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Cleveland BioLabs Reports Fourth Quarter and Fiscal 2012 Financial Results and Development Progress



Cleveland BioLabs Reports Fourth Quarter and Fiscal 2012 Financial Results and
Development Progress

BUFFALO, N.Y., March 14, 2013 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc.
(Nasdaq:CBLI) today reported financial results and development progress for
the fourth quarter and fiscal year ended December 31, 2012.

Cleveland BioLabs reported net income attributable to its common stockholders
for the fourth quarter of 2012 of $3.1 million, or $0.07 per share of common
stock, as compared to a net loss attributable to its common stockholders of
$7.2 million, or $0.20 per share of common stock, for the fourth quarter of
2011. Cleveland BioLabs reported a net loss attributable to its common
stockholders for fiscal 2012 of $18.2 million, or $0.49 per share of common
stock, as compared to a net loss attributable to its common stockholders of
$4.0 million, or $0.12 per share of common stock, for fiscal 2011. The
variances in reported net income/loss are largely due to variances in the
value of warrant liabilities which are required to be valued on a
mark-to-market basis for each reportable period.

At December 31, 2012, the Company had $28.3 million in cash, cash equivalents
and short-term investments, $18.0 million of which was available for general
use and $10.3 million of which was restricted for the use of majority-owned
subsidiaries.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "Over the course of
2012, we have brought Entolimod™ (previously known as CBLB502) into the
pivotal stage of its development and moved several of our oncology programs
forward in the clinic. With a broad pipeline of first-in-class oncology drugs
being developed by us and our majority-owned subsidiaries, we are focused on
delivering clinical results while achieving approval and sales for Entolimod
as a radiation countermeasure."

"Our agreements and further guidance from the U.S. Food and Drug
Administration (FDA) regarding the remaining development steps required to
file a Biologic License Application (BLA) for Entolimod as a radiation
countermeasure have yielded $2.3 million in additional and redirected awards
from the Defense Threat Reduction Agency and Chemical Biological Medical
Systems divisions of the Department of Defense (DoD) and enabled us to submit
a development proposal to the Biomedical Advanced Research and Development
Authority (BARDA) of the Department of Health and Human Services to fund
remaining activities," commented Dr. Kogan.

He continued, "While this process has unfolded, we have also dosed patients in
three oncology trials with Entolimod, CBL0137 and CBL0102, and are actively
working to design the next round of clinical protocols for these drugs. The
goal of these trials is to optimize efficacy data based on input accumulated
from preclinical experiments and companion diagnostic assays we have created
in conjunction with Roswell Park Cancer Institute to evaluate expression
levels of the molecular targets for these drugs in various tumor types."

Operational Highlights

Enrollment of the fourth cohort of the Entolimod advanced cancer trial at
Roswell Park Cancer Institute continues. To date, no serious adverse events
have been reported.

CBLB612 is progressing towards an Investigational New Drug application (IND)
for a clinical trial in healthy subjects to evaluate safety and potential
efficacy as a stimulator of hematopoietic stem cell proliferation and
mobilization. CBLB612 was awarded a three-year, approximately $4.6 million
development contract (based on current exchange rates) from the Ministry of
Industry and Trade of the Russian Federation awarded in July 2012.

Incuron, LLC, one of Cleveland BioLabs' majority-owned subsidiaries, continues
dosing of the oral formulation of CBL0137 in patients with advanced solid
tumors that are resistant or refractory to standard of care treatment in a
Phase 1, single agent, dose escalation study in Russia. An IND for the
intravenous formulation of CBL0137 is in process to open trials in the United
States.

Dosing has been completed in the sixth cohort of the dose-escalation arm in
Incuron's ongoing Phase 1 single-dose ascending trial of CBL0102 in refractory
advanced cancer patients with liver metastases. Progression into a higher dose
cohort will take place before initiating the efficacy arm. CBL0102 has been
granted Orphan Drug status by the FDA for treatment of hepatocellular
carcinoma.

Panacela Labs continued toxicology work in Russia for its five pipeline
candidates with a view towards potential IND filings. Panacela's Xenomycins, a
family of compounds in development as anti-infective agents, was awarded a
three-year, approximately $4.8 million development contract (based on current
exchange rates) from the Ministry of Industry and Trade of the Russian
Federation in November.

Further Financial Highlights

Revenue for the fourth quarter ended December 31, 2012 increased to $2.2
million compared to $1.9 million for the prior year period, primarily due to
an increase in funding from the Ministry of Industry and Trade of the Russian
Federation. Revenue for the year ended December 31, 2012 decreased to $3.6
million from $8.8 million for the prior year, primarily due to decreases in
research sponsored by the DoD, BARDA and a NY State/RPCI Sponsored Research
Agreement.

Research and development expense for the fourth quarter was $5.6 million
compared to $5.3 million for the same period in 2011. Research and development
expense for fiscal 2012 was $22.5 million for 2012 compared to $22.8 million
for 2011.  

G&A expense for the fourth quarter decreased to $2.1 million from $3.0 million
for the fourth quarter of 2011. G&A expense for fiscal 2012 remained flat in
comparison to 2011 at approximately $11.1 million. 

As of December 31, 2012, Cleveland BioLabs had approximately 44.5 million
shares of common stock outstanding.

Conference Call Information

Management will host a conference call at 10:00 a.m. EDT 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 March 14, 2013, at 1:00 p.m.
EDT through June 14, 2013, at 11:59 p.m. EDT. Interested parties may access
the replay by dialing 877-660-6853 (US) or 201-612-7415 (International) and
entering conference ID number 409100. 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.

The Cleveland BioLabs, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=11668

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 SHEETS
 
                                                   December 31,
                                                   2012          2011
                                                                  
ASSETS
Current assets:                                                   
Cash and cash equivalents                           $ 25,652,083  $ 22,872,589
Short-term investments                              2,633,944     5,520,000
Accounts receivable                                 41,896        1,740,629
Other current assets                                1,078,040     876,889
Total current assets                                29,405,963    31,010,107
                                                                  
                                                                  
Equipment, net                                      986,553       1,084,204
Restricted cash                                     1,577,920     -- 
Other long-term assets                              39,597        32,490
                                                                  
Total assets                                        $ 32,010,033  $ 32,126,801
                                                                  
LIABILITIES & STOCKHOLDERS' EQUITY
                                                                  
Current liabilities:                                              
Accounts payable                                    $ 1,523,875   $ 909,144
Accrued expenses                                    2,410,592     1,686,202
Deferred revenue                                    3,314,918     -- 
Accrued warrant liability                           4,105,659     7,285,959
Current portion of capital lease obligation         71,679        -- 
                                                    11,426,723    9,881,305
                                                                  
Noncurrent portion of capital lease obligation      97,602        -- 
                                                                  
Commitments and contingencies                       --            -- 
                                                                  
Total liabilities                                   11,524,325    9,881,305
                                                                  
Stockholders' equity:                                             
Total Cleveland BioLabs, Inc. stockholders' equity  6,333,167     9,060,672
Noncontrolling interest in stockholders' equity     14,152,541    13,184,824
Total stockholders' equity                          20,485,708    22,245,496
                                                                  
Total liabilities and stockholders' equity          $ 32,010,033  $ 32,126,801

 
CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
 
                    Quarter Ended December 31,  Year Ended December 31,
                    2012         2011           2012            2011
Revenues:                                                        
Grants and           $ 2,161,501  $ 1,945,911    $ 3,570,710     $ 8,790,209
contracts
                                                                 
Operating expenses:                                              
Research and         5,581,405    5,347,856      22,501,805      22,788,887
development
General and          2,141,562    3,002,153      11,115,511      11,106,493
administrative
Total operating      7,722,967    8,350,009      33,617,316      33,895,380
expenses
                                                                 
Loss from            (5,561,466)  (6,404,098)    (30,046,606)    (25,105,171)
operations
                                                                 
Other income                                                     
(expense):
Interest and other   (94,464)     (59,190)       (70,015)        53,659
income
Change in value of   7,862,730    (1,272,665)    7,701,981       19,821,787
warrant liability
Total other income   7,768,266    (1,331,855)    7,631,966       19,875,446
(expense)
                                                                 
Net loss             2,206,800    (7,735,953)    (22,414,640)    (5,229,725)
                                                                 
Net loss
attributable to      902,724      544,459        4,180,498       1,216,055
noncontrolling
interests
                                                                 
Net income (loss)
attributable to      $ 3,109,524  $ (7,191,494)  $ (18,234,142)  $ (4,013,670)
Cleveland BioLabs,
Inc.
                                                                 
Net income (loss)
available to common
stockholders per     $ 0.07       $ (0.20)       $ (0.49)        $ (0.12)
share of common
stock, basic
                                                                 
Net income (loss)
available to common
stockholders per     $ 0.07       $ (0.20)       $ (0.49)        $ (0.12)
share of common
stock, diluted
                                                                 
Weighted average
number of shares
used in calculating  42,236,226   35,553,413     37,388,847      32,561,743
net loss per share,
basic
                                                                 
Weighted average
number of shares
used in calculating  42,565,945   35,553,413     37,388,847      32,561,743
net loss per share,
diluted

 
CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
 
                                               Year Ended December 31,
                                               2012            2011
                                                                
Cash flows used in operating activities         $ (20,649,503)  $ (16,905,390)
Cash flows provided by (used in) investing      1,371,702       (6,066,889)
activities
Cash flows provided by financing activities     21,519,249      34,769,442
Effect of exchange rate change on cash and      538,046         156,889
equivalents
                                                                
Increase in cash and cash equivalents           2,779,494       11,954,052
                                                                
Cash and cash equivalents at beginning of       22,872,589      10,918,537
period
                                                                
Cash and cash equivalents at end of period      $ 25,652,083    $ 22,872,589

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