Nasdaq GlobeNewswire

Minerva Neurosciences Reports First Quarter 2018 Financial Results and Business Updates

Del

WALTHAM, Mass., May 03, 2018 (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 key business updates and financial results for the quarter ended March 31, 2018.

"Minerva now has five late-stage clinical efficacy trials ongoing with three compounds," said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva.  "These include our lead product, roluperidone (MIN-101) for schizophrenia, MIN-117 for MDD and seltorexant (MIN-202) for insomnia disorder and MDD. 

"In schizophrenia, the leading unmet medical need as ranked by psychiatrists is negative symptoms, the target indication for roluperidone," said Dr. Luthringer.  "Based on the improvement in negative symptoms measured in clinical tests with roluperidone to date, combined with the observed stability in positive symptoms and a favorable side effect profile, we believe this compound has the potential to be a differentiated therapy in schizophrenia, and we are working on commercialization strategies that address this significant commercial opportunity."

Clinical Development Updates

Roluperidone (MIN-101):

  • The Company's clinical sites in the U.S. are actively enrolling patients in the pivotal Phase 3 trial with roluperidone.  The Company has prioritized the initiation of U.S. sites, and now European sites have been initiated. Target enrollment in this trial is approximately 500 patients.  Top-line results are expected in the first half of 2019.

MIN-117:

  • As announced on April 9, 2018, the Company has enrolled the first patient in a Phase 2b trial of MIN-117 to treat the symptoms of patients diagnosed with MDD.  Approximately 324 patients will be enrolled at clinical sites in the U.S. and Europe. Top-line results are expected in the first half of 2019.

Seltorexant (MIN-202 or JNJ-42847922), under joint development with Janssen Pharmaceutica NV (Janssen):

  • Three Phase 2b clinical trials are ongoing with seltorexant, including two in MDD and one in insomnia disorder.  In the first MDD trial, approximately 280 patients are planned to be enrolled at clinical sites in the U.S., Europe and Japan.  In the second MDD trial, approximately 100 patients are planned to be randomized at clinical sites in the U.S.  The insomnia trial is expected to enroll a total of approximately 360 patients at clinical sites in the U.S., Europe and Japan. These trials are planned for completion in 2019.

First Quarter 2018 Financial Results

  • Net Loss:  Net loss was $12.4 million for the first quarter of 2018, or a loss per share of $0.32 (basic and diluted), compared to a net loss of $10.6 million for the first quarter of 2017, or a loss per share of $0.30 (basic and diluted).
     
  • R&D Expenses: Research and development (R&D) expenses were $8.4 million in the first quarter of 2018, compared to $7.6 million in the first quarter of 2017.  The increase in R&D expenses primarily reflects higher development expenses for the Phase 3 clinical trial of roluperidone and the Phase 2b clinical trial of MIN-117. These amounts were partially offset by lower development expenses for the seltorexant program due to the amendment to the Company's Co-Development and License Agreement with Janssen.  R&D expenses are expected to increase during 2018 with increased patient enrollment and related support activities for the roluperidone and MIN-117 clinical trials.
     
  • G&A Expenses: General and administrative (G&A) expenses were $4.3 million in the first quarter of 2018, compared to $2.9 million in the first quarter of 2017. This increase in G&A expenses was primarily due to an increase in non-cash stock-based compensation expenses and salary costs from increased staffing to support the Company's pre-commerical activities.  G&A expenses are expected to increase during 2018 with investment in the infrastructure necessary to support the Company's growth.
     
  • Cash Position: Cash, cash equivalents, restricted cash and marketable securities as of March 31, 2018 were approximately $121.1 million. 

Conference Call Information:

Minerva Neurosciences will host a conference call and live audio webcast today at 8:30 a.m. Eastern Time to discuss the quarter and recent business activities.  To participate, please dial (877) 312-5845 (domestic) or (765) 507-2618 (international) and refer to conference ID 8885379.

The live webcast can be accessed under "Events and Presentations" in the Investors and Media section of Minerva's website at ir.minervaneurosciences.com.  The archived webcast will be available on the website beginning approximately two hours after the event for 90 days.

About Minerva Neurosciences:

Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat CNS diseases.  Minerva's proprietary compounds include: roluperidone (MIN-101), in clinical development for schizophrenia; MIN-117, in clinical development for major depressive disorder (MDD); seltorexant (MIN-202 or JNJ-42847922), in clinical development for insomnia and MDD; and MIN-301, in pre-clinical development for Parkinson's disease.  Minerva's common stock is listed on the NASDAQ Global Market under the symbol "NERV."  For more information, please visit www.minervaneurosciences.com

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 statements herein with respect to the timing and scope of current clinical trials and results of clinical trials with roluperidone, seltorexant, MIN-117 and MIN-301; the timing and scope of future clinical trials and results of clinical trials with these compounds; the clinical and therapeutic potential of these compounds; our ability to successfully develop and commercialize our therapeutic products; the sufficiency of our current cash position to fund our operations; and management's ability to successfully achieve its goals.  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, seltorexant, MIN-117 and MIN-301 will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether any of our therapeutic products will be successfully marketed if approved; whether any of our therapeutic product discovery and development efforts will be successful; management's ability to successfully achieve its goals; our ability to raise additional capital to fund our operations on terms acceptable to us; and general economic conditions.  These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed under the caption "Risk Factors" in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-Q for the quarter ended March 31, 2018, filed with the Securities and Exchange Commission on May 3, 2018.  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.

   
CONDENSED CONSOLIDATED BALANCE SHEET DATA  
(Unaudited)  
  March 31, December 31,  
  2018     2017    
  (in thousands)  
ASSETS  
Current Assets:      
Cash and cash equivalents $   45,126   $   26,052    
Marketable securities     75,871       102,109    
Restricted cash     100       80    
Prepaid expenses and other current assets     4,243       1,299    
Total current assets     125,340       129,540    
Marketable securities - noncurrent     -        5,023    
Equipment, net     47       51    
Other noncurrent assets     15       15    
In-process research and development     34,200       34,200    
Goodwill     14,869       14,869    
Total Assets $   174,471   $   183,698    
       
LIABILITIES AND STOCKHOLDERS' EQUITY  
Current Liabilities:      
Notes payable $   2,697   $   3,962    
Accounts payable     2,825       1,436    
Accrued expenses and other current liabilities     2,393       1,439    
Total current liabilities     7,915       6,837    
Long-Term Liabilities:      
Deferred taxes     4,057       4,057    
Deferred revenue     41,176       41,176    
Other noncurrent liabilities     30       30    
Total liabilities     53,178       52,100    
Stockholders' Equity:      
Common stock     4       4    
Additional paid-in capital     298,089       295,975    
Accumulated deficit     (176,800 )     (164,381 )  
Total stockholders' equity     121,293       131,598    
Total Liabilities and Stockholders' Equity $   174,471   $   183,698    
       

 

 
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)      
    Three Months Ended March 31,
    (in thousands, except per share amounts)
      2018     2017  
       
Revenues   $   -    $   -   
Operating expenses:      
Research and development       8,449       7,614  
General and administrative       4,294       2,871  
Total operating expenses       12,743       10,485  
       
Foreign exchange losses       (18 )     (17 )
Investment income       414       59  
Interest expense       (71 )     (202 )
Net income (loss)   $   (12,418 ) $   (10,645 )
Loss per share:      
Basic and diluted   $   (0.32 ) $   (0.30 )
Weighted average shares:      
Basic and diluted       38,749       35,370  
       

 

Contact :

William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Minerva Neurosciences, Inc. via Globenewswire

Om Nasdaq GlobeNewswire

Nasdaq GlobeNewswire
Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra Nasdaq GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Nasdaq GlobeNewswire

Navigators Stockholders Approve Merger with The Hartford16.11.2018 22:01Pressemelding

STAMFORD, Conn., Nov. 16, 2018 (GLOBE NEWSWIRE) -- The Navigators Group, Inc. (NASDAQ:NAVG) (“Navigators”) announced that, at a special meeting of stockholders held today, Navigators’ stockholders approved the adoption of the previously announced merger agreement relating to the proposed transaction between Navigators and The Hartford Financial Services Group, Inc. (“The Hartford”), whereby Navigators will become a wholly owned subsidiary of The Hartford. Subject to the terms and conditions of the merger agreement, at the effective time of the merger, each eligible share of Navigators common stock will be cancelled and converted into the right to receive $70.00 in cash. The merger remains subject to various closing conditions, including receipt of various regulatory approvals, and is expected to close during the first half of 2019. About Navigators The Navigators Group, Inc. (NASDAQ: NAVG)(“Navigators” or the “Company”) is a global specialty insurance holding company. We provide custom

BlissCo Receives Cannabis Sales License from Health Canada16.11.2018 14:00Pressemelding

Not for distribution in the U.S. or to U.S. Newswires VANCOUVER, British Columbia, Nov. 16, 2018 (GLOBE NEWSWIRE) -- via NetworkWire – BlissCo Cannabis Corp. (CSE: BLIS) (OTCQB: HSTRF) (FRA: GQ4B) (“BlissCo” or the “Company”), is pleased to announce that it has received a comprehensive sales license from Health Canada to sell bulk cannabis and pre-packaged, labeled, and tested cannabis products. “We are thrilled to receive our sales license and to be able to start pre-registering clients and supplying both the robust medical and adult-use markets in Canada with our premium cannabis products,” said Damian Kettlewell, CEO of BlissCo. “BlissCo is committed to providing top-tier service to all of our customers.” The Company will soon be launching its e-commerce website and BlissConnect, a telemedicine app for medical cannabis consultations, to service its medical clients. The Company is currently ready to pre-register clients wishing to be first in line when shipping begins. To pre-registe

Gratomic Announces Non-Brokered Private Placement16.11.2018 14:00Pressemelding

TORONTO, Nov. 16, 2018 (GLOBE NEWSWIRE) -- Gratomic Inc. (“GRAT” or the “Company”) (TSX-V: GRAT) (FRANKFURT:CB81, WKN:A143MR) is pleased to announce the offering of a non-brokered private placement of up to 10,000,000 working capital units (the “WC Unit”) for up to $1,000,000 (the “Offering”). Each WC Unit is priced at $0.10 and consists of one (1) common share and one (1) common share purchase warrant (“WC Warrant”). Each WC Warrant entitles the holder to purchase one (1) common share (a “WC Warrant Share”) at a price of $0.20 per WC Warrant Share until the earlier of: (i) three (3) years following the Closing of the Offering; and (ii) in the event that the closing price of the Common Shares on the TSX Venture Exchange is at least $0.30 for ten (10) consecutive trading days, and the 10th trading day (the “Final Trading Day”) is at least four (4) months from the Closing Date, the date which is thirty (30) days from the Final Trading Day. Eligible Finders may receive 5% of the value of

Mitratech Listed Among Financial Times’ Inaugural Top 35 Intelligent Business Award Winners and Other Prestigious Categories16.11.2018 10:00Pressemelding

Legal Tech Top 10 FTIL Intelligent Business Award for Contracting FTIL Intelligent Business Award for Use of Legal Technology AUSTIN, Texas, Nov. 16, 2018 (GLOBE NEWSWIRE) -- The Financial Times’ inaugural FT Intelligent Business Special Report has recognized Mitratech among the top companies with the greatest impact on the practice and business of law. The report highlights the integration of people, processes, and data to solve a legal business’ operational challenges and how the ramifications of this back-office revolution are felt across organizations everywhere. “The fact that the Financial Times is now tracking the impact of legal technology reinforces that the industry is at a tipping point,” said Jason Parkman, Mitratech CEO. “There’s more transformation that lies ahead. We are honored and humbled to be a part of that movement and in good company with several clients we were recognized with.” The company was presented with the following honors: FT Intelligent Business Top 35: M

GridGain Ranked 77th Fastest Growing Company in North America on Deloitte’s 2018 Technology Fast 500™16.11.2018 09:00Pressemelding

1,724 Percent Growth Over the Past Four Years Ranks 19th in the San Francisco Bay Area FOSTER CITY, Calif., Nov. 16, 2018 (GLOBE NEWSWIRE) -- GridGain® Systems, provider of enterprise-grade in-memory computing solutions based on Apache® Ignite™, is ranked No. 77 on the Deloitte 2018 Technology Fast 500™, a ranking of the 500 fastest growing technology, media, telecommunications, life sciences and energy tech companies in North America. GridGain, which grew 1,724 percent over the past four years, was the 19th fastest growing company in the San Francisco Bay Area. “GridGain continues to benefit from strong market demand for our market-leading in-memory computing platform that helps customers realize their digital transformation and omnichannel customer experience initiatives,” said Abe Kleinfeld, President and CEO of GridGain Systems. “When you combine the best talent in the industry with great execution and strong customer demand, wonderful things happen.” “Congratulations to the Deloit

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom