On May 3, 2018 CTI BioPharma Corp. (NASDAQ:CTIC) reported financial results for the first quarter ended March 31, 2018 (Press release, CTI BioPharma, MAY 3, 2018, View Source;p=RssLanding&cat=news&id=2346898 [SID1234526065]).
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In March 2018, results from the Phase 3 PERSIST-2 clinical trial of pacritinib were published online in JAMA Oncology. The randomized, international, multicenter study compared the efficacy and safety of pacritinib at two dose levels, compared with best available therapy, which included ruxolitinib (a JAK1/JAK2 inhibitor), in patients with myelofibrosis and thrombocytopenia (defined as platelet counts ≤100 x 109/L).
Upcoming Milestones
In the second quarter of 2018, the interim analysis of the PAC203 study of pacritinib in patients with myelofibrosis will be conducted by an Independent Data Monitoring Committee. Full top-line data from the study is expected in the first quarter of 2019.
The Company expects to submit responses to the Day 120 List of Questions to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in May 2018.
Top-line results of the PIX306 Phase 3 trial of PIXUVRI in patients with aggressive B-cell or grade 3 follicular Non-Hodgkins Lymphoma are event-driven and are expected in the third quarter of 2018.
"We look forward to several important milestones over the next months, as we continue to make progress in the clinical development of pacritinib and PIXUVRI," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "We also significantly strengthened our cash position during the first quarter of 2018, which will carry us through key clinical and regulatory milestones into 2020."
First Quarter Financial Results
Total revenues for the first quarter ended March 31, 2018 were $10.5 million compared to $0.8 million for the same period in 2017. The increase in total revenues was primarily due to recognition of $10.0 million in milestone revenue from Teva Pharmaceutical Industries Ltd. related to the achievement of a milestone for FDA approval of TRISENOX for first line treatment of acute promyelocytic leukemia. We had no net product revenues of PIXUVRI for the first quarter of 2018 compared to $0.6 million for the same period in 2017. The decrease in net product sales for the period in 2018 compared to 2017, was primarily related to the April 2017 expansion of the PIXUVRI agreement with Servier under which they have rights in all markets except the United States.
GAAP operating loss for the first quarter of 2018 was $4.3 million compared to $19.3 million for the same period in 2017. Non-GAAP operating loss, which excludes non-cash share-based compensation expense, for the first quarter of 2018, was $3.0 million compared to $17.5 million for the same period in 2017. Non-cash share-based compensation expense for the first quarter of 2018 was $1.3 million compared to $1.8 million for the same period in 2017. The decrease in operating loss for the first quarter of 2018 was primarily due to a $10.0 million milestone revenue from Teva Pharmaceutical Industries Ltd. as well as a decrease in selling, general and administrative expenses related to personnel costs and legal fees. For information on CTI BioPharma’s use of non-GAAP operating loss and a reconciliation of such measure to GAAP operating loss, see the section below titled "Non-GAAP Financial Measures."
Net loss attributable to common stockholders for the first quarter of 2018 was $4.1 million, or ($0.08) per share, compared to $19.8 million, or ($0.71) per share, for the same period in 2017.
As of March 31, 2018, cash and cash equivalents totaled $104.6 million, compared to $43.2 million as of December 31, 2017.
Conference Call Information
CTI BioPharma management will host a conference call to review its first quarter 2018 financial results and provide an update on business activities. The event will be held today at 1:30 p.m. PT / 4:30 p.m. ET. Participants can access the call at 1-866-548-4713 (domestic) or +1 323-794-2093 (international). To access the live audio webcast or the subsequent archived recording, visit www.ctibiopharma.com. Webcast and telephone replays of the conference call will be available approximately two hours after completion of the call. Callers can access the replay by dialing 1-888-203-1112 (domestic) or +1 719-457-0820 (international). The access code for the replay is 9956153. The telephone replay will be available until Thursday, May 10, 2018.