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Minerva Neurosciences, Inc. (NERV): Business Model Canvas [Dec-2025 Updated] |
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Minerva Neurosciences, Inc. (NERV) Bundle
You're looking at a biotech that's sitting on a potential first-in-class treatment for schizophrenia's most stubborn negative symptoms, but the entire enterprise rests on one critical, FDA-mandated 52-week Phase 3 trial for roluperidone. Honestly, the recent financing-a potential $200 million haul, starting with $80 million in the bank-is the fuel for this high-stakes run, which is why their Key Activities are all about execution and cash management right now. This canvas distills exactly how Minerva Neurosciences, Inc. is deploying that capital, who their key partners are, and the stark reality of their zero-revenue streams as they chase that future approval. Keep reading to see the full strategic map.
Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Key Partnerships
You're looking at the core relationships Minerva Neurosciences, Inc. (NERV) relies on to push roluperidone toward a potential U.S. commercial launch. These partnerships are critical, especially following the major capital infusion in late 2025.
Institutional Investors Providing up to $200 million in Financing
Minerva Neurosciences, Inc. locked in a significant lifeline with a securities purchase agreement announced on October 21, 2025, which could yield up to $200 million in gross proceeds from institutional investors. This deal is what funds the next big push. Honestly, without this, the Phase 3 plan would look very different.
The structure of this financing is key to understanding the immediate cash runway. You get upfront cash, with more contingent on warrant exercises. The closing of this private placement was expected on or about October 23, 2025.
Here's the quick math on that capital raise:
| Financing Component | Potential Gross Proceeds | Status/Condition |
|---|---|---|
| Upfront Funding | $80 million | Received in exchange for Series A Convertible Preferred Stock |
| Tranche A Warrants | Up to $80 million | Immediately exercisable for cash |
| Tranche B Warrants | Up to $40 million | Exercisable upon achievement of a milestone event |
The investors leading this round include Vivo Capital LLC, with participation from Janus Henderson Investors, Federated Hermes Kaufmann Funds, Farallon Capital Management, and others. In conjunction with this financing, Minerva agreed to increase its board size and appoint up to three directors designated by the investors to bolster clinical operations management for the confirmatory Phase 3 trial.
Janssen Pharmaceutica NV for Seltorexant Co-development
Minerva Neurosciences, Inc. previously co-developed seltorexant with Janssen Pharmaceutica NV for insomnia disorder and as an adjunctive treatment for Major Depressive Disorder (MDD). However, Minerva exercised its right to opt out of the joint development agreement in 2020. This move eliminated Minerva's financial obligations to Janssen for the substantial Phase 3 program, which was estimated to save the company about $40 million in Phase 3 development costs in 2020, according to one analyst estimate at the time. That's a defintely significant cost avoidance.
The current relationship is purely financial, based on past work. Minerva is entitled to collect royalties, and its interest in those future payments was sold off.
- Royalty Rate Retained (Pre-Sale): Mid-single digits on potential future worldwide sales of seltorexant in certain indications.
- Financial Obligation to Janssen Post-Opt-Out: Zero.
- Royalty Interest Sale: Minerva sold its royalty interest to Royalty Pharma plc in January 2021.
- Royalty Sale Proceeds (to Minerva): An upfront payment of $60 million and up to an additional $95 million in potential milestone payments.
Janssen is currently conducting Phase 3 studies for seltorexant, and any future milestone payments to Minerva are contingent on those clinical, regulatory, and commercialization achievements by Janssen.
Key Opinion Leaders (KOLs) and Clinical Sites for Patient Recruitment
The success of the confirmatory Phase 3 trial for roluperidone hinges on effective patient recruitment. The FDA and Minerva agreed that best efforts will be made to secure 25-30% of patients from the U.S. for the study. This implies a reliance on established clinical sites and KOLs with access to the target patient population for the negative symptoms of schizophrenia.
The partnership with the investors also directly impacts this area, as they designated directors with significant schizophrenia clinical trial experience to support clinical operations management and the conduct of this trial.
Clinical Research Organizations (CROs) for the New Phase 3 Trial
While the $200 million financing is explicitly earmarked to finance the confirmatory Phase 3 trial of roluperidone, including upsizing the trial, specific financial terms or names of the Clinical Research Organizations (CROs) managing the trial execution are not publicly detailed in the late 2025 financial disclosures available.
Specialized Contract Manufacturers for Drug Substance and Product
Minerva Neurosciences, Inc. is focused on advancing roluperidone through clinical trials and preparing for a potential U.S. commercial launch. While the company is managing a drug substance validation campaign, the specific partnerships with specialized contract manufacturers for ongoing drug substance and finished product supply are not quantified with specific financial amounts or contract values in the latest public filings.
Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Key Activities
Executing the FDA-mandated 52-week confirmatory Phase 3 trial for roluperidone is a primary activity, following alignment with the U.S. Food and Drug Administration (FDA) on the trial design in August 2025.
- The trial is a 52-week confirmatory Phase 3 study.
- The study evaluates a 64 mg dose of roluperidone.
- The design is 1:1 randomized double-blind, placebo controlled.
- The sole primary endpoint is the change from Baseline in PANSS Marder negative symptoms factor score (NSFS) at 12 weeks.
- Minerva agreed with the FDA to make best efforts to secure 25-30% of patients from the U.S.
- To support a monotherapy indication, relapse assessment on an observational basis for at least 52 weeks is necessary.
Ongoing regulatory interactions and New Drug Application (NDA) resubmission planning is directly tied to the Phase 3 trial success. The financing secured in October 2025 is specifically earmarked to finance the confirmatory Phase 3 trial, preparation and resubmission of the NDA to the FDA.
Managing cash runway and securing additional funding via warrants was a critical activity, culminating in a major capital raise in late 2025.
| Financing Component | Amount / Terms | Date / Status |
| Total Potential Gross Proceeds | Up to $200 million | Announced October 21, 2025 |
| Initial Upfront Funding | $80 million gross proceeds | Received on October 23, 2025 |
| Series A Preferred Stock Issued | 80,000 shares at $1,000 per share | Part of the upfront funding |
| Tranche A Warrants Potential | Up to an additional $80 million | Exercisable upon public announcement of statistically significant Phase 3 primary endpoint at 12 weeks |
| Tranche B Warrants Potential | Additional $40 million | Contingent upon achievement of the Phase 3 primary endpoint milestone |
| Cash Position (Q3 End) | Approximately $12.4 million | As of September 30, 2025 |
| Cash Position (Year End 2024) | $21.5 million | As of December 31, 2024 |
Research and development for pipeline candidates like MIN-301 for Parkinson's disease is currently secondary to roluperidone. Minerva holds the exclusive global rights to MIN-301, which is in preclinical development for Parkinson's disease, but its development has been deferred until additional resources are available.
The financial impact of focused R&D on roluperidone versus the prior year is evident in the expense reporting for the nine months ended September 30, 2025.
- R&D Expense (Nine Months Ended Sept 30, 2025): $3.6 million
- R&D Expense (Nine Months Ended Sept 30, 2024): $9.9 million
- R&D Expense (Three Months Ended Sept 30, 2025): $0.9 million
General and administrative oversight of a small, focused team is reflected in the G&A expense figures for 2025, which showed a reduction compared to 2024, though expenses are anticipated to increase as clinical work ramps up.
| G&A Expense Period | Amount (2025) | Amount (2024) |
| Three Months Ended September 30 | $1.9 million | $2.5 million |
| Nine Months Ended September 30 | $6.5 million | $7.4 million |
The team structure is being reinforced to support clinical operations, as evidenced by the governance change associated with the October 2025 financing.
- Up to three additional directors with significant schizophrenia clinical trial experience are expected to be appointed to the board of directors.
Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Key Resources
When you look at the core assets Minerva Neurosciences, Inc. (NERV) relies on to drive its business, it really boils down to intellectual property, financial runway, and the people who can navigate the FDA process. These are the things that keep the lights on and the clinical trials moving forward.
Roluperidone (MIN-101) Intellectual Property and Clinical Data
The primary asset is the intellectual property surrounding roluperidone, specifically targeting the negative symptoms of schizophrenia. You know the FDA issued a Complete Response Letter (CRL) back in February 2024, which was a major hurdle. Anyway, the key resource now is the data supporting the path forward agreed upon with the FDA. The FDA confirmed that an additional confirmatory clinical trial is required to address those earlier deficiencies.
However, there's a strategic angle here: the FDA agreed that if Minerva Neurosciences, Inc. can provide robust, controlled data on long-term monotherapy efficacy and safety, an adjunctive trial with other antipsychotics won't be necessary for resubmission. This simplifies the path significantly.
- Lead indication: Negative symptoms of schizophrenia.
- Confirmatory Phase 3 trial design: Will evaluate a 64 mg dose.
- Primary endpoint: Change from Baseline in PANSS Marder negative symptoms factor score at 12 weeks compared to placebo.
Cash, Cash Equivalents, and Restricted Cash, Significantly Boosted by the $80 million Upfront Financing
Liquidity is always a top concern for a clinical-stage company, so this recent financing event is a massive resource injection. On October 21, 2025, Minerva Neurosciences, Inc. announced a securities purchase agreement that included an initial upfront funding of $80 million. This financing is intended to fund the confirmatory Phase 3 trial, NDA resubmission, and preparation for a potential U.S. commercial launch.
To be fair, the cash position was leaner before this. You can see the burn rate reflected in the balance sheet leading up to the closing of this deal, which was expected around October 23, 2025. Here's the quick math on the cash position as of the last reported quarter before the financing closed:
| Date | Cash, Cash Equivalents, and Restricted Cash (Approximate) |
| September 30, 2025 (Q3 2025) | $12.4 million |
| June 30, 2025 (Q2 2025) | $15.3 million |
| March 31, 2025 (Q1 2025) | $17.4 million |
| December 31, 2024 (Year End) | $21.5 million |
The total potential gross proceeds from this private placement are up to $200 million, which includes the $80 million upfront, an additional $80 million if Tranche A warrants are exercised, and a further $40 million upon achievement of a milestone event for Tranche B warrants.
Experienced CNS Drug Development and Regulatory Affairs Team
The expertise of the team is a non-financial but critical resource, especially when dealing with the FDA after a CRL. The company is actively strengthening this area as part of the financing agreement. Investors are putting money in based on their confidence in the team's ability to execute the new trial protocol and resubmit the New Drug Application (NDA).
The governance structure is being reinforced to support the next phase of development.
- New directors: Up to three directors with significant schizophrenia clinical trial experience expected to be appointed.
- Board appointment: Dr. Inderjit Kaul joined the Board and will consult on roluperidone development.
- Scientific oversight: The company will establish a Scientific Advisory Board to oversee the confirmatory trial.
Exclusive Rights to Roluperidone for Negative Symptoms of Schizophrenia
Minerva Neurosciences, Inc. holds the exclusive rights to develop and commercialize roluperidone for this specific indication. This exclusivity is the foundation of the company's near-term value proposition. Beyond roluperidone, the company also controls the exclusive rights to MIN-301, which is being developed for Parkinson's disease and other neurodegenerative disorders.
Nasdaq Listing Compliance, Regained in March 2025
Maintaining a listing on the Nasdaq Capital Market is essential for access to capital markets and investor visibility. Minerva Neurosciences, Inc. was formally notified by Nasdaq on March 17, 2025, that it had regained compliance with Listing Rule 5550(b)(3). This followed an extension granted after previous non-compliance issues.
This compliance status is not permanent yet, though. The company will remain listed but is now subject to a one-year monitoring period that ends on March 17, 2026. You need to watch that date closely; it means they must maintain compliance with all listing standards through that date.
Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Value Propositions
You're looking at a product, roluperidone, aimed squarely at a population where current treatments leave significant gaps. The value proposition centers on addressing the persistent negative symptoms of schizophrenia, which existing therapies often fail to manage effectively.
Potential first-in-class treatment for negative symptoms of schizophrenia
Minerva Neurosciences, Inc. is developing roluperidone specifically for patients suffering from the negative symptoms of schizophrenia, for which there are currently no approved treatment options in the United States, representing a major unmet need. The market context shows that globally, more than 24 million people are affected by schizophrenia, with 50% of patients in mental hospitals having the condition. The global schizophrenia drugs market size was estimated at $6.06 billion in 2025.
The company has secured significant capital to push this forward, announcing financing of up to $200 million in gross proceeds in October 2025 to advance the Phase 3 confirmatory trial and prepare for a potential US commercial launch. This financial backing underscores the perceived value of a successful first-in-class therapy.
Here's a snapshot of the financial context supporting the development:
| Metric | Value as of Q3 2025 / Recent Event |
| Upfront Private Placement Proceeds (Oct 2025) | $80 million |
| Total Potential Financing | Up to $200 million |
| Cash, Cash Equivalents, Restricted Cash (Sep 30, 2025) | Approx. $12.4 million |
| Net Loss (Three Months Ended Sep 30, 2025) | $2.7 million |
Roluperidone's distinct mechanism, avoiding dopamine receptor antagonism
The core differentiation for roluperidone lies in its receptor profile, which is designed to target pathways believed to regulate negative symptoms without the typical side effects associated with dopamine receptor blockade. Roluperidone is a novel compound that acts as an antagonist at several receptors.
The specific receptor targets include:
- Antagonistic properties for serotoninergic 5-HT2A receptors.
- Antagonistic properties for sigma2 receptors.
- Antagonistic properties for $\alpha_{1A}$-adrenergic receptors, and to a lesser extent, $\alpha_{1B}$-adrenergic receptors.
Critically, roluperidone has no affinity for DA (dopamine), cholinergic, or histaminergic receptors, which sets it apart from many existing antipsychotics. Pre-clinical data also suggest an effect on neuroplasticity, as in vitro studies showed roluperidone increased brain-derived neurotrophic factor (BDNF) release by astrocytes and hippocampal neurons.
Offering a new therapeutic option for a high unmet medical need population
The negative symptoms of schizophrenia-like asociality, anhedonia, alogia, avolition, and blunted affect-are lifelong, debilitating issues that current standard-of-care antipsychotics, which primarily target positive symptoms via dopamine antagonism, often aggravate or fail to treat. The fact that the FDA confirmed the requirement for a new confirmatory trial focusing on patients with impairing negative symptoms and stable positive symptoms underscores the high bar for this specific indication.
The clinical trial design reflects this focus on a specific, underserved group. The required confirmatory Phase 3 trial will evaluate a 64 mg dose of roluperidone against placebo, with the sole primary endpoint being the change from Baseline in PANSS Marder negative symptoms factor score (NSFS) at 12 weeks of treatment. This precise targeting of a specific symptom domain, which is poorly addressed by the dominant drug class (second-generation antipsychotics held a 73.05% revenue share in 2024), is a key value driver.
A non-antipsychotic monotherapy approach for stable patients
A significant part of the value proposition is the potential for roluperidone to be used as a monotherapy, meaning it could be used alone rather than as an add-on to existing antipsychotic medication. The FDA has confirmed that roluperidone can be studied in monotherapy where patients would receive a double-blinded single daily 64 mg dose of roluperidone or placebo. This contrasts with many previous trials for negative symptoms that used an add-on design, which can confound results.
Furthermore, previous clinical trials (C03 and C07) showed that roluperidone administered as monotherapy to patients suffering from mild to moderate negative symptoms and withdrawal from antipsychotic drugs improved those symptoms. The FDA also advised that, to support a monotherapy indication, it would be necessary to assess relapses on an observational basis for at least 52 weeks in patients treated in monotherapy with roluperidone, placebo or antipsychotics. This focus on a non-antipsychotic monotherapy option for stable patients offers a distinct clinical pathway, defintely something to watch as they move toward NDA resubmission.
Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Customer Relationships
You're looking at how Minerva Neurosciences, Inc. manages its critical external relationships as it navigates the late-stage clinical and regulatory path for roluperidone. This is all about managing expectations and securing the path to market.
High-touch, direct communication with the U.S. Food and Drug Administration (FDA)
The relationship with the FDA is defined by the need to satisfy requirements following the Complete Response Letter (CRL) received for the New Drug Application (NDA). Minerva Neurosciences has had multiple interactions with the FDA following the CRL receipt in February 2024. The FDA has confirmed the requirement for an additional confirmatory clinical trial. The FDA advised that to support a monotherapy indication, it would be necessary to assess relapses on an observational basis for at least 52 weeks in patients treated in monotherapy with roluperidone, placebo or antipsychotics. Minerva agreed with the FDA that best efforts will be made to secure 25-30% of patients from the USA for this mandated trial. The primary endpoint confirmed by the FDA is the change from Baseline in PANSS Marder negative symptoms factor score (NSFS) at 12 weeks of treatment.
Intensive investor relations to maintain confidence during clinical stage
Investor engagement focuses on transparency regarding the regulatory path and financial runway. For the nine months ended September 30, 2025, Minerva Neurosciences reported a net loss of $9.8 million. The net loss for the three months ended September 30, 2025, was $2.7 million, translating to a basic and diluted net loss per share of $0.36. The cash position, cash equivalents and restricted cash at September 30, 2025, stood at approximately $12.4 million, down from $21.5 million at December 31, 2024. To bolster operations, the Company received $80 million in gross proceeds in a private placement on October 23, 2025, before fees. This financing structure includes potential for up to an additional $80 million if all Tranche A warrants are exercised, plus another $40 million if all Tranche B warrants are exercised upon the achievement of the Phase 3 trial primary endpoint. The current average analyst rating on the company's shares is 'hold,' with no 'strong buy' or 'buy' recommendations, and no 'sell' or 'strong sell' recommendations.
Professional engagement with clinical trial investigators and sites
The engagement with clinical sites is centered on executing the FDA-mandated study. The required confirmatory clinical trial will include patients diagnosed with schizophrenia who present with impairing negative symptoms and stable positive symptoms for the six months prior to entering the trial. The trial design requires assessment of relapses on an observational basis for at least 52 weeks for monotherapy indications. Research and development (R&D) expense for the three months ended September 30, 2025, was $0.9 million, compared to $1.9 million for the same period in 2024. For the nine months ended September 30, 2025, R&D expense was $3.6 million, down from $9.9 million for the nine months ended September 30, 2024.
Here's a look at the operating expense trend related to these activities:
| Expense Category (3 Months Ended Sep 30, 2025) | Amount (in millions USD) | Expense Category (9 Months Ended Sep 30, 2025) | Amount (in millions USD) |
| Research and Development (R&D) | $0.9 | Research and Development (R&D) | $3.6 |
| General and Administrative (G&A) | $1.9 | General and Administrative (G&A) | $6.5 |
Future direct sales force and medical science liaison (MSL) team (if approved)
The Chairman and CEO indicated plans to prepare for a commercial launch in the US, if roluperidone receives approval. The company anticipates having sufficient funds for the Phase 3 study, NDA resubmission, and to prepare for this commercial launch.
- Minerva Neurosciences has not generated any revenue from the sales or license of any product candidates.
- The company is also developing MIN-301 for Parkinson's disease.
- Seltorexant, co-developed with Janssen Pharmaceutica NV, is currently in Phase 3 trials being conducted by Janssen.
Finance: review cash burn projections based on the $12.4 million cash balance as of September 30, 2025, against the anticipated costs for the Phase 3 study by Wednesday.
Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Channels
You're looking at how Minerva Neurosciences, Inc. gets its data, talks to regulators, and plans to get its product, roluperidone, to market. It's all about execution on the Phase 3 trial and the subsequent regulatory filing.
Clinical trial sites for data generation and regulatory submission
The primary channel for generating the data required for regulatory submission is the confirmatory Phase 3 clinical trial for roluperidone in schizophrenia with negative symptoms. The FDA has confirmed the requirements for this trial to support the New Drug Application (NDA) resubmission.
The design parameters for this critical data generation channel include:
- Trial duration: at least 52 weeks for observational assessment of relapses of positive symptoms.
- Efficacy primary endpoint: change from Baseline in PANSS Marder negative symptoms factor score (NSFS) at Week 12.
- Patient recruitment target: best efforts to secure 25-30% of patients from the U.S., subject to competitive recruitment.
This entire clinical operation is being funded by recent capital raises, which is a key enabler for this channel.
Direct regulatory pathway to the FDA for NDA resubmission
The direct channel to the U.S. Food and Drug Administration (FDA) is currently defined by the agreement on the confirmatory trial needed to address deficiencies cited in the Complete Response Letter (CRL) received in February 2024. Minerva Neurosciences, Inc. expects to be sufficiently funded through this trial and the subsequent NDA resubmission.
Here's a look at the financial backing directly supporting this regulatory path as of late 2025:
| Financing Component | Amount (Gross Proceeds) | Status/Condition |
| Upfront Funding (October 2025) | $80 million | Received in exchange for Series A Convertible Preferred Stock. |
| Tranche A Warrants Exercise | Up to an additional $80 million | Subject to exercise terms and conditions. |
| Tranche B Warrants Exercise | Additional $40 million | Contingent upon achievement of a specified milestone event. |
| Total Potential Gross Proceeds | Up to $200 million | To finance the Phase 3 trial and NDA resubmission. |
The cash position as of September 30, 2025, was approximately $12.4 million, following the upfront financing, though this was down from $21.5 million at December 31, 2024.
Future pharmaceutical wholesalers and specialty pharmacies for distribution
Minerva Neurosciences, Inc. is preparing for a potential commercial launch in the U.S., contingent upon FDA approval following the NDA resubmission. The financing secured is explicitly earmarked to prepare for this future distribution channel.
The preparation for commercial launch is part of the intended use of proceeds from the private placement, which secured an initial upfront funding of $80 million on or about October 23, 2025. Minerva has not disclosed specific agreements with pharmaceutical wholesalers or specialty pharmacies as of late 2025, as this is a pre-approval activity.
Scientific publications and conferences to reach CNS specialists
Reaching CNS specialists is a vital channel for establishing scientific credibility and awareness for roluperidone and MIN-301. This is achieved through dissemination of trial data and corporate updates.
Recent communication milestones serving as channels include:
- Reporting Third Quarter 2025 Financial Results on November 5, 2025.
- Announcing the appointment of Dr. Inderjit Kaul to the Board of Directors on November 19, 2025.
- The company has not received any regulatory approvals to commercialize its product candidates and has not generated any revenue from the sales or license of any product candidates.
The company's commitment is to provide investors access to news regarding product development programs, which inherently supports the scientific communication channel.
Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Customer Segments
You're looking at the core groups Minerva Neurosciences, Inc. (NERV) targets right now, as they push roluperidone through its final development stages. This isn't about the general population; it's highly specific, which is typical for a clinical-stage biopharma firm this late in the game.
Schizophrenia patients with impairing negative symptoms and stable positive symptoms
This is the ultimate end-user segment for roluperidone. The FDA alignment specifies the exact profile needed for the confirmatory Phase 3 trial. The trial design itself gives us concrete numbers about the target patient pool's required characteristics.
- Target patient diagnosis: Schizophrenia with impairing negative symptoms and stable positive symptoms.
- Required U.S. patient enrollment in the Phase 3 trial: Best efforts to secure 25-30% of patients from the USA.
- Dosing evaluated in the confirmatory trial: A single daily dose of 64 mg of roluperidone or placebo.
The company is defintely focused on demonstrating efficacy on the PANSS Marder negative symptoms factor score (NSFS) at the 12-week timepoint for this specific group.
CNS specialists and psychiatrists treating schizophrenia
While Minerva Neurosciences, Inc. isn't selling yet, this segment represents the key prescribers and gatekeepers for future adoption. The company is already strengthening its clinical operations team by planning to appoint up to three new directors with significant schizophrenia clinical trial experience, designated by the investors supporting the development.
- Investor-designated board appointments: Up to 3 new directors with significant schizophrenia clinical trial experience.
- The focus for these specialists is treating the unmet need represented by negative symptoms, which previous studies showed improvement in with the 64 mg dose over a one-year period.
Institutional and accredited investors funding the clinical development stage
This segment is crucial for Minerva Neurosciences, Inc.'s survival and progress, providing the capital needed to run the confirmatory trial and prepare for a potential launch. The recent financing event in October 2025 was a major influx for this purpose.
Here's a quick math on the October 2025 financing structure:
| Funding Component | Amount (Gross Proceeds) | Trigger/Condition |
| Upfront Funding | $80 million | Closing of the private placement (received October 23, 2025) |
| Tranche A Warrants | Up to $80 million | Exercise of all Tranche A warrants |
| Tranche B Warrants | Up to $40 million | Achievement of a milestone event (primary endpoint of Phase 3 trial) |
| Total Potential Proceeds | Up to $200 million | Full exercise of all warrants |
Looking at the ownership structure as of mid-2025, you see who is already committed:
| Metric | Value (as of June 2025) |
| Total Institutional Owners (13F filers) | 21 |
| Institutional Ownership Percentage | 27.81% |
| Total Shares Outstanding | 6,993,406 |
| Largest Single Institutional Holder | FEDERATED HERMES, INC. (over 1.35 million shares) |
The financing was led by Vivo Capital LLC, with participation from Janus Henderson Investors and Federated Hermes Kaufmann Funds, among others.
Payers and government health programs (future segment upon approval)
This segment is prospective, but the financing is explicitly intended to prepare for it. The proceeds are earmarked to fund the Phase 3 study, NDA resubmission, and potential commercial launch preparations in the US, if roluperidone gets approved.
- Cash position as of September 30, 2025: Approximately $12.4 million.
- Net loss for the nine months ended September 30, 2025: $9.8 million.
The company anticipates having sufficient funds from the recent placement to cover the Phase 3 study and resubmission, which directly impacts the timeline to reach this payer segment.
Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Cost Structure
You're looking at the major cash outflows for Minerva Neurosciences, Inc. as of late 2025, focusing on what it takes to keep the roluperidone development engine running. For a clinical-stage company, the cost structure is almost entirely driven by R&D and the necessary administrative overhead to manage that science and regulatory path.
Here's a look at the core operating expenses through the first nine months of fiscal year 2025, ending September 30, 2025:
| Cost Category | Amount (Nine Months Ended Sept 30, 2025) |
| Research and Development (R&D) expense | $3.6 million |
| General and Administrative (G&A) expense | $6.5 million |
The R&D expense of $3.6 million for the nine months ended September 30, 2025, was notably lower than the $9.9 million reported for the same period in 2024. This reduction was partly due to lower compensation expenses, but the big-ticket items are the costs for the upcoming clinical work.
The costs for the new 52-week confirmatory Phase 3 trial of roluperidone, along with the regulatory and legal fees tied to the New Drug Application (NDA) resubmission process, are substantial future expenditures. To cover these, Minerva Neurosciences secured significant capital in October 2025. The financing structure included:
- Initial upfront funding of $80 million.
- Up to an additional $80 million if all Tranche A warrants are exercised.
- Additional proceeds of $40 million contingent upon exercising Tranche B warrants after achieving a milestone related to the Phase 3 trial primary endpoint.
This financing provided up to $200 million in gross proceeds intended to finance the confirmatory Phase 3 trial, the NDA resubmission, and preparations for a potential U.S. commercial launch.
Regarding personnel and compensation expenses for the core team, while a specific standalone number isn't broken out for this category alone, the R&D expense reduction for the nine months ended September 30, 2025, was attributed in part to lower compensation expenses compared to the prior year. Also, the G&A expense for the nine months ended September 30, 2025, at $6.5 million, was lower than the $7.4 million in the prior year, primarily due to lower professional service fees.
The G&A for the three months ended September 30, 2025, was $1.9 million.
Minerva Neurosciences, Inc. (NERV) - Canvas Business Model: Revenue Streams
You're looking at the immediate cash infusion that keeps Minerva Neurosciences, Inc. moving forward with roluperidone. The revenue stream here is almost entirely capital-raising activity as of late 2025, not product sales.
The most significant recent event is the equity financing, which closed around October 23, 2025. This deal was structured to provide immediate capital while setting up future tranches contingent on progress. The initial cash hit was substantial.
The upfront proceeds from the private placement totaled $80 million in gross funding, received in exchange for shares of Series A Convertible Preferred Stock. This funding is earmarked to support the confirmatory Phase 3 trial for roluperidone and the New Drug Application (NDA) resubmission to the FDA.
The total potential financing package was up to $200 million in gross proceeds, structured across three components. Here's the quick math on the potential future cash:
| Financing Component | Maximum Potential Gross Proceeds | Condition/Status |
| Upfront Private Placement | $80 million | Received October 2025 |
| Tranche A Warrants Exercise | Up to $80 million | Immediately exercisable for cash upon Phase 3 primary endpoint announcement |
| Tranche B Warrants Exercise | Up to $40 million | Contingent upon achievement of a milestone event |
| Total Potential Gross Proceeds | Up to $200 million | Before fees and expenses |
You should note the specific triggers for the warrant exercises. The Tranche A warrants are tied to the Phase 3 trial success for roluperidone, and the Tranche B warrants are also tied to a milestone event. If stockholder approval for conversion mechanics isn't obtained within one year, the preferred shares face redemption.
Regarding other potential streams, the focus in recent reports is on the roluperidone program, but the outline requires mentioning the other asset.
- Potential future milestone payments or royalties from Janssen for seltorexant (MIN-202)
As of the Third Quarter 2025 results ending September 30, 2025, Minerva Neurosciences, Inc. reported zero in Other Income for the three-month period, which contrasts with the $26.6 million recognized in the third quarter of 2024 related to the sale of future royalties.
Currently, Minerva Neurosciences, Inc. has zero revenue from product sales or licenses, which makes sense given its status. The Q3 2025 financial data shows net losses, and the company's primary focus is advancing its clinical-stage assets through trials funded by the recent equity raise.
The current revenue picture is defined by these financing events:
- Proceeds from equity financing, including the upfront $80 million private placement.
- Potential future proceeds from Tranche A warrants, up to $80 million more.
- Potential future proceeds from Tranche B warrants, up to $40 million more.
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