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) has released its full year 2024 financial results, ending with $71.1 million in cash and no debt. The company announced a strategic shift to focus on metastatic breast cancer for its lead program, (Z)-endoxifen.
Key highlights include positive data from the Phase 2 EVANGELINE trial, showing tumor suppression rates above 85% across dose levels. The trial will continue with amended protocol comparing 40mg (Z)-endoxifen with OFS to exemestane plus OFS. The Phase 2 KARISMA-Endoxifen study demonstrated significant mammographic breast density reduction, with 1mg and 2mg doses achieving 17.3 and 23.5 percentage point reductions respectively.
Financial results show total operating expenses decreased by $3.8 million to $27.6 million in 2024, compared to $31.4 million in 2023. Interest income was $4.1 million, down $0.2 million from the previous year.
Atossa Therapeutics (NASDAQ: ATOS), a clinical-stage biopharmaceutical company focused on breast cancer medicines, has scheduled its fourth quarter and full year 2024 financial results conference call for Tuesday, March 25, 2025, at 8:30 a.m. ET.
The company will host both a conference call and live audio webcast to discuss corporate and financial results. Investors can access the webcast through the investor relations section of Atossa's website. For telephone access, U.S. callers should dial 1-800-836-8184, while international participants can dial 1-646-357-8785. The conference call name is 'Atossa Therapeutics Business Update'. A 30-day replay will be available on the company's website following the call.
Atossa Therapeutics (NASDAQ: ATOS) has announced its strategic focus on developing (Z)-endoxifen for metastatic breast cancer treatment, while simultaneously pursuing additional indications with FDA guidance.
Early clinical trials have shown promising results, with (Z)-endoxifen demonstrating:
- More than doubled median progression-free survival compared to tamoxifen (7.2 vs. 2.4 months) in CDK4/6i-naïve patients
- Clinical benefits in patients who progressed on tamoxifen, including partial responses and stable disease lasting 2-3 years
- Favorable safety profile comparable to tamoxifen
The company is also advancing additional indications including breast cancer prevention and neoadjuvant therapy. In early-stage patients, (Z)-endoxifen maintained a Ki-67 ≤10% response rate above 85% across all dose levels, suggesting effective tumor proliferation reduction.
Atossa Therapeutics (Nasdaq: ATOS) announces that board director Dr. Tessa Cigler and Weill Cornell Medicine have been awarded a $2.3 million CDC grant over five years. The grant aims to improve breast cancer care for young patients across New York City, focusing on equitable access, quality of life, and survival outcomes.
Dr. Cigler, who serves as Associate Professor of Clinical Medicine at Weill Cornell Medicine and co-principal investigator, will collaborate with Dr. Vered Stearns to enhance care coordination and provide culturally relevant resources. The initiative specifically targets patients from diverse racial, ethnic, and socio-economic backgrounds, implementing interventions to optimize physical, emotional, and mental well-being for both patients and caregivers.
Atossa Therapeutics (Nasdaq: ATOS) has responded to the Patent Trial and Appeal Board's (PTAB) final decision regarding U.S. Patent No. 11,572,334, which found all challenged claims unpatentable. While disappointed, the company states this ruling does not affect their current clinical development formulations.
Rather than pursuing an appeal due to time and cost considerations, Atossa will seek patent protection through a new Continuation Patent Application. The company also announced the issuance of a new patent (U.S. Patent No. 12,201,591) on January 21, 2025, for sustained release compositions of endoxifen.
Atossa's current patent portfolio includes multiple U.S. patents with numerous claims: No. 11,261,151 (21 claims), No. 11,680,036 (22 claims), No. 12,071,391 (44 claims), and the new No. 12,201,591 (31 claims), all covering their clinical development formulations.
Atossa Therapeutics (NASDAQ: ATOS) has released a shareholder letter highlighting significant progress in 2024 for their breast cancer prevention and treatment programs. The company completed the KARISMA-Endoxifen Phase 2 Study, which demonstrated significant reductions in mammographic breast density of 17.3% (1mg) and 23.5% (2mg) compared to placebo.
The EVANGELINE trial showed promising results in its pharmacokinetic run-in phase, with 50% of patients receiving 80mg (Z)-endoxifen with goserelin reaching target steady-state plasma concentrations. The I-SPY 2 Endocrine Optimization Pilot demonstrated 95% treatment compliance, with a 69% reduction in Ki-67 and 30.4% reduction in functional tumor volume after three weeks.
The company secured two additional U.S. patents for (Z)-endoxifen and maintains a strong financial position. For 2025, Atossa plans to focus on advancing (Z)-endoxifen into registrational trials and expanding global business development efforts.
Atossa Therapeutics (NASDAQ: ATOS) endorses the U.S. Surgeon General's Advisory highlighting alcohol as a major preventable cause of breast cancer. The Advisory reveals that alcohol contributes to nearly 100,000 cancer cases and 20,000 cancer deaths annually in the US, making it the third leading preventable cause of cancer after tobacco and obesity.
Breast cancer represents the largest portion of alcohol-related cancers in women, accounting for 44,180 cases annually (16.4% of all breast cancer diagnoses). The risk begins to rise with as little as one drink per day, yet less than 45% of Americans believe alcohol significantly affects cancer development.
The Advisory calls for updated health warning labels on alcoholic beverages, expanded public education efforts, and implementation of proven alcohol reduction strategies in cancer prevention initiatives.
Atossa Therapeutics (NASDAQ: ATOS) has announced groundbreaking research findings on compounds that work synergistically with (Z)-endoxifen for breast cancer treatment. The discovery, presented at the 2024 San Antonio Breast Cancer Symposium, utilized both insilico and chemical screening approaches to identify compounds that target specific enzymes and proteins involved in tumor survival.
The research demonstrated that combinations of these newly discovered compounds with (Z)-endoxifen induced enhanced cell death in MCF-7 breast cancer cells, particularly when using inhibitors of MEK, PI3K, and AKT. The findings suggest promising potential for combination therapies targeting topoisomerase, CDK, mTOR/PI3K, and AKT alongside (Z)-endoxifen, though further research is needed.
Atossa Therapeutics (NASDAQ: ATOS) announced full results from its Phase 2 KARISMA-Endoxifen trial, showing significant reductions in mammographic breast density (MBD) in premenopausal women. The randomized, double-blind study of 240 women aged 40-55 tested 1mg and 2mg doses of (Z)-endoxifen against placebo over six months.
The 1mg dose reduced MBD by 17.3 percentage points and the 2mg dose by 23.5 percentage points (both p<0.01), compared to 0.27 points for placebo. The 1mg dose showed no significant difference in adverse events versus placebo, while the 2mg dose had higher rates of side effects. Plasma concentrations were 4.8 ng/mL and 9.7 ng/mL for 1mg and 2mg doses respectively.
Atossa Therapeutics (ATOS) presented pharmacokinetic and tolerability data from its Phase 2 EVANGELINE trial at SABCS 2024. The trial investigates (Z)-endoxifen as a neoadjuvant treatment for premenopausal women with ER+/HER2-negative breast cancer. Key findings include: 50% of patients receiving 80mg (Z)-endoxifen with goserelin met target steady-state plasma concentrations, while 38% reached target levels without goserelin. The 80mg dose achieved tissue levels double that of plasma levels in 90% of patients.
The treatment showed substantial tumor suppression across all dosing levels, with Ki-67 response rates above 85%. Quality of life data indicated the treatment was generally well-tolerated. Based on these results, EVANGELINE will proceed with an amended protocol comparing 40mg/day (Z)-endoxifen plus OFS to exemestane plus OFS, with recruitment expected to begin in 2025.
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