On November 9, 2021 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported financial results for the third quarter of 2021 (Press release, Concert Pharmaceuticals, NOV 9, 2021, View Source [SID1234594978]).
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"The CTP-543 pivotal program is progressing on track to support an NDA filing with the FDA in early 2023," said Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. "We continue to believe that CTP-543, with its Breakthrough Therapy designation, has the potential to be a best in class compound to treat this challenging autoimmune disease and hope to make it available to patients as soon as possible."
Recent Business Highlights and Upcoming Milestones
CTP-543: An Investigational Treatment in Pivotal Clinical Program for Moderate to Severe Alopecia Areata
Completed Enrollment in the CTP-543 THRIVE-AA1 Phase 3 Trial in October 2021. THRIVE-AA1 is a randomized, double-blind, placebo-controlled Phase 3 clinical trial of CTP‑543 to evaluate hair regrowth using the Severity of Alopecia Tool (SALT) after 24 weeks of dosing. The study enrolled 708 adult patients with moderate to severe alopecia areata. The trial is evaluating 8 mg and 12 mg twice-daily doses of CTP-543 compared to placebo at sites in the U.S., Canada and Europe. The Company expects to report topline results from the THRIVE-AA1 trial in the second quarter of 2022.
CTP-543 THRIVE-AA2 Phase 3 Trial is Progressing. THRIVE-AA2 is a randomized, double-blind, placebo-controlled Phase 3 clinical trial of CTP‑543 to evaluate hair regrowth using SALT after 24 weeks of dosing in approximately 440 adult patients with moderate to severe alopecia areata. The trial is evaluating 8 mg and 12 mg twice-daily doses of CTP-543 compared to placebo at sites in the U.S., Canada and Europe. The Company expects to report topline results from the THRIVE-AA2 trial in the second half of 2022.
CTP-543 Long-term Data Presented at JAK Inhibitors Drug Development Summit in Q3 2021. Data from an ongoing open label, long-term extension study with CTP-543 were presented at the 2nd JAK Inhibitors Drug Development Summit on July 1, 2021. The presentation highlighted that in the extension study, treatment with CTP-543 showed continued maintenance of hair regrowth relative to the hair growth shown in the Company’s previously conducted Phase 2 trials in patients with alopecia areata. Approximately 57% of participants receiving 12 mg of CTP-543 twice-daily following 52 weeks of dosing achieved a clinically-meaningful SALT score of 20 or less. A SALT score ≤ 20 corresponds to 80% or more hair coverage on the scalp. CTP-543 has been generally well tolerated in the extension study, and adverse events are consistent with those reported in the Phase 2 trials.
New Publication Highlights Adoption of Alopecia Areata Disease Severity Scale. Concert participated as a co-author in a new publication in the Journal of the American Academy of Dermatology (JAAD) that highlights an academic-industry collaborative effort for the development of a new alopecia areata disease severity scale for use in clinical practice. The new alopecia areata disease severity scale, anchored in the amount of hair loss, captures key features commonly used by experts in clinical practice, and is intended to help physicians to easily and accurately assess alopecia areata severity in patients.
Third Quarter 2021 Financial Results
Cash and Investment Position. Cash, cash equivalents and investments as of September 30, 2021 totaled $103.7 million as compared to $130.0 million as of December 31, 2020. In November 2021, the Company raised gross proceeds of $65 million under a financing agreement with BVF Partners L.P. and RA Capital Management. The financing consists of the sale of common and preferred stock, warrants and a portion of Concert’s right to receive potential future AVP-786 royalties under an existing licensing agreement with Avanir Pharmaceuticals, Inc. Concert will have the potential to receive an additional $103 million upon the full exercise of warrants issued in connection with the agreement. Under its current operating plan, the Company expects its cash and cash equivalents to fund the Company into the fourth quarter of 2022.
Revenues. For the quarter ended September 30, 2021, revenue was $0.5 million, compared to $1.5 million for the same period in 2020.
R&D Expenses. Research and development expenses were $21.9 million for the quarter ended September 30, 2021, compared to $16.3 million for the same period in 2020. The increase in research and development expenses relates primarily to the clinical development for CTP-543.
G&A Expenses. General and administrative expenses were $5.5 million for the quarter ended September 30, 2021, compared to $4.5 million for the same period in 2020.
Net Loss. For the quarter ended September 30, 2021, net loss applicable to common stockholders was $26.7 million, or $0.78 per share, as compared to net loss applicable to common stockholders of $18.9 million, or $0.60 per share, for the quarter ended September 30, 2020.
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 third 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 third 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.