Concert Pharmaceuticals Reports First Quarter 2021 Financial Results
May 04 2021 - 07:00AM
Business Wire
CTP-543 Phase 3 Program for Alopecia Areata
Advancing as Planned to Support NDA Filing in Early 2023
Conference Call Scheduled Today at 8:30 a.m.
ET
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today reported
financial results for the first quarter of 2021.
“We are committed to advancing CTP-543, our breakthrough therapy
candidate for moderate to severe alopecia areata. Patients
currently lack effective, approved treatment options. We believe we
have the potential to provide patients with a new, clinically
meaningful and best-in-class treatment option,” stated Roger Tung,
Ph.D., President and Chief Executive Officer of Concert
Pharmaceuticals. “We remain on track with our THRIVE-AA Phase 3
clinical program with CTP-543, in support of our New Drug
Application that we anticipate filing in early 2023.”
Recent Business Highlights and Upcoming Milestones
CTP-543: An Investigational Treatment
for Moderate to Severe Alopecia Areata
- THRIVE-AA1 Phase 3 Trial in Alopecia Areata On Track to
Report Topline Data in 2022. The THRIVE-AA1 Phase 3 trial is a
randomized, double-blind, placebo-controlled clinical trial of
CTP-543 to evaluate hair regrowth after 24 weeks of dosing in
approximately 700 adults 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 2022. Additional information about the THRIVE-AA1 trial
(NCT04518995) is available at clinicaltrials.gov.
- Initiation of THRIVE-AA2 Phase 3 Trial in Alopecia Areata
Expected in May 2021. The Company expects to initiate a second
pivotal Phase 3 trial of CTP-543, THRIVE-AA2, later this month. The
planned THRIVE-AA2 Phase 3 trial is a randomized, double-blind,
placebo-controlled clinical trial of CTP-543 to evaluate hair
regrowth after 24 weeks of dosing in approximately 440 adults with
moderate to severe alopecia areata. The trial will evaluate 8 mg
and 12 mg twice-daily doses of CTP-543 compared to placebo at sites
in the U.S., Canada and Europe. Additional information about the
THRIVE-AA2 trial (NCT04797650) is available at
clinicaltrials.gov.
- Update on CTP-543 Open Label, Long-Term Extension Study to
be Presented at JAK Summit. Concert’s Chief Development
Officer, James V. Cassella, Ph.D., will present an update on the
ongoing open label, long-term extension study of CTP-543 at the 2nd
JAK Inhibitors Drug Development Summit scheduled for July 1, 2021.
The presentation will provide an update on the extension study,
building on the data presented at the late-breaking news session at
the European Academy of Dermatology and Venereology (EADV) in
October 2020, during which the Company showed the maintenance of
hair regrowth in patients on treatment for at least one year.
Details about the upcoming meeting are available at
https://jak-drugdevelopment.com/.
First Quarter 2021 Financial Results
- Cash and Investment Position. Cash, cash equivalents and
investments as of March 31, 2021 totaled $111.8 million as compared
to $130.0 million as of December 31, 2020. Under its current
operating plan, the Company expects its cash, cash equivalents and
investments to fund the Company through 2021.
- R&D Expenses. Research and development expenses were
$18.5 million for the quarter ended March 31, 2021, compared to
$14.0 million for the same period in 2020. The increase in research
and development expenses relates primarily to the ongoing CTP-543
Phase 3 THRIVE-AA clinical program.
- G&A Expenses. General and administrative expenses
were $5.5 million for the quarter ended March 31, 2021, compared to
$4.7 million for the same period in 2020, an increase of $0.8
million due to an increase in external professional service
expenses and non-cash stock-based compensation expense.
- Net Loss. Net loss applicable to common stockholders was
$22.7 million, or $0.67 per share, for the quarter ended March 31,
2021, as compared to net loss applicable to common stockholders of
$20.5 million, or $0.70 per share, for the quarter ended March 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 its
first quarter 2021 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.
Concert Pharmaceuticals,
Inc.
Condensed Consolidated
Statements of Operations
(in thousands, except per
share amounts)
(unaudited)
Three Months Ended
March 31,
2021
2020
Revenue:
License and research and development
revenue
$
5
$
7
Operating expenses:
Research and development
18,500
13,986
General and administrative
5,485
4,672
Total operating expenses
23,985
18,658
Loss from operations
(23,980
)
(18,651
)
Investment income
25
563
Unrealized gain (loss) on marketable
equity securities
1,286
(2,389
)
Net loss
$
(22,669
)
$
(20,477
)
Net loss per share applicable to common
stockholders - basic and diluted
$
(0.67
)
$
(0.70
)
Weighted-average number of common shares
used in net loss per share applicable to common stockholders -
basic and diluted
33,894
29,110
Concert Pharmaceuticals,
Inc.
Summary Balance Sheet
Data
(in thousands)
(unaudited)
March 31, 2021
December 31, 2020
Cash and cash equivalents
$
89,772
$
77,202
Investments, available for sale
22,009
52,766
Working capital
115,552
132,546
Total assets
139,991
159,263
Deferred revenue
2,750
2,750
Total stockholders’ equity
114,039
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 initiation and design of future clinical trials, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210504005106/en/
For additional information contact: Justine E.
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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