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Atossa THERAPEUTICS Atossa Therapeutics Announces First Quarter 2021 Financial Results and Provides Corporate Update May 14 , 2021 1:15 PM EDT SEATTLE , May 14 , 2021 ( GLOBE NEWSWIRE ) -- Atossa Therapeutics , Inc. ( Nasdaq : ATOS ) , a clinical - stage biopharmaceutical company seeking to discover and develop innovative medicines in oncology and infectious disease with a current focus on breast cancer and COVID - 19 , today announces financial results for the fiscal quarter ended March 31 , 2021 , and provides an update on recent company developments . Key developments from Q1 2021 and to date include : • Atossa concluded its open - label Phase 2 clinical study of oral Endoxifen administered in the " window of opportunity " between diagnosis of breast cancer and surgery based on positive results allowing acceleration of the Endoxifen program in the United States • Announced updated findings following 24 months of an Expanded Access ( or " compassionate use ” ) single - patient study of Endoxifen for breast cancer . The patient in the study had no cancer recurrence and suffered no side effects . Endoxifen did not cause other safety and tolerability concerns in this patient • Received a " Safe to Proceed ” letter under the Expanded Access Pathway from the FDA permitting the use of Atossa's oral Endoxifen as a treatment in an ovarian cancer patient and began treatment • Announced final results from its Phase 1 double - blinded , randomized , placebo - controlled clinical study using Atossa's proprietary drug candidate AT - 301 administered by nasal spray . AT - 301 was considered to be safe and well tolerated in healthy male and female participants in this study at two different dose levels over 14 days . AT - 301 is being developed for at home use for patients recently diagnosed with COVID - 19 • Completed financing transactions with net proceeds of approximately $ 136 million beginning in December 2020 through the end of Q1 Atossa's 2021 Annual Stockholder Meeting is scheduled for today , May 14 , 2021 at 1 p.m. Pacific Time . As part of the meeting , Atossa management has decided to withdraw from consideration the proposal to increase authorized shares of common stock by 325 million . " During the first quarter of 2021 we continued our two key development programs , namely our Phase 2 study of oral Endoxifen for the ' window of opportunity ' between diagnosis of breast cancer and surgery and our Phase 1 study of AT - 301 nasal spray for at - home use for patients recently diagnosed with COVID - 19 , " said Dr. Steven Quay , Atossa's President and Chief Executive Officer . " In addition , we continued our ongoing expanded access program with Endoxifen in which the drug continues to be well tolerated and breast cancer recurrence has not been seen clinically . We also received an important authorization from the FDA for an additional expanded access treatment program in an ovarian cancer patient . Combined with very encouraging results in our COVID - 19 program with AT - 301 nasal spray , we continued to make great progress over the quarter . " " In the meantime , we leveraged favorable conditions in the capital markets to strengthen our balance sheet over the last few months placing Atossa in a good position to execute on these and potential additional business opportunities during the remainder of 2021. As a result , we are diligently moving our existing programs forward , while actively exploring the possibility for strategic expansion into other areas where we might see near - term milestones and results . We look forward to continuing to update our stockholders on these opportunities as they develop , ” concluded Dr. Quay . Quarter Ended March 31 , 2021 Financial Results For the quarter ended March 31 , 2021 , Atossa has no source of sustainable revenue and no associated cost of revenue . As of March 31 , 2021 , the Company had cash , cash equivalents and restricted cash of approximately $ 137.7 million . Operating Expenses Total operating expenses were $ 3,531,000 for the quarter ended March 31 , 2021 , compared to $ 2,937,000 during the same period of 2020 , an increase of $ 594,000 or approximately 20 % . Operating expenses for 2021 consisted of research and development ( " R & D " ) expenses of $ 1,379,000 and general and administrative ( " G & A " ) expenses of $ 2,152,000 . Operating expenses for 2020 consisted of R & D expenses of $ 939,000 , and G & A