STOCK TITAN

Allarity gets Japan patent for stenoparib test

Japan grants Allarity a stenoparib DRP patent running into 2039, expanding global IP protection for its lead oncology program.

(Very High)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Allarity Therapeutics, Inc. (ALLR) reported that the Japan Patent Office has granted Japanese Patent No. 7917283, a key patent covering its proprietary stenoparib-specific Drug Response Predictor (DRP®) companion diagnostic, providing patent protection in Japan into 2039.

The patent covers DRP methods for predicting clinical benefit from stenoparib based on tumor gene-expression profiles and for selecting patients most likely to benefit from stenoparib treatment. Allarity already holds stenoparib DRP® patents in the United States, with protection into April 2042, as well as in certain European jurisdictions and Australia, and is advancing stenoparib through Phase 2 trials in ovarian and small cell lung cancer.

Positive

  • Japan grants key stenoparib DRP® patent with protection into 2039, strengthening Allarity’s intellectual property in a major pharma market.
  • Stenoparib DRP® patent protection in the U.S. extends into April 2042, supporting long-term exclusivity around its companion diagnostic strategy.

Negative

  • None.

Filing Explained

The Japanese patent is granted, but the filing says its scope, validity, enforceability, and commercial value remain subject to a six-month post-grant opposition period and other possible challenges; the grant does not itself establish regulatory approval or commercialization.

Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Japanese patent number Japanese Patent No. 7917283 Key patent covering stenoparib-specific DRP® companion diagnostic
Japanese patent term Protection into 2039 Stenoparib DRP® patent coverage in Japan
U.S. patent term for stenoparib DRP® Protection into April 2042 Patent coverage in the United States
Clinical stage of stenoparib Phase 2 Described as a Phase 2 clinical-stage program
Trial enrollment timing Summer 2025 Amended ovarian cancer protocol began enrolling
SCLC trial start Early 2026 Phase 2 stenoparib plus temozolomide in relapsed small cell lung cancer began enrolling
companion diagnostic medical
"stenoparib-specific Drug Response Predictor (DRP®) companion diagnostic"
A companion diagnostic is a medical test designed to identify which patients are likely to benefit from a specific drug or medical treatment, much like a key that shows whether a particular lock will open. For investors, these tests matter because they can increase a drug’s chances of approval and market uptake, create a separate revenue stream, and reduce commercial risk by matching treatments to the patients most likely to respond.
Drug Response Predictor (DRP®) medical
"Allarity’s proprietary stenoparib-specific Drug Response Predictor (DRP®) companion"
A drug response predictor (DRP®) is a laboratory test or computer-based tool that uses biological data from a patient’s tissue or blood to estimate how likely a specific medicine is to work for that person. For investors it matters because such predictors can improve drug trial success rates, speed regulatory approval, and boost commercial adoption by identifying the patients most likely to benefit—think of it as a weather forecast that helps decide whether to carry an umbrella for a given treatment.
PARP/tankyrase inhibitor medical
"stenoparib, a novel PARP/tankyrase inhibitor for patients with advanced"
WNT signaling pathway medical
"Tankyrases have emerged as potential therapeutic targets in cancer due in part to their role in regulating the WNT signaling pathway."
A cellular communication network that tells cells when to grow, divide, move or specialize, much like a traffic signal system that coordinates cars at intersections. It matters to investors because drugs or diagnostics that modify this pathway can lead to treatments for cancer, developmental disorders, or tissue repair, affecting a company’s drug pipeline, regulatory risk and long-term revenue prospects.
platinum-resistant ovarian cancer medical
"new protocol focused on patients with platinum-resistant ovarian cancer, which began"
A form of ovarian cancer that stops responding to standard platinum-based chemotherapy, typically when the disease returns within about six months after treatment; think of it like a pest becoming resistant to a once-effective pesticide. It matters to investors because this resistance creates a large unmet medical need, shaping demand for new drugs, clinical trial strategies, regulatory priority and potential pricing — all of which can materially affect company value and market opportunity.
small cell lung cancer medical
"Phase 2 trial evaluating stenoparib in combination with temozolomide for patients with relapsed small cell lung cancer"
A fast-growing form of lung cancer that tends to spread early to other organs, making it harder to treat than many slower-moving tumors. Investors care because its aggressive nature creates urgent demand for effective drugs, diagnostics and treatments; clinical trial results, regulatory decisions, or new therapies for this disease can quickly reshape a company’s revenue prospects much like a breakthrough product can transform a business in any industry.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did ALLR announce regarding its Japanese patent?

Allarity announced that the Japan Patent Office granted Japanese Patent No. 7917283, covering its stenoparib-specific DRP® companion diagnostic, providing patent protection in Japan into 2039.

How does the new Japanese patent affect Allarity Therapeutics (ALLR)?

The granted patent covers DRP® methods for predicting benefit from stenoparib and selecting patients for treatment in Japan, supporting Allarity’s intellectual property and potential future commercialization of stenoparib together with its DRP® test in that market.

What patent protection does ALLR have for the stenoparib DRP® outside Japan?

Allarity states it has stenoparib DRP® patent protection in the United States into April 2042 and in certain European jurisdictions and Australia, with related applications pending in additional markets.

What stage of development is stenoparib in for Allarity Therapeutics (ALLR)?

Stenoparib is in Phase 2 clinical development. Allarity completed a Phase 2 trial in advanced ovarian cancer and is running an amended protocol in platinum-resistant or platinum-ineligible ovarian cancer, plus a separate Phase 2 trial in relapsed small cell lung cancer.

What is the stenoparib DRP® companion diagnostic mentioned by ALLR?

The stenoparib DRP® companion diagnostic uses gene-expression profiles from tumor samples to predict which patients are more likely to benefit from stenoparib, generating drug-specific predictive scores intended to guide patient selection.

What type of company is Allarity Therapeutics (ALLR)?

Allarity is a clinical-stage pharmaceutical company focused on personalized cancer treatments. It is developing stenoparib, a dual PARP/tankyrase inhibitor, for advanced ovarian cancer and other cancers using its proprietary DRP® companion diagnostic technology.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google
Learn about SEC filing dates
false 0001860657 0001860657 2026-09-15 2026-09-15 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

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).

 

1

 

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

 

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

 

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

 

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

 

Page 3 of 3

Filing Exhibits & Attachments

4 documents

Keep reading