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.
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
1. Based on weighted-average common shares outstanding of
8,650,143.
2. Based on weighted-average common shares outstanding of
649,721.
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version on businesswire.com: http://www.businesswire.com/news/home/20160815005097/en/
MacDougall Biomedical CommunicationsDoug MacDougall or Joe
Rayne, 781-235-3060ir@cerecor.com
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