Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today reported financial results for the third quarter of 2017.
"This is an exciting time for our deuterium-based chemistry as we continue to demonstrate our technology's ability to meaningfully improve the clinical properties of existing medicines. The CTP-656 program and subsequent asset purchase agreement with Vertex Pharmaceuticals is a great example of leveraging our platform to rapidly create significant value," said , Ph.D., President and CEO of . "Our priorities now include advancing CTP-543 through its Phase 2 program for alopecia areata while assessing indication expansion opportunities and broadening our pipeline with new proprietary candidates."
Recent Business Highlights and Upcoming Milestones
- CTP-543 Phase 2a Trial Underway. The Company began dosing patients in the Phase 2a trial in the third quarter of 2017.The Phase 2a trial is designed to assess two doses (4 mg and 8 mg twice daily) of CTP-543 compared to placebo in patients with moderate-to-severe alopecia areata over 24 weeks of dosing. Dosing in the 8 mg arm of the trial is expected to begin after an independent Data Monitoring Committee completes a planned interim review of the safety data from the first dosing cohort in the first quarter of 2018. Concert expects to complete the trial in the second half of 2018.
- CTP-543 Patent Proceedings. In , the Patent Trial and Appeal Board (PTAB) denied Incyte's petition to institute inter partes review (IPR) of Patent No. 9,249,149. The denial of Incyte's IPR petition upholds the validity of Concert's composition of matter patent claims covering CTP-543.
- CTP-656 Asset Purchase Agreement Closed. In , Concert received a cash payment from Vertex Pharmaceuticals under an asset purchase agreement whereby Vertex acquired worldwide development and commercialization rights to CTP-656 and other assets related to the treatment of cystic fibrosis. CTP-656 is an investigational cystic fibrosis transmembrane conductance regulator (CFTR) potentiator that has the potential to be used as part of future once-daily combination regimens of CFTR modulators that treat the underlying cause of cystic fibrosis. Concert is eligible to receive up to in additional milestones based on regulatory approval in the and reimbursement in the , or .
- Alopecia Areata Patient Focused Drug Development Meeting. In , the (FDA) hosted a patient-focused meeting for alopecia areata as part of its Patient-Focused Drug Development Initiative. The meeting's goal was to obtain patient input on the impact of alopecia areata, including on daily life, patient views and experiences regarding current treatments, and decision factors taken into account when selecting a treatment. The meeting materials are available on the FDA's website at: https://www.fda.gov/ ForIndustry/UserFees/ PrescriptionDrugUserFee/ ucm554443.htm
- Repayment of Venture Debt. In , Concert paid to in repayment of the Company's outstanding obligations under a Loan Agreement. All outstanding obligations under the Loan Agreement were paid in full, and the agreement has been terminated.
Third Quarter 2017 Financial Results
- Cash and Investments Position. Cash, cash equivalents and investments as of , totaled as compared to as of . Concert expects its cash, cash equivalents and investments as of to be sufficient to fund the Company into 2021.
- Revenues. Revenue was for the quarter ended , compared to for the corresponding quarter in 2016. The increase in revenue relates to the close of the CTP-656 asset purchase agreement with Vertex.
- R&D Expenses. Research and development expenses were for the quarter ended , compared to for the same period in 2016, a decrease of . The decrease was primarily due to the discontinuation of development related to CTP-656 resulting from the asset purchase agreement.
- G&A Expenses. General and administrative expenses were for the quarter ended , compared to for the same period in 2016, an increase of . The increase in general and administrative expenses was primarily related to an increase in stock compensation, professional and legal fees in connection with the CTP-656 asset purchase agreement and intellectual property matters related to CTP-543.
- Net Income (Loss). For the quarter ended , net income was , or per share, as compared to a net loss of , or per share for the quarter ended .
Concert Pharmaceuticals is a clinical stage biopharmaceutical company focused on applying its DCE Platform® (deuterated chemical entity platform) to create novel medicines designed to address unmet patient needs. The Company's approach starts with approved drugs in which deuterium substitution has the potential to enhance clinical safety, tolerability or efficacy. Concert has a broad pipeline of innovative medicines targeting autoimmune and inflammatory diseases and central nervous systems (CNS) disorders. For more information please visit www.concertpharma.com.