UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended March 31, 2024
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: 001-41160
ALLARITY
THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware | | 87-2147982 |
(State or other jurisdiction of
incorporation or organization) | | (I.R.S. Employer Identification No.) |
24 School Street, 2nd Floor, Boston, MA | | 02108 |
(Address of principal executive offices) | | (Zip Code) |
(401)
426-4664
(Registrant’s
telephone number, including area code)
Not
Applicable
(Former name, former address and former fiscal year, if changed since
last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title of each class | | Trading Symbol(s) | | Name of each exchange on which registered |
Common Stock, par value $0.0001 per share | | ALLR | | The Nasdaq Stock Market LLC |
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 issuer 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 checkmark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
| | Emerging growth company | ☒ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of May 13, 2024, there
were 17,606,739 shares of the registrant’s common stock, par value $0.0001, outstanding.
Table
of Contents
Unless the context indicates
otherwise, references in this Quarterly Report on Form 10-Q (the “Quarterly Report”) to the “Company,” “Allarity,”
“we,” “us,” “our” and similar terms refer to Allarity Therapeutics, Inc., Allarity Therapeutics A/S
(as predecessor) and its respective consolidated subsidiaries. On April 9, 2024, we effected a 1-for-20 reverse stock split of the shares
of our Common Stock (the “Reverse Stock Split”). All historical share and per share amounts reflected throughout this Quarterly
Report have been adjusted to reflect the Reverse Stock Split.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report contains statements we believe are “forward-looking
statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Those forward-looking statements are intended
to enjoy the protection of the safe harbor for forward-looking statements provided by that act as well as protections afforded by other
federal securities laws. Generally, words such as “achieve,” “aim,” “ambitions,” “anticipate,”
“believe,” “committed,” “continue,” “could,” “designed,” “estimate,”
“expect,” “forecast,” “future,” “goals,” “grow,” “guidance,” “intend,”
“likely,” “may,” “milestone,” “objective,” “on track,” “opportunity,”
“outlook,” “pending,” “plan,” “position,” “possible,” “potential,”
“predict,” “progress,” “roadmap,” “seek,” “should,” “strive,”
“targets,” “to be,” “upcoming,” “will,” “would,” and variations of such words
and similar expressions identify forward-looking statements, which are not historical in nature. Forward-looking statements may appear
throughout this Quarterly Report and other documents we file with the Securities and Exchange Commission (the “SEC”). Forward-looking
statements involve risks and uncertainties that could cause actual results to differ materially from those anticipated by these forward-looking
statements. These risks and uncertainties include, but are not limited to, the factors described in the section captioned “Risk
Factors” in our Annual Report on Form 10-K, as amended (the “Form 10-K”), initially filed with the SEC on March
8, 2024.
We urge investors to consider
all of the risks, uncertainties, and other factors disclosed in these filings carefully in evaluating the forward-looking statements contained
in this Quarterly Report. We cannot assure you that the results or developments anticipated by us and reflected or implied by any forward-looking
statement contained in this Quarterly Report will be realized or, even if substantially realized, that those results or developments will
result in the forecasted or expected consequences for us or affect us, our operations or financial performance as we forecasted or expected.
As a result of the matters discussed above and other matters, including changes in facts, assumptions not being realized, or other factors,
the actual results relating to the subject matter of any forward-looking statement in this Quarterly Report may differ materially from
the anticipated results expressed or implied in that forward-looking statement. The forward-looking statements included in this Quarterly
Report are made only as of the date of this Quarterly Report, and we undertake no obligation to update any such statements to reflect
subsequent events or circumstances.
PART
I—FINANCIAL INFORMATION
Item
1. Financial Statements.
ALLARITY
THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S.
dollars in thousands, except for share and per share data)
| |
March 31, | | |
December 31, | |
| |
2024 | | |
2023 | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | |
| |
Current assets: | |
| | |
| |
Cash | |
$ | 312 | | |
$ | 166 | |
Other current assets | |
| 110 | | |
| 209 | |
Prepaid expenses | |
| 542 | | |
| 781 | |
Tax credit receivable | |
| 1,331 | | |
| 815 | |
Total current assets | |
| 2,295 | | |
| 1,971 | |
Non-current assets: | |
| | | |
| | |
Property, plant and equipment, net | |
| 18 | | |
| 20 | |
Intangible assets | |
| 9,656 | | |
| 9,871 | |
Total assets | |
$ | 11,969 | | |
$ | 11,862 | |
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 11,058 | | |
$ | 8,416 | |
Accrued liabilities | |
| 1,553 | | |
| 1,309 | |
Warrant derivative liability | |
| 2,664 | | |
| 3,083 | |
Income taxes payable | |
| 43 | | |
| 59 | |
Convertible promissory notes and accrued interest, net of debt discount | |
| 2,690 | | |
| 1,300 | |
Total current liabilities | |
| 18,008 | | |
| 14,167 | |
Non-current liabilities: | |
| | | |
| | |
Deferred tax | |
| 432 | | |
| 446 | |
Total liabilities | |
| 18,440 | | |
| 14,613 | |
Commitments and contingencies (Note 16) | |
| | | |
| | |
Stockholders’ (deficit) equity | |
| | | |
| | |
Series A Preferred stock $0.0001 par value (20,000 shares designated) shares issued and outstanding at March 31, 2024 and December 31, 2023 were 1,215 and 1,417, respectively (liquidation preference of $4.36 at March 31, 2024) | |
| 1,510 | | |
| 1,742 | |
Common stock, $0.0001 par value (750,000,000 shares authorized, at March 31, 2024 and December 31, 2023); shares issued and outstanding at March 31, 2024 and December 31, 2023 were 342,774 and 294,347, respectively | |
| — | | |
| — | |
Additional paid-in capital | |
| 90,699 | | |
| 90,369 | |
Accumulated other comprehensive loss | |
| (386 | ) | |
| (411 | ) |
Accumulated deficit | |
| (98,294 | ) | |
| (94,451 | ) |
Total stockholders’ deficit | |
| (6,471 | ) | |
| (2,751 | ) |
Total liabilities, preferred stock and stockholders’ (deficit) equity | |
$ | 11,969 | | |
$ | 11,862 | |
See
accompanying notes to condensed consolidated financial statements.
ALLARITY
THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(U.S. dollars in thousands, except for share and per share data)
| |
Three months ended March 31, | |
| |
2024 | | |
2023 | |
Operating expenses: | |
| | |
| |
Research and development | |
$ | 2,170 | | |
$ | 1,427 | |
General and administrative | |
| 2,070 | | |
| 2,241 | |
Total operating expenses | |
| 4,240 | | |
| 3,668 | |
Loss from operations | |
| (4,240 | ) | |
| (3,668 | ) |
Other income (expenses) | |
| | | |
| | |
Interest income | |
| — | | |
| 4 | |
Interest expense | |
| (102 | ) | |
| (92 | ) |
Foreign exchange gains | |
| 76 | | |
| 95 | |
Change in fair value adjustment of derivative and warrant liabilities | |
| 419 | | |
| 309 | |
Net other income | |
| 393 | | |
| 316 | |
Net loss for the period before tax benefit | |
| (3,847 | ) | |
| (3,352 | ) |
Income tax benefit | |
| 4 | | |
| — | |
Net loss | |
| (3,843 | ) | |
| (3,352 | ) |
Deemed dividend of 5% on Series C Convertible Preferred stock | |
| — | | |
| (4 | ) |
Gain on extinguishment of Series A Convertible Preferred
stock | |
| 191 | | |
| — | |
Deemed dividend on Series A Convertible Preferred stock | |
| (228 | ) | |
| — | |
Net loss attributable to common stockholders | |
$ | (3,880 | ) | |
$ | (3,356 | ) |
Basic and diluted net loss per common stock | |
$ | (22.14 | ) | |
$ | (6,356.06 | ) |
Weighted-average number of common stock outstanding, basic and diluted | |
| 175,266 | | |
| 528 | |
Other comprehensive loss, net of tax: | |
| | | |
| | |
Net loss | |
$ | (3,843 | ) | |
$ | (3,352 | ) |
Change in cumulative translation adjustment | |
| 25 | | |
| 84 | |
Total comprehensive loss attributable to common stockholders | |
$ | (3,818 | ) | |
$ | (3,268 | ) |
See
accompanying notes to condensed consolidated financial statements.
ALLARITY
THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES
IN REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
For
the three months ended March 31, 2024 and 2023
(Unaudited)
(U.S.
dollars in thousands, except for share data)
| |
Series A
Preferred Stock | | |
Series B
Preferred Stock | | |
Series C
Convertible
Preferred Stock | | |
Series A
Preferred Stock | | |
Common
Stock | | |
Additional
Paid in | | |
Accumulated
Other
Comprehensive | | |
Accumulated | | |
Total
Stockholders’
Equity | |
| |
Number | | |
Value | | |
Number | | |
Value | | |
Number | | |
Value | | |
Number | | |
Value | | |
Number | | |
Value | | |
Capital | | |
Loss | | |
Deficit | | |
(Deficit) | |
Balance,
December 31, 2022 | |
| 13,586 | | |
$ | 2,001 | | |
| 190,786 | | |
$ | 2 | | |
| — | | |
$ | — | | |
| — | | |
| — | | |
| 568 | | |
$ | — | | |
$ | 83,158 | | |
$ | (721 | ) | |
$ | (82,550 | ) | |
$ | (113 | ) |
Issuance
of Series C Convertible Preferred Stock, net | |
| — | | |
| — | | |
| — | | |
| — | | |
| 50,000 | | |
| 1,160 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
Deemed dividend of 5% and accretion of Series C Convertible Preferred Stock to redemption value | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 167 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (167 | ) | |
| — | | |
| — | | |
| (167 | ) |
Round up of common shares issued as a result of 1-for-35 and 1-for-40 reverse stock splits | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 15 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
Conversion
of Preferred Stock into common stock, net | |
| (3,838 | ) | |
| (565 | ) | |
| — | | |
| — | | |
| — | | |
| — | | |
| | | |
| | | |
| 902 | | |
| — | | |
| 565 | | |
| — | | |
| — | | |
| 565 | |
Redemption
of Series B Preferred Stock | |
| | | |
| | | |
| (190,786 | ) | |
| (2 | ) | |
| | | |
| | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 2 | | |
| — | | |
| — | | |
| 2 | |
Stock
based compensation (recoveries) | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (121 | ) | |
| — | | |
| — | | |
| (121 | ) |
Currency
translation adjustment | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 84 | | |
| — | | |
| 84 | |
Loss
for the period | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (3,352 | ) | |
| (3,352 | ) |
Balance,
March 31, 2023 | |
| 9,748 | | |
$ | 1,436 | | |
| — | | |
$ | — | | |
| 50,000 | | |
$ | 1,327 | | |
| — | | |
$ | — | | |
| 1,485 | | |
$ | — | | |
$ | 83,437 | | |
$ | (637 | ) | |
$ | (85,902 | ) | |
$ | (3,102 | ) |
See
accompanying notes to condensed consolidated financial statements.
| |
Series A
Convertible Preferred Stock | | |
Common Stock | | |
Additional Paid in | | |
Accumulated Other Comprehensive | | |
Accumulated | | |
Total Stockholders’
Equity | |
| |
Number | | |
Value, net | | |
Number | | |
Value | | |
Capital | | |
Loss | | |
Deficit | | |
(Deficit) | |
Balance, December 31, 2023 | |
| 1,417 | | |
$ | 1,742 | | |
| 294,390 | | |
$ | — | | |
$ | 90,369 | | |
$ | (411 | ) | |
$ | (94,451 | ) | |
$ | (2,751 | ) |
Conversion of preferred stock into common stock, net | |
| (202 | ) | |
| (269 | ) | |
| 27,092 | | |
| — | | |
| 269 | | |
| — | | |
| — | | |
| — | |
Extinguishment of preferred stock | |
| — | | |
| (191 | ) | |
| | | |
| — | | |
| 191 | | |
| — | | |
| — | | |
| — | |
Deemed dividend on preferred stock | |
| — | | |
| 228 | | |
| | | |
| — | | |
| (228 | ) | |
| — | | |
| — | | |
| — | |
Shares issued for compensation | |
| — | | |
| — | | |
| 14,500 | | |
| — | | |
| 90 | | |
| — | | |
| — | | |
| 90 | |
Sale of common shares, net | |
| — | | |
| — | | |
| 6,792 | | |
| — | | |
| 40 | | |
| — | | |
| — | | |
| 40 | |
Stock based compensation (recoveries) | |
| — | | |
| — | | |
| — | | |
| — | | |
| (32 | ) | |
| — | | |
| — | | |
| (32 | ) |
Currency translation adjustment | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 25 | | |
| | | |
| 25 | |
Loss for the period | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (3,843 | ) | |
| (3,843 | ) |
Balance, March 31, 2024 | |
| 1,215 | | |
$ | 1,510 | | |
| 342,774 | | |
$ | — | | |
$ | 90,699 | | |
$ | (386 | ) | |
$ | (98,294 | ) | |
$ | (6,471 | ) |
See
accompanying notes to condensed consolidated financial statements.
ALLARITY
THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(U.S. dollars in thousands)
| |
Three months ended March 31, | |
| |
2024 | | |
2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |
| | |
| |
Net loss for the period | |
$ | (3,843 | ) | |
$ | (3,352 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 2 | | |
| 10 | |
Stock-based compensation (recoveries) | |
| (121 | ) | |
| (121 | ) |
Unrealized foreign exchange gain | |
| (76 | ) | |
| (87 | ) |
Non-cash finance expense | |
| — | | |
| 4 | |
Non-cash interest | |
| 96 | | |
| 83 | |
Change in fair value adjustment of warrant and derivative liabilities | |
| (419 | ) | |
| (309 | ) |
Deferred income taxes | |
| (14 | ) | |
| — | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Other current assets | |
| 99 | | |
| (19 | ) |
Tax credit receivable | |
| (516 | ) | |
| (23 | ) |
Prepaid expenses | |
| 239 | | |
| (6 | ) |
Accounts payable | |
| 2,838 | | |
| 198 | |
Accrued liabilities | |
| 244 | | |
| 434 | |
Income taxes payable | |
| (16 | ) | |
| (5 | ) |
Operating lease liability | |
| — | | |
| (8 | ) |
Net cash used in operating activities | |
| (1,487 | ) | |
| (3,201 | ) |
CASH FLOWS FROM FINANCING ACTIVITIES: | |
| | | |
| | |
Proceeds from convertible promissory notes and accrued interest, net
of discount | |
| 1,340 | | |
| — | |
Net proceeds from sale of common shares | |
| 40 | | |
| — | |
Proceeds from Series C Convertible Preferred Stock issuance, net of costs | |
| — | | |
| 1,160 | |
Redemption of Series B Preferred Stock | |
| — | | |
| (2 | ) |
Net cash provided by financing activities | |
| 1,380 | | |
| 1,158 | |
Net decrease in cash | |
| (107 | ) | |
| (2,043 | ) |
Effect of exchange rate changes on cash | |
| 253 | | |
| 309 | |
Cash, beginning of period | |
| 166 | | |
| 2,029 | |
Cash, end of period | |
$ | 312 | | |
$ | 295 | |
Supplemental information | |
| | | |
| | |
Cash paid for income taxes | |
| — | | |
| 6 | |
Cash paid for interest | |
| — | | |
| 9 | |
Supplemental disclosure of non-cash investing and financing activities: | |
| | | |
| | |
Conversion of Series A Convertible Preferred stock to equity, net | |
| 269 | | |
| 565 | |
Deemed dividend on Series A Convertible Preferred Stock | |
| (228 | ) | |
| — | |
Gain on extinguishment of Series A Convertible Preferred
Stock | |
| 191 | | |
| — | |
Deemed 5% dividend on Series C Convertible Preferred Stock | |
| — | | |
| (4 | ) |
Accretion of Series C Preferred shares to redemption value |
|
|
— |
|
|
|
(163 |
) |
Stock issued in conjunction with consulting agreement | |
| 90 | | |
| — | |
See
accompanying notes to condensed consolidated financial statements.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
the three months ended March 31, 2024 and March 31, 2023
(UNAUDITED)
(U.S.
dollars in thousands, except for share and per share data and where otherwise noted)
1.
Organization, Principal Activities and Basis of Presentation
Allarity
Therapeutics, Inc. and Subsidiaries (the “Company”) is a clinical stage pharmaceutical company that develops drugs for the
personalized treatment of cancer using drug specific companion diagnostics generated by its proprietary drug response predictor technology,
DRP®. Additionally, the Company, through its Danish subsidiary, Allarity Denmark (previously Oncology Venture ApS), specializes
in the research and development of anti-cancer drugs.
The Company’s principal
operations are located at Venlighedsvej 1, 2970 Horsholm, Denmark. The Company’s business address in the Unites States is located
at 24 School Street, 2nd Floor, Boston, MA 02108.
(a)
Reverse Stock Split
On April 9, 2024, the Company
effected a 1-for-20 reverse stock split of the shares of its Common Stock (the “Reverse Stock Split”). All historical share
and per share amounts reflected throughout the Financial Statements (as defined below in 1(b)) and these notes to the financial statements
have been adjusted to reflect the Reverse Stock Split. See Note 10(a).
(b)
Liquidity and Going Concern
The accompanying unaudited
condensed interim consolidated financial statements (the “Financial Statements”) have been prepared on the basis of continuity
of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. The Financial
Statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be
necessary if the Company is unable to continue as a going concern.
Pursuant to the requirements
of Accounting Standard Codification (ASC) 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern,
management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s
ability to continue as a going concern within one year after the date that the financial statements are issued. This evaluation initially
does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of
the date of the Financial Statements, and (1) is probable that the plan will be effectively implemented within one year after the
date the financial statements are issued, and (2) it is probable that the plan, when implemented, will mitigate the relevant condition
or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date
the financial statements are issued. Certain elements of the Company’s operating plan to alleviate the conditions that raise substantial
doubt are outside of the Company’s control and cannot be included in management’s evaluation under the requirements of ASC
205-40.
Since
inception, the Company has devoted substantially all its efforts to business planning, research and development, clinical expenses, recruiting
management and technical staff, and securing funding via collaborations. The Company has historically funded its operations with proceeds
received from its collaboration arrangements, sale of equity capital and proceeds from sales of convertible notes.
The Company has incurred significant
losses and has an accumulated deficit of $98.3 million as of March 31, 2024. As of March 31, 2024, the Company’s cash of $312
is insufficient to fund the Company’s current operating plan and planned capital expenditures for the next 12 months. These conditions
give rise to substantial doubt over the Company’s ability to continue as a going concern.
Management’s plans to
mitigate the conditions or events that raise substantial doubt include additional funding through public equity, private equity, debt
financing, collaboration partnerships or other sources.
On March 19, 2024, the Company entered into an At-The-Market Issuance
Sales Agreement with Ascendiant Capital Markets, LLC to sell shares of the Company’s Common Stock, with aggregate gross sales proceeds
of up to $22 million, from time to time, through an “at-the-market” equity offering program (the “ATM Offering”).
As of March 31, 2024, the Company has up to approximately $21.29 million remaining in aggregate gross proceeds that can be issued through the ATM
Offering.
In light of the Company’s
cash position as of the date of this Quarterly Report, the Company does not have sufficient funds for its current operations and planned
capital expenditures. As discussed above, the Company intends to seek capital through sale of its securities or other sources. There are
no assurances, however, that the Company will be successful in raising additional working capital, or if it is able to raise additional
working capital, it may be unable to do so on commercially favorable terms. The Company’s failure to raise capital or enter into
other such capital raising arrangements if and when needed would have a negative impact on its business, results of operations and financial
condition and its ability to develop its product candidates.
Although management continues
to pursue its funding plans, there is no assurance that the Company will be successful in obtaining sufficient funding to fund continuing
operations on terms acceptable to the Company, if at all. Accordingly, based upon cash on hand at March 31, 2024, the Company does not
have sufficient funds to finance its operations for at least twelve months from March 31, 2024 and therefore has concluded that substantial
doubt exists about the Company’s ability to continue as a going concern.
(c)
Basis of Presentation
The Financial Statements have
been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) as
established by the Financial Accounting Standards Board (the “FASB”) for interim financial information and the rules and regulations
of the Securities and Exchange Commission (the “SEC”).
The Financial Statements contain
all normal and recurring adjustments necessary to state fairly the consolidated balance sheet, results of operations and comprehensive
loss, statements of changes in redeemable convertible preferred stock and stockholders’ equity (deficit), and cash flows of the
Company for the interim periods presented. Except as otherwise disclosed, all such adjustments consist only of those of a normal recurring
nature. Operating results for the three months ended March 31, 2024, are not necessarily indicative of the results that may be expected
for the current fiscal year ending December 31, 2024. The financial data presented herein do not include all disclosures required by U.S.
GAAP and should be read in conjunction with the audited consolidated financial statements and accompanying notes as of and for the fiscal
years ended December 31, 2023 and 2022, thereto included in the Company’s Annual Report on Form 10-K, as amended (the “Form
10-K”) initially filed with the SEC on March 8, 2024.
The preparation of the Financial
Statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets
and liabilities as of the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods.
The results of operations and cash flows for the interim periods included in the Financial Statements are not necessarily indicative of
the results to be expected for any future period or the entire fiscal year.
(d) Risks and Uncertainties
The Company is subject to
risks common to companies in the biotechnology industry, including but not limited to, risks of failure of preclinical studies and clinical
trials, the need to obtain marketing approval for any drug product candidate that it may identify and develop, the need to successfully
commercialize and gain market acceptance of its product candidates, dependence on key personnel and collaboration partners, protection
of proprietary technology, compliance with government regulations, development by competitors of technological innovations, and the ability
to secure additional capital to fund operations. Product candidates currently under development will require significant additional research
and development efforts, including preclinical and clinical testing and regulatory approval prior to commercialization. Even if the Company’s
research and development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product
sales.
2.
Summary of Significant Accounting Policies
There
have been no new or material changes to the significant accounting policies discussed in the Form 10-K, that are of significance, or
potential significance, to the Company.
(a)
Organization and Principles of Consolidation
The financial statements include
the accounts of the Company and its wholly owned subsidiaries:
Name |
|
Country of Incorporation |
Allarity Acquisition Subsidiary Inc. |
|
United States |
Allarity Therapeutics Europe ApS (formerly Oncology Venture Product Development ApS)* |
|
Denmark |
Allarity Therapeutics Denmark ApS (formerly OV-SPV2 ApS)* |
|
Denmark |
MPI Inc.*(1) |
|
United States |
* | |
(1) | In
the process of being dissolved because inactive. |
All intercompany transactions
and balances, including unrealized profits from intercompany sales, have been eliminated upon consolidation.
(b)
Use of Estimates and Assumptions
The preparation of financial
statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets
and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts
of revenues and expenses during the reporting years. Significant estimates and assumptions reflected in the Financial Statements include,
but are not limited to, the fair value of the Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, warrants,
convertible debt, convertible promissory note, and the accrual for research and development expenses, fair values of acquired intangible
assets and impairment review of those assets, share based compensation expense, and income tax uncertainties and valuation allowances.
The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes
to be reasonable under the circumstances. Estimates are periodically reviewed considering reasonable changes in circumstances, facts,
and experience. Changes in estimates are recorded in the period in which they become known and if material, their effects are disclosed
in the notes to the financial statements. Actual results could differ from those estimates or assumptions.
(c)
Foreign currency and currency translation
The
functional currency is the currency of the primary economic environment in which an entity’s operations are conducted. The Company
and its subsidiaries operate mainly in Denmark and the United States. The functional currencies of the Company’s subsidiaries
are their local currency.
The
Company’s reporting currency is the U.S. dollar. The Company translates the assets and liabilities of its Denmark subsidiaries
into the U.S. dollar at the exchange rate in effect on the balance sheet date. Revenues and expenses are translated at the average exchange
rate in effect during each monthly period. Unrealized translation gains and losses are recorded as a cumulative translation adjustment,
which is included in the condensed consolidated statements of changes in redeemable convertible preferred stock and stockholders’
equity (deficit) as a component of accumulated other comprehensive loss.
Monetary
assets and liabilities denominated in currencies other than the functional currency are remeasured into the functional currency at rates
of exchange prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are re-measured
into the functional currency at the exchange rates prevailing at the date of the transaction. Exchange gains or losses arising from foreign
currency transactions are included in the determination of net loss for the respective periods. Adjustments that arise from exchange
rate translations are included in other comprehensive loss in the condensed consolidated statements of operations and comprehensive loss
as incurred.
Adjustments
that arise from exchange rate translations are included in other comprehensive loss in the consolidated statements of operations and
comprehensive loss as incurred. The Company recorded a foreign exchange translation gain of $25 and $84, included in accumulated other
comprehensive loss for the three month periods ended March 31, 2024 and 2023, respectively.
(d)
Concentrations of credit risk and of significant suppliers
Financial
instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash. The Company maintains its
cash in financial institutions in amounts that could exceed government-insured limits. The Company does not believe it is subject to
additional credit risks beyond those normally associated with commercial banking relationships. The Company has not experienced losses
on its cash accounts and management believes, based upon the quality of the financial institutions, that the credit risk regarding these
deposits is not significant. The Company is dependent on third-party manufacturers to supply products for research and development
activities in its programs. In particular, the Company relies and expects to continue to rely on a small number of manufacturers to supply
its requirements for supplies and raw materials related to these programs. These programs could be adversely affected by a significant
interruption in these manufacturing services or the availability of raw materials.
(e)
Cash
Cash consists primarily of
highly liquid investments with original maturities of three months or less at date of purchase to be cash equivalents.
(f) Accumulated
other comprehensive loss
Accumulated other comprehensive
loss includes net loss as well as other changes in stockholders’ equity (deficit) that result from transactions and economic events
other than those with shareholders. The Company records unrealized gains and losses related to foreign currency translation and instrument
specific credit risk as components of other accumulated comprehensive loss in the condensed consolidated statements of operations and
comprehensive loss. During the three months ended March 31, 2024, and 2023, the Company’s other comprehensive gain was comprised
of currency translation adjustments.
(g)
Contingencies
Liabilities
for loss contingencies arising from claims, assessments, litigation, fines, penalties, and other sources are recorded when it is probable
that a liability has been incurred and the amount can be reasonably estimated. At each reporting date, the Company evaluates whether
a potential loss amount or a potential loss range is probable and reasonably estimable under the provisions of the authoritative guidelines
that address accounting for contingencies. The Company expenses costs as incurred in relation to such legal proceedings as general and
administrative expense within the condensed consolidated statements of operations and comprehensive loss.
(h) Reclassification
During
the three months ended March 31, 2023, we have reclassified financing costs of $9 from other income and expenses to general and
administrative expenses with no net impact upon our operating results or cash flows for either the current or prior periods.
(i)
Recently Issued Accounting Pronouncements
Changes to U.S. GAAP are established
by the FASB in the form of accounting standards updates (“ASUs”) to the FASB’s Accounting Standards Codification. The
Company considers the applicability and impact of all ASUs. All other ASUs issued through the date of the Financial Statements were assessed
and determined not to be applicable or are expected to have minimal impact on the Company’s condensed consolidated financial position
and results of operations.
3. Intangible assets
During the three months ended
March 31, 2024, because of continuing downward pressure on the Company’s shares of Common Stock, the Company performed an impairment
assessment with a WACC of 26% and determined that no further impairment of the Company’s intangible assets is required as of March
31, 2024.
The Company’s IPR&D
assets have been classified as indefinite-lived intangible assets. The Company’s individual material development project in progress,
Stenoparib, is recorded at $9,656 and $9,871 on March 31, 2024, and December 31, 2023, respectively.
4.
Accrued liabilities
The
Company’s accrued liabilities are comprised of the following:
| |
March 31, 2024 | | |
December 31, 2023 | |
Development cost liability | |
$ | 658 | | |
$ | 114 | |
Accrued interest on milestone liabilities | |
| 147 | | |
| 101 | |
Accrued audit and legal | |
| 65 | | |
| 425 | |
Payroll accruals | |
| 393 | | |
| 398 | |
Accrued consulting fees | |
| 150 | | |
| 150 | |
Accrued Board member and scientific advisory fees | |
| 140 | | |
| 60 | |
Other | |
| — | | |
| 61 | |
| |
$ | 1,553 | | |
$ | 1,309 | |
5.
Convertible promissory note due to Novartis
On January 26, 2024, we received
a termination notice from Novartis Pharma AG, a company organized under the laws of Switzerland (“Novartis”) due to a material
breach of that certain license agreement dated April 6, 2018, as amended to date (the “License Agreement”). Accordingly,
under the terms of the License Agreement, the Company ceased all development and commercialization activities with respect to all licensed
products, all rights and licenses granted by Novartis to the Company reverted to Novartis; and all liabilities due to Novartis became
immediately due and payable inclusive of interest which is continuing to accrue at 5% per annum. As of March 31, 2024, the liability
is recorded as a current liability on the Company’s condensed unaudited consolidated balance sheets as follows: $3,600 in accounts
payable, $1,317 convertible promissory notes and accrued interest, net of debt discount, and $147 in accrued liabilities.
6.
Convertible senior promissory notes due to 3i, LP (3i”)
| (a) | 3i
Convertible Senior Promissory Notes (2024) (collectively the “2024 Notes”) |
During the three months ended
March 31, 2024, the Company entered into a Securities Purchase Agreement (the “SPA”), as amended, with 3i, pursuant to which
three senior convertible promissory notes were issued as follows:
| i. | On January 18, 2024, in an aggregate principal amount of $440 due on
January 18, 2025, and with a set conversion price of $8.95 per share, for an aggregate purchase price of $400, representing an approximate
10% original issue discount (the “First Note”). |
| ii. | On February 13, 2024, in an aggregate principal amount of $440 due on February 13, 2025, and with a set conversion price of $8.10 per share, for an aggregate purchase price of $400, representing an approximately 10% original issue discount (the “Second Note”). |
| iii. | On March 14, 2024, in an aggregate principal amount of $660 due on March 14, 2025, and with a set conversion price of $7.00 per share, for an aggregate purchase price of $600, representing an approximately 10% original issue discount (the “Third Note”). |
The
Company agreed to use the net proceeds from the sale of the 2024 Notes, among other things, for accounts payable and for working capital
purposes. Unless the transaction documents state otherwise, the Company may not prepay any portion of the principal amount of the 2024
Notes without 3i’s prior written consent.
The
Company evaluated the terms of the 2024 Notes as required pursuant to ASC 570, 480, 815 and ASU 2020-06, and concluded the 2024 Notes
will be recorded at $1,340, net of share issuance costs of $40,
and accreted to redemption value of $440 on January 18, 2025, $440 on February 13, 2025, and $660 on March 14, 2025, using the effective
interest method. The total debt discount of $140 and costs of $60 of the 2024 Notes are being amortized to interest expense over the one
year term of each tranche of the debt. As of March 31, 2024, we have recorded $37 as interest expense. The balance outstanding at
March 31, 2024 is $1,377. See Note 17(a) iii.
The Company agreed to pay
interest to 3i on the aggregate unconverted and then outstanding principal amount of the 2024 Notes at the rate of 8% per annum with interest
payments commencing one month after the initial receipt of net proceeds. The interest on each of the 2024 Notes is payable in cash or,
at the 3i’s option, in shares of our Common Stock, at the 90% of the lowest VWAP during the previous ten trading days that is immediately
prior to the interest payment dates. Under the terms of the 2024 Notes, 3i has the exclusive right to choose whether to receive interest
payments in cash or as shares of our Common Stock.
Conversion of the 2024 Notes
The
Company has committed to keeping enough of its authorized but unissued shares of Common Stock available exclusively for conversion of
the 2024 Notes. The number of shares to be issued upon conversion of the 2024 Notes will be calculated by dividing the outstanding principal
amount of the respective 2024 Notes to be converted by their respective conversion prices as described above. The conversion prices of
the 2024 Notes are subject to adjustment to equal the price of subsequent equity sales. 3i’s ownership percentage of our shares
of Common Stock is limited to no more than 4.99%, as determined according to Section 13(d) of the Securities Exchange Act of 1934, as
amended (the “Exchange Act”), and its accompanying rules. Additionally, the Company cannot issue shares of its Common Stock
in relation to the 2024 Notes transaction, including shares due upon the 2024 Notes conversion or otherwise, that exceed 19.99% of its
total outstanding shares of Common Stock, unless otherwise permitted by the 2024 Notes and related documents.
Redemption
Subject to the provisions
of the 2024 Notes, if, at any time while the 2024 Notes are outstanding, the Company engages in one or more subsequent financings, 3i
may require us to first use up to 100% of the gross proceeds of such financing to redeem all or a portion of the 2024 Notes at 105%. However,
if the Company were to raise capital in the ATM Offering, 3i may request up to 20% of the proceeds to redeem the Series A Convertible
Preferred Stock (the “Series A Preferred Stock”) at the stated value.
Events
of Default
The 2024 Notes include customary
event of default provisions and provide for a mandatory default provision. Upon the occurrence of an event of default, 3i may require
the Company to pay in cash the “Mandatory Default Amount” which is defined in the 2024 Notes to mean the sum of (a) the greater
of (i) the outstanding principal amount of the First Note, the Second Note and the Third Note, plus all accrued and unpaid interest thereon,
divided by the lesser of (i) $8.95 in the case of the First Note, $8.10 in the case of the Second Note, and $7.00 in the case of the Third
Note, or (ii) 85% of the average of the three lowest VWAPs during the 10 trading days ending on the trading day that is immediately prior
to the applicable date the Mandatory Default Amount is either (A) demanded or otherwise due or (B) paid in full, whichever has a lower
conversion price, multiplied by the highest closing price for the Company’s shares of Common Stock on the trading market during
the period beginning on the date of first occurrence of the event of default and ending on the date the Mandatory Default Amount is paid
in full, or (ii) 130% of the sum of the outstanding principal amount of the First and Second Note, plus accrued and unpaid interest hereon,
and (b) all other amounts, costs, expenses and liquidated damages due in respect of the First Note, the Second Note and the Third Note.
Negative Covenants
While
any of the 2024 Notes are outstanding, without prior written consent from 3i and holders of at least 50.01% of the outstanding 2024 Notes,
the Company is restricted from (i) incurring any debt exceeding $250 in total; (ii) creating any liens on their property, except for permitted
ones; (iii) making amendments to their charter documents that adversely affect 3i’s rights; (iv) repurchasing the Company’s
shares of Common Stock or equivalents, except under specific conditions related to conversion shares under the Second Note and equity
incentives for departing officers and directors, capped at $50 in total; (v) repurchasing or acquiring any indebtedness other than the
First Note and the Second Note, unless it is done pro-rata; (vi) paying cash dividends or distributions on their equity securities; (vii)
engaging in transactions with any affiliates or related parties, unless permitted by the SPA; and (viii) entering into agreements related
to the above restrictions.
Registration Rights
The
Company agreed to register with the SEC the resale of its shares of the Common Stock issuable upon conversion of the 2024 Notes pursuant
to the SPA. We agreed to reimburse 3i of reasonable attorneys’ fees and expenses incurred by 3i for significant work in connection
with the closings contemplated in the SPA. The SPA also provides for indemnification of 3i if it incurs losses, liabilities, obligations,
claims, contingencies, damages, costs and expenses related to, among other things, a breach by us of any of our representations, warranties
or covenants under the SPA.
|
(b) |
3i Convertible Secured Promissory Notes (2023) |
On
November 22, 2022, the Company entered into a Secured Note Purchase Agreement (“Purchase Agreement”) with 3i, whereby the
Company authorized the sale and issuance of three Secured Promissory Notes (each a “Note” and collectively, the “Notes”).
Effective November 28, 2022, the Company issued: (1) a Note in the principal amount of $1,667 as payment of $1,667 due to 3i in Alternative
Conversion Floor Amounts (as defined in the Notes) that began to accrue on July 14, 2022; and (2) a Note in the principal amount of $350
in exchange for cash. Effective December 30, 2022, the Company issued an additional Note in the principal amount of $650 in exchange for
cash.
Each
Note matured on January 1, 2024, carried an interest rate of 5% per annum, and was secured by all of the Company’s assets pursuant
to a security agreement (the “Security Agreement”). In addition, the Holder may exchange the Notes for the Company’s
shares of Common Stock at an exchange price equal to the lowest price per share of the equity security sold to other purchasers, rounded
down to the nearest whole share, if the Company concludes a future equity financing prior to the maturity date or other repayment of
such promissory note. Lastly, each Note and interest earned thereon may be redeemed by the Company at its option at any time or the holder
may demand redemption if a) the Company obtains gross proceeds of at least $5 million in a financing in an amount of up to 35% of the
gross proceeds of the financing or b) there is an Event of Default (as defined in the Note agreement). Discounts to the principal amounts
are included in the carrying value of the Notes and amortized to interest expense over the contractual term of the underlying debt. During
2022, the Company recorded a $34 debt discount upon issuance of the Notes related to legal fees paid that were capitalized as debt issuance
costs. For the three months ended March 31, 2023, interest expense totaled $43, comprised of $33 for contractual interest and $10 for
the amortization of the debt discount.
The
3i Convertible Secured Promissory Notes were paid in full and cancelled on April 21, 2023.
7.
Preferred Stock
A. |
Series
A Convertible Preferred Stock and Common Stock Purchase Warrants |
(a)
Amendments to Series A Convertible Preferred Stock
|
i. |
Determination
of Conversion Price Adjustments for Series A Preferred Stock |
On
December 9, 2022, the Company and 3i entered into a letter agreement (the “2022 Letter Agreement”) which provided that pursuant
to Section 8(g) of the Company’s Certificate of Designations for the Series A Preferred Stock (the “COD”), the Company
and 3i agreed that the Conversion Price (as defined in the COD) was modified to mean the lower of: (i) the Closing Sale Price (as defined
in the COD) on the trading date immediately preceding the Conversion Date (as defined in the COD) and (ii) the average Closing Sale Price
(as defined in the COD) of the common stock for the five trading days immediately preceding the Conversion Date (as defined in the COD),
for the Trading Days (as defined in the COD) through and inclusive of January 19, 2023. Any conversion which occurs shall be voluntary
at the election of 3i, which shall evidence its election as to the Series A Preferred Stock being converted in writing on a conversion
notice setting forth the then Minimum Price (as defined in the COD). Management determined that the adjustment made to the Conversion
Price is not a modification of the COD which allows for adjustments to the Conversion Price (as defined in the COD) at any time by the
Company and the other terms of the COD remained unchanged.
On
January 23, 2023, the Company and 3i amended the 2022 Letter Agreement, to provide that the modification of the term Series A Preferred
Stock Conversion Price (the “Series A Preferred Stock Conversion Price”) to mean the lower of: (i) the Closing Sale Price
(as defined in the COD) on the trading date immediately preceding the Conversion Date (as defined in the COD and (ii) the average Closing
Sale Price (as defined in the COD) of the Company’s shares of Common Stock for the five trading days immediately preceding the
Conversion Date (as defined in the COD), for the Trading Days (as defined in the COD) will be in effect until terminated by the Company
and 3i.
|
ii. |
Modification
to Conversion Price of Series A Preferred Stock and 3i Exchange Warrants |
On January 14, 2024, pursuant
to the terms of the First Note, the Company modified the conversion price of the 3i Exchange Warrants from $20.00 to $8.95, thereby increasing
the number of Exchange Warrants outstanding from 220,361 at December 31, 2023 to 492,317 outstanding at January 14, 2024. Also on January 14,
2024, the conversion price of the outstanding 1,417 shares of Series A Preferred Stock was revised from $20.00 to $8.95. The Company filed
the Fifth Certificate of Amendment to Amended and Restated COD (the “Fifth Amendment”) with the Secretary of State of the
State of Delaware to reflect the new conversion price of the Series A Preferred Stock of $8.95. As of January 14, 2024, the Company used
the Black-Scholes option pricing model to determine the fair value of the 1,417 Series A Preferred Stock outstanding at $1,970 versus
their carrying value of $1,742. Accordingly, the Company has recorded a deemed dividend of $228 as at January 14, 2024. At a stated value
of $1,080 for each share of Series A Preferred Stock, the revised price of $8.95 per share results in the 1,417 shares being convertible
into 170,952 shares of Common Stock as of January 14, 2024.
On February 13, 2024, pursuant
to the terms of the Second Note, the Company modified the conversion price of the 3i Exchange Warrants from $8.95 to $8.10 and thereby
increased the number of Exchange Warrants outstanding from 492,317 on January 18, 2024, to 544,101 on February 13, 2024. The Company filed
the Sixth Certificate of Amendment to Amended and Restated COD (the “Sixth Amendment”) with the Secretary of State of the
State of Delaware to reflect the new conversion price of the Series A Preferred Stock of $8.10. As of February 14, 2024, the Company used
the Black-Scholes option pricing model to determine the fair value of the then 1,296 Series A Preferred Stock outstanding and concluded
there was a gain on extinguishment of $122. At a stated value of $1,080 for each share of Series A Preferred Stock, the revised price
of $8.10 per share results in the 1,296 shares being convertible into 493,573 shares of Common Stock.
On March 14, 2024, pursuant
to the terms of the Third Note, the Company modified the conversion price of the 3i Exchange Warrants from $8.10 to $7.00 and thereby
increased the number of Exchange Warrants outstanding from 544,101 on February 13, 2024, to 829,423 on March 14, 2024. The Company filed
the Seventh Certificate of Amendment to Amended and Restated COD (the “Seventh Amendment”) with the Secretary of State of
the State of Delaware to reflect the new conversion price of the Series A Preferred Stock of $7.00. As of March 14, 2024, the Company
used the Black-Scholes option pricing model to determine the fair value of the then 1,296 Series A Preferred Stock outstanding and concluded
there was a gain on extinguishment of $69. At a stated value of $1,080 for each share of Series A Preferred Stock, the revised price of
$7.00 per share results in the 1,215 shares being convertible into 535,286 shares of Common Stock.
(b) Accounting
|
i. |
Series A Preferred Stock |
As a result of fair value
adjustments during the three month period ended March 31, 2024, the Company recognized a deemed dividend of $228 and an extinguishment
gain of $191 on our outstanding Series A Preferred Stock. Inputs used in the Black-Scholes valuation models utilized to fair value the
modifications to the Series A Preferred Stock during the three month period ended March 31, 2024, are as follows:
| |
January 14, 2024 | | |
February 14, 2024 | | |
March 14, 2024 | |
Initial exercise price | |
$ | 20.00 | | |
$ | 8.95 | | |
$ | 8.10 | |
Stock price on valuation date | |
$ | 8.95 | | |
$ | 8.10 | | |
$ | 7.10 | |
Risk-free rate | |
| 4.82 | % | |
| 5.05 | % | |
| 5.10 | % |
Term (in years) | |
| 0.25 | | |
| 0.17 | | |
| 0.08 | |
Rounded annual volatility | |
| 145 | % | |
| 122 | % | |
| 130 | % |
The
3i Warrants were identified as a freestanding financial instrument and meet the criteria for derivative liability classification, initially
measured at fair value. Subsequent changes in fair value are recognized through earnings for as long as the contracts continue to be
classified as a liability. The measurement of fair value is determined utilizing an appropriate valuation model considering all relevant
assumptions current at the date of issuance and at each reporting period (i.e., share price, exercise price, term, volatility, risk-free
rate and expected dividend rate).
(c)
Series A Preferred Stock Conversions
|
i. |
Three
month period ended March 31, 2024 |
During
the three month period ended March 31, 2024, 3i exercised its option to convert 202 shares of Series A Preferred Stock for 27,092 shares
of common stock at the fair value of $269. As of March 31, 2024, we had 1,215 shares of Series A Preferred Stock issued and outstanding.
See Note 17(a) i.
|
ii. |
Three
month period ended March 31, 2023 |
During
the three month period ended March 31, 2023, 3i exercised its option to convert 3,838 shares of Series A Preferred Stock for 902 shares
of common stock at the fair value of $565. As of March 31, 2023, we had 9,748 shares of Series A Preferred Stock issued and outstanding.
The
accounting for the Series A Preferred Stock and Warrants is illustrated in the table below:
| |
Consolidated Balance Sheets | | |
Consolidated Statement of Operations & Comprehensive Loss | |
| |
3i Exchange
Warrant liability | | |
Series A Preferred Stock | | |
Common Stock | | |
Additional paid-in capital | | |
Fair value adjustment to derivative and warrant liabilities | |
Balances at December 31, 2023 | |
$ | 820 | | |
$ | 1,742 | | |
$ | — | | |
$ | (7,208 | ) | |
$ | — | |
Conversion of 202 Series A Preferred Stock, net | |
| — | | |
| (269 | ) | |
| — | | |
| 269 | | |
| — | |
Extinguishment of Series A Preferred Stock | |
| | | |
| (191 | ) | |
| | | |
| 191 | | |
| | |
Deemed dividend on January 14, 2024, modification | |
| — | | |
| 228 | | |
| — | | |
| (228 | ) | |
| — | |
Fair value adjustment at March 31, 2024 | |
| 736 | | |
| — | | |
| — | | |
| — | | |
| (736 | ) |
| |
$ | 1,556 | | |
$ | 1,510 | | |
$ | — | | |
$ | (6,976 | ) | |
$ | (736 | ) |
| |
Consolidated Balance Sheets | | |
Consolidated Statement of Operations & Comprehensive Loss | |
| |
3i Exchange
Warrant liability | | |
Series A Convertible Preferred Stock – Mezzanine Equity | | |
Common Stock | | |
Additional paid-in capital | | |
Fair value adjustment to derivative and warrant liabilities | |
Balances at December 31, 2022 | |
$ | 374 | | |
$ | 2,001 | | |
$ | — | | |
$ | (3,756 | ) | |
$ | — | |
Conversion of 3,838 Series A Preferred Stock, net | |
| — | | |
| (575 | ) | |
| — | | |
| 575 | | |
| — | |
Fair value adjustment at March 31, 2023 | |
| (309 | ) | |
| — | | |
| — | | |
| — | | |
| 309 | |
| |
$ | 65 | | |
$ | 1,426 | | |
$ | — | | |
$ | (3,181 | ) | |
$ | 309 | |
B. |
Series
C Convertible Preferred Stock |
On February 28, 2023, the
Company entered into a Securities Purchase Agreement (the “2023 SPA”) with 3i for the purchase and sale of 50,000 shares
of Series C Convertible Redeemable Preferred Stock (“Series C Preferred Stock”) at a purchase price of $24.00 per share,
for a subscription receivable in the aggregate amount equal to the total purchase price of $1.2 million (the “Series C Offering”).
The 50,000 shares of Series C Preferred Stock (the “Shares”) are convertible into shares of the Company’s Common Stock,
subject to the terms of the Series C Certificate of Designation (“Series C COD”).
The
Company evaluated the terms of the Series C Preferred Stock as required pursuant to ASC 570, 480, 815 and ASU 2020-06, and concluded
the Series C Preferred Stock will be recorded at fair value of $1,200, net of share issuance costs of $40, and accreted to redemption
value of $1,485 on April 21, 2023, using the effective interest method. The Company will also accrue dividends of 5%. The roll forward
of the Series C Preferred Stock as of March 31, 2023, is as follows:
|
|
March 31,
2023 |
|
Series
C Preferred Stock, cash received |
|
$ |
1,200 |
|
Less
debt discount, opening |
|
|
(40 |
) |
Plus, 5% dividend and accretion |
|
|
167 |
|
Series
C Preferred Stock – net, ending balance |
|
$ |
1,327 |
|
Effective
April 21, 2023, all of the 50,000 shares of Series C Preferred stock were exchanged for Series A Preferred Stock.
8.
Derivative Liabilities
| (a) | Continuity
of Common Share Purchase Warrant and 3i Warrant Derivative Liabilities |
The
Common Share Purchase Warrants, comprised of the April 2023, July 2023 and September 2023 Inducement Warrants, and 3i Exchange Warrant
derivative liabilities are measured at fair value at each reporting period and the reconciliation of changes in fair value the year ended
December 31, 2023, and for the three month period ended March 31, 2024, is presented in the following tables:
| |
Common Share Purchase Warrants | | |
3i Exchange Warrants | |
Balance as of January 1, 2023 | |
$ | — | | |
$ | 374 | |
Issuance date fair value of April, July & September 2023 Common share purchase warrants | |
| 15,161 | | |
| — | |
Modifications to fair value upon exercise | |
| 592 | | |
| — | |
Change in fair value adjustment of derivative and warrant liabilities | |
| (11,911 | ) | |
| 1,477 | |
Amount transferred to Equity | |
| (1,579 | ) | |
| (1,031 | ) |
Balance as of December 31, 2023 | |
$ | 2,263 | | |
$ | 820 | |
Fair value per Common warrant / 3i Warrant / issuable at period end | |
$ | 8.82 | | |
$ | 3.80 | |
| |
Common Share Purchase Warrants | | |
3i Exchange Warrants | |
Balance as of January 1, 2024 | |
$ | 2,263 | | |
$ | 820 | |
Change in fair value adjustment of derivative and warrant liabilities | |
| (1,155 | ) | |
| 736 | |
Balance as of March 31, 2024 | |
$ | 1,108 | | |
$ | 1,556 | |
Fair value per Common warrant / 3i Warrant / issuable at period end | |
$ | 4.32 | | |
$ | 2.40 | |
| (b) | Common
Share Purchase Warrants – Valuation Inputs |
On
March 31, 2024, the Company used the Black-Scholes Merton model to estimate the fair value of the Common Share Purchase Warrants derivative
liability at $1,108, using the following inputs:
|
|
April 2023
Warrants |
|
|
July 2023
Warrants |
|
|
September 2023
Inducement
Warrants |
|
Initial
exercise price |
|
$ |
20.00 |
|
|
$ |
20.00 |
|
|
$ |
20.00 |
|
Stock
price on valuation date |
|
$ |
6.02 |
|
|
$ |
6.02 |
|
|
$ |
6.02 |
|
Risk-free
rate |
|
|
4.19 |
% |
|
|
4.19 |
% |
|
|
4.13 |
% |
Term
(in years) |
|
|
4.28 |
|
|
|
4.28 |
|
|
|
4.95 |
|
Rounded
annual volatility |
|
|
123 |
% |
|
|
123 |
% |
|
|
121 |
% |
| (c) | 3i
Warrants – Valuation Inputs |
On March 31, 2024 and 2023,
the Company utilized the reset strike options Type 2 model by Espen Garder Haug and Black-Scholes Merton models to estimate the fair value
of the 3i Warrants to be approximately $65 and $2,265, respectively. The 3i Warrants were valued at March 31, 2024 and 2023, using the
following inputs:
| |
March 31, 2024 | | |
March 31, 2023 | |
Initial exercise price | |
$ | 0.35 | | |
$ | 9.91 | |
Stock price on valuation date | |
$ | 0.30 | | |
$ | 1.68 | |
Risk-free rate | |
| 5.09 | % | |
| 4.13 | % |
Expected life of the Warrant to convert (years) | |
| 0.72 | | |
| 1.73 | |
Rounded annual volatility | |
| 136 | % | |
| 175 | % |
Timing of liquidity event | |
| 6/30/2024 | | |
| 6/30/2023 | |
Expected probability of event | |
| 10 | % | |
| 90 | % |
The shares of Series A Preferred Stock converted in the three-month
periods ended March 31, 2024 and 2023, were recorded at $269 and $565, respectively.
9.
Stockholders’ Equity
(a) Amendment to Certificate of Incorporation
– Reverse Stock Split
On April 4, 2024, the Company
filed a Fifth Certificate of Amendment to the Certificate of Incorporation with the Delaware Secretary of State to effect a 1-for-20 share
consolidation of our shares of Common Stock effective as of April 9, 2024 (“Share Consolidation”). No fractional shares
were issued in connection with the Share Consolidation. If, as a result of the Share Consolidation, a stockholder would otherwise have
been entitled to a fractional share, each fractional share was rounded up to the next whole number. The Share Consolidation resulted in
a reduction of our outstanding shares of Common Stock as of March 31, 2024, from 6,854,604 to 342,774. The par value of our authorized
stock remained unchanged at $0.0001. As of the date of the Financial Statements all references to our Common Stock have been retrospectively
adjusted to reflect the one for 20 shares, unless otherwise noted. The Company is authorized to issue 750,500,000 shares, consisting of
(i) 750,000,000 shares of Common Stock, par value $0.0001 per share, and (ii) 500,000 shares of Preferred Stock, par value of $0.0001
per share.
(b)
Share issuances
|
i. |
Three
month period ended March 31, 2024 |
During
the three month period ended March 31, 2024,
| (a) | 3i exercised its option to convert 202 shares of Series A Preferred Stock for 27,092 shares of Common Stock at the fair value of $269. As of March 31, 2024, we had 1,215 shares of Series A Preferred Stock issued and outstanding. See Note 17(a) i; |
| (b) | The Company issued 14,500 shares of Common Stock valued at $90 to James G. Cullem (the Company’s former CEO) in exchange for consulting services; and |
| (c) | Pursuant to the terms of an ATM Offering, the Company issued and sold 6,792 shares of Common Stock in exchange for $40 in cash. |
|
i. |
Three month period ended March 31, 2023 |
During the three months ended
March 31, 2023, the Company issued 902 shares of Common Stock valued at $565, as a result of the conversion of 3,838 shares
of Series A Preferred Stock.
10.
Stock-based payment plan and stock-based payments
Amended
and Restated 2021 Equity Incentive Plan (the “Plan”)
During the three months ended
March 31, 2024, pursuant to approval by the Company’s Board of Directors, the Company has amended and restated the Plan as follows:
| i. | Number of shares available: increased the number of shares reserved and available for grant and issuance pursuant to the Plan to 108,416 Shares, plus an amount derived by the difference between 15% of the Company’s issued and outstanding shares of Common Stock issued in the Company’s Recapitalization Share Exchange covered by the Company’s registration statement on Form S-4 (SEC File No. 333-258968) and 108,416 Shares. For the sake of clarity, the initial number of Shares reserved and available for grant as of the date of adoption of the Plan by the Board is an amount equal to 15% of the Company’s issued and outstanding shares of Common Stock issued in the Company’s Recapitalization Share Exchange covered by the Company’s registration statement on Form S-4 (SEC File No. 333-258968). |
| ii. | Automatic Share Reserve Increase: The number of Shares available for grant and issuance under the Plan will be increased on January 1st of each of 2022 through 2031, by the lesser of (a) 5% of the number of shares of all classes of the Company’s common stock issued and outstanding on each December 31 immediately prior to the date of increase or (b) such number of Shares determined by the Board. |
Stock-based
payments
During
the three months ended March 31, 2024, total stock-based payment (recoveries) / expenses recorded in the condensed consolidated statement
of operations and comprehensive loss were ($32), of which ($21) and ($11) are recognized as general and administrative and research and
development recoveries, respectively. During the three months ended March 31, 2023, total stock-based payment (recoveries) / expenses
recorded in the condensed consolidated statement of operations and comprehensive loss were ($121), of which ($82) and ($39) are recognized
as general and administrative and research and development recoveries, respectively.
Total compensation cost for non-vested warrants as at March 31,
2024, is $32 and is expected to be realized through the end of December 31, 2024. During the three-month periods ended March 31, 2024,
and 2023, no options were granted.
A
summary of stock option activity under the Company’s stock option plans during the three-month period ended March 31, 2024,
is presented below:
| |
Options Outstanding | |
| |
Number of Shares | | |
Weighted Average Exercise Price Share | | |
Weighted Average Life (in years) | |
Outstanding December 31, 2023 | |
| 19 | | |
$ | 157,520 | | |
| 3.16 | |
Cancelled or expired | |
| (5 | ) | |
| 186,504 | | |
| — | |
Outstanding as of March 31, 2024 | |
| 14 | | |
$ | 104,354 | | |
| 2.81 | |
Options exercisable at March 31, 2024 | |
| 13 | | |
$ | 27,006 | | |
| 2.81 | |
11.
License and Development Agreements
(a)
License Agreement with Novartis for Dovitinib
On January 26, 2024, we received
a termination notice from Novartis due to a material breach of the License Agreement. Accordingly, under the terms of the License Agreement,
the Company ceased all development and commercialization activities with respect to all licensed products, all rights and licenses granted
by Novartis to the Company reverted to Novartis; and all liabilities due to Novartis became immediately due and payable inclusive of interest
which is continuing to accrue at 5% per annum. As of March 31, 2024, the liability is recorded as a current liability on the Company’s
condensed unaudited consolidated balance sheets as follows: $3,600 in accounts payable, $1,317 convertible promissory notes and accrued
interest, net of debt discount, and $147 in accrued liabilities.
(b)
License Agreement with Eisai Inc. for Stenoparib
The
Company holds the exclusive worldwide rights to all preventative, therapeutic and/or diagnostic uses related to cancer in humans and
by amendment to the agreement on December 11, 2020, viral infections in humans (including, but not limited to, coronaviruses) for Stenoparib
from Eisai, Inc. (“Eisai”) pursuant to a license agreement (the “Eisai License Agreement”). Pursuant to the Eisai
License Agreement, the Company is solely responsible for the development of Stenoparib during the term of the Eisai License Agreement.
Eisai License Agreement also provides for a joint development committee consisting of six members, three appointed by us and three appointed
by Eisai. One of the Company’s members of the joint development committee is designated chair of the committee and has the power
to break any deadlock in decisions by the committee that must be made by a majority vote with each representative having one vote. The
purpose of the committee is to implement and oversee development activities for Stenoparib pursuant to the clinical development plan,
serving as a forum for exchanging data, information and development strategy.
Effective July 12, 2022, the
Company’s July 6, 2017 Exclusive License Agreement with Eisai Inc. (the “Third Amendment”), the terms of the original
exclusive license were further amended in order to (1) further postpone the due date of the extension payment and extend the deadline
for the Company’s successful completion of its first Phase 1b or Phase 2 clinical trial for Stenoparib beyond December 31,
2022; and (2) amend terms related to Eisai’s right of termination of development.
On May 26, 2023, the Company
and Eisai entered into a fourth amendment to the Exclusive License Agreement with an effective date of May 16, 2023, to postpone the extension
payment, restructure the payment schedule and extend the deadline to complete enrollment in a further Phase 1b or Phase 2 Clinical Trial
for the Stenoparib. The Company agreed to pay Eisai in periodic payments as follows: (i) $100, which has been paid; (ii) $50 within 10
days of execution of the fourth amendment, which has been paid; (iii) $100 upon completion of a capital raise, which has been paid; and
(iv) $850 on or before March 1, 2024.
On February 26, 2024, in exchange
for an additional $150, paid as of May 1, 2024, the Company and Eisai entered into a fifth amendment to the Exclusive License Agreement
to postpone the payment of $850 until the completion of a ten million dollar financing, expected to be completed before the end of May
2024, but in no event later than September 1, 2024.
Development
Milestone Payments
The
Company has agreed to make milestone payments to Eisai in connection with the development of Stenoparib by the Company or its affiliates,
or by a third-party program acquirer that assumes control of the Stenoparib development program from the Company corresponding to: (i) successful
completion of a Phase 2 clinical trial; (ii) upon dosing of the first patient in the first Phase 3 clinical trial; (iii) upon
submission of the first NDA with the FDA; (iv) submission of an MAA to the EMA; (v) submission of an NDA to the MHLW in Japan;
(vi) upon receipt of authorization by the FDA to market and sell a licensed product; (vii) upon receipt of approval of an MAA
by the EMA for a licensed product; and (viii) upon receipt of approval by the MHLW in Japan for a licensed product. If all milestones
have been achieved, the Company may be obligated to pay Eisai up to a maximum of $94 million. In addition, the Company has agreed to pay
Eisai a one-time sales milestone payment in the amount of $50 million the first time the Company’s annual sales of licensed product
is $1 billion or more.
Royalty
Payments
In addition to the milestone
payments described above, the Company has agreed to pay Eisai royalties based on annual incremental sales of product derived from Stenoparib
in an amount between 5% and 10% of annual sales of between $0 and $100 million, between 6% and 10% of annual sales between $100 million
and $250 million, between 7% and 11% of annual sales between $250 million and $500 million, and between 11% and 15% of annual sales in
excess of $500 million.
The Company is obligated to
pay royalties under the agreement on a country-by-country and product-by-product basis for a period that commences with the first commercial
sale of a product until the later of (i) the expiration of the last to expire valid claim of any licensed patent covering such licensed
product in such country; or, (ii) the expiration of regulatory-based exclusivity for such licensed product in such country or (iii) the
15 year anniversary of the date of first commercial sale of such licensed product in such country. However, the agreement may be terminated
sooner without cause by the Company upon 120 days prior written notice, or upon written notice of a material breach of the agreement
by Eisai that is not cured within 90 days (30 days for a payment default).
Eisai
also has the right to terminate the agreement upon written notice of a material breach of the agreement by the Company that is not cured
within 90 days (30 days for a payment default) or if the Company files for bankruptcy. By an amendment effective as of August
3, 2021, and executed by Eisai on August 23, 2021, Eisai also has the right to terminate the agreement if the Company does not complete
a Phase 2 clinical trial before December 31, 2022, unless we elect to pay a $1,000 extension payment (the “Extension Payment”).
Notwithstanding the foregoing, in the event the Company fails to enroll and dose at least 30 patients with the first dose of cancer drug
in the ongoing Phase 2 Ovarian Cancer Clinical Trial by July 1, 2022, then the Extension Payment will be due and payable in fully by July
30, 2022. In addition, if the Company fails to achieve successful completion of first Phase 2 Clinical Trial prior to December 31, 2022,
and does not elect to pay the Extension Payment then Eisai may terminate the agreement in its sole discretion pursuant to the terms of
the amendment.
Option
to Reacquire Rights to Stenoparib
For the period commencing
with enrollment of the first five patients in a Phase 2 clinical trial pursuant to the clinical development plan and ending 90 days following
successful completion of such Phase 2 clinical trial, Eisai has the option to reacquire our licensed rights to develop Stenoparib for
a purchase price equal to the fair market value of our rights, giving effect to the stage of development of Stenoparib that we have completed
under the agreement. The Company commenced a Phase 2 clinical trial April 15, 2019, and as of the date of the Financial Statements, Eisai
has not indicated an intention to exercise its repurchase option.
(c)
Development, Option and License Agreement with R-Pharm for IXEMPRA®
On March 1, 2019, the Company
entered into an option to in-license the rights to any and all therapeutic and/or diagnostic uses in humans for IXEMPRA®
in the European Union (Great Britain but excluding Switzerland and Lichtenstein) (the “Territory”) from R-Pharm U.S. Operating,
LLC (“R-Pharm”), pursuant to a Development, Option and License Agreement (the “Option”). By an amendment to the
agreement dated August 4, 2022, for no consideration, the Option will expire on September 1, 2023, if not exercised by the Company before
then. The Option provides a right of extension, should we elect, for an additional $250. As of the date of this Quarterly Report, the
Company has not extended the option with R-Pharm.
12.
Related party
During
the three month periods March 31, 2024 and 2023, a director of the Company was paid $125 and $45 respectively, in fees as a consultant.
13.
Loss per share of common stock
Basic loss per share is derived
by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during each
period. Diluted loss per share includes the effect, if any, of the potential exercise or conversion of securities, such as warrants and
stock options, which would result in the issuance of incremental shares of common stock unless such effect is anti-dilutive. In calculating
the basic and diluted net loss per share applicable to common stockholders, the weighted average number of shares remained the same for
both calculations because when a net loss exists, dilutive shares are not included in the calculation. Potentially dilutive securities
outstanding, as determined by the latest applicable conversion price, that have been excluded from diluted loss per share due to being
anti-dilutive include the following:
| |
March 31, | | |
March 31, | |
| |
2024 | | |
2023 | |
Warrants and stock options | |
| 886,104 | | |
| 94 | |
Series A Convertible Preferred stock | |
| 535,286 | | |
| 190 | |
Series C Convertible Preferred stock | |
| — | | |
| 48 | |
Convertible debt | |
| 213,549 | | |
| 1,984 | |
| |
| 1,634,939 | | |
| 2,316 | |
14.
Financial Instruments
The
following tables present information about the Company’s financial instruments measured at fair value on a recurring basis and
indicate the level of the fair value hierarchy used to determine such fair values:
| |
Fair Value Measurements as of March 31, 2024, Using: | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
Liabilities: | |
| | |
| | |
| | |
| |
Warrant liability | |
$ | — | | |
$ | — | | |
$ | (1,107 | ) | |
$ | (1,107 | ) |
Derivative warrant liability | |
| — | | |
| — | | |
| (1,556 | ) | |
| (1,556 | ) |
| |
$ | — | | |
$ | — | | |
$ | (2,663 | ) | |
$ | (2,663 | ) |
| |
Fair Value Measurements as of December 31, 2023, Using: | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
Liabilities: | |
| | |
| | |
| | |
| |
Warrant liability | |
$ | — | | |
$ | — | | |
$ | (2,263 | ) | |
$ | (2,263 | ) |
Derivative warrant liability | |
| — | | |
| — | | |
| (820 | ) | |
| (820 | ) |
| |
$ | — | | |
$ | — | | |
$ | (3,083 | ) | |
$ | (3,083 | ) |
Methods used to estimate the
fair values of our financial instruments, not disclosed elsewhere in the Financial Statements, are as follows:
When available, the Company’s
marketable securities are valued using quoted prices for identical instruments in active markets. If the Company is unable to value its
marketable securities using quoted prices for identical instruments in active markets, the Company values its investments using broker
reports that utilize quoted market prices for comparable instruments. The Company has no financial assets or liabilities measured using
Level 2 inputs. Financial assets and liabilities are considered Level 3 when their fair values are determined using pricing models, discounted
cash flow methodologies, or similar techniques, and at least one significant model assumption or input is unobservable.
The Company recognizes its
derivative liabilities as Level 3 and values its derivatives using the methods discussed below. While the Company believes that its valuation
methods are appropriate and consistent with other market participants, it recognizes that the use of different methodologies or assumptions
to determine the fair value of certain financial instruments could result in a different estimate of fair value at the reporting date.
The primary assumptions that would significantly affect the fair values using terms in the notes that are subject to volatility and market
price of the underlying shares of Common Stock.
The Company reviews the fair
value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification
of levels for certain securities within the fair value hierarchy. The Company’s policy is to recognize transfers into and out of
levels within the fair value hierarchy at the date the actual event or change in circumstances that caused the transfer occurs. When a
determination is made to classify an asset or liability within Level 3, the determination is based upon the significance of the unobservable
inputs to the overall fair value measurement. There were no transfers between Level 1 or Level 2 during the three-month periods ended
March 31, 2024 and 2023.
15.
Income Taxes
The effective tax rate for
the three-month periods ended March 31, 2024 and 2023, was not impacted by unbenefited losses.
16.
Commitments and Contingencies
(a)
SEC Request
In
January 2023, the Company received a request to produce documents from the SEC that stated that the staff of the SEC is conducting an
investigation known as “In the Matter of Allarity Therapeutics, Inc.” to determine if violations of the federal securities
laws have occurred. The documents requested appear to focus on submissions, communications, and meetings with the FDA regarding our NDA
for Dovitinib or Dovitinib-DRP. The SEC letter also stated that investigation is a fact-finding inquiry and does not mean that that the
SEC has concluded that the Company or anyone else has violated the laws. As a result of the disclosure of the SEC request, The Nasdaq
Stock Market LLC (“Nasdaq”) staff has also requested us to provide them with the information requested by the SEC in which
the Company is complying.
(b)
Nasdaq Delisting Notifications
On February 1, 2024, the
Company attended a de-listing appeal hearing with Nasdaq, and on March 12, 2024, the Company received a response from Nasdaq granting
the Company’s request to continue its listing on Nasdaq subject to the requirement that on or before April 24, 2024, the Company
shall demonstrate compliance with the Bid Price and on Equity Rules. On April 27, 2024, we received a confirmation from Nasdaq that the
Company has regained compliance with the minimum bid price requirement in Listing Rule 5550(a)(2) (the “Bid Price Rule”),
as required by the Hearing Panel’s (“Panel”) decision of March 12, 2024. As a result of the capital raise under the
ATM Offering, the Company has communicated to Nasdaq its belief that it has achieved compliance with the Equity Rules, subject to a confirmation
from Nasdaq.
17.
Subsequent Events
For the Financial Statements,
and for the three months then ended, the Company evaluated subsequent events through the date on which the Financial Statements were issued.
All subsequent events not disclosed elsewhere in this Quarterly Report are disclosed below.
(a)
3i LP Transactions
During the period April
1, 2024, through May 6, 2024, 3i:
| i. | converted 1,215 Series A Preferred Stock for 452,131 shares of Common Stock at prices of between $1.15 and $7.00 per share (as of the date of the Financial Statements, all Series A Preferred Stock have been converted and there are no outstanding shares of Series A Preferred Stock); |
| ii. | converted 252,272 Exchange Warrants on a cashless basis for 84,712 shares of Common Stock at $2.30 per share of Common Stock on April 12, 2024, and 3,432,366 Exchange Warrants on a cashless basis for 2,274,938 shares of Common Stock at $1.15 per share of Common Stock (as of the date of the Financial Statements, there are no outstanding Exchange Warrants); and |
| iii. | completely redeemed the 2024 Notes and interest for cash in the amount of $1,747, inclusive of $1,540 principal and $207 interest. |
(b)
Amended and Restated COD of Series A Convertible Preferred Stock and Warrant Adjustments
During
the period April 1, 2024, through May 2, 2024, the Company has amended the conversion prices of the Series A Convertible Preferred Stock,
the Exchange Warrants and the 2024 Notes to equal the current last sale price of its shares of Common Stock of $1.15 as of May 1, 2024.
(c) ATM Offering – Sales
During
the period April 1, 2024 through May 13, 2024, the Company has sold 14,352,186 shares of its Common Stock for net proceeds of
$20,610.
(d)
Pro-forma Balance Sheet (unaudited)
The
following pro forma unaudited condensed consolidated balance sheet is provided to illustrate the impact of all subsequent event transactions
described in the foregoing subsequent events disclosure, as if they had occurred at March 31, 2024.
| |
As of March 31, 2024 (UNAUDITED) | |
(In thousands, except share data) | |
Actual | | |
Pro Forma | |
| |
| | |
| |
ASSETS | |
| | | |
| | |
Cash | |
$ | 312 | | |
$ | 19,135 | |
Total other current assets | |
| 1,983 | | |
| 1,983 | |
Total non-current assets | |
| 9,674 | | |
| 9,674 | |
Total assets | |
$ | 11,969 | | |
$ | 30,792 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDER’S EQUITY (DEFICIT) | |
| | | |
| | |
Total current liabilities | |
$ | 18,008 | | |
$ | 14,071 | |
Total non-current liabilities | |
| 432 | | |
| 432 | |
Total liabilities | |
| 18,440 | | |
| 14,503 | |
Shareholders equity (deficit) | |
| | | |
| | |
Total Redeemable preferred stock | |
| 1,689 | | |
| — | |
Additional paid-in capital | |
| 90,520 | | |
| | |
Accumulated other comprehensive loss | |
| (386 | ) | |
| (386 | ) |
Accumulated deficit | |
| (98,294 | ) | |
| (97,659 | ) |
Total Stockholders’ (deficit) equity | |
| (6,471 | ) | |
| 16,289 | |
Total liabilities and stockholders’ equity (deficit) | |
$ | 11,969 | | |
$ | 30,792 | |
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Forward-Looking Statements
You should read the
following discussion and analysis of our financial condition and results of operations together with “Cautionary Note Regarding
Forward-Looking Statements” and our condensed consolidated financial statements and related notes included under Item 1 of this
Quarterly Report as well as our most recent Annual Report on Form 10-K for the year ended December 31, 2023, as amended, including Part
1, Item 1A “Risk Factors.”
Overview
We
are a biopharmaceutical company focused on discovering and developing highly targeted anti-cancer drug candidates. Through the use of
its Drug Response Predictor (DRP®) platform, we identify the value in drug assets that have otherwise been discontinued
by identifying patient populations where these drugs are active. Our lead drug candidate is:, the poly-ADP-ribose polymerase (PARP)
inhibitor stenoparib, or Stenoparib.
Recent
Developments
NASDAQ
Delisting Notifications
On February 1, 2024, the
Company attended a de-listing appeal hearing with Nasdaq, and on March 12, 2024, the Company received a response from Nasdaq granting
the Company’s request to continue its listing on Nasdaq subject to the requirement that on or before April 24, 2024, the Company
shall demonstrate compliance with the Bid Price and on Equity Rules. On April 27, 2024, we received a confirmation from Nasdaq that the
Company has regained compliance with the minimum bid price requirement in Listing Rule 5550(a)(2) (the “Bid Price Rule”),
as required by the Hearing Panel’s (“Panel”) decision of March 12, 2024. As a result of the capital raise under the
ATM Offering, the Company has communicated to Nasdaq its belief that it has achieved compliance with the Equity Rules, subject to a confirmation
from Nasdaq.
Amendments
to the Certificate of Designation of Series A Preferred Stock
On January 14, 2024, pursuant
to the terms of the First Note, the Company modified the conversion price of the 3i Exchange Warrants from $20.00 to $8.95, thereby increasing
the number of Exchange Warrants outstanding from 220,361 at December 31, 2023 to 492,317 outstanding at January 14, 2024. Also on January 14,
2024, the conversion price of the outstanding 1,417 shares of Series A Preferred Stock was revised from $20.00 to $8.95. The Company filed
the Fifth Certificate of Amendment to Amended and Restated COD (the “Fifth Amendment”) with the Secretary of State of the
State of Delaware to reflect the new conversion price of the Series A Preferred Stock of $8.95. As of January 14, 2024, the Company used
the Black-Scholes option pricing model to determine the fair value of the 1,417 Series A Preferred Stock outstanding at $1,970 versus
their carrying value of $1,742. Accordingly, the Company has recorded a deemed dividend of $228 as at January 14, 2024. At a stated value
of $1,080 for each share of Series A Preferred Stock, the revised price of $8.95 per share results in the 1,417 shares being convertible
into 170,952 shares of Common Stock as of January 14, 2024.
On February 13, 2024, pursuant
to the terms of the Second Note, the Company modified the conversion price of the 3i Exchange Warrants from $8.95 to $8.10 and thereby
increased the number of Exchange Warrants outstanding from 492,317 on January 18, 2024, to 544,101 on February 13, 2024. The Company filed
the Sixth Certificate of Amendment to Amended and Restated COD (the “Sixth Amendment”) with the Secretary of State of the
State of Delaware to reflect the new conversion price of the Series A Preferred Stock of $8.10. As of February 14, 2024, the Company used
the Black-Scholes option pricing model to determine the fair value of the then 1,296 Series A Preferred Stock outstanding and concluded
there was a gain on extinguishment of $122. At a stated value of $1,080 for each share of Series A Preferred Stock, the revised price
of $8.10 per share results in the 1,296 shares being convertible into 493,573 shares of Common Stock.
On March 14, 2024, pursuant
to the terms of the Third Note, the Company modified the conversion price of the 3i Exchange Warrants from $8.10 to $7.00 and thereby
increased the number of Exchange Warrants outstanding from 544,101 on February 13, 2024, to 829,423 on March 14, 2024. The Company filed
the Seventh Certificate of Amendment to Amended and Restated COD (the “Seventh Amendment”) with the Secretary of State of
the State of Delaware to reflect the new conversion price of the Series A Preferred Stock of $7.00. As of March 14, 2024, the Company
used the Black-Scholes option pricing model to determine the fair value of the then 1,296 Series A Preferred Stock outstanding and concluded
there was a gain on extinguishment of $69. At a stated value of $1,080 for each share of Series A Preferred Stock, the revised price of
$7.00 per share results in the 1,215 shares being convertible into 535,286 shares of Common Stock.
During
the period April 1, 2024, through the date of this Quarterly Report, the Company has further amended the conversion prices of the Series
A Convertible Preferred Stock, the Exchange Warrants and the 2024 Notes to equal the current last sale price of shares of its common
stock of $1.15 as of May 1, 2024.
Special
Meeting of Stockholders; Share Consolidation
On April 1, 2024, we held
a Special Meeting of Stockholders (the “Special Meeting”) for our stockholders of record of our outstanding shares of Common
Stock and Series A Preferred Stock. At the Special Meeting, the stockholders of Common Stock and Series A Preferred Stock approved an
amendment to our Certificate of Incorporation, to, at the discretion of the Company’s board and after the Company’s stockholders’
approval, effected the Reverse Stock Split. In addition, the Company filed a Fifth Certificate of Amendment of the COD in Delware.
We effected a 1-for-20 share
consolidation of our Common Stock on April 9, 2024 (“Share Consolidation”). No fractional shares were issued in connection
with the Share Consolidation. If, as a result of the Share Consolidation, a stockholder would otherwise have been entitled to a fractional
share, each fractional share was rounded up to the next whole number. The Share Consolidation resulted in a reduction of our outstanding
shares of Common Stock on March 31, 2024 from 6,854,604 to 342,774. The par value of our authorized stock remained unchanged at $0.0001.
3i Transactions
During the period April 1, 2024, through May 6,
2024, 3i:
i. converted 1,215 Series
A Preferred Stock for 452,131 shares of Common Stock at prices of between $1.15 and $7.00 per share (as of the date of the Financial Statements,
all Series A Preferred Stock have been converted and there are no outstanding shares of Series A Preferred Stock);
ii. converted 200,000 Exchange
Warrants on a cashless basis for 84,712 shares of Common Stock at $2.30 per share on April 12 2024 and 3,432,366 Exchange Warrants at
$1.15 per share for 2,274,938 shares of Common Stock on May 2, 2024 (as of the date of the Financial Statements, there are no outstanding
Exchange Warrants); and
iii. completely
redeemed all of the 3i 2024 Notes and interest for cash in the amount of $1,746, inclusive of principal of $1,540 and interest of $123,200.
Risks
and Uncertainties
The
Company is subject to risks common to companies in the biotechnology industry, including but not limited to, risks of failure of preclinical
studies and clinical trials, the need to obtain marketing approval for any drug product candidate that it may identify and develop, the
need to successfully commercialize and gain market acceptance of its product candidates, dependence on key personnel and collaboration
partners, protection of proprietary technology, compliance with government regulations, development by competitors of technological innovations,
and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant
additional research and development efforts, including preclinical and clinical testing and regulatory approval prior to commercialization.
Even if the Company’s research and development efforts are successful, it is uncertain when, if ever, the Company will realize
significant revenue from product sales.
Financial
Operations Overview
Since
our inception in September of 2004, we have focused substantially all our resources on conducting research and development activities,
including drug discovery and preclinical studies, establishing, and maintaining our intellectual property portfolio, the manufacturing
of clinical and research material, hiring personnel, raising capital and providing general and administrative support for these operations.
In recent years, we have recorded very limited revenue from collaboration activities, or any other sources. We have funded our operations
to date primarily from convertible notes and the issuance and sale of our ordinary shares.
We
have incurred net losses in each year since inception. Our net losses were $3.8 million and $3.4 million for the three months ended March
31, 2024 and 2023, respectively. As of March 31, 2024, we had an accumulated deficit of $98.3 million and cash of $312 thousand. Substantially
all our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative
costs associated with our operations. We expect to continue to incur significant expenses and increasing operating losses over at least
the next several years. We expect our expenses will increase substantially in connection with our ongoing activities, as we:
|
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advance
drug candidates through clinical trials; |
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pursue
regulatory approval of drug candidates; |
|
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operate
as a public company; |
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continue
our preclinical programs and clinical development efforts; |
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continue
research activities for the discovery of new drug candidates; and |
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manufacture
supplies for our preclinical studies and clinical trials. |
Components
of Operating Expenses
Research
and Development Expenses
Research
and development expenses include:
|
● |
expenses
incurred under agreements with third-party contract organizations, and consultants; |
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|
● |
costs
related to production of drug substance, including fees paid to contract manufacturers; |
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● |
laboratory
and vendor expenses related to the execution of preclinical trials; and |
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employee-related
expenses, which include salaries, benefits, and stock-based compensation. |
We expense all research and
development costs in the periods in which they are incurred. Costs for certain development activities are recognized based on an evaluation
of the progress to completion of specific tasks and estimates of services performed using information and data provided to us by our
vendors and third-party service providers. Non-refundable advance payments for goods or services to be received in future periods for
use in research and development activities are deferred and accounted for as prepaid expenses. The prepayments are then expensed as the
related goods are delivered and as services are performed. To date, most of these expenses have been incurred to advance our lead drug
candidate Stenoparib.
We expect our research and
development expenses on Stenoparib to increase substantially for the foreseeable future as we continue to invest to accelerate Stenoparib
in clinical trials designed to attain regulatory approval. Costs related to dovitinib and IXEMPRA will decrease precipitously as these
have been deprioritized/ terminated. We expect additional costs in research and development activities as we continue to conduct clinical
trials. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the
successful development of our drug candidates is highly uncertain. As a result, we are unable to determine the duration and completion
costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale
of any of our drug candidates.
General
and Administrative Expenses
General and administrative
expenses consist primarily of personnel-related costs, facilities costs, depreciation and amortization expenses and professional services
expenses, including legal, human resources, audit, and accounting services. Personnel-related costs consist of salaries, benefits, and
stock-based compensation. Facilities costs consist of rent and maintenance of facilities. We expect our general and administrative expenses
to increase for the foreseeable future due to anticipated increases in headcount to advance our drug candidates and as a result of operating
as a public company, including expenses related to compliance with the rules and regulations of the SEC, Nasdaq, additional insurance
expenses, investor relations activities and other administrative and professional services.
Results
of Operations for the Three Months Ended March 31, 2024, and 2023 (unaudited) (in thousands, except where otherwise noted)
The
following table summarizes our results of operations for the three months ended March 31, 2024 and 2023:
| |
For the Three Months Ended March 31, | | |
Increase/ | |
| |
2024 | | |
2023 | | |
(Decrease) | |
| |
(In thousands) | | |
| |
Operating expenses: | |
| | |
| | |
| |
Research and development | |
$ | 2,170 | | |
$ | 1,427 | | |
$ | 743 | |
General and administrative | |
| 2,070 | | |
| 2,241 | | |
| (171 | ) |
Total operating expenses | |
| 4,240 | | |
| 3,668 | | |
| 572 | |
Loss from operations: | |
| (4,240 | ) | |
| (3,668 | ) | |
| (572 | ) |
Other income | |
| 393 | | |
| 316 | | |
| 77 | |
Net loss | |
$ | (3,847 | ) | |
$ | (3,352 | ) | |
$ | (491 | ) |
Research
and Development Expenses
For
the three months ended March 31, 2024, compared to March 31, 2023
The
increase of $743 thousand in research and development expenses was primarily because manufacturing and supplies expenses increased by
$524 thousand, research study expenses increased by $113 thousand, contractors and consultants expenses increased by $51 thousand, stock
based compensation expense increased by $28 thousand, and other research expense increased by $2 thousand; offset by increased tax credits
of $56 thousand, decreased staffing expenses of $71 thousand, and decreased amortization of $8 thousand. Manufacturing and supplies expenses
have increased because of increased drug manufacturing. Staffing and contractor costs have decreased as a result of cost-cutting measures.
General
and Administrative Expenses
General
and administrative expenses decreased by $171 thousand for the three months ended March 31, 2024, compared to March 31, 2023. The
decrease was primarily due to a decrease in insurance expense of $307 thousand, audit and legal expenses of $54 thousand, financial consultants’
expense of $39 thousand, communications expenses of $27 thousand, listings expenses of $16 thousand, finance expenses of $6 thousand,
and other expenses of $9 thousand; offset by increased staffing expenses of $115 thousand, and Delaware franchise tax of $162 thousand.
Staffing costs have increased as a result of severance accruals.
Other
Income (Expenses), Net
For
the three months ended March 31, 2024, compared to March 31, 2023
Other income (expense) of $393 thousand recognized in the three months
ended March 31, 2024, consisted primarily of a $419 thousand fair value adjustment to derivative and warrant liabilities and foreign
exchange gains of $76 thousand, offset by ($102) in interest expenses.
Other
income (expense) of $316 thousand recognized in the three months ended March 31, 2023, consisted primarily of a $309 thousand fair value
adjustment to derivative and warrant liabilities, foreign exchange gains of $95, and interest income of $4, offset by ($92) in interest
expenses.
Changes
in fair value of our derivative liabilities and convertible debt are measured using Level 3 inputs as described in our condensed consolidated
financial statements.
Liquidity,
Capital Resources and Plan of Operations
Since
our inception through March 31, 2024, our operations have been financed primarily by the sale of convertible promissory notes and the
sale and issuance of our securities. As of March 31, 2024, we had $312 in cash, and an accumulated deficit of $98.3 million. We had a
working capital deficit of $15.7 million.
Our primary use of cash is
to fund operating expenses, which consist of research and development as well as regulatory expenses related to our lead drug candidate
and clinical programs for Stenoparib, and to a lesser extent, general and administrative expenses. Cash used to fund operating expenses
is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.
As of March 31, 2024, the
Company’s cash deposits of $312 were determined to be insufficient to fund its current operating plan and planned capital expenditures
for the next month. On March 21, 2024, the Company commenced an at the market offering of its common shares and as of March 31,
2024, had sold 6,792 common shares for net proceeds of $40. Subsequent to March 31, 2024, an additional 8,259,150 shares of our common
stock were sold at the market for net proceeds of $15,572. In light of the Company’s cash position as of the date of this Quarterly
Report, the Company does not have sufficient funds for its current operations and planned capital expenditures. As discussed above the
Company intends to seek capital through sale of its securities or other sources. There are no assurances, however, that the Company will
be successful in raising additional working capital, or if it is able to raise additional working capital, it may be unable to do so
on commercially favorable terms. The Company’s failure to raise capital or enter into other such arrangements if and when needed
would have a negative impact on its business, results of operations and financial condition and its ability to develop its product candidates.
Management’s
plans to mitigate the conditions or events that raise substantial doubt include additional funding through public equity, private equity,
debt financing, collaboration partnerships, or other sources. We currently plan on completing an additional public offering in the near
future, however there are no assurances that the Company will be successful in raising additional working capital, or if it is able to
raise additional working capital, it may be unable to do so on commercially favorable terms. The Company’s failure to raise capital
or enter into other such arrangements when needed would have a negative impact on its business, results of operations and financial condition
and its ability to continue its plan of operations.
We
expect to incur substantial expenses in the foreseeable future for the development and potential commercialization of our drug candidates
and ongoing internal research and development programs. At this time, we cannot reasonably estimate the nature, timing, or aggregate
amount of costs for our development, potential commercialization, and internal research and development programs. However, to complete
our current and future preclinical studies and clinical trials, and to complete the process of obtaining regulatory approval for our
drug candidates, as well as to build the sales, marketing, and distribution infrastructure that we believe will be necessary to commercialize
our drug candidates, if approved, we may require substantial additional funding in the future.
Contractual
Obligations and Commitments
We
enter into agreements in the normal course of business with vendors for preclinical studies, clinical trials, and other service providers
for operating purposes. We have not included these payments in the table of contractual obligations above since these contracts are generally
cancellable at any time by us following a certain period after notice and therefore, we believe that our non-cancellable obligations
under these agreements are not material.
Cash
Flows
The
following table summarizes our cash flows for the periods indicated:
| |
For the three months ended March 31, | |
| |
2024 | | |
2023 | |
| |
(In thousands) | |
Net cash flows used in operating activities | |
$ | (1,487 | ) | |
$ | (3,201 | ) |
Net cash flows provided by financing activities | |
| 1,380 | | |
| 1,158 | |
Effect of foreign exchange rates on cash | |
| 253 | | |
| 309 | |
Net increase (decrease) in cash | |
$ | 146 | | |
$ | (1,734 | ) |
Operating
Activities
For
the three months ended March 31, 2024, net cash used in operating activities was approximately $1.5 million compared to approximately
$3.2 million for the three months ended March 31, 2023. The $1.7 million decrease in net cash used in operating activities was primarily
the result of an increase in cash provided non-cash operating assets of $2.3 million, offset by an increased loss of $500 thousand and
higher non-cash operating expenses of $100 thousand.
Investing
Activities
In the three months ended
March 31, 2024, and 2023, there were no cash flows from investing activities.
Financing Activities
For
the three months ended March 31, 2024, net cash provided by financing activities was approximately $1.4 million compared to $1.2 million
for the three months ended March 31, 2023. The increase in net cash provided by investing activities was primarily due to proceeds from
the sale of the 2024 Notes to 3i during the three months ended March 31, 2024.
Operating
Capital and Capital Expenditure Requirements
We believe that our existing cash and cash equivalents and our anticipated
expenditures and commitments for the next twelve months, will not enable us to fund our operating expenses and capital expenditure requirements
for at least twelve months from the date of this Quarterly Report. Our estimate as to how long we expect our cash to be able to continue
to fund our operations is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than
we currently expect. Further, changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly
faster than we currently anticipate, and we may need to seek additional funds sooner than planned.
Off-Balance
Sheet Arrangements
The
Company does not have any off-balance sheet arrangements.
Critical
Accounting Policies and Significant Judgments and Estimates
Our
management’s discussion and analysis of financial condition and results of operations is based upon our unaudited condensed interim
consolidated financial statements for the three months ended March 31, 2024 and 2023, and our audited consolidated financial statements
for the years ended December 31, 2023 and 2022, which have been prepared in accordance with U.S. GAAP. The preparation of these financial
statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses. On an on-going
basis, we evaluate our critical accounting policies and estimates. We base our estimates on historical experience and on various other
assumptions that we believe to be reasonable in the circumstances, the results of which form the basis for making judgments about the
carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates
under different assumptions and conditions.
Our
significant accounting policies are described in the notes to our consolidated financial statements for the years ended December 31,
2023 and 2022, included in the Form 10-K, and there have been no significant changes to our significant accounting policies during the
three months ended March 31, 2024. These unaudited condensed interim consolidated financial statements should be read in conjunction
with the Company’s audited financial statements and accompanying notes.
Recently Issued Accounting Pronouncements
See the sections titled “Recently
adopted accounting pronouncements” in Note 2(cc) and “Recently issued accounting pronouncements not yet adopted”
in Note 2(x) to the Company’s consolidated financial statements for the years ended December 31, 2023 and 2022, respectively,
appearing in the Form 10-K; and in Note 2(h) to the Company’s unaudited condensed interim consolidated financial statements
for the three months ended March 31, 2024 and 2023.
Item 3. Quantitative
and Qualitative Disclosures About Market Risk.
We are a smaller reporting
company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information under this item.
Item 4. Controls and
Procedures.
Evaluation of Disclosure
Controls and Procedures
Under the supervision and
with the participation of our management and consultants, including our Chief Executive Officer and our Chief Financial Officer, we have
conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as of March 31, 2024,
as such term is defined in Rules 13a-15I and 15d-15(e) of the Exchange Act. Based upon the foregoing, our Chief Executive Officer and
our Chief Financial Officer concluded that our disclosure controls and procedures were effective as of March 31, 2024.
Changes in Internal Control Over Financial
Reporting
There were no changes in our
internal control over financial reporting that occurred during the quarter ended March 31, 2024, 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.
From
time to time in the future, we may become involved in litigation or other legal proceedings that arise in the ordinary course of business.
We are not currently party to any legal proceedings, and we are not aware of any pending or threatened litigation against us that we
believe could have a material adverse effect on our business, operating results or financial condition. In the event we are subject to
a legal proceeding, it could have a material adverse impact on us because of litigation costs and diversion of management resources.
Item
1A. Risk Factors.
There
are no material changes to the “Risk Factors” set forth in the Form 10-K.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
In March 19, 2024, we entered
into an At-The-Market Issuance Sales Agreement, as may be amended from time to time (the “Sales Agreement”) with Ascendiant
Capital Markets, LLC (“Ascendiant”) under which we may, from time to time, issue and sell shares of our Common Stock having
aggregate sales proceeds of up to $22 million, in a series of one or more “at-the-market” equity offerings (the “ATM
Program”). Ascendiant is not required to sell any specific share amounts but acts as our sales agent, using commercially reasonable
efforts consistent with its normal trading and sales practices. We agreed to pay Ascendiant a commission equal to 3.0% of the aggregate
gross proceeds we receive from each sale of shares of our Common Stock. Pursuant to the Sales Agreement, any shares will be sold pursuant
to our shelf registration statement on Form S-3 (File No. 333-275282) filed with the SEC on November 2, 2023, including the base prospectus
contained therein, as declared effective by the SEC on November 29, 2023. Shares of our Common Stock will be sold at prevailing market
prices at the time of the sale, and as a result, prices may vary.
During
the period April 1, 2024, through May 13, 2024, the Company has sold 14,352,186 shares of its Common Stock for net proceeds of $20,610.
Item
3. Defaults Upon Senior Securities.
For a discussion of the “Convertible Promissory Note Due to
Novartis” refer to Note 5 to the Condensed Consolidated Financial Statements (Unaudited) in Part I, Item 1 of this Quarterly
Report.
Item
4. Mine Safety Disclosures.
Not
applicable.
Item
5. Other Information.
Our 2024 annual meeting of stockholders will be delayed by more than
30 days from February 3, the anniversary date of the 2023 annual meeting of stockholders. Our board of directors has not yet determined
the date of the 2024 annual meeting of stockholders. We will provide all required information about the 2024 annual meeting of stockholders
when it becomes available.
Item
6. Exhibits.
See
the Exhibit Index to this Quarterly Report immediately below and before the signature page hereto, which Exhibit Index is incorporated
by reference as if fully set forth herein.
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Incorporated by Reference |
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Exhibit
Number |
|
Exhibit Description |
|
Form |
|
File
No. |
|
Exhibit |
|
Filing
Date |
|
Filed
Herewith |
3.1 |
|
Certificate of Incorporation |
|
S-4 |
|
333-258968 |
|
3.1 |
|
August 20, 2021 |
|
|
3.2 |
|
Certificate of Amendment to the Certificate of Incorporation of Allarity Therapeutics, Inc. |
|
S-4/A |
|
333-259484 |
|
3.3 |
|
September 29, 2021 |
|
|
3.3 |
|
Second Certificate of Amendment to Certificate of Incorporation of Allarity Therapeutics, Inc. |
|
8-K |
|
001-41160 |
|
3.1 |
|
March 20, 2023 |
|
|
3.4 |
|
Third Certificate of Amendment to Certificate of Incorporation of Allarity Therapeutics, Inc. |
|
8-K |
|
001-41160 |
|
3.1 |
|
March 24, 2023 |
|
|
3.5 |
|
Fourth Certificate of Amendment to Certificate of Incorporation of Allarity Therapeutics, Inc. |
|
8-K |
|
001-41160 |
|
3.1 |
|
June 28, 2023 |
|
|
3.6 |
|
Specimen Common Stock Certificate of Allarity Therapeutics, Inc. |
|
S-4/A |
|
333-259484 |
|
4.1 |
|
September 29, 2021 |
|
|
3.7 |
|
Amended and Restated Bylaws of Allarity Therapeutics, Inc. |
|
S-4/A |
|
333-259484 |
|
3.4 |
|
October 18, 2021 |
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3.8 |
|
Amendment No. 1 to Amended and Restated Bylaws of Allarity Therapeutics, Inc. |
|
8-K |
|
001-41160 |
|
3.1 |
|
July 11, 2022 |
|
|
4.1 |
|
Seventh Certificate of Amendment (Series A Preferred Stock) |
|
8-K |
|
001-41160 |
|
3.1 |
|
March 15, 2024 |
|
|
4.2 |
|
Senior Convertible Note, dated as of March 14, 2024 |
|
8-K |
|
001-41160 |
|
4.1 |
|
March 15, 2024 |
|
|
4.3 |
|
Sixth Certificate of Amendment (Series A Preferred Stock) |
|
8-K |
|
001-41160 |
|
3.1 |
|
February 14, 2024 |
|
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4.4 |
|
Senior Convertible Note, dated as of February 13, 2024 |
|
8-K |
|
001-41160 |
|
4.1 |
|
February 14, 2024 |
|
|
4.5 |
|
Fifth Certificate of Amendment (Series A Preferred Stock) |
|
8-K |
|
001-41160 |
|
3.1 |
|
January 19, 2024 |
|
|
4.6 |
|
Senior Convertible Note |
|
8-K |
|
001-41160 |
|
4.1 |
|
January 19, 2024 |
|
|
10.1 |
|
At-The-Market Issuance Sales Agreement, dated March 19, 2024, by and between Allarity Therapeutics, Inc. and Ascendiant Capital Markets, LLC |
|
8-K |
|
001-41160 |
|
10.1 |
|
March 20, 2024 |
|
|
10.2 |
|
Amendment Senior Convertible Notes |
|
8-K |
|
001-41160 |
|
10.1 |
|
March 1, 2024 |
|
|
10.3 |
|
Limited Waiver Agreement, dated as of February 13, 2024, by and between the Company and the Purchaser listed on the signature page attached thereto |
|
8-K |
|
001-41160 |
|
10.1 |
|
February 14, 2024 |
|
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10.4 |
|
Amendment to Securities Purchase Agreement, dated as of January 25, 2024, by and between the Company and the Purchaser listed on the signature page attached thereto |
|
8-K |
|
001-41160 |
|
10.1 |
|
January 25, 2024 |
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+
|
Certain
of the exhibits and schedules to this Exhibit have been omitted in accordance with Regulation S-K Item 601. The Registrant agrees
to furnish a copy of all omitted exhibits and schedules to the SEC upon its request. |
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† |
Indicates
management contract or compensatory plan or arrangement. |
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* |
Furnished herewith. |
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.
|
ALLARITY
THERAPEUTICS, INC., |
|
|
Date: May
14, 2024 |
By: |
/s/
Thomas H. Jensen |
|
|
Thomas
H. Jensen |
|
|
Chief Executive Officer
(Principal Executive Officer) |
|
|
Date: May
14, 2024 |
By: |
/s/
Joan Y. Brown |
|
|
Joan
Y. Brown |
|
|
Chief
Financial Officer
(Principal Financial and Accounting Officer) |
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WHEREAS, Mr. Cullem
was previously employed by Allarity as Chief Executive Officer, from in or around June 2022 until his separation on or around December
8, 2023;
WHEREAS, Mr. Cullem
and Allarity entered into an Employment Agreement (effective January 12, 2023), which Employment Agreement includes certain severance
payment provisions in the event of Mr. Cullem’s separation from the Company;
WHEREAS, Allarity
terminated Mr. Cullem’s employment on December 8, 2023 and has not paid him any severance payments pursuant to the Employment Agreement;
WHEREAS, on December
12, 2023, Mr. Cullem, through his counsel, sent a demand letter to Allarity alleging breach of contract, breach of the covenant of good
faith and fair dealing, and violations of the Massachusetts Wage Act (the “Asserted Claims”);
WHEREAS, Allarity
denies the Asserted Claims and further denies any wrongdoing whatsoever;
WHEREAS, the Parties,
through counsel, engaged in settlement discussions that resulted in an agreement in principle to fully and finally resolve all claims,
defenses, and disputes between Mr. Cullem and Allarity, whether known or unknown, including but not limited to the Asserted Claims;
WHEREAS, to avoid
the uncertainties and expenses of litigation, and to effectuate a compromise of the Parties’ respective legal positions without
any admission of wrongdoing or liability, the Parties now wish to memorialize through this Agreement the full and complete terms of their
agreement to fully and finally settle and resolve all disputes between them;
NOW, THEREFORE, in
consideration of the mutual promises contained herein, the recitals above which are hereby incorporated by reference, and other good and
valuable consideration as hereinafter recited, the receipt and adequacy of which is hereby acknowledged, the Parties agree as follows:
a. In
General: For valuable consideration, including Allarity’s promises described in Section 1 of this Agreement, the receipt
and adequacy of which is hereby acknowledged, Mr. Cullem agrees to release all claims he may now have against Allarity and other
parties as set forth in this Section 4 of the Agreement and all subsections thereof.
b. Released
Parties: The “Released Parties” are: (i) Allarity Therapeutics, Inc.; (ii) any affiliate of Allarity Therapeutics,
Inc., and any parent entities, subsidiary entities, or successor entities; (iii) each of Allarity Therapeutics, Inc.’s and its affiliates’
past and present employees, officers, trustees, directors, shareholders, owners, representatives, assigns, attorneys, agents, insurers;
and (iv) any other persons acting through or with any of the persons or entities listed in this subsection.
c. Claims
Released by Mr. Cullem: Mr. Cullem understands and agrees that under this Section, he is hereby, as of the Effective Date, releasing
all known and unknown claims, promises, demands, obligations, damages or rights of any type that he may have, including the Asserted Claims
(collectively, “Claims”) against any of the Released Parties, except that Mr. Cullem is not releasing any Claims that
relate to: (i) his right to enforce this Agreement; (ii) his right, if any, to claim government-provided unemployment benefits and/or
workers’ compensation benefits; (iii) any vested benefits that Mr. Cullem has under any employee benefit plan, including any claim
for disability insurance; and (iv) the in-force Indemnification Agreement between the Company and Mr. Cullem (effective date August 2,
2022). Mr. Cullem understands that the Claims he is releasing may arise under many different laws (including but not limited to statutes,
regulations, other administrative guidance, and common law doctrines), including, but by no means limited to:
d. Sole
Remedy: Mr. Cullem hereby expressly acknowledges that, unless this Agreement is rendered null and void pursuant to Section 1(d), the
releases contained in this Section 4 are valid and binding upon execution of this Agreement. In the event that Allarity fails to satisfy
any of the promises contained in Section 1, Mr. Cullem acknowledges that the releases contained in this Section 4 survive such breach,
and that Mr. Cullem’s sole remedy shall be an action for damages for breach of this Agreement against Allarity.
e. The Company’s Release of Mr. Cullem
In consideration for, among other
terms, promises contained in this Agreement the Company, including Company subsidiary entities, or successor entities (“Company
Parties”), voluntarily release and forever discharge Mr. Cullem, his estate, and his heirs generally from all claims, demands, debts,
damages and liabilities of every name and nature, known or unknown (“Company Claims”) that, as of the date of this Agreement,
the Company Parties have, ever had, now claim to have or ever claimed to have had against you, your estate and your heirs.
The Company Parties represent
that they have not filed, and have not caused to be filed, against Mr. Cullem, any action or legal proceeding in any court or any
administrative agency concerning any matter involving him. As a material inducement to Mr. Cullem to enter into this Agreement, the
Company Parties represent that they have not assigned to any third party and they have not filed with any agency or court any Claim
released by this Agreement.
a. Covenant
Not to Sue: Mr. Cullem represents and warrants that he does not know of any claims, causes of action, grievances, charges, or other
complaints that have been asserted by his or on his behalf against any of the Released Parties that are currently pending in any local,
state, or federal court, tribunal, or administrative or regulatory agency. Mr. Cullem and the Company further covenant that they shall
not, after his execution of this Agreement, commence or cause to be commenced any suits, charges, complaints, or other legal proceedings
arising from any legal claims intended to be waived by this Agreement, including without limitation, the claims waived pursuant to the
General Release of Claims in Section 4 of this Agreement. To the extent this representation is false when either party signs this Agreement,
the General Release of Claims in Section 4 of this Agreement shall fully extinguish any other claims, complaints, or other causes of action
that are pending against any of the Released Parties
b. Confidentiality
of Allarity’s Confidential Information: Mr. Cullem hereby acknowledges that during his employment with Allarity, he may have
acquired proprietary, private, and/or otherwise confidential information (“Confidential Information,” as defined and described
in this Section). Confidential Information shall mean all non-public information, whether or not created or maintained in written or electronic
form, which constitutes, relates to, or refers to Allarity or any Released Party, and to any current, former or potential employee, service
provider, client, investor, or business partner of Allarity, and any aspect of the operation of the business of Allarity or any Released
Party, including without limitation, all financial, operational, marketing, investor, and statistical information. All the foregoing are
illustrative, and Confidential Information shall not be limited to those illustrations. By signing this Agreement, Mr. Cullem promises
that he has not divulged any Confidential Information to any third party and that he will not disclose Confidential Information in any
form to a third party. Mr. Cullem shall give immediate notice to Allarity if compelled by law to reveal any Confidential Information to
any third party. Mr. Cullem acknowledges and agrees that any unauthorized disclosure to any person or persons of Confidential Information
shall cause irreparable damage to Allarity and that, therefore, Allarity shall, in addition to any other available remedy, be entitled
to seek an injunction prohibiting Mr. Cullem from any further disclosure or attempted disclosure.
c. Allarity’s
Property: Mr. Cullem agrees and acknowledges that he has returned and/or deleted to Allarity all Confidential Information (as
defined in Section 5b herein) in his possession or otherwise under his control, unless expressly required to be preserved by the
SEC, in whatever format, whether written, recorded, electronically or digitally stored and/or retrieved. Mr. Cullem agrees that he
is not retaining any copies of any documents, records, or materials of any kind, whether written or electronically created or
stored, which contain, relate to, or refer to any Confidential Information, and affirms that he has no such documents, records, or
materials. It is understood and agreed that Mr. Cullem’s above-described return and non-retention of Allarity’s
Confidential Information is a material condition of this Agreement.
d. Ownership
of Claims: Mr. Cullem promises that he has not assigned any rights or claims he may have against any of the Released Parties to any
other person or entity, including but not limited to the Asserted Claim or any of the other Claims intended or purported to be waived
via this Agreement as of the Effective Date. Mr. Cullem also promises that no child support order, garnishment orders, or other orders
requiring him to pay money to any other person are now in effect.
e. Non-Admission
of Liability: Mr. Cullem agrees that this Agreement is not an admission of guilt or wrongdoing by any of the Released Parties.
f. Non-Disparagement:
Mr. Cullem agrees to refrain from making any statements or comments of a defamatory or disparaging nature to third parties regarding the
Company or its shareholders, officers, directors, personnel or products, or those of its affiliates. This prohibition against defamatory
or disparaging remarks includes, without limitation, statements to any individual or entity which could adversely affect Allarity’s
business or reputation. Notwithstanding the foregoing, nothing herein is intended to prevent Mr. Cullem from testifying in good faith
under oath pursuant to a subpoena or as otherwise required by law. Further, nothing in this Agreement prohibits Mr. Cullem from engaging
in protected activities under the NLRA, including those protected by Section 7 of the NLRA.
g. The
Company agrees to refrain from making any statements or comments of a defamatory or disparaging nature to third parties regarding Mr.
Cullem and will instruct the Company’s directors and officers not to make any statements of comments of a defamatory or disparaging
nature to third parties. This prohibition against defamatory or disparaging remarks includes, without limitation, statements to any individual
or entity which could affect adversely Mr. Cullem’s business or reputation. Notwithstanding the foregoing, nothing herein is intended
to prevent any directors, officers or employees of the Company from testifying in good faith under oath pursuant to a subpoena or as otherwise
required by law.
h. Confidentiality:
The terms and conditions of this Agreement, including but not limited to the amount of the Payment or any other provision of this
Agreement, as well as the Agreement itself, shall be kept strictly confidential and shall not be disclosed by Mr. Cullem to
any other person or entity without the express written consent of Allarity, except that, if asked about any employment dispute with
Allarity, Mr. Cullem may state that the matter is settled and except to the extent required by law, subpoena, court order, or the
rules of any governmental agency. For clarity, the Parties acknowledge that this provision does not prohibit Mr. Cullem from
initiating, testifying, assisting, complying with a subpoena from, or participating in any manner with an investigation conducted by
the appropriate local, state, or federal agency; or filing or disclosing any facts necessary to receive unemployment insurance,
Medicaid, or other public benefits to which the complainant is entitled; or speaking with law enforcement, the Equal Employment
Opportunity Commission, the Massachusetts Commission Against Discrimination, the New York State Division of Human Rights, a local
commission on human rights, or his attorney. Mr. Cullem may also disclose the terms of the Agreement to his accountant, tax advisor
or attorney who has a need to know to advise his as to his tax obligations or related obligations under the law; in any instance
where he makes such disclosure to an accountant, tax advisor or attorney, he agrees to inform them that they similarly are bound by
the confidentiality provisions set forth in this Paragraph. The provisions of this Paragraph shall survive the termination of this
Agreement. Any violation of this provision will be deemed a material breach.
i. Neutral
Reference: In the event that Allarity’s Human Resources Department or any of its Board Directors or Officers receives any inquiry
about Mr. Cullem from any prospective employer, Allarity’s Human Resources Department shall provide only Mr. Cullem’s dates
of employment and positions held. Nothing herein shall prevent Mr. Cullem from seeking, or any person from voluntarily providing, a personal
or professional reference for Mr. Cullem.
j. Cooperation by Mr.
Cullem: Mr. Cullem agrees that he shall reasonably cooperate with, and shall be reasonably available to, Allarity or any
Released Party to assist in any matter, including, without limitation, government agency investigations and actual or potential
court litigation or arbitration, in connection with which Mr. Cullem may have knowledge. If Mr. Cullem receives a subpoena or
process from any person or entity (including, but not limited to, any governmental agency) which would or may require Mr. Cullem to
disclose documents or information or provide testimony (in a deposition, court proceeding, or otherwise) regarding, in whole or in
part, any of the Released Parties or any proprietary or confidential information, Mr. Cullem shall: (i) notify Allarity of the
subpoena or other process within five (5) business days of receiving it (or a shorter period such that not less than one (1)
business day shall remain between such notification and any deadline for response thereto); and (ii) to the maximum extent
permissible under applicable law, not make any disclosure pursuant to the subpoena, until the appropriate Released Parties have had
a reasonable opportunity to contest the right of the requesting person or entity to such disclosure, limit the scope or nature of
such disclosure, and/or seek to participate in the proceeding or matter in which the disclosure is sought. Mr. Cullem shall further
cooperate with Allarity and any Released Party in responding to any such subpoena or process. If Mr. Cullem’s cooperation
obligation as described in this Section requires Mr. Cullem to use paid vacation time from Mr. Cullem’s position with his
then-current employer, Allarity will reimburse Mr. Cullem for the amount of paid vacation time he uses at a rate no less than
Allarity’s rate of pay from his then-current employer. Allarity further agrees that it shall reimburse Mr. Cullem for
reasonable expenses incurred by his in connection with his cooperation (as described in this Section) and in accordance with
Allarity’s policies for the reimbursement of employee’s expenses and in accordance with the in-force Indemnification
Agreement between the Company and Mr. Cullem (effective date August 2, 2022).
k. Consequences
of Violating Promises. In the event any action is brought to enforce the terms of this Agreement, the prevailing party shall be
entitled, in addition to any other right or remedy it may have at law or in equity, to all costs associated with enforcing this Section
and the Agreement overall, including but not limited to attorneys’ fees. The prevailing party also shall be entitled to recover
all reasonable attorneys’ fees and costs incurred in connection with proving entitlement and/or the amounts of attorneys’
fees and costs to be awarded under this Section.
Mr. Cullem may revoke this
Agreement at any time during the seven days after Mr. Cullem signs it, and the Agreement, and Mr. Cullem’s entitlement to the
consideration herein, shall not become effective until that revocation period passes without Mr. Cullem revoking the Agreement (the
“Effective Date”). If Mr. Cullem chooses to revoke the Agreement, such revocation must be by means of a writing signed
by Mr. Cullem and delivered within the seven-day revocation period by notice as provided in Section 10 of this Agreement. The
Companies advise Mr. Cullem of Mr. Cullem’s right to consult with an attorney prior to executing this Agreement. Mr. Cullem
understands that he has twenty-one (21) days from the date of receipt of this Agreement to consider whether to sign it and to
consult with an attorney (the “Consideration Period”). Mr. Cullem’s signature on this Agreement constitutes
an express waiver of the Consideration Period if affixed prior to the expiration of that period. By signing this Agreement, Mr.
Cullem expressly acknowledges that Mr. Cullem’s decision to sign this Agreement sooner than the expiration of the
Consideration Period was knowing and voluntary.
(a) He
is not suffering from any disability or impairment that would render his unable to read, consider, or understand this Agreement;
(b) He has carefully read and fully understands all
of the provisions of this Agreement;
(c) He
is freely and voluntarily entering into this Agreement and knowingly discharging the Company and other Released Parties in accordance
with the terms contained herein in exchange for the consideration described herein, which he acknowledges exceeds anything of value to
which he was or is already entitled;
(d) He
has not been pressured, coerced, threatened, or otherwise unduly influenced to enter into this Agreement, and he does so under his own
free will;
(e) He
has been offered a reasonable amount of time to review and consider whether to sign this Agreement;
(f) He
has been represented by counsel throughout the negotiation of this agreement and he has consulted with his counsel regarding the terms
and conditions set forth within this Agreement; and
(g) There
is no portion of this Agreement that Mr. Cullem does not understand because of his inability to understand a particular language.