Heron Therapeutics Announces Third Quarter and Year-to-Date 2014 Financial Results and Corporate Highlights
Third Quarter Highlights and
Due to a slower rate of enrollment than projected over the last
quarter for Heron’s ongoing Phase 3 study of SUSTOL®
(granisetron injection, extended release) for the prevention of
delayed-onset chemotherapy induced nausea and vomiting (CINV) in
patients receiving highly emetogenic chemotherapy (HEC) agents, the
Company now anticipates completing enrollment in the first quarter of
2015, with the resubmission of the new drug application (NDA) to the
U.S. Food and Drug Administration( FDA) shortly thereafter.
- The Company expects to initiate a Phase 1 study of HTX-011 in the coming weeks. HTX-011 is the Company’s lead candidate in its pain management program, and is a combination of local anesthetic bupivacaine and the anti-inflammatory meloxicam in a novel formulation utilizing the Company’s proprietary Biochronomer® polymer-based drug delivery platform.
The Company has disclosed a new development program as part of its
growing CINV franchise. HTX-019 is an intravenous (IV), polysorbate
80-free formulation of aprepitant, which is a substance P/neurokinin-1
(NK1) receptor antagonist. NK1 receptor
antagonists, such as HTX-019, are used in combination with 5-HT3
receptor antagonists in treatment of CINV, and are complimentary to
the Company’s SUSTOL program. Registration of HTX-019 is expected to
use the 505(b)(2) regulatory approval pathway for new drug
applications filed with the
FDA, with potential commercial launch in 2016.
“While we are disappointed that the HEC study will be a few months late
in completing, we continue to make significant progress with SUSTOL and
our internal pipeline programs,” commented Barry D. Quart, Pharm.D.,
Chief Executive Officer of
Results of Operations
Heron Therapeutics’ net loss for the three and nine months ended
September 30, 2014 was
The increase in net loss was primarily due to the initiation of the
Phase 3 HEC study of SUSTOL in 2014 and expenses related to new product
development, including our program targeting the relief of post-surgical
pain, which was initiated in
The decrease in net loss per share for the three and nine months ended
September 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 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). 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 receptor 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 has been shown in clinical studies to maintain therapeutic drug levels of SUSTOL for up to 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 HTX-011 and HTX-019 Development Programs
The Company has initiated development of HTX-011 for pain management. HTX-011 is a combination of local anesthetic bupivacaine and the anti-inflammatory meloxicam in a novel formulation utilizing the proprietary Biochronomer polymer-based drug delivery platform.
HTX-019 is a proprietary intravenous formulation of aprepitant, an NK1 receptor antagonist. HTX-019 does not contain polysorbate 80, which may cause hypersensitivity reactions in some patients. At present, there is only one intravenous NK1 receptor antagonist approved in the U.S. for the prevention of CINV. NK1 receptor antagonists are always used in combination with a 5-HT3 receptor antagonist for the prevention of CINV.
Forward Looking Statements
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. Heron cautions
readers that forward-looking statements are subject to certain risks and
uncertainties that could cause actual results to differ materially.
These risks and uncertainties include those associated with the timing
of completion of the HEC study, and the results thereof, and the NDA
resubmission for SUSTOL, potential regulatory approval of SUSTOL and the
timing for such approval, if approved at all; risks relating to progress
in research and development of HTX-019, HTX-011 and our other product
candidate programs, including the timing of planned toxicology and
clinical studies; the risk that safety and efficacy data from our
clinical studies may not warrant further development of our product
candidates, risks related to the launch and acceptance of new products
generally; risks related to our financial position and our ability to
raise additional capital to fund operations if necessary or to pursue
additional business opportunities; risks related to strategic business
alliances we may pursue or the potential acquisition of other products
or technologies 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||Nine Months Ended|
|September 30,||September 30,|
|Research and development||$||14,731||$||6,216||$||40,929||$||24,162|
|General and administrative||4,222||6,448||14,137||16,464|
|Total operating expenses||18,953||12,664||55,066||40,626|
|Loss from operations||(18,953||)||(12,664||)||(55,066||)||(40,626||)|
|Interest and other expense||(241||)||(209||)||(677||)||(614||)|
|Basic and diluted net loss per share||$||(0.66||)||$||(0.84||)||$||(2.17||)||$||(2.69||)|
|Shares used in computing basic and diluted net loss per share||
HERON THERAPEUTICS, INC.
Condensed Balance Sheet Data
|Total stockholders’ equity||$||81,008||$||68,945|
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