On August 2, 2018 CTI BioPharma Corp. (NASDAQ:CTIC) today reported financial results for the second quarter and six months ended June 30, 2018 (Press release, CTI BioPharma, AUG 2, 2018, View Source;p=RssLanding&cat=news&id=2361698 [SID1234528313]).

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In July 2018, CTI BioPharma announced the continuation without modification of the PAC203 Phase 2 study following a planned interim review by an Independent Data Monitoring Committee. The Company also announced a pacritinib program update following a Type B meeting with the U.S. Food and Drug Administration (FDA) and announced a plan to conduct a new, randomized, Phase 3 study of pacritinib in patients with myelofibrosis. The Company has recently received the Day 180 List of Outstanding Issues from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding the marketing authorization application (MAA) for pacritinib. Following the recently reported results from the PIX306 study, the Company is conducting a review of the clinical study data to assess the next steps for the PIXUVRI program.

Upcoming Milestones

In the third quarter of 2018, a second interim analysis of the PAC203 study of pacritinib in patients with myelofibrosis will be conducted by an Independent Data Monitoring Committee. PAC203 is expected to complete enrollment in the fourth quarter of 2018. Full top-line data from the study is expected in the second quarter of 2019.
The Company has been granted a two month extension for submitting the responses to the Day 180 List of Outstanding Issues. The extension will allow CTI to submit clinical data from PAC203 for review by the EMA. Given this extension, the CHMP opinion on the MAA is now expected in the fourth quarter of 2018.
"We believe we have now re-established a collaborative relationship with the FDA and have received greater clarity on the development path for pacritinib in the U.S.," commented Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "We plan to request a meeting with the FDA following the second interim analysis of PAC203 data with a meeting expected in the fourth quarter of 2018. The purpose of the meeting will be to discuss the interim data and to review the design of a registrational Phase 3 trial. We expect that this trial will begin in 2019, once the optimal dose of pacritinib has been confirmed using all pharmacokinetic, efficacy and safety data from the PAC203 study."

"In Europe, we continue to make progress with our marketing authorization application (MAA) and have now received the Day 180 List of Outstanding Issues report. The EMA has expressed interest in the emerging data from the PAC203 study, so the two month extension granted by CHMP will allow us to submit additional PAC203 data for review as part of our Day 180 responses."

Second Quarter Financial Results

Total revenues for the second quarter and six months ended June 30, 2018 were $0.6 million and $11.1 million, respectively, compared to $22.2 million and $23.0 million for the respective periods in 2017. The decrease in total revenues for the second quarter in 2018 compared to the same period in 2017 is primarily due to license and contract revenue that included the recognition of payments received from the expansion of the license and collaboration agreement for PIXUVRI with Servier in 2017 as well as the receipt of a payment from Teva Pharmaceutical Industries Ltd. related to the achievement of a sales milestone for TRISENOX (arsenic trioxide) in 2017. The decrease in total revenues for the six months ended June 30, 2018, compared to the same period in 2017 is primarily due to license and contract revenue that included the recognition of payments received from the expansion of the license and collaboration agreement for PIXUVRI with Servier in 2017.

GAAP operating loss was $14.0 million and $18.3 million for the second quarter and six months ended June 30, 2018, respectively, compared to GAAP operating income of $5.3 million and GAAP operating loss of $14.0 million for the respective periods in 2017. Non-GAAP operating loss, which excludes non-cash share-based compensation expense, for the second quarter and six months ended June 30, 2018 was $13.0 million and $16.0 million, respectively, compared to non-GAAP operating income of $6.4 million and non-GAAP operating loss of $11.1 million for the respective periods in 2017. Non-cash share-based compensation expense for the second quarter and six months ended June 30, 2018, was $1.0 million and $2.4 million, respectively, compared to $1.1 million and $2.9 million for the respective periods in 2017. Operating loss in the second quarter of 2018 as compared to an operating income for the same period in 2017 resulted primarily from the decrease in license and contract revenue as mentioned above and a decrease in selling, general and administrative expenses. Operating loss for the six months ended June 30, 2018, compared to the same period in 2017 resulted primarily from the decrease in license and contract revenue as mentioned above and a decrease in 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 titled "Non-GAAP Financial Measures."

Net loss for the second quarter of 2018 was $11.3 million, or $(0.20) per share, compared to a net income of $1.0 million, or $0.03 per share, for the same period in 2017. Net loss for six months ended June 30, 2018, was $15.4 million, or $(0.29) per share, compared to a net loss of $18.8 million, or ($0.63) per share, for the same period in 2017.

As of June 30, 2018, cash, cash equivalents and short-term investments totaled $92.8 million, compared to $43.2 million as of December 31, 2017.

Conference Call Information
CTI BioPharma management will host a conference call to review its second quarter 2018 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. Participants can access the call at 877-260-1479 (domestic) or +1 334-323-0522 (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 3255708. The telephone replay will be available until August 9, 2018.