Reviva Pharmaceuticals Holdings, Inc. announced positive topline results and successful completion of its pivotal Phase 3 RECOVER trial evaluating the efficacy, safety and tolerability of once-daily brilaroxazine, a serotonin-dopamine signaling modulator in adults with schizophrenia. The trial successfully met its primary endpoint, with brilaroxazine at the 50 mg dose achieving a statistically significant and clinically meaningful 10.1-point reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo (-23.9 brilaroxazine 50 mg vs. -13.8 placebo, p<0.001) at week 4. Brilaroxazine also achieved statistically significant and clinically meaningful reductions in all major symptom domains and secondary endpoints at week 4 with the 50 mg dose vs.

placebo. The 15 mg dose of brilaroxazine was numerically superior to placebo on the primary endpoint and most secondary endpoints, and reached statistical significance on two key secondary endpoints. Key clinical safety and tolerability findings of brilaroxazine support a well-tolerated safety profile: No drug related serious adverse events (SAEs) or treatment-emergent SAEs (TESAEs) observed or major safety concerns reported for brilaroxazine after 4 weeks of treatment, No incidence of suicidal ideation, No significant change in bodyweight, blood glucose levels, lipids levels, or endocrine hormones (prolactin, thyroid hormone) compared to placebo, Akathisia and extrapyramidal symptoms <1% reported for brilaroxazine 50 mg and none for 15 mg, Low discontinuation rates with brilaroxazine that were less than placebo (16% in brilaroxazine 50mg and 19% in brilaroxazine 15mg vs.

22% placebo). The brilaroxazine program consists of the completed positive Phase 2 REFRESH and Phase 3 RECOVER trials, as well as an ongoing 1-year OLE trial evaluating the long-term safety and tolerability, and soon to be initiated confirmatory global, randomized 6-week Phase 3 RECOVER-2 trial. The Company expects to report topline data from the OLE trial in Fourth Quarter 2024 and initiate the registrational Phase 3 RECOVER-2 trial in First Quarter 2024, with completion anticipated in early 2025.

These data from the brilaroxazine program will potentially support the planned NDA submission to the FDA in 2025. Conference Call and Webcast Information Reviva management will hold a conference call and webcast at 8:30 a.m. ET to discuss topline results from its Phase 3 RECOVER trial evaluating brilaroxazine for adults with schizophrenia. Dial In: The dial-in number for the conference call is 1-877-704-4453 (U.S./Canada) or 1-201-389-0920 (international).

Conference ID: The conference ID for all callers is 13742204. Call me?: Click here. Participants can use guest dial-in numbers above and be answered by an operator or they can click the Call me?

link for instant telephone access to the event (dial-out). The Call me? link will be made active 15 minutes prior to scheduled start time.

Live Webcast: The live webcast can be accessed here. The live webcast and replay may also be accessed by visiting Reviva?s website at https://revivapharma.com/events/. An archived version of the webcast will be available on the website for 30 days.

RECOVER is a global Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine in 412 patients with acute schizophrenia compared to placebo. Brilaroxazine was administered at fixed doses of 15 mg or 50 mg once daily for 28 days. The primary endpoint is a decrease in Positive and Negative Symptoms Assessment total score compared to placebo from baseline to Day 28.

Key secondary endpoints include clinical global impression (CGI) severity, positive and negative symptoms, social functioning and cognition.