CTP-543 THRIVE-AA1 Phase 3 Trial in Patients
with Moderate to Severe Alopecia Areata Fully Enrolled with Topline
Data Expected Second Quarter of 2022
CTP-543 THRIVE-AA2 Phase 3 Trial in Patients
with Moderate to Severe Alopecia Areata Progressing with Topline
Data Expected Second Half of 2022
CTP-543 Treatment Shows Maintenance of Hair
Regrowth in Open Label Extension Trial
Conference Call Scheduled Today at 8:30 a.m.
ET
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today reported
financial results for the third quarter of 2021.
“The CTP-543 pivotal program is progressing on track to support
an NDA filing with the FDA in early 2023,” said Roger Tung, Ph.D.,
President and Chief Executive Officer of Concert Pharmaceuticals.
“We continue to believe that CTP-543, with its Breakthrough Therapy
designation, has the potential to be a best in class compound to
treat this challenging autoimmune disease and hope to make it
available to patients as soon as possible.”
Recent Business Highlights and Upcoming Milestones
CTP-543: An Investigational Treatment in
Pivotal Clinical Program for Moderate to Severe Alopecia
Areata
- Completed Enrollment in the CTP-543 THRIVE-AA1 Phase 3 Trial
in October 2021. 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 study enrolled 708 adult patients with
moderate to severe alopecia areata. The trial is evaluating 8 mg
and 12 mg twice-daily doses of CTP-543 compared to placebo at sites
in the U.S., Canada and Europe. The Company expects to report
topline results from the THRIVE-AA1 trial in the second quarter of
2022.
- CTP-543 THRIVE-AA2 Phase 3 Trial is Progressing.
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 in approximately 440 adult patients with
moderate to severe alopecia areata. The trial is evaluating 8 mg
and 12 mg twice-daily doses of CTP-543 compared to placebo at sites
in the U.S., Canada and Europe. The Company expects to report
topline results from the THRIVE-AA2 trial in the second half of
2022.
- CTP-543 Long-term Data Presented at JAK Inhibitors Drug
Development Summit in Q3 2021. Data from an ongoing open label,
long-term extension study with CTP-543 were presented at the 2nd
JAK Inhibitors Drug Development Summit on July 1, 2021. The
presentation highlighted that in the extension study, treatment
with CTP-543 showed continued maintenance of hair regrowth relative
to the hair growth shown in the Company’s previously conducted
Phase 2 trials in patients with alopecia areata. Approximately 57%
of participants receiving 12 mg of CTP-543 twice-daily following 52
weeks of dosing achieved a clinically-meaningful SALT score of 20
or less. A SALT score ≤ 20 corresponds to 80% or more hair coverage
on the scalp. CTP-543 has been generally well tolerated in the
extension study, and adverse events are consistent with those
reported in the Phase 2 trials.
- New Publication Highlights Adoption of Alopecia Areata
Disease Severity Scale. Concert participated as a co-author in
a new publication in the Journal of the American Academy of
Dermatology (JAAD) that highlights an academic-industry
collaborative effort for the development of a new alopecia areata
disease severity scale for use in clinical practice. The new
alopecia areata disease severity scale, anchored in the amount of
hair loss, captures key features commonly used by experts in
clinical practice, and is intended to help physicians to easily and
accurately assess alopecia areata severity in patients.
Third Quarter 2021 Financial Results
- Cash and Investment Position. Cash, cash equivalents and
investments as of September 30, 2021 totaled $103.7 million as
compared to $130.0 million as of December 31, 2020. In November
2021, the Company raised gross proceeds of $65 million under a
financing agreement with BVF Partners L.P. and RA Capital
Management. The financing consists 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 Pharmaceuticals, Inc. Concert will
have the potential to receive an additional $103 million upon the
full exercise of warrants issued in connection with the agreement.
Under its current operating plan, the Company expects its cash and
cash equivalents to fund the Company into the fourth quarter of
2022.
- Revenues. For the quarter ended September 30, 2021,
revenue was $0.5 million, compared to $1.5 million for the same
period in 2020.
- R&D Expenses. Research and development expenses were
$21.9 million for the quarter ended September 30, 2021, compared to
$16.3 million for the same period in 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 $5.5 million for the quarter ended September 30, 2021,
compared to $4.5 million for the same period in 2020.
- Net Loss. For the quarter ended September 30, 2021, net
loss applicable to common stockholders was $26.7 million, or $0.78
per share, as compared to net loss applicable to common
stockholders of $18.9 million, or $0.60 per share, for the quarter
ended September 30, 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 third
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 the third quarter 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.
Condensed Consolidated
Statements of Operations
(in thousands, except per
share amounts)
(unaudited)
Three Months Ended September
30,
Nine Months Ended September
30,
2021
2020
2021
2020
Revenue:
License and research and development
revenue
$
4
$
1,501
$
26
$
7,895
Other revenue
539
—
32,539
—
Total revenue
543
1,501
32,565
7,895
Operating expenses:
Research and development
21,876
16,347
60,560
45,121
General and administrative
5,462
4,514
16,561
13,917
Total operating expenses
27,338
20,861
77,121
59,038
Loss from operations
(26,795
)
(19,360
)
(44,556
)
(51,143
)
Investment income
4
183
44
1,101
Unrealized gain (loss) on marketable
equity securities
113
269
590
(2,419
)
Loss before income taxes
(26,678
)
(18,908
)
(43,922
)
(52,461
)
Income tax benefit
—
—
—
(85
)
Net loss
$
(26,678
)
$
(18,908
)
$
(43,922
)
$
(52,376
)
Net loss per share applicable to common
stockholders - basic and diluted
$
(0.78
)
$
(0.60
)
$
(1.29
)
$
(1.71
)
Weighted-average number of common shares
used in net loss per share applicable to common stockholders -
basic and diluted
34,090
31,547
33,987
30,707
Concert Pharmaceuticals,
Inc.
Summary Balance Sheet
Data
(in thousands)
(unaudited)
September 30, 2021
December 31, 2020
Cash and cash equivalents
$
103,664
$
77,202
Investments, available for sale
—
52,766
Working capital
100,887
132,546
Total assets
128,208
159,263
Deferred revenue
2,750
2,750
Total stockholders’ equity
99,162
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 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/20211109005298/en/
For additional information contact: 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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