Allarity Therapeutics Presents Dovitinib Survival Data from DRP Screened RCC Patients at ESMO 2021 Virtual Congress

• Patient selection using DRP score of 50% resulted in a median survival of 15.0 month
• Patient selection using DRP score of 67% resulted in a median survival of 20.6 months

Press Release

Hørsholm, Denmark (September 16, 2021) – Allarity Therapeutics A/S (“Allarity” or the “Company”) today announced validation results for its Dovitinib DRP companion diagnostic utilizing data from Novartis’ prior Phase III trial of dovitinib in renal cell carcinoma (RCC), which will be included in a poster presentation at the European Society for Medical Oncology (ESMO) 2021 Virtual Congress taking place from September 16 until September 21, 2021.

The poster displays how the RCC patients selected with the Dovitinib DRP companion diagnostic (i.e., those who had a DRP score above 50%) had a median survival of 15.0 months (N=49), compared to a median survival of 11.2 months in the comparator sorafenib arm (N=286, Hazard Ratio: 0.69; 95% Confidence Interval 0.48-0.99) of the clinical trial. When the DRP-Dovitinib score was increased to a score above 67%, the survival in the DRP-selected group increased to a median of 20.6 months (95% Confidence Interval 9.53-35.6, N=15). These results validate that the Dovitinib DRP companion diagnostic can identify RCC patients that benefit from treatment with dovitinib when compared to alternative treatment with sorafenib. The benefit of dovitinib therapy was also evident in progression-free survival data.

Dovitinib, Allarity’s lead clinical-stage asset, is a small molecule, pan-tyrosine kinase inhibitor in-licensed from Novartis. Allarity plans to file a new drug application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) for the approval of dovitinib for the treatment of RCC during Q4 2021. Allarity has previously filed a pre-market approval (PMA) application for the Dovitinib-DRP. If the FDA provides the anticipated PMA for the Dovitinib-DRP as a companion diagnostic, as well as an NDA approval for dovitinib, Allarity will be able to commercialize dovitinib for DRP-selected RCC patients as an effective new therapy to treat their disease.

Allarity’s CEO Steve Carchedi noted, “The DRP validation data we have been able to publish today further establish the value of our DRP platform in advancing true personalized cancer care, and builds our confidence in a successful road ahead for our planned filing of an NDA for dovitinib. We remain committed to bringing novel oncology therapeutics to market, and to patients, together with their DRP companion diagnostics to improve patient outcomes.”