Reviva Pharmaceuticals (RVPH) investor relations material

Key clinical data and trial results

• Lead molecule brilaroxazine demonstrated robust efficacy in schizophrenia, with dose-dependent improvements and early onset of action, showing a 10-point separation from placebo and outperforming historical comparators.

• Statistically significant improvements were observed in both primary and secondary endpoints, especially in negative symptoms, with consistent results across phase 2 and 3 trials and validated by vocal biomarker analysis.

• Long-term data showed sustained efficacy over one year, with less than 1% relapse rate and a discontinuation rate of 36%, which is significantly lower than historical rates for other antipsychotics.

• Safety profile was favorable, with no drug-related serious adverse events, minimal motor side effects, benign weight gain, and improvements in lipid and endocrine markers.

• No cardiac, liver, or significant GI side effects were reported, and the drug compared favorably to top-selling antipsychotics in efficacy and safety.

Regulatory and development updates

• All required trials for NDA submission have been completed, including long-term safety and efficacy studies in nearly 900 patients.

• A pre-NDA meeting with the FDA resulted in a recommendation for one additional phase 3 trial, with the protocol already reviewed and accepted by the agency.

• The new phase 3 trial will use a mid-dose (30mg) and is expected to start in early Q2, with completion targeted for mid-2027 and NDA submission planned for Q4 2027.

• Current cash reserves are just over $12 million, with a need to raise at least $50 million to complete the new trial and NDA submission.

• No negative feedback was received from the FDA regarding the data; the additional trial is a standard requirement for approval.

Market and competitive positioning

• Brilaroxazine's efficacy and safety profile are comparable or superior to leading antipsychotics, including those with over $1 billion in annual sales.

• The drug is differentiated from recent high-profile approvals, such as Caplyta, and is positioned for strong market entry upon approval.

• Addressing key unmet needs in schizophrenia, especially negative symptoms and treatment adherence, supports significant commercial potential.

• The company plans to expand indications beyond schizophrenia to bipolar disorder, major depressive disorder, and ADHD in the future.

• Ongoing updates on capital raising and trial initiation are expected in the coming weeks.