CTP-543 Phase 3 Program for Treatment of Alopecia Areata Expected to Begin in 2020
New CTP-543 Patent Covers Pharmaceutical Compositions of CTP-543 and Methods of Treating Alopecia Areata with CTP-543
CTP-692 Phase 2 Topline Results as Adjunctive Treatment for Schizophrenia Expected by Year End 2020
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, 2019 and provided an update on its product pipeline and corporate activities.
“Our 2019 accomplishments provide a strong foundation for an exciting year at Concert in 2020. Both of our proprietary programs, CTP-543 for alopecia areata and CTP-692 for schizophrenia, exemplify great examples of innovative clinical compounds that originated from Concert’s technology and that have the potential to create meaningful impact for patients,” stated Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. “The robust results from our Phase 2 dose-ranging trial of CTP-543 for the treatment of alopecia areata support advancing the drug candidate into pivotal testing with a potential best-in-class product profile for this serious disease. With the recent initiation of the Phase 2 dose-ranging trial of CTP-692 in patients with schizophrenia, we expect to report topline data by year end that may enable us to advance the program directly into pivotal evaluation in 2021.”
Recent Business Highlights and Upcoming Milestones
CTP-543: An Investigational Treatment for Moderate-to-Severe Alopecia Areata
CTP-692: An Investigational Adjunctive Treatment for Schizophrenia
Full Year 2019 Financial Results
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 full year 2019 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.
– Financial Tables to Follow –
Concert Pharmaceuticals, Inc.
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Three Months Ended
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Twelve Months Ended
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2019 |
2018 |
2019 |
2018 |
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Revenue: |
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|
|
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|
|
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License and research and development revenue |
$ |
13 |
|
|
$ |
13 |
|
|
$ |
1,077 |
|
|
$ |
10,505 |
|
|
Total revenue |
|
13 |
|
|
|
13 |
|
|
|
1,077 |
|
|
|
10,505 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
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Research and development |
|
16,019 |
|
|
|
14,560 |
|
|
|
59,816 |
|
|
|
43,149 |
|
|
General and administrative |
|
4,947 |
|
|
|
5,516 |
|
|
|
20,276 |
|
|
|
22,940 |
|
|
Total operating expenses |
|
20,966 |
|
|
|
20,076 |
|
|
|
80,092 |
|
|
|
66,089 |
|
|
Loss from operations |
|
(20,953 |
) |
|
|
(20,063 |
) |
|
|
(79,015 |
) |
|
|
(55,584 |
) |
|
Interest and other income (expense), net |
|
466 |
|
|
|
(771 |
) |
|
|
849 |
|
|
|
(127 |
) |
|
Loss before income taxes |
|
(20,487 |
) |
|
|
(20,834 |
) |
|
|
(78,166 |
) |
|
|
(55,711 |
) |
|
Provision for income taxes |
— |
|
|
15 |
|
|
— |
|
|
313 |
|
|||||
Net loss |
$ |
(20,487 |
) |
|
$ |
(20,849 |
) |
|
$ |
(78,166 |
) |
|
$ |
(56,024 |
) |
|
|
|
|
|
|
|
|
|
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Net loss attributable to common stockholders - basic and diluted |
|
(20,487 |
) |
|
|
(20,849 |
) |
|
|
(78,166 |
) |
|
|
(56,024 |
) |
|
|
|
|
|
|
|
|
|
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Net loss per share applicable to common stockholders - basic and diluted |
$ |
(0.86 |
) |
|
$ |
(0.89 |
) |
|
$ |
(3.29 |
) |
|
$ |
(2.40 |
) |
|
|
|
|
|
|
|
|
|
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Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted |
|
23,848 |
|
|
|
23,432 |
|
|
|
23,740 |
|
|
|
23,370 |
|
|
Concert Pharmaceuticals, Inc.
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December 31,
|
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December 31,
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Cash and cash equivalents |
|
$ |
53,043 |
|
$ |
17,770 |
Investments, available for sale |
|
|
53,395 |
|
|
135,544 |
Working capital |
|
|
99,587 |
|
|
171,400 |
Total assets |
|
|
137,471 |
|
|
192,547 |
Total stockholders’ equity |
|
|
101,457 |
|
|
167,740 |
About Concert
Concert Pharmaceuticals is a clinical stage biopharmaceutical company focused on applying its DCE Platform® (deuterated chemical entity platform) to create novel medicines designed to treat serious diseases and address unmet patient needs. The Company’s approach starts with previously studied compounds, including approved drugs, in which deuterium substitution has the potential to enhance clinical safety, tolerability or efficacy. Concert’s pipeline of innovative medicines targets autoimmune diseases and central nervous systems (CNS) disorders. 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 on the progress of clinical development of CTP-543 and CTP-692, the timing of availability of clinical trial data 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 of future clinical 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200227005071/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