Core Viewpoint - Atossa Therapeutics is advancing its regulatory strategy for (Z)-endoxifen, focusing on expedited pathways for metastatic, neoadjuvant, and risk-reduction settings in breast cancer treatment [1][2]. Regulatory Strategy - The company completed a Type C meeting with the FDA on November 17, 2025, which provided feedback on potential expedited regulatory pathways and development options for (Z)-endoxifen [1][2]. - The meeting clarified routes to accelerate clinical development and regulatory review, allowing Atossa to pursue a faster development strategy across multiple breast cancer indications [2][3]. Clinical Development - Atossa has submitted an Investigational New Drug (IND) application for its metastatic breast cancer program and anticipates additional IND submissions in 2026 to explore combination strategies [4]. - The clinical program has involved nearly 800 participants across multiple trials, with a focus on creating value-creating milestones [5]. Product Profile - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) that can inhibit and potentially degrade estrogen receptors, showing activity in tumors resistant to other therapies [5]. - The company is developing a proprietary oral formulation of (Z)-endoxifen that bypasses stomach acid, enhancing bioavailability and therapeutic integrity [6]. Intellectual Property - Atossa's (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including four recently issued U.S. patents and numerous pending applications worldwide [7]. Clinical Trials and Indications - The company is preparing a dose-ranging study for metastatic breast cancer and continues enrollment in the Phase 2 EVANGELINE trial for neoadjuvant ER+/HER2- breast cancer [9]. - Development efforts also include a low-dose strategy targeting mammographic breast density and overall breast cancer risk [9].

Core Insights - Atossa Therapeutics is advancing its research on (Z)-endoxifen for breast cancer treatment and prevention, with four abstracts accepted for presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS) [1][2]. Presentation Details - The first poster presentation will cover initial results from the RECAST DCIS trial, focusing on active surveillance and novel endocrine therapy agents for DCIS management, scheduled for December 11, 2025 [3]. - The second presentation will discuss the use of low-dose (Z)-endoxifen in the I-SPY2 Endocrine Optimization Pilot, also on December 11, 2025 [3]. - The third presentation will explore how (Z)-endoxifen maintains ER antagonist function against ESR1 mutants, scheduled for December 12, 2025 [3]. - The final presentation will detail a randomized Phase 2 non-inferiority trial comparing (Z)-endoxifen plus Goserelin versus Exemestane plus Goserelin as neoadjuvant treatment for premenopausal women with ER+/HER2- breast cancer, set for December 12, 2025 [3]. Company Overview - Atossa Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative therapies for unmet needs in breast cancer, emphasizing disciplined capital allocation to support future regulatory submissions and potential commercialization [4].

Core Insights - Atossa Therapeutics has appointed CORE IR to enhance investor awareness and strengthen shareholder engagement [1][2] - The collaboration aims to broaden the company's reach to both institutional and retail audiences [1] - CORE IR will provide a comprehensive suite of investor relations services, including strategic messaging and investor outreach [2] Company Overview - Atossa Therapeutics is a clinical-stage biopharmaceutical company focused on innovative approaches to breast cancer treatment and prevention [3] - The company's lead product candidate, (Z)-endoxifen, is designed for use across the breast cancer spectrum, including risk-reduction and treatment in various settings [3] - Atossa is committed to advancing clinical research programs to improve patient outcomes and create sustainable value for shareholders [3]