Nasdaq GlobeNewswire

Minerva Neurosciences Reports Third Quarter 2017 Financial Results and Business Updates

Del

WALTHAM, Mass., Nov. 06, 2017 (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 September 30, 2017.

"As we approach year-end, we are completing the final steps prior to the initiation of a number of advanced-stage clinical efficacy trials with multiple compounds targeting significant unmet needs in CNS, highlighted by our lead product candidate, MIN-101 for the treatment of negative symptoms in schizophrenia," said Dr. Remy Luthringer, president and chief executive officer of Minerva.  "Our objective is to ensure rigorously conducted clinical trials that support well-defined product profiles, timely data readouts and a smooth transition to future regulatory review and commercialization."
                                          
MIN-101:

  • The Company is on schedule to initiate a pivotal Phase 3 trial of MIN-101 to treat negative symptoms in patients diagnosed with schizophrenia in the fourth quarter of 2017.  Top-line results from the three-month double blind phase of this trial are expected in the first half of 2019.
     
  • The final protocol for the Phase 3 trial has been submitted to the Investigational New Drug application (IND), and the first Institutional Review Board (IRB) approval has been received for the study in the U.S.   The trial will be a 12-week, double-blind, randomized, placebo-controlled, monotherapy study testing two doses of MIN-101 in schizophrenic patients with negative symptoms. These are the same two doses as those employed in the Phase 2b trial. After the double-blind phase, patients may enter a 40-week open label extension phase in which all will receive active treatment. This multi-center, international trial is expected to enroll approximately 500 patients at approximately 60 clinical sites across the U.S. and Europe, with 30 percent of patients coming from the U.S.
     
  • The Chemistry, Manufacturing and Controls (CMC) program has been initiated to ensure consistency between drug batches and its timely inclusion with the potential submission of a New Drug Application (NDA) pending a successful Phase 3 trial.

SELTOREXANT (MIN-202 OR JNJ-42847922):

  • The first patient has been enrolled in a Phase 2b clinical trial of seltorexant as adjunctive therapy to antidepressants in adult patients with major depressive disorder (MDD) who have responded inadequately to antidepressant therapy.  Approximately 280 patients are planned to be enrolled at more than 85 clinical sites in the U.S., Europe, Russia and Japan.  Two additional clinical trials of seltorexant are planned for initiation in the fourth quarter of 2017. These include a second Phase 2b trial in MDD and a Phase 2b trial in insomnia.
  • An amendment to the Company's co-development and license agreement with Janssen became effective on August 29, 2017 following approval of its terms by the European Commission.

MIN-117:

  • The Company plans to initiate patient recruitment in a Phase 2b clinical trial with MIN-117 in MDD in early 2018. This trial is expected to include patients with MDD who also have symptoms of anxiety, building upon previous Phase 2a clinical results that showed effects in both depressive symptomatology and anxiety.
     
  • In preparation for the Phase 2b trial, a food-effect study is currently ongoing with MIN-117 under the Company's IND.

MIN-301:

  • The Company is continuing to conduct pre-clinical, toxicology and other IND-enabling studies with MIN-301 as a prelude to advancing this compound into the initial stage of clinical development.
     
  • MIN-301 is a recombinant protein with the extra-cellular domain of neuregulin-1 beta primarily activating the ErbB4 receptor. Dysregulation of the NRG-1 signaling pathway has been linked to neurodevelopmental and neurodegenerative disorders including and beyond Parkinson's disease.

Third Quarter 2017 Financial Results 

  • Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2017 were approximately $143.3 million, compared to $83.0 million as of December 31, 2016.  As previously stated, Minerva expects that its cash, cash equivalents and marketable securities will be sufficient to fund its operations for at least the next 12 months.
     
  • R&D Expenses: Research and development (R&D) expenses were $9.0 million in the third quarter of 2017, compared to $5.9 million in the third quarter of 2016.  R&D expense in the three months ended September 30, 2017 and 2016 included non-cash stock-based compensation expenses of $0.5 million and $0.3 million, respectively. This increase in R&D expenses primarily reflects higher development expenses under the MIN-202 program for the Phase 2 clinical trials, increased expenses for the MIN-101 program and an increase in non-cash stock-based compensation expenses.

    For the nine months ended September 30, 2017, R&D expenses were $23.7 million, compared to $13.9 million for the nine months ended September 30, 2016. R&D expense in the nine months ended September 30, 2017 and 2016 included non-cash stock-based compensation expenses of $1.5 million and $0.7 million, respectively. This increase in R&D expenses primarily reflects higher development expenses under the MIN-202 program for the Phase 2 clinical trial, increased expenses for the MIN-101 program, an increase in personnel costs and an increase in non-cash stock-based compensation expenses. These amounts were partially offset by lower costs due to the completion of the Phase 2a clinical trial of MIN-117.

  • G&A Expenses: General and administrative (G&A) expenses were $2.5 million in the third quarter of 2017, compared to $2.4 million in the third quarter of 2016.  G&A expense in the three months ended September 30, 2017 and 2016 included non-cash stock-based compensation expenses of $0.8 million and $0.7 million, respectively. This increase was primarily due to an increase in professional fees during the three months ended September 30, 2017.

    For the nine months ended September 30, 2017, G&A expenses were $7.9 million, compared to $7.0 million for the same period in 2016. G&A expense in the nine months ended September 30, 2017 and 2016 included non-cash stock-based compensation expenses of $2.3 million and $1.8 million, respectively. This increase was primarily due to an increase in professional fees and an increase in non-cash stock-based compensation expenses during the nine months ended September 30, 2017.

  • Net Loss:  Net loss was $11.3 million for the third quarter of 2017, or a loss per share of $0.28 (basic and diluted), as compared to a net loss of $8.4 million, or a loss per share of $0.24 (basic and diluted) for the third quarter of 2016.  Net loss was $31.7 million for the first nine months of 2017, or a loss per share of $0.84 (basic and diluted), as compared to a net loss of $21.6 million, or a loss per share of $0.71 (basic and diluted) for the first nine months of 2016.

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 number 90294475.

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 products to treat CNS diseases.  Minerva's proprietary compounds include: MIN-101, in clinical development for schizophrenia; seltorexant (MIN-202 or JNJ-42847922), in clinical development for insomnia and major depressive disorder (MDD); MIN-117, in clinical development for 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 future clinical trials and results of clinical trials with MIN-101, seltorexant, MIN-117 and MIN-301.  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 MIN-101, seltorexant, MIN-117 and MIN-301 will advance further in the clinical trials process; 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, filed with the Securities and Exchange Commission on November 6, 2017.  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)
  September 30, December 31,
  2017     2016  
  (in thousands)
ASSETS
Current Assets:    
Cash and cash equivalents $   36,255   $   82,981  
Marketable securities     96,675      -  
Restricted cash     80       80  
Prepaid expenses and other current assets     1,073       803  
Total current assets     134,083       83,864  
Marketable securities - noncurrent     10,355     -  
Equipment, net   -       10  
In-process research and development     34,200       34,200  
Goodwill     14,869       14,869  
Total Assets $   193,507   $   132,943  
     
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:    
Notes payable - current portion $   5,194   $   4,854  
Accounts payable     1,504       1,467  
Accrued expenses and other current liabilities     2,022       816  
Accrued collaborative expenses   -       2,548  
Total current liabilities     8,720       9,685  
Long-Term Liabilities:    
Notes payable - noncurrent   -       3,841  
Deferred taxes     13,434       13,434  
Deferred revenue     41,176     -  
Total liabilities     63,330       26,960  
Stockholders' Equity:    
Common stock     4       4  
Additional paid-in capital     294,717       238,837  
Accumulated deficit     (164,544 )     (132,858 )
Total stockholders' equity     130,177       105,983  
Total Liabilities and Stockholders' Equity $   193,507   $   132,943  

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS      
(Unaudited)            
    Three Months Ended September 30,   Nine Months Ended September 30,
    (in thousands, except per share amounts)   (in thousands, except per share amounts)
      2017     2016       2017     2016  
             
Revenues   $ -   $ -     $ -   $ -  
Operating expenses:            
Research and development       8,956       5,852         23,715       13,941  
General and administrative       2,451       2,380         7,923       7,012  
Total operating expenses       11,407       8,232         31,638       20,953  
             
Foreign exchange losses       (9 )     (3 )       (46 )     (28 )
Investment income       294       70         508       137  
Interest expense       (138 )     (259 )       (510 )     (797 )
Net loss   $    (11,260 ) $    (8,424 )   $    (31,686 ) $   (21,641 )
Loss per share:            
Basic and diluted   $   (0.28 ) $   (0.24 )   $   (0.84 ) $   (0.71 )
Weighted average shares:            
Basic and diluted       40,880       34,806         37,677       30,393  

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

Constellation Brands Prices Offering of Senior Notes22.10.2018 23:52Pressemelding

VICTOR, N.Y., Oct. 22, 2018 (GLOBE NEWSWIRE) -- Constellation Brands, Inc. (NYSE: STZ and STZ.B), a leading beverage alcohol company, announced today that it priced the public offering of $2.15 billion aggregate principal amount of Senior Notes, consisting of (i) $650.0 million of Senior Floating Rate Notes due 2021 (the “senior floating rate notes”); (ii) $500.0 million of 4.400% Senior Notes due 2025 (the “2025 notes”) for a public offering price of 99.812% of the principal amount of the 2025 notes; (iii) $500.0 million of 4.650% Senior Notes due 2028 (the “2028 notes”) for a public offering price of 99.720% of the principal amount of the 2028 notes; and (iv) $500.0 million of 5.250% Senior Notes due 2048 (the “2048 notes”) for a public offering price of 99.592% of the principal amount of the 2048 notes (collectively, the “notes”). The notes will be senior obligations that rank equally with all of Constellation’s other senior unsecured indebtedness, and will be guaranteed by the subs

Forterra Announces Third Quarter 2018 Earnings Schedule22.10.2018 22:30Pressemelding

IRVING, Texas, Oct. 22, 2018 (GLOBE NEWSWIRE) -- Forterra, Inc. (“Forterra”) (Nasdaq: FRTA) plans to release third quarter 2018 financial results before the market opens on Tuesday, November 6, 2018. A conference call to review financial results will also be held on Tuesday, November 6, 2018 at 10:00 a.m. Eastern time (9:00 a.m. Central). Hosting the call will be Jeff Bradley, Chief Executive Officer, and Charlie Brown, Executive Vice President and Chief Financial Officer. CONFERENCE CALL AND WEBCAST DETAILS Webcast Information Event: Q3 2018 Forterra, Inc. Earnings Call Date: Tuesday, November 6, 2018 Time: 10:00 a.m. Eastern Time (9:00 a.m. Central) https://edge.media-server.com/m6/p/6dinjr8x Conference Call Information U.S.: 1-574-990-1396 Toll-Free: 1-844-498-0572 Participant Passcode: 2467118 Replay Information A replay of the conference call will be available within 24 hours after the call on the “Events & Presentations” page under the Investor section of the Company’s website at

Ondot Announces Investment from Citi Ventures to Power Enriched Transactions22.10.2018 17:00Pressemelding

The investment will fuel Ondot’s international growth and give cardholders accessing info via Ondot’s platform increased control over and visibility into each transaction Santa Clara, Ca, Oct. 22, 2018 (GLOBE NEWSWIRE) -- Ondot Systems, the global leader in mobile payments services, today announced that it has secured a strategic funding investment from Citi Ventures. Ondot works directly with financial institutions to give consumers increased control over and visibility into their personal payment transactions. With Ondot, consumers can manage functions such as fraud alerts, transaction limits and purchase location restrictions, all from the convenience of an app on their smartphone or desktop. This investment will further support Ondot’s efforts to grow its international presence and product offerings. Today’s digitally connected consumers are looking for more ways to access detailed information about their digital lives — including personal payment transactions. Ondot’s platform add

Auth0 Supports Global Growth with Office Expansions in US and UK22.10.2018 15:00Pressemelding

New offices accommodate rapid employee growth and reinforce customer commitment BELLEVUE, Wash. and LONDON, Oct. 22, 2018 (GLOBE NEWSWIRE) -- Auth0, a global leader in Identity-as-a-Service (IDaaS), today announced it has moved into larger offices in Bellevue, WA, and London, UK, to accommodate current and future growth. The company’s headquarters in Bellevue has experienced an upsurge in employees over the past year, signalling its continued growth trajectory in the region. Recently named a Gold winner in the Seattle Business Tech Impact awards, along with additional industry recognition as a great place to work, Auth0 is attracting top talent in the area. The new office occupies the entire 6th floor of the U.S. Bank Plaza, located at 10800 NE 8th St. The new London office at 182-194 Union St. is a former Victorian-style warehouse, located in the South Bank district. This opening also launches the new “Auth0 Identity Centre,” a 50-seat event space where the company will host customers

Paysafe’s Differentiated Solutions and Customer Service Recognized by Independent Research Firm22.10.2018 15:00Pressemelding

Recently Published Report Also Acknowledges its Bold Strategy and Vision LONDON, Oct. 22, 2018 (GLOBE NEWSWIRE) -- Paysafe Group (“Paysafe”), a leading global payments provider, has been named a ‘Strong Performer’ in a recently published third party report: The Forrester Wave™: Global Merchant Payment Providers, Q4 2018. In the report, Forrester acknowledges Paysafe’s bold strategy and vision and gives it the highest possible score in the omnichannel solution criterion. It also describes Paysafe as a “best fit for merchants that are positioned to take advantage of its many value-added services and consumer businesses” and states that the Paysafe product offering “is one of the most differentiated solution value propositions” of any provider in the report. The Forrester report also comments on Paysafe’s customer service focus, stating client references “were extremely pleased with Paysafe’s transparency and customer service.” Joel Leonoff, President and CEO, Paysafe Group, commented: “W

Mitratech Announces TeamConnect Essentials for Mid-Sized Legal Departments22.10.2018 15:00Pressemelding

New SaaS Legal Operations Solution Can Save $250,000 Per Year in Staff Time Savings and Reduced Legal Spend AUSTIN, Texas, Oct. 22, 2018 (GLOBE NEWSWIRE) -- Mitratech today announced the launch of TeamConnect Essentials, an easy-to-use, quick-to-implement SaaS legal operations solution designed for legal departments who want to leverage built-in best practices validated by 30 years of Mitratech’s client experience. Essentials is built on Mitratech’s TeamConnect platform and acts as a central hub for all legal operations, including integrated matter management, outside counsel management, e-Billing, Microsoft® Office integration, and reporting, delivered as an adaptable, cloud-based solution. “Thirty percent of FORTUNE 500 companies currently use TeamConnect as a platform for legal department innovation. We’ve taken our experience with those customers and others, coupled it with a streamlined implementation program, and created a unique solution for legal departments earlier in their tr

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

Besøk vårt presserom