Concert Pharmaceuticals Reports First Quarter 2018 Financial Results
May 03 2018 - 7:00AM
Business Wire
Conference Call Scheduled Today at 8:30 a.m.
EDT
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today reported
financial results for the first quarter of 2018.
“Concert has begun 2018 with strong momentum as our pipeline of
first-in-class drug candidates for serious diseases is progressing
in important efficacy trials, with the first data read out later
this year for CTP-543,” said Roger Tung, Ph.D., President and Chief
Executive Officer of Concert Pharmaceuticals. “We look forward to
the progression of multiple Concert-discovered compounds over the
coming quarters, including our proprietary drug candidates, CTP-543
for alopecia areata and CTP-692 for schizophrenia.”
Dr. Tung also commented, “As we’ve demonstrated with our
platform, early clinical studies of well-chosen deuterium-modified
drugs can rapidly create value. Two clear examples of that include
VX-561, which Vertex may advance into Phase 3 development for
cystic fibrosis, and AVP-786 which is in Phase 3 evaluation for
Alzheimer’s agitation under our collaboration with Avanir
Pharmaceuticals. Both VX-561 and AVP-786 have the potential to
provide substantial additional financial upside to Concert.”
Recent Business Highlights and Upcoming Milestones
Autoimmune Dermatology
- CTP-543 Phase 2a Trial for Alopecia
Areata Fully Enrolled. In April 2018, the Company completed
patient enrollment of its Phase 2a trial evaluating CTP-543 for the
treatment of moderate-to-severe alopecia areata. This is a
double-blind, randomized, placebo-controlled, sequential dose trial
to evaluate the safety and efficacy of two doses twice daily of
CTP-543 in approximately 90 patients. Topline data from the 4 mg
and 8 mg cohorts is expected in the fourth quarter of 2018. The
primary outcome measure will utilize the severity
of alopecia tool (SALT) after 24 weeks of dosing. If
appropriate, the protocol may be amended to explore 12 mg twice
daily of CTP-543.
- CTP-543 Granted Fast Track
Designation. In January 2018, the Company announced that the
U.S. Food and Drug Administration (FDA) granted Fast Track
designation for CTP-543. Fast Track designation is intended to
facilitate the development and expedite the review process for
therapies for serious medical conditions which offer the potential
to significantly advance the existing standard of care.
- FDA Voice of the Patient: Alopecia
Areata. Following the U.S. Food and Drug Administration’s (FDA)
Patient-Focused Drug Development meeting held in September 2017 on
alopecia areata, the FDA summarized the input shared by patients
and patient representatives in a Voice of the Patient report. The
public meeting on alopecia areata provided FDA with patient input
on the impact of alopecia areata, including on daily life, patient
views on treatment approaches, and decision factors taken into
account when selecting a treatment.
- PTAB Institutes IPR Proceeding.
In April 2018, the Patent Trial and Appeal Board (PTAB) granted the
request for rehearing of the PTAB’s decision denying institution of
the Inter Partes Review (IPR) filed by Incyte Corporation against
Concert’s U.S. Patent No. 9,249,149. Concert believes in the
validity of its patent claims and intends to vigorously defend the
patent.
Neuropsychiatry
- CTP-692 Preclinical Results Support
Development in Schizophrenia. In March 2018, Concert announced
the selection of CTP-692, a novel drug candidate for adjunctive
treatment of schizophrenia, as its next development candidate.
CTP-692 is a deuterated form of D-serine, an endogenous co-agonist
of the NMDA receptor. Patients with schizophrenia have been shown
to have lower plasma and cerebrospinal fluid concentrations of
D-serine than individuals without schizophrenia. Based on early
clinical results of D-serine and Concert’s initial preclinical
assessment of CTP-692, the Company believes that CTP-692 has the
potential to improve clinical outcomes in patients with
schizophrenia. The Company intends to advance CTP-692 into clinical
development by year-end 2018.
- CTP-692 NMDA Receptor Activity
Nearly Identical to D-Serine. In preclinical testing,
Concert demonstrated that CTP-692 and D-serine have nearly
identical binding and functional activity at the human NMDA
receptor.
First Quarter 2018 Financial Results
- Cash and Investments Position:
Cash, cash equivalents and investments as of March 31, 2018,
totaled $191.0 million as compared to $203.2 million as of December
31, 2017. Concert expects its cash, cash equivalents and
investments as of March 31, 2018 to be sufficient to fund the
Company into 2021.
- Revenues: Revenue was $10.5
million for the quarter ended March 31, 2018, compared to $20,000
for the same period in 2017. Revenue recognized in 2018 consists of
$10.5 million primarily in non-cash consideration received from
Processa Pharmaceuticals under a licensing agreement whereby
Processa has worldwide rights to develop and commercialize CTP-499,
a deuterated analog of 1-(S)-5-hydroxyhexyl-3,7-dimethylxanthine,
an active metabolite of pentoxifylline.
- R&D Expenses: Research and
development expenses were $8.7 million for the quarter ended March
31, 2018, compared to $8.2 million for the same period in 2017. In
the first quarter of 2018, research and development expenses were
primarily associated with the development of CTP-543 and CTP-692.
In the first quarter of 2017, research and development expenses
were primarily associated with the development of CTP-543 and
CTP-656, the Company’s product candidate for cystic fibrosis which
was acquired by Vertex Pharmaceuticals in July 2017.
- G&A Expenses: General and
administrative expenses were $5.6 million for the quarter ended
March 31, 2018, compared to $5.3 million for the same period in
2017. The increase in general and administrative expenses was
primarily related to an increase in non-cash stock-based
compensation expense.
- Net Loss: For the quarter ended
March 31, 2018, net loss applicable to common stockholders was $4.5
million, or $0.19 per share, compared with a net loss applicable to
common stockholders of $13.3 million, or $0.60 per share, for the
quarter ended March 31, 2017.
Conference Call and WebcastThe Company will host a
conference call and webcast today, Thursday, May 3, 2018, at 8:30
a.m. ET to provide an update on the Company and discuss first
quarter financial results. To access the conference call, please
dial (855) 354-1855 (U.S. and Canada) or (484) 365-2865
(International) five minutes prior to the start time.
A live webcast of Concert’s presentation may be accessed in the
Investors section of the Company’s website at
www.concertpharma.com. Please log on to the Concert website
approximately 15 minutes prior to the scheduled webcast to ensure
adequate time for any software downloads that may be required. A
replay of the webcast will be available on Concert’s website for
three months.
– Financial Tables to Follow –
Concert Pharmaceuticals, Inc.Condensed
Consolidated Statements of Operations(in thousands, except
per share amounts) Quarter Ended
March 31, 2018 2017 Revenue: License
and research and development revenue $ 10,479 $ 20 Operating
expenses: Research and development 8,656 8,237 General and
administrative 5,630 5,253 Total operating expenses
14,286 13,490 Loss from operations (3,807 ) (13,470 )
Investment income 640 137 Unrealized loss on marketable equity
securities (1,296 ) — Net loss $ (4,463 ) $ (13,333 )
Net loss per share applicable to common stockholders — basic and
diluted $ (0.19 ) $ (0.60 ) Weighted-average number of common
shares used in net loss per share applicable to common
stockholders— basic and diluted 23,223 22,377
Concert Pharmaceuticals, Inc.Summary Balance Sheet
Data(in thousands) March 31, 2018
December 31, 2017 Cash and cash equivalents $ 35,697
$ 27,665 Investments, available for sale 155,305 175,500 Working
capital 212,893 199,289 Total assets 227,646 211,736 Deferred
revenue 10,533 10,301 Total stockholders’ equity $ 210,397 $
196,432
About ConcertConcert Pharmaceuticals is a clinical stage
biopharmaceutical company focused on applying its DCE Platform®
(deuterated chemical entity platform) to create novel medicines
designed to address unmet patient needs. The Company’s approach
starts with starts with previously studied compounds, including
approved drugs, in which deuterium substitution has the potential
to enhance clinical safety, tolerability or efficacy. Concert has
a broad pipeline of innovative medicines targeting
autoimmune and inflammatory diseases and central nervous systems
(CNS) disorders. For more information please visit
www.concertpharma.com or follow us on Twitter at @ConcertPharma or
on LinkedIn.
Cautionary Note on Forward Looking StatementsAny
statements in this press release about our future expectations,
plans and prospects, including risks related to the clinical
development of our therapeutic candidates and expectations
regarding the sufficiency of our cash balance to fund operating
expenses and capital expenditures, and other statements containing
the words “anticipate,” “believe,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “would,” and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including: the
uncertainties inherent in the initiation of future clinical trials,
availability and timing of data from ongoing and future clinical
trials and the results of such trials, whether preliminary results
from a clinical trial will be predictive of the final results of
that trial or whether results of early clinical trials will be
indicative of the results of later clinical trials, expectations
for regulatory approvals, availability of funding sufficient for
our foreseeable and unforeseeable operating expenses and capital
expenditure requirements and other factors discussed in the “Risk
Factors” section of our most recent Quarterly Report on Form 10-Q
filed with the Securities and Exchange Commission and in other
filings that we make with the Securities and Exchange Commission.
In addition, any forward-looking statements included in this press
release represent our views only as of the date of this release and
should not be relied upon as representing our views as of any
subsequent date. We specifically disclaim any obligation to update
any forward-looking statements included in this press release.
Concert Pharmaceuticals Inc., the CoNCERT
Pharmaceuticals Inc. logo and DCE Platform are registered
trademarks of Concert Pharmaceuticals, Inc.
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Investors:Concert Pharmaceuticals, Inc.Justine
Koenigsberg, 781-674-5284ir@concertpharma.comorMedia:The Yates
NetworkKathryn Morris, 845-635-9828kathryn@theyatesnetwork.com
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