On August 5, 2019 ChemoCentryx, Inc., (Nasdaq:CCXI), reported financial results for the second quarter ended June 30, 2019 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, AUG 5, 2019, View Source [SID1234538164]).

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"Strong momentum is with us as we move closer to our goal of releasing topline data from no fewer than five clinical trials over the next 18 months," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "First and foremost, we look forward to announcing topline results from the pivotal ADVOCATE Phase III trial of avacopan in ANCA-associated vasculitis in the fourth quarter of this year. The ADVOCATE trial is based on a wealth of data from well controlled pharmacological and clinical studies, including the successful multi-center, placebo controlled CLEAR and CLASSIC Phase II clinical trials. That foundation provides the basis for optimism that avacopan will provide much needed relief for ANCA patients."

"Recently we reached another milestone by completing patient enrollment in our LUMINA 1 trial of our second drug candidate, CCX140, in patients with primary FSGS, and we expect to release topline data in the first half of the coming year."

"Rounding out the pipeline readout roster through the coming year, our clinical trials of avacopan in C3 glomerulopathy and hidradenitis suppurativa, along with our LUMINA 2 trial of CCX140 in patients with nephrotic proteinuria primary FSGS, are also enrolling well. We expect to release top line data from these three clinical trials during the course of 2020."

"We continue to execute on our 2019 goals, fortified by our strong financial position. In short, we have the people, the assets, and the experience to deliver real value to investors and patients alike, as I believe this important time in our history will now begin to reveal."

Recent Highlights

Remained on track for Q4 topline data from the ADVOCATE global Phase III trial of avacopan in 331 patients with ANCA-associated Vasculitis.

Completed patient screening 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. The last patient is expected to be randomized in mid-August and top line data anticipated in the first half of 2020. The single-arm, open label LUMINA 2 study continues to enroll, evaluating CCX140 in patients with the rarer and more severe nephrotic proteinuria primary FSGS.

ACCOLADE Phase II clinical trial of avacopan in patients with the rare kidney disease C3 Glomerulopathy (C3G, a devastating and expensive kidney disease with no approved effective treatment), reached fifty percent in overall enrollment and nearly 100% in the first stratum of patients with high levels of activated complement in the blood.

Acceleration in site activation and patient enrollment in the Company’s AURORA Phase IIb clinical trial of avacopan for the treatment of the chronic disabling skin disease Hidradenitis Suppurativa (HS), with over 50% sites now activated and approximately 25% patients enrolled to date.

First Quarter 2019 Financial Results

Revenue was $7.2 million for the second quarter of 2019, compared to $15.0 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. The decrease from 2018 to 2019 was primarily due to a higher proportion of avacopan related costs relative to budgeted costs incurred in 2018.

Research and development expenses were $17.6 million for the second quarter of 2019, compared to $17.8 million for the same period in 2018. Expenses decreased in 2019 for the avacopan ADVOCATE Phase III pivotal trial as the study was fully enrolled in 2018, while Phase II clinical expenses increased primarily due 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.

General and administrative expenses were $5.6 million for the second quarter of 2019, compared to $4.7 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 second quarter of 2019 was $15.2 million, compared to $6.9 million for the same period in 2018.

Total shares outstanding at June 30, 2019 were approximately 58.2 million shares.

Cash, cash equivalents and investments totaled $223.1 million at June 30, 2019. The Company expects to utilize cash and investments in the range of $70.0 million to $80.0 million in 2019.

Conference Call and Webcast

The Company will host a conference call and webcast today, August 5, 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 7548439. 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.