Oryzon Genomics (ORY) Q2 2024 earnings summary

Executive summary

• H1 2024 remained focused on clinical-stage drug development, with no licensing revenue recognized and results remaining loss-making.

• Lead programs were vafidemstat in CNS and psychiatric conditions and iadademstat in oncology, both in Phase II.

• Selected as an Associated Partner in the Med4Cure IPCEI project, providing additional non-dilutive EU funding for R&D.

• Expanded vafidemstat’s CNS IP portfolio with Japanese patents covering BPD and ADHD indications.

Financial highlights

• H1 operating loss was €2.404m versus €2.471m YoY; net loss was €1.040m versus €568k, while pre-tax loss was €2.918m versus €3.272m.

• Development work capitalized was €4.107m versus €7.483m YoY; R&D investment totaled €4.610m versus €7.945m.

• Other operating expenses fell to €4.672m from €8.149m, mainly reflecting lower clinical and preclinical activity costs; personnel costs were €1.689m versus €1.724m.

• Financial expenses declined to €529k from €1.056m, including €238k of implicit convertible-bond interest versus €773k YoY.

• An income-tax benefit of €1.878m included €1.738m of monetized R&D deductions; the comparable H1 2023 tax benefit was €2.704m.

Outlook and guidance

• Planned activity centered on advancing iadademstat and vafidemstat clinical programs and progressing earlier-stage research; no quantified financial guidance was stated.

• Preparing for an FDA End-of-Phase-II meeting to discuss Phase III planning for vafidemstat in BPD; the meeting was planned for late summer 2024.

• The HOPE Phase I/II vafidemstat study in Kabuki syndrome was being designed; an FDA IND application was subject to obtaining additional resources.

• An OHSU-led iadademstat combination study in first-line AML was expected to begin recruiting in Q3 2024; an iadademstat/ICI Phase II SCLC study IND was planned for 2025, subject to prior results.

• Full PORTICO data were scheduled for ECNP in September, with additional FRIDA data planned for ASH 2024.