Allarity Therapeutics Hit By SEC Notice Related Disclosures Of Once Lead Cancer Program

Allarity Therapeutics Inc ALLR revealed on Monday it received a “Wells Notice” from the U.S. Securities and Exchange Commission (SEC).

This notice pertains to the company’s disclosures about meetings with the Federal Drug Administration (FDA) regarding their New Drug Application (NDA) for Dovitinib or Dovitinib-DRP, submitted in 2021.

In December 2021, Allarity Therapeutics submitted a marketing application to the FDA seeking approval for dovitinib for the third-line treatment of renal cell carcinoma (RCC) patients.  

The company’s NDA filing was supported by its prior pre-market approval (PMA) submission with the FDA for using Dovitinib-DRP, its companion diagnostic for the drug, to select and treat RCC patients most likely to respond to dovitinib.

Additionally, three former officers of Allarity have received similar notices from the SEC related to this issue.

A Wells Notice indicates the SEC staff made a preliminary determination to recommend enforcement action, alleging violations of federal securities laws.

It is not a formal charge but suggests potential legal action.

Allarity disclosed that all conduct related to the SEC’s notice occurred during or before the fiscal year 2022.

The company remains cooperative with the SEC and plans to submit a formal response, asserting its actions were appropriate.

Allarity’s board of directors has proposed a reverse stock split to shareholders to regain and sustain compliance with NASDAQ’s listing requirements.

The company said it will focus on advancing stenoparib, a novel dual PARP and Tankyrase inhibitor.

Recently, Allarity Therapeutics announced the early discontinuation of its Phase 2 clinical trial of stenoparib for advanced recurrent ovarian cancer. 

The trial, evaluating stenoparib given twice daily, showed clear clinical benefits, including tumor shrinkage and long-term disease stability, in heavily pretreated ovarian cancer patients. 

Allarity Therapeutics announced the company has a financial runway extending into 2026 at its current burn rate with a cash balance of $20 million.

The company also plans to pause its ATM offering program for the foreseeable future.

ALLR Price Action: Allarity stock is down 8.33% at 15 cents at last check Monday.

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