The Seattle-based clinical-stage drug company is developing novel, proprietary therapeutics and delivery methods for breast cancer. It is developing a new drug called endoxifen, which can be applied directly to the breast like a lotion, and a new way to deliver therapies, such as “CAR-T” cells, through microcatheters to target the site of the breast cancer.
Atossa just completed a round of equity financing, raising US$13.4mln. The analysts estimated the company now had US$16mln in cash on the balance sheet or runway into late 2019.
The company currently has four programs underway: two using its proprietary endoxifen (oral and topical formulations) and two using the firm’s patented microcatheter technology.
“As we head into 2H18, Atossa has now raised enough capital to extend its cash runway into late 2019. The company is now positioned to execute on clinical programs and reach catalysts, which if positive should unlock shareholder value,” wrote Maxim Group analysts Jason McCarthy and Caroline Palomeque in a note to clients.
Expedited 505(b)2 pathway
Atossa’s endoxifen is being developed through the 505(b)(2) regulatory pathway, which is potentially quicker.
“As endoxifen is the active metabolite of tamoxifen, Atossa is able to leverage existing data sets and could potentially accelerate timelines for endoxifen trials (oral and topical),” wrote the analysts.
“In addition, the oral formulation, demonstrated peak therapeutic levels in women in only 7 days versus 50-200 for tamoxifen. As such, in addition to treating tamoxifen refractory breast cancer patients, endoxifen could potentially be used in the neoadjuvant setting.”
In layman's terms, Atossa is evaluating endoxifen in the 'neo-adjuvant setting,' meaning it would be used to treat breast cancer before surgery to remove the cancerous tumor.
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.
Shares of Atossa Genetics were down 2.5% to US$2.53 in afternoon trading.