0001558370-16-006680.txt : 20160720 0001558370-16-006680.hdr.sgml : 20160720 20160720122337 ACCESSION NUMBER: 0001558370-16-006680 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20160720 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160720 DATE AS OF CHANGE: 20160720 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Cerecor Inc. CENTRAL INDEX KEY: 0001534120 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 450705648 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37590 FILM NUMBER: 161774922 BUSINESS ADDRESS: STREET 1: 400 E. PRATT ST. STREET 2: SUITE 606 CITY: BALTIMORE STATE: MD ZIP: 21202 BUSINESS PHONE: 410-522-8707 MAIL ADDRESS: STREET 1: 400 E. PRATT ST. STREET 2: SUITE 606 CITY: BALTIMORE STATE: MD ZIP: 21202 8-K 1 cerc-20160720x8k.htm 8-K cerc_Current_Folio_8-K

 

 

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): July 20, 2016

 

 

Cerecor Inc.

(Exact name of Registrant as Specified in Its Charter) 

 

 

 

 

 

 

 

Delaware

 

001-37590

 

45-0705648

(State or Other Jurisdiction
of Incorporation)

 

(Commission
File Number)

 

(IRS Employer Identification No.)

 

 

 

 

 

 

 

400 E. Pratt Street

Suite 606

Baltimore, Maryland

 

21202

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (410) 522-8707

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 (see General Instructions A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

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.

 

On July 20, 2016, Cerecor Inc. (the “Company”) issued a press release, further described in Item 8.01 below, in connection with its research and development grant award from the National Institute on Alcohol Abuse and Alcoholism (“NIAAA”) at the National Institutes of Health. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

 

The information in this Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in this Current Report shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 8.01.Other Events.

 

Research and Development Grant from the NIAAA at the National Institutes of Health

 

On July 20, 2016, the Company announced that it has been awarded a research and development grant of $1.0 million from the NIAAA. The grant provides the Company with additional resources to progress the development of CERC-501 for the treatment of alcohol use disorder.

 

Item 9.01.Financial Statements and Exhibits.

 

 

 

 

Exhibit

No.

  

Description

 

 

 

99.1

 

Press Release, dated July 20, 2016, entitled “Cerecor Announces $1.0 Million Research & Development Grant from the National Institute on Alcohol Abuse and Alcoholism at the National Institutes of Health.”

 

 

 

2


 

 

 

SIGNATURES

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 thereunto duly authorized.

 

 

 

 

 

 

 

Cerecor Inc.

 

 

 

 

 

 

By:

/s/ Mariam Morris

 

 

 

Mariam Morris

 

 

 

Chief Financial Officer

 

Date:   July 20, 2016

3


 

 

EXHIBIT INDEX

 

 

 

 

Exhibit

No.

  

Description

 

 

 

99.1

 

Press Release, dated July 20, 2016, entitled “Cerecor Announces $1.0 Million Research & Development Grant from the National Institute on Alcohol Abuse and Alcoholism at the National Institutes of Health.”

 

 

 

4


EX-99.1 2 cerc-20160720ex9911b330d.htm EX-99.1 cerc_Exh_99_1

Exhibit 99.1

Picture 3

 

Cerecor Announces $1.0 Million Research & Development Grant from the National Institute on Alcohol Abuse and Alcoholism at the National Institutes of Health

Grant to Fund CERC-501 Development for Alcohol Use Disorder    

 

Baltimore, MD – July 20, 2016 – Cerecor Inc. (NASDAQ: CERC), a clinical-stage biopharmaceutical company developing treatments to make a difference in the lives of patients with neurological and psychiatric disorders, today announced that it has been awarded a grant (award number U44AA025253) from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) at the National Institutes of Health (NIH).  The grant of $1.0 million provides Cerecor with additional resources to progress the development of CERC-501 for the treatment of alcohol use disorder (AUD).  Upon successful completion of the development activities covered under this grant, Cerecor will have the opportunity to apply for continued funding.

 

CERC-501 is a potent and selective kappa opioid receptor (KOR) antagonist. KORs are believed to play key roles in modulating stress, mood and addictive behaviors. Both KORs and dynorphin, which together comprise the kappa opioid system, are upregulated by stress and chronic exposure to drugs of abuse, and are thought to mediate the negative emotional states seen in substance withdrawal and contribute to stress‑induced reinstatement of substance seeking behavior.

 

According to the NIAAA more than 16 million Americans have an AUD, almost 90,000 people die annually due to alcohol related causes, and the economic burden of AUD is approaching $250 million per year. “Current medical and psychosocial treatments are clearly inadequate to address this significant health issue,” said Dr. Ronald N. Marcus, Chief Medical Officer and Head of Regulatory Affairs at Cerecor. “We believe CERC-501 offers a unique approach to address the unmet needs in patients suffering from AUD.”

 

“We are most appreciative to yet another NIH organization for augmenting our own efforts in the development of CERC-501 for substance use disorders,” said Dr. Uli Hacksell, Cerecor’s Chief Executive Officer, President and Chairman.  “This grant from the NIAAA will enable us to pursue development in AUD, whilst the previously-communicated National Institute on Drug Abuse grant is co-funding Clin501-201, an on-going Phase 2 study of CERC-501 in smoking cessation. We believe both NIH grants validate the potential importance and scientific strength of the CERC-501 program.”

 

About CERC-501

CERC-501 is a potent and selective oral KOR antagonist being developed to treat substance use disorders and for adjunctive treatment of major depressive disorder (MDD). KORs have been shown to play an important role in stress, mood and addiction in animal models. CERC-501 has been observed to have positive preclinical activity in models of depression, nicotine withdrawal and alcohol dependence, and it has been generally well tolerated in three human clinical trials. An ongoing Phase 2 smoking cessation trial with CERC-501 is expected to provide top-line data in the fourth quarter of 2016.

 


 

About Cerecor

Cerecor is a biopharmaceutical company that is developing innovative drugs that make a difference in the lives of patients with neurological and psychiatric diseases. Cerecor is currently pursuing the development of two clinical Phase 2-stage product candidates:  CERC-501 and CERC-301, an oral, NR2B-specific, NMDA receptor antagonist. Cerecor is currently conducting a Phase 2 study of CERC-301 as an adjunctive treatment of MDD and expects to announce results from that study in the first half of 2017.  In addition, Cerecor is conducting preclinical testing of CERC-406, a brain penetrant COMT inhibitor with potential procognitive activity. For more information about the company and its products, please visit www.cerecor.com or contact Mariam E. Morris, Chief Financial Officer, at (443) 304-8002.

 

Forward-Looking Statements

This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond Cerecor’s control), which could cause actual results to differ from the forward-looking statements. Such statements include statements regarding potential benefits and uses of Cerecor’s product candidates, statements about the timing of expected trial results and other statements with respect to Cerecor’s plans, objectives, projections, expectations and intentions, including other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of Cerecor’s management but are subject to significant risks and uncertainties, including those detailed in Cerecor’s filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Cerecor expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Cerecor’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

 

 

MacDougall Biomedical Communications
Doug MacDougall or Joe Rayne, 781-235-3060
ir@cerecor.com  

 


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