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Business Wire 1-Aug-2019 7:00 AM
Conference Call Scheduled Today at 8:30 a.m. EDT
Concert Pharmaceuticals, Inc. (NASDAQ:CNCE) today reported financial results for the second quarter of 2019.
"As we move into the second half of the year, we are advancing our two wholly-owned clinical candidates for important chronic diseases that together affect millions of patients: CTP-543 for alopecia areata and CTP-692 for schizophrenia," said Roger D. Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. "For CTP-543, we are focused on completing the necessary clinical and development activities for the briefing package that we plan to submit to FDA to support an end of Phase 2 meeting early next year. Given the favorable safety profile observed in Phase 1 testing for CTP-692, we are preparing for our Phase 2 efficacy study to begin in the fourth quarter of 2019."
Recent Business Highlights and Upcoming Milestones
CTP-543: a Janus kinase (JAK) inhibitor for the treatment of moderate-to-severe alopecia areata
CTP-692: a deuterated form of D-serine for the adjunctive treatment of schizophrenia
AVP-786 for Neurological Disorders
Second Quarter 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 second quarter 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 of the second quarter financial results 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. |
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Condensed Consolidated Statements of Operations |
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(in thousands, except per share amounts) |
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2019 |
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2018 |
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2019 |
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2018 |
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Revenue: |
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|
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License and research and development revenue |
$ |
|
49 |
|
|
$ |
|
2 |
|
|
$ |
|
1,054 |
|
|
$ |
|
10,481 |
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|
Operating expenses: |
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|
|
|
|
|
|
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Research and development |
|
14,496 |
|
|
|
8,862 |
|
|
|
30,286 |
|
|
|
17,518 |
|
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General and administrative |
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4,978 |
|
|
|
5,514 |
|
|
|
10,587 |
|
|
|
11,144 |
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Total operating expenses |
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19,474 |
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|
|
14,376 |
|
|
|
40,873 |
|
|
|
28,662 |
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Loss from operations |
|
(19,425 |
) |
|
|
(14,374 |
) |
|
|
(39,819 |
) |
|
|
(18,181 |
) |
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Investment income |
|
883 |
|
|
|
660 |
|
|
|
1,750 |
|
|
|
1,300 |
|
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Unrealized (loss) gain on marketable equity securities |
|
(126 |
) |
|
|
669 |
|
|
|
(2,425 |
) |
|
|
(627 |
) |
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Loss before tax provision |
|
(18,668 |
) |
|
|
(13,045 |
) |
|
|
(40,494 |
) |
|
|
(17,508 |
) |
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Provision for income taxes |
— |
|
|
|
280 |
|
|
— |
|
|
|
280 |
|
|||||||
Net Loss |
$ |
|
(18,668 |
) |
|
$ |
|
(13,325 |
) |
|
$ |
|
(40,494 |
) |
|
$ |
|
(17,788 |
) |
|
|
|
|
|
|
|
|
|
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Net loss per share applicable to common stockholders — basic and diluted |
$ |
|
(0.78 |
) |
|
$ |
|
(0.57 |
) |
|
$ |
|
(1.71 |
) |
|
$ |
|
(0.76 |
) |
|
Weighted-average number of common shares used in net loss per share applicable to common stockholders— basic and diluted |
|
23,790 |
|
|
|
23,402 |
|
|
|
23,650 |
|
|
|
23,313 |
|
Concert Pharmaceuticals, Inc. |
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Summary Balance Sheet Data |
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(in thousands) |
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June 30, 2019 |
|
December 31, 2018 |
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Cash and cash equivalents |
|
$ |
|
43,714 |
|
|
$ |
|
17,770 |
|
Investments, available for sale |
|
|
92,923 |
|
|
|
135,544 |
|
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Working capital |
|
|
137,912 |
|
|
|
171,400 |
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||
Total assets |
|
|
166,601 |
|
|
|
192,547 |
|
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Deferred revenue |
|
|
10,533 |
|
|
|
10,533 |
|
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Total stockholders' equity |
|
|
133,701 |
|
|
|
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 risks related to the clinical development of our therapeutic candidates and expectations regarding the sufficiency of our cash balance to fund operating expenses and capital expenditures, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "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, 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 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.
Concert Pharmaceuticals Inc., the CoNCERT Pharmaceuticals Inc. logo and DCE Platform are registered trademarks of Concert Pharmaceuticals, Inc.
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