[May 05, 2016] |
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Concert Pharmaceuticals Reports First Quarter 2016 Financial Results
Concert
Pharmaceuticals, Inc. (NASDAQ: CNCE) today reported financial
results for the first quarter of 2016.
"We are continuing to build a diverse pipeline based on our deuterium
drug development platform as evidenced by our newest clinical candidate,
CTP-543, for the treatment of alopecia areata," said Roger Tung, Ph.D.,
President and Chief Executive Officer of Concert Pharmaceuticals. "By
year end, we expect to complete Phase 1 single and multiple ascending
dose trials for CTP-543 as well as open an Investigational New Drug
Application with CTP-656, our drug candidate for cystic fibrosis, to
initiate a Phase 2 trial. Both alopecia areata and cystic fibrosis
represent disease areas where we believe our compounds can offer
distinct patient benefits and where we believe we can independently
develop a product. We are excited about the prospects for our pipeline
in which we will have two wholly-owned drug candidates in efficacy
studies next year."
Recent Business Highlights and Upcoming Milestones
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CTP-656 Multiple Ascending Dose Phase 1 Results. In the Phase 1
multiple ascending dose trial, CTP-656 demonstrated enhanced exposure
to the parent drug and less exposure to metabolites after repeat
dosing, confirming earlier findings of the differentiated metabolite
profile of CTP-656 relative to Kalydeco®, the current standard of care
for cystic fibrosis patients with gating mutations. Results of the
Phase 1 trial also showed that CTP-656 was well tolerated, and its
safety profile has been comparable to that of Kalydeco. These findings
continue to support once-daily administration of CTP-656.
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CTP-656 Solid Dose Phase 1 Results. In a Phase 1 clinical
trial, Concert compared a single-dose tablet formulation of CTP-656 to
the commercial tablet formulation of Kalydeco. The results from this
study confirmed the superior pharmacokinetic profile of CTP-656
relative to Kalydeco, as was previously
reported from Concert's single ascending dose trial which was
conducted with an aqueous suspension of CTP-656. Concert intends to
use this tablet formulation in the Phase 2 clinical trial. The Company
expects to open an IND to commence its Phase 2 clinical trial in the
second half of 2016.
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CTP-656 Food Effect Phase 1 Results. Concert recently completed
a Phase 1 trial to evaluate the bioavailability and pharmacokinetics
of CTP-656 when dosed fasted or with a low fat or moderate
fat-containing meal in healthy volunteers. Results from this trial
showed that the exposure of CTP-656 was consistent when dosed with
either a low or moderate fat-containing meal and was also consistent
with the exposure previously observed when dosed with a high fat meal.
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European Cystic Fibrosis Society Conference. Concert will
present the Phase 1 multiple ascending dose and solid dose tablet
clinical results as part of an oral presentation at the 39th
European Cystic Fibrosis Conference being held June 10, 2016 at 3:00
p.m. GMT in Basel, Switzerland.
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CTP-543 Selected as Clinical Candidate for Alopecia Areata.
CTP-543 has been selected as Concert's next clinical drug candidate.
CTP-543 is a deuterium-modified version of ruxolitinib, a selective
inhibitor of Janus kinases 1 and 2, known as JAK1 and JAK2.
Ruxolitinib is commercially available under the name Jakafi® in the
United States for the treatment of myelofibrosis and polycythemia
vera. Ruxolitinib has been used in academic settings including an
investigator-sponsored clinical trial and has been shown to promote
hair growth in individuals with alopecia areata, an autoimmune disease
that results in patchy or widespread hair loss. A Phase 1 single
ascending dose clinical trial of CTP-543 is expected to begin in the
second quarter of 2016.
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New Board of Directors Appointments. Concert expanded its Board
of Directors with the appointments of Meghan FitzGerald in March 2016
and Christine van Heek in April 2016. Ms. FitzGerald serves as a
member of the Compensation Committee and Ms. van Heek serves as a
member of the Audit Committee.
First Quarter 2016 Financial Results
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Cash and Investment Position: Cash, cash equivalents and
investments as of March 31, 2016, totaled $127.7 million as compared
to $142.2 million as of December 31, 2015. Concert expects its cash,
cash equivalents and investments as of March 31, 2016 to be sufficient
to fund the Company into 2018.
Revenues: Revenue was
$56 thousand for the quarter ended March 31, 2016, compared to $1.3
million for the same period in 2015. Revenue recognized in 2016 and
2015 is comprised of services performed by Concert in connection with
its strategic collaborations with Celgene Corporation and Jazz
Pharmaceuticals. The Phase 1 clinical evaluations conducted by Concert
for each of these collaborations was completed in 2015.
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R&D Expenses: Research and development expenses were $10.5
million for the quarter ended March 31, 2016, compared to $6.9 million
for the same period in 2015. The increase was primarily due to
expenses associated with the development of CTP-656 and CTP-543.
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G&A Expenses: General and administrative expenses were $3.6
million for the quarter ended March 31, 2016, compared to $3.2 million
for the same period in 2015. The increase in general and
administrative expenses was primarily related to non-cash stock based
compensation expense.
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Net Loss: For the quarter ended March 31, 2016, net loss
applicable to common stockholders was $13.9 million, or $0.63 per
share, compared with a net loss applicable to common stockholders of
$9.0 million, or $0.48 per share, for the quarter ended March 31, 2015.
Conference Call and Webcast The Company will host a
conference call and webcast
today, Thursday, May 5, 2016, at 8:30 a.m. EDT to provide an update on
the Company and discuss first quarter financial results. To access the
conference call, please dial (855) 354-1855 (U.S. and Canada) or (484)
365-2865 (International) five minutes prior to the start time.
A live webcast of Concert's presentation may be accessed in the Investors
section of the Company's website at www.concertpharma.com.
Please log on to the Concert website approximately 15 minutes prior to
the scheduled webcast to ensure adequate time for any software downloads
that may be required. A replay of the webcast will be available on
Concert's website for three months.
- Financial Tables to Follow -
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Concert Pharmaceuticals, Inc.
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Condensed Consolidated Statements of Operations
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(in thousands, except per share amounts)
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Quarter ended March 31,
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2016
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2015
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Revenue:
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License and research and development revenue
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$
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56
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$
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1,306
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Total revenue
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56
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1,306
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Operating expenses:
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Research and development
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10,453
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6,944
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General and administrative
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3,577
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3,233
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Total operating expenses
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14,030
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10,177
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Loss from operations
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(13,974
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)
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(8,871
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)
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Interest and other income (expense), net
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94
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(131
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)
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Net loss
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$
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(13,880
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)
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$
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(9,002
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)
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Net loss per share applicable to common stockholders-basic and
diluted
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$
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(0.63
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)
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$
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(0.48
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)
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Weighted-average number of common shares used in net loss per share
applicable to common stockholders-basic and diluted
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22,198
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18,726
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Concert Pharmaceuticals, Inc.
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Summary Balance Sheet Data
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(in thousands)
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March 31, 2016
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December 31, 2015
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Cash and cash equivalents
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$
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37,821
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$
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92,510
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Investments, available for sale
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89,898
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49,680
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Working capital
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125,084
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137,481
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Total assets
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133,295
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146,932
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Deferred revenue
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10,135
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10,170
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Total stockholders' equity
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$
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118,262
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$
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130,635
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About Concert
Concert
Pharmaceuticals is a clinical stage biopharmaceutical company
focused on applying its DCE
Platform® (deuterated chemical entity platform) to create novel
small molecule drugs. This approach starts with approved drugs, advanced
clinical candidates or previously studied compounds that have the
potential to be improved with deuterium substitution to enhance clinical
safety, tolerability and efficacy. The Company is developing a broad
pipeline targeting genetic diseases, autoimmune disorders, CNS
disorders and inflammatory diseases, among others. For more information,
please visit www.concertpharma.com.
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 our therapeutic candidates, 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 Annual Report
on Form 10-K 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. Kalydeco®
is a registered trademark of Vertex (News - Alert) Pharmaceuticals, Inc. Jakafi®
is a registered trademark of Incyte Corporation
View source version on businesswire.com: http://www.businesswire.com/news/home/20160505005195/en/
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