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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, Inc. (Nasdaq: ATOS) reported its 2020 financial results, highlighting significant advancements in its clinical programs, particularly for Endoxifen and AT-301. The company concluded a Phase 2 study for Endoxifen early due to positive interim results, accelerated its development plans, and received FDA approval for expanded access in ovarian cancer treatment. Operating expenses declined 15% to approximately $14.6 million, with R&D expenses slightly decreasing. At year-end, Atossa held about $39.7 million in cash, positioning itself well for future opportunities.
On March 30, 2021, Dr. Steven Quay, CEO of Atossa Therapeutics (NASDAQ: ATOS), published an Open Letter addressing the WHO report, emphasizing evidence supporting the lab origin of COVID-19. The letter outlines five undisputed facts indicating the likelihood of a laboratory-acquired infection. Dr. Quay calls for recognition of these facts to prevent future pandemics. He has shared the letter with over thirty global scientists, including WHO investigators, and advocates for a moratorium on gain-of-function research to avoid similar crises.
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.
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