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Concert Pharmaceuticals Reports Second Quarter 2020 Financial Results and Provides Company Update

CTP-543 Phase 3 Trial Initiation in Alopecia Areata Expected to Begin Fourth Quarter 2020

CTP-692 Phase 2 Trial Enrollment in Schizophrenia Expected to be Complete by Year-End 2020

Conference Call Scheduled Today at 8:30 a.m. ET

LEXINGTON, Mass.–(BUSINESS WIRE)–$CNCE #CNCEConcert Pharmaceuticals, Inc. (NASDAQ: CNCE) today reported financial results for the second quarter of 2020.

“We continue to be committed to advancing both of our lead programs as we embark on moving CTP-543 into pivotal trials. Our priority is to work with our clinical sites to support the safety and well-being of our trial participants, investigators and employees,” said Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. “We remain on track with our clinical program goals for CTP-543 in alopecia areata and CTP-692 in schizophrenia, both of which could potentially address important medical needs and sizeable market opportunities. For CTP-543, the Phase 3 program is expected to begin in the fourth quarter of 2020, supporting a potential new drug application to the FDA in 2023. For CTP-692, we continue to expect the Phase 2 trial will be fully enrolled by year-end with data expected in 2021.”

Recent Business Highlights and Upcoming Milestones

CTP-543: An Investigational Treatment for Moderate-to-Severe Alopecia Areata

CTP-692: An Investigational Adjunctive Treatment for Schizophrenia

Second Quarter 2020 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.

Condensed Consolidated Statements of Operations

(in thousands, except per share amounts)

(unaudited)

 

 

Three Months Ended

June 30,

 

Six Months Ended

June 30,

 

2020

 

2019

 

2020

 

2019

Revenue:

 

 

 

 

 

 

 

License and research and development revenue

$

6,387

 

 

$

49

 

 

$

6,394

 

 

$

1,054

 

Operating expenses:

 

 

 

 

 

 

 

Research and development

14,788

 

 

14,496

 

 

28,774

 

 

30,286

 

General and administrative

4,731

 

 

4,978

 

 

9,403

 

 

10,587

 

Total operating expenses

19,519

 

 

19,474

 

 

38,177

 

 

40,873

 

Loss from operations

(13,132

)

 

(19,425

)

 

(31,783

)

 

(39,819

)

Investment income

355

 

 

883

 

 

918

 

 

1,750

 

Unrealized loss on marketable equity securities

(299

)

 

(126

)

 

(2,688

)

 

(2,425

)

Loss before income taxes

(13,076

)

 

(18,668

)

 

(33,553

)

 

(40,494

)

Income tax benefit

(85

)

(85

)

 

Net loss

$

(12,991

)

 

$

(18,668

)

 

$

(33,468

)

 

$

(40,494

)

 

 

 

 

 

 

 

 

Net loss per share applicable to common stockholders — basic and diluted

$

(0.41

)

 

$

(0.78

)

 

$

(1.11

)

 

$

(1.71

)

Weighted-average number of common shares used in net loss per share applicable to common stockholders— basic and diluted

31,455

 

 

23,790

 

 

30,283

 

 

23,650

 

 

Concert Pharmaceuticals, Inc.

Summary Balance Sheet Data

(in thousands)

(unaudited)

 

 

June 30, 2020

 

December 31, 2019

Cash and cash equivalents

 

$

27,094

 

 

$

53,043

 

Investments, available for sale

 

117,623

 

 

53,395

 

Working capital

 

144,967

 

 

99,587

 

Total assets

 

171,999

 

 

137,471

 

Deferred revenue

 

4,163

 

 

10,533

 

Total stockholders’ equity

 

144,085

 

 

101,457

 

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, among others, statements about our expectations on the progress of clinical development of CTP-543 and CTP-692, the timing of patient enrollment and availability of clinical trial data and the sufficiency of our cash, cash equivalents and investments to fund our operations, and any other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “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 and timing 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, expectations with respect to the protection of our intellectual property afforded by our patents 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.

Contacts

Justine Koenigsberg (investors)

Concert Pharmaceuticals, Inc.

(781) 674-5284

ir@concertpharma.com

Kathryn Morris (media)

The Yates Network

(914) 204-6412

kathryn@theyatesnetwork.com

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