On November 7, 2017 ChemoCentryx, Inc., (Nasdaq:CCXI), a biopharmaceutical company developing new medications targeted at inflammatory and autoimmune diseases and cancer, reported financial results for the third quarter ended September 30, 2017 (Press release, ChemoCentryx, NOV 7, 2017, View Source [SID1234521673]).
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"Our pursuit of new and better medicines for people with orphan diseases has been relentless," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "Dedicated to creating value for patients and shareholders alike, we at CCXI started with basic science in the discovery of novel molecules that selectively inhibit chemoattractant receptors, which are the molecular guidance systems of destructive inflammatory cells involved in a wide range of diseases and conditions. Now we have advanced two of those novel molecules, avacopan and CCX140, well into late-stage clinical trials. In doing so, we move closer to the next phase of value creation – the potential commercialization of our targeted medicines to help those suffering from serious renal diseases."
Recent Highlights
ChemoCentryx’s Phase III ADVOCATE trial of avacopan for the treatment of ANCA-associated vasculitis has surpassed 30 percent of its target patient enrollment with more than 185 sites activated. The trial will test the safety and efficacy of avacopan following 12 months of treatment and will include approximately 300 patients. 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.
ChemoCentryx recently received orphan designation in Switzerland from SwissMedic for avacopan for the treatment of two forms of ANCA-vasculitis: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener’s granulomatosis). This designation is in addition to the previously received orphan designations from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for avacopan to treat ANCA-vasculitis.
ChemoCentryx recently launched a registration-supporting clinical trial to study avacopan in a second indication, C3 Glomerulopathy (C3G), a rare disorder that often affects the young, requiring dialysis and often kidney transplant. Sites have been activated for the trial and patient enrollment has begun. Earlier this year ChemoCentryx announced that it had received both EMA orphan medicinal product designation and FDA orphan drug designation for avacopan in the treatment of C3G.
ChemoCentryx is launching a third registration-supporting trial, involving its CCR2 inhibitor, CCX140, to treat the debilitating kidney disorder known as Focal Segmental Glomerulosclerosis (FSGS), for which there is no approved treatment option. The Company plans to launch a trial in the fourth quarter of 2017.
Third Quarter 2017 Financial Results
Pro forma cash, cash equivalents, investments and remaining upfront commitments totaled $154.8 million at September 30, 2017.
Revenue was $9.0 million for the third quarter, compared to $4.1 million for the same period in 2016. The increase in revenue from 2016 to 2017 were 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 in 2017. These increases were partially offset by lower grant revenue from the FDA to support the clinical development of avacopan for the treatment of patients with ANCA vasculitis.
Research and development expenses were $12.3 million for the third quarter, compared to $8.4 million for the same period in 2016. The increase in research and development expenses from 2016 to 2017 was primarily attributable to the initiation and patient enrollment of the avacopan Phase III ADVOCATE trial in patients with ANCA vasculitis and start-up expenses for the Phase II clinical trial of avacopan for the treatment of C3G. These increases were partially offset by lower costs associated with the completion of the avacopan CLEAR and CLASSIC Phase II clinical trials for the treatment of ANCA vasculitis and enrollment completion of the CCX872 Phase I trial in patients with advanced pancreatic cancer in 2016.
General and administrative expenses were $3.6 million for the third quarter, compared to $3.2 million for the same period in 2016. The increase from 2016 to 2017 was primarily due to accounting related fees associated with preparing to meet the requirements pursuant to the Sarbanes-Oxley Act of 2002.
Net losses for the third quarter were $6.6 million, compared to $7.1 million for the same period in 2016.
Total shares outstanding at September 30, 2017 were approximately 48.8 million shares.
The Company expects to utilize cash and cash equivalents in the range of $50 million and $55 million in 2017, of which $39.0 million has been used for the nine months ended September 30, 2017.
Conference Call and Webcast
The Company will host a conference call and webcast today, November 7, 2017 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial 877-303-8028 (Domestic) or 760-536-5167 (International). The conference ID number is 7796287. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.