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

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SEATTLE, May 14, 2018 (GLOBE NEWSWIRE) -- Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced First Quarter ended March 31, 2018 financial results and provided an update on recent company developments.   

Steve Quay, President and CEO, commented, “During the first part of 2018, we have continued to make significant advances driving toward the next phase of our clinical plans – including a new program in men’s breast health and receiving regulatory approval to commence our Phase 2 breast density study in Sweden. We are especially excited about engaging additional experts that will advise us on important initiatives including seeking partners in the pharmaceutical industry to accelerate the clinical development of our Endoxifen programs. This quarter, we plan to complete our Phase 1 study of topical Endoxifen in men, commence enrollment in our Phase 2 study of topical Endoxifen in women with mammographic breast density, and open our Phase 2 study of oral Endoxifen in women who are “refractory” to tamoxifen.”

Recent Corporate Developments 

Atossa’s important recent developments include the following:

  • May 2018 - Formed strategic advisory board to accelerate growth with prominent former pharmaceutical executives from Pfizer and Boehringer Ingelheim.
  • April 2018 - Received approval from the Swedish Medical Products Agency (MPA) to conduct a Phase 2 Study of proprietary topical Endoxifen for the treatment of women with mammographic breast density.
  • April 2018 - Received a positive interim safety review on the Phase 1 study of topical Endoxifen in men, which is being developed to address gynecomastia (or male breast enlargement).
  • April 2018 - Announced a reverse split of common stock at a ratio of 1-for-12 that was effective on April 20, 2018 and which led to regaining compliance with Nasdaq.
  • March 2018 - Announced that Per Hall, MD, Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet in Stockholm, Sweden had been appointed as Scientific Advisor.
  • March 2018 - Expanded the breast health program by launching a men’s’ breast health initiative with enrollment opening in a Phase 1 study of the proprietary topical Endoxifen in men.
  • February 2018 - Announced important additional findings from the Phase 1 study of Atossa’s proprietary oral Endoxifen.

Q1 2018 Financial Results  

We generated no revenue or cost of revenue for the three months ended March 2018.  Currently we are in the research and development phase and do not market any products and services.

The Company recorded a net loss of $1.9 million for the three months ended March 31, 2018. Total operating expenses were approximately $1.9 million for the three months ended March 31, 2018, consisting of general and administrative (G&A) expenses of approximately $1.4 million, and research and development (R&D) expenses of approximately $0.5 million. Total operating expenses were approximately $1.7 million for the three months ended March 31, 2017, consisting of G&A expense of approximately $1.2 million and R&D expenses of $0.5 million.

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 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: 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

Source: Atossa Genetics Inc.

ATOSSA GENETICS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

  March 31,     December 31,  
  2018     2017  
Assets              
Current assets              
Cash and cash equivalents $ 4,779,519     $ 7,217,469  
Restricted cash   55,000       55,000  
Prepaid expenses   495,667       250,944  
Research and development tax rebate receivable   395,872       358,277  
Other current assets   9,316       16,344  
Total current assets   5,735,374       7,898,034  
               
Furniture and equipment, net   59,810       11,467  
Intangible assets, net   70,547       75,686  
Other assets   114,571       178,907  
Total assets $ 5,980,302     $ 8,164,094  
               
Liabilities and Stockholders’ Equity              
               
Current liabilities              
Accounts payable $ 168,347     $ 334,901  
Accrued expenses   172,613       90,105  
Payroll liabilities   356,427       784,867  
Other current liabilities   23,323       15,534  
Total current liabilities   720,710       1,225,407  
               
Commitments and contingencies              
               
Stockholders’ equity              
Preferred stock - $.001 par value; 10,000,000 shares authorized, no shares issued or outstanding              
Common stock - $.18 par value; 75,000,000 shares authorized, 2,651,952 shares issued and outstanding   477,342       477,342  
Additional paid-in capital   72,082,961       71,887,674  
Accumulated deficit   (67,300,711 )     (65,426,329 )
Total stockholders’ equity   5,259,592       6,938,687  
               
Total liabilities and stockholders’ equity $ 5,980,302     $ 8,164,094  

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

  For the Three Months Ended
March 31,
 
     
    2018       2017  
Operating expenses:              
Research and development $ 470,976     $ 544,302  
General and administrative   1,403,465       1,159,289  
Total operating expenses   1,874,441       1,703,591  
Operating loss   (1,874,441 )     (1,703,591 )
Other income, net   59       37  
Loss before income taxes   (1,874,382 )     (1,703,554 )
Income taxes              
Net loss $ (1,874,382 )   $ (1,703,554 )
Loss per common share - basic and diluted $ (0.71 )   $ (5.40 )
Weighted average shares outstanding, basic and diluted   2,651,952       315,576  

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Source: Atossa Genetics Inc.