Shares of Atossa Genetics Inc. (NASDAQ:ATOS) rose sharply after the company announced Wednesday that it has completed dosing and clinical visits in its Phase 1 study of its proprietary topical endoxifen in men.
The clinical-stage drug company is developing the topical drug for a condition in men called gynecomastia, which is male breast enlargement. According to the Mayo Clinic, 25% of men in the US between the ages of 50 and 69, or approximately 10 million men, suffer from gynecomastia.
“We are now proceeding to the final stages of this study, which are to complete analysis of blood samples and then collect and analyze the data,” said Atossa CEO Steve Quay. “We expect to report preliminary results from the study in the next quarter,” he added.
Shares of the drug maker were up 10.4% to US$2.76 in midday action.
Maxim’s investment thesis
Analysts at Maxim Group said data is expected in the third quarter of 2018 which should “set the stage to move into a Phase 2 program in gynecomastia.”
The Seattle-based company currently has four programs underway: two using its proprietary endoxifen (oral and topical formulations) and two using the firm’s patented microcatheter technology.
Topical endoxifen, which can be applied directly on the breast like a lotion is being developed for both men and women. In addition to the program targeting gynecomastia, a Phase 2 study is expected to initiate in women with high breast density.
In addition to the two programs for the topical, oral endoxifen is being developed in breast cancer for women who are refractory to tamoxifen. A Phase 2 study is expected to start later this year.
“Both the topical and oral formulations of endoxifen continue to advance and management is executing on its clinical strategy,” Maxim Group analysts Jason McCarthy and Caroline Palomeque wrote in a note to clients.
“Catalysts lie ahead as data emerges from ongoing and upcoming studies, which if positive should drive a higher valuation,” they added.
READ: Atossa Genetics poised to execute clinical programs that may unlock shareholder value, says Maxim Group
Atossa just completed a round of equity financing, raising US$13.4mln in capital. The analysts say the company now had US$16mln in cash on the balance sheet or runway into late 2019
Endoxifen is the most active ingredient in the FDA-approved drug tamoxifen, which has been used to prevent recurrence in breast cancer survivors for more than 40 years.
The analysts maintained their Buy rating and US$10 price target on the company.
--Updates headline to clarify nature of results--