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.
Overview
Atossa Therapeutics Inc (ATOS) is a clinical stage biopharmaceutical company that develops and markets innovative medicines, laboratory tests, and therapeutic delivery platforms focused on addressing unmet medical needs in oncology. With a primary emphasis on women’s breast health and breast cancer, the company is dedicated to advancing novel drug candidates and precision-targeted delivery systems, employing cutting-edge approaches such as selective estrogen receptor modulation and intraductal microcatheter technology.
Core Therapeutic Focus
The company’s flagship asset, (Z)-endoxifen, exemplifies its commitment to tackling critical challenges in breast cancer treatment. (Z)-endoxifen is a potent selective estrogen receptor modulator (SERM) that not only inhibits estrogen receptor activity but also facilitates its degradation. This dual action is strategically designed to address cases where resistance to traditional hormonal therapies exists, thus filling a significant therapeutic gap in oncology. Additionally, the formulation of (Z)-endoxifen is developed as an oral medication that bypasses the liver metabolism and gastric degradation issues, ensuring optimal bioavailability at therapeutic concentrations.
Innovative Drug Delivery Platforms
Beyond its core drug candidates, Atossa Therapeutics is also pioneering advanced delivery mechanisms to enhance therapeutic efficacy. The development of intraductal microcatheter technology represents a novel approach to deliver therapies directly to the site of breast cancer, thereby improving the targeting of treatments such as hormonal therapies, immunotherapies, and chimeric antigen receptor T-cell therapies. This targeted delivery strategy not only heightens the precision of treatment but also has the potential to reduce systemic side effects, contributing to an overall improved patient experience.
Clinical Development and Research Programs
Atossa’s development pipeline is robust, with multiple Phase 2 trials designed to evaluate the effectiveness of (Z)-endoxifen in diverse patient populations, including women with measurable breast density and those diagnosed with ductal carcinoma in situ. The company’s research initiatives extend to combination therapies, where (Z)-endoxifen is studied alongside other agents such as cyclin-dependent kinase (CDK) inhibitors, further broadening the therapeutic paradigm in breast cancer treatment. These programs underscore the company’s strategic emphasis on targeted oncology, employing rigorous clinical methods to substantiate the efficacy and safety of its novel therapies.
Intellectual Property and Market Position
Central to Atossa’s strategy is its strong intellectual property portfolio, which includes multiple issued U.S. patents and numerous pending applications. These patents cover both the composition of matter for (Z)-endoxifen and innovative formulation approaches, ensuring a competitive edge in the market. By protecting its technology and research investments, the company lays a solid foundation for long-term value creation, even as it navigates the challenges inherent to clinical stage development.
Competitive Landscape and Industry Expertise
Operating within the highly competitive biopharmaceutical industry, Atossa Therapeutics distinguishes itself through its integrated approach to drug development and delivery innovation. Its expertise in designing treatments that address both the efficacy and tolerability aspects of cancer care positions it uniquely among its peers. The company’s focus on precise molecular targeting and the development of therapeutics that are supported by robust scientific data bolsters its role as a knowledgeable and expertly positioned player in the oncology landscape.
Business Model and Operational Strategy
- Clinical Innovation: Concentrates on advancing clinical programs with a focus on unmet needs in breast cancer and breast health conditions.
- Targeted Delivery: Emphasizes pioneering approaches in delivering therapies directly to disease sites, using technologies like intraductal microcatheter systems.
- Intellectual Property: Leverages a strong portfolio of patents to secure its technological advancements and maintain market differentiation.
- Collaborative Research: Engages in strategic partnerships and clinical collaborations to enhance its research capabilities and validate its clinical hypotheses.
Conclusion
Atossa Therapeutics Inc exemplifies a focused, research-driven approach to addressing significant challenges in oncology. By combining novel therapeutic agents with innovative delivery systems, the company provides a comprehensive model for advancing personalized breast cancer treatment. Its commitment to enhancing patient outcomes through scientific rigor and technological innovation underscores its importance in the dynamic field of biopharmaceutical research. The detailed clinical programs, strategic intellectual property protections, and collaborative research efforts are all testaments to its expertise and nuanced understanding of complex oncology treatment paradigms.
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.
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.
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