On November 4, 2019 ChemoCentryx, Inc., (Nasdaq:CCXI), reported financial results for the third quarter ended September 30, 2019 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, NOV 4, 2019, View Source [SID1234550227]).
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"Strong and swift is the pace of our progress as we eagerly anticipate topline data from our Phase III pivotal ADVOCATE trial of avacopan in ANCA vasculitis," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "At our recent R&D Day in New York the stage was set for the upcoming data, as our schedule featured two pre-eminent nephrologists as well as an ANCA vasculitis patient who highlighted the patient journey, the disease burden and the noxious consequences of chronic steroid use as part of the current standard-of-care. We provided a comprehensive overview of ANCA disease assessment and therapeutic improvement—ranging from the primary endpoints, BVAS remission at 26 and 52 weeks, to key secondary endpoints in the trial, as we aim to demonstrate a new way to treat this deadly disease."
"Furthermore, topline data from ADVOCATE is just the first in a cadence of five data readouts expected between now and the end of 2020. These readouts include those from the LUMINA-1 and LUMINA-2 trials of our CCR2 inhibitor, CCX140, in Focal Segmental Glomerulosclerosis (FSGS), the ACCOLADE trial of avacopan in C3 Glomerulopathy (C3G) and the AURORA trial of avacopan in Hidradenitis Suppurativa (HS). Our financial position is strong, enabling this historic period of data readouts. We look forward to a time soon where our innovations can be brought to the real service of our patients, to the aid of clinicians and to the benefit of those who have invested in this inventive enterprise."
Recent Highlights
Remained on track for mid-to-late Q4 topline data from the ADVOCATE global Phase III trial of avacopan in 331 patients with ANCA-associated vasculitis.
Completed enrollment in the Company’s LUMINA-1 Phase II randomized clinical trial of CCX140, an inhibitor of the chemokine receptor known as CCR2, in patients with sub-nephrotic primary Focal Segmental Glomerulosclerosis (FSGS), another rare kidney disease. Topline data is
anticipated in the first half of 2020. The single-arm, open label LUMINA-2 study continues to enroll, evaluating CCX140 in primary FSGS patients with the more severe nephrotic levels of proteinuria.
Awarded a two-year $1 million grant from the orphan drug office of the FDA to support advancement in the Company’s ACCOLADE Phase II clinical trial of avacopan in patients with the rare kidney disease C3 Glomerulopathy, a disease with no effective approved treatment. Approaching 60 percent enrollment in the ACCOLADE trial.
Attended Symposium on Hidradenitis Suppurativa Advances (SHSA), held November 1-3 in Detroit, Michigan. The Company’s AURORA Phase IIb clinical trial of avacopan for the treatment of the chronic disabling skin disease Hidradenitis Suppurativa (HS) is progressing well, with almost 80 percent of sites now activated and over 55 percent of patients enrolled to date.
Third Quarter 2019 Financial Results
Revenue was $10.6 million for the third quarter of 2019, compared to $9.0 million for the same period in 2018. Revenue is recognized based on the proportionate amount of costs incurred as a percentage of total budgeted costs to fulfill the performance obligations under the Company’s avacopan and CCX140 commercialization agreements with Vifor Pharma.
Research and development expenses were $18.1 million for the third quarter of 2019, compared to $15.1 million for the same period in 2018. The increase from 2018 to 2019 was primarily attributable to patient enrollment of the avacopan AURORA Phase II clinical trial in patients with HS and the two CCX140 LUMINA Phase II clinical trials in patients with FSGS, partially offset by decreases in research and drug discovery expenses.
General and administrative expenses were $6.1 million for the third quarter of 2019, compared to $5.4 million for the same period in 2018. The increase from 2018 to 2019 was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, and higher professional fees.
Net loss for the third quarter of 2019 was $12.9 million, compared to $10.9 million for the same period in 2018.
Total shares outstanding at September 30, 2019 were approximately 58.3 million shares.
Cash, cash equivalents and investments totaled $205.8 million at September 30, 2019. The Company expects to close 2019 with cash and investments in excess of $185 million.
Conference Call and Webcast
The Company will host a conference call and webcast today, November 4, 2019 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 5867903. 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.