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Concert Pharmaceuticals Reports Third Quarter 2015 Financial Results And Provides Company Update

The following excerpt is from the company's SEC filing.

Lexington, MA (November 5, 2015)

Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today reported financial results for the third quarter of 2015.

“We have made progress with multiple drug candidates across our diverse pipeline, in each case focusing on creating an improved medicine by applying deuterium chemistry to meaningfully enhance patient care,” said Roger Tung, PhD, Chief Executive Officer of Concert Pharmaceuticals.

Dr. Tung continued, “In particular, we advanced the clinical development of CTP-656 for the treatment of cystic fibrosi s. Recently, in a Phase 1 trial we demonstrated that CTP-656 has a superior pharmacokinetic profile compared to current standard of care, Kalydeco®, which supports the potential for once-daily dosing. We look forward to rapidly developing CTP-656 as a new treatment option that may provide a meaningful benefit to individuals with cystic fibrosis.”

Recent Business Highlights and Upcoming Milestones

AVP-786 Clinical Development.

In September 2015, Avanir Pharmaceuticals began recruiting patients in a Phase 2 trial evaluating AVP-786 as an adjunctive treatment for patients with residual schizophrenia. In addition, Concert continues to expect Avanir to advance AVP-786 into Phase 3 clinical trials for the treatment of agitation in patients with dementia of the Alzheimer’s type. The Phase 3 trials are expected to begin in the fourth quarter of 2015.

CTP-656 Phase 1 Results for Cystic Fibrosis.

In September and October 2015, Concert presented CTP-656 Phase 1 single ascending dose clinical trial results. CTP-656 demonstrated a superior pharmacokinetic profile compared to Kalydeco, and the trial results support once-daily dosing. Results of the Phase 1 trial also showed that CTP-656 was well-tolerated and its safety profile was comparable to Kalydeco. The findings were presented at the Cystic Fibrosis UK Trust Conference and the North American Cystic Fibrosis Conference. Concert expects to initiate a multiple ascending dose Phase 1 trial of CTP-656 in healthy volunteers in the fourth quarter of 2015.

Development Milestone under Celgene Collaboration

. Under its collaboration with Celgene, Concert achieved an $8 million milestone in October 2015 based on the completion of the CTP-730 (deuterated apremilast) Phase 1 studies.

CTP-499 Special Protocol Assessment Agreement.

Concert has reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for a Phase 3 clinical trial of CTP-499 for the treatment of diabetic nephropathy. The SPA is a written agreement with the FDA on the design, endpoints and statistical analysis of a Phase 3 trial to support a New Drug Application (NDA). The Company intends to seek one or more collaborators for future development.

Third Quarter 2015 Financial Results

Cash and Investment Position.

Cash, cash equivalents and investments as of September 30, 2015, totaled $142.0 million as compared to $151.7 million as of June 30, 2015. In October 2015, the Company achieved an $8 million milestone under its collaboration with Celgene and expects to receive payment in the fourth quarter. Concert...