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Cleveland BioLabs Reports First Quarter 2013 Financial Results And Development Progress

Further Financial Highlights

Revenue for the first quarter ended March 31, 2013 increased to $1.4 million compared to $0.9 million for the prior year's period, primarily due to increases in funding from the Russian Federation's Ministry of Industry and Trade and Skolkovo Foundation.  

Research and development expense for the first quarter was $5.3 million compared to $6.0 million for the same period in 2012.  This decrease was primarily due to the efforts to complete a pivotal non-human primate study during the first quarter of 2012.

General and Administrative expense for the first quarter was $3.5 million compared to $2.4 million for the first quarter of 2012. This increase was primarily attributable to increases in general and administrative functions at our subsidiaries and business development expenditures, among other items.

As of December 31, 2012, Cleveland BioLabs had approximately 44.9 million shares of common stock outstanding.

Conference Call Information

Management will host a conference call at 10:00 a.m. ET today to provide updates and address investor questions regarding general business developments. Interested parties may participate by dialing 877-407-8031 (US) or 201-689-8031 (International), approximately five to ten minutes before the call start time.  A live webcast of the conference call will be available on the investor page of the Cleveland BioLabs web site at www.cbiolabs.com . A replay of the call will be available starting on May 9, 2013, at 1:00 p.m. ET through May 23, 2013, at 11:59 p.m. ET. Interested parties may access the replay by dialing 877-660-6853 (US) or 201-612-7415 (International) and entering conference ID number 413582.  An archived webcast of the conference call will be available on the investor page of the Cleveland BioLabs web site at www.cbiolabs.com .

About Cleveland BioLabs, Inc.

Cleveland BioLabs, Inc. is a clinical-stage biotechnology company leveraging a deep mechanistic understanding of the cell death process, apoptosis, to develop a robust pipeline of compounds primarily focused on oncology applications and mitigation of radiation injury. The Company's lead compound is being developed as both a radiation countermeasure and a cancer treatment. The Company has two operating subsidiaries, Incuron, LLC, and Panacela Labs, Inc., and strategic relationships with the Cleveland Clinic, Roswell Park Cancer Institute, the Children's Cancer Institute Australia and the Armed Forces Radiobiology Research 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 are not historical facts. Words such as "expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding our ability to successfully develop and commercialize our therapeutic products; our ability to expand our long-term business opportunities; the conduct and results of our various clinical trials; financial projections and estimates and their underlying assumptions; and future performance. 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. 

These factors include, among others, the Company's failure to successfully and timely develop new products; the Company's collaborative relationships and the financial risks related thereto; the Company's ability to comply with its obligations under license agreements; the risks inherent in the early stages of drug development and in conducting clinical trials; the Company's inability to obtain regulatory approval in a timely manner or at all; 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; the Company's need for substantial additional financing to meet its business objectives; the potential for the loss of funding from the Company's R&D grants and contracts and its ability to win additional funding under such grants and contracts. Some of these factors could cause future results to materially differ from the recent results or those projected in forward-looking statements. See also the "Risk Factors" and "Forward-Looking Statements" described in the Company's periodic filings with the Securities and Exchange Commission.

Contact:  Rachel Levine, Vice President, Investor Relations Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com

TABLES FOLLOW

     
CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SEEETS
     
  March 31, December 31,
  2012 2011
  (unaudited)  
ASSETS
Current assets:    
Cash and cash equivalents  $ 19,769,013  $ 25,652,083
Short-term investments  1,286,861  2,633,944
Accounts receivable  477,180  41,896
Other current assets  1,136,042  1,078,040
Total current assets  22,669,096  29,405,963
     
     
Equipment, net  910,897  986,553
Restricted cash  1,541,842  1,577,920
Other long-term assets  61,592  39,597
     
Total assets  $ 25,183,427  $ 32,010,033
     
LIABILITIES & STOCKHOLDERS' EQUITY
     
Current liabilities:    
Accounts payable  $ 1,234,575  $ 1,523,875
Accrued expenses  3,285,022  2,410,592
Deferred revenue  3,024,565  3,314,918
Accrued warrant liability  7,553,382  4,105,659
Current portion of capital lease obligation  74,276  71,679
Total current liabilities  15,171,820  11,426,723
     
Noncurrent portion of capital lease obligation  78,030  97,602
     
Commitments and contingencies  --  -- 
     
Total liabilities  15,249,850  11,524,325
     
Stockholders' equity:    
Total Cleveland BioLabs, Inc. stockholders' equity (deficit)  (3,130,884)  6,333,167
Noncontrolling interest in stockholders' equity  13,064,461  14,152,541
Total stockholders' equity  9,933,577  20,485,708
     
Total liabilities and stockholders' equity  $ 25,183,427  $ 32,010,033
     
CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
     
  Quarter Ended March 31,
  2013 2012
Revenues:    
Grants and contracts  $ 1,367,472  $ 931,397
     
Operating expenses:    
Research and development  5,331,615  5,985,801
General and administrative  3,483,372  2,427,471
Total operating expenses  8,814,987  8,413,272
     
Loss from operations  (7,447,515)  (7,481,875)
     
Other income (expense):    
Interest and other income  79,956  55,641
Foreign exchange gain (loss)  28,134  (692,416)
Change in value of warrant liability  (3,447,723)  1,719,756
Total other income (expense)  (3,339,633)  1,082,981
     
Net loss  (10,787,148)  (6,398,894)
     
Net loss attributable to noncontrolling interests  1,022,825  1,011,748
     
Net loss attributable to Cleveland BioLabs, Inc.  $ (9,764,323)  $ (5,387,146)
     
Net loss available to common stockholders per share of common stock, basic and diluted  $ (0.22)  $ (0.15)
     
Weighted average number of shares used in calculating net loss per share, basic and diluted  44,826,576  35,657,563
     
CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
     
  Quarter Ended March 31,
  2013 2012
     
Cash flows used in operating activities  $ (7,003,302)  $ (4,794,372)
Cash flows provided by (used in) investing activities  1,295,121  (81,560)
Cash flows provided by financing activities  (16,974)  (3,541)
Effect of exchange rate change on cash and equivalents  (157,915)  118,371
     
Increase in cash and cash equivalents  (5,883,070)  (4,761,102)
     
Cash and cash equivalents at beginning of period  25,652,083  22,872,589
     
Cash and cash equivalents at end of period  $ 19,769,013  $ 18,111,487

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