Allarity Therapeutics settles SEC investigation

BOSTON - Allarity Therapeutics, Inc. (NASDAQ: ALLR), a biopharmaceutical company in Phase 2 clinical stage trading at $1.02 per share, has announced the conclusion of its settlement with the U.S. Securities and Exchange Commission (SEC) regarding an investigation into the company’s past FDA disclosures. The settlement, which finalizes an agreement in principle from January 30, 2025, includes a $2.5 million civil penalty but does not require Allarity to admit or deny the SEC’s findings. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 2.75, indicating sufficient assets to cover short-term obligations.

The SEC’s investigation centered on Allarity’s disclosures related to its interactions with the U.S. Food and Drug Administration (FDA) over its New Drug Application for Dovitinib. The company has consented to an administrative cease-and-desist order to resolve allegations of violations of non-scienter-based provisions under the Securities Act of 1933 and the Securities Exchange Act of 1934.

Thomas Jensen, CEO of Allarity Therapeutics, stated, "Throughout this process, we have fully cooperated with regulators, and we are pleased to have finalized this resolution with the SEC." He emphasized that with the resolution and the recent dismissal of a securities class action lawsuit in February, Allarity can now focus on advancing its novel PARP/Wnt inhibitor, stenoparib, through clinical development.

Stenoparib is a dual-targeted inhibitor of PARP1/2 and tankyrase 1/2 being developed for advanced ovarian cancer, with plans to initiate a Phase 2 trial in recurrent small cell lung cancer. Allarity has secured exclusive global rights for stenoparib’s development and commercialization.

The settlement does not impact Allarity’s financial outlook or its cash position, which is expected to support operations into 2026. InvestingPro analysis indicates the company holds more cash than debt on its balance sheet, though investors should note the stock has experienced significant volatility, with a year-to-date return of -12.82%. The company remains committed to its clinical programs and share repurchase plan, trading at a price-to-book ratio of 0.35, suggesting potential undervaluation relative to its assets.

Allarity Therapeutics, headquartered in the U.S. with a research facility in Denmark, focuses on personalized cancer treatments using its DRP® technology to develop a companion diagnostic aimed at identifying patients who would benefit most from stenoparib. With a market capitalization of $4.52 million and a beta of 0.25, the company offers relatively low correlation with broader market movements. Discover more detailed financial metrics and 8 additional exclusive ProTips by visiting InvestingPro.

This report is based on a press release statement from Allarity Therapeutics.

In other recent news, Allarity Therapeutics has announced a new protocol for its ongoing clinical trial of stenoparib, aimed at treating advanced ovarian cancer. The company is focusing on refining patient selection and optimizing dosage to enhance the drug’s effectiveness. The trial will target patients with advanced, recurrent, platinum-resistant ovarian cancer, who have shown promising responses to stenoparib in previous trials. Additionally, the trial will explore stenoparib’s impact on the Wnt pathway, which is involved in various cancers, including colon cancer.

Allarity is also working to improve its Drug Response Predictor (DRP®) platform to identify patients most likely to benefit from stenoparib. The company has reported sustained clinical benefits from the drug, with some patients remaining on therapy for over 14 months. These developments have led Allarity to pursue an accelerated regulatory path for stenoparib’s development. Patient enrollment for the new trial protocol is expected to begin in the first half of 2025, pending regulatory review. The trial will initially recruit at leading U.S. sites, with the possibility of including U.K. sites.

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