ORYZON reports financial results and corporate update for quarter ended December 31st, 2025

Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a global leader in epigenetics, today reported financial results for the twelve months ended December 31, 2025 and provided a corporate update on recent developments.

“After securing over $60 million in the first half of 2025, marking a clear financial turnaround for Oryzon, we ended the year with a solid cash position of $33.3 million (€28.4 million),” said Dr. Carlos Buesa, Oryzon’s Chief Executive Officer. “This financial strength allows us to sharpen our focus on key regulatory catalysts across both of our programs: oncology and CNS.”

“In oncology-hematology, iadademstat continues to receive strong external validation, with seven ongoing trials, six of which are sponsored by the NCI or leading U.S. institutions, including the most recent study sponsored by Yale University,” Dr. Buesa added. “In first-line AML, the triple combination has shown a 100% overall response rate to date, with no dose-limiting toxicities, highlighting a highly competitive profile among emerging triplet regimens. The trial continues to enroll rapidly, and we plan to present data from 15-16 patients at the European Hematology Association Annual Congress (EHA) in June. This would represent approximately 75% of the planned enrollment, providing a very meaningful interim assessment of efficacy and safety. Encouraging results are also emerging in MDS and MPN.”

“In sickle cell disease, we are advancing iadademstat into what we believe represents a new paradigm for the pharmaceutical industry — medium-priced therapies addressing large patient populations. The first two cohorts of the RESTORE trial have been enrolled, and we expect to report meaningful data later this year.”

“In CNS, we have further strengthened our medical and regulatory capabilities with the appointment of renowned CMO Dr. Rolando Gutierrez, who brings extensive experience from the psychiatric field to lead vafidemstat through late-stage development and regulatory interactions, particularly with the U.S. Food and Drug Administration (FDA),” continued Dr. Buesa. “Discussions with the Agency are expected to continue in the coming months, and the Company anticipates a resubmission of the Phase III protocol before year-end, in line with standard regulatory timelines. At the same time, we continue to advance our programs in schizophrenia and ASD.”

More information in the attached press release.