Form 8-K

8-K — Allarity Therapeutics, Inc.

Accession: 0001213900-26-100350

Filed: 2026-09-16

Period: 2026-09-15

CIK: 0001860657

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ea0305570-8k_allarity.htm (Primary)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities

Exchange Act of 1934

Date of Report (Date of earliest event reported)

September 15, 2026

ALLARITY THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-41160

87-2147982

(State or other jurisdiction

of incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

123 E Tarpon Ave,

Tarpon Springs, FL 34689

(Address of principal executive offices)

(401) 426-4664

(Registrant’s telephone number, including

area code)

Not applicable

(Former name or former address, if changed since

last report)

Check the appropriate box below if the Form 8-K

filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b)

of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

ALLR

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant

is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the

Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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. ☐

Item 8.01 Other Matters.

On September 15, 2026, Allarity Therapeutics,

Inc. (the “Company”) announced that the Japan Patent Office had granted a key patent covering the Company’s proprietary

stenoparib-specific Drug Response Predictor (DRP®) companion diagnostic. A copy of the Company’s press release is attached hereto

as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

Number

Description

99.1

Press Release, dated September 15, 2026.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURE

Pursuant to the requirements

of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto

duly authorized.

Allarity Therapeutics, Inc.

Date: September 16, 2026

By:

/s/ Thomas H. Jensen

Thomas H. Jensen

Chief Executive Officer

EX-99.1 — PRESS RELEASE, DATED SEPTEMBER 15, 2026

EX-99.1

Filename: ea030557001ex99-1.htm · Sequence: 2

Exhibit 99.1

Allarity Therapeutics Granted Japanese

Patent for Stenoparib DRP® Companion Diagnostic, Further Strengthening Stenoparib Development

TARPON SPRINGS, Fla., September 15, 2026 – Allarity Therapeutics,

Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to

developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor—today announced that the Japan Patent

Office (JPO) has granted a key patent covering Allarity’s proprietary stenoparib-specific Drug Response Predictor (DRP®) companion

diagnostic. The newly granted patent, Japanese Patent No. 7917283, provides protection in Japan into 2039.

Thomas Jensen, Chief Executive Officer of Allarity Therapeutics, said:

“Japan is one of the world’s largest pharmaceutical markets and is also the home of Eisai, the original developer of stenoparib.

This award of the patented patent is critical to securing stenoparib’s developability in one of the world’s most important

pharmaceutical markets. This award reflects our ongoing strategic efforts to strengthen and extend our intellectual property, ensuring

the development and potential commercialization of stenoparib- together with its DRP® companion diagnostic- in the world’s most

important commercial markets.”

The granted patent covers the DRP methods for predicting clinical benefit

from stenoparib based on gene-expression profiles derived from tumor samples, as well as methods for selecting patients most likely to

benefit from stenoparib treatment using the stenoparib DRP® test.

Allarity has previously secured patent protection for the stenoparib

DRP® in the United States, with protection extending into April 2042, as well as in certain European jurisdictions and Australia.

Related patent applications remain pending in additional international markets.

About Allarity Therapeutics

Allarity Therapeutics, Inc. (NASDAQ: ALLR) is a clinical-stage pharmaceutical

company focused on developing personalized cancer treatments. The Company is developing stenoparib, a novel PARP/tankyrase inhibitor for

patients with advanced ovarian cancer, and is using its proprietary DRP® technology to develop a companion diagnostic designed to

identify patients expected to derive the greatest clinical benefit from stenoparib. Allarity’s principal operations are located

in Denmark, and its U.S. business address is in Florida. For more information, visit www.allarity.com.

Allarity

Page 1 of 3

About Stenoparib/2X-121

Stenoparib is an orally available, small-molecule dual-targeted inhibitor

of PARP1/2 and tankyrase 1/2. Tankyrases have emerged as potential therapeutic targets in cancer due in part to their role in regulating

the WNT signaling pathway. Aberrant WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers,

including drug-resistant cancers. Through its inhibition of PARP and the WNT signaling pathway, stenoparib has the potential to provide

therapeutic benefit across multiple cancer types, including ovarian cancer, small cell lung cancer and colorectal cancer.

Allarity has secured exclusive global rights to develop and commercialize

stenoparib, which was originally developed by Eisai Co., Ltd. and was formerly known as E7449 and 2X-121.

Allarity has completed its first Phase 2 trial evaluating stenoparib

in patients with advanced ovarian cancer. The trial demonstrated promising and durable clinical benefit in patients with ovarian cancer

who received two or more prior lines of therapy and were treated with stenoparib twice daily. Updated data from the trial were presented

at the AACR Special Conference on Advances in Ovarian Cancer in September 2025. These analyses remain subject to change as the study data

mature.

Based on the emerging clinical experience with stenoparib, Allarity

developed a new protocol focused on patients with platinum-resistant ovarian cancer, which began enrolling patients in the summer of 2025.

The amended protocol enrolls only platinum-resistant or platinum-ineligible patients and is designed to advance the clinical development

of stenoparib toward potential FDA approval.

In parallel, a separate Phase 2 trial evaluating stenoparib in combination

with temozolomide for patients with relapsed small cell lung cancer, or SCLC, began enrolling in early 2026 and is currently enrolling

patients at multiple U.S. Department of Veterans Affairs sites.

About the Drug Response Predictor – DRP® Companion Diagnostic

Allarity uses its drug-specific DRP® technology to identify patients

who, based on the gene expression signature of their cancer, may be more likely to benefit from a particular drug. By screening patients

before treatment, and selecting those with a sufficiently high, drug-specific DRP score, the DRP technology is designed to increase the

likelihood of therapeutic benefit.

The DRP methodology is based on the comparisons of sensitive and resistant

human cancer cell lines, and incorporates transcriptomic data, clinical tumor biology filters and prior clinical trial outcomes. The DRP

uses messenger RNA expression profiles derived from patient biopsies to generate drug-specific predictive scores.

The DRP® platform has demonstrated the ability to provide statistically

significant predictions of clinical outcome following drug treatment across dozens of retrospective and prospective clinical studies.

The platform is designed for potential application across multiple cancer types, is patented for dozens of anti-cancer drugs and has been

extensively described in peer-reviewed scientific literature.

Follow Allarity on Social Media

LinkedIn: https://www.linkedin.com/company/allaritytx/

Allarity

Page 2 of 3

Forward-Looking Statements

This press release contains forward-looking statements within the meaning

of applicable federal securities laws. Forward-looking statements reflect current expectations or forecasts regarding future events. The

words “anticipates,” “believes,” “continues,” “could,” “estimates,” “expects,”

“intends,” “may,” “might,” “plans,” “possible,” “potential,” “predicts,”

“projects,” “should,” “would” and similar expressions may identify forward-looking statements, but

the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not

limited to, statements regarding the term, scope, validity, enforceability and commercial value of the Company’s newly granted Japanese

patent covering its stenoparib-specific DRP® companion diagnostic, including the patent’s term extending into 2039; the ability

of the patent to protect the use of the stenoparib DRP® test to identify patients most likely to derive clinical benefit from stenoparib

treatment; the anticipated contribution of the patent to the Company’s intellectual property and commercial strategy; the potential

utility and regulatory acceptance of the DRP® companion diagnostic strategy; and the Company’s plans and ability to advance

stenoparib and its companion diagnostic toward clinical development, regulatory approval and commercialization. Any forward-looking statements

in this press release are based on management’s current expectations of future events and are subject to multiple risks and uncertainties

that could cause actual results to differ materially from those set forth in or implied by such forward-looking statements. These risks

and uncertainties include, but are not limited to, risks related to the scope, validity, enforceability, maintenance and interpretation

of the granted Japanese patent; the possibility of third-party challenges, including during the six-month post-grant opposition period,

administrative proceedings, litigation or other actions affecting the patent or the Company’s intellectual property rights; the

possibility that the actual patent term or scope of protection may differ from the Company’s expectations; the Company’s ability

to obtain, maintain and enforce intellectual property protection in Japan and other jurisdictions; the potential utility, clinical validation

and regulatory acceptance of the DRP® companion diagnostic strategy; the Company’s ability to conduct, enroll and complete its

ongoing and future clinical trials; the possibility that prior clinical observations may not be confirmed in ongoing or future studies;

the ability of stenoparib to demonstrate sufficient safety, efficacy, tolerability or clinical benefit to support further development

or regulatory approval; and the Company’s ability to secure sufficient financial, operational, manufacturing and clinical resources

to continue development of stenoparib. For a discussion of risks and uncertainties and other important factors that could cause actual

results to differ materially from those contained in the forward-looking statements, see the risk factors and other disclosures in Allarity’s

filings with the SEC, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q and Current Reports

on Form 8-K. These filings are available through the SEC’s website. All information in this press release is as of the date of the

release, and the Company undertakes no obligation to update or revise this information, except as required by applicable law.

###

Company Contact:

investorrelations@allarity.com

Media Contact:

Thomas Pedersen

Carrotize PR & Communications

+45 6062 9390

tsp@carrotize.com

Allarity

Page 3 of 3

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