On August 7, 2015 Heron Therapeutics, Inc. (NASDAQ:HRTX), a biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs, reported second quarter 2015 financial results and highlighted recent corporate progress (Press release, Heron Therapeutics, AUG 7, 2015, View Source;p=RssLanding&cat=news&id=2078084 [SID:1234507112]).
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Recent Corporate Progress:
In July 2015, Heron resubmitted its New Drug Application (NDA) for SUSTOL (granisetron) Injection, extended release, for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC) regimens, to the U.S. Food and Drug Administration (FDA).
In June and July 2015, Heron initiated two Phase 2 clinical trials of HTX-011 for the prevention of post-operative pain, one in patients undergoing bunionectomy and one in patients undergoing inguinal hernia repair.
In June 2015, Heron closed an underwritten public offering of 5,520,000 shares of common stock at a public offering price of $24.75 per share. Heron received total net proceeds from the offering of approximately $128.2 million.
In May 2015, Heron reported positive, top-line results from its recently completed Phase 3 MAGIC study for SUSTOL. The MAGIC study evaluated the efficacy and safety of SUSTOL as part of a three-drug regimen with the intravenous (IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the corticosteroid dexamethasone for the prevention of delayed CINV associated with HEC regimens.
In May 2015, the FDA accepted Heron’s proposal to use the 505(b)(2) regulatory pathway for HTX-019, Heron’s proprietary intravenous formulation of the NK1 receptor antagonist aprepitant for the prevention of CINV. Utilizing the 505(b)(2) regulatory pathway to significantly reduce the costs and time required for development, Heron intends to file an NDA for HTX-019 in the second half of 2016.
"We have achieved several critical milestones since our last quarterly update, including the resubmission of the SUSTOL NDA to the FDA," commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. "With a pipeline of four exciting product candidates with best-in-class potential and a healthy balance sheet following our successful financing in June, we are looking forward to an eventful and productive second half of 2015."
Results of Operations
As of June 30, 2015, Heron had approximately $171.5 million in cash and cash equivalents, compared to $72.7 million as of December 31, 2014. The net increase in cash and cash equivalents was primarily due to the June 2015 public offering noted above, partially offset by net cash used in operating activities.
Heron’s net cash used for operating activities for the three and six months ended June 30, 2015 was $15.8 million and $35.5 million, respectively, compared to net cash used for operating activities of $12.5 million and $28.2 million, respectively, for the same periods in 2014. Based on current operating plans and projections, Heron believes that its current cash and working capital are sufficient to fund operations through 2016.
Heron’s net loss for the three and six months ended June 30, 2015 was $23.1 million and $43.7 million, or $0.74 per share and $1.45 per share, respectively, compared to a net loss of $19.0 million and $36.5 million, or $0.78 per share and $1.52 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 clinical and manufacturing costs related to our Phase 1 and Phase 2 clinical studies for HTX-011, as well as costs associated with the development of HTX-019.