Financial Performance - Atossa Therapeutics ended 2024 with $71.1 million in cash and cash equivalents and no debt [1] - Total operating expenses decreased to $27.6 million in 2024 from $31.4 million in 2023, a reduction of $3.8 million [7] - The net loss for 2024 was $25.5 million, compared to a net loss of $30.1 million in 2023, indicating an improvement in financial performance [21] Research and Development - Atossa plans to advance its lead program, (Z)-endoxifen, targeting metastatic breast cancer, which is seen as a critical unmet need [3][5] - The Phase 2 EVANGELINE trial showed substantial tumor suppression with (Z)-endoxifen, achieving a 4-week Ki-67 ≤ 10 percent response rate above 85% across dosing levels [5] - The Phase 2 KARISMA-Endoxifen study demonstrated that a 1 mg dose of (Z)-endoxifen reduced mammographic breast density by 17.3 percentage points, while a 2 mg dose achieved a 23.5 percentage-point reduction [5] Strategic Focus - The company is pursuing an initial approval for (Z)-endoxifen in metastatic breast cancer to expedite availability for patients [3][5] - Atossa is also engaging with the FDA to explore additional indications for (Z)-endoxifen, including breast cancer prevention and neoadjuvant therapy [5] Operating Expenses Breakdown - Research and development expenses totaled $14.1 million in 2024, down from $17.3 million in 2023, primarily due to decreased spending on (Z)-endoxifen trials [8] - General and administrative expenses decreased to $13.5 million in 2024 from $14.0 million in 2023, with a notable reduction in compensation expenses [10][11] Cash Flow and Investments - Interest income for 2024 was $4.1 million, a decrease of $0.2 million from the previous year, attributed to reduced funds in the money market account [12] - The company recorded an impairment charge on investment in equity securities of $1.7 million in 2024, down from $3.0 million in 2023 [12]

Core Viewpoint - Atossa Therapeutics, Inc. will host a conference call and live audio webcast on March 25, 2025, to discuss its corporate and financial results for Q4 and full-year 2024 [1] Group 1: Conference Call Details - The conference call is scheduled for 8:30 a.m. Eastern Time [1] - U.S. callers can dial 1-800-836-8184, while international listeners should dial 1-646-357-8785 to join the call [2] - A replay of the conference call will be available for 30 days on the company's investor relations website [3] Group 2: Company Overview - Atossa Therapeutics is a clinical-stage biopharmaceutical company focused on innovative treatments for breast cancer [4] - The lead product candidate, (Z)-endoxifen, is designed for various breast cancer settings, including metastatic and prevention [4] - The company aims to advance clinical research programs to improve patient outcomes and create shareholder value [4]

Core Insights - Atossa Therapeutics congratulates Dr. Tessa Cigler and her team for receiving a $2.3 million grant from the CDC to improve care for young breast cancer patients in New York City [1][2][3] Group 1: Grant and Initiative Details - The CDC grant will fund initiatives aimed at enhancing equitable access to care, quality of life, and survival outcomes for young breast cancer patients [1] - Dr. Cigler will collaborate with Dr. Vered Stearns and a multidisciplinary team to address the unique needs of young breast cancer patients from diverse backgrounds [2] - The program will focus on care coordination, culturally relevant resources, and targeted interventions for the physical, emotional, and mental well-being of patients and caregivers [2] Group 2: Company Support and Vision - Atossa Therapeutics expresses pride in Dr. Cigler's dedication to advancing breast cancer care and addressing health disparities [3] - The company supports innovative and inclusive approaches to breast cancer treatment and survivorship [3] - Atossa looks forward to the positive impact of the initiative on young breast cancer patients and their families [3] Group 3: Company Overview - Atossa Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative medicines for significant unmet medical needs in oncology, particularly breast cancer [4]

Core Viewpoint - Atossa Therapeutics expresses disappointment over the Patent Trial and Appeal Board's (PTAB) decision to find all challenged claims in U.S. Patent No. 11,572,334 unpatentable, but the decision does not affect the formulations currently in clinical development [2][5] Patent Developments - Atossa will not appeal the PTAB decision due to cost and time considerations, and will instead focus on obtaining patent protection for its current formulations through a new Continuation Patent Application [2] - A new patent, U.S. Patent No. 12,201,591, was issued on January 21, 2025, covering sustained release compositions of endoxifen with 31 claims [3] - Atossa's patent estate includes several patents: U.S. Patent No. 11,261,151 (21 claims), U.S. Patent No. 11,680,036 (22 claims), U.S. Patent No. 12,071,391 (44 claims), and the newly issued U.S. Patent No. 12,201,591 (31 claims), providing a comprehensive coverage for its formulations [4] Product Development - Atossa is developing a proprietary oral formulation of (Z)-endoxifen designed to bypass stomach acidity, which can convert a significant portion of (Z)-endoxifen to an inactive form [6] - (Z)-endoxifen has shown good tolerability in Phase 1 studies and is currently being evaluated in five Phase 2 trials targeting various breast cancer conditions [6] - The company aims to provide better treatment options for breast cancer patients through its innovative (Z)-endoxifen formulations [5][7]

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]

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].

Core Insights - 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 education on this issue [1][3][5] Industry Insights - 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 after tobacco and obesity [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] - The Advisory indicates that the risk of breast cancer begins to rise with the consumption of as little as one drink per day, yet only 45% of Americans believe alcohol significantly affects cancer development [3][4] Company Initiatives - Atossa Therapeutics is committed to advancing therapies aimed at reducing breast cancer burden and supports public policies that inform and protect women's health [5] - The company has released a video to further educate the public about the Surgeon General's Advisory and its implications for breast cancer [4] - Atossa advocates for updating health warning labels on alcoholic beverages, expanding public education efforts, and incorporating 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 | --- | --- | |------- ...