Concert Pharmaceuticals Reports Third Quarter 2018 Financial Results and Provides Company Update
Conference Call Scheduled Today at
“This is an exciting time at Concert as we advance multiple pipeline
candidates, with our priority directed towards our lead compound,
CTP-543 for alopecia areata,” stated
Recent Business Highlights and Upcoming Milestones
- CTP-543 Initial Phase 2a Data Expected in
November 2018. In the second quarter of 2018, Concert completed enrollment of the 8 mg cohort in its Phase 2a trial evaluating CTP-543 for the treatment of moderate-to-severe alopecia areata. Topline data from the 4 mg and 8 mg twice daily cohorts is expected in November 2018. The double-blind, randomized, placebo-controlled, sequential dose trial is designed to evaluate the safety and efficacy of CTP-543 twice daily. The primary outcome measure will be a responder analysis utilizing the severity of alopecia tool (SALT) after 24 weeks of dosing.
- CTP-543 Protocol Amended to Evaluate 12 mg Twice Daily Dose.
In the third quarter of 2018, an independent Data Monitoring Committee
(DMC) conducted a planned interim safety data review after patients in
the trial had been dosed with an 8 mg dose of CTP-543 or placebo twice
daily for at least 12 weeks. The DMC’s review provided support for an
additional cohort to evaluate a 12 mg dose twice daily. Consistent
with its previously-stated intent, the Company initiated enrollment in
the 12 mg cohort as the final arm of this study in
- CTP-692 Phase 1 Trial Planned to Begin in the Fourth Quarter of 2018. The Company intends to advance CTP-692 into Phase 1 clinical testing by year-end 2018. The Phase 1 program will include a crossover pharmacokinetic comparison of CTP-692 to D-serine and single and multiple ascending doses of CTP-692. The Company is initially developing CTP-692 as an adjunctive treatment for schizophrenia.
- Relocation to New Headquarters. Effective
August 13, 2018, Concert relocated its corporate headquarters to 65 Hayden Avenue, Lexington, Massachusetts.
Third Quarter 2018 Financial Results
- Cash and Investment Position. Cash, cash equivalents and
investments as of
September 30, 2018, totaled $168.5 millionas compared to $203.2 millionas of December 31, 2017. Concert expects its cash, cash equivalents and investments to be sufficient to fund the Company into 2021 under its current operating plan.
- Revenues. Revenue was
$11,000for the quarter ended September 30, 2018, compared to $143.8 millionfor the same period in 2017. The revenue in 2017 relates primarily to an asset purchase agreement with Vertex Pharmaceuticals, whereby Vertex acquired worldwide rights to CTP-656 and other assets related to the treatment of cystic fibrosis.
- R&D Expenses. Research and development expenses were
$11.0 millionfor the quarter ended September 30, 2018, compared to $7.1 millionfor the same period in 2017. The increase in R&D expenses relate primarily to clinical development of CTP-543, including an ongoing Phase 2 clinical trial, and increased expenses associated with the advancement of CTP-692 in 2018 as a new development program.
- G&A Expenses. General and administrative expenses
$6.3 millionfor the quarter ended September 30, 2018, compared to $4.9 millionfor the same period in 2017. The increase in G&A expenses was primarily related to an increase in professional and legal fees in connection with intellectual property matters related to CTP-543.
- Net Loss. For the quarter ended
September 30, 2018, net loss applicable to common stockholders was $17.4 million, or $0.74per share, compared with a net income applicable to common stockholders of $128.1 million, or $5.61per share, for the quarter ended September 30, 2017.
Conference Call and Webcast
The Company will host a conference call and webcast today at
A live webcast of Concert’s presentation may be accessed in the Investors section of the Company’s website at www.concertpharma.com. Please log on to the Concert website approximately 15 minutes prior to the scheduled webcast to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Concert’s website for three months.
|Concert Pharmaceuticals, Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except per share amounts)|
Three Months Ended
|Nine Months Ended
|License and research and development revenue||$||11||$||17||$||10,492||$||52|
|Research and development||11,031||7,136||28,549||22,658|
|General and administrative||6,320||4,875||17,464||15,835|
|Total operating expenses||17,351||12,011||46,013||38,493|
|(Loss) Income from operations||(17,340||)||131,833||(35,521||)||105,386|
|Interest and other expense||—||(609||)||—||(814||)|
|Loss on extinguishment of debt||—||(1,432||)||—||(1,432||)|
|Unrealized loss on marketable equity securities||(732||)||—||(1,359||)||—|
|(Loss) Income before tax provision||(17,369||)||130,242||(34,877||)||103,882|
|Provision for income taxes||18||2,177||298||2,177|
|Net (loss) income||$ (17,387||)||$ 128,065||$ (35,175||)||$ 101,705|
|Net (loss) income attributable to common stockholders - basic||(17,387||)||127,324||(35,175||)||101,272|
|Net (loss) income attributable to common stockholders - diluted||(17,387||)||127,347||(35,175||)||101,284|
|Net (loss) income per share applicable to common stockholders|
|Weighted-average number of common shares used in net (loss) income per share applicable to common stockholders:|
|Concert Pharmaceuticals, Inc.|
|Summary Balance Sheet Data|
|Cash and cash equivalents||$||39,597||$||27,665|
|Investments, available for sale||128,923||175,500|
|Total stockholders’ equity||185,753||196,432|
Cautionary Note on Forward Looking Statements
Any statements in this press release about our future expectations,
plans and prospects, including statements about our expectations on the
progress of clinical development of CTP-543 and CTP-692, the sufficiency
of our cash, cash equivalents and investments to fund our operations 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, 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