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CTP-543 Poised to Advance into Phase 3 Testing. Following an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in March 2020, the Company plans to initiate its Phase 3 program of CTP-543 in patients with moderate-to-severe alopecia areata, an autoimmune disorder that results in patchy or complete hair loss. The planned Phase 3 program for CTP-543 will include two randomized, double-blind, placebo-controlled clinical trials at sites in the U.S., Canada and Europe. The Phase 3 study is expected to begin in the fourth quarter of 2020.
Federal Circuit Granted Concert’s Motion to Vacate and Remand PTAB Decision Involving CTP‑543, Effective as of April 16, 2020. The U.S. Court of Appeals for the Federal Circuit’s grant of Concert’s motion
CTP-543 Phase 2 Results to be Presented as Late-Breaking Research at AAD Virtual Meeting. Results from the Company’s Phase 2 dose-ranging trial of CTP-543 in alopecia areata was selected as an oral presentation at the Late-Breaking Research Program at the American Academy of Dermatology (AAD) Annual Meeting. The in-person meeting, originally scheduled for March 21, 2020, in Denver, will be a virtual meeting that will include dynamic digital content and is expected to take place in the Spring timeframe. This late-breaking presentation will include new analyses from the Company’s completed Phase 2 dose-ranging study.
CTP-692 Phase 1 Clinical and Nonclinical Findings to be Presented at ASCP Virtual Meeting. The 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 ranges tested, which included the doses being evaluated in Phase 2 testing. Importantly, key blood and urine markers of kidney function did not indicate any signs of renal impairment. These data are consistent with nonclinical findings showing an improved renal safety profile for CTP-692 compared to non-deuterated D-serine, which is known to produce renal toxicity in rats. In a nonclinical study, CTP-692 was found to produce higher brain exposure compared to D-serine. The clinical results will be presented during the pipeline presentation and the nonclinical results will be presented during the poster session at The American Society of Clinical Psychopharmacology (ASCP) annual meeting, to be held virtually on May 29-30, 2020.
CTP-692 Phase 2 Trial Ongoing. Following the successful completion of the CTP-692 Phase 1 program, the Company advanced CTP-692 into a Phase 2 dose-ranging trial as an adjunctive treatment in patients with schizophrenia in December 2019. The trial is designed to support advancement into pivotal Phase 3 evaluation. Enrollment in the Phase 2 trial is expected to be complete by year-end 2020.
Cash and Investment Position. Cash, cash equivalents and investments as of March 31, 2020 totaled $159.6 million as compared to $106.4 million as of December 31, 2019. In the first quarter of 2020, Concert closed a public offering of common stock and pre-funded warrants, raising net proceeds of approximately $70 million. Under its current operating plan, the Company expects its cash, cash equivalents and investments to fund the Company into the second half of 2021.
R&D Expenses. Research and development expenses were $14.0 million for the quarter ended March 31, 2020, compared to $15.8 million for the same period in 2019. The decrease in research and development expenses relates primarily to the completion of the CTP-543 Phase 2 dose-ranging study as well as related pharmaceutical development for CTP-543. R&D expenses are expected to increase in 2020 as the Company continues to develop CTP-692 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 March 31, 2020, compared to $5.6 million for the same period in 2019. The decrease in 2020 was primarily related to a decrease in legal expenses.
Net Loss. For the quarter ended March 31, 2020, net loss applicable to common stockholders was $20.5 million, or $0.70 per share, as compared to net loss applicable to common stockholders of $21.8 million, or $0.93 per share, for the quarter ended March 31, 2019.
Concert Pharmaceuticals, Inc.
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Concert Pharmaceuticals, Inc.
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March 31, 2020
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