Oryzon Genomics (ORY) Q2 2024 earnings summary

Executive summary

• Completed full data analysis from Phase IIb PORTICO trial of vafidemstat in BPD, showing clear improvement over topline data; preparing for End-of-Phase II FDA meeting for Phase III trial planning.

• Continued enrollment in EVOLUTION Phase IIb trial of vafidemstat in schizophrenia; expanded CNS IP portfolio with two Japanese patents for BPD and ADHD indications.

• Presented encouraging preliminary data from FRIDA Phase Ib trial of iadademstat plus gilteritinib in FLT3-mutant AML at EHA 2024; additional data to be presented at ASH 2024.

• Selected as Associated Partner in the Med4Cure IPCEI project, securing additional non-dilutive funding and EU grants to support R&D.

Financial highlights

• R&D expenses were $4.9M for H1 2024, down $3.7M year-over-year due to completion of the PORTICO trial.

• General and administrative expenses were $2.1M for H1 2024, slightly down from $2.3M in H1 2023.

• Net loss was $1.1M (-$0.02/share) for H1 2024, compared to a net loss of $0.6M (-$0.01/share) in H1 2023.

• Cash, cash equivalents, and marketable securities totaled $10.8M as of June 30, 2024.

• Total assets were $118.5M and stockholders' equity was $92.6M as of June 30, 2024.

Outlook and guidance

• Preparing for FDA End-of-Phase II meeting for vafidemstat in BPD, with Phase III trial design discussions planned.

• Full PORTICO data to be presented at ECNP conference in September; ongoing EVOLUTION trial in schizophrenia continues enrollment.

• Additional FRIDA trial data to be presented at ASH 2024; new trials for iadademstat in AML and SCLC to begin enrolling in 3Q2024.

• Continued focus on budgetary discipline and leveraging non-dilutive funding to support clinical execution.