- The DART clinical trial, an observational study designed to demonstrate the clinical performance characteristics of cell-free DNA (cfDNA) in detecting clinical and sub-clinical rejection in kidney allograft recipients, has enrolled more than 100 patients at 11 transplant centers.
CareDxremains on track to deliver an interim read-out in the first half of next year.
CareDx'sdonor-derived cfDNA (dd-cfDNA) assay was selected for a major National Institutes of Health(NIH) funded, multicenter study of clinical outcomes in kidney transplantation, called CTOT 19.
- Opened a dedicated
CLIAlab space for AlloSure, which will enable CareDxto test samples from kidney transplant patients across the US.
- Record volume of more than 3,400 AlloMap patient results provided, with a continued reimbursement rate of approximately 80% for all AlloMap results delivered through the 12 month period ended
March 31st, 2015.
- Announced new data related to the use of AlloMap® Score Variability (AMV) to predict the risk of future clinically significant events in heart transplant recipients, providing a new tool to facilitate improved patient management strategies.
- Brought AlloMap reimbursement billing process in house, reducing overall costs of the reimbursement effort and increasing effectiveness through direct control over the entire process.
"We made important progress in the third quarter on each of our three strategic objectives for 2015, including further development of cfDNA tests for transplantation, increasing patient adoption of AlloMap as a surveillance tool in heart transplantation, and pursuing inorganic growth opportunities. We continued to execute on the clinical development milestones we established earlier this year. This included our newly expanded lab space which will allow us to provide cfDNA results to transplant patients across the U.S.," said
Third Quarter Financial Results
Revenue for the three months ended
For the third quarter of 2015, net loss was
Basic and diluted net loss per share each were
Cash and cash equivalents were
Management will host a conference call today beginning at
A replay of the call will be available beginning
Forward Looking Statements
In addition to the historical information, this press release contains forward-looking statements with respect to our business, research, development and commercialization efforts and anticipated future financial results. These forward-looking statements are based upon information that is currently available to us and our current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including risks relating to our development and commercialization of additional diagnostic solutions, our dependence on the sales of one test, AlloMap, for substantially all of our current revenue, our dependence on
|Statements of Operations|
|(In thousands, except share and per share data)|
Three Months Ended
Nine Months Ended
|Collaboration and license revenue||144||53||349||209|
|Cost of testing||2,568||1,772||7,786||6,337|
|Research and development||2,698||1,036||6,629||2,548|
|Sales and marketing||2,062||1,753||6,453||4,837|
|General and administrative||3,361||1,976||8,553||6,087|
|Change in estimated fair value of contingent consideration||(345)||(1,276)||(456)||(1,276)|
|Total operating expenses||10,344||5,261||28,965||18,533|
|(Loss) income from operations||(3,193)||1,393||(7,469)||821|
|Interest expense, net||(251)||(535)||(1,334)||(1,727)|
|Other (expense) income, net||(45)||355||(142)||192|
|(Loss) income before income taxes||(3,489)||1,213||(8,945)||(714)|
|Income tax benefit||0||0||0||1,500|
|Net (loss) income||
|Net (loss) income per share:|
|Shares used to compute net (loss) income per share:|
|Cash and cash equivalents||
|Prepaid and other assets||960||542|
|Total current assets||37,969||40,346|
|Property and equipment, net||2,571||1,968|
|Intangible assets, net||6,650||6,650|
|Other noncurrent assets||0||25|
|Liabilities and stockholders' equity|
|Accrued payroll liabilities||2,192||1,684|
|Accrued and other liabilities||2,331||1,616|
|Current portion of long-term debt||3,594||5,961|
|Total current liabilities||10,454||11,135|
|Deferred rent, net of current portion||1,490||1,684|
|Deferred revenue, net of current portion||724||471|
|Long-term debt, net of current portion||12,125||5,451|
|Additional paid-in capital||202,213||200,661|
|Total stockholders' equity||33,903||41,298|
|Total liabilities and stockholders' equity||
CONTACT: Investor Relations Contact:
Westwicke Partners Leigh J. Salvo(415) 513-1281 Leigh.email@example.com
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