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Oryzon Genomics S.A.
- BME:ORY
- OTC PINK:ORYZF
Oryzon reports first-half 2026 results alongside clinical and financing updates
Published
At a glance
- Company
- Oryzon Genomics S.A.
- Listings
- BME:ORY, OTC PINK:ORYZF
- Announcement type
- Financial results
- Published
- Reporting period
- six months ended June 30th, 2026
- Source announcement
- oryzon.com
| Measure | Figure | Period | Compared with |
|---|---|---|---|
| Research and development (R&D) expenses | 11.4 million | six months ended June 30th, 2026 | $5.8 million in six months ended June 30th, 2025 |
| Gross proceeds | €12.0 million ($13.7 million) | Not stated | Not stated |
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 six-month financial results and clinical, regulatory, and financing updates.
- For the quarter and six months ended June 30, 2026, net losses were $1.6 and $3.6 million; cash totaled $16.7 million (€14.7 million).
- In ALICE-2, 18 evaluable patients produced a 100% (18/18) ORR, 89% (16/18) CRc rate, and 78% (14/18) CR rate; the trial targets 21 evaluable patients.
- FRIDA’s expansion cohort included 18 evaluable patients at the selected 75 μg iadademstat dose, with a 67% (12/18) CRc rate.
- Oryzon initiated IDEAL Phase II in essential thrombocythemia and enrolled its first patient; RESTORE in sickle cell disease remains actively enrolling.
- The company is preparing PORTICO-2 resubmission after FDA feedback, while EVOLUTION enrollment continues and HOPE-2 preparations are being finalized.
- It raised €12 million through a capital increase; COFIDES’s Social Impact Fund committed €25 million for future increases, subject to corporate, financial, business, and social impact conditions.
The company expects final ALICE-2 and FRIDA data by year-end. Subject to confirmation of current ALICE-2 efficacy and safety findings, it remains on track to engage FDA on a potentially registrational first-line AML study, with an objective of initiating it in 2027.
Investor FAQs
Oryzon reported financial results for the quarter and six months ended June 30, 2026, and provided a corporate update on clinical, regulatory, intellectual property and financing developments.
Oryzon is described as a clinical-stage biopharmaceutical company and a global leader in epigenetics. The source gives its ISIN Code as ES0167733015 and its ticker as ORY.
Oryzon's research and development expenses were $6.3 million for the quarter and 11.4 million for the six months ended June 30th, 2026, compared with $3.0 and $5.8 million for the corresponding periods in 2025.
General and administrative expenses were $1.3 and $2.8 million for the quarter and six months ended June 30th, 2026, compared with $1.4 and $2.7 million for the corresponding periods in 2025.
Oryzon reported net losses of $1.6 and $3.6 million for the quarter and six months ended June 30th, 2026, compared with $1.7 and $3.4 million for the corresponding periods in 2025. The negative net result for the six months was $1.6 million, or –$0.02 per share, compared with $1.8 million, or –$0.03 per share, for the same period in 2025.
Cash, cash equivalents and marketable securities totalled $16.7 million (€14.7 million) as of June 30, 2026. Oryzon 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.
After quarter-end, Oryzon raised gross proceeds of €12.0 million ($13.7 million) through a capital increase without the issuance of warrants, as announced on July 1, 2026.
The Social Impact Fund, managed by Compañía Española de Financiación del Desarrollo (COFIDES), committed as an anchor investor to subscribe for newly issued Oryzon shares in a future financing for an aggregate investment of €25 million. The commitment is subject to certain corporate, financial, business and social impact-related conditions.
Among evaluable patients (n=18), the iadademstat, azacitidine and venetoclax combination produced a 100% (18/18) overall response rate, an 89% (16/18) composite complete remission rate and a 78% (14/18) complete response rate. After a median follow-up of 8 months, median overall survival and event-free survival were not reached; estimated 12-month overall survival and event-free survival were 79% and 71%, respectively.
In the expansion cohort at the selected pharmacological active dose of 75 μg iadademstat, 18 patients were evaluable for response and the combination had a 67% (12/18) composite complete remission rate. The source describes the safety profile as favourable in a heavily pre-treated patient population.
Oryzon expects to present final data from ALICE-2 and FRIDA by year-end. Dr. Carlos Buesa said that, subject to confirmation of the current efficacy and safety findings in the final ALICE-2 dataset, the company remains on track to engage with the FDA on the design of a potentially registrational first-line AML study, with the objective of initiating the trial in 2027.
Oryzon initiated and enrolled the first patient in the IDEAL Phase II trial in adults with essential thrombocythemia who are resistant or intolerant to hydroxyurea. The study will assess safety, tolerability and clinical activity, including reduction of the percentage of adult patients with abnormal platelet counts; treatment will last up to 24 weeks, with an additional 24-week extension period available for those benefiting from treatment.
Oryzon is advancing vafidemstat towards a Phase III trial in aggression in borderline personality disorder and is preparing the HOPE-2 Phase II study in aggression in autism spectrum disorder. Enrollment is ongoing in the EVOLUTION Phase IIb schizophrenia trial, while the company is generating additional supporting information and protocol refinements for resubmission following written FDA feedback on the proposed PORTICO-2 study.
The United States Patent and Trademark Office granted U.S. Patent No. 12,673,044 covering methods of treating non-aggressive symptoms of borderline personality disorder using LSD1 inhibitors, including vafidemstat. The patent is expected to expire in March 2043, including 1,095 days of Patent Term Adjustment; this estimate does not include any potential Patent Term Extension that may become available following regulatory review, if applicable, and a corresponding patent application has been allowed in Canada.
Source announcement
- Company
- Oryzon Genomics S.A.
- Title
- ORYZON reports financial results and corporate update for half year ended June 30th, 2026
- Published
- Source site
- oryzon.com
Read the source announcement on oryzon.com
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