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About Atossa Therapeutics Inc.
Atossa Therapeutics Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company dedicated to addressing significant unmet medical needs in oncology, with a primary focus on breast cancer treatment and prevention. Headquartered in Seattle, Washington, Atossa leverages cutting-edge science and proprietary technologies to develop innovative therapeutics that aim to improve patient outcomes and quality of life.
Core Business and Focus Areas
The company's flagship program centers on the development of (Z)-endoxifen, a potent and proprietary Selective Estrogen Receptor Modulator (SERM) designed to treat and prevent estrogen receptor-positive (ER+) breast cancer. Unlike traditional tamoxifen therapies, (Z)-endoxifen bypasses liver metabolism, achieving therapeutic concentrations more efficiently and reducing the risk of side effects. This innovative formulation is encapsulated to prevent degradation in the stomach, ensuring higher bioavailability and efficacy.
Atossa's pipeline also includes intraductal microcatheter technology, which enables the targeted delivery of therapies directly to the site of breast cancer. This approach is being explored for the administration of fulvestrant, immunotherapies, and chimeric antigen receptor (CAR) T-cell therapies, offering a potentially transformative method for localized treatment.
Clinical Trials and Research
Atossa is actively advancing multiple clinical trials to validate the safety and efficacy of its therapies. The company's Phase 2 EVANGELINE study focuses on premenopausal women with ER+/HER2- breast cancer, evaluating (Z)-endoxifen as a neoadjuvant treatment. Preliminary data has demonstrated significant tumor shrinkage, reduction in Ki-67 proliferation markers, and a favorable safety profile. Additional Phase 2 trials are investigating (Z)-endoxifen's impact on mammographic breast density and its potential in treating ductal carcinoma in situ (DCIS).
Collaborations with organizations like Eli Lilly and Quantum Leap Healthcare Collaborative further enhance Atossa's clinical capabilities, enabling the exploration of combination therapies such as (Z)-endoxifen with abemaciclib (a CDK 4/6 inhibitor) for high-risk breast cancer patients.
Intellectual Property and Competitive Positioning
Atossa's robust intellectual property portfolio includes multiple issued U.S. patents and numerous pending applications for (Z)-endoxifen and related technologies. This strong patent protection underscores the company's commitment to innovation and provides a competitive edge in the oncology therapeutics market.
Operating within the highly competitive biopharmaceutical industry, Atossa differentiates itself through its focus on targeted therapies, proprietary drug formulations, and patient-centric approaches. The company's emphasis on addressing gaps in current treatment paradigms positions it as a key player in the oncology space.
Market and Growth Potential
The global breast cancer therapeutics market continues to expand, driven by rising incidence rates and advancements in treatment options. Atossa's innovative pipeline addresses critical gaps in this market, particularly for patients with endocrine-resistant tumors or those seeking alternatives to chemotherapy. By focusing on both treatment and prevention, Atossa aims to capture a significant share of this growing market segment.
Challenges and Opportunities
As a clinical-stage company, Atossa faces challenges typical of the biopharmaceutical sector, including high R&D costs, regulatory hurdles, and the need for successful clinical trial outcomes. However, its strategic partnerships, strong intellectual property position, and focus on unmet medical needs provide a solid foundation for long-term growth and success.
Conclusion
Atossa Therapeutics Inc. exemplifies innovation and dedication in the fight against breast cancer. Through its proprietary (Z)-endoxifen and advanced delivery technologies, the company is poised to make a meaningful impact on oncology therapeutics. With a strong clinical pipeline, strategic collaborations, and robust intellectual property, Atossa is well-positioned to address significant unmet medical needs and drive advancements in breast cancer treatment and prevention.
Atossa Therapeutics (NASDAQ: ATOS) announced Q3 2024 financial results and corporate updates. Key highlights include positive topline results from KARISMA-Endoxifen Phase 2 study showing significant mammographic breast density reductions of 19.3% and 26.5% in 1mg and 2mg treatment arms. The I-SPY 2 trial met its primary endpoint with 95% of patients completing treatment, showing 69% reduction in Ki-67 and 30.4% reduction in tumor volume. The company ended Q3 with $74.8 million in cash and no debt. Operating expenses decreased to $6.4 million in Q3 2024 from $7.5 million in Q3 2023.
Atossa Therapeutics (Nasdaq: ATOS) has appointed Claudia Lopez, DVM, MSc, as Vice President of Clinical Product Development. Dr. Lopez brings over 20 years of clinical development and strategic expertise, particularly in immunology, oncology, and metabolic disease. Previously Vice President of Clinical Development at Landos Biopharma, she has held leadership positions at Arena Pharmaceuticals and Takeda Pharmaceuticals. In her new role, Dr. Lopez will focus on advancing Atossa's clinical pipeline for breast cancer treatments, leveraging her experience in global clinical strategies, trial design, and regulatory alignment.
Atossa Therapeutics (ATOS) announced positive topline data from the KARISMA-Endoxifen Phase 2 study testing (Z)-endoxifen in premenopausal women with mammographic breast density (MBD). The study, conducted at Karolinska Institute, showed significant MBD reduction with low doses. Key results include:
- Relative density decrease of -19.3% and -26.5% for 1mg and 2mg doses respectively vs placebo
- Mean endoxifen plasma concentration of 5.18 ng/mL (1mg) and 10.87 ng/mL (2mg)
- side effects with only mild vasomotor symptoms reported
- Study included 240 women across three arms (80 each) over six months
Atossa Therapeutics (ATOS) announced promising preliminary results from a phase 2 trial of (Z)-endoxifen in the I-SPY 2 Endocrine Optimization Pilot study. The trial, involving 20 women with ER+/HER2- breast cancer, met its primary endpoint with 95% of patients receiving >75% of planned treatment at 10mg daily dose. Key findings showed a 69% reduction in Ki-67 (cancer cell division marker) and a 30.4% decrease in functional tumor volume after 3 weeks. The treatment was well-tolerated with only mild side effects reported, including hot flushes, insomnia, and fatigue, with no dose reductions or discontinuations required.
Atossa Therapeutics (NASDAQ: ATOS) announced its participation in a fireside chat at BIO-Europe 2024 in Stockholm, Sweden. The event, scheduled for November 4-6, 2024, will feature Dr. Steven Quay, CEO of Atossa, and Dr. Per Hall from the Karolinska Institute discussing the potential of combining AI-based risk models with emerging therapies to prevent breast cancer in high-risk patients.
The discussion will focus on the Stockholm Mammography Risk Stratified Trial (SMART), a study aiming to enroll 70,000 women to test an individualized, imaging-based screening model. This model is designed to identify women at the highest risk of developing breast cancer within two years. If validated, it could serve as a foundation for future trials investigating (Z)-endoxifen in breast cancer prevention.
Atossa Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines for oncology, with a focus on breast cancer prevention and treatment using (Z)-endoxifen.
Atossa Therapeutics, a clinical stage biopharmaceutical company focused on developing innovative medicines for breast cancer and other areas of significant unmet medical need in oncology, has announced its participation in the 2024 Maxim Healthcare Virtual Summit. Michael Parks, Vice President of Investor and Public Relations at Atossa, will engage in a virtual fireside chat on Wednesday, October 16, 2024, at 12:00 p.m. EDT.
The company, traded on Nasdaq under the ticker ATOS, invites interested parties to register and access the live webcast of the conference through a provided link. This event presents an opportunity for investors and stakeholders to gain insights into Atossa's current developments and future prospects in the oncology field.
Atossa Therapeutics (Nasdaq: ATOS) is recognizing Breast Cancer Awareness Month this October, emphasizing the need for innovation in breast cancer treatment. The company highlights the importance of education, early detection, and research in combating this disease that affects approximately one in eight women.
Atossa, a clinical-stage biopharmaceutical company, is currently evaluating its lead asset, (Z)-endoxifen, in multiple phase 2 clinical trials. The Karisma-Endoxifen study is investigating its potential to reduce mammographic breast density in premenopausal women, with data expected in Q4 2024.
The company is also supporting the SMART study, a phase 2 trial validating an AI-driven breast cancer risk assessment model. This model could potentially serve as the foundation for a future phase 3 trial of (Z)-endoxifen in breast cancer prevention.
Atossa's efforts align with the FDA's recent implementation of updated mammography rules, which now require healthcare providers to notify women of their breast density results, a known risk factor for breast cancer.
Atossa Therapeutics (Nasdaq: ATOS) supports the FDA's final rule update to mammography regulations, effective Sept. 10, 2024. The rule requires mammography facilities to provide patients with a breast density assessment in patient-friendly terms. This is important as breast density is a known risk factor for breast cancer and can obscure tumor detection. The regulation aims to improve early breast cancer detection by empowering women with dense breast tissue to discuss supplemental screening options with healthcare providers.
Atossa, focusing on breast cancer therapies, is evaluating its lead asset, (Z)-endoxifen, in multiple phase 2 trials. The Karisma-Endoxifen study investigates its potential to reduce mammographic breast density in premenopausal women, with data expected by year-end 2024. Atossa also supports the SMART study, testing an AI-driven breast cancer risk assessment model, which could form the basis for a future phase 3 trial of (Z)-endoxifen in breast cancer prevention.
Atossa Therapeutics (Nasdaq: ATOS) has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference, scheduled for September 9-11, 2024. The event will be held both in-person and virtually. Steven Quay, M.D., Ph.D., President and CEO of Atossa, will take part in a virtual fireside chat and meet with investors.
A recording of the fireside chat will be available at 7:00 a.m. EDT on Monday, September 9, 2024, on the conference website and in the Investors section of Atossa's website under Events & Presentations. Investors interested in one-on-one meetings with Atossa management should contact their H.C. Wainwright representative to arrange appointments.
Atossa Therapeutics (Nasdaq: ATOS) has been granted a new patent (U.S. Patent No. 12,071,391) by the United States Patent and Trademark Office (USPTO). This patent covers compositions comprising endoxifen (in free base or salt forms) and an enteric material, where at least 90% is (Z)-endoxifen. It also includes methods of administering these compositions to patients.
This is Atossa's fourth issued patent from the USPTO, expanding protection to include (Z)-endoxifen salt compositions and their usage methods. The company, a clinical-stage biopharmaceutical firm, focuses on developing innovative medicines for oncology, particularly breast cancer. CEO Steven Quay emphasized that this broader patent protection will create long-term stockholder value by further validating and expanding Atossa's patent portfolio beyond previously issued composition of matter patents.
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