Heron Therapeutics Announces Second Quarter and Year-to-Date 2014 Financial Results
Recent Corporate Highlights
June 30, 2014, Heron announced the closing of an underwritten public offering of 4.8 million shares of common stock at a public offering price of $11.75per share. In connection with the offering, the Company also sold an aggregate of 600,000 pre-funded warrants at a purchase price of $11.74per warrant. The Company received total net proceeds of approximately $58.9 million.
June 27, 2014, Heron joined the Russell 3000 Index, as well as the Russell Global and Russell Micro-Cap Indexes, as a result of the annual Russell Index Reconstitution.
June 2, 2014, Heron announced that it planned to include data from the ongoing Phase 3 study of SUSTOL™ for the prevention of delayed-onset CINV in patients receiving HEC agents in the resubmission of the new drug application (NDA) now planned for the fourth quarter of 2014. This represents an underserved population as there are no 5-HT3 receptor antagonists currently approved for this indication.
May 14, 2014, Heron reported that it has selected HTX-011, a unique combination of local analgesic agent bupivacaine and the anti-inflammatory drug meloxicam utilizing its proprietary Biochronomer™ polymer-based drug delivery platform as the lead product candidate for its post-surgical pain program. In a validated animal model, HTX-011 significantly reduced mean pain intensity compared to the current market leader, Exparel® for up to 72 hours following surgery. The Company expects to move this program into human clinical studies in the second half of 2014.
“Since our last quarterly update, we have significantly strengthened the
Company’s financial outlook with the completion of our recent public
financing, positioning the Company well for the second half of 2014 and
ahead of key milestones for both SUSTOL and our post-surgical pain
program, which should complete Phase 1 before year end,” commented Barry
D. Quart, Pharm.D., Chief Executive Officer of
Results of Operations
Heron Therapeutics’ net loss for the three and six months ended
The increase in net loss was primarily due to the initiation of a Phase
3 label expansion study of SUSTOL in the first quarter of 2014 and
expenses related to new product development, including our new program
targeting the relief of post-surgical pain, which was initiated in
The decrease in net loss per share for the three and six months ended
June 30, 2014 compared to the same periods in 2013 was mainly due to the
increase in shares outstanding in 2014 as a result of our
Heron's lead product candidate, SUSTOL™ (granisetron), is being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). One of the most debilitating side effects of cancer chemotherapy, CINV is a leading cause of premature discontinuation of treatment. There is only one injectable 5-HT3 antagonist approved for the prevention of delayed-onset CINV in patients receiving moderately emetogenic chemotherapy (MEC); none are approved for delayed-onset CINV in patients receiving highly emetogenic chemotherapy (HEC). SUSTOL contains the 5-HT3 receptor antagonist granisetron formulated in the Company's proprietary Biochronomer™ polymer-based drug delivery platform, which allows therapeutic drug levels to be maintained for five days with a single subcutaneous injection. Currently available intravenous and oral formulations of granisetron are approved only for the prevention of acute-onset CINV. Granisetron was selected for SUSTOL because it is widely prescribed by physicians based on a well-established record of safety and efficacy.
About Heron’s Post-Surgical Pain Program
Heron is utilizing its proprietary Biochronomer™ polymer-based drug delivery platform to develop drug candidates designed to extend the duration of action of known active ingredients to address important unmet medical needs. The Company has initiated full development of an established local anesthetic for the treatment of post-surgical pain formulated with its Biochronomer extended release technology. In animal models of post-surgical pain, the Company's drug candidates demonstrated statistically significant pain relief for three days, representing the potential to significantly reduce the need for opiates post-surgery and shorten the length of post-surgical hospital stays. Heron’s lead product candidate in this program, HTX-011, is a unique combination of local analgesic agent bupivacaine and the anti-inflammatory drug meloxicam utilizing its Biochronomer extended release technology.
Forward Looking Statements
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. These
forward-looking statements involve risks and uncertainties, including
uncertainties associated with the timing of completion of the HEC study
and the NDA resubmission, potential approval of SUSTOL™ and
the potential timing for such approval, if approved at all; risks
relating to progress in research and development of HTX-011, including
the timing of planned toxicology and clinical studies; risks related to
other programs; risks related to the launch and acceptance of new
products and other risks and uncertainties identified in the Company's
filings with the
HERON THERAPEUTICS, INC.
Condensed Statements of Operations
(in thousands, except per share amounts)
Three Months Ended
Six Months Ended
|Research and development||$||14,427||$||10,806||$||26,198||$||17,946|
|General and administrative||4,364||4,403||9,915||10,016|
|Total operating expenses||18,791||15,209||36,113||27,962|
|Loss from operations||(18,791||)||(15,209||)||(36,113||)||(27,962||)|
|Basic and diluted net loss per share||$||(0.78||)||$||(1.01||)||$||(1.52||)||$||(1.86||)|
|Shares used in computing basic and diluted net loss per share||
HERON THERAPEUTICS, INC.
Condensed Balance Sheet Data
|June 30,||December 31,|
|Total stockholders’ equity||
Heron Therapeutics, Inc.
Investor Relations Contact:
Jennifer Capuzelo, 858-703-6063
Sr. Manager, Investor Relations
Barry D. Quart, 650-366-2626
Pharm D., Chief Executive Officer