ORYZON Reports Financial Results and Corporate Update for Half-Year Ending June 30, 2025

Core Insights - Oryzon Genomics, a clinical-stage biopharmaceutical company, reported financial results for the first half of 2025 and highlighted significant advancements in its clinical pipeline, particularly with its LSD1 inhibitors, vafidemstat and iadademstat [1][3][9] Financial Overview - The company secured a total of $61 million in funding since December 2024, including €30 million from a capital raise in April 2025, which was oversubscribed despite challenging market conditions [2][4][13] - Research and development expenses for the first half of 2025 were $5.8 million, compared to $4.9 million in the same period of 2024 [9] - The net loss for the first half of 2025 was $3.4 million, an increase from $2.6 million in the first half of 2024, reflecting the typical financial model of biotechnology companies in development phases [10][11] Clinical Developments - The Phase III clinical trial protocol for vafidemstat in treating agitation and aggression in Borderline Personality Disorder (BPD) was submitted to the FDA, with the trial expected to enroll approximately 350 patients [3][7] - Oryzon is expanding its ongoing Phase IIb EVOLUTION study of vafidemstat in schizophrenia into additional European countries to enhance recruitment [4][7] - A new Phase II trial is being prepared to evaluate vafidemstat for aggression in Autism Spectrum Disorder (ASD), supported by a recent EU-IPCEI grant [3][4][7] Oncology Progress - Oryzon reported solid progress in ongoing iadademstat clinical trials, including the FRIDA trial in relapsed/refractory Acute Myeloid Leukemia (AML) and studies in first-line AML, Myelodysplastic Syndromes (MDS), and small cell lung cancer (SCLC) [3][4][6] - The company plans to present updates from these oncology programs at the ASH-2025 conference in December [3][4] Expansion into New Indications - Iadademstat is being evaluated for non-malignant hematological indications, with a clinical trial for sickle cell disease (SCD) in preparation, following promising preliminary data [3][4][12] - The company is also preparing a trial for iadademstat in essential thrombocythemia (ET), with submission planned for the second half of 2025 [12] Patent and Intellectual Property - Oryzon has strengthened its patent portfolio for vafidemstat, with new patents expected to cover the treatment of aggression and social withdrawal, set to last until at least 2038 [7][9]