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.
Atossa Therapeutics Inc (ATOS) is a clinical-stage biopharmaceutical company developing breast cancer therapies and targeted delivery technologies. The company's news flow reflects its position as an oncology-focused biotech advancing multiple programs through clinical development and regulatory pathways. Investors tracking Atossa Therapeutics can expect news spanning clinical trial results, regulatory interactions with the FDA, intellectual property developments, research partnerships, and quarterly financial reports.
Clinical development milestones represent the most significant category of news for Atossa Therapeutics. Updates on the endoxifen program—including patient enrollment, data readouts, and trial progression—directly impact the company's valuation and strategic direction. Similarly, developments in the intraductal microcatheter technology platform generate news when the company announces new therapeutic applications, partnership agreements, or technical achievements. These clinical and technological updates often include details about FDA feedback, regulatory designations such as Fast Track or Orphan Drug status, and advancement to new trial phases.
Regulatory news constitutes another major category, as interactions with the FDA and other regulatory bodies shape the company's development timeline and commercial prospects. This includes announcements of FDA meetings, guidance received on trial design, regulatory strategy updates, and submissions of clinical trial applications. Patent issuances and intellectual property developments also generate news, as these filings protect the company's therapeutic compounds and delivery technologies and can signal the breadth of potential applications for its platforms.
Research collaborations and strategic partnerships produce news when Atossa Therapeutics engages with contract research organizations, academic institutions, or biotechnology companies to advance its pipeline. These announcements often detail the scope of collaboration, the specific technologies or capabilities being contributed by each partner, and the therapeutic objectives of the joint effort. Financial news—including quarterly earnings reports, capital raises through equity offerings, and updates on cash runway—provides insight into the company's operational trajectory and ability to fund ongoing clinical programs.
Executive appointments, analyst coverage, and investor presentation announcements round out the news profile, offering context on the company's leadership team and its communication with the investment community. For investors evaluating Atossa Therapeutics, regular monitoring of this news flow provides visibility into clinical progress, regulatory momentum, and financial sustainability—the key determinants of value for clinical-stage biopharmaceutical companies.
Atossa Therapeutics (Nasdaq: ATOS) announced the advancement of its Phase 1/2a clinical study of AT-H201, targeting lung function improvement in hospitalized COVID-19 patients and long-haul patients with post-infection pulmonary disease. After successfully completing Part A of the study, the Australian Human Research Ethics Committee approved the initiation of Part B, which will include 60 participants. AT-H201, a nebulized combination therapy, aims to address the urgent need for additional COVID-19 treatments amidst rising hospitalizations due to the Omicron variant.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announced the enrollment initiation of its Phase 2 clinical study of oral Z-Endoxifen in Sweden, targeting premenopausal women with elevated mammographic breast density. This milestone aims to assess the dose-response relationship between daily Z-Endoxifen doses and breast density reduction, alongside safety evaluations. The study, led by Dr. Per Hall, will involve around 240 participants over six months. With significant public health implications, this initiative strives to address a condition affecting over 10 million women in the U.S.
Physician-Scientist Steven Quay, MD, PhD, has published a significant e-print on the coronavirus BANAL-236, which exhibits high homology to SARS-CoV-2 and can infect human cells. This research, reported by the Institut Pasteur, indicates that BANAL-236 evolved to infect human cells through a previously unknown mechanism. Quay emphasizes the urgency for an international effort to investigate this virus due to its potential transmissibility and implications for current therapeutic strategies.
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.
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