(State or Other Jurisdiction
65 Hayden Avenue, Suite 3000N
(Address of Principal Executive Offices)
Title of each class
Name of each exchange on which registered
Common Stock, par value $0.001 per share
Nasdaq Global Market
CONCERT PHARMACEUTICALS, INC.
/s/ Jeffrey A. Munsie
Date: November 7, 2019
Jeffrey A. Munsie
Chief Legal Officer
CTP-543 Phase 2 Data Supports Advancement into Phase 3. In September 2019, Concert reported that patients treated with either 8 mg twice-daily or 12 mg twice-daily of CTP-543 met the primary efficacy endpoint with statistically significant differences (p <0.001) relative to placebo in the percentage of patients achieving a ≥ 50% relative change from baseline at 24 weeks as measured by Severity of Alopecia Tool (SALT). The 8 mg twice-daily and 12 mg twice-daily groups were also significantly different from placebo in the number of patients achieving ≥ 75% and ≥ 90% relative change in SALT from baseline at 24 weeks. Treatment with CTP-543 was generally well tolerated, with one serious adverse event reported in the 12 mg dose group where the patient was able to complete the trial after a brief dose interruption. Based on the totality of the data, the Company intends to advance CTP-543 into Phase 3 development in 2020.
CTP-543 Phase 2 Data Presented in Late Breaking News Session at EADV 2019. Dose-ranging Phase 2 data were presented in the late breaking news session at the European Academy of Dermatology and Venereology (EADV) Annual Congress on October 12, 2019, in Madrid, Spain. The presentation highlighted the Phase 2 results in which CTP-543 met the primary efficacy endpoint for the 8 mg twice-daily and 12 mg twice-daily doses with greater hair regrowth on the scalp compared to placebo. The presentation also described patient data showing significantly greater self-reported
CTP-543 Open Label Trial Evaluating 12 mg Twice-Daily vs. 24 mg Once-Daily Fully Enrolled. In September 2019, the Company completed patient enrollment of an open label clinical trial to evaluate 24 mg once-daily compared to 12 mg twice-daily oral dosing of CTP-543 in adult patients with alopecia areata. Topline data from this dose regimen trial is expected in the first half of 2020. An open label clinical trial assessing 16 mg once-daily compared to 8 mg twice-daily oral dosing of CTP-543 completed enrollment in June 2019 with topline results expected in the fourth quarter of 2019.
CTP-692 Webcast with Key Opinion Leader. On November 14, 2019, the Company will host a webcast for investors to highlight the CTP-692 program. The event will include a presentation on mechanism and need for new treatments in schizophrenia by Dr. Joseph Coyle, Director, Laboratory for Psychiatric and Molecular Neuroscience at McLean Hospital and Harvard Medical School. The live webcast and replay of the event, with slides, can be accessed on the Events & Presentations page of the Investors section of Concert’s corporate website.
CTP-692 Phase 1 Results Presented at ECNP Annual Congress. The Company presented its CTP-692 Phase 1 single- and multiple-ascending dose clinical results during a poster session at the European College of Neuropsychopharmacology Congress on September 10, 2019, in Copenhagen, Denmark. The safety assessments in the single- and multiple-ascending dose Phase 1 trials in healthy volunteers showed that CTP-692 was generally well tolerated over the dose ranges tested, which included the doses to be evaluated in Phase 2 testing. Importantly, key blood and urine markers of kidney function did not indicate any signs of renal impairment.
CTP-692 Phase 2 Trial Initiation Planned in Fourth Quarter of 2019. The Company intends to advance CTP-692 into Phase 2 testing in the fourth quarter of 2019. CTP-692 will be initially developed as an adjunctive therapy administered in addition to standard antipsychotic medicines with the potential to improve positive and negative symptoms as well as cognitive function in patients with schizophrenia.
Avanir and Otsuka Report AVP-786 Phase 3 Topline Results. In September 2019, Avanir Pharmaceuticals and Otsuka Pharmaceuticals announced that a recently completed Phase 3 trial evaluating the efficacy, safety and tolerability of AVP-786 for the treatment of moderate-to-severe agitation in patients with Alzheimer’s dementia did not meet its primary and key secondary endpoints. Avanir and Otsuka have stated that they will analyze the full set of data from the first two studies of the AVP-786 Phase 3 clinical development program and explore the best path forward.
Jeffrey Munsie Joins Concert as Chief Legal Officer. In September 2019, Concert named Jeffrey A. Munsie to the position of Chief Legal Officer. In this role, Mr. Munsie will have overall responsibility for key general corporate legal functions, including the Company’s public reporting requirements, governance and intellectual property matters, and will serve as corporate secretary.
Cash and Investment Position. Cash, cash equivalents and investments as of September 30, 2019 totaled $121.5 million. The Company expects its cash, cash equivalents and investments to be sufficient to fund the Company through 2020 under its current operating plan.
R&D Expenses. Research and development expenses were $13.5 million for the quarter ended September 30, 2019, compared to $11.0 million for the same period in 2018. The increase in research and development expenses relates primarily to the clinical development of CTP-543 as well as increased expenses associated with the manufacturing of CTP-692 to support ongoing clinical development.
G&A Expenses. General and administrative expenses were $4.7 million for the quarter ended September 30, 2019, compared to $6.3 million for the same period in 2018. Decreases in legal and employee-related expenses were partially offset by an increase in professional fees.
Net Loss. For the quarter ended September 30, 2019, net loss applicable to common stockholders was $17.2 million, or $0.72 per share, compared with a net loss applicable to common stockholders of $17.4 million, or $0.74 per share, for the quarter ended September 30, 2018.
Concert Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
Three Months Ended September 30,
Nine Months Ended September 30,
License and research and development revenue
Research and development
General and administrative
Total operating expenses
Loss from operations
Unrealized gain (loss) on marketable equity securities
Loss before tax provision
Provision for income taxes
Net loss per share applicable to common stockholders — basic and diluted
Weighted-average number of common shares used in net loss per share applicable to common stockholders— basic and diluted
Concert Pharmaceuticals, Inc.
Summary Balance Sheet Data
September 30, 2019
December 31, 2018
Cash and cash equivalents
Investments, available for sale
Total stockholders’ equity