Reviva Pharmaceuticals (RVPH) investor relations material

Key clinical data and product differentiation

• Completed pivotal phase III trial for brilaroxazine in schizophrenia, treating nearly 900 subjects with robust efficacy and safety data.

• Demonstrated 10-point separation from placebo on PANSS score and strong effect size, with consistent results across phase II and III trials.

• Efficacy sustained over one year, with minimal relapse rates and broad-spectrum activity addressing both positive and negative symptoms.

• Safety profile shows minimal motor side effects (<1%) and benign weight gain, outperforming current antipsychotics.

• Comparative data indicate superior efficacy and safety versus leading antipsychotics, including CAPLYTA.

Pipeline, regulatory plans, and milestones

• Pipeline includes two molecules for CNS and immune disorders, with brilaroxazine as the lead candidate.

• Second confirmatory phase III study for brilaroxazine expected to start in Q3 2026, with top-line data anticipated in Q4 2027.

• NDA filing targeted for early 2028, pending successful completion of the second phase III trial.

• Patent strategy involves switching to a new form of brilaroxazine, potentially extending exclusivity to 2046.

• Awaiting FDA feedback mid-2026 to align on drug form switch and initiate the next trial phase.

Market need and scientific rationale

• Schizophrenia affects 24 million globally, with significant unmet needs due to relapse and partial response rates.

• Brilaroxazine targets key serotonin and dopamine receptors, addressing both neurotransmitter imbalance and inflammation.

• Biomarker data support efficacy in negative symptoms and inflammation, with consistent results across multiple endpoints.

• Product differentiation includes broad-spectrum efficacy and favorable safety compared to existing therapies.

• Patent extension and regulatory alignment are key to maximizing commercial potential.