SAN DIEGO, Aug. 3, 2009 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today reported financial results for the second quarter ended June 30, 2009.
Arena reported a lower net loss allocable to common stockholders in the second quarter of 2009 of $38.0 million, or $0.48 per share, compared to a net loss allocable to common stockholders in the second quarter of 2008 of $65.8 million, or $0.89 per share, and a net loss allocable to common stockholders in the first half of 2009 of $88.6 million, or $1.16 per share, compared to a net loss allocable to common stockholders in the first half of 2008 of $120.8 million, or $1.64 per share.
"We are on track to announce results from the BLOSSOM trial in September, which we expect will be the final piece of lorcaserin's NDA that we plan to submit by the end of this year," stated Jack Lief, Arena's President and Chief Executive Officer. "Based on its emerging efficacy, safety and tolerability profile, lorcaserin has the potential to be an important new treatment option for patients needing to better manage their weight and improve their overall health. Our improved financial position strengthens our ability to obtain marketing approval for lorcaserin and our position in partnership discussions."
As expected, research and development expenses declined significantly to $24.2 million in the second quarter of 2009 from $56.2 million in the second quarter of 2008. Research and development expenses declined to $66.8 million in the first half of 2009 from $103.6 million in the first half of 2008. This decrease primarily resulted from decreased clinical trial costs due to the completion of clinical and preclinical studies as Arena prioritized its spending towards activities that support filing a New Drug Application, or NDA, for lorcaserin. Arena expects its research and development expenses to continue to decline this year as dosing in BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), the second of two pivotal trials evaluating the safety and efficacy of lorcaserin for weight management, is now complete and Arena realizes expected cost savings from its recently completed workforce reduction and other cost-containment efforts. Research and development expenses in the first half of 2009 included $1.8 million in non-cash, share-based compensation expense, compared to $2.2 million in the first half of 2008. General and administrative expenses totaled $5.7 million in the second quarter of 2009, compared to $7.2 million in the second quarter of 2008, and $13.3 million in the first half of 2009, compared to $16.0 million in the first half of 2008. This decrease is primarily attributable to lower patent and other legal fees. General and administrative expenses in the first half of 2009 included $1.6 million in non-cash, share-based compensation expense, compared to $2.1 million in the first half of 2008.
At June 30, 2009, cash, cash equivalents and short-term investments totaled $39.6 million and approximately 80.1 million shares of common stock were outstanding. In July 2009, Arena received net proceeds of approximately $95.6 million from a $100.0 million secured loan and approximately $49.7 million from a public offering of 12.5 million shares of its common stock.
Arena's Recent and Second Quarter Developments
- Completed dosing in all lorcaserin clinical trials expected to be included in the planned NDA submission. Arena plans to report results from BLOSSOM in September 2009.
- Completed enrollment in BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus), a one-year study evaluating lorcaserin in obese and overweight patients with type 2 diabetes. Results from BLOOM-DM will be submitted as a supplement to the lorcaserin NDA filing.
- Announced a late-breaking poster presentation of positive results from BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), the first of two pivotal trials evaluating the safety and efficacy of lorcaserin for weight management, at the 69th Scientific Sessions of the American Diabetes Association. Lorcaserin patients achieved highly significant categorical and absolute weight loss in Year 1, and continued treatment with lorcaserin in Year 2 helped significantly more patients maintain their weight loss as compared to those on placebo. 66.4% of lorcaserin patients who completed one year of treatment according to the trial's protocol lost at least 5% of their weight and the average weight loss in this responder population was 26 pounds. Treatment with lorcaserin also resulted in highly significant improvements as compared to placebo in multiple secondary endpoints associated with cardiovascular risk. Lorcaserin was very well tolerated, did not result in increased risk of depression and was not associated with development of cardiac valvular insufficiency.
- Ortho-McNeil-Janssen completed a Phase 1 clinical trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single ascending dose of APD597 in healthy volunteers. Ortho-McNeil-Janssen has initiated another clinical trial evaluating multiple ascending doses of APD597.
- Completed a public offering of 12.5 million shares of common stock, resulting in net proceeds to Arena of approximately $49.7 million.
- Received net proceeds of $95.6 million from a $100.0 million secured loan provided by Deerfield Management. The outstanding principal accrues interest until maturity in June 2013 at a rate of 7.75% per annum. In connection with the loan, Arena issued Deerfield warrants for 28 million shares of its common stock at an exercise price of $5.42 per share.