Reviva Pharmaceuticals Holdings (RVPH) investor relations material

Conference overview

• The event featured a fireside chat with the CEO of a late-stage biopharma focused on novel schizophrenia treatments, moderated by a senior research analyst specializing in neurology and neuropsychiatry.

• The discussion covered the company’s clinical progress, business strategy, and competitive landscape, with management available for one-on-one meetings.

Clinical development highlights

• The lead asset, briloroxazine, targets serotonin, dopamine, and inflammatory pathways, showing robust efficacy in negative symptoms and relapse prevention in schizophrenia.

• Over 900 patients have been treated in multiple trials, with consistent efficacy and a favorable safety profile, including minimal motor, endocrine, metabolic, and cardiac side effects.

• Phase 3 data demonstrated a 10-point separation from placebo on the PANSS scale, outperforming historical antipsychotic benchmarks.

• Durable efficacy and low relapse rates were observed over one year, with discontinuation rates significantly lower than real-world antipsychotic treatments.

Regulatory and strategic outlook

• The company plans a pre-NDA (Type C) meeting with the FDA in late 2025, aiming for NDA submission based on existing data, referencing regulatory precedents like CAPLITA.

• Two scenarios were discussed: early NDA filing if FDA feedback is positive, or a second Phase 3 trial if required, with timelines and cash needs outlined for both.

• Management expressed confidence in meeting statutory requirements for approval, citing robust efficacy, safety, and long-term data.