Atossa Therapeutics Inc (NASDAQ:ATOS) shares have a 300% upside on the strength of the clinical-stage biopharmaceutical company’s lead asset Z-endoxifen as a potential breast cancer treatment, according to analysts at H.C. Wainwright & Co (HCW).
Its analysts initiated coverage on Atossa with a ‘buy’ rating and a $4 price target. In late morning trade, the stock was 8.9% higher at $1.
HCW said Atossa’s Z-endoxifen - the active metabolite of tamoxifen, a drug approved to treat advanced breast cancer in 1977 – may become the first treatment of measurable breast density. It described Z-endoxifen as a “standalone and superior” drug.
“Z-endoxifen has a half-life of 49 to 68 hours compared to 7 days with tamoxifen and reaches steady-state within 7 days compared to 4 weeks for tamoxifen, which enables a quick onset of action and potential for a better safety profile as the drug is washed out sooner,” HCW wrote.
“Given many of the pharmacokinetic/pharmacodynamics benefits of Z-endoxifen versus tamoxifen including greater potency, shorter time to steady-state, and improved safety, we believe Z-endoxifen could have a greater reduction in measurable breast density versus tamoxifen.”
The investment bank highlighted that there are currently no approved therapies for measurable breast density despite about 50% of women having dense breasts.
High breast density makes it harder to detect cancer because both appear white on a mammogram and women with high breast cancer have a higher risk of cancer, studies have shown.
“We believe low dose Z-endoxifen which is a simple oral medication for six months, if safe and effective could secure a large market share in women with the highest breast density, particularly, if Z-endoxifen is also found to lead to a reduction in breast cancer incidence,” HCW wrote.
Its analysts see several positive catalysts for Atossa stock as it receives data from its ongoing clinical studies.
Initial data from the Phase 2 Karisma trial evaluating Z-endoxifen in measurable breast density is due in the second half of 2024 and topline data from the Phase 2 EVANGELINE trial evaluating Z-endoxifen in neoadjuvant breast cancer is due in the third quarter of 2026.
Atossa is also conducting a study in partnership with Quantum Leap Healthcare called I-SPY-2 which involves the treatment of 20 women with neoadjuvant breast cancer with Z-endoxifen, with initial data expected in the second half of 2024.
“With the company’s share price trading near cash levels, we believe investors are currently attributing no value to the pipeline, and we significant upside potential on the second half of 2024 catalysts,” the analysts concluded.