Concert Pharmaceuticals Reports Second Quarter 2018 Financial Results and Provides Company Update
-- Clinical Programs Advance with CTP-543 Phase 2a Topline Data in Alopecia Areata and CTP-692 Phase 1 Trial Initiation Expected in the Fourth Quarter of 2018 --
-- Conference Call Scheduled Today at
“Our focus in the first half of this year has been to execute on
advancing our proprietary pipeline candidates to key clinical inflection
points. The Phase 2 trial evaluating the 4 and 8 mg twice daily cohorts
of CTP-543 for alopecia areata is on track for clinical completion later
this year with a topline data readout in the fourth quarter,” said
Recent Business Highlights and Upcoming Milestones
- CTP-543 Phase 2a Topline Data Expected in the Fourth Quarter of 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. The double-blind, randomized, placebo-controlled, sequential dose trial is designed to evaluate the safety and efficacy of 4 mg and 8 mg of CTP-543 twice daily. The primary outcome measure will utilize the severity of alopecia tool (SALT) after 24 weeks of dosing. Topline data from the 4 mg and 8 mg twice daily cohorts is expected in the fourth quarter of 2018.
- CTP-543 Protocol Amendment Planned. An independent Data
Monitoring Committee (DMC) will conduct a planned safety data review
of the second cohort of the CTP-543 Phase 2a trial following 12 weeks
of dosing with 8 mg of CTP-543 or placebo twice daily. Pending a
positive assessment by the DMC, the Company will propose to the
U.S. Food and Drug Administration( FDA) a protocol amendment to also evaluate 12 mg of CTP-543 compared to placebo twice daily. Any amendment to the existing protocol will not impact the planned data readout of the 4 mg and 8 mg twice daily cohorts in the fourth quarter of 2018.
- 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. Initial Phase 1 topline data is expected in the first quarter of 2019.
- CTP-692 Preclinical Findings to be Presented at ACT 2018.
Concert’s preclinical studies have demonstrated that selective
deuterium modification increased D-serine exposure and resulted in no
changes in creatinine and blood urea nitrogen. These results support
CTP-692’s potential to improve the safety profile of D-serine. These
findings will be presented as a poster at the
American College of Toxicology2018 Annual Meeting being held November 4-7, 2018.
- New Corporate Headquarters. Concert has leased office
and laboratory space located at
65 Hayden Avenue, Lexington, Massachusettsfor the Company’s new headquarters. Effective August 13, 2018, Concert will occupy the new space. The Company’s existing lease expires in September 2018.
Second Quarter 2018 Financial Results
- Cash and Investment Position.Cash, cash equivalents and
investments as of
June 30, 2018, totaled $180.3 millionas compared to $203.2 millionas of December 31, 2017. Concert expects its cash, cash equivalents and investments as of June 30, 2018to be sufficient to fund the Company into 2021 under its current operating plan.
- Revenues.Revenue was
$2,000for the quarter ended June 30, 2018, compared to $15,000for the same period in 2017. For the six months ended June 30, 2018, revenue was $10.5 million, compared to $35,000for the six months ended June 30, 2017. The increase in revenue in the first half of 2018 relates primarily to non-cash consideration received from Processa Pharmaceuticalsin the first quarter of 2018 under a license agreement whereby Processa has worldwide rights to develop and commercialize CTP-499.
- R&D Expenses. Research and development expenses were
$8.9 millionfor the quarter ended June 30, 2018, compared to $7.3 millionfor the same period in 2017. For the six months ended June 30, 2018, R&D expenses were $17.5 millioncompared to $15.5 millionfor the same period in 2017. The increase in R&D expenses relate primarily to activities associated with the ongoing CTP-543 Phase 2 clinical trial and increased expense associated with the advancement of CTP-692 in 2018 as a new development program.
- G&A Expenses.General and administrative expenses
$5.5 millionfor the quarter ended June 30, 2018, compared to $5.7 millionfor the same period in 2017. For the six months ended June 30, 2018, G&A expenses were $11.1 millioncompared to $11.0 millionfor the same period in 2017. The changes in G&A expenses reflect higher stock compensation in 2018 partially offset by lower professional fees in 2018.
- Net Loss.For the quarter ended
June 30, 2018, net loss applicable to common stockholders was $13.3 million, or $0.57per share, compared with a net loss applicable to common stockholders of $13.0 million, or $0.58per share, for the quarter ended June 30, 2017.
Conference Call and Webcast
The Company will host a conference call and webcast today at
A live webcast of the second quarter financial results may be accessed in the Investors section of the Company’s website at www.concertpharma.com. Please log on to the Concert website approximately 15 minutes prior to the scheduled webcast to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Concert’s website for three months.
- Financial Tables to Follow –
|Concert Pharmaceuticals, Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except per share amounts)|
|Six Months Ended
|License and research and development revenue||$||2||$||15||$||10,481||$||35|
|Research and development||8,862||7,285||17,518||15,522|
|General and administrative||5,514||5,707||11,144||10,960|
|Total operating expenses||14,376||12,992||28,662||26,482|
|Loss from operations||(14,374||)||(12,977||)||(18,181||)||(26,447||)|
|Interest and Other expense||—||(205||)||—||(205||)|
Unrealized gain (loss) on marketable equity securities
|Loss before tax provision||(13,045||)||(13,027||)||(17,508||)||(26,360||)|
|Provision for income taxes||280||—||280||—|
Net loss per share applicable to common stockholders — basic and diluted
Weighted-average number of common shares used in net loss per share applicable to common stockholders— basic and diluted
|Concert Pharmaceuticals, Inc.|
|Summary Balance Sheet Data|
|June 30, 2018||December 31, 2017|
|Cash and cash equivalents||$||58,359||$||27,665|
|Investments, available for sale||121,988||175,500|
|Total stockholders’ equity||200,283||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 for
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