SEATTLE, May 15, 2023 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative proprietary medicines to address significant unmet needs in oncology with a current focus on breast cancer, today announces financial results for the fiscal quarter ended March 31, 2023, and provides an update on recent company developments.

Key developments from Q1 2023 and year to date include:

“I am proud of the progress we’ve made to date in 2023 and look forward to further accelerating our (Z)-endoxifen development programs over the coming months,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “With three ongoing Phase 2 studies investigating (Z)-endoxifen, $103.9 million of cash and cash equivalents on our balance sheet, broad patent protection and a talented team in place, we are well positioned to change the treatment paradigm for women with dense breast tissue and those diagnosed with estrogen receptor positive breast cancer."

Comparison of the three months ended March 31, 2023 and 2022 (dollar amounts in thousands unless otherwise noted)

Revenue and Cost of Revenue: 
For the three months ended March 31, 2023 and 2022, we had no source of sustainable revenue and no associated cost of revenue.

Operating Expenses:
The following table provides a breakdown of major categories within Research and Development (R&D) and General and Administrative (G&A) expenses for the three months ended March 31, 2023 and 2022, together with the dollar and percentage change in those categories:

 March 31, 2023  March 31, 2022  Change  % Change 
Research and Development               
Clinical trials$2,336  $1,288  $1,048   81%
Compensation 1,034   1,094   (60)  -5%
Professional fees 101   115   (14)  -12%
Exclusivity agreements -   (1,000)  1,000   -100%
Other 37   2   35   * 
Research and Development Total$3,508  $1,499  $2,009   134%
                
General and Administrative               
Compensation$2,084  $2,005  $79   4%
Legal and professional fees 926   669   257   38%
Insurance and other 580   574   6   1%
General and Administrative Total$3,590  $3,248  $342   11%

*Percentage is not meaningful


Total operating expenses were $7,098 for the three months ended March 31, 2023, which was an increase of $2,351, or 50%, from the three months ended March 31, 2022. Operating expenses for the three months ended March 31, 2023 consisted of R&D expenses of $3,508 and G&A expenses of $3,590.

Operating expenses for the three months ended March 31, 2022 consisted of R&D expenses of $1,499 and G&A expenses of $3,248. Factors contributing to the increased operating expenses for the three months ended March 31, 2023 are explained below.

Research and Development Expenses: R&D expenses for the three months ended March 31, 2023, were $3,508, an increase of $2,009, from total R&D expenses for the three months ended March 31, 2022 of $1,499. Key changes were as follows:

G&A Expenses: G&A expenses for the three months ended March 31, 2023, were $3,590, an increase of $342, from total G&A expenses for quarter ended March 31, 2022 of $3,248. Key changes were as follows:

Interest Income: Interest income was $850 for the three months ended March 31, 2023 an increase of $849, from interest income of $1 for the three months ended March 31, 2022. The increase was due to the higher average balance of invested cash in a money market account and higher average interest rates for the three months ended March 31, 2023 compared to the prior year period. 

About (Z)-Endoxifen
(Z)-endoxifen is the most active metabolite of the FDA approved Selective Estrogen Receptor Modulator (SERM), tamoxifen. Studies by others have demonstrated that the anti-estrogenic effects of tamoxifen are driven in a concentration-dependent manner by (Z)-endoxifen. In addition to its potent anti-estrogen effects, (Z)-endoxifen at higher concentrations has been shown to target PKCβ1, a known oncogenic protein.

Atossa is developing a proprietary oral formulation of (Z)-endoxifen that does not require liver metabolism to achieve therapeutic concentrations and is encapsulated to bypass the stomach as acidic conditions in the stomach convert a greater proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa’s (Z)-endoxifen has been shown to be well tolerated in Phase 1 studies and in a small Phase 2 study of women with breast cancer. We are currently studying our (Z)-endoxifen in healthy women with measurable breast density and women with ER+/HER2- breast cancer. Atossa’s (Z)-endoxifen is protected by two issued U.S. patents and numerous pending patent applications.

About Atossa Therapeutics
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a current focus on breast cancer. For more information, please visit www.atossatherapeutics.com

CONTACTS:
Kyle Guse
General Counsel and Chief Financial Officer
kyle.guse@atossainc.com

Eric Van Zanten
VP, Investor and Public Relations
610-529-6219
eric.vanzanten@atossainc.com

FORWARD LOOKING STATEMENTS
Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with any variation between interim and final clinical results, actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence studies of (Z)-endoxifen, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa’s products, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others such as patent rights, whether reduction in breast density or in Ki-67 or any other result from a neoadjuvant study is an approvable endpoint for (Z)-endoxifen, whether Atossa can complete acquisitions, and other risks detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.


ATOSSA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except for par value)

         
  As of March
31, 2023
(unaudited)
  As of
December
31, 2022		 
     
Assets        
Current assets        
Cash and cash equivalents $103,868  $110,890 
Restricted cash  110   110 
Prepaid expenses  5,295   4,031 
Research and development tax rebate receivable  738   743 
Other current assets  858   2,423 
Total current assets  110,869   118,197 
         
Investment in equity securities  4,700   4,700 
Other assets  631   635 
Total assets $116,200  $123,532 
         
Liabilities and Stockholders' Equity        
Current liabilities        
Accounts payable $1,444  $2,965 
Accrued expenses  613   1,059 
Payroll liabilities  822   1,525 
Other current liabilities  65   19 
Total current liabilities  2,944   5,568 
         
Total liabilities  2,944   5,568 
         
Commitments and contingencies        
         
Stockholders' equity        
Series B convertible preferred stock - $0.001 par value; 10,000 shares authorized; 1 shares issued and outstanding as of March 31, 2023 and December 31, 2022  -   - 
Additional paid-in capital - Series B convertible preferred stock  582   582 
Common stock - $0.18 par value; 175,000 shares authorized; 126,624 shares issued and outstanding as of March 31, 2023 and December 31, 2022  22,792   22,792 
Additional paid-in capital - common stock  252,357   250,784 
Accumulated deficit  (162,475)  (156,194)
Total stockholders' equity  113,256   117,964 
Total liabilities and stockholders' equity $116,200  $123,532 



ATOSSA THERAPEUTICS, INC. 
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS 
(UNAUDITED)
(amounts in thousands, except for per share amounts)

 For the Three Months
Ended March 31,		 
 2023  2022 
        
Operating expenses       
Research and development$3,508  $1,499 
General and administrative 3,590   3,248 
Total operating expenses 7,098   4,747 
Operating loss (7,098)  (4,747)
Interest income 850   1 
Other expense, net (33)  (40)
Loss before income taxes (6,281)  (4,786)
Income taxes -   - 
Net loss (6,281)  (4,786)
Loss per share of common stock - basic and diluted$(0.05) $(0.04)
Weighted average shares outstanding - basic and diluted 126,624   126,624