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. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company whose news flow centers on the development of its lead investigational therapy, (Z)-Endoxifen. Company announcements frequently cover progress in breast cancer programs, regulatory interactions, intellectual property developments, and emerging opportunities in other serious diseases.
Investors following ATOS news can expect regular updates on clinical trials involving (Z)-Endoxifen, including studies in metastatic ER+/HER2- breast cancer, neoadjuvant treatment for premenopausal ER+/HER2- patients, breast cancer risk reduction strategies focused on mammographic breast density, and participation in the RECAST DCIS platform trial for hormone receptor–positive ductal carcinoma in situ. These releases often summarize trial design, early findings, and the potential implications for future registration strategies.
Atossa’s news also highlights regulatory milestones, such as FDA Type C meetings, Investigational New Drug (IND) submissions, and “Study May Proceed” letters. Additional coverage includes the FDA’s Rare Pediatric Disease designation for (Z)-Endoxifen in Duchenne Muscular Dystrophy, as well as AI-enabled research collaborations identifying new oncology indications like glioblastoma.
Another recurring theme in ATOS news is the company’s intellectual property position, including newly issued patents for enteric oral (Z)-Endoxifen formulations and methods of use in hormone-dependent breast disorders and estrogen-related conditions. Corporate updates, such as financial results, leadership appointments, and Nasdaq listing communications, provide context on Atossa’s operational and strategic direction.
By monitoring this news page, readers can review a chronological record of Atossa’s clinical, regulatory, scientific, and corporate announcements related to (Z)-Endoxifen and the company’s broader oncology and rare disease programs.
Atossa Therapeutics (Nasdaq: ATOS) announced a registered direct offering of $50 million in common stock and warrants priced at $2.88 per share. The agreement involves the sale of 17,361,100 shares and unregistered warrants for an additional 13,020,825 shares with a four-and-a-half-year expiration period. The offering, expected to close on March 24, 2021, is facilitated by Maxim Group LLC. Proceeds will support the company's clinical-stage operations focusing on oncology and infectious diseases. This move may impact shareholder equity through potential dilution.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announced that the FDA issued a "Safe to Proceed" letter allowing the use of their oral Endoxifen as a treatment for a patient with recurrent ovarian cancer. The treatment is being conducted at the University of Washington Medical Center by Dr. Barbara Goff. The patient's tumor responded well to a combination of Endoxifen and alpelisib, prompting Atossa to consider further clinical studies if successful.
Endoxifen, an active metabolite of tamoxifen, has shown significant efficacy in preclinical studies.
Atossa Therapeutics (Nasdaq: ATOS) released final results from its Phase 1 trial of AT-301, a nasal spray for COVID-19, indicating the treatment was safe and well-tolerated. Conducted on 32 healthy participants, the trial noted no serious adverse events, with only one case of moderate adverse events. The company plans to begin a pre-clinical study this quarter and aims to initiate a Phase 2 study in the U.S. AT-301 may also serve as a preventive measure against COVID-19, particularly in high-risk environments. The mechanism of AT-301 targets viral entry, suggesting potential effectiveness against variants.
Atossa Therapeutics (Nasdaq: ATOS) has provided an update on its progress amid the COVID-19 pandemic. The company raised approximately $81 million in net proceeds, enabling continued development in oncology and infectious diseases. Key developments include:
- AT-301 Nasal Spray for COVID-19, with Phase 1 study data expected in Q1 2021.
- AT-H201 Inhalation Therapy showing potential in clinical tests.
- Oral Endoxifen demonstrating significant tumor cell proliferation reduction.
Atossa's commitment to innovative therapies remains strong.
Atossa Therapeutics (Nasdaq: ATOS) reported promising results from a 26-month Expanded Access study involving its oral Endoxifen for a breast cancer patient. The patient has not experienced a recurrence of cancer, nor any adverse treatment-related effects, and has tolerated the drug well compared to tamoxifen. FDA authorization allowed the use of Endoxifen before and after surgery, marking a significant step in its development. The CEO noted the patient's experience as a model for future drug development efforts in addressing unmet medical needs.
Atossa Therapeutics (Nasdaq: ATOS) announced the receipt of $21 million from the exercise of outstanding warrants, contributing to a total of approximately $60 million raised since December 2020. The funds will accelerate the development of therapies for COVID-19 and breast cancer. CFO Kyle Guse emphasized the significance of these cash resources, stating they enable faster advancement of their programs in 2021. This financing marks a crucial step for Atossa as it seeks to address significant unmet medical needs in the biopharmaceutical sector.
On January 29, 2021, Dr. Steven Quay, CEO of Atossa Therapeutics, published a 193-page paper concluding that SARS-CoV-2 is 99.8% likely to be laboratory-derived rather than a natural zoonosis. The analysis scrutinized 26 independent facts, shifting initial beliefs from a 98.2% zoonotic origin to a strong lab-related conclusion. Dr. Quay raised concerns about potential conflicts of interest hindering true investigation into the virus's origin, especially citing genetic sequences linked to adenovirus vaccines in early Wuhan samples. The full paper is available on Zenodo for public access.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) will present a webinar titled “The Important Role of COVID Therapeutics in a Post Vaccine World” on February 2, 2021. CEO Dr. Steven Quay and CFO Kyle Guse will discuss the company’s focus on developing innovative medicines, particularly addressing COVID-19 and breast cancer. This complimentary event is hosted by Tribe Public and begins at 8am Pacific/11am Eastern. Participants can submit questions prior to the event or during the live session. Registration is available through Tribe Public's website.
Atossa Therapeutics (Nasdaq:ATOS) announced that Dr. Steven C. Quay will participate in the 2021 Precision Medicine World Conference, focusing on the development of new SARS-CoV-2 therapeutics. The event occurs virtually from January 25-27, 2021, with Dr. Quay's panel scheduled for January 26 at 11:30 AM PST. The conference highlights advancements in precision medicine and features notable speakers, including Dr. Anthony S. Fauci, the Director of the U.S. National Institute of Allergy and Infectious Diseases.
Dr. Steven Quay, M.D., PhD, recently shared insights into COVID-19's origins and spread, linking early cases to the People's Liberation Army Hospital in Wuhan, China, and the city's Metro Line 2. He noted a genetic cluster among four patients with a similar virus version, suggesting rapid global transmission via the subway system. Quay emphasized the importance of understanding these origins for improving treatments. His research continues to explore whether COVID-19's emergence was due to a market or laboratory incident, with potential revelations expected soon.
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