Heron Therapeutics Announces Fourth Quarter and Full Year 2014 Financial Results and Corporate Progress
Fourth Quarter and Recent Corporate Progress:
February 2015, the Company initiated a Phase 1 single-ascending dose, placebo-controlled clinical trial of HTX-011 in healthy volunteers. This study is evaluating safety, pharmacokinetics, and pharmacodynamics of the anesthetic effects of the product. HTX-011 is the Company’s lead product candidate in its pain management program targeting post-operative pain, and is a combination of the local anesthetic bupivacaine and the anti-inflammatory meloxicam in a novel formulation utilizing the Company’s proprietary Biochronomer® polymer-based drug delivery platform technology.
December 2014, the Company disclosed a new development program for HTX-003, a long-acting formulation of buprenorphine, for the treatment of chronic pain and opioid addiction. Utilizing the Company’s Biochronomer technology, HTX-003 was designed to maintain therapeutic levels of buprenorphine for 30 days following a single subcutaneous injection.
“We anticipate closing enrollment the end of this month in MAGIC, our
ongoing Phase 3 study of SUSTOL in patients receiving highly emetogenic
chemotherapy, and we look forward to resubmitting our NDA for SUSTOL to
Results of Operations
The Company’s net loss for the three and twelve months ended
December 31, 2014 was
The increase in net loss was primarily due to the ongoing Phase 3 HEC study of SUSTOL, which was initiated in 2014, and expenses related to new product development, including our program targeting the management of post-operative pain.
The decrease in net loss per share for the three and twelve months ended
December 31, 2014 compared to the same periods in 2013 was mainly due to
the increase in shares outstanding in 2014 as a result of our
About SUSTOL® and Chemotherapy Induced Nausea and Vomiting
Heron Therapeutics’ lead investigational product candidate, SUSTOL® (granisetron injection, extended release), is being developed for the prevention of both acute- and delayed-onset chemotherapy induced nausea and vomiting (CINV) following the administration of moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) agents. Affecting 70-80% of patients undergoing chemotherapy, CINV is one of the most debilitating side effects of such treatments, often attributed as a leading cause of premature discontinuation of cancer treatment. Injectable 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists have been shown to be among the most effective and preferred treatments for CINV, however, an unmet medical need exists for patients suffering from CINV during the delayed-onset phase, which typically occurs one to five days following administration of chemotherapy agents. Only one injectable 5-HT3 receptor antagonist is approved for use following the administration of MEC agents, and none are approved for use following administration of HEC agents. SUSTOL contains the 5-HT3 receptor antagonist granisetron, selected due to its broad use by physicians based on a well-established record of safety and efficacy, and the fact that it is only currently approved for the prevention of CINV during the acute-onset phase. SUSTOL is formulated with the Company's proprietary Biochronomer® polymer-based drug delivery platform technology and in clinical trials has been shown to maintain therapeutic drug levels of granisetron for up to five days with a single subcutaneous injection.
About HTX-019 for Chemotherapy Induced Nausea and Vomiting
HTX-019 is a proprietary injectable formulation of aprepitant, a neurokinin-1 (NK1) receptor antagonist for the prevention of CINV. NK1 receptor antagonists are typically used in combination with 5-HT3 receptor antagonists. At present, the only injectable NK1 receptor antagonist approved in the U.S. contains polysorbate 80, a surfactant, which may cause hypersensitivity reactions or other adverse reactions in some patients. Heron Therapeutics’ formulation for HTX-019 does not contain polysorbate 80, and may have a lower incidence of infusion-site reactions than reported with fosaprepitant.
About HTX-011 for Post-Operative Pain
HTX-011 is a combination of local anesthetic bupivacaine and the anti-inflammatory meloxicam for the management of post-operative pain. HTX-011 is formulated utilizing Heron Therapeutics’ proprietary Biochronomer technology, which extends its duration of action. In an animal model of post-operative pain, HTX-011 significantly reduced pain through 72 hours.
About HTX-003 for Chronic Pain and Addiction
HTX-003 is a long-acting formulation of buprenorphine for the management of chronic pain and opioid addiction. Utilizing Heron Therapeutics’ proprietary Biochronomer technology, HTX-003 is designed to maintain therapeutic drug levels of buprenorphine for 30 days following a single subcutaneous injection with a low potential for patient abuse.
Forward Looking Statements
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995.
HERON THERAPEUTICS, INC.
Statements of Operations
(in thousands, except per share amounts)
|Three Months Ended||Year Ended|
|December 31,||December 31,|
|Research and development||$||14,195||$||8,538||$||54,833||$||32,516|
|General and administrative||5,300||5,293||19,728||21,941|
|Total operating expenses||19,495||13,831||74,561||54,457|
|Loss from operations||(19,495||)||(13,831||)||(74,561||)||(54,457||)|
|Other expense, net||(1,129||)||(212||)||(1,806||)||(826||)|
|Basic and diluted net loss per share||$||(0.71||)||$||(0.75||)||$||(2.87||)||$||(3.42||)|
Shares used in computing basic and diluted net loss per share
|HERON THERAPEUTICS, INC.|
Condensed Balance Sheet Data
|Cash and cash equivalents||$||72,675||$||72,287|
|Total stockholders’ equity||63,062||68,945|
Heron Therapeutics, Inc.
Investor Relations Contact:
Jennifer Capuzelo, 858-703-6063
Sr. Manager, Investor Relations
Barry D. Quart, Pharm D., 650-366-2626
Chief Executive Officer