Company Plans to Submit NDA in First Half of
2023 for Deuruxolitinib in Adults with Moderate to Severe Alopecia
Areata
Deuruxolitinib (CTP-543) Phase 3 Data
Presented at the EADV Congress Late Breaking News Session
Additional Deuruxolitinib Phase 3 Results to
be Presented at the World Congress for Hair Research
Conference Call Scheduled Today at 8:30 a.m.
ET; Registration Required to Join Live Call
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today reported
financial results for the third quarter of 2022.
“With the THRIVE-AA clinical program completed and positive
Phase 3 results in hand for deuruxolitinib in alopecia areata, we
are well on our way to meeting our goal of submitting the NDA in
the first half of 2023,” said Roger Tung, Ph.D., President and
Chief Executive Officer of Concert Pharmaceuticals. “Given the
promising clinical properties and potential best-in-class profile
displayed by deuruxolitinib and the great needs of the alopecia
areata patient community, we are well-positioned to emerge as a
leader in the autoimmune dermatology field. All of our development
and precommercial efforts are strongly positioning us to make the
transition to being a commercially focused organization.”
Recent Highlights and Upcoming Milestones
Deuruxolitinib (CTP-543): An
Investigational Treatment for Moderate to Severe Alopecia
Areata
- Deuruxolitinib EADV Late Breaking Presentation: In
September 2022, Brett King, M.D., Department of Dermatology, Yale
University School of Medicine, presented THRIVE-AA1 Phase 3 results
in alopecia areata during the 31st European Academy of Dermatology
and Venereology (EADV) Congress late breaking news session. To
access the full presentation of the safety and efficacy findings
from the THRIVE-AA1 study, visit Concert’s Scientific Presentation
page on its website. Details of the presentation include:
- SALT Scores for Scalp Regrowth. Data from the THRIVE‑AA1
study showed the ability of deuruxolitinib to achieve more
stringent criteria for hair regrowth than was measured by the
study’s primary endpoint of a Severity of Alopecia Tool (SALT)
score of 20 or less (meaning 20 percent or less scalp hair loss) at
Week 24. Specifically, 21 percent and 35 percent of patients in the
deuruxolitinib 8 mg twice-daily and 12 mg twice-daily dose groups,
respectively, achieved a SALT score of 10 or less at Week 24,
compared to 0 percent of patients in the placebo group
(p<0.0001). Also, the relative improvement in SALT score from
baseline was significantly different for the 12 mg twice-daily dose
group compared to placebo (p<0.001) as early as Week 4.
- Eyebrow or Eyelash Regrowth. New data were presented
showing that patients in the THRIVE‑AA1 study with loss of eyebrow
or eyelash hair at baseline who were treated with deuruxolitinib
had significant improvement compared to placebo starting as early
as 12 weeks, which was the first time point measured, and
continuing through the 24-week treatment period (p<0.001).
- Positive Phase 3 Results Reported for Deuruxolitinib
THRIVE-AA2 Study. In August 2022, the Company reported positive
topline results for its second deuruxolitinib Phase 3 clinical
trial, THRIVE‑AA2. A statistically significant proportion of
patients treated with either 8 mg twice-daily or 12 mg twice-daily
of deuruxolitinib 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 33 percent in the 8 mg
twice-daily dose group and 38 percent in the 12 mg twice-daily dose
group, compared to 1 percent of patients in the placebo group. The
treatment difference for both dose groups relative to placebo was
statistically significant (p<0.0001). The safety profile seen
with deuruxolitinib in THRIVE-AA2 was consistent with previous
studies of CTP-543.
- Deuruxolitinib Phase 3 Presentation in Alopecia Areata at
the World Congress for Hair Research. Dr. King will present
additional results from the THRIVE-AA1 study during the 12th World
Congress for Hair Research being held November 18-21, 2022 in
Melbourne, Australia. The presentation will include additional
analyses of hair regrowth based on disease severity and time course
of disease.
Third Quarter 2022 Financial Results
- Cash and Investment Position. Cash, cash equivalents and
investments as of September 30, 2022 totaled $148.9 million,
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 through the second
quarter of 2023.
- R&D Expenses. Research and development expenses were
$24.4 million for the quarter ended September 30, 2022, compared to
$21.9 million for the same period in 2021. The increase in research
and development expenses relates primarily to the clinical
development program for deuruxolitinib.
- G&A Expenses. General and administrative expenses
were $5.3 million for the quarter ended September 30, 2022,
compared to $5.5 million for the same period in 2021. The decrease
in general and administrative expenses relates primarily to
decreased non-cash stock-based compensation and external
professional services.
- Net Loss. For the quarter ended September 30, 2022, net
loss attributable to common stockholders was $28.9 million, or
$0.58 per share, compared to net loss attributable to common
stockholders of $26.7 million, or $0.78 per share, for the quarter
ended September 30, 2021.
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 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 September
30,
Nine Months Ended September
30,
2022
2021
2022
2021
Revenue:
License and research and development
revenue
$
8
$
4
$
29
$
26
Other revenue
—
539
—
32,539
Total revenue
8
543
29
32,565
Operating expenses:
Research and development
24,364
21,876
75,708
60,560
General and administrative
5,250
5,462
15,639
16,561
Total operating expenses
29,614
27,338
91,347
77,121
Loss from operations
(29,606
)
(26,795
)
(91,318
)
(44,556
)
Investment income
785
4
951
44
Unrealized (loss) gain on marketable
equity securities
(164
)
113
(788
)
590
Unrealized gain on warrant liabilities
81
—
975
—
Net loss
$
(28,904
)
$
(26,678
)
$
(90,180
)
$
(43,922
)
Net loss attributable to common
stockholders — basic and diluted
(28,904
)
(26,678
)
(90,553
)
(43,922
)
Net loss per share attributable to common
stockholders — basic and diluted
$
(0.58
)
$
(0.78
)
$
(2.13
)
$
(1.29
)
Weighted-average number of common shares
used in net loss per share attributable to common stockholders –
basic and diluted
49,731
34,090
42,535
33,987
Concert Pharmaceuticals,
Inc.
Summary Balance Sheet
Data
(in thousands)
(unaudited)
September 30, 2022
December 31, 2021
Cash and cash equivalents
$
95,189
$
141,636
Investments, available for sale
53,669
—
Working capital
139,797
134,209
Total assets
171,134
165,316
Deferred revenue
7,595
7,595
Total stockholders’ equity
133,272
112,225
About Concert
Concert Pharmaceuticals is a late-stage clinical
biopharmaceutical company that is developing deuruxolitinib
(CTP-543), a novel, deuterated, oral JAK1/2 inhibitor. Concert has
successfully completed two Phase 3 trials with deuruxolitinib in
adults with alopecia areata, a serious autoimmune dermatological
disease. The Company is also evaluating the use of deuruxolitinib
in other indications and assessing a number of earlier-stage
pipeline candidates. For more information, please visit
www.concertpharma.com or follow us on Twitter, Instagram or
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
deuruxolitinib, the potential for deuruxolitinib to be a
best-in-class treatment for the treatment of alopecia areata, the
planned timing for filing a New Drug Application (NDA) for
deuruxolitinib 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20221107005107/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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