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Oryzon Genomics S.A.
- BME:ORY
- OTC PINK:ORYZF
Oryzon reports $4.6 million net loss for nine months ended September 30, 2025
Published
At a glance
- Company
- Oryzon Genomics S.A.
- Listings
- BME:ORY, OTC PINK:ORYZF
- Announcement type
- Financial results
- Published
- Reporting period
- nine months ended September 30, 2025
- Source announcement
- oryzon.com
| Measure | Figure |
|---|---|
| Overall response rate (ORR) | 100% (n=8) |
| Overall response rate | 67% overall response rate (8/12 patients) |
Figures are quoted from this announcement and selected automatically.
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Announcement Summary
Oryzon Genomics, S.A. (ORY) reported financial results for the nine months ended September 30, 2025, and provided a corporate update.
- R&D expenses were $3.9 million for the quarter and $9.6 million for nine months; G&A expenses were $1.2 million and $3.9 million.
- Net losses were $1.2 million for the quarter and $4.6 million for nine months, compared with $1.1 million and $3.8 million.
- The company said it secured over $60 million in the first half of 2025 and is exploring partnerships for iadademstat.
- The FDA provided written feedback on the PORTICO-2 Phase III protocol in October; Oryzon plans to revise and resubmit it.
- Oryzon appointed Dr. Iman Barilero, Dr. Christopher Breder, MD PhD, and Dr. Raymond Sanchez as Senior Advisors.
- The FRIDA Phase Ib study reported a 67% overall response rate and a 58% complete response rate among 12 evaluable patients with R/R AML.
- The company said its cash, cash equivalents, and marketable securities totaled $40.4 million as of September 30, 2025.
- The iadademstat and venetoclax, azacitidine combination reported a 100% overall response rate in eight patients with newly diagnosed AML; the study continues enrollment.
The company said RESTORE, a Phase Ib iadademstat study in SCD, was approved by the EMA and has started enrolling approximately 40 adult patients in Spain.
Investor FAQs
Oryzon reported financial results for the nine months ended September 30, 2025, alongside a corporate update on recent developments. The update covered its clinical programmes, management and advisory appointments, patent portfolio and financing position.
Oryzon is a clinical-stage biopharmaceutical company and a European leader in epigenetics. The company is pursuing programmes in central nervous system diseases, haematological malignancies and other conditions.
Oryzon identifies itself with ISIN Code: ES0167733015 and the symbol ORY. The source does not provide a separate trading venue.
Oryzon reported cash, cash equivalents and marketable securities totalling $40.4 million as of September 30, 2025.
Oryzon's research and development expenses were $9.6 million for the nine months ended September 30, 2025, compared with $7.1 million for the same period in 2024. Quarterly R&D expenses were $3.9 million in the third quarter of 2025, compared with $1.9 million in the third quarter of 2024.
Oryzon reported a net loss of $4.6 million for the nine months ended September 30, 2025, compared with a net loss of $3.8 million for the same period in 2024. The company also reported a negative net result of $1.5 million, or –$0.02 per share, compared with $2.5 million, or –$0.04 per share, for the nine months ended September 30, 2024.
Oryzon’s Chief Executive Officer, Dr. Carlos Buesa, said the company had secured over $60 million in the first half of 2025. He said the proceeds would enable Oryzon to advance its clinical programmes with a renewed strategic focus on the central nervous system, including studies in borderline personality disorder, schizophrenia and autism spectrum disorder.
Oryzon submitted the PORTICO-2 Phase III trial protocol for vafidemstat in borderline personality disorder to the U.S. Food & Drug Administration for approval in June and received written feedback in October. The company said it would incorporate the FDA’s guidance on study endpoints and certain non-clinical considerations before resubmitting the revised protocol.
Oryzon is preparing HOPE-2, a new Phase II trial evaluating vafidemstat for aggression in patients with autism spectrum disorder. The company plans initially to conduct the trial in Spain, including genetically defined subpopulations such as individuals with Phelan-McDermid syndrome, as part of activities supported by the Med4Cure IPCEI EU initiative.
Oryzon said the EVOLUTION Phase IIb trial of vafidemstat in schizophrenia continued to enrol participants and was being expanded from Spain into additional EU countries. The trial’s primary focus is negative symptoms, with cognitive impairment and positive symptoms included as secondary endpoints.
Oryzon reported an overall response rate of 100% (n=8) in a Phase I dose-finding trial combining iadademstat with venetoclax and azacitidine in newly diagnosed acute myeloid leukaemia. The source also states that 88% of patients achieved complete remission, 12.5% achieved morphologic leukaemia-free state, the estimated six-month overall survival rate was 88% after a median follow-up of nine months, and no dose-limiting toxicities were observed.
Oryzon reported a 67% overall response rate (8/12 patients) and a 58% complete response rate (CR + CRh + CRi; 7/12 patients) among 12 evaluable patients treated at the dose under expansion in the Phase Ib FRIDA trial. The study continued to enrol patients, had enrolled 34 patients at the data cut-off for the ASH abstract, and was expected to enrol up to approximately 45 patients.
RESTORE is an open-label, multicentre Phase Ib trial evaluating the safety and tolerability of iadademstat in adults with sickle cell disease. Oryzon said the trial would also determine the Recommended Phase 2 Dose and evaluate iadademstat’s effect on fetal haemoglobin expression; the EMA had approved the trial, which had started enrolling patients and aimed to enrol approximately 40 adults in Spain.
Oryzon said a new essential thrombocythaemia trial was in preparation, with Clinical Trial Application submission to the EMA planned for Q425. The company also said iadademstat studies in acute myeloid leukaemia and myeloproliferative neoplasms had been accepted for presentation at the ASH Annual Meeting on December 6–9, 2025, in Orlando, Florida, USA.
Dr. Carlos Buesa said Oryzon was exploring potential partnerships for iadademstat as part of its plan to become a central nervous system-focused company and strengthen its balance sheet. He said the company was continuing collaborations and generating clinical evidence under its CRADA agreement with the NCI, which he described as requiring only a minimal financial commitment from Oryzon.
Source announcement
- Company
- Oryzon Genomics S.A.
- Title
- ORYZON reports financial results and corporate update for quarter ended September 30, 2025
- Published
- Source site
- oryzon.com
Read the source announcement on oryzon.com
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