ORYZON reports financial results and corporate update for half-year ending June 30, 2025

Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a European leader in epigenetics, today reported financial results for the half-year ended June 30, 2025 and provided a corporate update on recent developments.

Since last December, the company has secured $61 million in funding, including $35.2 million (€30 million) from a successful capital raise completed in April through a straight equity issuance with no warrants attached. Despite challenging market conditions, the offering attracted strong investor demand and was significantly oversubscribed.

“Our successful €30 million capital raise, executed under extraodinarily challenging market conditions, represents a strong vote of confidence in Oryzon’s science, clinical pipeline, and long-term value proposition,” said Dr Carlos Buesa, Oryzon’s Chief Executive Officer. “The proceeds not only reinforce financial position but also elevate our visibility in the international biotech arena. This funding enables us to advance our clinical programs with renewed momentum and strategic clarity. We are confident that the clinical progress and data to be presented in the coming quarters will further validate the trust placed in us by the investment community.”

Dr. Buesa continued, “We are moving closer to becoming a Phase III-stage company, following the submission in June of the Phase III clinical trial protocol for vafidemstat in the treatment of agitation and aggression in Borderline Personality Disorder (BPD) to the FDA. This protocol incorporates all feedback and recommendations received from the agency regarding endpoints. In parallel, additional exploratory data from earlier Phase IIa studies suggest that vafidemstat may also reduce aggression in other patient populations. Building on this, we are now initiating preparations for a new Phase II trial to evaluate vafidemstat in aggression associated with autism spectrum disorder, which will be supported under the recently awarded EU-IPCEI grant. Following the recent financing, we are also expanding the ongoing EVOLUTION trial in schizophrenia, previously conducted exclusively in Spain, into additional European countries. This geographic expansion is designed to accelerate recruitment and further strengthen the robustness of the trial”.

“In oncology, we are pleased with the solid progress being made across all ongoing iadademstat clinical trials,” said Dr. Buesa. “This includes the company-sponsored FRIDA trial in relapsed/refractory FLT3- mutated AML, as well as the IIS and CRADA studies in first-line AML, MDS, and small cell lung cancer. We anticipate presenting updates and data from some of these programs at the upcoming ASH-2025 conference this December, marking an important opportunity to share our clinical advances with the
broader hematology and oncology community.”Dr. Buesa added, “We are extremely excited to expand iadademstat’s clinical evaluation into non-malignant hematological indications, beginning with sickle cell disease (SCD). In SCD, LSD1 inhibition plays a central
mechanistic role in re-inducing fetal hemoglobin, needed to rescue the disease phenotype. Our preliminary data in nonhuman primate models have been highly encouraging compared to other agents in development”. He added,“The SCD market is substantial, as highlighted by Pfizer’s experience with voxelotor (Oxbryta®), which received FDA accelerated approval in 2019. Although the drug was later withdrawn in 2024 due to emerging safety concerns, its initial commercial promise underscored the significant unmet medical need and the market potential in this indication.”