Atossa Therapeutics, Inc. develops clinical-stage medicines for oncology and other areas of unmet medical need. Its recurring news centers on (Z)-endoxifen, the company's lead product candidate, including breast cancer research, mammographic breast density data, and expansion into rare disease indications such as Duchenne muscular dystrophy and McCune-Albright Syndrome.
Company updates also cover FDA orphan and rare pediatric disease designations, clinical and preclinical data presentations, peer-reviewed publications, intellectual property developments, leadership additions, financial results, and capital-allocation commentary tied to Atossa's development strategy.
Atossa Therapeutics has announced its support for a Phase 2 study aiming to validate an AI-driven breast cancer risk assessment model. The Stockholm Mammography Risk stratified Trial (SMART) will enroll 70,000 women post-mammogram to assess their risk of developing breast cancer over the next two years. The Profound AI Model will analyze mammogram data and other personal risk factors to identify high-risk individuals. Those at highest risk will undergo a contrast-enhanced mammogram (CEM). The study aims to determine the predictive power of the AI model, potentially paving the way for a Phase 3 trial focusing on (Z)-endoxifen for breast cancer prevention.
Atossa Therapeutics announced the completion of patient dosing in its Phase 2 Karisma-Endoxifen clinical trial. This study, which enrolled 240 premenopausal women with mammographic breast density (MBD), aims to reduce MBD, a risk factor for breast cancer. The trial, fully enrolled in November 2023, tested daily doses of 1 mg and 2 mg (Z)-endoxifen versus placebo over six months. Results will be important for potential Phase 3 trials. MBD reduction is linked to a 50%-63% decrease in breast cancer risk over 3-15 years. Atossa is focusing on breast cancer treatments, with five ongoing Phase 2 studies.
Atossa Therapeutics announced its first-quarter 2024 financial results, showcasing positive data from the EVANGELINE study with a 100% disease control rate. They also initiated a study combining (Z)-endoxifen with abemaciclib, ended Q1 2024 with $84.0 million in cash, and appointed Dr. Tessa Cigler to the Board of Directors. The company is focused on developing innovative oncology medicines, particularly for breast cancer. Despite having no revenue, the operating expenses were $7.0 million, with a decrease from the previous year. R&D expenses increased slightly, primarily due to higher spending on clinical trials for (Z)-endoxifen. G&A expenses decreased, with a lower compensation cost driven by reduced non-cash stock-based compensation. Interest income also saw a slight increase due to a better rate of return.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) supports new breast cancer screening guidelines recommended by the U.S. Preventive Services Task Force (USPSTF), advising women to start biennial mammography screening at age 40. These guidelines aim to address rising breast cancer rates in younger women and racial disparities in diagnosis and mortality. The company is currently evaluating (Z)-endoxifen in Phase 2 trials to reduce breast density, a significant risk factor for breast cancer development.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announced an expanded research agreement with Weill Cornell Medicine to explore the synergy between antibody drug conjugates (ADCs) and (Z)-endoxifen in oncology, particularly breast cancer. The partnership aims to validate in silico research showing enhanced anti-tumor effects when combining (Z)-endoxifen with ADCs. Seven key opinion leaders support this approach for patients with advanced breast cancer. The research will focus on FDA-approved ADCs, TRODELVY® and ENHERTU®, currently used in monotherapies for metastatic breast cancer.
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