On August 8, 2017 ChemoCentryx, Inc., (Nasdaq:CCXI), a biopharmaceutical company developing new medications targeted at inflammatory and autoimmune diseases and cancer, reported financial results for the second quarter ended June 30, 2017 (Press release, ChemoCentryx, AUG 8, 2017, View Source [SID1234520164]).
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"We’ve had a highly productive second quarter, activating many new sites in our avacopan Phase III ADVOCATE trial, which is producing a multiplier effect on patient enrollment," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "Now we are launching a clinical trial for avacopan in a second indication, C3G, executing on our ‘pipeline in a drug’ strategy. We are also working with regulatory authorities on the design of a third trial, involving our CCR2 inhibitor, CCX140, intended to support registration in patients with Focal Segmental Glomerulosclerosis (FSGS)."
Recent Highlights
ChemoCentryx’s Phase III ADVOCATE trial of avacopan (formerly CCX168) for the treatment of ANCA-associated vasculitis is gaining momentum, with 143 sites activated in 18 countries across the world. The trial will test the safety and efficacy of avacopan following 12 months of treatment and will include approximately 300 patients. Enrollment rates per activated sites are exceeding projections, and the trial is on track to complete enrollment by mid 2018. In addition to testing the effect of avacopan on improving active vasculitis, the ADVOCATE trial will also test the effect of avacopan on preventing a recurrence of vasculitis, one of the major limitations of the current standard of care for this disease.
In May 2017, ChemoCentryx announced that the European Medicines Agency granted orphan medicinal product designation for avacopan in the treatment of patients with C3G, which followed shortly after orphan drug designation was granted for avacopan in the treatment of C3G by the U.S. Food and Drug Administration. The Company is launching a registration-supporting trial of avacopan in C3G patients. There is currently no approved therapy for C3G.
In June 2017, ChemoCentryx announced program advances in two oral presentations that were given during the 54th European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Congress in Madrid, which highlighted an additional potential clinical indication for avacopan and the potential for CCR2 inhibition in FSGS. The Company plans to launch a registration-supporting trial of CCR2 inhibitor CCX140 in patients with FSGS later this year.
Second Quarter 2017 Financial Results
Pro forma cash, cash equivalents, investments and remaining upfront commitments totaled $166.7 million at June 30, 2017.
Revenue was $8.9 million for the second quarter, compared to $2.8 million for the same period in 2016. The increase in revenues from 2016 to 2017 was due to; (i) amortization of the upfront license fee commitments from Vifor pursuant to the avacopan and CCX140 agreements, as well as (ii) collaboration revenue for development services under the CCX140 agreement.
Research and development expenses were $14.3 million for the second quarter, compared to $9.1 million for the same period in 2016. The increase in research and development expenses from 2016 to 2017 was primarily attributable to higher Phase III development expenses due to the initiation of the avacopan Phase III ADVOCATE trial in patients with AAV in the fourth quarter of 2016 and start-up expenses related to the Phase II clinical trial of avacopan for the treatment of C3G. These increases were partially offset by decreases in (i) Phase I clinical development expense due to the completion of enrollment in the Phase I clinical trial for CCX872 in patients with advanced pancreatic cancer in 2016 and (ii) Phase II development expense due to the completion of the avacopan CLEAR and CLASSIC Phase II clinical trials for the treatment of AAV in 2016.
General and administrative expenses were $4.2 million for the second quarter, compared to $3.9 million for the same period in 2016. The increase from 2016 to 2017 was primarily due to higher intellectual property related expenses and accounting related fees associated with preparing to meet the requirements pursuant to the Sarbanes-Oxley Act of 2002.
Net losses for the second quarter were $9.2 million, compared to $10.0 million for the same period in 2016.
Total shares outstanding at June 30, 2017 were approximately 48.6 million shares.
The Company expects to utilize cash and cash equivalents in the range of $50 million and $55 million in 2017.