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Atossa Therapeutics Announces First Quarter 2024 Financial Results and Provides Corporate Update

SEATTLE, May 13, 2024 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) today announced financial results for the fiscal quarter ended March 31, 2024, and provides an update on recent company developments. Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer

Key developments from Q1 2024 and the year to date include:

“The first quarter of 2024 was a period of significant progress for our Company,” said Steven Quay, M.D., Ph.D., Atossa’s President and Chief Executive Officer. “We initiated a new combination study, presented extremely promising monotherapy data at AACR and fully enrolled the second of our five ongoing Phase 2 studies. Our focus for the remainder of 2024 will be to continue driving our (Z)-endoxifen development program forward, preparing for critical data readouts expected in the second half of this year and further progressing conversations with regulatory authorities and prospective partners. Even with all of our significant accomplishments in the quarter, our cash balance remains strong, at $84.0 million.”

Comparison of Three Months Ended March 31, 2024 and 2023

Revenue and Cost of Revenue. For the three months ended March 31, 2024 and 2023, we had no source of revenue and no associated cost of revenue.

Operating Expenses. Total operating expenses were $7.0 million for the three months ended March 31, 2024, which was a decrease of $0.1 million, from total operating expenses for the three months ended March 31, 2023 of $7.1 million. Factors contributing to the decreased operating expenses in the three months ended March 31, 2024 are explained below.

R&D Expenses. R&D expenses for the three months ended March 31, 2024, were $3.7 million, an increase of $0.2 million from R&D expenses for the three months ended March 31, 2023 of $3.5 million

The following table provides a breakdown of major categories within R&D expense for the three months ended March 31 2024 and 2023, together with the dollar change in those categories (in thousands):

      For the Three Months Ended
March 31,
       
      2024     2023     Increase
(Decrease)
 
Research and Development Expense                    
  Clinical and non-clinical trials   $ 2,884     $ 2,336     $ 548  
  Compensation     626       1,034       (408 )
  Professional fees and other     238       138       100  
  Research and Development Expense Total   $ 3,748     $ 3,508     $ 240  
                           

General and Administrative (G&A) Expenses. G&A expenses for the three months ended March 31, 2024 were $3.2 million, a decrease of $0.4 million from total G&A expenses for the three months ended March 31, 2023 of $3.6 million.

The following table provides a breakdown of major categories within G&A expenses for the three months ended March 31, 2024 and 2023, together with the dollar change in those categories (in thousands):

      For the Three Months Ended
March 31,
       
      2024     2023     Increase
(Decrease)
 
General and Administrative Expense                    
  Compensation   $ 1,325     $ 2,084     $ (759 )
  Professional fees and other     1,680       1,164       516  
  Insurance     227       342       (115 )
  General and Administrative Expense Total   $ 3,232     $ 3,590     $ (358 )
                           

Interest Income. Interest income was $1.1 million for the three months ended March 31, 2024, an increase of $0.2 million from interest income of $0.9 million for the three months ended March 31, 2023. The increase was due to a change in the mix of our money market accounts which yielded a higher rate of return.

About (Z)-Endoxifen
(Z)-endoxifen is the most potent Selective Estrogen Receptor Modulator (SERM) for estrogen receptor inhibition and also causes estrogen receptor degradation. It has also been shown to have efficacy in the setting of patients with tumor resistance to other hormonal treatments. In addition to its potent anti-estrogen effects, (Z)-endoxifen has been shown to target PKCβ1, a known oncogenic protein, at clinically attainable blood concentrations. Finally, (Z)-endoxifen appears to deliver similar or even greater bone agonistic effects while resulting in little or no endometrial proliferative effects compared with standard treatments, like tamoxifen.

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 significant 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. (Z)-endoxifen is currently being studied in five Phase 2 trials: one in healthy women with measurable breast density, one in women diagnosed with ductal carcinoma in situ, and two other studies including the EVANGELINE study in women with ER+/HER2- breast cancer. Atossa’s (Z)-endoxifen is protected by three 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 focus on using (Z)-endoxifen to prevent and treat breast cancer. For more information, please visit www.atossatherapeutics.com.

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

FORWARD LOOKING STATEMENTS
This press release contains certain information that may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We may identify these forward-looking statements by the use of words such as “expect,” “potential,” “continue,” “may,” “will,” “should,” “could,” “would,” “seek,” “intend,” “plan,” “estimate,” “anticipate,” “believe,” “future,” or other comparable words. Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes, such as data related to the (Z)-endoxifen program and the potential of (Z)-endoxifen as a breast cancer prevention and treatment agent, to differ materially from those projected or anticipated, including risks and uncertainties associated with: macroeconomic conditions and increasing geopolitical instability; the expected timing of releasing data; any variation between interim and final clinical results; actions and inactions by the FDA and foreign regulatory bodies; the outcome or timing of regulatory approvals needed by Atossa, including those needed to continue our planned (Z)-endoxifen trials; our ability to satisfy regulatory requirements; our ability to remain compliant with the continued listing requirements of the Nasdaq Stock Market; our ability to successfully develop and commercialize new therapeutics; the success, costs and timing of our development activities, including our ability to successfully initiate or complete our clinical trials, including our (Z)-endoxifen trials; our anticipated rate of patient enrollment; our ability to contract with third-parties and their ability to perform adequately; our estimates on the size and characteristics of our potential markets; our ability to successfully defend litigation and other similar complaints and to establish and maintain intellectual property rights covering our products; whether we can successfully complete our clinical trial of oral (Z)-endoxifen in women with mammographic breast density and our trials of (Z)-endoxifen in women with breast cancer, and whether the studies will meet their objectives; our expectations as to future financial performance, expense levels and capital sources, including our ability to raise capital; our ability to attract and retain key personnel; our anticipated working capital needs and expectations around the sufficiency of our cash reserves; and other risks and uncertainties detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its Annual Reports on Form 10-K and Quarterly Reports on 10-Q. Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise.

ATOSSA THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except share and per share data)      
 
    March 31, 2024     December 31, 2023  
Assets            
Current assets            
Cash and cash equivalents   $ 83,960     $ 88,460  
Restricted cash     110       110  
Prepaid materials     1,372       1,487  
Prepaid expenses and other current assets     1,613       2,162  
Total current assets     87,055       92,219  
             
Investment in equity securities     1,710       1,710  
Other assets     2,322       2,323  
Total assets   $ 91,087     $ 96,252  
             
Liabilities and stockholders’ equity            
Current liabilities            
Accounts payable   $ 1,230     $ 806  
Accrued expenses     1,613       973  
Payroll liabilities     659       1,654  
Other current liabilities     1,826       1,803  
Total current liabilities     5,328       5,236  
Total liabilities     5,328       5,236  
             
Commitments and contingencies            
             
Stockholders’ equity            
Convertible preferred stock – $0.001 par value; 10,000,000 shares authorized;
582 shares issued and outstanding as of March 31, 2024 and December 31, 2023
           
Common stock – $0.18 par value; 175,000,000 shares authorized; 125,507,814 and 125,304,064 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively     22,829       22,792  
Additional paid-in capital     256,571       255,987  
Treasury stock, at cost; 1,320,046 shares of common stock at March 31, 2024 and December 31, 2023     (1,475 )     (1,475 )
Accumulated deficit     (192,166 )     (186,288 )
Total stockholders’ equity     85,759       91,016  
Total liabilities and stockholders’ equity   $ 91,087     $ 96,252  
 ATOSSA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except share and per share data)
 
    For the Three Months Ended
March 31,
 
    2024     2023  
Operating expenses            
Research and development   $ 3,748     $ 3,508  
General and administrative     3,232       3,590  
Total operating expenses     6,980       7,098  
Operating loss     (6,980 )     (7,098 )
Interest income     1,138       850  
Other expense, net     (36 )     (33 )
Loss before income taxes     (5,878 )     (6,281 )
Income tax benefit            
Net loss     (5,878 )     (6,281 )
Net loss per share of common stock – basic and diluted   $ (0.05 )   $ (0.05 )
Weighted average shares outstanding used to compute net loss per share – basic and diluted     125,319,778       126,624,110  

 


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