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Atossa Therapeutics Is Popular Right Now…. Here’s Why!

17 Feb Atossa Therapeutics Is Popular Right Now…. Here’s Why!

Atossa Therapeutics, Inc. (NASDAQ: ATOS), formerly known as Atossa Genetics, develops medical devices, laboratory tests and therapeutics to address issues in breast health. However, the Company has jumped on to the COVID-19 drug development bandwagon with its AT-H201, an inhalation therapy and AT-301, a nasal spray for at-home treatment of COVID-19.

Most recently the Company issued a letter from Dr. Steven C. Quay, Chairman and CEO of Atossa that provided an update on the progress of its pipeline and the way forward for the Company. We take a look at the Company below:

COVID Programs
AT-301 has completed in-vitro testing and a phase 1 clinical trail showing efficacy, safety and tolerability. The Company intends to release the final data from the study in Q1,2021 and complete pre-clinical and clinical studies, in order to initiate an investigational new drug application (IND) with the FDA. Atossa is seeking a partner in the diagnostic kit space that can help with co-promotion of the product with their kits. The candidate addresses the need for a preventive nasal spray for use in high-risk environments such as caregivers, emergency responders, healthcare providers and teachers.

AT-H201, a combination of two previously FDA approved drugs has completed in vitro testing and demonstrated the ability to inhibit SARS-CoV-2 infectivity of VERO cells. The AT-H201 components have shown 4X potency when compared to remdesivir and 20x potency than hydroxychloroquine. The Company is seeking permission to conduct the initial clinical study of AT-H201 in Australia and anticipating an approval in Q1,2021.

Atossa Therapeutics (NASDAQ: ATOS)

Market Cap: $249.08M; Current Share Price: 3.48 USDChart
Data by YCharts

Breast Cancer Programs
In May 2020, the Company reported interim results from a Phase 2 study of oral Endoxifen in Australia that showed a 74 percent reduction in tumor cell proliferation, prompting Atossa to halt the study due to compelling evidence. The Company believes that it shortens the development of the timeline of the drug by nearly one year, and intends to submit final data from the study in Q2,2021 and seek FDA inputs for further development in the U.S.

Atossa also reported positive results from a single patient FDA approved expanded access with no recurrence in over two years and no significant side-effects.

The Company is planning to conduct a phase 2 study to evaluate the safety, tolerability and efficacy of oral Endoxifen in reducing Mammographic Breast Density (MBD) in pre-menopausal women dosed over six months, subject to approval from the European Medical Product Authority and ethics board. The study will be initiated in Stockholm upon lifting of restrictions on patient recruitment due to COVID-19.

Breast cancer is the most common form of cancer in women with an estimated one in eight women and one in 1,000 men being diagnosed with breast cancer during their lifetime. According to data made available by centers for disease control and prevention (CDC) over 237,000 cases of breast cancer are diagnosed in women and about 2,100 in men in the U.S alone. Approximately 41,000 women and 450 men in the U.S. succumb to this malady every year.

The breast cancer therapeutics industry is likely to reach US$16.21 billion by 2023 growing at a CAGR of 8.4% CAGR from 2015 to 2023, according to a report by Transparency Market Research. Lifestyle changes such as rise in age of childbearing, high intake of oral contraceptive pills, reduced breast-feeding, and undergoing estrogen modifying drug treatments are leading to increased incidences of breast cancer according to the report. The rising spending on mergers and acquisition, strategic collaborations and the growth in research and development efforts to stay ahead of competitors will drive the growth in the market. Onslaught of generics could hamper the market from reaching its full growth potential.

The treatment plan for Breast Cancer consists of Surgery such as mammaplasty, mastectomy, lumpectomy, Radiation therapy, chemotherapy and oral medications. These come with their own set of limitations and side-effects. However, new advancements in technology are helping companies to develop novel therapeutics that with targeted delivery, improved efficacy, reduced side-effects and more positive patient outcomes.

The company is exclusively focused on the development of comprehensive breast cancer solutions starting from prevention to cure. Atossa is developing an oral formulation of “Endoxifen”, a key tamoxifen metabolite that has shown to reduce the chances of future recurrence, along with a topical lotion that can reduce breast density.

Image Source: Company

The Company’s Endoxifen offers an improvement over tamoxifen by directly delivering metabolite endoxifen to the body bypassing the need for metabolism by the liver. It also achieves a faster “steady-state” as compared to oral tamoxifen that can take up to 120 days. It is developing both oral and topical presentations of the drug. Additionally, the company has also received FDA approval permitting the use of Atossa’s oral Endoxifen as a post-mastectomy treatment in pre-menopausal, estrogen-receptor positive (ER+) breast cancer patients.

Image Source: Company

Its topical application of Endoxifen has shown to reduce mammographic breast density (MBD) and prevent/reduce gynecomastia in prostate cancer patients starting androgen deprivation therapy.

Key Takeaways  

  • Breast Cancer is the second most common form of cancer and an estimated 281,550 new cases of invasive breast cancer and 49,290 new cases of non-invasive (in situ) are likely to be diagnosed in 2021 according to an estimate by org. 43,600 women will succumb to the disease in the U.S alone. Tamoxifen, the most-prescribed treatment is a selective estrogen receptor modulator (SERM) that comes with some serious side-effects such as blood clots, endometrial cancer and increased risk of stroke. Endoxifen on the other hand offers many advantages over Tamoxifen, including minimal side effects. If the candidate continues to deliver consistent positive results in further trails, it will fill a large unmet need in the breast cancer treatment landscape.
  • Atossa is helmed by Dr. Steven Quay, a scientist with over 87 U.S patents and seven FDA-approved pharmaceuticals to his credit. His extensive experience in navigating regulatory framework to bring clinical candidates to the market will act in favor of the Company. Dr. Quay already has success with an FDA-approved B12 nasal spray and given that AT-301 and AT-H201 have passed in vitro analysis and phase I trials, there is a likely hood of the candidates being fast tracked due to the ongoing pandemic.
  • As of September 2020, the Company had approximately $9.2 million in cash and cash equivalents as per its Q3,2020 financial results. The Company has raised over $81 million through direct offerings in 2021, which it believes is sufficient to fund its trials and operations through 2021 and beyond.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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