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Form 8-K CONCERT PHARMACEUTICALS, For: Aug 04

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August 4, 2022 7:03 AM EDT
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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 4, 2022
Concert Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware 001-36310 20-4839882
(State or other jurisdiction
of incorporation)		 (Commission
File Number)		 (IRS Employer
Identification No.)
     65 Hayden Avenue, Suite 3000N
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))
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common stock, $0.001 par value per shareCNCENasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2).
Emerging growth company ☐    

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. ¨


Item 2.02. Results of Operations and Financial Condition.
On August 4, 2022, Concert Pharmaceuticals, Inc. (the “Company”) announced its financial results for the quarter ended June 30, 2022. 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 in this Item 2.02 and in Exhibit 99.1 attached hereto is intended to be furnished and 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 8.01. Other Events.
On August 4, 2022, the Company posted on its website the corporate presentation that is attached to this Current Report on Form 8-K as Exhibit 99.2 and incorporated herein by reference. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.2.
Item 9.01. Financial Statements and Exhibits.
 
(d)Exhibits
Exhibit No.  Description
  
104Cover Page Interactive Data File (embedded within the Inline XBRL document)


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.
Date:August 4, 2022  By:/s/ Jeffrey A. Munsie
   Jeffrey A. Munsie
   Chief Legal Officer


Exhibit 99.1
 
cnceimagea01.jpg
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 2022 Financial Results
CTP-543 Positive Topline Results Reported in THRIVE-AA1 and THRIVE-AA2 Phase 3 Studies in Alopecia Areata
CTP-543 Has the Potential to Address an Important Unmet Need for a Large, Underserved Patient Population
Conference Call Scheduled Today at 8:30 a.m. ET; Online Registration Required to Access Dial in and PIN for Live Call to Ask Questions
Lexington, MA (August 4, 2022) -- Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today reported financial results for the second quarter of 2022.
“We are very happy to have seen consistent efficacy and safety results across our two Phase 3 clinical trials of CTP-543 in alopecia areata. The positive results that we reported from THRIVE-AA1 in May and from THRIVE-AA2 earlier this week, will form the basis of our New Drug Application, which we expect to submit to the FDA in the first half of 2023,” said Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. “We have continued to execute well on a development program for CTP-543 that provides a robust data package in support of a potential FDA approval. We are proud that CTP‑543 could offer a near-term and potentially best-in-class treatment option for adults with moderate to severe alopecia areata.”
Recent Highlights and Upcoming Milestones
CTP-543: An Investigational Treatment for Moderate to Severe Alopecia Areata
•Positive Phase 3 Results Reported for CTP-543 THRIVE-AA1 Study. In May 2022, the Company reported positive topline results for its first CTP-543 Phase 3 clinical trial. A statistically significant proportion of patients treated with either 8 mg twice-daily or 12 mg twice-daily of CTP-543 in the THRIVE-AA1 study


experienced greater scalp regrowth compared to placebo. The proportion of patients achieving a Severity of Alopecia Tool (SALT) score of 20 or less (meaning 20 percent or less scalp hair loss) at Week 24 was 41.5 percent in the 12 mg twice-daily dose group and 29.6 percent in the 8 mg twice-daily dose group, compared to 0.8 percent of patients in the placebo group. The treatment difference for both dose groups of CTP-543 relative to placebo was statistically significant (p<0.0001). The safety profile seen with CTP-543 in THRIVE-AA1 was consistent with previous studies of CTP-543.
•Positive Phase 3 Results Reported for CTP-543 THRIVE-AA2 Study. In August 2022, the Company reported positive topline results for its second CTP-543 Phase 3 clinical trial. A statistically significant proportion of patients treated with either 8 mg twice-daily or 12 mg twice-daily of CTP-543 in the THRIVE-AA2 study experienced greater scalp regrowth compared to placebo. The proportion of patients achieving a SALT score of 20 or less at Week 24 was 38.3 percent in the 12 mg twice-daily dose group and 33.0 percent in the 8 mg twice-daily dose group, compared to 0.8 percent of patients in the placebo group. The treatment difference for both dose groups of CTP-543 relative to placebo was statistically significant (p<0.0001). The safety profile seen with CTP-543 in THRIVE-AA2 was consistent with previous studies of CTP-543.
•JAAD Publication Highlights Significant Reduction in Severity of Hair Loss with CTP-543. The Company recently published safety and efficacy data from its randomized, double-blind, placebo-controlled dose-ranging Phase 2 clinical trial of CTP‑543 in the Journal of the American Academy of Dermatology (JAAD). The publication reported clinically meaningful and statistically significant scalp hair regrowth after 24 weeks of treatment with CTP-543 in both the 8 mg twice-daily and 12 mg twice-daily dose groups in patients with alopecia areata, as well as safety data and patient-reported outcomes of improvement. This trial supported the advancement of CTP-543 into Phase 3 development.
•Concert to Participate in Alopecia Areata Awareness Month in September. Throughout the month of September, Concert, along with the alopecia areata community, will raise awareness and recognize the importance of alopecia areata, a serious autoimmune disorder that affects up to approximately 1.5 million individuals in the U.S. and which often results in poor health-related quality of life as well as high incidence of anxiety and depression. Follow our #LightItUpBlue4AlopeciaAreata campaign on Twitter at @ConcertPharma.
Second Quarter 2022 Financial Results
•Cash and Investment Position. Cash, cash equivalents and investments as of June 30, 2022 totaled $153.7 million as compared to $141.6 million as of December 31, 2021. Under its current operating plan, the Company expects its cash, cash equivalents and investments to fund the Company into the second quarter of 2023. In June 2022, Concert closed an equity offering raising gross proceeds of $54.6 million before underwriting discounts and offering expenses. Concurrent with the initial closing of the offering, Concert received $18.9 million from the partial exercise of the Tranche 1 warrants issued to BVF Partners L.P. and RA Capital Management in connection with its November 2021 financing. The Company has the potential to receive an additional $70.1 million in 2022 upon full exercise of the remaining warrants issued in connection with the November 2021 financing.
•R&D Expenses. Research and development expenses were $20.9 million for the quarter ended June 30, 2022, compared to $20.2 million for the same period in 2021. The increase in research and development expenses relates primarily to the clinical development program for CTP-543.
•G&A Expenses. General and administrative expenses were $4.8 million for the quarter ended June 30, 2022, compared to $5.6 million for the same period in 2021. The decrease in general and administrative expenses relates primarily to decreased non-cash stock-based compensation.
•Net (Loss) Income. For the quarter ended June 30, 2022, net loss applicable to common stockholders was $24.0 million, or $0.59 per share, as compared to net income applicable to common stockholders of


$5.4 million, or $0.16 per share, for the quarter ended June 30, 2021. Net income for the quarter ended June 30, 2021 included $32.0 million in revenue from proceeds received from Vertex Pharmaceuticals, Inc. for the purchase of potential future milestones under the companies’ 2017 asset purchase agreement related to VX-561.
Conference Call and Webcast: New System to Access Call Live and On Demand
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.
Please note that there is a new system to access the live call in order to ask questions. To join the live call, please register here. A dial in and unique PIN number will be provided to join the call.
An audio-only webcast of the call may be accessed in the Investors section of the Company’s website at www.concertpharma.com. 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)
(unaudited)
 Three Months Ended June 30,Six Months Ended June 30,
 2022202120222021
Revenue:
License and research and development revenue$21 $17 $22 $22 
Other revenue— 32,000 — 32,000 
Total revenue21 32,017 22 32,022 
Operating expenses:
Research and development20,855 20,184 51,344 38,684 
General and administrative4,849 5,614 10,389 11,099 
Total operating expenses25,704 25,798 61,733 49,783 
(Loss) income from operations(25,683)6,219 (61,711)(17,761)
Investment income145 15 165 40 
Unrealized (loss) gain on marketable equity securities(60)(809)(624)477 
Unrealized gain on warrant liabilities2,050 — 894 — 
Net (loss) income$(23,548)$5,425 $(61,276)$(17,244)
Net (loss) income attributable to common stockholders - basic and diluted(24,045)5,415 (61,773)(17,244)
Net (loss) income per share applicable to common stockholders - basic and diluted$(0.59)$0.16 $(1.59)$(0.51)
Weighted-average number of common shares used in net (loss) income per share applicable to common stockholders:
Basic41,042 33,974 38,877 33,934 
Diluted41,042 34,083 38,877 33,934 



Concert Pharmaceuticals, Inc.
Summary Balance Sheet Data
(in thousands)
(unaudited)
June 30, 2022December 31, 2021
Cash and cash equivalents$139,245 $141,636 
Investments, available for sale14,488 — 
Working capital145,956 134,209 
Total assets176,393 165,316 
Deferred revenue7,595 7,595 
Total stockholders’ equity127,792 112,225 

– more –
About Concert
Concert Pharmaceuticals is a late-stage clinical biopharmaceutical company that is developing small molecule drugs that it discovered through the application of its DCE Platform® (deuterated chemical entity platform). Selective incorporation of deuterium into known molecules has the potential, on a case-by-case basis, to provide better pharmacokinetic or metabolic properties, thereby enhancing their clinical safety, tolerability or efficacy. Concert’s lead product candidate CTP-543 is being developed for the treatment of alopecia areata, a serious autoimmune dermatological condition. Concert is also assessing a number of earlier-stage pipeline candidates. 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 regarding the development of CTP-543, the potential for CTP-543 to be a best-in-class treatment for the treatment of alopecia areata, the planned timing for filing an NDA for CTP-543 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, timing and design of future clinical trials, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results, including safety profiles, 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 the timing of the submission of an NDA, the availability of regulatory approvals, the 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.

###

Creating New Possibilities for Patients to Live Their Lives August 2022 © 2022 Concert Pharmaceuticals, Inc. All Rights Reserved. Exhibit 99.2

 
Forward-Looking Statements Any statements in this presentation about our future expectations, plans and prospects, including, among others, statements about our expectations regarding the development of CTP-543, the potential for CTP-543 to be a best-in-class treatment for the treatment of alopecia areata, the planned timing for filing an NDA for CTP-543 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, timing and design of future clinical trials, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results, including safety profiles, 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 the timing of the submission of an NDA, the availability of regulatory approvals, the 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 presentation represent our views only as of the date of this presentation 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 presentation. 2

 
CoNCERT: Creating New Opportunities in Dermatology 3 Developing small molecules for autoimmune dermatology Late-stage, patient-centric, clinical company Successfully out-licensed multiple candidates Cash into second quarter of 2023 • Successfully completed two pivotal trials to support NDA submission planned for 1H 2023 • Creating novel, patent-protected, potential best-in- class drug candidates for serious unmet medical needs • Potential to receive additional $70.1M in 2022 upon full exercise of remaining warrants outstanding* *Concert has the potential to receive an additional $70.1 million upon full exercise of the remaining warrants issued to BVF Partners L.P. and RA Capital Management in connection with its November 2021 financing. • Out-license of non-core development programs provides additive value and downstream potential Nasdaq Listed (CNCE) | Headquarters in Lexington, MA | 65 Employees | Seasoned Management Team

 
Late-Stage Clinical Program and Strategic Value Creation 4 Phase 1 Phase 2 Phase 3 Anticipated Milestones Ownership CTP-543 Deuruxolitinib Alopecia Areata NDA submission planned 1H 2023 AVP-786 Deudextromethorphan hydrobromide and quinidine sulfate Alzheimer’s Agitation Schizophrenia Negative Symptoms Traumatic Brain Injury Next trial completion expected in 2H 2022 THRIVE-AA1 Positive Topline Results Reported THRIVE-AA2 Positive Topline Results Reported NDA Supporting Studies/Open Label Extension Study Multiple Phase 3 Trials Ongoing Phase 2/3 Ongoing Phase 2 Ongoing Potential economics to Concert:  Up to $37M in regulatory milestones  Up to $125M in sales milestones  Royalties Wholly Owned By: Partnered with:

 
CTP-543: Compelling Opportunity for Alopecia Areata 5 • Serious autoimmune disorder with significant unmet patient need • CTP-543 has Breakthrough Therapy designation Large Market Opportunity • Plan to file NDA in 1H 2023 • Pre-commercial initiatives underway Preparing for Commercialization • Orange Book-eligible patent protection into 2037 • Patent portfolio expansion ongoing Strong Patent Protection • Phase 3 program: robust hair regrowth, met primary and key secondary endpoints • 3+ year extension study supports favorable safety/tolerability profile Potential Best-in-Class

 
Alopecia Areata: A Devasting Autoimmune Disease 6 Limited Treatment Options Available • Strong patient advocacy • FDA PFDDI meeting held September 2017 • CTP-543 potentially best- in-class ‒ Breakthrough Therapy designation granted by FDA Common Disorder 1 Est. 700,000-1,600,000 patients: Benigno M. Clinical, Cosmetic and Investigational Dermatology 2020 2 Mesinkovska N. Journal of Investigative Dermatology Symposium Proceedings 2020 Significant Burden of Disease • Disease profoundly impacts patients • Patients suffer increased burdens, including significant psychosocial impact2 ‒ Major impact on self esteem and self confidence • Associated with anxiety, depression and other autoimmune conditions • Up to approximately 1.5 million patients affected with alopecia areata in the U.S. at any given time1 • Estimated 40+% of patients reported to have ≥ 50% loss of scalp hair1 • Chronic condition affecting women, men and children of all ages

 
THRIVE-AA Studies Achieve Primary Endpoint: Both Doses Highly Statistically Different From Placebo • Randomized >1,200 adult patients with moderate to severe alopecia areata across two double- blind, randomized, placebo-controlled Phase 3 trials ‒ Inclusion criteria: at least 50% hair loss as measured by Severity of Alopecia Tool (SALT) ‒ Primary endpoint: SALT score ≤20 at Week 24 • SALT score ≤20 considered clinically meaningful ‒ Randomized to receive either 8 mg twice-daily or 12 mg twice-daily of CTP-543 or placebo for 24 weeks ‒ Primary endpoint met with statistical significance for both CTP-543 doses in both trials 7CTP-543 Response Over Treatment Period: 8 mg BID THRIVE-AA1: Meaningful Hair Regrowth Observed Baseline Week 24

 
THRIVE-AA1 Primary Endpoint: Patients Achieving Absolute SALT Score ≤20 at Week 24 8 0 10 20 30 40 50 60 8 mg BID 12 mg BID 42% 1% Placebo ***** 30%***** ***** p<0.0001 vs PBO THRIVE-AA1: CTP-543 Phase 3 Results n= 140 n= 351 n= 215 Pe rc en t o f P at ie nt s

 
0 10 20 30 40 50 60 8 mg BID 12 mg BID 38% 1% Placebo 33% 60 % THRIVE-AA2 Primary Endpoint: Patients Achieving Absolute SALT Score ≤20 at Week 24 9***** p<0.0001 vs PBO THRIVE-AA2: CTP-543 Phase 3 Results ***** ***** n= 127 n= 249 n= 127 Pe rc en t o f P at ie nt s

 
THRIVE-AA1: Statistically Significant Differences from Placebo of Hair Regrowth as Early as Eight Weeks 10 THRIVE-AA1 Key Secondary Endpoint: Patients Achieving Absolute SALT Score ≤20 by Weeks on Treatment 0 10 20 30 40 50 60 Week 8 Week 12 Week 16 Week 20 Week 24 Pe rc en t o f P at ie nt s Placebo 8 mg BID 12 mg BID ***** **** ***** ***** **** ***** ***** ***** 42% 30% 1% ********** ***** p<0.0001 vs PBO **** p<0.001 vs PBO

 
0 10 20 30 40 50 60 Week 8 Week 12 Week 16 Week 20 Week 24 Pe rc en t o f P at ie nt s Placebo 8 mg BID 12 mg BID ***** THRIVE-AA2: Statistically Significant Differences from Placebo of Hair Regrowth as Early as Twelve Weeks 11 THRIVE-AA2 Key Secondary Endpoint: Patients Achieving Absolute SALT Score ≤20 by Weeks on Treatment ***** ***** ***** ***** ***** 38% 33% 1% ***** **** ***** p<0.0001 vs PBO **** p<0.001 vs PBO

 
THRIVE-AA1: Statistically Significant Differences in Relative Change in SALT from Baseline as Early as 4 Weeks 12 0 10 20 30 40 50 60 Week 4 Week 8 Week 12 Week 16 Week 20 Week 24 M ea n % R el at iv e C ha ng e in S AL T Sc or e Placebo 8 mg BID 12 mg BID ***** ***** 2% 41% 50% ***** p<0.0001 vs PBO *** p<0.01 vs PBO *** ***** ***** ***** ********** ***** ***** ***** THRIVE-AA1 Secondary Endpoint: Relative Change in SALT Scores from Baseline by Weeks on Treatment This graph represents a decrease (improvement) in SALT score relative to baseline.

 
THRIVE-AA2: Statistically Significant Differences in Relative Change in SALT from Baseline as Early as 4 Weeks 13 -10 0 10 20 30 40 50 60 Week 4 Week 8 Week 12 Week 16 Week 20 Week 24 M ea n % R el at iv e C ha ng e in S AL T Sc or e Placebo 8 mg BID 12 mg BID ***** ***** - 2% ***** p<0.0001 vs PBO *** p<0.01 vs PBO 45% 53% *** ***** ********** ***** ***** ***** ***** ***** *** THRIVE-AA2 Secondary Endpoint: Relative Change in SALT Scores from Baseline by Weeks on Treatment This graph represents a decrease (improvement) in SALT score relative to baseline.

 
THRIVE-AA1: Highly Statistically Significant Differences vs Placebo in Patient Satisfaction at Week 24 14 THRIVE-AA1: Key Secondary Endpoint: Satisfaction of Hair Patient Reported Outcome (SPRO) Responders at Week 24 ***** p<0.0001 vs PBO 0 10 20 30 40 50 60 8 mg BID 12 mg BIDPlacebo Pe rc en ta ge o f R es po nd er s 53% 42% 5% ***** ***** Responder is defined as patient response of ‘very satisfied’ or ‘satisfied’ n= 140 n= 351 n= 215

 
THRIVE-AA2: Highly Statistically Significant Differences vs Placebo in Patient Satisfaction at Week 24 15 THRIVE-AA2 Key Secondary Endpoint: Satisfaction of Hair Patient Reported Outcome (SPRO) Responders at Week 24 Responder is defined as patient response of ‘very satisfied’ or ‘satisfied’ 0 10 20 30 40 50 60 8 mg BID 12 mg BIDPlacebo 60% 2% 47% 52% n= 127 n= 249 n= 127 ***** ***** ***** p<0.0001 vs PBO Pe rc en ta ge o f R es po nd er s

 
THRIVE-AA1: Favorable Safety/Tolerability Profile • CTP-543 treatment was generally well tolerated • 9 patients reported SAEs: placebo (4), 8 mg twice-daily (4) and 12 mg twice-daily (1) ‒ Only 1 patient (8 mg) reported SAEs (2) assessed as possibly related to treatment • No pulmonary embolisms or deep vein thromboses reported 16

 
THRIVE-AA2: Favorable Safety/Tolerability Profile • CTP-543 treatment was generally well tolerated • 5 patients reported SAEs: 8 mg twice-daily (3) and 12 mg twice-daily (2) ‒ Only 1 patient (8 mg) reported an SAE assessed as possibly related to treatment • No pulmonary embolisms or deep vein thromboses reported 17

 
CTP-543: Potential Best-in-Class Treatment in Alopecia Areata Conclusions from the THRIVE-AA Phase 3 program*:  Primary endpoint achieved: significant scalp regrowth at 24 weeks  Early onset of effect: significant differences as early as 8 to 12 weeks and maintained throughout study  Patient satisfaction: significant difference at 24 weeks vs placebo • >95% of eligible patients elected to roll into open label, long-term extension study  Favorable safety/tolerability profile: treatment generally well tolerated 18*Results for both 8 mg BID and 12 mg BID doses in THRIVE-AA1 and THRIVE-AA2 Baseline Week 12 Week 24 CTP-543 Response Over Treatment Period: 8 mg BID – Phase 2 Study

 
CTP-543 for Alopecia Areata: Pre-Commercial Planning • CTP-543 has highly competitive profile based on Phase 3 results • Alopecia areata represents potential blockbuster opportunity • High unmet need with strong patient advocacy and demand • Multiple pre-commercial initiatives underway ‒ Payor evidence and reimbursement strategy ‒ KOL segmentation and targeting ‒ Medical communication planning ‒ Patient journey 19 Large, chronic disease now recognized as autoimmune disorder A ready segment of motivated patients with high burden of disease Clear market opportunity with significant growth potential

 
CTP-543: Compelling Opportunity for Alopecia Areata 20 • Serious autoimmune disorder with significant unmet patient need • CTP-543 has Breakthrough Therapy designation Large Market Opportunity • Plan to file NDA in 1H 2023 • Pre-commercial initiatives underway Preparing for Commercialization • Orange Book-eligible patent protection into 2037 • Patent portfolio expansion ongoing Strong Patent Protection • Phase 3 program: robust hair regrowth, met primary and key secondary endpoints • 3+ year extension study supports favorable safety/tolerability profile Potential Best-in-Class

 
Financial Position Clinical Milestones Regulatory Milestones 21 Financial Position and Milestones  Successful THRIVE-AA1 Phase 3 trial topline results reported Q2 2022  Successful THRIVE-AA2 Phase 3 trial topline results reported Q3 2022 • Cash, cash equivalents and investments: $153.7M as of June 30, 2022 • Potential to receive additional $70.1M in 2022 upon full exercise of remaining warrants outstanding* • Plan to file NDA in 1H 2023 *In June 2022, Concert closed an equity offering raising gross proceeds of $54.6 million before underwriting discounts and offering expenses. Concurrent with the initial closing of the offering, Concert received $18.9 million from the partial exercise of warrants issued to BVF Partners L.P. and RA Capital Management in connection with its November 2021 financing. Concert has the potential to receive an additional $70.1 million upon full exercise of the remaining warrants issued to BVF Partners L.P. and RA Capital Management in connection with its November 2021 financing.

 
© 2022 Concert Pharmaceuticals, Inc. All Rights Reserved. NASDAQ: CNCE www.concertpharma.com @ConcertPharma For additional information contact: Justine Koenigsberg [email protected]

 

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