Maxim Group initiated coverage of Atossa Genetics (NASDAQ:ATOS) with a “buy” rating and 12-month price target of $2. The stock closed at 33 cents on Jan. 25.
Atossa is developing an oral formulation of endoxifen for prevention of breast cancer reoccurrence, as well as a topical lotion for reducing high-density breast tissue, respectively.
Both formulations should be in Phase 2 studies in 2018. Both the topical and oral formulations are 505(b)(2)-based on known data for safety and efficacy of tamoxifen and its metabolite, endoxifen, “meaning potentially accelerated timelines to approvals,” writes analyst Jason Kolbert.
Tamoxifen is the most widely used drug to prevent breast cancer recurrence, but it has considerable side effects. In addition, up to 50% of women do not generate enough of the most active metabolite, endoxifen, which likely limits efficacy.
Mr. Kolbert said Atossa is developing a microcatheter delivery system for the intraductal delivery of drugs or biologics, including CAR-T, directly into the breast.
A Phase 2 study of intraductal fulvestrant is ongoing. Atossa also initiated a preclinical program for intraductal CAR-T delivery in breast cancer. The CAR-T program could attract a partner and represents additional upside, he said, adding, “We see multiple catalysts ahead as trials begin and data emerges in 2018.”