- CTP-543 Investigational New Drug Filing. In October 2016, Concert filed an investigational new drug application (IND) for CTP-543 (deuterated ruxolitinib). Under the IND, the Company intends to conduct a Phase 2 efficacy trial in patients with moderate to severe alopecia areata that is expected to begin in the first quarter of 2017. We expect to report topline 6-month data by the end of 2017. The first study to be conducted under the IND will be a single-dose crossover trial in healthy volunteers comparing metabolism and pharmacokinetics of CTP-543 and ruxolitinib, and is expected to begin in the fourth quarter of 2016.
- CTP-543 Phase 1 Clinical Evaluation. In the second quarter of 2016, Concert initiated its Phase 1 program to evaluate single and multiple ascending doses of CTP-543 in healthy volunteers. The Company expects to report the CTP-543 Phase 1 pharmacokinetic results from the single and multiple ascending dose trials in the fourth quarter of 2016. Pharmacodynamic topline results from the multiple ascending dose trial are expected in the first quarter of 2017.
- CTP-656 Simplified Dosing To Support Improved Patient Benefit. In October 2016, Concert presented CTP-656 (deuterated ivacaftor) Phase 1 food effect clinical trial results at the North American Cystic Fibrosis Conference. The food effect results showed that the exposure of CTP-656 was the same regardless of the fat content of a meal. In addition, the safety, tolerability and pharmacokinetic profile of CTP-656 observed to date supports its development as a once-daily CFTR potentiator for the treatment of cystic fibrosis. Concert expects to open an IND with the U.S. Food and Drug Administration in the fourth quarter of 2016 to advance CTP-656 into a Phase 2 trial in patients with cystic fibrosis. The Company expects to report Phase 2 topline data by year-end 2017.
- Expansion of Management Team. In September, the Company announced the expansion of its senior management team with the appointment of executives in regulatory affairs and commercial strategy to serve in leadership roles as the Company advances its clinical pipeline. Christine Boisclair has been appointed as Vice President, Regulatory Affairs and Scott Weintraub has joined Concert in the newly created position of Vice President, Commercial and Product Strategy.
- Cash and Investments Position. Cash, cash equivalents and investments as of September 30, 2016, totaled $108.0 million as compared to $118.4 million as of June 30, 2016. Concert expects its cash, cash equivalents and investments as of September 30, 2016, to be sufficient to fund the Company through the second quarter of 2018.
- Revenues. Revenue was $26,000 for the quarter ended September 30, 2016, compared to $1.7 million for the corresponding quarter in 2015. The decrease in revenue relates to the completion of the Phase 1 clinical evaluation under our strategic collaboration with Celgene Corporation in 2015.
- R&D Expenses. Research and development expenses were $8.1 million for the quarter ended September 30, 2016, compared to $7.1 million for the same period in 2015, an increase of $1.0 million. The increase was primarily due to expenses associated with the development of the Company's proprietary programs CTP-656 and CTP-543.
- G&A Expenses. General and administrative expenses were $3.4 million for the quarter ended September 30, 2016, compared to $3.3 million for the same period in 2015, an increase of $0.1 million.
- Net Loss. For the quarter ended September 30, 2016, net loss was $11.4 million, or $0.51 per share, as compared to a net loss of $8.6 million, or $0.39 per share for the quarter ended September 30, 2015.
A live webcast of Concert's presentation may be accessed in the Investors section of the Company's website at www.concertpharma.com. Please log on to the Concert website approximately 15 minutes prior to the scheduled webcast to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Concert's website for three months.- Financial Tables to Follow -
|Concert Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations (in thousands, except per share amounts)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|License and research and development revenue||$||26||$||1,709||$||153||$||6,269|
|Research and development||8,054||7,135||28,323||22,499|
|General and administrative||3,440||3,268||10,845||9,800|
|Total operating expenses||11,494||10,403||39,168||32,299|
|(Loss) Income from operations||(11,468||)||(8,694||)||(39,015||)||24,125|
|Interest and other income (expense), net||112||(21||)||338||(229||)|
|(Loss) Income before income taxes||(11,356||)||(8,715||)||(38,677||)||23,896|
|(Benefit) Provision for income taxes||—||(161||)||—||406|
|Net (loss) income||$||(11,356||)||$||(8,554||)||$||(38,677||)||$||23,490|
|Net (loss) income per share applicable to common stockholders - basic||$||(0.51||)||$||(0.39||)||$||(1.74||)||$||1.13|
|Net (loss) income per share applicable to common stockholders - diluted||$||(0.51||)||$||(0.39||)||$||(1.74||)||$||1.07|
|Weighted-average number of common shares used in net (loss) income per share applicable to common stockholders - basic||22,229||21,949||22,215||20,824|
|Weighted-average number of common shares used in net (loss) income per share applicable to common stockholders - diluted||22,229||21,949||22,215||21,918|
|Concert Pharmaceuticals, Inc. Summary Balance Sheet Data (in thousands)|
|September 30, 2016||December 31, 2015|
|Cash and cash equivalents||$||29,803||$||92,510|
|Investments, available for sale||78,189||49,680|
|Total stockholders' equity||$||96,140||$||130,635|
Concert Pharmaceuticals Inc., the CoNCERT Pharmaceuticals Inc. logo and DCE Platform are registered trademarks of Concert Pharmaceuticals, Inc.