Allarity Therapeutics Announces Final Settlement with the U.S. Securities and Exchange Commission
Allarity Therapeutics (NASDAQ: ALLR) has reached a final settlement with the SEC regarding its past disclosures about FDA interactions concerning its New Drug Application for Dovitinib. The settlement follows the January 30, 2025 agreement in principle.
Key terms include:
- A $2.5 million civil penalty payment
- A cease-and-desist order without admitting or denying SEC findings
- Findings of violations under Securities Act Sections 17(a)(2) and (3) and Exchange Act Section 13(a)
The company confirms this penalty won't impact its financial outlook or ability to execute planned Phase 2 clinical trials. Allarity's cash position is expected to support operations into 2026. The settlement resolves all outstanding legal matters, including the recently dismissed securities class action lawsuit.
Allarity Therapeutics (NASDAQ: ALLR) ha raggiunto un accordo finale con la SEC riguardo alle sue precedenti comunicazioni sulle interazioni con la FDA relative alla sua Domanda di Nuovo Farmaco per il Dovitinib. L'accordo segue l'intesa di principio del 30 gennaio 2025.
I termini chiave includono:
- Un pagamento di penale civile di 2,5 milioni di dollari
- Un'ordinanza di cessazione e desistenza senza ammettere né negare le conclusioni della SEC
- Conclusioni di violazioni ai sensi delle Sezioni 17(a)(2) e (3) del Securities Act e della Sezione 13(a) dell'Exchange Act
La società conferma che questa penale non influenzerà le sue previsioni finanziarie o la capacità di eseguire i trial clinici di Fase 2 pianificati. La posizione di liquidità di Allarity è prevista per sostenere le operazioni fino al 2026. L'accordo risolve tutte le questioni legali in sospeso, inclusa la recente causa collettiva sui titoli recentemente archiviata.
Allarity Therapeutics (NASDAQ: ALLR) ha alcanzado un acuerdo final con la SEC sobre sus divulgaciones pasadas relacionadas con las interacciones de la FDA en relación con su Solicitud de Nuevo Medicamento para el Dovitinib. El acuerdo sigue la intención de acuerdo del 30 de enero de 2025.
Los términos clave incluyen:
- Un pago de penalización civil de 2,5 millones de dólares
- Una orden de cese y desistimiento sin admitir ni negar los hallazgos de la SEC
- Hallazgos de violaciones bajo las Secciones 17(a)(2) y (3) de la Ley de Valores y la Sección 13(a) de la Ley de Intercambio
La empresa confirma que esta penalización no afectará su perspectiva financiera ni su capacidad para llevar a cabo los ensayos clínicos de Fase 2 planificados. Se espera que la posición de efectivo de Allarity respalde las operaciones hasta 2026. El acuerdo resuelve todos los asuntos legales pendientes, incluida la reciente demanda colectiva de valores desestimada.
Allarity Therapeutics (NASDAQ: ALLR)는 Dovitinib의 신규 의약품 신청과 관련하여 FDA와의 상호 작용에 대한 과거 공시에 대해 SEC와 최종 합의에 도달했습니다. 이 합의는 2025년 1월 30일의 합의 원칙을 따릅니다.
주요 조건은 다음과 같습니다:
- 250만 달러의 민사 벌금 지급
- SEC의 결과를 인정하거나 부인하지 않는 중지 및 금지 명령
- 증권법 제17(a)(2) 및 (3) 조항 및 교환법 제13(a) 조항에 따른 위반 사실
회사는 이 벌금이 재무 전망이나 계획된 2상 임상 시험을 수행하는 능력에 영향을 미치지 않을 것이라고 확인했습니다. Allarity의 현금 위치는 2026년까지 운영을 지원할 것으로 예상됩니다. 이번 합의는 최근 기각된 증권 집단 소송을 포함하여 모든 미해결 법적 문제를 해결합니다.
Allarity Therapeutics (NASDAQ: ALLR) a conclu un règlement final avec la SEC concernant ses divulgations passées sur les interactions avec la FDA concernant sa Demande de Nouveau Médicament pour le Dovitinib. Le règlement fait suite à l'accord de principe du 30 janvier 2025.
Les termes clés incluent:
- Un paiement d'amende civile de 2,5 millions de dollars
- Une ordonnance de cessation et d'abstention sans admettre ni nier les conclusions de la SEC
- Conclusions de violations en vertu des sections 17(a)(2) et (3) de la Loi sur les valeurs mobilières et de la section 13(a) de la Loi sur les échanges
L'entreprise confirme que cette amende n'affectera pas ses prévisions financières ni sa capacité à réaliser les essais cliniques de phase 2 prévus. La position de liquidités d'Allarity devrait soutenir les opérations jusqu'en 2026. Le règlement résout toutes les questions juridiques en suspens, y compris la récente action en justice collective sur les valeurs mobilières qui a été récemment rejetée.
Allarity Therapeutics (NASDAQ: ALLR) hat eine endgültige Einigung mit der SEC über frühere Offenlegungen zu FDA-Interaktionen im Zusammenhang mit dem Antrag auf ein neues Medikament für Dovitinib erzielt. Die Einigung folgt der grundsätzlichen Vereinbarung vom 30. Januar 2025.
Wichtige Bedingungen sind:
- Eine zivilrechtliche Geldstrafe von 2,5 Millionen Dollar
- Eine Unterlassungsanordnung, ohne die Feststellungen der SEC zuzugeben oder zu bestreiten
- Feststellungen von Verstößen gemäß den Abschnitten 17(a)(2) und (3) des Wertpapiergesetzes sowie Abschnitt 13(a) des Börsengesetzes
Das Unternehmen bestätigt, dass diese Strafe keine Auswirkungen auf die finanzielle Prognose oder die Fähigkeit haben wird, die geplanten Phase-2-Studien durchzuführen. Die Liquiditätslage von Allarity wird voraussichtlich die Betriebe bis 2026 unterstützen. Die Einigung löst alle offenen rechtlichen Angelegenheiten, einschließlich der kürzlich abgewiesenen Sammelklage im Bereich Wertpapiere.
- Resolution of all outstanding legal matters and regulatory challenges
- Cash position sufficient to support operations into 2026
- SEC settlement doesn't impact planned clinical trials execution
- Securities class action lawsuit dismissed in February 2025
- $2.5 million civil penalty payment required
- Potential additional costs from indemnification obligations for former officers' legal expenses
- SEC violations found related to FDA disclosure practices
Insights
Allarity Therapeutics' SEC settlement represents a significant milestone in resolving regulatory uncertainty. The company has agreed to pay a
This resolution, combined with the recent dismissal of a securities class action lawsuit, eliminates all outstanding legal challenges for Allarity. While a
The timing of this announcement is strategically significant as it allows Allarity to redirect focus and resources toward clinical development rather than legal defense. For a clinical-stage biotech, eliminating regulatory overhang removes a significant investor concern, potentially improving capital raising conditions. The settlement terms - particularly the absence of admissions of wrongdoing and no individual penalties against current leadership - represent a relatively favorable outcome given the circumstances.
Allarity's resolution of SEC matters provides much-needed clarity for their stenoparib development program. As a dual PARP/Wnt pathway inhibitor, stenoparib represents a differentiated mechanism compared to existing PARP inhibitors like olaparib or niraparib. The company can now focus exclusively on their Phase 2 clinical strategy without the distraction and resource drain of regulatory investigations.
The settlement comes at a critical juncture for Allarity as they advance stenoparib through Phase 2 trials in advanced ovarian cancer, a setting where PARP inhibitors have established clinical utility. More importantly, the company confirmed plans to initiate a Phase 2 combination trial with temozolomide in recurrent small cell lung cancer - a high unmet need indication where targeted approaches have largely disappointed.
From a pipeline perspective, this resolution helps de-risk the stenoparib program by removing a potential regulatory roadblock that could have delayed development timelines. With operational funding secured into 2026, Allarity now has a clearer path to generating the clinical data necessary to establish stenoparib's potential value. The company's previous regulatory issues stemmed from their discontinued Dovitinib program rather than their current lead asset, which should reassure stakeholders about management's current clinical development approach.
Boston (March 13, 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/Wnt pathway inhibitor—today announced that it has reached a final settlement with the U.S. Securities and Exchange Commission (SEC) relating to the previously disclosed investigation regarding the Company’s past disclosures concerning its interactions with the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (“NDA”) for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021. This final settlement confirms the settlement in principle announced by the Company on January 30, 2025.
Under the terms of the settlement, Allarity has consented, without admitting or denying the SEC’s findings, to the entry of an administrative cease-and-desist order. The settlement resolves the SEC’s investigation as to the Company with findings of violations of non-scienter-based provisions under Sections 17(a)(2) and (3) of the Securities Act of 1933, as well as Section 13(a) of the Securities Exchange Act of 1934 and related rules.
Allarity has now resolved all regulatory and legal challenges related to these issues and all other previously outstanding legal matters.
Thomas Jensen, Chief Executive Officer of Allarity Therapeutics, commented: “Throughout this process, we have fully cooperated with regulators, and we are pleased to have finalized this resolution with the SEC. Coming shortly after the dismissal of the securities class action lawsuit in February, this marks the conclusion of all outstanding legal matters for Allarity. With these issues behind us, we can now fully focus on our mission of advancing our novel PARP/Wnt inhibitor through the clinical development plans we have already announced.”
As previously disclosed on January 30, 2025, the Company has agreed, as part of the settlement, to pay a one-time civil penalty of
As previously disclosed on November 14, 2024, Allarity’s cash position is expected to support operations into 2026. The
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 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
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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 resolution of the SEC investigation, the conclusion of all outstanding legal matters, and the Company’s continued commitment to regulatory compliance and corporate governance.. 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, potential legal and regulatory developments, compliance obligations, financial liabilities associated with past legal matters, and the Company’s ability to focus resources on advancing its clinical programs without further legal distractions. 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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FAQ
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