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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 its investment of $2 million in Dynamic Cell Therapies, acquiring a 19.99% stake. This move aligns with Atossa's strategy to explore CAR-T therapies in the immuno-oncology space, particularly for difficult-to-treat cancers. Previously, $3 million was invested in DCT, making a total of $5 million. The transaction is set to close in Q4 2022. DCT, based in Boston, is focused on developing controllable CAR-T therapies to enhance safety and efficacy in cancer treatments.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announced the appointment of Dr. Richard Graydon as interim chief medical officer. Dr. Graydon, previously with Johnson & Johnson, brings extensive experience in CAR-T cell therapy and oncology drug development. He aims to enhance Atossa's clinical programs, including the Phase 2 oral Endoxifen program for breast cancer. Atossa focuses on innovative treatments for oncology, highlighting the need for effective cancer therapies.
Atossa Therapeutics has announced the initiation of a Phase 2 neoadjuvant study for its proprietary drug, (Z)-endoxifen, in premenopausal women with early-stage ER+/HER2- breast cancer. The U.S. FDA has lifted the clinical hold, allowing this key trial to move forward, which will involve about 175 patients across 25 sites. The study aims to determine whether (Z)-endoxifen is non-inferior to the standard treatment of exemestane + goserelin. Atossa has also decided to discontinue its COVID-19 program to focus on this significant research.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) is set to participate in the 24th Annual H.C. Wainwright Global Investment Conference from September 12-14, 2022, at the Lotte New York Palace. Kyle Guse, General Counsel and CFO, will represent the company and is available for one-on-one meetings.
Atossa focuses on developing innovative therapies for unmet medical needs in oncology and infectious diseases, particularly in breast cancer and COVID-19.
For meeting requests and conference registration, visit here.
Atossa Therapeutics (Nasdaq: ATOS) will host a webinar on August 25, 2022, featuring CEO Dr. Steven Quay and CFO Kyle Guse. The event, starting at 8 AM Pacific, will discuss new opportunities for AT-H201, an inhalation therapy aimed at treating lung injuries from cancer treatments. Attendees can participate in a Q&A session regarding the company's research programs and future plans. Registration for the complimentary event is available online.
Atossa Therapeutics (Nasdaq: ATOS) announced the re-appointment of Drs. Mak Jawadekar, Per Hall, and Carl Novina to its Scientific Advisory Board (SAB) alongside the addition of Dr. Paul Wabnitz. The re-appointments are expected to strengthen Atossa's product development in oncology and infectious diseases, particularly in breast cancer and COVID-19. Dr. Wabnitz brings extensive clinical development experience, having worked on numerous oncology trials. This move aims to leverage their expertise to enhance Atossa's clinical programs and navigate challenges in drug development.
Atossa Therapeutics (Nasdaq: ATOS) reported its Q2 2022 financial results, highlighting key developments in their oncology and COVID-19 projects. The company completed dosing for AT-H201 in a Phase 1/2a trial aimed at hospitalized COVID-19 patients. Subsequently, they are shifting focus towards developing AT-H201 for cancer patients with lung damage from treatment. Financially, Atossa recorded operating expenses of $6,595, a 6% decrease from Q2 2021, with R&D expenses at $3,433, down 10%. Cash reserves stood at approximately $125,647, with no sustainable revenue reported.
Atossa Therapeutics (Nasdaq: ATOS) has completed dosing in Part C of its Phase 1/2a clinical study for AT-H201, an inhalation therapy aimed at treating lung injury from cancer treatments. The study involved administering two FDA-approved drugs in healthy volunteers. Due to evolving COVID-19 treatment landscapes, Atossa is shifting focus from COVID-19 to patients with lung injuries from radiation therapy, affecting 30-60% of cancer patients. The company plans to pursue this new development path and announce next steps in Q4 2022.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announced the appointment of Charles Butler as vice president of investor and public relations, effective June 2, 2022. With 25 years of experience in healthcare communications, Butler previously led communications at Exelixis, contributing to over $1B raised. His expertise is expected to enhance Atossa’s communications strategy as the company continues to develop innovative treatments for breast cancer and COVID-19. The management anticipates that Butler will play a crucial role in conveying Atossa's message of innovation within a competitive market.
On May 18, 2022, Atossa Therapeutics (Nasdaq: ATOS) announced that CFO Kyle Guse will present a corporate overview at the H.C. Wainwright Global Hybrid Investment Conference. The event takes place from May 23-26, 2022, at Fontainebleau Hotel in Miami Beach, FL, with Guse's presentation scheduled for May 24 at 12:30 PM ET. Attendees can request one-on-one meetings and register for both in-person and virtual participation.
Atossa focuses on developing innovative treatments for significant medical needs, particularly in oncology and infectious diseases.
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