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Atossa Genetics Announces Third Quarter 2018 Financial Results And Provides Company Update

SEATTLE, Nov. 13, 2018 (GLOBE NEWSWIRE) -- Atossa Genetics Inc. (ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced third quarter ended September 30, 2018 financial results and provided an update on recent company developments.   

Steven C. Quay, Ph.D., MD, President and CEO commented, “We continue to make great progress with our clinical programs. We successfully achieved all objectives in our Phase 1 study of topical Endoxifen in men and are looking forward to advancing that program into a Phase 2 study to address gynecomastia in men being treated for prostate cancer. We also completed enrollment in the Phase 2 study of our topical Endoxifen to treat mammographic breast density,” added Dr. Quay.

Recent Corporate Developments

Atossa’s important recent developments include the following:

  • October 2018 – Completed enrollment in Phase 2 study of topical Endoxifen to treat mammographic breast density.
  • September 2018 – Reported that all objectives were achieved in our Phase 1 study of topical Endoxifen in men.
  • August 2018 - Contracted with a US-based additional manufacturer of Endoxifen.
  • July 2018 - Announced intraductal microcatheter immunoOncology pre-clinical program.
  • June 2018 – Appointed two additional prominent industry executives from Pfizer and the Belgium-based Flemish Institute of Biotechnology to strategic advisory board.

Q3 2018 Financial Results  

For the three and nine months ended September 30, 2018 and 2017, we had no revenue and no associated cost of revenue.

Total operating expenses were approximately $3.3 million and $9.3 million for the three and nine months ended September 30, 2018, respectively, consisting of research and development (R&D) expenses of approximately $1.4 million and $3.4 million, respectively, and general and administrative (G&A) expenses of approximately $1.9 million and $6.0 million, respectively. Total operating expenses were approximately $2.1 million and $5.7 million for the three and nine months ended September 30, 2017, respectively, consisting of R&D expenses of $0.7 million and $2.1 million, respectively, and G&A expense of approximately $1.3 million and $3.5 million, respectively.

Total operating expenses for the three and nine months ended September 30, 2018 as compared to the same periods of 2017 increased approximately $1.3 million, or 61%, and increased $3.7 million, or 65%, respectively.

As of September 30, 2018, the Company had cash and cash equivalents and restricted cash of $13.0 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 Form 10-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
CorProminence LLC
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 (UNAUDITED)

    September 30,     December 31,  
Assets   2018     2017  
Current assets                
Cash and cash equivalents   $ 12,935,587     $ 7,217,469  
Restricted cash     55,000       55,000  
Prepaid expenses     290,331       250,944  
Research and development tax rebate receivable     480,495       358,277  
Other current assets     161,530       16,344  
Total current assets     13,922,943       7,898,034  
                 
Furniture and equipment, net     57,804       11,467  
Intangible assets, net     55,107       75,686  
Other assets     88,518       178,907  
  Total Assets   $ 14,124,372     $ 8,164,094  
                 
Liabilities and Stockholders' Equity                
                 
Current liabilities                
Accounts payable   $ 550,704     $ 334,901  
Accrued expenses     51,673       90,105  
Payroll liabilities     706,150       784,867  
Stock-based compensation liability     2,180,659          
Other current liabilities     66,077       15,534  
Total Current Liabilities     3,555,263       1,225,407  
                 
Commitments and contingencies                
Stockholders' equity                
Preferred stock - $0.001 par value; 10,000,000 shares authorized, consisting of Series A convertible preferred stock- $0.001 par value;
4,000 shares authorized, and 0 shares outstanding as of September 30, 2018 and December 31, 2017; Series B convertible preferred stock- $0.001 par value;
25,000 and 0 shares authorized, and 3,517 and 0 shares issued and outstanding as of September 30, 2018 and December 31, 2017, respectively
    4          
Additional paid-in capital- Series B convertible preferred stock     3,516,996          
Common stock - $0.18 par value; 175,000,000 shares authorized, and 5,523,255 and 2,651,952 shares issued and outstanding,
as of September 30, 2018 and December 31, 2017, respectively
    994,175       477,342  
Additional paid-in capital     80,811,088       71,887,674  
Accumulated deficit     (74,753,154 )     (65,426,329 )
Total Stockholders' Equity     10,569,109       6,938,687  
                 
Total Liabilities and Stockholders' Equity   $ 14,124,372     $ 8,164,094  
                 


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

    For the Three Months
Ended September 30,
    For the Nine Months
Ended September 30,
 
    2018     2017     2018     2017  
                                 
Operating Expenses                                
Research and development   $ 1,421,851     $ 742,450     $ 3,360,563     $ 2,110,846  
General and administrative     1,888,119       1,313,477       5,966,504       3,544,935  
Total operating expenses     3,309,970       2,055,927       9,327,067       5,655,781  
Operating loss     (3,309,970 )     (2,055,927 )     (9,327,067 )     (5,655,781 )
Change in fair value of common stock warrants             (128,300 )             (280,747 )
Warrant financing expense                             (192,817 )
Other income (expense)     104       (283 )     242       (208 )
Loss before income taxes     (3,309,866 )     (2,184,510 )     (9,326,825 )     (6,129,553 )
Income taxes                                
Net loss   $ (3,309,866 )   $ (2,184,510 )   $ (9,326,825 )   $ (6,129,553 )
Deemed Dividend attributable to preferred stock                     (11,479,308 )     (2,568,132 )
Net loss applicable to common shareholders   $ (3,309,866 )   $ (2,184,510 )   $ (20,806,133 )   $ (8,697,685 )
Loss per common share - basic and diluted   $ (0.64 )   $ (2.11 )   $ (5.71 )   $ (13.23 )
Weighted average shares outstanding - basic and diluted     5,183,492       1,034,262       3,645,682       657,184