ChemoCentryx Reports Second Quarter 2017 Financial Results and Recent Highlights
-- Pivotal Phase III ADVOCATE trial of avacopan on track to complete enrollment in mid-2018 as projected --
-- Launching second trial of avacopan in patients with C3 Glomerulopathy (C3G) --
-- Conference call today at
"We've had a highly productive second quarter, activating many new sites in our avacopan Phase III ADVOCATE trial, which is producing a multiplier effect on patient enrollment," said
- ChemoCentryx's Phase III ADVOCATE trial of avacopan (formerly CCX168) for the treatment of ANCA-associated vasculitis is gaining momentum, with 143 sites activated in 18 countries across the world. The trial will test the safety and efficacy of avacopan following 12 months of treatment and will include approximately 300 patients. Enrollment rates per
activated sites are exceeding projections, and the trial is on track to complete enrollment by mid 2018. In addition to testing the effect of avacopan on improving active vasculitis, the ADVOCATE trial will also test the effect of avacopan on preventing a recurrence of vasculitis, one of the major limitations of the current standard of care for this disease.
May 2017, ChemoCentryxannounced that the European Medicines Agencygranted orphan medicinal product designation for avacopan in the treatment of patients with C3G, which followed shortly after orphan drug designation was granted for avacopan in the treatment of C3G by the U.S. Food and Drug Administration. The Company is launching a registration-supporting trial of avacopan in C3G patients. There is currently no approved therapy for C3G.
June 2017, ChemoCentryxannounced program advances in two oral presentations that were given during the 54th European Renal Association- European Dialysis and Transplant Association (ERA-EDTA) Congressin Madrid, which highlighted an additional potential clinical indication for avacopan and the potential for CCR2 inhibition in FSGS. The Company plans to launch a registration-supporting trial of CCR2 inhibitor CCX140 in patients with FSGS later this year.
Second Quarter 2017 Financial Results
Pro forma cash, cash equivalents, investments and remaining
upfront commitments totaled
Research and development expenses were
General and administrative expenses were
losses for the second quarter were
Total shares outstanding at
The Company expects to utilize cash and cash equivalents in the range of
Conference Call and Webcast
The Company will host a conference call and webcast today,
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 (AAV). 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. Avacopan is also being developed in patients with C3 glomerulopathy (C3G) and atypical hemolytic uremic syndrome (aHUS). The U.S. Food and Drug Administration has granted avacopan orphan-drug designation for AAV, C3G and aHUS. The European Medicines Agency (EMA) has granted orphan medicinal product designation for avacopan for the treatment of two forms of AAV: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener's granulomatosis), as well as for C3G. Avacopan was also granted access to the EMA's 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.
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 timing of potential clinical trials, anticipated enrollment in clinical trials, whether the next clinical studies with avacopan in C3G and with CCX140 in FSGS will serve as registration-supporting trials, the Company's expectations regarding its utilization of cash and cash equivalents 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 ChemoCentryx business and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"). Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and ChemoCentryx undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading "Risk Factors" in ChemoCentryx's periodic reports filed with the SEC, including ChemoCentryx's Annual Report on Form 10-K filed with the SEC on March 14, 2017 and its other reports which are available from the SEC's website (www.sec.gov) and on ChemoCentryx's website (www.chemocentryx.com) under the heading "Investors." All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
|Consolidated Statement of Operations Data|
|(in thousands, except per share data)|
|Three Months Ended||Six Months Ended|
|Consolidated Statement of Operations Data:|
|Collaboration and license revenue||$||8,937||$||2,620||$||17,167||$||2,620|
|Research and development||14,329||9,062||24,299||20,307|
|General and administrative||4,184||3,877||8,757||7,961|
|Total operating expenses||18,513||12,939||33,056||28,268|
|Loss from operations||(9,576||)||(10,144||)||(15,889||)||(25,473||)|
|Basic and diluted net loss per share||$||(0.19||)||$||(0.22||)||$||(0.32||)||$||(0.56||)|
|Shares used to compute basic and diluted |
net loss per share
|Consolidated Balance Sheet Data|
|Cash, cash equivalents and investments (1)||$||136,644||$||123,761|
|Accounts receivable (1)||218||30,205|
|Total stockholders' equity||40,915||49,889|
(1) Cash, cash equivalents and investments and accounts receivable exclude the remaining
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