Minerva Neurosciences, Inc.

Our Clinical-Stage Programs for more information. While we are advancing plans for an additional confirmatory Phase 3 clinical trial for roluperidone for the treatment of negative symptoms in schizophrenia, which we refer to as the C19 trial, in consultation with the FDA and expect to fund such trial and our resubmission of the NDA in part with net proceeds from our October 2025 private placement, there can be no assurances that we will successfully resubmit the NDA and obtain approval for roluperidone in a timely manner, on favorable terms, or at all. As a result, the regulatory approval process for roluperidone in the United States is highly uncertain. If we do not obtain approval of roluperidone in the United States, or if the approval is delayed, it would have a material adverse impact on our business. Even if we are able to obtain approval, the expense and time to do so could adversely impact our ability to successfully commercialize roluperidone or conduct our other business operations and our financial condition could be materially harmed. We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and/or seek regulatory approvals for, roluperidone and other potential product candidates. If any of our product candidates fail in clinical trials or do not obtain regulatory approval, or if any of our product candidates, if approved, fail to achieve market acceptance, we may never generate revenue or become profitable.