Core Viewpoint - Atossa Therapeutics expresses disappointment over the Patent Trial and Appeal Board's decision to invalidate claims in U.S. Patent No. 11,572,334, but this decision does not affect its current clinical formulations [2][5] Patent Developments - The company is evaluating options following the PTAB's ruling but will not appeal due to cost and time considerations, opting instead to pursue additional patent protection through a new Continuation Patent Application [2] - A new patent, U.S. Patent No. 12,201,591, was issued on January 21, 2025, focusing on sustained release compositions of endoxifen, adding to Atossa's patent estate [3][4] Clinical Development - Atossa is developing a proprietary oral formulation of (Z)-endoxifen, which is designed to bypass stomach acidity that deactivates the drug [6] - (Z)-endoxifen is currently undergoing five Phase 2 clinical trials targeting various breast cancer conditions, demonstrating well-tolerated results in earlier studies [6] Company Mission - Atossa Therapeutics is committed to providing innovative treatment options for breast cancer, focusing on (Z)-endoxifen as a potential preventive and therapeutic agent [7]

Core Insights - Atossa Therapeutics has made significant progress in 2024, particularly with (Z)-endoxifen, which shows promise in breast cancer prevention and treatment [1][4][16] Clinical Program Updates - The completion of the KARISMA-Endoxifen Phase 2 Study demonstrated significant reductions in mammographic breast density (MBD), with decreases of 17.3 percentage points in the 1 mg arm and 23.5 percentage points in the 2 mg arm, both statistically significant (p<0.01) [2][3] - The EVANGELINE trial has shown promising initial results, achieving the primary endpoint with 50% of patients in the 80 mg (Z)-endoxifen with goserelin group meeting target plasma concentrations [5][6] - Significant tumor suppression was observed across all dosing levels in the EVANGELINE trial, with a Ki-67 ≤10% response rate consistently above 85% [7] Intellectual Property and Financial Position - The company secured two additional U.S. patents for (Z)-endoxifen, enhancing its intellectual property portfolio and pipeline value [14] - Atossa maintains a strong cash position, allowing for efficient funding of research and development efforts while ensuring operational stability [15] Future Directions - The company aims to advance (Z)-endoxifen into registrational clinical trials in 2025, focusing on expediting its market entry [18] - Ongoing business development efforts will be amplified to ensure global access to (Z)-endoxifen [18] - Collaborations with industry leaders and advocacy groups will be deepened to broaden the impact of Atossa's work [18]

SEATTLE, Jan. 06, 2025 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), a clinical-stage biopharmaceutical company dedicated to the prevention and treatment of breast cancer, commends the U.S. Surgeon General for issuing a crucial Advisory that describes the scientific evidence for the causal link between alcohol consumption and increased cancer risk, particularly breast cancer in women. The Surgeon General’s Advisory reveals that alcohol consumption contributes to n ...

Core Viewpoint - Atossa Therapeutics supports the U.S. Surgeon General's Advisory linking alcohol consumption to increased breast cancer risk, emphasizing the need for public awareness and proactive measures to reduce alcohol-related cancer cases [1][3]. Summary by Relevant Sections Alcohol Consumption and Cancer Risk - Alcohol consumption is responsible for nearly 100,000 cancer cases and approximately 20,000 cancer deaths annually in the U.S., making it the third leading preventable cause of cancer [2]. - Breast cancer accounts for about 44,180 alcohol-related cases in women each year, representing approximately 16.4% of all breast cancer diagnoses [2]. Company Position and Initiatives - Atossa Therapeutics aligns its mission with the Advisory, advocating for public education on the risks associated with alcohol consumption and breast cancer [3][5]. - The company has released a video to further educate the public about the Advisory and its implications for breast cancer prevention [4]. Recommendations for Public Health - The Advisory calls for updating health warning labels on alcoholic beverages to reflect cancer risks and expanding public education efforts to raise awareness of alcohol's link to breast cancer [8]. - It highlights alcohol consumption as a leading modifiable cancer risk factor and suggests incorporating proven alcohol reduction strategies into cancer prevention initiatives [8].

1 MG Dose (Z)-Endoxifen Shows Potential as a Well-Tolerated, Preventative Therapy for Premenopausal Women at Risk of Developing Breast Cancer Data to be Presented in a Poster Spotlight Session During the 2024 San Antonio Breast Cancer Symposium SEATTLE, Dec. 11, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), today announced full results from its Phase 2 KARISMA-Endoxifen trial conducted at the Karolinska Institute in Stockholm, Sweden. The data, which will be ...

Common Stock, $0.18 par value ATOS The Nasdaq Capital Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from XXXXXXXX XX, XXXX to XXXXXXXX XX, XXXX Commission File Number: 001-35610 | --- | --- | |------- ...

Exhibit 99.1 Atossa Therapeutics Announces Third Quarter 2024 Financial Results and Provides Corporate Update • Announced positive topline results from KARISMA-Endoxifen Phase 2 study which demonstrated that low doses of (Z)-endoxifen significantly reduced mammographic breast density (MBD), addressing a key breast cancer risk factor • Released a preliminary analysis from I-SPY 2 Endocrine Optimization Pilot (EOP) Phase 2 trial of (Z)- endoxifen which met the primary endpoint with 95 percent (19/20 patients) ...

Announced positive topline results from KARISMA-Endoxifen Phase 2 study which demonstrated that low doses of (Z)-endoxifen significantly reduced mammographic breast density (MBD), addressing a key breast cancer risk factorReleased a preliminary analysis from I-SPY 2 Endocrine Optimization Pilot (EOP) Phase 2 trial of (Z)-endoxifen which met the primary endpoint with 95 percent (19/20 patients) receiving > 75 percent of planned treatmentAnnounced the dosing of the first patient in a clinical trial conducted ...

(Z)-Endoxifen Shown to Significantly Reduce Mammographic Breast Density, Potentially Paving the Way for Innovative Cancer Prevention Strategies SEATTLE, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today released positive topline data from the KARISMA-Endoxifen Phase 2 study of (Z)-endoxifen in premenopausal women with mammographic breast density (MBD). The ...

SEATTLE, Oct. 14, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), today announced that Michael Parks, Vice President, Investor and Public Relations, will participate in a virtual fireside chat on Wednesday, October 16, 2024 at 12:00 p.m. EDT at the 2024 Maxim Healthcare Virtual Summit. Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer. Interes ...