KYTHERA Biopharmaceuticals, Inc. (KYTH) announced that it has initiated a public offering of its common stock worth $100 million.
The company intends to use the funds for further development and commercialization of its candidate, ATX-101, which is being evaluated for the reduction of submental fat. The remaing funds will be used for general corporate purposes and working capital requirements. Upon approval, ATX-101 will enjoy the status of being the first-in-class submental contouring injectable drug.
We believe that the utilization of funds for further development and commercialization of ATX-101, the lead candidate at KYTHERA, is a prudent move by the company. Last month, KYTHERA reported encouraging top line data from two phase III pivotal studies on ATX-101.
The pivotal studies, REFINE-1 (Study ATX-101-11-22) and REFINE-2 (Study ATX-101-11-23), were conducted in the U.S. and Canada. All primary as well as secondary endpoints were met. The studies evaluated the efficacy and safety of ATX-101 (2 mg/cm2) versus placebo in reducing submental fat.
The REFINE-1 study result showed that while 70.3% patients on ATX-101 (versus 18.7% in the placebo arm) showed an improvement of at least one grade, 13.4% patients on ATX-101 (versus 0% in the placebo arm) improved two grades from the baseline.
Results from the REFINE-2 study showed that while 66.9% patients on ATX-101 (versus 22.4% in the placebo arm) showed an improvement of at least one grade, 18.7% patients on ATX-101 (versus 3.2% in the placebo arm) improved two grades from the baseline.
The studies also achieved secondary endpoints which included reduction in volume of the submental region as measured by magnetic resonance imaging (:MRI), and improvement in visual and psychological impacts of submental fat, assessed using the Patient-Reported Submental Fat Impact Scale. The candidate was found to be safe with no treatment-related serious adverse events observed during the studies.
Kythera currently carries a Zacks Rank #3 (Hold). Currently, companies which look attractive include Actelion Ltd. (ALIOF) with a Zacks Rank #1 (Strong Buy), and Cempra, Inc. (CEMP) and Alexion Pharmaceuticals, Inc. (ALXN) with a Zacks Rank #2 (Buy).