Overview

* Atossa Therapeutics ( ATOS ) Q3 net loss widens to $8.7 mln, operating expenses rise to $9.3 mln

* Company advances (Z)-endoxifen program with regulatory strategies and clinical trials

* Appointed key leadership roles to drive (Z)-endoxifen development and commercialization and streamline development programs

Outlook

* Atossa targets IND submission for (Z)-endoxifen in Q4 2025

* Company plans to update shareholders on FDA meeting outcome by year-end 2025

* Atossa focuses on NDA-enabling activities for (Z)-endoxifen in 2026

Result Drivers

* R&D EXPENSES - Increased R&D expenses due to higher spending on (Z)-endoxifen trials and drug development costs

* REGULATORY STRATEGY - Co requested a Type C meeting with FDA to accelerate (Z)-endoxifen development for breast cancer risk reduction

* TRIAL STREAMLINING - Streamlined EVANGELINE breast cancer trial to focus on NDA-enabling activities and reduce costs

Key Details

Metric Beat/Mis Actual Consensu

s s

Estimate

Q3 EPS -$0.07

Q3 Net -$8.69

Income mln

Q3 $9.25

Operatin mln

g

Expenses

Q3 -$9.25

Operatin mln

g Income

Q3 -$8.69

Pretax mln

Profit

Analyst Coverage

* The current average analyst rating on the shares is "buy" and the breakdown of recommendations is 4 "strong buy" or "buy", no "hold" and no "sell" or "strong sell"

* The average consensus recommendation for the biotechnology & medical research peer group is "buy"

* Wall Street's median 12-month price target for Atossa Therapeutics Inc ( ATOS ) is $5.50, about 85% above its November 11 closing price of $0.83

Press Release:

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(This story was created using Reuters automation and AI based on LSEG and company data. It was checked and edited by a Reuters journalist prior to publication.)