Allarity Therapeutics Reaches Settlement in Principle with SEC

Allarity Therapeutics, Inc. recently disclosed that it has reached a settlement in principle with the Securities and Exchange Commission (SEC) resolving an investigation related to the company’s disclosures concerning meetings with the United States Food and Drug Administration (FDA) about the New Drug Application (NDA) for Dovitinib or Dovitinib-DRP, submitted to the FDA in 2021.

Under the terms of the settlement, the company, without admitting or denying the SEC’s findings, would agree to an administrative cease-and-desist order to resolve the SEC’s investigation. The order is expected to address violations of non-scienter based charges under Sections 17(a)(2) and (3) of the Securities Act of 1933, and Section 13(a) of the Securities Exchange Act of 1934, including Rules 12b-20, 13a-11, and 13a-13 under the Exchange Act. Additionally, Allarity Therapeutics would pay a one-time civil penalty of $2,500,000 and commit to full cooperation with the SEC in any future litigation. The settlement is subject to finalizing the terms and receiving SEC approval.

It was also noted that three former officers of Allarity Therapeutics received Wells Notices; these individuals are no longer associated with the company. While the agreement in principle refers to the company itself, there may be potential indemnification obligations for these former officers. Allarity Therapeutics has insurance coverage up to $3.5 million for costs related to the SEC investigation and possible subsequent litigation involving the former officers. As of the end of 2024, approximately $1.8 million had been accrued or paid for the representation of former officers.

The company emphasized that further updates will be provided once the settlement process is completed.

This article is for informational purposes only and does not constitute financial advice. Investors are encouraged to exercise caution when evaluating securities.

As per the report dated January 30, 2025, signed by Thomas H. Jensen, Chief Executive Officer of Allarity Therapeutics, Inc., all above information has been duly authorized for disclosure.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Allarity Therapeutics’s 8K filing here.

About Allarity Therapeutics

Allarity Therapeutics, Inc, a clinical-stage biopharmaceutical company, engages in developing oncology therapeutics using drug-specific companion diagnostics generated by its drug response predictor technology. Its drug candidates include Stenoparib, a poly-ADP-ribose polymerase inhibitor that is in Phase 2 clinical trials for ovarian cancer; Dovitinib, a pan- tyrosine kinase inhibitor for the treatment of renal cell carcinoma; IXEMPRA (ixabepilone), a selective microtubule inhibitor in phase 2 for the treatment of metastatic breast cancer; LiPlaCis, a liposomal formulation of cisplatin, which is in Phase 2 clinical trials for metastatic breast cancer; and 2X-111, a liposomal formulation of doxorubicin that is in Phase 2 clinical trials for metastatic breast cancer and glioblastoma multiforme.