ORYZON Announces H1 2024 Financial Results and Corporate Update

Oryzon Genomics, a clinical-stage biopharmaceutical company focusing on epigenetic therapies, recently shared its financial results for the first half of 2024 and provided an update on its ongoing projects. The company, headquartered in Madrid and Cambridge, leverages its expertise in epigenetics to address diseases with significant unmet medical needs.

Key Highlights:

1. Vafidemstat for CNS Indications:
- Borderline Personality Disorder (BPD): Oryzon completed a full data analysis from the Phase IIb PORTICO trial, showing significant improvements. An End-of-Phase II meeting with the FDA has been secured to discuss a Phase III trial design.
- Patents: The Japanese Patent Office has issued notices of intent to grant patents for the use of vafidemstat in treating BPD and ADHD, which will bolster Oryzon’s intellectual property portfolio.
- Schizophrenia: The EVOLUTION Phase IIb trial continues to enroll patients to evaluate vafidemstat's efficacy in treating negative symptoms and cognitive impairment in schizophrenia.

2. Iadademstat for Oncology:
- Acute Myeloid Leukemia (AML): The FRIDA Phase Ib trial, testing iadademstat in combination with gilteritinib for FLT3-mutant relapsed/refractory AML, showed promising initial data. Additional results are expected to be presented at the ASH conference in December.
- New Trials: Two new studies will explore iadademstat combined with venetoclax and azacitidine in first-line AML patients. One of these trials is part of a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI).
- Myelodysplastic Syndrome: Another investigator-initiated study will evaluate iadademstat in combination with azacitidine.

3. Financial Overview:
- R&D Expenses: Research and development expenses were $4.9 million for the first half of 2024, a decrease compared to the same period in 2023, due to the completion of the PORTICO trial.
- General and Administrative Expenses: These expenses were relatively stable, amounting to $2.1 million for the first half of 2024.
- Net Losses: The company reported a net loss of $2.6 million for the first half of 2024, consistent with the expected financial trajectory for a company in the development phase.
- Cash Position: As of June 30, 2024, Oryzon had $10.1 million in cash, cash equivalents, and marketable securities.

4. Corporate Developments:
- Oryzon has been selected as an Associated Partner in the Med4Cure project, the first Important Project of Common European Interest (IPCEI) in the health sector.

5. Future Plans:
- CNS Precision Medicine: Preparations for a precision medicine trial in Kabuki Syndrome are ongoing, with potential IND submission to the FDA in 2024.
- Additional Trials: Oryzon continues to explore other neurodevelopmental syndromes and is planning further studies to expand its clinical portfolio.

Oryzon Genomics remains committed to advancing its clinical programs and strengthening its intellectual property portfolio. The company aims to continue its progress in both CNS and oncology sectors while maintaining financial discipline in a challenging market environment. The recent IPCEI grant from the European Union will further support Oryzon's research and development efforts in personalized medicine.

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