Anacor Pharmaceuticals, Inc. (NASDAQ:ANAC) today announced its financial results for the first quarter ended March 31, 2014. “We made important progress in the first quarter on our two lead programs - Kerydin and AN2728,” said Paul Berns, President and Chief Executive Officer of Anacor Pharmaceuticals. “We have had a constructive dialogue with the FDA throughout its review of our New Drug Application for Kerydin, and we are preparing for Kerydin’s launch later this year, pending FDA approval. In addition, we recently initiated the pivotal Phase 3 studies of AN2728 for the treatment of mild-to-moderate atopic dermatitis which are continuing to enroll at sites throughout the United States.” First Quarter 2014 Highlights and Recent Developments Clinical Update and Anticipated Milestones
- Kerydin (tavaborole) – our lead topical antifungal product candidate for the treatment of mild-to-moderate onychomycosis of the toenail. Onychomycosis is a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States according to Podiatry Today.
- Kerydin has a PDUFA V goal date of July 29, 2014 and, subject to FDA approval, we anticipate launching Kerydin in the second half of 2014.
- In the first quarter of 2014, we initiated a clinical study of Kerydin to evaluate its efficacy, safety and local tolerability when treating mild-to-moderate toenail onychomycosis in conjunction with debridement, as needed. The objective of this study is to examine how Kerydin performs in treating mild-to-moderate onychomycosis of the toenail when podiatrists incorporate it into their typical onychomycosis treatment regimen, which may include debridement and other adjunctive treatments, but may not include any oral antifungal therapy.
- AN2728 – our lead topical anti-inflammatory product candidate for the treatment of mild-to-moderate atopic dermatitis. Atopic dermatitis is a chronic rash characterized by inflammation and itch. According to the National Eczema Association, almost 18 million people in the United States have atopic dermatitis, and approximately 8% - 18% of all infants and children are affected by the disease.
- In February 2014, we successfully completed an End of Phase 2 meeting with the FDA and reached agreement on the major parameters of the Phase 3 trial design.
- In March 2014, we enrolled the first patient in the pivotal Phase 3 studies of AN2728 to treat patients with mild-to-moderate atopic dermatitis. We plan to enroll approximately 750 patients in each of two Phase 3 clinical trials.
- We expect data from the Phase 3 studies of AN2728 in mild-to-moderate atopic dermatitis in the second half of 2015.
|ANACOR PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data)|
|Three Months Ended March 31,|
|Research and development (1)||15,935||11,159|
|General and administrative (1)||8,328||4,716|
|Total operating expenses||24,263||15,875|
|Loss from operations||(20,105||)||(14,167||)|
|Net loss per common share – basic and diluted||$||(0.51||)||$||(0.42||)|
|Weighted-average number of common shares used in calculating net loss per common share - basic and diluted||41,739,272||35,846,287|
|(1) Includes the following noncash, stock-based compensation expenses:|
|Research and development expenses||$||1,085||$||425|
|General and administrative expenses||$||3,651||$||334|
|ANACOR PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEET DATA (in thousands)|
|March 31,||December 31,|
|Cash, cash equivalents and investments (2)||$||146,737||$||166,815|
|Total stockholders’ equity||105,691||121,432|