0001104659-15-085337.txt : 20151217 0001104659-15-085337.hdr.sgml : 20151217 20151217084030 ACCESSION NUMBER: 0001104659-15-085337 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20151211 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20151217 DATE AS OF CHANGE: 20151217 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: 151292312 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 a15-25130_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): December 11, 2015

 


 

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 December 11, 2015, 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-501, a potent and selective oral kappa opioid receptor antagonist being developed by the Company to treat depression and substance use disorders, such as alcohol, nicotine and/or illicit drug dependence.  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 December 11, 2015, the Company announced the publication of data regarding the human brain receptor occupancy of CERC-501, formerly known as LY2456302, in a study entitled “Receptor Occupancy of the Kappa Opioid Antagonist LY2456302 Measured with PET and the Novel Radiotracer 11C-LY2795050.” In this study of healthy volunteers, CERC-501 demonstrated reproducible penetration of the blood-brain barrier and target engagement, as shown through positron emission tomography (PET) imaging. The study was conducted by researchers at the Yale University School of Medicine and Eli Lilly and Company and published in the December issue of the Journal of Pharmacology and Experimental Therapeutics.

 

Item 9.01.                                        Financial Statements and Exhibits.

 

Exhibit
No.

 

Description

 

 

 

99.1

 

Press Release, dated December 11, 2015, entitled “Publication Reports Human Brain Penetration and Target Engagement of Cerecor’s Oral Kappa Opioid Receptor Antagonist, CERC-501.”

 

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/ Blake M. Paterson

 

 

Blake M. Paterson

 

 

President and Chief Executive Officer

 

Date:  December 17, 2015

 

3



 

EXHIBIT INDEX

 

Exhibit
No.

 

Description

 

 

 

99.1

 

Press Release, dated December 11, 2015, entitled “Publication Reports Human Brain Penetration and Target Engagement of Cerecor’s Oral Kappa Opioid Receptor Antagonist, CERC-501”

 

4


EX-99.1 2 a15-25130_1ex99d1.htm EX-99.1

Exhibit 99.1

 

GRAPHIC

 

Publication Reports Human Brain Penetration and Target Engagement of Cerecor’s

Oral Kappa Opioid Receptor Antagonist, CERC-501

 

- Phase 2 Study of CERC-501 for Smoking Cessation to Begin in 1Q2016 -

 

Baltimore, Maryland — December 11, 2015 - Cerecor Inc., 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 data regarding the human brain receptor occupancy of CERC-501, formerly known as LY2456302.  In this study of healthy volunteers, CERC-501 demonstrated reproducible penetration of the blood-brain barrier and target engagement, as shown through PET (positron emission tomography) imaging.  CERC-501 is a potent and selective oral kappa opioid receptor, or KOR, antagonist being developed to treat depression and substance use disorders, such as alcohol, nicotine and/or illicit drug dependence.

 

The study ‘Receptor Occupancy of the Kappa Opioid Antagonist LY2456302 Measured with PET and the Novel Radiotracer 11C-LY2795050’ was conducted by researchers at the Yale University School of Medicine and Eli Lilly and Company and published in the December issue of the Journal of Pharmacology and Experimental Therapeutics (JPET).

 

“Kappa opioid receptor antagonists are an exciting new class of compounds that hold the promise to treat a broad range of mood and substance use disorders,” commented Dr. Blake Paterson, CEO of Cerecor. “This study demonstrated that CERC-501 gets to where it is needed in the brain to be effective and that a single dose of 10 mg of CERC-501 almost completely saturated kappa receptors in the brain at 2.5 hours post dose, supporting the exploration of doses between 4 and 25 mg in efficacy clinical trials. We wish to acknowledge the excellent scientific and collaborative effort put forth by our Lilly and Yale colleagues. We expect to initiate a Phase 2 proof-of-concept study of CERC-501 in heavy smokers in the near future with top-line data expected before the end of 2016.”

 

About CERC-501

 

Kappa opioid receptors have shown to play an important role in stress, mood and addiction.  CERC-501 is an oral, potent and selective kappa opioid receptor, or KOR, antagonist being developed for adjunctive treatment of substance use disorders (e.g., nicotine, alcohol, and/or cocaine) and major depressive disorders.  CERC-501 has demonstrated positive preclinical data in depression, nicotine withdrawal and alcohol dependence and data from three human clinical studies demonstrating that it is generally well tolerated.  Cerecor acquired CERC-501 from Eli Lilly and Company in February 2015

 



 

About Cerecor

 

Cerecor Inc. 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 by addressing the unmet medical needs of underserved patient segments. We are committed to the development of drugs that improve lives by applying our extensive knowledge and experience in central nervous system disorders.  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 (including, without limitation, the timing for the separation of Cerecor’s publicly traded units into their component securities as described herein) 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

 


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