Minerva Neurosciences (NERV) presented an updated view of its roluperidone program at the 12th Annual Cantor Fitzgerald Global Healthcare Conference on Wednesday, discussing confirmatory Phase III trial design, intellectual property positioning, and capital raised via a $200 million private investment in public equity offering.
Shares of Minerva closed regular trading at $4.12, down 5.72% from the prior session's $4.37. The stock has surged 92% over the past year but dropped 48.5% over the previous six months. Analysts have set price targets between $7 and $14, and the company's market capitalization stands at approximately $209 million.
CEO Rémy Luthringer addressed the company's Phase III results, which tested roluperidone against placebo for the treatment of negative symptoms in schizophrenia—a condition he described as a 70-year unmet need. In the U.S., an estimated 3 million people suffer from these symptoms, affecting at least 60% of diagnosed patients. Both doses tested in Phase II-A—32 mg and 64 mg—showed statistically significant improvement versus placebo with effect sizes above 0.5, which Luthringer called "quite unheard of" in psychiatry.
In Phase III, the higher 64 mg dose reached statistical significance and showed strong separation on the PSP functioning scale, while the 32 mg dose did not. However, after applying the Hochberg correction for multiple comparisons, the adjusted p-value came to 0.043, falling short of the prespecified 0.025 threshold. Data from one Phase III site was excluded due to implausible patterns identified prior to unblinding, as preplanned in the statistical analysis plan.
Confirmatory development will proceed via two studies. Phase III-A is a 12-week efficacy trial testing only the 64 mg dose across more than 40 sites; recruitment began at the end of March 2024, with top-line results expected in the second half of 2025. Phase III-B is a 52-week descriptive comparison with antipsychotics focused on relapse rates using a double-dummy design.
Minerva also completed a $200 million PIPE financing, including $80 million upfront with additional tranches tied to clinical milestones. About $10 million of the Tranche A portion has already been exercised, and the company noted the completion of financing ahead of any FDA approval as a sign of investor confidence. The exercise window for remaining Tranche A funds extends until 10 days after Phase III-A top-line results are released.
On the mechanism side, Luthringer said roluperidone combines 5-HT2A antagonism with sigma receptor activity. "The combination between 5-HT2A keeping the patients quite stable in terms of positive symptoms, improving sleep, deep sleep, cognition, and the sigma activity—this is what is explaining why the drug is improving negative symptoms," he said.
Minerva holds seven patent families for roluperidone, with formulation patent protection extending to at least 2038 without extensions. Luthringer also highlighted that around 800 patients have safely discontinued antipsychotics across Minerva's and other companies' studies, noting that 70% to 75% of patients want to stop antipsychotic treatments after 18 months.
Jim O'Connor, Minerva's chief business officer, participated in the conference discussion alongside Luthringer.
