Note 1 - Nature of Operations

3 Months Ended

Mar. 31, 2021

Notes to Financial Statements

Nature of Operations [Text Block]

NOTE

1:

NATURE OF OPERATIONS

On

January 6, 2020,

we changed our corporate name from Atossa Genetics Inc. to Atossa Therapeutics, Inc.

Atossa Therapeutics, Inc. (the “Company”) was incorporated on

April 30, 2009,

in the State of Delaware. The Company was initially formed to develop and market medical devices, laboratory tests and therapeutics to address breast health conditions. The Company is currently focused on development of its pharmaceuticals for the treatment of the novel coronavirus ("COVID-

19"

), breast cancer and other breast conditions. The Company's fiscal year ends on

December 31.

Impact of the Novel Coronavirus 

The continued spread of the COVID-

19

pandemic is affecting the United States and global economies and

may

affect the Company's operations and those of

third

parties on which the Company relies, including causing possible disruptions in the supply of the Company's Endoxifen, AT-

H201,

AT-

301

and the conduct of current and future clinical trials. In addition, the COVID-

19

pandemic

may

affect the operations of the U.S. FDA and other health authorities including similar entities/agencies in Sweden and Australia, which could result in delays in meetings, reviews and approvals. The evolving COVID-

19

pandemic could also directly or indirectly impact the pace of enrollment in our clinical trials for at least the next several months and possibly longer as patients

may

avoid or

may

not

be able to travel to healthcare facilities and physicians' offices except for a health emergency. Such facilities and offices

may

also be required to focus limited resources on non-clinical trial activities, including treatment of COVID-

19

patients, and

may

not

be available, in whole or in part, for clinical trial activities related to the Company's products under development. We have

not

experienced any delay in drug supply for our ongoing and planned clinical studies, including studies of Endoxifen, AT-

301

and AT-

H201.

However, our Phase

2

clinical study of Endoxifen that was being conducted in Australia was enrolling slower than expected due in part to COVID-

19

restrictions. Also, although we have

not

yet received regulatory approval to start our MBD Endoxifen study in Sweden, the study site we plan to use in Sweden has been negatively impacted by COVID-

19

restrictions which must be lifted before we can begin our study there. We anticipate commencing the MBD Endoxifen study in Sweden soon after receiving all necessary regulatory approvals; subject to delays in enrollment due to COVID-

19

disruptions, the duration and severity of which we cannot predict. Additionally, while the potential economic impact brought by, and the duration of, the COVID-

19

pandemic is difficult to assess or predict, the impact of the COVID-

19

pandemic on the global financial markets

may

reduce the Company's ability to access capital, which could negatively impact the Company's short-term and long-term liquidity. The ultimate impact of the COVID-

19

pandemic is highly uncertain and subject to change. We do

not

yet know the full extent of potential delays or impacts on our business, financing or clinical trial activities or on healthcare systems or the global economy as a whole. However, these effects could have a material adverse impact on the Company's liquidity, capital resources, operations, financial position and business and those of the

third

parties on which we rely. We will continue to monitor future enrollment in studies for potential restrictions on site visits, mammograms or the impositions of new restrictions on trials as a result of the COVID-

19

pandemic.

In response to the Coronavirus pandemic, the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”) was signed into law on

March 27, 2020. 

On

March 11, 2021,

President Biden signed an additional coronavirus relief package entitled the American Rescue Plan Act of

2021,

which included, among other things, provisions relating to stimulus payments to some Americans, extension of several CARES Act relief programs, expansion of the child tax credit, funding for vaccinations and other COVID-

19

related assistance programs. The CARES Act and the American Rescue Plan Act has

not

had a material impact on the Company; however, we will continue to examine the impacts that the CARES Act and the American Rescue Plan Act, as well as any future economic relief legislation,

may

have on our business.