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Oryzon Genomics S.A.
- BME:ORY
- OTC PINK:ORYZF
Oryzon reports first-quarter 2026 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
- three months ended March 31, 2026
- Source announcement
- oryzon.com
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 first-quarter financial results and a corporate update covering its iadademstat and vafidemstat programs.
- ALICE-2 data showed ORR 100% (14/14), CR 79% (11/14), CRc 93% (13/14), and estimated 12-month overall survival of 74%.
- FRIDA’s fully enrolled trial showed a 67% CRc rate (12/18 evaluable patients); additional data will be presented at EHA 2026.
- Yale University began enrolling patients in a Phase Ib ES-SCLC trial combining iadademstat, atezolizumab, and SBRT, followed by maintenance therapy.
- RESTORE Phase Ib in adults with sickle cell disease (SCD) is enrolling to assess safety, establish RP2D, and investigate fetal hemoglobin (HbF); the company expects updates by year-end.
- The EMA authorized IDEAL Phase II in adults with essential thrombocythemia resistant/intolerant to hydroxyurea; site activation and study start-up preparations are ongoing.
- For PORTICO-2, Oryzon is generating supporting information and refining the protocol after written FDA feedback on endpoints and non-clinical considerations, before resubmission.
At March 31, 2026, R&D expenses were $5.2 million, G&A expenses were $1.5 million, net losses were $2.0 million, and cash, cash equivalents, and marketable securities totaled $25.4 million. The negative net result was $1.4 million (–$0.02 per share).
Investor FAQs
Oryzon Genomics, S.A. reported financial results for the three months ended March 31, 2026, and provided a corporate update on recent developments. The update covered its oncology/haematology and CNS programmes, intellectual property and financial position.
Oryzon Genomics, S.A. is a clinical-stage biopharmaceutical company focused on epigenetics. The company is developing programmes across oncology, haematology and central nervous system indications.
Oryzon Genomics, S.A.’s research and development expenses were $5.2 million for the first quarter ended March 31, 2026, compared with $2.6 million for the first quarter ended March 31, 2025.
Oryzon Genomics, S.A.’s general and administrative expenses were $1.5 million for the first quarter ended March 31, 2026, compared with $1.2 million for the first quarter ended March 31, 2025.
Oryzon Genomics, S.A. reported net losses of $2.0 million for the first quarter ended March 31, 2026, compared with net losses of $1.6 million for the first quarter ended March 31, 2025. The company said the result was as expected for a biotechnology business in the development phase, where products typically have a long-term maturation period and companies do not have recurrent income.
Oryzon Genomics, S.A. had cash, cash equivalents and marketable securities totalling $25.4 million as of March 31, 2026.
Oryzon Genomics, S.A. reported a negative net result of $1.4 million, or –$0.02 per share, for the first three months ended March 31, 2026. This compared with a negative net result of $1.8 million, or –$0.03 per share, for the first three months ended March 31, 2025.
Oryzon Genomics, S.A. said the ongoing ALICE-2 Phase Ib study of iadademstat with venetoclax and azacitidine in newly diagnosed acute myeloid leukaemia continued to show favourable safety and high response rates at the February 2026 data cutoff. Among evaluable patients, the overall response rate was 100% (14/14), the complete response rate was 79% (11/14), and the composite complete remission rate was 93% (13/14); after a median follow-up of 6 months, the estimated 12-month overall survival rate was 74%.
Oryzon Genomics, S.A. said the ongoing Phase Ib FRIDA study of iadademstat with gilteritinib in relapsed or refractory FLT3-mutated acute myeloid leukaemia was fully enrolled. Updated data from the expansion cohort showed a favourable safety profile and a composite complete remission rate of 67% (12/18 patients evaluable for response harbouring canonical FLT3 mutations).
Oryzon Genomics, S.A. said a new Phase Ib study of iadademstat with an immune checkpoint inhibitor and radiotherapy in extensive-stage small cell lung cancer had initiated patient enrolment. The Yale University-sponsored study evaluates iadademstat with atezolizumab and stereotactic body radiation therapy, followed by maintenance therapy with atezolizumab and iadademstat.
Oryzon Genomics, S.A. expects initial clinical updates from the RESTORE Phase Ib study of iadademstat in adults with sickle cell disease by year-end. The study is actively enrolling and will assess safety and tolerability, establish the Recommended Phase II dose and investigate the effect on fetal haemoglobin expression.
Oryzon Genomics, S.A. said updated data from the ALICE-2 and FRIDA studies had been accepted for presentation at the European Hematology Association 2026 Congress. Updated ALICE-2 data, including additional patients and more mature responses, will be presented at EHA in June 2026, alongside additional FRIDA data.
Oryzon Genomics, S.A. is working on the activities required to support resubmission of the Phase III PORTICO-2 protocol following written FDA feedback, including additional supporting information, protocol refinements, qualitative research and endpoint-validation work. Enrolment continues in the EVOLUTION Phase IIb schizophrenia study, while preparations are being completed for the HOPE-2 Phase II study in aggression associated with autism spectrum disorder.
Chief Executive Officer Dr Carlos Buesa said iadademstat-based combinations could support advancement into a potentially pivotal Phase II/III programme with the objective of pursuing accelerated regulatory approval. He also said the platform could expand into non-malignant haematology, including sickle cell disease and essential thrombocythaemia, while noting that these statements reflect the company’s current view.
Oryzon Genomics, S.A. is identified by ISIN Code ES0167733015 and the symbol ORY in the announcement.
Source announcement
- Company
- Oryzon Genomics S.A.
- Title
- ORYZON reports financial results and corporate update for quarter ended March 31st, 2026
- Published
- Source site
- oryzon.com
Read the source announcement on oryzon.com
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