On May 4, 2021 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported financial results for the first quarter of 2021 (Press release, Concert Pharmaceuticals, MAY 4, 2021, View Source [SID1234584684]).
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"We are committed to advancing CTP-543, our breakthrough therapy candidate for moderate to severe alopecia areata. Patients currently lack effective, approved treatment options. We believe we have the potential to provide patients with a new, clinically meaningful and best-in-class treatment option," stated Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. "We remain on track with our THRIVE-AA Phase 3 clinical program with CTP-543, in support of our New Drug Application that we anticipate filing in early 2023."
Recent Business Highlights and Upcoming Milestones
CTP-543: An Investigational Treatment for Moderate to Severe Alopecia Areata
THRIVE-AA1 Phase 3 Trial in Alopecia Areata On Track to Report Topline Data in 2022. The THRIVE-AA1 Phase 3 trial is a randomized, double-blind, placebo-controlled clinical trial of CTP-543 to evaluate hair regrowth after 24 weeks of dosing in approximately 700 adults 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 2022. Additional information about the THRIVE-AA1 trial (NCT04518995) is available at clinicaltrials.gov.
Initiation of THRIVE-AA2 Phase 3 Trial in Alopecia Areata Expected in May 2021. The Company expects to initiate a second pivotal Phase 3 trial of CTP-543, THRIVE-AA2, later this month. The planned THRIVE-AA2 Phase 3 trial is a randomized, double-blind, placebo-controlled clinical trial of CTP-543 to evaluate hair regrowth after 24 weeks of dosing in approximately 440 adults with moderate to severe alopecia areata. The trial will evaluate 8 mg and 12 mg twice-daily doses of CTP-543 compared to placebo at sites in the U.S., Canada and Europe. Additional information about the THRIVE-AA2 trial (NCT04797650) is available at clinicaltrials.gov.
Update on CTP-543 Open Label, Long-Term Extension Study to be Presented at JAK Summit. Concert’s Chief Development Officer, James V. Cassella, Ph.D., will present an update on the ongoing open label, long-term extension study of CTP-543 at the 2nd JAK Inhibitors Drug Development Summit scheduled for July 1, 2021. The presentation will provide an update on the extension study, building on the data presented at the late-breaking news session at the European Academy of Dermatology and Venereology (EADV) in October 2020, during which the Company showed the maintenance of hair regrowth in patients on treatment for at least one year. Details about the upcoming meeting are available at https://jak-drugdevelopment.com/.
First Quarter 2021 Financial Results
Cash and Investment Position. Cash, cash equivalents and investments as of March 31, 2021 totaled $111.8 million as compared to $130.0 million as of December 31, 2020. Under its current operating plan, the Company expects its cash, cash equivalents and investments to fund the Company through 2021.
R&D Expenses. Research and development expenses were $18.5 million for the quarter ended March 31, 2021, compared to $14.0 million for the same period in 2020. The increase in research and development expenses relates primarily to the ongoing CTP-543 Phase 3 THRIVE-AA clinical program.
G&A Expenses. General and administrative expenses were $5.5 million for the quarter ended March 31, 2021, compared to $4.7 million for the same period in 2020, an increase of $0.8 million due to an increase in external professional service expenses and non-cash stock-based compensation expense.
Net Loss. Net loss applicable to common stockholders was $22.7 million, or $0.67 per share, for the quarter ended March 31, 2021, as compared to net loss applicable to common stockholders of $20.5 million, or $0.70 per share, for the quarter ended March 31, 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 its first quarter 2021 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 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.