COMPANY:

Allarity Therap

"Following several weeks of analysis by Company leadership together with clinical and regulatory experts, Allarity has now filed a formal request with the FDA for a 'Type C' meeting to further discuss potential clinical paths to support approval of dovitinib, together with its DRP^®-Dovitinib companion diagnostic, in view of the FDA’s recent RTFs....The Company anticipates providing a further update on the outcome of its FDA meeting and the future of the dovitinib program before the end of the third quarter of this year."

"Allarity Therapeutics...announced that the...FDA has provided the Company with Refusal to File ('RTF') letters regarding the new drug application ('NDA') for dovitinib, and its accompanying pre-market approval ('PMA') application for the DRP®-Dovitinib companion diagnostic, for the third-line treatment of metastatic renal cell carcinoma ('mRCC'). Upon preliminary review, the FDA determined that the NDA, submitted on December 22, 2021, and the PMA application, submitted on April 2, 2021, were not sufficiently complete to permit substantive reviews....Allarity intends to seek guidance from the FDA on how to further advance dovitinib and its accompanying DRP®-Dovitinib companion diagnostic towards approval."

"Allarity Therapeutics, Inc...and Oncoheroes Biosciences, Inc...announced that they have entered into licensing agreements under which Oncoheroes will acquire exclusive, global development rights to Allarity’s therapeutic candidates dovitinib, a pan-targeted kinase inhibitor (pan-TKI), and stenoparib, a PARP inhibitor, and assume responsibility for their further clinical development in pediatric cancers...Under the terms of the licensing agreements, Oncoheroes acquires global, exclusive rights to fund and conduct further clinical development of both dovitinib and stenoparib in pediatric cancers...Allarity will support Oncoheroes’ pediatric clinical trials by providing clinical-grade drug inventory at cost and by facilitating DRP® companion diagnostic screening of pediatric patients for each drug...the Company is also planning a clinical trial of dovitnib in pediatric patients with osteosarcoma, in partnership with Oncoheroes..."

"Allarity Therapeutics, Inc...announced the submission of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) seeking marketing approval for dovitinib for the third-line treatment of renal cell carcinoma (RCC) patients....The Company’s NDA filing is supported by its prior PMA submission with the FDA for use of Dovitinib-DRP^®, the Company’s validated companion diagnostic for the drug, to select and treat RCC patients most likely to respond to dovitinib."

"Allarity Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has provided a positive administrative acceptance and review notification for the Company's PMA application for its Dovitinib-DRP®, the Company’s validated companion diagnostic for the drug dovitinib....FDA approval to use the Dovitinib-DRP® as a companion diagnostic to select and treat patients likely to respond to dovitinib, supports the Company’s imminent NDA filing for the drug, and is the Company’s first PMA filing for a drug-specific DRP® companion diagnostic....Allarity plans to file an NDA with the FDA for the approval of dovitinib for the treatment of renal cell carcinoma (kidney cancer) during 2021."

“Allarity Therapeutics…announced the submission of a premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA) for DRP®-Dovitinib, the Company’s validated companion diagnostic for the drug dovitinib…Allarity plans to file a New Drug Application (‘NDA’) with the FDA for the approval of dovitinib for the treatment of renal cell carcinoma (kidney cancer) during 2021. If the FDA provides the anticipated premarket approval of the dovitinib DRP® as a companion diagnostic, as well as an NDA approval for dovitinib, Allarity will be able to market dovitinib to DRP®-selected RCC patients as an effective new therapy to treat their disease.”