Form 8-K

8-K — Allarity Therapeutics, Inc.

Accession: 0001213900-26-104317

Filed: 2026-09-29

Period: 2026-09-28

CIK: 0001860657

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ea0306873-8k_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 28, 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 28, 2026, Allarity Therapeutics,

Inc. (the “Company”) announced the expansion of its in-house medical laboratory capabilities to include proteomics and cell

line research. 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 28, 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 29, 2026

By:

/s/ Thomas H. Jensen

Thomas H. Jensen

Chief Executive Officer

EX-99.1 — PRESS RELEASE, DATED SEPTEMBER 28, 2026

EX-99.1

Filename: ea030687301ex99-1.htm · Sequence: 2

Exhibit 99.1

Allarity Therapeutics Expands Laboratory Capabilities to Include

Proteomics and Cell Line Research

- Expanded laboratory capabilities support deeper mechanism-of-action

research for stenoparib

- New proteomics and cell line capabilities will broaden Allarity’s

research capabilities to enable external partnerships

TARPON SPRINGS, Fla., September 28, 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 it has expanded

the capabilities of its in-house medical laboratory to include proteomics and cell line research.

The new capabilities build on the laboratory’s existing transcriptomics

research and CLIA clinical testing services and are expected to support Allarity in several areas. Internally, the expanded capabilities

will allow the Company to conduct additional research into the mechanism of action of its lead asset, stenoparib. Externally, these capabilities

broaden the range of research projects and laboratory services that Allarity can offer to existing and prospective customers.

Proteomics has become an increasingly important component of translational

cancer research by providing information about protein expression, signaling pathways and the molecular mechanisms involved in tumor growth,

progression and treatment response. Integrating proteomic analysis with transcriptomic and cell-based research can provide a more comprehensive

view of tumor biology and help identify therapeutic targets and modulators of drug response.

“By combining transcriptomics, proteomics and cell line research

within our own laboratory infrastructure, we can generate a broader set of molecular insights to support our stenoparib development program.

We expect this to be particularly valuable as we continue to deepen our dialogue with leading oncologists and other stakeholders, both

to better understand stenoparib’s differentiated mechanism of action and to further sharpen our understanding of the cancer indications

in which it may have the greatest potential,” said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. “At the

same time, these expanded capabilities allow us to broaden the scientific services we can provide to external partners.”

Allarity

Page 1 of 4

Allarity’s medical laboratory is equipped

with an nCounter® Pro instrument that supports the Company’s transcriptomics research and CLIA clinical services. The platform

can now also be applied to proteomics research using the nCounter® Human Tumor Signaling Protein Panel, which measures approximately

300 protein targets. Together with the addition of cell line research capabilities, this significantly expands the range of molecular

and preclinical research that Allarity can conduct in-house.

The expanded laboratory capabilities will not affect the Company’s

current cash runway. Rather, these may generate significant cost efficiencies by enabling more research activities to be conducted in-house.

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.

Page 2 of 4

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/

Page 3 of 4

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 anticipated benefits of the Company’s expanded laboratory capabilities, including the use of

proteomics and cell line research to support mechanism-of-action studies for stenoparib; the potential for these capabilities to generate

additional molecular insights; and the Company’s ability to broaden the research and laboratory services offered to existing and

prospective external partners. 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 Company’s ability to successfully implement and utilize its expanded proteomics and cell line research capabilities; the possibility

that these capabilities may not generate the anticipated scientific insights or support the development of stenoparib as expected; operational,

technical, regulatory or quality-related challenges associated with laboratory service delivery; the Company’s ability to attract

and retain external customers for its expanded laboratory services; and the Company’s overall financial resources. 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

Page 4 of 4

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