0001104659-16-090345.txt : 20160119 0001104659-16-090345.hdr.sgml : 20160118 20160119112702 ACCESSION NUMBER: 0001104659-16-090345 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20160119 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160119 DATE AS OF CHANGE: 20160119 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: 161347438 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 a16-2605_18k.htm 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): January 19, 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):

 

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.

 

On January 19, 2016, Cerecor Inc. (the “Company”) issued a press release, further described in Item 8.01 below, in connection with the publication of a study regarding CERC-301, an oral, NR2B specific, NMDA antagonist being developed by the Company as an adjunctive medication for patients with major depressive disorder who are failing to achieve an adequate response to their current antidepressant treatment and are severely depressed.  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.

 

On January 19, 2016, the Company announced the publication of preclinical data suggesting the antidepressant activity of CERC-301, in a paper entitled “Preclinical pharmacology and pharmacokinetics of CERC-301, a GluN2B-selective N-methyl-D-aspartate receptor antagonist,” which was published in the December issue of the Journal of Pharmacology Research & Perspectives.

 

Item 9.01.                                        Financial Statements and Exhibits.

 

Exhibit
No.

 

Description

 

 

 

99.1

 

Press Release, dated January 19, 2016, entitled “Cerecor Announces Publication Describing Antidepressant Activity of CERC-301 in Preclinical Model.”

 

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:  January 19, 2016

 

 

 

3



 

EXHIBIT INDEX

 

Exhibit
No.

 

Description

 

 

 

99.1

 

Press Release, dated January 19, 2016, entitled “Cerecor Announces Publication Describing Antidepressant Activity of CERC-301 in Preclinical Model.”

 

4


EX-99.1 2 a16-2605_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

Cerecor Announces Publication Describing Antidepressant Activity of CERC-301 in Preclinical Model

 

Baltimore, Maryland — January 19, 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 the publication of preclinical data suggesting antidepressant activity of CERC-301.  The paper, titled ‘Preclinical pharmacology and pharmacokinetics of CERC-301, a GluN2B-selective N-methyl-D-aspartate receptor antagonist’, was published in the December issue of the Journal of Pharmacology Research & Perspectives. This publication reports results of CERC-301 in an acute preclinical depression model known as the forced swim test, a common model of antidepressant efficacy. In test animals, CERC-301 showed antidepressant activity at doses that had minimal side effects

 

About CERC-301

 

CERC-301 is an NR2B specific, NMDA antagonist being developed as adjunctive medication for patients with MDD who are failing to achieve an adequate response to their current antidepressant treatment and are severely depressed.  The antidepressant activity of adjunctive treatment with CERC-301 in patients with MDD is being evaluated in an ongoing Phase 2 clinical trial. This adjunctive treatment may have the potential for rapid onset of effect.  Top-line results are expected in the second half of 2016. CERC-301 has received Fast Track designation by the FDA.

 

About Cerecor

 

Cerecor is a Baltimore-based biopharmaceutical company with the goal of becoming a leader in the development of innovative drugs that make a difference in the lives of patients with neurological and psychiatric diseases. We are committed to the development of drugs that improve lives by applying our extensive knowledge and experience in central nervous system disorders. Cerecor is currently pursuing the development of two clinical Phase II-stage product candidates:  CERC-301:  An oral, NR2B specific, NMDA receptor antagonist targeting the adjunctive treatment of patients with MDD who are failing to achieve adequate response, and  CERC-501:  A potent and selective kappa opiod reception (KOR) antagonist targeting the adjunctive treatment of MDD and substance use disorders.  In addition Cerecor is conducting preclinical testing of CERC-406, a brain penetrant COMT inhibitor with potential procognitive activity.   www.cerecor.com

 



 

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 may include, without limitation, statements with respect to Cerecor’s plans, objectives, projections, expectations and intentions and 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.

 

Media Contact

 

MacDougall Biomedical Communications

Doug MacDougall or Joe Rayne — 781-235-3060

jrayne@macbiocom.com

 


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