On August 4, 2016 CTI BioPharma Corp. (NASDAQ and MTA:CTIC) reported financial results for the second quarter ended June 30, 2016 (Press release, CTI BioPharma, AUG 4, 2016, View Source [SID:1234514251]). Schedule your 30 min Free 1stOncology Demo! "The interest from oncologists generated by the Phase 3 PERSIST-1 long-term safety and efficacy results of pacritinib showing durable reduction in spleen volume and symptom burden including in patients that crossed over to pacritinib from best available therapy, presented at ASCO (Free ASCO Whitepaper), supports our belief that pacritinib may play an important role in the treatment of myelofibrosis," said James A. Bianco, M.D., President and Chief Executive Officer of CTI BioPharma. "We are now in the process of preparing for the release of top-line results from the second Phase 3 trial of pacritinib, PERSIST-2, which we expect to report in the third quarter of 2016. The results from the full analysis of the PERSIST-2 trial are a key requirement as we continue to work with the FDA to seek to address their recommendations for getting pacritinib off clinical hold."
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Second Quarter Event
In June 2016, researchers presented long-term safety and efficacy results from the pivotal Phase 3 trial, PERSIST-1, evaluating pacritinib versus best available therapy, excluding treatment with JAK2 inhibitors (BAT), in patients with myelofibrosis. As previously reported, the PERSIST-1 trial met its primary endpoint in the intent-to-treat population with statistically significant reduction in spleen volume when compared to patients receiving BAT. The results presented were an update on the efficacy and safety for all patients regardless of their initial platelet count, including patients with very low platelet counts at study entry, a condition known as severe or life-threatening thrombocytopenia. A planned analysis of the study up to 72 weeks demonstrated treatment with pacritinib led to durable reductions in spleen volume and symptom burden, two key measures of disease control, in patients with myelofibrosis, including patients with low platelets at baseline. These and other findings were presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).
Second Quarter Financial Results
Total revenues for the second quarter and six months ended June 30, 2016, were $7.4 million and $43.8 million, respectively, compared to $1.1 million and $3.8 million for the respective periods in 2015. The increase in total revenue for the six month period in 2016 is primarily due to recognition of $32 million in milestone payments and reimbursement of development costs from Baxalta, which is now part of Shire plc, related to pacritinib. CTI BioPharma had previously received a cash advance for these milestone payments from Baxalta in the second quarter of 2015 that was accounted for as long-term debt until the achievement of the associated milestones in the first quarter of 2016. Net product sales of PIXUVRI for the second quarter and the six months ended June 30, 2016, were $1.1 million and $2.3 million, respectively, compared to $0.8 million and $1.7 million for the respective periods in 2015.
GAAP operating loss for the second quarter and six months ended June 30, 2016, was $19.1 million and $14.9 million, respectively, compared to GAAP operating loss of $31.0 million and $58.5 million for the respective periods in 2015. Non-GAAP operating loss, which excludes non-cash share-based compensation expense, for the second quarter and six months ended June 30, 2016, was $16.7 million and $8.8 million, respectively, compared to the non-GAAP operating loss of $28.3 million and $51.4 million for the respective periods in 2015. The decrease in CTI BioPharma’s operating loss for the six month period ended June 30, 2016 is primarily due to recognition in the first quarter of 2016 of $32 million in milestone payments as license and contract revenue related to pacritinib as mentioned above. Non-cash share-based compensation expense for the second quarter and six months ended June 30, 2016, was $2.3 million and $6.2 million, respectively, compared to $2.8 million and $7.1 million for the respective periods in 2015. 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 second quarter of 2016 was $19.8 million, or ($0.07) per share, compared to a net loss of $32.6 million, or ($0.19) per share, for the same period in 2015. Net loss for the six months ended June 30, 2016 was $16.5 million, or ($0.06) per share, compared to a net loss of $61.2 million, or ($0.35) per share, for the same period in 2015. The decrease in net loss for the second quarter and the six months ended June 30, 2016 compared to the respective periods in 2015 is primarily due to increased net product sales and license and contract revenue and decreased operating expenses.
As of June 30, 2016, cash and cash equivalents totaled $76.7 million, compared to $128.2 million as of December 31, 2015.