Oryzon raises €12m to push AML and CNS pipeline

Spanish epigenetics biotech Oryzon Genomics has raised €12m in a capital increase and signed a financing agreement with COFIDES that could add another €25m in future share subscriptions.

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Why it matters: The Barcelona-based company is trying to keep momentum behind two clinical-stage LSD1 inhibitors: iadademstat in haematology and oncology, and vafidemstat in psychiatric and CNS disorders.

How it works: LSD1 (lysine specific demethylase 1) is an epigenetic enzyme that helps regulate which genes are switched on or off.

  • Oryzon is applying the same target in two different ways. Iadademstat is being developed mainly in haematological cancers, where LSD1 inhibition is intended to disrupt leukaemia cell survival and differentiation. Vafidemstat is designed to cross into the brain, where the company is testing whether modulating LSD1-controlled gene expression can affect aggression and other psychiatric symptoms.

Zoom in: Oryzon issued 4,444,445 new ordinary shares at €2.70 per share on the Spanish Stock Exchange.

  • The proceeds will be used to strengthen the balance sheet, advance iadademstat in acute myeloid leukaemia, progress other haematology and psychiatry programmes, and cover general corporate expenses.
  • The COFIDES agreement gives Oryzon a potential anchor investor for future capital increases over the next six months, subject to conditions. At least 40% of those proceeds would need to go to mental-health programmes, particularly borderline personality disorder and other psychiatric indications.

Backstory: The latest raise follows a larger €30m private placement in April 2025, which exceeded Oryzon’s initial €25m target and was framed as part of its longer-term push toward a possible Nasdaq listing.

The pipeline: The company describes vafidemstat as Phase III-ready in agitation/aggression in borderline personality disorder (BPD), following the completion of the Phase IIb PORTICO trial.

  • Oryzon is preparing to resubmit the protocol for PORTICO-2, a planned Phase III trial in aggression in borderline personality disorder, after receiving written FDA feedback on endpoints and non-clinical considerations.
  • Beyond BPD, the EVOLUTION Phase IIb trial in schizophrenia is ongoing and expanding beyond Spain into additional European countries, with a focus on negative symptoms and secondary measures including cognition and positive symptoms.
  • The company is also preparing HOPE-2, a Phase II study of vafidemstat in aggression in autism spectrum disorder, including genetically defined subgroups such as Phelan-McDermid syndrome.

What we’re watching: In haematology, Oryzon has been increasingly leaning into acute myeloid leukemia (AML) data for iadademstat. At EHA 2026, the company reported updated Phase Ib data showing a 100% overall response rate in 18 evaluable newly diagnosed AML patients treated with iadademstat plus azacitidine and venetoclax, alongside an 89% composite complete remission rate.

  • In relapsed or refractory FLT3-mutated AML, iadademstat plus gilteritinib showed a 67% composite complete remission rate in 18 evaluable patients.

Yes, but: Both sides of the pipeline still need larger, decisive trials. The AML readouts are encouraging but come from small early-stage datasets, while vafidemstat’s next major test is whether Oryzon can turn the Phase IIb BPD programme into a regulator-aligned Phase III study.

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