On May 9, 2018 ChemoCentryx, Inc., (Nasdaq:CCXI), reported financial results for the first quarter ended March 31, 2018 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, MAY 9, 2018, View Source [SID1234526364]).

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"Positive momentum continues to build throughout our product pipeline," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "A major goal is on the near horizon: the completion of patient enrollment in our global Phase III ADVOCATE pivotal trial of avacopan for the treatment of ANCA-associated vasculitis, while a second trial of avacopan in the orphan kidney disease of C3G is well underway. Standing also on the threshold of a new value-creating era, we intend to expand avacopan’s scope into orphan dermatological disease with the launch of clinical trials in HS in 2018. Advances continue with our CCR2 inhibitor CCX140, with trials launched in primary FSGS, a devastating disease with no approved therapies. With such progress continuing, we are laying the foundation for commercialization of these novel therapies in the U.S. in order to bring the benefits of our precision medicines to those enduring these serious diseases."

Recent Highlights

Patient enrollment in ChemoCentryx’s Phase III ADVOCATE pivotal trial of avacopan for the treatment of ANCA-associated vasculitis is nearing completion with over 85% of the 300 patient target enrolled to date. The trial will evaluate the safety and efficacy of avacopan following 52 weeks of treatment. The ADVOCATE trial is designed to show the effect of avacopan on improving active vasculitis, as well as testing durable clinical benefit, which is one of the major limitations of the current standard of care. The Company’s CMA application for avacopan for the treatment of ANCA-associated vasculitis is currently under review by the EMA.

ChemoCentryx has reached approximately 30% of the patient enrollment target in its clinical trial evaluating avacopan for C3G. 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.

In 2018, ChemoCentryx plans to launch clinical trials of avacopan in HS, an inflammatory and chronic skin disease characterized by recurrent, painful, boil-like nodules under the skin.

The Company’s CCR2 inhibitor CCX140 is currently being studied in two sub-populations of primary FSGS, an orphan kidney disease with no approved treatment option. One trial involves sub-nephrotic primary FSGS patients, whose disease cause is idiopathic; and the other trial is for primary FSGS patients with nephrotic syndrome, where reduction in proteinuria may constitute the registration endpoint. Further support of CCR2’s role in FSGS is highlighted in the peer reviewed findings published in March in the journal PLOS-ONE.
First Quarter 2018 Financial Results

Cash, cash equivalents and investments totaled $177.1 million at March 31, 2018.

Revenue was $9.5 million for the first quarter of 2018, compared to $8.2 million for 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. The increase from 2017 to 2018 was primarily due to the Company’s adoption of Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers effective January 1, 2018.

Research and development expenses were $14.7 million for the first quarter of 2018, compared to $10.0 million for the same period in 2017. The increase from 2017 to 2018 was primarily due to continued patient enrollment of the avacopan Phase III ADVOCATE pivotal trial in patients with ANCA-associated vasculitis and start-up expenses related to the CCX140 and avacopan Phase II clinical trials in patients with FSGS and C3G, respectively.

General and administrative expenses were $4.7 million for the first quarter of 2018, compared to $4.6 million for the same period in 2017. The increase from 2017 to 2018 was primarily due to higher employee-related expenses partially offset by a decrease in professional legal fees.

Net loss for the first quarter of 2018 was $9.4 million, compared to $6.0 million for the same period in 2017.

Total shares outstanding at March 31, 2018 were approximately 49.1 million shares.

The Company expects to utilize cash and investments between $65 million and $75 million for the twelve months ending December 31, 2018.

Conference Call and Webcast

The Company will host a conference call and webcast today, May 9, 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 2479786. 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.