Two Phase 3 Registrational Clinical Trials
Fully Enrolled for CTP-543 for the Treatment of Alopecia
Areata
CTP-543 THRIVE-AA1 Phase 3 Trial Topline
Data Expected Second Quarter of 2022
CTP-543 THRIVE-AA2 Phase 3 Trial Topline
Data Expected Third Quarter of 2022
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, 2021.
“Our team is extremely proud and motivated by our success in
enrolling more than 1,200 patients in our THRIVE-AA Phase 3 program
in line with our projected timelines. This represents a significant
milestone for Concert as we focus on commercializing CTP-543 to
help meet the needs of the alopecia areata patient community,” said
Roger Tung, Ph.D., President and Chief Executive Officer of Concert
Pharmaceuticals. “We expect 2022 to be a data rich year, with the
first key CTP-543 Phase 3 data readout next quarter.”
Recent Business Highlights and Upcoming Milestones
CTP-543: An Investigational Treatment in
Phase 3 Trials for Moderate to Severe Alopecia Areata
- Topline Data in THRIVE-AA1 Expected in the Second Quarter of
2022. The Company expects to report topline results from the
first CTP-543 Phase 3 trial, THRIVE-AA1, in the second quarter of
2022. THRIVE-AA1 is a randomized, double-blind, placebo-controlled
Phase 3 clinical trial of CTP-543 to evaluate hair regrowth using
the Severity of Alopecia Tool (SALT) after 24 weeks of dosing. The
trial is evaluating 8 mg and 12 mg twice-daily doses of CTP-543
compared to placebo. The trial enrolled 708 adult patients with
moderate to severe alopecia areata at sites in the U.S., Canada and
Europe.
- Enrollment Completed in the THRIVE-AA2 Phase 3 Trial.
Similar to THRIVE-AA1, THRIVE-AA2 is a randomized, double-blind,
placebo-controlled Phase 3 clinical trial of CTP-543 to evaluate
hair regrowth using SALT after 24 weeks of dosing. The trial is
evaluating 8 mg and 12 mg twice-daily doses of CTP-543 compared to
placebo. The trial enrolled 517 adult patients with moderate to
severe alopecia areata at sites in the U.S., Canada and Europe. The
Company expects to report topline results from the THRIVE-AA2 trial
in the third quarter of 2022.
- New Drug Application (NDA) Filing Expected for Alopecia
Areata in the First Half of 2023. If the CTP-543 clinical
program is successful, the Company intends to file an NDA with the
U.S. Food and Drug Administration (FDA) in the first half of 2023.
The FDA has granted CTP-543 Breakthrough Therapy designation for
the treatment of adult patients with moderate to severe alopecia
areata and Fast Track designation for the treatment of alopecia
areata. Alopecia areata is an autoimmune disease that may affect up
to approximately 1.5 million Americans at any given time1.
Partnered Program: AVP-786 for
Neurological Disorders
- AVP-786 Late-Stage Trials to Complete in Third Quarter of
2022. Avanir Pharmaceuticals and Otsuka Pharmaceuticals are
conducting a number of clinical trials evaluating AVP-786 in
certain neurological disorders, including multiple Phase 3 studies
in Alzheimer’s agitation. Avanir and Otsuka have full
responsibility for the development, reporting of clinical results
and commercialization of AVP-786. Concert is entitled to potential
future milestones and royalties. Two trials are expected to
complete in the third quarter of 2022:
- AVP-786 Phase 3 trial in Alzheimer’s Agitation is projected to
complete in July 2022.
- AVP-786 Phase 2/3 trial in Negative Symptoms of Schizophrenia
is projected to complete in August 2022.
Full Year 2021 Financial Results
- Cash and Investment Position. Cash, cash equivalents and
investments as of December 31, 2021 totaled $141.6 million,
compared to $130.0 million as of December 31, 2020. In November
2021, the Company raised gross proceeds of $65.0 million under a
financing arrangement with BVF Partners L.P. and RA Capital
Management, L.P. The financing consisted of the sale of common and
preferred stock, warrants and a portion of Concert’s right to
receive potential future AVP-786 royalties under an existing
licensing agreement with Avanir. Under its current operating plan,
the Company expects its current cash and cash equivalents to fund
the Company into the fourth quarter of 2022. In addition, Concert
has the potential to receive an additional $103.1 million upon the
full exercise of the warrants issued in connection with the
November 2021 financing.
- Revenue. Revenue was $32.6 million for the year ended
December 31, 2021, compared to $7.9 million for the year ended
December 31, 2020. Revenue recognized in 2021 was primarily
attributable to the $32.0 million in cash proceeds received from
Vertex Pharmaceuticals, Inc. for the purchase of potential future
milestones under the companies’ 2017 asset purchase agreement
related to VX-561. Revenue recognized in 2020 was the result of the
expiration of licensing options under a previous collaboration with
Celgene Corporation.
- R&D Expenses. Research and development expenses were
$87.6 million for the year ended December 31, 2021, compared to
$61.6 million for the year ended December 31, 2020. The increase in
research and development expenses relates primarily to the clinical
development for CTP-543.
- G&A Expenses. General and administrative expenses
were $22.5 million for the year ended December 31, 2021, compared
to $18.9 million for the year ended December 31, 2020. The increase
in general and administrative expenses relates primarily to
increased external professional service expenses and non-cash
stock-based compensation.
- Net Loss. For the year ended December 31, 2021, net loss
attributable to common stockholders was $80.1 million, or $2.33 per
share, compared to net loss applicable to common stockholders of
$74.8 million, or $2.40 per share, for the year ended December 31,
2020.
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
financial results for the year ended December 31, 2021. 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 the financial results 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.
Consolidated Statements of
Operations
(in thousands, except per
share amounts)
(unaudited)
Three Months Ended December
31,
Twelve Months Ended December
31,
2021
2020
2021
2020
Revenue:
License and research and development
revenue
$
13
$
7
$
39
$
7,902
Other revenue
—
—
32,539
—
Total revenue
13
7
32,578
7,902
Operating expenses:
Research and development
26,995
16,503
87,555
61,624
General and administrative
5,970
5,008
22,531
18,925
Total operating expenses
32,965
21,511
110,086
80,549
Loss from operations
(32,952
)
(21,504
)
(77,508
)
(72,647
)
Investment income
2
102
46
1,202
Unrealized loss on marketable equity
securities
(1,096
)
(988
)
(506
)
(3,406
)
Unrealized loss on warrant liabilities
(2,083
)
—
(2,083
)
—
Loss before income taxes
(36,129
)
(22,390
)
(80,051
)
(74,851
)
Income tax benefit
—
—
—
85
Net loss
$
(36,129
)
$
(22,390
)
$
(80,051
)
$
(74,766
)
Net loss per share attributable to common
stockholders - basic and diluted
$
(1.01
)
$
(0.69
)
$
(2.33
)
$
(2.40
)
Weighted-average number of common shares
used in net loss per share attributable to common stockholders -
basic and diluted
35,646
32,666
34,405
31,200
Concert Pharmaceuticals,
Inc.
Summary Balance Sheet
Data
(in thousands)
(unaudited)
December 31, 2021
December 31, 2020
Cash and cash equivalents
$
141,636
$
77,202
Investments, available for sale
—
52,766
Working capital
134,209
132,546
Total assets
165,316
159,263
Deferred revenue
7,595
2,750
Total stockholders’ equity
112,225
131,162
About Concert
Concert Pharmaceuticals is a clinical stage biopharmaceutical
company that is developing small molecule drugs that it discovered
through the application of its DCE Platform® (deuterated chemical
entity platform). Selective incorporation of deuterium into known
molecules has the potential, on a case-by-case basis, to provide
better pharmacokinetic or metabolic properties, thereby enhancing
their clinical safety, tolerability or efficacy. Concert’s lead
product candidate is in late-stage development for the treatment of
alopecia areata, a serious autoimmune dermatological condition.
Concert is also assessing a number of earlier-stage pipeline
candidates. 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 regarding the development of
CTP-543, the timing of availability of clinical trial data, the
timing of regulatory filings 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, timing and design of future clinical trials, the
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, 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.
1Benigno M. Clinical, Cosmetic and Investigational Dermatology
2020.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220302005985/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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