Core Viewpoint - Allarity Therapeutics has reached an agreement in principle with the SEC to resolve an investigation related to its disclosures concerning FDA meetings for its New Drug Application for Dovitinib, allowing the company to focus on advancing its cancer treatment, stenoparib [1][2][3]. Company Overview - Allarity Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing personalized cancer treatments, particularly stenoparib, a novel PARP/tankyrase inhibitor for advanced ovarian cancer patients [6]. - The company utilizes its proprietary drug-specific patient selection technology, DRP®, in its ongoing Phase 2 clinical trial for stenoparib [6]. SEC Investigation and Settlement - The SEC investigation pertains to the company's disclosures made during or prior to fiscal year 2022 regarding its NDA for Dovitinib, submitted in 2021 [2]. - The settlement is still subject to mutual agreement on final language and SEC approval, with no assurance that it will be finalized [2]. Clinical Development - The CEO of Allarity expressed optimism about stenoparib, noting that some patients in the Phase 2 trial have exceeded 14 months on treatment [3]. - The company aims to finalize the design of a follow-on trial to advance stenoparib toward FDA registration [3]. Financial Position - Allarity is financially positioned to continue its core operations and the development of stenoparib as planned into 2026 [3]. Product Information - Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2, with potential therapeutic benefits due to its unique action on the Wnt signaling pathway [5]. - The company holds exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. [5].
Allarity Therapeutics Announces Filing of Form 8-K Regarding Settlement Agreement in Principle with SEC