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Atossa Therapeutics (ATOS) investor relations material
Atossa Therapeutics H.C. Wainwright 27th Annual Global Investment Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.H.C. Wainwright 27th Annual Global Investment Conference summary8 Sep, 2025
Lead asset overview and differentiation
(Z)-endoxifen, the active form of tamoxifen, offers efficacy with fewer side effects and can be dosed higher than tamoxifen.
It uniquely blocks and degrades estrogen receptors, unlike most current therapies.
At higher doses, it activates PKC beta, leading to cancer cell apoptosis.
Clinical safety and efficacy insights
Clinical trials with about 700 women showed reduced hot flashes compared to tamoxifen.
Higher (Z)-endoxifen levels correlated with fewer vasomotor side effects.
In metastatic settings, high-dose (Z)-endoxifen showed clinical response in 25% and partial response in 50% of patients resistant to other endocrine therapies.
Development strategy and trial design
Low doses (1–4 mg) target prevention, while high doses (20–80 mg) are for metastatic disease.
Project Optimus Phase 2 will determine optimal dosing, likely around 40 mg.
Combination trials with CDK4/6 inhibitors are ongoing, with strong recruitment and promising early data.
IND filing for new trials is targeted for early to mid-fourth quarter.
Zinhoxifen hot flash reduction vs tamoxifen?
Metastatic: Rationale for combination therapy focus
Low-dose prevention: Type C meeting outcome timeline
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Next Atossa Therapeutics earnings date
Q3 202511 Nov, 2025
Next Atossa Therapeutics earnings date
Q3 202511 Nov, 2025
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Frequently asked questions
Atossa Therapeutics Inc. is a clinical-stage biopharmaceutical company developing medicines that address significant unmet medical needs in oncology, with a specific focus on breast cancer. The company's lead program is Endoxifen, an active metabolite of tamoxifen, currently in clinical trials for the treatment and prevention of breast cancer. Additionally, Atossa is working on AT-H201 for lung injury caused by cancer treatment and is involved in developing immunotherapy/chimeric antigen receptor therapy programs. The company is headquartered in Seattle, Washington, and its shares are listed on the NASDAQ.
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