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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) 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.
Atossa Therapeutics (Nasdaq: ATOS) will present at the Sidoti Small-Cap Investor Conference on June 12-13, 2024. Dr. Steven Quay, CEO, will deliver the presentation on June 13 at 9:15 am ET. Atossa, a clinical-stage biopharma company, focuses on developing innovative oncology treatments, particularly for breast cancer. Interested parties can register to view the live webcast through the event's website. A recording will be available afterward on Atossa's investor relations page.
Atossa Therapeutics has announced its support for a Phase 2 study aiming to validate an AI-driven breast cancer risk assessment model. The Stockholm Mammography Risk stratified Trial (SMART) will enroll 70,000 women post-mammogram to assess their risk of developing breast cancer over the next two years. The Profound AI Model will analyze mammogram data and other personal risk factors to identify high-risk individuals. Those at highest risk will undergo a contrast-enhanced mammogram (CEM). The study aims to determine the predictive power of the AI model, potentially paving the way for a Phase 3 trial focusing on (Z)-endoxifen for breast cancer prevention.
Atossa Therapeutics announced the completion of patient dosing in its Phase 2 Karisma-Endoxifen clinical trial. This study, which enrolled 240 premenopausal women with mammographic breast density (MBD), aims to reduce MBD, a risk factor for breast cancer. The trial, fully enrolled in November 2023, tested daily doses of 1 mg and 2 mg (Z)-endoxifen versus placebo over six months. Results will be important for potential Phase 3 trials. MBD reduction is linked to a 50%-63% decrease in breast cancer risk over 3-15 years. Atossa is focusing on breast cancer treatments, with five ongoing Phase 2 studies.
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