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Oryzon Genomics S.A.
- BME:ORY
- OTC PINK:ORYZF
Oryzon reports 2025 results as clinical programmes advance
Published
At a glance
- Company
- Oryzon Genomics S.A.
- Listings
- BME:ORY, OTC PINK:ORYZF
- Announcement type
- Financial results
- Published
- Reporting period
- twelve months ended December 31, 2025
- Source announcement
- oryzon.com
| Measure | Figure |
|---|---|
| Overall response rate (ORR) | 100% |
Figures are quoted from this announcement and selected automatically.
FAQSIR Generated from this announcement View original release below for safe harbor and regulatory notices
Announcement Summary
Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY) reported 2025 financial results and a corporate update.
- Cash, cash equivalents, and marketable securities totaled $33.3 million as of December 31, 2025; twelve-month R&D expenses were $14.8 million and net losses were $6.7 million.
- In ALICE-2, iadademstat with venetoclax and azacitidine achieved ORR of 100% (n=10), with 90% strict CR and 70% transitioning to HSCT.
- The company said ALICE-2 continues enrolling at DL2, plans up to 24 patients, and aims to present an update at EHA in June 2026.
- FRIDA is fully enrolled; Oryzon intends to submit updated data for EHA-2026 after reporting 67% CCR (10/15) and 47% CR+CRh (7/15).
- RESTORE has enrolled its first two cohorts and aims to enroll approximately 40 adult patients with SCD; Oryzon expects data later this year.
- For vafidemstat, FDA discussions are expected to continue in coming months; the company anticipates resubmitting the Phase III protocol before year-end and appointed Rolando Gutierrez-Esteinou, M.D., as CMO.
Oryzon plans IDEAL following recent approval by the EMA, a Phase II study in Spain for adults with ET resistant or intolerant to hydroxyurea. Japanese patent decisions to grant for iadademstat and vafidemstat remain subject to formal grants.
Investor FAQs
Oryzon Genomics reported financial results for the twelve months ended December 31, 2025, and provided a corporate update on recent developments. The update covered its oncology and CNS programmes, including iadademstat and vafidemstat.
The financial results cover the quarter and twelve months ended December 31, 2025. Oryzon Genomics compared the figures with the quarter and twelve months ended December 31, 2024.
Oryzon Genomics reported cash, cash equivalents and marketable securities of $33.3 million as of December 31, 2025. Chief Executive Officer Dr. Carlos Buesa also described the year-end cash position as $33.3 million (€28.4 million).
Research and development expenses were $5.2 million for the fourth quarter and $14.8 million for the twelve months ended December 31, 2025. The corresponding figures for 2024 were $2.1 million and $8.7 million.
General and administrative expenses were $1.7 million for the fourth quarter and $5.6 million for the twelve months ended December 31, 2025. The comparable 2024 figures were $0.9 million and $3.7 million.
Oryzon Genomics reported net losses of $2.1 million for the fourth quarter and $6.7 million for the twelve months ended December 31, 2025, compared with $1.1 million and $4.6 million for the corresponding periods in 2024. The company also reported a negative net result of $3.1 million (–$0.04 per share) for the twelve months ended December 31, 2025, compared with $3.7 million (–$0.06 per share) in 2024.
Oryzon Genomics said the iadademstat combination with venetoclax and azacitidine in the ALICE-2 Phase Ib trial had an overall response rate of 100% (n=10), with 90% of patients achieving strict complete remission. The company said the trial continues to enrol patients at dose level 2 and plans to present a data update at the European Hematology Association congress in June 2026.
Oryzon Genomics reported that the FRIDA Phase Ib trial of iadademstat with gilteritinib in relapsed or refractory AML had a 67% composite complete remission rate (10/15 patients) and a 47% CR+CRh rate (7/15) among 15 patients evaluable for response at the reported dose. The trial is now fully enrolled, and the company intends to submit updated data for presentation at EHA-2026.
The RESTORE Phase Ib trial is evaluating the safety and tolerability of iadademstat in adults with sickle cell disease, determining its Recommended Phase 2 dose and investigating its effect on fetal haemoglobin expression. Oryzon Genomics said the first two cohorts had been enrolled and that the study aims to enrol approximately 40 adult patients across several sites in Spain.
Oryzon Genomics plans to initiate the IDEAL multicentre, single-arm Phase II study in Spain following recent approval by the European Medicines Agency. The trial will evaluate iadademstat in adults with essential thrombocythemia who are resistant or intolerant to hydroxyurea, with objectives including safety, tolerability and reduction of abnormal platelet counts.
Oryzon Genomics is continuing the Phase III PORTICO-2 trial of vafidemstat in aggression associated with borderline personality disorder following written feedback from the U.S. FDA. The company is undertaking qualitative research on proposed clinical outcome measures and anticipates resubmitting the Phase III protocol before year-end, in line with standard regulatory timelines.
Oryzon Genomics appointed Dr. Rolando Gutierrez-Esteinou as Chief Medical Officer for CNS programmes and said discussions with the FDA are expected to continue in the coming months. The company is finalising preparations for the HOPE-2 Phase II trial in autism spectrum disorder and continues to enrol patients in the EVOLUTION Phase IIb schizophrenia trial, which is being expanded to additional EU countries.
Oryzon Genomics said it had received a “Decision to grant” communication from the Japanese Patent Office for an iadademstat patent application covering combinations with PD1 or PD-L1 inhibitors. It also reported an additional Japanese “Decision to grant” communication for vafidemstat claims covering treatment of aggressiveness and social withdrawal; once formally granted, the patents are stated to remain in force until at least 2040 and 2038 respectively, excluding potential patent term extensions.
Oryzon Genomics describes itself as a clinical-stage biopharmaceutical company focused on epigenetics. Its update covered iadademstat programmes in oncology, sickle cell disease and other haematological disorders, vafidemstat programmes in CNS conditions, and ORY-4001, an HDAC6 inhibitor progressing through IND-enabling studies.
The announcement identifies Oryzon Genomics, S.A. with ISIN Code ES0167733015 and the symbol ORY. The source does not provide a trading venue.
Source announcement
- Company
- Oryzon Genomics S.A.
- Title
- ORYZON reports financial results and corporate update for quarter ended December 31st, 2025
- Published
- Source site
- oryzon.com
Read the source announcement on oryzon.com
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