Allarity Therapeutics’ Stenoparib Shows Clear Clinical Benefit and Achieves Significant Milestone with Early Conclusion of Phase 2 Trial in Advanced Ovarian Cancer

Boston (May 2, 2024)—Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today announced the early discontinuation of its Phase 2 clinical trial of stenoparib, a novel PARP inhibitor, for the treatment of advanced recurrent ovarian cancer. The patients enrolled in the trial had been pre-screened by Allarity’s unique Drug Response predictor (DRP) companion diagnostic (CDx) in order to treat only patients with the highest likelihood of deriving clinical benefit.

The trial, evaluating stenoparib given twice daily, has shown clear clinical benefit, including tumor shrinkage and long-term disease stability, in heavily pre-treated ovarian cancer patients who otherwise have limited life expectancy. These results have provided sufficient clinical proof of concept for stenoparib as monotherapy, prompting Allarity to halt further enrollment in this trial to enable and accelerate the development of a follow-on trial with FDA regulatory intent.

"Based on the substantial clinical benefit observed in the early stages of the trial, we have achieved proof of concept results that surpassed our initial expectations and provided the critical insights we were seeking," stated Thomas Jensen, CEO of Allarity Therapeutics. "Concluding the trial now is the most effective way to re-allocate our financial resources to develop a follow-on trial with the fastest route to regulatory submission for stenoparib. The patients enrolled in this trial are heavily pretreated, having undergone multiple prior treatments, often including PARP inhibitors. It is highly noteworthy that stenoparib, used in patients selected with the DRP CDx, has delivered sustained clinical benefit for such very heavily pre-treated patients in the trial.”

This Company’s decision will not affect the ongoing treatment of current patients, as described in greater detail in Allarity’s March 27, 2024, press release.

Allarity is committed to rapidly analyzing the trial data and plans to present more comprehensive data as early as possible in a clinical update. This early trial conclusion marks a significant milestone in developing stenoparib, reflecting Allarity's dedication to advancing stenoparib to address the urgent needs of advanced ovarian cancer patients.