Minerva Neurosciences Reports Fiscal 2017 Fourth Quarter and Year End Financial Results and Business Updates
Four late-stage trials underway, targeting schizophrenia, major depressive disorder and insomnia disorder
Planning for commercialization moves forward
Management to host conference call today at 8:30 a.m. Eastern Time
WALTHAM, Mass., March 12, 2018 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat unmet medical needs of central nervous system (CNS) disorders, today reported key business updates and financial results for the fourth quarter and fiscal year ended December 31, 2017.
"We have initiated four late-stage clinical efficacy trials with two compounds during late 2017, and we are planning to initiate a fifth with a third compound in the near future," said Dr. Remy Luthringer, executive chairman and chief executive officer of Minerva. "We have also expanded our internal capabilities in the areas of strategic development, market research and commercial expertise as we plan for the transition from late-stage clinical development to the market for our product candidates," said Dr. Luthringer. "This evolution supports our corporate strategy to develop and commercialize first-in-class products with novel mechanisms of action that address critical needs in targeted CNS areas, led by roluperidone (MIN-101) for negative symptoms in patients with schizophrenia."
- In December 2017, the first patient was screened in the pivotal Phase 3 clinical trial of roluperidone as monotherapy for negative symptoms in patients diagnosed with schizophrenia. This multicenter, randomized, double-blind, parallel-group, placebo-controlled, 12-week trial will evaluate the efficacy and safety of 32 milligrams (mg) and 64 mg of roluperidone in adult patients with negative symptoms of schizophrenia. The 12-week study will be followed by a 40-week, open-label extension period during which patients on drug will continue receiving their original dose and patients on placebo will receive either 32 mg or 64 mg of roluperidone.
- The effect of roluperidone as compared to placebo will be determined with respect to the primary endpoint, the change from baseline in negative symptoms using the Positive and Negative Syndrome Scale (PANSS) Marder's negative symptoms factor score (NSFS) over the 12-week double-blind treatment period. The key secondary endpoint is the effect of roluperidone compared to placebo as measured by the change from baseline in the Personal and Social Performance (PSP) total score over the same period. Additional secondary endpoints will be the Clinical Global Impression of Severity (CGI-S) score and safety and tolerability.
- Approximately 500 patients are expected to be enrolled at approximately 60 clinical sites in the U.S. and Europe, with about 30 percent of patients coming from the U.S. Top-line results from the 12-week double blind phase of this trial are expected in the first half of 2019.
Seltorexant (MIN-202 or JNJ-42847922), under joint development with Janssen Pharmaceutica NV (Janssen):
- In September 2017, the first patient was enrolled in a Phase 2b multi-center, double-blind, randomized, parallel-group, placebo-controlled, adaptive-dose finding clinical trial of seltorexant as adjunctive therapy to antidepressants in adult patients with major depressive disorder (MDD) who have responded inadequately to antidepressant therapy. The primary objectives of this study are: (1) to assess the dose-response relationship and augmentation of antidepressant effect of up to three doses of seltorexant (10 mg, 20 mg, and 40 mg), and (2) to assess the safety and tolerability of seltorexant compared to placebo. Approximately 280 patients are planned to be enrolled at more than 85 clinical sites in the U.S., Europe, Russia and Japan.
- In December 2017, the first patient was enrolled in a Phase 2b multi-center, double-blind, randomized, parallel-group, active- and placebo-controlled dose finding clinical trial of seltorexant in patients with insomnia disorder. The primary objective is to assess the dose-response of three doses of seltorexant (5, 10 and 20 milligrams daily) compared to placebo on sleep onset as measured by the latency to persistent sleep using polysomnography (PSG). The key secondary objective is to assess the dose-response of these three doses compared to placebo on wake after sleep onset over the first six hours using PSG. In addition, the effects of seltorexant on sleep and cognition will be compared to those effects of zolpidem to determine potential differences between the compounds. Approximately 360 patients are planned to be randomized at clinical sites in the U.S., European Union and Japan.
- In December 2017, the first patient was enrolled in a Phase 2b multi-center, double-blind, randomized, flexible-dose, parallel-group study to assess the efficacy of flexibly dosed seltorexant compared to flexibly dosed quetiapine as adjunctive therapy to a baseline antidepressant drug in delaying time to all-cause discontinuation of study drug over a 6-month treatment period. Approximately 100 patients are planned to be randomized at approximately 34 sites in the U.S. to receive either flexibly dosed seltorexant, 20 mg or 40 mg, or flexibly dosed quetiapine XR, 150 mg or 300 mg.
- Under the amended agreement with Janssen that became effective in August, 2017, Janssen has waived its right to royalties on seltorexant insomnia sales in the Minerva territory (the European Union, Switzerland, Liechtenstein, Iceland and Norway). Minerva retains all of its rights to seltorexant, including commercialization for the treatment of insomnia and as an adjunctive therapy for MDD, which includes an exclusive license in the Minerva Territory. Minerva has also assumed strategic control for the clinical development of seltorexant in insomnia but has no further financial obligations until the Phase 2b development milestone is complete, which is expected to occur in the second half of 2019.
- Building upon the results of an earlier Phase 2a trial with MIN-117 in Europe, the Company is planning to initiate a Phase 2b trial in MDD in the U.S. and Europe in early 2018. The Company expects to enroll patients with MDD who also have symptoms of anxiety. In preparation for this trial, a food effect study was recently completed, and no food effect was observed on the PK exposure parameters, therefore allowing dosing with or without food.
- The Company is continuing the pre-clinical development of MIN-301, a soluble recombinant form of the Neuregulin-1b1 protein, for the treatment of Parkinson's disease and potentially for other neurodegenerative disorders. The next planned steps in this program include the completion of the pre-clinical package to enable the filing of an Investigational New Drug application (IND) in the U.S. and/or an Investigational Medicinal Product Dossier in Europe, and pending acceptance by regulatory authorities, the initiation of Phase 1 clinical testing thereafter.
Fourth Quarter and Year Ended 2017 Financial Results
Net Income (Loss): Net income was $0.2 million for the fourth quarter of 2017, or income per share of $0.00 (basic and diluted), compared to a net loss of $9.4 million for the fourth quarter of 2016, or a loss per share of $0.27 (basic and diluted). Net loss was $31.5 million for the year ended December 31, 2017, or a loss per share of $0.83 (basic and diluted), compared to a net loss of $31.0 million, or a loss per share of $0.99 (basic and diluted), for the year ended December 31, 2016.
R&D Expenses: Research and development (R&D) expenses were $6.5 million in the fourth quarter of 2017 and 2016. R&D expenses were $30.3 million for the year ended December 31, 2017, compared to $20.4 million for the year ended December 31, 2016. This increase in R&D expenses primarily reflects higher development expenses under the seltorexant program, 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 $3.0 million in the fourth quarter of 2017, compared to $2.7 million in the fourth quarter of 2016. G&A expenses were $10.9 million for the year ended December 31, 2017, compared to $9.8 million for the year ended December 31, 2016. The increase in general and administrative expenses was primarily due to an increase in professional fees and an increase in non-cash stock-based compensation expenses.
Benefit for income taxes: Benefit for income taxes was $9.4 million in the fourth quarter of 2017, compared to zero in the fourth quarter of 2016. Benefit for income taxes was $9.4 million for the year ended December 31, 2017, compared to zero for the year ended December 31, 2016. On December 22, 2017, the United States enacted tax reform legislation commonly known as the Tax Cuts and Jobs Act (the "Act"), resulting in significant modifications to existing law. In the year ended December 31, 2017, these tax reforms resulted in a benefit of $9.4 million related to future implications of indefinite lived deferred tax positions.
- Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2017 were approximately $133.2 million, compared to $83.0 million as of December 31, 2016. During 2017, the Company received approximately $41.6 million in net proceeds from a July 2017 public offering of common stock, proceeds from the exercise of common stock warrants of $9.4 million, proceeds from the exercise of common stock options of $1.1 million, and $30 million in an upfront payment in connection with the amendment to the Company's Co-Development and License Agreement with Janssen for seltorexant. Minerva presently expects that its existing cash and cash equivalents will be sufficient to meet its anticipated capital requirements for at least the next 12 months from today. The assumptions upon which this estimate is based are routinely evaluated and may be subject to change.
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 1581007.
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 product candidates to treat CNS diseases. Minerva's proprietary compounds include: roluperidone (MIN-101), in Phase 3 clinical development for schizophrenia; seltorexant (MIN-202 or JNJ-42847922) in Phase 2b 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 roluperidone, seltorexant, MIN-117 and MIN-301; the timing and scope of future clinical trials and results of clinical trials with these compounds; the clinical and therapeutic potential of these compounds; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies; our ability to successfully develop and commercialize our therapeutic products; 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, whether roluperidone, seltorexant, MIN-117 and MIN-301 will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether any of our therapeutic products will be successfully marketed if approved; whether any of our therapeutic product discovery and development efforts will be successful; 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 Annual Report on Form 10-K for the year ended December 31, 2017, filed with the Securities and Exchange Commission on March 12, 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|
|December 31,||December 31,|
|Cash and cash equivalents||$||26,052||$||82,981|
|Prepaid expenses and other current assets||1,299||803|
|Total current assets||129,540||83,864|
|Marketable securities - noncurrent||5,023||-|
|Other non-current assets||15||-|
|In-process research and development||34,200||34,200|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Notes payable - current portion||$||3,962||$||4,854|
|Accrued expenses and other current liabilities||1,439||816|
|Accrued collaborative expenses||-||2,548|
|Total current liabilities||6,837||9,685|
|Notes payable - noncurrent||-||3,841|
|Other non-current liabilities||30||-|
|Additional paid-in capital||295,975||238,837|
|Total stockholders' equity||131,598||105,983|
|Total Liabilities and Stockholders' Equity||$||183,698||$||132,943|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended December 31,||Twelve Months Ended December 31,|
|(in thousands, except per share amounts)||(in thousands, except per share amounts)|
|Research and development||6,541||6,499||30,256||20,440|
|General and administrative||2,991||2,739||10,914||9,751|
|Total operating expenses||9,532||9,238||41,170||30,191|
|Foreign exchange losses||(11||)||4||(57||)||(23||)|
|Loss before income taxes||(9,214||)||(9,405||)||(40,899||)||(31,046||)|
|Benefit for income taxes||(9,376||)||-||(9,376||)||-|
|Net income (loss)||$||162||$||(9,405||)||$||(31,523||)||$||(31,046||)|
|Loss per share:|
|Basic and diluted||$||0.00||$||(0.27||)||$||(0.83||)||$||(0.99||)|
|Weighted average shares:|
|Basic and diluted||38,710||34,852||37,937||31,514|
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
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Følg saker fra GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra GlobeNewswire
RCI Banque S.A.: Post Stabilisation Notice18.12.2018 15:55 | Pressemelding
PARIS, Dec. 18, 2018 (GLOBE NEWSWIRE) -- 18th December 2018 RCI Banque S.A. Post Stabilisation Notice HSBC (contact: Syndicate desk, telephone: +44 207 992 8066) hereby gives notice that no stabilisation (within the meaning of the rules of the Financial Conduct Authority) was undertaken in relation to RCI Banque S.A. GBP Fixed due 30th Oct 2023 because the transaction did not complete. Issuer: RCI Banque S.A. Guarantor (if any): NA Aggregate nominal amount: GBP Benchmark Description: Fixed due 30th Oct 2023 Offer price: na Stabilising Managers: HSBC, Lloyds, Natwest This announcement is for information purposes only and does not constitute an invitation or offer to underwrite, subscribe for or otherwise acquire or dispose of any securities of the Issuer in any jurisdiction. This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and condit
The North American Bitcoin Conference Stands Out as One of 2019’s Most Important Worldwide Crypto Events18.12.2018 15:35 | Pressemelding
MIAMI, Dec. 18, 2018 (GLOBE NEWSWIRE) -- via CryptoCurrencyWire – 2019 will kick off with what has become widely accepted as one of the most important blockchain conferences of the year. The North American Bitcoin Conference, sponsored by Keynote and part of the World Blockchain Forum, will take place Jan. 16-18, 2019, at the James L. Knight Center in Miami, Florida. This premier crypto conference, now in its seventh year, will draw cryptocurrency and blockchain leaders from all across the globe as they come together for this historical event. The North American Bitcoin Conference is the longest-running, most-attended finance conference for the blockchain and crypto industries, with each event attracting thousands of attendees. The 2019 conference will feature a lineup of more than 60 world-class presenters, including technology veterans and company founders who have collectively raised more than $18.1 billion in initial coin offerings (ICOs). Speakers that have been announced thus far
Inspirata Subsidiary, Artificial Intelligence in Medicine (AIM), Signs Contract with the National Cancer Institute (NCI) to Use Its E-Path Reporter Software for Reporting by U.S. Central Cancer Registries18.12.2018 15:06 | Pressemelding
The NCI has licensed AIM’s E-Path Reporter software for the last 15 years to provide an automated solution that enables cancer registries to more efficiently collect and report cancer incidence and survival data. Toronto, CA, Dec. 18, 2018 (GLOBE NEWSWIRE) -- Artificial Intelligence In Medicine Inc. (AIM), an Inspirata company, announced today that the National Cancer Institute (NCI) has extended its license agreement for AIM’s E-Path Reporter software. The software has been licensed for use within the SEER (Surveillance, Epidemiology and End Results) program, for 14 central registries and 286 major reporting hospitals and laboratories across the U.S. NCI supports cancer data collection and research through the SEER program and publishes cancer statistics for 20 U.S. geographic areas. The NCI requires participating cancer registries to collect data on cancer patient demographics, primary tumor site, tumor morphology and disease stage at diagnosis. The registries also must report on fir
Crown Bioscience Creates Center of Excellence for Bioinformatics, Big Data, and Biomarker Discovery Services18.12.2018 14:30 | Pressemelding
Services and Capacity Increase with New Site Opening SAN DIEGO, Dec. 18, 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 recently announced the expansion of its existing translational oncology research capacity by opening a new site in Suzhou, Jiangsu, China. The large amount of data now available from preclinical and clinical research requires specialized expertise in bioinformatics, big data analysis and dedicated storage facilities. CrownBio’s new site will focus on integrating the company’s experience in preclinical and translational research with cutting-edge digital technologies for the discovery of predictive biomarkers and the development of new and companion diagnostics. The Suzhou site will become CrownBio’s center of excellence for systems biology and clinical sample testing. Located at the heart of the Bi
Family of Constant-Current Dimmable Buck LED Drivers18.12.2018 11:00 | Pressemelding
1.5A, 3A Buck LED Drivers Target ISO26262 automotive and industrial applications MILPITAS, Calif., Dec. 18, 2018 (GLOBE NEWSWIRE) -- AMS, the Analog Mixed-Signal division of ISSI, has introduced a family of switching buck LED Drivers for automotive and industrial applications. This family of highly integrated switching constant current buck LED Drivers are targeted for 12V/24V battery connected, space-constrained, electromagnetic (EMC) sensitive applications such as Headlight, Front and Rear Fog lights, Day time Running lights to name a few. The device family supports a wide DC voltage input range of 4.5V to 38V and outputs a 5% regulated current of 1.5A or 3A; depending on the particular device, see table. The integrated power MOSFET is configured to switch in the constant on-time mode delivering true average current. Switching at a frequency of up to 2MHz which is adjustable with an external resistor, these buck LED Drivers can use smaller output inductor and capacitor values thereby
John Charman Appointed Chief Executive Officer of Sompo Holdings Overseas Insurance Business and Nigel Frudd Appointed as Chief Executive Officer of Sompo International18.12.2018 10:13 | Pressemelding
Mr. Charman and Mr. Frudd to Join Sompo Holdings New Global Executive Committee PEMBROKE, Bermuda, Dec. 18, 2018 (GLOBE NEWSWIRE) -- Sompo International Holdings Ltd. (Sompo International), a Bermuda-based specialty provider of property and casualty insurance and reinsurance, announced today that effective April 1, 2019, Mr. John Charman, currently Chairman of the Board of Directors and Chief Executive Officer of Sompo International, will be promoted to Chief Executive Officer of Overseas Insurance Business in Sompo Holdings, Inc. (Sompo Holdings). This segment of Sompo Holdings’ business currently represents more than 27% of Sompo Holdings Group’s adjusted profit, employing around 9,000 people in 30 countries and regions and is projected to have more than $10 billion in gross premiums by 2020. In such capacity, Mr. Charman will join the new Global Executive Committee of Sompo Holdings (Global ExCo) which will be established in April 2019 to provide expertise and input on group-wide st