SOURCE: Cleveland BioLabs, Inc.

Cleveland BioLabs, Inc.

March 11, 2014 07:30 ET

Cleveland BioLabs Reports Fourth Quarter and Fiscal 2013 Financial Results and Development Progress

BUFFALO, NY--(Marketwired - Mar 11, 2014) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today reported financial results and development progress for the fourth quarter and fiscal year ended December 31, 2013.

For the quarters ended December 31, 2013 and 2012, losses from operations were $3.0 million and $5.6 million, respectively.  For the years ended December 31, 2013 and 2012, losses from operations were $23.1 million and $30.0 million, respectively.  The decreases in the 2013 operating losses for both periods, as compared to the same periods in 2012 resulted from increases in revenue and reductions in research and development costs. Revenue increased in both periods in 2013 due to additional funding from both the Russian Federation and United States Department of Defense in support of our development efforts, while total research and development costs declined in 2013, largely due to the completion of an expensive study in irradiated non-human primates conducted for Entolimod as a radiation countermeasure. 

For the quarters ended December 31, 2013 and 2012, other income was $2.2 million and $7.8 million, respectively, and for the years ended December 31, 2013 and 2012, reported other income was $2.9 million and $7.6 million, respectively.  These amounts primarily consisted of noncash changes to the fair market value of accrued warrant liabilities.

The net loss attributable to Cleveland BioLabs for the fourth quarter of 2013 was $0.4 million, or $0.01 per share, as compared to net income attributable to Cleveland BioLabs of $3.1 million, or $0.07 per share, for the fourth quarter of 2012.  The net loss attributable to Cleveland BioLabs for fiscal 2013 was $17.3 million, or $0.38 per share, as compared to $18.2 million, or $0.49 per share, for the same period in 2012.

At December 31, 2013, we had $10.4 million in cash, cash equivalents and short-term investments, $8.0 million of which was available for general use and $2.4 million of which was restricted for the use of majority-owned subsidiaries.  On January 16, 2014, we closed a registered direct offering with two institutional investors of 5,737,706 shares at a price of $1.22 per share.  Including estimated net proceeds from the offering of $6.4 million and the $10.4 million of available cash resources as of December 31, 2013, our available cash resources as of December 31, 2013 would have been approximately $16.8 million.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "We are prioritizing our assets and positioning CBLI to capitalize on our most promising opportunities.  We are focused on three primary objectives: Pursuing a meeting with the U.S. Food and Drug Administration (FDA) to evaluate the potential for a pre-emergency use authorization submission for the Entolimod radiation program; establishing pharmacodynamic support for Entolimod as a cancer immunotherapy; and achieving clinical proof of pharmacodynamic activity for CBL0137 as an enabler of oncogenic transcription.  Simultaneously, we are securing senior drug development expertise to guide and execute our clinical strategy and help us optimize data readouts along the way."

Operational Highlights

Completion of dose-conversion analysis and projection of an estimated efficacious human dose for Entolimod as a radiation countermeasure has been completed and a meeting with the FDA has been requested.

Dosing of Entolimod in patients with advanced cancer continues at RPCI, following amendment of the trial protocol in August to optimize immuno-stimulatory effects of the study drug.  We are currently dosing the sixth cohort, which includes two cohorts post protocol amendment.  To date, no drug-related serious adverse events have been reported in this trial.  Preparations are in progress to initiate a healthy subject study with Entolimod in the Russian federation following a similar dosing regimen as the advanced cancer trial.  This study is supported by a contract with the Ministry of Industry and Trade of the Russian Federation.  Both of these studies will incorporate pharmacodynamic assays measuring response of specific types of immune cells to administrations of Entolimod.

Evaluation of the second cohort has been completed in a multi-center, Phase 1 trial assessing the intravenous administration of Curaxin CBL0137 in patients with metastatic or unresectable advanced solid cancers and lymphomas.  In parallel, evaluation of the sixth cohort is ongoing in a multicenter, Phase 1 study assessing the oral administration of Curaxin CBL0137 in patients with advanced solid tumors that are resistant or refractory to current standard treatment.  To date, no drug-related serious adverse events have been reported in either trial.  

An Investigational New Drug application for CBLB612, a drug in development for the induction and mobilization of hematopoietic stem cells was filed with the regulatory authorities in the Russian Federation in the third quarter of 2013.  A Phase 1 healthy subject study is planned to start mid-year, with the primary goal of establishing a maximally tolerated dose and a secondary objective of characterizing functional stem cell response.  This study is funded by a contract from the Ministry of Industry and Trade of the Russian Federation.

Further Financial Highlights

Revenue for the fourth quarter of 2013 increased to $3.9 million compared to $2.2 million for the fourth quarter of 2012.  Revenue for fiscal 2013 increased to $8.5 million compared to $3.6 million for the same period in 2012.  These revenue increases were primarily due to increases in contract funding from the Russian Federation and the United States Department of Defense.  

Research and development costs for the fourth quarter of 2013 decreased to $4.6 million compared to $5.6 million for the same period in 2012.  Research and development costs for fiscal 2013 decreased to $19.5 million compared to $22.5 million for the same period in 2012.  These net decreases result from reduced development costs of Entolimod as a radiation countermeasure as an irradiated non-human primate study was completed in 2012, offset by increases in development activities for several of our oncology drug candidates.

General and administrative costs for the fourth quarter of 2013 increased slightly to $2.3 million compared to $2.1 million for the same period in 2012.  General and administrative costs for fiscal 2013 increased to $12.0 million from $11.1 million for the same period in 2012.  These increases were primarily attributable to higher general and administrative costs for our Russian-based subsidiaries and higher corporate legal and intellectual property fees.

Cleveland BioLabs had approximately 45 million shares of common stock outstanding at December 31, 2013, and 51 million shares giving pro forma effect to the sale of equity in January 2014.

The Company also announced receipt of a letter citing a deficiency in continued listing requirements for The Nasdaq Capital Market, which requires listed securities to maintain a minimum bid price of $1 per share.  The Company has a period of 180 calendar days in which to regain compliance.  In the event the Company does not regain compliance, the Company may be eligible for an extension.

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 877-407-9205 (US) or 201-689-8054 (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 March 11, 2014, at 1:00 p.m. ET through March 28, 2014, 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 13576596.  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

Cleveland BioLabs, Inc. is an innovative drug development company seeking to develop first-in-class pharmaceuticals designed to address diseases with significant medical need. The company's lead product candidates are Entolimod, which is being developed as radiation countermeasure and a potential cancer treatment and Curaxin CBL0137, our lead oncology product candidate. The company conducts business in the United States and in the Russian Federation through our three operating subsidiaries, Incuron, LLC, BioLabs 612, LLC and Panacela Labs, Inc. The company maintains strategic relationships with the Cleveland Clinic, Roswell Park Cancer Institute, and the Children's Cancer Institute Australia for Medical Research. 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 the likelihood of receiving funding; our ability to successfully develop and commercialize our therapeutic products; the conduct and results of our various clinical trials; 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 decisions of third parties regarding whether or not to fund the Company through grants; the Company's failure to successfully and timely develop existing and new products; the Company's collaborative relationships and the financial risks related thereto; the Company's inability to obtain regulatory approval in a timely manner or at all; the risks inherent in the early stages of drug development and in conducting clinical trials; the Company's ability to comply with its obligations under license agreements;  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. 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.

TABLES FOLLOW

 
CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
           
    December 31,
    2013     2012
               
ASSETS      
Current assets:              
Cash and cash equivalents   $ 10,048,466     $ 25,652,083
Short-term investments     305,538       2,633,944
Accounts receivable     458,391       41,896
Other current assets     344,386       1,078,040
Total current assets     11,156,781       29,405,963
               
               
Equipment, net     457,912       986,553
Restricted cash     2,921,724       1,577,920
Other long-term assets     159,224       39,597
               
Total assets   $ 14,695,641     $ 32,010,033
               
LIABILITIES & STOCKHOLDERS' EQUITY      
               
Current liabilities:              
Accounts payable   $ 794,397     $ 1,523,875
Accrued expenses     2,445,446       2,410,592
Deferred revenue     1,069,438       3,314,918
Accrued warrant liability     1,241,311       4,105,659
Current portion of note payable     351,527       -
Current portion of capital lease obligation     83,634       71,679
      5,985,753       11,426,723
               
Noncurrent portion of capital lease obligation     7,522       97,602
Long-term debt     7,121,388       -
               
Commitments and contingencies     -       -
Total liabilities     13,114,663       11,524,325
               
Stockholders' equity:              
Total Cleveland BioLabs, Inc. stockholders' equity (deficit)     (9,522,945 )     6,333,167
Noncontrolling interest in stockholders' equity     11,103,923       14,152,541
Total stockholders' equity     1,580,978       20,485,708
               
Total liabilities and stockholders' equity   $ 14,695,641     $ 32,010,033
               
               
   
CLEVELAND BIOLABS, INC. AND SUBSIDIARIES  
CONSOLIDATED STATEMENTS OF OPERATIONS  
   
                         
    Quarter Ended December 31     Year to Date December 31  
    2013     2012     2013     2012  
Revenues:                                
Grants and contracts   $ 3,871,632     $ 2,161,501     $ 8,487,966     $ 3,570,710  
                                 
Operating expenses:                                
Research and development     4,616,068       5,581,405       19,525,950       22,501,805  
General and administrative     2,251,722       2,141,562       12,038,775       11,115,511  
Total operating expenses     6,867,790       7,722,967       31,564,725       33,617,316  
                                 
Loss from operations     (2,996,158 )     (5,561,466 )     (23,076,759 )     (30,046,606 )
                                 
Other income:                                
Interest and other income (expense)     (202,025 )     (94,464 )     83,127       (70,015 )
Change in value of warrant liability     2,353,429       7,862,730       2,864,348       7,701,981  
Total other income     2,151,404       7,768,266       2,947,475       7,631,966  
                                 
Net income (loss)     (844,754 )     2,206,800       (20,129,284 )     (22,414,640 )
                                 
Net loss attributable to noncontrolling interests     479,507       902,724       2,866,407       4,180,498  
                                 
Net income (loss) attributable to Cleveland BioLabs, Inc.   $ (365,247 )   $ 3,109,524     $ (17,262,877 )   $ (18,234,142 )
                                 
Net income (loss) available to common stockholders per share of common stock, basic   $ (0.01 )   $ 0.07     $ (0.38 )   $ (0.49 )
                                 
Net income (loss) available to common stockholders per share of common stock, diluted   $ (0.01 )   $ 0.07     $ (0.38 )   $ (0.49 )
                                 
Weighted average number of shares used in calculating net income (loss) per share, basic     45,170,429       42,236,226       45,002,823       37,388,847  
                                 
Weighted average number of shares used in calculating net income (loss) per share, diluted     45,170,429       42,565,945       45,002,823       37,388,847  
                                 
                                 
   
CLEVELAND BIOLABS, INC. AND SUBSIDIARIES  
CONSOLIDATED STATEMENTS OF CASH FLOWS  
   
             
    For the Year Ended December 31  
    2013     2012  
                 
Cash flows used in operating activities   $ (23,102,647 )   $ (20,649,503 )
Cash flows provided by investing activities     560,709       1,371,702  
Cash flows provided by financing activities     7,261,942       21,519,249  
Effect of exchange rate changes on cash and equivalents     (323,621 )     538,046  
                 
Increase in cash and cash equivalents     (15,603,617 )     2,779,494  
                 
Cash and cash equivalents at beginning of period     25,652,083       22,872,589  
                 
Cash and cash equivalents at end of period   $ 10,048,466     $ 25,652,083