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

Resverlogix Provides Unrestricted Educational Grant for Epigenetic Symposium at International Renal Congress25.5.2018 07:45Pressemelding

CALGARY, Alberta, May 24, 2018 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) today announced that on Friday, May 25, 2018, at the European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) Congress in Copenhagen, Denmark, the Company is supporting a symposium titled: "Epigenetics in CKD & CVD: A potential breakthrough therapy?" The symposium highlights the role of epigenetics and BET-inhibition in chronic kidney disease and cardiovascular disease, especially in patients with diabetes mellitus, and the significant unmet need that still exists in this patient population. The symposium is co-chaired by Vincent M. Brandenburg, MD - Nephrologist, Aachen, Germany and Kamyar Kalantar-Zadeh, MD - UC Irvine School of Medicine, Irvine, CA, USA, both leading scientists also serving as advisors to Resverlogix's Renal program. The speakers and agenda are as follows: Introduction Vincent M. Brandenburg, MD - University Hospital of the RWTH

Atico Reports Consolidated Financial Results for the First Quarter of 201824.5.2018 22:30Pressemelding

(All amounts expressed in US dollars, unless otherwise stated) VANCOUVER, British Columbia, May 24, 2018 (GLOBE NEWSWIRE) -- Atico Mining Corporation (the "Company" or "Atico") (TSX.V:ATY) (OTC:ATCMF) today announced its financial results for the three months ended March 31, 2018, posting a net income of $0.4 million. Fernando E. Ganoza, CEO and Director, commented, "The strong production and all-in sustaining cash cost of $1.85 achieved this quarter is not reflected in the financial results as a large concentrate shipment was delayed to the second quarter, along with the revenue associated with those tonnes. The shipping schedule is expected to stabilize during the second quarter, where we will then benefit from the additional shipped concentrate and recognized revenue. We anticipate strong financial results in the next quarter." Mr. Ganoza continued, "Our emphasis will continue to be on further strengthening our balance sheet, improving production costs and most importantly regional

Luxembourg Announced as SNOMED International's Newest Member24.5.2018 15:16Pressemelding

London, United Kingdom, May 24, 2018 (GLOBE NEWSWIRE) -- SNOMED International and Agence eSanté Luxembourg are pleased to announce that Luxembourg has joined the organization as its thirty-second Member. Luxembourg, one of the leading nations in the area of information and communication technology, has set the development of eHealth technologies as a high priority. Agence eSanté, Luxembourg's national agency for the exchange and sharing of medical data, has set an overall mission to facilitate clinical information exchange both within Luxembourg and across other international actors. To work towards this reality, the agency has taken part in discussions about standardization across Europe, a contributing building block achieved with its membership in SNOMED International. With their membership, Agence eSanté has committed their support for the use of structured clinical terminology. When applied to the health sector, interoperability ensures that information systems, and through them h

SEMAFO Signs Underground Mining Services Contract with AUMS24.5.2018 14:00Pressemelding

MONTREAL, May 24, 2018 (GLOBE NEWSWIRE) -- SEMAFO Inc. (TSX:SMF) (OMX:SMF) reports that it has signed a mining services contract with African Underground Mining Services ("AUMS") to provide turnkey mining services for Siou underground. AUMS is a well-known and reputable mining contractor with underground experience in Burkina Faso and across Africa. Under the mining services contract, AUMS will be responsible for supplying the mining fleet and a skilled labour force for Siou underground in addition to ensuring development, production and auxiliary services. SEMAFO will provide technical services including geology and engineering as well as leveraging the existing surface infrastructure at Mana. The mining services contract has a term of 70 months. The economic terms of the mining services contract are consistent with the economics presented in the Mana pre-feasibility study filed March 29, 2018 on SEDAR. Preparatory work has already commenced on Siou underground with full project deplo

Merus Announces First Patient Dosed in Phase 1 Clinical Trial of MCLA-158 in Patients with Solid Tumors24.5.2018 13:00Pressemelding

- IND Accepted in April by the U.S. FDA for MCLA-158 - UTRECHT, The Netherlands, May 24, 2018 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced that the first patient has been dosed in a Phase 1, first-in human clinical trial of MCLA-158 in patients with solid tumors with an initial focus on metastatic colorectal cancer. The trial will be conducted in Europe, where several Clinical Trial Applications (CTAs) have been approved to date. The Company also announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MCLA-158, which was accepted by the FDA in April 2018. With this acceptance, Merus plans to open additional sites for this trial in the United States. MCLA-158 is designed to bind to cancer stem cells expressing leucine-rich repeat-containing G protein-coupled receptor 5 (Lgr5) and epidermal grow

PRA Named International Clinical Research Company of the Year24.5.2018 10:00Pressemelding

RALEIGH, N.C., May 24, 2018 (GLOBE NEWSWIRE) -- PRA Health Sciences, Inc. (NASDAQ:PRAH) is pleased to announce it was recognized by PharmaTimes as the International Clinical Research Company of the Year. This is the fifth year in a row that PRA has received this award. "This award celebrates excellence in the clinical research industry and we are honored to once again be recognized by our peers," said Colin Shannon, President and Chief Executive Officer. "This award is possible thanks to the incredibly talented PRA team members we have working around the world who are deeply committed to their work in bringing new and life-saving therapies to the patients who need them." PRA also swept the Clinical Research Associate and Clinical Trial Administrator categories capturing a total of 11 awards. These awards follow PRA's recognition earlier this month in the PharmaTimes Americas competition where PRA also received 11 awards, including Company of the Year. The PharmaTimes, International Cli

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

Besøk vårt presserom