Reviva Pharmaceuticals (RVPH) Study update summary

Clinical program overview

• Brilaroxazine is a serotonin-dopamine dual modulator in late-stage development for CNS, inflammatory, and cardiometabolic diseases, with schizophrenia as the lead indication.

• Over 800 patients have been treated in schizophrenia trials, with safety data from more than 900 patients.

• Completed two phase II trials and a phase III registrational trial (RECOVER-1) in 411 patients, plus a long-term safety study in 450 patients.

• A second phase III trial (RECOVER-2) is planned as the final confirmatory study before NDA submission.

Patent strategy and formulation change

• A new formulation of brilaroxazine is being introduced to extend patent life to 2046, pending FDA feedback expected mid-year.

• Patent extension is critical for commercial exclusivity and attracting partners, as current exclusivity would otherwise end around 2036.

• The formulation switch involves changes in salt form, polymorph, and drug product, aiming for strong IP protection.

• Similar strategies have been used by other CNS drug developers, such as Intra-Cellular Therapies with CAPLYTA.

Financial position and milestones

• Recently raised $10 million, bringing pro forma cash to $23 million, providing runway into Q1 2027.

• Key upcoming milestones include FDA alignment on the new formulation and initiation of the RECOVER-2 phase III trial.

• Approximately $50–55 million is needed to complete the second phase III trial and NDA filing.

• Extended patent life is expected to enhance value and facilitate strategic partnerships or further fundraising.