Reviva Pharmaceuticals (RVPH) investor relations material

Market overview and unmet needs

• CNS and immune-related disorders represent a $40+ billion market, with schizophrenia alone projected to reach $15 billion by 2033.

• Schizophrenia affects over 24 million globally, with high relapse and discontinuation rates highlighting significant unmet needs.

• Current treatments leave 30% of patients unresponsive or partially responsive, and 90% relapse within five years.

Clinical data and efficacy

• Lead molecule brilaroxazine demonstrated robust efficacy in phase III trials, with a 10-point separation from placebo on the PANSS scale, outperforming historical antipsychotic data.

• Early onset of action observed within the first week for the higher dose, with durable effects over one year and less than 1% relapse rate.

• Secondary endpoints, including negative symptom scales and digital biomarkers, showed strong efficacy, especially in patients with significant negative symptoms.

• Consistent efficacy observed across both short-term and long-term studies, with increasing magnitude over time.

Safety and tolerability

• Discontinuation rates for brilaroxazine were 12%-16% in short-term and 36% in long-term studies, significantly lower than historical comparators.

• Safety profile showed minimal motor side effects (<1%), benign weight gain, and no clinically meaningful hormonal, cardiac, or liver-related adverse events.

• Prolactin levels normalized within four weeks and remained stable over one year.

• No drug-induced liver injury or significant cardiac or gastrointestinal side effects reported in over 900 patients.