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.
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) has announced the enrollment of the first cohort in a Phase 1 clinical study for its nasal spray drug candidate, AT-301, aimed at treating COVID-19. The initial cohort includes 8 healthy participants who received either a placebo or the active drug. The study, conducted in Australia, is designed to evaluate the safety and tolerability of AT-301. The company aims to complete enrollment quickly, emphasizing the potential of AT-301 to act as a protective barrier against COVID-19, which could significantly impact public health if successful.
Atossa Therapeutics (NASDAQ: ATOS) announced its Q2 2020 financial results, reporting no sustainable revenue during the quarter. Operating expenses decreased by 46% to approximately $3.94 million, primarily due to reduced research and administrative costs. Atossa received approval for a Phase 1 clinical study of its COVID-19 nasal spray, AT-301, in Australia, and reported promising in vitro results for its therapies. The company has approximately $7.5 million in cash, bolstered by an additional $4.3 million raised in July.
Atossa Therapeutics (NASDAQ: ATOS) has received ethics committee approval to initiate a Phase 1 clinical study in Australia for AT-301, a nasal spray drug aimed at treating COVID-19. Enrollment is expected to start within 30 days. The drug's unique mechanism targets the nasal cavity to enhance protection and potentially lower symptoms of COVID-19. The study will assess safety and tolerability in 32 participants and could influence future FDA applications. With rising COVID-19 cases in Australia, the trial is timely and significant for public health.
Atossa Therapeutics (Nasdaq: ATOS) has announced positive interim findings from an Expanded Access study of its oral Endoxifen for breast cancer treatment, which shows no recurrence of cancer in a patient after 18 months. The treatment did not cause common side effects associated with tamoxifen, and significant reductions in tumor markers Ki-67 (50%) and ER+ cells (22%) were observed. A Phase 2 study is ongoing, focusing on newly diagnosed patients, with all interim patients showing considerable Ki-67 reduction.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announces a webinar on July 30, 2020, hosted by CEO Dr. Steven Quay. The 30-minute event will discuss the company's breast cancer programs and advancements in two COVID-19 treatments. Registration is free via Tribe Public's website. Dr. Quay, a prominent figure in medical research, holds multiple patents and has contributed significantly to COVID-19 and breast cancer solutions. The event aims to provide insights into Atossa's progress and engage with investors.
Atossa Therapeutics (NASDAQ: ATOS) has contracted with Avance Clinical to conduct a clinical study of its nasal spray drug candidate, AT-301, aimed at treating COVID-19 in non-hospitalized patients. The double-blinded, randomized, placebo-controlled study will evaluate the safety of AT-301 in 32 healthy adults. The primary goal is to assess tolerability and local irritation, while secondary objectives include bronchospasm evaluations. Atossa plans to file for further regulatory approvals and aims to begin the study soon. The company has also filed provisional patents for AT-301.
Atossa Therapeutics (Nasdaq: ATOS) has announced positive in vitro results for its COVID-19 nasal spray, AT-301. The drug candidate demonstrated the ability to inhibit SARS-CoV-2 infectivity in VERO cells, suggesting potential efficacy in blocking virus entry into nasal cells. AT-301 aims to create a protective mucosal barrier in the nasal cavity, which could lower COVID-19 symptoms and infectivity. A Phase 1 clinical study is expected to commence soon. Atossa has filed provisional patents related to AT-301's formulation and methods of use.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) has announced the hiring of key personnel to enhance its clinical, regulatory, and chemistry manufacturing capabilities. Key hires include Heather Fraser, Ph.D., as vice president of clinical, regulatory and CMC; Natalie Farris, MS, as senior director of CMC; and Devon Payne as director of clinical operations. CEO Steven Quay emphasized that these acquisitions will accelerate the company's development pipeline, focusing on breast cancer and COVID-19 treatments, enhancing their strategic value creation efforts.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announced promising in vitro test results for its COVID-19 drug candidate, AT-H201. The study indicates that AT-H201 significantly inhibits SARS-CoV-2 infectivity in VERO cells, showing it to be at least four times more potent than remdesivir and 20 times more potent than hydroxychloroquine. A provisional patent has been filed for AT-H201, although further safety and efficacy studies, as well as regulatory approvals, are required before commercialization.
Atossa Therapeutics (Nasdaq: ATOS) has initiated development of a second COVID-19 program using its proprietary nasal spray candidate, AT-301. This drug is designed for patients diagnosed with COVID-19 but not requiring hospitalization, aiming to reduce symptoms and slow infection rates. AT-301 targets essential human host proteases to inhibit SARS-CoV-2. The company plans to commence human clinical trials in Q3 2020, pending regulatory approvals. Summit Biosciences has been retained for product development. Provisional patent applications have been filed for AT-301.
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