Form 8-K

8-K — Allarity Therapeutics, Inc.

Accession: 0001213900-26-105457

Filed: 2026-10-01

Period: 2026-09-30

CIK: 0001860657

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ea0307298-8k_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 30, 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 30, 2026, Allarity Therapeutics, Inc. (the “Company”)

provided an update on recent advances in its proprietary Drug Response Predictor (DRP®) technology, patent portfolio and in-house

laboratory capabilities, which support the clinical development of stenoparib and expand potential external partnership opportunities.

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 30, 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: October 1, 2026

By:

/s/ Thomas H. Jensen

Thomas H. Jensen

Chief Executive Officer

EX-99.1 — PRESS RELEASE, DATED SEPTEMBER 30, 2026

EX-99.1

Filename: ea030729801ex99-1.htm · Sequence: 2

Exhibit 99.1

Allarity Provides Update on Key Recent

Advances Solidifying Drug Response Predictor® to Drive Stenoparib’s Clinical Development

- Recently awarded patents

have solidified Allarity’s strategy to leverage DRP to ensure the commercial exclusivity of stenoparib

TARPON SPRINGS, Fla., September 30, 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 provided an update on recent

advances in its proprietary Drug Response Predictor (DRP®) technology, patent portfolio and in-house laboratory capabilities that

strengthen its ability to drive stenoparib’s clinical development while expanding external partnership opportunities.

Allarity Therapeutics was established on its proprietary patient selection

technology—the Drug Response Predictor (DRP®). DRP® allows Allarity to assess a patient’s tumor tissue for the gene

expression changes that indicate the patient’s tumor is either more or less likely to respond to a given cancer therapy. DRP®

tests have been successfully developed for dozens of cancer therapies. Most notably, DRP® has been developed for Allarity’s

lead asset, stenoparib, and has been deployed in the clinic to pre-select patients for stenoparib-based therapy.

The stenoparib-DRP® is comprised of a unique 414-gene expression

signature, notably including genes associated with WNT pathway activity. At AACR 2026, Allarity presented an exploratory analysis of its

prior Phase 2 cohort of patients with advanced ovarian cancer treated with twice-daily stenoparib. Higher pretreatment DRP scores were

associated with longer overall survival, supporting the test’s potential to identify patients who may derive the most durable benefit.

Recent patent awards coupled with the CLIA certification of Allarity’s

in-house lab allow the company to extend the utility of the test as a companion diagnostic test and to retain sole control of that clinical

test. These developments extend the commercial viability of both stenoparib and the stenoparib-DRP test.

Collectively, these advances support Allarity’s ongoing strategy

to use DRP to inform patient selection for a pivotal trial, making the technology an integral part of stenoparib’s development

toward FDA approval.

“Over the past few months, we have significantly strengthened the clinical foundation for our DRP-guided stenoparib program,”

said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. “For stenoparib, the association between higher DRP scores

and longer overall survival helps inform our clinical development strategy as we work toward FDA approval. While stenoparib remains our

principal development focus, our extensive experience developing predictors for other drugs also provides a foundation for external partnerships.”

Page 1 of 4

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.

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.

Page 2 of 4

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/

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 potential of the DRP® platform to identify patients most likely to benefit from stenoparib and

other therapies; Allarity's plans to use DRP to inform patient selection for a potential pivotal trial of stenoparib; the potential for

stenoparib to achieve FDA approval; the expected benefits of Allarity's in-house CLIA laboratory capability, including support for patient-selection

testing, the development of companion diagnostics and the delivery of laboratory services to external partners; opportunities for diagnostic

licensing and other external partnerships; the scope and duration of Allarity's patent protection; and the Company's ability to create

long-term enterprise value. 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 exploratory nature of the DRP analyses described in this press release and the possibility that such results may not be replicated

in future clinical trials; the risk that the DRP may not successfully identify patients who benefit from stenoparib or other therapies;

risks related to the design, timing, enrollment, conduct and results of clinical trials, including any potential pivotal trial of stenoparib;

the risk that stenoparib or any DRP-based companion diagnostic may not receive regulatory approval; risks related to the operation of

Allarity's CLIA laboratory, including regulatory compliance; the Company's ability to enter into and maintain licensing and laboratory

services agreements with external partners; the Company's ability to obtain, maintain, defend and enforce its patents and other intellectual

property rights; the Company's need for additional financing; and general market, economic and competitive conditions. 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.

###

Page 3 of 4

Company Contact:

investorrelations@allarity.com

Media Contact:

Thomas Pedersen

Carrotize PR & Communications

+45 6062 9390

tsp@carrotize.com

Allarity

Page 4 of 4

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