ChemoCentryx Reports First Quarter 2021 Financial Results and Recent Highlights
-- Applications for regulatory approval of avacopan in ANCA-associated vasculitis under review in
-- Novel orally administered checkpoint inhibitor CCX559 featured at
-- Other avacopan programs: severe Hidradenitis Suppurativa (HS) Phase III and Lupus Nephritis development initiation on track for 2H 2021 --
-- Conference call today at 5:00 p.m. Eastern Time --
"Momentum builds with each passing quarter, bringing us closer to our goal of bringing novel, precisely targeted medicine to those that need it most,” said
Key First Quarter 2021 Highlights and Recent Developments
- In April, the Company held an R&D Day which focused on avacopan in ANCA-associated vasculitis, with a patient describing his journey with the disease, and the Company’s novel checkpoint inhibitor CCX559.
- Two leading clinical experts on ANCA-associated vasculitis, Dr.
Peter Merkelfrom the University of Pennsylvaniaand Dr. David Jaynefrom the University of Cambridge, explained in detail the widespread effects of this devastating disease and the shortcomings of current therapy with glucocorticoids and other immunosuppressive drugs. Drs. Merkel and Jayne expressed their belief that avacopan could transform the treatment landscape for ANCA-associated vasculitis.
- The Company reported new data from the ADVOCATE trial, covering an 8 week period immediately following the 52-week endpoint. During this period from week 52 to week 60, there were 6 relapses out of 158 in the avacopan group and 7 relapses out of 157 in the prednisone group, suggesting a waning of efficacy after drug treatment is stopped. In addition, the estimated Glomerular Filtration Rate (eGFR), which had increased in the avacopan group through week 52, declined in the 8 weeks after patients stopped taking avacopan.
- Tausif “Tosh” Butt, who joined the Company in
February 2021as Executive Vice President and Chief Operating Officer, summarized the Company’s preparations and readiness for the anticipated commercial launch of avacopan shortly after its PDUFA goal date. He reported on primary market research that a survey of 125 rheumatologists and nephrologists indicated that 97% would prescribe avacopan upon FDA approval. The Company plans to focus initially on the estimated eight thousand patients who are newly diagnosed or relapsing with organ or life-threatening disease, out of an estimated eligible patient population for avacopan of twenty thousand patients.
- Two leading clinical experts on ANCA-associated vasculitis, Dr.
- CCX559 was featured in an abstract at the 2021 Annual Meeting of the
American Association for Cancer Research(AACR) in April. The abstract highlighted laboratory and in vivo data demonstrating potent PD-1/PD-L1 checkpoint inhibition. As a next generation therapy, small molecule inhibitors of PD-L1 may have advantageous properties compared to approved monoclonal antibodies, such as better penetration into solid tumors and reduced immunogenicity. The Company plans to initiate Phase I clinical development of CCX559 in Q2 2021.
- 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 same issue of NEJM featured an editorial entitled “Avacopan – Time to Replace Glucocorticoids?”.
- In February the Japanese New Drug Application for avacopan in the treatment of ANCA-associated vasculitis was accepted for review by the
Pharmaceuticals and Medical Devices Agency(PMDA), triggering a milestone payment of $10 millionto ChemoCentryxfrom its partner Vifor Pharma.
- The Company plans to advance avacopan into Phase III development in patients with Hurley Stage III (severe) HS in Q4 2021. In the Phase II AURORA trial, avacopan demonstrated a statistically significant higher response than placebo in Hurley Stage III patients.
- The Company plans to initiate clinical development of avacopan in patients with lupus nephritis in Q4 2021.
- The Company plans to schedule a meeting with the FDA to discuss evidence of clinical benefit from the ACCOLADE trial of avacopan in the very rare disorder C3 Glomerulopathy (C3G), for which there are no approved therapies. In the trial, avacopan demonstrated statistically significant improvement in renal function as measured by the pre-specified endpoint of eGFR and in the pre-specified secondary endpoint of C3G Histology Index (HI) Disease Chronicity score, compared to placebo over 26 weeks of blinded treatment, but did not achieve a statistically significant improvement in the primary endpoint of the C3G HI Disease Activity Score. Avacopan was safe and well tolerated in C3G patients.
- The Company maintained a strong balance sheet, with reported cash, cash equivalents and investments of
$424.2 millionat March 31, 2021.
First Quarter 2021 Financial Results
Research and development expenses were
General and administrative expenses were
Net loss for the first quarter of 2021 was
Total shares outstanding at
Cash, cash equivalents and investments totaled
Conference Call and Webcast
The Company will host a conference call and webcast today,
ChemoCentryx is a biopharmaceutical company developing new medications for inflammatory and autoimmune diseases and cancer. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally administered therapies. ChemoCentryx’s lead drug candidate, avacopan (CCX168), successfully completed a pivotal Phase III trial in ANCA-associated vasculitis and a New Drug Application is under review by the
ChemoCentryx also has early stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer.
Executive Vice President,
Chief Financial and Administrative Officer
|Condensed Consolidated Financial Statements Data|
|(in thousands, except per share data)|
|Three Months Ended|
|Condensed Consolidated Statements of Operations Data:|
|Collaboration and license revenue from related party||$||10,223||$||5,855|
|Research and development||23,418||19,311|
|General and administrative||16,262||8,820|
|Total operating expenses||39,680||28,131|
|Loss from operations||(29,327||)||(22,123||)|
|Other income (expense), net||(384||)||436|
|Basic and diluted net loss per common share||$||(0.43||)||$||(0.35||)|
|Shares used to compute basic and diluted net loss per common share||69,608||61,295|
|Condensed Consolidated Balance Sheets Data:|
|Cash, cash equivalents and investments||$||424,159||$||460,370|
|Long-term debt, net||24,475||24,401|
|Total stockholders’ equity||361,004||385,613|
Source: ChemoCentryx, Inc.