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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 the receipt of $21 million from the exercise of outstanding warrants, contributing to a total of approximately $60 million raised since December 2020. The funds will accelerate the development of therapies for COVID-19 and breast cancer. CFO Kyle Guse emphasized the significance of these cash resources, stating they enable faster advancement of their programs in 2021. This financing marks a crucial step for Atossa as it seeks to address significant unmet medical needs in the biopharmaceutical sector.
On January 29, 2021, Dr. Steven Quay, CEO of Atossa Therapeutics, published a 193-page paper concluding that SARS-CoV-2 is 99.8% likely to be laboratory-derived rather than a natural zoonosis. The analysis scrutinized 26 independent facts, shifting initial beliefs from a 98.2% zoonotic origin to a strong lab-related conclusion. Dr. Quay raised concerns about potential conflicts of interest hindering true investigation into the virus's origin, especially citing genetic sequences linked to adenovirus vaccines in early Wuhan samples. The full paper is available on Zenodo for public access.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) will present a webinar titled “The Important Role of COVID Therapeutics in a Post Vaccine World” on February 2, 2021. CEO Dr. Steven Quay and CFO Kyle Guse will discuss the company’s focus on developing innovative medicines, particularly addressing COVID-19 and breast cancer. This complimentary event is hosted by Tribe Public and begins at 8am Pacific/11am Eastern. Participants can submit questions prior to the event or during the live session. Registration is available through Tribe Public's website.
Atossa Therapeutics (Nasdaq:ATOS) announced that Dr. Steven C. Quay will participate in the 2021 Precision Medicine World Conference, focusing on the development of new SARS-CoV-2 therapeutics. The event occurs virtually from January 25-27, 2021, with Dr. Quay's panel scheduled for January 26 at 11:30 AM PST. The conference highlights advancements in precision medicine and features notable speakers, including Dr. Anthony S. Fauci, the Director of the U.S. National Institute of Allergy and Infectious Diseases.
Dr. Steven Quay, M.D., PhD, recently shared insights into COVID-19's origins and spread, linking early cases to the People's Liberation Army Hospital in Wuhan, China, and the city's Metro Line 2. He noted a genetic cluster among four patients with a similar virus version, suggesting rapid global transmission via the subway system. Quay emphasized the importance of understanding these origins for improving treatments. His research continues to explore whether COVID-19's emergence was due to a market or laboratory incident, with potential revelations expected soon.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announced a securities purchase agreement with institutional investors to raise $25.2 million through a registered direct offering. 23,850,000 shares of common stock and warrants for 17,887,500 shares will be sold, priced at $1.055 each. The offering's gross proceeds are expected to close by January 8, 2021, subject to customary conditions. Maxim Group LLC acts as the placement agent for this offering, which is conducted under a shelf registration statement effective from September 10, 2020.
Atossa Therapeutics (Nasdaq: ATOS) has entered into a securities purchase agreement with institutional investors for approximately $14.0 million of its common stock in a direct registered offering priced at-the-market. The offering includes the sale of 14,000,000 shares at $1.00 per share, along with warrants for 10,500,000 shares concurrently. The expected closing date is December 21, 2020. Maxim Group LLC is the placement agent, and the offering is made under a previously effective registration statement with the SEC.
Atossa Therapeutics (Nasdaq: ATOS) has announced a public offering priced to yield gross proceeds of $20 million. The offering consists of 14,575,000 Units, each including one share of common stock and 0.75 Warrants priced at $1.00 per Unit, alongside 5,425 Units of Series C Convertible Preferred Stock. This offering is set to close around December 11, 2020, pending typical conditions. Maxim Group LLC is the sole book-running manager and has an option to purchase an additional 3 million shares and 2.25 million Warrants.
Atossa Therapeutics (Nasdaq: ATOS) reported its third-quarter financial results for the period ending September 30, 2020. The company has no sustainable revenue and reported total operating expenses of approximately $3.5 million for Q3 2020, a slight increase from Q3 2019. Significant advancements include the completion of a Phase 1 study of its AT-301 nasal spray for COVID-19, showing safety and tolerability. Atossa also applied for regulatory approval for a Phase 2 study of Endoxifen in Sweden to address mammographic breast density.
Atossa Therapeutics (Nasdaq: ATOS) announced positive preliminary results from its Phase 1 clinical study of AT-301, a nasal spray for treating COVID-19. In this study involving 32 participants, AT-301 was found to be safe and well-tolerated, with no serious adverse events reported. Following this success, Atossa plans to advance AT-301 into a Phase 2 study and prepare for a pre-IND meeting with the FDA. The company aims to co-develop AT-301 with COVID-19 diagnostic partners, targeting at-home use and potentially preventing infection in high-risk groups.
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