Atossa Genetics, Inc. Announces First Quarter 2016 Financial Results And Provides Company Update

SEATTLE, WA--(Marketwired - May 05, 2016) -

Steve Quay, President and CEO, commented, "We were especially pleased to announce in early March, 2016 the opening for enrollment of our '007' trial, a Phase 2 clinical trial of intraductal fulvestrant administration in women with ductal carcinoma in situ (DCIS) or invasive breast cancer slated for mastectomy or lumpectomy. This study will assess the safety and tolerability of fulvestrant when delivered directly into breast milk ducts of these patients. We look forward to reviewing study data in the second half of the year and are optimistic about its outcomes. The primary endpoint of the clinical trial is to assess the safety and tolerability of intraductal administration of fulvestrant in women with DCIS or Stage 1 or 2 invasive ductal carcinoma prior to mastectomy or lumpectomy. The secondary objective of the study is to determine if there are changes in the expression of Ki67 as well as estrogen and progesterone receptors between a pre-fulvestrant biopsy and post-fulvestrant surgical specimen." Dr. Quay continued, "We are continuing in our strident efforts in identifying one or more additional drug candidates to enhance our business and drive shareholder value."

Recent Corporate Developments

Atossa's important recent developments include the following:

• In March 2016, Opened Phase 2 Clinical Trial of Intraductal Fulvestrant Administration in Women with DCIS or Breast Cancer in the United States, which is Called the '007 Trial
  
  
• In December 2015, Completed Sale of Wholly-Owned Subsidiary, The National Reference Laboratory for Breast Health, Inc. (the "NRLBH")
  
  
• Raised Approximately $2.2 Million in Working Capital through the Sale of Common Stock to Aspire Capital in the First Quarter of 2016
  
  

Q1 2016 Financial Results

As a result of the sale of the NRLBH in December 2015, we generated no revenue or cost of revenue for the three months ended March 2016. Revenue and cost of service from NRLBH activities are presented as discontinued operations for the three months ended 2015. The NLRBH had total net revenue of $1,871,137 and cost of revenue of $1,206,311, for the three months ended March 31, 2015, consisting of mainly pharmacogenomics testing.

Total operating expenses were $2,327,540 for the three months ended March 31, 2016, consisting of general and administrative (G&A) expenses of $2,177,569 and R&D expenses of $149,971. As a result of the sale of NRLBH, operating expenses related to the NRLBH are presented separately as discontinued operations for the three months ended March 31, 2015.

Operating expenses from continuing operations for three months ended March 31, 2016 decreased $945,132, or 29%, from $3,272,672 for the three months ended March 31, 2015, which consisted of G&A expenses of $2,361,026, R&D expenses of $565,801, and selling expenses of $345,845. The decrease in operating expenses is mainly attributed to the 2015 launch of new devices and services which are not being pursued in 2016 and investing more in new R&D programs in the first quarter of 2015 compared to 2016.

The Company recorded a net loss of $2,327,540, for the three months ended March 31, 2016. The loss from discontinued operations for the three months ended March 31, 2015 was $61,204.

Conference Call Information

Management will host a conference call today, May 5, 2016, at 4:30 pm Eastern Time to review the financial results and recent corporate developments. To listen to the call by phone, interested parties within the U.S. should call 1-866-652-5200 and International callers should call 1-412-317-6060. All callers should ask for the Atossa Genetics conference call. The conference call will also be available through a live webcast at www.atossagenetics.com. Details for the webcast may be found on the Company's IR events page at http://ir.atossagenetics.com/ir-calendar.

A replay of the call will be available approximately one hour after the end of the call through June 5, 2016. The replay can be accessed via Atossa's website or by dialing 877-344-7529 (domestic) or 412-317-0088 (international) or Canada Toll Free at 855-669-9658. The replay conference ID number is 10085791.

About Atossa Genetics

Atossa Genetics, Inc. is a clinical-stage pharmaceutical 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 actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa, lower than anticipated rate of patient enrollment, results of clinical studies, 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, such as patent rights, 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 GENETICS INC.                            
                   CONDENSED CONSOLIDATED BALANCE SHEETS                    
                                                                            
                                                 March 31,     December 31, 
                                                    2016           2015     
                                                (Unaudited)                 
                                               -------------  ------------- 
                    Assets                                                  
Current assets                                                              
  Cash and cash equivalents                    $   2,882,657  $   3,715,895 
  Restricted cash                                    275,000        275,000 
  Prepaid expense                                    227,936        193,293 
  Other current assets                                     -        110,663 
                                               -------------  ------------- 
    Total current assets                           3,385,593      4,294,851 
                                                                            
  Furniture and equipment, net                       145,970        171,568 
  Intangible assets, net                           1,492,121      1,700,565 
  Other assets                                        76,337         76,337 
                                               -------------  ------------- 
    Total assets                               $   5,100,021  $   6,243,321 
                                               =============  ============= 
                                                                            
     Liabilities and Stockholders' Equity                                   
                                                                            
Current liabilities                                                         
  Accounts payable                             $     429,052  $     814,448 
  Accrued expenses                                   169,001        463,676 
  Payroll liabilities                                724,934      1,159,335 
  Other current liabilities                            3,848         64,128 
                                               -------------  ------------- 
    Total current liabilities                      1,326,835      2,501,587 
                                               -------------  ------------- 
                                                                            
Stockholders' equity                                                        
  Preferred stock - $.001 par value;                                        
   10,000,000 shares authorized, 0 shares                                   
   issued and outstanding                                  -              - 
  Common stock - $.001 par value; 75,000,000                                
   shares authorized, 38,823,464 and                                        
   32,657,257 shares issued and outstanding           38,823         32,657 
  Additional paid-in capital                      56,996,766     54,643,940 
  Accumulated deficit                            (53,262,403)   (50,934,863)
                                               -------------  ------------- 
    Total stockholders' equity                     3,773,186      3,741,734 
                                               -------------  ------------- 
                                                                            
  Total liabilities and stockholders' equity   $   5,100,021  $   6,243,321 
                                               =============  ============= 
                                                                            
                                                                            
                            ATOSSA GENETICS INC.                            
              CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS               
                                (UNAUDITED)                                 
                                                                            
                                                For the Three Months Ended  
                                                         March 31,          
                                               ---------------------------- 
                                                    2016           2015     
                                               -------------  ------------- 
Net revenue                                                -              - 
Cost of revenue                                            -              - 
                                               -------------  ------------- 
  Gross profit                                             -              - 
                                               -------------  ------------- 
Selling expenses                                           -        345,845 
Research and development expenses                    149,971        565,801 
General and administrative expenses                2,177,569      2,361,026 
                                               -------------  ------------- 
  Total operating expenses                         2,327,540      3,272,672 
                                               -------------  ------------- 
Operating loss                                    (2,327,540)    (3,272,672)
                                               -------------  ------------- 
Other expenses                                             -         (1,415)
                                               -------------  ------------- 
Loss before income taxes                          (2,327,540)    (3,274,087)
                                               -------------  ------------- 
Income taxes                                               -              - 
                                               -------------  ------------- 
Loss from continuing operations                $  (2,327,540) $  (3,274,087)
                                               -------------  ------------- 
Loss from discontinued operations                          -        (61,204)
                                               -------------  ------------- 
Net loss                                       $  (2,327,540) $  (3,335,291)
                                               =============  ============= 
Loss per common share from continuing                                       
 operations - basic and diluted                $       (0.07) $       (0.13)
Loss per common share from discontinued                                     
 operations- basic and diluted                             -              - 
                                               -------------  ------------- 
Loss per common share - basic and diluted      $       (0.07) $       (0.13)
                                               =============  ============= 
Weighted average shares outstanding, basic and                              
 diluted                                          31,511,623     24,916,867 
                                               =============  =============