NASDAQ OMX

Minerva Neurosciences Reports Third Quarter 2017 Financial Results and Business Updates

Dela

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 OMX
NASDAQ OMX



Följ NASDAQ OMX

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från NASDAQ OMX

Aurora Solar Technologies Named to TSX Venture 5022.2.2018 21:29Pressmeddelande

Aurora Solar Technologies Inc. / Aurora Solar Technologies Named to TSX Venture 50 . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement. NORTH VANCOUVER, British Columbia, Feb. 22, 2018 (GLOBE NEWSWIRE) -- Aurora Solar Technologies Inc. ("Aurora")("Company")(TSX.V:ACU) (OTCBB:AACTF) (FSE:A82), a leader in inline measurement and control technology for the photovoltaic manufacturing industry, is pleased to announce that it has been named to the 2018 TSX Venture 50. The Venture 50 are the top ten companies listed on TSX Venture Exchange in each of five major industry sectors - mining, energy & energy services, clean technology & life sciences, diversified industries and technology - based on a ranking formula with equal weighting given to return on investment, market cap growth, trading volume and analyst coverage. All data was as of December 31, 2017. Michael Heaven, President, CEO, and Director of Aurora Solar T

CP Kelco Appoints Jennifer Aspen Mason as Sr. Vice President, Global Innovation22.2.2018 20:00Pressmeddelande

ATLANTA, Feb. 22, 2018 (GLOBE NEWSWIRE) -- CP Kelco, a leading global producer of specialty hydrocolloid solutions, announced today that Jennifer Aspen Mason has joined its Executive Leadership Team as Senior Vice President, Global Innovation, reporting directly to CP Kelco President Didier Viala. A global executive with more than 20 years of industry experience, Mason has an extensive background leading science organizations with Fortune 100 companies. Most recently, she spent more than five years with Mars, Incorporated, where she served as Technology and Science Strategy Officer for all Mars segments. In her new role, Mason is responsible for leading CP Kelco's global research and development (R&D) function, including strategic innovation imperatives to drive the company's long-term growth, as well as oversight of technical teams focused on new product innovation, process R&D and research. "We are truly delighted to welcome Jennifer to our team, and will surely benefit from her glob

Leading the industry: Excel Dryer is the first hand dryer manufacturer to publish third-party, verified Environmental Product Declarations (EPDs)22.2.2018 16:00Pressmeddelande

High-speed, energy-efficient XLERATOR®, XLERATOReco® and ThinAir® Hand Dryers evaluated and proven to be sustainable EAST LONGMEADOW, Mass., Feb. 22, 2018 (GLOBE NEWSWIRE) -- Excel Dryer, Inc., today announced that three of their hand dryers, the original, patented, high-speed, energy-efficient XLERATOR® Hand Dryer, the XLERATOReco® Hand Dryer and the ThinAir® Hand Dryer, were evaluated, and their environmental claims, substantiated with the publication of the hand dryer industry's first Environmental Product Declarations (EPDs) by UL Environment, a business division of Underwriters' Laboratories. An Environmental Product Declaration is a standardized way of quantifying the environmental impact of a product by studying the raw materials and energy consumption during its production, use and disposal. For buyers and specifiers, the EPDs are a disclosure tool that helps purchasers better understand a product's sustainable qualities and environmental repercussions so they can make more inf

Intrinsyc Technologies (TSX: ITC and OTC: ISYRF) debuts system on module and development kit powered by NXP i.MX 8M processor22.2.2018 15:00Pressmeddelande

Powerful Embedded Computing Solutions Optimized for Multimedia Applications VANCOUVER, British Columbia, Feb. 22, 2018 (GLOBE NEWSWIRE) -- Intrinsyc Technologies Corporation (TSX:ITC) (OTC:ISYRF) ("Intrinsyc" or the "Company"), a leading provider of solutions for the development and production of embedded and Internet of Things ("IoT") products, today announced the availability of the Open-X(TM) 8M System on Module ("SOM") and Development Kit. Intrinsyc's Open-X(TM) 8M SOM incorporates the new 64-bit NXP i.MX 8M processor and is ideal for powering IoT devices ranging from consumer smart home appliances to industrial building automation products. Its ultra-compact (55mm x 35mm) size enables its use in a wide range of form factors. The feature-rich SOM, with its advanced video and audio features, is ideal for streaming video/audio devices, voice control applications, and human-machine interface solutions. It offers high quality video playback with full 4K UHD and HDR along with the highe

Danal Inc. Creates Largest and Best Global Mobile Identity Solution22.2.2018 14:00Pressmeddelande

On track to cover 3 Billion+ Consumers SAN JOSE, Calif., Feb. 22, 2018 (GLOBE NEWSWIRE) -- Danal, Inc., a global leader in mobile identity and authentication services, today announced that customer demand is driving its expansion into Asia and LATAM. The company is expanding to eight countries in Asia and LATAM this year in addition to its continued expansion in Europe and UK - creating the largest and most comprehensive Mobile Network Operator (MNO) based identity solution in the market. It is on track to cover over 3 Billion consumers worldwide and support numerous Fortune 500 Enterprises in their endeavor to fight fraud, account takeovers, assuring reliable consumer authentication with best in class experiences, and help conform to regulatory compliance including GDPR, TCPA, KYC and AML. Danal is experiencing strong demand by global brands for the US, EU, and Asian markets - especially in the financial sector like banks, insurances, money remitters, payment processors and innovative

Valeritas Announces V-Go® Distribution Agreement in Italy with Movi SpA22.2.2018 13:00Pressmeddelande

BRIDGEWATER, N.J., Feb. 22, 2018 (GLOBE NEWSWIRE) -- Valeritas Holdings, Inc. (NASDAQ:VLRX), a medical technology company which offers patients with type 2 diabetes V-Go® Wearable Insulin Delivery device, a simple, affordable, all-in-one insulin delivery option that is worn like a patch and can eliminate the need for taking multiple daily shots, today announced it has signed an exclusive distribution agreement with Movi SpA ("Movi") for the commercialization of V-Go Wearable Insulin Delivery device in Italy. Under the terms of the agreement, Valeritas has granted Movi the rights to promote, market, and sell the Company's flagship product V-Go Wearable Insulin Delivery device to diabetes clinics and patients in Italy. "We are thrilled to have Movi as our partner, and our distribution agreement is a significant first step to expand market access for V-Go Wearable Insulin Delivery device outside of the United States," said John Timberlake, CEO and President of Valeritas. "Movi is a truste

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum