Allarity Therapeutics, Inc. announced a strategic pivot aimed at advancing its clinical-stage candidate stenoparib, a novel PARP/Tankyrase dual inhibitor, toward registration in advanced recurrent ovarian cancer, leveraging its DRP platform to identify and enroll only the patients most likely to derive clinical benefit. This decision is the outcome of an extensive analysis of the Company?s strategic opportunities, initiated immediately after Thomas Jensen stepped into his role as Interim CEO in early December 2023. In partnership with Executive Advisor Jeremy R. Graff, PhD and in agreement with the Board of Directors, this analysis was meticulously carried out with a dual objective: to rapidly channel the Company?s proprietary DRP technology towards benefiting a patient population with an unmet medical need while at the same time taking the clinical risk/reward balance as well as commercial and regulatory probabilities of success into consideration.

This decisive shift in priorities is driven by the compelling initial data from the Phase 2 monotherapy trial evaluating stenoparib in advanced, recurrent ovarian cancer patients, as announced on December 5, 2023. For this trial, the patients enrolled have advanced through multiple lines of therapy, including platinum, taxanes, anti-angiogenesis inhibitors, and even the recently approved Antibody Drug Conjugate, Elahere. Importantly, all but two enrolled patients to date have been previously treated with a PARP inhibitor.

These patients have few, if any, effective treatment options and typically advance through available therapies after only a few months. Emerging and maturing data continue to show that the clinical benefit and duration on stenoparib are substantially exceeding expectations: Clinical benefit has now exceeded 20 weeks for each of the five patients originally mentioned in the December release, with the first patient on trial remaining on treatment for more than ten months. The Complete Responder, referenced in the December release, has confirmed continued response through multiple additional scans and remains on therapy.

Durable clinical benefit is evident in patients with: Platinum-sensitive or resistant disease. Homologous repair proficient or deficient tumors; and both BRCA-wt or mutant cancers. These points highlight the differentiated mechanism of therapeutic action for stenoparib and accentuate the benefit of pre-selecting patients with DRP.

These data have prompted the Company to funnel its finances and internal resources to accelerate stenoparib development for this advanced patient population. As part of this strategic shift, the Company will deprioritize the other clinical trials for dovitinib and IXEMPRA. An additional outcome of the strategic review is that Allarity Therapeutics has been able to materially reduce its ongoing costs and cash burn and still prioritize stenoparib to better align with its new strategic priorities.