Minerva secures $80 million up front and up to an additional $80 million subject to the full exercise of Tranche A warrants.

密涅瓦公司 upfront 获得 8000 万美元，并且在完全行使 A 类权证的情况下，可能再获得高达 8000 万美元的资金。

Minerva and the FDA have defined a path forward for roluperidone’s clinical development and NDA resubmission.

米纳瓦和FDA已经为罗鲁哌酮的临床开发和NDA重新提交定义了前进的道路。

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..

可能还会收到与Tranche B认股权证现金行权相关的4000万美元收益，但需以达成里程碑事件为条件。通过此次融资的收益以及与FDA的协调，Minerva预计将获得充足的资金，用于支持roluperidone的确证性III期试验及其新药申请（NDA）向FDA的重新提交。

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.

预计还将任命多达三名具有丰富精神分裂症临床试验经验的董事加入董事会，以进一步加强和支持米涅瓦的临床运营团队。

BURLINGTON, Mass., Oct. 21, 2025 (GLOBE NEWSWIRE) --

马萨诸塞州伯灵顿，2025年10月21日（环球新闻社）--

Minerva Neurosciences, Inc.

米内尔瓦神经科学公司

(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 $200 million in gross proceeds, before deducting placement agent fees and other expenses, to Minerva through a private placement that includes initial upfront funding of $80 million in exchange for shares of the Company’s Series A preferred stock, par value $0.0001 per share (the “Series A Convertible Preferred Stock”) and up to an additional $80 million in gross proceeds if all Tranche A warrants are exercised, subject to the terms and conditions specified therein.

(Nasdaq: NERV)（“公司”），一家专注于开发治疗中枢神经系统疾病疗法的临床阶段生物制药公司，今天宣布公司已与某些机构投资者（“买方”）签订了一份证券购买协议。根据该协议，通过私募方式，公司将获得高达2亿美元的总收益，其中包含扣除配售代理费用及其他开支前的8,000万美元初始前期资金，用于购买公司票面价值为每股0.0001美元的A系列优先股（“A系列可转换优先股”）。若所有Tranche A认股权证被行使，还将额外获得最高8,000万美元的总收益，具体取决于协议中规定的条款和条件。

Additional proceeds of $40 million may be received if all Tranche B warrants are exercised by cash payment upon the achievement of milestone event as further described below..

如果所有B类认股权证在达成如下所述的里程碑事件后通过现金支付方式行使，可能会收到额外的4000万美元收益。

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..

与融资同时进行的是，弥涅耳瓦将扩大其董事会的规模，并将任命多达三名董事，预计这些董事将具有显著的精神分裂症临床试验经验，由投资者指派，以加强和支持临床运营管理以及 roluperidone 的确证性 III 期试验的开展。

The closing of the private placement is expected to occur on or about October 23, 2025, subject to customary closing conditions.

私人配售的完成预计将在2025年10月23日左右进行，但需符合惯例的交割条件。

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..

本次定向增发是在公司八月份宣布与美国食品药物管理局（“FDA”）就roluperidone确证性III期试验设计达成一致之后进行的。本轮融资由Vivo Capital LLC领投，新投资者和现有投资者参与，包括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和Spruce Street Capital，以及多家专注于医疗保健的基金，Jefferies LLC担任唯一的配售代理。

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..

米内尔瓦预计，此次私募的净收益将用于资助罗鲁吡酮的确证性第三阶段试验，包括扩大试验规模、准备和重新提交其新药申请、在美国推出罗鲁吡酮的商业准备（如果获得批准的话），以及用于营运资金和一般公司用途。

“

“

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.

米内尔瓦公司正在开发roluperidone，用于治疗遭受精神分裂症阴性症状的患者。现在，我们将重新集中所有精力于确证性试验的成功执行，目标是证明roluperidone能有效治疗有损害性的阴性症状患者。

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.

我要感谢FDA积极参与确定roluperidone开发的前进路径。他们的指导和建议，包括2024年8月的FDA公开会议，都具有不可估量的价值。我还要感谢我们的投资者，他们对我们推动roluperidone发展的能力充满信心，并提供了必要的财务资源，使Minerva能够进行确证性的第三阶段试验，并在成功后将roluperidone带给全球数百万患者。

,” said Dr. Remy Luthringer, Chairman and Chief Executive Officer of Minerva.

”，Minerva的董事长兼首席执行官雷米·卢特林格博士说。

About the Private Placement

关于私募 placement

Pursuant to the securities purchase agreement, Minerva is expected to issue to Purchasers (i) an aggregate of $80 million in shares of its Series A Convertible Preferred Stock and (ii) two tranches of warrants that are exercisable for shares of the Company’s Series A Convertible Preferred Stock as follows:.

根据证券购买协议，Minerva预计将向买方发行 (i) 总计8000万美元的A系列可转换优先股，以及 (ii) 两个部分的认股权证，这些认股权证可行使以获得公司的A系列可转换优先股，具体如下：

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.

A类认股权证的总行权价格为8000万美元，可立即行权且仅能以现金方式行权。A类认股权证将持续有效，直至Minerva公开宣布其在精神分裂症roluperidone的三期确证性试验中，在12周时间点上基于统计学显著性达成主要终点后的第十天（“里程碑事件”）为止。

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.

Tranche B认股权证的总现金行权价格为4000万美元，将在以下两种情况中较早发生时可行权：(i) 达到里程碑事件；(ii) 自Tranche B认股权证发行之日起三年后。Tranche B认股权证可通过无现金行权方式行使，并将于Tranche B认股权证发行之日起四周年到期。

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..

此外，如果在出售于交割时购买的A系列可转换优先股或由此类A系列可转换优先股转换的公司普通股（“普通股”）的情况下，B类分期认股权证将按比例被没收。

Shares of Series A Convertible Preferred Stock will be issued at a price of $1,000.00 per share (the “Original Per Share Price”). Conversion of the Series A Convertible Preferred Stock into shares of Common Stock is subject to approval by the Company’s stockholders. Each share of Series A Preferred Stock will be convertible into a number of shares of Common Stock obtained by dividing the Original Per Share Price by $2.11 (the “Conversion Price”)..

A系列可转换优先股的股票将以每股1,000.00美元的价格发行（“原始每股价格”）。A系列可转换优先股转换为普通股须经公司股东批准。每股A系列优先股可转换为通过将原始每股价格除以2.11美元（“转换价格”）得出的普通股股数。

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..

在私募配售完成后，购买者有权任命三名额外成员加入米涅尔瓦的董事会。此外，根据证券购买协议，米涅尔瓦将设立一个科学顾问委员会（“SAB”），为罗鲁吡酮的确认性第三阶段试验提供监督和支持。

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.

公司将就包括股东投票批准在A系列优先股转换时发行普通股等事项提交委托书声明。本次私募中出售的证券是在不涉及公开发行的交易中提供的，且尚未根据修订后的《1933年证券法》（“该法案”）进行注册，除非依据有效的注册声明或适用的法案豁免，否则不得在美国境内发售或销售。

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..

公司已同意向美国证券交易委员会（“SEC”）提交转售登记声明，以注册与私募发行相关的可发行普通股的转售。

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..

本新闻稿不构成出售这些证券的要约或购买这些证券的要约邀请，也不应在任何州或其他司法管辖区进行这些证券的销售，因为在这些州或其他司法管辖区，此类要约、邀请或销售在根据任何此类州或其他司法管辖区的证券法进行注册或资格确认之前是非法的。

Design of the Confirmatory Phase 3 Trial

确证性III期试验的设计

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.

与公司之前进行的两次roluperidone（C03和C07）临床试验一致，确认性的第三阶段试验将包括在入组前六个月内出现稳定的功能损害性阴性症状和稳定阳性症状的精神分裂症患者。

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..

美国食品药品监督管理局（FDA）已确认，如同之前的两项临床试验（C03 和 C07）一样，roluperidone 可以作为单一疗法进行研究。验证性的第三阶段试验将采用 1:1 随机双盲、安慰剂对照的研究设计，评估 roluperidone 64 毫克的剂量。先前的研究（C03 和 C07）测试了 roluperidone 的 32 毫克和 64 毫克剂量。

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 25-30% of patients from the U.S., subject to competitive recruitment.

FDA 还确认，评估疗效的唯一主要终点将是与安慰剂相比，roluperidone 治疗 12 周时 PANSS Marder 阴性症状因子评分（NSFS）从基线的变化。Minerva 同意 FDA 的意见，将尽最大努力确保 25-30% 的患者来自美国，但需视竞争性招募情况而定。

The FDA and Minerva have agreed that, to support a monotherapy indication, they will assess relapses of positive symptoms on an observational basis for at least 52 weeks in patients treated in monotherapy with roluperidone, placebo or antipsychotics. The FDA stated it would consider a resubmission of the NDA that included a double-blind, placebo- or active-controlled trial of roluperidone with a duration of at least 52 weeks with the efficacy primary endpoint at week 12..

FDA和Minerva已达成一致，为支持单药治疗的适应症，他们将对接受roluperidone、安慰剂或抗精神病药物单药治疗的患者，基于观察至少52周的时间来评估阳性症状的复发情况。FDA表示，会考虑重新提交包含一项双盲、安慰剂或活性对照的roluperidone试验的NDA申请，该试验持续时间至少为52周，主要疗效终点在第12周。

About Negative Symptoms of Schizophrenia

关于精神分裂症的阴性症状

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.

精神分裂症是一种复杂且致残的精神疾病，影响着全球数百万成年人，给健康、社会和经济带来了沉重的负担。精神分裂症的症状分为阳性症状、阴性症状和认知症状。阴性症状极其致残，最终会阻止患者独立生活的能力。

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..

阴性症状包括情感淡漠、言语贫乏、意志减退、快感缺失和社交退缩。遭受严重阴性症状困扰的患者通常需要医疗系统和家庭的全面照料，其生活质量显著下降，表现为更严重的思想紊乱和精神病症状、住院可能性增加、社交功能较差、显著的社会认知障碍、失业或低质量就业的可能性增加等。

Approximately 50-60% of people living with schizophrenia experience at least one primary/disease related negative symptom. Although antipsychotics have been shown to reduce positive symptoms (i.e., delusions and hallucinations) and can reduce secondary negative symptoms (i.e., the negative symptoms associated with psychosis, delusions and treatment with antipsychotics) the primary negative symptoms (i.e., fundamental to the disease) do not respond to antipsychotics.

大约50-60%的精神分裂症患者会经历至少一种主要的或与疾病相关的阴性症状。尽管抗精神病药物已被证明可以减轻阳性症状（即，妄想和幻觉），并能减轻继发性阴性症状（即，与精神病、妄想和抗精神病药物治疗相关的阴性症状），但主要的阴性症状（即，疾病的根本特征）对抗精神病药物没有反应。

While several antipsychotics are approved by the FDA for the treatment of schizophrenia, none are specifically approved to treat negative symptoms, which the FDA has acknowledged is currently an unmet medical need..

虽然FDA批准了几种抗精神病药物用于治疗精神分裂症，但没有一种特别被批准用于治疗阴性症状，而FDA也承认目前这方面存在未满足的医疗需求。

Forward-Looking Safe Harbor Statement

前瞻性安全港声明

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.

本新闻稿包含前瞻性声明，这些声明受1995年《私人证券诉讼改革法案》（经修订）的避风港条款保护。前瞻性声明不是历史事实，而是反映管理层截至本新闻稿发布日期的预期，并涉及某些风险和不确定性。

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.

前瞻性声明包括但不限于本文中关于以下方面的明示或暗示声明：私募发行的总收益金额、私募发行的完成情况以及私募发行收益的预期用途；Minerva预计通过roluperidone的确证性III期试验及其向FDA重新提交NDA的资金支持；Minerva计划重新集中精力成功执行III期试验；Minerva对roluperidone作为治疗精神分裂症阴性症状的安全有效疗法潜力的信念，以及对此类治疗的关键需求和市场机会；计划中的III期试验的设计与结果；以及任命三名具有丰富精神分裂症临床试验经验的董事。

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 .

这些前瞻性陈述基于我们当前的预期，但由于多种因素，实际结果可能与此存在重大差异，这些因素包括但不限于：Minerva未来的财务表现和状况可能无法改善，从而导致在实施Minerva的业务战略、计划及未来运营目标时遇到困难；Minerva现有现金资源和资金周转期的预期充足性可能不准确，导致需要比预期更早进行额外融资或出现意外的流动性问题。

December 31, 2024, filed with the

2024年12月31日，提交给

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

证券交易委员会于2025年2月25日更新，其截至2025年6月30日的季度的10-Q表季度报告。向其提交的报告副本

SEC

证券交易委员会

are posted on Minerva’s website at

发布在密涅瓦网站上

http://ir.minervaneurosciences.com/

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.

本新闻稿中的前瞻性陈述基于公司截至本日可获得的信息，公司不承担更新任何前瞻性陈述的义务，除非法律要求。

Contact

联系

:

：

Investor inquiries:

投资者询问：

Frederick Ahlholm

弗雷德里克·阿霍姆

Chief Financial Officer

首席财务官

Minerva Neurosciences, Inc.

米内尔瓦神经科学公司

info@minervaneurosciences.com

info@minervaneurosciences.com

Media inquiries:

媒体询问：

Helen Shik

海伦·希克

Principal

校长

Shik Communications LLC

四克通讯有限责任公司

helen@shikcommunications.com

海伦@shikcommunications.com