ChemoCentryx Reports Fourth Quarter and Full Year 2018 Financial Results and Recent Highlights
-- Strong Progress Across Company’s Orphan Disease Franchise of Novel Renal and Dermal Therapeutics --
-- Pivotal top-line data expected from ADVOCATE Phase III trial of C5a receptor inhibitor avacopan in ANCA-associated vasculitis, Q4 --
-- Launched AURORA clinical trial of avacopan in Hidradenitis Suppurativa (HS) in
-- Marked momentum evident in enrollment of avacopan in C3 Glomerulopathy (C3G) trial, and with CCR2 inhibitor CCX140 in Focal Segmental Glomerulosclerosis (FSGS) --
-- Conference call today at 5:00 p.m. Eastern Time --
"We at CCXI marched through 2018, achieving essential objectives both tactical and strategic,” said
"But ADVOCATE was just the beginning of the pipeline in a drug strategy for avacopan. Another step was the launching in December of the AURORA trial of avacopan in hidradenitis suppurativa, a disfiguring and debilitating skin disorder. AURORA is a large, potentially registration-supporting clinical trial of avacopan, and we aim for top-line data as soon as mid-2020. The third step in the strategy is avacopan in C3 glomerulopathy. The C3G trial has shown strong enrollment trends; putting us again in a position to obtain top-line data for this devastating condition in 2020. Keen observers will be mindful that our renal orphan disease franchise has a second unique asset: the CCR2 inhibitor CCX140 for the treatment of focal segmental glomerulosclerosis in our LUMINA trials program.”
“CCXI’s financial position remains strong and provides us the financial foundation to run these trials simultaneously, and to achieve the data objectives outlined here. Our basic science and discovery platform continues to create value – identifying novel modes of action of our late stage pipeline assets avacopan and CCX140, while also moving toward additional, novel pipeline candidates in renal and dermal disease. For all of these reasons, I think this is one of the most exciting and most promising times in the history of the enterprise.”
- Launched the Company’s Phase IIb clinical trial of avacopan for the treatment of Hidradenitis Suppurativa (HS), called the AURORA trial. HS is a chronic disabling skin autoimmune disease characterized by recurrent, painful, nodules, boils and abscesses. A proof-of-concept study has demonstrated that HS is driven by neutrophils produced by C5a. The AURORA trial aims to enroll 390 patients with moderate to severe HS. The primary endpoint will assess avacopan against placebo at 12 weeks of treatment, using the HiSCR (hidradenitis suppurativa clinical response) scale, which has been validated by the
FDA. All groups will be followed for an additional 24 weeks. Secondary endpoints include percent improvement from baseline to week 12 between groups, validated secondary measurements and quality of life measured using the HS Quality of Life Instrument (HiSQOL) and SF36 health assessment.
- Advanced enrollment in the Company’s clinical trial of avacopan in patients with the kidney disease C3 Glomerulopathy (C3G). Enrollment in this randomized control trial of 88 C3G patients now approaches 50%. 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 for C3G.
- Reached a milestone in the Company’s clinical trials of CCX140 in two sub-populations of Focal Segmental Glomerulosclerosis (FSGS), a rare kidney disease: the LUMINA 1 trial, evaluating patients with sub-nephrotic primary FSGS, is over 50% enrolled. Enrollment in LUMINA 2, evaluating nephrotic syndrome primary FSGS, continues.
- Maintained a robust balance sheet, with reported cash and investments exceeding
$175 millionat December 31, 2018, excluding an additional cash raise of $20 millionin January 2019.
Fourth Quarter and Full Year 2018 Financial Results
Cash and investments totaled
Research and development expenses were
General and administrative expenses were
Net loss for the fourth quarter of 2018 was
Total shares outstanding at
The Company expects to utilize cash and investments in the range of
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. Avacopan is in Phase III development for the treatment of anti-neutrophil cytoplasmic auto-antibody-associated vasculitis (ANCA-associated Vasculitis). In clinical studies to date, avacopan was shown to be safe, well tolerated and provided effective control of the disease while allowing elimination of high-dose steroids, part of the current standard of care. ChemoCentryx is also developing avacopan for the treatment of patients with C3 glomerulopathy (C3G) and hidradenitis suppurativa (HS). The U.S. Food and Drug Administration has granted avacopan orphan-drug designation for ANCA-associated Vasculitis, C3G and atypical hemolytic uremic syndrome (aHUS). The European Commission has granted orphan medicinal product designation for avacopan for the treatment of two forms of ANCA-associated Vasculitis: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener's granulomatosis), as well as for C3G. Avacopan was also granted access to the European Medicines Agency's (EMA) PRIority MEdicines (PRIME) initiative, which supports accelerated assessment of investigational therapies addressing unmet medical need.
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 U.S. Food and Drug Administration has granted CCX140 orphan-drug designation for the treatment of FSGS.
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 clinical data might become available or be released, the rate at which enrollment in clinical trials may continue, whether avacopan and CCX140 will be commercialized, whether cash utilization projections for 2019 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||Twelve Months Ended|
|December 31,||December 31,|
|Condensed Consolidated Statements of Operations Data:|
|Collaboration and license revenue from related party||$||9,332||$||56,301||$||42,875||$||82,497|
|Research and development||15,100||12,881||62,736||49,495|
|General and administrative||5,628||4,128||20,409||16,509|
|Total operating expenses||20,728||17,009||83,145||66,004|
|Income (loss) from operations||(11,396||)||39,292||(40,270||)||16,493|
|Total other income, net||611||363||2,304||1,366|
|Net income (loss)||$||(10,785||)||$||39,655||$||(37,966||)||$||17,859|
|Net income (loss) per common share|
|Shares used to compute net income (loss) per common share|
|Condensed Consolidated Balance Sheets Data:|
|Cash, cash equivalents and investments||$||176,984||$||135,220|
|Accounts receivable from related party(1)||2,058||51,090|
|Long-term debt, net||19,689||4,676|
|Total stockholders’ equity||14,738||79,267|
|(1) December 31, 2017 accounts receivable excluded the remaining $10.0 million cash commitment for the Avacopan Amendment received from Vifor in February 2018.|
Source: ChemoCentryx, Inc.