CTI BioPharma Corp (NASDAQ:CTIC) reported financial results for the first quarter ended March 31, 2015.
“After reporting positive top-line results from the PERSIST-1 Phase 3 clinical trial of pacritinib during the quarter, we have subsequently received positive feedback from a number of treating physicians who are excited by the potential opportunity for pacritinib to meet a current unmet medical need in the treatment of patients with myelofibrosis, specifically in the portion of patients that have low-blood platelets as a result of their disease or other treatment,” saidJames A. Bianco, M.D., CTI BioPharma’s President and CEO. “We look forward to the oral presentation of data from this trial at ASCO and remain focused on completing the second pacritinib Phase 3 trial, PERSIST-2, in the second-half of this year and, with our partner Baxter, starting a planned regulatory submission late in 2015.”
First Quarter 2015 Financial Results
Total revenues for the quarter ended March 31, 2015 were $2.7 million compared to $1.4 million for the same period in 2014, which includes PIXUVRI net product revenues of $0.8 million and license contract revenues of $1.9 million for the quarter ended March 31, 2015compared to $1.3 million and $0.1 million, respectively, for the same period in 2014.
The non-GAAP operating loss, which excludes non-cash share-based compensation expense, for the quarter ended March 31, 2015 was $23.1 million, compared to non-GAAP operating loss of $19.8 million for the same period in 2014. The GAAP operating loss for the quarter endedMarch 31, 2015 was $27.5 million, compared to a GAAP operating loss of $27.7 million for the same period in 2014. Non-cash share-based compensation expense for the quarter endedMarch 31, 2015 was $4.3 million compared to $7.8 million for the same period in 2014. For information on CTI BioPharma’s use of the aforementioned non-GAAP measure and a reconciliation of such measure to GAAP operating loss, see the section below entitled “Non-GAAP Financial Measures.”
Net loss for the quarter ended March 31, 2015 was $28.6 million, or $0.16 per share, compared to a net loss of $29.0 million, or $0.20 per share, for the same period in 2014.
For the quarter ended March 31, 2015, cash and cash equivalents totaled $44.4 million.
2015 Financial Outlook
CTI BioPharma reaffirms prior financial guidance that it expects total revenues for 2015 will be approximately $50 million to $55 million, and it expects that non-GAAP operating loss for 2015 will be approximately $75 million to $85 million, which excludes non-cash share-based compensation expense. These financial projections are primarily based on factors previously outlined in the Company’s fourth quarter and full year 2014 financial results press release.
Recent Clinical Highlights
Recent clinical highlights concerning pacritinib, a JAK2 and FLT3 inhibitor, are as follows:
- PERSIST-1, a randomized (2:1), open-label, multinational Phase 3 clinical trial evaluating the investigational agent pacritinib in patients with primary and secondary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, without exclusion for low platelet counts, met its primary endpoint of reducing spleen size by 35 percent or more from baseline to Week 24 as measured by MRI or CT, when compared with BAT, excluding treatment with JAK2 inhibitors. Additionally, the safety profile of pacritinib was generally consistent with previous Phase 2 studies.
- PERSIST-1 data will be highlighted in a late-breaking oral presentation and will be a part of the official press briefing session titled ‘Targeted Therapy,’ at the American Society of Clinical Oncology (ASCO) 2015 Meeting on May 30, 2015.
- Results from a Phase 2 study of pacritinib in patients with myelofibrosis were published in the journal Blood. Results from this study demonstrated that pacritinib is active in patients with myelofibrosis, resulting in spleen volume reduction, while producing substantial and prolonged improvement in disease-related symptoms without causing clinically significant myelosuppression. (Original Source)
Shares of CTI BioPharma Corp. closed today at $1.74, down $0.04 or 2.25%. CTIC has a 1-year high of $3.23 and a 1-year low of $1.71. The stock’s 50-day moving average is $1.88 and its 200-day moving average is $2.21.
On the ratings front, Roth Capital analyst Debjit Chattopadhyay reiterated a Buy rating on CTIC, with a price target of $4.50. The current target implies an upside of 147.3% from current levels. According to TipRanks.com, Chattopadhyay has a total average return of 8.0%, a 37.4% success rate, and is ranked #709 out of 3590 analysts.