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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Carlos Buesa
CEO
Forecast net cash (€m)
19.1
Forecast gearing ratio (%)
N/A
% | 1M | 3M | 12M |
---|---|---|---|
Actual | (11.9) | (11.0) | (21.4) |
Relative | (9.4) | (14.9) | (33.3) |
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 (BPD) 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. The final analysis showed improved significance compared to the top-line results. The data were discussed with the FDA at a recent EoP2 meeting, which concluded with an endorsement of management’s plans for a Phase III programme. The next steps are to submit a full trial protocol for PORTICO-2 to the FDA (expected in Q125). The Phase IIb EVOLUTION trial (schizophrenia) is ongoing. In oncology, the ongoing FRIDA trial (AML) and planned CRADA/STELLAR trials (SCLC) may be pivotal. FRIDA is a key strategic priority; positive interim data were reported in June and the next update is due at the EHA conference (June 2025).
Y/E Dec | Revenue (€m) | EBITDA (€m) | PBT (€m) | EPS (fd) (c) | P/E (x) | P/CF (x) |
---|---|---|---|---|---|---|
2022A | 15.7 | (5.3) | (6.6) | (7.49) | N/A | N/A |
2023A | 14.2 | (4.4) | (6.1) | (5.65) | N/A | N/A |
2024E | 7.6 | (4.0) | (4.9) | (3.13) | N/A | N/A |
2025E | 40.5 | 26.8 | 25.5 | 43.90 | 3.6 | 3.4 |