Atossa Genetics Announces Third Quarter 2016 Financial Results And Provides Company Update

Published: Nov 15, 2016

SEATTLE, WA--(Marketwired - November 14, 2016) -

Atossa Genetics Inc. (NASDAQ: ATOS) today announced Third Quarter ended September 30, 2016 financial results and provided an update on recent company developments.

Dr. Steve Quay, President and CEO, commented, "We are pleased with our continuing achievements in the Third Quarter 2016, which enabled us to strengthen Atossa's foundation and further our drug development program goals. Our settlement with Besins Healthcare, and our recently completed capital raise provided Atossa with approximately $4 million in additional capital with which to advance our two exciting drug development programs."

Dr. Quay added, "We continue to make progress on both of our drug development programs: Our Phase 2 clinical trial of intraductal fulvestrant is proceeding and I am pleased to report that the study has been accepted for presentation at the CTRC-AARC San Antonio Breast Cancer Symposium to be held December 6-10, 2016. We also made strong progress with our proprietary oral endoxifen, which we are developing for breast cancer patients who do not respond to tamoxifen. The initial drug supply for Phase 1 and Phase 2 studies is under development and we'll provide updates as we head towards the clinical studies."

Recent Corporate Developments
Atossa's important recent developments include the following:

  • Atossa's Intraductal Fulvestrant/Microcatheter Study was Accepted for Presentation at the CTRC-AARC San Antonio Breast Cancer Symposium Being Held December 6-10, 2016
  • In September 2016, Atossa Regained Compliance with NASDAQ Listing Rule 5550(A)(2)
  • In August 2016, Atossa Completed an Underwritten Public Offering of Common Stock with Gross Proceeds of $2,875,000
  • In August 2016, Atossa Settled Litigation With Besins Healthcare with Atossa Receiving Cash Payment of $1.76 Million

Q3 2016 Financial Results

Total operating expenses were approximately $1.6 million and $5.4 million for the three months and nine months ended September 30, 2016, respectively, consisting of general and administrative (G&A) expenses of approximately $1.5 million and $5.0 million, respectively and R&D expenses of approximately $85,000 and $404,000 respectively. As a result of the sale of NRLBH, operating expenses related to the NRLBH are presented separately as discontinued operations for the three months and nine months ended September 30, 2015.

Operating expenses from continuing operations for the three months and nine months ended September 30, 2016 decreased approximately $2.2 million and $4.9 million, or 57.9% and 47.6% respectively, from approximately $3.8 million and $10.3 million for the three months and nine months ended September 30, 2015, respectively, which consisted of G&A expenses of approximately $2.4 million and $7.2 million, respectively, R&D expenses of approximately $949,000 and $1.9 million, respectively, and selling expenses of approximately $499,000 and $1.2 million, respectively. 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.

Net loss for the nine months ended September 30, 2016 was $3.8 million and cash and cash equivalents were approximately $4.4 million.

Conference Call Information

Management will host a business update conference call on Monday November 14, 2016 at 5:30 pm eastern time to review Third Quarter ended September 30, 2016 financial results and provide a company update. Following management's formal remarks, there will be a question and answer session.

To listen to the call by phone, interested parties within the U.S. should call 1-844-824-3830 and International callers should call 1-412-317-5140. 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 December 14, 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 10096671.

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 with respect to fulvestrant, 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                   
                                                                            
                                               September 30,   December 31, 
                                                    2016           2015     
                                                (Unaudited)                 
                                               -------------  ------------- 
                    Assets                                                  
Current assets                                                              
  Cash and cash equivalents                    $   4,388,177  $   3,715,895 
  Restricted cash                                     55,000        275,000 
  Prepaid expense                                    120,751        193,293 
  Other current assets                                     -        110,663 
                                               -------------  ------------- 
    Total current assets                           4,563,928      4,294,851 
                                                                            
  Furniture and equipment, net                        84,537        171,568 
  Intangible assets, net                           1,401,899      1,700,565 
  Other assets                                       227,877         76,337 
                                               -------------  ------------- 
    Total assets                               $   6,278,241  $   6,243,321 
                                               =============  ============= 
                                                                            
     Liabilities and Stockholders' Equity                                   
                                                                            
Current liabilities                                                         
  Accounts payable                             $     197,354  $     814,448 
  Accrued expenses                                    12,480        463,676 
  Payroll liabilities                                635,047      1,159,335 
  Other current liabilities                           18,886         64,128 
                                               -------------  ------------- 
    Total current liabilities                        863,767      2,501,587 
                                               -------------  ------------- 
                                                                            
Commitments and contingencies (note 13)                                     
                                                                            
Stockholders' equity                                                        
  Preferred stock - $.001 par value;                                        
   10,000,000 shares authorized, 0 shares                                   
   issued and outstanding                                  -              - 
  Common stock - $.015 par value; 75,000,000                                
   shares authorized, 3,787,967 and 2,177,151                               
   shares issued and outstanding                      56,820         32,657 
  Additional paid-in capital                      60,137,752     54,643,940 
  Accumulated deficit                            (54,780,098)   (50,934,863)
                                               -------------  ------------- 
    Total stockholders' equity                     5,414,474      3,741,734 
                                               -------------  ------------- 
                                                                            
Total liabilities and stockholders' equity     $   6,278,241  $   6,243,321 
                                               =============  ============= 
                                                                            
                                                                            
                                                                            
                            ATOSSA GENETICS INC.                            
               CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS              
                                 (UNAUDITED)                                
                                                                            
                          For the Three Months                              
                                  Ended           For the Nine Months Ended 
                              September 30,             September 30,       
                        ------------------------  ------------------------- 
                            2016         2015         2016         2015     
                        -----------  -----------  -----------  ------------ 
Net revenue             $         -  $         -  $         -  $          - 
                                                                            
                                                                            
Operating expenses:                                                         
  Selling                         -      498,609            -     1,187,777 
  Research and                                                              
   development               85,000      948,961      403,963     1,888,236 
  General and                                                               
   administrative         1,473,435    2,395,089    5,040,939     7,208,508 
                        -----------  -----------  -----------  ------------ 
    Total operating                                                         
     expenses             1,558,435    3,842,659    5,444,902    10,284,521 
                        -----------  -----------  -----------  ------------ 
Operating loss           (1,558,435)  (3,842,659)  (5,444,902)  (10,284,521)
Other income, net         1,763,124       69,350    1,599,667       116,108 
                        -----------  -----------  -----------  ------------ 
Income (Loss) before                                                        
 income taxes               204,689   (3,773,309)  (3,845,235)  (10,168,413)
Income taxes                      -            -            -             - 
  Income (Loss) from                                                        
   continuing                                                               
   operations               204,689   (3,773,309)  (3,845,235)  (10,168,413)
  Loss from                                                                 
   discontinued                                                             
   operations                     -     (544,802)           -      (630,314)
                        -----------  -----------  -----------  ------------ 
Net income (loss)       $   204,689  $(4,318,111) $(3,845,235) $(10,798,727)
                        ===========  ===========  ===========  ============ 
Income (Loss) per                                                           
 common share from                                                          
 continuing operations-                                                     
 basic and diluted      $      0.07  $     (2.04) $     (1.72) $      (5.91)
                        ===========  ===========  ===========  ============ 
Loss per common share                                                       
 from discontinued                                                          
 operations - basic and                                                     
 diluted                          -  $     (0.30)           -  $      (0.37)
                        ===========  ===========  ===========  ============ 
Weighted average shares                                                     
 outstanding, basic &                                                       
 diluted                  2,799,082    1,845,747    2,240,869     1,720,353 
                        ===========  ===========  ===========  ============ 
                                                                            
                                                                            

Atossa Genetics Company Contact:

Atossa Genetics Inc.
Kyle Guse
CFO and General Counsel
(O) 800-351-3902
kyle.guse@atossagenetics.com

Investor Relations Contact

Scott Gordon
CorProminence LLC
377 Oak Street
Concourse 2
Garden City, NY 11530
Office: 516.222.2560
scottg@corprominence.com

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