On November 8, 2018 ChemoCentryx, Inc., (Nasdaq:CCXI), reported financial results for the third quarter ended September 30, 2018 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, NOV 8, 2018, View Source [SID1234531155]).

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"We embark now upon exciting times. Looking forward to the coming year, we have set the stage for a sequence of key top-line data readouts from multiple clinical programs; readouts which could change the treatment landscape in woefully underserved orphan diseases," said Thomas J. Schall, Ph. D., President and Chief Executive Officer of ChemoCentryx. "We completed enrollment of our landmark ADVOCATE Phase III pivotal trial in ANCA-associated vasculitis in the third quarter, and plan to report top-line data in the fourth quarter of this coming year. We have clinical trials of avacopan in C3G and another unique asset, CCX140 in FSGS underway, and we stand on the brink of launching our definitive clinical trial of avacopan in Hidradenitis Suppurativa, our first foray into orphan dermatological disease. Our momentum grows ever stronger, enabled by a robust balance sheet that allows us to conduct multiple registration-supporting trials simultaneously."

Recent Highlights

Completed enrollment of the Company’s pivotal Phase III ADVOCATE trial of avacopan for the treatment of ANCA-associated vasculitis; top line data expected in the fourth quarter of 2019.

Submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the Phase IIb clinical development of avacopan in HS, a chronic and inflammatory skin disease. The Company expects to launch a comprehensive, randomized, double-blind, placebo-controlled clinical trial with avacopan in HS by the end of 2018. The study is expected to enroll approximately 390 patients with moderate to severe HS in the United States. The primary endpoint will be proportion of patients with a clinical response as assessed by the Hidradenitis Suppurativa Clinical Response (HiSCR) score compared to placebo after 12 weeks of treatment.

Advanced the Company’s clinical trial of avacopan in patients with C3 Glomerulopathy (C3G); enrollment now at 61% of the initial cohort of 44 patients; 35% of the expanded study targeting a combined 88 patients. C3G is a rare disorder that often affects the young, requiring dialysis and often kidney transplant with relapsing disease common. There is no approved effective treatment.

Received orphan drug designation from the FDA for CCR2 inhibitor CCX140 for the treatment of FSGS, a rare kidney disease. Clinical trials are underway in two FSGS sub-populations: nephrotic syndrome primary FSGS and sub-nephrotic primary FSGS.

Began active enrollment of patients with FSGS at multiple sites in the U.S. and Europe.

Presented at the American Society of Nephrology and American College of Rheumatology annual meetings on the avacopan ADVOCATE Phase III trial design and the potential new role of CCR2 in the treatment of FSGS with the first demonstration of CCR2 presence on renal progenitor cells destined to be podocytes.

Maintained a very strong balance sheet with reported cash and investments of approximately $186.0 million at September 30, 2018.

Third Quarter 2018 Financial Results

Cash and investments totaled approximately $186.0 million at September 30, 2018. ChemoCentryx was cash flow positive for the nine months ended September 30, 2018 (driven by cash receipts from milestone and upfront payments and credit facility advances), and reported a net increase of $50.8 million in cash and investments for period then ended. Excluding cash receipts from milestone and upfront payments and credit facility advances, the Company utilized cash and investments of approximately $40.7 million for the first nine months of the year and expects to end 2018 with approximately $170 million.

Revenue was $9.0 million for the third quarter of 2018, consistent with the same period in 2017. Revenue recognized represents amortization of the upfront license fee commitments, milestone payments and collaboration funding from Vifor pursuant to the Avacopan Agreement, Avacopan Amendment and CCX140 Agreement.

Research and development expenses were $15.1 million for the third quarter of 2018, compared to $12.3 million for the same period in 2017. The increase from 2017 to 2018 was primarily due to the advancement of the avacopan ADVOCATE Phase III pivotal trial which completed enrollment in July 2018.

General and administrative expenses were $5.4 million for the third quarter of 2018, compared to $3.6 million for the same period in 2017. The increase from 2017 to 2018 was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, and increased professional fees.

Net loss for the third quarter of 2018 was $10.9 million, compared to $6.6 million for the same period in 2017.

Total shares outstanding at September 30, 2018 were approximately 50.4 million shares.

Conference Call and Webcast

The Company will host a conference call and webcast today, November 8, 2018 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 4672117. 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.