Allarity Therapeutics Announces Filing of Form 8-K Regarding Settlement Agreement in Principle with SEC
Allarity Therapeutics (NASDAQ: ALLR) has announced an agreement in principle with the SEC to resolve a previously disclosed investigation. The settlement concerns the company's disclosures made during or before 2022 regarding FDA meetings about their New Drug Application for Dovitinib/Dovitinib-DRP submitted in 2021.
The agreement remains subject to final language approval and SEC confirmation. CEO Thomas Jensen highlighted that some patients in their Phase 2 stenoparib trial have exceeded 14 months of treatment, expressing optimism about the molecule's prospects. The company plans to design a follow-on trial aimed at FDA registration for stenoparib.
Allarity confirms it maintains sufficient financial positioning to continue core operations, including stenoparib development, into 2026.
Allarity Therapeutics (NASDAQ: ALLR) ha annunciato un accordo di principio con la SEC per risolvere un'indagine precedentemente divulgata. L'accordo riguarda le comunicazioni dell'azienda effettuate durante o prima del 2022 riguardanti riunioni con la FDA relative alla loro Domanda di Nuovo Farmaco per Dovitinib/Dovitinib-DRP presentata nel 2021.
L'accordo resta soggetto all'approvazione del linguaggio finale e alla conferma della SEC. Il CEO Thomas Jensen ha evidenziato che alcuni pazienti nel loro studio di Fase 2 su stenoparib hanno superato i 14 mesi di trattamento, esprimendo ottimismo sulle prospettive della molecola. L'azienda prevede di progettare uno studio di follow-up mirato alla registrazione FDA per stenoparib.
Allarity conferma di mantenere una posizione finanziaria sufficiente per continuare le operazioni core, inclusa lo sviluppo di stenoparib, fino al 2026.
Allarity Therapeutics (NASDAQ: ALLR) ha anunciado un acuerdo de principio con la SEC para resolver una investigación previamente divulgada. El acuerdo se refiere a las declaraciones de la empresa realizadas durante o antes de 2022 sobre reuniones con la FDA respecto a su Solicitud de Nuevo Medicamento para Dovitinib/Dovitinib-DRP presentada en 2021.
El acuerdo está sujeto a la aprobación del lenguaje final y a la confirmación de la SEC. El CEO Thomas Jensen destacó que algunos pacientes en su ensayo de Fase 2 de stenoparib han superado los 14 meses de tratamiento, expresando optimismo sobre las perspectivas de la molécula. La empresa planea diseñar un ensayo complementario destinado a la inscripción en la FDA para stenoparib.
Allarity confirma que mantiene una posición financiera suficiente para continuar con las operaciones principales, incluido el desarrollo de stenoparib, hasta 2026.
올라리티 치료제 (NASDAQ: ALLR)는 SEC와의 원칙 합의 발표 및 이전에 공개된 조사의 해결을 알렸습니다. 이 합의는 2021년에 제출된 Dovitinib/Dovitinib-DRP에 대한 FDA 회의에 관한 회사의 2022년 이전 또는 그해에 이루어진 공시에 관련된 것입니다.
합의는 최종 언어 승인과 SEC 확인을 기다리고 있습니다. CEO인 토마스 잰센은 스테노파립의 2상 시험에 참가한 일부 환자들이 14개월 이상의 치료를 받았으며 이 분자의 전망에 대해 낙관적인 입장을 나타냈습니다. 회사는 스테노파립에 대한 FDA 등록을 목표로 하는 후속 시험을 설계할 계획입니다.
올라리티는 2026년까지 스테노파립 개발을 포함한 핵심 운영을 계속할 수 있는 충분한 재정적 여력을 유지하고 있다고 확인했습니다.
Allarity Therapeutics (NASDAQ: ALLR) a annoncé un accord de principe avec la SEC pour résoudre une enquête précédemment divulguée. Le règlement concerne les déclarations de l'entreprise faites pendant ou avant 2022 concernant des réunions avec la FDA au sujet de leur Demande de Nouveau Médicament pour Dovitinib/Dovitinib-DRP soumise en 2021.
L'accord est encore soumis à l'approbation de la langue finale et à la confirmation de la SEC. Le PDG Thomas Jensen a souligné que certains patients dans leur essai de phase 2 sur le stenoparib ont dépassé 14 mois de traitement, exprimant son optimisme quant aux perspectives de la molécule. L'entreprise prévoit de concevoir un essai complémentaire visant à l'enregistrement par la FDA pour le stenoparib.
Allarity confirme qu'elle maintient une position financière suffisante pour continuer ses opérations essentielles, y compris le développement de stenoparib, jusqu'en 2026.
Allarity Therapeutics (NASDAQ: ALLR) hat eine Grundsatzvereinbarung mit der SEC angekündigt, um eine zuvor offengelegte Untersuchung zu klären. Die Einigung betrifft die Unternehmensmeldungen, die während oder vor 2022 bezüglich der FDA-Meetings zu ihrem New Drug Application für Dovitinib/Dovitinib-DRP, die 2021 eingereicht wurde, gemacht wurden.
Die Vereinbarung steht noch unter dem Vorbehalt der finalen Sprachgenehmigung und der Bestätigung durch die SEC. CEO Thomas Jensen hob hervor, dass einige Patienten in ihrer Phase-2-Studie zu Stenoparib eine Behandlungsdauer von mehr als 14 Monaten erreicht haben, was seine Zuversicht über die Aussichten des Moleküls zum Ausdruck bringt. Das Unternehmen plant, eine Folgestudie zu entwerfen, die auf die FDA-Zulassung für Stenoparib abzielt.
Allarity bestätigt, dass es über ausreichend finanzielle Mittel verfügt, um die zentralen Betriebe, einschließlich der Entwicklung von Stenoparib, bis 2026 fortzusetzen.
- Phase 2 trial patients showing extended treatment response (>14 months) with stenoparib
- Financial runway secured until 2026 for core operations
- Progress toward potential SEC investigation resolution
- Ongoing SEC settlement process regarding FDA meeting disclosures
- Settlement agreement not yet finalized and subject to SEC approval
Insights
The SEC settlement agreement represents a significant regulatory milestone for Allarity Therapeutics, addressing historical disclosure issues related to their FDA communications about Dovitinib. While SEC settlements can often signal serious compliance concerns, several key factors mitigate the potential negative impact:
Settlement Context and Implications:
- The investigation focuses on past disclosures (2022 or earlier), suggesting these are legacy issues rather than ongoing concerns
- The agreement in principle indicates the company has likely negotiated manageable terms, though financial details remain undisclosed
- Resolution of this regulatory overhang could improve investor confidence and allow management to focus on core development programs
Strategic Positioning:
- The company's pivot to stenoparib development appears well-timed, with encouraging Phase 2 data showing 14+ month treatment durability in some patients
- Financial runway extending into 2026 provides substantial operational flexibility for advancing stenoparib's development
- The focus on advanced ovarian cancer represents a significant market opportunity with competition
However, investors should note several risk factors:
- The settlement remains subject to final approval and could face modifications
- Past disclosure issues might lead to enhanced scrutiny of future communications
- While financially positioned through 2026, biotech development often requires additional capital raises
This settlement marks a important step in addressing historical compliance issues while allowing the company to focus on its promising clinical programs. The combination of regulatory resolution and encouraging clinical data could potentially improve Allarity's market position, though careful monitoring of settlement terms and development milestones remains essential.
Boston (January 30, 2025)—Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments using its proprietary, drug-specific patient selection technology, has filed a Form 8-K with the U.S. Securities and Exchange Commission (“SEC”) regarding its agreement in principle with the SEC staff to resolve the previously disclosed SEC investigation.
The settlement relates to the Company’s disclosures, occurring during or prior to fiscal year 2022, regarding meetings with the United States Food and Drug Administration (the “FDA”) concerning our New Drug Application ("NDA") for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021. This settlement in principle with the SEC staff remains subject to mutual agreement on the final language of the settlement documents and approval by the SEC. Accordingly, the Company emphasizes that there is no assurance that the settlement will be finalized or approved on the terms set forth above, or at all.
“We are pleased to have reached this agreement in principle with the SEC. This settlement allows us to fully focus on advancing stenoparib and delivering a novel therapy to advanced ovarian cancer patients, who currently have very few or no treatment options,” said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. “As we have previously announced, some patients in our Phase 2 trial have exceeded 14 months on treatment with stenoparib, and this data fills us with optimism about the prospects of this novel molecule and by extension, the prospects for Allarity as well. Our primary objective now is to finalize the design of a follow-on trial that we expect will advance stenoparib toward FDA registration.”
Allarity remains financially positioned to continue its core operations, including the ongoing development of stenoparib, as planned into 2026.
The full Form 8-K filing is available on the SEC’s website at www.sec.gov and on the Company’s website at www.allarity.com/sec-filings.
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. 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 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® companion diagnostic for patient selection in the ongoing phase 2 clinical trial, NCT03878849. 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
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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 anticipated resolution of the SEC investigation, the ongoing development and regulatory progress of stenoparib, and plans to initiate a follow-up clinical trial aimed at FDA registration. 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 finalization and approval of the proposed SEC settlement, the successful execution of clinical trials for stenoparib, securing regulatory approval, and other operational and financial risks that could impact the Company’s ability to achieve its goals. 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 S-1/A registration statement filed on April 17, 2024, our Form 10-K annual report on file with the Securities and Exchange Commission (the “SEC”) and our Form 10-Q quarterly report filed with the SEC on November 14, 2024, 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.
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Company Contact:
investorrelations@allarity.com
Media Contact:
Thomas Pedersen
Carrotize PR & Communications
+45 6062 9390
tsp@carrotize.com
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