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.
Atossa Therapeutics has appointed Heather Rees as its new Chief Financial Officer (CFO). Rees, who has been with Atossa for seven years and previously served as Senior Vice President of Finance and Principal Accounting Officer, brings nearly 30 years of experience in accounting, business, and finance to this role. She first joined Atossa as Controller in 2017. Prior to Atossa, Rees led a consulting practice providing services to companies like Getty Images and Avalara, and served as Controller of the Americas for Irdeto Inc. Atossa's CEO, Steven Quay, praised Rees for her contributions, which have been key to the company's success. With multiple data milestones expected this year and sufficient working capital for approximately three years, Atossa is well-positioned to enhance shareholder value.
Atossa Therapeutics has updated the protocol for its study on (Z)-endoxifen combined with abemaciclib (VERZENIO®) for ER+/HER2- breast cancer. Based on Phase 2 EVANGELINE study data, the study dose of (Z)-endoxifen has been increased from 40 mg to 80 mg daily due to positive safety and efficacy results. Participants showed a 92% average reduction in Ki-67 and a 37% decrease in tumor size. The updated protocol now includes 80 participants split into two cohorts, with premenopausal women in one cohort also receiving ovarian function suppression (OFS). This expanded protocol aims to validate the efficacy and safety of (Z)-endoxifen without OFS in premenopausal women.
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.
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.
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.
FAQ
What is the current stock price of Atossa Therapeutics (ATOS)?
What is the market cap of Atossa Therapeutics (ATOS)?
What is Atossa Therapeutics' primary focus?
What is (Z)-endoxifen?
What are some of Atossa's recent achievements?
Who are Atossa's key collaborators?
What financial condition is Atossa in?
What other conditions is Atossa targeting besides breast cancer?
Where is Atossa Therapeutics headquartered?
When was Atossa Therapeutics founded?
What is the significance of (Z)-endoxifen Phase II trials?
How does Atossa contribute to breast cancer risk assessment?
