On February 19, 2016 Heron Therapeutics, Inc. (NASDAQ: HRTX), a biotechnology company focused on improving the lives of patients by developing best-in-class medicine that address major unmet medical needs, reported fourth quarter and full year 2015 financial results and highlighted recent corporate progress (Filing, 8-K, Heron Therapeutics, FEB 19, 2016, View Source [SID:1234509115]).
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Recent Corporate Progress:
In February 2016, Heron successfully demonstrated bioequivalence of HTX-019 to intravenous (IV) fosaprepitant in a study that included 100 healthy volunteers. In this study, HTX-019 demonstrated a substantially improved safety profile compared to IV fosaprepitant, which contains polysorbate 80. HTX-019, a polysorbate 80-free, IV formulation of the neurokinin-1 (NK1) receptor antagonist aprepitant, is being developed for the prevention of chemotherapy-induced nausea and vomiting (CINV).
In February 2016, Heron initiated a placebo-controlled, dose-finding, Phase 2 clinical trial of HTX-011 for the treatment of post-operative pain in approximately 100 patients undergoing abdominoplasty. HTX-011 is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam formulated with Heron’s Biochronomer drug delivery technology.
In January 2016, the U.S. Food and Drug Administration (FDA) informed Heron that it has not yet completed its review of the New Drug Application (NDA) of SUSTOL (granisetron) Injection, extended release and was unable to take action by the Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016. The FDA stated that it is targeting taking action in late February 2016.
"While we were disappointed that the FDA was unable to complete the review of the SUSTOL NDA by the original January 2016 PDUFA goal date, we appreciate the work of the FDA and remain confident in the potential of SUSTOL as an important option for the prevention of CINV in patients with cancer," commented Barry D. Quart, Chief Executive Officer of Heron Therapeutics. "Earlier this month, we achieved important milestones for our pipeline programs. We confirmed bioequivalence for HTX-019 compared with IV fosaprepitant and showed substantially improved tolerability of HTX-019, our polysorbate 80-free, IV formulation of aprepitant. In addition, we initiated our third Phase 2 study of HTX-011, which is evaluating HTX-011 in patients undergoing abdominoplasty."
Results of Operations
As of December 31, 2015, Heron had approximately $131.2 million in cash, cash equivalents and short-term investments, compared to $72.7 million as of December 31, 2014. The net increase in cash, cash equivalents and short-term investments was primarily due to Heron’s June 2015 public equity offering that resulted in total net proceeds to us of approximately $128.2 million, partially offset by net cash used in operating activities in 2015. Based on current operating plans and projections, Heron believes that its current working capital is sufficient to fund operations through 2016.
Heron’s net cash used for operating activities for the quarter and year ended December 31, 2015 was $23.2 million and $78.5 million, respectively, compared to net cash used for operating activities of $12.9 million and $60.3 million, respectively, for the same periods in 2014.
Heron’s net loss for the quarter and year ended December 31, 2015 was $31.2 million and $97.6 million, or $0.87 per share and $2.95 per share, respectively, compared to a net loss of $20.6 million and $76.4 million, or $0.71 per share and $2.87 per share, respectively, for the same periods in 2014.
The increases in net cash used for operating activities and net loss in 2015 as compared to 2014 were primarily due to costs incurred in preparation for the commercial launch of SUSTOL, as well as clinical and manufacturing costs related to our Phase 1 and Phase 2 clinical studies for HTX-011 and costs associated with the development of HTX-019.