ChemoCentryx Reports Second Quarter 2020 Financial Results and Recent Highlights
-- Balance sheet bolstered with
-- Topline data from AURORA trial in Hidradenitis Suppurativa (HS) expected early Q4; C3 Glomerulopathy (C3G) ACCOLADE trial topline data YE 2020 --
-- Novel orally administered checkpoint inhibitor CCX559 for next generation cancer treatment to enter clinical development in H1 2021 --
-- Conference call today at 5:00 p.m. Eastern Time --
"A major milestone was accomplished recently with the filing of the NDA for avacopan for the treatment of ANCA-associated vasculitis with the
“We are also ever closer to realizing avacopan’s potential as a pipeline-in-a-drug with upcoming readouts in HS and C3G expected later this year. We will not stop there. The innovation seen in such new pipeline assets as CCX559, our novel orally administered checkpoint inhibitor for next generation cancer treatment, has real potential to fuel future growth and create significant value. I believe that we are poised to achieve our ultimate mission to be a fully integrated and self-sustaining enterprise that provides better therapies for previously neglected, underserved patient needs. And the
- Filed the New Drug Application (NDA) for avacopan in the treatment of ANCA-associated vasculitis in July. The Company’s NDA submission is supported by the results of its pivotal Phase III ADVOCATE trial, which demonstrated statistical superiority in sustaining remission at 52 weeks in the avacopan group compared to the prednisone group. In the trial, the avacopan group also showed significantly lower glucocorticoid toxicity, greater improvement in kidney function and greater improvement in health-related quality of life measures compared to the prednisone group. Finally, avacopan demonstrated favorable safety results in this serious and life-threatening disease, with fewer subjects having serious adverse events in the avacopan group than in the prednisone group.
- Presented additional data from the ADVOCATE trial were selected for oral plenary presentations in June at the leading European rheumatology and nephrology conferences: EULAR (European League Against Rheumatism) and ERA-EDTA (European Renal Association - European Dialysis and Transplant Association).
- Presented data at the
American Association for Cancer Research(AACR) meeting in June, demonstrating that the Company’s orally administered checkpoint inhibitors led to marked inhibition of PD-1/PD-L1 interaction and signaling in vitro and potent anti-tumor effects in animal models. The Company has identified its orally administered checkpoint inhibitor, CCX559, as a candidate for next generation cancer treatment and plans to initiate clinical studies in the first half of 2021.
- Completed enrollment in
May 2020of more than 400 patients in the Company’s AURORA Phase IIb clinical trial of avacopan for the treatment of the chronic disabling skin disease Hidradenitis Suppurativa (HS). Topline data from AURORA are now expected early in the fourth quarter of 2020, a modest delay caused by the resurgence of COVID-19 impacting certain sites where we have been conducting this trial.
- Strengthened the balance sheet with
$325.7 millionin net proceeds from a successful equity follow-on offering, including full exercise of the underwriters’ option to purchase additional shares. Proceeds from the offering will be used to support the anticipated commercial launch of avacopan in ANCA vasculitis; avacopan lifecycle management, including expansion into additional indications and formulation development; and development of additional drug candidates, including CCX559.
- Reported cash, cash equivalents and investments exceeded
$504.6 millionat June 30, 2020.
Second Quarter 2020 Financial Results
Research and development expenses were
General and administrative expenses were
Net income for the second quarter of 2020 was
Total shares outstanding at
Cash, cash equivalents and investments totaled
Conference Call and Webcast
The Company will host a conference call and webcast today,
ChemoCentryx is a biopharmaceutical company developing new medications targeted at inflammatory and autoimmune diseases and cancer. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally administered therapies. ChemoCentryx’s lead drug candidate, avacopan (CCX168), successfully completed a pivotal Phase III trial in ANCA-associated vasculitis.
ChemoCentryx also has early stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer.
Executive Vice President,
Chief Financial and Administrative Officer
|Condensed Consolidated Financial Statements Data|
|(in thousands, except per share data)|
|Three Months Ended||Six Months Ended|
|Condensed Consolidated Statements of Operations Data:|
|Collaboration and license revenue from related party||$||49,283||$||7,173||$||55,138||$||15,500|
|Research and development||18,762||17,624||38,073||32,978|
|General and administrative||10,292||5,570||19,112||11,071|
|Total operating expenses||29,054||23,194||57,185||44,049|
|Income (loss) from operations||20,386||(16,021||)||(1,737||)||(28,549||)|
|Total other income (loss), net||(119||)||871||317||1,450|
|Net income (loss)||$||20,267||$||(15,150||)||$||(1,420||)||$||(27,099||)|
|Net income (loss) per common share:|
|Shares used to compute net income (loss) per common share:|
|Condensed Consolidated Balance Sheets Data:|
|Cash, cash equivalents and investments||$||504,620||$||202,240|
|Long-term debt, net||24,252||19,786|
|Total stockholders’ equity||421,141||66,000|
Source: ChemoCentryx, Inc.