ChemoCentryx Reports First Quarter 2020 Financial Results and Recent Highlights
-- On track to file
-- Topline data from CCX140 LUMINA-1 Phase II clinical trial in Focal Segmental Glomerulosclerosis (FSGS) expected Q2 --
-- Completed enrollment of the AURORA clinical trial of avacopan in Hidradenitis Suppurativa (HS), with topline data expected Q3 --
-- ACCOLADE clinical trial of avacopan in C3 Glomerulopathy (C3G) on track to report topline data expected by year-end --
-- Conference call today at 5:00 p.m. Eastern Time --
"In the face of this global infection pandemic, we pause in sympathy for those suffering while we are reminded of the deep importance of our mission,” said
- On track to file the NDA for avacopan in the treatment of ANCA-associated vasculitis in mid-2020, following the ADVOCATE Phase III pivotal clinical trial, which demonstrated avacopan’s statistical superiority in sustaining remission at 52 weeks over the prednisone-containing standard-of-care.
- Fully-enrolled over 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 continue to be expected in the third quarter 2020.
- On track to report topline data from the LUMINA-1 Phase II randomized dose-ranging clinical trial of CCX140, an inhibitor of the chemokine receptor known as CCR2, in patients with sub-nephrotic primary FSGS, a rare kidney disease in the second quarter of 2020.
- Open-label LUMINA-2 study continues to enroll, evaluating CCX140 in patients with nephrotic syndrome primary FSGS (≥3 gram/day baseline proteinuria), the more severe and rarer form of the disease. Data from LUMINA-2 are expected in the second half of 2020.
- Strengthened the balance sheet with an additional credit facility of up to
$100 millionsecured in January 2020. Reported cash and investments exceeded $188 millionat March 31, 2020.
First Quarter 2020 Financial Results
Research and development expenses were
General and administrative expenses were
Net loss for the first 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 is currently focusing on its late stage drug candidates for patients with rare diseases, avacopan (CCX168) and CCX140.
Avacopan is an orally-administered small molecule that is a selective inhibitor of the complement C5a receptor, or C5aR. In the pivotal Phase III ADVOCATE trial, avacopan demonstrated the ability to induce vasculitis remission at 26 weeks and statistical superiority in sustaining vasculitis remission at 52 weeks. The topline safety results revealed an acceptable safety profile in this serious and life-threatening disease with fewer subjects having serious after events in the avacopan group than in the glucocorticoid-containing standard of care. ChemoCentryx is also developing avacopan for the treatment of patients with C3 glomerulopathy (C3G) and hidradenitis suppurativa (HS). The
The Company's other late stage drug candidate is CCX140, an inhibitor of the chemokine receptor known as CCR2, which is currently being developed for patients with focal segmental glomerulosclerosis (FSGS), a debilitating kidney disease. The
ChemoCentryx also has early stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer.
ChemoCentryx cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "may," "could," "will," "would," "should," "expect," "plan," "anticipate," "believe," "estimate," "intend," "predict," "seek," "contemplate," "potential," "continue" or "project" or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include the Company's statements regarding the achievement of anticipated goals and milestones, when the avacopan ANCA vasculitis NDA regulatory filing with the FDA will be submitted, whether such filing will be validated by the FDA, whether avacopan will receive marketing authorization by the FDA for the treatment of ANCA vasculitis, whether avacopan will be an effective treatment in other indications such as C3G or HS, whether CCX140 will advance to a registration trial for the treatment of FSGS, when full data analysis of LUMINA-1 and topline LUMINA-2, AURORA and ACCOLADE clinical data might become available or be released, whether CCX140 will be an effective treatment for FSGS, the rate at which enrollment in clinical trials may continue, whether avacopan and CCX140 will be commercialized, whether cash utilization projections for 2020 will fall within the projected range and whether the Company's drug candidates will be shown to be effective in ongoing or future clinical trials. The inclusion of forward-looking statements should not be regarded as a representation by ChemoCentryx that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in the
Executive Vice President,
Chief Financial and Administrative Officer
|Condensed Consolidated Financial Statements Data
|(in thousands, except per share data)
| Three Months Ended
| March 31,
|Condensed Consolidated Statements of Operations Data:|
|Collaboration and license revenue from related party||$||5,855||$||8,327|
|Research and development||19,311||15,354|
|General and administrative||8,820||5,501|
|Total operating expenses||28,131||20,855|
|Loss from operations||(22,123||)||(12,528||)|
|Total other income, net||436||579|
|Basic and diluted net loss per common share||$||(0.35||)||$||(0.23||)|
|Shares used to compute basic and diluted net loss per common share||61,295||52,395|
| March 31,
|| December 31,
|Condensed Consolidated Balance Sheets Data:|
|Cash, cash equivalents and investments||$||188,831||$||202,240|
|Long-term debt, net||24,178||19,786|
|Total stockholders’ equity||60,161||66,000|
Source: ChemoCentryx, Inc.