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Minerva Neurosciences Reports Third Quarter 2024 Financial Results and Business Updates

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Minerva Neurosciences (NERV) reported Q3 2024 financial results with notable changes in expenses and income. R&D expenses decreased to $1.9 million from $3.4 million in Q3 2023, while G&A expenses slightly decreased to $2.5 million from $2.6 million. The company reported net income of $22.5 million for Q3 2024, compared to a net loss of $7.8 million in Q3 2023. Cash position stood at $26.6 million as of September 30, 2024. The FDA previously issued a Complete Response Letter for roluperidone's NDA for treating negative symptoms in schizophrenia patients, and the company continues interactions with the FDA to address raised questions.

Minerva Neurosciences (NERV) ha riportato i risultati finanziari del terzo trimestre del 2024 con cambiamenti significativi nelle spese e nei ricavi. Le spese per ricerca e sviluppo sono diminuite a $1,9 milioni rispetto ai $3,4 milioni del terzo trimestre del 2023, mentre le spese generali e amministrative sono leggermente scese a $2,5 milioni rispetto ai $2,6 milioni. L'azienda ha registrato un utile netto di $22,5 milioni per il terzo trimestre del 2024, rispetto a una perdita netta di $7,8 milioni nel terzo trimestre del 2023. La posizione di cassa si attesta a $26,6 milioni al 30 settembre 2024. La FDA ha precedentemente emesso una Lettera di Risposta Completa per la NDA di roluperidone per il trattamento dei sintomi negativi nei pazienti affetti da schizofrenia, e l'azienda continua i contatti con la FDA per affrontare le questioni sollevate.

Minerva Neurosciences (NERV) reportó los resultados financieros del tercer trimestre de 2024 con cambios notables en los gastos y los ingresos. Los gastos en I+D disminuyeron a $1,9 millones desde $3,4 millones en el tercer trimestre de 2023, mientras que los gastos generales y administrativos cayeron ligeramente a $2,5 millones desde $2,6 millones. La compañía reportó un ingreso neto de $22,5 millones para el tercer trimestre de 2024, comparado con una pérdida neta de $7,8 millones en el tercer trimestre de 2023. La posición de efectivo se ubicó en $26,6 millones al 30 de septiembre de 2024. La FDA emitió previamente una Carta de Respuesta Completa para la NDA de roluperidona para tratar los síntomas negativos en pacientes con esquizofrenia, y la empresa continúa con las interacciones con la FDA para abordar las preguntas planteadas.

미네르바 뉴로사이언스 (NERV)는 2024년 3분기 재무 결과를 보고하며 경비 및 수익에서 주목할 만한 변화를 보여주었습니다. 연구개발(R&D) 비용은 2023년 3분기의 $3.4 백만에서 $1.9 백만으로 감소했으며, 일반 및 관리(G&A) 비용은 $2.6 백만에서 $2.5 백만으로 약간 감소했습니다. 회사는 2024년 3분기에 $22.5 백만의 순이익을 기록했으며, 2023년 3분기에는 $7.8 백만의 순손실을 기록했습니다. 현금 보유액은 2024년 9월 30일 기준으로 $26.6 백만으로 나타났습니다. FDA는 이전에 조현병 환자의 음성 증상을 치료하기 위한 로루페리돈의 NDA에 대해 완전 응답 편지를 발송했으며, 회사는 제기된 질문에 대해 FDA와의 상호작용을 계속하고 있습니다.

Minerva Neurosciences (NERV) a annoncé les résultats financiers du troisième trimestre 2024, avec des changements notables dans les dépenses et les revenus. Les dépenses de R&D ont diminué à 1,9 million de dollars contre 3,4 millions de dollars au troisième trimestre 2023, tandis que les dépenses générales et administratives ont légèrement diminué à 2,5 millions de dollars contre 2,6 millions de dollars. La société a enregistré un revenu net de 22,5 millions de dollars pour le troisième trimestre 2024, comparé à une perte nette de 7,8 millions de dollars au troisième trimestre 2023. La position de trésorerie s'élevait à 26,6 millions de dollars au 30 septembre 2024. La FDA a précédemment émis une lettre de réponse complète pour la NDA de roluperidone pour traiter les symptômes négatifs chez les patients atteints de schizophrénie, et la société continue d'interagir avec la FDA pour répondre aux questions soulevées.

Minerva Neurosciences (NERV) hat die finanziellen Ergebnisse für das dritte Quartal 2024 veröffentlicht, mit bemerkenswerten Veränderungen bei den Ausgaben und Einnahmen. Die Ausgaben für Forschung und Entwicklung sanken auf $1,9 Millionen von $3,4 Millionen im dritten Quartal 2023, während die allgemeinen und administrativen Ausgaben leicht auf $2,5 Millionen von $2,6 Millionen zurückgingen. Das Unternehmen berichtete von einem Nettoeinkommen von $22,5 Millionen für das dritte Quartal 2024, verglichen mit einem Nettoverlust von $7,8 Millionen im dritten Quartal 2023. Die Liquiditätsposition betrug zum 30. September 2024 $26,6 Millionen. Die FDA hatte zuvor einen vollständigen Antwortbrief für die NDA von Roluperidon zur Behandlung negativer Symptome bei Patienten mit Schizophrenie ausgestellt, und das Unternehmen setzt die Gespräche mit der FDA fort, um die aufgeworfenen Fragen zu klären.

Positive
  • Net income of $22.5 million in Q3 2024 vs net loss of $7.8 million in Q3 2023
  • Reduction in R&D expenses from $3.4M to $1.9M in Q3 2024
  • Decrease in G&A expenses from $2.6M to $2.5M in Q3 2024
  • Strong cash position of $26.6 million as of September 30, 2024
Negative
  • FDA Complete Response Letter rejection for roluperidone NDA
  • Cash position decreased from $41.0M (Dec 2023) to $26.6M (Sep 2024)
  • Higher nine-month R&D expenses: $9.9M in 2024 vs $8.0M in 2023

Insights

The Q3 2024 results show mixed financial signals for Minerva Neurosciences. The company reported a notable net income of $22.5 million for Q3, primarily driven by a one-time $26.6 million gain from adjusting the future royalties liability. However, the core business metrics reveal ongoing challenges:

R&D expenses decreased by 44% to $1.9 million, while G&A expenses remained relatively stable at $2.5 million. The cash position declined significantly from $41.0 million at year-end 2023 to $26.6 million, indicating substantial cash burn. The FDA's Complete Response Letter for roluperidone creates uncertainty around the company's lead product candidate, potentially requiring additional development costs and timeline extensions.

The FDA's Complete Response Letter (CRL) for roluperidone represents a significant setback in the company's development pipeline. While management continues discussions with the FDA, the CRL typically indicates substantial concerns that need addressing, potentially requiring additional clinical trials or data. This is particularly critical as roluperidone is the company's lead candidate for negative symptoms in schizophrenia, an area with significant unmet medical need. The ongoing MIN-101C18 study and substance validation campaign suggest continued investment in development, but the regulatory hurdle poses significant challenges to commercialization timeline.

BURLINGTON, Mass., Nov. 05, 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 third quarter of 2024 ending September 30, 2024.   

Roluperidone NDA Update

As announced in February 2024, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to our New Drug Application (NDA) for roluperidone (f/k/a MIN-101) for the treatment of negative symptoms in patients with schizophrenia. Interactions with the FDA continue with the goal of addressing questions raised in the CRL. 

Third Quarter 2024 Financial Results

Research and development (R&D) expense: For the three months ended September 30, 2024 and 2023, R&D expense was $1.9 million and $3.4 million, respectively. R&D expense was lower versus the prior year period primarily due to lower costs associated with the FDA’s review of our NDA for roluperidone and lower compensation expenses. For the nine months ended September 30, 2024 and 2023, R&D expense was $9.9 million and $8.0 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 and the conduct of the MIN-101C18 study, partially offset by lower compensation expenses.

General and administrative (G&A) expense: For the three months ended September 30, 2024 and 2023, G&A expense was $2.5 million and $2.6 million, respectively. G&A expense was lower versus the prior year period primarily due to lower compensation expenses. For the nine months ended September 30, 2024 and 2023, G&A expense was $7.4 million and $8.0 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 nine months ended September 30, 2024, non-cash interest expense for the sale of future royalties was zero and $4.6 million, respectively, as compared to $2.1 million and $6.1 million for the three and nine months ended September 30, 2023, respectively. The non-cash interest expense was lower versus the prior year periods primarily due to the change in the effective annual interest rate of the liability related to the sale of future royalties, whereby we no longer recognize interest on the liability as the effective annual interest rate is negative.

Other income: For the three and nine months ended September 30, 2024 and 2023, other income was $26.6 million and zero, respectively. Other income was higher versus the prior year periods due to the gain associated with the adjustment to the carrying amount of the liability related to the sale of future royalties.

Net income (loss): Net income for the three and nine months ended September 30, 2024 was $22.5 million and $5.7 million, or a basic and diluted net income per share of $2.97 and $0.75, respectively, as compared to a net loss for the three and nine months ended September 30, 2023 of $7.8 million and $21.0 million or a basic and diluted net loss per share of $1.03 and $3.41, respectively.

Cash Position: Cash, cash equivalents and restricted cash at September 30, 2024 were approximately $26.6 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 September 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)
 September 30, 2024December 31, 2023
 (in thousands)
ASSETS
Current assets:  
Cash and cash equivalents$26,529  $40,913 
Restricted cash 100   100 
Prepaid expenses and other current assets 1,307   989 
Total current assets 27,936   42,002 
Equipment and capitalized software, net 7   29 
Goodwill 14,869   14,869 
Total assets$42,812  $56,900 
   
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities:  
Accounts payable$553  $1,805 
Accrued expenses and other current liabilities 3,930   1,535 
Total current liabilities 4,483   3,340 
Long-term liabilities:  
Liability related to the sale of future royalties 60,000   82,017 
Total liabilities 64,483   85,357 
Stockholders' deficit:  
Common stock 1   1 
Additional paid-in capital 369,433   368,357 
Accumulated deficit (391,105)  (396,815)
Total stockholders' deficit (21,671)  (28,457)
Total liabilities and stockholders' deficit$42,812  $56,900 
   
   


CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)     
 Three Months Ended
September 30,

(in thousands,
except per share amounts)
 Nine Months Ended
September 30,

(in thousands,
except per share amounts)
  2024   2023   2024   2023 
Operating expenses:     
Research and development$1,888  $3,444  $9,916  $7,985 
General and administrative 2,479   2,635   7,410   7,963 
Total operating expenses 4,367   6,079   17,326   15,948 
Loss from operations (4,367)  (6,079)  (17,326)  (15,948)
      
Foreign exchange losses (13)  (5)  (12)  (21)
Investment income 314   349   1,032   1,079 
Non-cash interest expense for the sale of future royalties -   (2,085)  (4,562)  (6,093)
Other income 26,579   -   26,579   - 
Net income (loss)$22,513  $(7,820) $5,711  $(20,983)
      
Net income (loss) per share, basic$2.97  $(1.03) $0.75  $(3.41)
Weighted average shares outstanding, basic 7,569   7,569   7,569   6,148 
Net income (loss) per share, diluted$2.97  $(1.03) $0.75  $(3.41)
Weighted average shares outstanding, diluted 7,569   7,569   7,578   6,148 

FAQ

What was Minerva Neurosciences (NERV) Q3 2024 net income?

Minerva Neurosciences reported a net income of $22.5 million in Q3 2024, or $2.97 per basic and diluted share.

How much cash does NERV have as of September 30, 2024?

Minerva Neurosciences had approximately $26.6 million in cash, cash equivalents and restricted cash as of September 30, 2024.

What happened with NERV's roluperidone FDA application in 2024?

The FDA issued a Complete Response Letter (CRL) to Minerva's New Drug Application for roluperidone in February 2024, effectively rejecting the application for treating negative symptoms in schizophrenia patients.

Minerva Neurosciences, Inc

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