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Note 1 - Organization and Business | 12 Months Ended
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Dec. 31, 2014
Disclosure Text Block [Abstract] |
Business Description and Basis of Presentation [Text Block] |
1. | Organization and Business
Heron Therapeutics, Inc. (formerly A.P. Pharma, Inc.) is a biotechnology company using its proprietary technology and innovative efforts to develop products to address unmet medical needs. Our product development efforts focus on identifying new delivery methods and formulations utilizing known compounds that may expand or extend the therapeutic effect or duration of action, or eliminate the drawbacks of current therapies. Our proprietary Biochronomer polymer-based drug delivery platform technology is designed to improve the therapeutic profile of injectable pharmaceuticals. We continue to evaluate other development programs, technologies or product candidates that may be complementary to or synergistic with our existing programs and product development goals. Our Biochronomer technology, with which SUSTOL and certain of our other product candidates are formulated, consists of bioerodible polymers designed to release drugs over a defined period of time, depending on the medical need of a given therapeutic target. We have demonstrated that our Biochronomer technology can deliver drugs over periods varying from days to weeks and that the technology is potentially applicable to a range of therapeutic areas, including the prevention of chemotherapy-induced nausea and vomiting (“CINV”) and pain management, among others. Furthermore, we have completed comprehensive animal and human toxicology studies that have established that our Biochronomer polymer is well tolerated. Our lead product candidate, SUSTOL, is in development for the prevention of CINV following administration of chemotherapeutic agents. Our development programs include HTX-011 for the management of post-operative pain, HTX-019 for the prevention of CINV and HTX-003 for management of chronic pain and opioid addiction. Our lead investigational product candidate, APF530, which we intend to market as SUSTOL (granisetron injection, extended release), subject to regulatory approval, is being developed for the prevention of both acute- and delayed-onset CINV. The 5-hydroxytryptamine type 3 (“5-HT3”) receptor antagonist granisetron was selected for SUSTOL because it is widely prescribed by physicians based on a well-established record of safety and efficacy. Injectable and oral formulations of granisetron are currently approved, but are only for the treatment of acute-onset CINV. SUSTOL is formulated utilizing our proprietary Biochronomer technology and has been shown in clinical studies to maintain therapeutic drug levels of granisetron for up to five days with a single subcutaneous injection. In 2014, we initiated a Phase 3 clinical study with SUSTOL for the prevention of delayed-onset CINV following the administration of highly emetogenic agents (“HEC study”), which, if successful, would differentiate SUSTOL from the other 5-HT3 receptor antagonists that are currently approved. W e anticipate completing enrollment of our HEC study at the end of the first quarter of 2015. In May 2009, we filed a New Drug Application (“NDA”) for SUSTOL with the U.S Food and Drug Administration (“FDA”) under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. In March 2010, we received our first Complete Response Letter (“CRL”), which stated that the May 2009 NDA requesting approval of SUSTOL, could not be approved as it was initially submitted. The primary points raised in the initial CRL were related to the dosing system, certain identified deficiencies in the chemistry, manufacturing, and control (“CMC”) review, and the request we perform additional studies showing bioequivalence and metabolic rates and on human factors, and to perform a QT study. We met with the FDA in 2011 to clarify the comments and requests and subsequently performed additional work and data analyses which we believed addressed the concerns raised in the 2010 CRL. In September 2012, we resubmitted the NDA seeking approval for SUSTOL and in March 2013, the FDA issued a second CRL. The FDA identified several additional issues precluding the approval of the SUSTOL NDA resubmission, including further issues relating to the CMC review and deficiencies at certain of our contract manufacturers, and requested that we repeat human factors testing using commercially equivalent material, as well to provide data to allow reanalysis of our Phase 3 clinical results under the revised ASCO 2011 CINV guidelines. We believe that we have substantially addressed the issues raised in the March 2013 CRL, which will be reflected in our upcoming resubmission. We intend to include the results of our ongoing HEC study in the resubmission of our NDA for SUSTOL, which we anticipate filing mid-year 2015. In November 2013, we initiated a development program targeting pain management. In recent years, the FDA has focused on approving drugs to successfully treat post-surgical pain, to reduce reliance on opioids, which can lead to post-surgical complications, extended hospitalization, as well as abuse and addiction. We believe there is significant opportunity for a non-opioid, sustained-release product targeting the post-surgical pain market. Our lead product candidate for this program is HTX-011, a combination of the local anesthetic bupivacaine and the anti-inflammatory meloxicam formulated utilizing our proprietary Biochronomer technology to release drug for up to 72 hours. We intend to evaluate this product in soft-tissue, nerve block, and orthopedic post-surgical settings. In the first quarter of 2015, we initiated a Phase 1 study to evaluate the safety of HTX-011 in healthy volunteers. Following the completion of the ongoing Phase 1 study, we plan to initiate additional Phase 1b/2 studies in 2015. In November 2014, we announced our development program for HTX-019. HTX-019 is a proprietary injectable formulation of aprepitant, a neurokinin-1 (“NK1”) receptor antagonist used in combination with 5-HT3 receptor antagonists for the prevention of CINV. The HTX-019 formulation is distinguishable from the only injectable NK1 receptor antagonist approved in the U.S. for the prevention of CINV, in that it does not contain polysorbate 80, which may cause hypersensitivity or other adverse reactions in some patients. We believe there is an unmet need for expanded options for NK1 receptor antagonists, particularly those which may potentially reduce the risk of complications from hypersensitivity reactions. Subject to discussion with the FDA, we plan to develop HTX-019 utilizing the 505(b)(2) registration pathway. In December 2014, we disclosed a second investigational product in our pain management program. HTX-003 is a long-acting formulation of buprenorphine for the treatment of chronic pain and opioid addiction. HTX-003 is formulated with our Biochronomer technology to deliver drug over 30 days with a single subcutaneous injection and accordingly is expected to have a low potential for patient abuse. We are presently evaluating our plans for further development for this product. In January 2014, we changed our name from A.P. Pharma, Inc. to Heron Therapeutics, Inc. Effective January 13, 2014, we effected a 1-for-20 reverse split of our outstanding common stock (“Reverse Stock Split”) (See Note 7). Liquidity We have incurred significant operating losses and negative cash flows from operations and we have an accumulated deficit of $315.2 million as of December 31, 2014. Since 2011, we completed a total of five rounds of equity and/or convertible debt financings, which provided us with cash of approximately $194.3 million, net of issuance costs, to fund operations (see Notes 5 and 6). As of December 31, 2014, we had cash and cash equivalents on hand of $72.7 million. We believe that our current working capital is sufficient to fund operations through 2015, including pursuing regulatory approval to market SUSTOL, and completing Phase 1 human clinical studies commenced in 2015 relative to our HTX-011 and HTX-019 development programs and related preclinical activities. In the event we were to pursue clinical product development in other areas, potentially acquire other strategic assets, or begin to make significant investments in preparing for commercialization of SUSTOL, we would need to raise additional capital. If we are unable to obtain sufficient financing on acceptable terms or otherwise, we may be required to reduce or defer our activities. Our capital requirements going forward will depend on numerous factors, including: the scope, rate of progress, results and costs of preclinical testing and clinical trials, including completing our HEC Study; an approval decision by the FDA with respect to SUSTOL; the timing of and costs associated with the commercial launch of SUSTOL, if approved; the degree of commercial success of SUSTOL; the number and characteristics of product development programs we pursue and the pace of each program including the timing of clinical trials; the time, cost and outcome involved in seeking other regulatory approvals; scientific progress in our research and development programs; the magnitude and scope of our research and development programs; our ability to establish and maintain strategic collaborations or partnerships for research, development, clinical testing, manufacturing and marketing of our product candidates; the cost and timing of establishing sales, marketing and distribution capabilities if we commercialize products independently; the cost of establishing clinical and commercial supplies of our product candidates and any products that we may develop; and general market conditions. We may not be able to raise sufficient additional capital when we need it on favorable terms, or at all. The sale of additional equity in the future may be dilutive to our stockholders. If we are unable to obtain adequate funds on reasonable terms, we may be required to curtail operations significantly or to obtain funds by entering into financing, supply or collaboration agreements on unattractive terms.

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