On May 3, 2017 CTI BioPharma Corp. (NASDAQ and MTA:CTIC) reported financial results for the first quarter ended March 31, 2017 (Press release, CTI BioPharma, MAY 3, 2017, View Source [SID1234518805]).
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Recent Highlights
In April 2017, CTI BioPharma announced the expansion of the existing license and development collaboration agreement with Servier for PIXUVRI (pixantrone). Under the expanded agreement, Servier will have rights to PIXUVRI in all markets except in the U.S. where CTI BioPharma will retain the commercialization rights. Servier will pay CTI BioPharma €12 million and is obligated to purchase a certain amount of PIXUVRI drug product for an additional €0.9 million. CTI BioPharma is eligible to receive €76 million in additional sales and regulatory milestone payments as well as royalties on net product sales.
In March 2017, Adam Craig, M.D., Ph.D., became President and CEO and as a Director of CTI BioPharma. Dr. Craig has over 20 years of experience in hematology, oncology and drug development in both the US and Europe. Dr. Craig has worked as an independent consultant providing strategic and operational advice and support to CTI BioPharma and other hematology/oncology biotechnology companies since 2016. Prior to consulting, Dr. Craig was Chief Medical Officer (CMO) and Executive Vice President of Development of Sunesis Pharmaceuticals from 2012 to 2016. From 2008 to 2012, Dr. Craig was CMO and Senior Vice President of Chemgenex Pharmaceuticals Ltd, a publicly-traded biotechnology company which was acquired by Cephalon/Teva Pharmaceuticals in 2011. Dr. Craig is a Member of the Royal College of Physicians (UK) and undertook Post-Graduate Training in Pediatrics and Pediatric Oncology.
“We have made excellent progress since the start of the year on the regulatory/clinical front and operationally. We plan to submit the Marketing Authorization Application for pacritinib to treat patients with myelofibrosis to the European Medicines Agency mid-year,” said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. “We are currently preparing to initiate this quarter the PAC203 dose exploration study that was requested by the FDA and would expect to have interim data by the end of 2017. We are also pleased to have recently expanded our partnership with Servier for commercialization of PIXUVRI in the E.U.”
First Quarter Financial Results
Total revenues for the first quarter ended March 31, 2017 were $0.8 million compared to $36.5 million for the same period in 2016. The decrease in total revenues for the first quarter of 2017 is primarily due to recognition of $32 million in milestone revenue related to pacritinib in the first quarter of 2016. Additionally, net product revenues of PIXUVRI for the first quarter of 2017 decreased to $0.7 million compared to $1.2 million for the same period in 2016.
GAAP operating loss for the first quarter of 2017, was $19.3 million compared to GAAP operating income of $4.1 million for the same period in 2016. Non-GAAP operating loss, which excludes non-cash share-based compensation expense, for the first quarter of 2017, was $17.5 million compared to the non-GAAP operating income of $8.0 million for the same period in 2016. The Company’s operating loss for the first quarter of 2017, as compared to an operating income for the same period in 2016, is primarily due to recognition of $32 million in milestone revenue related to pacritinib as mentioned above. Research and development expenses decreased to $9.3 million for the first quarter of 2017 compared to $20.8 million for the same period in 2016. The decrease was primarily attributable to reductions in costs related to pacritinib clinical development due to the timing of completion of the Phase 3 clinical trials. Additionally, the decrease was attributable to a decrease in personnel costs related to a reduction in average headcount between periods and reductions in costs for PIXUVRI clinical development and pacritinib manufacturing. Non-cash share-based compensation expense for the first quarter of 2017, was $1.8 million compared to $3.8 million for the same period in 2016. For information on CTI BioPharma’s use of this non-GAAP measure and a reconciliation of such measure to GAAP operating loss, see the section below entitled “Non-GAAP Financial Measures.”
Net loss for the first quarter of 2017 was $19.8 million, or ($0.71) per share, compared to a net income of $3.3 million, or $0.12 per share, for the same period in 2016.
As of March 31, 2017, cash and cash equivalents totaled $33.3 million, compared to $44.0 million as of December 31, 2016.