UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
(Mark
One)
☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the fiscal year ended December 31, 2023
OR
☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _________ to_________
Commission
file number: 001-41160
ALLARITY
THERAPEUTICS, INC.
(Exact
name of registrant as specified in its charter)
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) 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)
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
Securities
registered pursuant to Section 12(g) of the Act: None
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No
☒
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No
☒
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 check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
Emerging growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report. ☐
If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate
by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The
aggregate market value of voting stock held by non-affiliates of the registrant, as of June 30, 2023, the last day of the registrant’s
most recently completed second fiscal quarter, was $3,323,760 (based on the closing price for shares of the registrant’s common
stock as reported by the Nasdaq Capital Market on June 30, 2023). Shares of common stock held by each executive officer and director
have been excluded in that such persons may be deemed to be affiliates. This determination of affiliate status is not necessarily a conclusive
determination for other purposes.
As
of March 7, 2024, there were 6,178,892 shares of the registrant’s common stock outstanding.
DOCUMENTS
INCORPORATED BY REFERENCE
Portions
of the registrant’s Proxy Statement for the 2024 Annual Meeting of Stockholders are incorporated herein by reference in Part III
of this Annual Report on Form 10-K to the extent stated herein. Such proxy statement will be filed with the Securities and Exchange Commission
within 120 days of the registrant’s fiscal year ended December 31, 2023.
ALLARITY
THERAPEUTICS, INC.
ANNUAL
REPORT ON FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2023
INDEX
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS ii
NOTE
PART I 1
ITEM 1. BUSINESS 1
ITEM 1A. RISK FACTORS 79
ITEM 1B. UNRESOLVED STAFF COMMENTS 138
ITEM 1C. CYBERSECURITY 138
ITEM 2. PROPERTIES 138
ITEM 3. LEGAL PROCEEDINGS 139
ITEM 4. MINE SAFETY DISCLOSURES 139
PART II
ITEM 6. [RESERVED] 140
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 151
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 151
ITEM 9A CONTROLS AND PROCEDURES 153
ITEM 9B. OTHER INFORMATION 154
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTION THAT PREVENTS INSPECTIONS 154
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 155
ITEM 11. EXECUTIVE COMPENSATION 155
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 155
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 156
FINANCIAL STATEMENTS F-1
When
used herein, unless the context requires otherwise, references to the “Company,” “we,” “our” and
“us” refer to Allarity Therapeutics, Inc., a Delaware corporation.
i
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Annual Report on Form 10-K (the “Annual Report”) contains forward-looking statements that involve substantial risks and uncertainties.
We make such forward-looking statements pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act,
Section 21E of the Securities Exchange Act of 1934, as amended, and other federal securities laws. All statements, other than statements
of historical fact, contained in this Annual Report. including statements regarding our strategy, future preclinical studies and clinical
trials, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The
words “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,”
“intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,”
“project,” “target,” “aim,” “should,” ‘will” “would,” or the
negative of these words or other similar expressions are intended to identify forward-looking statements, although not all forward-looking
statements contain these words. Forward-looking statements reflect our current views with respect to future events and are based on assumptions
and subject to risks and uncertainties. If one or more of these risk factors or uncertainties materialize, or if any underlying assumptions
prove incorrect, our actual results, performance or achievements may vary materially from any future results, performance or achievements
expressed or implied by these forward-looking statements. Furthermore, we operate in a competitive and rapidly changing environment.
New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could
have an impact on the forward-looking statements contained in this Annual Report. Given these uncertainties, you should not place undue
reliance on these forward-looking statements. Forward-looking statements relating to Allarity in this Annual Report include, but are
not limited to, statements about:
● our plans to develop and commercialize the Company’s drug candidates;
● our ability to generate any revenue or become profitable;
ii
● the unknown consequences of a request for documents from the SEC;
● the market price of our common stock has been and may continue to be volatile;
● our ability to retain key employees, consultants and advisors;
● the impact of governmental laws and regulations;
● any future currency exchange and interest rates; and
These
forward-looking statements are based on information available as of the date of this report, and current expectations, forecasts and
assumptions, and involve a number of risks and uncertainties. We do not assume any obligation to update any forward-looking statements,
Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date, and we do not
undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether
as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
iii
PART
I
Item
1. Business.
Overview
Allarity
is a clinical-stage, precision medicine pharmaceutical company actively advancing in-licensed oncology therapeutics for patients with
difficult-to-treat cancers leveraging Allarity’s core technology, the Drug Response Predictor (DRP®) platform, to
identify the patients most likely to derive clinical benefit from any individual therapeutic. In Q4, 2023, Allarity made significant
changes to its business to align with current financial realities and to streamline the Allarity pipeline in order to focus resources
on the clinical asset with the highest likelihood to create near and mid-term value, stenoparib. Other assets in the portfolio, namely
dovitinib and Ixempra, have been terminated or deprioritized, respectively. Outlicensed assets, namely 2X-111, LiPlaCis and Irofulven,
are being developed exclusively by partners in a variety of indications at the partner’s discretion with support from Allarity
limited to the DRP® technology for each asset. Our DRP® technology has been broadly validated across an
extensive array of therapies and tumor types with a high degree of accuracy for matching the right patient to the right drug. By identifying
those patients who will and who will not respond to a cancer therapeutic, the DRP® companion diagnostics platform has
the potential to transform cancer therapeutic development by isolating and enrolling only those patients most likely to receive benefit.
As a consequence, clinical trials can be smaller and more efficient and can provide profound clinical outcomes, enabling an enhanced
probability of clinical and regulatory success. Stenoparib (formerly known as E7449 or 2X-121) is a novel dual inhibitor of poly-ADP-ribose
polymerase (PARP) as well as Tankyrases, enzymes critically important in the WNT pathway. Stenoparib is currently being explored in a
phase 2 clinical study in patients with advanced, recurrent ovarian cancer who have been pre-selected for enrollment using the stenoparib
DRP®. As per the press release from December 5, 2023, emerging clinical data from this trial in heavily pre-treated, advanced
ovarian cancer patients show promising clinical benefit across all evaluable patients and include a patient with complete response (i.e.
absence of active disease).
In
2023, Allarity seated two new independent directors to its board- Laura Benjamin, PhD and Joe Vazzano. Along with the Chairman of the
board, Jerry McLaughlin, Dr. Benjamin and Mr. Vazzano took the decision to replace the CEO, Mr. James Cullen, with Thomas Jensen. Mr.
Jensen serves as interim CEO and is a co-founder of Allarity. He has extensive experience not only with the DRP® platform
but also with capital fund raising. Mr. Jensen is currently in the process of streamlining the organization and its finances to fuel
the focused development of stenoparib in ovarian cancer.
Our
Corporate Approach to Developing Novel Cancer Therapeutics using the DRP® Platform
Our
focused approach to address major unmet needs in oncology leverages our management’s expertise in cancer drug discovery and development
and in deploying Allarity’s proprietary DRP® platform to identify patients whose tumors have a particular gene expression
signature that reflects high likelihood of drug sensitivity. As a result, we have created substantial intellectual property around the
composition of matter for our in-licensed clinical assets. The foundations of our approach include:
1
While
we have not yet successfully received regulatory or marketing approval for any of our therapeutic candidates or companion diagnostics,
and while we believe that our approach has the potential to reduce the cost and time of drug development through the identification and
selection of patient populations more likely to respond to therapy, our strategy involves risks and uncertainties that differ from other
biotechnology companies that focus solely on new therapeutic candidates that do not have a history of clinical development. By utilizing
our DRP® platform to generate a drug-specific companion diagnostic for each of our therapeutic candidates, we believe
our therapeutic candidates have the potential to advance the goal of personalized medicine by selecting only the patients most likely
to benefit from each of our therapeutic candidates. Moreover, this pre-selection excludes patients who are unlikely to get benefit from
a specific therapy, allowing those patients to find more effective therapeutic options. As used in this report, statements regarding
the use of our proprietary DRP® companion diagnostics or our proprietary DRP® platform or our observations
that a therapeutic candidate may have anti-cancer or anti-tumor activity or is observed to be well tolerated in a patient population
should not be construed to mean that we have resolved all issues of safety and/or efficacy for any of our therapeutic candidates or DRP®
companion diagnostic. Issues of safety and efficacy for any therapeutic candidate or companion diagnostic may only be determined
by the FDA or other applicable regulatory authorities in jurisdictions outside the United States.
Our
Lead Clinical Asset, Stenoparib
Stenoparib
is a novel inhibitor of the key DNA damage repair enzyme PARP. Distinct from other PARP inhibitors, stenoparib also inhibits Tankyrases,
enzymes critically important in the WNT pathway- a pathway commonly activated in many different cancers that drives cancer cell survival
and proliferation as well as invasion and metastasis. Stenoparib was formerly developed by Eisai, Inc. (Eisai) through Phase 1 clinical
trials. We have in-licensed the intellectual property rights to develop, use and market stenoparib. Consequently, we must perform all
of the obligations under these license agreements, including the payment to Esai pharmaceuticals of substantial development milestones
and royalties on future sales in the event we receive marketing approval for stenoparib. If we fail to perform our obligations under
our license agreement, we may lose the intellectual property rights to this therapeutic candidate, which would have a material adverse
effect on our business. We are currently advancing a Phase 2 clinical trial of this therapeutic candidate for the treatment of ovarian
cancer at trial sites in the U.S. and Europe together using the stenoparib-specific DRP® companion diagnostic for which
the FDA has previously approved an Investigational Device Exemption (IDE) application to prospectively enroll patients onto clinical
trial.
2
Implications
of Being an Emerging Growth Company and a Smaller Reporting Company
We
are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and we
intend to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that
are not “emerging growth companies” including not being required to comply with the auditor attestation requirements of Section
404(b) of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements,
and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any
golden parachute payments not previously approved. In addition, Section 107 of the JOBS Act also provides that an “emerging growth
company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying
with new or revised accounting standards.
Additionally,
we are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Even after we no longer qualify as an
emerging growth company, we may still qualify as a “smaller reporting company,” which would allow us to continue to take
advantage of many of the same exemptions from disclosure requirements, including presenting only the two most recent fiscal years of
audited financial statements and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements.
We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250
million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of
our stock held by non-affiliates is less than $700 million. To the extent we take advantage of such reduced disclosure obligations, it
may also make comparison of our financial statements with other public companies difficult or impossible.
Corporate
Information
Our
former parent, Allarity Therapeutics A/S, was founded in Denmark in 2004 by our chief scientific officer, Steen Knudsen, Ph.D., and our
Interim Chief Executive Officer, Director and Senior Vice President of Investor Relations, Thomas Jensen, both of whom were formerly
academic researchers at the Technical University of Denmark working to advance novel bioinformatic and diagnostic approaches to improving
cancer patient response to therapeutics. On May 20, 2021, we entered a Plan of Reorganization and Asset Purchase Agreement (the “Recapitalization
Share Exchange”), between us, Allarity Acquisition Subsidiary, our wholly owned Delaware subsidiary (“Acquisition Sub”),
and Allarity Therapeutics A/S, an Aktieselskab organized under the laws of Denmark. Pursuant to the terms of the Recapitalization Share
Exchange, our Acquisition Sub acquired substantially all of the assets and liabilities of Allarity Therapeutics A/S in exchange for shares
of our common stock on December 20, 2021, and our common stock began trading on the Nasdaq Global Market on that same day. See section
titled “BUSINESS — Recapitalization Share Exchange, Asset Acquisition and Financing.”
Our
principal executive offices are located at 24 School Street, 2nd Floor, Boston, MA 02108 and our telephone number is (401) 426-4664. Our
corporate website address is www.allarity.com. Information contained on or accessible through our website is not a part of this
report, and the inclusion of our website address in this report is an inactive textual reference only.
Allarity
and its subsidiaries own or have rights to trademarks, trade names and service marks that they use in connection with the operation of
their business. In addition, their names, logos and website names and addresses are their trademarks or service marks. Other trademarks,
trade names and service marks appearing in this report are the property of their respective owners. Solely for convenience, in some cases,
the trademarks, trade names and service marks referred to in this report are listed without the applicable ®, TM and
SM symbols, but they will assert, to the fullest extent under applicable law, their rights to these trademarks, trade names and service
marks.
3
BUSINESS
This
Annual Report contains estimates, projections and other information concerning our industry, our business and the markets for our therapeutic
candidates, including data regarding the estimated size of such markets and the incidence of certain medical conditions. We obtained
the industry, market and similar data set forth in this Annual Report from our internal estimates and research and from academic and
industry research, publications, surveys and studies conducted by third parties, including governmental agencies. In some cases, we do
not expressly refer to the sources from which this data is derived. Information that is based on estimates, forecasts, projections, market
research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from
events and circumstances that are assumed in this information. While we believe our internal research is reliable, such research has
not been verified by any third party.
Our
Corporate History
We
were founded in Denmark in 2004 by our chief scientific officer, Steen Knudsen, Ph.D., and our Interim Chief Executive Officer, Director,
and Senior Vice President of Investor Relations, Thomas Jensen, both of whom were formerly academic researchers at the Technical University
of Denmark working to advance novel bioinformatic and diagnostic approaches to improving cancer patient response to therapeutics. On
May 20, 2021, we entered a Plan of Reorganization and Asset Purchase Agreement (the “Recapitalization Share Exchange”), between
us, Allarity Acquisition Subsidiary, our wholly owned Delaware subsidiary (“Acquisition Sub”), and Allarity Therapeutics
A/S, an Aktieselskab organized under the laws of Denmark. Pursuant to the terms of the Recapitalization Share Exchange, our Acquisition
Sub acquired substantially all of the assets and liabilities of Allarity Therapeutics A/S in exchange for shares of our common stock
on December 20, 2021, and our common stock began trading on Nasdaq on that same day.
Our
Business
Our
DRP® companion diagnostic platform has been retrospectively validated by us using retrospective observational studies
in 35 clinical trials that were conducted or sponsored by other companies. The FDA considers a retrospective observational study
to be one in which the study identifies the population and determines the exposure/treatment from historical data (i.e. data generated
prior to the initiation of the study) with the variables and outcomes of interest determined at the time the study is designed. See,
Framework for FDA’s Real-World Evidence Program, page 6 (December 2018), https://www.fda.gov/media/120060/download.
The FDA has accepted our retrospective validation in support of two IDE applications to conduct clinical trials, one with respect to
LiPlaCis® and one with respect to stenoparib. However, while retrospective studies guide our clinical development of our
companion diagnostics, prospective clinical trials are typically required in order to receive a PMA from the FDA.
We
submitted a New Drug Application (NDA) to the FDA for our now de-prioritized therapeutic candidate, dovitinib, a second-generation “pan”-tyrosine
kinase inhibitor (TKI), on December 21, 2021, for the third line treatment of mRCC in patients selected by our Dovitinib-DRP®
companion diagnostic. Subsequently the FDA determined that our NDA was not sufficiently complete to permit a substantive review
and therefore or NDA was not accepted for filing. The primary grounds of rejection asserted by the FDA relates to our use of prior Phase
3 clinical trial data, generated by Novartis in a “superiority” endpoint study against sorafenib (Bayer), to support a “non-inferiority”
endpoint in connection with the DRP® Dovitinib companion diagnostic. We anticipate that the FDA will require a prospective
Phase 3 clinical trial as well as additional dosage studies before regulatory approval of Dovitinib as a monotherapy and its companion
diagnostic Dovitinib-DRP can be obtained. We have decided that the costs, risks and potential benefits of conducting these studies for
dovitinib as a monotherapy for mRCC are no longer the best path toward regulatory or commercial success.
While
we have suffered delays due to the COVID-19 pandemic, we continue to expand patient enrollment in our ongoing Phase 2 clinical trial
for our priority program, stenoparib, a novel dual inhibitor of the key DNA damage repair enzyme PARP, as well as tankyrases, key enzymes
in the WNT pathway implicated in many cancer types. We also intend to opportunistically acquire other promising oncology assets that
can benefit from DRP® platform based patient identification. Our programs for dovitinib and Ixempra have been de-prioritized.
Novartis has terminated the license agreement for dovitinib. These pro-active decisions to trim the pipeline allow us to funnel all resources
into the development of stenoparib.
4
The
Private Placement (PIPE Financing)
Concurrently
with the execution of the Recapitalization Share Exchange on May 20, 2021, we entered into a Securities Purchase Agreement (“SPA”)
and related agreements with an institutional investor (the “Investor”) wherein we agreed to sell, and the Investor agreed
to purchase, 20,000 shares of our Series A Preferred Stock and a warrant to purchase additional shares of our common stock (the “PIPE
Warrant”) for an aggregate purchase price of $20 million with a closing conditioned upon the consummation of our Recapitalization
Share Exchange and a listing of our common stock on Nasdaq. Simultaneously with the execution of the SPA, we also entered into a Registration
Rights Agreement (“RRA”) with the Investor wherein we agreed to register a number of shares of our common stock equal to
the maximum number of shares of our common stock that could be issued upon conversion of the Series A Preferred Stock using a conversion
price equal to 20% of $80,000,000 divided by the number of shares of common stock then outstanding (the “Floor Price”) price
plus 125% of the shares of common stock issuable upon exercise of the PIPE Warrant, or a maximum of 12,618,590 shares of our common stock.
Such shares were registered for resale on a Registration Statement on Form S-1 originally filed with the SEC on September 13, 2021 (SEC
File No. 333-259484), which was declared effective on December 20, 2021. Under the terms of the RRA, if we fail to maintain the effectiveness
of the registration statement beyond defined allowable grace periods set forth in the RRA, we will incur certain registration delay payments
equal to 2% of the Investor’s investment upon our failure to maintain the effectiveness of the registration statement and every
30 days thereafter. Failure to maintain the effectiveness of the registration statement also constitutes a “triggering event”
under the Certificate of Designations for the Series A Preferred Stock that would result in the accrual and payment of a dividend and
provide the Investor the right to have its remaining Series A Preferred Stock redeemed for a premium of a minimum of 125% of the Conversion
Amount of the Series A Preferred Stock, as more specifically described below.
Simultaneously
with the closing of its Recapitalization Share Exchange, we closed on the PIPE Investment pursuant to the SPA. On December 20, 2021,
we issued 20,000 shares of Series A Preferred Stock at $1,000 per share and a common stock purchase warrant to purchase 2,018,958 shares
of common stock at an initial exercise price of $9.9061 to the Investor for an aggregate purchase price of $20 million. Each share of
Series A Preferred Stock has a right to convert into shares of our common stock at an initial fixed conversion price of $9.9061. However,
if (i) the price of our shares of common stock trade below $9.9061 (a “Price Failure”) for a specified period of time; or
(ii) in the event that the sum of (x) the aggregate daily dollar trading volume (as reported on Bloomberg) of our common stock on Nasdaq
during the 10 trading day period ending on the trading day immediately preceding such date of determination, divided by (y) 10, is less
than $1,500,000 (a “Volume Maximum Failure”), each share of Series A Preferred Stock is entitled to convert at a price equal
to 90% of the sum of the two lowest VWAPs during the 10 trading day period immediately preceding delivery divided by two (the “90%
Conversion Price”), but not less than the Floor Price, or, at the time of such Price Failure or Volume Maximum Failure, the sum
of the average daily U.S. Dollar volume for our common stock during the 10 days previous to conversion divided by 10 is less than $2,000,000
(a “Volume Alternate Failure”), then each share of Series A Preferred Stock is entitled to convert at the lower of the fixed
conversion price or a price equal to 80% of the sum of the two lowest VWAPs during the 10 trading day period immediately preceding delivery
divided by two (the “80% Conversion Price”), but not less than the Floor Price (such 90% Conversion Price or 80% Conversion
Price, as the case may be, the “Alternate Conversion Price”). If certain defined “Triggering Events” defined
in the Certificate of Designations occur, such as a breach of the Registration Rights Agreement, suspension of trading, or our failure
to convert the Series A Preferred Stock into common stock when a conversion right is exercised, failure to issue our common stock when
the PIPE Warrant is exercised, failure to declare and pay to any holder any dividend on any dividend date, certain defaults on our debts
or contractual obligations, or upon a “bankruptcy triggering event” (as defined in the Certificate of Designations), then
we may be required to pay a dividend that is added to the stated value on the Series A Preferred Stock in the amount of 18% per annum,
but paid quarterly in cash, so long as the triggering event is continuing, or to redeem the Series A Preferred Stock for cash in an amount
of a minimum of 125% of the Conversion Amount (as defined in the Certificate of Designations) of the Series A Preferred Stock or 125%
of the Conversion Amount of the Series A Preferred Stock would be entitled to convert into our common stock at the Alternate Conversion
Price. In the event that we experience a “Change of Control” (as defined in the Certificate of Designations) we may also
be required to redeem the Series A Preferred Stock for cash at a minimum of 125% of their Conversion Amount. In addition, if thirty days
after our common stock commences trading on Nasdaq the sum of the average daily dollar volume for the 10 days previous to conversion
divided by 10 is less than $2,500,000, then the Series A Preferred Stock shall be entitled to a one-time dividend equal to an 8% increase
in the stated value of the Series A Preferred Stock, or an $80 increase per share in stated value, resulting in a stated value of $1,080
per share of Series A Preferred Stock. This dividend was paid during the first quarter of 2022. The Certificate of Designations of Series
A Convertible Preferred Stock of Allarity Therapeutics, Inc. was filed as Exhibit 3.4 to the Company’s Registration Statement on
Form S-1, as amended, filed with the SEC on September 13, 2021.
5
On
May 4, 2022, the Company and the Investor entered into a Forbearance Agreement and Waiver, dated April 27, 2022, wherein the Investor
confirmed that no Triggering Event as defined under the Certificate of Designations has occurred prior to April 27, 2022, that a Triggering
Event under Section 5(a)(ii) will and has occurred on April 29, 2022, and that in consideration for the Registration Delay Payments the
Company is obligated to pay under the RRA, and additional amounts the Company is obligated to pay under the Certificate of Designations
and the Investor’s legal fees incurred in the preparation of the Forbearance Agreement and Waiver in the aggregate of $538,823
paid upon execution of the Forbearance Agreement and Waiver, and so long as the Company pays the Registration Delay Payments that become
due and payable under the RRA after the execution of the Forbearance Agreement and Waiver, the Investor has agreed to forbear exercising
any rights or remedies that it may have under the Certificate of Designations that arises as a result of a Triggering Event under Section
5(a)(ii) of the Certificate of Designations and Section 4(c)(ii) of the PIPE Warrant until the earlier to occur of (i) the date immediately
prior to the date of occurrence of a Bankruptcy Triggering Event, (ii) the date of occurrence of any other Triggering Event under Section
5(a) of the Certificate of Designations (excluding any Triggering Event arising solely as a result of Section 5(a)(ii) of the Certificate
of Designations and Section 4(c)(ii) of the PIPE Warrant), (iii) the time of any breach by the Company under the Forbearance Agreement
and Waiver, (iv) the Resale Availability Date as defined therein and (v) June 4, 2022, which was subsequently extended to June 20, 2022
(such period, the “Forbearance Period”). Provided that the Company is not in breach of its obligations under Forbearance
Agreement and Waiver, effective as of the Trading Day immediately following the Resale Availability Date, the Investor agrees to waive
any rights or remedies that it may have under the Certificate of Designations that arises as a result of a Triggering Event under Section
5(a) of the Certificate of Designations and Section 4(c)(ii) of the PIPE Warrant that may have arisen prior to the date of the Forbearance
Agreement and Waiver. The Resale Availability Date was achieved on June 6, 2022, resulting in the Investor waiving any rights or remedies
that it may have under the Certificate of Designations that arises as a result of a Triggering Event under Section 5(a) of the Certificate
of Designations and Section 4(c)(ii) of the PIPE Warrant that may have arisen prior to the date of the Forbearance Agreement and Waiver.
On
June 6, 2022, we entered into that certain First Amendment to the Forbearance Agreement and Waiver with 3i, LP (the “Amendment”)
to extend the forbearance period date under subsection 5 of Section 2 of the Forbearance Agreement and Waiver dated April 27, 2022 (the
“Original Agreement”) from June 4, 2022, to June 20, 2022. In addition, the parties agreed that the forbearance period
of June 20, 2022 may also be extended for an additional 15 days to July 5, 2022, provided that, on June 20, 2022 the Company will remove
the restrictive legend on 441,005 shares of common stock of the Company issued in connection with the conversion of certain shares of
Series A Preferred Stock (“Conversion Shares”) by 3i, LP pursuant to the conversion notice dated May 2, 2022, and 3i,
LP is able to sell the Conversion Shares free of restrictions (including volume restrictions) pursuant to SEC Rule 144(b)(1)(i).
On
December 9, 2022, the Company and 3i, LP entered into a letter agreement which provided that pursuant to Section 8(g) of the Certificate
of Designations for the Series A Preferred Stock, the parties agreed that the Conversion Price (as defined in such Certificate of Designations)
was modified to mean the lower of: (i) the Closing Sale Price (as defined in the Certificate of Designations) on the trading date immediately
preceding the Conversion Date (as defined in the Certificate of Designations) and (ii) the average Closing Sale Price of the common stock
for the five trading days immediately preceding the Conversion Date, for the Trading Days (as defined in the Certificate of Designations)
through and until the Company and 3i agree to terminate that definition.
On
January 14, 2024, pursuant to the terms of the January 14th, 2024, 3i, LP Bridge Loan, the Company modified the conversion price of the
3i Exchange Warrants from $1.00 to $0.4476, thereby increasing the number of Exchange Warrants outstanding from 4,407,221 at December
31, 2023, to 9,846,339 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 $1.00 to $0.4476. We filed the Fifth Certificate of Amendment to Amended and Restated Certificate
of Designations of Series A Convertible Preferred Stock (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 $0.4476. At a stated value of $1,080 for each share
of Series A Preferred Stock, the revised price of $0.4476 per share results in the 1,417 shares being convertible into 3,419,035 common
shares as of January 14, 2024.
6
On
February 13, 2024, pursuant to the terms of the February 13, 2024, 3i, LP Bridge Loan, the Company modified the conversion price of the
3i Exchange Warrants from $0.4476 to $0.4050 and thereby increased the number of Exchange Warrants outstanding from 9,846,339 on January
18, 2024, to 10,882,028 on February 13, 2024. The Company also agreed to amend the conversion price of the Series A Preferred Stock to
equal $0.405 as soon as practicable. We filed the Sixth Certificate of Amendment to Amended and Restated Certificate of Designations
of Series A Convertible Preferred Stock (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 $0.405. At a stated value of $1,080 for each share of Series A Preferred
Stock, the revised price of $0.405 per share results in the 1,296 shares being convertible into 3,456,000 common shares.
Bridge
Loans
On
November 22, 2022, the Company entered into a Secured Note Purchase Agreement with 3i, LP (the “Secured Note Purchase Agreement”)
for a bridge loan to extend the Company’s cash runaway beyond December 31, 2022, in order to provide the Company with more time
to complete the process of amending its Certificate of Incorporation to increase it authorized share capital and proposed reverse stock
split to facilitate additional capital investments (the “Bridge Loan”). Under the Secured Note Purchase Agreement, the Company
has authorized the sale and issuance of three 3i Promissory Notes, with the first note in an aggregate principal amount of $350,000 to
be issued at closing (which was received in November 2022); the second note in the principal amount of $1,666,640 to be issued at closing
and which represents the payment of $1,666,640 due to 3i, LP in Alternative Conversion Floor Amounts, as defined in the Certificate of
Designations, that began to accrue on July 14, 2022; and the third note in an aggregate principal amount of $650,000 with respect to
a new loan to be funded upon the Company filing a registration statement with SEC in connection with a registered offering. As of December
31, 2022, all of the notes have been issued and are outstanding. Each 3i Promissory Note matures on January 1, 2024, carries an interest
rate of 5% per annum, and is secured by all of the Company’s assets pursuant to the Security Agreement. In addition, 3i, LP may
exchange the 3i Promissory Notes for the Company’s common stock, or other equity security, 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 the 3i Promissory Notes. In addition, each 3i Promissory Note
and interest earned thereon may be redeemed by the Company at its option or the holder may demand redemption if 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.
On
April 19, 2023, 3i, provided the Company with a loan for $350,000, which was evidenced by a Secured Promissory Note dated April 19, 2023
(the “April Note”).
On
April 20, 2023, the Company entered into a Cancellation of Debt Agreement with 3i, which became effective as of the April Offering Closing.
Upon the closing, pursuant to the terms of the Cancellation of Debt Agreement, all of the Company’s outstanding indebtedness under
the Notes (as defined therein) and the Alternative Conversion Amount (as defined therein) due by the Company to 3i were paid in full.
Accordingly, any and all obligations in connection therewith were extinguished without any additional further action on the part of 3i
upon payment of $3,348 in cash from a portion of the proceeds from the April Offering.
On
June 29, 2023, the Company entered into a Secured Note Purchase Agreement with 3i, (the “June 2023 Purchase Agreement”),
pursuant to which, on June 30, 2023, 3i purchased a secured promissory note for a principal amount of $350,000 (the “3i June Promissory
Note”). Such note matured on July 31, 2023, and carried an interest rate of 5% per annum, and is secured by all of the Company’s
assets pursuant to that certain security agreement dated June 29, 2023 (the “Security Agreement”). As contemplated by
the June 2023 Purchase Agreement, the Company filed the Second Certificate of Amendment with the Delaware Secretary of State on June
30, 2023. From the proceeds of the July Offering, on July 10, 2023, the Company redeemed the 3i June Promissory Note for $351,000 in
cash.
On
January 18th, 2024, we entered into a Securities Purchase Agreement with 3i, pursuant to which we issued and sold 3i a senior convertible
promissory notes in an aggregate principal amount of $440,000 due on January 18, 2025 (the “First Note”, and together with
the Purchase Agreement, the “Transaction Documents”) for an aggregate purchase price of $400,000, representing an approximate
10% original issue discount (the “Transaction”). We agreed to use the net proceeds from the sale of the Note for accounts
payable and working capital purposes. Unless the Transaction Documents state otherwise, we may not prepay any portion of the principal
amount of the Note without the Purchaser’s prior written consent.
7
On
February 13, 2024 (the “Second Closing”), the Parties entered into a Limited Waiver Agreement (the “Waiver Agreement”)
and agreed that the Second Closing can be consummated prior to the 30th calendar day following January 18, 2024. The Parties further
waive any rights or remedies that they may have under Section 2.3 of the Purchase Agreement, solely in connection with the Second Closing,
including any rights of termination, defaults, amendment, acceleration or cancellation that be triggered under the Purchase Agreement
solely as a result of accelerating the Second Closing. As of the Second Closing, we issued and sold to the Purchaser a senior convertible
promissory note in an aggregate principal amount of $440,000 (the “Principal Amount”) due on February 13, 2025 (the “Second
Note,” and together with the First Note dated January 18, 2024, and Purchase Agreement, the “Second Transaction Documents”)
for an aggregate purchase price of $400,000, representing an approximately 10% original issue discount (the “Second Transaction”).
We agreed to use the net proceeds from the sale of the Second Note for accounts payable and working capital purposes. Unless the Transaction
Documents state otherwise, we may not prepay any portion of the principal amount of the Second Note without the Purchaser’s prior
written consent.
Amendments
to the Certificate of Designation of Series A Preferred Stock
On
November 22, 2022, the Company amended Section 12 of the Certificate of Designation of Series A Preferred Stock to provide for voting
rights. Subject to a 9.99% beneficial ownership limitation, the holders of Series A Preferred Stock were granted the right to vote on
all matters presented to the stockholders for approval together with the shares of common stock, voting together as a single class, on
an “as converted” basis using the “Conversion Price” (initially $9.9061 per share before any adjustment) (rounded
down to the nearest whole number and using the record date for determining the stockholders of the Company eligible to vote on such matters),
except as required by law (including without limitation, the DGCL) or as otherwise expressly provided in the Company’s Certificate
of Incorporation or the Certificate of Designations of Series A Preferred Stock. The voting rights described above expired on February
28, 2023.
On
December 9, 2022, the Company and 3i entered into a letter agreement which provided that pursuant to Section 8(g) of the Certificate
of Designations for the Series A Preferred Stock, the parties agreed that the Conversion Price was modified to mean the lower of: (i)
the Closing Sale Price on the trading date immediately preceding the Conversion Date and (ii) the average Closing Sale Price of the common
stock for the five trading days immediately preceding the Conversion Date, for the Trading Days through and inclusive of January 19,
2023. Any conversion which occurs shall be voluntary at the election of the Holder, which shall evidence its election as to the Series
A being converted in writing on a conversion notice setting forth the then Minimum Price. 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 at any time by the Company
and the other terms of the Certificate of Designations remained unchanged.
On
January 23, 2023, we and 3i amended the letter agreement entered into on December 8, 2022, to provide that the modification of the term
Series A Preferred Stock Conversion Price (“Series A Preferred Stock Conversion Price”) to mean the lower of: (i) the Closing
Sale Price (as defined in the Certificate of Designations of Series A Preferred Stock (“Series A Certificate of Designations”))
on the trading date immediately preceding the Conversion Date (as defined in the Series A Certificate of Designations and (ii) the average
Closing Sale Price of the common stock for the five trading days immediately preceding the Conversion Date, for the Trading Days (as
defined in the Series A Certificate of Designations) will be in effect until terminated by us and 3i.
On
April 20, 2023, the Company entered into a certain Modification and Exchange Agreement (the “Exchange Agreement”) with 3i
pursuant to which the parties agreed to, among other things, subject to the April Offering Closing, (i) amend the Certificate of Designations
for the Series A Convertible Preferred Stock (the “Amended COD”), which among other things, eliminates the Series A Preferred
Stock redemption right and dividend (except for certain exceptions as specified in the Amended COD), and provides for the conversion
of Series A Preferred Stock into Common Stock at a conversion price of $0.75 which is equal to the price for a share of Common Stock
sold in the April Offering, (ii) exchange 50,000 shares of Series C Preferred Stock (the “Series C Shares”) beneficially
owned by 3i for 5,577 shares of Series A Preferred Stock (the “Exchange Shares”), (iii) exchange a warrant to purchase common
stock issued on December 20, 2021 to 3i (the “Original Warrant”) for a new warrant (the “Exchange Warrant”),
which reflects an exercise price of $30.00 (the “New Exercise Price”) and represents a right to acquire 315,085 shares of
Common Stock (the “New Warrant Shares”).
8
In
addition to the satisfaction or waiver of customary and additional closing conditions set forth in the Exchange Agreement, the transactions
contemplated by the Exchange Agreement were subject to (a) the occurrence of the closing of the Offering and (b) the filing of the Amended
COD with the Delaware Secretary of State. On April 21, 2023, the closing of the transactions contemplated by the Exchange Agreement occurred
and the Exchange Warrant and the Exchange Shares were issued to 3i, and the Original Warrant and the Series C Shares were cancelled.
In addition, on April 21, 2023, the Amended COD was filed with the Delaware Secretary of State.
On
April 20, 2023, the Company also entered into a Cancellation of Debt Agreement. Pursuant to such agreement, 1,550 shares of Series A
Preferred Stock (the “Redemption Shares”) beneficially owned by 3i were redeemed in full for a purchase price of $1,652,
which redemption price was paid in cash from the portion of the proceeds from the April Offering. The Company also entered into the First
Amendment to the Registration Rights Agreement dated May 20, 2023 (the “RRA”), which became effective upon the April Offering
Closing, to amend certain defined terms under the RRA to include the Exchange Shares, the New Warrant Shares and the Note Conversion
Shares.
On
April 21, 2023, in connection with the transactions contemplated under the Exchange Agreement, the Company filed an Amended and Restated
Certificate of Designations of Series A Convertible Preferred Stock of the Company (the “Amended and Restated Series A COD”) with
the Delaware Secretary of State. The Amended and Restated Series A COD eliminates the Series A Preferred Stock redemption right
and dividend (except for certain exceptions as specified therein), and provides for the conversion of Series A Preferred Stock into Common
Stock at a conversion price equal to the price for a share of Common Stock sold in the April Offering, $30.00 per share, and based on
a stated value of $1,080 per share. As a result of the Amended and Restated Series A COD, the Company determined that the Series A Preferred
Stock met the definition of equity and reclassified it from mezzanine equity.
On
May 30, 2023, the Company filed an amendment to the Amended and Restated Certificate of Designations for the Series A Preferred Stock
with the Delaware Secretary of State (the “Amended COD”) to amend the voting rights of the Series A Preferred Stock which
among other things provided additional voting rights to the Series A Preferred Stock.
Under
the Amended COD, holders of the Series A Preferred Stock have the following voting rights: (1) holders of the Series A Preferred Stock
have a right to vote on all matters presented at the Special Meeting together with the Common Stock as a single class on an “as
converted” basis using the conversion price of $30.00 and based on stated value of $1,080 subject to a beneficial ownership limitation
of 9.99%, and (2), in addition, holders of Series A Preferred Stock have granted the Board the right to vote, solely for the purpose
of satisfying quorum and casting the votes necessary to adopt a reverse stock split of the Company’s issued and outstanding shares
of Common Stock (the “Reverse Stock Split Proposal”) and to adjourn any meeting of stockholders called for the purpose of
voting on reverse stock split (the “Adjournment Proposal”) under Delaware law, that will “mirror” the votes cast
by the holders of shares of Common Stock and Series A Preferred Stock, voting together as a single class, with respect to the Reverse
Stock Split Proposal and the Adjournment Proposal. The number of votes per each share of Series A Preferred Stock that may be voted by
the Board shall be equal to the quotient of (x) the sum of (1) the original aggregated stated value of the Series A Preferred Stock when
originally issued on December 20, 2021 (calculated based on the original stated value of $1,000 of the Series A Preferred Stock multiplied
by 20,000 shares of Series A Preferred Stock) and (2) $1,200,000, which represents the purchase price of the Series C Preferred Stock
when originally issued; divided by (y) the conversion price of $30.00. If the Board decides to cast the vote, it must vote all votes
created by the Amended COD in the same manner and proportion as votes cast by the holders of Common Stock and Series A Preferred Stock,
voting as single class. The Series A Preferred Stock voting rights granted to the holders thereof relating to the Reverse Stock Split
Proposal and the Adjournment Proposal 2 expired automatically on July 31, 2023.
On
June 6, 2023, 3i and the Company entered into a separate limited waiver and amendment agreement whereby 3i (“3i Waiver Agreement”)
agreed to waive certain rights granted under a Series A Preferred Stock securities purchase agreement dated December 20, 2021, the Exchange
Agreement, and the securities purchase agreement related to the April Offering in exchange for, among other things, amending the conversion
price of the Series A Preferred Stock to equal the public offering price of the shares of Common Stock in the July Offering. Upon the
consummation of the July Offering, the conversion price of the Series A Preferred Stock was reduced to $4.50. On July 10, 2023, the Company
filed a Third Certificate of Amendment to the Amended and Restated Certificate of Designations of Series A Preferred Stock (“Third
Amendment”) to effect the change to conversion price.
9
In
connection with the September 2023 Inducement Letter and the transactions contemplated therein, the Company and 3i, LP entered into a
limited waiver agreement (the “Waiver”) pursuant to which 3i, LP agreed to allow the filing of the Resale Registration Statement
not otherwise permitted under certain agreements with 3i, LP. In consideration of entering in the Waiver, the Company agreed to amend
the “Conversion Price” of the Series A Convertible Preferred Stock to equal $1.00 as soon as practicable. On September 22,
2023, the Company filed the Fourth Certificate of Amendment to the Amended and Restated Certificate of Designations of Series A Convertible
Preferred Stock (“Fourth Amendment”) with the Secretary of State of the State of Delaware to reflect the new conversion price
of the Series A Preferred Stock of $1.00. In addition, as a result of the issuance of the Inducement Warrants, pursuant to the terms
of the Exchange Warrant, in September 2023 the number of shares exercisable and the exercise price of the Exchange Warrant was adjusted
to 9,452,667 shares of Common Stock and $1.00 per share, respectively.
On
January 14, 2024, pursuant to the terms of the January 14th, 2024, 3i, LP Bridge Loan, the Company modified the conversion price of the
3i Exchange Warrants from $1.00 to $0.4476, thereby increasing the number of Exchange Warrants outstanding from 4,407,221 at December
31, 2023, to 9,846,339 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 $1.00 to $0.4476. We filed 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 $0.4476. At a stated value of $1,080 for each share
of Series A Preferred Stock, the revised price of $0.4476 per share results in the 1,417 shares being convertible into 3,419,035 common
shares as of January 14, 2024.
On
February 13, 2024, pursuant to the terms of the February 13, 2024, 3i, LP Bridge Loan, the Company modified the conversion price of the
3i Exchange Warrants from $0.4476 to $0.4050 and thereby increased the number of Exchange Warrants outstanding from 9,846,339 on January
18, 2024, to 10,882,028 on February 13, 2024. The Company also agreed to amend the conversion price of the Series A Preferred Stock to
equal $0.405 as soon as practicable. We filed 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 $0.405. At a stated value of $1,080 for each share of Series A Preferred Stock,
the revised price of $0.405 per share results in the 1,296 shares being convertible into 3,456,000 common shares.
Modifications
to Conversion Price of Series A Preferred Stock
On
December 9, 2022, the Company and 3i, LP, the holder of outstanding shares of Series A Preferred Stock, entered into a letter agreement
which provided that pursuant to Section 8(g) of the Certificate of Designations, the parties agreed that the Conversion Price (as defined
in such Certificate of Designations) was modified to mean the lower of: (i) the Closing Sale Price (as defined in the Certificate of
Designations) on the trading date immediately preceding the Conversion Date (as defined in the Certificate of Designations) and (ii)
the average Closing Sale Price of the common stock for the five trading days immediately preceding the Conversion Date, for the Trading
Days (as defined in the Certificate of Designations) through and inclusive of January 19, 2023.On January 23, 2023, the