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, today reported third quarter 2015 financial results and highlighted recent corporate progress.
Recent Corporate Progress:
- In October 2015, Heron appointed Neil J. Clendeninn, M.D., Ph.D. as Senior Vice President and Chief Medical Officer. Dr. Clendeninn brings more than 25 years of drug development and clinical practice experience to his role at Heron. Prior to his appointment, Dr. Clendeninn advised Heron during the recently completed MAGIC study for SUSTOL®(granisetron) Injection, extended release and with the resubmission of Heron’s New Drug Application (NDA) for SUSTOL to the U.S. Food and Drug Administration (FDA). Dr. Clendeninn, in addition to his experience as a practicing physician, has held academic positions, and served as a board member and scientific advisor for numerous institutions and companies within the oncology field.
- In September 2015, Heron reported positive, top-line results from its recently completed Phase 2 clinical study of HTX-011 in the management of post-operative pain in patients undergoing bunionectomy. In the study, HTX-011 showed a significant reduction in pain intensity, reduction in the need for opioid rescue medications, and increase in time to first use of rescue medications.
- In September 2015, the FDA accepted for review Heron’s NDA resubmission for SUSTOL for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) regimens. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016.
- Based on the positive Phase 2 results of HTX-011 in patients undergoing bunionectomy, the Company plans to expand target enrollment for its ongoing Phase 2 clinical trial of HTX-011 in patients undergoing inguinal hernia repair. The increased target enrollment to approximately 100 patients now is expected to provide 90% power to detect a statistical improvement (p < 0.05) in the study. The Company expects to report results from this study in the first half of 2016.
- Heron plans to study HTX-011 as part of a broad-based development program designed to target patients undergoing a wide range of surgeries who experience significant post-operative pain, potentially including abdominoplasty, orthopedic procedures, nerve block and further studies in inguinal hernia repair and bunionectomy.
“This has been an exciting quarter for Heron with the FDA’s acceptance of the SUSTOL NDA and the release of positive, top-line results from our Phase 2 study of HTX-011 in patients undergoing bunionectomy,” commented Barry D. Quart, Pharm.D., Chief Executive Officer ofHeron Therapeutics. “We look forward to a productive fourth quarter with the continuation of our activities in preparation for the potential commercial launch of SUSTOL, if approved by theFDA, and the expansion of our Phase 2 program for HTX-011 in anticipation of an End-of-Phase 2 meeting with the FDA in 2016.”
Results of Operations
As of September 30, 2015, Heron had approximately $153.0 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 Heron’s June 2015 public equity offering resulting in total net proceeds to us of approximately $128.2 million, partially offset by net cash used in operating activities. 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 cash used for operating activities for the three and nine months ended September 30, 2015 was $19.9 million and $55.4 million, respectively, compared to net cash used for operating activities of $19.2 million and $47.4 million, respectively, for the same periods in 2014.
Heron’s net loss for the three and nine months ended September 30, 2015 was $22.7 millionand $66.3 million, or $0.63 per share and $2.07 per share, respectively, compared to a net loss of $19.2 million and $55.7 million, or $0.66 per share and $2.17 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, costs associated with the development of HTX-019, as well as costs incurred in preparation for the commercial launch of SUSTOL, if approved by the FDA. (Original Source)
Shares of Heron Therapeutics Inc closed yesterday at $28.23. HRTX has a 1-year high of $42.25 and a 1-year low of $7.09. The stock’s 50-day moving average is $27.20 and its 200-day moving average is $27.00.
On the ratings front, Heron has been the subject of a number of recent research reports. In a report issued on October 1, Brean Murray Carret analyst Jonathan Aschoff maintained a Buy rating on HRTX, with a price target of $55, which represents a potential upside of 94.8% from where the stock is currently trading. Separately, on September 30, Cowen’s Boris Peaker reiterated a Buy rating on the stock and has a price target of $47.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jonathan Aschoff and Boris Peaker have a total average return of -2.9% and 21.8% respectively. Aschoff has a success rate of 41.3% and is ranked #3556 out of 3827 analysts, while Peaker has a success rate of 48.5% and is ranked #107.
Overall, 5 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $54.50 which is 93.1% above where the stock closed yesterday.
Heron Therapeutics Inc is a biotechnology company, developing products to address unmet medical needs. Its proprietary Biochronomer polymer-based drug delivery platform is designed to improve the therapeutic profile of injectable pharmaceuticals.