DELAWARE
|
20-0077155
|
|
(State
or other jurisdiction of incorporation
or
organization)
|
(I.R.S.
Employer Identification No.)
|
73
High Street, Buffalo, NY 14203
|
(716)
849-6810
|
|
(Address
of principal executive offices)
|
Telephone
No.
|
Title
of each class
|
Name
of each exchange which registered
|
|
Common
Stock, par value $0.005 per share
|
NASDAQ
Capital Market
|
Large
accelerated filer
o
|
Accelerated
filer
o
|
Non-accelerated
filer
o
|
Smaller
reporting company
x
|
Page
|
|||||
PART
I
|
|||||
Item
1
|
Description
of Business
|
1
|
|||
Item
1A
|
Risk
Factors
|
17
|
|||
Item
1B
|
Unresolved
Staff Comments
|
26
|
|||
Item
2
|
Description
of Property
|
26
|
|||
Item
3
|
Legal
Proceedings
|
26
|
|||
Item
4
|
Removed
and Reserved
|
26
|
|||
|
|||||
PART
II
|
|||||
Item
5
|
Market for
Registrant’s Common Equity, Related Stockholder Matters and
Issuer
Purchases
of Equity Securities
|
27
|
|||
Item
6
|
Selected
Financial Data
|
27
|
|||
Item
7
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
28
|
|||
Item
7A
|
Quantitative
and Qualitative Disclosures About Market Risk
|
35
|
|||
Item
8
|
Financial
Statements and Supplementary Data
|
36
|
|||
Item
9
|
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosures
|
65
|
|||
Item
9A
|
Controls
and Procedures
|
65
|
|||
Item
9B
|
Other
Information
|
65
|
|||
PART
III
|
|||||
Item
10
|
Directors,
Executive Officers and Corporate Governance
|
66
|
|||
Item
11
|
Executive
Compensation
|
66
|
|||
Item
12
|
Security Ownership
of Certain Beneficial Owners and Management and Related
Stockholder
Matters
|
66
|
|||
Item
13
|
Certain
Relationships and Related Transactions, and Director
Independence
|
66
|
|||
Item
14
|
Principal
Accountant Fees and Services
|
66
|
|||
PART
IV
|
|
||||
Item
15
|
Exhibits
and Financial Statement Schedules
|
66
|
|||
SIGNATURES
|
70
|
·
|
Protectans
- modified factors of microbes that protect cells from apoptosis, and
which therefore have a broad spectrum of potential applications. The
potential applications include both non-medical applications such as
protection from exposure to radiation, whether as a result of military or
terrorist action or as a result of a nuclear accident, as well as medical
applications such as reducing cancer treatment
toxicities.
|
·
|
Curaxins
- small molecules designed to kill tumor cells by simultaneously targeting
two regulators of apoptosis. Initial test results indicate that curaxins
can be effective against a number of malignancies, including
hormone-refractory prostate cancer, renal cell carcinoma, or RCC (a highly
fatal form of kidney cancer), and soft-tissue
sarcoma.
|
·
|
During
the first stage, biotech companies fund their development through equity
or debt financings while conducting R&D, which culminates in phased
drug trials.
|
·
|
During
the second stage, when their lead drug candidates enter the drug trials,
biotech companies may start licensing their drug candidates to Pharma
companies in order to (1) generate revenue, (2) gain access to additional
expertise, and (3) establish relations with Pharma companies who can
eventually take a leading role in distributing successful
drugs.
|
·
|
At
the most advanced stage, biotech companies generate revenues by selling
drugs or other biotech products to consumers or through alliances of
equals.
|
·
|
Facilitate
R&D efforts of biomedical countermeasures by the National Institutes
of Health;
|
·
|
Provide
for the procurement of needed countermeasures through a special reserve
fund of $5.6 billion over ten years;
and
|
·
|
Authorize,
under limited circumstances, the emergency use of medical products that
have not been approved by the FDA.
|
·
|
Aggressively working towards
the commercialization of Protectan CBLB502
. Our most advanced drug
candidate, Protectan CBLB502, offers the potential to protect normal
tissues against exposure to radiation. Because of the potential military
and defense implications of such a drug, the normally lengthy FDA approval
process for these non-medical applications is substantially abbreviated
resulting in a large cost savings to us. We expect to complete development
of Protectan CBLB502 for these non-medical applications and complete
submission of the Biologic License Application, or BLA, with the FDA in
the first half of 2011.
|
·
|
Leveraging our relationship
with leading research and clinical development
institutions.
The Cleveland Clinic, one of the top research
medical facilities in the world, is one of our co-founders. In addition to
providing us with drug leads and technologies, the Cleveland Clinic will
share valuable expertise with us as development efforts are performed on
our drug candidates. In January 2007, we entered into a strategic research
partnership with Roswell Park Cancer Institute, or RPCI, in Buffalo, New
York. This partnership will enhance the speed and efficiency of our
clinical research and provide us with access to the state-of-the-art
clinical development facilities of a globally recognized cancer research
center.
|
·
|
Utilizing governmental
initiatives to target our markets.
Our focus on drug candidates
such as Protectan CBLB502, which has applications that have been deemed
useful for military and defense purposes, provides us with a built-in
market for our drug candidates. This enables us to invest less in costly
retail and marketing resources. In an effort to improve our responsiveness
to military and defense needs, we have established a collaborative
relationship with the Armed Forces Radiobiology Research Institute, or
AFRRI.
|
·
|
Utilizing and developing other
strategic relationships.
We have collaborative relationships with
other leading organizations that enhance our drug development and
marketing efforts. For example, one of our founders, with whom we maintain
a strategic partnership, is ChemBridge Corporation. Known for its
medicinal chemistry expertise and synthetic capabilities, ChemBridge
provides valuable resources to our drug development research including
access to a chemical library of over 1,000,000
compounds.
|
·
|
Conducting
pivotal animal efficacy studies with the cGMP manufactured drug candidate.
We expect to complete these studies in 2010. The studies have an
approximate cost of $2,500,000 and are covered by a government development
contract.
|
·
|
Performing
a second Phase I safety study in approximately 100 healthy human
volunteers started in January 2010. This study has an approximate cost of
$1,400,000 and is covered by a government development
contract
|
·
|
Performing
a Phase II human safety study in a larger number of volunteers using the
dose of Protectan CBLB502 previously shown to be safe in humans and
efficacious in animals. We estimate completion of this study in early 2011
at an approximate cost of $7,000,000 based on 500 subjects tested in four
locations. This study is covered by a government development contract
pending approval.
|
·
|
Filing
a BLA which we expect to complete in the first half of
2011. At the present time, the costs of the filing cannot
be approximated with any level of
certainty.
|
·
|
Submitting
an amendment to our CBLB502 IND application and receiving allowance from
the FDA. We expect to submit the amendment in the first half of 2010. We
estimate that the approximate cost of filing will be less than $100,000
which is covered by a government
grant.
|
·
|
Performing
a Phase I/II human efficacy study on a small number of head and neck
cancer patients. We expect to complete this study two years from the
receipt of allowance from the FDA of the IND amendment at an approximate
cost of $1,500,000 which is covered by a government development
grant.
|
·
|
Performing
an additional Phase II efficacy study on a larger number of cancer
patients. At the present time, the costs and the scope of this study
cannot be approximated with any level of
certainty.
|
·
|
Performing
a Phase III human clinical study on a large number of cancer patients and
filing a BLA with the FDA. At the present time, the costs and scope of
these steps cannot be approximated with any level of
certainty.
|
·
|
Conducting
pivotal animal safety studies with cGMP-manufactured
CBLB612;
|
·
|
Submitting
an IND application and receiving approval from the FDA to conduct clinical
trials;
|
·
|
Performing
a Phase I dose-escalation human
study;
|
·
|
Performing
Phase II and Phase III human efficacy studies using the dose of CBLB612
selected from the previous studies previously shown to be safe in humans
and efficacious in animals; and
|
·
|
Filing
a New Drug Application.
|
·
|
Issue
to the Cleveland Clinic 1,341,000 shares of common
stock;
|
·
|
Make
certain milestone payments (ranging from $50,000 to $4,000,000, depending
on the type of drug and the stage of such drug’s
development);
|
·
|
Make
royalty payments (calculated as a percentage of the net sales of the drugs
ranging from 1-2%); and
|
·
|
Make
sublicense royalty payments (calculated as a percentage of the royalties
received from the sublicenses ranging from
5-35%).
|
File
IND application for Protectan CBLB502 (completed February
2008)
|
$ | 50,000 | ||
Commence
Phase II clinical trials for Protectan CBLB502
|
$ | 100,000 | ||
File
BLA application for Protectan CBLB502
|
$ | 350,000 | ||
Receive
regulatory approval to sell Protectan CBLB502
|
$ | 1,000,000 | ||
File
IND application for Curaxin CBLC102 (completed May 2006)
|
$ | 50,000 | ||
Commence
Phase II clinical trials for Curaxin CBLC102 (completed January
2007)
|
$ | 250,000 | ||
Commence
Phase III clinical trials for Curaxin CBLC102
|
$ | 700,000 | ||
File
NDA application for Curaxin CBLC102
|
$ | 1,500,000 | ||
Receive
regulatory approval to sell Curaxin CBLC102
|
$ | 4,000,000 |
·
|
our
ability to obtain approval for, and if approved, to successfully
commercialize, Protectan CBLB502;
|
·
|
our
ability to bring to market other proprietary drugs that are progressing
through our development process;
|
·
|
our
R&D efforts, including the timing and cost of clinical trials;
and
|
·
|
our
ability to enter into favorable alliances with third-parties who can
provide substantial capabilities in clinical development, manufacturing,
regulatory affairs, sales, marketing and
distribution.
|
·
|
are
found to be unsafe or ineffective in clinical
trials;
|
·
|
do
not receive necessary approval from the FDA or foreign regulatory
agencies;
|
·
|
fail
to conform to a changing standard of care for the diseases they seek to
treat; or
|
·
|
are
less effective or more expensive than current or alternative treatment
methods.
|
·
|
pre-clinical
or clinical study results that may show the product to be less effective
than desired (e.g., the study failed to meet its primary objectives) or to
have harmful or problematic side
effects;
|
·
|
failure
to receive the necessary regulatory approvals or a delay in receiving such
approvals; among other things, such delays may be caused by slow
enrollment in clinical studies, length of time to achieve study endpoints,
additional time requirements for data analysis or a NDA/BLA,
preparation, discussions with the FDA, an FDA request for additional
pre-clinical or clinical data or unexpected safety or manufacturing
issues;
|
·
|
manufacturing
costs, pricing or reimbursement issues, or other factors that cause the
product to be not economically
unfeasible; and
|
·
|
the
proprietary rights of others and their competing products and technologies
that may prevent the product from being
commercialized.
|
·
|
the
number and outcome of clinical studies we are planning to conduct; for
example, our R&D expenses may increase based on the number of
late-stage clinical studies that we may be required to
conduct;
|
·
|
the
number of products entering into development from late-stage research; for
example, there is no guarantee that internal research efforts will succeed
in generating sufficient data for us to make a positive development
decision or that an external candidate will be available on terms
acceptable to us, and some promising candidates may not yield sufficiently
positive pre-clinical results to meet our stringent development
criteria;
|
·
|
in-licensing
activities, including the timing and amount of related development funding
or milestone payments; for example, we may enter into agreements requiring
us to pay a significant up-front fee for the purchase of in-process
R&D that we may record as R&D expense;
or
|
·
|
future
levels of revenue; R&D expenses as a percentage of future potential
revenues can fluctuate with the changes in future levels of revenue and
lower revenues can lead to less spending on R&D
efforts.
|
·
|
suspend
or prevent us for a set period of time from receiving new contracts or
extending existing contracts based on violations or suspected violations
of laws or regulations;
|
·
|
terminate
our existing contracts;
|
·
|
reduce
the scope and value of our existing
contracts;
|
·
|
audit
and object to our contract-related costs and fees, including allocated
indirect costs;
|
·
|
control
and potentially prohibit the export of our products;
and
|
·
|
change
certain terms and conditions in our
contracts.
|
·
|
decreased
demand for our product candidates;
|
·
|
injury
to our reputation;
|
·
|
withdrawal
of clinical trial participants;
|
·
|
costs
of related litigation;
|
·
|
diversion
of our management’s time and
attention;
|
·
|
substantial
monetary awards to patients or other
claimants;
|
·
|
loss
of revenues;
|
·
|
the
inability to commercialize product candidates;
and
|
·
|
increased
difficulty in raising required additional funds in the private and public
capital markets.
|
·
|
pre-clinical
study results that may show the product to be less effective than desired
(e.g., the study failed to meet its primary objectives) or to have harmful
or problematic side effects;
|
·
|
failure
to receive the necessary regulatory approvals or a delay in receiving such
approvals. Among other things, such delays may be caused by slow
enrollment in clinical studies, length of time to achieve study endpoints,
additional time requirements for data analysis or a BLA, preparation,
discussions with the FDA, an FDA request for additional pre-clinical or
clinical data or unexpected safety or manufacturing
issues;
|
·
|
manufacturing
costs, pricing or reimbursement issues, or other factors that make the
product not
economically
feasible
; and
|
·
|
the
proprietary rights of others and their competing products and technologies
that may prevent the product from being
commercialized.
|
·
|
price
and volume fluctuations in the overall stock market from time to
time;
|
·
|
fluctuations
in stock market prices and trading volumes of similar
companies;
|
·
|
actual
or anticipated changes in our earnings or fluctuations in our operating
results or in the expectations of securities
analysts;
|
·
|
general
economic conditions and trends;
|
·
|
major
catastrophic events;
|
·
|
sales
of large blocks of our stock;
|
·
|
departures
of key personnel;
|
·
|
changes
in the regulatory status of our product candidates, including results of
our clinical trials;
|
·
|
events
affecting the Cleveland Clinic, RPCI or any other
collaborators;
|
·
|
announcements
of new products or technologies, commercial relationships or other events
by us or our competitors;
|
·
|
regulatory
developments in the United States and other
countries;
|
·
|
failure
of our common stock to be listed or quoted on the NASDAQ Capital Market,
other national market system or any national stock
exchange;
|
·
|
changes
in accounting principles; and
|
·
|
discussion
of us or our stock price by the financial and scientific press and in
online investor communities.
|
2009
|
High
|
Low
|
||||||
First
Quarter
|
$ | 3.87 | $ | 1.15 | ||||
Second
Quarter
|
$ | 4.50 | $ | 1.75 | ||||
Third
Quarter
|
$ | 6.35 | $ | 3.40 | ||||
Fourth
Quarter
|
$ | 4.97 | $ | 3.31 |
2008
|
High
|
Low
|
||||||
First
Quarter
|
$ | 8.79 | $ | 2.03 | ||||
Second
Quarter
|
$ | 6.40 | $ | 3.82 | ||||
Third
Quarter
|
$ | 5.65 | $ | 3.70 | ||||
Fourth
Quarter
|
$ | 4.59 | $ | 1.51 |
2009
|
2008
|
2007
|
2006
|
2005
|
||||||||||||||||
Total
Operating Revenue
|
$ | 14,346 | $ | 4,706 | $ | 2,019 | $ | 1,708 | $ | 1,139 | ||||||||||
Government
contract or grant
|
12,696 | 4,586 | 1,729 | 1,503 | 1,000 | |||||||||||||||
Commercial
|
1,650 | 120 | 290 | 205 | 139 | |||||||||||||||
Net
loss
|
$ | (12,826 | ) (1) | $ | (14,026 | ) (1) | $ | (26,997 | ) (1) | $ | (7,223 | ) (1) | $ | (2,678 | ) | |||||
Net
loss per share, basic and diluted
|
$ | (0.82 | ) | $ | (1.13 | ) | $ | (2.34 | ) | $ | (0.84 | ) | $ | (0.43 | ) | |||||
Total
assets
|
$ | 6,554 | $ | 4,706 | $ | 17,422 | $ | 6,417 | $ | 4,253 | ||||||||||
Long-term
debt
|
- | - | - | 50 | 303 | |||||||||||||||
Stockholder's
equity (deficit)
|
(6,800 | ) | 538 | 14,194 | 5,593 | 3,557 |
(1)
|
Net
loss in 2009, 2008, 2007 and 2006 included employee stock-based
compensation costs of $2.8 million, $1.5 million, $7.8 million and $0.5
million, net of tax, respectively, due to our adoption of the provisions
of the Codification on stock-based compensation on January 1, 2005. No
employee stock-based compensation expense was recognized in reported
amounts in any period prior to January 1,
2005.
|
·
|
the
exercise price of the Series B Warrants to be reduced from $6.79 to $6.73,
and the aggregate number of shares of Common Stock issuable upon exercise
of the Series B Warrants to increase from 3,609,300 to 3,641,479;
and
|
·
|
the
exercise price of the Series C Warrants to be reduced from $7.20 to $7.13,
and the aggregate number of shares of Common Stock issuable upon exercise
of the Series C Warrants to increase from 408,036 to
412,042.
|
·
|
the
exercise price of the Series B Warrants to be reduced from $6.73 to $6.68,
and the aggregate number of shares of Common Stock issuable upon exercise
of the Series B Warrants to increase from 3,641,479 to 3,668,727;
and
|
·
|
the
exercise price of the Series C Warrants to be reduced from $7.13 to $7.08,
and the aggregate number of shares of Common Stock issuable upon exercise
of the Series C Warrants to increase from 412,042 to
414,952.
|
·
|
the
exercise price of the Series B Warrants to be reduced from $6.68 to $6.37,
and the aggregate number of shares of Common Stock issuable upon exercise
of the Series B Warrants to increase from 3,668,727 to 3,847,276;
and
|
·
|
the
exercise price of the Series C Warrants to be reduced from $7.08 to $6.76,
and the aggregate number of shares of Common Stock issuable upon exercise
of the Series C Warrants to increase from 414,952 to
434,956.
|
Year
Ended
December
31,
2009
|
Year
Ended
December
31,
2008
|
Year
Ended
December
31,
2007
|
||||||||||
Revenues
|
$ | 14,345,908 | $ | 4,705,597 | $ | 2,018,558 | ||||||
Operating
expenses
|
20,728,837 | 19,050,965 | 27,960,590 | |||||||||
Other
expense (income)
|
6,463,208 | (59,597 | ) | 2,058,236 | ||||||||
Net
interest expense (income)
|
(19,728 | ) | (259,844 | ) | (1,003,766 | ) | ||||||
Net
income (loss)
|
$ | (12,826,409 | ) | $ | (14,025,927 | ) | $ | (26,996,502 | ) |
Agency
|
Program
|
Amount
|
Period
of
Performance
|
Revenue
2009
|
Revenue
2008
|
|||||||||
DoD
|
DTRA
Contract
|
$ | 1,263,836 |
03/2007-02/2009
|
$ | 183,613 | $ | 613,901 | ||||||
NIH
|
Phase
II NIH SBIR program
|
$ | 750,000 |
07/2006-06/2008
|
$ | - | $ | 77,971 | ||||||
NY
State/RPCI
|
Sponsored
Research Agreement
|
$ | 3,000,000 |
03/2007-02/2012
|
$ | 35,696 | $ | 305,298 | ||||||
NIH
|
NCI
Contract
|
$ | 750,000 |
09/2006-08/2008
|
$ | - | $ | 219,618 | ||||||
DoD
|
DOD
Contract
|
$ | 8,900,000 |
05/2008-09/2009
|
$ | 4,843,303 | $ | 2,938,357 | ||||||
HHS
|
BARDA
Contract
|
$ | 13,300,000 |
09/2008-09/2011
|
$ | 5,374,535 | $ | 219,412 | ||||||
NIH
|
NIAID
Grant
|
$ | 1,232,695 |
09/2008-02/2010
|
$ | 1,021,095 | $ | 211,040 | ||||||
NIH
|
NIAID
GO Grant
|
$ | 5,329,543 |
09/2009-09/2011
|
$ | 1,237,666 | $ | - | ||||||
Totals
|
$ | 12,695,908 | $ | 4,585,597 |
Year
Ended
December
31,
2009
|
Year
Ended
December
31,
2008
|
Year
Ended
December
31,
2007
|
Total
Since
Inception
|
|||||||||||||
Research
and development
|
$ | 14,331,673 | $ | 13,160,812 | $ | 17,429,652 | $ | 57,588,395 | ||||||||
General
|
$ | - | $ | 931,441 | $ | 892,456 | $ | 5,106,630 | ||||||||
Protectan
CBLB502 - non-medical applications
|
$ | 13,676,289 | $ | 7,264,813 | $ | 9,885,776 | $ | 35,277,485 | ||||||||
Protectan
CBLB502 - medical applications
|
$ | 56,127 | $ | 756,227 | $ | 815,399 | $ | 1,833,056 | ||||||||
Protectan
CBLB612
|
$ | 6,567 | $ | 974,459 | $ | 1,127,248 | $ | 3,136,941 | ||||||||
Curaxin
CBLC102
|
$ | 262,637 | $ | 1,741,194 | $ | 2,712,521 | $ | 6,729,120 | ||||||||
Other
Curaxins
|
$ | 330,053 | $ | 1,492,678 | $ | 1,996,252 | $ | 5,505,163 |
·
|
the
exercise price of the Series B Warrants reduced from $6.37 to
$5.99, and the aggregate number of shares of common stock issuable upon
exercise of the Series B Warrants increased from 3,847,276 to 4,091,345;
and
|
·
|
the
exercise price of the Series C Warrants reduced from $6.76 to $6.35, and
the aggregate number of shares of common stock issuable upon exercise of
the Series C Warrants increased from 434,596 to
462,654.
|
CLEVELAND
BIOLABS, INC.
|
BALANCE
SHEETS
|
December
31, 2009 and December 31, 2008
|
December
31
|
December
31
|
|||||||
2009
|
2008
|
|||||||
ASSETS
|
||||||||
CURRENT
ASSETS
|
||||||||
Cash
and equivalents
|
$ | 963,100 | $ | 299,849 | ||||
Short-term
investments
|
- | 1,000,000 | ||||||
Accounts
receivable:
|
||||||||
Trade
|
3,391,347 | 1,043,821 | ||||||
Interest
|
- | 9,488 | ||||||
Other
current assets
|
381,030 | 510,707 | ||||||
Total
current assets
|
4,735,477 | 2,863,865 | ||||||
EQUIPMENT
|
||||||||
Computer
equipment
|
323,961 | 309,323 | ||||||
Lab
equipment
|
1,159,478 | 1,102,465 | ||||||
Furniture
|
376,882 | 312,134 | ||||||
1,860,321 | 1,723,922 | |||||||
Less
accumulated depreciation
|
995,408 | 637,840 | ||||||
864,913 | 1,086,082 | |||||||
OTHER
ASSETS
|
||||||||
Intellectual
property
|
929,976 | 733,051 | ||||||
Deposits
|
23,482 | 23,482 | ||||||
953,458 | 756,533 | |||||||
TOTAL
ASSETS
|
$ | 6,553,848 | $ | 4,706,480 |
CLEVELAND
BIOLABS, INC.
|
||||||||
BALANCE
SHEETS
|
||||||||
December
31, 2009 and December 31, 2008
|
||||||||
December
31
|
December
31
|
|||||||
2009
|
2008
|
|||||||
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
||||||||
CURRENT
LIABILITIES
|
||||||||
Accounts
payable
|
$ | 1,208,632 | $ | 1,101,961 | ||||
Deferred
revenue
|
2,329,616 | 2,365,312 | ||||||
Dividends
payable
|
- | 321,293 | ||||||
Accrued
expenses
|
1,405,715 | 379,653 | ||||||
Accrued
warrant liability
|
8,410,379 | - | ||||||
Total
current liabilities
|
13,354,342 | 4,168,219 | ||||||
STOCKHOLDERS'
EQUITY
|
||||||||
Preferred
stock, $.005 par value
|
||||||||
Authorized
- 10,000,000 shares at December 31, 2009
|
||||||||
and
December 31, 2008
|
||||||||
Series
B convertible preferred stock,
|
||||||||
Issued
and outstanding 0 and 3,160,974
|
||||||||
shares
at December 31, 2009 and December 31, 2008, respectively
|
- | 15,805 | ||||||
Series
D convertible preferred stock,
|
||||||||
Issued
and outstanding 466.85 and 0
shares
at December 31, 2009 and December 31, 2008,
respectively
|
2 | - | ||||||
Common
stock, $.005 par value
|
||||||||
Authorized
- 80,000,000 and 40,000,000 shares at December 31, 2009
|
||||||||
and
December 31, 2008, respectively
|
||||||||
Issued
and outstanding 20,203,508 and 13,775,805
|
||||||||
shares
at December 31, 2009 and December 31, 2008, respectively
|
101,018 | 68,879 | ||||||
Additional
paid-in capital
|
62,786,418 | 56,699,750 | ||||||
Accumulated
deficit
|
(69,687,932 | ) | (56,246,173 | ) | ||||
Total
stockholders' equity
|
(6,800,494 | ) | 538,261 | |||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$ | 6,553,848 | $ | 4,706,480 |
CLEVELAND
BIOLABS, INC.
|
||||||||||||
STATEMENTS
OF OPERATIONS
|
||||||||||||
Years
Ended December 31, 2009, 2008, and 2007
|
||||||||||||
December 31
|
December 31
|
December 31
|
||||||||||
2009
|
2008
|
2007
|
||||||||||
REVENUES
|
||||||||||||
Grant
and Contract
|
$ | 12,695,908 | $ | 4,585,597 | $ | 1,728,558 | ||||||
Commercial
|
1,650,000 | 120,000 | 290,000 | |||||||||
14,345,908 | 4,705,597 | 2,018,558 | ||||||||||
OPERATING
EXPENSES
|
||||||||||||
Research
and development
|
14,331,673 | 13,160,812 | 17,429,652 | |||||||||
Selling,
general and administrative
|
6,397,164 | 5,890,153 | 10,530,938 | |||||||||
Total
operating expenses
|
20,728,837 | 19,050,965 | 27,960,590 | |||||||||
LOSS
FROM OPERATIONS
|
(6,382,929 | ) | (14,345,368 | ) | (25,942,032 | ) | ||||||
OTHER
INCOME
|
||||||||||||
Interest
income
|
21,688 | 259,844 | 1,004,853 | |||||||||
Buffalo
relocation reimbursement
|
- | 220,000 | - | |||||||||
Sublease
revenue
|
71,427 | 12,475 | 4,427 | |||||||||
Gain
on disposal of fixed assets
|
- | 1,394 | - | |||||||||
Gain
on investment
|
- | 3,292 | - | |||||||||
Total
other income
|
93,115 | 497,005 | 1,009,280 | |||||||||
OTHER
EXPENSE
|
||||||||||||
Warrant
issuance costs
|
266,970 | - | - | |||||||||
Interest
expense
|
1,960 | - | 1,087 | |||||||||
Corporate
relocation
|
- | 177,564 | 1,741,609 | |||||||||
Loss
on disposal of fixed assets
|
- | - | 15,575 | |||||||||
Loss
on investment
|
- | - | 305,479 | |||||||||
Change
in value of warrant liability
|
6,267,665 | - | - | |||||||||
6,536,595 | 177,564 | 2,063,750 | ||||||||||
NET
LOSS
|
(12,826,409 | ) | (14,025,927 | ) | (26,996,502 | ) | ||||||
DIVIDENDS
ON CONVERTIBLE PREFERRED STOCK
|
(615,352 | ) | (1,182,033 | ) | (1,265,800 | ) | ||||||
NET
LOSS AVAILABLE TO COMMON STOCKHOLDERS
|
$ | (13,441,761 | ) | $ | (15,207,960 | ) | $ | (28,262,302 | ) | |||
NET
LOSS AVAILABLE TO COMMON STOCKHOLDERS
|
||||||||||||
PER
SHARE OF COMMON STOCK - BASIC AND
|
||||||||||||
DILUTED
|
$ | (0.82 | ) | $ | (1.13 | ) | $ | (2.34 | ) | |||
WEIGHTED
AVERAGE NUMBER OF SHARES USED
|
||||||||||||
IN
CALCULATING NET LOSS PER SHARE, BASIC AND
|
||||||||||||
DILUTED
|
16,405,129 | 13,492,391 | 12,090,430 |
CLEVELAND
BIOLABS, INC.
|
STATEMENTS
OF STOCKHOLDERS' EQUITY AND COMPREHENSIVE LOSS
|
Period
From January 1, 2007 to December 31,
2009
|
Stockholders'
Equity
|
||||||||
Common
Stock
|
||||||||
Shares
|
Amount
|
|||||||
Balance
at January 1, 2007
|
11,826,389 | $ | 59,132 | |||||
Issuance
of options
|
- | - | ||||||
Options
to be issued in 2008
|
- | - | ||||||
Issuance
of shares - Series B financing
|
- | - | ||||||
Fees
associated with Series B Preferred offering
|
- | - | ||||||
Issuance
of restricted shares
|
190,000 | 950 | ||||||
Exercise
of options
|
126,046 | 630 | ||||||
Exercise
of warrants
|
48,063 | 240 | ||||||
Conversion
of Series B Preferred Shares to Common
|
708,743 | 3,544 | ||||||
Dividends
on Series B Preferred shares
|
- | - | ||||||
Net
Loss
|
- | - | ||||||
Other
comprehensive income
|
||||||||
Unrealized
gains (losses) on short term investments
|
||||||||
Changes
in unrealized holding gains (losses)
|
||||||||
arising
during period
|
- | - | ||||||
Less
reclassification adjustment for (gains) losses
|
||||||||
included
in net loss
|
- | - | ||||||
Comprehensive
loss
|
||||||||
Balance
at December 31, 2007
|
12,899,241 | $ | 64,496 | |||||
Issuance
of options
|
- | - | ||||||
Partial
recapture of expense for options expensed in 2007 but issued in
2008
|
- | - | ||||||
Issuance
of restricted shares
|
130,000 | 650 | ||||||
Restricted
stock awards
|
- | - | ||||||
Exercise
of options
|
37,271 | 186 | ||||||
Conversion
of Series B Preferred Shares to Common
|
709,293 | 3,547 | ||||||
Dividends
on Series B Preferred shares
|
- | - | ||||||
Net
Loss
|
- | - | ||||||
Balance
at December 31, 2008
|
13,775,805 | $ | 68,879 | |||||
Issuance
of options
|
- | - | ||||||
Issuance
of restricted shares
|
291,532 | 1,458 | ||||||
Recapture
of expense for nonvested options forfeited
|
- | - | ||||||
Restricted
stock awards
|
- | |||||||
Exercise
of options
|
194,675 | 973 | ||||||
Conversion
of Series B Preferred Shares to Common
|
4,693,530 | 23,468 | ||||||
Dividends
on Series B Preferred shares
|
- | - | ||||||
Issuance
of shares - Series D financing
|
- | - | ||||||
Allocation
of financing proceeds to fair value of Series D warrants
|
- | - | ||||||
Fees
associated with Series D Preferred offering
|
- | - | ||||||
Conversion
of Series D Preferred Shares to Common
|
572,353 | 2,862 | ||||||
Exercise
of warrants
|
675,613 | 3,378 | ||||||
Net
Loss
|
- | - | ||||||
Balance
at December 31, 2009
|
20,203,508 | $ | 101,018 |
CLEVELAND
BIOLABS, INC.
|
STATEMENTS
OF STOCKHOLDERS' EQUITY AND COMPREHENSIVE LOSS
|
Period
From January 1, 2007 to December 31,
2009
|
Stockholders'
Equity
|
||||||||||||||||
Preferred
Stock
|
||||||||||||||||
Series
B
|
Amount
|
Series
D
|
Amount
|
|||||||||||||
Balance
at January 1, 2007
|
- | $ | - | - | $ | - | ||||||||||
Issuance
of options
|
- | - | - | - | ||||||||||||
Options
to be issued in 2008
|
- | - | - | - | ||||||||||||
Issuance
of shares - Series B financing
|
4,579,010 | 22,895 | 4,579,010 | 22,895 | ||||||||||||
Fees
associated with Series B Preferred offering
|
- | - | - | - | ||||||||||||
Issuance
of restricted shares
|
- | - | - | - | ||||||||||||
Exercise
of options
|
- | - | - | - | ||||||||||||
Exercise
of warrants
|
- | - | - | - | ||||||||||||
Conversion
of Series B Preferred Shares to Common
|
(708,743 | ) | (3,544 | ) | 708,743 | 3,544 | ||||||||||
Dividends
on Series B Preferred shares
|
- | - | - | - | ||||||||||||
Net
Loss
|
- | - | - | - | ||||||||||||
Other
comprehensive income
|
||||||||||||||||
Unrealized
gains (losses) on short term investments
|
||||||||||||||||
Changes
in unrealized holding gains (losses)
|
||||||||||||||||
arising
during period
|
- | - | - | - | ||||||||||||
Less
reclassification adjustment for (gains) losses
|
||||||||||||||||
included
in net loss Comprehensive loss
|
- | - | - | - | ||||||||||||
Balance
at December 31, 2007
|
3,870,267 | $ | 19,351 | - | $ | - | ||||||||||
Issuance
of options
|
- | - | - | - | ||||||||||||
Partial
recapture of expense for options expensed in 2007 but issued in
2008
|
- | - | - | - | ||||||||||||
Issuance
of restricted shares
|
- | - | - | - | ||||||||||||
Restricted
stock awards
|
- | - | - | - | ||||||||||||
Exercise
of options
|
- | - | - | - | ||||||||||||
Conversion
of Series B Preferred Shares to Common
|
(709,293 | ) | (3,547 | ) | - | - | ||||||||||
Dividends
on Series B Preferred shares
|
- | - | - | - | ||||||||||||
Net
Loss
|
- | - | - | - | ||||||||||||
Balance
at December 31, 2008
|
3,160,974 | $ | 15,805 | - | $ | - | ||||||||||
Issuance
of options
|
- | - | - | - | ||||||||||||
Issuance
of restricted shares
|
- | - | - | - | ||||||||||||
Recapture
of expense for nonvested options forfeited
|
- | - | - | - | ||||||||||||
Restricted
stock awards
|
- | - | - | - | ||||||||||||
Exercise
of options
|
- | - | - | - | ||||||||||||
Conversion
of Series B Preferred Shares to Common
|
(3,160,974 | ) | (15,805 | ) | - | - | ||||||||||
Dividends
on Series B Preferred shares
|
- | - | - | - | ||||||||||||
Issuance
of shares - Series D financing
|
- | - | 543 | 3 | ||||||||||||
Allocation
of financing proceeds to fair value of Series D warrants
|
- | - | - | - | ||||||||||||
Fees
associated with Series D Preferred offering
|
- | - | - | - | ||||||||||||
Conversion
of Series D Preferred Shares to Common
|
(76 | ) | (1 | ) | ||||||||||||
Exercise
of warrants
|
||||||||||||||||
Net
Loss
|
- | - | - | - | ||||||||||||
Balance
at December 31, 2009
|
- | $ | - | 467 | $ | 2 |
CLEVELAND
BIOLABS, INC.
|
||||||||||||
STATEMENTS
OF CASH FLOWS
|
||||||||||||
For
the Years Ended December 31, 2009, 2008 and 2007
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
||||||||||||
Net
loss
|
$ | (12,826,409 | ) | $ | (14,025,927 | ) | $ | (26,996,502 | ) | |||
Adjustments
to reconcile net loss to net cash
|
||||||||||||
used
by operating activities:
|
||||||||||||
Depreciation
|
357,568 | 324,351 | 188,395 | |||||||||
Amortization
|
4,575 | - | - | |||||||||
Noncash
salaries and consulting expense
|
2,760,446 | 1,527,600 | 7,789,305 | |||||||||
Series
D warrant issuance costs
|
266,970 | - | - | |||||||||
Change
in value of warrant liability
|
6,267,665 | - | - | |||||||||
Loss
on disposal of fixed assets
|
- | - | 15,575 | |||||||||
Loss
on investments
|
- | 305,479 | ||||||||||
Loss
on abandoned patents
|
35,564 | 60,045 | - | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Accounts
receivable - trade
|
(2,347,526 | ) | (880,419 | ) | (3,652 | ) | ||||||
Accounts
receivable - interest
|
9,488 | 40,553 | (12,870 | ) | ||||||||
Other
current assets
|
129,677 | (185,081 | ) | 109,049 | ||||||||
Deposits
|
- | 1,963 | (10,390 | ) | ||||||||
Accounts
payable
|
106,672 | 391,232 | 65,923 | |||||||||
Deferred
revenue
|
(35,696 | ) | 694,702 | 1,670,610 | ||||||||
Accrued
expenses
|
1,026,062 | (70,121 | ) | 321,206 | ||||||||
Milestone
payments
|
- | - | (50,000 | ) | ||||||||
Total
adjustments
|
8,581,465 | 1,904,825 | 10,388,630 | |||||||||
Net
cash (used by) provided by operating
|
||||||||||||
activities
|
(4,244,944 | ) | (12,121,102 | ) | (16,607,872 | ) | ||||||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
||||||||||||
Purchase
of short-term investments
|
- | (2,000,000 | ) | (1,000,000 | ) | |||||||
Sale
of short-term investments
|
1,000,000 | 2,000,000 | 2,000,000 | |||||||||
Issuance
of notes receivable
|
- | - | (250,000 | ) | ||||||||
Purchase
of equipment
|
(136,400 | ) | (224,413 | ) | (987,649 | ) | ||||||
Sale
of equipment
|
- | - | 1,250 | |||||||||
Costs
of patents pending
|
(237,064 | ) | (333,994 | ) | (206,124 | ) | ||||||
Net
cash (used in) provided by investing activities
|
626,536 | (558,407 | ) | (442,523 | ) | |||||||
CASH
FLOWS FROM FINANCING ACTIVITIES
|
||||||||||||
Issuance
of preferred stock
|
5,428,307 | - | 30,020,984 | |||||||||
Financing
costs on preferred stock
|
(720,175 | ) | - | (1,152,857 | ) | |||||||
Series
D warrant issuance costs
|
(266,970 | ) | ||||||||||
Dividends
|
(936,644 | ) | (1,257,209 | ) | (869,331 | ) | ||||||
Exercise
of stock options
|
362,857 | 24,378 | 111,280 | |||||||||
Exercise
of warrants
|
414,284 | - | 90,515 | |||||||||
Net
cash (used in) provided by financing activities
|
4,281,659 | (1,232,831 | ) | 28,200,591 | ||||||||
INCREASE
(DECREASE) IN CASH AND EQUIVALENTS
|
663,251 | (13,912,340 | ) | 11,150,196 | ||||||||
CASH
AND EQUIVALENTS AT BEGINNING OF
|
299,849 | 14,212,189 | 3,061,993 | |||||||||
PERIOD
|
||||||||||||
CASH
AND EQUIVALENTS AT END OF PERIOD
|
$ | 963,100 | $ | 299,849 | $ | 14,212,189 |
CLEVELAND
BIOLABS, INC.
|
||||||||||||
STATEMENTS
OF CASH FLOWS
|
||||||||||||
For
the Years Ended December 31, 2009, 2008 and 2007
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Supplemental
disclosures of cash flow information:
|
||||||||||||
Cash
paid during the period for interest
|
$ | 1,960 | $ | - | $ | 1,087 | ||||||
Cash
paid during the period for income taxes
|
$ | - | $ | - | $ | - | ||||||
Supplemental
schedule of noncash financing activities:
|
||||||||||||
Issuance
of stock options to employees, consultants, and
|
$ | 1,784,240 | $ | 2,287,803 | $ | 3,401,499 | ||||||
independent
board members
|
||||||||||||
Expense
recapture of expense for options expensed in 2007 but issued in
2008
|
$ | - | $ | (1,459,425 | ) | $ | - | |||||
Expense
recapture of expense for options that were nonvested and
forfeited
|
$ | (50,197 | ) | $ | - | $ | - | |||||
Stock
options due to employees and a consultant
|
$ | - | $ | - | $ | 2,687,355 | ||||||
Issuance
of shares to consultants and employees
|
$ | 993,070 | $ | 626,500 | $ | 1,700,450 | ||||||
Amortization
of restricted shares to be issued to employees and
consultants
|
$ | 33,333 | $ | 72,722 | $ | - | ||||||
Issuance
of non-cash financing fees
|
$ | - | $ | - | $ | 2,032,086 | ||||||
Accrual
of Series B preferred stock dividends
|
$ | - | $ | 321,293 | $ | 396,469 | ||||||
Conversion
of warrant liability to equity due to exercise of warrants
|
$ | 874,119 | $ | - | $ | - |
A.
|
Cash
and Equivalents - The Company considers highly liquid investments with a
maturity date of three months or less to be cash equivalents. In addition,
the Company maintains cash and equivalents at financial institutions,
which may exceed federally insured amounts at times and which may, at
times, significantly exceed balance sheet amounts due to outstanding
checks.
|
B.
|
Marketable
Securities and Short Term Investments - The Company considers investments
with a maturity date of more than three months to be short-term
investments and has classified these securities as available-for-sale.
Such investments are carried at fair value, with unrealized gains and
losses included as accumulated other comprehensive income (loss) in
stockholders' equity. The cost of available-for-sale securities sold is
determined based on the specific identification
method.
|
C.
|
Accounts
Receivable - The Company extends unsecured credit to customers under
normal trade agreements, which generally require payment within 30 days.
Management estimates an allowance for doubtful accounts which is based
upon management's review of delinquent accounts and an assessment of the
Company's historical evidence of collections. There is no allowance for
doubtful accounts as of December 31, 2009 and December 31,
2008.
|
D.
|
Equipment
- Equipment is stated at cost and depreciated over the estimated useful
lives of the assets (generally five years) using the straight-line method.
Leasehold improvements are depreciated on the straight-line method over
the shorter of the lease term or the estimated useful lives of the assets.
Expenditures for maintenance and repairs are charged to expense as
incurred. Major expenditures for renewals and betterments are capitalized
and depreciated. Depreciation expense was $357,568, $324,351, and $188,395
for the years ended December 31, 2009, 2008 and 2007,
respectively.
|
E.
|
Impairment
of Long-Lived Assets - Long-lived assets to be held and used, including
equipment and intangible assets subject to depreciation and amortization,
are reviewed for impairment at least annually and whenever events or
changes in circumstances indicate that the carrying amounts of the assets
or related asset group may not be recoverable. Determination of
recoverability is based on an estimate of discounted future cash flows
resulting from the use of the asset and its eventual disposition. In the
event that such cash flows are not expected to be sufficient to recover
the carrying amount of the asset or asset group, the carrying amount of
the asset is written down to its estimated net realizable
value.
|
F.
|
Intellectual
Property - The Company capitalizes the costs associated with the
preparation, filing, and maintenance of patent applications relating to
intellectual property. If the patent applications are approved, costs paid
by the Company associated with the preparation, filing, and maintenance of
the patents will be amortized on a straight-line basis over the shorter of
20 years or the anticipated useful life of the patent. If the patent
application is not approved, the costs associated the patent application
will be expensed as part of selling, general and administrative expenses
at that time. Capitalized intellectual property is reviewed annually for
impairment.
|
As
of December 31, 2009
|
||||||||||||||||
Intangible
Assets
|
Cost
|
Accumulated
Amortization
|
Net
Intangible
Asset
|
Weighted
Average
Amortization
Period
(Years)
|
||||||||||||
Patents
|
$ | 150,888 | $ | 4,574 | $ | 146,314 | 14.9 | |||||||||
Patent
Applications
|
783,662 | - | 783,663 |
n.a.
|
||||||||||||
$ | 934,550 | $ | 4,574 | $ | 929,976 |
2010
|
$ | 9,801 | ||
2011
|
$ | 9,801 | ||
2012
|
$ | 9,801 | ||
2013
|
$ | 9,801 | ||
2014
|
$ | 9,801 |
G.
|
Line
of Credit - The Company has a working capital line of credit that is fully
secured by cash equivalents and short-term investments. This
fully-secured, working capital line of credit carries an interest rate of
prime minus 1%, a borrowing limit of $600,000, and expires on May 31,
2010. At December 31, 2009 and 2008, there were no outstanding borrowings
under this credit facility.
|
H.
|
Fair
Value of Financial Instruments - Financial instruments, including cash and
equivalents, accounts receivable, notes receivable, accounts payable and
accrued liabilities, are carried at net realizable
value
|
Warrant
Value
at
December
31,
2009
|
||||
Stock
price
|
$ | 3.31 | ||
Exercise
price
|
$ | 1.60 | ||
Term
in years
|
1.25 | |||
Volatility
|
105.81 | % | ||
Annual
rate of quarterly dividends
|
- | |||
Discount
rate- bond equivalent yield
|
0.52 | % |
Fair
Value As
of December
31,
2009
|
Fair
Value Measurements at
December
31, 2009
Using
Fair Value Hierarchy
|
|||||||||||||||
Liabilities
|
Level
1
|
Level
2
|
Level
3
|
|||||||||||||
Warrant
liability
|
$ | 8,410,379 | $ | - | $ | - | $ | 8,410,379 |
I.
|
Use
of Estimates - The preparation of financial statements in conformity with
accounting principles generally accepted in the U.S. requires management
to make estimates and assumptions that affect the reported amounts of
assets and liabilities and disclosure of contingent assets and liabilities
at the date of the financial statements and the reported amounts of
revenues and expenses during the reporting period. The Company bases its
estimates on historical experience and on various other assumptions that
the Company believes to be reasonable under these circumstances. Actual
results could differ from those
estimates.
|
J.
|
Revenue
Recognition - Revenue sources consist of government grants, government
contracts and commercial licensing and development
contracts.
|
K.
|
Deferred
Revenue – Deferred revenue results when payment is received in advance of
revenue being earned. The Company makes a determination as to whether the
revenue has been earned by applying a percentage-of-completion analysis to
compute the need to recognize deferred revenue. The percentage of
completion method is based upon (1) the total income projected for the
project at the time of completion and (2) the expenses incurred to date.
The percentage-of-completion can be measured using the proportion of costs
incurred versus the total estimated cost to complete the
contract.
|
Activity
|
||||
Beginning
Balance, December 31, 2007
|
$ | 1,670,610 | ||
Funds
Recived From State of NY
|
$ | 1,000,000 | ||
Funds
Recognized as Revenue
|
$ | (305,298 | ) | |
Ending
Balance, December 31, 2008
|
$ | 2,365,312 | ||
Funds
Recived From State of NY
|
$ | - | ||
Funds
Recognized as Revenue
|
$ | (35,696 | ) | |
Ending
Balance, December 31, 2009
|
$ | 2,329,616 |
L.
|
Research
and Development - Research and development expenses consist primarily of
costs associated with salaries and related expenses for personnel, costs
of materials used in research and development, costs of facilities and
costs incurred in connection with third-party efforts. Expenditures
relating to research and development are expensed as
incurred.
|
M.
|
Equity
Incentive Plan - On May 26, 2006, the Company's Board of Directors adopted
the 2006 Equity Incentive Plan (“Plan”) to attract and retain persons
eligible to participate in the Plan, motivate participants to achieve
long-term Company goals, and further align participants' interests with
those of the Company's other stockholders. The Plan was to expire on May
26, 2016 and the aggregate number of shares of stock which could be
delivered under the Plan may not exceed 2,000,000 shares. On February 14,
2007, these 2,000,000 shares were registered with the SEC by filing a Form
S-8 registration statement. On April 29, 2008, the stockholders of the
Company approved an amendment and restatement of the Plan (“Amended
Plan”). The Amended Plan increased the number of shares available for
issuance by an additional 2,000,000 shares, clarified other aspects of the
Plan, contained updates that reflected changes and developments in federal
tax laws and extended the expiration date to April 29, 2018. As
of December 31, 2009 there were 2,490,653 stock options and 446,532 shares
granted under the Amended Plan and 43,177 shares forfeited leaving
1,105,992 shares of stock to be awarded under the Amended
Plan.
|
N.
|
Executive
Compensation Plan - On May 11, 2007, the Compensation Committee of the
Board of Directors (“Compensation Committee”) approved an executive
compensation program designed to reward each of the Company’s Chief
Executive Officer, Chief Operating Officer, Chief Financial Officer and
Chief Scientific Officer (“Executive Officers”) for the achievement of
certain pre-determined milestones. The purpose of the program is to link
each Executive Officer’s compensation to the achievement of key Company
milestones that the Compensation Committee believes have a strong
potential to create long-term stockholder
value.
|
O.
|
Stock-Based
Compensation - The Company recognizes and values stock-based compensation
under the provisions of the Codification on stock
compensation.
|
2009
|
2008
|
2007
|
||||||||||
Risk-free
interest rate
|
1.87-2.74 | % | 2.43-3.58 | % | 3.38-5.11 | % | ||||||
Expected
dividend yield
|
0 | % | 0 | % | 0 | % | ||||||
Expected
life
|
5-6
years
|
5-6
years
|
2.74-6
years
|
|||||||||
Expected
volatility
|
84.13-90.06 | % | 64.25-82.47 | % | 71.86-76.29 | % |
Shares
|
Weighted
Average Exercise Price per Share
|
Weighted
Average Remaining Contractual Term (in Years)
|
||||||||||
Outstanding,
December 31, 2008
|
1,948,874 | $ | 6.17 | |||||||||
Granted
|
787,932 | $ | 2.82 | |||||||||
Exercised
|
(194,675 | ) | $ | 1.86 | ||||||||
Forfeited,
Canceled
|
(25,124 | ) | $ | 5.52 | ||||||||
Outstanding,
December 31, 2009
|
2,517,007 | $ | 5.46 | 8.02 | ||||||||
Exercisable,
December 31, 2009
|
2,185,632 | $ | 5.12 | 7.99 |
Shares
|
Weighted
Average Exercise Price per Share
|
Weighted
Average Remaining Contractual Term (in Years)
|
||||||||||
Outstanding,
December 31, 2007
|
1,011,740 | $ | 7.29 | |||||||||
Granted
|
997,721 | $ | 3.16 | |||||||||
Exercised
|
(42,534 | ) | $ | 1.04 | ||||||||
Forfeited,
Canceled
|
(18,053 | ) | $ | 9.00 | ||||||||
Outstanding,
December 31, 2008
|
1,948,874 | $ | 6.17 | 8.53 | ||||||||
Exercisable,
December 31, 2008
|
1,597,837 | $ | 5.52 | 8.50 |
P.
|
Net
Loss Per Share - Basic and diluted net loss per share has been computed
using the weighted-average number of shares of common stock outstanding
during the period.
|
2009
|
2008
|
2007
|
||||||||||
Net
loss available to common stockholders
|
$ | (13,441,761 | ) | $ | (15,207,960 | ) | $ | (28,262,302 | ) | |||
Net
loss per share, basic and diluted
|
$ | (0.82 | ) | $ | (1.13 | ) | $ | (2.34 | ) | |||
Weighted-average
shares used in computing net loss per share, basic and
diluted
|
16,405,129 | 13,492,391 | 12,090,430 |
Common
Equivalent Securities
|
December
31,
2009
|
December
31,
2008
|
December
31,
2007
|
|||||||||
Preferred
Shares
|
4,576,979 | 3,160,974 | 3,870,267 | |||||||||
Warrants
|
8,641,893 | 3,453,268 | 3,453,268 | |||||||||
Options
|
2,517,007 | 1,948,874 | 1,011,740 | |||||||||
Total
|
15,735,879 | 8,563,116 | 8,335,275 |
Q.
|
Concentrations
of Risk - Grant revenue accounted for 88.5%, 97.4% and 85.6% of total
revenue for the years ended December 31 2009, 2008 and 2007, respectively.
Although the Company anticipates ongoing federal government contract and
grant revenue, there is no guarantee that this revenue stream will
continue in the future.
|
R.
|
Foreign
Currency Exchange Rate Risk - The Company has entered into a manufacturing
agreement to produce one of its drug compounds with a foreign third party
and is required to make payments in the foreign currency. As a result, the
Company's financial results could be affected by changes in foreign
currency exchange rates. Currently, the Company's exposure primarily
exists with the Euro. As of December 31, 2009, the Company is obligated to
make payments under the agreements of 790,242 Euros. As of December 31,
2009, the Company has not purchased any forward contracts for Euros
and, therefore, at December 31, 2009, had foreign currency commitments of
$1,138,423 for Euros given prevailing currency exchange spot
rates.
|
S.
|
Comprehensive
Income/ (Loss) - The Company applies the Codification on comprehensive
income that requires disclosure of all components of comprehensive income
on an annual and interim basis. Comprehensive income is defined as the
change in equity of a business enterprise during a period from
transactions and other events and circumstances from non-owner
sources.
|
T.
|
Segment
Reporting – As of December 31, 2009, the Company has determined that it
operates in only one segment. Accordingly, no segment
disclosures have been included in the notes to the consolidated financial
statements.
|
U.
|
Recently
Issued Accounting Pronouncements
|
Warrants Issued
on
February 13,
2009
|
Warrants Issued
on
March 20,
2009
|
Warrants Issued
on
March 27,
2009
|
||||||||||
Stock
price (prior day close)
|
$ | 2.95 | $ | 1.41 | $ | 2.44 | ||||||
Exercise
price
|
$ | 2.60 | $ | 1.60 | $ | 1.60 | ||||||
Term
in years
|
2.00 | 2.00 | 2.00 | |||||||||
Volatility
|
110.14 | % | 108.87 | % | 111.57 | % | ||||||
Annual
rate of quarterly dividends
|
- | - | - | |||||||||
Discount
rate- bond equivalent yield
|
0.89 | % | 0.87 | % | 0.90 | % | ||||||
Discount
due to limitations on marketability,
|
||||||||||||
liquidity
and other credit factors
|
40 | % | 40 | % | 40 | % |
2009
|
2008
|
2007
|
||||||||||
Deferred
tax assets:
|
||||||||||||
Operating
loss carryforwards
|
$ | 22,784,000 | $ | 18,383,000 | $ | 13,289,000 | ||||||
Tax
credit carryforwards
|
2,149,000 | 1,772,000 | 737,000 | |||||||||
Accrued
expenses
|
4,226,000 | 3,102,000 | 2,765,000 | |||||||||
Other
|
4,000 | 4,000 | - | |||||||||
Total
deferred tax assets
|
29,163,000 | 23,261,000 | 16,791,000 | |||||||||
Deferred
tax liabilities
|
||||||||||||
Equipment
|
(32,000 | ) | (83,000 | ) | (61,000 | ) | ||||||
Net
deferred tax asset
|
29,131,000 | 23,178,000 | 16,730,000 | |||||||||
Valuation
allowance
|
(29,131,000 | ) | (23,178,000 | ) | (16,730,000 | ) | ||||||
$ | - | $ | - | $ | - |
2009
|
2008
|
2007
|
||||||||||
Tax
at the U.S. statutory rate
|
$ | (4,570,000 | ) | $ | (4,769,000 | ) | $ | (9,474,000 | ) | |||
Stock
option exercises
|
(56,000 | ) | (20,000 | ) | (363,000 | ) | ||||||
Valuation
allowance
|
4,699,000 | 4,879,000 | 9,831,000 | |||||||||
Other
|
(73,000 | ) | (90,000 | ) | 6,000 | |||||||
$ | - | $ | - | $ | - |
Unrecognized
|
Interest
|
|||||||
Tax
Benefits
|
and
Penalties
|
|||||||
Balance
at January 1, 2008
|
$ | 230,000 | $ | - | ||||
- | ||||||||
Prior
year tax positions
|
- | - | ||||||
Current
year tax positions
|
- | - | ||||||
Deferred
tax positions
|
24,000 | - | ||||||
Settlements
with tax authorities
|
- | - | ||||||
Expiration
of the statute of limitations
|
- | - | ||||||
Balance
at December 31, 2008
|
254,000 | - | ||||||
Prior
year tax positions
|
- | - | ||||||
Current
year tax positions
|
- | - | ||||||
Deferred
tax positions
|
57,000 | - | ||||||
Settlements
with tax authorities
|
- | - | ||||||
Expiration
of the statute of limitations
|
- | - | ||||||
Balance
at December 31, 2009
|
$ | 311,000 | $ | - |
Cost
|
Accrued
Interest
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair
Value
|
||||||||||||||||
December
31, 2009 - Current Marketable Securities
|
$ | - | $ | - | $ | - | $ | - | $ | - | ||||||||||
December
31, 2008 - Current Marketable Securities
|
$ | 1,000,000 | $ | 9,488 | $ | - | $ | - | $ | 1,009,488 |
Operating
Leases
|
||||
2010
|
$ | 343,657 | ||
2011
|
311,803 | |||
2012
|
144,375 | |||
2013
|
- | |||
2014
|
- | |||
$ | 799,835 |
Number
of
|
Weighted
Average
|
|||||||
Options
|
Exercise Price
|
|||||||
Outstanding
at December 31, 2007
|
1,011,740 | $ | 7.29 | |||||
Granted
|
997,721 | $ | 3.16 | |||||
Exercised
|
(42,534 | ) | $ | 1.04 | ||||
Forfeited
|
(18,053 | ) | $ | 9.00 | ||||
Outstanding
at December 31, 2008
|
1,948,874 | $ | 6.17 | |||||
Granted
|
787,932 | $ | 2.82 | |||||
Exercised
|
(194,675 | ) | $ | 1.86 | ||||
Forfeited
|
(25,124 | ) | $ | 5.52 | ||||
Outstanding
at December 31, 2009
|
2,517,007 | $ | 5.46 |
Outstanding
|
Exercisable
|
|||||||||||||
Exercise
Price
|
Number
of
Options
|
Weighted
Average
Years
to
Expiration
|
Number
of
Options
|
|||||||||||
$ | 0.66 | 92,558 | 5.50 | 92,558 | ||||||||||
$ | 0.67 | 35,849 | 5.50 | 35,849 | ||||||||||
$ | 1.90 | 238,015 | 9.27 | 139,015 | ||||||||||
$ | 3.10 | 14,842 | 8.87 | 14,842 | ||||||||||
$ | 3.33 | 140,000 | 9.49 | 140,000 | ||||||||||
$ | 3.48 | 60,000 | 9.49 | 60,000 | ||||||||||
$ | 3.89 | 64,656 | 9.88 | 64,656 | ||||||||||
$ | 3.91 | 56,174 | 9.39 | 56,174 | ||||||||||
$ | 3.98 | 24,986 | 8.54 | 24,986 | ||||||||||
$ | 4.00 | 550,012 | 8.09 | 545,887 | ||||||||||
$ | 4.18 | 40,000 | 8.27 | 40,000 | ||||||||||
$ | 4.50 | 111,500 | 6.17 | 111,500 | ||||||||||
$ | 4.57 | 65,221 | 9.62 | 65,221 | ||||||||||
$ | 4.69 | 35,000 | 8.73 | 17,500 | ||||||||||
$ | 4.81 | 1,000 | 8.20 | 1,000 | ||||||||||
$ | 5.28 | 14,694 | 8.35 | 14,694 | ||||||||||
$ | 5.33 | 140,000 | 8.33 | 140,000 | ||||||||||
$ | 6.00 | 45,000 | 6.56 | 45,000 | ||||||||||
$ | 8.00 | 160,000 | 8.01 | 80,000 | ||||||||||
$ | 8.36 | 152,500 | 7.27 | 152,500 | ||||||||||
$ | 8.82 | 20,000 | 7.22 | 20,000 | ||||||||||
$ | 9.14 | 77,000 | 7.12 | 58,000 | ||||||||||
$ | 9.40 | 140,000 | 7.45 | 140,000 | ||||||||||
$ | 9.93 | 20,000 | 7.46 | 17,500 | ||||||||||
$ | 10.00 | 117,000 | 7.93 | 87,750 | ||||||||||
$ | 10.61 | 18,000 | 3.00 | 18,000 | ||||||||||
$ | 10.84 | 3,000 | 7.48 | 3,000 | ||||||||||
$ | 11.00 | 25,000 | 7.46 | - | ||||||||||
$ | 14.00 | 25,000 | 7.46 | - | ||||||||||
$ | 17.00 | 30,000 | 7.46 | - | ||||||||||
Total
|
2,517,007 | 8.02 | 2,185,632 |
Number
of
|
Weighhted
Average
|
Number
of Common Shares Exeriseable
|
||||||||||
Warrants
|
Exercise
Price
|
Into
|
||||||||||
Outstanding
at December 31, 2007
|
3,453,268 | $ | 8.86 | 3,453,268 | ||||||||
Granted
|
- | n/a | - | |||||||||
Exercised
|
- | n/a | - | |||||||||
Forfeited,
Canceled
|
- | n/a | - | |||||||||
Outstanding
at December 31, 2008
|
3,453,268 | $ | 8.86 | 3,453,268 | ||||||||
Granted
|
4,265,122 | $ | 1.60 | 4,265,122 | ||||||||
Exercise
Price Adjustment
|
- | $ | (3.08 | ) | 1,756,772 | |||||||
Exercised
|
(761,717 | ) | $ | 1.52 | (833,269 | ) | ||||||
Forfeited,
Canceled
|
- | n/a | - | |||||||||
Outstanding
at December 31, 2009
|
6,956,673 | $ | 3.71 | 8,641,893 |
·
|
the
exercise price of the Series B Warrants reduced from $6.37 to
$5.99, and the aggregate number of shares of common stock issuable upon
exercise of the Series B Warrants increased from 3,847,276 to 4,091,345;
and
|
·
|
the
exercise price of the Series C Warrants reduced from $6.76 to $6.35, and
the aggregate number of shares of common stock issuable upon exercise of
the Series C Warrants will increase from 434,596 to
462,654.
|
Exhibit
No.
|
|
Description
|
3.1
|
|
Restated
Certificate of Incorporation filed with the Secretary of State of Delaware
on March 18, 2010
|
3.2
|
|
Second
Amended and Restated By-Laws*******
|
4.1
|
|
Form
of Specimen Common Stock Certificate*
|
4.2
|
|
Form
of Warrants issued to designees of Sunrise Securities Corp., dated March
2005*
|
4.3
|
|
Form
of Warrants issued to underwriters***
|
4.4
|
|
Warrant
to Purchase Common Stock issued to ChemBridge Corporation, dated April 27,
2004*
|
4.5
|
Form
of Series B Warrant ******
|
|
4.6
|
Form
of Series C Warrant ******
|
|
4.7
|
Form
of Common Stock Purchase Warrant (Series D
Transaction).†
|
|
4.8
|
Form
of Common Stock Purchase Warrant (Private Placement closed on March 2,
2010). ††††††
|
|
10.1
|
|
Restricted
Stock Agreement between Cleveland BioLabs, Inc. and Michael Fonstein,
dated as of July 5, 2003*
|
10.2
|
|
Restricted
Stock Agreement between Cleveland BioLabs, Inc. and Yakov Kogan, dated as
of July 5, 2003*
|
10.3
|
|
Restricted
Stock Agreement between Cleveland BioLabs, Inc. and Andrei Gudkov, dated
as of July 5, 2003*
|
10.4
|
|
Library
Access Agreement by and between ChemBridge Corporation and Cleveland
BioLabs, Inc., effective as of April 27, 2004*
|
10.5
|
|
Restricted
Stock and Investor Rights Agreement between Cleveland BioLabs, Inc. and
ChemBridge Corporation, dated as of April 27, 2004*
|
10.6
|
|
Common
Stockholders Agreement by and among Cleveland BioLabs, Inc. and the
stockholders named therein, dated as of July 1, 2004*
|
10.7
|
|
Exclusive
License Agreement by and between The Cleveland Clinic Foundation and
Cleveland BioLabs, Inc., effective as of July 1, 2004*
|
10.8
|
|
Employment
Agreement by and between Cleveland BioLabs, Inc. and Dr. Michael Fonstein,
dated August 1, 2004*
|
10.9
|
|
Employment
Agreement by and between Cleveland BioLabs, Inc. and Dr. Yakov Kogan,
dated August 1, 2004*
|
10.10
|
|
Consulting
Agreement between Cleveland BioLabs, Inc. and Dr. Andrei Gudkov, dated
August 1, 2004*
|
10.11
|
|
Cooperative
Research and Development Agreement by and between the Uniformed Services
University of the Health Sciences, the Henry M. Jackson Foundation for the
Advancement of Military Medicine, Inc., the Cleveland Clinic Foundation,
and Cleveland BioLabs, Inc., dated as of August 1,
2004**
|
10.12
|
|
Employment
Agreement by and between Cleveland BioLabs, Inc. and Dr. Farrel Fort,
dated June 1, 2005*
|
10.13
|
|
Amendment
to Employment Agreement by and between Cleveland BioLabs, Inc. and Dr.
Farrel Fort, dated September 30, 2005*
|
10.14
|
|
Amendment
to Consulting Agreement between Cleveland BioLabs, Inc. and Dr. Andrei
Gudkov, dated as of January 23, 2006*
|
10.15
|
|
Amendment
to Restricted Stock Agreement between Cleveland BioLabs, Inc. and Michael
Fonstein, dated as of January 23, 2006*
|
10.16
|
|
Amendment
to Restricted Stock Agreement between Cleveland BioLabs, Inc. and Yakov
Kogan, dated as of January 23, 2006*
|
10.17
|
|
Amendment
to Restricted Stock Agreement between Cleveland BioLabs, Inc. and Andrei
Gudkov, dated as of January 23, 2006*
|
10.18
|
|
Amendment
to Common Stockholders Agreement by and among Cleveland BioLabs, Inc. and
the parties thereto, dated as of January 26, 2006*
|
10.19
|
|
Cleveland
BioLabs, Inc. 2006 Equity Incentive Plan***
|
10.20
|
Cleveland
BioLabs, Inc. Equity Incentive Plan††
|
|
10.21
|
|
Process
Development and Manufacturing Agreement between Cleveland BioLabs, Inc.
and SynCo Bio Partners B.V., effective as of August 31,
2006****
|
10.22
|
|
Sponsored
Research Agreement between Cleveland BioLabs, Inc. and Roswell Park Cancer
Institute Corporation, effective as of January 12,
2007*****
|
10.23
|
Securities
Purchase Agreement, dated March 16, 2007******
|
|
10.24
|
Registration
Rights Agreement, dated March 16, 2007******
|
|
10.25
|
|
Amendment
to Employment Agreement by and between Cleveland BioLabs, Inc. and Dr.
Michael Fonstein, dated as of December 31, 2008.
|
10.26
|
|
Amendment
to Employment Agreement by and between Cleveland BioLabs, Inc. and Dr.
Yakov Kogan, dated as of December 31, 2008.
|
10.27
|
Form
of Securities Purchase Agreement. †
|
|
10.28
|
Form
of Registration Rights Agreement.†
|
10.29
|
Form
of Voting Agreement.†
|
|
10.30
|
Amendment
and Waiver Agreement, dated March 20, 2009.†
|
|
10.31
|
Form
of Amendment and Reaffirmation Agreement.†
|
|
10.32
|
License
Agreement between Cleveland BioLabs, Inc. and Zhejiang Hisun
Pharmaceutical Co., Ltd., dated September 3, 2009. †††
|
|
10.33
|
Participation
Agreement, dated December 30, 2009, by and between Cleveland BioLabs, Inc.
and Bioprocess Capital Partners, LLC. ††††
|
|
10.34
|
Form
of Securities Purchase Agreement dated February 25, 2010.
†††††
|
|
23.1
|
|
Consent
of Meaden & Moore, Ltd.
|
31.1
|
|
Rule
13a-14(a)/15d-14(a) Certification of Michael Fonstein
|
31.2
|
|
Rule
13a-14(a)/15d-14(a) Certification of John A. Marhofer,
Jr.
|
32.1
|
|
Section
1350 Certification.
|
*
|
Incorporated
by reference to Amendment No. 1 to Registration Statement on Form SB-2 as
filed on April 25, 2006 (File No. 333-131918).
|
**
|
Incorporated
by reference to Amendment No. 2 to Registration Statement on Form SB-2 as
filed on May 31, 2006 (File No. 333-131918).
|
***
|
Incorporated
by reference to Amendment No. 3 to Registration Statement on Form SB-2 as
filed on July 10, 2006 (File No. 333-131918).
|
****
|
Incorporated
by reference to Form 8-K as filed on October 25, 2006.
|
*****
|
Incorporated
by reference to Form 8-K as filed on January 12, 2007.
|
******
|
Incorporated
by reference to Form 8-K as filed on March 19, 2007.
|
*******
|
Incorporated
by reference to Form 8-K as filed on December 5, 2007.
|
†
|
Incorporated
by reference to Form 8-K as filed on March 30, 2009.
|
††
|
Incorporated
by reference to Proxy Statement on Schedule 14A as filed on April 1,
2008.
|
†††
|
Incorporated
by reference to Form 8-K as filed on September 3, 2009.
|
††††
|
Incorporated
by reference to Form 8-K as filed on December 30, 2009.
|
†††††
|
Incorporated
by reference to Form 8-K as filed on February 25, 2010.
|
††††††
|
Incorporated
by reference to Form 8-K/A as filed on February 26,
2010.
|
CLEVELAND
BIOLABS, INC.
|
|||
Dated:
March 22, 2010
|
By:
|
/s/ MICHAEL
FONSTEIN
|
|
Michael
Fonstein
|
|||
Chief
Executive Officer
|
CLEVELAND
BIOLABS, INC.
|
|||
Dated:
March 22, 2010
|
By:
|
/s/ JOHN
A. MARHOFER, JR.
|
|
John
A. Marhofer, Jr.
|
|||
Chief
Financial Officer
|
Signature
|
Title
|
Date
|
||
/ S
/ Michael Fonstein
|
Chief
Executive Officer, President, and Director (Principal Executive
Officer)
|
March
22, 2010
|
||
Michael
Fonstein
|
||||
/ S
/ John A. Marhofer, Jr.
|
Chief
Financial Officer (Principal Financial and Accounting
Officer)
|
March
22, 2010
|
||
John
A. Marhofer, Jr.
|
||||
/ S
/ James Antal
|
Director
|
March
22, 2010
|
||
James
Antal
|
||||
/
S / Paul DiCorleto
|
Director
|
March
22, 2010
|
||
Paul
DiCorleto
|
||||
/
S / Andrei Gudkov
|
Chief
Scientific Officer, and Director
|
March
22, 2010
|
||
Andrei
Gudkov
|
||||
/
S / Bernard L. Kasten
|
Director
|
March
22, 2010
|
||
Bernard
L. Kasten
|
||||
/
S / Yakov Kogan
|
Chief
Operating Officer, Secretary, and Director
|
March
22, 2010
|
||
Yakov
Kogan
|
||||
/
S / H. Daniel Perez
|
Director
|
March
22, 2010
|
||
H.
Daniel Perez
|
Exhibit
No.
|
|
Description
|
3.1
|
|
Restated
Certificate of Incorporation filed with the Secretary of State of Delaware
on March 18, 2010
|
3.2
|
|
Second
Amended and Restated By-Laws*******
|
4.1
|
|
Form
of Specimen Common Stock Certificate*
|
4.2
|
|
Form
of Warrants issued to designees of Sunrise Securities Corp., dated March
2005*
|
4.3
|
|
Form
of Warrants issued to underwriters***
|
4.4
|
|
Warrant
to Purchase Common Stock issued to ChemBridge Corporation, dated April 27,
2004*
|
4.5
|
Form
of Series B Warrant ******
|
|
4.6
|
Form
of Series C Warrant ******
|
|
4.7
|
Form
of Common Stock Purchase Warrant (Series D
Transaction).†
|
|
4.8
|
Form
of Common Stock Purchase Warrant (Private Placement closed on March 2,
2010). ††††††
|
|
10.1
|
|
Restricted
Stock Agreement between Cleveland BioLabs, Inc. and Michael Fonstein,
dated as of July 5, 2003*
|
10.2
|
|
Restricted
Stock Agreement between Cleveland BioLabs, Inc. and Yakov Kogan, dated as
of July 5, 2003*
|
10.3
|
|
Restricted
Stock Agreement between Cleveland BioLabs, Inc. and Andrei Gudkov, dated
as of July 5, 2003*
|
10.4
|
|
Library
Access Agreement by and between ChemBridge Corporation and Cleveland
BioLabs, Inc., effective as of April 27, 2004*
|
10.5
|
|
Restricted
Stock and Investor Rights Agreement between Cleveland BioLabs, Inc. and
ChemBridge Corporation, dated as of April 27, 2004*
|
10.6
|
|
Common
Stockholders Agreement by and among Cleveland BioLabs, Inc. and the
stockholders named therein, dated as of July 1, 2004*
|
10.7
|
|
Exclusive
License Agreement by and between The Cleveland Clinic Foundation and
Cleveland BioLabs, Inc., effective as of July 1, 2004*
|
10.8
|
|
Employment
Agreement by and between Cleveland BioLabs, Inc. and Dr. Michael Fonstein,
dated August 1, 2004*
|
10.9
|
|
Employment
Agreement by and between Cleveland BioLabs, Inc. and Dr. Yakov Kogan,
dated August 1, 2004*
|
10.10
|
|
Consulting
Agreement between Cleveland BioLabs, Inc. and Dr. Andrei Gudkov, dated
August 1, 2004*
|
10.11
|
|
Cooperative
Research and Development Agreement by and between the Uniformed Services
University of the Health Sciences, the Henry M. Jackson Foundation for the
Advancement of Military Medicine, Inc., the Cleveland Clinic Foundation,
and Cleveland BioLabs, Inc., dated as of August 1,
2004**
|
10.12
|
|
Employment
Agreement by and between Cleveland BioLabs, Inc. and Dr. Farrel Fort,
dated June 1, 2005*
|
10.13
|
|
Amendment
to Employment Agreement by and between Cleveland BioLabs, Inc. and Dr.
Farrel Fort, dated September 30, 2005*
|
10.14
|
|
Amendment
to Consulting Agreement between Cleveland BioLabs, Inc. and Dr. Andrei
Gudkov, dated as of January 23, 2006*
|
10.15
|
|
Amendment
to Restricted Stock Agreement between Cleveland BioLabs, Inc. and Michael
Fonstein, dated as of January 23, 2006*
|
10.16
|
|
Amendment
to Restricted Stock Agreement between Cleveland BioLabs, Inc. and Yakov
Kogan, dated as of January 23, 2006*
|
10.17
|
|
Amendment
to Restricted Stock Agreement between Cleveland BioLabs, Inc. and Andrei
Gudkov, dated as of January 23, 2006*
|
10.18
|
|
Amendment
to Common Stockholders Agreement by and among Cleveland BioLabs, Inc. and
the parties thereto, dated as of January 26, 2006*
|
10.19
|
|
Cleveland
BioLabs, Inc. 2006 Equity Incentive Plan***
|
10.20
|
Cleveland
BioLabs, Inc. Equity Incentive Plan††
|
|
10.21
|
|
Process
Development and Manufacturing Agreement between Cleveland BioLabs, Inc.
and SynCo Bio Partners B.V., effective as of August 31,
2006****
|
10.22
|
|
Sponsored
Research Agreement between Cleveland BioLabs, Inc. and Roswell Park Cancer
Institute Corporation, effective as of January 12,
2007*****
|
10.23
|
Securities
Purchase Agreement, dated March 16, 2007******
|
|
10.24
|
Registration
Rights Agreement, dated March 16, 2007******
|
|
10.25
|
|
Amendment
to Employment Agreement by and between Cleveland BioLabs, Inc. and Dr.
Michael Fonstein, dated as of December 31, 2008.
|
10.26
|
|
Amendment
to Employment Agreement by and between Cleveland BioLabs, Inc. and Dr.
Yakov Kogan, dated as of December 31, 2008.
|
10.27
|
Form
of Securities Purchase Agreement. †
|
|
10.28
|
Form
of Registration Rights Agreement.†
|
10.29
|
Form
of Voting Agreement.†
|
|
10.30
|
Amendment
and Waiver Agreement, dated March 20, 2009.†
|
|
10.31
|
Form
of Amendment and Reaffirmation Agreement.†
|
|
10.32
|
License
Agreement between Cleveland BioLabs, Inc. and Zhejiang Hisun
Pharmaceutical Co., Ltd., dated September 3, 2009. †††
|
|
10.33
|
Participation
Agreement, dated December 30, 2009, by and between Cleveland BioLabs, Inc.
and Bioprocess Capital Partners, LLC. ††††
|
|
10.34
|
Form
of Securities Purchase Agreement dated February 25, 2010.
†††††
|
|
23.1
|
|
Consent
of Meaden & Moore, Ltd.
|
31.1
|
|
Rule
13a-14(a)/15d-14(a) Certification of Michael Fonstein
|
31.2
|
|
Rule
13a-14(a)/15d-14(a) Certification of John A. Marhofer,
Jr.
|
32.1
|
|
Section
1350 Certification.
|
*
|
Incorporated
by reference to Amendment No. 1 to Registration Statement on Form SB-2 as
filed on April 25, 2006 (File No. 333-131918).
|
**
|
Incorporated
by reference to Amendment No. 2 to Registration Statement on Form SB-2 as
filed on May 31, 2006 (File No. 333-131918).
|
***
|
Incorporated
by reference to Amendment No. 3 to Registration Statement on Form SB-2 as
filed on July 10, 2006 (File No. 333-131918).
|
****
|
Incorporated
by reference to Form 8-K as filed on October 25, 2006.
|
*****
|
Incorporated
by reference to Form 8-K as filed on January 12, 2007.
|
******
|
Incorporated
by reference to Form 8-K as filed on March 19, 2007.
|
*******
|
Incorporated
by reference to Form 8-K as filed on December 5, 2007.
|
†
|
Incorporated
by reference to Form 8-K as filed on March 30, 2009.
|
††
|
Incorporated
by reference to Proxy Statement on Schedule 14A as filed on April 1,
2008.
|
†††
|
Incorporated
by reference to Form 8-K as filed on September 3, 2009.
|
††††
|
Incorporated
by reference to Form 8-K as filed on December 30, 2009.
|
†††††
|
Incorporated
by reference to Form 8-K as filed on February 25, 2010.
|
††††††
|
Incorporated
by reference to Form 8-K/A as filed on February 26,
2010.
|
Cleveland BioLabs, Inc. | |||
|
|
/s/ Michael Fonstein | |
Michael Fonstein | |||
President and Chief Executive Officer | |||
Date:
March 22, 2010
|
By:
|
/s/
Michael Fonstein
|
|
Michael
Fonstein
|
|||
President
and Chief Executive Officer
|
|||
(Principal
Executive Officer)
|
Date:
March 22, 2010
|
By:
|
/s/
John A. Marhofer, Jr.
|
|
John
A. Marhofer, Jr.
|
|||
Chief
Financial Officer
|
|||
(Principal
Financial Officer)
|
Dated:
March 22, 2010
|
By:
|
/s/
Michael Fonstein
|
|
Michael
Fonstein
|
|||
Chief Executive Officer | |||
(Principal Executive Officer) | |||
Dated:
March 22, 2010
|
By:
|
/s/
John A. Marhofer, Jr.
|
|
John
A. Marhofer, Jr.
|
|||
Chief
Financial Officer
|
|||
(Principal
Financial and Accounting Officer)
|
*
|
This
certification accompanies the Annual Report to which it relates, is not
deemed filed with the Securities and Exchange Commission and is not to be
incorporated by reference into any filing of Cleveland BioLabs, Inc. under
the Securities Act of 1933, as amended, or the Securities Exchange Act of
1934, as amended (whether made before or after the date of the Annual
Report), irrespective of any general incorporation language contained in
such filing.
|