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CST: 23/05/2019 21:53:36   

Atossa Genetics Announces First Quarter 2019 Financial Results and Provides Company Update

10 Days ago

Completes First Quarter with Cash and Cash Equivalents of $19.6 Million

SEATTLE, May 13, 2019 (GLOBE NEWSWIRE) -- Atossa Genetics Inc. (Nasdaq:ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced financial results for the quarter ended March 31, 2019 and provided an update on recent company developments.

Steven C. Quay, M.D., Ph.D., Atossa Genetics’ President and CEO commented, "As we anticipated, we completed dosing in the topical Endoxifen breast density study in April and we look forward to announcing initial top-line results later this quarter. Further, as previously reported, the FDA approved an ‘Expanded Access’ program for use of our oral Endoxifen to treat a breast cancer patient prior to her surgery and in March 2019 we received a second approval for this patient to continue treatment post-surgery. We are planning a Phase 2 clinical study using our oral Endoxifen to reduce breast density and we look forward to providing updates on the launch of that study and progress with our other programs."

Q1 2019 Corporate Developments 

Developments during the first quarter include the following:

  • April 2019 – Completed dosing of Phase 2 topical Endoxifen breast density trial
  • April 2019 – Completed the first phase of a preclinical study using proprietary intraductal delivery technology. The company is now advancing to the next preclinical phase, which involves the intraductal administration of immune modulating formulations. These results will form the basis for advancing the intraductal delivery program into humans and to ultimately deliver immunotherapy to treat breast cancer using Atossa's proprietary intraductal delivery technology
  • March 2019 – FDA approval of oral Endoxifen for expanded access as post-mastectomy treatment for a U.S. breast cancer patient
  • March 2019 – Atossa received $11.3 million from the exercise of warrants that were previously outstanding
  • February 2019 – Atossa provided breast cancer prevention recommendations to the United States Preventative Services Task Force
  • February 2019 – Atossa reports results from expanded access program for a U.S. breast cancer patient taking oral Endoxifen: sizeable reduction in cancer cell biological activity; no safety or tolerability issues
  • January 2019 – Successfully completed and provided final results from male Phase 1 study of topical Endoxifen; no clinically significant safety nor tolerability issues and acceptable pharmacokinetics

Q1 2019 Financial Results 

For the quarter ended March 31, 2019 the company reported no revenue and no associated cost of revenue.

Total operating expenses were approximately $4,064,000 for the three months ended March 31, 2019, which is an increase of approximately $2,190,000 or 117 percent, from the three months ended March 31, 2018. Operating expenses for the three months ended March 31, 2019 consisted of research and development (R&D) expenses of approximately $1,451,000 and general and administrative (G&A) expenses of approximately $2,613,000. Operating expenses for the same period in 2018 consisted of R&D expenses of approximately $471,000, and G&A expenses of approximately $1,403,000.
    
R&D expenses for the three months ended March 31, 2019, were approximately $1,451,000, an increase of approximately $980,000 or 208 percent from total R&D expenses for the three months ended March 31, 2018 of approximately $471,000. The increase in R&D expense is attributed to salaries, stock-based compensation, and clinical trial expenses associated with our Endoxifen program. Stock-based compensation expense increased approximately $668,000 in 2019 resulting from the cancellation of stock options. There were no option cancellations in the comparable period in 2018. We expect our R&D expenses to increase throughout 2019 as we commence additional Phase 2 clinical studies of Endoxifen, continue the clinical trial of Fulvestrant administered via our intraductal technology and continue the development of other indications and therapeutics, including CAR-T and immunotherapies administered via our intraductal technologies.

G&A expenses were approximately $2,613,000 for the three months ended March 31, 2019, an increase of approximately $1,210,000, or 86 percent from the total G&A expenses for the three months ended March 31, 2018, of approximately $1,403,000. G&A expenses consist primarily of personnel and related benefit costs, facilities, professional services, insurance, and public company related expenses. The increase in G&A expenses for the quarter ended March 31, 2019, is mainly attributed to an increase in stock-based compensation expense due to the cancellation of 2018 options of approximately $1,074,000, payroll expenses resulting from salary increases, and increased legal and professional consulting expenses over the prior year.

As of March 31, 2019, Atossa had approximately $19.6 million in cash and cash equivalents and working capital of approximately $19.3 million.

About Atossa Genetics 

Atossa Genetics Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. For more information, please visit www.atossagenetics.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 preliminary 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, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa's products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others with respect to fulvestrant, such as patent rights, potential market sizes for Atossa's drugs under development 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 Form10-K and 10-Q, each as amended and supplemented from time to time.

Atossa Genetics Company Contact:
Atossa Genetics Inc.
Kyle Guse, CFO and General Counsel
Office: 866 893-4927
kyle.guse@atossagenetics.com

Investor Relations Contact:
Scott Gordon
Core IR
377 Oak Street
Concourse 2
Garden City, NY 11530
Office:(516) 222-2560
scottg@corprominence.com 

Source: Atossa Genetics Inc.


ATOSSA GENETICS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS

    As of March 31,     As of December 31,  
    2019     2018  
Assets   (Unaudited)          
Current assets                
Cash and cash equivalents   $ 19,568,247     $ 10,380,493  
Restricted cash     110,000       110,000  
Prepaid expenses     835,468       509,833  
Research and development tax rebate receivable     237,856       518,098  
Other current assets     27,957       30,942  
Total current assets     20,779,528       11,549,366  
                 
Furniture and equipment, net     48,212       54,487  
Intangible assets, net     91,667       99,375  
Right-of-use asset     88,103          
Other assets     17,218       17,218  
Total Assets   $ 21,024,728     $ 11,720,446  
                 
Liabilities and Stockholders' Equity                
Current liabilities                
Accounts payable   $ 463,970     $ 353,328  
Accrued expenses     74,844       177,074  
Payroll liabilities     891,758       935,070  
Stock-based compensation liability             1,410,025  
Lease liability     50,706          
Other current liabilities     9,863       39,939  
Total current liabilities     1,491,141       2,915,436  
Long term liabilities                
Lease liability long term     37,397          
Total Liabilities     1,528,538       2,915,436  
                 
Commitments and contingencies (note 11)                
Stockholders' equity                
Preferred stock - $0.001 par value; 10,000,000 shares authorized, consisting of Series B convertible preferred stock- $0.001 par value; 702 and 2,379 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively     1       2  
Additional paid-in capital- Series B convertible preferred stock     701,999       2,378,997  
Common stock - $0.18 par value; 175,000,000 shares authorized, and 9,122,171 and 5,846,552 shares issued and outstanding, as of March 31, 2019 and December 31, 2018, respectively     1,641,979       1,052,372  
Additional paid-in capital     98,056,781       82,204,902  
Accumulated deficit     (80,904,570 )     (76,831,263 )
Total Stockholders' Equity     19,496,190       8,805,010  
                 
Total Liabilities and Stockholders' Equity   $ 21,024,728     $ 11,720,446  



ATOSSA GENETICS INC. 
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)

    For the Three Months Ended March 31,  
    2019     2018  
                 
Operating expenses                
Research and development   $ 1,451,236     $ 470,976  
General and administrative     2,613,093       1,403,465  
Total operating expenses     4,064,329       1,874,441  
Operating loss     (4,064,329 )     (1,874,441 )
Other income (expense)     (8,978 )     59  
Loss before income taxes     (4,073,307 )     (1,874,382 )
Income taxes                
Net loss   $ (4,073,307 )   $ (1,874,382 )
Loss per common share - basic and diluted   $ (0.62 )   $ (8.48 )
Weighted average shares outstanding - basic and diluted     6,565,514       220,996  

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