SOURCE: Cleveland BioLabs, Inc.

Cleveland BioLabs, Inc.

August 14, 2017 08:12 ET

Cleveland BioLabs Reports Second Quarter 2017 Financial Results and Development Progress

BUFFALO, NY--(Marketwired - Aug 14, 2017) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today reported financial results and development progress for the second quarter ended June 30, 2017.

Cleveland BioLabs reported a net loss of $(5.6) million, excluding minority interests, for the second quarter of 2017, or $(0.50) per share, compared to a net loss, excluding minority interests, of $(1.9) million, or $(0.17) per share, for the same period in 2016. The increase in net loss was primarily due to an increase in the non-cash adjustment to our warrant liabilities and decreased revenues and expenses due to the completion of our development contracts with the Russian Federation Ministry of Industry and Trade ("MPT"), which was partially offset by reduced operating costs aligned with our streamlined focus primarily on pursuing a pre Emergency Use Authorization with the U.S. Food and Drug Administration ("FDA") and a Marketing Authorization Application with the European Medicines Agency ("EMA") for entolimod as a medical radiation countermeasure.

As of June 30, 2017, the Company had $11.5 million in cash, cash equivalents and short-term investments, which, based on the Company's current operational plan, is expected to fund operations for at least one year beyond the filing date of our Form 10-Q.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The pursuit of approval by the EMA and FDA and commercialization for entolimod as a medical radiation countermeasure remains our top priority."

Further Financial Results

Revenue for the second quarter of 2017 decreased to $0.2 million compared to $0.6 million for the second quarter of 2016. The net decrease was primarily attributable to reduced revenue from our development contracts with MPT which completed in 2016 and reduced revenue due to completion of manufacturing activities from our Joint Warfighter Medical Research Program ("JWMRP") contract from the Department of Defense ("DoD") for the continued development of the entolimod as a medical radiation countermeasure.

Research and development costs for the second quarter of 2017 decreased to $1.2 million compared to $1.3 million for the second quarter of 2016. The reduction in research and development costs is due to completion of a clinical study of the safety and tolerability of entolimod as a neo-adjuvant therapy in treatment-naïve patients with primary colorectal cancer and completion of associated preparatory research studies, offset by an increase in entolimod for biodefense applications for continued preclinical development along with drug manufacturing activities associated with our JWMRP contract and expenses associated with our regulatory activities in support of filing a Marketing Authorization Application with EMA.

General and administrative costs for the second quarter of 2017 decreased to $0.6 million compared to $0.8 million for the second quarter of 2016. This decrease was primarily attributable to reductions in personnel and other operating costs in connection with cost savings efforts to streamline operations.

About Cleveland BioLabs
Cleveland BioLabs, Inc. is an innovative biopharmaceutical company developing novel approaches to activate the immune system and address serious medical needs. The company's proprietary platform of Toll-like immune receptor activators has applications in radiation mitigation, immuno-oncology, and vaccines. The company's most advanced product candidate is entolimod, which is being developed as a medical radiation countermeasure for the prevention of death from acute radiation syndrome, an immunotherapy for oncology and other indications. The company conducts business in the United States and in the Russian Federation through a wholly-owned subsidiary, BioLab 612, LLC, and a joint venture with Joint Stock Company RUSNANO, Panacela Labs, Inc. The company maintains strategic relationships with the Cleveland Clinic and Roswell Park Cancer Institute. To learn more about Cleveland BioLabs, Inc., please visit the company's website at http://www.cbiolabs.com.

This press release contains certain forward-looking information about Cleveland BioLabs that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that do not relate strictly to historical or current facts. Words and phrases such as "potential," "may," "future," "will," "plan," "anticipate," "believe," "intend," "estimate," "expect" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding the company's future financial position, business strategy, new products, budgets, liquidity, cash flows, projected costs, research and clinical analyses and trials, regulatory approvals or the impact of any laws or regulations applicable to the company, and plans and objectives of management for future operations. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.

Factors that could contribute to such differences include, among others, the risks inherent in the early stages of drug development and in conducting clinical trials; the company's plans and expectations with respect to future clinical trials and commercial scale-up activities; the company's ability to attract collaborators with development, regulatory and commercialization expertise and the financial risks related to those relationships; the company's ability to comply with its obligations under license agreements; the company's inability to obtain regulatory approval in a timely manner or at all; the commercialization of the company's product candidates, if approved; the company's plans to research, develop and commercialize its product candidates; future agreements with third parties in connection with the commercialization of any approved product; the size and growth potential of the markets for the company's product candidates, and its ability to serve those markets; the rate and degree of market acceptance of the company's product candidates; the company's history of operating losses and the potential for future losses, which may lead the company to not be able to continue as a going concern; regulatory developments in the United States and foreign countries; the performance of the company's third-party suppliers and manufacturers; and the success of competing therapies that are or may become available. Some of these factors could cause future results to materially differ from the recent results or those projected in forward-looking statements. Any forward-looking statements speak only as of the date on which such statements are made, and the company undertakes no obligation to update any forward-looking statement to reflect events or circumstances occurring or arising after the date on which such statement is made, except as may be required by law. See also the "Risk Factors" and "Forward-Looking Statements" described in the company's periodic filings with the Securities and Exchange Commission.

 
CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
CONSOLIDATED CONDENDSED BALANCE SHEETS
 
    June 30, 2017   December 31, 2016
    (Unaudited)    
ASSETS        
Current assets:        
  Cash and cash equivalents   $ 3,932,001   $ 6,901,816
  Short-term investments     7,524,765     8,343,657
  Accounts receivable     427,184     352,700
  Other current assets     292,783     289,768
    Total current assets     12,176,733     15,887,941
  Equipment, net     23,599     37,376
  Other long-term assets     30,619     30,553
    Total assets   $ 12,230,951   $ 15,955,870
LIABILITIES AND STOCKHOLDERS' EQUITY            
Current liabilities:            
  Accounts payable   $ 298,280   $ 336,435
  Accrued expenses     1,200,216     1,823,235
  Accrued warrant liability     861,016     949,419
    Total current liabilities     2,359,512     3,109,089
Commitments and contingencies     --     --
    Total liabilities     2,359,512     3,109,089
Stockholders' equity:            
  Total Cleveland BioLabs, Inc. stockholders' equity     4,607,157     7,523,970
  Noncontrolling interest in stockholders' equity     5,264,282     5,322,811
    Total stockholders' equity     9,871,439     12,846,781
    Total liabilities and stockholders' equity   $ 12,230,951   $ 15,955,870
                 

See Notes to Consolidated Financial Statements

   
CLEVELAND BIOLABS, INC. AND SUBSIDIARIES  
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS  
(UNAUDITED)  
   
    For the Three Months Ended
June 30,
    For the Six Months Ended
June 30,
 
    2017     2016     2017     2016  
Revenues:                        
  Grants and contracts   $ 206,156     $ 575,025     $ 781,130     $ 1,387,525  
Operating expenses:                                
  Research and development     1,188,380       1,292,167       2,605,378       3,233,407  
  General and administrative     588,288       777,107       1,365,712       1,960,673  
Total operating expenses     1,776,668       2,069,274       3,971,090       5,194,080  
Loss from operations     (1,570,512 )     (1,494,249 )     (3,189,960 )     (3,806,555 )
Other income (expense):                                
  Interest and other income     50,434       121,969       99,723       303,734  
  Foreign exchange gain (loss)     (4,055 )     33,102       (12,285 )     80,188  
  Change in value of warrant liability     (4,124,009 )     (547,163 )     (4,245,707 )     865,550  
Total other income (expense)     (4,077,630 )     (392,092 )     (4,158,269 )     1,249,472  
Net loss     (5,648,142 )     (1,886,341 )     (7,348,229 )     (2,557,083 )
Net loss (income) attributable to noncontrolling interests   $ 35,354     $ (11,527 )     71,747       (8,721 )
Net loss attributable to Cleveland BioLabs, Inc.   $ (5,612,788 )   $ (1,897,868 )   $ (7,276,482 )   $ (2,565,804 )
Net loss attributable to common stockholders per share of common stock, basic and diluted   $ (0.50 )   $ (0.17 )   $ (0.66 )   $ (0.23 )
Weighted average number of shares used in calculating net loss per share, basic and diluted     11,218,727       10,987,166       11,103,586       10,987,166  
                                 

See Notes to Consolidated Financial Statements

   
CLEVELAND BIOLABS, INC. AND SUBSIDIARIES  
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS  
(UNAUDITED)  
   
    For the Six Months Ended June 30,  
    2017     2016  
Cash flows used in operating activities   $ (3,898,680 )   $ (3,947,633 )
Cash flows provided by investing activities     874,167       2,857,506  
Cash flows provided by financing activities     --       539,998  
Effect of exchange rate change on cash and equivalents     54,698       43,772  
Increase (decrease) in cash and cash equivalents     (2,969,815 )     (506,357 )
Cash and cash equivalents at beginning of period     6,901,816       5,918,424  
Cash and cash equivalents at end of period   $ 3,932,001     $ 5,412,067