On March 12, 2020 CTI BioPharma Corp. (Nasdaq: CTIC) reported its financial results for the fourth quarter and full year ended December 31, 2019 (Press release, CTI BioPharma, MAR 12, 2020, View Source [SID1234555486]).
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"In the latter half of 2019 and beginning of 2020, we further advanced our pacritinib development program, including presenting data at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting that reinforced the clinical and scientific rationale for our ongoing PAC203 Phase 3 PACIFICA trial evaluating pacritinib at 200 mg BID in severely thrombocytopenic myelofibrosis patients." said Adam R. Craig, M.D., Ph.D. "Severely thrombocytopenic myelofibrosis patients have limited, and often ineffective, therapeutic options. In an effort to advance pacritinib as quickly as possible to these patients, we established an accelerated approval pathway with the U.S. Food and Drug Administration ("FDA") by amending the PACIFICA pivotal Phase 3 trial protocol to allow for the primary analysis of Spleen Volume Reduction ("SVR") rates on the first 168 patients, with an end-of-study analysis of Total Symptom Score ("TSS") and Overall Survival ("OS") following the full enrollment of 348 patients. If the primary endpoint of SVR is met following the planned review of data from the first 168 patients, we intend to submit a New Drug Application ("NDA") under the FDA’s subpart H regulations. We expect to report primary SVR data by the end of 2021, with a potential NDA filing in early 2022. Additionally, we recently raised an additional $59.3 million in a rights offering, which provides us with additional cash runway into Q1 2022 as we continue to develop pacritinib."
Fourth Quarter Financial Results
Operating loss was $9.5 million and $40.7 million for the three months and year ended December 31, 2019, respectively, compared to operating income of $0.2 million and operating loss of $32.9 million for the respective periods in 2018. The operating loss during the three-month period ended December 31, 2019 as compared to the operating income for the comparable period in 2018 resulted primarily from the decrease in license and contract revenue as discussed below, partially offset by a decrease in operating expenses. The increase in operating loss for the year ended December 31, 2019 as compared to the same period in 2018 resulted primarily from a decrease in license and contract revenues between periods as discussed below, partially offset by a decrease in operating expenses. As of December 31, 2019, cash, cash equivalents and short-term investments totaled $33.7 million, compared to $67.0 million as of December 31, 2018. In March 2020, we completed our rights offering and received approximately $59.3 million in net proceeds. We expect current cash, cash equivalents and short-term investments,
when combined with the net proceeds we received from the rights offering, will enable us to fund our operations into the first quarter of 2022.
License and contract revenues for the three months ended December 31, 2018 were $14.1 million while no revenues were recognized during the three months ended December 31, 2019. License and contract revenues for the three months ended December 31, 2018 were primarily related to milestone revenues recognized upon the achievement of a regulatory milestone under the license and collaboration agreement for PIXUVRI with Les Laboratoires Servier and Institut de Recherches Internationales Servier as well as the attainment of a worldwide net sales milestone of TRISENOX (arsenic trioxide) under the agreement with Teva Pharmaceutical Industries Ltd. ("Teva"). License and contract revenues for the years ended December 31, 2019 and 2018 were $3.3 million and $26.3 million, respectively. The decrease between periods primarily resulted from milestone revenues recognized in 2018 from Teva related to the achievement of a milestone for FDA approval of TRISENOX for first-line treatment of acute promyelocytic leukemia, in addition to the license and contract revenues recognized during the three months ended December 31, 2018, as discussed above.
Net loss attributable to common stockholders for the three months ended December 31, 2019 was $8.2 million, or $(0.14) for basic and diluted loss per share, compared to net income attributable to common stockholders of $0.8 million, or $0.01 for basic and diluted income per share, for the same period in 2018. Net loss attributable to common stockholders for the year ended December 31, 2019 was $40.0 million, or $(0.69) for basic and diluted loss per share, compared to net loss attributable to common stockholders of $29.4 million, or $(0.52) for basic and diluted loss per share, for the same period in 2018.