BURLINGTON, Mass., March 08, 2023 (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 reported business updates and financial results for the fourth quarter and year ended December 31, 2022.

Corporate Update

“In 2022, we had multiple interactions with the FDA regarding the regulatory path forward for our lead compound, roluperidone. After submitting an NDA for roluperidone to the FDA in August, we received a Refuse to File letter (RTF) in the fall, which was upheld following another meeting with the FDA. We remain committed to developing roluperidone as a potentially transformative treatment for those patients with negative symptoms of schizophrenia and we anticipate further discussion with the FDA over the coming months,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva.

Roluperidone

Fourth Quarter and Year End Financial Results

Conference Call Information:

The live conference call will begin this morning at 8:30 a.m. ET and may be accessed here and on the Company’s website under Events and Presentations.

The archived webcast will be available on the Company’s website beginning approximately two hours after the event for 90 days.

About Minerva Neurosciences

Minerva Neurosciences, Inc. (Nasdaq: NERV) is a clinical-stage biopharmaceutical company focused on developing product candidates to treat central nervous system (CNS) diseases. Our goal is to transform the lives of patients with improved therapeutic options. Minerva’s portfolio of compounds includes roluperidone (MIN-101), for negative symptoms of schizophrenia, and MIN-301, for Parkinson’s disease. For more information, please visit our 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 the clinical and therapeutic potential of roluperidone (MIN-101); and the expectations regarding continued conversation with the FDA with respect to roluperidone and the timing 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 roluperidone will advance further in the clinical trials process and whether and when, if at all, it will receive final approval from the FDA or equivalent foreign regulatory agencies and for which indications; whether we will be able to continue the discussion with the FDA regarding our NDA submission for roluperidone and the outcome thereof; management’s ability to successfully achieve its goals; our ability to raise additional capital to fund our operations and corporate objectives on terms acceptable to us; general economic conditions; and other factors that are described under the caption “Risk Factors” in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission on March 8, 2023. Copies of reports filed with the SEC are posted on our website at www.minervaneurosciences.com. The forward-looking statements in this press release are based on information available to us as of the date hereof, and we disclaim 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 
(in thousands) 
 December 31,
2022		December 31,
2021
ASSETS
Current Assets:  
Cash and cash equivalents$36,094 $60,755 
Restricted cash 100  100 
Refundable regulatory fee 3,117  - 
Prepaid expenses and other current assets 848  1,346 
Total current assets 40,159  62,201 
Equipment & capitalized software, net 59  52 
Goodwill 14,869  14,869 
Total Assets$55,087 $77,122 
LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY
Current Liabilities:  
Accounts payable$969 $1,853 
Accrued expenses and other current liabilities 408  966 
Total current liabilities 1,377  2,819 
Long-Term Liabilities:  
Liability related to the sale of future royalties 73,734  66,327 
Total liabilities 75,111  69,146 
Stockholders' (Deficit) Equity:  
Common stock 1  1 
Additional paid-in capital 346,785  342,676 
Accumulated deficit (366,810) (334,701)
Total stockholders' (deficit) equity (20,024) 7,976 
Total Liabilities and Stockholders' (Deficit) Equity$55,087 $77,122 
   




CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS		  
  Three Months Ended December 31,
(in thousands, except per share amounts)		 Twelve Months Ended December 31
(in thousands, except per share amounts)
   2022  2021   2022  2021 
Operating expenses:      
Research and development $3,190 $18,746  $14,649 $32,039 
General and administrative  1,880  2,631   10,582  13,327 
Total operating expenses  5,070  21,377   25,231  45,366 
Loss from operations  (5,070) (21,377)  (25,231) (45,366)
       
Foreign exchange loss  (28) (4)  (28) (33)
Investment income  297  4   557  17 
Non-cash interest expense for the sale of future royalties  (1,925) (1,733)  (7,407) (6,327)
Loss before income taxes  (6,726) (23,110)  (32,109) (51,709)
Benefit for income taxes  -  1,803   -  1,803 
Net loss  (6,726) (21,307)  (32,109) (49,906)
Net loss per share, basic and diluted $(1.26)$(3.99) $(6.01)$(9.35)
Weighted average shares outstanding, basic and diluted 5,340  5,340   5,340  5,340