UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

 
FORM 8-K

 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): September 4, 2014

 
Minerva Neurosciences, Inc.
(Exact name of registrant as specified in its charter)

 
Delaware	 	001-36517	 	26-0784194	
(State or other jurisdiction
of incorporation)	 	(Commission
File Number)	 	(I.R.S. Employer
Identification No.)	
 
245 First Street	 	 	 	
Suite 1800	 	 	 	
Cambridge, MA	 	 	02142	
(Address of principal executive offices)	 	 	(Zip Code)	
 
(Registrant’s telephone number, including area code): (617) 444-8444
 
Not Applicable
(Former name or former address, if changed since last report)

 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
o                 Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o                 Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o                 Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o                 Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 
Item 7.01                       Regulation FD Disclosure
 
Minerva Neurosciences, Inc. (the “Company”) is presenting at the Baird 2014 Health Care Conference on Thursday, September 4, 2014 in New York City, New York. The materials that the Company intends to utilize in the presentation are furnished as Exhibit 99.1 to this current report and incorporated herein by reference.
 
The Company expressly disclaims any obligation to update this presentation and cautions that it is only accurate on the date it was presented. The inclusion of any data or statements in this presentation does not signify that the information is considered material.
 
This information contained or incorporated herein, including the presentation furnished as Exhibit 99.1, is being furnished, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any of the Company’s filings, whether made before or after the date hereof, regardless of any general incorporation language in any such filing.
 
Item 9.01                       Financial Statements and Exhibits
 
(d) Exhibits
 
 	Exhibit 
No.	 	Description	
 	99.1	 	Presentation of the Company dated September 4, 2014	
 
2

 
SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 	 	MINERVA NEUROSCIENCES, INC.	

Date:	September 4, 2014	 	By:	/s/ Rogerio Vivaldi Coelho MD, MBA	
 	 	 	 	 	
 	 	Name:	Rogerio Vivaldi Coelho MD, MBA	
 	 	Title:	President, Chief Executive Officer and Director	
 
3

 
EXHIBIT INDEX
 
Exhibit	 	Description	
99.1	 	Presentation of the Company dated September 4, 2014	
 
4

Exhibit 99.1
 
 	Exhibit 99.1 September 4, 2014 Dedicated to transforming the lives of people affected by neuropsychiatric diseases through innovative science that addresses patients’ unmet needs Rogerio Vivaldi, MD President & CEO	

 	Forward-Looking Statement Safe-Harbor 2 This presentation contains certain forward-looking statements about Minerva Neurosciences that are intended to be covered by the safe harbor for “forward-looking statements” provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words such as “expect(s),” “feel(s),” “believe(s),” “will,” “may,” “anticipate(s)” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding our ability to successfully develop and commercialize our therapeutic products; our ability to expand our long-term business opportunities; our expectations regarding approval for our products by the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; estimates regarding the market potential for our products; financial projections and estimates and their underlying assumptions; and future performance. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, but are not limited to: whether any of our therapeutic candidates 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 candidates will be successfully marketed if approved; whether our therapeutic product discovery and development efforts will be successful; our ability to achieve the results contemplated by our collaboration agreements; the strength and enforceability of our intellectual property rights; competition from pharmaceutical and biotechnology companies; the development of and our ability to take advantage of the market for our therapeutic products; our ability to raise additional capital to fund our operations on terms acceptable to us; general economic conditions; and the other risk factors contained in our periodic and interim reports filed with the Securities and Exchange Commission which are available on the SEC website at www.sec.gov. Our audience is cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events. People shown within this presentation are models used for illustrative purposes and are not patients. All trademarks, trade names and service marks appearing in this presentation are the property of their respective owners	

 	The Minerva Story: A company for all stakeholders: patients, investors, science and beyond 3 Represents patients in the seven major markets (U.S., Japan, France, Germany, Italy, Spain and the United Kingdom) Datamonitor, Decision Resources. Represents 2012 Drug Sales Portfolio of First in Class Neuropsychiatric Drugs Large Addressable Market Leadership Team With Proven Track Record World Class Pharma Collaborators Patient-centric neuropsychiatric biopharmaceutical company Four clinical-stage compounds with transformative potential Validated MOAs differentiated by additional innovative receptor activities 90M patients covered under our commercial rights1 Significant unmet medical need $14B total addressable market2 $10B in product sales in the last 10 years addressing unmet needs 8 FDA-approved neuropsychiatry drugs in the last 5 years Experience building patient-centric organizations	

 	Proven Leadership Team & External R&D 4 Rogerio Vivaldi, MD, MBA President & CEO Launched & commercialized 20 drugs for unmet medical needs in the last 20 years.Built Genzyme in Latin America Remy Luthringer, PhD EVP & Head of R&D Conducted over 750 clinical studies in neuropsychiatry space Geoff Race, FCMA, MBA EVP & CFO 7 biotech start-ups and executed 4 sale transactions Joseph Reilly COO Built Commercial Operations team focused on a patient centric business model Mark Levine General Counsel More than 17 years of experience as a corporate and commercial attorney Senior Management Neuropsychiatry's Drug Development Experts Jean Yves Schaffhauser CRO Management Corinne Stanner, MD Medical Affairs Nadine Noel, PhD Drug Development Sandra Werner, PhD Program Management Jay Saoud Biostatistics & Medical Writing	

 	Pipeline: Transformative Therapies Next generation of first in class neuropsychiatry pharmaceuticals 5 Ph IIB TBD Ph IIB Starts in Q4 14 Ph IB ongoing Ph I TBD Phase I Completed Phase IIA Completed Once a Day Formulation ongoing Phase IA Completed Preclinical ongoing 90M $14B 1. Source: Datamonitor and Decision Resources. Represents 2012 drug sales.	

 	MIN-101: Potential first in class transformative schizophrenia therapy 6 Potential to be the first drug to treat negative disease symptoms While potentially addressing the entire spectrum of symptoms Potential to avoid severe side effects of existing therapies Sedation, involuntary movements, prolactin increase, metabolic syndrome, cognitive impairment, sleep disorders and weight gain Potential to market as a mono and/or combination treatment Seeking approval as monotherapy to address spectrum of schizophrenia symptoms Phase III trial will also study use as adjunctive therapy with atypical antipsychotics to improve negative symptoms, cognitive symptoms and insomnia Potential to combine with other neuropsychiatric drugs to address a broad range of indications outside of schizophrenia	

 	MIN-101 Mechanism of Action 7	

 	Dopamine Modulation 8	

 	MIN-101: Compelling Efficacy on Spectrum of Symptoms (Phase IIA) 9 Mean Changes from Baseline (around 90) Total PANSS Weighted Score Decrease: -24.1 for MIN-101 versus -17.9 Placebo Placebo Placebo Placebo Placebo Placebo p < 0.05 p = 0.08 Placebo Mean Changes from Baseline Placebo Placebo Placebo 2.4X 1.5X 2.0X (Motivation) Improves Several Cognitive Dimensions After Three Months (1) (1) As measured at day 84 by BACS-Subscales Score - PPC	

 	MIN-101: Compelling Efficacy On Sleep - Objective1 and Subjective 2 Measurements (Phase IIA) Quicker onset of sleep after 2 weeks of treatment with MIN-101 vs. Placebo 10 Objective Measures of Sleep Onset (By PSG) Subjective Measures By PSQI Scale MIN-101 Placebo MIN-101 Placebo Day 84 Day 84 Mean +/- SEM(3) Mean +/- SEM(3) (Changes from Baseline) Improved sleep quality after 3 months of treatment with MIN-101 versus Placebo (1) Polysomnography (2) Pittsburgh Sleep Quality Index (3) Standard Error of the Mean min	

 	 1H 2016 Phase IIB Results Expected to be submitted in 4Q 2014 – Phase IIB Multicenter, randomized, double-blind, placebo controlled, parallel group design study in approximately 234 schizophrenic patients with predominantly negative symptoms, randomized in a 1:1:1 ratio to receive MIN-101 64 mg, MIN-101 32 mg or placebo once daily for 3 months (12 weeks) followed by an optional extension of 6 months Primary Endpoint: Evaluate the efficacy of MIN-101 compared to placebo on negative symptoms of schizophrenia as measured by the change from baseline in PANSS negative subscale of the pentagonal model over 3 months of treatment Secondary Endpoints: Evaluate the efficacy of MIN-101 compared to placebo on other symptoms of schizophrenia as measured by change from baseline in PANSS total score and Positive, Dysphoric mood, Activation and Autistic preoccupation subscores of the pentagonal model over 3 months of treatment Assess the effects of MIN-101 compared to placebo on the Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Improvement (CGI-I) over 3 months of treatment Assess the effects versus placebo of MIN-101 on cognitive function and on sleep architecture and subjective sleep Evaluate the safety and tolerability of MIN-101 compared to placebo Assess MIN-101 and its metabolites PK profile using PK population MIN-101: Path to Phase III 11	

 	Huge Commercial Opportunity: Significant Unmet Medical Need in Schizophrenia 12 SEVERITY OF ILLNESS Chronic Progression of Negative Symptoms & Cognitive Impairment Youth 0-18 Adult 18-40 Mature >40 Cognitive Symptoms Negative Symptoms Positive Symptoms Current Treatments Focus On Positive Symptoms $3.9B Rx Annual Sales 2 For 60% to 80% Discontinuation Rate1 Lack of efficacy on negative symptoms Lack of efficacy on cognitive symptoms Lack of efficacy on insomnia Progression of side effects MIN-101 for Potential Lifelong Treatment Represents discontinuation rate over the course of 18 months. Lieberman, J et al; NEJM; Sept 22, 2005; vol.353 no. 12 Source: Datamonitor and Decision Resources. Represents 2012 drug sales.	

 	MIN-202: New generation of mechanism of action 13 Blocks Wake Drive Efficacy that’s equal or superior to Standard of Care Enables true, restorative sleep Normal levels of REM sleep No residual sedation No daytime impairment Normal motion suppression No alcohol interaction No abuse potential Mechanism of Action SELECTIVE OREXIN-2 RECEPTOR ANTAGONIST (SORA) MODULATES HISTAMINERGIC AND OTHER ENDOCRINOLOGIC PATHWAYS AT NEURONS IN THE POSTERIOR HYPOTHALAMUS BEING INVESTIGATED FOR RAPID RESTORATION OF PHYSIOLOGIC SLEEP ARCHITECTURE AND SLEEP-WAKEFULNESS CYCLES FOR RESTORATIVE SLEEP WITHOUT IMPAIRING DAYTIME FUNCTIONING IN PATIENTS WITH PRIMARY AND SECONDARY INSOMNIA	

 	Pipeline: Transformative Therapies Next generation of first in class neuropsychiatry pharmaceuticals 14 Ph IIB TBD Ph IIB Starts in Q4 14 Ph IB ongoing Ph I TBD Phase I Completed Phase IIA Completed Once a Day Formulation ongoing Phase IA Completed Preclinical ongoing 90M $14B 1. Source: Datamonitor and Decision Resources. Represents 2012 drug sales.	

 	Dedicated to transforming the lives of people affected by neuropsychiatric diseases through innovative science that addresses patients’ unmet needs Thank You