Form 8-K

8-K — Allarity Therapeutics, Inc.

Accession: 0001213900-26-052542

Filed: 2026-05-06

Period: 2026-05-05

CIK: 0001860657

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ea0289243-8k_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)

May 5, 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 May 5, 2026, Allarity Therapeutics, Inc. (the “Company”)

announced that its active pharmaceutical ingredient manufacturing campaign for stenoparib is progressing in line with the planned timeline,

with completion expected no later than the third quarter of 2026 at its contract development and manufacturing organization. The Company’s

press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

Number

Description

99.1

Press Release, dated May 5, 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: May 6, 2026

By:

/s/ Thomas H. Jensen

Thomas H. Jensen

Chief Executive Officer

EX-99.1 — PRESS RELEASE, DATED MAY 5, 2026

EX-99.1

Filename: ea028924301ex99-1.htm · Sequence: 2

Exhibit

99.1

Allarity

Therapeutics Advances Stenoparib Toward Pivotal Development with Phase 3 Manufacturing Campaign

- Phase 3 manufacturing campaign on track for completion no later than third quarter 2026, supporting expected pivotal trial in advanced ovarian cancer

- Supports accelerating stenoparib toward FDA approval following FDA Fast Track designation

- All manufacturing-related payments completed; no additional cash outlays for manufacturing are anticipated

TARPON

SPRINGS, Fla., MAY 5, 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 its active pharmaceutical ingredient (API) manufacturing campaign for stenoparib is progressing

in line with the planned timeline for completion no later than the third quarter of 2026 at its world-class contract development and

manufacturing organization (CDMO).

This

milestone represents a key operational advance as the Company works to secure robust drug supply while preparing for potential pivotal-stage

clinical development. The decision to move forward with the campaign reflects the continuously growing confidence in stenoparib’s

therapeutic potential, based on previously reported data showing extended overall survival in advanced, platinum-resistant ovarian cancer

patients.

“With

the Phase 3 manufacturing campaign of stenoparib approaching completion, we are taking an important step to ensuring timely advancement

into potential pivotal-stage clinical trials,” said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. “This

campaign reflects our confidence in the long-term potential of the program, and is particularly important as we work to leverage the

FDA Fast Track designation to accelerate the development and potential approval of stenoparib.”

Page 1 of 4

The

CDMO site, located in Europe, operates in full compliance with GMP (Good Manufacturing Practice) standards set by both the U.S. Food

and Drug Administration (FDA) and the European Medicines Agency (EMA). Drug manufacturing for late-stage clinical development requires

heightened manufacturing standards that go above and beyond the standards necessary for phase 1 and phase 2 clinical development. Triggering

this campaign now ensures that the higher standard API is ready when the company is ready to advance a pivotal trial for FDA approval.

From

a financial standpoint, the company has completed all payments for the manufacturing and no additional cash outlays for manufacturing

are anticipated.

The

manufacturing campaign is expected to be completed well in advance of the anticipated generation of critical data from Allarity’s

ongoing Phase 2 trial in advanced ovarian cancer. The ongoing phase 2 trial continues to enroll patients under the new protocol, generating

enthusiastic investigator engagement.

About

Stenoparib/2X-121

Stenoparib

is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant

attention as emerging therapeutic targets for cancer, principally due 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. By inhibiting PARP and blocking

WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types,

including ovarian cancer, Small Cell Lung Cancer and colorectal cancer. Allarity has secured exclusive global rights for the development

and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and

2X-121. Allarity has two ongoing Phase 2 trial protocols for stenoparib in Ovarian Cancer patients. In the first, patients who had had

2+ lines of therapy were enrolled on stenoparib and given drug twice daily. This protocol has been closed to further enrollment but continues

for the enrolled patients who are still receiving benefit from stenoparib administration. The updated data from this study were presented

at the AACR special conference on advances in Ovarian Cancer in September 2025. Note that, as these data are from an ongoing trial, analyses

may change as the study fully matures. An amended protocol designed expressly to capitalize on the emerging clinical experience with

stenoparib in platinum resistant patients began enrolling patients in the summer of 2025. This amended protocol enrolls only platinum

resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval. In

parallel, a separate Phase 2 trial evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer (SCLC)

began enrolling patients in early 2026 and is currently enrolling patients across multiple U.S. Veterans Administration (VA) sites.

Page 2 of 4

About

the Drug Response Predictor – DRP® Companion Diagnostic

Allarity

uses its drug-specific DRP® to select those patients who, by the gene expression signature of their cancer, may have

a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a

sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of

sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology

filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP® platform

has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients

across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and

is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.

About

Allarity Therapeutics

Allarity

Therapeutics, Inc. (NASDAQ: ALLR) is a clinical-stage biopharmaceutical company dedicated to developing personalized cancer treatments.

The Company is focused on development of stenoparib, a novel PARP/tankyrase inhibitor for advanced ovarian cancer patients, using its

DRP® technology to develop a companion diagnostic that can be used to select those patients expected to derive the

greatest clinical benefit from stenoparib. Allarity is headquartered in the U.S., with a research facility in Denmark, and is committed

to addressing significant unmet medical needs in cancer treatment. For more information, visit www.allarity.com.

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 the Private Securities Litigation Reform Act of

1995. Forward-looking statements provide the Company’s current expectations or forecasts of future events. The words “anticipates,”

“believe,” “continue,” “could,” “estimate,” “expect,” “intends,”

“may,” “might,” “plan,” “possible,” “potential,” “predicts,”

“project,” “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, regarding the Company’s manufacturing readiness and supply strategy for stenoparib, the availability of drug supply

to support ongoing and potential future clinical trials, including potential pivotal studies, the timing and progression of late-stage

clinical development, future regulatory interactions and submissions, and the potential commercialization of stenoparib. 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 and adversely 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 manufacturing execution and scale-up, potential

disruptions in the supply of raw materials or drug product, regulatory review and approval processes, the results and timing of ongoing

and future clinical trials, the Company’s ability to maintain sufficient financial resources to support development activities,

and other operational, clinical, and regulatory risks. For a discussion of other risks and uncertainties, and other important factors,

any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled

“Risk Factors” in our Form 10-K annual report filed with the Securities and Exchange Commission (the “SEC”) on

March 30, 2026, available at the SEC’s website at www.sec.gov, and as well as discussions of potential risks, uncertainties and

other important factors in the Company’s subsequent filings with the SEC. All information in this press release is as of the date

of the release, and the Company undertakes no duty to update this information unless required by 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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