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ALLR US Equity

Allarity Therapeutics, Inc.Health Care · Pharmaceutical Preparations · CIK 1860657 · FY ends Dec 31
$1.43
+0.08 (+5.93%)
USD · as of 2026-08-19 · marketstack

ALLR · 10-K · period ended 2023-12-31

← all ALLR documents
filed 2024-03-08 · EDGAR original ↗

Our rendering of the filing — original pagination and typography are not reproduced, and tables are reduced to their short label cells (the figures live on FA). Nothing is summarized: every line below is the filing's own text.

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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

Source: SEC EDGAR (public domain) · 10-K for the period ended 2023-12-31, filed 2024-03-08 · accession 0001213900-24-020864

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