CTP-543 Positive Topline Results Reported in
THRIVE-AA1 and THRIVE-AA2 Phase 3 Studies in Alopecia
Areata
CTP-543 Has the Potential to Address an
Important Unmet Need for a Large, Underserved Patient
Population
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Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today reported
financial results for the second quarter of 2022.
“We are very happy to have seen consistent efficacy and safety
results across our two Phase 3 clinical trials of CTP-543 in
alopecia areata. The positive results that we reported from
THRIVE-AA1 in May and from THRIVE-AA2 earlier this week, will form
the basis of our New Drug Application, which we expect to submit to
the FDA in the first half of 2023,” said Roger Tung, Ph.D.,
President and Chief Executive Officer of Concert Pharmaceuticals.
“We have continued to execute well on a development program for
CTP-543 that provides a robust data package in support of a
potential FDA approval. We are proud that CTP‑543 could offer a
near-term and potentially best-in-class treatment option for adults
with moderate to severe alopecia areata.”
Recent Highlights and Upcoming Milestones CTP-543: An Investigational Treatment for Moderate to
Severe Alopecia Areata
- Positive Phase 3 Results Reported for CTP-543 THRIVE-AA1
Study. In May 2022, the Company reported positive topline
results for its first CTP-543 Phase 3 clinical trial. A
statistically significant proportion of patients treated with
either 8 mg twice-daily or 12 mg twice-daily of CTP-543 in the
THRIVE-AA1 study experienced greater scalp regrowth compared to
placebo. The proportion of patients achieving a Severity of
Alopecia Tool (SALT) score of 20 or less (meaning 20 percent or
less scalp hair loss) at Week 24 was 41.5 percent in the 12 mg
twice-daily dose group and 29.6 percent in the 8 mg twice-daily
dose group, compared to 0.8 percent of patients in the placebo
group. The treatment difference for both dose groups of CTP-543
relative to placebo was statistically significant (p<0.0001).
The safety profile seen with CTP-543 in THRIVE-AA1 was consistent
with previous studies of CTP-543.
- Positive Phase 3 Results Reported for CTP-543 THRIVE-AA2
Study. In August 2022, the Company reported positive topline
results for its second CTP-543 Phase 3 clinical trial. A
statistically significant proportion of patients treated with
either 8 mg twice-daily or 12 mg twice-daily of CTP-543 in the
THRIVE-AA2 study experienced greater scalp regrowth compared to
placebo. The proportion of patients achieving a SALT score of 20 or
less at Week 24 was 38.3 percent in the 12 mg twice-daily dose
group and 33.0 percent in the 8 mg twice-daily dose group, compared
to 0.8 percent of patients in the placebo group. The treatment
difference for both dose groups of CTP-543 relative to placebo was
statistically significant (p<0.0001). The safety profile seen
with CTP-543 in THRIVE-AA2 was consistent with previous studies of
CTP-543.
- JAAD Publication Highlights Significant Reduction in
Severity of Hair Loss with CTP-543. The Company recently
published safety and efficacy data from its randomized,
double-blind, placebo-controlled dose-ranging Phase 2 clinical
trial of CTP‑543 in the Journal of the American Academy of
Dermatology (JAAD). The publication reported clinically meaningful
and statistically significant scalp hair regrowth after 24 weeks of
treatment with CTP-543 in both the 8 mg twice-daily and 12 mg
twice-daily dose groups in patients with alopecia areata, as well
as safety data and patient-reported outcomes of improvement. This
trial supported the advancement of CTP-543 into Phase 3
development.
- Concert to Participate in Alopecia Areata Awareness Month in
September. Throughout the month of September, Concert, along
with the alopecia areata community, will raise awareness and
recognize the importance of alopecia areata, a serious autoimmune
disorder that affects up to approximately 1.5 million individuals
in the U.S. and which often results in poor health-related quality
of life as well as high incidence of anxiety and depression. Follow
our #LightItUpBlue4AlopeciaAreata campaign on Twitter at
@ConcertPharma.
Second Quarter 2022 Financial Results
- Cash and Investment Position. Cash, cash equivalents and
investments as of June 30, 2022 totaled $153.7 million as compared
to $141.6 million as of December 31, 2021. Under its current
operating plan, the Company expects its cash, cash equivalents and
investments to fund the Company into the second quarter of 2023. In
June 2022, Concert closed an equity offering raising gross proceeds
of $54.6 million before underwriting discounts and offering
expenses. Concurrent with the initial closing of the offering,
Concert received $18.9 million from the partial exercise of the
Tranche 1 warrants issued to BVF Partners L.P. and RA Capital
Management in connection with its November 2021 financing. The
Company has the potential to receive an additional $70.1 million in
2022 upon full exercise of the remaining warrants issued in
connection with the November 2021 financing.
- R&D Expenses. Research and development expenses were
$20.9 million for the quarter ended June 30, 2022, compared to
$20.2 million for the same period in 2021. The increase in research
and development expenses relates primarily to the clinical
development program for CTP-543.
- G&A Expenses. General and administrative expenses
were $4.8 million for the quarter ended June 30, 2022, compared to
$5.6 million for the same period in 2021. The decrease in general
and administrative expenses relates primarily to decreased non-cash
stock-based compensation.
- Net (Loss) Income. For the quarter ended June 30, 2022,
net loss applicable to common stockholders was $24.0 million, or
$0.59 per share, as compared to net income applicable to common
stockholders of $5.4 million, or $0.16 per share, for the quarter
ended June 30, 2021. Net income for the quarter ended June 30, 2021
included $32.0 million in revenue from proceeds received from
Vertex Pharmaceuticals, Inc. for the purchase of potential future
milestones under the companies’ 2017 asset purchase agreement
related to VX-561.
Conference Call and Webcast: New System to Access Call Live
and On Demand 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 second quarter financial results.
Please note that there is a new system to access the live call
in order to ask questions. To join the live call, please register
here. A dial in and unique PIN number will be provided to join the
call.
An audio-only webcast of the call may be accessed in the
Investors section of the Company’s website at
www.concertpharma.com. 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 June
30,
Six Months Ended June
30,
2022
2021
2022
2021
Revenue:
License and research and development
revenue
$
21
$
17
$
22
$
22
Other revenue
—
32,000
—
32,000
Total revenue
21
32,017
22
32,022
Operating expenses:
Research and development
20,855
20,184
51,344
38,684
General and administrative
4,849
5,614
10,389
11,099
Total operating expenses
25,704
25,798
61,733
49,783
(Loss) income from operations
(25,683)
6,219
(61,711
)
(17,761
)
Investment income
145
15
165
40
Unrealized (loss) gain on marketable
equity securities
(60
)
(809)
(624
)
477
Unrealized gain on warrant liabilities
2,050
—
894
—
Net (loss) income
$
(23,548
)
$
5,425
$
(61,276
)
$
(17,244
)
Net (loss) income attributable to common
stockholders — basic and diluted
(24,045
)
5,415
(61,773
)
(17,244
)
Net (loss) income per share applicable to
common stockholders — basic and diluted
$
(0.59
)
$
0.16
$
(1.59
)
$
(0.51
)
Weighted-average number of common shares
used in net (loss) income per share applicable to common
stockholders:
Basic
41,042
33,974
38,877
33,934
Diluted
41,042
34,083
38,877
33,934
Concert Pharmaceuticals,
Inc.
Summary Balance Sheet
Data
(in thousands)
(unaudited)
June 30, 2022
December 31, 2021
Cash and cash equivalents
$
139,245
$
141,636
Investments, available for sale
14,488
—
Working capital
145,956
134,209
Total assets
176,393
165,316
Deferred revenue
7,595
7,595
Total stockholders’ equity
127,792
112,225
About Concert
Concert Pharmaceuticals is a late-stage clinical
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 CTP-543 is being developed 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 potential for CTP-543 to be a best-in-class treatment
for the treatment of alopecia areata, the planned timing for filing
an NDA for CTP-543 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,
including safety profiles, 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 the timing of the submission of an NDA,
the availability of regulatory approvals, the 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/20220804005099/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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