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- Completed enrollment in the European Vasculitis Phase II CLEAR trial of C5aR inhibitor CCX168; top line data expected by year-end 2015 -
- North American Vasculitis Phase II CLASSIC trial of CCX168 reaches halfway mark in target patient enrollment -
- Initiated Phase II proof-of-concept trial in atypical hemolytic uremic syndrome with CCX168 -
- Pancreatic cancer proof-of-concept trial with CCX872 progressing -
- Conference Call Today at 5:00 p.m. Eastern Time -
MOUNTAIN VIEW, Calif., Aug. 6, 2015 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, today reported financial results for the second quarter ended June 30, 2015 and provided an update on the Company's corporate and clinical development activities.
"We continued to execute on all of our planned initiatives during the quarter and remain on track to deliver on several key milestones during 2015. We are particularly excited about the progress in our orphan and rare diseases program with our lead drug candidate, CCX168," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "Both the CLEAR and CLASSIC Phase II trials of CCX168 in patients with ANCA-associated vasculitis reached significant enrollment milestones, and we also initiated an important proof-of-concept trial in patients with atypical Hemolytic Uremic Syndrome. Further, in the immuno-oncology area, we have completed the first part of a two-part clinical trial of CCX872 in patients with advanced pancreatic cancer and we look forward to reporting early results from this trial by year-end."
Recent Pipeline Developments Across Key Therapeutic Areas
Orphan and Rare Diseases: CCX168 is one of the Company's lead drug candidates. It is an orally-administered inhibitor of the complement C5a receptor (C5aR), and is being developed for several rare disease indications, including ANCA-associated vasculitis (AAV) and atypical Hemolytic Uremic Syndrome (aHUS). These are severe and often fatal autoimmune diseases that are characterized by inflammation that can negatively affect many different areas of the body.
Chronic Kidney Disease: CCX140, an inhibitor of the chemokine receptor known as CCR2 and one of the Company's lead drug candidates, is being developed as an orally administered therapy for the treatment of diabetic nephropathy, a form of chronic kidney disease.
Immuno-Oncology: CCX872, a potent and selective inhibitor of the chemokine receptor known as CCR2, is being evaluated in patients with non-resectable pancreatic cancer.
Orphan and Rare Diseases:
Chronic Kidney Disease:
Second Quarter 2015 Financial Results
Research and development expenses were $8.6 million for the three months ended June 30, 2015 compared to $9.0 million reported for the same period in 2014. The decrease in research and development expenses from 2014 to 2015 were primarily attributable to lower expenses associated with CCX140, the Company's CCR2 inhibitor, due to the completion of the Phase II clinical trial in patients with diabetic nephropathy in the fourth quarter of 2014 and CCX507, the Company's second generation CCR9 inhibitor, due to the completion of Phase I clinical development in the third quarter of 2014. These decreases were partially offset by higher expenses associated with CCX168, the Company's C5aR inhibitor, due to continuing patient enrollment in the third and final step of the CLEAR Phase II clinical trial in Europe and the CLASSIC Phase II clinical trial in North America for the treatment of AAV. Further, the commencement of enrollment in Phase II proof of concept clinical trials in patients with Immunoglobulin A nephropathy, or IgAN and aHUS and costs associated with initiating a Phase Ib clinical trial with CCX872, the Company's second generation CCR2 inhibitor, in patients with pancreatic cancer in the second quarter of 2015 contributed to the increase.
General and administrative expenses were $3.6 million for the three months ended June 30, 2015 compared to $3.4 million for the comparable period in 2014. The increase in general and administrative expenses from 2014 to 2015 was primarily due to increases in stock based compensation expense for stock option grants and restricted stock unit awards and professional service expenses.
Net loss was $12.1 million for the second quarter ended June 30, 2015 compared to $12.3 million in the same period in 2014.
Total shares outstanding at June 30, 2015 were approximately 44.1 million shares.
Cash, cash equivalents and investments totaled $94.2 million at June 30, 2015.
Conference Call and Webcast
The Company will host a conference call and webcast today, August 6, 2015, at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial 877-303-8028 (Domestic) or 760-536-5167 (International). The conference ID number is 90824990. A live and archived audio webcast can be accessed through the Investors section of the Company's website at www.ChemoCentryx.com. The archived webcast will remain available on the Company's website for fourteen (14) days following the conference call.
ChemoCentryx, Inc. is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing orally-administered therapeutics that target the chemokine and chemoattractant systems in order to treat autoimmune diseases, inflammatory disorders and cancer. The chemokine system is a biological network that regulates inflammation via a collection of secreted chemokine molecules, or ligands, and their specific cell surface receptors. Based on its proprietary drug discovery and drug development platform, ChemoCentryx has generated multiple clinical and preclinical-stage programs, each targeting distinct chemokine and chemoattractant receptors with different small molecule compounds. CCX140, a CCR2 inhibitor, successfully completed a Phase II clinical trial where it was shown to be safe and well tolerated while demonstrating statistically significant improvements in kidney function in patients with diabetic nephropathy. CCX168, a C5aR inhibitor, is in Phase II development for the treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV). CCX168 appears to be safe, well tolerated and successful in allowing both reduction and elimination of high-dose corticosteroids, part of standard of care for AAV patients, without compromising efficacy or safety during a 12-week treatment period. CCX168 is also in Phase II pilot studies for the treatment of atypical Hemolytic Uremic Syndrome (aHUS) and Immunoglobulin A nephropathy, or IgA nephropathy (IgAN). CCX872, a second CCR2 inhibitor, successfully completed Phase I development and is in development for the treatment of non-resectable pancreatic cancer. Vercirnon (also known as Traficet-EN or CCX282) is a specific CCR9 inhibitor for the treatment of inflammatory bowel disease. Other clinical programs include CCX507, a next generation CCR9 inhibitor, which has successfully completed Phase I development and CCX354, a CCR1 inhibitor which successfully completed a Phase II clinical trial for the treatment of rheumatoid arthritis. ChemoCentryx also has several programs in advanced preclinical development.
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 milestones in 2015 and 2016 or whether the Company's product 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 March 13, 2015 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.
Source: ChemoCentryx, Inc.
|Consolidated Statement of Operations Data|
|(in thousands, except per share data)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Consolidated Statement of Operations Data:|
|Research and development||8,602||9,002||17,022||17,151|
|General and administrative||3,576||3,382||7,265||6,905|
|Total operating expenses||12,178||12,384||24,287||24,056|
|Loss from operations||(12,178)||(12,384)||(24,287)||(24,056)|
|Net loss||$ (12,078)||$ (12,261)||$ (24,084)||$ (23,798)|
|Basic and diluted net loss per share||$ (0.28)||$ (0.28)||$ (0.55)||$ (0.55)|
|Shares used to compute basic and diluted net loss per share||43,842||43,274||43,672||43,191|
|June 30,||December 31,|
|Consolidated Balance Sheet Data|
|Cash, cash equivalents and investments||$ 94,171||$ 114,620|
|Total stockholders' equity||90,905||108,606|
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