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Clovis Reports Increased Q2 Net Loss, Spending with Advancing Personalized Cancer Drug Trials

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Originally published August 8.

NEW YORK (GenomeWeb) – Clovis Oncology this week reported that the company had incurred a net loss for the second quarter of $34.8 million, compared to $19.3 million in the second quarter of 2013.

The increased loss comes as the company has bolstered resources behind the development programs for several molecularly-characterized, investigational cancer agents, including rociletinib and rucaparib.

During the last quarter, R&D expenses totaled $28.4 million compared to $15.8 million from the year-ago quarter. The company attributed the nearly 80 percent increase in R&D spend to the launch of the ARIEL2 and ARIEL3 studies for rucaparib; the growth in the number of patients enrolled in the Phase I/II study for rociletinib; and the start of the TIGER2 and Japanese Phase I studies for rociletinib. Manufacturing clinical drug supplies for these trials and the additional personnel hired to support these activities also added to the costs.

Clovis is developing the PARP inhibitor rucaparib as a treatment for pancreatic and platinum-sensitive breast cancer. The firm recently announced that it had enrolled the first patient in the Phase II RUCAPANC study in BRCA-mutated pancreatic cancer. Meanwhile, in ARIEL2 and ARIEL3, Clovis is studying the drug in ovarian cancer. ARIEL2 will evaluate biomarkers for predicting ovarian cancer patients' responses to the treatment and ARIEL3 will test the drug's efficacy and safety further with the help of a companion test that picks out best responders.

"An additional charge for acquired in-process research and development expense of $0.4 million was recorded in the second quarter of 2014 related to the achievement of a Phase II milestone for rucaparib," the company said in a statement.

Rociletinib, or CO-1686, is an irreversible EGFR inhibitor that Clovis is advancing in non-small cell lung cancer patients with EGFR and T790M mutations. In June, the company said it had dosed the first patient in the TIGER2 Phase I/II study of the drug.

In the first quarter of 2014, Clovis received milestone revenue of $13.6 million due to a collaboration and license agreement for lucitanib, and recognized $8.4 million in R&D expenses associated with milestone payments incurred for rociletinib and lucitanib. Clovis will soon initiate a Phase II program to investigate lucitanib in treatment-refractory FGF-aberrant breast cancer and in patients with advanced squamous NSCLC with FGFR1 amplification. In another Phase II trial of lucitanib, researchers are hoping to identify advanced breast cancer patient populations most likely to benefit from treatment.

General and administrative expenses for the second quarter of 2014 were $5.3 million compared to $3.5 million for the second quarter in 2013. Operating expenses were $35 million, compared to $19 million from the year ago period, and net cash burn for the second quarter amounted to $30.4 million, up from $19.6 million in the first quarter of this year.

As of June 30, Clovis reported cash and cash equivalents of $273.2 million and 33.9 million outstanding shares of common stock.

“This is a very busy and exciting time at our company,” Clovis CEO Patrick Mahaffy said in a statement. The company, he said, is rapidly enrolling patients in the rociletinib Phase II expansion cohorts and TIGER2 studies, in an effort to submit an NDA by mid-2015. Additionally, the company is hoping to present data from the rucaparib ARIEL2 trial at an upcoming medical conference.

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