Atossa Therapeutics Inc Stock Price, News & Analysis

Atossa Therapeutics (Nasdaq: ATOS) announced a significant milestone with the completion of a pre-investigational new drug (PIND) meeting with the FDA regarding its proprietary Z-endoxifen for treating breast cancer in the neoadjuvant setting. The FDA's feedback will aid in preparing a request to open an IND for a Phase 2 study, focusing on pre-menopausal women with ER+/HER2- breast cancer. Atossa plans to initiate the IND request in Q2 2022 and conduct a pharmacokinetic study alongside the Phase 2 trial, seeking to compare Z-endoxifen against standard treatment options.

Atossa Therapeutics, Inc. (Nasdaq: ATOS) announces a live Q&A session on November 30, 2021, at 8 AM Pacific/11 AM Eastern. CEO Dr. Steven Quay and CFO Kyle Guse will address questions regarding Atossa's research initiatives focused on breast cancer and COVID-19. The event, hosted by Tribe Public, is complimentary, with registration available here. For more details about Atossa, visit atossatherapeutics.com.

Atossa Therapeutics, Inc. (Nasdaq: ATOS) reported its financial results for Q3 2021, ending September 30, with cash reserves of approximately $140 million. The company has no sustainable revenue and incurred operating expenses of about $5.16 million for Q3 2021, a 47% increase year-over-year. Key developments include initiating a clinical study for AT-H201 targeting COVID-19 patients and receiving Swedish regulatory approval for a Phase 2 trial of Endoxifen in women with mammographic breast density. The company anticipates ongoing increases in R&D expenses as trials progress.

Atossa Therapeutics (Nasdaq: ATOS) CEO Dr. Steven Quay addressed the significant decline in mammograms during the global pandemic in a recent video for Breast Cancer Awareness Month. He emphasized that many women have not been seeking mammograms since COVID-19 began, which is particularly concerning for women of color and those in lower income brackets, as highlighted in a peer-reviewed article. Atossa continues to focus on innovative treatments for oncology and COVID-19, aiming to address these urgent medical needs.

Atossa Therapeutics has begun enrolling participants in a clinical study for its nebulized formulation, AT-H201, aimed at improving lung function in both moderately to severely ill hospitalized COVID-19 patients and those suffering from post-infection pulmonary issues. The study will include 60 participants and is being conducted in Australia. AT-H201 combines two FDA-approved drugs and has shown to be significantly more potent than existing treatments like Remdesivir. Successful completion of this study and obtaining regulatory approval is crucial for commercialization.

Atossa Therapeutics (Nasdaq: ATOS) adjourns a special stockholder meeting to October 7, 2021, to allow more time for voting on a proposal to increase authorized shares. Currently, 73% of voted shares support the proposal, but only 58% of outstanding shares have been voted. Leading advisory firms ISS and Glass Lewis recommend approval. The new shares aim to fund acquisitions and collaborations, with no intention to raise capital below $10 per share in the nine months following approval. Stockholders can vote via phone at (833) 786-6488.

Atossa Therapeutics (Nasdaq: ATOS) has received approval from the Swedish Ethics Review Authority to initiate a Phase 2 clinical trial of oral Endoxifen aimed at reducing mammographic breast density (MBD). MBD affects over 10 million women in the U.S. and can complicate cancer detection. The trial, named Karisma-Endoxifen, will enroll around 240 healthy premenopausal women for a six-month study period. The primary goal is to evaluate the dose-response relationship of daily Endoxifen on MBD, with secondary objectives assessing safety and tolerability.

Atossa Therapeutics, Inc. (Nasdaq: ATOS) reported financial results for Q2 2021, ending June 30, with cash balances of $142.4 million. The company achieved significant outcomes in its Phase 2 clinical studies, notably a 65.1% reduction in Ki-67 levels in breast cancer patients. Regulatory approvals from Sweden and Australia allow for the initiation of further clinical studies of Endoxifen and AT-H201. However, operating expenses surged by 78% and R&D costs rose by 130% compared to the previous year, reflecting increased clinical trial activities.

Atossa Therapeutics, Inc. (Nasdaq: ATOS) announces participation in the BTIG Virtual Biotechnology Conference on August 9-10, 2021. Steven Quay, President and CEO, and Kyle Guse, CFO, will engage in a fireside chat scheduled for August 9 at 10:00 a.m. ET. This event will be available for live streaming on the conference website, and a recording will follow. Investors are invited to schedule one-on-one meetings with the executives during the conference.

Atossa focuses on developing innovative treatments for unmet medical needs in oncology and infectious diseases, with emphasis on breast cancer and COVID-19.