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.
Overview
Atossa Therapeutics Inc (ATOS) is a clinical stage biopharmaceutical company that develops and markets innovative medicines, laboratory tests, and therapeutic delivery platforms focused on addressing unmet medical needs in oncology. With a primary emphasis on women’s breast health and breast cancer, the company is dedicated to advancing novel drug candidates and precision-targeted delivery systems, employing cutting-edge approaches such as selective estrogen receptor modulation and intraductal microcatheter technology.
Core Therapeutic Focus
The company’s flagship asset, (Z)-endoxifen, exemplifies its commitment to tackling critical challenges in breast cancer treatment. (Z)-endoxifen is a potent selective estrogen receptor modulator (SERM) that not only inhibits estrogen receptor activity but also facilitates its degradation. This dual action is strategically designed to address cases where resistance to traditional hormonal therapies exists, thus filling a significant therapeutic gap in oncology. Additionally, the formulation of (Z)-endoxifen is developed as an oral medication that bypasses the liver metabolism and gastric degradation issues, ensuring optimal bioavailability at therapeutic concentrations.
Innovative Drug Delivery Platforms
Beyond its core drug candidates, Atossa Therapeutics is also pioneering advanced delivery mechanisms to enhance therapeutic efficacy. The development of intraductal microcatheter technology represents a novel approach to deliver therapies directly to the site of breast cancer, thereby improving the targeting of treatments such as hormonal therapies, immunotherapies, and chimeric antigen receptor T-cell therapies. This targeted delivery strategy not only heightens the precision of treatment but also has the potential to reduce systemic side effects, contributing to an overall improved patient experience.
Clinical Development and Research Programs
Atossa’s development pipeline is robust, with multiple Phase 2 trials designed to evaluate the effectiveness of (Z)-endoxifen in diverse patient populations, including women with measurable breast density and those diagnosed with ductal carcinoma in situ. The company’s research initiatives extend to combination therapies, where (Z)-endoxifen is studied alongside other agents such as cyclin-dependent kinase (CDK) inhibitors, further broadening the therapeutic paradigm in breast cancer treatment. These programs underscore the company’s strategic emphasis on targeted oncology, employing rigorous clinical methods to substantiate the efficacy and safety of its novel therapies.
Intellectual Property and Market Position
Central to Atossa’s strategy is its strong intellectual property portfolio, which includes multiple issued U.S. patents and numerous pending applications. These patents cover both the composition of matter for (Z)-endoxifen and innovative formulation approaches, ensuring a competitive edge in the market. By protecting its technology and research investments, the company lays a solid foundation for long-term value creation, even as it navigates the challenges inherent to clinical stage development.
Competitive Landscape and Industry Expertise
Operating within the highly competitive biopharmaceutical industry, Atossa Therapeutics distinguishes itself through its integrated approach to drug development and delivery innovation. Its expertise in designing treatments that address both the efficacy and tolerability aspects of cancer care positions it uniquely among its peers. The company’s focus on precise molecular targeting and the development of therapeutics that are supported by robust scientific data bolsters its role as a knowledgeable and expertly positioned player in the oncology landscape.
Business Model and Operational Strategy
- Clinical Innovation: Concentrates on advancing clinical programs with a focus on unmet needs in breast cancer and breast health conditions.
- Targeted Delivery: Emphasizes pioneering approaches in delivering therapies directly to disease sites, using technologies like intraductal microcatheter systems.
- Intellectual Property: Leverages a strong portfolio of patents to secure its technological advancements and maintain market differentiation.
- Collaborative Research: Engages in strategic partnerships and clinical collaborations to enhance its research capabilities and validate its clinical hypotheses.
Conclusion
Atossa Therapeutics Inc exemplifies a focused, research-driven approach to addressing significant challenges in oncology. By combining novel therapeutic agents with innovative delivery systems, the company provides a comprehensive model for advancing personalized breast cancer treatment. Its commitment to enhancing patient outcomes through scientific rigor and technological innovation underscores its importance in the dynamic field of biopharmaceutical research. The detailed clinical programs, strategic intellectual property protections, and collaborative research efforts are all testaments to its expertise and nuanced understanding of complex oncology treatment paradigms.
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.
Atossa Therapeutics (Nasdaq: ATOS) and Quantum Leap Healthcare Collaborative have dosed the first patient in their clinical trial evaluating Atossa's (Z)-endoxifen combined with abemaciclib (VERZENIO®) for ER+/HER2- breast cancer. The study, part of the I-SPY 2 Endocrine Optimization Pilot Protocol, aims to enroll 80 participants across two cohorts, focusing on patients with newly diagnosed ER+ invasive breast cancer. Participants will receive 80 mg (Z)-endoxifen daily and 150 mg abemaciclib twice daily for 24 weeks before surgery. The second cohort will also include ovarian function suppression for premenopausal women. Results are expected in 2026, potentially validating (Z)-endoxifen's safety and efficacy in both pre- and postmenopausal breast cancer patients.
Atossa Therapeutics (Nasdaq: ATOS) has appointed Michael Parks as Vice President of Investor and Public Relations. With nearly 30 years of experience in the biopharmaceutical and healthcare industries, Parks will oversee corporate communications, investor relations, and branding for the company. Atossa, a clinical-stage biopharmaceutical company, focuses on developing innovative medicines for breast cancer and other areas of unmet medical need in oncology.
Parks' extensive background includes roles at PAVmed, Lucid Diagnostics, Liquidia , and his own consulting firm, Pitch360. He also held positions at Johnson & Johnson's Centocor, Pfizer, Pharmacia, and Searle Pharmaceuticals. Dr. Steven Quay, Atossa's CEO, expressed excitement about Parks joining the team, highlighting his seasoned experience and multidisciplined approach to communications.
Atossa Therapeutics (NASDAQ: ATOS) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
- Completed enrollment in 80mg PK Run-in Cohort for EVANGELINE trial
- Presented data showing 100% disease control rate after 24-week treatment with (Z)-Endoxifen in 40mg cohort of Phase 2 EVANGELINE study
- Completed Phase 2 Karisma-Endoxifen clinical trial dosing
- Ended Q2 with $79.5 million in cash and no debt
Financial results: Total operating expenses decreased to $7.1 million for Q2 2024, down from $7.8 million in Q2 2023. R&D expenses slightly decreased, while G&A expenses saw a significant reduction in compensation costs. Interest income increased to $1.1 million for Q2 2024.
Atossa Therapeutics (Nasdaq: ATOS) has completed enrollment for the 80mg pharmacokinetic run-in cohort in its Phase 2 EVANGELINE clinical trial. This study evaluates (Z)-endoxifen as a neoadjuvant treatment for ER+ / HER2- breast cancer. The cohort includes 12 pre-menopausal women who will receive 80mg/day of (Z)-endoxifen for four weeks. Key points:
- The full study aims to enroll 175 patients across 25 U.S. sites
- Previous 40mg cohort showed 92% average reduction in Ki-67 and 37% average target lesion decrease
- 80mg dose is expected to optimize PKCβ1 inhibition and enhance antitumor efficacy
- EVANGELINE compares (Z)-endoxifen to exemestane plus goserelin in pre-menopausal women with Grade 1 or 2 ER+ / HER2- breast cancer
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.
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