ORYZON Reports Financial Results and Corporate Update for Quarter Ended December 31st, 2025

Financial Overview - Oryzon Genomics reported a strong cash position of $33.3 million (€28.4 million) at the end of 2025, following a financial turnaround with over $60 million secured in the first half of 2025 [4][14]. - Research and development (R&D) expenses for Q4 2025 were $5.2 million, totaling $14.8 million for the year, compared to $2.1 million and $8.7 million in the same periods of 2024 [12]. - General and administrative expenses were $1.7 million for Q4 2025 and $5.6 million for the full year, up from $0.9 million and $3.7 million in 2024 [12]. - The net loss for Q4 2025 was $2.1 million, with a total net loss of $6.7 million for the year, compared to losses of $1.1 million and $4.6 million in 2024 [13][14]. Oncology Developments - Iadademstat, Oryzon's lead oncology program, is currently involved in seven ongoing trials, with six sponsored by the National Cancer Institute (NCI) or leading U.S. institutions [4][6]. - The drug has shown a 100% overall response rate (ORR) in first-line acute myeloid leukemia (AML) trials, with no dose-limiting toxicities reported [4][8]. - Preliminary data from the ALICE-2 Phase Ib trial indicated a 100% ORR and 90% strict complete remission (CR) in newly diagnosed AML patients [8]. - A new Phase Ib trial of iadademstat in combination with immune checkpoint inhibitors and radiotherapy for extensive-stage small cell lung cancer (ES-SCLC) has commenced [8]. CNS Program Updates - Oryzon has appointed Dr. Rolando Gutierrez as Chief Medical Officer for CNS programs, enhancing its medical and regulatory capabilities [4][7]. - The company is preparing for a protocol resubmission to the FDA for the Phase III PORTICO-2 trial in aggression in Borderline Personality Disorder (BPD) [13]. - Oryzon is expanding its Phase IIb schizophrenia trial into additional EU countries and finalizing preparations for a new Phase II trial in aggression in autism spectrum disorder (ASD) [7][13]. Intellectual Property and Future Trials - Oryzon has strengthened its intellectual property protection for iadademstat, with a patent application granted in Japan, expected to remain in force until at least 2040 [9]. - The company plans to initiate a clinical trial for iadademstat in essential thrombocythemia (ET) following EMA approval [8]. - Oryzon's earlier stage program, ORY-4001, a selective HDAC6 inhibitor, is progressing through IND enabling studies for neurological diseases [11].