On March 10, 2020 ChemoCentryx, Inc., (Nasdaq: CCXI), reported financial results for the fourth quarter and full year ended December 31, 2019 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, MAR 10, 2020, View Source [SID1234555361]).

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"The power of data to transform the world was evident in the results of our Phase III ADVOCATE trial of avacopan in ANCA-associated vasculitis," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "The ADVOCATE data marked a critical turning point, in my view, in the treatment of this debilitating disease, with avacopan demonstrating superiority over the current standard of care which employs daily dosing of glucocorticoids. Those results transformed not just thousands of lives potentially, but changed the face of our enterprise as well. We intend to file an NDA for avacopan with the FDA by the middle of this year, and are laying the groundwork for US commercialization. Furthermore, the success of ADVOCATE not only validated the biology of C5a receptor inhibition by avacopan as a powerful therapy but it surpassed expectations and may open doors to additional renal disease opportunities in underserved indications such as lupus nephritis. The momentous readout in ADVOCATE now sets the stage for a data-rich 2020, during which we expect to share topline results from four additional ongoing clinical trials. An epochal year for CCXI was 2019, and we expect 2020 to be extraordinary as well."

Key Highlights

Exceeded expectations for avacopan with topline data from the ADVOCATE Phase III pivotal clinical trial announced in the fourth quarter of 2019, which demonstrated avacopan’s statistical superiority in sustaining remission at 52 weeks over the prednisone-containing standard-of-care, eliminating the need for daily noxious steroids. Avacopan was shown to lower all four aspects of the total burden of disease: stopping active vasculitis; significantly lowering current therapy-induced illness, with a statistically significant reduction in the Glucocorticoid Toxicity Index (GTI) and other accepted assessments of glucocorticoid toxicity; significantly improving kidney function as evidenced by a marked improvement in Estimated Glomerular Filtration Rate, or eGFR; and statistically significant improvements in quality of life, assessed by the SF-36 QOL instrument and the EuroQOL-5D-5L instrument (Visual Analogue Scale and EQ Index).

On track to announce topline data from the 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, in the second quarter of 2020. The single-arm, open label LUMINA-2 study continues to enroll, evaluating CCX140 in primary FSGS patients with the more severe nephrotic levels of proteinuria, and we expect to announce topline data by year-end 2020.

Advanced enrollment in our ACCOLADE Phase II clinical trial of avacopan in patients with the rare kidney disease C3 Glomerulopathy (C3G). C3G often afflicts the young, requiring dialysis and often kidney transplant with recurring disease common. There is no approved effective treatment for C3G. In 2019 we were awarded a two-year $1 million grant from the orphan drug office of the FDA to support advancement in the ongoing ACCOLADE trial. Topline data from ACCOLADE are expected in the second half of 2020.

Surpassed 90 percent target enrollment in our AURORA Phase IIb clinical trial of avacopan for the treatment of the chronic disabling skin disease Hidradenitis Suppurativa (HS). Topline data from AURORA are expected in the third quarter 2020.

Maintained a strong balance sheet, with reported cash and investments exceeding $202 million at December 31, 2019, and an additional credit facility of up to $100 million secured in January 2020.

Fourth Quarter and Full Year 2019 Financial Results

Cash and investments, totaled $202.2 million at December 31, 2019, excluding the credit facility of up to $100 million that was secured in January 2020.

Revenue was $10.0 million for the fourth quarter of 2019, compared to $9.3 million for the same period in 2018. For the full year ended December 31, 2019, revenue was $36.1 million, compared to $42.9 million for 2018. The quarterly increase in revenue from 2018 to 2019 was primarily due to the full enrollment of the CCX140 LUMINA-1 Phase II trial in patients with FSGS in 2019. Revenue in 2019 also included $176,000 of grant revenue from the FDA to support the clinical development of avacopan in patients with C3G.

Research and development expenses were $19.2 million for the fourth quarter of 2019, compared to $15.1 million for the same period in 2018. Full year 2019 research and development expenses were $70.3 million compared to $62.7 million in 2018. The increase in research and development expenses from 2018 to 2019 was primarily attributable to (i) an increase in Phase II clinical study expense driven by patient enrollment in the avacopan AURORA trial in patients with HS and the two CCX140 LUMINA trials in patients with FSGS, and (ii) an increase in Phase I clinical study expense due to the initiation of avacopan ancillary studies. These increases were partially offset by decreases in 2019 in research and drug discovery expenses and expenses for the avacopan ADVOCATE Phase III pivotal trial as the study was fully enrolled in 2018.

General and administrative expenses were $7.0 million for the fourth quarter of 2019, compared to $5.6 million for the same period in 2018. Full year 2019 general and administrative expenses were $24.2 million, compared to $20.4 million 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 fourth quarter of 2019 was $15.5 million, compared to net loss of $10.8 million for the same period in 2018. Full year 2019 net loss was $55.5 million, compared to net loss of $38.0 million in 2018.

Total shares outstanding at December 31, 2019 were approximately 60.2 million shares.

We expect to utilize cash and investments in the range of $85 million to $95 million in 2020.

Conference Call and Webcast

The Company will host a conference call and webcast today, March 10, 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 5494029. 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.