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Atossa Therapeutics, Inc. (NASDAQ: ATOS) is a pioneering biopharmaceutical company headquartered in Seattle, Washington. Established in 2009, Atossa focuses on developing innovative and proprietary medicines targeting unmet medical needs in oncology, with a particular emphasis on breast cancer. The company is currently in the clinical stage, advancing several key programs designed to improve cancer treatment and prevention.
Atossa's core program is the development of (Z)-endoxifen, a potent metabolite of tamoxifen, crucial for treating and preventing breast cancer. Currently, (Z)-endoxifen is in Phase II clinical trials aimed at various breast cancer conditions, including estrogen receptor-positive breast cancer, ductal carcinoma in situ (DCIS), and mammographic breast density. The company is also exploring its efficacy in combination therapies with drugs like abemaciclib, a CDK 4/6 inhibitor.
In addition to breast cancer, Atossa has ventured into COVID-19 therapeutics with two potential treatments: AT-H201 for improving lung function in severe COVID-19 patients and AT-301, a nasal spray for at-home use.
Recently, Atossa has achieved several milestones, including the successful dosing of the first patient in the RECAST DCIS study, full enrollment of its Phase II Karisma-Endoxifen trial, and promising preliminary data from the 40mg cohort in the EVANGELINE study. The company also regained compliance with Nasdaq's minimum bid price requirement.
Atossa's collaborative efforts include partnerships with Quantum Leap Healthcare Collaborative and Weill Cornell Medicine, advancing studies in combination therapies and breast cancer risk assessment through innovative AI models. With a strong financial position, including $84 million in cash and no debt as of Q1 2024, Atossa is well-positioned to continue its groundbreaking work in oncology.
Atossa Therapeutics (Nasdaq: ATOS) reported its financial results for the year ended December 31, 2022, highlighting significant clinical advancements. The company initiated its Phase 2 EVANGELINE study for neoadjuvant treatment in premenopausal women with ER+ breast cancer and continues enrollment in the Karisma-Endoxifen study. Notably, Atossa added a new arm to the ongoing I-SPY 2 trial, evaluating (Z)-endoxifen. Financially, the company reported an operating loss of $27.7 million, a 35% increase from 2021, driven mostly by rising R&D costs. Cash reserves stood at approximately $111 million, supporting ongoing clinical endeavors.
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