NERV — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-05

• We are a clinical-stage biopharmaceutical company focused on the development and commercialization of certain proprietary product candidates to treat patients suffering from central nervous system (“CNS”) diseases.

• On March 31, 2026, we announced that the first patient had been screened in the C19 trial. The trial is designed to enroll 380 patients, randomized on a 1:1 basis to receive either placebo or a double-blinded single daily 64 mg dose of roluperidone. The primary efficacy endpoint is expected to be th…

• In addition, we previously co-developed seltorexant with Janssen Pharmaceutica NV (“Janssen”), a subsidiary of Johnson & Johnson, for the treatment of insomnia disorder and adjunctive treatment of Major Depressive Disorder (“MDD”). As a result of our collaboration with Janssen, we were entitled to c…

• We have not received any regulatory approvals to commercialize any of our product candidates, and we have not generated any revenue from the sales or license of our product candidates. We routinely evaluate the status of our drug development programs as well as potential strategic options. We have i…

• Changes in fair value of the warrant liability consist of the gain (loss) associated with the adjustment to the carrying amount of the warranty liability.

Text removed vs the prior filing · source: 10-Q · 2025-11-05

• We are a clinical-stage biopharmaceutical company focused on the development and commercialization of proprietary product candidates to treat patients suffering from central nervous system diseases. We are currently developing roluperidone for the treatment of negative symptoms in patients diagnosed…

• We have not received any regulatory approvals to commercialize any of our product candidates, and we have not generated any revenue from the sales or license of our product candidates. We routinely evaluate the status of our drug development programs as well as potential strategic options. We have i…

• On October 21, 2025, we entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain accredited investors, pursuant to which we agreed to issue and sell, in a private placement (the “Private Placement”), (i) 80,000 shares of Series A Convertible Preferred Stock, pa…

• The gross proceeds of the Private Placement are estimated to be up to approximately $200 million, before deducting fees paid to the placement agent of the Private Placement and other estimated offering expenses payable by us, including initial upfront gross proceeds of $80 million in exchange for sh…

• This private placement followed our announcement in August 2025 of our alignment with the FDA on the design of a confirmatory Phase 3 trial of roluperidone. We expect the net proceeds of this private placement will be sufficient to fund the confirmatory Phase 3 trial of roluperidone and our resubmis…

Text added vs the prior filing · source: 10-Q · 2026-05-05

• Our lead product candidate, roluperidone, is in development for the treatment of negative symptoms in patients diagnosed with schizophrenia. In August 2022, we submitted a New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) for roluperidone for the treatment of negative s…

• 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 cli…

• Stockholders will be diluted by any conversions of outstanding Series A Preferred Stock and exercises of outstanding warrants.

• As of March 31, 2026, there were (i) 1,559,008 shares of common stock issuable upon conversion of outstanding Series A Preferred Stock for no additional consideration, (ii) 37,272,400 shares of common stock issuable upon exercise of outstanding tranche A warrants to purchase Series A Preferred Stock…

Text removed vs the prior filing · source: 10-Q · 2025-11-05

• In August 2022, we submitted a New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) for our lead product candidate, roluperidone, for the treatment of negative symptoms in schizophrenia. On February 26, 2024, the FDA issued a Complete Response Letter (the “CRL”) to our NDA…

• 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. Even if we achieve profitability in the future, we may not be able to sustain prof…

• The market price of our stock may be volatile, and you could lose all or part of your investment.

• The trading price of our common stock is likely to be highly volatile and subject to wide fluctuations in response to various factors, some of which we cannot control. As a result of this volatility, investors may not be able to sell their securities at a profit. The market price of our securities c…