Arena Pharmaceuticals Announces Third Quarter 2011 Financial Results
"We are focused on submitting our response to the
Research and development expenses continued to decline in the third quarter of 2011 to
Total interest and other expense in the third quarter of 2011 decreased to
Lorcaserin Regulatory Update
- Modified and repeated two preclinical studies to further assess lorcaserin's abuse potential: A study of serotonin 2A and 2C receptor-associated behaviors and a drug discrimination study. Arena believes the results of these studies are consistent with the results of the similar studies previously conducted and that were included in the original lorcaserin New Drug Application (NDA).
- Investigated the potency of lorcaserin relative to a spectrum of 33 reference compounds, including compounds known to cause valvulopathy and those not known to cause valvulopathy, as part of the serotonin 2B receptor analyses to further refine lorcaserin's receptor activity. Arena believes the results demonstrate that lorcaserin's potency is closer to the reference compounds not known to cause valvulopathy than the reference compounds known to cause valvulopathy. Arena expects to
complete the remainder of the receptor work, including analyses to relate receptor potency to human exposure, in time to submit the complete response to the
US Food and Drug Administration(FDA) around the end of the year.
- Analyzed time to death due to mammary adenocarcinoma as an additional indicator of rat mammary tumor aggressiveness using the Pathology Working Group's updated data set. Time to death specifically attributed to mammary adenocarcinoma was significantly decreased only in the lorcaserin high-dose group. In a second analysis which assumed deaths due to unspecified mammary tumor in rats with both fibroadenoma and adenocarcinoma were caused by adenocarcinoma, time to death was accelerated in the lorcaserin mid-dose group as well, although the incidence of mammary adenocarcinoma was not increased over controls in the mid-dose group.
- A series of
mechanistic studies that are intended to test whether there is a causal relationship between lorcaserin, prolactin and mammary tumor development in rats is ongoing. Arena expects to complete these studies in time to submit the complete response to the
FDAaround the end of the year.
- Assigned the
UK's Medicines and Healthcare products Regulatory Agency as marketing authorization application Rapporteur and Sweden's Medical Products Agencyas Co-rapporteur. Arena also received approval from the Pediatric Development Committee for its pediatric investigation plan application, which defers all pediatric studies until after European Medicines Agencyapproval.
Other recent developments include:
- Entered into an equity line of credit agreement with
Azimuth Opportunity, L.P., or Azimuth, that provides that, upon the terms and subject to the conditions and limitations set forth in the agreement, Azimuth is committed to purchase up to $50 million worth of shares of Arena common stock over a 24-month term. Arena will determine, at its sole discretion, the timing and amount of any sales of its stock, subject to certain conditions.
- Presented three posters of new data analyses from the lorcaserin Phase 3 clinical trial program at Obesity 2011, the 29th Annual Scientific Meeting of
The Obesity Society.
- Announced that
Robert E. Hoffmanrejoined Arena as Vice President, Finance and Chief Financial Officer.
Scheduled Financial Results Call
Arena will host a conference call and webcast to discuss the third quarter 2011 financial results and to provide a business and financial update tomorrow,
The conference call may be accessed by dialing 877.643.7155 for domestic callers and 914.495.8552 for international callers. Please specify to the operator that you would like to join the "
Upcoming Corporate Presentations
Arena is planning to present at upcoming investment and industry conferences, including:
- Piper Jaffray 23rd Annual
Health Care Conference, November 29-30, 2011, New York, New York
- 30th Annual
J.P. Morgan Healthcare Conference, January 9-12, 2012, San Francisco, California
Lorcaserin is an investigational drug candidate intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (BMI greater than or equal to 30) or patients who are overweight (BMI greater than or equal to 27) and have at least one weight-related co-morbid condition. Lorcaserin is a new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism. Arena has patents that cover lorcaserin in
Arena submitted a NDA for lorcaserin to the
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate is intended for weight management.
Arena Pharmaceuticals® and Arena® are registered service marks of the company.
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the advancement, therapeutic indication and use, safety, efficacy, tolerability, abuse potential, mechanism of action and potential of lorcaserin; lorcaserin's potency with respect to compounds known to cause valvulopathy; the response to the lorcaserin CRL and the filing of an MAA for lorcaserin, including related plans, activities, progress and timing; the Eisai collaboration and potential activities thereunder; the equity line of credit with Azimuth and potential activities thereunder; lorcaserin's patent coverage; and Arena's focus, goals, strategy, research and development programs, and ability to develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private
Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the following: the timing of regulatory review and approval is uncertain; regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than we or others do, request additional information, have additional recommendations or change their guidance or requirements before or after approval; the risk that data and other information related to Arena's research and development programs may not meet safety or efficacy requirements or otherwise be sufficient for regulatory approval; Arena's response to the CRL for the lorcaserin NDA or submission of a Marketing Authorization Application for regulatory
approval of lorcaserin may not be submitted when anticipated, if at all; unexpected or unfavorable new data; risks related to commercializing new products; Arena's ability to obtain and defend its patents; the timing, success and cost of Arena's research and development programs; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in the manner expected or at all; Arena's ability to obtain adequate funds; risks related to relying on collaborative agreements; the timing and receipt of payments and fees, if any, from collaborators; and satisfactory resolution of pending and any future litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's
forward-looking statements are disclosed in Arena's filings with the
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
Three months ended
Nine months ended
Cost of manufacturing services
Research and development
General and administrative
Amortization of acquired technology & other intangibles
Total operating expenses
Interest and Other Income (Expense)
Gain (Loss) from valuation of derivative liabilities
Loss on extinguishment of debt
Total interest and other expense, net
Deemed dividend related to beneficial conversion feature of convertible preferred stock
Net loss allocable to common stockholders
Net loss per share allocable to common stockholders, basic
Net loss per share allocable to common stockholders, diluted
Shares used in calculating net loss per share allocable to common stockholders, basic
Shares used in calculating net loss per share allocable to common stockholders, diluted
Condensed Consolidated Balance Sheet Data
Cash and cash equivalents
Other current assets
Land, property & equipment, net
Acquired technology & other non-current assets
Liabilities and Stockholders' Equity
Accounts payable and accrued liabilities
Total deferred revenues
Total derivative liabilities
Total note payable to Siegfried
Total note payable to
Total lease financing obligations & other long-term liabilities
Total stockholders' equity
Total liabilities & stockholders' equity
The Condensed Consolidated Balance Sheet Data has been derived from the audited financial statements as of that date.
The outstanding principal balance of the note payable to
Vice President, Finance and Chief Financial Officer
858.453.7200, ext. 222
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