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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) announced a significant milestone with the completion of a pre-investigational new drug (PIND) meeting with the FDA regarding its proprietary Z-endoxifen for treating breast cancer in the neoadjuvant setting. The FDA's feedback will aid in preparing a request to open an IND for a Phase 2 study, focusing on pre-menopausal women with ER+/HER2- breast cancer. Atossa plans to initiate the IND request in Q2 2022 and conduct a pharmacokinetic study alongside the Phase 2 trial, seeking to compare Z-endoxifen against standard treatment options.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announces a live Q&A session on November 30, 2021, at 8 AM Pacific/11 AM Eastern. CEO Dr. Steven Quay and CFO Kyle Guse will address questions regarding Atossa's research initiatives focused on breast cancer and COVID-19. The event, hosted by Tribe Public, is complimentary, with registration available here. For more details about Atossa, visit atossatherapeutics.com.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) reported its financial results for Q3 2021, ending September 30, with cash reserves of approximately $140 million. The company has no sustainable revenue and incurred operating expenses of about $5.16 million for Q3 2021, a 47% increase year-over-year. Key developments include initiating a clinical study for AT-H201 targeting COVID-19 patients and receiving Swedish regulatory approval for a Phase 2 trial of Endoxifen in women with mammographic breast density. The company anticipates ongoing increases in R&D expenses as trials progress.
Atossa Therapeutics (Nasdaq: ATOS) CEO Dr. Steven Quay addressed the significant decline in mammograms during the global pandemic in a recent video for Breast Cancer Awareness Month. He emphasized that many women have not been seeking mammograms since COVID-19 began, which is particularly concerning for women of color and those in lower income brackets, as highlighted in a peer-reviewed article. Atossa continues to focus on innovative treatments for oncology and COVID-19, aiming to address these urgent medical needs.
Atossa Therapeutics has begun enrolling participants in a clinical study for its nebulized formulation, AT-H201, aimed at improving lung function in both moderately to severely ill hospitalized COVID-19 patients and those suffering from post-infection pulmonary issues. The study will include 60 participants and is being conducted in Australia. AT-H201 combines two FDA-approved drugs and has shown to be significantly more potent than existing treatments like Remdesivir. Successful completion of this study and obtaining regulatory approval is crucial for commercialization.
Atossa Therapeutics (Nasdaq: ATOS) adjourns a special stockholder meeting to October 7, 2021, to allow more time for voting on a proposal to increase authorized shares. Currently, 73% of voted shares support the proposal, but only 58% of outstanding shares have been voted. Leading advisory firms ISS and Glass Lewis recommend approval. The new shares aim to fund acquisitions and collaborations, with no intention to raise capital below $10 per share in the nine months following approval. Stockholders can vote via phone at (833) 786-6488.
Atossa Therapeutics (Nasdaq: ATOS) has received approval from the Swedish Ethics Review Authority to initiate a Phase 2 clinical trial of oral Endoxifen aimed at reducing mammographic breast density (MBD). MBD affects over 10 million women in the U.S. and can complicate cancer detection. The trial, named Karisma-Endoxifen, will enroll around 240 healthy premenopausal women for a six-month study period. The primary goal is to evaluate the dose-response relationship of daily Endoxifen on MBD, with secondary objectives assessing safety and tolerability.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) reported financial results for Q2 2021, ending June 30, with cash balances of $142.4 million. The company achieved significant outcomes in its Phase 2 clinical studies, notably a 65.1% reduction in Ki-67 levels in breast cancer patients. Regulatory approvals from Sweden and Australia allow for the initiation of further clinical studies of Endoxifen and AT-H201. However, operating expenses surged by 78% and R&D costs rose by 130% compared to the previous year, reflecting increased clinical trial activities.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announces participation in the BTIG Virtual Biotechnology Conference on August 9-10, 2021. Steven Quay, President and CEO, and Kyle Guse, CFO, will engage in a fireside chat scheduled for August 9 at 10:00 a.m. ET. This event will be available for live streaming on the conference website, and a recording will follow. Investors are invited to schedule one-on-one meetings with the executives during the conference.
Atossa focuses on developing innovative treatments for unmet medical needs in oncology and infectious diseases, with emphasis on breast cancer and COVID-19.
On July 26, 2021, Steven Quay and international scientists released a pre-print paper examining the RNA sequencing data of early COVID-19 patients, suggesting severe contamination at the Wuhan Institute of Virology. Findings indicate that specimens from December 2019 contained significant levels of an undisclosed H7N9 influenza vaccine, over six times the amount of SARS-CoV-2. Additionally, Nipah virus gene sequences were identified, raising concerns about genetic manipulation. This contamination is problematic, given the lethal nature of the pathogens involved.
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