What is the expected cost and timeline of the confirmatory trial, and how will it affect the company's runway and need for equity financing?

Confirmatory‑trial cost & timing

The FDA’s request that Minerva conduct a confirmatory Phase III study of roluperidone means the company will have to fund a full‑scale pivotal trial. Based on comparable CNS‑programs, the out‑of‑pocket expense is likely in the $30 million–$40 million range (clinical‑site costs, CRO fees, and data‑management). The trial will enrol roughly 300–400 patients and is expected to run 12–15 months from first‑patient‑in to primary‑endpoint read‑out, putting the earliest possible data in the late‑2026/early‑2027 window.

Impact on cash runway & equity needs

Minerva reported Q2 cash of about $115 million and a net burn of roughly $30 million per quarter. Adding a $35 million confirmatory spend will shave ≈ 1 quarter off the existing runway, leaving the company with just ~9–10 months of cash after the trial is launched. That shortfall makes an equity‑financing round (or a convertible debt facility) highly likely before the end of 2025 to keep the program alive and to fund any post‑approval activities. The dilution risk is therefore material: a $100 million equity raise at current levels would expand the share base by ≈ 15‑20 %, pressuring the stock on a near‑term basis.

Trading implications

* Short‑term: Expect price pressure as the market prices in the near‑term cash‑runway squeeze and the probability of a dilutive financing. A break‑even or modest upside on the headline of a confirmatory requirement is unlikely; the stock could test the $0.70–0.80 range (its 200‑day low) if financing terms look unfavorable.

* Long‑term: If the trial proceeds on schedule and delivers a positive read‑out, the upside could be 3‑5× the current level, given the unmet need in negative‑symptom schizophrenia. Positioning a small‑size long‑position now, with a stop just below the recent swing‑low (~$0.68), keeps risk limited while preserving upside if the confirmatory data eventually clear the regulatory path.

In short, the confirmatory study will cost roughly $35 million and take 12–15 months, compressing Minerva’s cash runway and likely forcing a equity raise that could dilute existing shareholders. The near‑term bias is negative, but the longer‑term upside remains tied to trial success. Traders should stay short‑biased until financing terms are clarified, then consider a modest long‑position on any signs of a successful read‑out.