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Atossa Therapeutics, Inc. (NASDAQ: ATOS) is a pioneering biopharmaceutical company headquartered in Seattle, Washington. Established in 2009, Atossa focuses on developing innovative and proprietary medicines targeting unmet medical needs in oncology, with a particular emphasis on breast cancer. The company is currently in the clinical stage, advancing several key programs designed to improve cancer treatment and prevention.
Atossa's core program is the development of (Z)-endoxifen, a potent metabolite of tamoxifen, crucial for treating and preventing breast cancer. Currently, (Z)-endoxifen is in Phase II clinical trials aimed at various breast cancer conditions, including estrogen receptor-positive breast cancer, ductal carcinoma in situ (DCIS), and mammographic breast density. The company is also exploring its efficacy in combination therapies with drugs like abemaciclib, a CDK 4/6 inhibitor.
In addition to breast cancer, Atossa has ventured into COVID-19 therapeutics with two potential treatments: AT-H201 for improving lung function in severe COVID-19 patients and AT-301, a nasal spray for at-home use.
Recently, Atossa has achieved several milestones, including the successful dosing of the first patient in the RECAST DCIS study, full enrollment of its Phase II Karisma-Endoxifen trial, and promising preliminary data from the 40mg cohort in the EVANGELINE study. The company also regained compliance with Nasdaq's minimum bid price requirement.
Atossa's collaborative efforts include partnerships with Quantum Leap Healthcare Collaborative and Weill Cornell Medicine, advancing studies in combination therapies and breast cancer risk assessment through innovative AI models. With a strong financial position, including $84 million in cash and no debt as of Q1 2024, Atossa is well-positioned to continue its groundbreaking work in oncology.
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.
Atossa Therapeutics (NASDAQ: ATOS) presented research on the anti-cancer activity of (Z)-endoxifen and its byproducts at the AACR Special Conference. The study investigated four (Z)-endoxifen byproducts for treating estrogen receptor-positive (ERα+) breast cancer, including endocrine-resistant tumors.
Two compounds, AT416E and AT402E, showed strong anti-proliferative activity, with AT416E demonstrating enhanced inhibition of cell migration and invasion. All four byproducts exhibited greater anti-proliferative effects than (Z)-endoxifen in estrogen-deficient conditions, while (Z)-endoxifen proved most effective at inducing cell cycle arrest and apoptosis.
The company plans future in vivo studies to validate these compounds' potential in overcoming current endocrine therapy limitations.
Atossa Therapeutics (NASDAQ: ATOS) announced its upcoming presentation at the AACR Special Conference in Cancer Research in Toronto, December 9-11, 2024. The company will present a poster titled 'Anti-cancer Activity of (Z)-Endoxifen-Related Compounds in ERα+ Breast Cancer' on December 10, 2024.
The research focuses on optimizing therapeutic efficacy and tolerability through modifications to (Z)-endoxifen chemistry in treating estrogen receptor alpha-positive breast cancer. The presentation aims to demonstrate how these compounds could enhance potency and reduce adverse effects in cancer treatment outcomes.
Atossa Therapeutics (ATOS) announced that five abstracts featuring data on (Z)-endoxifen have been accepted for presentation at the San Antonio Breast Cancer Symposium (SABCS) in December 2024. The presentations will showcase findings from various studies evaluating (Z)-endoxifen in breast cancer prevention and treatment, including phase 2 trials and combination therapy research. Key presentations include studies on breast cancer prevention, quality of life outcomes in premenopausal patients, pharmacokinetic profiles, synergistic treatment combinations, and a non-inferiority trial comparing (Z)-endoxifen to existing treatments.
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.
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