Document



UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
 _____________________
FORM 8-K
 _____________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): August 2, 2018
 
Concert Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
 
 
 
 
 
 
 
Delaware
 
001-36310
 
20-4839882
(State or Other Jurisdiction
of Incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)
 
 
 
 
99 Hayden Avenue, Suite 500
Lexington, Massachusetts
 
02421
(Address of Principal Executive Offices)
 
(Zip Code)
Registrant’s telephone number, including area code: (781) 860-0045
 
(Former Name or Former Address, if Changed Since Last Report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))





Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ý    

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ý




Item 2.02. Results of Operations and Financial Condition.
On August 2, 2018, Concert Pharmaceuticals, Inc. announced its financial results for the quarter ended June 30, 2018. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in Item 2.02 in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
 
(d)
Exhibits
 
 
 
Exhibit
No.
  
Description
 
 
99.1
  


SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CONCERT PHARMACEUTICALS, INC.
 
 
 
 
 
 
 
 
By:
 
/s/ Roger D. Tung
Date: August 2, 2018
 
 
 
 
 
Roger D. Tung
 
 
 
 
 
 
President and Chief Executive Officer








Exhibit


Exhibit 99.1
 
http://api.tenkwizard.com/cgi/image?quest=1&rid=23&ipage=12384738&doc=3
NEWS RELEASE


For additional information 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

FOR IMMEDIATE RELEASE

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 8:30 a.m. EDT --

Lexington, MA (August 2, 2018) -- Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today reported financial results for the second quarter of 2018

“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 Roger D. Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. “In addition, our team is poised to move our next candidate, CTP-692 for schizophrenia, into Phase 1 evaluation by year-end. Importantly, both of these candidates are expected to advance in Phase 2 trials in 2019 in support of their respective registration programs.”

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 Toxicology 2018 Annual Meeting being held November 4-7, 2018.

New Corporate Headquarters. Concert has leased office and laboratory space located at 65 Hayden Avenue, Lexington, Massachusetts for 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 million as compared to $203.2 million as of December 31, 2017.  Concert expects its cash, cash equivalents and investments as of June 30, 2018 to be sufficient to fund the Company into 2021 under its current operating plan.

Revenues. Revenue was $2,000 for the quarter ended June 30, 2018, compared to $15,000 for the same period in 2017.  For the six months ended June 30, 2018, revenue was $10.5 million, compared to $35,000 for 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 Pharmaceuticals in 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 million for the quarter ended June 30, 2018, compared to $7.3 million for the same period in 2017. For the six months ended June 30, 2018, R&D expenses were $17.5 million compared to $15.5 million for 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 were $5.5 million for the quarter ended June 30, 2018, compared to $5.7 million for the same period in 2017.  For the six months ended June 30, 2018, G&A expenses were $11.1 million compared to $11.0 million for 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 $0.57 per share, compared with a net loss applicable to common stockholders of $13.0 million, or $0.58 per share, for the quarter ended June 30, 2017.






Conference Call and Webcast
The Company will host a conference call and webcast today at 8:30 a.m. EDT 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.

- Financial Tables to Follow -






Concert Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
 
 
Three Months Ended June 30,
 
Six Months Ended 
 June 30,
 
2018

2017
 
2018
 
2017
Revenue:



 
 
 
 
License and research and development revenue
$
2


$
15

 
$
10,481

 
$
35

Operating expenses:



 
 
 
 
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
)
Investment income
660


155

 
1,300

 
292

Interest and Other expense

 
(205
)
 

 
(205
)
       Unrealized gain (loss) on marketable equity securities
669



 
(627
)
 

Loss before tax provision
(13,045
)

(13,027
)
 
(17,508
)
 
(26,360
)
Provision for income taxes
280

 

 
280

 

Net Loss
$
(13,325
)
 
$
(13,027
)
 
$
(17,788
)
 
$
(26,360
)
 





 
 
 
 
Net loss per share applicable to common stockholders — basic and diluted
$
(0.57
)

$
(0.58
)
 
$
(0.76
)
 
$
(1.17
)
Weighted-average number of common shares used in net loss per share applicable to common stockholders— basic and diluted
23,402


22,579

 
23,313

 
22,479

Concert Pharmaceuticals, Inc.
Summary Balance Sheet Data
(in thousands)
 
 
June 30, 2018
 
December 31, 2017
Cash and cash equivalents
 
$
58,359

 
$
27,665

Investments, available for sale
 
121,988

 
175,500

Working capital
 
202,828

 
199,289

Total assets
 
220,515

 
211,736

Deferred revenue
 
10,533

 
10,301

Total stockholders’ equity
 
200,283

 
196,432


- more -





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 has a broad pipeline of innovative medicines targeting autoimmune and inflammatory 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 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 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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