Nasdaq GlobeNewswire

Minerva Neurosciences Reports Third Quarter 2017 Financial Results and Business Updates


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."

  • 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.


  • 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.


  • 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  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

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 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.


  September 30, December 31,
  2017     2016  
  (in thousands)
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  
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  


    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  


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 8700

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

Pinnacle Studio 22 Ultimate Amps Up Video Editing with New Pro-inspired Features14.8.2018 15:11Pressemelding

New Three- and Four-Point Editing, Color Grading, and MultiCam Capture Lite deliver advanced video editing options to bring your videos even closer to pro OTTAWA, Aug. 14, 2018 (GLOBE NEWSWIRE) -- Introducing Pinnacle Studio™ 22 Ultimate, Pinnacle’s flagship video editing software that offers powerful features, precise editing controls, and premium effects to create eye-catching video projects with professional flair. With new Three- and Four-Point Editing, Color Grading, dynamic Split Screen videos, MultiCam Capture Lite, and more, Pinnacle Studio 22 Ultimate gives users a complete collection of pro-inspired features to express their unique vision and achieve stunning results. “Pinnacle Studio Ultimate is the go-to choice for users looking for true creative control and a sophisticated editing experience from a consumer video editor,” said Michel Yavercovski, Senior Director of Product Management for Pinnacle. “With the latest version, we’re pushing this even further with a pro-inspire

Keesal, Young & Logan and Mitratech Announce TAP Workflow Automation Partnership with the Launch of Keesal Propulsion Labs14.8.2018 15:02Pressemelding

NEW YORK, Aug. 14, 2018 (GLOBE NEWSWIRE) -- Keesal, Young & Logan (KYL) and Mitratech announced today the TAP Workflow Automation partnership to help a greater number of legal professionals quickly implement standardization and compliance across a wide range of legal processes, starting with KYL’s own clients. But it doesn’t stop there. The partnership has resulted in the launch of Keesal Propulsion Labs (KPL) designed to position KYL as an extension of their clients’ teams — helping them to expand and connect their tech stack to solve complex legal and business process challenges. “The goal of KPL is to break down the walls between solution providers, law firms and clients so they can operate as one unit and transform legal operations into a center of excellence that drives innovation across the entire organization,” said Justin Hectus, CIO/CISO at KYL. “By creating cross-ecosystem collaboration, we are uniting people, processes, and compliance, to help mitigate risk and position the

Meltwater launches data science platform to tame real-time market signals found in world’s online data14.8.2018 15:00Pressemelding

AI-powered platform democratises analytics of forward-looking indicators based on insights from the outside, known as Outside Insight SAN FRANCISCO, Aug. 14, 2018 (GLOBE NEWSWIRE) -- In the quest to become data-driven, companies are increasingly investing in Business Intelligence software to gain a competitive advantage. Yet the insights generated by those tools are mostly fuelled by data from within a company’s walls, instead of the real-time market signals found externally online – from consumer opinions to corporate filings. This outside data can unlock key indicators about an industry or competitor, but harnessing the volume and variety of global data is a time-intensive task. And although advances in artificial intelligence have made it easier to capture and analyse this data to create powerful insights, most commercial AI tools are one-size-fits-all models with limited capabilities. That’s why Meltwater – a pioneer of media intelligence and curator of the world’s most diverse col

Gratomic Provides Update on Perpetuus Graphene Development Program14.8.2018 14:00Pressemelding

TORONTO, Aug. 14, 2018 (GLOBE NEWSWIRE) -- Gratomic Inc. (“GRAT” or the “Company”) (TSX-V: GRAT) (FRANKFURT:CB81, WKN:A2JAP3). Gratomic, is pleased to provide an update on its previously announced Graphene development program primarily targeted towards elastomer and polymer tire markets, launched with its European partner, Perpetuus Carbon Technologies Limited (“Perpetuus”), a wholly owned subsidiary of Perpetuus Advanced Materials. As disclosed by Gratomic on April 22, 2018, Perpetuus and Gratomic executed a letter of collaboration pursuant to which Perpetuus undertook to build three specialized process tooling chambers (“Chambers”) to be used solely for processing Graphite from Gratomic’s Aukam Graphite mine in Namibia. The first of such Chambers has passed the testing phase and is ready to process the Aukam sourced Graphite, the second Chamber is presently under construction with the third to follow immediately thereafter. Photos accompanying this announcement are available at http:

CrownBio Expands Genetically Engineered Model Selection Via Strategic Alliance with Shanghai Model Organisms Center (SMOC)14.8.2018 14:00Pressemelding

Alliance enables researchers to access thousands of GEMMs SAN DIEGO, Aug. 14, 2018 (GLOBE NEWSWIRE) -- Crown Bioscience, a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, has entered a strategic alliance with Shanghai Model Organisms Center (SMOC) to exclusively license and commercialize SMOC’s comprehensive collection of genetically engineered models, including proprietary transgenic and reporter models for oncology, cardiovascular and immunology research. SMOC leverages expertise in several gene editing technologies to develop conventional knockout (KO), conditional KO, transgenic knock-in and humanized models. These capabilities are now exclusively available to CrownBio’s international clients for custom model generation, breeding, IVF, rapid expansion and re-derivation capabilities. “The strategic alliance with SMOC helps CrownBio become a leading global provid

Paper in Scientific Reports Highlights Ability of 4D Pharma’s MRx0004 to Protect Against Airway Inflammation in Severe Asthma14.8.2018 08:00Pressemelding

Data suggest that MRx0004 is a promising next-generation therapeutic for management of asthma LEEDS, United Kingdom, Aug. 14, 2018 (GLOBE NEWSWIRE) -- 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of live biotherapeutics, today announces the publication of a paper demonstrating that MRx0004, a live biotherapeutic derived from the human gut microbiome, can protect against airway inflammation by reducing both neutrophilic and eosinophilic infiltration in a mouse model of severe asthma. The paper “Bifidobacterium breve MRx0004 protects against airway inflammation in a severe asthma model by suppressing both neutrophil and eosinophil lung infiltration” (Raftis et al.) is published in the Nature Publishing Group journal Scientific Reports . Asthma is a phenotypically heterogeneous disease. Between 5-10 % of asthma patients have a severe form of the disease which is refractory to steroid treatment and whose symptoms cannot be controlled despite the application o

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

Besøk vårt presserom