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LEXINGTON, Mass.--(BUSINESS WIRE)--Nov 7, 2022--
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
Third Quarter 2022 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 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 |
| Nine Months Ended | ||||||||||||
| 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.
View source version on businesswire.com:https://www.businesswire.com/news/home/20221107005107/en/
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
KEYWORD: MASSACHUSETTS UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: BIOTECHNOLOGY HEALTH SCIENCE PHARMACEUTICAL RESEARCH
SOURCE: Concert Pharmaceuticals, Inc.
Copyright Business Wire 2022.
PUB: 11/07/2022 07:00 AM/DISC: 11/07/2022 07:02 AM
http://www.businesswire.com/news/home/20221107005107/en