CTP-543 On Track to Report Topline Phase 2a
Results in Alopecia Areata by Year-End
New Neuropsychiatric Product Candidate
Poised to Enter Clinical Development in 2018
Conference Call Scheduled Today at 8:30 a.m.
ET
Concert Pharmaceuticals, Inc. (NASDAQ:CNCE) today reported
financial results for the year ended December 31, 2017, as well as
provided an update on its product pipeline and corporate
activities.
“Our focus for Concert in 2018 centers around pipeline
advancement, notably CTP-543 for moderate-to-severe alopecia
areata, and our newly announced development candidate, CTP-692, for
adjunctive treatment of schizophrenia. These differentiated product
candidates were created with our deuterium platform to address
important unmet patient needs,” said Roger Tung, Ph.D., President
and Chief Executive Officer of Concert Pharmaceuticals. “We believe
that we have numerous ways to further grow our pipeline and we will
be exploring additional opportunities to do so throughout
2018.”
Dr. Tung added, “The achievements we realized in 2017, including
the CTP-656, now VX-561, asset purchase agreement with Vertex and
the Patent Trial and Appeal Board decision upholding the validity
of our CTP-543 patent, position us well to capitalize on our
product candidate opportunities and continue to validate our
deuterium approach.”
Recent Business Highlights and Upcoming Milestones
- Enrollment in Second Cohort of
CTP-543 Phase 2a Trial Initiated. In February 2018, the Company
initiated enrollment of the second cohort of its Phase 2a clinical
trial evaluating CTP-543. Concert is developing CTP-543 for the
treatment of moderate-to-severe alopecia areata, an autoimmune
disease in which the immune system attacks hair follicles resulting
in patchy or complete hair loss. The Company expects to report
topline data from the 4 mg and 8 mg cohorts of the Phase 2a trial
in the fourth quarter of 2018.
- 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 reserved for
therapies for serious medical conditions which offer the potential
to significantly advance the existing standard of care, and is
designed to facilitate their development and expedite the review
process.
- CTP-543 Patent Proceedings. In
October 2017, the Patent Trial and Appeal Board (PTAB) denied
Incyte’s petition to institute inter partes review (IPR) of
Concert’s U.S. Patent No. 9,249,149. The denial of Incyte’s IPR
petition upholds the validity of Concert’s composition of matter
patent claims covering CTP-543. In January 2018, the PTAB denied
Concert’s petition to institute Post Grant Review (PGR) of U.S.
Patent No. 9,662,335 assigned to Incyte. The January PTAB decision
does not prohibit Concert from developing CTP-543 for alopecia
areata and the development timelines for CTP-543 remain on
track.
- CTP-692 Selected as New Development
Candidate. Concert selected 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 N-methyl-D-aspartate (NMDA) receptor. Based on
the clinically demonstrated effects of d-serine and our initial
preclinical assessment of CTP-692, the Company believes that
CTP-692 has the potential to help restore NMDA receptor activity in
key areas of the brain to improve clinical outcomes in patients
with schizophrenia. The Company intends to conduct preclinical
evaluation and advance CTP-692 into clinical development by
year-end 2018.
- Marc Becker Named Chief Financial
Officer. Effective January 4, 2018, Marc Becker joined Concert
as Chief Financial Officer. Mr. Becker is a seasoned financial
executive with more than 15 years of experience in the
biotechnology industry. Prior to joining Concert, he was Senior
Vice President and Chief Financial Officer at CRISPR
Therapeutics.
- NASDAQ Biotechnology Index. In
December 2017, Concert was selected for addition to the NASDAQ
Biotechnology Index. The NASDAQ Biotechnology Index is designed to
track the performance of a set of NASDAQ-listed securities that are
classified as either biotechnology or pharmaceutical according to
the Industry Classification Benchmark.
Full Year 2017 Financial Results
- Cash and Investments Position.
Cash, cash equivalents and investments as of December 31, 2017,
totaled $203.2 million as compared to $96.2 million as of December
31, 2016. Concert expects its cash, cash equivalents and
investments as of December 31, 2017 to be sufficient to fund the
Company into 2021.
- Revenues. Revenue was $143.9
million for the year ended December 31, 2017, compared to $174,000
for the year ended December 31, 2016. The increase in revenue
relates to the asset purchase agreement with Vertex Pharmaceuticals
whereby Vertex acquired worldwide development and commercialization
rights to CTP-656 and other assets related to the treatment of
cystic fibrosis for $160 million.
- R&D Expenses. Research and
development expenses were $30.2 million for the year ended December
31, 2017, compared to $37.0 million for the year ended December 31,
2016, a decrease of $6.8 million. The decrease was primarily due to
the discontinuation of CTP-656 as a result of the asset purchase
agreement with Vertex.
- G&A Expenses. General and
administrative expenses were $21.0 million for the year ended
December 31, 2017, compared to $14.4 million for the year ended
December 31, 2016, an increase of $6.6 million. The increase in
general and administrative expenses was primarily related to an
increase in stock compensation as well as professional and legal
fees in connection with the CTP-656 asset purchase agreement and
intellectual property matters related to CTP-543.
- Net Income (Loss). For the year
ended December 31, 2017, net income was $95.6 million, or $4.20 per
share, as compared to a net loss of $50.7 million, or $2.28 per
share for the year ended December 31, 2016.
Conference Call and Webcast
The Company will host a conference call and webcast today at
8:30 a.m. ET to provide an update on the Company and discuss full
year 2017 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 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)
Three Months EndedDecember
31,
Twelve Months EndedDecember
31,
2017 2016 2017
2016 Revenue: License and research and development revenue $
10 $ 21 $ 62 $ 174 Other Revenue 2 — 143,829 —
Total revenue 12 21 143,891 174
Operating expenses: Research and development 7,565 8,658 30,223
36,983 General and administrative 5,184 3,515 21,019
14,358 Total operating expenses 12,749 12,173
51,242 51,341 Income (loss) from operations
(12,737 ) (12,152 ) 92,649 (51,167 ) Interest and other income, net
4,194 109 2,690 447 Income (loss)
before tax (provision) benefit (8,543 ) (12,043 ) 95,339 (50,720 )
Benefit from income taxes (2,477 ) — (300 ) — Net
income (loss) $ (6,066 ) $ (12,043 ) $ 95,639 $ (50,720 )
Net income (loss) attributable to common stockholders -
basic (6,066 ) (12,043 ) 95,195 (50,720 ) Net income (loss)
attributable to common stockholders - diluted (6,066 ) (12,043 )
95,210 (50,720 ) Net income (loss) per share attributable to
common stockholders: Basic $ (0.26 ) $ (0.54 ) $ 4.20 $ (2.28 )
Diluted $ (0.26 ) $ (0.54 ) $ 4.06 $ (2.28 ) Weighted-average
number of common shares used in net income (loss) per share
attributable to common stockholders: Basic 22,909 22,287 22,641
22,233 Diluted 22,909 22,287 23,442 22,233
Concert
Pharmaceuticals, Inc. Summary Balance Sheet Data (in
thousands)
December 31,2017
December 31,2016
Cash and cash equivalents $ 27,665 $ 40,555 Investments, available
for sale 175,500 55,630 Working capital 199,289 92,159 Total assets
211,736 100,395 Deferred revenue 10,301 10,050 Total stockholders’
equity $ 196,432 $ 85,594
Additional information about Concert’s pipeline product, CTP-543
and CTP-692 and their therapeutic indications, are available online
at: https://www.concertpharma.com/product-pipeline/.
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 Annual Report on Form 10-K
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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version on businesswire.com: http://www.businesswire.com/news/home/20180301005128/en/
Concert Pharmaceuticals, Inc.Justine Koenigsberg (Investors),
781-674-5284ir@concertpharma.comorThe Yates NetworkKathryn Morris
(Media), 914-204-6412kathryn@theyatesnetwork.com
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