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Allarity Therapeutics Receives Australian Patent Acceptance Notice for Stenoparib DRP® Companion Diagnostic

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Allarity Therapeutics (NASDAQ: ALLR) has received a patent acceptance notice from IP Australia for its Stenoparib DRP® companion diagnostic. The acceptance covers 40 claims for the company's proprietary drug-specific Drug Response Predictor (DRP®) technology used in conjunction with stenoparib, their Phase 2 dual PARP and WNT pathway inhibitor for personalized cancer treatment.

The patent will be advertised in the Australian Official Journal of Patents on June 26, 2025, followed by a three-month opposition period. If unopposed, the patent should be granted within 20 working days. Allarity currently holds 18 granted patents for drug-specific DRPs, including eight in the United States, and has additional Stenoparib DRP® patent applications pending in the U.S., Canada, Japan, China, and India.

Allarity Therapeutics (NASDAQ: ALLR) ha ricevuto una notifica di accettazione del brevetto da IP Australia per il suo diagnostico companion Stenoparib DRP®. L'accettazione riguarda 40 rivendicazioni relative alla tecnologia proprietaria Drug Response Predictor (DRP®) specifica per il farmaco, utilizzata in combinazione con stenoparib, il loro inibitore duale PARP e della via WNT in fase 2 per il trattamento personalizzato del cancro.

Il brevetto sarà pubblicato sul Bollettino Ufficiale Australiano dei Brevetti il 26 giugno 2025, seguito da un periodo di opposizione di tre mesi. Se non verranno presentate opposizioni, il brevetto dovrebbe essere concesso entro 20 giorni lavorativi. Allarity detiene attualmente 18 brevetti concessi per DRP specifici per farmaci, di cui otto negli Stati Uniti, e ha ulteriori domande di brevetto per Stenoparib DRP® in corso negli Stati Uniti, Canada, Giappone, Cina e India.

Allarity Therapeutics (NASDAQ: ALLR) ha recibido una notificación de aceptación de patente por parte de IP Australia para su diagnóstico complementario Stenoparib DRP®. La aceptación cubre 40 reivindicaciones de la tecnología propietaria Drug Response Predictor (DRP®) específica para el medicamento, utilizada junto con stenoparib, su inhibidor dual PARP y de la vía WNT en fase 2 para el tratamiento personalizado del cáncer.

La patente se publicará en el Diario Oficial de Patentes de Australia el 26 de junio de 2025, seguido de un período de oposición de tres meses. Si no se presentan oposiciones, la patente debería ser concedida dentro de los 20 días hábiles siguientes. Allarity actualmente posee 18 patentes concedidas para DRP específicos de medicamentos, incluyendo ocho en Estados Unidos, y tiene solicitudes adicionales de patente para Stenoparib DRP® pendientes en EE.UU., Canadá, Japón, China e India.

Allarity Therapeutics (NASDAQ: ALLR)가 IP Australia로부터 Stenoparib DRP® 동반 진단기기에 대한 특허 승인 통지를 받았습니다. 이번 승인은 회사의 독자적인 약물 특이적 Drug Response Predictor(DRP®) 기술에 대한 40건의 청구항을 포함하며, 이는 개인 맞춤형 암 치료를 위한 2상 이중 PARP 및 WNT 경로 억제제인 스테노파립과 함께 사용됩니다.

특허는 2025년 6월 26일 호주 공식 특허 저널에 게재될 예정이며, 이후 3개월간의 이의신청 기간이 이어집니다. 이의신청이 없으면 특허는 20영업일 내에 승인될 것으로 예상됩니다. Allarity는 현재 미국 내 8건을 포함하여 18건의 승인된 약물 특이적 DRP 특허를 보유하고 있으며, 미국, 캐나다, 일본, 중국, 인도에서 추가적인 Stenoparib DRP® 특허 출원이 진행 중입니다.

Allarity Therapeutics (NASDAQ : ALLR) a reçu un avis d'acceptation de brevet de la part d'IP Australia pour son diagnostic compagnon Stenoparib DRP®. L'acceptation couvre 40 revendications concernant la technologie propriétaire Drug Response Predictor (DRP®) spécifique au médicament, utilisée en association avec le stenoparib, leur inhibiteur dual PARP et voie WNT en phase 2 pour un traitement personnalisé du cancer.

Le brevet sera publié dans le Journal Officiel Australien des Brevets le 26 juin 2025, suivi d'une période d'opposition de trois mois. En l'absence d'opposition, le brevet devrait être délivré dans les 20 jours ouvrables. Allarity détient actuellement 18 brevets délivrés pour des DRP spécifiques aux médicaments, dont huit aux États-Unis, et a d'autres demandes de brevet Stenoparib DRP® en cours aux États-Unis, au Canada, au Japon, en Chine et en Inde.

Allarity Therapeutics (NASDAQ: ALLR) hat von IP Australia eine Mitteilung über die Annahme eines Patents für seinen Stenoparib DRP® Begleitdiagnostiktest erhalten. Die Annahme umfasst 40 Ansprüche für die firmeneigene, medikamentspezifische Drug Response Predictor (DRP®) Technologie, die in Verbindung mit Stenoparib, ihrem dualen PARP- und WNT-Signalweg-Inhibitor in Phase 2 für die personalisierte Krebsbehandlung, verwendet wird.

Das Patent wird am 26. Juni 2025 im australischen Amtsblatt für Patente veröffentlicht, gefolgt von einer dreimonatigen Einspruchsfrist. Wenn kein Einspruch eingelegt wird, sollte das Patent innerhalb von 20 Arbeitstagen erteilt werden. Allarity hält derzeit 18 erteilte Patente für medikamentspezifische DRPs, darunter acht in den USA, und hat weitere Patentanmeldungen für Stenoparib DRP® in den USA, Kanada, Japan, China und Indien anhängig.

Positive
  • Patent acceptance strengthens intellectual property protection in key global market
  • Company already holds 18 granted patents for drug-specific DRPs, including 8 in the U.S.
  • Previous successful securing of European patent for Stenoparib DRP®
Negative
  • Patent still subject to three-month opposition period before final grant
  • Patent applications still pending in major markets including U.S., China, and India

Insights

Allarity's Australian patent acceptance strengthens IP portfolio for stenoparib companion diagnostic, supporting global commercialization strategy.

The acceptance of Allarity's patent application by IP Australia represents a strategic IP milestone for the company's DRP® companion diagnostic specific to stenoparib. With 40 claims accepted, this development strengthens Allarity's intellectual property position in a key international market. The DRP® technology is essential to Allarity's business model as it enables personalized patient selection for its dual PARP/WNT inhibitor stenoparib, currently in Phase 2 clinical trials.

This Australian patent acceptance complements Allarity's existing European patent for the Stenoparib DRP® and adds to their portfolio of 18 granted patents for drug-specific DRPs, including eight in the United States. The company is pursuing additional patent protections in major markets including the U.S., Canada, Japan, China, and India, indicating a comprehensive global IP strategy.

From a competitive standpoint, securing broad patent protection for companion diagnostics is particularly valuable in oncology, where personalized medicine approaches are increasingly important for regulatory approval and commercial success. The three-month opposition period represents a standard procedural step, with patent grant expected within 20 working days thereafter if unopposed. This patent acceptance strengthens Allarity's position to potentially commercialize both stenoparib and its companion diagnostic as an integrated precision medicine approach for cancer treatment.

       

TARPON SPRINGS, Fla., June 30, 2025 -- Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor—as a personalized cancer treatment using its proprietary, drug-specific Drug Response Predictor (DRP®) patient selection technology—today announced that IP Australia, the Australian Government agency that administers intellectual property rights in the country, has formally accepted the Company’s patent application for its DRP® companion diagnostic specific to stenoparib.

The acceptance covers 40 claims and marks a key step in Allarity’s global strategy to protect the potential international commercialization of its proprietary DRP® platform alongside the clinical development of stenoparib. The granted patent will be officially advertised in the Australian Official Journal of Patents on June 26, 2025, followed by a three-month opposition period. If unopposed, the patent is expected to be granted within 20 working days thereafter.

Thomas Jensen, CEO of Allarity Therapeutics, commented: “This latest patent acceptance from Australia represents another important achievement in our efforts to secure international IP protection for our DRP® technology. As we continue advancing stenoparib through Phase 2 trials toward U.S. regulatory approval, we are also building a robust intellectual property position in key global markets.”

Allarity previously secured a European patent for the Stenoparib DRP® and holds 18 granted patents for drug-specific DRPs, including eight in the United States. Patent applications for the Stenoparib DRP® remain pending in the U.S., Canada, Japan, China, and India.

About Stenoparib
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. 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.

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.

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 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, statements regarding the expected grant and scope of the Australian patent for the Stenoparib DRP®; the anticipated contribution of this patent to the Company’s global intellectual property strategy; and the Company’s ability to advance and commercialize stenoparib in Australia and other key markets. 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 the potential for opposition to the patent grant; changes in regulatory timelines or requirements; failure to obtain regulatory approval for stenoparib or its companion diagnostic; and risks inherent in developing and commercializing biopharmaceutical products. 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 31, 2025, 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

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FAQ

What is the status of Allarity Therapeutics' Stenoparib DRP® patent in Australia?

IP Australia has formally accepted Allarity's patent application for the Stenoparib DRP® companion diagnostic, covering 40 claims. The patent will be advertised on June 26, 2025, followed by a three-month opposition period.

How many patents does Allarity Therapeutics (ALLR) currently hold for its DRP technology?

Allarity Therapeutics currently holds 18 granted patents for drug-specific DRPs, including 8 patents in the United States.

What is the current development stage of Allarity Therapeutics' Stenoparib?

Stenoparib is currently in Phase 2 clinical trials as a personalized cancer treatment using the company's proprietary DRP® patient selection technology.

In which countries does Allarity Therapeutics (ALLR) have pending patent applications for Stenoparib DRP®?

Allarity has pending patent applications for Stenoparib DRP® in the United States, Canada, Japan, China, and India.

What type of drug is Stenoparib?

Stenoparib is a differentiated, dual PARP and WNT pathway inhibitor being developed as a personalized cancer treatment.
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