Oryzon Genomics - FRIDA funding and orphan drug designation

Oryzon Genomics has been awarded a $2m public grant to support its ongoing Phase Ib FRIDA clinical study. This follows recent FDA approval of its investigational new drug (IND) application of this initiation Phase Ib study of iadademstat. FRIDA aims to investigate the safety, tolerability and recommended dose for Phase II of one of Oryzon’s lead assets, the LSD1 inhibitor iadademstat, in combination with FDA-approved FLT3 inhibitor gilteritinib for treating patients with FLT3-mutated acute myeloid leukaemia (AML) in a second-line setting. We anticipate a positive readout from the FRIDA trial would likely provide a positive catalyst for the company’s shares. Iadademstat is also being investigated for its use as a first-line treatment in patients with metastatic small-cell lung cancer (SCLC) for which the FDA has now granted orphan drug designation (ODD). This ODD in SCLC will help expedite development in a further area of high unmet clinical need. Based on the current annual burn rate of around €13–15m (c €15m cash spent in FY21) and the company’s gross cash position of $28m (€26.2m) at end-March 2022, we estimate Oryzon has a cash runway through early FY24. We will revisit our estimates and valuation based on this news.