Minerva Neurosciences Reports Second Quarter 2024 Financial Results and Business Updates

Rhea-AI Summary

Minerva Neurosciences (Nasdaq: NERV) reported its Q2 2024 financial results and business updates. Key highlights include:

1. The FDA issued a Complete Response Letter (CRL) for roluperidone's NDA for treating negative symptoms in schizophrenia patients.

2. R&D expenses increased to $3.9 million in Q2 2024 from $1.9 million in Q2 2023.

3. G&A expenses decreased to $2.4 million in Q2 2024 from $2.6 million in Q2 2023.

4. Net loss for Q2 2024 was $8.2 million ($1.09 per share) compared to $6.2 million ($1.12 per share) in Q2 2023.

5. Cash position as of June 30, 2024, was $31.0 million, down from $41.0 million on December 31, 2023.

Positive

• Continued interactions with FDA to address CRL questions for roluperidone
• Lower G&A expenses due to reduced compensation and professional service fees

Negative

• FDA issued Complete Response Letter for roluperidone NDA
• R&D expenses doubled year-over-year in Q2 2024
• Net loss increased to $8.2 million in Q2 2024 from $6.2 million in Q2 2023
• Cash position decreased by $10 million in the first half of 2024

Insights

Financial Analyst

Minerva Neurosciences' Q2 2024 results reveal a concerning financial picture. The company's net loss widened to $8.2 million from $6.2 million year-over-year, despite a slight improvement in loss per share. R&D expenses nearly doubled to $3.9 million, primarily due to drug substance validation costs. While G&A expenses decreased slightly, the overall financial health appears strained.

The company's cash position has deteriorated significantly, dropping from $41.0 million at the end of 2023 to $31.0 million by June 30, 2024. This 24.4% decrease in just six months raises concerns about cash burn rate and future funding needs. The ongoing FDA interactions regarding the Complete Response Letter for roluperidone add uncertainty to the company's near-term prospects and potential revenue streams.

Medical Research Analyst

The FDA's Complete Response Letter (CRL) for roluperidone is a significant setback for Minerva's lead candidate in treating negative symptoms of schizophrenia. While the company continues to engage with the FDA, the lack of clear resolution suggests potential delays or additional studies may be required, impacting the drug's path to market.

The increased R&D spending on drug substance validation and the MIN-101C18 study indicates ongoing commitment to development. However, without positive regulatory signals, these investments carry heightened risk. The company's focus on CNS disorders, particularly schizophrenia and Parkinson's disease, remains strategically relevant given the high unmet need in these areas, but near-term success appears challenging without a clear path forward for roluperidone.

BURLINGTON, Mass., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported business updates and financial results for the second quarter of 2024 ending June 30, 2024.

Roluperidone NDA Update

During the first quarter of this year, the Company announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to its New Drug Application (NDA) for roluperidone (f/k/a MIN-101) for the treatment of negative symptoms in patients with schizophrenia. Since receiving the CRL, the Company has continued to have interactions with the FDA with the goal of addressing questions raised in the CRL.

Second Quarter 2024 Financial Results

Research and development (R&D) expense: For the three months ended June 30, 2024 and 2023, R&D expense was $3.9 million and $1.9 million, respectively. R&D expense was higher versus the prior year period primarily due to higher subcontractor fees related to costs associated with our drug substance validation campaign, partially offset by lower compensation expenses. For the six months ended June 30, 2024 and 2023, R&D expense was $8.0 million and $4.5 million, respectively. R&D expense was higher versus the prior year period primarily due to costs associated with our drug substance validation campaign and the conduct of the MIN-101C18 study.

General and administrative (G&A) expense: For the three months ended June 30, 2024 and 2023, G&A expense was $2.4 million and $2.6 million, respectively. G&A expense was lower versus the prior year period primarily due to lower compensation expenses. For the six months ended June 30, 2024 and 2023, G&A expense was $4.9 million and $5.3 million, respectively. G&A expense was lower versus the prior year period primarily due to lower compensation expenses and professional service fees.

Non-cash interest expense: For the three and six months ended June 30, 2024, non-cash interest expense for the sale of future royalties was $2.3 million and $4.6 million, respectively, as compared to $2.0 million and $4.0 million for the three and six months ended June 30, 2023, respectively. The increase versus the prior year period was primarily due to the amortization of non-cash interest expense for the difference between the balance of the liability related to the sale of future royalties and the estimated amount of future royalties to be received over the royalty period.

Net loss: Net loss for the three and six months ended June 30, 2024 was $8.2 million and $16.8 million, or a basic and diluted net loss per share of $1.09 and $2.22, respectively, as compared to a net loss for the three and six months ended June 30, 2023 of $6.2 million and $13.2 million or a basic and diluted net loss per share of $1.12 and $2.43, respectively.

Cash Position: Cash, cash equivalents and restricted cash at June 30, 2024 were approximately $31.0 million, as compared to $41.0 million at December 31, 2023.

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 and MIN-301 for Parkinson’s disease. 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 expectations concerning Minerva’s ability to remediate or otherwise resolve issues and deficiencies identified in the CRL and the timing and outcome of its interactions with the FDA. 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 ability to address FDA’s feedback and timing thereof; uncertainties associated with regulatory processes, including the content and timing of decisions by the FDA; general risks associated with developing biopharmaceutical product candidates; management’s ability to successfully achieve its goals; our ability to raise additional capital to fund its operations and corporate objectives on terms acceptable to Minerva; 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, 2023, filed with the Securities and Exchange Commission on February 22, 2024, as updated by its Quarterly Report on Form 10-Q for the quarter ended June 30, 3024. 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, 2024				December 31, 2023
	(in thousands)
ASSETS
Current assets:
Cash and cash equivalents	$	30,881			$	40,913
Restricted cash		100				100
Prepaid expenses and other current assets		428				989
Total current assets		31,409				42,002
Equipment and capitalized software, net		13				29
Goodwill		14,869				14,869
Total assets	$	46,291			$	56,900
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities:
Accounts payable	$	829			$	1,805
Accrued expenses and other current liabilities		3,375				1,535
Total current liabilities		4,204				3,340
Long-term liabilities:
Liability related to the sale of future royalties		86,579				82,017
Total liabilities		90,783				85,357
Stockholders' deficit:
Common stock		1				1
Additional paid-in capital		369,125				368,357
Accumulated deficit		(413,618	)			(396,815	)
Total stockholders' deficit		(44,492	)			(28,457	)
Total liabilities and stockholders' deficit	$	46,291			$	56,900

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)
			2024				2023				2024				2023
Operating expenses:
Research and development		$	3,860			$	1,887			$	8,028			$	4,541
General and administrative			2,417				2,633				4,932				5,327
Total operating expenses			6,277				4,520				12,960				9,868
Loss from operations			(6,277	)			(4,520	)			(12,960	)			(9,868	)
Foreign exchange (losses) gains			(5	)			(7	)			1				(16	)
Investment income			361				365				719				730
Non-cash interest expense for the sale of future royalties			(2,312	)			(2,030	)			(4,562	)			(4,008	)
Net loss		$	(8,233	)		$	(6,192	)		$	(16,802	)		$	(13,162	)
Net loss per share, basic and diluted		$	(1.09	)		$	(1.12	)		$	(2.22	)		$	(2.43	)
Weighted average shares outstanding, basic and diluted			7,569				5,511				7,569				5,426

FAQ

What was Minerva Neurosciences' (NERV) net loss per share in Q2 2024?

Minerva Neurosciences (NERV) reported a net loss of $1.09 per share for Q2 2024.

How much cash did Minerva Neurosciences (NERV) have as of June 30, 2024?

Minerva Neurosciences (NERV) had approximately $31.0 million in cash, cash equivalents, and restricted cash as of June 30, 2024.

What was the status of Minerva Neurosciences' (NERV) roluperidone NDA in Q2 2024?

The FDA issued a Complete Response Letter (CRL) for Minerva Neurosciences' (NERV) roluperidone NDA for treating negative symptoms in schizophrenia patients. The company continues to interact with the FDA to address questions raised in the CRL.

How did Minerva Neurosciences' (NERV) R&D expenses change in Q2 2024 compared to Q2 2023?

Minerva Neurosciences' (NERV) R&D expenses increased from $1.9 million in Q2 2023 to $3.9 million in Q2 2024, primarily due to higher subcontractor fees related to drug substance validation campaign costs.