ChemoCentryx Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Highlights
-- Applications for regulatory approval of avacopan in ANCA-associated vasculitis under review in the
-- Topline data from AURORA Phase II clinical trial of avacopan in Hidradenitis Suppurativa (HS) leads to Company plans for Phase III trial of avacopan in patients with most severe form of HS --
-- Topline Results of ACCOLADE Phase II clinical trial of avacopan in C3 Glomerulopathy (C3G) include improved estimated Glomerular Filtration Rate (eGFR); Company plans to discuss evidence of clinical benefit with FDA --
-- Novel orally administered checkpoint inhibitor CCX559 expected to enter clinical development for next generation cancer treatment in H1 2021; avacopan study initiation for Lupus Nephritis in Q3 2021 --
-- Conference call today at 5:00 p.m. Eastern Time --
"Inexorably our march of progress advances, drummed on by the call to improve the lives of patients enduring diseases with grossly inadequate treatments,” said
Key Fourth Quarter 2020 Highlights and Recent Developments
- In February,
The New England Journal of Medicine(NEJM) published the results of the Company’s Phase III ADVOCATE trial of avacopan in ANCA-associated vasculitis, in which avacopan achieved statistical superiority in sustained remission at 52 weeks over prednisone containing standard of care.
- The article also reported additional benefits of avacopan including significantly lower risk of relapse, enhanced renal function, decreased toxicities related to glucocorticoids, and improved quality of life.
- The avacopan article was accompanied by an editorial in the NEJM entitled “Avacopan – Time to Replace Glucocorticoids?” By Dr.
Kenneth J. Warrington, Chair in the Division of Rheumatology, Department of Internal Medicineat Mayo Clinicin Rochester, Minn.
- In February, the Company announced the appointment of Tausif “Tosh” Butt as Executive Vice President, Chief Operating Officer.
Mr. Buttbrings more than 20 years of executive management expertise in roles including sales and marketing with global pharmaceutical companies such as AstraZeneca, GlaxoSmithKline and Sanofi.
- In December, the Company announced topline data from the ACCOLADE trial of avacopan for patients with the very rare disorder known as C3 Glomerulopathy (C3G). As in ANCA vasculitis, avacopan demonstrated statistically significant improvement in renal function as measured by the pre-specified endpoint of eGFR compared to placebo over 26 weeks of blinded treatment. While the change from baseline to Week 26 in C3 Glomerulopathy Histologic Index (C3G HI) Disease Activity score (primary endpoint) was improved with avacopan but not statistically different between the two treatment groups, the pre-specified secondary histology endpoint of C3G HI Disease Chronicity score (measuring progression of fibrosis) did demonstrate statistically significant benefit for avacopan over placebo. Avacopan was safe and well tolerated in C3G patients. Based on these data,
ChemoCentryxplans to discuss evidence of clinical benefit for avacopan in C3G, for which there are no approved therapies, with the FDA.
- The marketing authorization application for avacopan in the treatment of ANCA-associated vasculitis was validated by the
European Medicines Agency(EMA) in November, and very recently (February) the Japanese New Drug Application was accepted for review by the Pharmaceuticals and Medical Devices Agency(PMDA).
- In October,
ChemoCentryxreported topline data from AURORA, the randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial of avacopan for the treatment of Hidradenitis Suppurativa (HS) in patients with moderate or severe disease. Avacopan at 30 mg BID demonstrated a statistically significant higher response than placebo in the pre-specified Hurley Stage III (severe) HS patients and the Company plans to advance avacopan into Phase III development in this patient population.
- The Company remains on track to initiate Phase I clinical development of its orally administered checkpoint inhibitor, CCX559, for cancer in the first half of 2021, and a clinical study of avacopan in lupus nephritis in the third quarter of 2021.
- The Company maintained a strong balance sheet, with reported cash, cash equivalents and investments of
$460.4 millionat December 31, 2020.
Fourth Quarter and Full Year 2020 Financial Results
Research and development expenses were
General and administrative expenses were
Net loss for the fourth quarter of 2020 was
Total shares outstanding at
Cash, cash equivalents and investments totaled
Conference Call and Webcast
The Company will host a conference call and webcast today,
ChemoCentryx is a biopharmaceutical company developing new medications for inflammatory and autoimmune diseases and cancer. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally administered therapies. ChemoCentryx’s lead drug candidate, avacopan (CCX168), successfully completed a pivotal Phase III trial in ANCA-associated vasculitis and a New Drug Application is under review by the
ChemoCentryx also has early stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer.
Executive Vice President,
Chief Financial and Administrative Officer
|Condensed Consolidated Financial Statements Data|
|(in thousands, except per share data)|
|Three Months Ended||Twelve Months Ended|
|Condensed Consolidated Statements of Operations Data:|
|Collaboration and license revenue from related party||$||4,227||$||9,871||$||64,392||$||35,952|
|Research and development||21,227||19,202||77,882||70,276|
|General and administrative||12,712||6,968||42,186||24,155|
|Total operating expenses||33,939||26,170||120,068||94,431|
|Loss from operations||(29,581||)||(16,123||)||(55,177||)||(58,303||)|
|Other income (expense), net||(295||)||595||(179||)||2,814|
|Basic and diluted net loss per common share||$||(0.43||)||$||(0.26||)||$||(0.84||)||$||(0.98||)|
|Shares used to compute basic and diluted net loss per common share||69,253||58,938||65,688||56,898|
|Condensed Consolidated Balance Sheets Data:|
|Cash, cash equivalents and investments||$||460,370||$||202,240|
|Long-term debt, net||24,401||19,786|
|Total stockholders’ equity||385,613||66,000|
Source: ChemoCentryx, Inc.