0001558370-16-007981.txt : 20160815 0001558370-16-007981.hdr.sgml : 20160815 20160815095738 ACCESSION NUMBER: 0001558370-16-007981 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20160815 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160815 DATE AS OF CHANGE: 20160815 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: 161830508 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-20160815x8k.htm 8-K cerc_Current_Folio_8-K_Earnings_Release

 

 

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): August 15, 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 2.02.Results of Operations and Financial Condition.

 

On August 15, 2016, Cerecor Inc. (the “Registrant”) issued a press release announcing the Registrant’s financial results for the second quarter ended June 30, 2016. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

The information in this Item 2.02 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 9.01.Financial Statements and Exhibits.

 

Exhibit
No.

 

Description

 

 

 

99.1

 

Press Release, dated August 15, 2016, entitled “Cerecor Inc. Reports Second Quarter 2016 Financial Results.”

 

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:   August 15, 2016

3

 


 

 

EXHIBIT INDEX

 

Exhibit
No.

 

Description

 

 

 

99.1

 

Press Release, dated August 15, 2016, entitled “Cerecor Inc. Reports Second Quarter 2016 Financial Results.”

 

4

 


EX-99.1 2 cerc-20160815ex991161db4.htm EX-99.1 cerc_Exh_99_1_Earnings_Release

Exhibit 99.1

 

Cerecor Inc. Reports Second Quarter 2016 Financial Results

 

BALTIMORE—(BUSINESS WIRE)—August 15, 2016—Cerecor Inc. (NASDAQ: CERC), a clinical-stage biopharmaceutical company developing innovative drug candidates to make a difference in the lives of patients with neurological and psychiatric disorders, today announced its financial results for the second quarter ended June 30, 2016.

 

“We are excited about both of our Phase 2 programs and are encouraged by the scientific community’s increasing interest in CERC-501, having recently received grants from both the National Institute on Drug Abuse and the National Institute on Alcohol Abuse and Alcoholism and being accepted for participation in a consortium with the Pharmacotherapies for Alcohol and Substance Use Disorders,” said Dr. Uli Hacksell, President and Chief Executive Officer of Cerecor. “We expect top-line data from our Phase 2 study with CERC-501 in the fourth quarter of this year and are enthusiastic about the potential use of CERC-501 for substance use disorders. Additionally, our Phase 2 study with CERC-301 for the adjunctive treatment of major depressive disorder continues to advance in line with our expectations.”

 

Business and Other Highlights

 

Research and Development

 

   In April, awarded a $1 million research and development grant from the National Institute on Drug Abuse at the National Institutes of Health, which provides additional resources for the ongoing Phase 2 proof-of-concept clinical trial with CERC-501 for smoking cessation.

 

·

In July, awarded a $1 million research and development grant from the National Institute on Alcohol Abuse and Alcoholism at the National Institutes of Health, which provides additional resources to progress the development of CERC-501 for the treatment of alcohol use disorder.

 

·

In July, announced a research grant from the Pharmacotherapies for Alcohol and Substance Use Disorders Consortium to assess the efficacy of CERC-501, separately and in combination with one of two anti-hypertensive drugs, in reducing post-traumatic stress disorder-induced alcohol use disorder in animal models.

 

Business and Leadership

 

   Held our first Annual Meeting of Stockholders as a public company in May.

 

   The board of directors and stockholders re-elected Eugene A. Bauer, M.D. and Magnus Persson, M.D., Ph.D. to the board of directors to hold office until the 2019 Annual Meeting of Stockholders.

 

Second Quarter 2016 Financial Results

 

Cerecor reported a net loss of $3.5 million, or $0.41 per common share1, for the second quarter of 2016, compared to a net loss of $2.9 million, or $4.48 per common share2, for the second quarter of 2015.


1.

Based on weighted-average common shares outstanding of 8,650,143.

2.

Based on weighted-average common shares outstanding of 649,721.


 

As of June 30, 2016, Cerecor’s cash and cash equivalents totaled $11.9 million, compared to $21.2 million at December 31, 2015. This decrease resulted from the funding of our research and development activities, our ongoing operations, and payments made on our term loan.

 

Research and development (“R&D”) expenses increased to $2.5 million for the second quarter of 2016, compared to $1.9 million for the second quarter of 2015. The increase was driven primarily by the costs for the ongoing Phase 2 trial with CERC-501 for smoking cessation, which experienced significant enrollment activity during the second quarter.  During the comparable period, R&D expenses for CERC-501 were primarily limited to in-licensing fees.

 

General and administrative (“G&A”) expenses increased to $1.6 million for the second quarter of 2016, compared to $1.0 million for the second quarter of 2015. The increase was primarily due to increased legal, consulting and other professional fees associated with becoming a public company as well as increased salaries and related costs.

 

About Cerecor

 

Cerecor is a clinical-stage biopharmaceutical company developing innovative drug candidates to make a difference in the lives of patients with neurological and psychiatric disorders. 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 2-stage product candidates: CERC-301 and CERC-501.

 

CERC‑301 is currently in Phase 2 development as an oral, rapidly acting adjunctive treatment for patients with severe major depressive disorder (“MDD”) who are failing to achieve an adequate response to their current antidepressant treatment, with a rapid onset of effect. Cerecor received fast track designation by the United States Food and Drug Administration in November 2013 for CERC‑301 for the treatment of MDD. CERC‑301 belongs to a class of compounds known as antagonists, or inhibitors, of the N‑methyl‑D‑aspartate (“NMDA”) receptor, a receptor subtype of the glutamate neurotransmitter system that is responsible for controlling neurological adaptation. We believe CERC‑301 will be a first-in-class medication that will cause a significant reduction in depressive symptoms in a matter of days, as compared to weeks or months with conventional therapies, because it specifically blocks the NMDA receptor subunit 2B, which we believe provides rapid and significant antidepressant activity without the adverse side effect profile of non‑selective NMDA receptor antagonists.

 

CERC‑501 is currently in Phase 2 development for smoking cessation. 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. Ultimately, Cerecor intends to pursue development of CERC-501 for the treatment of substance use disorders more broadly (e.g., nicotine, alcohol, and/or cocaine) and as an adjunctive treatment of MDD. In addition to Cerecor’s Phase 2 trial, two externally-funded clinical trials are being conducted to evaluate the use of CERC-501 in treating cocaine addiction and mood disorders. One study is being conducted under the auspices of the National Institute of Mental Health and the second study is being funded by a private foundation.

 

In addition to our two clinical Phase 2-stage product candidates, Cerecor has one preclinical stage asset, CERC-406, a brain penetrant catechol‑O‑methyltransferase (“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 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,” “continue,” “seeks,” “aims,” “predicts,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions (including their use in the negative), or by discussions of future matters such as the development of product candidates or products, technology enhancements, possible changes in legislation, and other statements that are not historical. 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.

 

Cerecor Inc.

Unaudited Condensed Statements of Operations

(in thousands, except share and per share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Six Months Ended

 

 

June 30,

 

June 30,

 

 

2016

 

2015

 

2016

 

2015

Grant revenue

 

$

650

 

$

 —

 

$

650

 

$

 —

Operating expenses:

 

 

 

    

 

 

 

 

 

    

 

 

Research and development

 

 

2,502

 

 

1,875

 

 

4,795

 

 

3,599

General and administrative

 

 

1,636

 

 

1,016

 

 

4,286

 

 

1,777

Loss from operations

 

 

(3,488)

 

 

(2,891)

 

 

(8,431)

 

 

(5,376)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Change in fair value of warrant liability, unit purchase option liability and investor rights obligation

 

 

91

 

 

197

 

 

44

 

 

(337)

Interest income (expense), net

 

 

(127)

 

 

(219)

 

 

(277)

 

 

(437)

Total other income (expense)

 

 

(36)

 

 

(22)

 

 

(233)

 

 

(774)

Net loss

 

$

(3,524)

 

$

(2,913)

 

$

(8,664)

 

$

(6,150)

Net loss per share of common stock, basic and diluted

 

$

(0.41)

 

$

(4.48)

 

$

(1.00)

 

$

(9.47)

Weighted-average shares of common stock outstanding, basic and diluted

 

 

8,650,143

 

 

649,721

 

 

8,650,143

 

 

649,721

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

Cerecor Inc.

Condensed Balance Sheets

(in thousands)

 

 

 

 

 

 

 

 

 

 

June 30,

 

December 31,

 

 

2016

 

2015

 

 

(unaudited)

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

11,880

 

$

21,162

Grants receivable

 

 

650

 

 

 —

Prepaid expenses and other current assets

 

 

542

 

 

402

Restricted cash

 

 

59

 

 

59

Total current assets

 

 

13,131

 

 

21,623

Property and equipment, net

 

 

41

 

 

35

Total assets

 

$

13,172

 

$

21,658

Liabilities and stockholders’ equity

 

 

 

 

 

 

Liabilities

 

$

7,601

 

$

8,574

Stockholders’ equity

 

 

5,571

 

 

13,084

Total liabilities and stockholders’ equity

 

$

13,172

 

$

21,658

 

 

 

Media Contact

MacDougall Biomedical Communications

Doug MacDougall or Joe Rayne – 781-235-3060

ir@cerecor.com