GlobeNewswire·Mar 30, 2026, 6:05 AM ET

Reviva Reports Full Year 2025 Financial Results and Recent Business Highlights

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FDA issued written recommendations requiring a second Phase 3 trial to generate additional efficacy & safety data prior to NDA submission for brilaroxazine in schizophrenia
Reviva plans to initiate the RECOVER-2 registrational trial in mid-2026 with U.S. patient enrollment starting in Q3-2026
Clinical data shows brilaroxazine has a well-tolerated long-term safety profile, broad-spectrum efficacy, & favorable adherence for once-daily dosing up to one year
The 1-year open-label extension study (RECOVER OLE) reported robust efficacy in 446 patients with <1% symptom relapse & no clinically meaningful motor side effects
Safety findings included benign weight gain (~1.5 kg), favorable lipid profiles, & normalization of elevated prolactin levels without sexual side effects or liver injury
Non-clinical development completed NDA-enabling carcinogenicity studies & cGMP manufacturing of drug substance & product registration batches
Three new U.S. provisional patent applications were filed covering brilaroxazine compositions & specific symptom treatments
European Patent EP3749324 was granted in November 2025 for treating pulmonary fibrosis & idiopathic pulmonary fibrosis
Three public equity offerings completed in 2025 & March 2026 raised a total of $29.0 million in gross proceeds
Following the March 2026 offering, Reviva holds approximately $23 million in cash & cash equivalents to fund operations into Q1-2027
The company reported a net loss of $19.9 million for the fiscal year ended December 31, 2025, compared to $29.9 million in 2024
Cash & cash equivalents increased to $14.4 million as of December 31, 2025, from $13.5 million in the prior year