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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.
A recent study by Dr. Steven Quay, head of COVID-19 therapeutic programs at Atossa Therapeutics (NASDAQ: ATOS), published on Zenodo, suggests that the SARS-CoV-2 pandemic may have originated at the PLA Hospital in Wuhan, China. The research indicates that early patient records dated back to December 10, 2019, prior to official announcements. The study highlights that the hospital is near the Wuhan Institute of Virology, where genetic links to bat coronaviruses exist. Additionally, it identifies the Wuhan Metro Line 2 as a significant conduit for virus transmission.
Atossa Therapeutics (Nasdaq: ATOS) has completed enrollment in its Phase 1 clinical study of AT-301, a nasal spray drug candidate aimed at treating COVID-19. This is a significant milestone as the ongoing pandemic intensifies. The study, conducted in Australia with 32 healthy adults, assesses the safety and tolerability of AT-301. Atossa plans to report preliminary results soon and is also seeking partners for co-development of AT-301 while preparing for a Phase 2 study in the first half of 2021.
Atossa Therapeutics (Nasdaq: ATOS) is set to present on October 13, 2020, at a Tribe Public Zoom Webinar during Breast Cancer Awareness Month. CEO Dr. Steven Quay and CFO Kyle Guse will lead a discussion titled “Atossa Therapeutics: Tackling our Greatest Health Challenges – COVID-19 and Breast Cancer”. The event, beginning at 8 AM PT/11 AM ET, will include a Q&A on Atossa’s breast cancer initiatives and COVID-19 treatment programs, particularly the nasal spray therapy AT-301. Registration for the event is complimentary but limited.
On October 2, 2020, Dr. Steven Quay, CEO of Atossa Therapeutics (NASDAQ: ATOS), gifted 50 copies of his book, "Stay Safe: a Physician's Guide to Survive Coronavirus," to the White House after President Trump and the First Lady tested positive for COVID-19. The book provides essential advice on preventing and managing COVID-19, aiming to aid recovery. Profits from the book sales are donated to a military veterans group assisting COVID-19 impacted communities. Dr. Quay's extensive experience in drug development underpins the book's insights.
Atossa Therapeutics (Nasdaq: ATOS), a clinical-stage biopharmaceutical company, announced that CEO Dr. Steven Quay and CFO Kyle Guse will present at the Oppenheimer & Co. Fall Healthcare Life Sciences and MedTech Summit. The event is being held virtually from September 21-23, 2020, with Atossa's presentation scheduled for September 22 at 9:10 AM ET. The company focuses on innovative medicines for breast cancer and COVID-19, and interested participants can register via email.
Atossa Therapeutics (Nasdaq: ATOS) announced a positive interim safety assessment from the second cohort in its Phase 1 clinical study of AT-301, a nasal spray for COVID-19. The safety committee's favorable review allows the company to proceed with the next cohort. The study aims to evaluate AT-301's safety and tolerability among healthy adults. Atossa plans to develop AT-301 for home use to help patients recover faster from early COVID-19 symptoms, targeting high-risk communities and healthcare workers.
Dr. Steven Quay, CEO of Atossa Therapeutics (NASDAQ: ATOS), has released a book titled "Stay Safe: A Physician's Guide to Survive Coronavirus", which has reached number one on five Amazon New Release Bestseller lists in various medical categories. The book offers vital information on navigating the pandemic, including tips on school safety and flu vaccinations. With over 28 million confirmed COVID-19 cases globally, Dr. Quay emphasizes the importance of sharing science-backed insights during this critical time, especially amidst ongoing vaccine trials.
Dr. Steven Quay, CEO of Atossa Therapeutics (NASDAQ: ATOS), shares effective tips for enhancing cloth Covid-19 masks, featured in FOX 26 Houston and his new book, "Stay Safe: A Physician's Guide to Survive Coronavirus." This guide compiles science-backed insights to alleviate pandemic-related concerns, offering practical solutions for better protection. Quay's innovative "salt spray" method, made from salt, water, and dish soap, enhances mask effectiveness. His book is available on Amazon, providing dozens of lifesaving recommendations for Covid-19 safety.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) reported a positive interim safety assessment from the first cohort of its Phase 1 clinical study for AT-301, a nasal spray drug candidate aimed at treating COVID-19. The study involved 8 healthy participants who received either a placebo or an active dose, leading to a favorable safety review. This milestone allows the company to proceed with patient enrollment for higher doses and repeated dose cohorts. The Phase 1 study, taking place in Australia, focuses on the safety and tolerability of AT-301, thus paving the way for further efficacy investigations.
Atossa Therapeutics (Nasdaq: ATOS) announced that CEO Dr. Steven Quay will present at the LD Micro 500 virtual conference on September 4, 2020, at 9:00 AM ET. This presentation will be followed by a live Q&A session for registered investors and attendees. Additionally, Dr. Quay is available for one-on-one virtual meetings from September 1-4, 2020. Atossa focuses on developing innovative medicines for unmet medical needs, particularly in breast cancer and COVID-19. For further details, visit www.atossatherapeutics.com.