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.
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) reported its financial results for the year ended December 31, 2022, highlighting significant clinical advancements. The company initiated its Phase 2 EVANGELINE study for neoadjuvant treatment in premenopausal women with ER+ breast cancer and continues enrollment in the Karisma-Endoxifen study. Notably, Atossa added a new arm to the ongoing I-SPY 2 trial, evaluating (Z)-endoxifen. Financially, the company reported an operating loss of $27.7 million, a 35% increase from 2021, driven mostly by rising R&D costs. Cash reserves stood at approximately $111 million, supporting ongoing clinical endeavors.
Atossa Therapeutics (Nasdaq: ATOS) announces its proprietary Selective Estrogen Receptor Modulator, (Z)-endoxifen, will be assessed in a new arm of the I-SPY 2 clinical trial targeting locally advanced breast cancer. This trial, involving approximately 20 patients, aims to evaluate treatment effectiveness prior to surgery. The study focuses on estrogen receptor-positive invasive breast cancer patients, who have high recurrence risks and require more effective treatments. Dr. Steven Quay highlighted the urgency of new alternatives for these patients. Atossa is also conducting two Phase 2 studies for (Z)-endoxifen with promising implications for breast cancer management.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) has announced its participation in the Sidoti Small-Cap Virtual Conference, scheduled for March 22-23, 2023. Dr. Steven Quay, the Company’s President and CEO, along with Kyle Guse, General Counsel and CFO, will present on March 23 at 1:00 PM Eastern Time. Investors can register for the live webcast through the event's website. A recording will also be made available post-conference on Atossa's investor relations page. Atossa focuses on developing innovative medicines for unmet medical needs in oncology, particularly breast cancer.
Atossa Therapeutics (Nasdaq: ATOS) has initiated the Phase 2 EVANGELINE study, dosing its first patient for a trial evaluating the efficacy of (Z)-endoxifen versus exemestane plus goserelin in treating ER+/HER2- breast cancer in premenopausal women. This randomized study aims to assess the endocrine sensitive disease rate after four weeks of treatment with approximately 175 participants across 25 sites in the U.S. The previous study showed (Z)-endoxifen reduced Ki-67 by 65.1%, indicating potential efficacy. Atossa is also exploring (Z)-endoxifen's application in reducing mammographic breast density, an important breast cancer risk factor.
Atossa Therapeutics (Nasdaq: ATOS) announced the granting of a new patent (No. 11,572,334) by the USPTO for (Z)-endoxifen encapsulated in an enteric capsule, enhancing its intellectual property related to this compound. This patent positions Atossa as the sole provider of orally delivered (Z)-endoxifen with an enteric capsule in the U.S., aimed at optimizing drug delivery. The company is advancing Phase 2 trials, including the EVANGELINE study with approximately 175 participants and the Karisma-Endoxifen study with 240 participants, targeting unmet needs in breast cancer treatment. The new patent is expected to create long-term value for shareholders.
Atossa Therapeutics (Nasdaq: ATOS) announced significant progress in 2022, focusing on its breast cancer program with the patented (Z)-endoxifen. Currently, Phase 2 studies are underway to prevent and treat breast cancer, particularly targeting ER+/HER2- patients. The FDA authorized the EVANGELINE study for neoadjuvant treatment, expecting to enroll 175 patients across 25 sites. The company reported a 65.1% reduction in Ki-67 levels from a prior study, suggesting improved outcomes. Atossa also invested $4.7 million in Dynamic Cell Therapies, enhancing its oncology portfolio. As of September 30, 2022, Atossa holds approximately $117 million in cash and equivalents, with no debt.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) has appointed Eric Van Zanten as Vice President of Investor and Public Relations. With over 25 years in corporate communications, particularly in biopharmaceuticals, Van Zanten will enhance the company's investor and public messaging. His previous roles include leadership positions at Faron Pharmaceuticals and Bristol-Myers Squibb. CEO Steven Quay expressed confidence in Van Zanten's ability to articulate Atossa's mission in oncology. Atossa focuses on innovative cancer treatments, specifically targeting breast cancer and lung injury from therapies.
Atossa Therapeutics (Nasdaq: ATOS) reported its financial results for Q3 2022, showing no revenue but a notable increase in operating expenses of 59% year-over-year, totaling $8,205, driven mainly by a 134% rise in R&D expenses. The company received FDA authorization for a Phase 2 study of (Z)-endoxifen for premenopausal women with ER+/HER2- breast cancer and is pursuing new immuno-oncology opportunities. As of September 30, 2022, Atossa had approximately $117,477 in cash. The total operating expenses for the first nine months of 2022 were $19,553, a 25% increase compared to 2021.
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