Oryzon Genomics (ORY) Q3 2024 earnings summary

Executive summary

• Presented final Phase IIb PORTICO trial data for vafidemstat in BPD, showing improved efficacy and safety, and received FDA feedback to proceed to Phase III PORTICO-2 trial preparations.

• Strengthened IP position for vafidemstat with new patents and "intention to grant" communications in multiple jurisdictions, extending protection to at least 2038-2040.

• Advanced oncology pipeline with new trials for iadademstat in AML and myelodysplastic syndrome, and ongoing FRIDA Phase Ib trial in FLT3-mutant AML.

• Maintained strict budget discipline, reduced R&D expenses by $5.1M year-over-year, and secured additional funding through an EU IPCEI grant.

Financial highlights

• R&D expenses were $7.1M for the nine months ended September 30, 2024, down from $12.2M year-over-year due to PORTICO trial completion.

• General and administrative expenses were $3.1M for the nine months, up slightly from $2.9M year-over-year.

• Net loss was $3.8M for the nine months ended September 30, 2024, compared to $3.4M in the prior year period.

• Cash, cash equivalents, and marketable securities totaled $8.4M as of September 30, 2024.

• Total assets increased to $122.7M from $108.3M year-over-year; stockholders' equity rose to $96.9M from $83.9M.

Outlook and guidance

• Preparing to submit the full Phase III PORTICO-2 protocol to the FDA, targeting approval by end of 1Q2025.

• EVOLUTION Phase IIb trial in schizophrenia continues enrollment with an increased recruitment target.

• Anticipates further financial support from the EU IPCEI grant and is exploring additional financing and partnership opportunities.