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Atossa THERAPEUTICS Atossa Therapeutics Announces Third Quarter 2021 Financial Results and Provides Corporate Update November 15 , 2021 2:30 PM EST SEATTLE , Nov. 15 , 2021 ( GLOBE NEWSWIRE ) -- Atossa Therapeutics , Inc. ( Nasdaq : ATOS ) , a clinical - stage biopharmaceutical company seeking to develop innovative proprietary 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 September 30 , 2021 , and provides an update on recent company developments . Key developments from Q3 2021 and to date include : • Began to enroll participants in its clinical study of AT - H201 in Australia . The nebulized formulation , AT - H201 , is being developed as an inhalation therapy for moderately to severely ill hospitalized COVID - 19 patients and for " long - haul ” patients with post - infection pulmonary disease . • Received authorization from Swedish regulators to initiate a Phase 2 clinical study of Endoxifen to assess safety and pharmacodynamics in women with mammographic breast density ( MBD ) . • Scheduled a pre - IND meeting with the U.S. FDA to obtain input on the potential clinical and regulatory pathway for use of Atossa's Endoxifen to treat breast cancer patients in the neoadjuvant ( sometimes called " window of opportunity " ) setting . The meeting is currently scheduled for December 2021 . " Our progress in both the Endoxifen and COVID - 19 programs , with our initiation of our trial in Australia for AT - H201 , and our receipt of regulatory authorization in Sweden to commence an Endoxifen Phase 2 trial , have been key recent milestones , positioning us to move both of these programs forward and take the next steps toward developing therapies in urgent unmet patient needs , " said Dr. Steven Quay , Atossa's President and Chief Executive Officer . " Further , our strong balance sheet will continue to facilitate our development plans as we not only execute on these trials but also explore additional options that could create significant shareholder value , " concluded Dr. Quay . Quarter Ended September 30 , 2021 , Financial Results For the quarter ended September 30 , 2021 , Atossa has no source of sustainable revenue and no associated cost of revenue . As of September 30 , 2021 , the Company had cash , cash equivalents and restricted cash of approximately $ 140 million . Operating Expenses : Total operating expenses were approximately $ 5,159,000 and $ 15,693,000 for the three and nine months ended September 30 , 2021 , respectively , consisting of research and development ( " R & D " ) expenses of approximately $ 2,206,000 and $ 7,383,000 respectively , and general and administrative ( " G & A " ) expenses of approximately $ 2,952,000 and $ 8,310,000 , respectively . Total operating expenses were approximately $ 3,509,000 and $ 10,382,000 , respectively for the three and nine month ended September 30 , 2020 , and consisted of R & D expenses of approximately $ 1,659,000 and $ 4,251,000 , respectively , and G & A expenses of approximately $ 1,850,000 and $ 6,131,000 respectively . Total operating expenses for the three and nine months ended September 30 , 2021 as compared to the same period in 2020 increased approximately $ 1,650,000 and $ 5,311,000 or 47 % and 51 % , respectively . The basis for the increased operating expenses in 2021 is explained below . Research and Development Expenses : R & D expenses for the three months ended September 30 , 2021 , were approximately $ 2,206,000 , an increase of approximately $ 547,000 or 33 % from total R & D expenses for the three months ended September 30 , 2020 , of approximately $ 1,659,000 . The increase of approximately $ 547,000 for the three month period is attributed to an increase in clinical trial expense of approximately $ 81,000 , an increase in compensation of approximately $ 380,000 driven by non - cash stock - based compensation and an increase in R & D professional fees of approximately $ 82,000 . R & D expenses for the nine months ended September 30 , 2021 , were approximately $ 7,383,000 , an increase of approximately $ 3,132,000 or 74 % from total R & D expenses for the nine months ended September 30 , 2020 , of approximately $ 4,251,000 . The increase in R & D expense for the nine months ended September 30 , 2021 , is attributed primarily to an increase in clinical trial expense of approximately $ 1,390,000 and an increase in compensation of approximately $ 591,000 due primarily to non - cash stock - based compensation and the addition of two employees , as compared to the same period in 2020. Also included in R & D expenses is an increase of $ 1,000,000 attributable to a one - time fee we paid in June 2021 to a U.S. leading research institution for the exclusive right to negotiate for the acquisition of the world - wide rights to two oncology R & D programs . Those negotiations are ongoing , and no assurance can be given that they will lead to a definitive agreement . We expect our R & D expenses to continue to increase through 2021 as we have commenced a clinical study of AT - H201 , complete studies of AT - 301 , launch a Phase 2 clinical trial of Endoxifen in women with high breast density , and continue the development of other indications and therapeutics . General and Administrative Expenses : G & A expenses were approximately $ 2,952,000 for the three months ended September 30 , 2021 , an