Minerva Neurosciences Reports Second Quarter 2017 Financial Results and Business Updates
FDA feedback on clinical trial design and completion of bridging study with new formulation enable initiation of Phase 3 trial with MIN-101 to treat negative symptoms of schizophrenia in second half of 2017
Amended agreement with Janssen supports dual focus of clinical development with MIN-202 in insomnia and major depressive disorder
Extended financial runway allows for timely advancement of clinical development with multiple product candidates
WALTHAM, Mass., Aug. 03, 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 June 30, 2017.
"A highly productive second quarter of 2017 included progress on a number of fronts related to clinical trial preparation, business development and financing activities," said Dr. Remy Luthringer, president and chief executive officer of Minerva. "This progress will support the timely initiation of five late-stage clinical efficacy trials with three product candidates by the end of 2017."
· Following an "end-of-Phase 2 meeting" with the U.S. Food and Drug Administration (FDA), the Company is finalizing the design of a pivotal Phase 3 trial of MIN-101 to treat negative symptoms in patients with a diagnosis of schizophrenia. Key elements in this design include:
- A three-month randomized, double blind placebo controlled core stage followed by a nine-month extension phase;
- Monotherapy administration of MIN-101;
- Testing of the same daily doses, 32 milligrams (mg) and 64 mg, as those used in the successfully completed Phase 2b study;
- Primary outcome of improvement in negative symptoms;
- Recruitment of approximately 500 patients from approximately 60 clinical sites, one third of whom will come from the U.S.;
- Recruitment of patients who have been symptomatically stable in terms of positive and negative symptoms for six months, with moderate to severe negative symptoms.
· The Company has recently completed a bridging study to identify a new, improved formulation of MIN-101 to be used in the Phase 3 trial. The improved formulation is designed to provide bioequivalent exposures with the Phase 2b formulation while enhancing the safety profile of the compound.
· The Phase 3 trial is planned to be initiated on schedule in the second half of 2017, and we expect to release top-line results from the three-month double blind phase of the trial in the first half of 2019.
· The Company announced on May 31, 2017 that it entered into an amended agreement with Janssen, conditional upon final approval by the European Commission, whereby Minerva will gain strategic control of the development of MIN-202 to treat insomnia. Janssen will forego its right to royalties on MIN-202 insomnia sales in Minerva territories. Minerva will retain all of its current rights to MIN-202 in all indications.
· Key financial terms of the amended agreement include payments to Minerva by Janssen of $30 million on final approval by the European Commission, $20 million at the start of a Phase 3 insomnia trial and $20 million when 50% of the patients are enrolled in this trial. Janssen will waive all remaining costs payable by Minerva (approximately $13 million) to completion of Phase 2 development of this compound. Minerva will assume all responsibility for Phase 3 development costs in insomnia and contribute 40% of Phase 3 development costs in other indications, including major depressive disorder (MDD).
· All Minerva stock currently owned by Johnson & Johnson Innovation - JJDC, Inc., totaling approximately 3.9 million shares and representing approximately 10% of total Minerva shares outstanding at June 30, 2017 will be repurchased by Minerva at par value of $.0001 per share or approximately $389 in total.
· Three Phase 2b trials with MIN-202 are planned for initiation before the end of 2017, including two trials in patients suffering from MDD and one in insomnia disorder without neuropsychiatric comorbid symptoms.
· A Phase 2b clinical trial with MIN-117 in MDD is planned for initiation in late 2017 and expected to include patients who have both mood and anxiety disorders.
· The Company currently plans to define a primary endpoint of MDD and a secondary endpoint of anxiety in this trial, building upon previous Phase 2a clinical results that showed effects in both depressive symptomatology and anxiety, as well pharmacodynamic effects showing the preservation of sleep continuity and architecture with no detrimental effects on rapid eye movement sleep distribution and duration.
· Minerva is planning to advance its pre-clinical stage compound, MIN-301, into the initial stage of clinical development as a treatment for Parkinson's disease.
· MIN-301 is a recombinant protein with the extra-cellular domain of neuregulin-1 beta primarily activating the ErbB4 receptor. Pre-clinically, MIN-301 has been shown to cross the blood-brain barrier and to have neuro-protective and neuro-restorative effects.
· The next planned steps in the MIN-301 program, after completion of the regular toxicology studies and final production of the GMP batch, will include filing an Investigational New Drug application (IND) and/or Investigational Medicinal Product Dossier (IMPD).
· The Company completed a public offering of 5,750,000 shares of common stock, including 750,000 shares sold pursuant to the underwriters' full exercise of their option to purchase additional shares, on July 5, 2017 that resulted in net proceeds of approximately $41.5 million. These resources will support the continued clinical development of MIN-101, MIN-202 and MIN-117, as well as the initial clinical development of MIN-301 for Parkinson's disease.
Second Quarter 2017 Financial Results
· Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2017 were approximately $77.6 million, compared to $83.0 million as of December 31, 2016.
· R&D Expenses: Research and development (R&D) expenses were $7.1 million in the second quarter of 2017, compared to $2.7 million in the second quarter of 2016, an increase in total expense of $4.4 million. R&D expense in the three months ended June 30, 2017 and 2016 included non-cash stock-based compensation expenses of $0.5 million and $0.2 million, respectively. This increase in R&D expenses primarily reflects higher development expenses under the MIN-202 program for Phase 2 clinical trial preparation, increased expenses for the MIN-101 program and an increase in non-cash stock-based compensation expenses. These amounts were partially offset by reduced costs related to our Phase 2a clinical trial of MIN-117 due to its completion in May 2016.
For the six months ended June 30, 2017, R&D expenses were $14.8 million, compared to $8.1 million for the six months ended June 30, 2016, an increase in total expense of $6.7 million. R&D expense in the six months ended June 30, 2017 and 2016 included non-cash stock-based compensation expenses of $1.0 million and $0.5 million, respectively. This increase in R&D expenses primarily reflects higher development expenses under the MIN-202 program for Phase 2 clinical trial preparation, increased expenses for the MIN-101 program and an increase in non-cash stock-based compensation expenses. These amounts were partially offset by reduced costs related to our Phase 2a clinical trial of MIN-117 due to its completion in May 2016.
· G&A Expenses: General and administrative (G&A) expenses were $2.6 million in the second quarter of 2017, compared to $2.3 million in the second quarter of 2016, an increase of approximately $0.3 million. G&A expense in the three months ended June 30, 2017 and 2016 included non-cash stock-based compensation expenses of $0.7 million and $0.6 million, respectively. This increase was primarily due to an increase in professional fees during the three months ended June 30, 2016.
For the six months ended June 30, 2017, G&A expenses were $5.5 million, compared to $4.6 million for the same period in 2016, an increase of approximately $0.9 million. G&A expense in the six months ended June 30, 2017 and 2016 included non-cash stock-based compensation expenses of $1.5 million and $1.2 million, respectively. This increase was primarily due to an increase in professional fees during the six months ended June 30, 2017.
· Net Loss: Net loss was $9.8 million for the second quarter of 2017, or a loss per share of $0.27 (basic and diluted), as compared to a net loss of $5.2 million, or a loss per share of $0.18 (basic and diluted) for the second quarter of 2016. Net loss was $20.4 million for the first six months of 2017, or a loss per share of $0.57 (basic and diluted), as compared to a net loss of $13.2 million, or a loss per share of $0.47 (basic and diluted) for the first six 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 53086270.
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; MIN-202 (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 improved formulation of MIN-101 to be used in the planned Phase 3 trial of MIN-101; the approval by the European Commission of the amendment to our co-development agreement with Janssen and the related stock repurchase agreement; our ability to negotiate and execute the definitive agreements described above; the timing and results of future clinical milestones with MIN-202 in insomnia and major depressive disorder, including the timing and scope of future clinical trials and results of clinical trials with this compound; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies; our agreements with Janssen related to MIN-202; our ability to successfully develop and commercialize MIN-101, MIN-202, MIN-117 and MIN-301; 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, the inherent uncertainty in approval by the European Commission of the amendment to our co-development agreement with Janssen and the related stock repurchase agreement; whether MIN-101, MIN-202, MIN-117 and MIN-301 will advance further in the clinical trials process and whether and when, if at all, it will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether the results of future clinical trials of MIN-101, MIN-202, MIN-117 and MIN-301, if any, will be consistent with the results of past clinical trials; whether MIN-101, MIN-202, MIN-117 and MIN-301 will be successfully marketed if approved; whether any of our therapeutic product discovery and development efforts will be successful; our ability to achieve the results contemplated by our co-development agreements; 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 June 30, 2017, filed with the Securities and Exchange Commission on August 3, 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|
|June 30,||December 31,|
|Cash and cash equivalents||$||50,191||$||82,981|
|Prepaid expenses and other current assets||423||803|
|Total current assets||78,075||83,864|
|In-process research and development||34,200||34,200|
|Deferred public offering costs||233||-|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Notes payable - current portion||$||5,067||$||4,854|
|Accrued expenses and other current liabilities||1,443||816|
|Accrued collaborative expenses||6,646||2,548|
|Total current liabilities||14,588||9,685|
|Notes payable - noncurrent||1,326||3,841|
|Additional paid-in capital||251,311||238,837|
|Total stockholders' equity||98,032||105,983|
|Total Liabilities and Stockholders' Equity||$||127,380||$||132,943|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended June 30,||Six Months Ended June 30,|
|(in thousands, except per share amounts)||(in thousands, except per share amounts)|
|Research and development||7,144||2,714||14,758||8,089|
|General and administrative||2,601||2,250||5,472||4,632|
|Total operating expenses||9,745||4,964||20,230||12,721|
|Foreign exchange losses||(20||)||(16||)||(37||)||(25||)|
|Loss per share:|
|Basic and diluted||$||(0.27||)||$||(0.18||)||$||(0.57||)||$||(0.47||)|
|Weighted average shares:|
|Basic and diluted||36,720||29,122||36,048||28,163|
William B. Boni
VP, Investor Relations/
Minerva Neurosciences, Inc.
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
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
Bombardier Delivers First 90-seat Q400 Aircraft to SpiceJet21.9.2018 16:00 | Pressemelding
SpiceJet becomes the first airline to take advantage of the Q400 aircraft’s increased profit potential TORONTO, Sept. 21, 2018 (GLOBE NEWSWIRE) -- Bombardier Commercial Aircraft today announced the delivery of its first 90-seat Q400 aircraft. The aircraft was handed over to India’s SpiceJet Limited (“SpiceJet”) the launch operator for the extra-capacity, 90-seat aircraft. “We are excited to induct the 90-seat Q400 aircraft into our fleet,” said Ajay Singh, Chairman and Managing Director, SpiceJet. “The additional seats and performance improvements will result in substantial reduction in unit costs and also we will enable us to address our market needs in the regional space.” “The delivery of the first 90-seat Q400 aircraft showcases the commitment of Bombardier’s Q Series turboprop program to respond to customer requirements as they address traffic growth in regional markets,” said Todd Young, Head of the Q Series Aircraft Program, Bombardier Commercial Aircraft. “I thank and congratul
Service Providers Speed Deployment, Reduce Costs with Patton Cloud Edge Orchestration Service20.9.2018 22:16 | Pressemelding
Now, Telecom and UCaaS service providers can easily provision, manage, monitor, secure, alert, troubleshoot, analyze, and optimize services on the customer premise GAITHERSBURG, Md., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Patton Electronics—US-manufacturer of UC, cloud, and IoT-enabling solutions for carrier, enterprise, and industrial networks—has launched the new Patton Cloud service for carriers and service providers that deliver All-IP and hybrid voice-and-data services to business subscribers. Patton Cloud delivers a low-cost, easy-to-use, web-based edge-orchestration service that delivers a superior user experience. It offers remote touchless provisioning, monitoring, and troubleshooting—as well as security and alerting tools that reduce service turn-up costs, trouble tickets, and subscriber attrition. The Patton Cloud service offers quality-control mechanisms including pro-active monitoring and troubleshooting—combined with feature-license distribution pools for managing value-added
Inspirata Promotes Top Executives to Expanded Roles in Digital Pathology20.9.2018 21:12 | Pressemelding
Inspirata Founder and Executive Vice President, Mark Lloyd, is taking on an expanded role overseeing product management, and Inspirata Senior Vice President, Andrew Chomos, has been appointed to General Manager, Digital Pathology, overseeing the Center of Excellence in Pittsburgh along with all North America sales and customer support efforts. Tampa, FL, Sept. 20, 2018 (GLOBE NEWSWIRE) -- Cancer informatics and digital pathology workflow solution provider Inspirata®, Inc. announced today that two of its executives have taken on expanded roles in the company. The two are Inspirata Executive Vice President and Founder, Mark Lloyd, and Senior Vice President and General Manager, Digital Pathology, Andrew Chomos. Dr. Lloyd has accepted the expansion of his role to include product management for Digital Pathology. He is former cancer researcher at both Lombardi Cancer and Moffitt Cancer Center and is Inspirata’s foremost subject matter expert and thought leader on digital pathology and image
Tetraphase Pharmaceuticals Announces Adoption of Commission Decision Granting Marketing Authorisation Approval in the European Union for XERAVA™ (eravacycline) for the Treatment of Complicated Intra-Abdominal Infections20.9.2018 19:08 | Pressemelding
– Broad Product Label for Treatment of Complicated Intra-Abdominal Infections – – Phased Commercial Launch Expected in the First Half of 2019 – WATERTOWN, Mass., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that the European Commission (EC) has adopted the Decision granting marketing authorisation for XERAVA (eravacycline) for injection for the treatment of complicated intra-abdominal infections (cIAI) in adults in the European Union. In clinical trials, XERAVA was well-tolerated and achieved high clinical cure rates in patients with cIAI, demonstrating statistical non-inferiority to two widely used comparators – ertapenem and meropenem. “The European approval of XERAVA, right after our recently announced FDA approval, marks our second significant regulatory approval within one month
UPDATE— Taconic Biosciences Becomes the First Animal Model Provider on General Services Administration Contract Schedule20.9.2018 18:07 | Pressemelding
RENSSELAER, N.Y., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Taconic Biosciences, a global leader in providing genetically engineered rodent model solutions, announces a new relationship with Government Scientific Source (GSS). GSS is a leading dedicated distributor of laboratory equipment to federal, state, and local governments on contract with the GSA (General Services Administration). By having Taconic’s products available via GSS, they can now be accessed by all federal agencies, including but not limited to the National Institutes of Health and the Department of Defense. Taconic is the only animal model provider affiliated with GSS and the only animal model provider available on GSA Contract. “An important component of providing customers with the best animal model solutions is access to key resources. Through this exciting new relationship with GSS, Taconic can now easily connect with scientists doing some of the most valuable research in the world and provide them with high quality sol
Digital Transformation is Not a One-Off — It’s About the Digital Journey20.9.2018 17:44 | Pressemelding
SoftServe study confirms four digital journey states with 71 percent of enterprises reporting early stages of adoption AUSTIN, Texas, Sept. 20, 2018 (GLOBE NEWSWIRE) -- SoftServe, a leading digital authority and consulting company, today released the results of its market research study that examines how enterprises are responding to the digital economy. The research found that 71 percent of the respondents in the United States and the European Union are in the early stages—Reveal and Transform—of four unique states across the Enterprise Digital Journey. For an in-depth analysis and the full results, read The Enterprise Digital Journey white paper. With fierce competition in today’s global landscape, leveraging cutting-edge technology and deploying new business models is not a one-off pursuit, but rather a continuous process of iteration and refinement. Companies should stop referring to Digital Transformation and instead plan for a continuous Digital Journey. “The term Digital Transfo
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom