CTI BioPharma Reports Fourth Quarter and Full Year 2017 Financial Results

SEATTLE, March 7, 2018 /PRNewswire/ -- CTI BioPharma Inc. (NASDAQ:CTIC) today reported financial results for the fourth quarter and full year ended December 31, 2017.

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 and/or have thrombocytopenia, to evaluate the dose response relationship for safety and efficacy. The Company expects to complete an interim analysis of data in the second quarter of 2018, with full top-line data expected in the first quarter of 2019.
• In January 2018, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a three-month extension for submitting responses to the Day 120 List of Questions (D120 LoQ) for the MAA for pacritinib. As a result of the extension, the Company anticipates submitting its response to the D120 LoQ in May 2018 and receipt of the CHMP’s opinion on the Marketing Authorization Application (MAA) in the third quarter of 2018.
• In August 2017, enrollment was completed in the PIX306 Phase 3 trial of PIXUVRI^® (pixantrone). Top-line results are event-driven and are expected in the second quarter of 2018.

Financial and Partnerships

• In February 2018, received gross proceeds of $69 million from an underwritten public offering of common stock. In June 2017, the Company received gross proceeds of $45 million through an underwritten public offering of preferred stock.
• In January 2018, the Company reincorporated in the State of Delaware, triggering an automatic delisting of the Company’s common stock from the Borsa Italiana MTA exchange.
• In January 2018 and again in June 2017, the Company announced that it received a $10 million milestone payment from Teva Pharmaceutical Industries Ltd. related to a regulatory approval milestone for TRISENOX^®.
• In April 2017, the Company announced the expansion of the existing license and collaboration agreement with Servier, providing Servier with rights to PIXUVRI^® (pixantrone) in all markets except in the United States.

Board of Directors and Management

• In September 2017, Laurent Fischer, M.D. was appointed Chairman of the Board of Directors. The Company also announced the appointment of David Parkinson, M.D. and Michael A. Metzger to the Board of Directors in 2017. Phillip M. Nudelman, Ph.D. and Jack W. Singer, M.D. resigned as members of the Board.
• In March 2017, Adam Craig, M.D., Ph.D., was appointed President and CEO and a Director of the Company, succeeding Richard Love, who continues to serve on the Company’s Board. Additional management changes in 2017 included the promotion of David H. Kirske to Chief Financial Officer and Bruce J. Seeley to Chief Operating Officer.

“CTI BioPharma is now focused on the enrollment of patients in the PAC203 study of our lead compound, pacritinib, for the treatment of myelofibrosis. We are well-financed after recently completing an over-subscribed public offering of our common stock, and we believe we have sufficient cash to carry us through key clinical and regulatory milestones over the next 24 months,” said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. “We look forward to several key clinical and regulatory milestones in 2018, including an interim data analysis for the PAC203 study of pacritinib and top-line results in the PIX306 Phase 3 trial of PIXUVRI^® in the second quarter.”

Fourth Quarter Financial Results

Total revenues for the fourth quarter and twelve months ended December 31, 2017, were $0.46 million and $25.1 million, respectively, compared to $9.1 million and $57.4 million for the respective periods in 2016. The decrease in total revenues for the twelve 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 fourth quarter and twelve months ended December 31, 2017, were zero and $0.9 million, respectively, compared to $1.0 million and $4.1 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 PIXUVRI agreement with Servier under which they have rights in all markets except the United States.

GAAP operating loss for the fourth quarter and twelve months ended December 31, 2017, was $13.7 million and $39.5 million, respectively, compared to GAAP operating loss of $5.6 million and $49.2 million for the respective periods in 2016. Non-GAAP operating loss, which excludes non-cash share-based compensation expense, for the fourth quarter and twelve months ended December 31, 2017 was $12.3 million and $33.8 million, respectively, compared to non-GAAP operating loss of $3.5million and $35.8 million for the respective periods in 2016. Non-cash share-based compensation expense for the fourth quarter and twelve months ended December 31, 2017, was $1.4 million and $5.7 million, respectively, compared to $2.1 million and $13.3 million for the respective periods in 2016. The decrease in operating loss for the fourth quarter and twelve 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 fourth quarter of 2017 was $14.3 million, or ($0.33) per share, compared to a net loss of $6.4 million, or ($0.23) per share, for the same period in 2016. Net loss for the twelve months ended December 31, 2017, was $45.0 million, or ($1.24) per share, compared to a net loss of $52.0 million, or ($1.86) per share, for the same period in 2016.

As of December 31, 2017, cash, cash equivalents and restricted cash totaled $43.2 million, compared to $44.0 million at December 31, 2016.

Conference Call Information

CTI BioPharma management will host a conference call to review its fourth quarter and full year 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 1-800-289-0517 (domestic) or + +1 323-994-2084 (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 2516357. The telephone replay will be available until March 14, 2018.