|
GOODWILL |
NOTE 12 – GOODWILL
Following the APT Acquisition, the Company
recognized goodwill valued at $801 after adjustment made during the measurement period as described in Note 1D above. In the third quarter
of 2024, the Company experienced a decline in its stock price resulting in its market capitalization being less than the Company’s
stockholders’ equity. Thus, the Company performed quantitative assessments of the Company’s goodwill. The assessments utilizes
the Company’s market capitalization plus an appropriate control premium. Market capitalization is determined by multiplying the
outstanding number of shares of Common Stock by the Company’s stock price. The control premium is determined by utilizing publicly
available data from studies for similar transactions of public companies. As a result of this assessment, the Company recorded a goodwill
impairment of $801 during the three and nine months ended September 30, 2024.
|
X |
- DefinitionThe entire disclosure for goodwill.
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v3.24.3
Events During the Period
|
9 Months Ended |
Sep. 30, 2024 |
Events During the Period [Abstract] |
|
EVENTS DURING THE PERIOD |
NOTE 13 – EVENTS DURING THE PERIOD
In October 2021, the Company entered into
a Stock Purchase Agreement with a subsidiary of Maruho Co. Ltd., (“Maruho”), pursuant to which the Company issued to Maruho
shares of Common Stock of the Company and granted Maruho a right of first offer to license its atopic dermatitis product candidate, BX005,
in Japan. The right of first offer was supposed to commence following the availability of results from the Phase 1/2 study which were
expected in 2022. Part of the consideration paid under the agreements, equal to the grant date fair value of the shares issued to Maruho
was attributed to the issuance of shares. The remainder of $1,976 was attributed to a contract liability, to be recognized as other income,
at a point in time, once the clinical trials related to the product candidate are completed. In April 2024, following the Acquisition,
the Company decided to pause the development of BX005. As a result, the parties agreed that the right of first offer to license BX005
is no longer applicable. As a result, the Company reversed the full amount of the contract liability and recognized $1,976 as Other Income
in the condensed consolidated statements of operations.
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v3.24.3
Subsequent Events
|
9 Months Ended |
Sep. 30, 2024 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE 14 – SUBSEQUENT EVENTS
| a. | On October 15, 2024, the Company announced that effective October 25, 2024, the Company’s Units
will be mandatorily separated and the Units will no longer trade on the NYSE American. In the separation, Unit-holders received shares
of Common Stock and warrants underlying their units, which warrants expired on October 28, 2024. The Common Stock continues to trade on
the NYSE American under the symbol “PHGE” with the other existing shares of the Company’s Common Stock. |
| b. | On October 17, 2024, the Company received a payment of $600 from MTEC in connection with the Agreement
for reimbursement of approved costs. See Note 8 for further information. |
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v3.24.3
Accounting Policies, by Policy (Policies)
|
9 Months Ended |
Sep. 30, 2024 |
Significant Accounting Policies [Abstract] |
|
Unaudited Condensed Financial Statements |
| A. | Unaudited Condensed Financial Statements | The accompanying unaudited condensed
consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”)
for condensed financial information. They do not include all the information and footnotes required by GAAP for complete financial statements.
In the opinion of management, all adjustments considered necessary for a fair statement have been included (consisting only of normal
recurring adjustments except as otherwise discussed). The financial information contained
in this report should be read in conjunction with the annual financial statements included in the Company’s Annual Report on Form
10-K for the fiscal year ended December 31, 2023, that the Company filed with the U.S. Securities and Exchange Commission (the “SEC”)
on April 4, 2024. The year-end balance sheet data was derived from the audited consolidated financial statements as of December 31, 2023.
|
Principles of Consolidation |
| B. | Principles of Consolidation | The condensed consolidated financial
statements include the accounts of the Company and its subsidiaries. Intercompany balances and transactions have been eliminated upon
consolidation.
|
Use of Estimates in the Preparation of Financial Statements |
| C. | Use of Estimates in the Preparation of Financial Statements | The preparation of financial statements in conformity with GAAP requires
management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets
and liabilities in the financial statements and the amounts of expenses during the reported years. The most significant estimates in the
Company’s financial statements relate to accruals for research and development expenses, valuation of stock-based compensation awards,
purchase price allocation related to the Acquisition and the Private Placement Warrants fair value revaluation; estimates used in the
IPR&D impairment assessment for calculating the fair value of the Company’s assets by using discounted cash flow incorporate
the Company’s estimated post-tax weighted average cost of capital, amounts and timing of projected future cash flows that are influenced
by the expected outcome of research and development activities, the probability of success and timing in gaining regulatory approval,
size of the potential market and the Company’s specific market share. These estimates and assumptions are based on current facts,
future expectations, and various other factors believed to be reasonable under the circumstances, the results of which form the basis
for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from
other sources. Actual results may differ materially and adversely from these estimates. The full extent to which Israel’s
war with Hamas and Hezbollah may directly or indirectly impact the Company’s business, results of operations and financial condition
will depend on future developments that are uncertain, as well as the economic impact on local, regional, national and international markets.
|
Business Combination |
The Company allocates the fair value
of consideration transferred in a business combination to the assets acquired, liabilities assumed based on their fair values at the acquisition
date. Acquisition-related expenses are recognized separately from the business combination and are expensed as incurred. The excess of
the fair value of the consideration transferred over the fair value of the assets acquired, liabilities assumed in the acquired business
is recorded as goodwill. The fair value of the consideration transferred included equity securities. The allocation of the consideration
transferred in certain cases may be subject to revision based on the final determination of fair values during the measurement period,
which may be up to one year from the acquisition date. The cumulative impact of revisions during the measurement period is recognized
in the reporting period in which the revisions are identified. The Company includes the results of operations of the businesses that it
has acquired in its consolidated results prospectively from the respective dates of Acquisition.
|
Financial instruments |
When the Company issues freestanding
instruments, it first analyzes the provisions of ASC 480, “Distinguishing Liabilities From Equity” (“ASC 480”)
in order to determine whether the instrument should be classified as a liability, with subsequent changes in fair value recognized in
the consolidated statements of operations in each period. If the instrument is not within the scope of ASC 480, the Company further analyzes
the provisions of ASC 815-10 in order to determine whether the instrument is considered indexed to the entity’s own stock and qualifies
for classification within equity. When the Company issues preferred shares,
it first considers the provisions of ASC 480, in order to determine whether the preferred shares should be classified as a liability.
If the instrument is not within the scope of ASC 480, the Company further analyzes the instrument’s characteristics in order to
determine whether it should be classified within temporary equity (mezzanine) or within permanent equity in accordance with the provisions
of ASC 480-10-S99. The Company reassesses the classification of a contract over its own equity under the guidance above at each balance
sheet date. If classification changes as a result of events during the reporting period, the Company reclassifies the contract as of the
date of the event that caused the reclassification. See Note 1D regarding the reclassification of the Redeemable Convertible Preferred
Shares. When the Company issues warrants, it
first considers the provisions of ASC 815-40, “Contracts in Entity’s Own Equity” (“ASC 815-40”) in order
to determine whether the warrants should be classified as equity. Equity classification is permitted when warrants are indexed to the
Company’s own shares and meet the classification requirements for stockholders’ equity classification under ASC 815-40. If
the warrants are not within the scope of ASC 815-40, the Company accounts for the warrants in accordance with the guidance contained in
Accounting Standards Codification 815 (“ASC 815”), “Derivatives and Hedging”, under which the warrants do not
meet the criteria for equity treatment and must be recorded as derivative liabilities. Accordingly, the Company classifies the Private
Placement Warrants as liabilities at their fair value and adjusts the warrants to fair value at each reporting period. This liability
is subject to re-measurement at each balance sheet date until the warrants are exercised or expire, and any change in fair value is recognized
in the condensed consolidated statements of operations. See Note 10A for further information regarding the Private Placement Warrants.
|
Basic and diluted loss (earnings) per share |
| F. | Basic and diluted loss (earnings) per share | Basic loss (earnings) per share is
computed by dividing net loss (income) by the weighted average number of shares of Common Stock outstanding during the period, fully vested
warrants with no exercise price for the Company’s Common Stock and fully vested Pre-Funded Warrants for the Company’s Common
Stock at an exercise price of $0.001 per share, as the Company considers these shares to be exercised for little to no additional consideration.
The calculation excludes shares of Common Stock purchased by the Company and held as treasury shares. Diluted loss (income) per share
is computed by dividing net loss by the weighted average number of shares of Common Stock outstanding during the period, plus the number
of shares of Common Stock that would have been outstanding if all potentially dilutive shares of Common Stock had been issued, using the
treasury stock and if-converted method, in accordance with ASC 260-10, “Earnings per Share.” The Company computes net loss (income)
per share using the two-class method required for participating securities. The two-class method requires income available to common stockholders
for the period to be allocated between shares of Common Stock and participating securities based upon their respective rights to receive
dividends as if all income for the period had been distributed. The Company considers its Redeemable Convertible Preferred Shares to be
participating securities as the holders of the Redeemable Convertible Preferred Shares would be entitled to dividends that would be distributed
to the holders of Common Stock, on a pro-rata basis assuming conversion of all Redeemable Convertible Preferred Shares into shares of
Common Stock. These participating securities do not contractually require the holders of such shares to participate in the Company’s
losses. As such, net loss for the periods presented was not allocated to the Company’s participating securities.
|
Intangible Assets |
Goodwill Goodwill reflects the excess of the
consideration transferred at the business combination date over the fair values of the identifiable net assets acquired. Goodwill is an
asset representing the future economic benefits arising from other assets acquired in a business combination that are not individually
identified and separately recognized. The primary items that generate goodwill include the value of the synergies between the acquired
company and the Company and the acquired assembled workforce, neither of which qualifies for recognition as an intangible asset. ASC 350,
“Intangibles—Goodwill and Other” allows an entity to first assess qualitative factors to determine whether a
quantitative goodwill impairment test is necessary. Further testing is only required if the entity determines, based on the qualitative
assessment, that it is more likely than not that the fair value is less than its carrying amount. Otherwise, no further impairment testing
is required. The Company’s goodwill is tested
for impairment at least on an annual basis, on the last day of the third quarter of the fiscal year and whenever events or changes in
circumstances indicate the carrying value of a reporting unit may not be recoverable. When necessary, the Company records charges for
impairments of goodwill for the amount by which the carrying amount of the respective reporting unit exceeds its fair value. However,
the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. During the three months ended September
30, 2024, the Company recorded goodwill impairment in the amount of $801. See note 12 for further information. Intangible assets IPR&D assets acquired in a business combination are recognized
at fair value as of the acquisition date and subsequently accounted for as indefinite-lived intangible assets until completion or abandonment
of the associated R&D efforts. Indefinite-lived intangible assets are reviewed for impairment at least annually, on the last day of
the third quarter of the fiscal year or whenever there is an indication that the asset may be impaired.
|
Recent Accounting Standards |
| H. | Recent Accounting Standards | Recently issued accounting pronouncements,
not yet adopted In December 2023, the Financial Accounting
Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-09 “Income Taxes (Topic 740): Improvements
to Income Tax Disclosures” (“ASU 2023-09”). This guidance is intended to enhance the transparency and decision-usefulness
of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily through
changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S. and in foreign jurisdictions. ASU 2023-09 is
effective for fiscal years beginning after December 15, 2024 on a prospective basis, with the option to apply the standard retrospectively.
Early adoption is permitted. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated
financial statements disclosures. In November 2023, the FASB issued ASU
2023-07 “Segment Reporting: Improvements to Reportable Segment Disclosures” (“ASU 2023-07”). This guidance expands
public entities’ segment disclosures primarily by requiring disclosure of significant segment expenses that are regularly provided
to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of
its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets that are currently
required annually. Public entities with a single reportable segment are required to provide the new disclosures and all the disclosures
required under ASC 280, “Segment Reporting”. The guidance is effective for fiscal years beginning after December 15, 2023,
and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The amendments are required
to be applied retrospectively to all prior periods presented in an entity’s financial statements. The Company is currently evaluating
this guidance to determine the impact it may have on its consolidated financial statements disclosures.
|
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v3.24.3
General (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
General (Tables) [Line Items] |
|
Schedule of Fair Value Acquired Identifiable Assets And Assumed Liabilities |
The following sets forth the fair value
of acquired identifiable assets and assumed liabilities of APT, after considering measurement period adjustment as described
below, which includes adjustments to reflect the fair value of intangible assets acquired as of March 15, 2024:
| |
Amounts | |
Cash and cash equivalents | |
| 509 | |
Restricted cash | |
| 154 | |
Other current assets | |
| 1,780 | |
Property, plant and equipment | |
| 3,748 | |
Operating lease right-of-use asset | |
| 7,953 | |
IPR&D assets and Goodwill | |
| 16,088 | |
Total assets | |
| 30,232 | |
| |
| | |
Trade accounts payable | |
| (3,667 | ) |
Other accounts payable | |
| (2,895 | ) |
Operating lease liability | |
| (7,819 | ) |
Total liabilities | |
| (14,381 | ) |
Total consideration | |
| 15,851 | |
|
Schedule of Fair Value of the Consideration Transferred to APT Shareholders Acquisition |
The following table summarizes the
fair value of the consideration transferred to APT shareholders for the Acquisition:
| |
Amounts | |
Common Stock | |
| 3,041 | |
Redeemable Convertible Preferred Shares | |
| 12,610 | |
Merger Warrants | |
| 200 | |
| |
| 15,851 | |
|
Schedule of Fair Value of the Merger Warrants |
The main assumptions used are as follows:
| |
September 30, 2024 | | |
December 31, 2023 | |
Underlying value of Common Stock ($) | |
| 1.02 | | |
| - | |
Exercise price ($) | |
| 2.31 | | |
| - | |
Expected volatility (%) | |
| 117.6 | | |
| - | |
Expected terms (years) | |
| 1.75 | | |
| - | |
Risk-free interest rate (%) | |
| 3.6 | | |
| - | |
|
Schedule of Condensed Consolidated Statements of Operations |
The actual APT net loss included in
the Company’s condensed consolidated statements of operations for the nine months ended September 30, 2024, is as follows:
| |
September 30, 2024 | |
Net loss attributable to APT | |
| 5,884 | |
|
Schedule of Pro Forma Financial Information |
The following unaudited table provides
certain pro forma financial information for the Company as if the Acquisition occurred on January 1, 2023:
| |
September 30, 2024* | |
Net loss | |
| 2,698 | |
| * | The pro forma amounts above are derived from historical numbers of the Company and APT. |
|
Merger Warrants |
|
General (Tables) [Line Items] |
|
Schedule of Fair Value of the Merger Warrants |
The Company determined the fair value of the Merger Warrants using the Black-Scholes model as of the
Closing Date. The main assumptions used are as follows:
Underlying value of Common Stock ($) | |
| 0.37 | |
Exercise price ($) | |
| 5.0 | |
Expected volatility (%) | |
| 117.7 | |
Expected terms (years) | |
| 2.87 | |
Risk-free interest rate (%) | |
| 4.5 | |
|
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v3.24.3
Fair Value of Financial Instruments (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Fair Value of Financial Instruments [Abstract] |
|
Schedule of Fair Value of Our Financial Assets and Liabilities |
The following table summarizes the
fair value of our financial assets and liabilities that were accounted for at fair value on a recurring basis, by level within the fair
value hierarchy:
| |
September 30, 2024 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Fair Value | |
Assets: | |
| | |
| | |
| | |
| |
Cash equivalents: | |
| | |
| | |
| | |
| |
Money market funds | |
| 20,325 | | |
| - | | |
| - | | |
| 20,325 | |
Foreign exchange contracts receivable | |
| - | | |
| 15 | | |
| - | | |
| 15 | |
| |
| 20,325 | | |
| 15 | | |
| - | | |
| 20,340 | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Contingent consideration | |
| - | | |
| - | | |
| 161 | | |
| 161 | |
Private Placement Warrants | |
| - | | |
| - | | |
| 4,328 | | |
| 4,328 | |
| |
| - | | |
| - | | |
| 4,489 | | |
| 4,489 | |
| |
December 31, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Fair Value | |
Assets: | |
| | |
| | |
| | |
| |
Cash equivalents: | |
| | |
| | |
| | |
| |
Money market funds | |
| 11,377 | | |
| - | | |
| - | | |
| 11,377 | |
Foreign exchange contracts receivable | |
| | | |
| 256 | | |
| - | | |
| 256 | |
| |
| 11,377 | | |
| 256 | | |
| - | | |
| 11,633 | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Contingent consideration | |
| - | | |
| - | | |
| 155 | | |
| 155 | |
| |
| - | | |
| - | | |
| 155 | | |
| 155 | |
|
Schedule of Fair Value Level 3 financial liabilities |
The changes in the fair value of the
Company’s Level 3 financial liabilities, which are measured on a recurring basis are as follows:
| |
Nine Months Ended September 30, 2024 | | |
Nine Months Ended September 30, 2023 | |
Beginning balance | |
- | | |
- | |
Private Placement Warrants | |
| 28,745 | | |
| - | |
Change in fair value | |
| (24,417 | ) | |
| - | |
Ending balance | |
| 4,328 | | |
| - | |
|
Schedule of Fair Value of the Liabilities for the Private Placement Warrants |
The main assumptions used are as follows:
| |
September 30, 2024 | | |
December 31, 2023 | |
Underlying value of Common Stock ($) | |
| 1.02 | | |
| - | |
Exercise price ($) | |
| 2.31 | | |
| - | |
Expected volatility (%) | |
| 117.6 | | |
| - | |
Expected terms (years) | |
| 1.75 | | |
| - | |
Risk-free interest rate (%) | |
| 3.6 | | |
| - | |
|
X |
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v3.24.3
Other Current Assets (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Other Current Assets [Abstract] |
|
Schedule of Other Current Assets |
| |
September 30,
2024 | | |
December 31, 2023 | |
Government institutions | |
| 84 | | |
| 66 | |
Prepaid insurance | |
| 1,165 | | |
| 505 | |
Other prepaid expenses | |
| 574 | | |
| 128 | |
Grants receivable | |
| 950 | | |
| 574 | |
Other | |
| 892 | | |
| 495 | |
Other current assets | |
| 3,665 | | |
| 1,768 | |
|
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v3.24.3
Other Accounts Payable (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Other Accounts Payable [Abstract] |
|
Schedule of Other Accounts Payable |
| |
September 30,
2024 | | |
December 31, 2023 | |
Employees and related institutions | |
| 956 | | |
| 1,852 | |
Accrued expenses | |
| 3,421 | | |
| 1,289 | |
Government institutions | |
| 622 | | |
| 175 | |
Prepaid sublease income | |
| - | | |
| 28 | |
Severance related to former employees of APT | |
| 70 | | |
| - | |
| |
| 5,069 | | |
| 3,344 | |
|
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v3.24.3
Stockholders Equity (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Stockholders Equity [Abstract] |
|
Schedule of Outstanding Warrants to Purchase Common Stock Issued to Stockholders |
As of September 30, 2024, the Company
had the following outstanding warrants to purchase Common Stock issued to stockholders: Warrant | | Issuance Date | | Expiration Date | | Exercise Price Per Share | | | Number of Shares of Common Stock Underlying Warrants | | Public Warrants | | IPO (December 13, 2018) | | October 28, 2024 | | | 115.00 | | | | 350,000 | | 2021 Registered Direct Offering Warrants | | SPA (July 28, 2021) | | January 28, 2027 | | | 50.00 | | | | 281,251 | | Merger Warrants | | March 15, 2024 | | January 28, 2027 | | | 50.00 | | | | 216,650 | | Private Placement Warrants | | March 15, 2024 | | July 9, 2026 | | | 2.31 | | | | 10,820,850 | | Agents Warrants | | March 15, 2024 | | July 9, 2026 | | | 2.31 | | | | 952,381 | | | | | | | | | | | | | 12,621,132 | |
|
Schedule of Fair Value Of The Agents Warrants Using The Black-Scholes Model |
The Company determined the fair value
of the Agents Warrants using the Black-Scholes model as of March 5, 2024. The main assumptions used are as follows: Underlying value of Common Stock ($) | | | 2.31 | | Exercise price ($) | | | 2.31 | | Expected volatility (%) | | | 100.6 | | Expected terms (years) | | | 2.32 | | Risk-free interest rate (%) | | | 4.4 | |
|
Schedule of Options Granted to Purchase |
A summary of options granted to purchase the Company’s Common Stock under the Company’s share option plans is as follows: | | For the Nine Months Ended September 30, 2024 | | | | Number of Options | | | Weighted Average Exercise Price | | | Aggregate Intrinsic Value | | Outstanding at the beginning of period | | | 528,112 | | | | 5.41 | | | | 72 | | Granted | | | 1,567,795 | | | | 3.63 | | | | | | Forfeited | | | (26,808 | ) | | | 3.96 | | | | | | Expired | | | (6,449 | ) | | | 4.58 | | | | | | Exercised | | | - | | | | - | | | | | | Outstanding at the end of period | | | 2,062,650 | | | | 4.08 | | | | 22 | | Exercisable at the end of period | | | 351,109 | | | | 5.79 | | | | | | Weighted average remaining contractual life of outstanding options – years as of September 30, 2024 | | | 8.85 | | | | | | | | | |
|
Schedule of Outstanding Compensation Related Warrants to Purchase Common Stock |
As of September 30, 2024, the Company
had the following outstanding compensation related warrants to purchase Common Stock: Warrant | | Issuance Date | | Expiration Date | | | Exercise Price Per Share | | | Number of Shares of Common Stock Underlying Warrants | | Private Warrants issued to scientific founders | | November 27, 2017 | | | - | | | | - | | | | 298 | | Landlord Warrants* | | March 15, 2024 | | | January 28, 2027 | | | | 50.00 | | | | 25,000 | | | | | | | | | | | | | | | 25,298 | |
|
Schedule of Stock-Based Payment Expenses |
The following table sets forth the total stock-based payment expenses resulting from options granted, included in the statements of operations:
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development expenses, net | |
| 273 | | |
| 31 | | |
| 336 | | |
| 202 | |
General and administrative | |
| 556 | | |
| 164 | | |
| 747 | | |
| 439 | |
| |
| 829 | | |
| 195 | | |
| 1,083 | | |
| 641 | |
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v3.24.3
Basic and Diluted Loss (Earnings) Per Share (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Basic and Diluted Loss (Earnings) Per Share [Abstract] |
|
Schedule of Anti-dilutive Financial Instruments |
The calculation of diluted loss per
share for the nine and three months ended September 30, 2024 and September 30, 2023, does not include the shares underlying
the following financial instruments because their effect would be anti-dilutive:
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Options | |
| 2,041,139 | | |
| 591,034 | | |
| 2,062,650 | | |
| 591,034 | |
Warrants | |
| 12,646,132 | | |
| 921,251 | | |
| 1,825,281 | | |
| 921,251 | |
Contingent shares | |
| 200,000 | | |
| 400,000 | | |
| 200,000 | | |
| 400,000 | |
Redeemable Convertible Preferred Shares | |
| 14,773,500 | | |
| - | | |
| 14,773,500 | | |
| - | |
|
Schedule of Basic and Diluted Loss (earnings) Per Share |
The following table presents the computation
of basic and diluted loss (earnings) per share:
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Basic loss (earnings) per share of common stock | |
| | |
| | |
| | |
| |
Numerator: | |
| | |
| | |
| | |
| |
Net loss (income) | |
| (9,642 | ) | |
| 7,906 | | |
| 3,214 | | |
| 20,678 | |
Amount allocated to Redeemable Convertible Preferred Shares | |
| (4,575 | ) | |
| - | | |
| - | | |
| - | |
Net loss (income) attributable to shares of common stock | |
| (5,067 | ) | |
| 7,906 | | |
| 3,214 | | |
| 20,678 | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Number of shares of common stock outstanding | |
| 16,365,824 | | |
| 4,597,403 | | |
| 9,943,968 | | |
| 3,951,624 | |
Number of shares upon Pre-Funded Warrants exercise | |
| - | | |
| 1,461,073 | | |
| - | | |
| 867,736 | |
Number of shares upon Fully vested Warrants exercise | |
| 298 | | |
| 298 | | |
| 298 | | |
| 298 | |
Total weighted-average number of shares of common stock, shares upon Pre-Funded Warrants and Fully vested Warrants exercise used in computing basic loss (earnings) per share | |
| 16,366,122 | | |
| 6,058,774 | | |
| 9,944,267 | | |
| 4,819,658 | |
Basic loss (earnings) per share of common stock | |
| (0.31 | ) | |
| 1.30 | | |
| 0.32 | | |
| 4.29 | |
| |
| | | |
| | | |
| | | |
| | |
Diluted net loss per share of common stock | |
| | | |
| | | |
| | | |
| | |
Numerator: | |
| | | |
| | | |
| | | |
| | |
Net loss (income) | |
| (9,642 | ) | |
| 7,906 | | |
| 3,214 | | |
| 20,678 | |
Change in fair value of Private Placement Warrants | |
| - | | |
| - | | |
| 24,417 | | |
| - | |
Diluted net loss | |
| (9,642 | ) | |
| 7,906 | | |
| 27,631 | | |
| 20,678 | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted-average number of shares of common stock outstanding | |
| 16,366,122 | | |
| 6,058,774 | | |
| 9,944,267 | | |
| 4,819,658 | |
Private Placement Warrants | |
| - | | |
| - | | |
| 1,350,613 | | |
| - | |
Options | |
| 21,511 | | |
| - | | |
| - | | |
| - | |
Total weighted-average number of shares of common stock outstanding, after giving effect to dilutive securities | |
| 16,387,633 | | |
| 6,058,774 | | |
| 11,294,880 | | |
| 4,819,658 | |
Diluted net loss per share of common stock | |
| (0.31 | ) | |
| 1.30 | | |
| 2.45 | | |
| 4.29 | |
|
X |
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v3.24.3
General (Details) - USD ($)
|
|
|
|
3 Months Ended |
9 Months Ended |
|
Jul. 15, 2024 |
Jul. 09, 2024 |
Mar. 15, 2024 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
General [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Shares received |
|
|
|
216,417
|
|
|
|
|
|
|
|
|
Preferred stock, par value (in Dollars per share) |
|
|
|
|
$ 0.0001
|
|
|
|
|
$ 0.0001
|
|
$ 0.0001
|
Aggregate gross proceeds (in Dollars) |
|
|
|
|
|
|
|
|
|
|
$ 7,485,000
|
|
Reverse stock split |
|
|
|
|
|
|
|
|
|
1-for-10
|
|
|
Accumulated deficit (in Dollars) |
|
|
|
|
$ (166,184,000)
|
|
|
|
|
$ (166,184,000)
|
|
$ (162,970,000)
|
Expiration term |
|
|
|
Jan. 28, 2027
|
|
|
|
|
|
|
|
|
Proceeds from business combination (in Dollars) |
|
|
|
|
|
|
|
|
|
50,000,000
|
|
|
Goodwill value (in Dollars) |
|
|
|
|
801,000
|
|
|
|
|
801,000
|
|
|
Increase to goodwill (in Dollars) |
|
|
|
|
|
|
|
|
|
300
|
|
|
Goodwill impairment (in Dollars) |
|
|
|
|
$ 801,000
|
|
|
|
|
$ 801,000
|
|
|
Percentage of discount for lack of marketability |
|
|
|
|
|
|
|
|
|
9.40%
|
|
|
Merger Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
General [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate shares |
|
|
|
216,650
|
|
|
|
|
|
|
|
|
Multi-Period Excess Earnings Method (“MPEEM”) [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
General [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets (in Dollars) |
|
|
$ 15,287,000
|
|
|
|
|
|
|
|
|
|
Goodwill value (in Dollars) |
|
|
$ 501,000
|
|
|
|
|
|
|
|
|
|
Business Combination [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
General [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of stock, shares converted |
|
|
|
100
|
|
|
|
|
|
|
|
|
APT’s stockholders [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
General [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Business acquisition percentage |
|
|
|
|
45.00%
|
|
|
|
|
45.00%
|
|
|
Transaction costs (in Dollars) |
|
|
|
|
|
|
|
|
|
$ 874,000
|
|
|
APT’s stockholders [Member] | Private Placement Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
General [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Business acquisition percentage |
|
|
|
|
55.00%
|
|
|
|
|
55.00%
|
|
|
Redeemable convertible preferred shares [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
General [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, par value (in Dollars per share) |
|
|
|
$ 0.0001
|
|
|
|
|
|
|
|
|
Redeemable Convertible Preferred Shares [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
General [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of discount for lack of marketability |
|
|
14.90%
|
|
|
|
|
|
|
|
|
|
Redeemable Convertible Preferred Shares [Member] | Business Combination [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
General [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of stock, shares converted |
|
|
|
40,470
|
|
|
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
General [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Shares received |
|
|
|
916,497
|
|
|
|
|
|
|
|
|
Aggregate shares |
[1],[2] |
|
|
|
|
|
|
1,279,796
|
319,950
|
|
|
|
Exercise price per share (in Dollars per share) |
|
|
|
|
$ 0.001
|
|
|
|
|
$ 0.001
|
|
|
Redeemable Convertible Preferred Shares conversion into shares of Common Stock |
|
10,915,200
|
|
10,915,200
|
10,915,200
|
[2] |
|
|
|
|
|
|
Common Stock [Member] | Merger Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
General [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price per share (in Dollars per share) |
|
|
|
$ 50
|
|
|
|
|
|
|
|
|
Common Stock [Member] | Business Combination [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
General [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of stock, shares converted |
|
|
|
100
|
|
|
|
|
|
|
|
|
Preferred Shares [Member] | Redeemable Convertible Preferred Shares [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
General [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable Convertible Preferred Shares conversion into shares of Common Stock |
|
109,152
|
|
109,152
|
|
|
|
|
|
|
|
|
Private Placement Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
General [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate shares |
|
|
|
10,820,850
|
|
|
|
|
|
|
|
|
Aggregate gross proceeds (in Dollars) |
|
|
|
$ 50,000,000
|
|
|
|
|
|
|
|
|
|
|
X |
- Definition
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v3.24.3
General (Details) - Schedule of Fair Value Acquired Identifiable Assets and Assumed Liabilities - Purchase Price Allocation [Member] $ in Thousands |
Mar. 15, 2024
USD ($)
|
Schedule of Fair Value Acquired Identifiable Assets and Assumed Liabilities [Line Items] |
|
Cash and cash equivalents |
$ 509
|
Restricted cash |
154
|
Other current assets |
1,780
|
Property, plant and equipment |
3,748
|
Operating lease right-of-use asset |
7,953
|
IPR&D assets and Goodwill |
16,088
|
Total assets |
30,232
|
Trade accounts payable |
(3,667)
|
Other accounts payable |
(2,895)
|
Operating lease liability |
(7,819)
|
Total liabilities |
(14,381)
|
Total consideration |
$ 15,851
|
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v3.24.3
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v3.24.3
Fair Value of Financial Instruments (Details) - Schedule of Fair Value of Our Financial Assets and Liabilities - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
Cash equivalents: |
|
|
Money market funds |
$ 20,325
|
$ 11,377
|
Foreign exchange contracts receivable |
15
|
256
|
Total assets |
20,340
|
11,633
|
Liabilities: |
|
|
Contingent consideration |
161
|
155
|
Private Placement Warrants |
4,328
|
|
Total liabilities |
4,489
|
155
|
Level 1 [Member] |
|
|
Cash equivalents: |
|
|
Money market funds |
20,325
|
11,377
|
Foreign exchange contracts receivable |
|
|
Total assets |
20,325
|
11,377
|
Liabilities: |
|
|
Contingent consideration |
|
|
Private Placement Warrants |
|
|
Total liabilities |
|
|
Level 2 [Member] |
|
|
Cash equivalents: |
|
|
Money market funds |
|
|
Foreign exchange contracts receivable |
15
|
256
|
Total assets |
15
|
256
|
Liabilities: |
|
|
Contingent consideration |
|
|
Private Placement Warrants |
|
|
Total liabilities |
|
|
Level 3 [Member] |
|
|
Cash equivalents: |
|
|
Money market funds |
|
|
Foreign exchange contracts receivable |
|
|
Total assets |
|
|
Liabilities: |
|
|
Contingent consideration |
161
|
155
|
Private Placement Warrants |
4,328
|
|
Total liabilities |
$ 4,489
|
$ 155
|
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v3.24.3
Leases (Details) $ in Thousands |
|
|
3 Months Ended |
9 Months Ended |
Mar. 15, 2024
USD ($)
|
Aug. 09, 2019
USD ($)
m²
|
Sep. 30, 2024
USD ($)
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2024
USD ($)
shares
|
Sep. 30, 2023
USD ($)
|
Leases [Line Items] |
|
|
|
|
|
|
Square feet of area (in Square Meters) | m² |
|
49,625
|
|
|
|
|
Payments for rent |
|
$ 255
|
|
|
|
|
Lease payments |
|
|
|
|
$ 134
|
|
Premises fee |
$ 1,500
|
|
|
|
|
|
Warrants issued (in Shares) | shares |
|
|
|
|
25,000
|
|
Termination fee |
|
|
|
|
$ 3,000
|
|
Lease expenses |
|
|
$ 995
|
$ 161
|
$ 2,543
|
$ 488
|
Lease Agreement [Member] |
|
|
|
|
|
|
Leases [Line Items] |
|
|
|
|
|
|
Square feet of area (in Square Meters) | m² |
|
25,894
|
|
|
|
|
Common Stock [Member] | Lease Agreement [Member] |
|
|
|
|
|
|
Leases [Line Items] |
|
|
|
|
|
|
Aggregate shares (in Shares) | shares |
|
|
|
|
50
|
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v3.24.3
Commitments and Contingencies (Details) ₪ in Thousands, $ in Thousands |
|
|
|
|
|
9 Months Ended |
|
Jan. 18, 2024
USD ($)
|
Mar. 31, 2023
USD ($)
|
Mar. 31, 2023
ILS (₪)
|
Jun. 23, 2022
USD ($)
|
Mar. 31, 2022
USD ($)
|
Mar. 31, 2022
ILS (₪)
|
Aug. 31, 2021
USD ($)
|
Aug. 31, 2021
ILS (₪)
|
Sep. 30, 2024
USD ($)
|
Sep. 30, 2024
ILS (₪)
|
Sep. 30, 2024
ILS (₪)
|
Commitments and Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Oyster paid upfront payment |
|
|
|
|
|
|
|
|
$ 500
|
|
|
Payment from APT to Oyster |
|
|
|
|
|
|
|
|
300
|
|
|
Other accounts payable |
|
|
|
|
|
|
|
|
300
|
|
|
Manufacturing capabilities |
|
|
|
|
|
|
$ 1,778
|
₪ 5,737
|
|
|
|
Fund approved budget |
|
|
|
|
|
|
50.00%
|
50.00%
|
|
|
|
Received amount |
|
|
|
|
|
|
|
|
395
|
|
₪ 1,365
|
Aggregate budget |
|
$ 3,164
|
₪ 11,283
|
|
$ 4,094
|
₪ 13,004
|
|
|
|
|
|
Percentage of approved budgets |
|
30.00%
|
30.00%
|
|
30.00%
|
30.00%
|
|
|
|
|
|
Total approved grants |
|
|
|
|
|
|
|
|
9,353
|
₪ 32,068
|
|
Royalty expense |
|
|
|
|
|
|
|
|
7,413
|
|
|
Contingent obligation |
|
|
|
|
|
|
|
|
8,250
|
|
|
Receive fees |
|
|
|
$ 1,411
|
|
|
|
|
|
|
|
Installment amount |
$ 211
|
|
|
|
|
|
|
|
|
|
|
Cystic Fibrosis Product [Member] |
|
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Received amount |
|
|
|
|
|
|
|
|
768
|
₪ 2,783
|
|
Grant receivable |
|
|
|
|
|
|
|
|
8,003
|
|
27,423
|
Israel Innovation Authority [Member] |
|
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Received amount |
|
|
|
|
|
|
|
|
$ 577
|
|
₪ 1,912
|
Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Royalties rate |
|
|
|
|
|
|
|
|
3.00%
|
3.00%
|
|
Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Royalties rate |
|
|
|
|
|
|
|
|
3.50%
|
3.50%
|
|
X |
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v3.24.3
Long-Term Debt (Details) - USD ($) $ in Thousands |
|
3 Months Ended |
9 Months Ended |
|
Mar. 19, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Aug. 16, 2021 |
Long-Term Debt [Line Items] |
|
|
|
|
|
Interest expense term loan amount |
$ 10,428
|
|
|
|
|
Prepayment |
983
|
|
|
|
|
Prepaid principal amount |
94
|
|
|
|
|
Interest expense |
|
$ 574
|
$ 850
|
$ 1,884
|
|
Loan Agreement [Member] |
|
|
|
|
|
Long-Term Debt [Line Items] |
|
|
|
|
|
Prepayment charge, percentage |
|
|
1.00%
|
|
|
Long Term Debts [Member] |
|
|
|
|
|
Long-Term Debt [Line Items] |
|
|
|
|
|
Accrued interest |
$ 69
|
|
|
|
|
Hercules Capital Inc [Member] |
|
|
|
|
|
Long-Term Debt [Line Items] |
|
|
|
|
|
Prepayment charge, percentage |
|
|
1.00%
|
|
|
Line of Credit [Member] |
|
|
|
|
|
Long-Term Debt [Line Items] |
|
|
|
|
|
Term loan facility |
|
|
6.55%
|
|
|
First Tranche [Member] |
|
|
|
|
|
Long-Term Debt [Line Items] |
|
|
|
|
|
Advanced amount |
|
|
|
|
$ 15,000
|
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v3.24.3
Stockholders Equity (Details) - Part-1 - USD ($) $ / shares in Units, $ in Thousands |
|
|
|
|
3 Months Ended |
9 Months Ended |
|
Jul. 15, 2024 |
Mar. 15, 2024 |
Dec. 31, 2023 |
Feb. 22, 2023 |
Sep. 30, 2024 |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Jul. 09, 2024 |
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, shares outstanding |
|
|
|
4,723,320
|
[1] |
|
18,176,602
|
[1] |
|
|
|
|
|
|
18,176,602
|
[1] |
|
7,800,000
|
Common stock, shares issued |
[1] |
|
|
4,723,320
|
|
|
18,176,602
|
|
|
|
|
|
|
|
18,176,602
|
|
|
|
Common stock, shares authorized |
|
|
|
120,000,000
|
[1] |
|
750,000,000
|
[1] |
|
|
|
|
|
|
750,000,000
|
[1] |
|
750,000,000
|
Common stock, par value (in Dollars per share) |
|
|
|
$ 0.0001
|
[1] |
|
$ 0.0001
|
[1] |
|
|
|
|
|
|
$ 0.0001
|
[1] |
|
$ 0.0001
|
Preferred stock, shares authorized |
|
|
|
1,000,000
|
|
|
1,000,000
|
|
|
|
|
|
|
|
1,000,000
|
|
|
|
Preferred stock, par value (in Dollars per share) |
|
|
|
$ 0.0001
|
|
|
$ 0.0001
|
|
|
|
|
|
|
|
$ 0.0001
|
|
|
|
Additional shares |
|
|
216,417
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from PIPE (in Dollars) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 507
|
|
|
|
Total consideration amount (in Dollars) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 6
|
|
|
|
Exercise price per share (in Dollars per share) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 0.001
|
|
|
|
Private placement warrants (in Dollars) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 28,745
|
|
|
|
Warrant exercise price (in Dollars per share) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 2.31
|
|
|
|
Share based compensation (in Dollars) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 1,083
|
|
$ 641
|
|
Aggregate offering price (in Dollars) |
|
|
|
$ 7,500
|
|
|
|
|
|
|
$ 5,859
|
[2] |
$ 1,293
|
[2] |
|
|
|
|
Sale of stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,518
|
|
|
|
Sale of stock price (in Dollars per share) |
|
|
|
|
|
|
$ 2.71
|
|
|
|
|
|
|
|
$ 2.71
|
|
|
|
Aggregate net proceeds (in Dollars) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 19
|
|
|
|
Aggregate commission (in Dollars) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 1
|
|
|
|
Pre funded warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate warrants |
|
|
|
|
|
|
533,031
|
|
|
|
|
|
|
|
533,031
|
|
|
|
Private Placement Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of redeemable convertible preferred shares upon March 2024 PIPE, net of issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
216,417
|
|
|
|
Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, shares outstanding |
|
|
|
|
|
|
178,958,447
|
|
|
|
|
|
|
|
178,958,447
|
|
|
|
Maximum [Member] | Pre funded warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price (in Dollars per share) |
|
|
|
|
|
$ 2.45
|
|
|
|
|
|
|
|
|
|
|
|
|
Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, shares outstanding |
|
|
|
|
|
|
18,021,173
|
|
|
|
|
|
|
|
18,021,173
|
|
|
|
Minimum [Member] | Pre funded warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price (in Dollars per share) |
|
|
|
|
|
$ 2.44
|
|
|
|
|
|
|
|
|
|
|
|
|
March 2024 PIPE [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Converted shares of common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,410,000
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, shares issued |
|
|
40,470
|
|
|
|
125,328
|
|
|
|
|
|
|
|
125,328
|
|
|
|
Redeemable convertible preferred shares |
[3],[4] |
|
|
|
|
|
|
|
|
916,497
|
|
|
|
|
|
|
|
|
Issuance of redeemable convertible preferred shares upon March 2024 PIPE, net of issuance costs |
[2],[4] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable convertible preferred shares |
|
10,915,200
|
10,915,200
|
|
|
|
10,915,200
|
[4] |
|
|
|
|
|
|
|
|
|
|
Additional shares |
|
|
916,497
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price (in Dollars per share) |
|
|
|
|
|
|
$ 0.001
|
|
|
|
|
|
|
|
$ 0.001
|
|
|
|
Exercised shares |
[2],[4] |
|
|
|
|
|
|
|
980,811
|
477,827
|
|
|
|
|
|
|
|
|
Total consideration amount (in Dollars) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price per share (in Dollars per share) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 0.01
|
|
|
|
Convertible preferred shares |
|
|
216,650
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate offering price (in Dollars) |
[2],[4] |
|
|
|
|
|
|
|
|
|
$ 1
|
|
|
[5] |
|
|
|
|
Common Stock [Member] | Pre funded warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate warrants |
|
|
|
|
|
|
928,041
|
|
|
|
|
|
|
|
928,041
|
|
|
|
Exercised shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
925,607
|
|
|
|
March 2024 PIPE [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate warrants |
|
|
952,381
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 2024 PIPE [Member] | Private Placement Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate warrants |
|
|
|
|
|
|
10,820,850
|
|
|
|
|
|
|
|
10,820,850
|
|
|
|
March 2024 PIPE [Member] | Preferred Shares [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, par value (in Dollars per share) |
|
|
$ 0.0001
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Business Combination [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Combination price (in Dollars per share) |
|
|
|
|
|
|
$ 231.1
|
|
|
|
|
|
|
|
$ 231.1
|
|
|
|
Transaction cost (in Dollars) |
|
|
|
|
|
|
$ 3,317
|
|
|
|
|
|
|
|
$ 3,317
|
|
|
|
Converted shares of common stock |
|
|
100
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Business Combination [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable convertible preferred shares |
|
|
916,497
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Converted shares of common stock |
|
|
100
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, shares authorized |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
120,000,000
|
Common Stock [Member] | Private Placement Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
533,031
|
|
|
|
Redeemable Convertible Preferred Shares [Member] | Preferred Shares [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable convertible preferred shares |
|
|
40,470
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable convertible preferred shares |
|
109,152
|
109,152
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable Convertible Preferred Shares [Member] | Business Combination [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Converted shares of common stock |
|
|
40,470
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable convertible preferred shares [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, par value (in Dollars per share) |
|
|
$ 0.0001
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of redeemable convertible preferred shares upon March 2024 PIPE, net of issuance costs |
|
|
216,417
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Private Placement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional shares |
|
|
|
|
|
1,599,746
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance cost (in Dollars) |
|
|
|
|
|
$ 333
|
|
|
|
|
|
|
|
|
|
|
|
|
Private placement warrants (in Dollars) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 50,000
|
|
|
|
Private Placement [Member] | Pre funded warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate warrants |
|
|
|
|
|
1,461,072
|
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from PIPE (in Dollars) |
|
|
|
|
|
$ 7,152
|
|
|
|
|
|
|
|
|
|
|
|
|
Private Placement [Member] | March 2024 PIPE [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Private placement warrants (in Dollars) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,907
|
|
|
|
Share based compensation (in Dollars) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 1,273
|
|
|
|
|
|
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v3.24.3
Stockholders Equity (Details) - Part-2 - $ / shares
|
Sep. 16, 2024 |
Jul. 11, 2024 |
Jul. 09, 2024 |
Sep. 30, 2024 |
[1] |
Mar. 15, 2024 |
Dec. 31, 2023 |
[1] |
Stockholders Equity [Line Items] |
|
|
|
|
|
|
Total number of fully-diluted shares |
|
|
15.00%
|
|
|
|
Common stock, shares outstanding |
|
|
7,800,000
|
18,176,602
|
|
4,723,320
|
Stock Issued During Period, Shares, Restricted Stock Award, Gross |
155,429
|
|
|
|
|
|
Restricted stock unit fair value (in Dollars per share) |
$ 0.99
|
|
|
|
|
|
Options granted exercise price (in Dollars per share) |
|
$ 3.63
|
|
|
|
|
PIPE [Member] |
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
Aggregate warrants |
|
|
|
|
952,381
|
|
Agents Warrants [Member] | PIPE [Member] |
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
Exercise price (in Dollars per share) |
|
|
|
|
$ 2.31
|
|
Board of Directors [Member] |
|
|
|
|
|
|
Stockholders Equity [Line Items] |
|
|
|
|
|
|
Grant of options |
|
1,567,795
|
|
|
|
|
|
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v3.24.3
Stockholders Equity (Details) - Schedule of Outstanding Warrants to Purchase Common Stock Issued to Stockholders - Warrants [Member]
|
9 Months Ended |
Sep. 30, 2024
$ / shares
shares
|
Schedule of Outstanding Warrants to Purchase Common Stock Issued to Stockholders [Line Items] |
|
Number of Shares of Common Stock Underlying Warrants |
12,621,132
|
Public Warrants [Member] | IPO (December 13, 2018) [Member] |
|
Schedule of Outstanding Warrants to Purchase Common Stock Issued to Stockholders [Line Items] |
|
Issuance Date |
IPO (December 13, 2018)
|
Expiration Date |
Oct. 28, 2024
|
Exercise Price Per Share | $ / shares |
$ 115
|
Number of Shares of Common Stock Underlying Warrants |
350,000
|
2021 Registered Direct Offering Warrants [Member] | SPA (July 28, 2021) [Member] |
|
Schedule of Outstanding Warrants to Purchase Common Stock Issued to Stockholders [Line Items] |
|
Issuance Date |
SPA (July 28, 2021)
|
Expiration Date |
Jan. 28, 2027
|
Exercise Price Per Share | $ / shares |
$ 50
|
Number of Shares of Common Stock Underlying Warrants |
281,251
|
Merger Warrants [Member] | March 15, 2024 [Member] |
|
Schedule of Outstanding Warrants to Purchase Common Stock Issued to Stockholders [Line Items] |
|
Issuance Date |
March 15, 2024
|
Expiration Date |
Jan. 28, 2027
|
Exercise Price Per Share | $ / shares |
$ 50
|
Number of Shares of Common Stock Underlying Warrants |
216,650
|
Private Placement Warrants [Member] | March 15, 2024 [Member] |
|
Schedule of Outstanding Warrants to Purchase Common Stock Issued to Stockholders [Line Items] |
|
Issuance Date |
March 15, 2024
|
Expiration Date |
Jul. 09, 2026
|
Exercise Price Per Share | $ / shares |
$ 2.31
|
Number of Shares of Common Stock Underlying Warrants |
10,820,850
|
Agents Warrants [Member] | March 15, 2024 [Member] |
|
Schedule of Outstanding Warrants to Purchase Common Stock Issued to Stockholders [Line Items] |
|
Issuance Date |
March 15, 2024
|
Expiration Date |
Jul. 09, 2026
|
Exercise Price Per Share | $ / shares |
$ 2.31
|
Number of Shares of Common Stock Underlying Warrants |
952,381
|
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v3.24.3
Stockholders Equity (Details) - Schedule of Options Granted to Purchase - Stock Option [Member] $ / shares in Units, $ in Thousands |
9 Months Ended |
Sep. 30, 2024
USD ($)
$ / shares
shares
|
Schedule of Options Granted to Purchase [Line Items] |
|
Number of Options, Beginning Balance | shares |
528,112
|
Weighted Average Exercise Price, Beginning Balance | $ / shares |
$ 5.41
|
Aggregate Intrinsic Value, Beginning Balance | $ |
$ 72
|
Number of Options, Granted | shares |
1,567,795
|
Weighted Average Exercise Price, Granted | $ / shares |
$ 3.63
|
Number of Options, Forfeited | shares |
(26,808)
|
Weighted Average Exercise Price, Forfeited | $ / shares |
$ 3.96
|
Number of Options, Expired | shares |
(6,449)
|
Weighted Average Exercise Price, Expired | $ / shares |
$ 4.58
|
Number of Options, Exercised | shares |
|
Weighted Average Exercise Price, Exercised | $ / shares |
|
Number of Options, Ending Balance | shares |
2,062,650
|
Weighted Average Exercise Price, Ending Balance | $ / shares |
$ 4.08
|
Aggregate Intrinsic Value, Ending Balance | $ |
$ 22
|
Number of Options, Exercisable at end of period | shares |
351,109
|
Weighted Average Exercise Price, Exercisable at the end of period | $ / shares |
$ 5.79
|
Weighted average remaining contractual life of outstanding options – years as of September 30, 2024 |
8 years 10 months 6 days
|
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v3.24.3
Basic and Diluted Loss (Earnings) Per Share (Details) - Schedule of Anti-dilutive Financial Instruments - shares
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Options [Member] |
|
|
|
|
Schedule of Anti-dilutive Financial Instruments [Line Items] |
|
|
|
|
Anti-dilutive shares |
2,041,139
|
591,034
|
2,062,650
|
591,034
|
Warrants [Member] |
|
|
|
|
Schedule of Anti-dilutive Financial Instruments [Line Items] |
|
|
|
|
Anti-dilutive shares |
12,646,132
|
921,251
|
1,825,281
|
921,251
|
Contingent shares [Member] |
|
|
|
|
Schedule of Anti-dilutive Financial Instruments [Line Items] |
|
|
|
|
Anti-dilutive shares |
200,000
|
400,000
|
200,000
|
400,000
|
Redeemable Convertible Preferred Shares [Member] |
|
|
|
|
Schedule of Anti-dilutive Financial Instruments [Line Items] |
|
|
|
|
Anti-dilutive shares |
14,773,500
|
|
14,773,500
|
|
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v3.24.3
Basic and Diluted Loss (Earnings) Per Share (Details) - Schedule of Basic and Diluted Loss (earnings) Per Share - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Jun. 30, 2024 |
Mar. 31, 2024 |
Sep. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Numerator: |
|
|
|
|
|
|
|
|
|
Net loss (income) (in Dollars) |
|
$ (9,642)
|
$ (4,471)
|
$ 17,327
|
$ 7,906
|
$ 6,411
|
$ 6,361
|
$ 3,214
|
$ 20,678
|
Change in fair value of Private Placement Warrants (in Dollars) |
|
20,559
|
|
|
|
|
|
24,417
|
|
Diluted net loss (in Dollars) |
|
(9,642)
|
|
|
7,906
|
|
|
27,631
|
20,678
|
Amount allocated to Redeemable Convertible Preferred Shares (in Dollars) |
|
(4,575)
|
|
|
|
|
|
|
|
Net loss (income) attributable to shares of common stock (in Dollars) |
|
$ (5,067)
|
|
|
$ 7,906
|
|
|
$ 3,214
|
$ 20,678
|
Denominator: |
|
|
|
|
|
|
|
|
|
Weighted-average number of shares of common stock outstanding |
|
16,366,122
|
|
|
6,058,774
|
|
|
9,944,267
|
4,819,658
|
Private Placement Warrants |
|
|
|
|
|
|
|
1,350,613
|
|
Options |
|
21,511
|
|
|
|
|
|
|
|
Total weighted-average number of shares of common stock outstanding, after giving effect to dilutive securities |
|
16,387,633
|
|
|
6,058,774
|
|
|
11,294,880
|
4,819,658
|
Diluted net loss per share of common stock (in Dollars per share) |
[1] |
$ (0.31)
|
|
|
$ 1.3
|
|
|
$ 2.45
|
$ 4.29
|
Denominator: |
|
|
|
|
|
|
|
|
|
Number of shares of common stock outstanding |
|
16,365,824
|
|
|
4,597,403
|
|
|
9,943,968
|
3,951,624
|
Number of shares upon Pre-Funded Warrants exercise |
|
|
|
|
1,461,073
|
|
|
|
867,736
|
Number of shares upon Fully vested Warrants exercise |
|
298
|
|
|
298
|
|
|
298
|
298
|
Total weighted-average number of shares of common stock, shares upon Pre-Funded Warrants and Fully vested Warrants exercise used in computing basic loss (earnings) per share |
|
16,366,122
|
|
|
6,058,774
|
|
|
9,944,267
|
4,819,658
|
Basic loss (earnings) per share of common stock (in Dollars per share) |
[1] |
$ (0.31)
|
|
|
$ 1.3
|
|
|
$ 0.32
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$ 4.29
|
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- DefinitionAmount of cash outflow for fees classified as other.
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