x |
Annual
Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act
of 1934
|
¨ |
Transition
Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act
1934
|
DELAWARE
|
|
20-0077155
|
(State
or other jurisdiction of incorporation or organization)
|
|
(I.R.S.
Employer Identification No.)
|
CLEVELAND
BIOLABS, INC.
|
|
|
||
FORM
10-KSB
|
|
|
|
|
03/29/07
|
|
|
|
Page
|
||||
PART I | ||||
Item
1
|
Description
of Business
|
2
|
||
Item
2
|
Description
of Property
|
26
|
||
Item
3
|
Legal
Proceedings
|
27
|
||
Item
4
|
Submission
of Matters to a Vote of Security Holders
|
27
|
||
|
||||
PART
II
|
||||
Item
5
|
Market
for Common Equity, Related Stockholder Matters and Small Business
Issuer
Purchases of Equity Securities
|
27
|
||
Item
6
|
Management’s
Discussion and Analysis
|
28
|
||
Item
7
|
Financial
Statements
|
39
|
||
Item
8
|
Changes
In and Disagreements With Accountants on Accounting and Financial
Disclosure
|
40
|
||
Item
8A
|
Controls
and Procedures
|
40
|
||
Item
8B
|
Other
Information
|
41
|
||
|
||||
PART
III
|
||||
Item
9
|
Directors,
Executive Officers, Promoters, Control Persons and Corporate Governance;
Compliance with Section 16(a) of the Exchange Act
|
42
|
||
Item
10
|
Executive
Compensation
|
43
|
||
Item
11
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
46
|
||
Item
12
|
Certain
Relationships and Related Transactions and Director
Independence
|
50
|
||
Item
13
|
Exhibits
|
52
|
||
Item
14
|
Principal
Accountant Fees and Services
|
55
|
||
SIGNATURES |
57
|
Item 1.
Description
of Business
|
· |
Manufacture
our drug candidate according to current Good Manufacturing Practices,
or
cGMP, guidelines;
|
· |
Repeat
our animal studies with the GMP manufactured drug
candidate;
|
· |
File
an IND and receive a response from the
FDA;
|
· |
Perform
a Phase I Human Study (which does not require GMP-manufactured material
and can be done concurrently with the rest of the steps); and
|
· |
File
a Biologic License Application, or
BLA.
|
· |
Facilitate
R&D efforts of biomedical countermeasures by the National Institutes
of Health, or NIH;
|
· |
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.
|
· |
Determined
that sufficient and satisfactory clinical experience or research
data
(including data, if available, from pre-clinical and clinical trials)
support a reasonable conclusion that the countermeasure will qualify
for
approval or licensing within eight years after the date of a
determination; and
|
· |
Determined
that the product is authorized for emergency use.
|
· |
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
|
$
|
50,000
|
||
Complete
Phase I studies for Protectan CBLB502
|
$
|
100,000
|
||
File
NDA 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
|
· |
Methods
of Inhibiting Apoptosis Using Latent
TFGß;
|
· |
Methods
of Identifying Modulators of Apoptosis From Parasites and Uses
Thereof;
|
· |
Methods
of Inhibiting Apoptosis Using Inducers of
NF-kB;
|
· |
Methods
of Protecting Against Radiation Using Inducers of
NF-kB;
|
· |
Methods
of Protecting Against Radiation Using
Flagellin;
|
· |
Small
Molecules Inhibitors of MRP1 and Other Multidrug
Transporters;
|
· |
Flagellin
Related Polypeptides and Uses
Thereof;
|
· |
Modulation
of Apoptosis Using Aminoacridines;
|
· |
Modulation
of Immune Responses;
|
· |
Activation
of p53 and Inhibition of NF-kB for Cancer
Treatment;
|
· |
Methods
of Protecting Against Apoptosis Using
Lipopeptides;
|
· |
Modulation
of Cell Growth; and
|
· |
Mitochondrial
Cytochrome B.
|
· |
Quinacrine
Isomers;
|
· |
Modulation
of Androgen Receptor for Treatment of Prostate Cancer;
and
|
· |
Method
of Increasing Hematopoietic Stem Cells (filed in January 2007)
|
· |
Delays
in the delivery of quantities needed for multiple clinical trials
or
failure to manufacture such quantities to our specifications, either
of
which could cause delays in clinical trials, regulatory submissions
or
commercialization of our drug
candidates;
|
· |
Inability
to fulfill our commercial needs in the event market demand for
our drug
candidates suddenly increases, which may require us to seek new
manufacturing arrangements, which, in turn, could be expensive
and time
consuming; and
|
· |
Ongoing
inspections by the FDA and other regulatory authorities for compliance
with rules, regulations and standards, the failure to comply with
which
may subject us to, among other things, product seizures, recalls,
fines,
injunctions, suspensions or revocations of marketing licenses, operating
restrictions and criminal
prosecution.
|
· |
The
FDA or foreign regulators may interpret data from pre-clinical testing
and
clinical trials differently than we interpret
them;
|
· |
If
regulatory approval of a product is granted, the approval may be
limited
to specific indications or limited with respect to its distribution.
In
addition, many foreign countries control pricing and coverage under
their
respective national social security
systems;
|
· |
The
FDA or foreign regulators may not approve our manufacturing processes
or
manufacturing facilities;
|
· |
The
FDA or foreign regulators may change their approval policies or adopt
new
regulations;
|
· |
Even
if regulatory approval for any product is obtained, the marketing
license
will be subject to continual review, and newly discovered or developed
safety or effectiveness data may result in suspension or revocation
of the
marketing license;
|
· |
If
regulatory approval of the product candidate is granted, the marketing
of
that product would be subject to adverse event reporting requirements
and
a general prohibition against promoting products for unapproved or
“off-label” uses;
|
· |
In
some foreign countries, we may be subject to official release requirements
that require each batch of the product we produce to be officially
released by regulatory authorities prior to its distribution by us;
and
|
· |
We
will be subject to continual regulatory review and periodic inspection
and
approval of manufacturing modifications, including compliance with
current
GMP regulations.
|
Name
|
|
Age
|
|
Position
|
Bernard
L. Kasten (1)(2)(3)
|
|
60
|
Director,
Chairman of the Board
|
|
James
J. Antal (1)(2)(3)
|
56
|
Director
|
||
Paul
DiCorleto (1)
(3)
|
55
|
Director
|
||
Michael
Fonstein, Ph.D. (1)
|
|
47
|
Director,
President and Chief Executive Officer
|
|
Andrei
Gudkov, Ph.D. (1)
|
|
50
|
Director,
Chief Scientific Officer
|
|
Yakov
Kogan, Ph.D. (1)
|
|
33
|
Director,
Executive Vice President, Business Development
|
|
H.
Daniel Perez (1)(2)(3)
|
57
|
Director
|
||
John
A. Marhofer, Jr., CMA, CFM
|
|
44
|
Chief
Financial Officer
|
(1) |
Each
of the directors has been appointed to hold office until the next
annual
meeting
of stockholders or until their successor is duly elected or appointed,
unless
their office is earlier vacated.
|
(2) |
Member
of the Audit Committee, Nominating and Corporate Governance Committee
and
Compensation Committee.
|
(3) |
Determined
to be independent, in accordance with the rules of the Nasdaq Capital
Market.
|
Common
Stock
|
|||||||
2006
|
|||||||
High
|
Low
|
||||||
4th
Quarter
|
$
|
5.87
|
$
|
4.25
|
|||
3rd
Quarter (from July 21, 2006)
|
$
|
6.00
|
$
|
4.17
|
|
Year
Ended December 31,
2006
|
Year
Ended
December 31,
2005
|
Year
Ended
December 31,
2004
|
|||||||
Revenues
|
$
|
1,708,214
|
$
|
1,138,831
|
$
|
636,341
|
||||
Operating
expenses
|
9,126,315 |
3,626,664
|
3,155,784
|
|||||||
Net
interest expense (income)
|
(195,457 | ) |
(101,378
|
)
|
3,699
|
|||||
Net
income (loss)
|
$
|
(7,222,644
|
)
|
$
|
(2,386,455
|
)
|
$
|
(2,523,142
|
)
|
Agency
|
|
Program
|
|
Amount
|
|
Period
of
Performance
|
|
Revenue
2006
|
|
Revenue
2005
|
|||
|
|
|
|
|
|
|
|
|
|
|
|||
NIH
|
|
Phase
I NIH SBIR program
|
|
$
|
100,000
|
|
08/2004-04/2005
|
|
|
—
|
|
$
|
49,998
|
DARPA
|
|
DARPA,
program BAA04-12
|
|
$
|
475,000
|
|
11/2004-08/2005
|
|
|
—
|
|
$
|
283,185
|
NIH
|
|
Phase
I NIH SBIR program
|
|
$
|
100,000
|
|
06/2005-01/2006
|
|
|
—
|
|
$
|
100,000
|
NIH
|
|
BioShield
program (NIAID)
|
|
$
|
1,500,000
|
|
07/2005-01/2007
|
|
$
|
1,100,293
|
|
$
|
399,707
|
NIH
|
|
Phase
I NIH SBIR program
|
|
$
|
100,000
|
|
08/2005-01/2006
|
|
$
|
33,334
|
|
$
|
66,666
|
NIH
|
|
Phase
I NIH SBIR program
|
|
$
|
100,000
|
|
09/2005-02/2006
|
|
|
—
|
|
$
|
100,000
|
NASA
|
|
Phase
I NASA STTR program
|
|
$
|
100,000
|
|
01/2006-01/2007
|
|
$
|
66,393
|
|
$
|
—
|
NIH
|
Phase
II NIH SBIR program
|
$
|
750,000
|
07/2006-06/2008
|
$
|
212,713
|
$ |
—
|
|||||
NIH
|
NCI
Contract
|
$
|
750,000
|
09/2006-08/2008
|
$
|
90,481
|
|||||||
|
|
|
|
|
|
|
Totals
|
|
$
|
1,503,214
|
|
$
|
999,556
|
File
IND application for Protectan CBLB502
|
$
|
50,000
|
||
Complete
Phase I studies for Protectan CBLB502
|
$
|
100,000
|
||
File
NDA 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
|
Page
|
||
Report
of Independent Registered Public Accounting Firm
|
F-1
|
|
Financial
Statements:
|
||
Balance
Sheets
|
F-2
|
|
Statement
of Operations
|
F-4
|
|
Statements
of Stockholders' Equity and Comprehensive Loss
|
F-5
|
|
Statement
of Cash Flows
|
F-8
|
|
Notes
to Financial Statements
|
F-9
|
2006
|
2005
|
||||||
ASSETS
|
|||||||
CURRENT
ASSETS
|
|||||||
Cash
and equivalents
|
$
|
3,061,993
|
$
|
1,206,462
|
|||
Short-term
investments
|
1,995,836
|
2,382,190
|
|||||
Accounts
receivable:
|
|||||||
Trade
|
159,750
|
-
|
|||||
Interest
|
42,479
|
37,035
|
|||||
Notes
Receivable - Orbit Brands
|
50,171
|
-
|
|||||
Prepaid
expenses - IPO
|
-
|
210,987
|
|||||
Other
prepaid expenses
|
434,675
|
12,249
|
|||||
Deferred
compensation
|
-
|
5,134
|
|||||
Total
current assets
|
5,744,904
|
3,854,057
|
|||||
EQUIPMENT
|
|||||||
Computer
equipment
|
132,572
|
91,788
|
|||||
Lab
equipment
|
347,944
|
225,997
|
|||||
Furniture
|
65,087
|
40,158
|
|||||
545,603
|
357,943
|
||||||
Less
accumulated depreciation
|
142,011
|
47,080
|
|||||
403,592
|
310,863
|
||||||
OTHER
ASSETS
|
|||||||
Deferred
compensation
|
-
|
752
|
|||||
Intellectual
Property
|
252,978
|
76,357
|
|||||
Deposits
|
15,055
|
11,304
|
|||||
268,033
|
88,413
|
||||||
TOTAL
ASSETS
|
$
|
6,416,529
|
$
|
4,253,333
|
2006
|
2005
|
||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
CURRENT
LIABILITIES
|
|||||||
Accounts
payable:
|
|||||||
Trade
|
$
|
644,806
|
$
|
264,783
|
|||
Deferred
revenue
|
-
|
100,293
|
|||||
Accrued
expenses
|
128,569
|
28,579
|
|||||
Total
current liabilities
|
773,375
|
393,655
|
|||||
LONG-TERM
LIABILITIES
|
|||||||
Convertible
notes payable
|
-
|
303,074
|
|||||
Milestone
payables
|
50,000
|
-
|
|||||
Total
long-term liabilities
|
50,000
|
303,074
|
|||||
STOCKHOLDERS'
EQUITY
|
|||||||
Series
A convertible preferred stock, $.005 par value
|
|||||||
Authorized
- 10,000,000 and 4,000,000 shares at December 31, 2006 and December
31,
2005, respectively
|
- |
15,256
|
|||||
Issued
and outstanding 0 and 3,051,219 shares
at December 31, 2006 and December 31, 2005,
respectively
|
|||||||
Additional
paid-in capital
|
-
|
4,932,885
|
|||||
Unissued
shares - preferred stock
|
-
|
360,000
|
|||||
Common
stock, $.005 par value
|
|||||||
Authorized
- 40,000,000 and 12,000,000 shares at December 31, 2006 and
December 31, 2005, respectively
|
|||||||
Issued
and outstanding 11,826,389 and 6,396,801 shares at December
31, 2006 and
December 31, 2005, respectively
|
59,132
|
31,984
|
|||||
Additional
paid-in capital
|
18,314,097
|
3,338,020
|
|||||
Unissued
shares - common stock
|
-
|
81,125
|
|||||
Accumulated
other comprehensive income (loss)
|
(4,165
|
)
|
(17,810
|
)
|
|||
Accumulated
deficit
|
(12,775,910
|
)
|
(5,184,856
|
)
|
|||
Total
stockholders' equity
|
5,593,154
|
3,556,604
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
6,416,529
|
$
|
4,253,333
|
2006
|
|
2005
|
|
2004
|
||||||
REVENUES
|
||||||||||
Grant
|
$
|
1,503,214
|
$
|
999,556
|
$
|
531,341
|
||||
Service
|
205,000
|
139,275
|
105,000
|
|||||||
1,708,214
|
1,138,831
|
636,341
|
||||||||
OPERATING
EXPENSES
|
||||||||||
Research
and Development
|
6,989,804
|
2,640,240
|
2,892,967
|
|||||||
General
and administrative
|
2,136,511
|
986,424
|
262,817
|
|||||||
Total
operating expenses
|
9,126,315
|
3,626,664
|
3,155,784
|
|||||||
LOSS
FROM OPERATIONS
|
(7,418,101
|
)
|
(2,487,833
|
)
|
(2,519,443
|
)
|
||||
OTHER
INCOME (EXPENSE)
|
||||||||||
Interest
Income
|
206,655
|
119,371
|
320
|
|||||||
Interest
Expense
|
(11,198
|
)
|
(17,993
|
)
|
(4,019
|
)
|
||||
Total
other income (expense), net
|
195,457
|
101,378
|
(3,699
|
)
|
||||||
NET
LOSS
|
$
|
(7,222,644
|
)
|
$
|
(2,386,455
|
)
|
$
|
(2,523,142
|
)
|
|
DIVIDENDS
ON CONVERTIBLE PREFERRED STOCK
|
(214,928
|
)
|
(291,914
|
)
|
-
|
|||||
NET
LOSS AVAILABLE TO COMMON SHAREHOLDERS
|
$
|
(7,437,572
|
)
|
$
|
(2,678,369
|
)
|
$
|
(2,523,142
|
)
|
|
NET
LOSS AVAILABLE TO COMMON SHAREHOLDERS
|
||||||||||
PER
SHARE OF COMMON STOCK - BASIC AND
|
||||||||||
DILUTED
|
$
|
(0.84
|
)
|
$
|
(0.43
|
)
|
$
|
(0.55
|
)
|
|
WEIGHTED
AVERAGE NUMBER OF SHARES USED
|
||||||||||
IN
CALCULATING NET LOSS PER SHARE, BASIC AND
|
||||||||||
DILUTED
|
8,906,266
|
6,250,447
|
4,615,571
|
Stockholders'
Equity
|
|||||||||||||
Common
Stock
|
|||||||||||||
Additional
|
|||||||||||||
Paid-in
|
Penalty
|
||||||||||||
Shares
|
Amount
|
Capital
|
Shares
|
||||||||||
Balance
at January 1, 2004
|
3,993,200
|
$
|
19,966
|
$
|
5,034
|
$
|
-
|
||||||
Issuance
of shares
|
1,966,800
|
9,834
|
2,250,920
|
-
|
|||||||||
Net
loss
|
-
|
-
|
-
|
-
|
|||||||||
Balance
at December 31, 2004
|
5,960,000
|
29,800
|
2,255,954
|
-
|
|||||||||
Issuance
of shares - Series A financing
|
308,000
|
1,540
|
588,122
|
-
|
|||||||||
Issuance
of shares - stock dividend
|
69,201
|
346
|
138,056
|
-
|
|||||||||
Issuance
of options (383,840 options issued,
|
-
|
-
|
318,111
|
-
|
|||||||||
324,240
outstanding)
|
|||||||||||||
Exercise
of options (59,600 options exercised)
|
59,600
|
298
|
118,902
|
-
|
|||||||||
Accrue
unissued shares
|
-
|
-
|
(81,125
|
)
|
81,125
|
||||||||
Net
loss
|
-
|
-
|
-
|
-
|
|||||||||
Other
comprehensive income
|
|||||||||||||
Unrealized
gains (losses) on short term investments
|
|||||||||||||
Unrealized
holding gains (losses) arising during period
|
-
|
-
|
-
|
-
|
|||||||||
Comprehensive
loss
|
|||||||||||||
Balance
at December 31, 2005
|
6,396,801.00
|
31,984
|
3,338,020
|
81,125
|
|||||||||
Issuance
of shares - previously accrued penalty shares
|
54,060
|
270
|
80,855
|
(81,125
|
)
|
||||||||
Issuance
of shares - stock dividend
|
184,183
|
922
|
367,445
|
-
|
|||||||||
Issue
penalty shares
|
15,295
|
76
|
(76
|
)
|
-
|
||||||||
Issuance
of shares - initial public offering
|
1,700,000
|
8,500
|
10,191,500
|
-
|
|||||||||
Fees
associated with initital public offering
|
-
|
-
|
(1,890,444
|
)
|
-
|
||||||||
Conversion
of preferred stock to common stock
|
3,351,219
|
16,756
|
5,291,385
|
-
|
|||||||||
Conversion
of notes payable to common stock
|
124,206
|
621
|
312,382
|
-
|
|||||||||
Issuance
of options
|
-
|
-
|
506,078
|
-
|
|||||||||
Exercise
of options
|
625
|
3
|
2,810
|
-
|
|||||||||
Issuance
of warrants
|
-
|
-
|
114,032
|
-
|
|||||||||
Proceeds
from sales of warrants
|
-
|
-
|
110
|
-
|
|||||||||
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, 2006
|
11,826,389
|
$
|
59,132
|
$
|
18,314,097
|
$
|
-
|
Stockholders'
Equity
|
|||||||||||||
Preferred
Stock
|
|||||||||||||
Additional
|
|||||||||||||
Paid-in
|
Penalty
|
||||||||||||
Shares
|
Amount
|
Capital
|
Shares
|
||||||||||
Balance
at January 1, 2004
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
|||||
Issuance
of shares
|
- |
-
|
-
|
-
|
|||||||||
Net
loss
|
- |
-
|
-
|
-
|
|||||||||
Balance
at December 31, 2004
|
- |
-
|
-
|
-
|
|||||||||
Issuance
of shares - Series A financing
|
3,051,219 |
15,256
|
5,292,885
|
-
|
|||||||||
Issuance
of shares - stock dividend
|
- |
-
|
-
|
-
|
|||||||||
Issuance
of options (383,840 options issued,
|
- |
-
|
-
|
-
|
|||||||||
324,240
outstanding)
|
|||||||||||||
Exercise
of options (59,600 options exercised)
|
- |
-
|
-
|
-
|
|||||||||
Accrue
unissued shares
|
(360,000
|
)
|
360,000
|
||||||||||
Net
loss
|
- |
-
|
-
|
-
|
|||||||||
Other
comprehensive income
|
|||||||||||||
Unrealized
gains (losses) on short term investments
|
|||||||||||||
Unrealized
holding gains (losses) arising during period
|
- |
-
|
-
|
-
|
|||||||||
Comprehensive
loss
|
|||||||||||||
Balance
at December 31, 2005
|
3,051,219 |
15,256
|
4,932,885
|
360,000
|
|||||||||
Issuance
of shares - previously accrued penalty shares
|
240,000 |
1,200
|
358,800
|
(360,000
|
)
|
||||||||
Issuance
of shares - stock dividend
|
- |
-
|
-
|
-
|
|||||||||
Issue
penalty shares
|
60,000 |
300
|
(300
|
)
|
-
|
||||||||
Issuance
of shares - initial public offering
|
- |
-
|
-
|
-
|
|||||||||
Fees
associated with initital public offering
|
- |
-
|
-
|
-
|
|||||||||
Conversion
of preferred stock to common stock
|
(3,351,219 | ) |
(16,756
|
)
|
(5,291,385
|
)
|
-
|
||||||
Conversion
of notes payable to common stock
|
- |
-
|
-
|
-
|
|||||||||
Issuance
of options
|
- |
-
|
-
|
-
|
|||||||||
Exercise
of options
|
- |
-
|
-
|
-
|
|||||||||
Issuance
of warrants
|
- |
-
|
-
|
-
|
|||||||||
Proceeds
from sales of warrants
|
- |
-
|
-
|
-
|
|||||||||
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, 2006
|
- |
$
|
-
|
$
|
-
|
$
|
-
|
Stockholders'
Equity
|
|||||||||||||
Other
|
Comprehensive
|
||||||||||||
Comprehensive
|
Accumulated
|
Income
|
|||||||||||
Loss
|
Deficit
|
Total
|
(Loss)
|
||||||||||
Balance
at January 1, 2004
|
$
|
-
|
$
|
(136,826
|
)
|
$
|
(111,826
|
)
|
|||||
Issuance
of shares
|
-
|
-
|
2,260,754
|
||||||||||
Net
loss
|
-
|
(2,523,142
|
)
|
(2,523,142
|
)
|
$
|
(2,523,142
|
)
|
|||||
Balance
at December 31, 2004
|
-
|
(2,659,968
|
)
|
(374,214
|
)
|
||||||||
Issuance
of shares - Series A financing
|
-
|
-
|
5,897,803
|
||||||||||
Issuance
of shares - stock dividend
|
-
|
(138,433
|
)
|
(31
|
)
|
||||||||
Issuance
of options (383,840 options issued,
|
-
|
-
|
318,111
|
||||||||||
324,240
outstanding)
|
|||||||||||||
Exercise
of options (59,600 options exercised)
|
-
|
-
|
119,200
|
||||||||||
Accrue
unissued shares
|
-
|
-
|
-
|
||||||||||
Net
loss
|
-
|
(2,386,455
|
)
|
(2,386,455
|
)
|
(2,386,455
|
)
|
||||||
Other
comprehensive income
|
|||||||||||||
Unrealized
gains (losses) on short term investments
|
|||||||||||||
Unrealized
holding gains (losses) arising during period
|
(17,810
|
)
|
-
|
(17,810
|
)
|
$
|
(17,810
|
)
|
|||||
Comprehensive
loss
|
$
|
(2,404,265
|
)
|
||||||||||
Balance
at December 31, 2005
|
(17,810
|
)
|
(5,184,856
|
)
|
3,556,604
|
||||||||
Issuance
of shares - previously accrued penalty shares
|
-
|
-
|
-
|
||||||||||
Issuance
of shares - stock dividend
|
-
|
(368,410
|
)
|
(43
|
)
|
||||||||
Issue
penalty shares
|
-
|
-
|
-
|
||||||||||
Issuance
of shares - initial public offering
|
-
|
-
|
10,200,000
|
||||||||||
Fees
associated with initital public offering
|
-
|
-
|
(1,890,444
|
)
|
|||||||||
Conversion
of preferred stock to common stock
|
-
|
-
|
-
|
||||||||||
Conversion
of notes payable to common stock
|
-
|
-
|
313,003
|
||||||||||
Issuance
of options
|
-
|
-
|
506,078
|
||||||||||
Exercise
of options
|
-
|
-
|
2,813
|
||||||||||
Issuance
of warrants
|
-
|
-
|
114,032
|
||||||||||
Proceeds
from sales of warrants
|
-
|
-
|
110
|
||||||||||
Net
loss
|
-
|
(7,222,644
|
)
|
(7,222,644
|
)
|
(7,222,644
|
)
|
||||||
Other
comprehensive income
|
|||||||||||||
Unrealized
gains (losses) on short term investments
|
|||||||||||||
Changes
in unrealized holding gains (losses)
|
|||||||||||||
arising
during period
|
6,678
|
-
|
6,678
|
$
|
6,678
|
||||||||
Less
reclassification adjustment for (gains) losses
|
|||||||||||||
included
in net loss
|
6,967
|
-
|
6,967
|
$
|
6,967
|
||||||||
Comprehensive
loss
|
$
|
(7,208,999
|
)
|
||||||||||
Balance
at December 31, 2006
|
$
|
(4,165
|
)
|
$
|
(12,775,910
|
)
|
$
|
5,593,154
|
2006
|
|
2005
|
|
2004
|
|
|||||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
||||||||||
Net
loss
|
$
|
(7,222,644
|
)
|
$
|
(2,386,455
|
)
|
$
|
(2,523,142
|
)
|
|
Adjustments
to reconcile net loss to net cash
|
||||||||||
used
by operating activities:
|
||||||||||
Depreciation
|
94,931
|
44,762
|
2,299
|
|||||||
Noncash
interest expense
|
9,929
|
17,993
|
4,019
|
|||||||
Noncash
salaries and consulting expense
|
620,119
|
437,311
|
-
|
|||||||
Deferred
compensation
|
5,886
|
9,141
|
10,449
|
|||||||
Research
and development
|
-
|
-
|
2,256,067
|
|||||||
Changes
in operating assets and liabilities:
|
||||||||||
Accounts
receivable - trade
|
(159,750
|
)
|
225,013
|
(225,013
|
)
|
|||||
Accounts
receivable - interest
|
(5,616
|
)
|
(37,035
|
)
|
-
|
|||||
Other
prepaid expenses
|
(422,427
|
)
|
(12,249
|
)
|
-
|
|||||
Deposits
|
(3,750
|
)
|
(3,734
|
)
|
(7,570
|
)
|
||||
Accounts
payable
|
380,023
|
10,869
|
169,980
|
|||||||
Deferred
revenue
|
(100,293
|
)
|
100,293
|
-
|
||||||
Accrued
expenses
|
99,990
|
(136,421
|
)
|
105,000
|
||||||
Milestone
payments
|
50,000
|
-
|
-
|
|||||||
Total
adjustments
|
569,042
|
655,942
|
2,315,231
|
|||||||
Net
cash (used) provided by operating
|
||||||||||
activities
|
(6,653,602
|
)
|
(1,730,513
|
)
|
(207,911
|
)
|
||||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
||||||||||
Sale/(purchase)
of short-term investments
|
400,000
|
(2,400,000
|
)
|
-
|
||||||
Issuance
of notes receivable
|
(50,000
|
)
|
-
|
-
|
||||||
Purchase
of equipment
|
(187,660
|
)
|
(328,756
|
)
|
(27,991
|
)
|
||||
Costs
of patents pending
|
(176,621
|
)
|
(76,357
|
)
|
-
|
|||||
Net
cash provided by investing activities
|
(14,281
|
)
|
(2,805,113
|
)
|
(27,991
|
)
|
||||
CASH
FLOWS FROM FINANCING ACTIVITIES
|
||||||||||
Issuance
of preferred stock
|
-
|
6,000,000
|
-
|
|||||||
Financing
costs
|
(1,679,456
|
)
|
(402,622
|
)
|
(13,000
|
)
|
||||
Dividends
|
(43
|
)
|
(31
|
)
|
-
|
|||||
Issuance
of common stock
|
10,200,000
|
-
|
17
|
|||||||
Exercise
of stock options
|
2,813
|
-
|
-
|
|||||||
Issuance
of warrants
|
100
|
-
|
-
|
|||||||
Proceeds
from convertible notes payable
|
-
|
50,000
|
333,500
|
|||||||
Net
cash provided by financing activities
|
8,523,414
|
5,647,347
|
320,517
|
|||||||
NET
INCREASE IN CASH AND EQUIVALENTS
|
1,855,531
|
1,111,721
|
84,615
|
|||||||
CASH
AND EQUIVALENTS AT BEGINNING OF
|
1,206,462
|
94,741
|
10,126
|
|||||||
YEAR
|
||||||||||
CASH
AND EQUIVALENTS AT END OF YEAR
|
$
|
3,061,993
|
$
|
1,206,462
|
$
|
94,741
|
2006
|
|
|
2005
|
|
|
2004
|
|
|||
Supplemental
disclosures of cash flow information:
|
||||||||||
Cash
paid during the period for interest
|
$
|
1,269
|
$
|
-
|
$
|
-
|
||||
Cash
paid during the year for income taxes
|
$
|
-
|
$
|
-
|
$
|
-
|
Supplemental
schedule of noncash financing activities:
|
2006
|
|
|
2005
|
|
|
2004
|
|||
Common
stock issued as financing fees on issuance of preferred
shares
|
$
|
-
|
$
|
589,662
|
$
|
-
|
||||
Conversion
of notes payable and accrued interest to preferred stock
|
$
|
-
|
$
|
102,438
|
$
|
-
|
||||
Issuance
of stock options to employees, consultants, and independent
board
members
|
$
|
506,078
|
$
|
318,511
|
$
|
-
|
||||
Issuance
of warrants to consultant
|
$
|
114,042
|
$
|
-
|
$
|
-
|
||||
Exercise
of stock options into 59,600 common shares by consultant
|
$
|
-
|
$
|
119,200
|
$
|
-
|
||||
Issuance
of common stock dividend to preferred shareholders
|
$
|
368,367
|
$
|
138,402
|
$
|
-
|
||||
Unissued
shares to preferred shareholders for penalty per agreement
|
$
|
-
|
$
|
441,125
|
$
|
-
|
||||
Conversion
of notes payable and accrued interest to common stock
|
$
|
313,003
|
$
|
-
|
$
|
-
|
||||
Conversion
of preferred stock to common stock
|
$
|
5,308,141
|
$
|
-
|
$
|
-
|
A.
|
Cash
and Equivalents - The Company considers highly liquid debt instruments
with original maturities 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 maturity 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, 2006, and 2005.
|
D.
|
Notes
Receivable - On December 7, 2006 the Company entered into an agreement
with the Orbit Brands Corporation (Borrower) and its subsidiaries
whereby
the Company would lend up to $150,000 each on two promissory notes
to the
Borrower at a rate of 5% per annum with a maturity date of one
year. The
proceeds of the loans shall be used by the Borrower solely to cover
expenses associated with converting the notes into common stock
and
preparing the lending motions for the bankruptcy case involving
the
Borrower. The loans are convertible into common stock of the Borrower
and
its subsidiaries. The Company is under no obligation to fund or
loan any
additional amount to the Borrower, although in the event the Company
terminates, ceases or withholds its funding, any amounts funded
prior
thereto shall be forfeited, unless such termination is due to a
breach by
Borrower. As of December 31, 2006 the balance outstanding was $50,000
plus
accrued interest of $171.
|
E.
|
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 $94,931, $44,762, and
$2,299 for
the years ended December 31, 2006, 2005, and 2004
respectively.
|
F.
|
Impairment
of Long-Lived Assets - In accordance with Statements of Financial
Accounting Standards, or SFAS, No. 144, Accounting for the Impairment
or
Disposal 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 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.
|
G.
|
Deferred
Compensation - The Company realized deferred compensation upon
the
valuation of restricted stock granted to the founding stockholders.
This
deferred compensation was expensed over the three-year vesting
period from
the grant of the stock. Capitalized Deferred Compensation was $0
and
$5,887 at December 31, 2006, and 2005, respectively. The Company
expensed
$5,887, $9,140, and $9,164 in compensation expense in 2006, 2005
and 2004,
respectively.
|
H.
|
Intellectual
Property - The Company capitalizes the costs associated with the
preparation, filing, and maintenance of certain intellectual property
rights. Capitalized intellectual property is reviewed annually
for
impairment.
|
I.
|
Lines
of Credit - The Company has a working capital line of credit that
is fully
secured by short-term investments. This fully-secured working capital
line
of credit carries an interest rate of prime minus 1%, a borrowing
limit of
$500,000, and expires on July 1, 2007. At December 31, 2006, there
were no
outstanding borrowings under this credit facility
|
J.
|
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. The carrying
amounts of the convertible notes payable approximate their respective
fair
values as they bear terms that are comparable to those available
under
current market conditions.
|
K.
|
Stock
Split - As a result of a 596 for 1 stock split of the Company’s issued and
outstanding shares of common stock, which became effective on February
28,
2005, the 10,000 issued and outstanding shares converted into 5,960,000
shares of common stock. Per SAB Topic 4C, all share and per share
stock
amounts have been retroactively adjusted to reflect the stock
split.
|
L.
|
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.
|
M.
|
Revenue
Recognition - The Company recognizes revenue in accordance with
Staff
Accounting Bulletin No. 104, “Revenue Recognition.” Revenue sources
consist of government grants, government contracts and commercial
development contracts.
|
N.
|
Deferred
Revenue - Deferred Revenue results when payment is received in
advance of
revenue being earned. When cash is received, 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.
|
O.
|
Research
and Development - Research and development expenses consist primarily
of
costs associated with the clinical trials of drug candidates, compensation
and other expenses for research and development, personnel, supplies
and
development materials, costs for consultants and related contract
research
and facility costs. Expenditures relating to research and development
are
expensed as incurred.
|
P.
|
Employee
Benefit Plan - The Company maintains a 401(k) retirement savings
plan that
is available to all full-time employees who have reached age 21.
The plan
is intended to qualify under Section 401(k) of the Internal Revenue
Code
of 1986, as amended. The plan provides that each participant may
contribute up to a statutory limit of their pre-tax compensation,
which
was $15,000 for employees under age 50 and $20,000 for employees
50 and
older in calendar year 2006. Employee contributions are held in
the
employees’ name and invested by the plan trustee. The plan currently
provides for the Company to make matching contributions, subject
to
established limits. The Company made matching contributions of
$48,858,
$0, and $0 for 2006, 2005, and 2004,
respectively.
|
Q.
|
2006
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 expires on May
26, 2016 and allows up to 2,000,000 shares of stock to be awarded.
For the
year ended December 31, 2006, 45,000 options were granted to independent
board members. On February 14, 2007, these 2,000,000 shares were
registered with the SEC by filing a Form S-8 registration statement.
|
R.
|
Stock-Based
Compensation - The FASB issued SFAS No. 123(R) (revised December
2004),
Share Based Payment, which is a revision of SFAS No. 123 Accounting
for
Stock-Based Compensation. SFAS 123(R) requires all share-based
payments to
employees, including grants of employee stock options, to be recognized
in
the statement of operations based on their fair values. The Company
values
employee stock based compensation under the provisions of SFAS
123(R) and
related interpretations.
|
The
fair value of each stock option granted is estimated on the grant
date
using the Black-Scholes option valuation model. The assumptions
used to
calculate the fair value of options granted are evaluated and revised,
as
necessary, to reflect the Company’s experience. The Company uses a
risk-free rate based on published rates from the St. Louis Federal
Reserve
at the time of the option grant, assumes a forfeiture rate of zero,
assumes an expected dividend yield rate of zero based on the Company’s
intent not to issue a dividend in the foreseeable future, uses
an expected
life based on the Company’s best judgment using facts and circumstances
based on its limited experience, and computes an expected volatility
based
on similar high-growth, publicly-traded, biotechnology companies.
The
Company does not include the use of its own stock in the volatility
calculation at this time because of the brief history of the stock
as a
publicly traded security on a listed exchange. Compensation expense
is
recognized using the straight-line amortization method for all
stock-based
awards.
|
The
fair value of warrants issued to a key consultant in exchange for
services
is estimated using the Black-Scholes option valuation model with
the same
assumptions.
|
|
March 1, 2006
|
July
20, 2006
|
November
16, 2006
|
|||||||
Risk-free
interest rate
|
4.66
|
%
|
5.04 | % |
4.80
|
%
|
||||
Expected
dividend yield
|
0
|
%
|
0 | % |
0
|
%
|
||||
Expected
life
|
5
years
|
5 years |
2.5
Years
|
|||||||
Expected
volatility
|
75.11
|
%
|
71.43 | % |
68.26
|
%
|
|
Shares
|
Weighted
Average
Exercise
Price
per
Share
|
Weighted
Average
Remaining
Contractual
Term
(in
Years)
|
|||||||
Outstanding,
December 31, 2005
|
324,240
|
$
|
0.82
|
|||||||
Granted,
March 1, 2006
|
116,750
|
4.50
|
||||||||
Granted,
July 20, 2006
|
45,000
|
6.00
|
||||||||
Exercised
|
625
|
4.50
|
||||||||
Forfeited,
Canceled
|
1,875
|
4.50
|
||||||||
Outstanding,
December 31, 2006
|
483,490
|
$
|
2.17
|
8.77
|
||||||
Exercisable,
December 31, 2006
|
243,183
|
$
|
2.27
|
8.78
|
|
Options
|
Weighted
Average
Exercise
Price
per
Share
|
Weighted
Average
Remaining
Contractual
Term
(in
Years)
|
|||||||
Outstanding,
December 31, 2004
|
-
|
$
|
-
|
|||||||
Granted,
March 1, 2005
|
10,000
|
3.00
|
||||||||
Granted,
July 1, 2005
|
353,840
|
0.55
|
||||||||
Granted,
December 1, 2005
|
20,000
|
2.00
|
||||||||
Exercised,
September 30, 2005
|
59,600
|
-
|
||||||||
Forfeited,
Canceled
|
-
|
-
|
||||||||
Outstanding,
December 31, 2005
|
324,240
|
$
|
0.82
|
9.52
|
||||||
Exercisable,
December 31, 2005
|
83,560
|
$
|
0.88
|
9.50
|
S.
|
Income
Taxes - The Company utilizes Statement of Financial Accounting
Standards
No. 109, “Accounting for Income Taxes,” which requires an asset and
liability approach to financial accounting and reporting for income
taxes.
The difference between the financial statement and tax basis of
assets and
liabilities is determined annually. Deferred income tax assets
and
liabilities are computed for those temporary differences that have
future
tax consequences using the current enacted tax laws and rates that
apply
to the periods in which they are expected to affect taxable income.
Valuation allowances are established, if necessary, to reduce the
deferred
tax asset to the amount that will, more likely than not, be realized.
Income tax expense is the current tax payable or refundable for
the year
plus or minus the net change in the deferred tax assets and
liabilities.
|
T.
|
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.
|
2006
|
2005
|
2004
|
||||||||
Net
loss available to common stockholders
|
$
|
(7,437,572
|
)
|
$
|
(2,678,369
|
)
|
$
|
(2,523,142
|
)
|
|
Net
loss per share, basic and diluted
|
$
|
(0.84
|
)
|
$
|
(0.43
|
)
|
$
|
(0.55
|
)
|
|
Weighted-average
shares used in computing net loss per share, basic and
diluted
|
8,906,266
|
6,250,447
|
4,615,571
|
U.
|
Concentrations
of Risk - Grant revenue was comprised wholly from grants issued
by the
federal government and accounted for 88.0%, 88.9% and 83.5% of
total
revenue for the years ended December 31, 2006, 2005 and 2004,
respectively. Although the company anticipates ongoing federal
grant
revenue, there is no guarantee that this revenue stream will continue
in
the future.
|
V.
|
Foreign
Currency Exchange Rate Risk - The Company has entered into a manufacturing
agreement with a foreign third party to produce one of its drug
compounds
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 Dollar. As of December 31, 2006, the Company
is
obligated to make payments under the agreement of 1,295,385 Euros.
The
Company has established means to purchase forward contracts to
hedge
against this risk. As of December 31, 2006, no hedging transactions
have
been consummated.
|
W.
|
Comprehensive
Income/(Loss) - The Company applies Statement of Financial Accounting
Standards (SFAS) No. 130, “Reporting Comprehensive Income.” SFAS No. 130
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.
|
X.
|
Segment
Reporting - As of December 31, 2006 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.
|
Y.
|
Effect
of New Accounting Standards - In May 2005, the FASB issued SFAS
No. 154,
“Accounting Changes and Error Correction - a Replacement of APB
Opinion
No. 20 and FASB Statement No. 3” (“SFAS 154”). SFAS 154 changes the
requirements for the accounting for and the reporting of a change
in
accounting principle. SFAS 154 requires that a voluntary change
in
accounting principle be applied retroactively with all prior period
financial statements presented under the new accounting principle.
SFAS
154 is effective for accounting changes and corrections of errors
in
fiscal years beginning after December 15, 2005. The Company has
determined
that the adoption of the requirements required under SFAS 154 will
not
have a material impact on the financial statements of the
Company.
|
Name
|
Position
|
Number
of
Shares
|
||
Dr.
Andrei Gudkov
|
Chief
Scientific Officer
|
1,579,400
|
||
Dr.
Michael Fonstein
|
Chief
Executive Officer, President, Chairman of the Board
|
1,311,200
|
||
Dr.
Yakov Kogan
|
Executive
Vice President of Business Development, Secretary
|
715,200
|
||
Dr.
Elena Feinstein
|
Executive
Vice President of Research and Development
|
268,200
|
||
Dr.
Veronika Vonstein
|
General
Manager
|
119,200
|
2006
|
2005
|
2004
|
||||||||
Unsecured
note to a research collaborator of the Company, bearing interest
at 6% per
annum, principal and interest due October 2007. Mandatory conversion
into
common stock upon an initial public offering of the Company at the
fixed
conversion price of $2.52 per share. Optional conversion into common
stock
or a new debt agreement depending on whether the Company raises additional
capital through additional equity or debt. Upon the option conversion,
the
conversion amount will be converted into common stock at the new
issue
price per share or into a new debt instrument with a principal amount
equal to the conversion amount.
|
—
|
$
|
109,000
|
$
|
109,000
|
|||||
Unsecured
note to stockholder, bearing interest at 5% per annum, principal
and
interest due May 2007. This note was converted into preferred stock
in
March 2005.
|
—
|
—
|
50,000
|
|||||||
Two
unsecured notes to a research collaborator of the Company, bearing
interest at 6% per annum, principal and interest due November 2007.
Mandatory conversion into common stock upon an initial public offering
of
the Company at the fixed conversion price of $2.52 per share. Optional
conversion into common stock or a new debt agreement depending on
whether
the Company raises additional capital through additional equity or
debt.
Upon the optional conversion, the conversion amount will be converted
into
common stock at the new issue price per share or into a new debt
instrument with a principal amount equal to the conversion
amount.
|
—
|
174,500
|
174,500
|
|||||||
$
|
283,500
|
$
|
333,500
|
|||||||
Current
portion
|
—
|
—
|
—
|
|||||||
283,500
|
333,500
|
|||||||||
Long-term
accrued interest
|
—
|
19,574
|
4,019
|
|||||||
|
—
|
$
|
303,074
|
$
|
337,519
|
2006
|
2005
|
2004
|
||||||||
Deferred
tax asset
|
||||||||||
Net
operating loss carryforwards
|
$
|
4,586,000
|
$
|
1,897,000
|
$
|
1,003,000
|
||||
Deferred
compensation
|
345,000
|
135,000
|
66,000
|
|||||||
Loss
on short term investments
|
2,000
|
7,000
|
—
|
|||||||
Depreciation
|
(35,000)
|
)
|
(17,000)
|
)
|
(6,000)
|
)
|
||||
Total
|
4,898,000
|
2,022,000
|
1,063,000
|
|||||||
Valuation
allowance
|
$
|
(4,898,000)
|
)
|
$
|
(2,022,000)
|
)
|
$
|
(1,063,000)
|
)
|
|
Net
deferred tax asset
|
$
|
—
|
$
|
—
|
$
|
—
|
Cost
|
Accrued
Interest
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair
Value
|
||||||||||||
December
31, 2006 - Current Marketable Securities
|
$
|
2,000,000
|
$
|
42,479
|
$
|
-
|
$
|
4,165
|
$
|
2,038,314
|
2006
|
2005
|
||||||
Laboratory
Equipment
|
$
|
347,944
|
$
|
225,997
|
|||
Computer
Equipment
|
132,572
|
91,788
|
|||||
Furniture
|
65,087
|
40,158
|
|||||
545,603
|
357,943
|
||||||
Less
accumulated depreciation
|
(142,011
|
)
|
(47,080
|
)
|
|||
$
|
403,592
|
$
|
310,863
|
Operating
Leases
|
||||
2007
|
$
|
63,460
|
||
2008
|
4,949
|
|||
2009
|
1,935
|
|||
$
|
70,344
|
|
Number of
Options
|
Weighted Average
Exercise
Price
|
|||||
Outstanding
at December 31, 2004
|
—
|
N/A
|
|||||
Granted
|
383,840
|
$
|
0.69
|
||||
Exercised
|
59,600
|
$
|
—
|
||||
Forfeited
|
—
|
N/A
|
|||||
Outstanding
at December 31, 2005
|
324,240
|
$
|
0.82
|
||||
Granted
|
161,750
|
$
|
4.92
|
||||
Exercised
|
625
|
$
|
4.50
|
||||
Forfeited
|
1,875
|
$
|
4.50
|
||||
Outstanding
at December 31, 2006
|
483,490
|
$
|
2.17
|
|
Outstanding
|
Exercisable
|
||||||||
Exercise
Price
|
Number
of
Options
|
Weighted
Average
Years
to
Expiration
|
Number
of
Options
|
|||||||
$0.66
|
190,000
|
8.5
|
95,000
|
|||||||
0.67
|
104,240
|
8.5
|
52,120
|
|||||||
2.00
|
20,000
|
8.92
|
12,500
|
|||||||
3.00
|
10,000
|
8.17
|
10,000
|
|||||||
4.50
|
114,250
|
9.17
|
28,563
|
|||||||
6.00
|
45,000
|
9.56
|
45,000
|
|||||||
Total
|
483,490
|
8.77
|
243,183
|
|
Number of
Warrants
|
Weighted Average
Exercise
Price
|
|||||
Outstanding
at December 31, 2004
|
294,424
|
$
|
1.22
|
||||
Granted
|
300,000
|
$
|
2.00
|
||||
Exercised
|
—
|
N/A
|
|||||
Forfeited
|
—
|
N/A
|
|||||
Outstanding
at December 31, 2005
|
594,424
|
$
|
1.61
|
||||
Granted
|
220,000
|
$
|
8.09
|
||||
Exercised
|
—
|
N/A
|
|||||
Forfeited
|
—
|
N/A
|
|||||
Outstanding
at December 31, 2006
|
814,424
|
$
|
3.36
|
Name
and Principal Position
|
Year
|
Salary
($)
|
Bonus
($)
(1)
|
Stock
Awards
($)
|
Option
Awards
($)
(2)
|
Non-Equity
Incentive
Plan
Compens-
ation
($)
|
Non-
Qualified
Deferred Compens
-ation
Earnings
($)
|
All
Other
Compensation
($)
|
Total
|
|||||||||||||||||||
|
||||||||||||||||||||||||||||
Michael
Fonstein
Chief
Executive Officer
|
2006
2005
|
191,667
155,000
|
35,375
-
|
-
-
|
-
-
|
-
-
|
-
-
|
-
-
|
227,042
155,000
|
(3) | ||||||||||||||||||
|
||||||||||||||||||||||||||||
Yakov
N. Kogan
Executive
Vice President
|
2006
2005
|
166,667
143,725
|
34,500
-
|
-
-
|
-
-
|
-
-
|
-
-
|
48,855
-
|
(4) |
250,022
143,725
|
||||||||||||||||||
|
||||||||||||||||||||||||||||
John
A. Marhofer, Jr.
Chief
Financial Officer
|
2006
2005
|
90,000
64,460
|
17,750
558
|
-
-
|
49,559
18,552
|
-
-
|
-
-
|
-
-
|
157,309
83,571
|
(1)
|
Bonuses
earned in a given year are paid during the current and the next year.
For
example, the bonuses indicated as earned in respect of 2006 were
paid
in September of 2006 and January of
2007.
|
(2)
|
Option
award amounts are calculated using the provisions of Statement of
Financial Accounting Standards (“SFAS”) No. 123R, Share-Based Payment.
Further details can be found in Item 6 under “Critical Accounting Policies
- Stock
Based Compensation.”
|
(3)
|
Total
compensation figure does not include amounts for commuting from primary
residence in Chicago, Illinois of $9,083 for 2006 and $9,922 for
2005.
|
(4)
|
Represents
tuition reimbursement for masters in business administration
program.
|
Option
Awards
|
||||||||||||||||
Number
of
Securities
Underlying
Unexercised
Options
(#)
Exercisable
|
Number
of
Securities
Underlying
Unexercised
Options
(#)
Unexercisable
|
Equity
Incentive
Plan
Awards:
Number
of
Securities
Underlying
Unexercised
Unearned
Options
(#)
|
Option
Exercise
Price
($)
|
Option
Expiration
Date
|
||||||||||||
JoJohn
A. Marhofer, Jr.
|
5,000
11,592
|
15,000
11,592
|
-
-
|
4.50
0.67
|
2/28/2016
6/30/2015
|
Name
|
Fees
Earned or
Paid
in Cash
($)
|
Stock
Awards
($)
|
Option
Awards
($)
(1)
|
Non-Equity
Incentive
Plan Compensation
($)
|
Change
in
Pension
Value
and Nonqualified Deferred Compensation Earnings
($)
|
All
Other Compensation
($)
|
Total
($)
|
|||||||||||||||
|
|
|||||||||||||||||||||
Bernard
L. Kasten Jr.
|
12,500
|
-
|
56,449
|
-
|
-
|
-
|
68,949
|
|||||||||||||||
|
||||||||||||||||||||||
H.
Daniel Perez
|
12,500
|
-
|
56,449
|
-
|
-
|
-
|
68,949
|
|||||||||||||||
|
||||||||||||||||||||||
James
J. Antal
|
12,500
|
-
|
56,449
|
-
|
-
|
-
|
68,949
|
|||||||||||||||
|
||||||||||||||||||||||
Paul
E. DiCorleto
|
-
|
-
|
-
|
-
|
-
|
-
|
0
|
|||||||||||||||
|
||||||||||||||||||||||
Andrei
V. Gudkov
|
-
|
-
|
-
|
-
|
-
|
-
|
0
|
(1) |
Messrs.
Kasten, Perez, and Antal each held fully vested options to purchase
15,000
shares of common stock outstanding as of December 31, 2006. Award
amounts
are calculated using the provisions of Statement of Financial Accounting
Standards (“SFAS”) No. 123R, Share-Based Payment. Further details can be
found in Item 6 under “Critical Accounting Policies - Stock
Based Compensation.”
|
Plan
category
|
Number
of securities to be issued upon exercise of outstanding options,
warrants
and rights
(a)
|
Weighted-average
exercise price of outstanding options, warrants and rights
(b)
|
Number
of securities remaining available for future issuance under equity
compensation plans (excluding securities reflected in column
(a))
(c)
|
|||||||
Equity
compensation plans approved by security holders
|
45,000
|
$
|
6.00
|
1,955,000
|
||||||
Equity
compensation plans not approved by security holders
|
1,252,914
|
$
|
2.81
|
-
|
||||||
Total
|
1,297,914
|
$
|
2.92
|
1,955,000
|
Name
and Address
|
Number
of Shares
of
Registrant
Common
Stock
Beneficially
Owned
|
|
Percentage of
Class
Beneficially
Owned
|
|||||||
|
|
|
|
|||||||
Directors
and Executive Officers
|
|
|
|
|||||||
Bernard
L. Kasten Jr.
|
15,000
|
(3
|
)
|
*
|
||||||
Director,
Chairman of the Board
|
||||||||||
James
J. Antal
|
15,000
|
(2
|
)
|
*
|
||||||
Director
|
||||||||||
Paul
E. DiCorleto
|
0
|
0
|
%
|
|||||||
Director
|
||||||||||
Michael
Fonstein
|
1,311,200
|
11.03
|
%
|
|||||||
Director,
CEO & President
|
||||||||||
Andrei
V. Gudkov
|
1,549,600
|
(1
|
)
|
13.03
|
%
|
|||||
Director,
Chief Scientific Officer
|
||||||||||
Yakov
N. Kogan
|
715,200
|
6.02
|
%
|
|||||||
Director,
Executive Vice President of Business
Development, Secretary
|
||||||||||
H.
Daniel Perez
|
15,000
|
(4
|
)
|
*
|
||||||
Director
|
||||||||||
John
A. Marhofer, Jr.
|
21,592
|
(5
|
)
|
*
|
||||||
Chief
Financial Officer
|
||||||||||
All
directors and officers as a group (eight people)
|
3,642,592
|
30.47
|
%
|
|||||||
|
||||||||||
5%
Stockholders
|
||||||||||
The
Cleveland Clinic Foundation(6)
|
1,341,000
|
(7
|
)
|
11.28
|
%
|
|||||
ChemBridge
Corporation(8)
|
622,224
|
(9
|
)
|
5.23
|
%
|
|||||
Sunrise
Equity Partners, LP(10)
|
1,436,548
|
(11
|
)
|
12.08
|
%
|
|||||
Sunrise
Securities Corp.(12)
|
1,436,548 | (13 | ) | 12.08 | % |
Exhibit
No.
|
|
Description
|
3.1
|
|
Certificate
of Incorporation filed with the Secretary of State of Delaware on
June 5,
2003***
|
3.2
|
|
Certificate
of Amendment of Certificate of Incorporation filed with the Secretary
of
State of Delaware on February 25, 2005***
|
3.3
|
Certificate
of Designation of Series A Participating Convertible Preferred Stock
filed
with the Secretary of State of Delaware on March 8,
2005***
|
|
3.4
|
|
Second
Certificate of Amendment of Certificate of Incorporation filed with
Secretary of State of Delaware on June 30, 2006***
|
3.5
|
|
Certificate
of Designations, Preferences and Rights of Series B Convertible Preferred
Stock, dated March 16, 2007******
|
3.6
|
|
Amended
and Restated By-Laws***
|
4.1
|
|
Form
of Specimen Common Stock Certificate*
|
4.2
|
|
Form
of Warrants issues 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 ******
|
|
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
|
|
Form
of Stock Purchase Agreement between Cleveland BioLabs, Inc. and the
Purchasers party thereto, dated as of March 15, 2005*
|
10.13
|
|
Form
of Series A Rights Agreement by and among Cleveland BioLabs, Inc.
and the
parties thereto, dated as of March 15, 2005*
|
10.14
|
|
Employment
Agreement by and between Cleveland BioLabs, Inc. and Dr. Farrel Fort,
dated June 1, 2005*
|
10.15
|
|
Amendment
to Employment Agreement by and between Cleveland BioLabs, Inc. and
Dr.
Farrel Fort, dated September 30, 2005*
|
10.16
|
|
Amendment
to Consulting Agreement between Cleveland BioLabs, Inc. and Dr. Andrei
Gudkov, dated as of January 23, 2006*
|
10.17
|
|
Amendment
to Restricted Stock Agreement between Cleveland BioLabs, Inc. and
Michael
Fonstein, dated as of January 23, 2006*
|
10.18
|
|
Amendment
to Restricted Stock Agreement between Cleveland BioLabs, Inc. and
Yakov
Kogan, dated as of January 23, 2006*
|
10.19
|
|
Amendment
to Restricted Stock Agreement between Cleveland BioLabs, Inc. and
Andrei
Gudkov, dated as of January 23, 2006*
|
10.20
|
|
Amendment
to Common Stockholders Agreement by and among Cleveland BioLabs,
Inc. and
the parties thereto, dated as of January 26, 2006*
|
10.21
|
|
Form
of Amendment to Series A Rights Agreement by and among Cleveland
BioLabs,
Inc. and the parties thereto, dated as of February 17,
2006*
|
10.22
|
|
Cleveland
BioLabs, Inc. 2006 Equity Incentive Plan***
|
10.23
|
|
Process
Development and Manufacturing Agreement between Cleveland BioLabs,
Inc.
and SynCo Bio Partners B.V., effective as of August 31,
2006****
|
10.24
|
|
Sponsored
Research Agreement between Cleveland BioLabs, Inc. and Roswell Park
Cancer
Institute Corporation, effective as of January 12,
2007*****
|
10.25
|
Securities
Purchase Agreement, dated March 16, 2007******
|
|
10.26
|
Registration
Rights Agreement, dated March 16, 2007******
|
|
10.27
|
Voting
Agreement, dated March 16, 2007******
|
|
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.
|
CLEVELAND
BIOLABS, INC.
|
||
|
|
|
Dated:
March 29, 2007
|
By: |
/s/
MICHAEL FONSTEIN
|
Michael
Fonstein
|
||
Chief
Executive Officer
|
||
(Principal
Executive Officer)
|
CLEVELAND
BIOLABS, INC.
|
||
|
|
|
Dated:
March 29, 2007
|
By: |
/s/
JOHN A. MARHOFER JR.
|
John
A. Marhofer Jr.
|
||
Chief
Financial Officer
|
||
(Principal
Financial and Accounting Officer)
|
Signature
|
Title
|
Date
|
|||
/S/ Michael
Fonstein
Michael
Fonstein
|
|
Chief
Executive Officer, President, and Director (Principal Executive
Officer)
|
|
March 29, 2007
|
|
/S/ John
A. Marhofer Jr.
John
A. Marhofer Jr.
|
|
Chief
Financial Officer (Principal Financial and Accounting
Officer)
|
|
March 29, 2007
|
|
/S/ James
Antal
James
Antal
|
|
Director
|
|
March 29, 2007
|
|
/S/ Paul
DiCorleto
Paul
DiCorleto
|
|
Director
|
|
March 29, 2007
|
|
/S/ Andrei
Gudkov
Andrei
Gudkov
|
|
Chief
Scientific Officer, and Director
|
|
March 29, 2007
|
|
/S/ Bernard
L. Kasten
Bernard
L. Kasten
|
|
Director
|
|
March 29, 2007
|
|
/S/ Yakov
Kogan
Yakov
Kogan
|
|
Executive
Vice President, and Director
|
|
March 29, 2007
|
|
/S/ H.
Daniel Perez
H.
Daniel Perez
|
|
Director
|
|
March 29, 2007
|
Exhibit
No.
|
|
Description
|
3.1
|
|
Certificate
of Incorporation filed with the Secretary of State of Delaware on
June 5,
2003***
|
3.2
|
|
Certificate
of Amendment of Certificate of Incorporation filed with the Secretary
of
State of Delaware on February 25, 2005***
|
3.3
|
Certificate
of Designation of Series A Participating Convertible Preferred Stock
filed
with the Secretary of State of Delaware on March 8,
2005***
|
|
3.4
|
|
Second
Certificate of Amendment of Certificate of Incorporation filed with
Secretary of State of Delaware on June 30, 2006***
|
3.5
|
|
Certificate
of Designations, Preferences and Rights of Series B Convertible Preferred
Stock, dated March 16, 2007******
|
3.6
|
|
Amended
and Restated By-Laws***
|
4.1
|
|
Form
of Specimen Common Stock Certificate*
|
4.2
|
|
Form
of Warrants issues 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 ******
|
|
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
|
|
Form
of Stock Purchase Agreement between Cleveland BioLabs, Inc. and
the
Purchasers party thereto, dated as of March 15, 2005*
|
10.13
|
|
Form
of Series A Rights Agreement by and among Cleveland BioLabs, Inc.
and the
parties thereto, dated as of March 15, 2005*
|
10.14
|
|
Employment
Agreement by and between Cleveland BioLabs, Inc. and Dr. Farrel
Fort,
dated June 1, 2005*
|
10.15
|
|
Amendment
to Employment Agreement by and between Cleveland BioLabs, Inc.
and Dr.
Farrel Fort, dated September 30,
2005*
|
10.16
|
|
Amendment
to Consulting Agreement between Cleveland BioLabs, Inc. and Dr.
Andrei
Gudkov, dated as of January 23, 2006*
|
10.17
|
|
Amendment
to Restricted Stock Agreement between Cleveland BioLabs, Inc. and
Michael
Fonstein, dated as of January 23, 2006*
|
10.18
|
|
Amendment
to Restricted Stock Agreement between Cleveland BioLabs, Inc. and
Yakov
Kogan, dated as of January 23, 2006*
|
10.19
|
|
Amendment
to Restricted Stock Agreement between Cleveland BioLabs, Inc. and
Andrei
Gudkov, dated as of January 23, 2006*
|
10.20
|
|
Amendment
to Common Stockholders Agreement by and among Cleveland BioLabs,
Inc. and
the parties thereto, dated as of January 26, 2006*
|
10.21
|
|
Form
of Amendment to Series A Rights Agreement by and among Cleveland
BioLabs,
Inc. and the parties thereto, dated as of February 17,
2006*
|
10.22
|
|
Cleveland
BioLabs, Inc. 2006 Equity Incentive Plan***
|
10.23
|
|
Process
Development and Manufacturing Agreement between Cleveland BioLabs,
Inc.
and SynCo Bio Partners B.V., effective as of August 31,
2006****
|
10.24
|
|
Sponsored
Research Agreement between Cleveland BioLabs, Inc. and Roswell
Park Cancer
Institute Corporation, effective as of January 12,
2007*****
|
10.25
|
Securities
Purchase Agreement, dated March 16, 2007******
|
|
10.26
|
Registration
Rights Agreement, dated March 16, 2007******
|
|
10.27
|
Voting
Agreement, dated March 16, 2007******
|
|
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.
|