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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)
October 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 1.01 Entry into a Material Definitive Agreement.
On October 28, 2026, Allarity
Therapeutics, Inc. (the “Company”) entered into a Settlement and Release Agreement (the “Settlement Agreement”)
with Novartis Pharma AG (“Novartis”) relating to an aggregate current liability of $4,900,000, plus interest, due to Novartis
(the “Liability”). The Liability arose under a license agreement between Novartis and Allarity Therapeutics Europe ApS, an
affiliate of the Company, which license agreement was previously terminated effective January 26, 2024.
Pursuant to the Settlement
Agreement, Novartis agreed to accept a payment of $1,000,000 from the Company as full payment of the Liability. Upon receipt of such payment,
Novartis and its related parties will release the Company and its related parties from claims in respect of the Liability, and the Company
and its related parties will release Novartis and its related parties from claims, subject in each case to claims relating to or arising
from the enforcement of the Settlement Agreement.
The foregoing description
of the Settlement Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Settlement
Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 8.01 Other Matters.
On October 30, 2026, the
Company issued a press release announcing its first revenue-generating contract under its newly established CLIA-certified laboratory
services strategy. A copy of the 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 |
| 10.1* |
|
Settlement and Release Agreement, dated as of October 28, 2026, by and between Allarity Therapeutics, Inc. and Novartis Pharma AG. |
| 99.1 |
|
Press Release, dated October 30, 2026. |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
| * | Certain personally identifiable information has been omitted
from this exhibit pursuant to Item 601(a)(6) of Regulation S-K. Redacted information is indicated by the notation “[***]”. |
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: November 2, 2026 |
By: |
/s/ Thomas H. Jensen |
| |
|
Thomas H. Jensen Chief Executive Officer |
Exhibit 99.1

Allarity Therapeutics Secures First
Commercial Agreement Under New CLIA Laboratory Services Strategy, Establishing Potential Path to Additional Recurring Revenue
- Agreement complements
revenue from standard gene expression and DRP® services
- Development and validation services
will support a European biotechnology company’s precision oncology predictive device for use in the United States
- Strategy expands commercial use
of existing laboratory capabilities
- Stenoparib remains the Company’s
top development priority
TARPON SPRINGS, Fla., October 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 announced its first revenue-generating contract under its newly
established CLIA-certified laboratory services strategy.
CLIA certification is a U.S. regulatory requirement for laboratories
performing testing on specimens from humans, such as blood, body fluids, and tissue. The agreement represents the first commercial validation
of Allarity’s CLIA-certified laboratory services strategy following the Company’s receipt of CLIA certification in July 2026.
Under the agreement, Allarity will provide a European biotechnology
company with development, validation and related laboratory services to support implementation of a proprietary precision oncology predictive
device for use in the United States. Successful completion of the program could lead to ongoing commercial testing and CLIA-related service
revenues.
“This agreement moves our newly established CLIA laboratory services
strategy into commercial execution, building on our existing gene expression and DRP® services business,” said Thomas Jensen,
Chief Executive Officer of Allarity Therapeutics. “For shareholders, the opportunity is to generate additional value from capabilities
we have already built while maintaining stenoparib as our top development priority.”
Allarity Therapeutics, Inc. | 123 E Tarpon Ave | Tarpon Springs, Florida | U.S.A. | NASDAQ: ALLR | www.allarity.com

Allarity obtained a Certificate of Registration under the Clinical
Laboratory Improvement Amendments (CLIA) for its Hørsholm laboratory, in part to enable the Company to perform biomarker testing
internally in support of the continued clinical development of stenoparib and its DRP® companion diagnostic strategy.
The Company also identified the opportunity to offer its CLIA-certified
laboratory capabilities to other biotechnology and pharmaceutical companies, particularly European drug developers seeking laboratory
support for precision oncology programs intended for U.S. clinical development or commercialization. This first commercial agreement provides
an initial foundation for pursuing that broader service opportunity.
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.
Allarity Therapeutics, Inc. | 123 E Tarpon Ave | Tarpon Springs, Florida | U.S.A. | NASDAQ: ALLR | www.allarity.com

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 Therapeutics, Inc. | 123 E Tarpon Ave | Tarpon Springs, Florida | U.S.A. | NASDAQ: ALLR | www.allarity.com

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 successful performance of services under the Company’s CLIA-certified laboratory services agreement;
the potential for the agreement and the Company’s laboratory capabilities to generate recurring commercial revenue; future demand
for the Company’s CLIA-certified services; the continued development of stenoparib and the Company’s DRP® companion diagnostic
strategy; and the Company’s expectation that its existing working capital will be sufficient to fund operations into the summer
of 2028. 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 that the development or validation
activities may not be successfully completed; that the customer’s program may not advance to commercial testing; that the agreement
may not generate recurring revenues or lead to additional commercial agreements; changes in applicable regulatory requirements; and the
possibility that the Company’s operating expenses, financing needs or other circumstances may differ from current expectations.
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 Therapeutics, Inc. | 123 E Tarpon Ave | Tarpon Springs, Florida | U.S.A. | NASDAQ: ALLR | www.allarity.com