On August 9, 2021 ChemoCentryx, Inc., (Nasdaq: CCXI), reported financial results for the second quarter ended June 30, 2021 and provided an overview of recent corporate highlights (Press release, ChemoCentryx, AUG 9, 2021, View Source [SID1234586178]).

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"We appreciate the recent opportunity to provide the U.S. FDA with supplementary data and analyses to our NDA, which the Agency deemed to be a major amendment," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "We are looking forward to decisions later this year on regulatory submissions for avacopan in ANCA-associated vasculitis in the U.S. and abroad. Meanwhile, we are further developing our pipeline, as evidenced by the launch of a Phase I study with our novel orally-administered immune checkpoint inhibitor CCX559, which we hope will be part of a new era of precise cancer treatment. Further clinical work in other high need areas, such as the initiation of a Phase III trial of avacopan in patients with severe Hidradenitis Suppurativa, constitute important next steps in building the CCXI pipeline to benefit patients most in need."

Key Second Quarter 2021 Highlights and Recent Developments

In July the Company announced the filing of additional information to its NDA submission, which the FDA deemed to be a major amendment. The PDUFA review period for avacopan in the treatment of ANCA-associated vasculitis was extended, with a new PDUFA goal date of October 7, 2021. The Company’s filing followed the May 6 meeting of the FDA’s Arthritis Advisory Committee.
In Q2, the Company initiated Phase I clinical development of CCX559, a novel, orally-administered, PD-1/PD-L1 checkpoint inhibitor. CCX559 was featured in an abstract at the April 2021 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). As a next generation therapy, small molecule inhibitors may have advantageous properties compared to approved monoclonal antibodies, such as better penetration into solid tumors, reduced immunogenicity, lack of Fc-mediated side effects, and the convenience of oral administration.
The Company plans to meet with the FDA to discuss the Phase III development of avacopan in patients with Hurley Stage 3 (severe) Hidradenitis Suppurativa (HS) with the goal of initiating a Phase III clinical trial in those patients. In the Phase II AURORA trial, avacopan demonstrated a statistically significant higher response than placebo in a pre-specified subgroup of Hurley Stage 3 patients, which will further guide clinical development.
The Company plans to initiate clinical development of avacopan in patients with lupus nephritis in the first half of 2022.
The Company also plans to schedule a meeting later this year with the FDA to discuss evidence of clinical benefit from the ACCOLADE trial of avacopan in the very rare disorder C3 Glomerulopathy (C3G). There are no FDA approved therapies for this rare disorder. In the ACCOLADE trial, avacopan demonstrated statistically significant improvement in renal function as measured by pre-specified secondary endpoints of eGFR and also improvement in the pre-specified endpoint of C3G Histology Index (HI) Disease Chronicity score, compared to placebo over 26 weeks of blinded treatment, while not attaining a statistically significant improvement in the primary endpoint of the C3G HI Disease Activity Score. Avacopan was well tolerated in C3G patients.
The Company ended Q2 with cash, cash equivalents and investments of $402.6 million at June 30, 2021.
Second Quarter 2021 Financial Results

Revenue was $1.8 million for the second quarter of 2021, compared to $49.4 million for the same period in 2020. The decrease in revenue from 2020 to 2021 was principally attributable to the acceleration of revenue recognition in 2020 associated with the decision to discontinue development of CCX140 in Focal Segmental Glomerulosclerosis (FSGS).

Research and development expenses were $20.9 million for the second quarter of 2021, compared to $18.8 million for the same period in 2020. The increase from 2020 to 2021 was primarily attributable to the manufacture of commercial drug supply in anticipation of the launch of avacopan for the treatment of ANCA vasculitis and higher research and drug discovery expenses, including those associated with the development of CCX559, the Company’s orally-available small molecule checkpoint (PD-1/PD-L1) inhibitor. These increases were partially offset by lower Phase II related expenses due to the completion of the avacopan AURORA Phase IIb clinical trial in patients with HS and the discontinuation of further clinical development of CCX140 in FSGS in 2020.

General and administrative expenses were $19.7 million for the second quarter of 2021, compared to $10.3 million for the same period in 2020. The increase from 2020 to 2021 was primarily due to higher employee-related expenses, including those associated with the Company’s commercialization planning efforts, and higher professional fees.

Net loss for the second quarter of 2021 was $39.2 million, compared to net income of $20.3 million for the same period in 2020.

Total shares outstanding at June 30, 2021 were approximately 69.9 million shares.

Cash, cash equivalents and investments totaled $402.6 million at June 30, 2021.

Conference Call and Webcast

The Company will host a conference call and webcast today, August 9, 2021 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 2164528. 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 call.