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Cleveland BioLabs Reports Third Quarter 2013 Financial Results and Development Progress



Cleveland BioLabs Reports Third Quarter 2013 Financial Results and Development
Progress

BUFFALO, N.Y., Nov. 6, 2013 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc.
(Nasdaq:CBLI) today reported financial results and development progress for
the third quarter and nine-month periods ended September 30, 2013.

Cleveland BioLabs reported a net loss for the third quarter of 2013 of $4.1
million, or $0.09 per share, as compared to a net loss of $10.9 million, or
$0.30 per share, for the third quarter of 2012. Cleveland BioLabs reported a
net loss for the first nine months of 2013 of $16.9 million, or $0.38 per
share, as compared to a net loss of $21.3 million, or $0.60 per share, for the
same period in 2012.

At September 30, 2013, the company had $14.6 million in cash, cash equivalents
and short-term investments, $10.8 million of which was available for general
use and $3.8 million of which was restricted for the use of majority-owned
subsidiaries. On September 30, 2013, the company entered into a loan and
security agreement with Hercules Technology Growth Capital, Inc. (NYSE:HTGC)
providing for a senior secured term loan of up to $10 million, $6 million of
which was funded upon closing, with net proceeds of $5.8 million reflected in
the $14.6 million figure above.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "2013 has been a
dynamic year for CBLI. We have significantly restructured our organization
enabling it to better promote the advancement and maturation of our pipeline.
We are focused on delivering value-driving data through execution of oncology
trials and registration-enabling studies for the Entolimod radiation
countermeasure program."

Jean Viallet, MD, Chief Development Officer, commented, "Our clinical oncology
strategy is centered on two key aspects of our pipeline: Immuno-stimulatory
capabilities of Entolimod and the role of the molecular target of CBL0137 as
an essential enabler of tumor transformation and survival for several
aggressive oncogenes. Both of these directions are driven by recent insights
regarding the mechanisms of action of these drug candidates and are aligned
with exciting trends in oncology development. We are in the midst of drafting
trial protocols to characterize these properties and exploring opportunities
to partner with the National Cancer Institute and key clinical thought
leaders."

Operational Highlights

CBLI's wholly-owned Russian subsidiary, BioLab 612, LLC, entered into a
three-year contract valued at approximately 149 million rubles, or
approximately $4.6 million, with the Ministry of Industry and Trade of the
Russian Federation to support the clinical safety and efficacy assessment of
Entolimod in colorectal cancer. Recruitment of the fifth cohort continued in a
Phase 1 study of Entolimod in advanced cancer patients in the U.S. To date, no
drug-related serious adverse events have been reported in this trial.

Incuron, LLC, one of CBLI's majority-owned subsidiaries, is enrolling the
first cohort of a multi-center, Phase 1 trial in the U.S. evaluating
intravenous administration of CBL0137 in patients with metastatic or
unresectable advanced solid cancers and lymphomas. In parallel, Incuron is
enrolling the fifth cohort in its Phase 1 study of oral administration of
CBL0137 in patients with advanced solid tumors that are resistant or
refractory to current standard treatment in the Russian Federation. To date,
no drug-related serious adverse events have been reported in either trial.

In the fourth quarter of 2013, the company expects to receive results from
Incuron's Phase 1 trial of CBL0102 in patients with liver metastases that is
being conducted in the Russian Federation.

Panacela Labs, Inc., one of CBLI's majority-owned subsidiaries entered into a
three-year contract valued at approximately 149 million rubles, or
approximately $4.6 million, with the Ministry of Industry and Trade of the
Russian Federation to support preclinical and clinical studies of Mobilan, a
cancer vaccine in preclinical development.

Further Financial Highlights

Revenue for the third quarter of 2013 increased to $1.6 million compared to
$0.2 million for the prior year's third quarter. Revenue for the first nine
months of 2013 increased to $4.6 million compared to $1.4 million for the same
period in 2012. For both periods, the increased revenue was primarily due to
increases in contract and grant funding from both the Russian Federation and
the U.S. Department of Defense.

Research and development costs for the third quarter of 2013 decreased to $4.2
million compared to $4.8 million for the same period in 2012. Research and
development costs for the first nine months of 2013 decreased to $14.9 million
compared to $16.9 million for the same period in 2012. These decreases were
primarily due to a shift in development focus to later stage compounds at
Panacela Labs, and completion of a pivotal non-human primate study in the
first nine months of 2012.

General and administrative costs for the third quarter of 2013 increased to
$3.3 million compared to $3.2 million for the same period in 2012. General and
administrative costs for the first nine months of 2013 increased to $9.8
million from $9.0 million for the same period in 2012. These increases were
primarily attributable to higher general and administrative costs for our
Russian-based subsidiaries including BioLabs 612, LLC which was not
operational in 2012 and to higher corporate legal and intellectual property
fees.

On October 18, the Company announced the transfer of laboratory and
preclinical services personnel to Buffalo BioLabs, LLC, an entity affiliated
with one of the Company's co-founders, Andrei Gudkov, Ph.D., D. Sci. CBLI has
executed a service agreement providing for continued access to this team on an
as-needed basis.

As of September 30, 2013, Cleveland BioLabs had approximately 45 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 877-407-9205 (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 November 6, 2013, at 1:00
p.m. ET through November 20, 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 100723. 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 a clinical-stage biotechnology company leveraging
deep understanding of molecular and cellular mechanisms of biological stress
responses to develop a robust pipeline of compounds primarily focused on
oncology applications and mitigation of radiation injury. The company's lead
compound, Entolimod, is being developed as both a radiation countermeasure and
a cancer treatment. The Company has three operating subsidiaries, Incuron,
LLC, BioLabs 612, LLC and Panacela Labs, Inc., and strategic relationships
with the Cleveland Clinic, Roswell Park Cancer Institute, the Children's
Cancer Institute Australia for Medical Research 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 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.

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
 
                                          September 30, 2013 December 31, 2012
                                          (unaudited)         
ASSETS
Current assets:                                               
Cash and cash equivalents                  $ 14,312,921       $ 25,652,083
Short-term investments                     309,166            2,633,944
Accounts receivable                        603,494            41,896
Other current assets                       590,714            1,078,040
Total current assets                       15,816,295         29,405,963
                                                              
                                                              
Equipment, net                             825,746            986,553
Restricted cash                            2,871,553          1,577,920
Other long-term assets                     174,822            39,597
                                                              
Total assets                               $ 19,688,416       $ 32,010,033
 
LIABILITIES & STOCKHOLDERS' EQUITY
 
Current liabilities:                                          
Accounts payable                           $ 1,202,198        $ 1,523,875
Accrued expenses                           3,082,585          2,410,592
Deferred revenue                           2,035,120          3,314,918
Accrued warrant liability                  3,594,741          4,105,659
Current portion of capital lease           80,709             71,679
obligation
                                           9,995,353          11,426,723
                                                              
Noncurrent portion of capital lease        29,560             97,602
obligation
Long-term debt                             7,330,449          -- 
                                                              
Commitments and contingencies              --                 -- 
Total liabilities                          17,355,362         11,524,325
                                                              
Stockholders' equity:                                         
Total Cleveland BioLabs, Inc.              (9,267,398)        6,333,167
stockholders' equity (deficit)
Noncontrolling interest in stockholders'   11,600,452         14,152,541
equity
Total stockholders' equity                 2,333,054          20,485,708
                                                              
Total liabilities and stockholders'        $ 19,688,416       $ 32,010,033
equity

 
CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
 
                Quarter Ended September 30     Year to Date September 30
                2013           2012            2013            2012
Revenues:                                                       
Grants and       $ 1,635,600    $ 219,575       $ 4,616,334     $ 1,409,209
contracts
                                                                
Operating                                                       
expenses:
Research and     4,205,238      4,841,324       14,909,882      16,920,400
development
General and      3,286,830      3,219,792       9,787,053       8,973,949
administrative
Total operating  7,492,068      8,061,116       24,696,935      25,894,349
expenses
                                                                
Loss from        (5,856,468)    (7,841,541)     (20,080,601)    (24,485,140)
operations
                                                                
Other income                                                    
(expense):
Interest and     97,534         228,580         225,299         354,473
other income
Foreign
exchange gain    (15,057)       (278,940)       59,853          (330,024)
(loss)
Change in value
of warrant       1,163,030      (4,423,775)     510,919         (160,749)
liability
Total other
income           1,245,507      (4,474,135)     796,071         (136,300)
(expense)
                                                                
Net loss         (4,610,961)    (12,315,676)    (19,284,530)    (24,621,440)
                                                                
Net loss
attributable to  519,765        1,437,840       2,386,900       3,277,774
noncontrolling
interests
                                                                
Net loss
attributable to  $ (4,091,196)  $ (10,877,836)  $ (16,897,630)  $ (21,343,666)
Cleveland
BioLabs, Inc.
                                                                
Net loss
available to
common
stockholders     $ (0.09)       $ (0.30)        $ (0.38)        $ (0.60)
per share of
common stock,
basic and
diluted
                                                                
Weighted
average number
of shares used
in calculating   45,061,274     35,879,245      44,946,340      35,761,260
net loss per
share, basic
and diluted

 
CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
 
                                        For the Nine Months Ended September 30
                                        2013                2012
                                                             
Cash flows used in operating activities  $ (18,923,142)      $ (15,455,211)
Cash flows provided by (used in)         666,920             (1,492,244)
investing activities
Cash flows provided by (used in)         7,251,055           5,858,953
financing activities
Effect of exchange rate change on cash   (333,995)           404,486
and equivalents
                                                             
Increase in cash and cash equivalents    (11,339,162)        (10,684,016)
                                                             
Cash and cash equivalents at beginning   25,652,083          22,872,589
of period
                                                             
Cash and cash equivalents at end of      $ 14,312,921        $ 12,188,573
period

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