Clovis Oncology reports net loss of $15.7 million for second quarter 2012

Clovis Oncology, Inc. (NASDAQ:CLVS) today reported financial results for the second quarter 2012, and provided an update on the progress of its clinical development programs and expected milestones for the rest of the year.    

"We had a productive second quarter and continued to make progress in each of our programs," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We are seeking to expand our pipeline through our collaboration with Array BioPharma for the discovery of a novel mutant KIT inhibitor; each of our three current clinical programs continues to advance, and most importantly, we remain on track to announce the results from our pivotal LEAP trial of CO-101 in metastatic pancreatic cancer during the fourth quarter this year."

2012 Financial Results and Outlook

Clovis reported a net loss of $15.7 million for the second quarter of 2012, and $34.7 million for the first half of 2012. This compares to a net loss of $18.5 million for the second quarter and $26.8 million for the first six months of 2011. Net loss attributable to common stockholders for the second quarter of 2012 was $0.61 per share and $1.45 per share for the year to date, compared to $14.32 per share for the second quarter and $21.07 per share for first six months of 2011.

Research and development expenses totaled $12.6 million for the second quarter and $25.2 million for first half of 2012, compared to $9.7 million for the second quarter and $16.7 million for the first six months of 2011. The increase in research and development expenses over the comparable periods in 2011 was driven by the in-licensing of rucaparib in June 2011, expanded development activities for CO-101 and an increase in internal resources to manage the Company's development programs.

General and administrative expenses totaled $2.7 million for the second quarter and $5.1 million for the first six months of 2012, compared to $1.7 million for the second quarter and $3.1 million for the first six months of 2011. The increase in general and administrative expenses over the comparable periods in 2011 was primarily due to increased internal resources and third party costs to support the activities associated with being a public company.

Operating expenses for the second quarter of 2012 include $1.2 million of stock compensation expense, compared to $0.3 million of stock compensation expense for the second quarter of 2011. Operating expenses for the first half of 2012 included $2.1 million of stock compensation expense, compared to $0.4 million of stock compensation expense for the first half of 2011.

As of June 30, 2012, Clovis had $176.9 million in cash and cash equivalents and 26.1 million outstanding shares of common stock. The Company continues to expect a cash burn of $67 to $72 million for 2012, and to end the year with approximately $140 million in cash.

Recent highlights for Clovis include the following:

• Initiated a Phase I study of CO-101, the Company's lipid drug conjugate of gemcitabine, in combination with cisplatin in non-small cell lung cancer (NSCLC);
• Continued enrollment in the dose escalation phase of the US/EU Phase I/II study of CO-1686, the Company's oral, targeted covalent inhibitor of epidermal growth factor receptor (EGFR) mutations currently being studied for the treatment of NSCLC;
• Signed a diagnostic collaboration with Foundation Medicine for the discovery of a companion diagnostic for rucaparib, the Company's oral, small molecule inhibitor of PARP (poly ADP-ribose polymerase) being explored for use in patients with tumors with defective BRCA function in ovarian and breast cancer;
• Continued enrollment in the dose escalation phase of the Phase I/II monotherapy study of rucaparib;
• Received Orphan Drug Designation for rucaparib from the U.S. Food and Drug Association (FDA) for the treatment of ovarian cancer;
• Announced an agreement with Array BioPharma to discover a novel KIT inhibitor targeting secondary mutations occurring in the majority of gastronintestinal stromal tumor (GIST) patients;

Importantly, the Company continues to expect to announce top-line overall survival results of the pivotal LEAP study of CO-101 in metastatic pancreatic cancer during the fourth quarter of 2012.