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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, Inc. (Nasdaq: ATOS) reported its Q1 2022 financial results, revealing no sustainable revenue and an operating loss of $4.7 million. Operating expenses rose 34% year-over-year to $4.7 million, primarily due to increased R&D expenses of $1.5 million and G&A expenses of $3.2 million, each reflecting heightened clinical trial activities. The company maintains cash reserves of approximately $131.6 million. Key advancements include a new U.S. patent for Endoxifen and the initiation of a Phase 2 study in premenopausal women with breast cancer, with an IND submission expected in Q2 2022.
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company focusing on oncology and infectious diseases, will present at the Q2 Investor Summit Conference on May 3-4, 2022. Kyle Guse, CFO and General Counsel, will provide a corporate overview during the event. The presentation is scheduled for May 3, 2022, at 10:15 am ET. Investors can access the presentation through a webcast link and request one-on-one meetings.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) has successfully completed participant enrollment for Part B of its Phase 1/2a clinical study of AT-H201 in Australia, focusing on inhalation therapy for COVID-19 patients and long-haulers. The study aims to investigate the efficacy of AT-H201 in improving lung function in both moderately to severely ill patients. While there’s a pressing need for additional therapies amid COVID-19 surges, the pathway to commercialization requires successful clinical outcomes and regulatory approvals. No assurances of success or approval are guaranteed.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announced its participation in the Maxim Group 2022 Virtual Growth Conference from March 28-30, 2022. Management, including Dr. Steven Quay and Kyle Guse, will present a corporate overview on March 28, 2022, at 9:00 AM ET. Investors can view the presentation via the investor relations section of the company's website. Atossa is focused on developing innovative treatments for oncology and infectious diseases, particularly breast cancer and COVID-19.
Atossa Therapeutics (Nasdaq: ATOS) has announced the issuance of U.S. Patent No. 11,261,151, enhancing its intellectual property regarding Endoxifen, a therapy under development for breast cancer and related conditions. The patent, expected to expire in 2038, strengthens Atossa's position against generic competition. Atossa is advancing Endoxifen in two clinical studies: one for breast cancer treatment and another for addressing mammographic breast density, a significant public health issue affecting millions of women. The company plans to submit an IND to the FDA for further trials.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) reported its fiscal year 2021 results, highlighting a cash position of $136 million. The company initiated a Phase 2 trial for its oral Z-endoxifen in Sweden, targeting premenopausal women with breast cancer. Notably, operating expenses rose by 40% to $20,521, driven by increased R&D costs of $9,210. The company aims to submit an IND for a U.S. study comparing Endoxifen to standard care and plans further development for its COVID-19 therapy, AT-H201, with completion expected in mid-2022.
Atossa Therapeutics (Nasdaq: ATOS) has emphasized its commitment to addressing significant health challenges, particularly in breast cancer and COVID-19. The company reported a successful Phase 2 study of Endoxifen, showing a 65.1% reduction in Ki-67, indicating reduced tumor activity. Atossa also initiated a Phase 2 study targeting women with increased mammographic breast density and advanced its AT-301 nasal spray and AT-H201 inhalation therapy for COVID-19. In 2021, Atossa raised over $110 million to further its clinical programs.
Atossa Therapeutics (Nasdaq: ATOS) announced the advancement of its Phase 1/2a clinical study of AT-H201, targeting lung function improvement in hospitalized COVID-19 patients and long-haul patients with post-infection pulmonary disease. After successfully completing Part A of the study, the Australian Human Research Ethics Committee approved the initiation of Part B, which will include 60 participants. AT-H201, a nebulized combination therapy, aims to address the urgent need for additional COVID-19 treatments amidst rising hospitalizations due to the Omicron variant.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announced the enrollment initiation of its Phase 2 clinical study of oral Z-Endoxifen in Sweden, targeting premenopausal women with elevated mammographic breast density. This milestone aims to assess the dose-response relationship between daily Z-Endoxifen doses and breast density reduction, alongside safety evaluations. The study, led by Dr. Per Hall, will involve around 240 participants over six months. With significant public health implications, this initiative strives to address a condition affecting over 10 million women in the U.S.
Physician-Scientist Steven Quay, MD, PhD, has published a significant e-print on the coronavirus BANAL-236, which exhibits high homology to SARS-CoV-2 and can infect human cells. This research, reported by the Institut Pasteur, indicates that BANAL-236 evolved to infect human cells through a previously unknown mechanism. Quay emphasizes the urgency for an international effort to investigate this virus due to its potential transmissibility and implications for current therapeutic strategies.
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