Reviva Pharmaceuticals FY Conference Summary Company Overview - **Company**: Reviva Pharmaceuticals (NasdaqCM: RVPH) - **Focus**: Late-stage pharmaceutical company developing next-generation therapies for neurodysfunction diseases, particularly schizophrenia [2][21] Key Points on Schizophrenia and Unmet Needs - **Prevalence**: Approximately 24 million people globally suffer from schizophrenia, which is a lifelong condition for most patients [3] - **Treatment Challenges**: - Around 30% of patients do not respond to current treatments - High treatment discontinuation rates: 30%-45% in the short term and up to 80% in the long term - Relapse rates are significant, with 25% of patients experiencing relapse within a year, increasing to 90% in the long run [4] Brilaroxazine Development - **Lead Molecule**: Brilaroxazine, currently in development for schizophrenia, with potential for other indications like bipolar disorder and ADHD [2] - **Clinical Trials**: - Completed multiple trials, treating nearly 900 patients - Pivotal trial design included acute treatment for one month and stable treatment for one year, involving around 850 patients [5][11] Efficacy Data - **Primary Endpoint**: Brilaroxazine showed a statistically significant improvement of around 10 points compared to placebo, indicating robust efficacy [6] - **Negative Symptoms**: - Significant improvement in negative symptoms, a critical unmet need in schizophrenia treatment - Data from the Marder factor indicated early onset of action and progressive improvement [9][10] - **Long-term Efficacy**: - Sustained efficacy over one year with a reduction in PANS score by nearly 50 points for patients transitioning from acute to long-term treatment [11] - Less than 1% of patients reported relapse or near relapse symptoms during long-term treatment [14] Safety and Tolerability - **Safety Profile**: - No serious drug-related adverse events reported - Common side effects included headaches and sleep disturbances, occurring in less than 5% of patients [15][16] - **Endocrine Effects**: - Prolactin levels decreased to normal, avoiding common side effects associated with other antipsychotics [17][18] - **Cardiac Safety**: No QTc prolongation or significant cardiac side effects observed [19] Regulatory Path and Future Plans - **NDA Submission**: - Completed trials required for NDA filing; however, FDA recommended an additional phase three study - Anticipated initiation of the second trial in early Q2 2027, with NDA submission expected in Q4 2027 [20][21] - **Funding Needs**: Company requires approximately $50 million to complete the second study and submit the NDA [21] Competitive Landscape - **Market Comparison**: Brilaroxazine's efficacy data is competitive with leading antipsychotics, some of which have over $1 billion in sales [19][20] Conclusion Reviva Pharmaceuticals is positioned to address significant unmet needs in schizophrenia treatment with Brilaroxazine, demonstrating promising efficacy and safety data. The company is preparing for further clinical trials and regulatory submissions to bring this innovative therapy to market.