SEC Staff Recommends Enforcement Action Against Allarity Over Potential Federal Securities Laws Violations

1. SEC Notice: The U.S. Securities and Exchange Commission (SEC) has issued a Wells Notice to Allarity Therapeutics, indicating a preliminary determination to recommend enforcement action against the company for alleged violations of federal securities laws.
2. Alleged Violations: The notice pertains to Allarity's disclosures regarding meetings with the Federal Drug Administration (FDA) about its New Drug Application (NDA) for dovitinib, submitted in 2021.
3. Dovitinib Background: Dovitinib is a cancer treatment for which Allarity submitted a marketing application to the FDA in 2021, supported by a prior pre-market approval (PMA) submission for its companion diagnostic, Dovitinib-DRP.
4. Former Officers Involved: Three former officers of Allarity have also received similar Wells Notices from the SEC related to the same issue.
5. Company Response: Allarity remains cooperative with the SEC and plans to submit a formal response, asserting that its actions were appropriate.
6. Financial Status: The company has a cash balance of $20 million, which will extend its financial runway into 2026, and has taken cost-cutting measures to strengthen its finances.