Minerva Neurosciences Provides Business Updates and Second Quarter Financial Results

Rhea-AI Summary

Minerva Neurosciences (NASDAQ: NERV) has provided significant updates regarding its drug roluperidone and financial results for Q2 2025. The FDA has confirmed that a new confirmatory clinical trial is required for roluperidone's NDA resubmission, following the Complete Response Letter received in February 2024. The trial must be a 52-week double-blind study with 25-30% US patients receiving 64mg daily doses.

Financial highlights include Q2 2025 R&D expenses of $1.3M (down from $3.9M in Q2 2024), G&A expenses of $2.1M (down from $2.4M), and a net loss of $3.3M ($0.43 per share). Cash position stands at $15.3M as of June 30, 2025.

Due to the required confirmatory study and current cash position, Minerva has initiated a strategic alternatives review process to maximize stockholder value while implementing cost reduction measures.

Positive

• Reduced R&D expenses by 67% year-over-year to $1.3M in Q2 2025
• Decreased net loss to $3.3M in Q2 2025 from $8.2M in Q2 2024
• FDA provided clear guidance for roluperidone's path forward
• FDA confirmed no requirement for adjunctive trial with antipsychotics

Negative

• FDA requires additional confirmatory clinical trial before NDA resubmission
• Cash position declined to $15.3M from $21.5M in December 2024
• Company forced to explore strategic alternatives due to cash constraints
• 52-week trial requirement adds significant time and cost to drug approval path

Insights

Pharmaceutical Regulatory Expert

Minerva faces major setback as FDA requires new 52-week trial for roluperidone, forcing strategic alternatives exploration amid dwindling cash.

The FDA's requirement for a new confirmatory clinical trial for roluperidone represents a significant regulatory hurdle for Minerva Neurosciences. This follows their February 2024 Complete Response Letter (CRL) rejection. The FDA has specified that a 52-week, double-blind, controlled trial would be necessary for NDA resubmission - a substantial undertaking requiring significant resources.

The trial parameters are demanding: patients with schizophrenia presenting with stable positive symptoms and impairing negative symptoms, with 25-30% of participants from the US. The primary endpoint would measure change in PANSS Marder negative symptoms factor score at 12 weeks, with a key secondary endpoint assessing social functioning via the Personal and Social Performance scale.

Most notably, the FDA wants to assess relapses observationally for at least 52 weeks in patients treated with roluperidone monotherapy - a significant extension beyond previous studies. While the FDA has indicated an adjunctive trial with antipsychotics wouldn't be required if Minerva provides robust data on long-term monotherapy, the overall requirements represent a substantial clinical and financial commitment that appears beyond Minerva's current resources.

This regulatory pathway creates a nearly insurmountable barrier given Minerva's $15.3 million cash position. A large Phase 3 trial of this magnitude would typically cost $20-30 million at minimum. The company's exploration of "strategic alternatives" strongly suggests they lack sufficient capital to independently fulfill these requirements, making a partnership, sale, or major restructuring almost inevitable.

Financial Analyst

Minerva's cash position cannot support required FDA trial, forcing strategic alternatives as losses narrow but future remains uncertain.

Minerva's financial position has shown modest improvement but remains precarious given the regulatory demands. Q2 2025 net loss narrowed to $3.3 million ($0.43 per share) from $8.2 million ($1.09 per share) in Q2 2024. For the six-month period, losses decreased to $7.0 million from $16.8 million.

The improvement stems primarily from reduced operational expenses. R&D expenses fell significantly to $1.3 million in Q2 2025 from $3.9 million in Q2 2024, driven by lower drug substance validation campaign costs and reduced consultant fees. Similarly, G&A expenses decreased to $2.1 million from $2.4 million year-over-year.

The elimination of non-cash interest expense (compared to $2.3 million in Q2 2024) contributed to the improved bottom line, following the company's revision of estimates for future royalty payments and adjustment of the carrying amount to the initial $60 million payment.

Most critically, the cash position has deteriorated to $15.3 million as of June 30, 2025, down from $21.5 million at year-end 2024. With a six-month cash burn of approximately $6.2 million, the company has roughly 15 months of runway at current spending levels.

However, the FDA's requirement for an additional confirmatory trial would significantly accelerate cash depletion, making the strategic alternatives review an inevitable necessity rather than a choice. The announcement of cost-cutting measures alongside strategic alternatives exploration suggests management recognizes the impossibility of funding the required clinical program independently. Potential outcomes likely include seeking a partner with deep pockets, selling the asset, or a complete corporate sale.

FDA confirms requirement for confirmatory study of roluperidone for the treatment of negative symptoms in schizophrenia

Evaluation of strategic alternatives

BURLINGTON, Mass., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today provided business updates.

FDA Discussions & Roluperidone Update

The Company has had multiple interactions with the FDA following receipt of the Complete Response Letter (CRL) for its New Drug Application (NDA) in February 2024 and the FDA has confirmed the requirement for an additional confirmatory clinical trial to address the deficiencies cited in the CRL and resubmit the NDA.

As in the two previous studies (C03 and C07), the required confirmatory clinical trial would include patients diagnosed with schizophrenia who present with impairing negative symptoms and stable positive symptoms. Patients would be selected based on stable positive symptoms and impairing negative symptoms for the six months prior to entering the trial. Minerva agreed with FDA that best efforts will be made to secure 25-30% of patients from USA (subject to competitive recruitment). 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. The FDA has also confirmed that, the primary endpoint would be the change from Baseline in PANSS Marder negative symptoms factor score (NSFS) at 12 weeks of treatment with roluperidone compared to placebo. 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. The FDA has stated that 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.

The trial’s potential sole key secondary endpoint would be the comparison of the change from Baseline in the Personal and Social Performance scale total score (PSP) to Week 12, which is a scale to assess patients’ social functioning. The trial will also potentially measure the change from Baseline in Clinical Global Impression of Severity (CGI-S), change from Baseline in NSFS, PSP, and CGI-S at earlier timepoints and safety & tolerability.

The FDA has agreed that an adjunctive trial with antipsychotics would not be required for resubmission of the NDA if Minerva could provide robust, controlled data demonstrating the efficacy and safety of long-term monotherapy with roluperidone in subjects with negative symptoms of schizophrenia.

Second Quarter 2025 Financial Results

Research and development (R&D) expense: For the three months ended June 30, 2025 and 2024, R&D expense was $1.3 million and $3.9 million, respectively. R&D expense was lower versus the prior year period primarily due to lower costs associated with our drug substance validation campaign and lower consultant fees. For the six months ended June 30, 2025 and 2024, R&D expense was $2.7 million and $8.0 million, respectively. R&D expense was lower versus the prior year period primarily due to lower costs associated with our drug substance validation campaign, costs for the C18 study, consultant fees, and lower compensation expenses.

General and administrative (G&A) expense: For the three months ended June 30, 2025 and 2024, G&A expense was $2.1 million and $2.4 million, respectively. For the six months ended June 30, 2025 and 2024, G&A expense was $4.6 million and $4.9 million, respectively. G&A expense was lower versus the prior year periods primarily due to lower professional service fees.

Non-cash interest expense: For the three and six months ended June 30, 2025, non-cash interest expense for the sale of future royalties was zero, as compared to $2.3 million and $4.6 million for the three and six months ended June 30, 2024, respectively. Non-cash interest expense was lower versus the prior year periods due to revising our estimates for the timing and amount of future royalty payments to be received under the royalty arrangement. During the third quarter of 2024, we adjusted the carrying amount of our liability related to the sale of future royalties to the initial payment of $60 million. This adjustment resulted in the recognition of $26.6 million in other income during the third quarter of 2024, representing the amount of non-cash interest expense amortized through June 30, 2024.

Net loss: Net loss for the three and six months ended June 30, 2025 was $3.3 million and $7.0 million, or a basic and diluted net loss per share of $0.43 and $0.93, respectively, as compared to a net loss for the three and six months ended June 30, 2024 of $8.2 million and $16.8 million or a basic and diluted net loss per share of $1.09 and $2.22, respectively.

Cash Position: Cash, cash equivalents and restricted cash at June 30, 2025 were approximately $15.3 million, as compared to $21.5 million at December 31, 2024.

Review of Strategic Alternatives

As a result of the requirement for the confirmatory study and the Company’s current cash position, Minerva is taking additional steps to reduce costs. The Company has also initiated a review process to explore strategic alternatives to maximize value for its stockholders. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or as to the timing of any such agreements or transactions. Minerva does not intend to discuss or disclose further developments regarding the exploration of strategic alternatives unless and until its board of directors has approved a definitive action or otherwise determined that further disclosure is appropriate or required by law.

About Minerva Neurosciences

Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing product candidates to treat CNS diseases. Minerva’s goal is to transform the lives of patients with improved therapeutic options, including roluperidone for negative symptoms of schizophrenia. For more information, please visit the Company’s website.

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 Minerva’s expectations regarding the confirmatory clinical trial of roluperidone and related regulatory developments; and Minerva’s cost reduction measures, the exploration of strategic alternatives for the company to maximize value for stockholders, and the outcomes thereof. 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, whether the objectives of the strategic alternative review process will be achieved; the terms, structure, benefits and costs of any strategic transaction; the timing of any transaction and whether any transaction will be consummated at all; the risk of any unexpected costs or expenses resulting from the review; uncertainties associated with regulatory processes; whether Minerva will maintain compliance with Nasdaq’s listing standards and will be able to continue its listing on the Nasdaq Capital Market; 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

CONDENSED CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
	June 30, 2025			December 31, 2024
	(in thousands)
ASSETS
Current assets:
Cash and cash equivalents	$	15,248		$	21,362
Restricted cash		100			100
Prepaid expenses and other current assets		200			807
Total current assets		15,548			22,269
Equipment, net		3			6
Goodwill		14,869			14,869
Total assets	$	30,420		$	37,144
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities:
Accounts payable	$	897		$	1,608
Accrued expenses and other current liabilities		1,632			1,229
Total current liabilities		2,529			2,837
Long-term liabilities:
Liability related to the sale of future royalties		60,000			60,000
Total liabilities		62,529			62,837
Stockholders' deficit:
Common stock		1			1
Additional paid-in capital		370,278			369,683
Accumulated deficit		(402,388	)		(395,377	)
Total stockholders' deficit		(32,109	)		(25,693	)
Total liabilities and stockholders' deficit	$	30,420		$	37,144

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
		Three Months Ended June 30, (in thousands, except per share amounts)							Six Months Ended June 30, (in thousands, except per share amounts)
			2025			2024				2025			2024
Operating expenses:
Research and development		$	1,298		$	3,860			$	2,660		$	8,028
General and administrative			2,076			2,417				4,617			4,932
Total operating expenses			3,374			6,277				7,277			12,960
Loss from operations			(3,374	)		(6,277	)			(7,277	)		(12,960	)
Foreign exchange (losses) gains			(21	)		(5	)			(30	)		1
Investment income			136			361				295			719
Non-cash interest expense for the sale of future royalties			-			(2,312	)			-			(4,562	)
Net loss		$	(3,259	)	$	(8,233	)		$	(7,012	)	$	(16,802	)
Net loss per share, basic and diluted		$	(0.43	)	$	(1.09	)		$	(0.93	)	$	(2.22	)
Weighted average shares outstanding, basic and diluted			7,569			7,569				7,569			7,569

FAQ

What did the FDA require from Minerva Neurosciences (NERV) for roluperidone's approval?

The FDA required a new 52-week double-blind, placebo- or active-controlled confirmatory clinical trial for roluperidone, with 25-30% US patients receiving 64mg daily doses. The primary endpoint will measure changes in PANSS Marder negative symptoms factor score.

What were Minerva Neurosciences' (NERV) key financial results for Q2 2025?

Minerva reported R&D expenses of $1.3M, G&A expenses of $2.1M, and a net loss of $3.3M ($0.43 per share). The company's cash position was $15.3M as of June 30, 2025.

Why is Minerva Neurosciences (NERV) exploring strategic alternatives?

Minerva is exploring strategic alternatives due to its current cash position of $15.3M and the requirement for an expensive confirmatory study for roluperidone, leading the company to seek ways to maximize stockholder value.

What are the primary endpoints for Minerva's new roluperidone trial?

The primary endpoint is the change from Baseline in PANSS Marder negative symptoms factor score (NSFS) at 12 weeks. The potential secondary endpoint is the change in Personal and Social Performance scale total score (PSP) to Week 12.

How much did Minerva Neurosciences (NERV) reduce its expenses in Q2 2025?

Minerva reduced its R&D expenses by 67% to $1.3M (from $3.9M in Q2 2024) and G&A expenses to $2.1M (from $2.4M in Q2 2024).