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
• 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 expenses of $1,998,000.

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  Research and Development Expenses
  R&D expenses for the three months  ended March  31, 2021, were $1,379,000, an increase of $440,000 or 47% from total R&D expenses for the same period in  2020  of $939,000. The increase in R&D expense is attributed primarily  an increase in clinical trial expense of approximately $319,000 and an increase in salaries  of approximately $118,000 due to the addition of employees, as compared to the same period in 2020. We expect our R&D expenses to continue to increase into 2021 as we seek to commence a 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 $2,152,000 for the three months  ended March  31, 2021, an increase of $154,000, or 8% from the total G&A expenses for the three months  ended March 31, 2020, of $1,998,000. The increase  in G&A expenses for the three months  ended March  31, 2021,  is mainly attributed  to an increase in insurance and professional fees of approximately $286,000 offset by a reduction in legal fees and compensation  of approximately $152,000 compared to the same period in 2020. G&A expenses consist primarily of personnel and related benefit costs, facilities, professional services, insurance, and public company related expenses.

  ABOUT ATOSSA THERAPEUTICS

  Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in oncology and infectious diseases with a current focus on breast cancer and COVID-19.

CWEB Analyst’s have initiated a BUY Rating for Atossa Therapeutics, Inc. (Nasdaq: ATOS) and potential upside of $3.50 in 2021. The fundamentals of the company are to strong and cash on hand has increased .