LEXINGTON, Mass.--(BUSINESS WIRE)--Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today reported financial results for the year ended December 31, 2020, and provided an update on its product pipeline.

“As we enter 2021, Concert is now a Phase 3 company, moving our lead drug candidate, CTP-543, towards a new drug application and commercialization for the treatment of adults with moderate to severe alopecia areata. With our CTP-543 Phase 3 THRIVE-AA program advancing under Breakthrough Therapy designation, we believe that positive results from these trials would support submission of a new drug application in early 2023,” said Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. “We look forward to continuing the clinical development program for CTP-543, which we believe has the potential to become one of the first FDA-approved treatment options for adults impacted by alopecia areata.”

Recent Business Highlights and Upcoming Milestones

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

• CTP-543 Maintains Hair Regrowth Beyond Initial 24-Week Treatment in Open Label, Long-Term Extension Study. In the fourth quarter, the Company presented initial data from its ongoing open label, long-term extension study with CTP-543 in the late-breaking news session at the European Academy of Dermatology and Venereology (EADV) Virtual Congress. The presentation highlighted that in the open label extension study, treatment with CTP-543 showed that hair regrowth was maintained or improved, relative to the hair growth in the Company’s previously conducted Phase 2 trials with 24-week treatment periods in patients with alopecia areata. The 8 mg and 12 mg twice-daily doses continued to be generally well tolerated, and adverse events were consistent with those reported in the Phase 2 trials.

• CTP-543 THRIVE-AA1 Phase 3 Trial Enrollment Underway. In November 2020, Concert began enrolling patients in the THRIVE-AA1 Phase 3 clinical trial. The Company expects to report topline results from the THRIVE-AA1 trial in 2022.

• CTP-543 THRIVE-AA2 Phase 3 Trial Initiation Expected in the First Half of 2021. A second Phase 3 trial of CTP-543, THRIVE-AA2, is expected to begin in the first half of 2021. Similar to the THRIVE-AA1 trial, THRIVE-AA2 will evaluate the regrowth of scalp hair after 24 weeks of dosing using the Severity of Alopecia Tool (SALT) in patients with moderate to severe alopecia areata.

Pipeline Updates

• CTP-692 Phase 2 Results Reported. In February 2021, Concert announced that its Phase 2 proof of concept clinical trial to evaluate CTP-692 as an adjunctive treatment for schizophrenia did not meet the primary or secondary endpoints. The Company does not intend to invest additional resources for the development of CTP-692.

• Evaluation of Additional Pipeline Candidates Ongoing. The Company is evaluating additional pipeline opportunities.

Full Year 2020 Financial Results

• Cash and Investment Position. Cash, cash equivalents and investments as of December 31, 2020 totaled $130.0 million as compared to $106.4 million as of December 31, 2019. In the first quarter of 2020, the Company closed a public offering of common stock and pre-funded warrants, raising net proceeds of $70.1 million. In the fourth quarter of 2020, the Company raised net proceeds of $22.5 million through its at-the-market offering program. Under its current operating plan, the Company expects its cash, cash equivalents and investments to fund the Company through 2021.

• Revenue. Revenue was $7.9 million for the year ended December 31, 2020, compared to $1.1 million for the year ended December 31, 2019. Revenue recognized in 2020 was primarily from the non-cash recognition of deferred revenue related to a previous agreement with Celgene Corporation.

• R&D Expenses. Research and development expenses were $61.6 million for the year ended December 31, 2020, compared to $59.8 million for the year ended December 31, 2019. The increase in R&D expenses in 2020 relates primarily to costs associated with the Company’s CTP-692 Phase 2 clinical trial in schizophrenia. R&D expenses are expected to increase in 2021 as the Company advances its CTP-543 Phase 3 THRIVE-AA clinical program in alopecia areata.

• G&A Expenses. General and administrative expenses were $18.9 million for the year ended December 31, 2020, compared to $20.3 million for the year ended December 31, 2019, a decrease of $1.4 million primarily due to a decrease in legal expenses.

• Net Loss. For the year ended December 31, 2020, net loss attributable to stockholders was $74.8 million, or $2.40 per share, as compared to net loss attributable to stockholders of $78.2 million, or $3.29 per share, for the year ended December 31, 2019.

About Concert

Concert Pharmaceuticals is a clinical stage 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 is in late-stage development 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.