Heron Therapeutics Announces First Quarter 2014 Financial Results
05/08/2014
|
“During the first quarter, we achieved a major milestone with the
initiation of a Phase 3 label expansion study of SUSTOL™ (granisetron),
our lead product candidate for the prevention of CINV,” commented Barry
D. Quart, Pharm.D., Chief Executive Officer of
Results of Operations
As of
Heron Therapeutics’ net loss for the first quarter of 2014 was
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 quarter ended
About SUSTOL™
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
In addition to SUSTOL, Heron is also utilizing its proprietary
Biochronomer polymer-based drug delivery platform to develop other drugs
designed to extend the duration of action of known active ingredients to
address important unmet medical needs. In
About
HERON THERAPEUTICS, INC. | ||||||||||
Condensed Statements of Operations |
||||||||||
(in thousands, except per share amounts) |
||||||||||
Three Months Ended | ||||||||||
March 31, | ||||||||||
(Unaudited) | ||||||||||
2014 | 2013 | |||||||||
Operating expenses: | ||||||||||
Research and development | $ | 11,771 | $ | 7,140 | ||||||
General and administrative | 5,551 | 5,612 | ||||||||
Total operating expenses | 17,322 | 12,752 | ||||||||
Loss from operations | (17,322 | ) | (12,752 | ) | ||||||
Interest expense | (216 | ) | (201 | ) | ||||||
Net loss | $ | (17,538 | ) | $ | (12,953 | ) | ||||
Basic and diluted net loss per share | $ | (0.74 | ) | $ | (0.85 | ) | ||||
Shares used in computing basic and diluted net loss per share | 23,686 | 15,254 | ||||||||
HERON THERAPEUTICS, INC. | ||||||||
Condensed Balance Sheet Data |
||||||||
(in thousands) |
||||||||
March 31, | December 31, | |||||||
2014 | 2013 | |||||||
(unaudited) | ||||||||
Cash | $ | 57,475 | $ | 72,287 | ||||
Total assets | 62,793 | 75,937 | ||||||
Total stockholders’ equity |
$ |
55,409 | $ | 68,945 | ||||
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 potential approval of SUSTOL™
(granisetron) and the potential timing for such approval, if approved at
all; progress in research and development programs; timing for
completion of our ongoing Phase 3 study as well as for commencement of
clinical studies of new drug candidates; launch and acceptance of new
products and other risks and uncertainties identified in the Company's
filings with the
Source:
Heron Therapeutics, Inc.
Investor Relations Contact:
Jennifer
Capuzelo, 858-703-6063
jcapuzelo@herontx.com
Corporate
Contact:
Stephen R. Davis, 650-366-2626
Executive Vice
President and Chief Operating Officer