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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
(Mark
one)
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2023
or
☐ 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 001-15771
ABEONA
THERAPEUTICS INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
83-0221517 |
(State
or other jurisdiction of incorporation or organization) |
|
(I.R.S.
Employer I.D. No.) |
6555
Carnegie Avenue, 4thFloor
Cleveland,
OH 44103
(Address
of principal executive offices, zip code)
(646)
813-4701
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Securities Exchange Act of 1934:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, $0.01 par value |
|
ABEO |
|
Nasdaq
Capital Market |
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 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 common stock as of August 1, 2023 was 24,755,873 shares.
ABEONA
THERAPEUTICS INC.
Form
10-Q
For
the Quarter Ended June 30, 2023
INDEX
FORWARD-LOOKING
STATEMENTS
This
Quarterly Report on Form 10-Q contains statements that express management’s opinions, expectations, beliefs, plans, objectives,
assumptions or projections regarding future events or future results and therefore are, or may be deemed to be, “forward-looking
statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended. Words such as “expects,” “anticipates,” “intends,” “plans,”
“believes,” “could,” “would,” “seeks,” “estimates,” and variations of such
words and similar expressions, and the negatives thereof, are intended to identify such forward-looking statements. Such “forward-looking
statements” speak only as of the date made and are not guarantees of future performance and involve certain risks, uncertainties,
estimates, and assumptions by management that are difficult to predict. Various factors, some of which are beyond the Company’s
control, could cause actual results to differ materially from those expressed in, or implied by, such forward-looking statements. In
addition, we disclaim any obligation to update any forward-looking statements to reflect events or circumstances after the date of this
report, except as may otherwise be required by the federal securities laws.
Forward-looking
statements necessarily involve risks and uncertainties, and our actual results could differ materially from those anticipated in forward-looking
statements due to a number of factors. These statements include statements about: our plans to submit a Biologics License Application
for EB-101 and the timing thereof; our plans to continue development of AAV-based gene therapies designed to treat ophthalmic and other
diseases and next-generation AAV-based gene therapies; the achievement of or expected timing, progress and results of clinical development,
clinical trials and potential regulatory approvals; our pipeline of product candidates; our belief that EB-101 could potentially benefit
patients with RDEB; development of our novel AAV-based gene therapy platform technology; our belief in the adequacy of the clinical trial
data from our VIITAL™ clinical trial, together with the data generated in the program to date, to support regulatory approvals;
our dependence upon our third-party and related-party customers and vendors and their compliance with regulatory bodies; our estimates
regarding expenses, future revenues, capital requirements, and needs for additional financing; our intellectual property position and
our ability to obtain, maintain and enforce intellectual property protection and exclusivity for our proprietary assets; our estimates
regarding the size of the potential markets for our product candidates, the strength of our commercialization strategies and our ability
to serve and supply those markets; and future economic conditions or performance.
Important
factors that could affect performance and cause results to differ materially from management’s expectations are described in the
sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results
of Operations” in the Company’s Annual Report on Form 10-K/A for the fiscal year ended December 31, 2022, as updated from
time to time in the Company’s SEC filings, including this Quarterly Report on Form 10-Q. These factors include: our ability to
successfully submit a Biologics License Application for EB-101 and the outcome thereof; our ability to find a potential commercialization
partner for EB-101; our ability to access our existing at-the-market sale agreement; our ability to access additional financial resources
and/or our financial flexibility to reduce operating expenses if required; our ability to obtain additional equity funding from current
or new stockholders; the potential impacts of global healthcare emergencies, such as pandemics, on our business, operations, and financial
condition; our ability to out-license technology and/or other assets, deferring and/or eliminating planned expenditures, restructuring
operations and/or reducing headcount, and sales of assets; the dilutive effect that raising additional funds by selling additional equity
securities would have on the relative equity ownership of our existing investors, including under our existing at-the-market sale agreement;
the outcome of any interactions with the U.S. Food and Drug Administration (“FDA”) or other regulatory agencies relating
to any of our products or product candidates; our ability to continue to secure and maintain regulatory designations for our product
candidates; our ability to develop manufacturing capabilities compliant with current good manufacturing practices for our product candidates;
our ability to manufacture cell and gene therapy products and produce an adequate product supply to support clinical trials and potentially
future commercialization; the rate and degree of market acceptance of our product candidates for any indication once approved; and our
ability to meet our obligations contained in license agreements to which we are party.
PART
I – FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
Abeona
Therapeutics Inc. and Subsidiaries
Condensed
Consolidated Balance Sheets
($
in thousands, except share and per share amounts)
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 6,225 | | |
$ | 14,217 | |
Short-term investments | |
| 30,547 | | |
| 37,932 | |
Restricted cash | |
| 338 | | |
| 338 | |
Accounts receivable | |
| 3,500 | | |
| — | |
Other receivables | |
| 2,227 | | |
| 188 | |
Prepaid expenses and other current assets | |
| 1,201 | | |
| 424 | |
Total current assets | |
| 44,038 | | |
| 53,099 | |
Property and equipment, net | |
| 4,489 | | |
| 5,741 | |
Right-of-use lease assets | |
| 4,915 | | |
| 5,331 | |
Other assets | |
| 108 | | |
| 43 | |
Total assets | |
$ | 53,550 | | |
$ | 64,214 | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 3,477 | | |
$ | 1,811 | |
Accrued expenses | |
| 4,161 | | |
| 3,991 | |
Current portion of lease liability | |
| 1,597 | | |
| 1,773 | |
Other current liabilities | |
| 205 | | |
| 204 | |
Total current liabilities | |
| 9,440 | | |
| 7,779 | |
Payable to licensor | |
| 4,367 | | |
| 4,163 | |
Long-term lease liabilities | |
| 4,377 | | |
| 5,854 | |
Warrant liabilities | |
| 26,021 | | |
| 19,657 | |
Total liabilities | |
| 44,205 | | |
| 37,453 | |
Commitments and contingencies | |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Preferred stock - $0.01 par value; authorized 2,000,000 shares; No shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively | |
| — | | |
| — | |
Common stock - $0.01 par value; authorized 200,000,000 shares; 21,478,157 and 17,719,720 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively | |
| 215 | | |
| 177 | |
Additional paid-in capital | |
| 730,322 | | |
| 722,049 | |
Accumulated deficit | |
| (721,097 | ) | |
| (695,336 | ) |
Accumulated other comprehensive loss | |
| (95 | ) | |
| (129 | ) |
Total stockholders’ equity | |
| 9,345 | | |
| 26,761 | |
Total liabilities and stockholders’ equity | |
$ | 53,550 | | |
$ | 64,214 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated statements.
Abeona
Therapeutics Inc. and Subsidiaries
Condensed
Consolidated Statements of Operations and Comprehensive Loss
($
in thousands, except share and per share amounts)
(Unaudited)
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For
the three months ended June 30, | | |
For
the six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Revenues: | |
| | | |
| | | |
| | | |
| | |
License and other revenues | |
$ | 3,500 | | |
$ | 1,000 | | |
$ | 3,500 | | |
$ | 1,346 | |
| |
| | | |
| | | |
| | | |
| | |
Expenses: | |
| | | |
| | | |
| | | |
| | |
Royalties | |
| 1,575 | | |
| 350 | | |
| 1,575 | | |
| 350 | |
Research and development | |
| 8,523 | | |
| 6,658 | | |
| 16,564 | | |
| 17,203 | |
General and administrative | |
| 5,021 | | |
| 3,460 | | |
| 9,018 | | |
| 7,684 | |
Impairment of licensed technology | |
| — | | |
| — | | |
| — | | |
| 1,355 | |
Loss/(gain) on right-of-use lease assets | |
| (1,065 | ) | |
| — | | |
| (1,065 | ) | |
| 1,561 | |
Impairment of construction-in-progress | |
| — | | |
| (1,460 | ) | |
| — | | |
| 1,792 | |
Total expenses | |
| 14,054 | | |
| 9,008 | | |
| 26,092 | | |
| 29,945 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (10,554 | ) | |
| (8,008 | ) | |
| (22,592 | ) | |
| (28,599 | ) |
| |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 417 | | |
| 31 | | |
| 781 | | |
| 38 | |
Interest expense | |
| (103 | ) | |
| (200 | ) | |
| (204 | ) | |
| (401 | ) |
Change in fair value of warrant liabilities | |
| (8,629 | ) | |
| 4,198 | | |
| (6,364 | ) | |
| 2,945 | |
Other income (expense) | |
| 2,215 | | |
| (118 | ) | |
| 2,618 | | |
| (124 | ) |
Net loss | |
$ | (16,654 | ) | |
$ | (4,097 | ) | |
$ | (25,761 | ) | |
$ | (26,141 | ) |
Deemed dividends related to Series A and Series B Convertible Redeemable Preferred Stock | |
| — | | |
| (3,782 | ) | |
| — | | |
| (3,782 | ) |
Net loss attributable to Common Shareholders | |
$ | (16,654 | ) | |
$ | (7,879 | ) | |
$ | (25,761 | ) | |
$ | (29,923 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted loss per common share | |
$ | (0.92 | ) | |
$ | (1.36 | ) | |
$ | (1.48 | ) | |
$ | (5.16 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average number of common shares outstanding – basic and diluted | |
| 18,017,874 | | |
| 5,806,473 | | |
| 17,464,026 | | |
| 5,800,822 | |
| |
| | | |
| | | |
| | | |
| | |
Other comprehensive income (loss): | |
| | | |
| | | |
| | | |
| | |
Change in unrealized gains (losses) related to available-for-sale debt securities | |
| (30 | ) | |
| (4 | ) | |
| 34 | | |
| (7 | ) |
Comprehensive loss | |
$ | (16,684 | ) | |
$ | (7,883 | ) | |
$ | (25,727 | ) | |
$ | (29,930 | ) |
The
accompanying notes are an integral part of these unaudited condensed consolidated statements.
Abeona
Therapeutics Inc. and Subsidiaries
Condensed
Consolidated Statements of Stockholders’ Equity
($
in thousands, except share amounts)
(Unaudited)
| |
|
|
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
Equity | |
Three months ended June 30, 2023 |
| |
|
|
| | |
| | |
| | |
| | |
Accumulated | | |
| |
| |
|
|
| | |
| | |
Additional | | |
| | |
Other | | |
Total | |
| |
|
|
Common Stock | | |
Paid-in | | |
Accumulated | | |
Comprehensive | | |
Stockholders’ | |
| |
|
|
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
Equity | |
| |
|
|
| | |
| | |
| | |
| | |
| | |
| |
Balance at March 31, 2023 | - |
- |
|
| 17,929,344 | | |
$ | 179 | | |
$ | 723,069 | | |
$ | (704,443 | ) | |
$ | (65 | ) | |
$ | 18,740 | |
Stock-based compensation expense | |
|
|
| — | | |
| — | | |
| 927 | | |
| — | | |
| — | | |
| 927 | |
Issuance of common stock in connection with restricted share awards, net of cancellations and shares settled for tax withholding settlement | |
|
|
| 1,657,052 | | |
| 17 | | |
| (22 | ) | |
| — | | |
| — | | |
| (5 | ) |
Issuance of common stock, net of offering costs under open market sale agreement (ATM) | |
|
|
| 1,891,761 | | |
| 19 | | |
| 6,348 | | |
| — | | |
| — | | |
| 6,367 | |
Net loss | - |
- |
|
| — | | |
| — | | |
| — | | |
| (16,654 | ) | |
| — | | |
| (16,654 | ) |
Other comprehensive loss | |
|
|
| — | | |
| — | | |
| — | | |
| — | | |
| (30 | ) | |
| (30 | ) |
Balance at June 30, 2023 | - |
- |
|
| 21,478,157 | | |
$ | 215 | | |
$ | 730,322 | | |
$ | (721,097 | ) | |
$ | (95 | ) | |
$ | 9,345 | |
Six months ended June 30, 2023 |
| |
|
|
| | |
| | |
| | |
| | |
Accumulated | | |
| |
| |
|
|
| | |
| | |
Additional | | |
| | |
Other | | |
Total | |
| |
|
|
Common Stock | | |
Paid-in | | |
Accumulated | | |
Comprehensive | | |
Stockholders’ | |
| |
|
|
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
Equity | |
| |
|
|
| | |
| | |
| | |
| | |
| | |
| |
Balance at December 31, 2022 | - |
- |
|
| 17,719,720 | | |
$ | 177 | | |
$ | 722,049 | | |
$ | (695,336 | ) | |
$ | (129 | ) | |
$ | 26,761 | |
Stock-based compensation expense | |
|
|
| — | | |
| — | | |
| 1,697 | | |
| — | | |
| — | | |
| 1,697 | |
Issuance of common stock in connection with restricted share awards, net of cancellations and shares settled for tax withholding settlement | |
|
|
| 1,768,116 | | |
| 18 | | |
| (27 | ) | |
| — | | |
| — | | |
| (9 | ) |
Issuance of common stock, net of offering costs under open market sale agreement (ATM) | |
|
|
| 1,990,321 | | |
| 20 | | |
| 6,603 | | |
| — | | |
| — | | |
| 6,623 | |
Net loss | - |
- |
|
| — | | |
| — | | |
| — | | |
| (25,761 | ) | |
| — | | |
| (25,761 | ) |
Other comprehensive income | |
|
|
| — | | |
| — | | |
| — | | |
| — | | |
| 34 | | |
| 34 | |
Balance at June 30, 2023 | - |
- |
|
| 21,478,157 | | |
$ | 215 | | |
$ | 730,322 | | |
$ | (721,097 | ) | |
$ | (95 | ) | |
$ | 9,345 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated statements.
Abeona
Therapeutics Inc. and Subsidiaries
Condensed
Consolidated Statements of Stockholders’ Equity (Continued)
($
in thousands, except share amounts)
(Unaudited)
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
Equity | |
Three months ended June 30, 2022 |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
| |
Convertible Redeemable
Preferred Stock | | |
| | |
| | |
Additional | | |
| | |
Accumulated
Other | | |
Total | |
| |
Series A | | |
Series B | | |
Common Stock | | |
Paid-in | | |
Accumulated | | |
Comprehensive | | |
Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance at March 31, 2022 | |
| — | | |
$ | — | | |
| — | | |
$ | — | | |
| 5,883,196 | | |
$ | 1,471 | | |
$ | 697,426 | | |
$ | (677,684 | ) | |
$ | (30 | ) | |
$ | 21,183 | |
Stock-based compensation expense | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 724 | | |
| — | | |
| — | | |
| 724 | |
Issuance of common stock in connection with restricted share awards, net of cancellations | |
| — | | |
| — | | |
| — | | |
| — | | |
| (12,821 | ) | |
| (4 | ) | |
| 4 | | |
| — | | |
| — | | |
| — | |
Issuance of Series A and Series B Convertible Redeemable Preferred Stock | |
| 1,000,006 | | |
| 17,974 | | |
| 250,005 | | |
| 4,494 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
Deemed dividends related to Series A and Series B Convertible Redeemable Preferred Stock | |
| — | | |
| 3,026 | | |
| — | | |
| 756 | | |
| — | | |
| — | | |
| (3,782 | ) | |
| — | | |
| — | | |
| (3,782 | ) |
Redemption of Series A and Series B Convertible Redeemable Preferred Stock | |
| (1,000,006 | ) | |
| (21,000 | ) | |
| (250,005 | ) | |
| (5,250 | ) | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (4,097 | ) | |
| — | | |
| (4,097 | ) |
Other comprehensive loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (4 | ) | |
| (4 | ) |
Balance at June 30, 2022 | |
| — | | |
$ | — | | |
| — | | |
$ | — | | |
| 5,870,375 | | |
$ | 1,467 | | |
$ | 694,372 | | |
$ | (681,781 | ) | |
$ | (34 | ) | |
$ | 14,024 | |
Six months ended June 30, 2022 |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| |
| |
Convertible Redeemable
Preferred Stock | | |
| | |
| | |
Additional | | |
| | |
Accumulated
Other | | |
Total | |
| |
Series A | | |
Series B | | |
Common Stock | | |
Paid-in | | |
Accumulated | | |
Comprehensive | | |
Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance at December 31, 2021 | |
| — | | |
$ | — | | |
| — | | |
$ | — | | |
| 5,888,217 | | |
$ | 1,472 | | |
$ | 696,563 | | |
$ | (655,640 | ) | |
$ | (27 | ) | |
$ | 42,368 | |
Balance | |
| — | | |
$ | — | | |
| — | | |
$ | — | | |
| 5,888,217 | | |
$ | 1,472 | | |
$ | 696,563 | | |
$ | (655,640 | ) | |
$ | (27 | ) | |
$ | 42,368 | |
Stock-based compensation expense | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 1,586 | | |
| — | | |
| — | | |
| 1,586 | |
Issuance of common stock in connection with restricted share awards, net of cancellations | |
| — | | |
| — | | |
| — | | |
| — | | |
| (17,842 | ) | |
| (5 | ) | |
| 5 | | |
| — | | |
| — | | |
| — | |
Issuance of Series A and Series B Convertible Redeemable Preferred Stock | |
| 1,000,006 | | |
| 17,974 | | |
| 250,005 | | |
| 4,494 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
Deemed dividends related to Series A and Series B Convertible Redeemable Preferred Stock | |
| — | | |
| 3,026 | | |
| — | | |
| 756 | | |
| — | | |
| — | | |
| (3,782 | ) | |
| — | | |
| — | | |
| (3,782 | ) |
Redemption of Series A and Series B Convertible Redeemable Preferred Stock | |
| (1,000,006 | ) | |
| (21,000 | ) | |
| (250,005 | ) | |
| (5,250 | ) | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (26,141 | ) | |
| — | | |
| (26,141 | ) |
Other comprehensive loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (7 | ) | |
| (7 | ) |
Other
comprehensive income (loss) | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (7 | ) | |
| (7 | ) |
Balance at June 30, 2022 | |
| — | | |
$ | — | | |
| — | | |
$ | — | | |
| 5,870,375 | | |
$ | 1,467 | | |
$ | 694,372 | | |
$ | (681,781 | ) | |
$ | (34 | ) | |
$ | 14,024 | |
Balance | |
| — | | |
$ | — | | |
| — | | |
$ | — | | |
| 5,870,375 | | |
$ | 1,467 | | |
$ | 694,372 | | |
$ | (681,781 | ) | |
$ | (34 | ) | |
$ | 14,024 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated statements.
Abeona
Therapeutics Inc. and Subsidiaries
Condensed
Consolidated Statements of Cash Flows
($
in thousands)
(Unaudited)
| |
2023 | | |
2022 | |
| |
For the six months ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Cash flows from operating activities: | |
| | | |
| | |
Net loss | |
$ | (25,761 | ) | |
$ | (26,141 | ) |
Adjustments to reconcile net loss to cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 1,276 | | |
| 1,584 | |
Stock-based compensation expense | |
| 1,697 | | |
| 1,586 | |
Change in fair value of warrant liabilities | |
| 6,364 | | |
| (2,945 | ) |
Non-cash impairment of licensed technology | |
| — | | |
| 1,355 | |
Non-cash loss/(gain) of right-of-use lease assets | |
| (1,065 | ) | |
| 1,561 | |
Non-cash impairment of construction-in-progress | |
| — | | |
| 1,792 | |
Accretion and interest on short-term investments | |
| (74 | ) | |
| (177 | ) |
Amortization of right-of-use lease assets | |
| 450 | | |
| 899 | |
Non-cash interest | |
| 204 | | |
| 402 | |
Loss on disposal of property and equipment | |
| 47 | | |
| 106 | |
Change in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| (3,500 | ) | |
| 2,000 | |
Other receivables | |
| (2,039 | ) | |
| (1,827 | ) |
Prepaid expenses and other current assets | |
| (777 | ) | |
| 937 | |
Other assets | |
| (65 | ) | |
| 148 | |
Accounts payable, accrued expenses and lease liabilities | |
| 1,214 | | |
| (3,684 | ) |
Other current liabilities | |
| 1 | | |
| — | |
Change in payable to licensor | |
| — | | |
| (296 | ) |
Net cash used in operating activities | |
| (22,028 | ) | |
| (22,700 | ) |
| |
| | | |
| | |
Cash flows from investing activities: | |
| | | |
| | |
Capital expenditures | |
| (250 | ) | |
| (103 | ) |
Proceeds from disposal of property and equipment | |
| 179 | | |
| 1,487 | |
Purchases of short-term investments | |
| (14,156 | ) | |
| (34,442 | ) |
Proceeds from maturities of short-term investments | |
| 21,649 | | |
| 32,735 | |
Net cash provided by (used in) investing activities | |
| 7,422 | | |
| (323 | ) |
| |
| | | |
| | |
Cash flows from financing activities: | |
| | | |
| | |
Proceeds from ATM sales of common stock, net of issuance costs | |
| 6,623 | | |
| — | |
Proceeds from net settlement of restricted share awards | |
| (9 | ) | |
| — | |
Proceeds from issuance of Series A and Series B Convertible Redeemable Preferred Stock, net of issuance costs | |
| — | | |
| 22,468 | |
Redemption of Series A and Series B Convertible Redeemable Preferred Stock | |
| — | | |
| (26,250 | ) |
Net cash provided by (used in) financing activities | |
| 6,614 | | |
| (3,782 | ) |
| |
| | | |
| | |
Net decrease in cash, cash equivalents and restricted cash | |
| (7,992 | ) | |
| (26,805 | ) |
Cash, cash equivalents and restricted cash at beginning of period | |
| 14,555 | | |
| 38,829 | |
Cash, cash equivalents and restricted cash at end of period | |
$ | 6,563 | | |
$ | 12,024 | |
| |
| | | |
| | |
Supplemental cash flow information: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 6,225 | | |
$ | 6,133 | |
Restricted cash | |
| 338 | | |
| 5,891 | |
Total cash, cash equivalents and restricted cash | |
$ | 6,563 | | |
$ | 12,024 | |
| |
| | | |
| | |
Supplemental non-cash flow information: | |
| | | |
| | |
Right-of-use asset obtained in exchange for new operating lease liabilities | |
$ | 419 | | |
$ | — | |
The
accompanying notes are an integral part of these unaudited condensed consolidated statements.
ABEONA
THERAPEUTICS INC. AND SUBSIDIARIES
Notes
to Unaudited Condensed Consolidated Financial Statements
NOTE
1 – NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES
Background
Abeona
Therapeutics Inc. (together with the Company’s subsidiaries, “Abeona” or the “Company”), a Delaware corporation,
is a clinical-stage biopharmaceutical company developing cell and gene therapies for life-threatening diseases. The Company’s lead
clinical program is EB-101, an autologous, engineered cell therapy currently in development for recessive dystrophic epidermolysis bullosa
(“RDEB”). The Company’s development portfolio also features adeno-associated virus (“AAV”)-based gene therapies
designed to treat highly unmet, medically needed ophthalmic diseases using the novel AIM™ capsid platform that the Company has
exclusively licensed from the University of North Carolina at Chapel Hill, and internal AAV vector research programs.
Basis
of Presentation
The
Company’s unaudited interim condensed consolidated financial statements have been prepared in conformity with accounting principles
generally accepted in the United States of America (“U.S. GAAP”). All intercompany balances and transactions have been eliminated
in consolidation. In the opinion of management, all adjustments, consisting only of normal recurring adjustments, except as otherwise
disclosed, necessary for the fair presentation of the financial position, results of operations, and changes in financial position for
such periods, have been made. These unaudited interim condensed consolidated financial statement results are not necessarily indicative
of results to be expected for the full fiscal year or any future period. Certain information that is normally required by U.S. GAAP has
been condensed or omitted in accordance with rules and regulations of the U.S. Securities and Exchange Commission (“SEC”).
The December 31, 2022 condensed consolidated balance sheet was derived from the audited statements, but does not include all disclosures
required by U.S. GAAP.
Therefore,
these unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial
statements and notes thereto included in our Annual Report on Form 10-K/A for the year ended December 31, 2022, which was filed with
the SEC on April 10, 2023.
Reverse
Stock Split
As
described in Note 1 to the consolidated financial statements included in the Company’s 2022 Annual Report on Form 10-K/A, on June
30, 2022, the Company filed a Certificate of Amendment to the Company’s Restated Certificate of Incorporation with the Secretary
of State of the State of Delaware (the “Certificate of Amendment”), to effectuate a reverse stock split of the Company’s
outstanding common stock, par value $0.01 per share (“Common Stock”), at an exchange ratio of 25-to-1 (the “Reverse
Stock Split”). The Reverse Stock Split was effective on July 1, 2022. The number of authorized shares of Common Stock immediately
after the Reverse Stock Split (“New Common Stock”) remained at 200,000,000 shares. All share and per share information has
been retroactively adjusted to give effect to the Reverse Stock Split for all periods presented, unless otherwise indicated.
Uses
and Sources of Liquidity
The
unaudited interim condensed consolidated financial statements have been prepared on the going concern basis, which assumes the Company
will have sufficient cash to pay its operating expenses, as and when they become payable, for a period of at least 12 months from the
date the financial report is issued.
As
of June 30, 2023, the Company had cash, cash equivalents, restricted cash and short-term investments of $37.1 million. For the six months
ended June 30, 2023, the Company had cash outflows from operations of $22.0 million. The Company has not generated significant revenues
and has not achieved profitable operations. There is no assurance that profitable operations will ever be achieved, and, if achieved,
could be sustained on a continuing basis. In addition, development activities, clinical and nonclinical testing, and commercialization
of the Company’s product candidates will require significant additional financing.
The
Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the
successful discovery and development of product candidates, obtaining the necessary regulatory approval to market the Company’s
product candidates, raising additional capital to continue to fund the Company’s operations, development of competing drugs and
therapies and protection of proprietary technology. As a result of these and other risks and the related uncertainties, there can be
no assurance of the Company’s future success.
Subsequent
to June 30, 2023, as described in Note 12, the Company raised $25.0 million, with net proceeds
of $23.0 million, after offering costs through the issuance of common stock and warrants.
The
Company believes that its current cash and cash equivalents, restricted cash and short-term investments are sufficient resources to fund
operations through at least the next 12 months from the date of this quarterly report on Form 10-Q. The Company may need to secure additional
funding to carry out all of its planned research and development and commercialization activities. If the Company is unable to obtain
additional financing or generate license or product revenue, the lack of liquidity and sufficient capital resources could have a material
adverse effect on its future prospects.
Use
of Estimates
The
preparation of unaudited interim condensed consolidated financial statements in conformity with U.S. GAAP requires management to make
estimates and assumptions that affect the reported amount of assets and disclosure of contingent assets and liabilities at the date of
the unaudited interim condensed consolidated financial statements and the reported amounts of revenue and expenses during the reported
period. Actual results could differ from these estimates and assumptions.
Other
receivables
Other
receivables include employee retention credits (“ERC”), sublease rent receivables and other miscellaneous receivables. As
of June 30, 2023 and December 31, 2022, the Company had ERC receivables of $2.1 million and nil, respectively.
Summary
of Significant Accounting Policies
There
have been no new, anticipated or material changes to the significant accounting policies disclosed in the Company’s Annual Report
on Form 10-K/A for the year ended December 31, 2022.
Correction
of Error
During
the fourth quarter of 2022, the Company identified errors in the accounting for certain common stock warrants that were issued in 2021.
The common stock warrants were not indexed to the Company’s own stock and therefore should have been classified as liabilities
at their estimated fair value instead of additional paid-in capital. Although the errors were immaterial to prior periods, the 2021 financial
statements were restated in accordance with Staff Accounting Bulletin No. 108, “Considering the Effects of Prior Year Misstatements
when Quantifying Misstatements in Current Year Financial Statements”, due to the significance of the out-of-period correction to
the 2021 period. There was no impact to the Company’s consolidated statements of operations and comprehensive loss for 2021. The
correction of the error resulted in the Company adjusting its quarterly information presented for the three and six months ended June
30, 2022. The matter was correctly presented in the fiscal year end December 31, 2022 consolidated financial statements included in the
Company’s 2022 Annual Report on Form 10-K/A.
The
following tables present the effects of the correction of the prior period error to the condensed consolidated statement of operations
and comprehensive loss (in thousands, except for per share data):
SCHEDULE
OF EFFECTS OF THE RESTATEMENT TO AMOUNTS IN THE PREVIOUSLY REPORTED CONSOLIDATED FINANCIAL STATEMENTS
| |
| | |
| | |
| |
| |
For the three months ended June 30, 2022 | |
Condensed Consolidated Statement of Operations and Comprehensive Loss | |
As Reported | | |
Adjustment | | |
As Revised | |
| |
| | |
| | |
| |
Change in fair value of warrant liabilities | |
$ | — | | |
$ | 4,198 | | |
$ | 4,198 | |
Net loss | |
$ | (8,295 | ) | |
$ | 4,198 | | |
$ | (4,097 | ) |
Net loss attributable to Common Shareholders | |
$ | (12,077 | ) | |
$ | 4,198 | | |
$ | (7,879 | ) |
Basic and diluted loss per common share | |
$ | (2.08 | ) | |
$ | 0.72 | | |
$ | (1.36 | ) |
Comprehensive loss | |
$ | (12,081 | ) | |
$ | 4,198 | | |
$ | (7,883 | ) |
| |
| | |
| | |
| |
| |
For the six months ended June 30, 2022 | |
Condensed Consolidated Statement of Operations and Comprehensive Loss | |
As Reported | | |
Adjustment | | |
As Revised | |
| |
| | |
| | |
| |
Change in fair value of warrant liabilities | |
$ | — | | |
$ | 2,945 | | |
$ | 2,945 | |
Net loss | |
$ | (29,086 | ) | |
$ | 2,945 | | |
$ | (26,141 | ) |
Net loss attributable to Common Shareholders | |
$ | (32,868 | ) | |
$ | 2,945 | | |
$ | (29,923 | ) |
Basic and diluted loss per common share | |
$ | (5.67 | ) | |
$ | 0.51 | | |
$ | (5.16 | ) |
Comprehensive loss | |
$ | (32,875 | ) | |
$ | 2,945 | | |
$ | (29,930 | ) |
The
following tables present the effects of the correction of the prior period error to the condensed consolidated cash flow statement (in
thousands):
| |
For the six months ended June 30, 2022 | |
Condensed Consolidated Cash Flow Statement | |
As Reported | | |
Adjustment | | |
As Revised | |
| |
| | |
| | |
| |
Net loss | |
$ | (29,086 | ) | |
$ | 2,945 | | |
$ | (26,141 | ) |
Adjustments to reconcile net loss to cash used in operating activities: | |
| | | |
| | | |
| | |
Change in fair value of warrant liabilities | |
$ | — | | |
$ | (2,945 | ) | |
$ | (2,945 | ) |
Net cash provided by operating activities | |
$ | (22,700 | ) | |
$ | — | | |
$ | (22,700 | ) |
The
following tables present the effects of the correction of the prior period error to the condensed consolidated statement of stockholders’
equity (in thousands):
| |
As of June 30, 2022 | |
Condensed Consolidated Statement of Stockholders’ Equity | |
As Reported | | |
Adjustment | | |
As Revised | |
| |
| | |
| | |
| |
Additional paid-in capital, December 31, 2021 | |
$ | 705,570 | | |
$ | (9,007 | ) | |
$ | 696,563 | |
Total stockholders’ equity, December 31, 2021 | |
$ | 51,375 | | |
$ | (9,007 | ) | |
$ | 42,368 | |
Additional paid-in capital, March 31, 2022 | |
$ | 706,433 | | |
$ | (9,007 | ) | |
$ | 697,426 | |
Additional paid-in capital, March 31, 2022 | |
$ | 31,443 | | |
$ | (10,260 | ) | |
$ | 21,183 | |
Net loss | |
$ | (29,086 | ) | |
$ | 2,945 | | |
$ | (26,141 | ) |
Additional paid-in capital, June 30, 2022 | |
$ | 703,379 | | |
$ | (9,007 | ) | |
$ | 694,372 | |
Total stockholders’ equity, June 30, 2022 | |
$ | 20,086 | | |
$ | (6,062 | ) | |
$ | 14,024 | |
Net
Loss Per Share
Basic
and diluted net loss per share is computed by dividing net loss attributable to common shareholders by the weighted-average number of
shares of common stock. The Company does not include the potential impact of dilutive securities in diluted net loss per share, as the
impact of these items is anti-dilutive. Potential dilutive securities result from outstanding restricted stock, stock options, and stock
purchase warrants.
The
following table sets forth the potential securities that could potentially dilute basic income/(loss) per share in the future that were
not included in the computation of diluted net loss per share because to do so would have been anti-dilutive for the periods presented:
SCHEDULE
OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE
| |
For the three and six months ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Stock options | |
| 230,723 | | |
| 265,411 | |
Restricted stock | |
| 2,566,303 | | |
| 61,108 | |
Warrants | |
| 9,397,879 | | |
| 1,788,000 | |
Total | |
| 12,194,905 | | |
| 2,114,519 | |
New
Accounting Pronouncements
No
new accounting pronouncement issued or effective had, or is expected to have, a material impact on the Company’s condensed consolidated
financial statements.
NOTE
2 – SHORT-TERM INVESTMENTS
The
following table provides a summary of the short-term investments (in thousands):
SCHEDULE
OF AVAILABLE FOR SALE SHORT-TERM INVESTMENTS
| |
June 30, 2023 | |
| |
Amortized Cost | | |
Gross
Unrealized Gain | | |
Gross
Unrealized Loss | | |
Fair Value | |
| |
| | |
| | |
| | |
| |
Available-for-sale, short-term investments: | |
| | | |
| | | |
| | | |
| | |
U.S. treasury and federal agency securities | |
$ | 30,613 | | |
| — | | |
| (66 | ) | |
$ | 30,547 | |
Total available-for-sale, short-term investments | |
$ | 30,613 | | |
| — | | |
| (66 | ) | |
$ | 30,547 | |
| |
December 31, 2022 | |
| |
Amortized Cost | | |
Gross
Unrealized Gain | | |
Gross
Unrealized Loss | | |
Fair Value | |
| |
| | |
| | |
| | |
| |
Available-for-sale, short-term investments: | |
| | | |
| | | |
| | | |
| | |
U.S. treasury and federal agency securities | |
$ | 38,032 | | |
| — | | |
| (100 | ) | |
$ | 37,932 | |
Total available-for-sale, short-term investments | |
$ | 38,032 | | |
| — | | |
| (100 | ) | |
$ | 37,932 | |
As
of June 30, 2023, the available-for-sale securities classified as short-term investments mature in one year or less. Unrealized losses
on available-for-sale securities as of June 30, 2023, were not significant and were primarily due to changes in interest rates, including
market credit spreads, and not due to increased credit risks associated with specific securities. None of the short-term investments
have been in a continuous unrealized loss position for more than 12 months. Accordingly, no other-than-temporary impairment was recorded
for the three and six months ended June 30, 2023.
There
were no significant realized gains or losses recognized on the sale or maturity of available-for-sale investments for the three and six
months ended June 30, 2023 or 2022.
NOTE
3 – PROPERTY AND EQUIPMENT, NET
Property
and equipment are stated at cost and depreciated or amortized using the straight-line method based on useful lives as follows (in thousands):
SCHEDULE OF PROPERTY AND EQUIPMENT
| |
Useful lives (years) | |
June 30, 2023 | | |
December 31, 2022 | |
| |
| |
| | |
| |
Laboratory equipment | |
5 | |
$ | 7,276 | | |
$ | 7,636 | |
Furniture, software and office equipment | |
3 to 5 | |
| 991 | | |
| 1,379 | |
Leasehold improvements | |
Shorter of remaining lease term or useful life | |
| 8,603 | | |
| 8,605 | |
Subtotal | |
| |
| 16,870 | | |
| 17,620 | |
Less: accumulated depreciation | |
| |
| (12,381 | ) | |
| (11,879 | ) |
Total property and equipment, net | |
| |
$ | 4,489 | | |
$ | 5,741 | |
Depreciation
expense was $0.6 million and $0.8 million for the three months ended June 30, 2023 and 2022, respectively, and $1.3 million and $1.6
million for the six months ended June 30, 2023 and 2022, respectively.
On
March 31, 2022, the Company announced that it was pursuing a strategic partner to take over development activities of ABO-102 and that
it was discontinuing development of ABO-101. As a result, the Company determined the construction-in-progress that was dedicated to the
ABO-101 and ABO-102 programs had no future value, and thus recorded an impairment charge of $1.8 million for the six months ended June
30, 2022.
NOTE
4 – LICENSED TECHNOLOGY
On
May 15, 2015, we acquired Abeona Therapeutics LLC, which had an exclusive license through Nationwide Children’s Hospital to the
AB-101 and AB-102 patent portfolios for developing treatments for patients with Sanfilippo Syndrome Type A and Type B. The license is
amortized to expense over the life of the license of 20 years. On March 31, 2022, the Company announced that it was pursuing a strategic
partner to take over development activities of ABO-102 and that it was discontinuing development of ABO-101. As a result of this shift
in priorities, the Company determined the remaining value of the licensed technology had no future value and thus, recorded an impairment
charge of $1.4 million for the six months ended June 30, 2022. There is no remaining net value of licensed technology as of June 30,
2023 and December 31, 2022.
Amortization
expense on licensed technology was nil and $29,000 for the six months ended June 30, 2023 and 2022, respectively. There was no amortization
expense for the three months ended June 30, 2023 or 2022.
NOTE
5 – FAIR VALUE MEASUREMENTS
The
Company calculates the fair value of the Company’s assets and liabilities that qualify as financial instruments and includes additional
information in the notes to the consolidated financial statements when the fair value is different than the carrying value of these financial
instruments. The estimated fair value of other receivables, prepaid expenses and other current assets, other assets, accounts payable,
accrued expenses, and payables to licensor approximate their carrying amounts due to the relatively short maturity of these instruments.
U.S.
GAAP defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in
the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement
date. This guidance establishes a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy
requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used
to measure fair value are as follows:
|
● |
Level
1 – Quoted prices in active markets for identical assets or liabilities. |
|
|
|
|
● |
Level
2 – Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities
in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs
that are observable or can be corroborated by observable market data. |
|
|
|
|
● |
Level
3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the
assets and liabilities. This includes certain pricing models, discounted cash flow methodologies and similar valuation techniques
that use significant unobservable inputs. |
The
Company has segregated all financial assets and liabilities that are measured at fair value on a recurring basis (at least annually)
into the most appropriate level within the fair value hierarchy based on the inputs used to determine the fair value at the measurement
date in the table below.
The
following table provides a summary of financial assets measured at fair value on a recurring and non-recurring basis as of June 30, 2023
and December 31, 2022 (in thousands):
SCHEDULE
OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS
Description | |
Fair Value at
June 30, 2023 | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Recurring Assets | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
| | | |
| | | |
| | | |
| | |
Money market fund | |
$ | 5,678 | | |
$ | 5,678 | | |
$ | — | | |
$ | — | |
Short-term investments | |
| | | |
| | | |
| | | |
| | |
U.S. treasury and federal agency securities | |
| 30,547 | | |
| — | | |
| 30,547 | | |
| — | |
Total assets measured at fair value | |
$ | 36,225 | | |
$ | 5,678 | | |
$ | 30,547 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Warrant liabilities | |
$ | 26,021 | | |
| — | | |
| — | | |
$ | 26,021 | |
Total liabilities measured at fair value | |
$ | 26,021 | | |
$ | — | | |
$ | — | | |
$ | 26,021 | |
Description | |
Fair Value at
December 31, 2022 | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Recurring Assets: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
| | | |
| | | |
| | | |
| | |
Money market fund | |
$ | 12,923 | | |
$ | 12,923 | | |
$ | — | | |
$ | — | |
Short-term investments | |
| | | |
| | | |
| | | |
| | |
U.S. treasury and federal agency securities | |
| 37,932 | | |
| — | | |
| 37,932 | | |
| — | |
Total assets measured at fair value | |
$ | 50,855 | | |
$ | 12,923 | | |
$ | 37,932 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Warrant liabilities | |
$ | 19,657 | | |
| — | | |
| — | | |
$ | 19,657 | |
Total liabilities measured at fair value | |
$ | 19,657 | | |
$ | — | | |
$ | — | | |
$ | 19,657 | |
Warrant
Liabilities
The
warrant liabilities are valued using significant inputs not observable in the market. Accordingly, the warrant liability is measured
at fair value on a recurring basis using unobservable inputs and are classified as Level 3 inputs within the fair value hierarchy. Fair
value measurements categorized within Level 3 are sensitive to changes in the assumptions or methodology used to determine fair value
and such changes could result in a significant increase or decrease in the fair value. The Company’s valuation of the common stock
warrants utilized the Black-Scholes option-pricing model, which incorporated assumptions and estimates to value the common stock warrants.
The Company assessed these assumptions and estimates at the end of each reporting period. Assumptions used to estimate the fair value
of the warrants in the Black-Scholes option-pricing model are as follows:
SCHEDULE
OF ESTIMATE FAIR VALUE OF WARRANTS
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
| | |
| |
Common share price | |
| $4.03 | | |
| $3.08 | |
Expected term (years) | |
| 3.47 – 4.35 | | |
| 3.96 – 4.84 | |
Risk-free interest rate (%) | |
| 4.13% – 4.28% | | |
| 3.91% – 4.01% | |
Volatility (%) | |
| 100.00% – 105.04% | | |
| 102.40% – 107.55% | |
As
of June 30, 2023, the Company had outstanding warrant liabilities related to the 2022 private placement that allow the holders to purchase
7,609,879 shares of common stock at an exercise price of $4.75 per share. The expiration date for these warrant liabilities is November
2027. As of June 30, 2023 and December 31, 2022, the Company had outstanding warrant liabilities related to the 2021 public offering
that allow the holders to purchase 1,788,000 shares of common stock at an exercise price of $9.75 per share. The expiration date for
these warrant liabilities is December 2026.
The
following table provides a summary of the activity on the warrant liabilities (in thousands):
SCHEDULE
OF ACTIVITY OF WARRANT LIABILITIES
| |
| | |
Warrant liabilities as of December 31, 2022 | |
$ | 19,657 | |
Loss recognized in earnings from change in fair value | |
| 6,364 | |
Warrant liabilities as of June 30, 2023 | |
$ | 26,021 | |
NOTE
6 – SETTLEMENT LIABILITY
On
November 12, 2021, the Company entered into a settlement agreement (“Settlement Agreement”) with the Company’s prior
licensor REGENXBIO Inc. (“REGENXBIO”) to resolve all existing disputes between the parties. In accordance with the Settlement
Agreement, the Company agreed to pay REGENXBIO a total of $30.0 million, payable as follows: (1) $20.0 million paid in November 2021
after execution of the Settlement Agreement, (2) $5.0 million on the first anniversary of the effective date of the Settlement Agreement,
and (3) $5.0 million upon the earlier of (i) the third anniversary of the effective date of the Settlement Agreement or (ii) the closing
of a Strategic Transaction, as defined in the Settlement Agreement.
As
of June 30, 2023, the Company recorded the payable due to REGENXBIO in the condensed consolidated balance sheets based on the present
value of the remaining payments due to REGENXBIO under the Settlement Agreement using an interest rate of 9.6%. The long-term portion
due in November 2024 was $4.4 million and $4.2 million as of June 30, 2023 and December 31, 2022, respectively.
NOTE
7 – ACCRUED EXPENSES
The
following table provides a summary of the components of accrued expenses (in thousands):
SCHEDULE OF ACCRUED EXPENSES
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
| | |
| |
Accrued employee compensation | |
$ | 1,434 | | |
$ | 2,593 | |
Accrued contracted services and other | |
| 2,727 | | |
| 1,398 | |
Total accrued expenses | |
$ | 4,161 | | |
$ | 3,991 | |
NOTE
8 – LEASES
The
Company leases space under operating leases for administrative, manufacturing and laboratory facilities in Cleveland, Ohio. The Company
also leases office space in New York, New York, that the Company sublets. The Company also leases certain office equipment under operating
leases, which have a non-cancelable lease term of less than one year and, therefore, the Company has elected the practical expedient
to exclude these short-term leases from the Company’s right-of-use assets and lease liabilities.
In
June 2023, the Company terminated one of its operating leases for office space. The termination resulted in a gain of $1.1
million from the difference of the right-of-use
assets and lease liabilities in the three and six months ended June 30, 2023 and is included in loss/(gain) on right-of-use lease assets
in the condensed consolidated statement of operations and comprehensive loss.
On
March 31, 2022, the Company announced that they were pursuing a strategic partner to take over development activities of ABO-102 and
that the Company was discontinuing development of ABO-101. As a result of this shift in priorities, the Company determined the portion
of the lease that was dedicated to the future facility for the ABO-101 and ABO-102 programs, had no future value and thus, the Company
recorded an impairment charge of $1.6 million for the six months ended June 30, 2022.
The
following table provides a summary of the components of lease costs and rent (in thousands):
SCHEDULE OF COMPONENTS OF LEASE COST
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For the three months ended June 30, | | |
For the six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Operating lease cost | |
$ | 353 | | |
$ | 461 | | |
$ | 708 | | |
$ | 933 | |
Variable lease cost | |
| 116 | | |
| 116 | | |
| 215 | | |
| 212 | |
Short-term lease cost | |
| 13 | | |
| 20 | | |
| 31 | | |
| 41 | |
Total operating lease costs | |
$ | 482 | | |
$ | 597 | | |
$ | 954 | | |
$ | 1,186 | |
Future
minimum lease payments and obligations, which do not include short-term leases, of the Company’s operating lease liabilities as
of June 30, 2023 were as follows (in thousands):
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES
Future minimum lease payments and obligations | |
Operating Leases | |
| |
| | |
2023, remainder | |
$ | 799 | |
2024 | |
| 993 | |
2025 | |
| 1,552 | |
2026 | |
| 791 | |
2027 | |
| 807 | |
Thereafter | |
| 2,516 | |
Total undiscounted operating lease payments | |
| 7,458 | |
Less: imputed interest | |
| 1,484 | |
Present value of operating lease liabilities | |
$ | 5,974 | |
The
weighted-average remaining term of the Company’s operating leases was 68 months and the weighted-average discount rate used to
measure the present value of the Company’s operating lease liabilities was 7.5% as of June 30, 2023.
Future
cash receipts from the Company’s sublease agreements as of June 30, 2023 are as follows (in thousands):
SCHEDULE OF FUTURE CASH RECEIPTS FROM OPERATING SUBLEASE
| |
Operating | |
Future cash receipts | |
Subleases | |
| |
| | |
2023, remainder | |
$ | 270 | |
2024 | |
| 634 | |
2025 | |
| 485 | |
Total future cash receipts | |
$ | 1,389 | |
NOTE
9 – EQUITY
Reverse
Stock Split
Effective
July 1, 2022, the Company’s stock underwent a 25:1 Reverse Stock Split. The number of authorized shares of Common Stock immediately
after the Reverse Stock Split remained at 200,000,000 shares.
Public
Offerings
On
December 21, 2021, the Company closed an underwritten public offering of 1,788,000 post-split shares of common stock at a public offering
price of $9.75 post-split per share and stock purchase warrants to purchase 1,788,000 post-split shares of common stock at an exercise
price of $9.75 post-split. The net proceeds to the Company were approximately $16.0 million, after deducting $1.5 million of underwriting
discounts and commissions and offering expenses payable by the Company. The net proceeds were allocated to the warrant liability as noted
below with the remainder of $7.0 million recorded in common stock and additional paid-in capital. In the event of certain fundamental
transactions involving the Company, the holders of the stock purchase warrants may require the Company to make a payment based on a Black-Scholes
valuation, using specific inputs that are not considered indexed to the Company’s stock in accordance with ASC 815, Derivatives
and Hedging (“ASC 815”). Therefore, the Company accounted for the stock purchase warrants as liabilities and were recorded
at the closing date fair value of $9.0 million which was based on a Black-Scholes option pricing model. The remainder of the proceeds
were allocated to common stock issued and recorded as a component of equity.
As
of June 30, 2023, there were 1,788,000 post-split stock purchase warrants outstanding. These stock purchase warrants expire on December
21, 2026. During such time as each warrant is outstanding, the holder of the warrant is entitled to participate in any dividends or other
distribution of assets to holders of shares of common stock. There was no warrant activity during the three or six months ended June
30, 2023.
Open
Market Sale Agreement
On
August 17, 2018, the Company entered into an open market sale agreement (as amended, the “ATM Agreement”) with Jefferies
LLC (“Jefferies”) pursuant to which, the Company may sell from time to time, through Jefferies, shares of its common stock
for an aggregate sales price of up to $150.0 million. Any sales of shares pursuant to this agreement are made under the Company’s
effective “shelf” registration statement on Form S-3 that is on file with and has been declared effective by the SEC. The
Company sold 1,990,321 shares of its common stock under the ATM Agreement resulting in net proceeds of $6.6 million during the six months
ended June 30, 2023. There were no sales under the ATM Agreement during the three and six months ended June 30, 2022.
Private
Placement Offerings
On
November 3, 2022, the Company sold 7,065,946 shares of its common stock, and in lieu of shares of common stock, pre-funded warrants exercisable
for 543,933 shares of common stock, and accompanying warrants to purchase 7,609,879 shares of its common stock to a group of new and
existing institutional investors in a private placement. The offering price for each share of common stock and accompanying warrant was
$4.60, and the offering price for each pre-funded warrant and accompanying warrant was $4.59, which equaled the offering price per share
of the common stock and accompanying warrant, less the $0.01 per share exercise price of each pre-funded warrant. Each accompanying warrant
represents the right to purchase one share of the Company’s common stock at an exercise price of $4.75 per share of common stock.
The pre-funded warrants were exercised in December 2022 and converted to 543,933 shares of commons stock. Total shares sold and converted
during the year ended December 31, 2022 were 7,609,879 for an aggregate purchase price of $35.0 million gross, or $32.6 million net of
related costs of $1.5 million which was expensed to general and administrative expenses and $0.9 million which was recorded as a reduction
to additional paid-in-capital. The net proceeds were allocated to the warrant liability as noted below with the remainder of $12.9 million
and $0.1 million recorded in additional paid-in capital and common stock, respectively.
In
the event of certain fundamental transactions involving the Company, the holders of the stock purchase warrants may require the Company
to make a payment based on a Black-Scholes valuation, using specific inputs that are not considered indexed to the Company’s stock
in accordance with ASC 815. Therefore, the Company accounted for the stock purchase warrants as liabilities. The stock purchase warrants
were recorded at the closing date fair value of $22.0 million which was based on a Black-Scholes option pricing model. The remainder
of the proceeds were allocated to common stock issued and recorded as a component of equity.
As
of June 30, 2023, there were 7,609,879 warrants outstanding related to this private placement offering. The warrants expire on November
3, 2027. During such time as each warrant is outstanding, the holder of the warrant is entitled to participate in any dividends or other
distribution of assets to holders of shares of common stock.
NOTE
10 – STOCK-BASED COMPENSATION
The
Company previously granted stock options under its 2005 Equity Incentive Plan (the “2005 Incentive Plan”), under which no
further grants can be made. In addition, prior to May 17, 2023, the Company had previously granted stock options and stock awards under
the Abeona Therapeutics Inc. 2015 Equity Incentive Plan (the “2015 Incentive Plan”). As of May 17, 2023, no further grants
can be made under the 2015 Incentive Plan. The Company now grants stock options and stock awards under the Abeona Therapeutics Inc. 2023
Equity Incentive Plan (the “2023 Incentive Plan”) which was approved by stockholders on May 17, 2023. As of June 30, 2023,
there were 149,291 shares available to be granted under the 2023 Incentive Plan. In addition, in 2023, the Company’s board of directors
approved various restricted stock awards to be granted to six new hires as inducement grants (“Inducement Grants”).
The
following table summarizes stock-based compensation expense for the three and six months ended June 30, 2023 and 2022 (in thousands):
SCHEDULE
OF STOCK BASED COMPENSATION
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For the three months ended June 30, | | |
For the six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 218 | | |
$ | 184 | | |
$ | 404 | | |
$ | 556 | |
General and administrative | |
| 709 | | |
| 540 | | |
| 1,293 | | |
| 1,030 | |
Total stock-based compensation expense | |
$ | 927 | | |
$ | 724 | | |
$ | 1,697 | | |
$ | 1,586 | |
Stock
Options
The
Company estimates the fair value of each option award on the date of grant using the Black-Scholes option valuation model. The Company
then recognize the grant date fair value of each option as compensation expense ratably using the straight-line attribution method over
the service period (generally the vesting period). The Black-Scholes model incorporates the following assumptions:
|
● |
Expected
volatility – the Company estimates the volatility of the share price at the date of grant using a “look-back” period
which coincides with the expected term, defined below. The Company believes using a “look-back” period which coincides
with the expected term is the most appropriate measure for determining expected volatility. |
|
|
|
|
● |
Expected
term – the Company estimates the expected term using the “simplified” method, as outlined in SEC Staff Accounting
Bulletin No. 107, “Share-Based Payment.” |
|
|
|
|
● |
Risk-free
interest rate – the Company estimates the risk-free interest rate using the U.S. Treasury yield curve for periods equal to
the expected term of the options in effect at the time of grant. |
|
|
|
|
● |
Dividends
– the Company uses an expected dividend yield of zero because the Company has not declared nor paid a cash dividend, nor are
there any plans to declare a dividend. |
The
Company estimated the fair value of stock options granted in the periods presented utilizing a Black-Scholes option-valuation model utilizing
the following assumptions:
SCHEDULE
OF WEIGHTED-AVERAGE ASSUMPTIONS TO ESTIMATE THE FAIR VALUE OF THE OPTIONS GRANTED
| |
For the six months ended June 30, | |
| |
2023* | | |
2022 | |
| |
| | |
| |
Expected volatility | |
| n/a | | |
| 95.1% - 96.0% | |
Expected term | |
| n/a | | |
| 6.07 - 6.08 years | |
Risk-free interest rate | |
| n/a | | |
| 1.7% - 3.3% | |
Expected dividend yield | |
| n/a | | |
| 0% | |
* the Company did not grant any stock options in the six months ended June 30, 2023.
The
following table summarizes stock option activity for the 2015 Incentive Plan and the 2005 Incentive Plan during the six months ended
June 30, 2023 (there were no stock options granted under the 2023 Incentive Plan during the six months ended June 30, 2023):
SCHEDULE
OF STOCK OPTIONS ACTIVITY
| |
| | |
| | |
Weighted Average | | |
| |
| |
| | |
Weighted | | |
Remaining | | |
Aggregate | |
| |
Number of | | |
Average | | |
Contractual Term | | |
Intrinsic Value | |
| |
Options | | |
Exercise Price | | |
(years) | | |
(in thousands) | |
| |
| | |
| | |
| | |
| |
Outstanding at December 31, 2022 | |
| 240,770 | | |
$ | 37.04 | | |
| 6.42 | | |
$ | — | |
Granted | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Cancelled/forfeited | |
| (10,047 | ) | |
$ | 36.19 | | |
| — | | |
$ | — | |
Exercised | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Outstanding at June 30, 2023 | |
| 230,723 | | |
$ | 37.08 | | |
| 5.82 | | |
$ | — | |
Exercisable | |
| 169,637 | | |
$ | 36.33 | | |
| 5.09 | | |
$ | — | |
Unvested | |
| 61,086 | | |
$ | 39.17 | | |
| 7.87 | | |
$ | — | |
The
aggregate intrinsic value of options is calculated as the difference between the exercise price of the underlying options and the fair
value of the Company’s common stock for those options that had exercise prices lower than the fair value of the Company’s
common stock. As of June 30, 2023, the total compensation cost related to non-vested option awards not yet recognized was approximately
$2.0 million with a weighted average remaining vesting period of 1.7 years.
Restricted
Stock
The
following table summarizes restricted stock award activity for the 2023 Incentive Plan, 2015 Incentive Plan and Inducement Grants during
the six months ended June 30, 2023:
SCHEDULE
OF RESTRICTED STOCK AWARD ACTIVITY
| |
| | |
Weighted Average | |
| |
| | |
Grant Date Fair | |
| |
Number of Awards | | |
Value Per Unit | |
| |
| | |
| |
Outstanding at December 31, 2022 | |
| 816,958 | | |
$ | 5.35 | |
Granted | |
| 1,817,559 | | |
$ | 3.96 | |
Cancelled/forfeited | |
| (46,394 | ) | |
$ | 4.40 | |
Vested | |
| (21,820 | ) | |
$ | 28.34 | |
Outstanding at June 30, 2023 | |
| 2,566,303 | | |
$ | 4.18 | |
As
of June 30, 2023, there was approximately $9.7 million of total unrecognized compensation expense related to unvested restricted stock
awards, which is expected to be recognized over a weighted average vesting period of 2.5 years. The total fair value of restricted stock
awards that vested during the six months ended June 30, 2023 was $0.6 million.
NOTE
11 – LICENSE/SUPPLIER AGREEMENT
Sublicense
Agreement Relating to Rett Syndrome:
In
October 2020, the Company entered into a sublicense agreement with Taysha Gene Therapies (“Taysha”)
for a gene therapy for Rett syndrome and MECP2 gene constructs and regulation of their expression. The agreement grants Taysha
worldwide exclusive rights to intellectual property developed by scientists at the University of North Carolina at Chapel Hill, the University
of Edinburgh and the Company, and the Company’s know-how relating to the research, development, and manufacture of the gene therapy
for Rett syndrome and MECP2 gene constructs and regulation of their expression.
The
transaction price of the contract includes (i) $3.0
million of fixed consideration, (ii) up to $26.5
million of variable consideration in the form of event-based milestone payments, (iii) up to $30.0
million of variable consideration in the form of sales-based milestone payments, and (iv) other royalty-based payments based on net
sales. The event-based milestone payments are based on certain development and regulatory events occurring. The Company evaluated
whether the milestone conditions have been achieved and if it is probable that a significant revenue reversal would not occur before
recognizing the associated revenue. The Company determined that these milestone payments are not within the Company’s control
or the licensee’s control, such as regulatory approvals, and are not considered probable of being achieved until those
approvals are received. Accordingly, the Company has fully constrained the $26.5
million of event-based milestone payments until such time that it is probable that a significant revenue reversal would not occur.
The sales-based milestone payments and other royalty-based payments are based on a level of sales for which the license is deemed to
be the predominant item to which the royalties relate. The Company will recognize revenue for these payments at the later of (i)
when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has
been satisfied or partially satisfied. To date, the Company has not recognized any sales-based or royalty revenue resulting from
this licensing arrangement.
Under
this arrangement, the Company recognized $3.5 million and $1.0 million in revenue during the three and six months ended June 30, 2023
and 2022, respectively based on event-based-milestone payments. As of June 30, 2023 and December 31, 2022, the Company had $3.5 million
and nil in contract assets included in accounts receivable on the Company’s condensed consolidated balance sheet, respectively.
As of June 30, 2023 and December 31, 2022, the Company had $1.6 million and nil in contract liabilities included in accounts payable
on the Company’s condensed consolidated balance sheet, respectively, as a result of this transaction.
Ultragenyx
License Agreement
On
May 16, 2022, the Company and Ultragenyx Pharmaceutical Inc. (“Ultragenyx”) entered into an exclusive license agreement (the
“License Agreement”) for AAV gene therapy ABO-102 for the treatment of Sanfilippo syndrome type A (MPS IIIA). Under the License
Agreement, Ultragenyx assumed responsibility for the ABO-102 program from the Company, with the exclusive right to develop, manufacture,
and commercialize ABO-102 worldwide. Also pursuant to the License Agreement, following regulatory approval, the Company is eligible to
receive tiered royalties from mid-single-digit up to 10% on net sales and up to $30.0 million in commercial milestone payments. Both
forms of consideration comprise the transaction price to which the Company expects to be entitled in exchange for transferring the related
intellectual property and certain, contractually-specified, transition services to Ultragenyx. The sales-based royalty and milestone
payments are subject to the royalty recognition constraint. As such, these fees are not recognized as revenue until the later of: (a)
the occurrence of the subsequent sale, and (b) the performance obligation to which they relate has been satisfied.
Additionally,
pursuant to the License Agreement, Ultragenyx will reimburse the Company for certain development and transition costs actually incurred
by the Company. These costs are passed through to Ultragenyx without mark-up. The Company has determined that these costs are not incurred
for the purpose of satisfying any performance obligation under the License Agreement. Accordingly, the reimbursement of these costs is
recognized as a reduction of research and development costs. There were no amounts due to the Company from Ultragenyx under the License
Agreement as of June 30, 2023 and December 31, 2022, respectively.
NOTE
12 – SUBSEQUENT EVENTS
On
July 3, 2023, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with certain existing institutional
investors relating to the issuance and sale of an aggregate of (a) 3,284,407 shares of the Company’s common stock (the “Shares”),
and (b) pre-funded warrants to purchase 2,919,140 shares of the Company’s common stock (the “2023 Pre-Funded Warrants”)
to certain of such investors (the “Offering”). On July 6, 2023, the Shares were sold to the investors at an offering price
of $4.03 per share for $25.0 million with net proceeds of $23.0 million after offering costs. The 2023 Pre-Funded Warrants were sold
to certain of the investors at an offering price of $4.0299 per 2023 Pre-Funded Warrant, which represents the per share offering price
for the Company’s common stock less a $0.0001 per share exercise price for each such 2023 Pre-Funded Warrant. The 2023 Pre-Funded
Warrants are immediately exercisable at a nominal exercise price of $0.0001 per share and may be exercised at any time until the 2023
Pre-Funded Warrants are exercised in full.
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You
should read the following discussion and analysis together with our unaudited condensed consolidated financial statements and accompanying
notes included elsewhere in this Quarterly Report on Form 10-Q and our audited consolidated financial statements included in our Annual
Report on Form 10-K/A for the year ended December 31, 2022 (the “Annual Report”). This discussion and analysis contains forward-looking
statements, which involve risks and uncertainties. As a result of many factors, such as those described under “Forward-Looking
Statements,” “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q and in our Annual Report, our actual
results may differ materially from those anticipated in these forward-looking statements.
OVERVIEW
Abeona
is a clinical-stage biopharmaceutical company developing cell and gene therapies for life-threatening diseases. Our lead clinical program
is EB-101, a genetically engineered, autologous cell therapy, currently in development for recessive dystrophic epidermolysis bullosa
(“RDEB”). We have announced positive data from the VIITAL™ study evaluating the efficacy, safety and tolerability of
EB-101. The VIITAL™ study met its two co-primary efficacy endpoints demonstrating statistically significant, clinically meaningful
improvements in wound healing and pain reduction in large chronic RDEB wounds. Based on the positive results, we intend to submit a Biologics
License Application (“BLA”) for EB-101 to the U.S. Food and Drug Administration (“FDA”) in the third quarter
of 2023.
Our
development portfolio also features adeno-associated virus (“AAV”) based gene therapies designed to treat ophthalmic diseases
using the novel AIM™ capsid platform that we have exclusively licensed from the University of North Carolina at Chapel Hill, and
internal AAV vector research programs.
We
have continued to prepare our current Good Manufacturing Practices (“cGMP”) commercial facility in Cleveland, Ohio for manufacturing
EB-101 drug product to support our planned commercial launch of EB-101, if approved. EB-101 study drug product for all our VIITAL™
study participants has been manufactured at our Cleveland facility. As part of our commercial planning, we continue to engage with stakeholders
across the healthcare system, including public and private payors, and healthcare providers to better understand market access and potential
pricing for EB-101.
Preclinical
Pipeline
Our
preclinical programs are investigating the use of novel AAV capsids in AAV-based therapies for serious genetic eye diseases, including
ABO-504 for Stargardt disease, ABO-503 for X-linked retinoschisis (“XLRS”) and ABO-505 for autosomal dominant optic atrophy
(“ADOA”). We completed pre-Investigational New Drug Application (“IND”) meetings with the FDA regarding the preclinical
development plans and regulatory requirements to support first-in-human trials. We plan to initiate IND-enabling preclinical studies
in the second half of 2023.
Recent
Developments
On
July 6, 2023, we closed on a $25.0 million, with net proceeds of $23.0 million after offering costs,
registered direct offering priced at-the market under Nasdaq rules to certain existing institutional investors. We sold 3,284,407
shares of our common stock (and, in lieu of common stock for certain investors, pre-funded warrants to purchase 2,919,140 shares of our
common stock) at an offering price of $4.03 per share (or $4.0299 per pre-funded warrant, which represents the per share offering price
for the common stock less the $0.0001 per share exercise price for each pre-funded warrant). The pre-funded warrants are immediately
exercisable at a nominal exercise price of $0.0001 per share and may be exercised at any time until the pre-funded warrants are exercised
in full.
In
July 2023, we submitted the briefing package for the pre-BLA meeting with the FDA for our anticipated submission of EB-101 in the treatment
of RDEB. The briefing package contains information regarding Chemistry, Manufacturing, and Controls (“CMC”) and clinical
data. The pre-BLA meeting is scheduled for late-August 2023 and Abeona anticipates filing its EB-101 BLA in the third quarter of 2023
following a successful pre-BLA meeting with the FDA.
RESULTS
OF OPERATIONS
Comparison
of Three Months Ended June 30, 2023 and June 30, 2022
| |
For the three months ended | | |
Change | |
($ in thousands) | |
June 30, 2023 | | |
June 30, 2022 | | |
$ | | |
% | |
| |
| | |
| | |
| | |
| |
Revenues: | |
| | | |
| | | |
| | | |
| | |
License and other revenues | |
$ | 3,500 | | |
$ | 1,000 | | |
$ | 2,500 | | |
| 250 | % |
| |
| | | |
| | | |
| | | |
| | |
Expenses: | |
| | | |
| | | |
| | | |
| | |
Royalties | |
| 1,575 | | |
| 350 | | |
| 1,225 | | |
| 350 | % |
Research and development | |
| 8,523 | | |
| 6,658 | | |
| 1,865 | | |
| 28 | % |
General and administrative | |
| 5,021 | | |
| 3,460 | | |
| 1,561 | | |
| 45 | % |
Loss/(gain) on right-of-use lease assets | |
| (1,065 | ) | |
| — | | |
| (1,065 | ) | |
| N/A | |
Impairment of construction-in-progress | |
| — | | |
| (1,460 | ) | |
| 1,460 | | |
| N/A | |
Total expenses | |
| 14,054 | | |
| 9,008 | | |
| 5,046 | | |
| 56 | % |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (10,554 | ) | |
| (8,008 | ) | |
| (2,546 | ) | |
| 32 | % |
| |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 417 | | |
| 31 | | |
| 386 | | |
| 1,245 | % |
Interest expense | |
| (103 | ) | |
| (200 | ) | |
| 97 | | |
| (49 | )% |
Change in fair value of warrant liabilities | |
| (8,629 | ) | |
| 4,198 | | |
| (12,827 | ) | |
| (306 | )% |
Other income (expense) | |
| 2,215 | | |
| (118 | ) | |
| 2,333 | | |
| (1,977 | )% |
Net loss | |
$ | (16,654 | ) | |
$ | (4,097 | ) | |
$ | (12,557 | ) | |
| 306 | % |
N/A
– not applicable or not meaningful
License
and other revenues
License
and other revenues for the three months ended June 30, 2023 was $3.5 million as compared to $1.0 million for the same period of 2022.
The revenues in both periods result from clinical milestones achieved under a sublicense agreement
we entered into with Taysha Gene Therapies (“Taysha”) in October 2020 relating to an investigational AAV-based gene therapy
for Rett syndrome (“Rett”).
Royalties
Total
royalties were $1.6 million for the three months ended June 30, 2023, as compared to $0.4 million for the same period of 2022, an increase
of $1.2 million. The increase in expense was due to royalties owed to our licensors resulting from the milestones due from Taysha related
to Rett.
Research
and development
Research
and development expenses include, but are not limited to, payroll and personnel expense, lab supplies, preclinical and development costs,
clinical trial costs, manufacturing and manufacturing facility costs, costs associated with regulatory approvals, depreciation on lab
supplies and manufacturing facilities, and consultant-related expenses.
Total
research and development spending for the three months ended June 30, 2023 was $8.5 million, as compared to $6.7 million for the same
period of 2022, an increase of $1.9 million. The increase in expenses was primarily due to:
|
● |
increased
clinical and development work and related costs of $0.7 million associated with our planned BLA filing for EB-101; |
|
● |
increased
salary and related costs of $0.8 million; and |
|
● |
increased
other costs of $0.4 million. |
We
expect our research and development activities to continue as we work towards advancing our product candidates towards potential regulatory
approval, reflecting costs associated with the following:
|
● |
employee
and consultant-related expenses; |
|
● |
preclinical
and developmental costs; |
|
● |
clinical
trial costs; |
|
● |
the
cost of acquiring and manufacturing clinical trial materials; and |
|
● |
costs
associated with regulatory approvals. |
General
and administrative
General
and administrative expenses primarily consist of payroll and personnel costs, office facility costs, public reporting company related
costs, professional fees (e.g., legal expenses) and other general operating expenses not otherwise included in research and development
expenses.
Total
general and administrative expenses were $5.0 million for the three months ended June 30, 2023, as compared to $3.4 million for the same
period of 2022, an increase of $1.6 million. The increase in expenses was primarily due to:
|
● |
increased
salary and related costs of $1.1 million; |
|
● |
increased
non-cash stock-based compensation of $0.2 million; |
|
● |
increased
professional fees of $0.2 million; and |
|
● |
increased
other costs of $0.1 million. |
Loss/(gain)
on right-of-use lease assets
The
gain on right-of-use lease assets was $1.1 million for the three months ended June 30, 2023, as compared to nil in the same period of
2022. At the end of June 2023, we terminated an operating lease for office space that we no longer use, resulting in a gain from the
difference of the right-of-use lease assets and the lease liabilities.
Impairment
of construction-in-progress
Construction-in-progress
impairment charge was nil for the three months ended June 30, 2023, as compared to a reduction in the impairment charge of $1.5 million
in the same period of 2022. The construction-in-progress was for a facility for the MPS IIIA and MPS IIIB development programs. As
a result of our shift in priorities, we determined the remaining value of the construction-in-progress facility had no future value and
thus, we recorded impairment of $3.3 million for the three months ended March 31, 2022. We subsequently received certain refunds pertaining
to the planned facility build-out, which reduced the overall impairment charge by $1.5 million for the three months ended June 30, 2022.
Interest
income
Interest
income was $0.4 million for the three months ended June 30, 2023, as compared to $31,000 in the same period of 2022. The increase resulted
from higher earnings on short-term investments driven by higher interest rates and increased short-term investment balances.
Interest
expense
Interest
expense was $0.1 million for the three months ended June 30, 2023, as compared to $0.2 million in the same period of 2022. The decrease
results primarily from the $5.0 million settlement payment made in November 2022 of a disputed liability owed to our prior licensor,
REGENXBIO, Inc.
Change
in fair value of warrant liabilities
The
change in fair value of warrant liabilities was a loss of $8.6 million for the three months ended June 30, 2023, as compared to a gain
of $4.2 million for the same period in 2022.
We
issued stock purchase warrants that are required to be classified as a liability and valued at fair market value at each reporting period.
The change in the fair value of warrant liabilities was primarily due to the fluctuation in our stock price year over year and a shorter
term.
Other
income (expense)
Other
income was $2.2 million for the three months ended June 30, 2023, as compared to other expense of $118,000 in the same period of 2022.
The change was primarily a result of $2.1 million in other income related to the impact of the employee retention credit that we have
submitted for 2020 and 2021.
Comparison
of Six Months Ended June 30, 2023 and June 30, 2022
| |
For the six months ended | | |
Change | |
($ in thousands) | |
June 30, 2023 | | |
June 30, 2022 | | |
$ | | |
% | |
| |
| | |
| | |
| | |
| |
Revenues: | |
| | | |
| | | |
| | | |
| | |
License and other revenues | |
$ | 3,500 | | |
$ | 1,346 | | |
$ | 2,154 | | |
| 160 | % |
| |
| | | |
| | | |
| | | |
| | |
Expenses: | |
| | | |
| | | |
| | | |
| | |
Royalties | |
| 1,575 | | |
| 350 | | |
| 1,225 | | |
| 350 | % |
Research and development | |
| 16,564 | | |
| 17,203 | | |
| (639 | ) | |
| (4 | )% |
General and administrative | |
| 9,018 | | |
| 7,684 | | |
| 1,334 | | |
| 17 | % |
Impairment of licensed technology | |
| — | | |
| 1,355 | | |
| (1,355 | ) | |
| N/A | |
Loss/(gain) on right-of-use lease assets | |
| (1,065 | ) | |
| 1,561 | | |
| (2,626 | ) | |
| (168 | )% |
Impairment of construction-in-progress | |
| — | | |
| 1,792 | | |
| (1,792 | ) | |
| N/A | |
Total expenses | |
| 26,092 | | |
| 29,945 | | |
| (3,853 | ) | |
| (13 | )% |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (22,592 | ) | |
| (28,599 | ) | |
| 6,007 | | |
| (21 | )% |
| |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 781 | | |
| 38 | | |
| 743 | | |
| 1,955 | % |
Interest expense | |
| (204 | ) | |
| (401 | ) | |
| 197 | | |
| (49 | )% |
Change in fair value of warrant liabilities | |
| (6,364 | ) | |
| 2,945 | | |
| (9,309 | ) | |
| (316 | )% |
Other income (expense) | |
| 2,618 | | |
| (124 | ) | |
| 2,742 | | |
| (2,211 | )% |
Net loss | |
$ | (25,761 | ) | |
$ | (26,141 | ) | |
$ | 380 | | |
| (1 | )% |
N/A
– not applicable or not meaningful
License
and other revenues
License
and other revenues for the six months ended June 30, 2023 was $3.5 million, as compared to $1.3 million for the same period of 2022.
The revenues in both periods mainly result from clinical milestones achieved under a sublicense
agreement we entered into with Taysha in October 2020 relating to an investigational AAV-based gene therapy for Rett syndrome. In 2022,
there was also revenue consisting of the recognition of deferred revenue related to grants for the ABO-102 and ABO-101 development programs.
Royalties
Total
royalties were $1.6 million for the six months ended June 30, 2023, as compared to $0.4 million for the same period of 2022, an increase
of $1.2 million. The increase in expense was due to royalties owed to our licensors resulting from the milestones due from Taysha related
to Rett.
Research
and development
Research
and development expenses include, but are not limited to, payroll and personnel expense, lab supplies, preclinical and development costs,
clinical trial costs, manufacturing and manufacturing facility costs, costs associated with regulatory approvals, depreciation on lab
supplies and manufacturing facilities, and consultant-related expenses.
Total
research and development spending for the six months ended June 30, 2023 was $16.6 million, as compared to $17.2 million for the same
period of 2022, a decrease of $0.6 million. The decrease in expenses was primarily due to:
|
● |
decreased
clinical and development work for our cell and gene therapy product candidates and other related costs of $1.0 million which was
due to the discontinuation of the ABO-102 and ABO-101 programs partially offset by increased costs related to our planned BLA filing; |
|
● |
decreased
stock compensation expenses of $0.2 million; partially offset by |
|
● |
increased
other costs of $0.6 million. |
We
expect our research and development activities to continue as we work towards advancing our product candidates towards potential regulatory
approval, reflecting costs associated with the following:
|
● |
employee
and consultant-related expenses; |
|
● |
preclinical
and developmental costs; |
|
● |
clinical
trial costs; |
|
● |
the
cost of acquiring and manufacturing clinical trial materials; and |
|
● |
costs
associated with regulatory approvals. |
General
and administrative
General
and administrative expenses primarily consist of payroll and personnel costs, office facility costs, public reporting company related
costs, professional fees (e.g., legal expenses) and other general operating expenses not otherwise included in research and development
expenses.
Total
general and administrative expenses were $9.0 million for the six months ended June 30, 2023, as compared to $7.7 million for the same
period of 2022, an increase of $1.3 million. The increase in expenses was primarily due to:
● |
increased
salary and related costs of $1.4 million; |
● |
increased
non-cash stock-based compensation of $0.3 million; partially offset by |
● |
decreased
other costs of $0.4 million. |
Impairment
of licensed technology
Impairment
of licensed technology was nil for the six months ended June 30, 2023, as compared to $1.4 million in the same period of 2022. The licensed
technology was for the ABO-102 and ABO-101 development programs and as a result of our shift in priorities, we determined the remaining
value of the licensed technology had no future value and thus recorded an impairment charge of $1.4 million for the six months ended
June 30, 2022.
Loss/(gain)
of right-of-use lease assets
The
gain on right-of-use lease assets was $1.1 for the six months ended June 30, 2023, as compared to a loss on right-of-use assets of $1.6
million in the same period of 2022. The gain on right-of-use assets for 2023 was related to the termination of our operating leases for
office space that we no longer use, resulting in a gain from the difference of the right-of-use lease assets and the lease liabilities.
The
loss on right-of-use assets for 2022 was related to a lease for a future manufacturing facility for the ABO-102 and ABO-101 development
programs, which, as a result of our shift in priorities, we determined the remaining value of the portion of this lease had no future
value and thus recorded an impairment charge of $1.6 million for the six months ended June 30, 2022.
Impairment
of construction-in-progress
Construction-in-progress
impairment charge was nil for the six months ended June 30, 2023, as compared to $1.8 million in the same period of 2022. The construction-in-progress
was for a facility for the MPS IIIA and MPS IIIB development programs. The construction-in-progress
was for a facility for the ABO-102 and ABO-101 development programs. As a result of our shift in priorities, we determined the remaining
value of the construction-in-progress facility had no future value and thus, we recorded impairment of $1.8 million for the six months
ended June 30, 2022.
Interest
income
Interest
income was $0.8 million for the six months ended June 30, 2023, as compared to $38,000 in the same period of 2022. The increase resulted
from higher earnings on short-term investments driven by higher interest rates and increased short-term investment balances.
Interest
expense
Interest
expense was $0.2 million for the six months ended June 30, 2023, as compared to $0.4 million in the same period of 2022. The decrease
results primarily from the $5.0 million settlement payment made in November 2022 of a disputed liability owed to our prior licensor,
REGENXBIO, Inc.
Change
in fair value of warrant liabilities
The
change in fair value of warrant liabilities was a loss of $6.4 million for the six months ended June 30, 2023, as compared to a gain
of $2.9 million for the same period in 2022.
We
issued stock purchase warrants that are required to be classified as a liability and valued at fair market value at each reporting period.
The change in the fair value of warrant liabilities is primarily due to the fluctuation in our stock price year over year and a shorter
term.
Other
income (expense)
Other
income was $2.6 million for the six months ended June 30, 2023, as compared to other expense of $0.1 million in the same period of 2022.
The change was primarily a result of $2.1 million in other income related to the impact of the employee retention credit that we have
submitted for 2020 and 2021.
LIQUIDITY
AND CAPITAL RESOURCES
Cash
Flows for the Six Months Ended June 30, 2023 and 2022
| |
For the six months ended | |
($ in thousands) | |
June 30, 2023 | | |
June 30, 2022 | |
| |
| | |
| |
Total cash, cash equivalents and restricted cash (used in) provided by: | |
| | | |
| | |
Operating activities | |
$ | (22,028 | ) | |
$ | (22,700 | ) |
Investing activities | |
| 7,422 | | |
| (323 | ) |
Financing activities | |
| 6,614 | | |
| (3,782 | ) |
Net decrease in cash, cash equivalents and restricted cash | |
$ | (7,992 | ) | |
$ | (26,805 | ) |
Operating
activities
Net
cash used in operating activities was $22.0 million for the six months ended June 30, 2023, primarily comprised of our net loss of $25.8
million, increases in operating assets and liabilities of $5.1 million and net non-cash charges of $8.9 million.
Net
cash used in operating activities was $22.7 million for the six months ended June 30, 2022, primarily comprised of our net loss of $29.1
million and a decrease in operating assets and liabilities of $2.7 million, partially offset by net non-cash charges of $9.1 million.
Investing
activities
Net
cash provided by investing activities was $7.4 million for the six months ended June 30, 2023, primarily comprised of proceeds from maturities
of short-term investments of $21.6 million, partially offset by purchases of short-term investments of $14.2 million.
Net
cash used in investing activities was $0.3 million for the six months ended June 30, 2022, primarily comprised of proceeds from maturities
of short-term investments of $32.7 million and proceeds from disposal of property and equipment of $1.5 million, partially offset by
purchases of short-term investments of $34.4 million and capital expenditures of $0.1 million.
Financing
activities
Net
cash provided by financing activities was $6.6 million for the six months ended June 30, 2023, primarily comprised of $6.6 million in
net proceeds from ATM sales of common stock.
Net
cash used in financing activities was $3.8 million for the six months ended June 30, 2022, primarily comprised of the proceeds and redemption
of our convertible redeemable preferred stock.
We
have historically funded our operations primarily through sales of common stock.
Our
principal source of liquidity is cash, cash equivalents, restricted cash and short-term investments, collectively referred to as our
cash resources. As of June 30, 2023, our cash resources were $37.1 million. On July 6, 2023, we raised a further $23.0 million net proceeds
in cash via a registered direct offering priced at-the market under Nasdaq rules to existing investors . As a result, we believe that
our current cash and cash equivalents, restricted cash and short-term investments are sufficient to fund operations through at least
the next 12 months from the date of this report on Form 10-Q. We may need to secure additional funding to carry out all of our planned
research and development activities. If we are unable to obtain additional financing or generate license or product revenue, the lack
of liquidity and sufficient capital resources could have a material adverse effect on our future prospects.
We
have an open market sale agreement with Jefferies LLC (as amended, the “ATM Agreement”) pursuant to which, we may sell from
time to time, through Jefferies LLC, shares of our common stock for an aggregate sales price of up to $150.0 million. Any sales of shares
pursuant to this agreement are made under our effective “shelf” registration statement on Form S-3 that is on file with and
has been declared effective by the SEC. We sold 1,990,321 shares of our common stock under the ATM Agreement resulting in net proceeds
of $6.6 million for the six months ended June 30, 2023.
Since
our inception, we have incurred negative cash flows from operations and have expended, and expect to continue to expend substantial funds
to complete our planned product development efforts. We have not been profitable since inception and to date have received limited revenues
from the sale of products or licenses. We expect to incur losses for the next several years as we continue to invest in product research
and development, preclinical studies, clinical trials, and regulatory compliance and cannot provide assurance that we will ever be able
to generate sufficient product sales or royalty revenue to achieve profitability on a sustained basis, or at all.
If
we raise additional funds by selling additional equity securities, the relative equity ownership of our existing investors will be diluted,
and the new investors could obtain terms more favorable than previous investors. If we raise additional funds through collaborations,
strategic alliances, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future
revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us. If we are unable
to raise additional funds through equity or debt financing when needed, we may be required to delay, limit, or terminate our product
development programs or any future commercialization efforts or grant rights to develop and market product candidates to third parties
that we would otherwise prefer to develop and market ourselves.
Our
future capital requirements and adequacy of available funds depend on many factors, including:
|
● |
the
successful development, regulatory approval and commercialization of our cell and gene therapy and other product candidates; |
|
● |
the
ability to establish and maintain collaborative arrangements with corporate partners for the research, development, and commercialization
of products; |
|
● |
continued
scientific progress in our research and development programs; |
|
● |
the
magnitude, scope and results of preclinical testing and clinical trials; |
|
● |
the
costs involved in filing, prosecuting, and enforcing patent claims; |
|
● |
the
costs involved in conducting clinical trials; |
|
● |
any
continuing impact to our business, operations, and clinical programs from the COVID-19 pandemic and government actions related thereto; |
|
● |
competing
technological developments; |
|
● |
the
cost of manufacturing and scale-up; |
|
● |
the
ability to establish and maintain effective commercialization arrangements and activities; and |
|
● |
the
successful outcome of our regulatory filings. |
Due
to uncertainties and certain of the risks described above, our ability to successfully commercialize our product candidates, our ability
to obtain applicable regulatory approval to market our product candidates, our ability to obtain necessary additional capital to fund
operations in the future, our ability to successfully manufacture our products and our product candidates in clinical quantities or for
commercial purposes, government regulation to which we are subject, the uncertainty associated with preclinical and clinical testing,
intense competition that we face, the potential necessity of licensing technology from third parties and protection of our intellectual
property, it is not possible to reliably predict future spending or time to completion by project or product category or the period in
which material net cash inflows from significant projects are expected to commence. If we are unable to timely complete a particular
project, our research and development efforts could be delayed or reduced, our business could suffer depending on the significance of
the project and we might need to raise additional capital to fund operations, as discussed in the risks above.
We
plan to continue our policy of investing any available funds in suitable certificates of deposit, money market funds, government securities
and investment-grade, interest-bearing securities. We do not invest in derivative financial instruments.
Critical
Accounting Estimates
The
preparation of financial statements in accordance with accounting principles generally accepted in the United States of America requires
management to make estimates and assumptions that affect the reported amounts and related disclosures in the financial statements. Management
considers an accounting estimate to be critical if:
|
● |
it
requires assumptions to be made that were uncertain at the time the estimate was made, and |
|
● |
changes
in the estimate or different estimates that could have been selected could have material impact in our results of operations or financial
condition. |
While
we base our estimates and judgments on our experience and on various other factors that we believe to be reasonable under the circumstances,
actual results could differ from those estimates and the differences could be material. For a discussion of the critical accounting estimates
that affect the unaudited condensed consolidated financial statements, see “Critical Accounting Estimates” included in Item
7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report.
See
Note 1 to our unaudited condensed consolidated financial statements for a discussion of our significant accounting policies.
Recently
Issued Accounting Standards Not Yet Effective or Adopted
See
Note 1 to our unaudited condensed consolidated financial statements for a discussion of recently issued accounting standards not yet
effective or adopted.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not
applicable.
ITEM
4. CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
Under
the supervision and with the participation of our management and consultants, including the Chief Executive Officer (our principal executive
officer) and Chief Financial Officer (our principal financial officer), we have conducted an evaluation of the effectiveness of the design
and operation of our disclosure controls and procedures (“Disclosure Controls and Procedures”), as of June 30, 2023, as such
term is defined in Rules 13a-15I and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
Conclusion
of Evaluation — Based on this Disclosure Controls and Procedures evaluation, the Chief Executive Officer and Chief Financial
Officer concluded that our Disclosure Controls and Procedures as of June 30, 2023 were effective.
Changes
in Internal Control Over Financial Reporting – There were no changes in our internal control over financial reporting that
occurred during the quarter ended June 30, 2023 that have materially affected, or are reasonably likely to materially affect, our internal
control over financial reporting.
PART
II — OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
None.
ITEM
1A. RISK FACTORS
Our
business and financial results are subject to numerous risks and uncertainties. As a result, the risks and uncertainties discussed in
Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K/A for the year ended December 31, 2022 should be carefully considered.
There have been no material changes in the assessment of our risk factors from those set forth in our Annual Report on Form 10-K/A for
the year ended December 31, 2022.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
The following table provides information about purchases of equity securities that are registered pursuant to Section 12 of the Exchange
Act for the quarter ended June 30, 2023:
| |
Total number | | |
| |
| |
of shares | | |
Average price | |
| |
(or units) | | |
paid per share | |
| |
purchased (a) | | |
(or unit) | |
Shares delivered or withheld pursuant to restricted stock awards | |
| | | |
| | |
April 1, 2023 – April 30, 2023 | |
| — | | |
$ | — | |
May 1, 2023 – May 31, 2023 | |
| — | | |
$ | — | |
June 1, 2023 – June 30, 2023 | |
| 1,125 | | |
$ | 3.42 | |
| |
| 1,125 | | |
$ | 3.42 | |
(a) |
Reflects
shares of common stock surrendered to the Company for payment of tax withholding obligations in connection with the vesting of restricted
stock. |
ITEM 5. OTHER INFORMATION
On June 15, 2023, the Company
awarded retention bonuses (the “Retention Bonus Agreements”) to Vishwas Seshadri, Ph.D., Joseph Vazzano, and Brendan
O’Malley, Ph.D. (collectively, the “NEOs”). Under the Retention Bonus Agreements, the Company has awarded the NEOs
bonus payments in addition to their base salaries in three installments conditioned upon their continued employment at the Company
through the second anniversary of the effective date of the applicable Retention Bonus Agreement. Such bonuses are to be disbursed
at the Company’s sole discretion, including upon the determination that the Company’s financial performance permits such
payment. In the event the Company undergoes a change of control transaction, then any outstanding payment shall immediately become
due and payable to the employee upon the closing of such change of control transaction.
The foregoing description of the Retention Bonus Agreements is qualified
in its entirety by reference to the full text of the Retention Bonus Agreements, which are filed herewith as Exhibits 10.3, 10.4, and
10.5 and incorporated by reference herein in their entirety.
ITEM
6. EXHIBITS
See
Exhibit Index below, which is incorporated by reference herein.
Exhibit
Index
Exhibits:
3.1 |
|
Restated Certificate of Incorporation of Abeona Therapeutics Inc. (incorporated by reference to Exhibit 3.1 of our Form 10-Q for the quarter ended March 31, 2019) |
|
|
|
3.2 |
|
Amended and Restated Bylaws of Abeona Therapeutics Inc. (incorporated by reference to Exhibit 3.3 of our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 29. 2023). |
|
|
|
4.1 |
|
Pre-Funded Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 of our Current Report on Form 8-K filed with the Securities and Exchange Commission on July 3, 2023). |
|
|
|
10.1 |
|
Securities Purchase Agreement Warrant, dated as of July 3, 2023, between the Company and the purchasers thereto (incorporated by reference to Exhibit 10.1 of our Current Report on Form 8-K filed with the Securities and Exchange Commission on July 3, 2023). |
|
|
|
10.2 |
|
2023 Equity Incentive Plan (incorporated by reference to Exhibit 99.1 of our Registration Statement on Form S-8 filed with the Securities and Exchange Commission on May 19, 2023). |
|
|
|
10.3 |
|
Retention Bonus Letter, dated June 15, 2023, to Vishwas Seschadri, Ph.D. |
|
|
|
10.4 |
|
Retention Bonus Letter, dated June 15, 2023, to Joseph Vazzano. |
|
|
|
10.5 |
|
Retention Bonus Letter, dated June 15, 2023, to Brendon O’Malley, Ph.D. |
|
|
|
31.1 |
|
Principal Executive Officer Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934. |
|
|
|
31.2 |
|
Principal Financial Officer Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934. |
|
|
|
32* |
|
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
101.1 |
|
The
following materials from Abeona’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, formatted in Inline XBRL
(Extensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets at June 30, 2023 and December 31, 2022 (unaudited),
(ii) Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2023 and
2022 (unaudited), (iii) Condensed Consolidated Statements of Stockholders’ Equity for the three and six months ended June 30,
2023 and 2022 (unaudited), (iv) Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2023 and 2022 (unaudited),
and (v) Notes to Condensed Consolidated Financial Statements (unaudited). |
*
Pursuant to Item 601(b)(32)(ii) of Regulation S-K, this exhibit shall not be deemed “filed” for purposes of Section 18 of
the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference
in any filings under the Securities Act of 1933 or the Securities Exchange Act of 1934, whether made before or after the date hereof
and irrespective of any general incorporation language in any filing.
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.
|
|
ABEONA
THERAPEUTICS INC. |
|
|
|
|
Date: August 8, 2023 |
By: |
/s/
Vishwas Seshadri |
|
|
|
Vishwas
Seshadri |
|
|
|
President
and Chief Executive Officer |
|
|
|
(Principal
Executive Officer) |
|
|
|
|
Date: August 8, 2023 |
By: |
/s/
Joseph Vazzano |
|
|
|
Joseph
Vazzano |
|
|
|
Chief
Financial Officer |
|
|
|
(Principal
Financial Officer) |
EXHIBIT
10.3
June
15, 2023
Vishwas
Seshadri
Re:
Retention Bonus
Dear
Vishwas,
We
consider your continued service and dedication to Abeona Therapeutics Inc. (“Abeona” or the “Company”) essential
to our business and future success. To incentivize you to remain employed with Abeona, we are pleased to inform you of Abeona’s
retention bonus, as described herein.
In
recognition of your continued service with Abeona, we are offering you a retention bonus in the total gross amount of $1,600,000, less
all applicable withholdings and deductions (the “Retention Bonus”), payable in three annual payments (each a “Payment,”
and separately the “First Payment,” “Second Payment,” and “Third Payment”). Each Payment is subject
to a “Retention Period” beginning on the date of that Payment, through and until the date that is one year from that date.
By way of example, if the First Payment is made on June 30, 2023, the First Payment Retention Period would expire at the end of the workday
on June 30, 2024. The Retention Bonus is in addition to the compensation already provided to you in your role for the Company.
You
will be eligible to receive this Retention Bonus if all the following eligibility criteria are satisfied and the Company determines in
its sole discretion that the financial performance of the Company permits each Payment:
1. | You
remain a full-time, active employee of Abeona through the end of the Retention Period. |
2. | Your
performance has been satisfactory and meets expectations, as determined in Abeona’s
sole discretion, from the date of this letter through the end of the Retention Period. |
3. | You
do not receive a disciplinary action, such as a written warning, during the Retention Period. |
4. | You
are actively and continuously employed by Abeona through each of the bonus payments dates
described herein, including the last day of the Retention Period. |
5. | You
have not given notice of your intent to resign from employment on or before the last day
of the Retention Period. |
6. | Abeona
Therapeutics has not given you notice of its intent to terminate your employment on or before
the last day of the Retention Period. |
For
the avoidance of doubt, the Retention Bonus payment is within the sole discretion of Abeona based on a variety of factors, including,
but not limited to, overall financial performance of the Company. There will be no pro-rata apportionment of the bonus and you must meet
all of the eligibility criteria to be considered for this discretionary bonus. For the sake of clarity, an approved leave of absence
in compliance with Abeona’s Time Off policy during the Retention Period will be treated as active and continuous employment for
the purpose of the bonus eligibility criteria.
6555
Carnegie Avenue, Suite 400, Cleveland,
oh 44103
AbeonaTherapeutics.com
If
you remain eligible to receive the Retention Bonus pursuant to the requirements above, and the Company in its discretion determines to
pay you a Retention Bonus, it will be paid in three lump sum cash Payments (with each Payment subject to the Company’s discretion):
|
● |
The
First Payment will be in the gross amount of $533,333, less applicable withholdings, payable on the Effective Date of the Agreement.
|
|
|
|
|
● |
The
Second Payment will be in the gross amount of $533,333, less applicable withholdings, payable on the date of the first anniversary
of the Effective Date of the Agreement. |
|
|
|
|
● |
The
Third Payment will be in the gross amount of $533,333, less applicable withholdings, payable on the date of the second anniversary
of the Effective Date of the Agreement. |
In
the event that there is a change in ownership or control of the Company effected through any of the following transactions:
(A)
a merger, consolidation or other reorganization approved by the Company’s stockholders, unless securities representing at least
fifty percent (50%) of the total combined voting power of the voting securities of the successor corporation are immediately thereafter
beneficially owned, directly or indirectly and in substantially the same proportion, by the persons who beneficially owned the Company’s
outstanding voting securities immediately prior to such transaction,
(B)
a sale, transfer or other disposition of all or substantially all of the Company’s assets, or
(C)
the closing of any transaction or series of related transactions pursuant to which any person or any group of persons comprising a “group”
within the meaning of Rule 13d-5(b)(1) of the Securities Exchange Act of 1934 (“1934 Act”) (other than the Company or a person
that, prior to such transaction or series of related transactions, directly or indirectly controls, is controlled by or is under common
control with, the Company) becomes directly or indirectly (whether as a result of a single acquisition or by reasons of one or more acquisitions
within the twelve (12)-month period ending with the most recent acquisition) the beneficial owner (within the meaning of Rule 13d-3 of
the 1934 Act) of securities possessing (or convertible into or exercisable for securities possessing) more than fifty percent (50%) of
the total combined voting power of the Company’s securities (as measured in terms of the power to vote with respect to the election
of Board members) outstanding immediately after the consummation of such transaction or series of related transactions, whether such
transaction involves a direct issuance from the Company or the acquisition of outstanding securities held by one or more of the Company’s
existing stockholders.
6555
Carnegie Avenue, Suite 400, Cleveland,
oh 44103
AbeonaTherapeutics.com
(D)
a change in the composition of the Board over a period of twelve (12) consecutive months or less such that a majority of the Board members
ceases to be comprised of individuals who either (A) have been Board members continuously since the beginning of such period (“Incumbent
Directors”) or (B) have been elected or nominated for election as Board members during such period by at least a majority of the
Incumbent Directors who were still in office at the time the Board approved such election or nomination; provided that any individual
who becomes a Board member subsequent to the beginning of such period and whose election or nomination was approved by two-thirds of
the Board members then comprising the Incumbent Directors will be considered an Incumbent Director.
(Each
of A through D shall collectively be defined as a “Triggering Event”), then any outstanding Retention Bonus payments shall
immediately become due to you upon the closing of the Triggering Event (the “Accelerated Bonus Payment”), provided that such
Triggering Event constitutes a change in ownership or control event within the meaning of Treasury Regulations Section 1.409A-3(i)(5)(v)
or (vii). The Accelerated Bonus Payment shall be made in a single lump sum to you at or within ten days after the closing date of the
Triggering Event.
The
Retention Bonus described herein does not alter the at-will nature of your employment. Your employment remains at-will, meaning that
you and Abeona may terminate the employment relationship at any time, with or without cause, and with or without notice, subject to the
terms and conditions contained within your employment agreement, if any.
In
the event that (1) you are terminated for Cause (as defined below) or (2) voluntarily resign and/or leave your employment with Abeona
prior to the end of the Retention Period, you are required to pay Abeona an amount equal to the total amount of the Payment paid to you
at the beginning of the then-current Retention Period, prior to your separation of employment. By way of example, if the Second Payment
is made to you on June 30, 2024, and you are terminated for Cause or voluntarily resign before the end of the workday on June 30, 2025,
you will be required to pay back the Second Payment; whereas, if you are terminated for Cause or voluntarily resign after the end of
the workday on June 30, 2025, you will not be required to return the Second Payment. Under the scenarios in the preceding sentence, you
would not be required to pay back the First Payment in either case.
For
the purpose of this Retention Bonus only, “Cause” shall mean: (A) your substantial failure to perform your duties and job
responsibilities (other than any such failure resulting from incapacity due to physical or mental disability) that continues for fifteen
(15) calendar days after written notice from the Company; (B) your failure to comply with any valid and legal directive of the CEO or
the Board (as applicable) that continues for fifteen (15) calendar days after written notice from the Company; (C) your engagement in
dishonesty, illegal conduct, or misconduct (or the discovery of your having engaged in such conduct in the past), which, in each case,
materially harms or is reasonably likely to materially harm, reputationally, financially or otherwise, the Company or its subsidiaries;
(D) your engagement in embezzlement, misappropriation, or fraud, whether or not related to your employment with the Company; (E) your
conviction of or plea of guilty or nolo contendere to a crime that constitutes a felony; (F) your willful violation of a material policy
of the Company; (G) your willful or grossly negligent unauthorized disclosure of Confidential Information as defined in your Employee
Confidentiality, Non-Competition, and Proprietary Information Agreement; (H) your material breach of any material obligation under any
written agreement between you and the Company that continues for fifteen (15) calendar days after written notice from the Company (if
such breach is reasonably curable); (I) any willful material failure by you to comply with the Company’s written policies or written
rules, as they may be in effect from time to time; (J) you perform your duties for the Company under the influence of illegal drugs or
substantial intoxication; or (K) you fail, in the Company’s sole judgment, to perform your duties and responsibilities in a satisfactory
manner.
6555
Carnegie Avenue, Suite 400, Cleveland,
oh 44103
AbeonaTherapeutics.com
This
Retention Bonus shall not renew automatically or extend beyond the Third Payment Retention Period unless set forth otherwise in a written
instrument signed by a duly authorized officer of Abeona.
This
Retention Bonus is intended to comply with, or be exempt from, Section 409A of the Internal Revenue Code of 1986, as amended (“Section
409A”) and shall be construed and administered in accordance with Section 409A, including, but not limited to, a scenario where
there is a change of control within the meaning of the regulations under Section 409A.
In
the event of a change in ownership or control of the Company under Section 280G of the Code, if it shall be determined that any payment
or distribution in the nature of compensation (within the meaning of Section 280G(b)(2) of the Code) to or for your benefit, whether
paid or payable or distributed or distributable pursuant to the terms of this Agreement or otherwise (“Compensation”),
would constitute an “excess parachute payment” within the meaning of Section 280G of the Code, the aggregate present value
of the total such Compensation under this Agreement or other agreement shall be reduced (but not below zero) to the Reduced Amount (defined
below) if and only if the Accounting Firm (described below) determines that the reduction will provide you with a greater net after-tax
benefit than would no reduction. No reduction shall be made unless the reduction would provide you with a greater net after-tax benefit.
The determinations under this Section shall be made as follows:
(i)
The “Reduced Amount” shall be an amount expressed in present value which maximizes the aggregate present value of
Compensation under this Agreement and other agreements without causing any Compensation under this Agreement or other agreements to be
subject to the Excise Tax (defined below), determined in accordance with Section 280G(d)(4) of the Code. The term “Excise Tax”
means the excise tax imposed under Section 4999 of the Code, together with any interest or penalties imposed with respect to such excise
tax.
(ii)
Compensation under this Agreement and other agreements shall be reduced on a nondiscretionary basis in such a way as to minimize the
reduction in the economic value deliverable to you. Where more than one payment of Compensation has the same value for this purpose and
they are payable at different times, they will be reduced in reverse order as to when paid, with the furthest out reduced first, provided
no violation of Section 409A Code would result. If a violation of Section 409A of the Code would result, then such Compensation shall
be reduced on a pro-rata basis.
(iii)
All determinations to be made under this Section shall be made by an independent certified public accounting firm selected by the Company
and agreed to by you immediately prior to the change in ownership or control transaction (the “Accounting Firm”).
The Accounting Firm shall provide its determinations and any supporting calculations both to the Company and you within ten (10) days
of the transaction. Any such determination by the Accounting Firm shall be binding upon the Company and you. All of the fees and expenses
of the Accounting Firm in performing the determinations referred to in this Section shall be borne solely by the Company.
6555
Carnegie Avenue, Suite 400, Cleveland,
oh 44103
AbeonaTherapeutics.com
In
the event there is a provision regarding the impact of Section 280G on Compensation, within the meaning above, in any other agreement
between the Company and you, to the extent there is a conflict with the provisions regarding 280G in this Agreement, the provisions in
this Agreement shall control and supersede such other provision, provided there is not a violation of Section 409A of the Code.
This
letter contains all of the understandings and representations between Abeona and you relating to the Retention Bonus and supersedes all
prior and contemporaneous understandings, discussions, agreements, representations and warranties, both written and oral, with respect
to any retention bonus. This letter shall not supersede any other agreements between Abeona and you, including, without limitation, your
offer letter, employment agreement, and any non-compete and/or confidentiality agreement between you and Abeona, which shall remain in
full force and effect. This letter may not be amended or modified unless in a writing signed by both the VP, Human Resources of Abeona
and you.
By
signing this letter, you acknowledge that you have read it in its entirety, understand all of its terms and conditions, that you have
had the opportunity to consult with counsel, that you are entering this Agreement knowingly and voluntarily, and that you agree to abide
by all of the terms and conditions set forth herein.
This
letter and all related documents are governed by, and construed in accordance with, the laws of Ohio without regard to conflicts-of-law
principles.
If
you agree to these terms, please sign and date this letter and return the signed copy to Alison Hardgrove, VP, Human Resources June 20,
2023. We look forward to your continued employment with us and sincerely appreciate your commitment to Abeona’s future success.
Best
Regards, |
|
Agreed
to and accepted: |
|
|
|
|
|
|
|
Joseph
Vazzano |
|
Employee
Signature |
Chief
Financial Officer |
|
Date |
|
6555
Carnegie Avenue, Suite 400, Cleveland,
oh 44103
AbeonaTherapeutics.com
EXHIBIT
10.4
June
15, 2023
Joseph
Vazzano
Re:
Retention Bonus
Dear
Joseph,
We
consider your continued service and dedication to Abeona Therapeutics Inc. (“Abeona” or the “Company”) essential
to our business and future success. To incentivize you to remain employed with Abeona, we are pleased to inform you of Abeona’s
retention bonus, as described herein.
In
recognition of your continued service with Abeona, we are offering you a retention bonus in the total gross amount of $706,000, less
all applicable withholdings and deductions (the “Retention Bonus”), payable in three annual payments (each a “Payment,”
and separately the “First Payment,” “Second Payment,” and “Third Payment”). Each Payment is subject
to a “Retention Period” beginning on the date of that Payment, through and until the date that is one year from that date.
By way of example, if the First Payment is made on June 30, 2023, the First Payment Retention Period would expire at the end of the workday
on June 30, 2024. The Retention Bonus is in addition to the compensation already provided to you in your role for the Company.
You
will be eligible to receive this Retention Bonus if all the following eligibility criteria are satisfied and the Company determines in
its sole discretion that the financial performance of the Company permits each Payment:
1. | You
remain a full-time, active employee of Abeona through the end of the Retention Period. |
2. | Your
performance has been satisfactory and meets expectations, as determined in Abeona’s
sole discretion, from the date of this letter through the end of the Retention Period. |
3. | You
do not receive a disciplinary action, such as a written warning, during the Retention Period. |
4. | You
are actively and continuously employed by Abeona through each of the bonus payments dates
described herein, including the last day of the Retention Period. |
5. | You
have not given notice of your intent to resign from employment on or before the last day
of the Retention Period. |
6. | Abeona
Therapeutics has not given you notice of its intent to terminate your employment on or before
the last day of the Retention Period. |
For
the avoidance of doubt, the Retention Bonus payment is within the sole discretion of Abeona based on a variety of factors, including,
but not limited to, overall financial performance of the Company. There will be no pro-rata apportionment of the bonus and you must meet
all of the eligibility criteria to be considered for this discretionary bonus. For the sake of clarity, an approved leave of absence
in compliance with Abeona’s Time Off policy during the Retention Period will be treated as active and continuous employment for
the purpose of the bonus eligibility criteria.
6555
Carnegie Avenue, Suite 400, Cleveland,
oh 44103
AbeonaTherapeutics.com
If
you remain eligible to receive the Retention Bonus pursuant to the requirements above, and the Company in its discretion determines to
pay you a Retention Bonus, it will be paid in three lump sum cash Payments (with each Payment subject to the Company’s discretion):
|
● |
The
First Payment will be in the gross amount of $235,333, less applicable withholdings, payable on the Effective Date of the Agreement.
|
|
|
|
|
● |
The
Second Payment will be in the gross amount of $235,333, less applicable withholdings, payable on the date of the first anniversary
of the Effective Date of the Agreement. |
|
|
|
|
● |
The
Third Payment will be in the gross amount of $235,333, less applicable withholdings, payable on the date of the second anniversary
of the Effective Date of the Agreement. |
In
the event that there is a change in ownership or control of the Company effected through any of the following transactions:
(A)
a merger, consolidation or other reorganization approved by the Company’s stockholders, unless securities representing at least
fifty percent (50%) of the total combined voting power of the voting securities of the successor corporation are immediately thereafter
beneficially owned, directly or indirectly and in substantially the same proportion, by the persons who beneficially owned the Company’s
outstanding voting securities immediately prior to such transaction,
(B)
a sale, transfer or other disposition of all or substantially all of the Company’s assets, or
(C)
the closing of any transaction or series of related transactions pursuant to which any person or any group of persons comprising a “group”
within the meaning of Rule 13d-5(b)(1) of the Securities Exchange Act of 1934 (“1934 Act”) (other than the Company or a person
that, prior to such transaction or series of related transactions, directly or indirectly controls, is controlled by or is under common
control with, the Company) becomes directly or indirectly (whether as a result of a single acquisition or by reasons of one or more acquisitions
within the twelve (12)-month period ending with the most recent acquisition) the beneficial owner (within the meaning of Rule 13d-3 of
the 1934 Act) of securities possessing (or convertible into or exercisable for securities possessing) more than fifty percent (50%) of
the total combined voting power of the Company’s securities (as measured in terms of the power to vote with respect to the election
of Board members) outstanding immediately after the consummation of such transaction or series of related transactions, whether such
transaction involves a direct issuance from the Company or the acquisition of outstanding securities held by one or more of the Company’s
existing stockholders.
6555
Carnegie Avenue, Suite 400, Cleveland,
oh 44103
AbeonaTherapeutics.com
(D)
a change in the composition of the Board over a period of twelve (12) consecutive months or less such that a majority of the Board members
ceases to be comprised of individuals who either (A) have been Board members continuously since the beginning of such period (“Incumbent
Directors”) or (B) have been elected or nominated for election as Board members during such period by at least a majority of the
Incumbent Directors who were still in office at the time the Board approved such election or nomination; provided that any individual
who becomes a Board member subsequent to the beginning of such period and whose election or nomination was approved by two-thirds of
the Board members then comprising the Incumbent Directors will be considered an Incumbent Director.
(Each
of A through D shall collectively be defined as a “Triggering Event”), then any outstanding Retention Bonus payments shall
immediately become due to you upon the closing of the Triggering Event (the “Accelerated Bonus Payment”), provided that such
Triggering Event constitutes a change in ownership or control event within the meaning of Treasury Regulations Section 1.409A-3(i)(5)(v)
or (vii). The Accelerated Bonus Payment shall be made in a single lump sum to you at or within ten days after the closing date of the
Triggering Event.
The
Retention Bonus described herein does not alter the at-will nature of your employment. Your employment remains at-will, meaning that
you and Abeona may terminate the employment relationship at any time, with or without cause, and with or without notice, subject to the
terms and conditions contained within your employment agreement, if any.
In
the event that (1) you are terminated for Cause (as defined below) or (2) voluntarily resign and/or leave your employment with Abeona
prior to the end of the Retention Period, you are required to pay Abeona an amount equal to the total amount of the Payment paid to you
at the beginning of the then-current Retention Period, prior to your separation of employment. By way of example, if the Second Payment
is made to you on June 30, 2024, and you are terminated for Cause or voluntarily resign before the end of the workday on June 30, 2025,
you will be required to pay back the Second Payment; whereas, if you are terminated for Cause or voluntarily resign after the end of
the workday on June 30, 2025, you will not be required to return the Second Payment. Under the scenarios in the preceding sentence, you
would not be required to pay back the First Payment in either case.
For
the purpose of this Retention Bonus only, “Cause” shall mean: (A) your substantial failure to perform your duties and job
responsibilities (other than any such failure resulting from incapacity due to physical or mental disability) that continues for fifteen
(15) calendar days after written notice from the Company; (B) your failure to comply with any valid and legal directive of the CEO or
the Board (as applicable) that continues for fifteen (15) calendar days after written notice from the Company; (C) your engagement in
dishonesty, illegal conduct, or misconduct (or the discovery of your having engaged in such conduct in the past), which, in each case,
materially harms or is reasonably likely to materially harm, reputationally, financially or otherwise, the Company or its subsidiaries;
(D) your engagement in embezzlement, misappropriation, or fraud, whether or not related to your employment with the Company; (E) your
conviction of or plea of guilty or nolo contendere to a crime that constitutes a felony; (F) your willful violation of a material policy
of the Company; (G) your willful or grossly negligent unauthorized disclosure of Confidential Information as defined in your Employee
Confidentiality, Non-Competition, and Proprietary Information Agreement; (H) your material breach of any material obligation under any
written agreement between you and the Company that continues for fifteen (15) calendar days after written notice from the Company (if
such breach is reasonably curable); (I) any willful material failure by you to comply with the Company’s written policies or written
rules, as they may be in effect from time to time; (J) you perform your duties for the Company under the influence of illegal drugs or
substantial intoxication; or (K) you fail, in the Company’s sole judgment, to perform your duties and responsibilities in a satisfactory
manner.
6555
Carnegie Avenue, Suite 400, Cleveland,
oh 44103
AbeonaTherapeutics.com
This
Retention Bonus shall not renew automatically or extend beyond the Third Payment Retention Period unless set forth otherwise in a written
instrument signed by a duly authorized officer of Abeona.
This
Retention Bonus is intended to comply with, or be exempt from, Section 409A of the Internal Revenue Code of 1986, as amended (“Section
409A”) and shall be construed and administered in accordance with Section 409A, including, but not limited to, a scenario where
there is a change of control within the meaning of the regulations under Section 409A.
In
the event of a change in ownership or control of the Company under Section 280G of the Code, if it shall be determined that any payment
or distribution in the nature of compensation (within the meaning of Section 280G(b)(2) of the Code) to or for your benefit, whether
paid or payable or distributed or distributable pursuant to the terms of this Agreement or otherwise (“Compensation”),
would constitute an “excess parachute payment” within the meaning of Section 280G of the Code, the aggregate present value
of the total such Compensation under this Agreement or other agreement shall be reduced (but not below zero) to the Reduced Amount (defined
below) if and only if the Accounting Firm (described below) determines that the reduction will provide you with a greater net after-tax
benefit than would no reduction. No reduction shall be made unless the reduction would provide you with a greater net after-tax benefit.
The determinations under this Section shall be made as follows:
(i)
The “Reduced Amount” shall be an amount expressed in present value which maximizes the aggregate present value of
Compensation under this Agreement and other agreements without causing any Compensation under this Agreement or other agreements to be
subject to the Excise Tax (defined below), determined in accordance with Section 280G(d)(4) of the Code. The term “Excise Tax”
means the excise tax imposed under Section 4999 of the Code, together with any interest or penalties imposed with respect to such excise
tax.
(ii)
Compensation under this Agreement and other agreements shall be reduced on a nondiscretionary basis in such a way as to minimize the
reduction in the economic value deliverable to you. Where more than one payment of Compensation has the same value for this purpose and
they are payable at different times, they will be reduced in reverse order as to when paid, with the furthest out reduced first, provided
no violation of Section 409A Code would result. If a violation of Section 409A of the Code would result, then such Compensation shall
be reduced on a pro-rata basis.
(iii)
All determinations to be made under this Section shall be made by an independent certified public accounting firm selected by the Company
and agreed to by you immediately prior to the change in ownership or control transaction (the “Accounting Firm”).
The Accounting Firm shall provide its determinations and any supporting calculations both to the Company and you within ten (10) days
of the transaction. Any such determination by the Accounting Firm shall be binding upon the Company and you. All of the fees and expenses
of the Accounting Firm in performing the determinations referred to in this Section shall be borne solely by the Company.
6555
Carnegie Avenue, Suite 400, Cleveland,
oh 44103
AbeonaTherapeutics.com
In
the event there is a provision regarding the impact of Section 280G on Compensation, within the meaning above, in any other agreement
between the Company and you, to the extent there is a conflict with the provisions regarding 280G in this Agreement, the provisions in
this Agreement shall control and supersede such other provision, provided there is not a violation of Section 409A of the Code.
This
letter contains all of the understandings and representations between Abeona and you relating to the Retention Bonus and supersedes all
prior and contemporaneous understandings, discussions, agreements, representations and warranties, both written and oral, with respect
to any retention bonus. This letter shall not supersede any other agreements between Abeona and you, including, without limitation, your
offer letter, employment agreement, and any non-compete and/or confidentiality agreement between you and Abeona, which shall remain in
full force and effect. This letter may not be amended or modified unless in a writing signed by both the VP, Human Resources of Abeona
and you.
By
signing this letter, you acknowledge that you have read it in its entirety, understand all of its terms and conditions, that you have
had the opportunity to consult with counsel, that you are entering this Agreement knowingly and voluntarily, and that you agree to abide
by all of the terms and conditions set forth herein.
This
letter and all related documents are governed by, and construed in accordance with, the laws of Ohio without regard to conflicts-of-law
principles.
If
you agree to these terms, please sign and date this letter and return the signed copy to Alison Hardgrove, VP, Human Resources June 20,
2023. We look forward to your continued employment with us and sincerely appreciate your commitment to Abeona’s future success.
Best
Regards, |
|
Agreed
to and accepted: |
|
|
|
|
|
|
|
Vishwas
Seshadri |
|
Employee
Signature |
Chief
Executive Officer |
|
Date |
|
6555
Carnegie Avenue, Suite 400, Cleveland,
oh 44103
AbeonaTherapeutics.com
EXHIBIT
10.5
June
15, 2023
Brendan
O’Malley
Re:
Retention Bonus
Dear
Brendan,
We
consider your continued service and dedication to Abeona Therapeutics Inc. (“Abeona” or the “Company”) essential
to our business and future success. To incentivize you to remain employed with Abeona, we are pleased to inform you of Abeona’s
retention bonus, as described herein.
In
recognition of your continued service with Abeona, we are offering you a retention bonus in the total gross amount of $450,000, less
all applicable withholdings and deductions (the “Retention Bonus”), payable in three annual payments (each a “Payment,”
and separately the “First Payment,” “Second Payment,” and “Third Payment”). Each Payment is subject
to a “Retention Period” beginning on the date of that Payment, through and until the date that is one year from that date.
By way of example, if the First Payment is made on June 30, 2023, the First Payment Retention Period would expire at the end of the workday
on June 30, 2024. The Retention Bonus is in addition to the compensation already provided to you in your role for the Company.
You
will be eligible to receive this Retention Bonus if all the following eligibility criteria are satisfied and the Company determines in
its sole discretion that the financial performance of the Company permits each Payment:
1. | You
remain a full-time, active employee of Abeona through the end of the Retention Period. |
2. | Your
performance has been satisfactory and meets expectations, as determined in Abeona’s
sole discretion, from the date of this letter through the end of the Retention Period. |
3. | You
do not receive a disciplinary action, such as a written warning, during the Retention Period. |
4. | You
are actively and continuously employed by Abeona through each of the bonus payments dates
described herein, including the last day of the Retention Period. |
5. | You
have not given notice of your intent to resign from employment on or before the last day
of the Retention Period. |
6. | Abeona
Therapeutics has not given you notice of its intent to terminate your employment on or before
the last day of the Retention Period. |
For
the avoidance of doubt, the Retention Bonus payment is within the sole discretion of Abeona based on a variety of factors, including,
but not limited to, overall financial performance of the Company. There will be no pro-rata apportionment of the bonus and you must meet
all of the eligibility criteria to be considered for this discretionary bonus. For the sake of clarity, an approved leave of absence
in compliance with Abeona’s Time Off policy during the Retention Period will be treated as active and continuous employment for
the purpose of the bonus eligibility criteria.
6555
Carnegie Avenue, Suite 400, Cleveland,
oh 44103
AbeonaTherapeutics.com
If
you remain eligible to receive the Retention Bonus pursuant to the requirements above, and the Company in its discretion determines to
pay you a Retention Bonus, it will be paid in three lump sum cash Payments (with each Payment subject to the Company’s discretion):
|
● |
The
First Payment will be in the gross amount of $150,000, less applicable withholdings, payable on the Effective Date of the Agreement.
|
|
|
|
|
● |
The
Second Payment will be in the gross amount of $150,000, less applicable withholdings, payable on the date of the first anniversary
of the Effective Date of the Agreement. |
|
|
|
|
● |
The
Third Payment will be in the gross amount of $150,000, less applicable withholdings, payable on the date of the second anniversary
of the Effective Date of the Agreement. |
In
the event that there is a change in ownership or control of the Company effected through any of the following transactions:
(A)
a merger, consolidation or other reorganization approved by the Company’s stockholders, unless securities representing at least
fifty percent (50%) of the total combined voting power of the voting securities of the successor corporation are immediately thereafter
beneficially owned, directly or indirectly and in substantially the same proportion, by the persons who beneficially owned the Company’s
outstanding voting securities immediately prior to such transaction,
(B)
a sale, transfer or other disposition of all or substantially all of the Company’s assets, or
(C)
the closing of any transaction or series of related transactions pursuant to which any person or any group of persons comprising a “group”
within the meaning of Rule 13d-5(b)(1) of the Securities Exchange Act of 1934 (“1934 Act”) (other than the Company or a person
that, prior to such transaction or series of related transactions, directly or indirectly controls, is controlled by or is under common
control with, the Company) becomes directly or indirectly (whether as a result of a single acquisition or by reasons of one or more acquisitions
within the twelve (12)-month period ending with the most recent acquisition) the beneficial owner (within the meaning of Rule 13d-3 of
the 1934 Act) of securities possessing (or convertible into or exercisable for securities possessing) more than fifty percent (50%) of
the total combined voting power of the Company’s securities (as measured in terms of the power to vote with respect to the election
of Board members) outstanding immediately after the consummation of such transaction or series of related transactions, whether such
transaction involves a direct issuance from the Company or the acquisition of outstanding securities held by one or more of the Company’s
existing stockholders.
6555
Carnegie Avenue, Suite 400, Cleveland,
oh 44103
AbeonaTherapeutics.com
(D)
a change in the composition of the Board over a period of twelve (12) consecutive months or less such that a majority of the Board members
ceases to be comprised of individuals who either (A) have been Board members continuously since the beginning of such period (“Incumbent
Directors”) or (B) have been elected or nominated for election as Board members during such period by at least a majority of the
Incumbent Directors who were still in office at the time the Board approved such election or nomination; provided that any individual
who becomes a Board member subsequent to the beginning of such period and whose election or nomination was approved by two-thirds of
the Board members then comprising the Incumbent Directors will be considered an Incumbent Director.
(Each
of A through D shall collectively be defined as a “Triggering Event”), then any outstanding Retention Bonus payments shall
immediately become due to you upon the closing of the Triggering Event (the “Accelerated Bonus Payment”), provided that such
Triggering Event constitutes a change in ownership or control event within the meaning of Treasury Regulations Section 1.409A-3(i)(5)(v)
or (vii). The Accelerated Bonus Payment shall be made in a single lump sum to you at or within ten days after the closing date of the
Triggering Event.
The
Retention Bonus described herein does not alter the at-will nature of your employment. Your employment remains at-will, meaning that
you and Abeona may terminate the employment relationship at any time, with or without cause, and with or without notice, subject to the
terms and conditions contained within your employment agreement, if any.
In
the event that (1) you are terminated for Cause (as defined below) or (2) voluntarily resign and/or leave your employment with Abeona
prior to the end of the Retention Period, you are required to pay Abeona an amount equal to the total amount of the Payment paid to you
at the beginning of the then-current Retention Period, prior to your separation of employment. By way of example, if the Second Payment
is made to you on June 30, 2024, and you are terminated for Cause or voluntarily resign before the end of the workday on June 30, 2025,
you will be required to pay back the Second Payment; whereas, if you are terminated for Cause or voluntarily resign after the end of
the workday on June 30, 2025, you will not be required to return the Second Payment. Under the scenarios in the preceding sentence, you
would not be required to pay back the First Payment in either case.
For
the purpose of this Retention Bonus only, “Cause” shall mean: (A) your substantial failure to perform your duties and job
responsibilities (other than any such failure resulting from incapacity due to physical or mental disability) that continues for fifteen
(15) calendar days after written notice from the Company; (B) your failure to comply with any valid and legal directive of the CEO or
the Board (as applicable) that continues for fifteen (15) calendar days after written notice from the Company; (C) your engagement in
dishonesty, illegal conduct, or misconduct (or the discovery of your having engaged in such conduct in the past), which, in each case,
materially harms or is reasonably likely to materially harm, reputationally, financially or otherwise, the Company or its subsidiaries;
(D) your engagement in embezzlement, misappropriation, or fraud, whether or not related to your employment with the Company; (E) your
conviction of or plea of guilty or nolo contendere to a crime that constitutes a felony; (F) your willful violation of a material policy
of the Company; (G) your willful or grossly negligent unauthorized disclosure of Confidential Information as defined in your Employee
Confidentiality, Non-Competition, and Proprietary Information Agreement; (H) your material breach of any material obligation under any
written agreement between you and the Company that continues for fifteen (15) calendar days after written notice from the Company (if
such breach is reasonably curable); (I) any willful material failure by you to comply with the Company’s written policies or written
rules, as they may be in effect from time to time; (J) you perform your duties for the Company under the influence of illegal drugs or
substantial intoxication; or (K) you fail, in the Company’s sole judgment, to perform your duties and responsibilities in a satisfactory
manner.
6555
Carnegie Avenue, Suite 400, Cleveland,
oh 44103
AbeonaTherapeutics.com
This
Retention Bonus shall not renew automatically or extend beyond the Third Payment Retention Period unless set forth otherwise in a written
instrument signed by a duly authorized officer of Abeona.
This
Retention Bonus is intended to comply with, or be exempt from, Section 409A of the Internal Revenue Code of 1986, as amended (“Section
409A”) and shall be construed and administered in accordance with Section 409A, including, but not limited to, a scenario where
there is a change of control within the meaning of the regulations under Section 409A.
In
the event of a change in ownership or control of the Company under Section 280G of the Code, if it shall be determined that any payment
or distribution in the nature of compensation (within the meaning of Section 280G(b)(2) of the Code) to or for your benefit, whether
paid or payable or distributed or distributable pursuant to the terms of this Agreement or otherwise (“Compensation”),
would constitute an “excess parachute payment” within the meaning of Section 280G of the Code, the aggregate present value
of the total such Compensation under this Agreement or other agreement shall be reduced (but not below zero) to the Reduced Amount (defined
below) if and only if the Accounting Firm (described below) determines that the reduction will provide you with a greater net after-tax
benefit than would no reduction. No reduction shall be made unless the reduction would provide you with a greater net after-tax benefit.
The determinations under this Section shall be made as follows:
(i)
The “Reduced Amount” shall be an amount expressed in present value which maximizes the aggregate present value of
Compensation under this Agreement and other agreements without causing any Compensation under this Agreement or other agreements to be
subject to the Excise Tax (defined below), determined in accordance with Section 280G(d)(4) of the Code. The term “Excise Tax”
means the excise tax imposed under Section 4999 of the Code, together with any interest or penalties imposed with respect to such excise
tax.
(ii)
Compensation under this Agreement and other agreements shall be reduced on a nondiscretionary basis in such a way as to minimize the
reduction in the economic value deliverable to you. Where more than one payment of Compensation has the same value for this purpose and
they are payable at different times, they will be reduced in reverse order as to when paid, with the furthest out reduced first, provided
no violation of Section 409A Code would result. If a violation of Section 409A of the Code would result, then such Compensation shall
be reduced on a pro-rata basis.
(iii)
All determinations to be made under this Section shall be made by an independent certified public accounting firm selected by the Company
and agreed to by you immediately prior to the change in ownership or control transaction (the “Accounting Firm”).
The Accounting Firm shall provide its determinations and any supporting calculations both to the Company and you within ten (10) days
of the transaction. Any such determination by the Accounting Firm shall be binding upon the Company and you. All of the fees and expenses
of the Accounting Firm in performing the determinations referred to in this Section shall be borne solely by the Company.
6555
Carnegie Avenue, Suite 400, Cleveland,
oh 44103
AbeonaTherapeutics.com
In
the event there is a provision regarding the impact of Section 280G on Compensation, within the meaning above, in any other agreement
between the Company and you, to the extent there is a conflict with the provisions regarding 280G in this Agreement, the provisions in
this Agreement shall control and supersede such other provision, provided there is not a violation of Section 409A of the Code.
This
letter contains all of the understandings and representations between Abeona and you relating to the Retention Bonus and supersedes all
prior and contemporaneous understandings, discussions, agreements, representations and warranties, both written and oral, with respect
to any retention bonus. This letter shall not supersede any other agreements between Abeona and you, including, without limitation, your
offer letter, employment agreement, and any non-compete and/or confidentiality agreement between you and Abeona, which shall remain in
full force and effect. This letter may not be amended or modified unless in a writing signed by both the VP, Human Resources of Abeona
and you.
By
signing this letter, you acknowledge that you have read it in its entirety, understand all of its terms and conditions, that you have
had the opportunity to consult with counsel, that you are entering this Agreement knowingly and voluntarily, and that you agree to abide
by all of the terms and conditions set forth herein.
This
letter and all related documents are governed by, and construed in accordance with, the laws of Ohio without regard to conflicts-of-law
principles.
If
you agree to these terms, please sign and date this letter and return the signed copy to Alison Hardgrove, VP, Human Resources June 20,
2023. We look forward to your continued employment with us and sincerely appreciate your commitment to Abeona’s future success.
Best
Regards, |
|
Agreed
to and accepted: |
|
|
|
|
|
|
|
Vishwas Seshadri |
|
Employee
Signature |
Chief
Executive Officer |
|
Date |
|
6555
Carnegie Avenue, Suite 400, Cleveland,
oh 44103
AbeonaTherapeutics.com
EXHIBIT
31.1
PRINCIPAL
EXECUTIVE OFFICER CERTIFICATION PURSUANT TO 18 U.S.C.
SECTION
1350, AS ADOPTED PURSUANT TO SECTION 302
OF
THE SARBANES-OXLEY ACT OF 2002
I,
Vishwas Seshadri, certify that:
1. |
I
have reviewed this report on Form 10-Q for the quarterly period ended June 30, 2023, of Abeona Therapeutics 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 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)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-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 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: August 8, 2023 |
By: |
/s/
Vishwas Seshadri |
|
|
|
Vishwas
Seshadri |
|
|
|
President
and Chief Executive Officer |
|
|
|
(Principal
Executive Officer) |
EXHIBIT
31.2
PRINCIPAL
FINANCIAL OFFICER CERTIFICATION PURSUANT TO 18 U.S.C.
SECTION
1350, AS ADOPTED PURSUANT TO SECTION 302
OF
THE SARBANES-OXLEY ACT OF 2002
I,
Joseph Vazzano, certify that:
1. |
I
have reviewed this report on Form 10-Q for the quarterly period ended June 30, 2023, of Abeona Therapeutics 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 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)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-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 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: August 8, 2023 |
By: |
/s/
Joseph Vazzano |
|
|
|
Joseph
Vazzano |
|
|
|
Chief
Financial Officer |
|
|
|
(Principal
Financial Officer) |
EXHIBIT
32
CERTIFICATION
PURSUANT TO 18 U.S.C.
SECTION
1350 AS ADOPTED PURSUANT TO SECTION 906
OF
THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of Abeona Therapeutics Inc. (the “Company”) on Form 10-Q for the quarterly period ended
June 30, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), we, Vishwas Seshadri,
President and Chief Executive Officer of the Company, and Joseph Vazzano, Chief Financial Officer of the Company, certify, pursuant to
18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
|
(1) |
The
Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
|
|
(2) |
The
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company. |
Date: August 8, 2023 |
By: |
/s/
Vishwas Seshadri |
|
|
|
Vishwas
Seshadri |
|
|
|
President
and Chief Executive Officer |
|
|
|
(Principal
Executive Officer) |
|
|
|
|
Date: August 8, 2023 |
By: |
/s/
Joseph Vazzano |
|
|
|
Joseph
Vazzano |
|
|
|
Chief
Financial Officer |
|
|
|
(Principal
Financial Officer) |
v3.23.2
Cover - shares
|
6 Months Ended |
|
Jun. 30, 2023 |
Aug. 01, 2023 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Jun. 30, 2023
|
|
Document Fiscal Period Focus |
Q2
|
|
Document Fiscal Year Focus |
2023
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-15771
|
|
Entity Registrant Name |
ABEONA
THERAPEUTICS INC.
|
|
Entity Central Index Key |
0000318306
|
|
Entity Tax Identification Number |
83-0221517
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
6555
Carnegie Avenue
|
|
Entity Address, Address Line Two |
4thFloor
|
|
Entity Address, City or Town |
Cleveland
|
|
Entity Address, State or Province |
OH
|
|
Entity Address, Postal Zip Code |
44103
|
|
City Area Code |
(646)
|
|
Local Phone Number |
813-4701
|
|
Title of 12(b) Security |
Common
Stock, $0.01 par value
|
|
Trading Symbol |
ABEO
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
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Entity Interactive Data Current |
Yes
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true
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v3.23.2
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash and cash equivalents |
$ 6,225
|
$ 14,217
|
Short-term investments |
30,547
|
37,932
|
Restricted cash |
338
|
338
|
Accounts receivable |
3,500
|
|
Other receivables |
2,227
|
188
|
Prepaid expenses and other current assets |
1,201
|
424
|
Total current assets |
44,038
|
53,099
|
Property and equipment, net |
4,489
|
5,741
|
Right-of-use lease assets |
4,915
|
5,331
|
Other assets |
108
|
43
|
Total assets |
53,550
|
64,214
|
Current liabilities: |
|
|
Accounts payable |
3,477
|
1,811
|
Accrued expenses |
4,161
|
3,991
|
Current portion of lease liability |
1,597
|
1,773
|
Other current liabilities |
205
|
204
|
Total current liabilities |
9,440
|
7,779
|
Long-term lease liabilities |
4,377
|
5,854
|
Warrant liabilities |
26,021
|
19,657
|
Total liabilities |
44,205
|
37,453
|
Stockholders’ equity: |
|
|
Preferred stock - $0.01 par value; authorized 2,000,000 shares; No shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively |
|
|
Common stock - $0.01 par value; authorized 200,000,000 shares; 21,478,157 and 17,719,720 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively |
215
|
177
|
Additional paid-in capital |
730,322
|
722,049
|
Accumulated deficit |
(721,097)
|
(695,336)
|
Accumulated other comprehensive loss |
(95)
|
(129)
|
Total stockholders’ equity |
9,345
|
26,761
|
Total liabilities and stockholders’ equity |
53,550
|
64,214
|
Related Party [Member] |
|
|
Current liabilities: |
|
|
Payable to licensor |
$ 4,367
|
$ 4,163
|
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v3.23.2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, par value |
$ 0.01
|
$ 0.01
|
Preferred stock, shares authorized |
2,000,000
|
2,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0.01
|
$ 0.01
|
Common stock, shares authorized |
200,000,000
|
200,000,000
|
Common stock, shares issued |
21,478,157
|
17,719,720
|
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21,478,157
|
17,719,720
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.2
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Revenues: |
|
|
|
|
License and other revenues |
$ 3,500
|
$ 1,000
|
$ 3,500
|
$ 1,346
|
Expenses: |
|
|
|
|
Royalties |
1,575
|
350
|
1,575
|
350
|
Research and development |
8,523
|
6,658
|
16,564
|
17,203
|
General and administrative |
5,021
|
3,460
|
9,018
|
7,684
|
Impairment of licensed technology |
|
|
|
1,355
|
Loss/(gain) on right-of-use lease assets |
(1,065)
|
|
(1,065)
|
1,561
|
Impairment of construction-in-progress |
|
(1,460)
|
|
1,792
|
Total expenses |
14,054
|
9,008
|
26,092
|
29,945
|
Loss from operations |
(10,554)
|
(8,008)
|
(22,592)
|
(28,599)
|
Interest income |
417
|
31
|
781
|
38
|
Interest expense |
(103)
|
(200)
|
(204)
|
(401)
|
Change in fair value of warrant liabilities |
(8,629)
|
4,198
|
(6,364)
|
2,945
|
Other income (expense) |
2,215
|
(118)
|
2,618
|
(124)
|
Net loss |
(16,654)
|
(4,097)
|
(25,761)
|
(26,141)
|
Deemed dividends related to Series A and Series B Convertible Redeemable Preferred Stock |
|
(3,782)
|
|
(3,782)
|
Net loss attributable to Common Shareholders |
$ (16,654)
|
$ (7,879)
|
$ (25,761)
|
$ (29,923)
|
Net Loss per share - basic |
$ 0.92
|
$ 1.36
|
$ 1.48
|
$ 5.16
|
Net Loss per share - diluted |
$ 0.92
|
$ 1.36
|
$ 1.48
|
$ 5.16
|
Weighted average number of shares - basic |
18,017,874
|
5,806,473
|
17,464,026
|
5,800,822
|
Weighted average number of shares - diluted |
18,017,874
|
5,806,473
|
17,464,026
|
5,800,822
|
Other comprehensive income (loss): |
|
|
|
|
Change in unrealized gains (losses) related to available-for-sale debt securities |
$ (30)
|
$ (4)
|
$ 34
|
$ (7)
|
Comprehensive loss |
$ (16,684)
|
$ (7,883)
|
$ (25,727)
|
$ (29,930)
|
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v3.23.2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands |
Convertible Redeemable Preferred Stock Series A [Member] |
Convertible Redeemable Preferred Stock Series B [Member] |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
AOCI Attributable to Parent [Member] |
Total |
Balance at Dec. 31, 2021 |
|
|
$ 1,472
|
$ 696,563
|
$ (655,640)
|
$ (27)
|
$ 42,368
|
Balance, shares at Dec. 31, 2021 |
|
|
5,888,217
|
|
|
|
|
Stock-based compensation expense |
|
|
|
1,586
|
|
|
1,586
|
Issuance of common stock in connection with restricted share awards, net of cancellations |
|
|
$ (5)
|
5
|
|
|
|
Issuance of common stock in connection with restricted share awards, net of cancellations, shares |
|
|
(17,842)
|
|
|
|
|
Net loss |
|
|
|
|
(26,141)
|
|
(26,141)
|
Other comprehensive income (loss) |
|
|
|
|
|
(7)
|
(7)
|
Issuance of Series A and Series B Convertible Redeemable Preferred Stock |
$ 17,974
|
$ 4,494
|
|
|
|
|
|
Issuance of Series A and Series B Convertible Redeemable Preferred Stock, net of issuance costs, shares |
1,000,006
|
250,005
|
|
|
|
|
|
Deemed dividends related to Series A and Series B Convertible Redeemable Preferred Stock |
$ 3,026
|
$ 756
|
|
(3,782)
|
|
|
(3,782)
|
Redemption of Series A and Series B Convertible Redeemable Preferred Stock |
$ (21,000)
|
$ (5,250)
|
|
|
|
|
|
Redemption of Series A and Series B Convertible Redeemable Preferred Stock, shares |
(1,000,006)
|
(250,005)
|
|
|
|
|
|
Balance at Jun. 30, 2022 |
|
|
$ 1,467
|
694,372
|
(681,781)
|
(34)
|
14,024
|
Balance, shares at Jun. 30, 2022 |
|
|
5,870,375
|
|
|
|
|
Balance at Mar. 31, 2022 |
|
|
$ 1,471
|
697,426
|
(677,684)
|
(30)
|
21,183
|
Balance, shares at Mar. 31, 2022 |
|
|
5,883,196
|
|
|
|
|
Stock-based compensation expense |
|
|
|
724
|
|
|
724
|
Issuance of common stock in connection with restricted share awards, net of cancellations |
|
|
$ (4)
|
4
|
|
|
|
Issuance of common stock in connection with restricted share awards, net of cancellations, shares |
|
|
(12,821)
|
|
|
|
|
Net loss |
|
|
|
|
(4,097)
|
|
(4,097)
|
Other comprehensive income (loss) |
|
|
|
|
|
(4)
|
(4)
|
Issuance of Series A and Series B Convertible Redeemable Preferred Stock |
$ 17,974
|
$ 4,494
|
|
|
|
|
|
Issuance of Series A and Series B Convertible Redeemable Preferred Stock, net of issuance costs, shares |
1,000,006
|
250,005
|
|
|
|
|
|
Deemed dividends related to Series A and Series B Convertible Redeemable Preferred Stock |
$ 3,026
|
$ 756
|
|
(3,782)
|
|
|
(3,782)
|
Redemption of Series A and Series B Convertible Redeemable Preferred Stock |
$ (21,000)
|
$ (5,250)
|
|
|
|
|
|
Redemption of Series A and Series B Convertible Redeemable Preferred Stock, shares |
(1,000,006)
|
(250,005)
|
|
|
|
|
|
Balance at Jun. 30, 2022 |
|
|
$ 1,467
|
694,372
|
(681,781)
|
(34)
|
14,024
|
Balance, shares at Jun. 30, 2022 |
|
|
5,870,375
|
|
|
|
|
Balance at Dec. 31, 2022 |
|
|
$ 177
|
722,049
|
(695,336)
|
(129)
|
26,761
|
Balance, shares at Dec. 31, 2022 |
|
|
17,719,720
|
|
|
|
|
Stock-based compensation expense |
|
|
|
1,697
|
|
|
1,697
|
Issuance of common stock in connection with restricted share awards, net of cancellations |
|
|
$ 18
|
(27)
|
|
|
(9)
|
Issuance of common stock in connection with restricted share awards, net of cancellations, shares |
|
|
1,768,116
|
|
|
|
|
Issuance of common stock, net of offering costs under open market sale agreement (ATM) |
|
|
$ 20
|
6,603
|
|
|
6,623
|
Issuance of common stock, net of offering costs under open market sale agreement (ATM), shares |
|
|
1,990,321
|
|
|
|
|
Net loss |
|
|
|
|
(25,761)
|
|
(25,761)
|
Other comprehensive income (loss) |
|
|
|
|
|
34
|
34
|
Balance at Jun. 30, 2023 |
|
|
$ 215
|
730,322
|
(721,097)
|
(95)
|
9,345
|
Balance, shares at Jun. 30, 2023 |
|
|
21,478,157
|
|
|
|
|
Balance at Mar. 31, 2023 |
|
|
$ 179
|
723,069
|
(704,443)
|
(65)
|
18,740
|
Balance, shares at Mar. 31, 2023 |
|
|
17,929,344
|
|
|
|
|
Stock-based compensation expense |
|
|
|
927
|
|
|
927
|
Issuance of common stock in connection with restricted share awards, net of cancellations |
|
|
$ 17
|
(22)
|
|
|
(5)
|
Issuance of common stock in connection with restricted share awards, net of cancellations, shares |
|
|
1,657,052
|
|
|
|
|
Issuance of common stock, net of offering costs under open market sale agreement (ATM) |
|
|
$ 19
|
6,348
|
|
|
6,367
|
Issuance of common stock, net of offering costs under open market sale agreement (ATM), shares |
|
|
1,891,761
|
|
|
|
|
Net loss |
|
|
|
|
(16,654)
|
|
(16,654)
|
Other comprehensive income (loss) |
|
|
|
|
|
(30)
|
(30)
|
Balance at Jun. 30, 2023 |
|
|
$ 215
|
$ 730,322
|
$ (721,097)
|
$ (95)
|
$ 9,345
|
Balance, shares at Jun. 30, 2023 |
|
|
21,478,157
|
|
|
|
|
X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement.
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v3.23.2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Cash flows from operating activities: |
|
|
|
|
|
Net loss |
$ (16,654)
|
$ (4,097)
|
$ (25,761)
|
$ (26,141)
|
|
Adjustments to reconcile net loss to cash used in operating activities: |
|
|
|
|
|
Depreciation and amortization |
|
|
1,276
|
1,584
|
|
Stock-based compensation expense |
927
|
724
|
1,697
|
1,586
|
|
Change in fair value of warrant liabilities |
8,629
|
(4,198)
|
6,364
|
(2,945)
|
|
Non-cash impairment of licensed technology |
|
|
|
1,355
|
|
Non-cash loss/(gain) of right-of-use lease assets |
|
|
(1,065)
|
1,561
|
|
Non-cash impairment of construction-in-progress |
|
|
|
1,792
|
|
Accretion and interest on short-term investments |
|
|
(74)
|
(177)
|
|
Amortization of right-of-use lease assets |
|
|
450
|
899
|
|
Non-cash interest |
|
|
204
|
402
|
|
Loss on disposal of property and equipment |
|
|
47
|
106
|
|
Change in operating assets and liabilities: |
|
|
|
|
|
Accounts receivable |
|
|
(3,500)
|
2,000
|
|
Other receivables |
|
|
(2,039)
|
(1,827)
|
|
Prepaid expenses and other current assets |
|
|
(777)
|
937
|
|
Other assets |
|
|
(65)
|
148
|
|
Accounts payable, accrued expenses and lease liabilities |
|
|
1,214
|
(3,684)
|
|
Other current liabilities |
|
|
1
|
|
|
Change in payable to licensor |
|
|
|
(296)
|
|
Net cash used in operating activities |
|
|
(22,028)
|
(22,700)
|
|
Cash flows from investing activities: |
|
|
|
|
|
Capital expenditures |
|
|
(250)
|
(103)
|
|
Proceeds from disposal of property and equipment |
|
|
179
|
1,487
|
|
Purchases of short-term investments |
|
|
(14,156)
|
(34,442)
|
|
Proceeds from maturities of short-term investments |
|
|
21,649
|
32,735
|
|
Net cash provided by (used in) investing activities |
|
|
7,422
|
(323)
|
|
Cash flows from financing activities: |
|
|
|
|
|
Proceeds from ATM sales of common stock, net of issuance costs |
|
|
6,623
|
|
|
Proceeds from net settlement of restricted share awards |
|
|
(9)
|
|
|
Proceeds from issuance of Series A and Series B Convertible Redeemable Preferred Stock, net of issuance costs |
|
|
|
22,468
|
|
Redemption of Series A and Series B Convertible Redeemable Preferred Stock |
|
|
|
(26,250)
|
|
Net cash provided by (used in) financing activities |
|
|
6,614
|
(3,782)
|
|
Net decrease in cash, cash equivalents and restricted cash |
|
|
(7,992)
|
(26,805)
|
|
Cash, cash equivalents and restricted cash at beginning of period |
|
|
14,555
|
38,829
|
$ 38,829
|
Cash, cash equivalents and restricted cash at end of period |
6,563
|
12,024
|
6,563
|
12,024
|
14,555
|
Supplemental cash flow information: |
|
|
|
|
|
Cash and cash equivalents |
6,225
|
6,133
|
6,225
|
6,133
|
$ 14,217
|
Restricted cash |
338
|
5,891
|
338
|
5,891
|
|
Total cash, cash equivalents and restricted cash |
$ 6,563
|
$ 12,024
|
6,563
|
12,024
|
|
Supplemental non-cash flow information: |
|
|
|
|
|
Right-of-use asset obtained in exchange for new operating lease liabilities |
|
|
$ 419
|
|
|
X |
- DefinitionAdditions to right-of-use lease assets obtained from new operating lease liabilities resulting from modification of original lease arrangement.
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v3.23.2
NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES |
NOTE
1 – NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES
Background
Abeona
Therapeutics Inc. (together with the Company’s subsidiaries, “Abeona” or the “Company”), a Delaware corporation,
is a clinical-stage biopharmaceutical company developing cell and gene therapies for life-threatening diseases. The Company’s lead
clinical program is EB-101, an autologous, engineered cell therapy currently in development for recessive dystrophic epidermolysis bullosa
(“RDEB”). The Company’s development portfolio also features adeno-associated virus (“AAV”)-based gene therapies
designed to treat highly unmet, medically needed ophthalmic diseases using the novel AIM™ capsid platform that the Company has
exclusively licensed from the University of North Carolina at Chapel Hill, and internal AAV vector research programs.
Basis
of Presentation
The
Company’s unaudited interim condensed consolidated financial statements have been prepared in conformity with accounting principles
generally accepted in the United States of America (“U.S. GAAP”). All intercompany balances and transactions have been eliminated
in consolidation. In the opinion of management, all adjustments, consisting only of normal recurring adjustments, except as otherwise
disclosed, necessary for the fair presentation of the financial position, results of operations, and changes in financial position for
such periods, have been made. These unaudited interim condensed consolidated financial statement results are not necessarily indicative
of results to be expected for the full fiscal year or any future period. Certain information that is normally required by U.S. GAAP has
been condensed or omitted in accordance with rules and regulations of the U.S. Securities and Exchange Commission (“SEC”).
The December 31, 2022 condensed consolidated balance sheet was derived from the audited statements, but does not include all disclosures
required by U.S. GAAP.
Therefore,
these unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial
statements and notes thereto included in our Annual Report on Form 10-K/A for the year ended December 31, 2022, which was filed with
the SEC on April 10, 2023.
Reverse
Stock Split
As
described in Note 1 to the consolidated financial statements included in the Company’s 2022 Annual Report on Form 10-K/A, on June
30, 2022, the Company filed a Certificate of Amendment to the Company’s Restated Certificate of Incorporation with the Secretary
of State of the State of Delaware (the “Certificate of Amendment”), to effectuate a reverse stock split of the Company’s
outstanding common stock, par value $0.01 per share (“Common Stock”), at an exchange ratio of 25-to-1 (the “Reverse
Stock Split”). The Reverse Stock Split was effective on July 1, 2022. The number of authorized shares of Common Stock immediately
after the Reverse Stock Split (“New Common Stock”) remained at 200,000,000 shares. All share and per share information has
been retroactively adjusted to give effect to the Reverse Stock Split for all periods presented, unless otherwise indicated.
Uses
and Sources of Liquidity
The
unaudited interim condensed consolidated financial statements have been prepared on the going concern basis, which assumes the Company
will have sufficient cash to pay its operating expenses, as and when they become payable, for a period of at least 12 months from the
date the financial report is issued.
As
of June 30, 2023, the Company had cash, cash equivalents, restricted cash and short-term investments of $37.1 million. For the six months
ended June 30, 2023, the Company had cash outflows from operations of $22.0 million. The Company has not generated significant revenues
and has not achieved profitable operations. There is no assurance that profitable operations will ever be achieved, and, if achieved,
could be sustained on a continuing basis. In addition, development activities, clinical and nonclinical testing, and commercialization
of the Company’s product candidates will require significant additional financing.
The
Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the
successful discovery and development of product candidates, obtaining the necessary regulatory approval to market the Company’s
product candidates, raising additional capital to continue to fund the Company’s operations, development of competing drugs and
therapies and protection of proprietary technology. As a result of these and other risks and the related uncertainties, there can be
no assurance of the Company’s future success.
Subsequent
to June 30, 2023, as described in Note 12, the Company raised $25.0 million, with net proceeds
of $23.0 million, after offering costs through the issuance of common stock and warrants.
The
Company believes that its current cash and cash equivalents, restricted cash and short-term investments are sufficient resources to fund
operations through at least the next 12 months from the date of this quarterly report on Form 10-Q. The Company may need to secure additional
funding to carry out all of its planned research and development and commercialization activities. If the Company is unable to obtain
additional financing or generate license or product revenue, the lack of liquidity and sufficient capital resources could have a material
adverse effect on its future prospects.
Use
of Estimates
The
preparation of unaudited interim condensed consolidated financial statements in conformity with U.S. GAAP requires management to make
estimates and assumptions that affect the reported amount of assets and disclosure of contingent assets and liabilities at the date of
the unaudited interim condensed consolidated financial statements and the reported amounts of revenue and expenses during the reported
period. Actual results could differ from these estimates and assumptions.
Other
receivables
Other
receivables include employee retention credits (“ERC”), sublease rent receivables and other miscellaneous receivables. As
of June 30, 2023 and December 31, 2022, the Company had ERC receivables of $2.1 million and nil, respectively.
Summary
of Significant Accounting Policies
There
have been no new, anticipated or material changes to the significant accounting policies disclosed in the Company’s Annual Report
on Form 10-K/A for the year ended December 31, 2022.
Correction
of Error
During
the fourth quarter of 2022, the Company identified errors in the accounting for certain common stock warrants that were issued in 2021.
The common stock warrants were not indexed to the Company’s own stock and therefore should have been classified as liabilities
at their estimated fair value instead of additional paid-in capital. Although the errors were immaterial to prior periods, the 2021 financial
statements were restated in accordance with Staff Accounting Bulletin No. 108, “Considering the Effects of Prior Year Misstatements
when Quantifying Misstatements in Current Year Financial Statements”, due to the significance of the out-of-period correction to
the 2021 period. There was no impact to the Company’s consolidated statements of operations and comprehensive loss for 2021. The
correction of the error resulted in the Company adjusting its quarterly information presented for the three and six months ended June
30, 2022. The matter was correctly presented in the fiscal year end December 31, 2022 consolidated financial statements included in the
Company’s 2022 Annual Report on Form 10-K/A.
The
following tables present the effects of the correction of the prior period error to the condensed consolidated statement of operations
and comprehensive loss (in thousands, except for per share data):
SCHEDULE
OF EFFECTS OF THE RESTATEMENT TO AMOUNTS IN THE PREVIOUSLY REPORTED CONSOLIDATED FINANCIAL STATEMENTS
| |
| | |
| | |
| |
| |
For the three months ended June 30, 2022 | |
Condensed Consolidated Statement of Operations and Comprehensive Loss | |
As Reported | | |
Adjustment | | |
As Revised | |
| |
| | |
| | |
| |
Change in fair value of warrant liabilities | |
$ | — | | |
$ | 4,198 | | |
$ | 4,198 | |
Net loss | |
$ | (8,295 | ) | |
$ | 4,198 | | |
$ | (4,097 | ) |
Net loss attributable to Common Shareholders | |
$ | (12,077 | ) | |
$ | 4,198 | | |
$ | (7,879 | ) |
Basic and diluted loss per common share | |
$ | (2.08 | ) | |
$ | 0.72 | | |
$ | (1.36 | ) |
Comprehensive loss | |
$ | (12,081 | ) | |
$ | 4,198 | | |
$ | (7,883 | ) |
| |
| | |
| | |
| |
| |
For the six months ended June 30, 2022 | |
Condensed Consolidated Statement of Operations and Comprehensive Loss | |
As Reported | | |
Adjustment | | |
As Revised | |
| |
| | |
| | |
| |
Change in fair value of warrant liabilities | |
$ | — | | |
$ | 2,945 | | |
$ | 2,945 | |
Net loss | |
$ | (29,086 | ) | |
$ | 2,945 | | |
$ | (26,141 | ) |
Net loss attributable to Common Shareholders | |
$ | (32,868 | ) | |
$ | 2,945 | | |
$ | (29,923 | ) |
Basic and diluted loss per common share | |
$ | (5.67 | ) | |
$ | 0.51 | | |
$ | (5.16 | ) |
Comprehensive loss | |
$ | (32,875 | ) | |
$ | 2,945 | | |
$ | (29,930 | ) |
The
following tables present the effects of the correction of the prior period error to the condensed consolidated cash flow statement (in
thousands):
| |
For the six months ended June 30, 2022 | |
Condensed Consolidated Cash Flow Statement | |
As Reported | | |
Adjustment | | |
As Revised | |
| |
| | |
| | |
| |
Net loss | |
$ | (29,086 | ) | |
$ | 2,945 | | |
$ | (26,141 | ) |
Adjustments to reconcile net loss to cash used in operating activities: | |
| | | |
| | | |
| | |
Change in fair value of warrant liabilities | |
$ | — | | |
$ | (2,945 | ) | |
$ | (2,945 | ) |
Net cash provided by operating activities | |
$ | (22,700 | ) | |
$ | — | | |
$ | (22,700 | ) |
The
following tables present the effects of the correction of the prior period error to the condensed consolidated statement of stockholders’
equity (in thousands):
| |
As of June 30, 2022 | |
Condensed Consolidated Statement of Stockholders’ Equity | |
As Reported | | |
Adjustment | | |
As Revised | |
| |
| | |
| | |
| |
Additional paid-in capital, December 31, 2021 | |
$ | 705,570 | | |
$ | (9,007 | ) | |
$ | 696,563 | |
Total stockholders’ equity, December 31, 2021 | |
$ | 51,375 | | |
$ | (9,007 | ) | |
$ | 42,368 | |
Additional paid-in capital, March 31, 2022 | |
$ | 706,433 | | |
$ | (9,007 | ) | |
$ | 697,426 | |
Additional paid-in capital, March 31, 2022 | |
$ | 31,443 | | |
$ | (10,260 | ) | |
$ | 21,183 | |
Net loss | |
$ | (29,086 | ) | |
$ | 2,945 | | |
$ | (26,141 | ) |
Additional paid-in capital, June 30, 2022 | |
$ | 703,379 | | |
$ | (9,007 | ) | |
$ | 694,372 | |
Total stockholders’ equity, June 30, 2022 | |
$ | 20,086 | | |
$ | (6,062 | ) | |
$ | 14,024 | |
Net
Loss Per Share
Basic
and diluted net loss per share is computed by dividing net loss attributable to common shareholders by the weighted-average number of
shares of common stock. The Company does not include the potential impact of dilutive securities in diluted net loss per share, as the
impact of these items is anti-dilutive. Potential dilutive securities result from outstanding restricted stock, stock options, and stock
purchase warrants.
The
following table sets forth the potential securities that could potentially dilute basic income/(loss) per share in the future that were
not included in the computation of diluted net loss per share because to do so would have been anti-dilutive for the periods presented:
SCHEDULE
OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE
| |
For the three and six months ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Stock options | |
| 230,723 | | |
| 265,411 | |
Restricted stock | |
| 2,566,303 | | |
| 61,108 | |
Warrants | |
| 9,397,879 | | |
| 1,788,000 | |
Total | |
| 12,194,905 | | |
| 2,114,519 | |
New
Accounting Pronouncements
No
new accounting pronouncement issued or effective had, or is expected to have, a material impact on the Company’s condensed consolidated
financial statements.
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v3.23.2
SHORT-TERM INVESTMENTS
|
6 Months Ended |
Jun. 30, 2023 |
Investments, Debt and Equity Securities [Abstract] |
|
SHORT-TERM INVESTMENTS |
NOTE
2 – SHORT-TERM INVESTMENTS
The
following table provides a summary of the short-term investments (in thousands):
SCHEDULE
OF AVAILABLE FOR SALE SHORT-TERM INVESTMENTS
| |
June 30, 2023 | |
| |
Amortized Cost | | |
Gross
Unrealized Gain | | |
Gross
Unrealized Loss | | |
Fair Value | |
| |
| | |
| | |
| | |
| |
Available-for-sale, short-term investments: | |
| | | |
| | | |
| | | |
| | |
U.S. treasury and federal agency securities | |
$ | 30,613 | | |
| — | | |
| (66 | ) | |
$ | 30,547 | |
Total available-for-sale, short-term investments | |
$ | 30,613 | | |
| — | | |
| (66 | ) | |
$ | 30,547 | |
| |
December 31, 2022 | |
| |
Amortized Cost | | |
Gross
Unrealized Gain | | |
Gross
Unrealized Loss | | |
Fair Value | |
| |
| | |
| | |
| | |
| |
Available-for-sale, short-term investments: | |
| | | |
| | | |
| | | |
| | |
U.S. treasury and federal agency securities | |
$ | 38,032 | | |
| — | | |
| (100 | ) | |
$ | 37,932 | |
Total available-for-sale, short-term investments | |
$ | 38,032 | | |
| — | | |
| (100 | ) | |
$ | 37,932 | |
As
of June 30, 2023, the available-for-sale securities classified as short-term investments mature in one year or less. Unrealized losses
on available-for-sale securities as of June 30, 2023, were not significant and were primarily due to changes in interest rates, including
market credit spreads, and not due to increased credit risks associated with specific securities. None of the short-term investments
have been in a continuous unrealized loss position for more than 12 months. Accordingly, no other-than-temporary impairment was recorded
for the three and six months ended June 30, 2023.
There
were no significant realized gains or losses recognized on the sale or maturity of available-for-sale investments for the three and six
months ended June 30, 2023 or 2022.
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- DefinitionThe entire disclosure for investments in certain debt and equity securities.
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v3.23.2
PROPERTY AND EQUIPMENT, NET
|
6 Months Ended |
Jun. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
PROPERTY AND EQUIPMENT, NET |
NOTE
3 – PROPERTY AND EQUIPMENT, NET
Property
and equipment are stated at cost and depreciated or amortized using the straight-line method based on useful lives as follows (in thousands):
SCHEDULE OF PROPERTY AND EQUIPMENT
| |
Useful lives (years) | |
June 30, 2023 | | |
December 31, 2022 | |
| |
| |
| | |
| |
Laboratory equipment | |
5 | |
$ | 7,276 | | |
$ | 7,636 | |
Furniture, software and office equipment | |
3 to 5 | |
| 991 | | |
| 1,379 | |
Leasehold improvements | |
Shorter of remaining lease term or useful life | |
| 8,603 | | |
| 8,605 | |
Subtotal | |
| |
| 16,870 | | |
| 17,620 | |
Less: accumulated depreciation | |
| |
| (12,381 | ) | |
| (11,879 | ) |
Total property and equipment, net | |
| |
$ | 4,489 | | |
$ | 5,741 | |
Depreciation
expense was $0.6 million and $0.8 million for the three months ended June 30, 2023 and 2022, respectively, and $1.3 million and $1.6
million for the six months ended June 30, 2023 and 2022, respectively.
On
March 31, 2022, the Company announced that it was pursuing a strategic partner to take over development activities of ABO-102 and that
it was discontinuing development of ABO-101. As a result, the Company determined the construction-in-progress that was dedicated to the
ABO-101 and ABO-102 programs had no future value, and thus recorded an impairment charge of $1.8 million for the six months ended June
30, 2022.
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v3.23.2
LICENSED TECHNOLOGY
|
6 Months Ended |
Jun. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
LICENSED TECHNOLOGY |
NOTE
4 – LICENSED TECHNOLOGY
On
May 15, 2015, we acquired Abeona Therapeutics LLC, which had an exclusive license through Nationwide Children’s Hospital to the
AB-101 and AB-102 patent portfolios for developing treatments for patients with Sanfilippo Syndrome Type A and Type B. The license is
amortized to expense over the life of the license of 20 years. On March 31, 2022, the Company announced that it was pursuing a strategic
partner to take over development activities of ABO-102 and that it was discontinuing development of ABO-101. As a result of this shift
in priorities, the Company determined the remaining value of the licensed technology had no future value and thus, recorded an impairment
charge of $1.4 million for the six months ended June 30, 2022. There is no remaining net value of licensed technology as of June 30,
2023 and December 31, 2022.
Amortization
expense on licensed technology was nil and $29,000 for the six months ended June 30, 2023 and 2022, respectively. There was no amortization
expense for the three months ended June 30, 2023 or 2022.
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v3.23.2
FAIR VALUE MEASUREMENTS
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
FAIR VALUE MEASUREMENTS |
NOTE
5 – FAIR VALUE MEASUREMENTS
The
Company calculates the fair value of the Company’s assets and liabilities that qualify as financial instruments and includes additional
information in the notes to the consolidated financial statements when the fair value is different than the carrying value of these financial
instruments. The estimated fair value of other receivables, prepaid expenses and other current assets, other assets, accounts payable,
accrued expenses, and payables to licensor approximate their carrying amounts due to the relatively short maturity of these instruments.
U.S.
GAAP defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in
the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement
date. This guidance establishes a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy
requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used
to measure fair value are as follows:
|
● |
Level
1 – Quoted prices in active markets for identical assets or liabilities. |
|
|
|
|
● |
Level
2 – Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities
in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs
that are observable or can be corroborated by observable market data. |
|
|
|
|
● |
Level
3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the
assets and liabilities. This includes certain pricing models, discounted cash flow methodologies and similar valuation techniques
that use significant unobservable inputs. |
The
Company has segregated all financial assets and liabilities that are measured at fair value on a recurring basis (at least annually)
into the most appropriate level within the fair value hierarchy based on the inputs used to determine the fair value at the measurement
date in the table below.
The
following table provides a summary of financial assets measured at fair value on a recurring and non-recurring basis as of June 30, 2023
and December 31, 2022 (in thousands):
SCHEDULE
OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS
Description | |
Fair Value at
June 30, 2023 | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Recurring Assets | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
| | | |
| | | |
| | | |
| | |
Money market fund | |
$ | 5,678 | | |
$ | 5,678 | | |
$ | — | | |
$ | — | |
Short-term investments | |
| | | |
| | | |
| | | |
| | |
U.S. treasury and federal agency securities | |
| 30,547 | | |
| — | | |
| 30,547 | | |
| — | |
Total assets measured at fair value | |
$ | 36,225 | | |
$ | 5,678 | | |
$ | 30,547 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Warrant liabilities | |
$ | 26,021 | | |
| — | | |
| — | | |
$ | 26,021 | |
Total liabilities measured at fair value | |
$ | 26,021 | | |
$ | — | | |
$ | — | | |
$ | 26,021 | |
Description | |
Fair Value at
December 31, 2022 | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Recurring Assets: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
| | | |
| | | |
| | | |
| | |
Money market fund | |
$ | 12,923 | | |
$ | 12,923 | | |
$ | — | | |
$ | — | |
Short-term investments | |
| | | |
| | | |
| | | |
| | |
U.S. treasury and federal agency securities | |
| 37,932 | | |
| — | | |
| 37,932 | | |
| — | |
Total assets measured at fair value | |
$ | 50,855 | | |
$ | 12,923 | | |
$ | 37,932 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Warrant liabilities | |
$ | 19,657 | | |
| — | | |
| — | | |
$ | 19,657 | |
Total liabilities measured at fair value | |
$ | 19,657 | | |
$ | — | | |
$ | — | | |
$ | 19,657 | |
Warrant
Liabilities
The
warrant liabilities are valued using significant inputs not observable in the market. Accordingly, the warrant liability is measured
at fair value on a recurring basis using unobservable inputs and are classified as Level 3 inputs within the fair value hierarchy. Fair
value measurements categorized within Level 3 are sensitive to changes in the assumptions or methodology used to determine fair value
and such changes could result in a significant increase or decrease in the fair value. The Company’s valuation of the common stock
warrants utilized the Black-Scholes option-pricing model, which incorporated assumptions and estimates to value the common stock warrants.
The Company assessed these assumptions and estimates at the end of each reporting period. Assumptions used to estimate the fair value
of the warrants in the Black-Scholes option-pricing model are as follows:
SCHEDULE
OF ESTIMATE FAIR VALUE OF WARRANTS
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
| | |
| |
Common share price | |
| $4.03 | | |
| $3.08 | |
Expected term (years) | |
| 3.47 – 4.35 | | |
| 3.96 – 4.84 | |
Risk-free interest rate (%) | |
| 4.13% – 4.28% | | |
| 3.91% – 4.01% | |
Volatility (%) | |
| 100.00% – 105.04% | | |
| 102.40% – 107.55% | |
As
of June 30, 2023, the Company had outstanding warrant liabilities related to the 2022 private placement that allow the holders to purchase
7,609,879 shares of common stock at an exercise price of $4.75 per share. The expiration date for these warrant liabilities is November
2027. As of June 30, 2023 and December 31, 2022, the Company had outstanding warrant liabilities related to the 2021 public offering
that allow the holders to purchase 1,788,000 shares of common stock at an exercise price of $9.75 per share. The expiration date for
these warrant liabilities is December 2026.
The
following table provides a summary of the activity on the warrant liabilities (in thousands):
SCHEDULE
OF ACTIVITY OF WARRANT LIABILITIES
| |
| | |
Warrant liabilities as of December 31, 2022 | |
$ | 19,657 | |
Loss recognized in earnings from change in fair value | |
| 6,364 | |
Warrant liabilities as of June 30, 2023 | |
$ | 26,021 | |
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v3.23.2
SETTLEMENT LIABILITY
|
6 Months Ended |
Jun. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
SETTLEMENT LIABILITY |
NOTE
6 – SETTLEMENT LIABILITY
On
November 12, 2021, the Company entered into a settlement agreement (“Settlement Agreement”) with the Company’s prior
licensor REGENXBIO Inc. (“REGENXBIO”) to resolve all existing disputes between the parties. In accordance with the Settlement
Agreement, the Company agreed to pay REGENXBIO a total of $30.0 million, payable as follows: (1) $20.0 million paid in November 2021
after execution of the Settlement Agreement, (2) $5.0 million on the first anniversary of the effective date of the Settlement Agreement,
and (3) $5.0 million upon the earlier of (i) the third anniversary of the effective date of the Settlement Agreement or (ii) the closing
of a Strategic Transaction, as defined in the Settlement Agreement.
As
of June 30, 2023, the Company recorded the payable due to REGENXBIO in the condensed consolidated balance sheets based on the present
value of the remaining payments due to REGENXBIO under the Settlement Agreement using an interest rate of 9.6%. The long-term portion
due in November 2024 was $4.4 million and $4.2 million as of June 30, 2023 and December 31, 2022, respectively.
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v3.23.2
ACCRUED EXPENSES
|
6 Months Ended |
Jun. 30, 2023 |
Payables and Accruals [Abstract] |
|
ACCRUED EXPENSES |
NOTE
7 – ACCRUED EXPENSES
The
following table provides a summary of the components of accrued expenses (in thousands):
SCHEDULE OF ACCRUED EXPENSES
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
| | |
| |
Accrued employee compensation | |
$ | 1,434 | | |
$ | 2,593 | |
Accrued contracted services and other | |
| 2,727 | | |
| 1,398 | |
Total accrued expenses | |
$ | 4,161 | | |
$ | 3,991 | |
|
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v3.23.2
LEASES
|
6 Months Ended |
Jun. 30, 2023 |
Leases |
|
LEASES |
NOTE
8 – LEASES
The
Company leases space under operating leases for administrative, manufacturing and laboratory facilities in Cleveland, Ohio. The Company
also leases office space in New York, New York, that the Company sublets. The Company also leases certain office equipment under operating
leases, which have a non-cancelable lease term of less than one year and, therefore, the Company has elected the practical expedient
to exclude these short-term leases from the Company’s right-of-use assets and lease liabilities.
In
June 2023, the Company terminated one of its operating leases for office space. The termination resulted in a gain of $1.1
million from the difference of the right-of-use
assets and lease liabilities in the three and six months ended June 30, 2023 and is included in loss/(gain) on right-of-use lease assets
in the condensed consolidated statement of operations and comprehensive loss.
On
March 31, 2022, the Company announced that they were pursuing a strategic partner to take over development activities of ABO-102 and
that the Company was discontinuing development of ABO-101. As a result of this shift in priorities, the Company determined the portion
of the lease that was dedicated to the future facility for the ABO-101 and ABO-102 programs, had no future value and thus, the Company
recorded an impairment charge of $1.6 million for the six months ended June 30, 2022.
The
following table provides a summary of the components of lease costs and rent (in thousands):
SCHEDULE OF COMPONENTS OF LEASE COST
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For the three months ended June 30, | | |
For the six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Operating lease cost | |
$ | 353 | | |
$ | 461 | | |
$ | 708 | | |
$ | 933 | |
Variable lease cost | |
| 116 | | |
| 116 | | |
| 215 | | |
| 212 | |
Short-term lease cost | |
| 13 | | |
| 20 | | |
| 31 | | |
| 41 | |
Total operating lease costs | |
$ | 482 | | |
$ | 597 | | |
$ | 954 | | |
$ | 1,186 | |
Future
minimum lease payments and obligations, which do not include short-term leases, of the Company’s operating lease liabilities as
of June 30, 2023 were as follows (in thousands):
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES
Future minimum lease payments and obligations | |
Operating Leases | |
| |
| | |
2023, remainder | |
$ | 799 | |
2024 | |
| 993 | |
2025 | |
| 1,552 | |
2026 | |
| 791 | |
2027 | |
| 807 | |
Thereafter | |
| 2,516 | |
Total undiscounted operating lease payments | |
| 7,458 | |
Less: imputed interest | |
| 1,484 | |
Present value of operating lease liabilities | |
$ | 5,974 | |
The
weighted-average remaining term of the Company’s operating leases was 68 months and the weighted-average discount rate used to
measure the present value of the Company’s operating lease liabilities was 7.5% as of June 30, 2023.
Future
cash receipts from the Company’s sublease agreements as of June 30, 2023 are as follows (in thousands):
SCHEDULE OF FUTURE CASH RECEIPTS FROM OPERATING SUBLEASE
| |
Operating | |
Future cash receipts | |
Subleases | |
| |
| | |
2023, remainder | |
$ | 270 | |
2024 | |
| 634 | |
2025 | |
| 485 | |
Total future cash receipts | |
$ | 1,389 | |
|
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v3.23.2
EQUITY
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
EQUITY |
NOTE
9 – EQUITY
Reverse
Stock Split
Effective
July 1, 2022, the Company’s stock underwent a 25:1 Reverse Stock Split. The number of authorized shares of Common Stock immediately
after the Reverse Stock Split remained at 200,000,000 shares.
Public
Offerings
On
December 21, 2021, the Company closed an underwritten public offering of 1,788,000 post-split shares of common stock at a public offering
price of $9.75 post-split per share and stock purchase warrants to purchase 1,788,000 post-split shares of common stock at an exercise
price of $9.75 post-split. The net proceeds to the Company were approximately $16.0 million, after deducting $1.5 million of underwriting
discounts and commissions and offering expenses payable by the Company. The net proceeds were allocated to the warrant liability as noted
below with the remainder of $7.0 million recorded in common stock and additional paid-in capital. In the event of certain fundamental
transactions involving the Company, the holders of the stock purchase warrants may require the Company to make a payment based on a Black-Scholes
valuation, using specific inputs that are not considered indexed to the Company’s stock in accordance with ASC 815, Derivatives
and Hedging (“ASC 815”). Therefore, the Company accounted for the stock purchase warrants as liabilities and were recorded
at the closing date fair value of $9.0 million which was based on a Black-Scholes option pricing model. The remainder of the proceeds
were allocated to common stock issued and recorded as a component of equity.
As
of June 30, 2023, there were 1,788,000 post-split stock purchase warrants outstanding. These stock purchase warrants expire on December
21, 2026. During such time as each warrant is outstanding, the holder of the warrant is entitled to participate in any dividends or other
distribution of assets to holders of shares of common stock. There was no warrant activity during the three or six months ended June
30, 2023.
Open
Market Sale Agreement
On
August 17, 2018, the Company entered into an open market sale agreement (as amended, the “ATM Agreement”) with Jefferies
LLC (“Jefferies”) pursuant to which, the Company may sell from time to time, through Jefferies, shares of its common stock
for an aggregate sales price of up to $150.0 million. Any sales of shares pursuant to this agreement are made under the Company’s
effective “shelf” registration statement on Form S-3 that is on file with and has been declared effective by the SEC. The
Company sold 1,990,321 shares of its common stock under the ATM Agreement resulting in net proceeds of $6.6 million during the six months
ended June 30, 2023. There were no sales under the ATM Agreement during the three and six months ended June 30, 2022.
Private
Placement Offerings
On
November 3, 2022, the Company sold 7,065,946 shares of its common stock, and in lieu of shares of common stock, pre-funded warrants exercisable
for 543,933 shares of common stock, and accompanying warrants to purchase 7,609,879 shares of its common stock to a group of new and
existing institutional investors in a private placement. The offering price for each share of common stock and accompanying warrant was
$4.60, and the offering price for each pre-funded warrant and accompanying warrant was $4.59, which equaled the offering price per share
of the common stock and accompanying warrant, less the $0.01 per share exercise price of each pre-funded warrant. Each accompanying warrant
represents the right to purchase one share of the Company’s common stock at an exercise price of $4.75 per share of common stock.
The pre-funded warrants were exercised in December 2022 and converted to 543,933 shares of commons stock. Total shares sold and converted
during the year ended December 31, 2022 were 7,609,879 for an aggregate purchase price of $35.0 million gross, or $32.6 million net of
related costs of $1.5 million which was expensed to general and administrative expenses and $0.9 million which was recorded as a reduction
to additional paid-in-capital. The net proceeds were allocated to the warrant liability as noted below with the remainder of $12.9 million
and $0.1 million recorded in additional paid-in capital and common stock, respectively.
In
the event of certain fundamental transactions involving the Company, the holders of the stock purchase warrants may require the Company
to make a payment based on a Black-Scholes valuation, using specific inputs that are not considered indexed to the Company’s stock
in accordance with ASC 815. Therefore, the Company accounted for the stock purchase warrants as liabilities. The stock purchase warrants
were recorded at the closing date fair value of $22.0 million which was based on a Black-Scholes option pricing model. The remainder
of the proceeds were allocated to common stock issued and recorded as a component of equity.
As
of June 30, 2023, there were 7,609,879 warrants outstanding related to this private placement offering. The warrants expire on November
3, 2027. During such time as each warrant is outstanding, the holder of the warrant is entitled to participate in any dividends or other
distribution of assets to holders of shares of common stock.
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- DefinitionThe entire disclosure for equity.
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v3.23.2
STOCK-BASED COMPENSATION
|
6 Months Ended |
Jun. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
STOCK-BASED COMPENSATION |
NOTE
10 – STOCK-BASED COMPENSATION
The
Company previously granted stock options under its 2005 Equity Incentive Plan (the “2005 Incentive Plan”), under which no
further grants can be made. In addition, prior to May 17, 2023, the Company had previously granted stock options and stock awards under
the Abeona Therapeutics Inc. 2015 Equity Incentive Plan (the “2015 Incentive Plan”). As of May 17, 2023, no further grants
can be made under the 2015 Incentive Plan. The Company now grants stock options and stock awards under the Abeona Therapeutics Inc. 2023
Equity Incentive Plan (the “2023 Incentive Plan”) which was approved by stockholders on May 17, 2023. As of June 30, 2023,
there were 149,291 shares available to be granted under the 2023 Incentive Plan. In addition, in 2023, the Company’s board of directors
approved various restricted stock awards to be granted to six new hires as inducement grants (“Inducement Grants”).
The
following table summarizes stock-based compensation expense for the three and six months ended June 30, 2023 and 2022 (in thousands):
SCHEDULE
OF STOCK BASED COMPENSATION
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For the three months ended June 30, | | |
For the six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 218 | | |
$ | 184 | | |
$ | 404 | | |
$ | 556 | |
General and administrative | |
| 709 | | |
| 540 | | |
| 1,293 | | |
| 1,030 | |
Total stock-based compensation expense | |
$ | 927 | | |
$ | 724 | | |
$ | 1,697 | | |
$ | 1,586 | |
Stock
Options
The
Company estimates the fair value of each option award on the date of grant using the Black-Scholes option valuation model. The Company
then recognize the grant date fair value of each option as compensation expense ratably using the straight-line attribution method over
the service period (generally the vesting period). The Black-Scholes model incorporates the following assumptions:
|
● |
Expected
volatility – the Company estimates the volatility of the share price at the date of grant using a “look-back” period
which coincides with the expected term, defined below. The Company believes using a “look-back” period which coincides
with the expected term is the most appropriate measure for determining expected volatility. |
|
|
|
|
● |
Expected
term – the Company estimates the expected term using the “simplified” method, as outlined in SEC Staff Accounting
Bulletin No. 107, “Share-Based Payment.” |
|
|
|
|
● |
Risk-free
interest rate – the Company estimates the risk-free interest rate using the U.S. Treasury yield curve for periods equal to
the expected term of the options in effect at the time of grant. |
|
|
|
|
● |
Dividends
– the Company uses an expected dividend yield of zero because the Company has not declared nor paid a cash dividend, nor are
there any plans to declare a dividend. |
The
Company estimated the fair value of stock options granted in the periods presented utilizing a Black-Scholes option-valuation model utilizing
the following assumptions:
SCHEDULE
OF WEIGHTED-AVERAGE ASSUMPTIONS TO ESTIMATE THE FAIR VALUE OF THE OPTIONS GRANTED
| |
For the six months ended June 30, | |
| |
2023* | | |
2022 | |
| |
| | |
| |
Expected volatility | |
| n/a | | |
| 95.1% - 96.0% | |
Expected term | |
| n/a | | |
| 6.07 - 6.08 years | |
Risk-free interest rate | |
| n/a | | |
| 1.7% - 3.3% | |
Expected dividend yield | |
| n/a | | |
| 0% | |
* the Company did not grant any stock options in the six months ended June 30, 2023.
The
following table summarizes stock option activity for the 2015 Incentive Plan and the 2005 Incentive Plan during the six months ended
June 30, 2023 (there were no stock options granted under the 2023 Incentive Plan during the six months ended June 30, 2023):
SCHEDULE
OF STOCK OPTIONS ACTIVITY
| |
| | |
| | |
Weighted Average | | |
| |
| |
| | |
Weighted | | |
Remaining | | |
Aggregate | |
| |
Number of | | |
Average | | |
Contractual Term | | |
Intrinsic Value | |
| |
Options | | |
Exercise Price | | |
(years) | | |
(in thousands) | |
| |
| | |
| | |
| | |
| |
Outstanding at December 31, 2022 | |
| 240,770 | | |
$ | 37.04 | | |
| 6.42 | | |
$ | — | |
Granted | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Cancelled/forfeited | |
| (10,047 | ) | |
$ | 36.19 | | |
| — | | |
$ | — | |
Exercised | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Outstanding at June 30, 2023 | |
| 230,723 | | |
$ | 37.08 | | |
| 5.82 | | |
$ | — | |
Exercisable | |
| 169,637 | | |
$ | 36.33 | | |
| 5.09 | | |
$ | — | |
Unvested | |
| 61,086 | | |
$ | 39.17 | | |
| 7.87 | | |
$ | — | |
The
aggregate intrinsic value of options is calculated as the difference between the exercise price of the underlying options and the fair
value of the Company’s common stock for those options that had exercise prices lower than the fair value of the Company’s
common stock. As of June 30, 2023, the total compensation cost related to non-vested option awards not yet recognized was approximately
$2.0 million with a weighted average remaining vesting period of 1.7 years.
Restricted
Stock
The
following table summarizes restricted stock award activity for the 2023 Incentive Plan, 2015 Incentive Plan and Inducement Grants during
the six months ended June 30, 2023:
SCHEDULE
OF RESTRICTED STOCK AWARD ACTIVITY
| |
| | |
Weighted Average | |
| |
| | |
Grant Date Fair | |
| |
Number of Awards | | |
Value Per Unit | |
| |
| | |
| |
Outstanding at December 31, 2022 | |
| 816,958 | | |
$ | 5.35 | |
Granted | |
| 1,817,559 | | |
$ | 3.96 | |
Cancelled/forfeited | |
| (46,394 | ) | |
$ | 4.40 | |
Vested | |
| (21,820 | ) | |
$ | 28.34 | |
Outstanding at June 30, 2023 | |
| 2,566,303 | | |
$ | 4.18 | |
As
of June 30, 2023, there was approximately $9.7 million of total unrecognized compensation expense related to unvested restricted stock
awards, which is expected to be recognized over a weighted average vesting period of 2.5 years. The total fair value of restricted stock
awards that vested during the six months ended June 30, 2023 was $0.6 million.
|
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v3.23.2
LICENSE/SUPPLIER AGREEMENT
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
LICENSE/SUPPLIER AGREEMENT |
NOTE
11 – LICENSE/SUPPLIER AGREEMENT
Sublicense
Agreement Relating to Rett Syndrome:
In
October 2020, the Company entered into a sublicense agreement with Taysha Gene Therapies (“Taysha”)
for a gene therapy for Rett syndrome and MECP2 gene constructs and regulation of their expression. The agreement grants Taysha
worldwide exclusive rights to intellectual property developed by scientists at the University of North Carolina at Chapel Hill, the University
of Edinburgh and the Company, and the Company’s know-how relating to the research, development, and manufacture of the gene therapy
for Rett syndrome and MECP2 gene constructs and regulation of their expression.
The
transaction price of the contract includes (i) $3.0
million of fixed consideration, (ii) up to $26.5
million of variable consideration in the form of event-based milestone payments, (iii) up to $30.0
million of variable consideration in the form of sales-based milestone payments, and (iv) other royalty-based payments based on net
sales. The event-based milestone payments are based on certain development and regulatory events occurring. The Company evaluated
whether the milestone conditions have been achieved and if it is probable that a significant revenue reversal would not occur before
recognizing the associated revenue. The Company determined that these milestone payments are not within the Company’s control
or the licensee’s control, such as regulatory approvals, and are not considered probable of being achieved until those
approvals are received. Accordingly, the Company has fully constrained the $26.5
million of event-based milestone payments until such time that it is probable that a significant revenue reversal would not occur.
The sales-based milestone payments and other royalty-based payments are based on a level of sales for which the license is deemed to
be the predominant item to which the royalties relate. The Company will recognize revenue for these payments at the later of (i)
when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has
been satisfied or partially satisfied. To date, the Company has not recognized any sales-based or royalty revenue resulting from
this licensing arrangement.
Under
this arrangement, the Company recognized $3.5 million and $1.0 million in revenue during the three and six months ended June 30, 2023
and 2022, respectively based on event-based-milestone payments. As of June 30, 2023 and December 31, 2022, the Company had $3.5 million
and nil in contract assets included in accounts receivable on the Company’s condensed consolidated balance sheet, respectively.
As of June 30, 2023 and December 31, 2022, the Company had $1.6 million and nil in contract liabilities included in accounts payable
on the Company’s condensed consolidated balance sheet, respectively, as a result of this transaction.
Ultragenyx
License Agreement
On
May 16, 2022, the Company and Ultragenyx Pharmaceutical Inc. (“Ultragenyx”) entered into an exclusive license agreement (the
“License Agreement”) for AAV gene therapy ABO-102 for the treatment of Sanfilippo syndrome type A (MPS IIIA). Under the License
Agreement, Ultragenyx assumed responsibility for the ABO-102 program from the Company, with the exclusive right to develop, manufacture,
and commercialize ABO-102 worldwide. Also pursuant to the License Agreement, following regulatory approval, the Company is eligible to
receive tiered royalties from mid-single-digit up to 10% on net sales and up to $30.0 million in commercial milestone payments. Both
forms of consideration comprise the transaction price to which the Company expects to be entitled in exchange for transferring the related
intellectual property and certain, contractually-specified, transition services to Ultragenyx. The sales-based royalty and milestone
payments are subject to the royalty recognition constraint. As such, these fees are not recognized as revenue until the later of: (a)
the occurrence of the subsequent sale, and (b) the performance obligation to which they relate has been satisfied.
Additionally,
pursuant to the License Agreement, Ultragenyx will reimburse the Company for certain development and transition costs actually incurred
by the Company. These costs are passed through to Ultragenyx without mark-up. The Company has determined that these costs are not incurred
for the purpose of satisfying any performance obligation under the License Agreement. Accordingly, the reimbursement of these costs is
recognized as a reduction of research and development costs. There were no amounts due to the Company from Ultragenyx under the License
Agreement as of June 30, 2023 and December 31, 2022, respectively.
|
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v3.23.2
SUBSEQUENT EVENTS
|
6 Months Ended |
Jun. 30, 2023 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE
12 – SUBSEQUENT EVENTS
On
July 3, 2023, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with certain existing institutional
investors relating to the issuance and sale of an aggregate of (a) 3,284,407 shares of the Company’s common stock (the “Shares”),
and (b) pre-funded warrants to purchase 2,919,140 shares of the Company’s common stock (the “2023 Pre-Funded Warrants”)
to certain of such investors (the “Offering”). On July 6, 2023, the Shares were sold to the investors at an offering price
of $4.03 per share for $25.0 million with net proceeds of $23.0 million after offering costs. The 2023 Pre-Funded Warrants were sold
to certain of the investors at an offering price of $4.0299 per 2023 Pre-Funded Warrant, which represents the per share offering price
for the Company’s common stock less a $0.0001 per share exercise price for each such 2023 Pre-Funded Warrant. The 2023 Pre-Funded
Warrants are immediately exercisable at a nominal exercise price of $0.0001 per share and may be exercised at any time until the 2023
Pre-Funded Warrants are exercised in full.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.23.2
NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Reverse Stock Split |
Reverse
Stock Split
As
described in Note 1 to the consolidated financial statements included in the Company’s 2022 Annual Report on Form 10-K/A, on June
30, 2022, the Company filed a Certificate of Amendment to the Company’s Restated Certificate of Incorporation with the Secretary
of State of the State of Delaware (the “Certificate of Amendment”), to effectuate a reverse stock split of the Company’s
outstanding common stock, par value $0.01 per share (“Common Stock”), at an exchange ratio of 25-to-1 (the “Reverse
Stock Split”). The Reverse Stock Split was effective on July 1, 2022. The number of authorized shares of Common Stock immediately
after the Reverse Stock Split (“New Common Stock”) remained at 200,000,000 shares. All share and per share information has
been retroactively adjusted to give effect to the Reverse Stock Split for all periods presented, unless otherwise indicated.
|
Uses and Sources of Liquidity |
Uses
and Sources of Liquidity
The
unaudited interim condensed consolidated financial statements have been prepared on the going concern basis, which assumes the Company
will have sufficient cash to pay its operating expenses, as and when they become payable, for a period of at least 12 months from the
date the financial report is issued.
As
of June 30, 2023, the Company had cash, cash equivalents, restricted cash and short-term investments of $37.1 million. For the six months
ended June 30, 2023, the Company had cash outflows from operations of $22.0 million. The Company has not generated significant revenues
and has not achieved profitable operations. There is no assurance that profitable operations will ever be achieved, and, if achieved,
could be sustained on a continuing basis. In addition, development activities, clinical and nonclinical testing, and commercialization
of the Company’s product candidates will require significant additional financing.
The
Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the
successful discovery and development of product candidates, obtaining the necessary regulatory approval to market the Company’s
product candidates, raising additional capital to continue to fund the Company’s operations, development of competing drugs and
therapies and protection of proprietary technology. As a result of these and other risks and the related uncertainties, there can be
no assurance of the Company’s future success.
Subsequent
to June 30, 2023, as described in Note 12, the Company raised $25.0 million, with net proceeds
of $23.0 million, after offering costs through the issuance of common stock and warrants.
The
Company believes that its current cash and cash equivalents, restricted cash and short-term investments are sufficient resources to fund
operations through at least the next 12 months from the date of this quarterly report on Form 10-Q. The Company may need to secure additional
funding to carry out all of its planned research and development and commercialization activities. If the Company is unable to obtain
additional financing or generate license or product revenue, the lack of liquidity and sufficient capital resources could have a material
adverse effect on its future prospects.
|
Use of Estimates |
Use
of Estimates
The
preparation of unaudited interim condensed consolidated financial statements in conformity with U.S. GAAP requires management to make
estimates and assumptions that affect the reported amount of assets and disclosure of contingent assets and liabilities at the date of
the unaudited interim condensed consolidated financial statements and the reported amounts of revenue and expenses during the reported
period. Actual results could differ from these estimates and assumptions.
|
Other receivables |
Other
receivables
Other
receivables include employee retention credits (“ERC”), sublease rent receivables and other miscellaneous receivables. As
of June 30, 2023 and December 31, 2022, the Company had ERC receivables of $2.1 million and nil, respectively.
|
Summary of Significant Accounting Policies |
Summary
of Significant Accounting Policies
There
have been no new, anticipated or material changes to the significant accounting policies disclosed in the Company’s Annual Report
on Form 10-K/A for the year ended December 31, 2022.
|
Correction of Error |
Correction
of Error
During
the fourth quarter of 2022, the Company identified errors in the accounting for certain common stock warrants that were issued in 2021.
The common stock warrants were not indexed to the Company’s own stock and therefore should have been classified as liabilities
at their estimated fair value instead of additional paid-in capital. Although the errors were immaterial to prior periods, the 2021 financial
statements were restated in accordance with Staff Accounting Bulletin No. 108, “Considering the Effects of Prior Year Misstatements
when Quantifying Misstatements in Current Year Financial Statements”, due to the significance of the out-of-period correction to
the 2021 period. There was no impact to the Company’s consolidated statements of operations and comprehensive loss for 2021. The
correction of the error resulted in the Company adjusting its quarterly information presented for the three and six months ended June
30, 2022. The matter was correctly presented in the fiscal year end December 31, 2022 consolidated financial statements included in the
Company’s 2022 Annual Report on Form 10-K/A.
The
following tables present the effects of the correction of the prior period error to the condensed consolidated statement of operations
and comprehensive loss (in thousands, except for per share data):
SCHEDULE
OF EFFECTS OF THE RESTATEMENT TO AMOUNTS IN THE PREVIOUSLY REPORTED CONSOLIDATED FINANCIAL STATEMENTS
| |
| | |
| | |
| |
| |
For the three months ended June 30, 2022 | |
Condensed Consolidated Statement of Operations and Comprehensive Loss | |
As Reported | | |
Adjustment | | |
As Revised | |
| |
| | |
| | |
| |
Change in fair value of warrant liabilities | |
$ | — | | |
$ | 4,198 | | |
$ | 4,198 | |
Net loss | |
$ | (8,295 | ) | |
$ | 4,198 | | |
$ | (4,097 | ) |
Net loss attributable to Common Shareholders | |
$ | (12,077 | ) | |
$ | 4,198 | | |
$ | (7,879 | ) |
Basic and diluted loss per common share | |
$ | (2.08 | ) | |
$ | 0.72 | | |
$ | (1.36 | ) |
Comprehensive loss | |
$ | (12,081 | ) | |
$ | 4,198 | | |
$ | (7,883 | ) |
| |
| | |
| | |
| |
| |
For the six months ended June 30, 2022 | |
Condensed Consolidated Statement of Operations and Comprehensive Loss | |
As Reported | | |
Adjustment | | |
As Revised | |
| |
| | |
| | |
| |
Change in fair value of warrant liabilities | |
$ | — | | |
$ | 2,945 | | |
$ | 2,945 | |
Net loss | |
$ | (29,086 | ) | |
$ | 2,945 | | |
$ | (26,141 | ) |
Net loss attributable to Common Shareholders | |
$ | (32,868 | ) | |
$ | 2,945 | | |
$ | (29,923 | ) |
Basic and diluted loss per common share | |
$ | (5.67 | ) | |
$ | 0.51 | | |
$ | (5.16 | ) |
Comprehensive loss | |
$ | (32,875 | ) | |
$ | 2,945 | | |
$ | (29,930 | ) |
The
following tables present the effects of the correction of the prior period error to the condensed consolidated cash flow statement (in
thousands):
| |
For the six months ended June 30, 2022 | |
Condensed Consolidated Cash Flow Statement | |
As Reported | | |
Adjustment | | |
As Revised | |
| |
| | |
| | |
| |
Net loss | |
$ | (29,086 | ) | |
$ | 2,945 | | |
$ | (26,141 | ) |
Adjustments to reconcile net loss to cash used in operating activities: | |
| | | |
| | | |
| | |
Change in fair value of warrant liabilities | |
$ | — | | |
$ | (2,945 | ) | |
$ | (2,945 | ) |
Net cash provided by operating activities | |
$ | (22,700 | ) | |
$ | — | | |
$ | (22,700 | ) |
The
following tables present the effects of the correction of the prior period error to the condensed consolidated statement of stockholders’
equity (in thousands):
| |
As of June 30, 2022 | |
Condensed Consolidated Statement of Stockholders’ Equity | |
As Reported | | |
Adjustment | | |
As Revised | |
| |
| | |
| | |
| |
Additional paid-in capital, December 31, 2021 | |
$ | 705,570 | | |
$ | (9,007 | ) | |
$ | 696,563 | |
Total stockholders’ equity, December 31, 2021 | |
$ | 51,375 | | |
$ | (9,007 | ) | |
$ | 42,368 | |
Additional paid-in capital, March 31, 2022 | |
$ | 706,433 | | |
$ | (9,007 | ) | |
$ | 697,426 | |
Additional paid-in capital, March 31, 2022 | |
$ | 31,443 | | |
$ | (10,260 | ) | |
$ | 21,183 | |
Net loss | |
$ | (29,086 | ) | |
$ | 2,945 | | |
$ | (26,141 | ) |
Additional paid-in capital, June 30, 2022 | |
$ | 703,379 | | |
$ | (9,007 | ) | |
$ | 694,372 | |
Total stockholders’ equity, June 30, 2022 | |
$ | 20,086 | | |
$ | (6,062 | ) | |
$ | 14,024 | |
|
Net Loss Per Share |
Net
Loss Per Share
Basic
and diluted net loss per share is computed by dividing net loss attributable to common shareholders by the weighted-average number of
shares of common stock. The Company does not include the potential impact of dilutive securities in diluted net loss per share, as the
impact of these items is anti-dilutive. Potential dilutive securities result from outstanding restricted stock, stock options, and stock
purchase warrants.
The
following table sets forth the potential securities that could potentially dilute basic income/(loss) per share in the future that were
not included in the computation of diluted net loss per share because to do so would have been anti-dilutive for the periods presented:
SCHEDULE
OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE
| |
For the three and six months ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Stock options | |
| 230,723 | | |
| 265,411 | |
Restricted stock | |
| 2,566,303 | | |
| 61,108 | |
Warrants | |
| 9,397,879 | | |
| 1,788,000 | |
Total | |
| 12,194,905 | | |
| 2,114,519 | |
|
New Accounting Pronouncements |
New
Accounting Pronouncements
No
new accounting pronouncement issued or effective had, or is expected to have, a material impact on the Company’s condensed consolidated
financial statements.
|
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v3.23.2
NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
SCHEDULE OF EFFECTS OF THE RESTATEMENT TO AMOUNTS IN THE PREVIOUSLY REPORTED CONSOLIDATED FINANCIAL STATEMENTS |
The
following tables present the effects of the correction of the prior period error to the condensed consolidated statement of operations
and comprehensive loss (in thousands, except for per share data):
SCHEDULE
OF EFFECTS OF THE RESTATEMENT TO AMOUNTS IN THE PREVIOUSLY REPORTED CONSOLIDATED FINANCIAL STATEMENTS
| |
| | |
| | |
| |
| |
For the three months ended June 30, 2022 | |
Condensed Consolidated Statement of Operations and Comprehensive Loss | |
As Reported | | |
Adjustment | | |
As Revised | |
| |
| | |
| | |
| |
Change in fair value of warrant liabilities | |
$ | — | | |
$ | 4,198 | | |
$ | 4,198 | |
Net loss | |
$ | (8,295 | ) | |
$ | 4,198 | | |
$ | (4,097 | ) |
Net loss attributable to Common Shareholders | |
$ | (12,077 | ) | |
$ | 4,198 | | |
$ | (7,879 | ) |
Basic and diluted loss per common share | |
$ | (2.08 | ) | |
$ | 0.72 | | |
$ | (1.36 | ) |
Comprehensive loss | |
$ | (12,081 | ) | |
$ | 4,198 | | |
$ | (7,883 | ) |
| |
| | |
| | |
| |
| |
For the six months ended June 30, 2022 | |
Condensed Consolidated Statement of Operations and Comprehensive Loss | |
As Reported | | |
Adjustment | | |
As Revised | |
| |
| | |
| | |
| |
Change in fair value of warrant liabilities | |
$ | — | | |
$ | 2,945 | | |
$ | 2,945 | |
Net loss | |
$ | (29,086 | ) | |
$ | 2,945 | | |
$ | (26,141 | ) |
Net loss attributable to Common Shareholders | |
$ | (32,868 | ) | |
$ | 2,945 | | |
$ | (29,923 | ) |
Basic and diluted loss per common share | |
$ | (5.67 | ) | |
$ | 0.51 | | |
$ | (5.16 | ) |
Comprehensive loss | |
$ | (32,875 | ) | |
$ | 2,945 | | |
$ | (29,930 | ) |
The
following tables present the effects of the correction of the prior period error to the condensed consolidated cash flow statement (in
thousands):
| |
For the six months ended June 30, 2022 | |
Condensed Consolidated Cash Flow Statement | |
As Reported | | |
Adjustment | | |
As Revised | |
| |
| | |
| | |
| |
Net loss | |
$ | (29,086 | ) | |
$ | 2,945 | | |
$ | (26,141 | ) |
Adjustments to reconcile net loss to cash used in operating activities: | |
| | | |
| | | |
| | |
Change in fair value of warrant liabilities | |
$ | — | | |
$ | (2,945 | ) | |
$ | (2,945 | ) |
Net cash provided by operating activities | |
$ | (22,700 | ) | |
$ | — | | |
$ | (22,700 | ) |
The
following tables present the effects of the correction of the prior period error to the condensed consolidated statement of stockholders’
equity (in thousands):
| |
As of June 30, 2022 | |
Condensed Consolidated Statement of Stockholders’ Equity | |
As Reported | | |
Adjustment | | |
As Revised | |
| |
| | |
| | |
| |
Additional paid-in capital, December 31, 2021 | |
$ | 705,570 | | |
$ | (9,007 | ) | |
$ | 696,563 | |
Total stockholders’ equity, December 31, 2021 | |
$ | 51,375 | | |
$ | (9,007 | ) | |
$ | 42,368 | |
Additional paid-in capital, March 31, 2022 | |
$ | 706,433 | | |
$ | (9,007 | ) | |
$ | 697,426 | |
Additional paid-in capital, March 31, 2022 | |
$ | 31,443 | | |
$ | (10,260 | ) | |
$ | 21,183 | |
Net loss | |
$ | (29,086 | ) | |
$ | 2,945 | | |
$ | (26,141 | ) |
Additional paid-in capital, June 30, 2022 | |
$ | 703,379 | | |
$ | (9,007 | ) | |
$ | 694,372 | |
Total stockholders’ equity, June 30, 2022 | |
$ | 20,086 | | |
$ | (6,062 | ) | |
$ | 14,024 | |
|
SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE |
SCHEDULE
OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE
| |
For the three and six months ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Stock options | |
| 230,723 | | |
| 265,411 | |
Restricted stock | |
| 2,566,303 | | |
| 61,108 | |
Warrants | |
| 9,397,879 | | |
| 1,788,000 | |
Total | |
| 12,194,905 | | |
| 2,114,519 | |
|
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v3.23.2
SHORT-TERM INVESTMENTS (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Investments, Debt and Equity Securities [Abstract] |
|
SCHEDULE OF AVAILABLE FOR SALE SHORT-TERM INVESTMENTS |
The
following table provides a summary of the short-term investments (in thousands):
SCHEDULE
OF AVAILABLE FOR SALE SHORT-TERM INVESTMENTS
| |
June 30, 2023 | |
| |
Amortized Cost | | |
Gross
Unrealized Gain | | |
Gross
Unrealized Loss | | |
Fair Value | |
| |
| | |
| | |
| | |
| |
Available-for-sale, short-term investments: | |
| | | |
| | | |
| | | |
| | |
U.S. treasury and federal agency securities | |
$ | 30,613 | | |
| — | | |
| (66 | ) | |
$ | 30,547 | |
Total available-for-sale, short-term investments | |
$ | 30,613 | | |
| — | | |
| (66 | ) | |
$ | 30,547 | |
| |
December 31, 2022 | |
| |
Amortized Cost | | |
Gross
Unrealized Gain | | |
Gross
Unrealized Loss | | |
Fair Value | |
| |
| | |
| | |
| | |
| |
Available-for-sale, short-term investments: | |
| | | |
| | | |
| | | |
| | |
U.S. treasury and federal agency securities | |
$ | 38,032 | | |
| — | | |
| (100 | ) | |
$ | 37,932 | |
Total available-for-sale, short-term investments | |
$ | 38,032 | | |
| — | | |
| (100 | ) | |
$ | 37,932 | |
|
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v3.23.2
PROPERTY AND EQUIPMENT, NET (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
SCHEDULE OF PROPERTY AND EQUIPMENT |
Property
and equipment are stated at cost and depreciated or amortized using the straight-line method based on useful lives as follows (in thousands):
SCHEDULE OF PROPERTY AND EQUIPMENT
| |
Useful lives (years) | |
June 30, 2023 | | |
December 31, 2022 | |
| |
| |
| | |
| |
Laboratory equipment | |
5 | |
$ | 7,276 | | |
$ | 7,636 | |
Furniture, software and office equipment | |
3 to 5 | |
| 991 | | |
| 1,379 | |
Leasehold improvements | |
Shorter of remaining lease term or useful life | |
| 8,603 | | |
| 8,605 | |
Subtotal | |
| |
| 16,870 | | |
| 17,620 | |
Less: accumulated depreciation | |
| |
| (12,381 | ) | |
| (11,879 | ) |
Total property and equipment, net | |
| |
$ | 4,489 | | |
$ | 5,741 | |
|
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v3.23.2
FAIR VALUE MEASUREMENTS (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS |
The
following table provides a summary of financial assets measured at fair value on a recurring and non-recurring basis as of June 30, 2023
and December 31, 2022 (in thousands):
SCHEDULE
OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS
Description | |
Fair Value at
June 30, 2023 | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Recurring Assets | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
| | | |
| | | |
| | | |
| | |
Money market fund | |
$ | 5,678 | | |
$ | 5,678 | | |
$ | — | | |
$ | — | |
Short-term investments | |
| | | |
| | | |
| | | |
| | |
U.S. treasury and federal agency securities | |
| 30,547 | | |
| — | | |
| 30,547 | | |
| — | |
Total assets measured at fair value | |
$ | 36,225 | | |
$ | 5,678 | | |
$ | 30,547 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Warrant liabilities | |
$ | 26,021 | | |
| — | | |
| — | | |
$ | 26,021 | |
Total liabilities measured at fair value | |
$ | 26,021 | | |
$ | — | | |
$ | — | | |
$ | 26,021 | |
Description | |
Fair Value at
December 31, 2022 | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Recurring Assets: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
| | | |
| | | |
| | | |
| | |
Money market fund | |
$ | 12,923 | | |
$ | 12,923 | | |
$ | — | | |
$ | — | |
Short-term investments | |
| | | |
| | | |
| | | |
| | |
U.S. treasury and federal agency securities | |
| 37,932 | | |
| — | | |
| 37,932 | | |
| — | |
Total assets measured at fair value | |
$ | 50,855 | | |
$ | 12,923 | | |
$ | 37,932 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Warrant liabilities | |
$ | 19,657 | | |
| — | | |
| — | | |
$ | 19,657 | |
Total liabilities measured at fair value | |
$ | 19,657 | | |
$ | — | | |
$ | — | | |
$ | 19,657 | |
|
SCHEDULE OF ESTIMATE FAIR VALUE OF WARRANTS |
SCHEDULE
OF ESTIMATE FAIR VALUE OF WARRANTS
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
| | |
| |
Common share price | |
| $4.03 | | |
| $3.08 | |
Expected term (years) | |
| 3.47 – 4.35 | | |
| 3.96 – 4.84 | |
Risk-free interest rate (%) | |
| 4.13% – 4.28% | | |
| 3.91% – 4.01% | |
Volatility (%) | |
| 100.00% – 105.04% | | |
| 102.40% – 107.55% | |
|
SCHEDULE OF ACTIVITY OF WARRANT LIABILITIES |
The
following table provides a summary of the activity on the warrant liabilities (in thousands):
SCHEDULE
OF ACTIVITY OF WARRANT LIABILITIES
| |
| | |
Warrant liabilities as of December 31, 2022 | |
$ | 19,657 | |
Loss recognized in earnings from change in fair value | |
| 6,364 | |
Warrant liabilities as of June 30, 2023 | |
$ | 26,021 | |
|
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v3.23.2
ACCRUED EXPENSES (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Payables and Accruals [Abstract] |
|
SCHEDULE OF ACCRUED EXPENSES |
The
following table provides a summary of the components of accrued expenses (in thousands):
SCHEDULE OF ACCRUED EXPENSES
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
| | |
| |
Accrued employee compensation | |
$ | 1,434 | | |
$ | 2,593 | |
Accrued contracted services and other | |
| 2,727 | | |
| 1,398 | |
Total accrued expenses | |
$ | 4,161 | | |
$ | 3,991 | |
|
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v3.23.2
LEASES (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Leases |
|
SCHEDULE OF COMPONENTS OF LEASE COST |
The
following table provides a summary of the components of lease costs and rent (in thousands):
SCHEDULE OF COMPONENTS OF LEASE COST
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For the three months ended June 30, | | |
For the six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Operating lease cost | |
$ | 353 | | |
$ | 461 | | |
$ | 708 | | |
$ | 933 | |
Variable lease cost | |
| 116 | | |
| 116 | | |
| 215 | | |
| 212 | |
Short-term lease cost | |
| 13 | | |
| 20 | | |
| 31 | | |
| 41 | |
Total operating lease costs | |
$ | 482 | | |
$ | 597 | | |
$ | 954 | | |
$ | 1,186 | |
|
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES |
Future
minimum lease payments and obligations, which do not include short-term leases, of the Company’s operating lease liabilities as
of June 30, 2023 were as follows (in thousands):
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES
Future minimum lease payments and obligations | |
Operating Leases | |
| |
| | |
2023, remainder | |
$ | 799 | |
2024 | |
| 993 | |
2025 | |
| 1,552 | |
2026 | |
| 791 | |
2027 | |
| 807 | |
Thereafter | |
| 2,516 | |
Total undiscounted operating lease payments | |
| 7,458 | |
Less: imputed interest | |
| 1,484 | |
Present value of operating lease liabilities | |
$ | 5,974 | |
|
SCHEDULE OF FUTURE CASH RECEIPTS FROM OPERATING SUBLEASE |
Future
cash receipts from the Company’s sublease agreements as of June 30, 2023 are as follows (in thousands):
SCHEDULE OF FUTURE CASH RECEIPTS FROM OPERATING SUBLEASE
| |
Operating | |
Future cash receipts | |
Subleases | |
| |
| | |
2023, remainder | |
$ | 270 | |
2024 | |
| 634 | |
2025 | |
| 485 | |
Total future cash receipts | |
$ | 1,389 | |
|
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v3.23.2
STOCK-BASED COMPENSATION (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
SCHEDULE OF STOCK BASED COMPENSATION |
The
following table summarizes stock-based compensation expense for the three and six months ended June 30, 2023 and 2022 (in thousands):
SCHEDULE
OF STOCK BASED COMPENSATION
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For the three months ended June 30, | | |
For the six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 218 | | |
$ | 184 | | |
$ | 404 | | |
$ | 556 | |
General and administrative | |
| 709 | | |
| 540 | | |
| 1,293 | | |
| 1,030 | |
Total stock-based compensation expense | |
$ | 927 | | |
$ | 724 | | |
$ | 1,697 | | |
$ | 1,586 | |
|
SCHEDULE OF WEIGHTED-AVERAGE ASSUMPTIONS TO ESTIMATE THE FAIR VALUE OF THE OPTIONS GRANTED |
The
Company estimated the fair value of stock options granted in the periods presented utilizing a Black-Scholes option-valuation model utilizing
the following assumptions:
SCHEDULE
OF WEIGHTED-AVERAGE ASSUMPTIONS TO ESTIMATE THE FAIR VALUE OF THE OPTIONS GRANTED
| |
For the six months ended June 30, | |
| |
2023* | | |
2022 | |
| |
| | |
| |
Expected volatility | |
| n/a | | |
| 95.1% - 96.0% | |
Expected term | |
| n/a | | |
| 6.07 - 6.08 years | |
Risk-free interest rate | |
| n/a | | |
| 1.7% - 3.3% | |
Expected dividend yield | |
| n/a | | |
| 0% | |
|
SCHEDULE OF STOCK OPTIONS ACTIVITY |
The
following table summarizes stock option activity for the 2015 Incentive Plan and the 2005 Incentive Plan during the six months ended
June 30, 2023 (there were no stock options granted under the 2023 Incentive Plan during the six months ended June 30, 2023):
SCHEDULE
OF STOCK OPTIONS ACTIVITY
| |
| | |
| | |
Weighted Average | | |
| |
| |
| | |
Weighted | | |
Remaining | | |
Aggregate | |
| |
Number of | | |
Average | | |
Contractual Term | | |
Intrinsic Value | |
| |
Options | | |
Exercise Price | | |
(years) | | |
(in thousands) | |
| |
| | |
| | |
| | |
| |
Outstanding at December 31, 2022 | |
| 240,770 | | |
$ | 37.04 | | |
| 6.42 | | |
$ | — | |
Granted | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Cancelled/forfeited | |
| (10,047 | ) | |
$ | 36.19 | | |
| — | | |
$ | — | |
Exercised | |
| — | | |
$ | — | | |
| — | | |
$ | — | |
Outstanding at June 30, 2023 | |
| 230,723 | | |
$ | 37.08 | | |
| 5.82 | | |
$ | — | |
Exercisable | |
| 169,637 | | |
$ | 36.33 | | |
| 5.09 | | |
$ | — | |
Unvested | |
| 61,086 | | |
$ | 39.17 | | |
| 7.87 | | |
$ | — | |
|
SCHEDULE OF RESTRICTED STOCK AWARD ACTIVITY |
The
following table summarizes restricted stock award activity for the 2023 Incentive Plan, 2015 Incentive Plan and Inducement Grants during
the six months ended June 30, 2023:
SCHEDULE
OF RESTRICTED STOCK AWARD ACTIVITY
| |
| | |
Weighted Average | |
| |
| | |
Grant Date Fair | |
| |
Number of Awards | | |
Value Per Unit | |
| |
| | |
| |
Outstanding at December 31, 2022 | |
| 816,958 | | |
$ | 5.35 | |
Granted | |
| 1,817,559 | | |
$ | 3.96 | |
Cancelled/forfeited | |
| (46,394 | ) | |
$ | 4.40 | |
Vested | |
| (21,820 | ) | |
$ | 28.34 | |
Outstanding at June 30, 2023 | |
| 2,566,303 | | |
$ | 4.18 | |
|
X |
- DefinitionTabular disclosure of allocation of amount expensed and capitalized for award under share-based payment arrangement to statement of income or comprehensive income and statement of financial position. Includes, but is not limited to, corresponding line item in financial statement.
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v3.23.2
SCHEDULE OF EFFECTS OF THE RESTATEMENT TO AMOUNTS IN THE PREVIOUSLY REPORTED CONSOLIDATED FINANCIAL STATEMENTS (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
6 Months Ended |
|
|
|
|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Mar. 31, 2023 |
Dec. 31, 2022 |
Mar. 31, 2022 |
Dec. 31, 2021 |
Change in fair value of warrant liabilities |
$ (8,629)
|
$ 4,198
|
$ (6,364)
|
$ 2,945
|
|
|
|
|
Additional paid in capital |
(16,654)
|
(4,097)
|
(25,761)
|
(26,141)
|
|
|
|
|
Net loss attributable to Common Shareholders |
$ (16,654)
|
$ (7,879)
|
$ (25,761)
|
$ (29,923)
|
|
|
|
|
Net Loss per share - basic |
$ 0.92
|
$ 1.36
|
$ 1.48
|
$ 5.16
|
|
|
|
|
Net Loss per share - diluted |
$ 0.92
|
$ 1.36
|
$ 1.48
|
$ 5.16
|
|
|
|
|
Comprehensive loss |
$ (16,684)
|
$ (7,883)
|
$ (25,727)
|
$ (29,930)
|
|
|
|
|
Change in fair value of warrant liabilities |
8,629
|
(4,198)
|
6,364
|
(2,945)
|
|
|
|
|
Net cash provided by operating activities |
|
|
(22,028)
|
(22,700)
|
|
|
|
|
Additional paid in capital |
730,322
|
694,372
|
730,322
|
694,372
|
|
$ 722,049
|
$ 697,426
|
$ 696,563
|
Additional paid in capital |
$ 9,345
|
14,024
|
$ 9,345
|
14,024
|
$ 18,740
|
$ 26,761
|
21,183
|
42,368
|
Previously Reported [Member] |
|
|
|
|
|
|
|
|
Change in fair value of warrant liabilities |
|
|
|
|
|
|
|
|
Additional paid in capital |
|
(8,295)
|
|
(29,086)
|
|
|
|
|
Net loss attributable to Common Shareholders |
|
$ (12,077)
|
|
$ (32,868)
|
|
|
|
|
Net Loss per share - basic |
|
$ 2.08
|
|
$ 5.67
|
|
|
|
|
Net Loss per share - diluted |
|
$ 2.08
|
|
$ 5.67
|
|
|
|
|
Comprehensive loss |
|
$ (12,081)
|
|
$ (32,875)
|
|
|
|
|
Change in fair value of warrant liabilities |
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
|
(22,700)
|
|
|
|
|
Additional paid in capital |
|
703,379
|
|
703,379
|
|
|
706,433
|
705,570
|
Additional paid in capital |
|
20,086
|
|
20,086
|
|
|
31,443
|
51,375
|
Revision of Prior Period, Adjustment [Member] |
|
|
|
|
|
|
|
|
Change in fair value of warrant liabilities |
|
4,198
|
|
2,945
|
|
|
|
|
Additional paid in capital |
|
4,198
|
|
2,945
|
|
|
|
|
Net loss attributable to Common Shareholders |
|
$ 4,198
|
|
$ 2,945
|
|
|
|
|
Net Loss per share - basic |
|
$ 0.72
|
|
$ 0.51
|
|
|
|
|
Net Loss per share - diluted |
|
$ 0.72
|
|
$ 0.51
|
|
|
|
|
Comprehensive loss |
|
$ 4,198
|
|
$ 2,945
|
|
|
|
|
Change in fair value of warrant liabilities |
|
(4,198)
|
|
(2,945)
|
|
|
|
|
Net cash provided by operating activities |
|
|
|
|
|
|
|
|
Additional paid in capital |
|
(9,007)
|
|
(9,007)
|
|
|
(9,007)
|
(9,007)
|
Additional paid in capital |
|
$ (6,062)
|
|
$ (6,062)
|
|
|
$ (10,260)
|
$ (9,007)
|
X |
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v3.23.2
SCHEDULE OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE (Details) - shares
|
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
12,194,905
|
2,114,519
|
Stock Options [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
230,723
|
265,411
|
Restricted Stock [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
2,566,303
|
61,108
|
Warrant [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
9,397,879
|
1,788,000
|
X |
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v3.23.2
NATURE OF OPERATIONS AND SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands |
|
|
3 Months Ended |
6 Months Ended |
|
|
Jul. 06, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Jul. 01, 2022 |
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
Common stock, par value |
|
$ 0.01
|
$ 0.01
|
$ 0.01
|
$ 0.01
|
$ 0.01
|
|
Reverse stock split ratio |
|
exchange ratio of 25-to-1 (the “Reverse
Stock Split”)
|
|
|
|
|
|
Common stock, shares authorized |
|
|
200,000,000
|
200,000,000
|
|
200,000,000
|
200,000,000
|
Cash, cash equivalents, restricted cash and short-term investments |
|
|
$ 37,100
|
$ 37,100
|
|
|
|
Cash flow from operating activities |
|
|
|
22,028
|
$ 22,700
|
|
|
Stock issued during period, value, new issues |
|
|
6,367
|
6,623
|
|
|
|
Proceeds from issuance of common stock |
|
|
|
6,623
|
|
|
|
Other receivables |
|
|
$ 2,100
|
$ 2,100
|
|
|
|
Subsequent Event [Member] |
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
Stock issued during period, value, new issues |
$ 25,000
|
|
|
|
|
|
|
Proceeds from issuance of common stock |
$ 23,000
|
|
|
|
|
|
|
X |
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v3.23.2
SCHEDULE OF AVAILABLE FOR SALE SHORT-TERM INVESTMENTS (Details) - USD ($) $ in Thousands |
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Marketable Securities [Line Items] |
|
|
Amortized cost |
$ 30,613
|
$ 38,032
|
Gross Unrealized Gain |
|
|
Gross Unrealized Loss |
(66)
|
(100)
|
Fair Value |
30,547
|
37,932
|
US Treasury Securities [Member] |
|
|
Marketable Securities [Line Items] |
|
|
Amortized cost |
30,613
|
38,032
|
Gross Unrealized Gain |
|
|
Gross Unrealized Loss |
(66)
|
(100)
|
Fair Value |
$ 30,547
|
$ 37,932
|
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v3.23.2
SCHEDULE OF PROPERTY AND EQUIPMENT (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] |
|
|
Subtotal |
$ 16,870
|
$ 17,620
|
Less: accumulated depreciation |
(12,381)
|
(11,879)
|
Total property and equipment, net |
$ 4,489
|
5,741
|
Laboratory Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Useful lives (years) |
5 years
|
|
Subtotal |
$ 7,276
|
7,636
|
Furniture, Software and Office Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Subtotal |
$ 991
|
1,379
|
Furniture, Software and Office Equipment [Member] | Minimum [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Useful lives (years) |
3 years
|
|
Furniture, Software and Office Equipment [Member] | Maximum [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Useful lives (years) |
5 years
|
|
Leasehold Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Subtotal |
$ 8,603
|
$ 8,605
|
Property, Plant, and Equipment, Useful Life, Term, Description [Extensible Enumeration] |
Useful Life, Lease Term [Member]
|
|
X |
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v3.23.2
LICENSED TECHNOLOGY (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
May 15, 2015 |
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
|
Impairment of licensed technology |
|
|
|
$ 1,355,000
|
|
|
Remaining net value of licenced technology |
0
|
|
0
|
|
$ 0
|
|
License [Member] |
|
|
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
|
|
Finite-Lived Intangible Asset, Useful Life |
|
|
|
|
|
20 years
|
Amortization of licensed technology |
$ 0
|
$ 0
|
|
$ 29,000
|
|
|
X |
- DefinitionThe aggregate expense charged against earnings to allocate the cost of intangible assets (nonphysical assets not used in production) in a systematic and rational manner to the periods expected to benefit from such assets. As a noncash expense, this element is added back to net income when calculating cash provided by or used in operations using the indirect method.
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v3.23.2
SCHEDULE OF FAIR VALUE, ASSETS AND LIABILITIES MEASURED ON RECURRING AND NON-RECURRING BASIS (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Warrant liabilities |
$ 26,021
|
$ 19,657
|
Fair Value, Recurring [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total assets measured at fair value |
36,225
|
50,855
|
Total liabilities measured at fair value |
26,021
|
19,657
|
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total assets measured at fair value |
5,678
|
12,923
|
Total liabilities measured at fair value |
|
|
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total assets measured at fair value |
30,547
|
37,932
|
Total liabilities measured at fair value |
|
|
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total assets measured at fair value |
|
|
Total liabilities measured at fair value |
26,021
|
19,657
|
Fair Value, Recurring [Member] | Money Market Funds [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents fair value |
5,678
|
12,923
|
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents fair value |
5,678
|
12,923
|
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents fair value |
|
|
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents fair value |
|
|
Fair Value, Recurring [Member] | US Treasury Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Short-term investments fair value |
30,547
|
37,932
|
Fair Value, Recurring [Member] | US Treasury Securities [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Short-term investments fair value |
|
|
Fair Value, Recurring [Member] | US Treasury Securities [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Short-term investments fair value |
30,547
|
37,932
|
Fair Value, Recurring [Member] | US Treasury Securities [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Short-term investments fair value |
|
|
Fair Value, Recurring [Member] | Warrant Liabilities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Warrant liabilities |
26,021
|
19,657
|
Fair Value, Recurring [Member] | Warrant Liabilities [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Warrant liabilities |
|
|
Fair Value, Recurring [Member] | Warrant Liabilities [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Warrant liabilities |
|
|
Fair Value, Recurring [Member] | Warrant Liabilities [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Warrant liabilities |
$ 26,021
|
|
Fair Value, Recurring [Member] | Licensed Technology Net [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Warrant liabilities |
|
$ 19,657
|
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v3.23.2
FAIR VALUE MEASUREMENTS (Details Narrative) - $ / shares
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Dec. 21, 2021 |
Subsidiary, Sale of Stock [Line Items] |
|
|
|
Warrants purchase, shares |
|
|
1,788,000
|
Warrants exercise price |
|
|
$ 9.75
|
Private Placement [Member] |
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
Warrants purchase, shares |
7,609,879
|
|
|
Warrants exercise price |
$ 4.75
|
|
|
2021 Public Offering [Member] |
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
Warrants purchase, shares |
1,788,000
|
1,788,000
|
|
Warrants exercise price |
$ 9.75
|
$ 9.75
|
|
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- DefinitionExercise price per share or per unit of warrants or rights outstanding.
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v3.23.2
EQUITY (Details Narrative) - USD ($)
|
|
|
|
|
1 Months Ended |
6 Months Ended |
12 Months Ended |
Nov. 03, 2022 |
Jul. 01, 2022 |
Dec. 21, 2021 |
Aug. 17, 2018 |
Dec. 31, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
Reverse stock split ratio |
|
the Company’s stock underwent a 25:1 Reverse Stock Split
|
|
|
|
|
|
|
Common stock, shares authorized |
|
200,000,000
|
|
|
200,000,000
|
200,000,000
|
|
200,000,000
|
Shares issued |
|
|
1,788,000
|
|
|
|
|
|
Public offering price |
|
|
$ 9.75
|
|
|
|
|
|
Warrants purchase, shares |
|
|
1,788,000
|
|
|
|
|
|
Offering price |
|
|
$ 9.75
|
|
|
|
|
|
Proceeds from public offering |
|
|
$ 16,000,000.0
|
|
|
|
|
|
Stock issuance costs |
|
|
1,500,000
|
|
|
|
|
|
Additional paid-in capital |
|
|
7,000,000.0
|
|
|
|
|
|
Warrant liabilities |
|
|
$ 9,000,000.0
|
|
|
|
|
|
Warrants outstanding |
|
|
|
|
|
1,788,000
|
|
|
Warrants maturity date |
|
|
|
|
|
Dec. 21, 2026
|
|
|
Purchase price of common stock |
|
|
|
|
|
$ 6,623,000
|
|
|
Private Placement Offerings [Member] |
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
Shares issued |
7,065,946
|
|
|
|
|
|
|
|
Warrant liabilities |
$ 22,000,000.0
|
|
|
|
|
|
|
|
Warrants maturity date |
|
|
|
|
|
Nov. 03, 2027
|
|
|
Exercise price |
$ 4.75
|
|
|
|
|
|
|
|
Warrant outstanding |
|
|
|
|
|
$ 7,609,879
|
|
|
Private Placement Offerings [Member] | Pre Funded Warrant [Member] |
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
Offering price |
$ 0.01
|
|
|
|
|
|
|
|
Additional paid-in capital |
$ 100,000
|
|
|
|
|
|
|
|
Sale of stock |
|
|
|
|
|
|
|
7,609,879
|
Warrants exercised |
543,933
|
|
|
|
543,933
|
|
|
|
Purchase price of common stock |
|
|
|
|
|
|
|
$ 35,000,000.0
|
Additional paid in capital stock reduction |
|
|
|
|
|
|
|
900,000
|
Proceeds from warrant liability' |
$ 12,900,000
|
|
|
|
|
|
|
|
Private Placement Offerings [Member] | Pre Funded Warrant [Member] | General and Administrative Expense [Member] |
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
Stock issuance costs |
|
|
|
|
|
|
|
1,500,000
|
Private Placement Offerings [Member] | Common Stock And Accompanying Warrant [Member] |
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
Offering price |
$ 4.60
|
|
|
|
|
|
|
|
Private Placement Offerings [Member] | Pre Funded Warrant And Accompanying Warrant [Member] |
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
Offering price |
$ 4.59
|
|
|
|
|
|
|
|
Private Placement [Member] |
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
Warrants purchase, shares |
|
|
|
|
|
7,609,879
|
|
|
Offering price |
|
|
|
|
|
$ 4.75
|
|
|
Private Placement [Member] | Pre Funded Warrant [Member] |
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
Warrants purchase, shares |
7,609,879
|
|
|
|
|
|
|
|
ATM Agreement [Member] |
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
Sale of stock value |
|
|
|
|
|
$ 6,600,000
|
|
|
Sale of stock |
|
|
|
|
|
1,990,321
|
|
|
ATM Agreement [Member] | Jefferies LLC [Member] |
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
Sale of stock value |
|
|
|
$ 150,000,000.0
|
|
|
|
|
Private Placement Offerings [Member] | Pre Funded Warrant [Member] |
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
Purchase price of common stock |
|
|
|
|
|
|
|
$ 32,600,000
|
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v3.23.2
SCHEDULE OF STOCK BASED COMPENSATION (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock-based compensation expense |
$ 927
|
$ 724
|
$ 1,697
|
$ 1,586
|
Research and Development Expense [Member] |
|
|
|
|
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|
|
|
|
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|
184
|
404
|
556
|
General and Administrative Expense [Member] |
|
|
|
|
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|
|
|
|
Total stock-based compensation expense |
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|
$ 540
|
$ 1,293
|
$ 1,030
|
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v3.23.2
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v3.23.2
SCHEDULE OF STOCK OPTIONS ACTIVITY (Details) - 2015 and 2005 Equity Incentive Plan [Member] - USD ($)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Number of Options, Beginning balance |
240,770
|
|
Weighted Average Exercise Price, Beginning balance |
$ 37.04
|
|
Weighted Aaverage Remaining Contractual Term (years), Outstanding |
5 years 9 months 25 days
|
6 years 5 months 1 day
|
Aggregate Intrinsic Value, Beginning balance |
|
|
Number of Options, Granted |
|
|
Weighted Average Exercise Price, Granted |
|
|
Number of Options, Cancelled/forfeited |
(10,047)
|
|
Weighted Average Exercise Price, Cancelled/forfeited |
$ 36.19
|
|
Number of Options, Exercised |
|
|
Weighted Average Exercise Price, Exercised |
|
|
Number of Options, Ending balance |
230,723
|
240,770
|
Weighted Average Exercise Price, Ending balance |
$ 37.08
|
$ 37.04
|
Aggregate Intrinsic Value, Ending balance |
|
|
Number of Options, Exerciasble |
169,637
|
|
Weighted Average Exercise Price, Exercisable |
$ 36.33
|
|
Weighted Aaverage Remaining Contractual Term (years), Exercisable |
5 years 1 month 2 days
|
|
Aggregate Intrinsic Value, Exercisable |
|
|
Number of Options, Unvested options |
61,086
|
|
Weighted Average Exercise Price, Unvested |
$ 39.17
|
|
Weighted Aaverage Remaining Contractual Term (years), Unvested |
7 years 10 months 13 days
|
|
Aggregate Intrinsic Value, Unvested |
|
|
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v3.23.2
SCHEDULE OF RESTRICTED STOCK AWARD ACTIVITY (Details) - 2015 Equity Incentive Plan Inducement Grants [Member] - Restricted Stock [Member]
|
6 Months Ended |
Jun. 30, 2023
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of Awards, Beginning balance | shares |
816,958
|
Weighted Average Grant Date Fair Value Per Unit, Beginning balance | $ / shares |
$ 5.35
|
Number of Awards, Granted | shares |
1,817,559
|
Weighted Average Grant Date Fair Value Per Unit, Granted | $ / shares |
$ 3.96
|
Number of Awards, Cancelled/forfeited | shares |
(46,394)
|
Weighted Average Grant Date Fair Value Per Unit, Forfeited | $ / shares |
$ 4.40
|
Number of Awards, Vested | shares |
(21,820)
|
Weighted Average Grant Date Fair Value Per Unit, Vested | $ / shares |
$ 28.34
|
Number of Awards, Ending balance | shares |
2,566,303
|
Weighted Average Grant Date Fair Value Per Unit, Ending balance | $ / shares |
$ 4.18
|
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v3.23.2
LICENSE/SUPPLIER AGREEMENT (Details Narrative) - USD ($) $ in Thousands |
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
|
May 16, 2022 |
Oct. 31, 2020 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Revenue recognized |
|
|
$ 3,500
|
$ 1,000
|
$ 3,500
|
$ 1,346
|
|
License Agreement Terms [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Milestone payments |
$ 30,000
|
|
|
|
|
|
|
Sublicense And Inventory Purchase Agreements [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Fixed consideration |
|
$ 3,000
|
|
|
|
|
|
Contract assets |
|
|
3,500
|
|
3,500
|
|
|
Contract liabilities |
|
|
1,600
|
|
1,600
|
|
|
Sublicense And Inventory Purchase Agreements [Member] | Event Based Milestone Payments [Member] | Maximum [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Variable consideration |
|
26,500
|
|
|
|
|
|
Sublicense And Inventory Purchase Agreements [Member] | Sales Based Milestone Payments [Member] | Maximum [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Variable consideration |
|
$ 30,000
|
|
|
|
|
|
Sublicense And Inventory Purchase Agreements [Member] | License [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Revenue recognized |
|
|
$ 3,500
|
$ 1,000
|
$ 3,500
|
$ 1,000
|
|
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v3.23.2
SUBSEQUENT EVENTS (Details Narrative) - USD ($) $ / shares in Units, $ in Millions |
Jul. 06, 2023 |
Dec. 21, 2021 |
Jul. 03, 2023 |
Jun. 30, 2023 |
Nov. 03, 2022 |
Subsequent Event [Line Items] |
|
|
|
|
|
Warrants issued to purchase of common stock, shares |
|
1,788,000
|
|
|
|
Net proceeds, offering costs |
|
$ 16.0
|
|
|
|
Excrise price |
|
$ 9.75
|
|
|
|
Private Placement [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
Warrants issued to purchase of common stock, shares |
|
|
|
7,609,879
|
|
Excrise price |
|
|
|
$ 4.75
|
|
Pre Funded Warrant [Member] | Private Placement [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
Warrants issued to purchase of common stock, shares |
|
|
|
|
7,609,879
|
Subsequent Event [Member] | Securities Purchase Agreement [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
Number of stock, value |
$ 25.0
|
|
|
|
|
Net proceeds, offering costs |
$ 23.0
|
|
|
|
|
Excrise price |
$ 0.0001
|
|
|
|
|
Subsequent Event [Member] | Securities Purchase Agreement [Member] | Common Stock [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
Number of stock, shares |
|
|
3,284,407
|
|
|
Excrise price |
0.0001
|
|
|
|
|
Subsequent Event [Member] | Securities Purchase Agreement [Member] | Warrant [Member] | Private Placement [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
Warrants issued to purchase of common stock, shares |
|
|
2,919,140
|
|
|
Subsequent Event [Member] | Securities Purchase Agreement [Member] | Common Stock And Accompanying Warrant [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
Offering price |
4.03
|
|
|
|
|
Subsequent Event [Member] | Securities Purchase Agreement [Member] | Pre Funded Warrant [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
Offering price |
$ 4.0299
|
|
|
|
|
X |
- DefinitionExercise price per share or per unit of warrants or rights outstanding.
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Abeona Therapeutics (NASDAQ:ABEO)
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