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Atossa Therapeutics, Inc. - $ATOS STOCK NEWS

Welcome to our dedicated page for Atossa Therapeutics news (Ticker: $ATOS), a resource for investors and traders seeking the latest updates and insights on Atossa Therapeutics stock.

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.

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Atossa Therapeutics (Nasdaq: ATOS) announced its upcoming inclusion in the Russell 3000® Index, effective after market close on June 28, 2024. This marks a significant milestone for the clinical-stage biopharmaceutical company, which focuses on developing innovative oncology medicines, particularly for breast cancer. The inclusion reflects the progress of Atossa's (Z)-endoxifen development program. In 2024, the company presented promising monotherapy data at the AACR Annual Meeting and initiated a Phase 2 study combining (Z)-endoxifen with Eli Lilly's abemaciclib. With $10.5 trillion in assets benchmarked against Russell US indexes, this inclusion is expected to increase Atossa's visibility and expand its shareholder base.

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Atossa Therapeutics (Nasdaq: ATOS) will present at the Sidoti Small-Cap Investor Conference on June 12-13, 2024. Dr. Steven Quay, CEO, will deliver the presentation on June 13 at 9:15 am ET. Atossa, a clinical-stage biopharma company, focuses on developing innovative oncology treatments, particularly for breast cancer. Interested parties can register to view the live webcast through the event's website. A recording will be available afterward on Atossa's investor relations page.

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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.

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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.

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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.

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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.

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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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Atossa Therapeutics and Quantum Leap Healthcare Collaborative have initiated a new study to evaluate (Z)-endoxifen in combination with abemaciclib in women with ER+/HER2- breast cancer. The study will enroll approximately 20 women with newly diagnosed ER+/HER2- invasive breast cancer to receive the combination therapy prior to surgery.
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Atossa Therapeutics, Inc. (ATOS) CEO to Speak at Noble Capital Markets Healthcare Conference. Atossa is a clinical stage biopharmaceutical company focusing on breast cancer treatments.
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Atossa Therapeutics (ATOS) announces positive safety and efficacy data from Phase 2 EVANGELINE trial for ER+/HER2- breast cancer treatment. The study shows significant reduction in Ki-67 levels, target lesion decreases, and promising clinical outcomes.
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FAQ

What is Atossa Therapeutics' primary focus?

Atossa Therapeutics primarily focuses on developing innovative medicines for oncology, specifically targeting breast cancer.

What is (Z)-endoxifen?

(Z)-endoxifen is an active metabolite of tamoxifen, currently in Phase II trials, developed to treat and prevent breast cancer.

What are some of Atossa's recent achievements?

Recent achievements include dosing the first patient in the RECAST DCIS study, full enrollment of the Karisma-Endoxifen trial, and promising data from the EVANGELINE study.

Who are Atossa's key collaborators?

Atossa collaborates with Quantum Leap Healthcare Collaborative and Weill Cornell Medicine to advance studies in oncology and innovative treatment methods.

What financial condition is Atossa in?

As of Q1 2024, Atossa has $84 million in cash and no debt, positioning it well for continued research and development.

What other conditions is Atossa targeting besides breast cancer?

Atossa is also developing treatments for COVID-19, including AT-H201 for severe cases and AT-301, a nasal spray for at-home use.

Where is Atossa Therapeutics headquartered?

Atossa Therapeutics is headquartered in Seattle, Washington.

When was Atossa Therapeutics founded?

Atossa Therapeutics was founded in 2009.

What is the significance of (Z)-endoxifen Phase II trials?

These trials are crucial for developing effective treatments for various breast cancer conditions, potentially improving patient outcomes significantly.

How does Atossa contribute to breast cancer risk assessment?

Atossa supports innovative AI-driven models like the Profound AI Model to improve breast cancer risk assessment and prevention strategies.

Atossa Therapeutics, Inc.

Nasdaq:ATOS

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