On August 3, 2017 CTI BioPharma Corp. (NASDAQ and MTA:CTIC) reported financial results for the second quarter ended June 30, 2017 (Press release, CTI BioPharma, AUG 3, 2017, View Source [SID1234520024]). Schedule your 30 min Free 1stOncology Demo! Clinical / Regulatory
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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).
In August 2017, enrollment was completed in the PIX306 Phase 3 trial of PIXUVRI (pixantrone). The PIX306 trial is evaluating PIXUVRI combined with rituximab in comparison to that of rituximab combined with gemcitabine in patients with aggressive B-cell non-Hodgkin lymphoma (NHL). PIXUVRI has previously been granted conditional marketing authorization from the European Commission for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL. The trial is being conducted as a post-authorization requirement of conditional marketing authorization. If positive, the results from this trial could support broader indications. Top-line results are event-driven and are expected in the first half of 2018.
Financing and Partnerships
In June 2017, received gross proceeds of $45 million through an underwritten public offering.
In April 2017, CTI BioPharma announced the expansion of the existing license and development collaboration agreement with Servier for PIXUVRI. Under the expanded agreement, Servier will have rights to PIXUVRI in all markets except in the U.S. where CTI BioPharma will retain the commercialization rights. In May 2017, CTI BioPharma received €12 million from Servier, which includes €2 million for a new milestone previously achieved, and Servier purchased a certain amount of PIXUVRI drug product for an additional €0.9 million. CTI BioPharma is eligible to receive €76 million in additional sales and regulatory milestone payments as well as royalties on net product sales.
Board of Directors
In July 2017, Laurent Fischer, M.D. was appointed to the Board of Directors (BOD). 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 June 2017, David Parkinson, M.D. was appointed to the BOD. Dr. Parkinson has significant experience in oncology clinical development and currently is President and Chief Executive Officer of Essa Pharmaceuticals, Inc and has also served as a venture partner at New Enterprise Associates (NEA), Inc. since 2012 moving into the role of venture advisor to NEA in 2016.
"Over the last quarter we have worked hard to become a leaner, more focused company that is adequately financed to meet our objectives," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "The EMA validated the MAA for pacritinib which is now under review and the PAC203 trial is now enrolling. Our cash position has improved through an expanded partnership with Servier and the recent $45 million financing. Changes to the board have added three new independent board members with many years of experience in successfully developing and commercializing novel therapeutics."
Second Quarter Financial Results
Total revenues for the second quarter and six months ended June 30, 2017, were $22.2 million and 23.0 million, respectively, compared to $7.4 million and $43.8 million for the respective periods in 2016. The increase in total revenues for the second quarter compared to the same period in 2016 is primarily due to license and contract revenue that includes the recognition of payments received from the expansion of the license and collaboration agreement for PIXUVRI with Servier and the receipt of a payment from Teva Pharmaceutical Industries Ltd. related to the achievement of sales milestones for TRISENOX (arsenic trioxide). The decrease in total revenues for the six 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 second quarter and six months ended June 30, 2017, were $0.3 million and $1.0 million, respectively, compared to $1.1 million and $2.3 million for the respective periods in 2016
GAAP operating income for the second quarter was $5.3 million and GAAP operating loss for the six months was $14.0 million for the period ended June 30, 2017, compared to GAAP operating loss of $19.1 million and $14.9 million for the respective periods in 2016. Non-GAAP operating income, which excludes non-cash share-based compensation expense, for the second quarter was $6.4 million and non-GAAP operating loss for the six months was $11.1 million for the period ended June 30, 2017, compared to non-GAAP operating loss of $16.7 million and $8.8 million for the respective periods in 2016. Non-cash share-based compensation expense for the second quarter and six months ended June 30, 2017, was $1.1 million and $2.9 million, respectively, compared to $2.3 million and $6.2 million for the respective periods in 2016. Operating income in the second quarter of 2017 as compared to an operating loss for the same period in 2016 resulted primarily from the increase in license and contract revenue as mentioned above and decrease in research and development and selling, general and administrative expenses. 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 income for the second quarter of 2017 was $1.0 million, or $0.03 per share, compared to a net loss of $19.8 million, or ($0.71) per share, for the same period in 2016. Net loss for six months ended June 30, 2017, was $18.8 million, or ($0.63) per share, compared to a net loss of $16.5 million, or ($0.59) per share, for the same period in 2016.
As of June 30, 2017, cash and cash equivalents totaled $74.7 million, compared to $44.0 million at December 31, 2016.