Allarity Therapeutics A/S 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 with the U.S. Food and Drug Administration for the approval of dovitinib for the treatment of RCC during Fourth Quarter 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.