REVIVA PHARMACEUTICALS HOLDINGS, INC. 8-K

What Happened
Reviva Pharmaceuticals Holdings, Inc. (RVPH) reported on an 8‑K that at its 2025 Annual Meeting shareholders approved an amendment to raise authorized common stock from 315,000,000 to 515,000,000 shares (filed with Delaware on Dec 18, 2025). In a Dec 23, 2025 regulatory update the company said the FDA advised it to conduct an additional Phase 3 trial for brilaroxazine for schizophrenia (a trial similar to the RECOVER study using 30 mg and 50 mg doses). Reviva said it plans to start the RECOVER‑2 Phase 3 study in the first half of 2026, subject to financing, with projected RECOVER‑2 data in Q2 2027, a potential NDA filing in Q4 2027 and possible approval in Q4 2028.

Key Details

• Share authorization increased from 315,000,000 to 515,000,000 shares; amendment filed Dec 18, 2025 and effective immediately.
• FDA recommended a second Phase 3 similar to RECOVER using 30 mg and 50 mg doses; Reviva will incorporate FDA feedback on analysis and nonclinical data requirements.
• Planned RECOVER‑2 timeline (subject to financing): start H1 2026 → data Q2 2027 → potential NDA Q4 2027 → potential approval Q4 2028.
• Estimated costs: RECOVER‑2 ≈ $60 million (≈ $35M direct trial costs + ≈ $24M G&A); a potential negative symptoms/bipolar Phase 3 ≈ $30 million.
• Recent financing activity: 19,794,000 warrants exercised from Oct 1–Dec 16, 2025 for net proceeds ≈ $6.7M; cash & cash equivalents ≈ $14.7M as of Dec 16, 2025 (believed sufficient for operations through Q2 2026, excluding RECOVER‑2). Shares outstanding after exercises: 116,849,932 (as of Dec 16, 2025).

Why It Matters
The FDA’s recommendation for an additional Phase 3 trial lengthens the development pathway for brilaroxazine and will materially increase near‑term funding needs. Reviva has given investors a target development timeline and cost estimates, but the company’s current cash (~$14.7M) is not sufficient to fund the RECOVER‑2 trial, which is projected at about $60M; the authorized share increase gives the company flexibility to raise capital (which can dilute existing shareholders). The filing also reiterates patent and capital‑raising risks and updates risk disclosures—items investors should weigh when assessing financing and dilution risk, development milestones, and timing to potential approval.