CTP-543 Phase 3 Program for Treatment of
Alopecia Areata Expected to Begin in 2020
New CTP-543 Patent Covers Pharmaceutical
Compositions of CTP-543 and Methods of Treating Alopecia Areata
with CTP-543
CTP-692 Phase 2 Topline Results as
Adjunctive Treatment for Schizophrenia Expected by Year End
2020
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, 2019 and provided
an update on its product pipeline and corporate activities.
“Our 2019 accomplishments provide a strong foundation for an
exciting year at Concert in 2020. Both of our proprietary programs,
CTP-543 for alopecia areata and CTP-692 for schizophrenia,
exemplify great examples of innovative clinical compounds that
originated from Concert’s technology and that have the potential to
create meaningful impact for patients,” stated Roger Tung, Ph.D.,
President and Chief Executive Officer of Concert Pharmaceuticals.
“The robust results from our Phase 2 dose-ranging trial of CTP-543
for the treatment of alopecia areata support advancing the drug
candidate into pivotal testing with a potential best-in-class
product profile for this serious disease. With the recent
initiation of the Phase 2 dose-ranging trial of CTP-692 in patients
with schizophrenia, we expect to report topline data by year end
that may enable us to advance the program directly into pivotal
evaluation in 2021.”
Recent Business Highlights and Upcoming Milestones
CTP-543: An Investigational Treatment
for Moderate-to-Severe Alopecia Areata
- New CTP-543 Patent Provides Protection until 2037. In
February 2020, the U.S. Patent and Trademark Office issued U.S.
Patent No. 10,561,659 (’659 patent) related to CTP-543. The patent,
which will expire in 2037, covers pharmaceutical compositions of
CTP-543 and methods of treating alopecia areata with CTP-543.
Importantly, this patent covers the clinical doses of CTP-543 that
produced the robust results observed in the Company’s Phase 2
dose-ranging trial for the treatment of alopecia areata and will be
Orange Book eligible on approval of CTP-543.
- Federal Circuit Granted Concert’s Motion to Vacate and
Remand PTAB Decision Involving CTP-543. The U.S. Court of
Appeals for the Federal Circuit (CAFC) granted the Company’s motion
to vacate and remand the Patent Trial and Appeal Board (PTAB)
decision to invalidate U.S. Patent No. 9,249,149 (’149 patent).
Concert’s motion was made in light of the recent CAFC ruling on the
Constitution’s Appointments Clause (Arthrex, Inc. v. Smith &
Nephew, Inc., No. 18-2140). The case will now be remanded for
reconsideration by a new panel of PTAB judges. The PTAB proceeding
is limited to the ’149 patent and has no bearing on the ’659
patent, which provides independent protection of CTP-543.
- CTP-543 Dose Regimen Trial Successfully Completed. In
the fourth quarter of 2019, the Company completed an open label
trial evaluating 8 mg twice-daily compared to 16 mg once-daily
dosing of CTP‑543 in patients with moderate-to-severe alopecia
areata. Results in the 8 mg twice-daily arm were consistent with
the previously-reported 8 mg twice-daily results from the Company’s
Phase 2 dose-ranging trial of CTP-543. Treatment with CTP-543 was
generally well tolerated in both arms of the study. All but one of
the patients who completed this trial elected to continue in an
open-label long-term extension study. Based on the results
observed, the twice-daily regimen is preferred and will be utilized
in the future efficacy trials in the CTP-543 clinical development
program.
- CTP-543 Phase 2 Data Presented in Late-Breaking News Session
at EADV 2019. In October 2019, Phase 2 dose-ranging data of
CTP-543 in patients with moderate-to-severe alopecia areata were
presented in the late-breaking news session at the European Academy
of Dermatology and Venereology (EADV) Annual Congress. The
presentation highlighted the Phase 2 results in which CTP-543 met
the primary efficacy endpoint for the 8 mg twice-daily and 12 mg
twice-daily doses with greater hair regrowth on the scalp compared
to placebo. In the study, treatment with CTP-543 was generally well
tolerated.
- CTP-543 Phase 2 Results Selected for Late-Breaking Oral
Presentation at AAD. Results from the Company’s Phase 2
dose-ranging trial of CTP-543 in alopecia areata will be presented
during an oral presentation at the Late-Breaking Research Program
at the American Academy of Dermatology (AAD) Annual Meeting on
March 21, 2020, in Denver, CO. This late-breaking presentation will
include new analyses from the Company’s completed Phase 2
dose-ranging study.
- End of Phase 2 Meeting and Phase 3 Initiation Expected in
2020. Data from the Company’s Phase 2 trials will support an
end of Phase 2 meeting with the U.S. Food and Drug Administration
(FDA) to review and discuss the Company’s registration pathway for
CTP-543 for the treatment of alopecia areata. The Company expects
to meet with the FDA in the first quarter of 2020 and initiate
Phase 3 testing of CTP-543 in the second half of 2020.
CTP-692: An Investigational Adjunctive
Treatment for Schizophrenia
- CTP-692 Phase 2 Trial Initiation. Following the
successful completion of the CTP-692 Phase 1 program, the Company
advanced CTP-692 into a Phase 2 dose-ranging trial as an adjunctive
treatment in patients with schizophrenia in December 2019. The
trial is designed to support advancement into pivotal evaluation.
The Company expects to report topline Phase 2 data by year end
2020.
- CTP-692 Webcast with Key Opinion Leader.
In November 2019, the Company hosted a webcast for investors to
highlight the CTP-692 program. The event included a presentation on
mechanism and the need for new treatments in schizophrenia by Dr.
Joseph Coyle, Director, Laboratory for Psychiatric and Molecular
Neuroscience at McLean Hospital and Harvard Medical School. The
replay of the event, with slides, can be accessed on the Events
& Presentations page of the Investors section of Concert’s
corporate website.
Full Year 2019 Financial
Results
- Cash and Investment Position. Cash, cash equivalents and
investments as of December 31, 2019 totaled $106.4 million as
compared to $153.3 million as of December 31, 2018. In the first
quarter of 2020, Concert announced the closing of a public offering
of common stock and pre-funded warrants, raising net proceeds of
$70.3 million, before offering expenses. Under its current
operating plan, the Company expects its cash, cash equivalents and
investments to fund the Company into the second half of 2021.
- Revenue. Revenue was $1.1 million for the year ended
December 31, 2019, compared to $10.5 million for the year ended
December 31, 2018. Revenue recognized in 2019 was primarily from an
upfront payment from a license agreement with Cipla Technologies
regarding CTP-354, a novel GABAA receptor subtype-selective
modulator. Revenue recognized in 2018 consisted of 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 an active
metabolite of pentoxifylline.
- R&D Expenses. Research and development expenses were
$59.8 million for the year ended December 31, 2019, compared to
$43.1 million for the year ended December 31, 2018, an increase of
$16.7 million. The increase in expenses in 2019 primarily related
to external expenses to support Phase 2 development of CTP-543 as
well as Phase 1 clinical trials and manufacturing costs to support
the continued development of CTP-692 into Phase 2 testing.
- G&A Expenses. General and administrative expenses
were $20.3 million for the year ended December 31, 2019, compared
to $22.9 million for the year ended December 31, 2018, a decrease
of $2.6 million. Decreases in legal and employee-related expenses
were partially offset by an increase in audit fees.
- Net Loss. For the year ended December 31, 2019, net loss
attributable to stockholders was $78.2 million, or $3.29 per share,
as compared to net loss attributable to stockholders of $56.0
million, or $2.40 per share, for the year ended December 31,
2018.
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 2019 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)
(unaudited)
Three Months Ended December
31,
Twelve Months Ended December
31,
2019
2018
2019
2018
Revenue:
License and research and development
revenue
$
13
$
13
$
1,077
$
10,505
Total revenue
13
13
1,077
10,505
Operating expenses:
Research and development
16,019
14,560
59,816
43,149
General and administrative
4,947
5,516
20,276
22,940
Total operating expenses
20,966
20,076
80,092
66,089
Loss from operations
(20,953
)
(20,063
)
(79,015
)
(55,584
)
Interest and other income (expense),
net
466
(771
)
849
(127
)
Loss before income taxes
(20,487
)
(20,834
)
(78,166
)
(55,711
)
Provision for income taxes
—
15
—
313
Net loss
$
(20,487
)
$
(20,849
)
$
(78,166
)
$
(56,024
)
Net loss attributable to common
stockholders - basic and diluted
(20,487
)
(20,849
)
(78,166
)
(56,024
)
Net loss per share applicable to common
stockholders - basic and diluted
$
(0.86
)
$
(0.89
)
$
(3.29
)
$
(2.40
)
Weighted-average number of common shares
used in net loss per share applicable to common stockholders -
basic and diluted
23,848
23,432
23,740
23,370
Concert Pharmaceuticals,
Inc. Summary Balance Sheet Data (in thousands)
(unaudited)
December 31, 2019
December 31, 2018
Cash and cash equivalents
$
53,043
$
17,770
Investments, available for sale
53,395
135,544
Working capital
99,587
171,400
Total assets
137,471
192,547
Total stockholders’ equity
101,457
167,740
About Concert
Concert Pharmaceuticals is a clinical stage biopharmaceutical
company focused on applying its DCE Platform® (deuterated chemical
entity platform) to create novel medicines designed to treat
serious diseases and address unmet patient needs. The Company’s
approach starts with previously studied compounds, including
approved drugs, in which deuterium substitution has the potential
to enhance clinical safety, tolerability or efficacy. Concert’s
pipeline of innovative medicines targets autoimmune 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 Statements
Any statements in this press release about our future
expectations, plans and prospects, including, among others,
statements about our expectations on the progress of clinical
development of CTP-543 and CTP-692, the timing of availability of
clinical trial data and the sufficiency of our cash, cash
equivalents and investments to fund our operations, and any other
statements containing the words “anticipate,” “believe,”
“continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “should,” “target,” “will,”
“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, 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, expectations with respect to the
protection of our intellectual property afforded by our patents and
other factors discussed in the “Risk Factors” section of our most
recent Annual Report on Form 10-K or 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200227005071/en/
Justine Koenigsberg (Investors) Concert Pharmaceuticals, Inc.
(781) 674-5284 ir@concertpharma.com
Kathryn Morris (Media) The Yates Network (914) 204-6412
kathryn@theyatesnetwork.com
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