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Atossa Therapeutics, Inc. (NASDAQ: ATOS) is a pioneering biopharmaceutical company headquartered in Seattle, Washington. Established in 2009, Atossa focuses on developing innovative and proprietary medicines targeting unmet medical needs in oncology, with a particular emphasis on breast cancer. The company is currently in the clinical stage, advancing several key programs designed to improve cancer treatment and prevention.
Atossa's core program is the development of (Z)-endoxifen, a potent metabolite of tamoxifen, crucial for treating and preventing breast cancer. Currently, (Z)-endoxifen is in Phase II clinical trials aimed at various breast cancer conditions, including estrogen receptor-positive breast cancer, ductal carcinoma in situ (DCIS), and mammographic breast density. The company is also exploring its efficacy in combination therapies with drugs like abemaciclib, a CDK 4/6 inhibitor.
In addition to breast cancer, Atossa has ventured into COVID-19 therapeutics with two potential treatments: AT-H201 for improving lung function in severe COVID-19 patients and AT-301, a nasal spray for at-home use.
Recently, Atossa has achieved several milestones, including the successful dosing of the first patient in the RECAST DCIS study, full enrollment of its Phase II Karisma-Endoxifen trial, and promising preliminary data from the 40mg cohort in the EVANGELINE study. The company also regained compliance with Nasdaq's minimum bid price requirement.
Atossa's collaborative efforts include partnerships with Quantum Leap Healthcare Collaborative and Weill Cornell Medicine, advancing studies in combination therapies and breast cancer risk assessment through innovative AI models. With a strong financial position, including $84 million in cash and no debt as of Q1 2024, Atossa is well-positioned to continue its groundbreaking work in oncology.
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.
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.
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