Minerva Neurosciences Announces Financing of up to $200 Million to Advance Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia Through a Phase 3 Confirmatory Trial and Resubmission of its New Drug Application and Preparation for US Commercial Launch, if Approved
Minerva Neurosciences (Nasdaq: NERV) announced a private placement providing up to $200 million in gross proceeds to advance roluperidone for negative symptoms of schizophrenia.
The financing includes an $80 million upfront Series A preferred stock sale, up to $80 million from Tranche A warrant exercises, and $40 million contingent on a milestone tied to Tranche B warrant cash exercises. Minerva says proceeds are expected to fund the confirmatory Phase 3 trial, NDA resubmission and U.S. commercial readiness; closing is expected on or about October 23, 2025. Up to three investor‑designated directors will be added to the board to support clinical operations.
Minerva Neurosciences (Nasdaq: NERV) ha annunciato un collocamento privato che fornirà fino a 200 milioni di dollari di proventi lordi per avanzare roluperidone per i sintomi negativi della schizofrenia.
Il finanziamento include una vendita in preferred stock di Series A per 80 milioni di dollari upfront, fino a 80 milioni di dollari da esercizi di warrant della Tranche A, e 40 milioni di dollari contingentati da un traguardo legato agli esercizi di cassa dei warrant della Tranche B. Minerva afferma che i proventi dovrebbero finanziare lo studio di Fase 3 di conferma, la resubmission della NDA e la prontezza commerciale negli Stati Uniti; la chiusura è prevista per o intorno al 23 ottobre 2025. Fino a tre direttori designati dagli investitori verranno aggiunti al consiglio per supportare le operazioni cliniche.
Minerva Neurosciences (Nasdaq: NERV) anunció una colocación privada que proporcionará hasta 200 millones de dólares brutos para avanzar roluperidone para los síntomas negativos de la esquizofrenia.
La financiación incluye una venta de acciones preferentes Series A por 80 millones de dólares iniciales, hasta 80 millones de dólares por ejercicios de warrants de la Tranche A, y 40 millones de dólares condicionados a un hito vinculado a ejercicios de efectivo de warrants de la Tranche B. Minerva dice que los fondos se destinarán a financiar el ensayo de Fase 3 de confirmación, la re-presentación de la NDA y la preparación comercial en EE. UU.; se espera el cierre alrededor de 23 de octubre de 2025. Hasta tres directores designados por inversionistas se añadirán a la junta para apoyar las operaciones clínicas.
Minerva Neurosciences (나스닥: NERV)는 롤루페리돈(roluperidone)을 음성 증상의 조현병 치료에 진행하기 위한 비공개 배정을 발표했습니다. 총 수익은 2억 달러까지입니다.
자금 조달에는 초기 8천만 달러의 시리즈 A 우선주 매각, 트랜치 A의 워런트 행사로 최대 8천만 달러, 그리고 4천만 달러가 트랜치 B 워런트 현금 행사에 연결된 이정표에 따라 contingency로 포함됩니다. Minerva는 수익이 확정 임상 3상(확인 임상)을 위한 자금, NDA 재제출 및 미국 상업 준비에 사용될 것으로 보이며, 마감은 대략 2025년 10월 23일에 예상됩니다. 임원으로 투자자 지명이 있는 이사가 최대 세 명 이사회에 추가되어 임상 운영을 지원합니다.
Minerva Neurosciences (Nasdaq : NERV) a annoncé une placement privé qui fournira jusqu'à 200 millions de dollars de produits bruts pour faire progresser la roluperidone pour les symptômes négatifs de la schizophrénie.
Le financement comprend une vente d'actions privilégiées Série A d'à l'avance 80 millions de dollars, jusqu'à 80 millions de dollars provenant des exercices de warrants de la Tranche A, et 40 millions de dollars conditionnés à un jalon lié aux exercices de trésorerie des warrants de la Tranche B. Minerva indique que les produits devraient financer l'essai de phase 3 de confirmation, la resoumission du NDA et la préparation commerciale américaine; la clôture est prévue vers le 23 octobre 2025. Jusqu'à trois administrateurs désignés par les investisseurs seront ajoutés au conseil pour soutenir les opérations cliniques.
Minerva Neurosciences (Nasdaq: NERV) gab eine private Platzierung bekannt, die bis zu 200 Millionen US-Dollar Bruttoerlöse zur Weiterentwicklung von Roluperidone für negative Symptome der Schizophrenie liefert.
Die Finanzierung umfasst einen 80 Millionen US-Dollar upfront Series-A-Privatplatzierung, bis zu 80 Millionen US-Dollar aus Ausübungen von Tranche-A-Warrants und 40 Millionen US-Dollar abhängig von einem Meilenstein, der an die Barausübungen der Tranche-B-Warrants geknüpft ist. Minerva erklärt, dass die Mittel voraussichtlich die bestätigende Phase-3-Studie, die NDA-Wiedereinreichung und die US-kommerzielle Bereitschaft finanzieren sollen; der Abschluss wird voraussichtlich um den 23. Oktober 2025 erfolgen. Bis zu drei von Investoren designierte Direktoren werden dem Vorstand hinzugefügt, um die klinischen Operationen zu unterstützen.
Minerva Neurosciences (ناسداك: NERV) أعلنت عن طرح خاص يتيح حتى 200 مليون دولار من العوائد الإجمالية لتطوير roluperidone لعلاج الأعراض السلبية للفصام.
يشمل التمويل بيع أسهم مفضلة من الفئة A بمبلغ 80 مليون دولار مقدماً، حتى 80 مليون دولار من تمارين وارنز من فئة A، و40 مليون دولار مرتبطة بإنجاز معين مرتبط بتمارين وارن B. تقول مينيرفا إن العوائد من المتوقع أن تمول تجربة المرحلة الثالثة التأكيدية، وإعادة تقديم NDA والاستعداد التجاري في الولايات المتحدة؛ من المتوقع الإغلاق في نحو 23 أكتوبر 2025. سيُضاف حتى ثلاثة مديرين معينين من قبل المستثمرين إلى المجلس لدعم العمليات السريرية.
Minerva Neurosciences (纳斯达克：NERV) 宣布一项私募配售，预计将带来高达2亿美元的毛额资金，用于推进 roluperidone 在精神分裂症阴性症状治疗中的应用。
该融资包括一轮8000万美元的前期 Series A 优先股出售，来自 Tranche A 的认股权证行使最多可达 8000万美元，以及 4000万美元 将取决于与 Tranche B 认股权证现金行使相关的里程碑。Minerva 表示，资金预计用于资助确证性三期试验、NDA 重新提交和美国的商业就绪；预计在大约 2025年10月23日 完成交割。最多将增聘三名由投资者指定的董事加入董事会，以支持临床运营。
- Up to $200 million total financing capacity
- $80 million received upfront in Series A preferred stock
- Financing expected to fund confirmatory Phase 3 and NDA resubmission
- Board expansion: up to 3 investor‑designated directors
- Potential shareholder dilution from Series A preferred and warrants
- $40 million contingent financing depends on achieving a milestone
- Closing subject to customary conditions, expected ~Oct 23, 2025
Insights
Minerva raises structured capital and gains FDA alignment to fund a confirmatory Phase 3 and NDA resubmission, reducing near‑term execution risk.
What happens: The company secured
Dependencies and risks: Execution depends on successful trial conduct, timely exercise of warrants by investors, and maintaining the FDA alignment already described; costs could rise if the trial is upsized. Board additions with schizophrenia trial experience strengthen operational oversight but do not guarantee clinical success. The contingent
Near-term items to watch: confirmation of the closing on or about
- Minerva secures
$80 million up front and up to an additional$80 million subject to the full exercise of Tranche A warrants. - Minerva and the FDA have defined a path forward for roluperidone’s clinical development and NDA resubmission.
- Further
$40 million proceeds may be received in connection with cash exercise of Tranche B warrants contingent upon achievement of milestone event. With the proceeds of the financing and alignment with the FDA, Minerva is expected to be sufficiently funded through the confirmatory Phase 3 trial for roluperidone and the resubmission of its New Drug Application (NDA) to the FDA. - Up to three additional directors with significant schizophrenia clinical trial experience are expected to be appointed to the board of directors to further strengthen and support Minerva’s clinical operations team.
BURLINGTON, Mass., Oct. 21, 2025 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today announced that the Company has entered into a securities purchase agreement with certain institutional investors (the “Purchasers”) that will provide up to
In conjunction with the financing, Minerva will increase the size of its board of directors and will appoint up to three directors, expected to have significant schizophrenia clinical trial experience, designated by the investors to strengthen and support clinical operations management and the conduct of the confirmatory Phase 3 trial of roluperidone.
The closing of the private placement is expected to occur on or about October 23, 2025, subject to customary closing conditions.
This private placement follows the Company’s announcement in August of its alignment with the U.S. Food and Drug Administration (“FDA”) on the design of the confirmatory Phase 3 trial of roluperidone. The financing is led by Vivo Capital LLC, with participation from new and existing investors including Janus Henderson Investors, Federated Hermes Kaufmann Funds, Farallon Capital Management, Coastlands Capital, Balyasny Asset Management, Logos Capital, BSQUARED Capital, Trails Edge Capital Partners, Ally Bridge Group, Foresite Capital and Spruce Street Capital as well as several healthcare-focused funds, with Jefferies LLC acting as sole placement agent.
Minerva expects that the net proceeds of this private placement will be used to finance the confirmatory Phase 3 trial of roluperidone including upsizing the trial, preparation and resubmission of its NDA, the readiness of the commercial launch of roluperidone in the U.S., if approved, and for working capital and general corporate purposes.
“Minerva is developing roluperidone for the treatment of patients suffering from the negative symptoms of schizophrenia. We will now refocus all of our efforts on the successful execution of the confirmatory trial with the objective of demonstrating that roluperidone can effectively treat patients with impairing negative symptoms. I would like to thank the FDA for their engagement in defining a path forward for roluperidone’s development. Their guidance and advice, including the FDA Public Meeting in August 2024 has been invaluable. I would also like to thank our investors for their confidence in our ability to advance roluperidone and for providing the financial resources necessary to enable Minerva to conduct the confirmatory Phase 3 trial and, if successful make roluperidone available to millions of patients worldwide,” said Dr. Remy Luthringer, Chairman and Chief Executive Officer of Minerva.
About the Private Placement
Pursuant to the securities purchase agreement, Minerva is expected to issue to Purchasers (i) an aggregate of
- Tranche A warrants for an aggregate exercise price of
$80 million are immediately exercisable and may only be exercised for cash. Tranche A warrants will remain exercisable until ten days following the date on which Minerva publicly announces that it has achieved, on a statistically significant basis, the primary endpoint of its Phase 3 confirmatory trial of roluperidone in schizophrenia at the 12-week timepoint (the “Milestone Event”); and - Tranche B warrants for an aggregate cash exercise price of
$40 million will become exercisable upon the earlier of: (i) achievement of the Milestone Event and (ii) three years after the date of issuance of the Tranche B warrants. Tranche B warrants may be exercised by a cashless exercise and will expire on the four-year anniversary of the date of issuance of the Tranche B warrants. In addition, Tranche B warrants will be forfeited proportionally in the event of a sale of the shares of Series A Convertible Preferred Stock purchased at the closing, or of the shares of the Company’s common stock (the “Common Stock”) converted from such shares of Series A Convertible Preferred Stock.
Shares of Series A Convertible Preferred Stock will be issued at a price of
Upon completion of the private placement, the Purchasers have the right to appoint three additional members to Minerva’s board of directors. In addition, pursuant to the securities purchase agreement, Minerva will establish a Scientific Advisory Board (“SAB”) to provide oversight and support to the confirmatory Phase 3 trial of roluperidone.
The Company will file a proxy statement for, among other things, a vote of its stockholders to approve the issuance of common stock upon conversion of the Series A Preferred Stock. The securities to be sold in the private placement are being offered in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the “Act”), and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the Act. The Company has agreed to file a resale registration statement with the U.S. Securities and Exchange Commission (the “SEC”) for purposes of registering the resale of the Common Stock issuable in connection with the private placement.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
Design of the Confirmatory Phase 3 Trial
Consistent with the Company’s two previous clinical trials for roluperidone (C03 and C07), the confirmatory Phase 3 trial will include patients diagnosed with schizophrenia who present with stable impairing negative symptoms and stable positive symptoms for the six months prior to entering the trial. The FDA has confirmed that roluperidone can be studied in monotherapy, as in the two previous clinical trials (C03 & C07). The confirmatory Phase 3 trial will evaluate a 64 mg dose of roluperidone in a 1:1 randomized double-blind, placebo controlled study design. Previous studies (C03 & C07) tested both 32 mg and 64 mg doses of roluperidone.
The FDA also confirmed that the sole primary endpoint to assess efficacy would be the change from Baseline in PANSS Marder negative symptoms factor score (NSFS) at 12 weeks of treatment with roluperidone compared to placebo. Minerva agreed with FDA that best efforts will be made to secure 25
About Negative Symptoms of Schizophrenia
Schizophrenia is a complex and disabling psychiatric disorder that affects millions of adults worldwide imposing a substantial health, social, and economic burden. Symptoms of schizophrenia are described in terms of positive, negative and cognitive symptoms. Negative symptoms are extremely debilitating and ultimately prevent people from being able to live independently. Negative symptoms include blunted affect, alogia, avolition, anhedonia, and asociality. People suffering with impairing negative symptoms often require comprehensive care from healthcare systems and families and experience a reduced quality of life including significantly greater conceptual disorganization and psychosis, increased likelihood of hospitalization, poorer social functioning, pronounced social cognitive impairment, increased likelihood of unemployment or low-quality employment.
Approximately 50
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include, but are not limited to, statements herein with respect to implied or express statements regarding the aggregate amount of proceeds to be received from the private placement, the closing of the private placement, and the anticipated use of proceeds from the private placement; Minerva’s expected funding through the confirmatory Phase 3 trial for roluperidone and the resubmission of its NDA to the FDA; Minerva’s plans to refocus efforts on the successful execution of the Phase 3 trial; Minerva’s belief in roluperidone’s potential as a safe and effective therapy for the treatment of negative symptoms of schizophrenia and critical need and market opportunities for such treatment; the design and results of the contemplated Phase 3 trial; and the appointment of three additional directors with significant schizophrenia clinical trial experience. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, Minerva’s future financial performance and position may not improve, resulting in difficulties in implementing Minerva’s business strategy, and plans and objectives for future operations; the expected sufficiency of Minerva’s existing cash resources and runway may not be accurate resulting in the need for additional financing sooner than anticipated or unexpected liquidity constraints; the internal and external costs required for Minerva’s ongoing and planned activities, and the resulting impact on expense and use of cash, may be higher than expected, which may cause the company to use cash more quickly than expected or to change or curtail some of Minerva’s plans or both; trials and studies may be delayed and may not have satisfactory outcomes, and earlier trials and studies may not be predictive of later trials and studies; the design and rate of enrollment for clinical trials, including the current design of the Phase 3 confirmatory trial evaluating roluperidone may not enable successful completion of the trial(s); the commercial opportunity for roluperidone in negative symptoms of Schizophrenia may be smaller than anticipated; Minerva may be unable to obtain and maintain regulatory approvals; Minerva may experience uncertainties inherent in the initiation and completion of clinical trials and clinical development; the need to align with collaborators or partners may hamper or delay development and regulatory efforts or increase costs; uncertainties of patent protection and litigation; general economic conditions; and other factors that are described under the caption “Risk Factors” in Minerva’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on February 25, 2025, as updated by its Quarterly Report on Form 10-Q for the quarter ended June 30, 2025. Copies of reports filed with the SEC are posted on Minerva’s website at http://ir.minervaneurosciences.com/. The forward-looking statements in this press release are based on information available to the Company as of the date hereof, and the Company disclaims any obligation to update any forward-looking statements, except as required by law.
Contact:
Investor inquiries:
Frederick Ahlholm
Chief Financial Officer
Minerva Neurosciences, Inc.
info@minervaneurosciences.com
Media inquiries:
Helen Shik
Principal
Shik Communications LLC
helen@shikcommunications.com
FAQ
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