On November 6, 2017 CTI BioPharma Corp. (NASDAQ and MTA:CTIC) reported financial results for the third quarter ended September 30, 2017 (Press release, CTI BioPharma, NOV 6, 2017, View Source;p=RssLanding&cat=news&id=2314662 [SID1234521603]).
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Recent Highlights
Clinical / Regulatory
In July 2017, the first patient was enrolled in PAC203, a Phase 2 clinical trial of pacritinib in patients with primary myelofibrosis who have failed prior ruxolitinib therapy. PAC203 is designed to evaluate the dose response relationship for safety and efficacy (spleen volume reduction at 12 and 24 weeks) of three dose regimens: 100 mg once-daily, 100 mg twice-daily (BID) and 200 mg BID. The 200 mg BID dose regimen was used in the Phase 3 PERSIST-2 trial of pacritinib in patients with myelofibrosis. The trial is expected to enroll up to approximately 105 patients.
In July 2017, the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for pacritinib for the treatment of patients with myelofibrosis who have thrombocytopenia (platelet counts less than 100,000 per microliter). Validation confirms that the submission is complete and initiates the centralized review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Board of Directors and Management
In September 2017, Laurent Fischer, M.D. was appointed Chairman of the Board of Directors. Dr. Fischer has more than 20 years of experience in developing and commercializing novel medicines in the biopharmaceutical industry and currently serves as liver therapeutic area head at Allergan following its acquisition of Tobira Therapeutics in 2016.
In September 2017, David H. Kirske was promoted to Chief Financial Officer and Bruce J. Seeley to Chief Operating Officer of the company.
"In the third quarter, we solidified our board and senior management leadership and continue to make significant progress in reducing expenses to operate as a leaner organization as we approach important milestones," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "We believe there remains a significant unmet need for myelofibrosis patients with low platelets and continue activating sites in the PAC203 trial of pacritinib. We also look forward to continuing to work with the EMA over the next nine months during their review of the MAA for pacritinib."
Third Quarter Financial Results
Total revenues for the third quarter and nine months ended September 30, 2017, were $1.7 million and $24.7 million, respectively, compared to $4.4 million and $48.3 million for the respective periods in 2016. The decrease in total revenues for the nine months of 2017 is primarily due to recognition of $32 million in milestone revenue related to pacritinib in the first quarter of 2016. Net product sales of PIXUVRI for the third quarter and nine months ended September 30, 2017, were zero and $0.9 million, respectively, compared to $0.9 million and $3.1 million for the respective periods in 2016. The decrease in net product sales for the periods in 2017 compared to 2016, is primarily related to the April 2017 expansion of the PXUVRI agreement with Servier under which they have rights in all markets except the U.S.
GAAP operating loss for the third quarter and nine months ended September 30, 2017, was $11.8 million and $25.8 million, respectively, compared to GAAP operating loss of $28.7 million and $43.6 million for the respective periods in 2016. Non-GAAP operating loss, which excludes non-cash share-based compensation expense, for the third quarter and nine months ended September 30, 2017 was $10.4 million and $21.5 million, respectively, compared to non-GAAP operating loss of $23.6 million and $32.4 million for the respective periods in 2016. Non-cash share-based compensation expense for the third quarter and nine months ended September 30, 2017, was $1.4 million and $4.3 million, respectively, compared to $5.1 million and $11.2 million for the respective periods in 2016. The decrease in operating loss for the third quarter and nine months of 2017 was due to a significant decrease in research and development and selling, general and administrative expenses primarily related to a decrease in pacritinib development costs as a result of the completion of the Phase 3 clinical studies in 2017 and a decrease in expenses for the manufacture of pacritinib and personnel costs. 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 entitled "Non-GAAP Financial Measures."
Net loss for the third quarter of 2017 was $12.0 million, or ($0.28) per share, compared to a net loss of $29.2 million, or ($1.04) per share, for the same period in 2016. Net loss for the nine months ended September 30, 2017, was $30.8 million, or ($0.90) per share, compared to a net loss of $45.6 million, or ($1.63) per share, for the same period in 2016.
As of September 30, 2017, cash and cash equivalents totaled $52.8 million, compared to $44.0 million at December 31, 2016.
Conference Call Information
CTI BioPharma management will host a conference call to review its third quarter 2017 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 / 10:30 p.m. CET. Participants can access the call at 1-888-461-2021 (domestic) or +1 719-325-2359 (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 1048572. The telephone replay will be available until November 13, 2017.