Oryzon Genomics (ORY) Q4 2024 earnings summary

Executive summary

• FY24 net sales were €7,359 thousand, down from €14,192 thousand in FY23; operating loss narrowed to €4,423 thousand, while net loss widened to €3,665 thousand.

• Year-end cash and equivalents fell to €5,619 thousand from €12,257 thousand; total assets were €108,717 thousand and equity was €87,042 thousand.

• FDA feedback supports Phase III planning for vafidemstat in BPD agitation/aggression; protocol submission is targeted within 1–2 months and trial approval is expected in 1H2025.

• Board restructuring is planned to add three Bay Area-based directors and strengthen U.S. outreach as operations transition toward Phase III.

Financial highlights

• FY24 net sales were €7,359 thousand vs €14,192 thousand in FY23; H2 sales were €3,251 thousand vs €6,709 thousand in H2 2023.

• FY24 operating loss was €4,423 thousand vs €4,549 thousand; pre-tax loss was €5,571 thousand vs €6,104 thousand.

• FY24 net loss was €3,665 thousand vs €3,353 thousand; income-tax benefit was €1,906 thousand vs €2,751 thousand.

• FY2024 R&D expense was $8.7M vs $16.6M in FY2023, with PORTICO completion reducing expense by $7.9M; G&A was $3.7M vs $4.2M.

• The U.S. financial release reported FY2024 net loss of $4.6M vs $5.0M and net result loss of $3.8M vs $3.7M; Q4 net loss was $1.0M vs $1.4M.

Outlook and guidance

• PORTICO-2 is planned for 350 patients, randomized 1:1, with an 18-week duration; STAXI-2 Trait anger is the primary endpoint.

• Subject to FDA review of final data, PORTICO-2 may serve as one of two required registrational trials; FDA approval is expected in 1H2025.

• A Phase I/II iadademstat and immune-checkpoint-inhibitor trial in first-line extensive-stage SCLC is expected to begin enrollment in 1Q2025, targeting 45–50 patients.

• A potential FDA IND submission for the HOPE precision-medicine trial in Kabuki syndrome is under evaluation for 2025.