Reviva Pharmaceuticals (RVPH) A.G.P.'s Annual Virtual Healthcare Conference summary

Clinical development updates

• Lead molecule brilaroxazine is in late-stage development for schizophrenia, with over 900 patients treated in prior trials and strong efficacy, especially for negative symptoms, and a favorable safety profile.

• FDA pre-NDA meeting in December reviewed all clinical data positively, but requested data from an additional 300 patients to meet historical approval benchmarks for antipsychotics.

• Second phase III RECOVER-2 trial is planned to start in mid-2026, pending FDA feedback on a new formulation, with NDA submission targeted for early 2028.

• New formulation aims to extend patent life to 2046, enhancing commercial exclusivity and value.

• The new formulation and trial design are modeled after successful strategies used by other blockbuster drugs to maximize exclusivity and market potential.

Commercial strategy and exclusivity

• Patent and regulatory strategies are focused on extending commercial exclusivity from 2035 to 2046 through new formulation and additional patents.

• Extended exclusivity is critical for expanding indications beyond schizophrenia to bipolar disorder, major depressive disorder, and ADHD.

• The approach mirrors successful paths taken by drugs like CAPLYTA and LIPITOR, which led to significant acquisitions and market success.

• Robust efficacy and biomarker data differentiate brilaroxazine from competitors, supporting expansion and partnership opportunities.

• Major pharma interest is contingent on securing long-term exclusivity, which is seen as the main value driver.

Financial position and capital markets

• Recently raised $10 million, bringing total cash to over $20 million, with a low quarterly burn rate of just over $2 million.

• Current cash runway extends into Q2 of the following year, with major catalysts expected in the next two to three months.

• Regaining Nasdaq compliance is a top priority, targeted for later in the year following key FDA feedback.

• The company is focused on securing additional capital and partnerships after achieving regulatory milestones.

• Anticipates a transformative period in the second half of the year, driven by regulatory and commercial catalysts.