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

8/6/20

LEXINGTON, Mass.--(BUSINESS WIRE)--Concert 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

  • Released CTP-543 Phase 2 SALT 20 Results. The Company released new data analyses from its completed Phase 2 dose-ranging study, including an analysis of patients achieving a SALT score ? 20 using the Severity of Alopecia Tool (SALT). Results showed that 26% and 42% of patients in the CTP-543 8 mg and 12 mg twice-daily dose groups, respectively, achieved a SALT score ? 20, showing statistically significant improvements of hair regrowth compared to placebo. A SALT score ? 20 corresponds to 80% or more hair coverage on the scalp. The Company plans to utilize a SALT score ? 20 as the primary endpoint in its Phase 3 program. The results were originally selected for an oral presentation at the Late-Breaking Research Program at the American Academy of Dermatology (AAD) Annual Meeting in March 2020; however, the in-person meeting was cancelled and the corresponding abstract for the CTP-543 results was published by AAD.
  • CTP-543 Granted Breakthrough Therapy Designation for the Treatment of Alopecia Areata. In July 2020,the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for CTP-543, for the treatment of adult patients with moderate-to-severe alopecia areata. FDA Breakthrough Therapy Designation is intended to expedite the development and review of medicines aimed at treating a serious or life-threatening disease where there is preliminary clinical evidence that the investigational therapy may offer substantial improvement over existing therapies. There are currently no drugs approved by the FDA for the treatment of alopecia areata.
  • PTAB Remand of IPR on Hold. In January 2020, the U.S. Court of Appeals for the Federal Circuit (CAFC) granted Concert’s motion to vacate and remand the previous inter partes review (IPR) decision by the Patent Trial and Appeal Board (PTAB) relating to Concert’s Patent No. 9,249,149 in light of the recent CAFC ruling on the Constitution’s Appointments Clause in Arthrex, Inc. v. Smith & Nephew, Inc., 941 F.3d 1320 (Fed. Cir. 2019). In May 2020, the PTAB issued an Order putting on hold the reconsideration of any IPR proceedings, including Concert’s IPR, that had been remanded by the CAFC under Arthrex until the Supreme Court acts on the petitions for certiorari that have been filed related to Arthrex.
  • CTP-543 Phase 3 Program On Track to Begin in the Fourth Quarter 2020. The planned Phase 3 program to evaluate CTP-543 in patients with moderate-to-severe alopecia areata will include two randomized, double-blind, placebo-controlled clinical trials in the U.S., Canada and Europe. The first Phase 3 study is expected to begin in the fourth quarter of 2020.

CTP-692: An Investigational Adjunctive Treatment for Schizophrenia

  • CTP-692 Phase 2 Enrollment On Track to Complete by Year-End 2020. The Company continues to expect to complete enrollment in the CTP-692 Phase 2 clinical trial by year-end 2020. The primary outcome measure is the change in the Positive and Negative Syndrome Scale (PANSS) total score at 12 weeks compared to baseline. Topline data is expected soon after trial completion.
  • New CTP-692 Patent Provides Protection until 2038. In June 2020, the U.S. Patent and Trademark Office issued U.S. Patent No. 10,668,036 related to CTP-692. The patent, which will expire in 2038, covers methods of treating schizophrenia with CTP-692.
  • CTP-692 Findings Presented at ASCP Virtual Meeting. CTP-692 Phase 1 clinical results and nonclinical results were highlighted at the 2020 American Society of Clinical Psychopharmacology (ASCP) Virtual Annual Meeting on May 29-30. In a nonclinical study, CTP?692 was found to produce higher brain exposure compared to D-serine. Safety assessments in the single- and multiple-ascending dose Phase 1 trials in healthy volunteers showed that CTP?692 was well tolerated over the dose range tested, which include the doses being evaluated in the ongoing Phase 2 trial.

Second Quarter 2020 Financial Results

  • Cash and Investment Position. Cash, cash equivalents and investments as of June 30, 2020 totaled $144.7 million as compared to $106.4 million as of December 31, 2019. Under its current operating plan, the Company expects its cash, cash equivalents and investments to fund the Company into the second half of 2021.
  • Revenues. For the quarter ended June 30, 2020, revenue was $6.4 million. Revenue recognized during this period was the result of the expiration of licensing options under an existing collaboration with Celgene Corporation.
  • R&D Expenses. Research and development expenses were $14.8 million for the quarter ended June 30, 2020, compared to $14.5 million for the same period in 2019. The increase in research and development expenses relates primarily to the clinical development program for CTP-692. R&D expenses are expected to increase in 2020 as the Company continues to develop CTP-692 in its Phase 2 clinical trial and prepares to advance CTP-543 into Phase 3 testing in the fourth quarter of 2020.
  • G&A Expenses. General and administrative expenses were $4.7 million for the quarter ended June 30, 2020, compared to $5.0 million for the same period in 2019.
  • Net Loss. For the quarter ended June 30, 2020, net loss applicable to common stockholders was $13.0 million, or $0.41 per share, as compared to net loss applicable to common stockholders of $18.7 million, or $0.78 per share, for the quarter ended June 30, 2019.

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.