Spanish biotech Oryzon Genomics is focused on epigenetics. Iadademstat is being explored for acute leukaemias, small-cell lung cancer (SCLC) and neuroendocrine tumours. Central nervous system (CNS) asset vafidemstat has completed several Phase IIa trials and a Phase IIb trial in borderline personality disorder, and is in a Phase IIb trial for schizophrenia.
Oryzon is among the leading clinical-stage drug developers with a second generation of epigenetic therapeutics, which have greater selectivity and a potentially favourable safety/efficacy profile compared with the first-generation HDAC inhibitors.
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Update
Carlos Buesa
CEO
Forecast net cash (€m)
19.1
Forecast gearing ratio (%)
N/A
% | 1M | 3M | 12M |
---|---|---|---|
Actual | (2.2) | 9.5 | (10.9) |
Relative | (0.3) | 9.1 | (25.1) |
52 week high/low | €2.2/€1.6 |
Oryzon’s lead assets, both inhibitors of LSD1 (an epigenetic target), are vafidemstat (CNS indications) and iadademstat (oncology). In CNS, the Phase IIb PORTICO trial (borderline personality disorder, results announced January 2024) did not meet the primary endpoint with statistical significance, but vafidemstat was favoured over placebo in all efficacy measures with statistical significance in key secondary endpoints; management plans to request an FDA end-of-Phase II meeting to discuss a potential registrational Phase III programme. The Phase IIb EVOLUTION trial (schizophrenia) is ongoing. Oryzon is also deploying a CNS personalised medicine approach with its Phase I/II HOPE trial (Kabuki syndrome), expected to start in 2024. In oncology, the ongoing FRIDA trial (AML) and planned CRADA-MSKCC/STELLAR trials (SCLC) may be pivotal; the FDA has granted Orphan Drug designation for iadademstat in these indications. FRIDA is one of Oryzon’s key strategic priorities in oncology; encouraging interim results were reported in June 2024.
Y/E Dec | Revenue (€m) | EBITDA (€m) | PBT (€m) | EPS (fd) (c) | P/E (x) | P/CF (x) |
---|---|---|---|---|---|---|
2022A | 15.7 | (5.3) | (6.3) | (7.49) | N/A | N/A |
2023A | 14.2 | (4.4) | (6.0) | (5.65) | N/A | N/A |
2024E | 12.9 | (3.1) | (4.1) | (2.53) | N/A | N/A |
2025E | 33.7 | 16.9 | 15.4 | 29.08 | 6.2 | 6.1 |