On November 9, 2020 ChemoCentryx, Inc., (Nasdaq: CCXI), reported financial results for the third quarter ended September 30, 2020 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, NOV 9, 2020, View Source [SID1234570385]).

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"A powerful current of progress propels our enterprise, as exemplified by the recent FDA acceptance for review of our NDA for avacopan for the treatment of ANCA-associated vasculitis," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "We ready ourselves for the bright prospect of changing the treatment paradigm in ANCA vasculitis, while also pursuing the rest of our avacopan pipeline-in-a-drug strategy. To that end, we expect to announce topline data from avacopan in C3G by the end of this year, and we are also on track to start clinical development of avacopan in lupus nephritis and initiate a pivotal Phase III trial of avacopan in patients with severe hidradenitis suppurativa in 2021. Beyond that — let’s not forget — our orally-administered small molecule checkpoint inhibitor CCX559, designed to be a next generation cancer treatment, is also slated to enter the clinic in the first half of 2021."

Dr. Schall continued, "The marked progress that we have generated in recent quarters at ChemoCentryx continues to drive us toward our goal of becoming a fully-integrated company that provides new kinds of therapies for the most critical diseases. History shows that our unique discovery and development platform has generated not just avacopan but multiple drug candidates for the highest need indications. We will always follow where the science leads, continuing to focus on the areas of the greatest need and greatest promise for patients, and also with the greatest potential reward for our shareholders."

Key Highlights

In September, the FDA accepted for review the Company’s New Drug Application (NDA) for avacopan in the treatment of ANCA-associated vasculitis and set July 7, 2021 as the Prescription Drug User Fee Act (PDUFA) goal date. The NDA included data from the global, Phase III ADVOCATE trial.
In November, the Company’s Kidney Health Alliance partner Vifor Fresenius Medical Care Renal Pharma announced that their marketing authorization application (MAA) for avacopan in the treatment of ANCA-associated vasculitis has been validated by the European Medicines Agency (EMA). Approval is expected in the second half of 2021.
The results of the Phase III ADVOCATE trial of avacopan for the treatment of ANCA-Associated Vasculitis were shared in oral presentations at Kidney Week 2020, the annual meeting of the American Society of Nephrology (ASN), and ACR Convergence 2020, the annual meeting of the American College of Rheumatology (ACR).
In October, the Company announced topline data from the randomized, double-blind, placebo-controlled, multi-center Phase II AURORA clinical trial of avacopan for the treatment of the chronic disabling skin disease Hidradenitis Suppurativa (HS) in patients with moderate or severe disease. Avacopan at 30 mg BID demonstrated a statistically significant higher response than placebo in the pre-specified Hurley Stage III (severe) HS patients and the Company plans to advance avacopan into Phase III development for the treatment of severe HS.
The Company expects to announce topline data from the ACCOLADE trial of avacopan for patients with C3 Glomerulopathy (C3G) by year end 2020.
The Company remains on track to initiate clinical studies of avacopan in lupus nephritis and its orally administered checkpoint inhibitor, CCX559, for cancer in the first half of 2021.
Third Quarter 2020 Financial Results

Revenue was $5.1 million for the third quarter of 2020, compared to $10.6 million for the same period in 2019. Revenue is recognized based on actual costs incurred as a percentage of total budgeted costs as the Company completes its performance obligations under its alliance agreements. The decrease from 2019 to 2020 was primarily attributable to lower costs incurred in 2020 due to the completion of the avacopan ADVOCATE Phase III pivotal trial.

Research and development expenses were $18.6 million for the third quarter of 2020, compared to $18.1 million for the same period in 2019. The increase from 2019 to 2020 was primarily attributable to professional fees associated with the preparation of the NDA submission for avacopan for the treatment of ANCA vasculitis and higher research and drug discovery expenses, including those tied to the advancement of CCX559, the Company’s orally administered checkpoint inhibitor. These increases were partially offset by lower expenses due to the completion of the avacopan ADVOCATE Phase III pivotal trial and the CCX140 LUMINA-1 Phase II clinical trial in 2019.

General and administrative expenses were $10.4 million for the third quarter of 2020, compared to $6.1 million for the same period in 2019. The increase from 2019 to 2020 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 2020 was $24.1 million, compared to net loss of $12.9 million for the same period in 2019.

Total shares outstanding at September 30, 2020 were approximately 69.1 million shares.

Cash, cash equivalents and investments totaled $485.8 million at September 30, 2020 and the Company projects to end 2020 with cash and investments in excess of $460 million.

Conference Call and Webcast

The Company will host a conference call and webcast today, November 9, 2020 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 7147318. 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.