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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.
An international team of scientists, led by Dr. Steven Quay, has published a paper suggesting that a laboratory-acquired infection could be a more likely origin of COVID-19 than natural zoonotic transmission. The paper, presented to the US Congress, highlights insufficient biosafety levels in Wuhan labs and the absence of animal-to-human transmission evidence. Dr. Quay advocates for treating the lab leak theory as the primary hypothesis until new evidence emerges. Quay, a prominent figure in medicine, has contributed significantly to pharmaceuticals and pandemic survival strategies.
Atossa Therapeutics (Nasdaq: ATOS) has received regulatory approval from the HREC to initiate a clinical study of its nebulized formulation AT-H201 in Australia. This therapy aims to assist both moderately to severely ill COVID-19 patients and long-haul patients suffering from post-infection pulmonary issues. The Phase 1/2a study will evaluate 60 participants and aims to determine the efficacy of AT-H201, which has shown promising potency in in vitro tests against SARS-CoV-2. Successful trial results and regulatory approvals are essential for commercialization.
Atossa Therapeutics (Nasdaq: ATOS) announced its inclusion in the Russell 2000 and Russell 3000 Indexes, effective June 28, 2021. This event follows the announcement of preliminary additions on June 4 and June 14, 2021. CFO Kyle Guse highlighted this milestone as an opportunity to enhance investor awareness and liquidity. Membership in these indexes is determined by market-capitalization rankings and provides automatic inclusion in growth and value style indexes, impacting approximately $10.6 trillion in assets benchmarked against Russell's U.S. Indexes.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) has received approval from the Swedish Medical Product Agency to launch a Phase 2 clinical trial of its oral Endoxifen aimed at reducing mammographic breast density (MBD), a significant public health concern affecting millions of women. The study will involve about 240 pre-menopausal women and aims to assess the dose-response relationship of Endoxifen over six months. The company plans to initiate the trial once COVID-19 restrictions in Stockholm are lifted, with potential for broader future studies to evaluate Endoxifen's impact on breast cancer incidence.
Atossa Therapeutics (Nasdaq:ATOS) reported final results from its Phase 2 study of oral Endoxifen for breast cancer. The primary endpoint was met, showing a 65.1% reduction in tumor cell activity, measured by Ki-67, dropping from 25.6% to 6%. All patients achieved a Ki-67 level below 25%, which correlates with improved long-term survival. Secondary endpoints confirmed Endoxifen's safety and tolerability, with no severe adverse events. Atossa plans to advance Endoxifen toward FDA approval, targeting the unmet need for effective treatments for ER+ breast cancer.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) will hold a webinar on June 9, 2021, at 8 am PT to discuss final data from its Phase 2 study of Endoxifen for breast cancer patients before surgery. The event will feature key executives, including Dr. Steven Quay, and will allow participants to engage with the management team. The company focuses on developing innovative therapies for oncology and infectious diseases, particularly breast cancer and COVID-19. Interested attendees can register via Tribe Public's platform.
Atossa Therapeutics, led by Dr. Steven Quay, published research challenging the claim that the Wuhan Institute of Virology had no COVID-19 cases. The study highlights a statistical improbability given the 4.4% prevalence of COVID-19 in Wuhan during early 2020. The researchers argue that proper testing would likely have revealed positive cases among the 590 staff members at WIV. This analysis raises serious questions about the integrity of WIV's reported COVID cases.
Physician-Scientist Dr. Steven C. Quay, CEO of Atossa Therapeutics (NASDAQ: ATOS), has been invited to brief U.S. Congress on his research concerning the origins of COVID-19. The virtual meeting will occur on May 24, 2021, where Dr. Quay will discuss evidence supporting the theory of a laboratory-origin virus from Wuhan, China. He contends existing data indicates a lab-leak scenario rather than natural zoonosis. The briefing aims to inform congressional members about these findings, which could influence future safety measures against pandemics.
Atossa Therapeutics (Nasdaq: ATOS) reported its Q1 2021 financial results, revealing no sustainable revenue and cash reserves of approximately $137.7 million. The company concluded a Phase 2 study for oral Endoxifen, which showed positive results, and received FDA clearance for expanded access treatment in an ovarian cancer patient. Operating expenses increased by 20% to $3.5 million, driven by a 47% rise in R&D costs. The company plans to expand clinical studies and explore new opportunities moving forward.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announced its participation in the Investor Summit Conference on May 18, 2021. CEO Dr. Steven Quay and CFO Kyle Guse will present at 8:45 am ET. The company focuses on developing innovative medicines for unmet medical needs, particularly in oncology and infectious diseases, including breast cancer and COVID-19. Investors can request one-on-one meetings with management after the presentation. For more details, visit Atossa's website.
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