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Atossa Therapeutics President and CEO Dr. Steven C. Quay Issues Annual Letter to Stockholders Highlighting Key Recent Accomplishments and Strategy for 2022

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SEATTLE, Jan. 27, 2022 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company seeking to develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases with a current focus on breast cancer and COVID-19, today issued the following letter from President and CEO Dr. Steven C. Quay to Atossa stockholders:

To Our Valued Stockholders:

The last two years have changed the face of public health and uncovered the urgency to develop products not only to prevent widely spread infectious diseases, but to treat them with the same level of focus and dedication applied to prevention. Despite the launch of highly efficacious vaccines during 2021, the toll that COVID-19 was taking on public health was not reduced. The rise of the Omicron variant toward the end of the year, and emerging long-term impact of long COVID, remain an important public health priority, and one that Atossa is dedicated to addressing. A key feature of the original SARS-CoV-2 virus, and that is retained in both the Delta and Omicron variants, is the furin cleavage site found on the Spike protein which facilitates viral infection. Our COVID-19 programs under development are designed to interact with this cleavage site so they are expected to be effective against both current and future COVID-19 variants that continue to contain a furin cleavage site.

In the meantime, we are also very excited about the ongoing development of our breast health programs with our proprietary drug Endoxifen, with one Phase 2 study underway and another expected to commence in the next quarter. We raised over $110 million in capital in 2021 and we are well positioned to execute on our programs in 2022.

For all of our programs, our longer-term development strategy is to complete clinical studies as rapidly as possible and then to partner with leading research institutions or pharmaceutical companies for later-stage development and commercialization. We are also actively evaluating potential acquisition/in-licensing opportunities of new programs to further drive stockholder value.

We are pleased to report the following highlights of our recent progress:

Endoxifen to Treat Breast Cancer in the Neoadjuvant Setting (the Window Between Diagnosis and Surgery).

In 2021, we reported final results from our Endoxifen Phase 2 clinical study in Australia showing the primary endpoint was met, a significant reduction in Ki-67, a common measure of breast cancer tumor cell activity, which was reduced from an average of 25.6% at screening to 6% on the day of surgery, a 65.1% reduction. All adverse events were mild and considered related to the study drug, and, based on these results, Endoxifen was considered safe and well tolerated in this study.