Core Viewpoint - Atossa Therapeutics has received positive feedback from the FDA regarding its proposed dose optimization trial for (Z)-endoxifen, aimed at treating ER+/HER2- metastatic breast cancer, which is a significant milestone for the company [1][2][3] FDA Feedback and Clinical Development - The FDA's constructive responses affirm key elements of Atossa's clinical development plan, eliminating the need for a virtual pre-IND meeting and facilitating a potential IND submission by Q4 2025 [2][3] - The FDA supports Atossa's dose optimization strategy and agrees with the existing nonclinical data package, enhancing confidence in the company's regulatory approach [3][7] Dose Optimization Strategy - The FDA has confirmed that existing clinical and nonclinical data are sufficient to initiate Part A (monotherapy) of the proposed dose optimization study, providing guidance on study design enhancements [7] - Atossa plans to explore multiple dose levels in its upcoming clinical study to define the optimal dose for combination therapy, aligning with the FDA's Project Optimus initiative [6][7] Combination Study Support - The FDA agrees with the scientific rationale for combining (Z)-endoxifen with standard-of-care therapies for breast cancer, which helps narrow the strategic approach for the potential IND [7] Cardiac Safety and Nonclinical Data - The FDA has confirmed that Atossa's cardiac safety assessment plan, including ECGs and QT interval monitoring, is sufficient for the monotherapy portion of the trial [7] - The existing nonclinical safety data package is deemed adequate, allowing Atossa to proceed without additional toxicity studies [7] Next Steps and Strategic Momentum - Atossa will announce plans for the target patient population, combination backbone, and overall trial design for the upcoming dose-ranging study in the coming weeks [7] - The company is positioned to maintain strategic momentum and meet regulatory milestones, aiming to deliver (Z)-endoxifen to patients and enhance shareholder value [5][10] About (Z)-Endoxifen - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator (SERM) that inhibits and potentially degrades estrogen receptors, showing activity in tumors resistant to other therapies [8][10] - Atossa is developing an oral formulation of (Z)-endoxifen that is enteric-coated to ensure optimal bioavailability and therapeutic integrity [9] Clinical Trials and Intellectual Property - Atossa is prioritizing (Z)-endoxifen for metastatic breast cancer, currently evaluating it in three Phase 2 trials [10] - The program is supported by a growing global intellectual property portfolio, including recently issued U.S. patents [10]

Core Viewpoint - Atossa Therapeutics has been granted a new patent for (Z)-endoxifen formulations, enhancing its intellectual property portfolio and supporting its mission to advance breast cancer treatment [1][2][3] Group 1: Patent and Intellectual Property - The newly granted patent (U.S. Patent No. 12,281,056) includes 58 claims related to (Z)-endoxifen formulations, focusing on purity, stability, and therapeutic methods [2] - Atossa's patent estate now encompasses over 200 claims related to (Z)-endoxifen formulations and their clinical applications, reinforcing the company's leadership in targeted therapies for hormone receptor-positive breast cancer [3] Group 2: Product Development and Efficacy - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator (SERM) that may cause estrogen receptor degradation and has shown efficacy in patients resistant to other hormonal treatments [4] - The company is developing an oral formulation of (Z)-endoxifen designed to bypass the stomach, which converts a significant portion of the drug to an inactive form [5] - Clinical studies indicate that (Z)-endoxifen is well tolerated in women with and without breast cancer, and it is being studied for both treatment and prevention of breast cancer, including a program for metastatic breast cancer [5] Group 3: Company Mission and Vision - Atossa is dedicated to transforming breast cancer treatment through innovative science and patient-focused solutions, aiming to improve the lives of millions of women while generating substantial value for shareholders [3][6]

Core Viewpoint - Atossa Therapeutics has been granted a new patent for enteric oral formulations of (Z)-endoxifen, enhancing its intellectual property portfolio and supporting its mission to develop innovative treatments for breast cancer [1][2][3]. Intellectual Property - The newly granted U.S. Patent No. 12,275,684 covers enteric oral formulations of (Z)-endoxifen and methods for treating hormone-dependent breast and reproductive tract disorders [2]. - Atossa's patent estate now includes multiple U.S. patents with over 100 claims related to (Z)-endoxifen formulations and their clinical applications, reinforcing the company's leadership in targeted therapies for hormone receptor-positive breast cancer [3]. Product Development - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator (SERM) that may cause estrogen receptor degradation and has shown efficacy in patients resistant to other hormonal treatments [4]. - Atossa is developing a proprietary oral formulation of (Z)-endoxifen designed to bypass the stomach, as acidic conditions convert a significant portion of (Z)-endoxifen to the inactive (E)-endoxifen [5]. - Clinical studies indicate that (Z)-endoxifen is well tolerated in women with and without breast cancer, and it is currently being studied for both treatment and prevention of breast cancer, including a program in metastatic breast cancer [5]. Company Overview - Atossa Therapeutics is a clinical-stage biopharmaceutical company focused on transforming breast cancer treatment through innovative science and patient-centered solutions [6]. - The company's lead product candidate, (Z)-endoxifen, is designed for use across the breast cancer spectrum, including prevention, neoadjuvant, adjuvant, and metastatic settings [6].