On May 2, 2019 CTI BioPharma Corp. (Nasdaq: CTIC) reported its financial results for the first quarter ended March 31, 2019 (Press release, CTI BioPharma, MAY 2, 2019, View Source [SID1234535548]).
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"Advancing our U.S. and European development program for pacritinib for the treatment of myelofibrosis patients with severe thrombocytopenia remains our top priority for 2019, and we anticipate multiple important milestone events for pacritinib this year," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "We are currently preparing to meet with the U.S. Food and Drug Administration (FDA) and report the determination of an optimal dose of pacritinib in mid-2019, and we expect to begin enrolling a Phase 3 registration study of pacritinib soon after. We also anticipate announcing top-line safety and efficacy data from the Phase 2 study of pacritinib and are targeting presentation of the results at a scientific conference before the end of the year."
Expected 2019 Milestones
FDA meeting and determination of the optimal dose of pacritinib – mid-2019
Commence enrollment in Phase 3 study of pacritinib in myelofibrosis patients with severe thrombocytopenia (platelet counts of less than 50,000 per microliter) – Q3 2019
Reporting of top-line efficacy and safety data from PAC203 Phase 2 study at a major medical meeting by the end of 2019
First Quarter Financial Results
Total revenues for the three months ended March 31, 2019 were $0.6 million compared to $10.8 million for the same period in 2018. The decrease in total revenues for the first quarter in 2019 compared to the same period in 2018 is primarily due to the recognition of $10.0 million in license and contract revenue in 2018 from Teva Pharmaceutical Industries Ltd. related to the achievement of a milestone for FDA approval of TRISENOX (arsenic trioxide) for first-line treatment of acute promyelocytic leukemia.
Operating loss was $10.5 million for the first quarter of 2019, compared to operating loss of $4.3 million for the same period in 2018. Operating loss in the first quarter of 2019 as compared to operating loss in the same period in 2018 resulted primarily from the decrease in license and contract revenue as mentioned above.
Net loss attributable to common stockholders for the first quarter of 2019 was $10.8 million, or $(0.19) for basic and diluted loss per share, compared to net loss attributable to common stockholders of $4.1 million, or $(0.08) for basic and diluted loss per share, for the same period in 2018.
As of March 31, 2019, cash, cash equivalents and short-term investments totaled $62.3 million, compared to $67.0 million as of December 31, 2018. CTI BioPharma expects current cash, cash equivalents and short-term investments will enable it to fund operating and capital expenditures through the second quarter of 2020.