On May 6, 2019 ChemoCentryx, Inc., (Nasdaq:CCXI), reported financial results for the first quarter ended March 31, 2019 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, MAY 6, 2019, View Source [SID1234535746]).
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"Achieving our ambitious objectives for 2019 is on track," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "Strong positive momentum continues from 2018, and we are working toward the Q4 release of topline results from our pivotal ADVOCATE Phase III trial of avacopan in ANCA-associated Vasculitis. We are making steady progress in our other late-stage trials as well."
"Our AURORA trial of avacopan in hidradenitis suppurativa, a disfiguring skin disorder, represents a particularly large opportunity for us. We are aiming for topline data in this potentially registration-supporting trial in 2020. The HS community has made it abundantly clear: patient interest is intense in an orally-administered long-lasting treatment option."
"We continue our march of progress: being now another quarter closer to realizing our goal of delivering a succession of topline data, starting this year, from late-stage clinical trials. Our financial position is robust: we strengthened the balance sheet with an additional $73.3 million in net proceeds from the issuance of our common stock during the quarter, and expanded our shareholder base with top-tier institutions, reflecting the increasing enthusiasm about the prospects of our innovative pipeline."
Recent Highlights
On track for Q4 topline data from the ADVOCATE Phase III trial of avacopan in ANCA-associated Vasculitis, now including all patients from the Japan cohort of patients for a total of 331 patients in the global study.
Accelerated activation of clinical sites and convened an investigators meeting in April for the Company’s Phase IIb AURORA clinical trial of avacopan for the treatment of Hidradenitis Suppurativa (HS). HS is a chronic disabling skin autoimmune disease characterized by recurrent, painful, nodules, boils and abscesses. The AURORA trial aims to enroll 390 patients with moderate to severe HS.
Surpassed 70 percent enrollment in the Company’s LUMINA 1 clinical trial of CCX140 in patients with sub-nephrotic primary Focal Segmental Glomerulosclerosis (FSGS), another rare kidney disease; the LUMINA 2 trial, evaluating CCX140 in nephrotic syndrome primary FSGS, continues to enroll.
Advanced enrollment in the Company’s randomized controlled clinical trial of avacopan in patients with the kidney disease C3 Glomerulopathy (C3G) to approximately 50 percent. C3G is a rare disorder that often affects the young, requiring dialysis and often kidney transplant, with recurring disease common. There is no approved effective treatment.
Strengthened the balance sheet with an additional $73.3 million in net proceeds from the issuance of common stock during the first quarter, with reported cash and investments totaling $234.1 million at March 31, 2019.
First Quarter 2019 Financial Results
Revenue was $8.3 million for the first quarter of 2019, compared to $9.5 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 obligation. As such, the decrease in revenue from 2018 to 2019 was primarily due to lower actual costs incurred in 2019 related to the our avacopan collaboration and license agreement, partially offset by a higher actual cost incurred in 2019 related to our CCX140 collaboration and license agreement.
Research and development expenses were $15.4 million for the first quarter of 2019, compared to $14.7 million for the same period in 2018. The increase from 2018 to 2019 was primarily due to the initiation and patient enrollment of the avacopan Phase IIb clinical trial in patients with HS and the CCX140 Phase II clinical trials in patients with FSGS. These increases were partially offset by a decrease in the avacopan ADVOCATE Phase III pivotal trial expenses as the study was fully enrolled in the second half of 2018.
General and administrative expenses were $5.5 million for the first 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 first quarter of 2019 was $11.9 million, compared to $9.4 million for the same period in 2018.
Total shares outstanding at March 31, 2019 were approximately 57.7 million shares.
Cash, cash equivalents and investments totaled $234.1 million at March 31, 2019. The Company expects to utilize cash and investments in the range of $75.0 million to $85.0 million in 2019.
Conference Call and Webcast
The Company will host a conference call and webcast today, May 6, 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 4968809. 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.