x
|
Quarterly
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.)
|
|
|
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PAGE
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PART
I - FINANCIAL INFORMATION
|
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ITEM
1:
|
Financial
Statements
|
|
|
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Balance Sheets as of September 30, 2006 and December 31, 2005 |
3-4
|
|||
Statements
of Operations For Three and Nine Months Ended September 30, 2006
and 2005
|
5
|
|||
Statements of Cash Flows For Nine Months Ended September 30, 2006 and 2005 |
6
|
|||
Statement of Stockholders' Equity January 1, 2005 to September 30, 2006 |
7
|
|||
Notes to Condensed Consolidated Financial Statements |
9
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|||
|
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|
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ITEM
2:
|
Management’s
Discussion and Analysis of Financial Conditions
and Results of Operations
|
|
16
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|
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ITEM
3:
|
Controls
and Procedures
|
|
24
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PART
II - OTHER INFORMATION
|
|
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||
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ITEM
1:
|
Legal
Proceedings
|
|
25
|
|
|
|
|
|
|
ITEM
2:
|
Unregistered
Sales of Equity Securities and Use of
Proceeds
|
|
25
|
|
|
|
|
|
|
ITEM
3:
|
Defaults
Upon Senior Securities
|
|
25
|
|
|
|
|
|
|
ITEM
4:
|
Submission
of Matters to a Vote of Securities Holders
|
25
|
||
ITEM
5:
|
Other
Information
|
|
25
|
|
ITEM
6:
|
Exhibits
|
|
25
|
|
|
|
|
|
|
Signatures
|
|
|
26
|
September
30
2006
|
December
31
2005
|
||||||
(unaudited)
|
|||||||
ASSETS
|
|||||||
CURRENT
ASSETS
|
|||||||
Cash
and equivalents
|
$
|
5,441,611
|
$
|
1,206,462
|
|||
Short-term
investments
|
2,892,447
|
2,382,190
|
|||||
Accounts
receivable:
|
|||||||
Trade
|
76,644
|
-
|
|||||
Interest
|
42,205
|
37,035
|
|||||
Prepaid
expenses - IPO
|
-
|
210,987
|
|||||
Other
prepaid expenses
|
144,978
|
12,249
|
|||||
Deferred
compensation
|
846
|
5,134
|
|||||
Total
current assets
|
8,598,731
|
3,854,057
|
|||||
EQUIPMENT
|
|||||||
Computer
equipment
|
118,465
|
91,788
|
|||||
Lab
equipment
|
318,083
|
225,997
|
|||||
Furniture
|
65,087
|
40,158
|
|||||
501,635
|
357,943
|
||||||
Less
accumulated depreciation
|
115,284
|
47,080
|
|||||
386,351
|
310,863
|
||||||
OTHER
ASSETS
|
|||||||
Deferred
compensation
|
188
|
752
|
|||||
Intellectual
Property
|
182,416
|
76,357
|
|||||
Deposits
|
14,360
|
11,304
|
|||||
196,964
|
88,413
|
||||||
TOTAL
ASSETS
|
$
|
9,182,046
|
$
|
4,253,333
|
September
30
2006
|
December
31
2005
|
||||||
(unaudited)
|
|||||||
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
|||||||
CURRENT
LIABILITIES
|
|||||||
Accounts
payable:
|
|||||||
Trade
|
$
|
573,581
|
$
|
264,783
|
|||
Deferred
revenue
|
-
|
100,293
|
|||||
Accrued
expenses
|
44,175
|
28,579
|
|||||
Total
current liabilities
|
617,756
|
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 September 30, 2006
|
|||||||
and
December 31, 2005, respectively
|
|||||||
Issued
and outstanding -0- and 3,051,219
|
-
|
15,256
|
|||||
shares
at September 30, 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 September 30, 2006
|
|||||||
and
December 31, 2005, respectively
|
|||||||
Issued
and outstanding 11,826,389 and 6,396,801
|
59,132 | 31,984 | |||||
shares
at September 30, 2006 and December 31, 2005, respectively
|
|||||||
Additional
paid-in capital
|
18,133,661
|
3,338,020
|
|||||
Unissued
shares - common stock
|
-
|
81,125
|
|||||
Accumulated
other comprehensive income (loss)
|
(7,553
|
)
|
(17,810
|
)
|
|||
Accumulated
deficit
|
(9,670,950
|
)
|
(5,184,856
|
)
|
|||
Total
stockholders' equity
|
8,514,290
|
3,556,604
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
9,182,046
|
$
|
4,253,333
|
Three
Months Ended
|
Nine
Months Ended
|
||||||||||||
September
30 2006
|
September
30 2005
|
September
30 2006
|
September
30 2005
|
||||||||||
(unaudited)
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
||||||||||
REVENUES
|
|||||||||||||
Grant
|
$
|
263,368
|
$
|
446,194
|
$
|
1,271,787
|
$
|
624,850
|
|||||
Service
|
60,000
|
120,000
|
205,000
|
139,275
|
|||||||||
323,368
|
566,194
|
1,476,787
|
764,125
|
||||||||||
OPERATING
EXPENSES
|
|||||||||||||
Research
and Development
|
1,281,055
|
846,454
|
4,341,535
|
1,507,040
|
|||||||||
Selling,
general and administrative
|
708,776
|
406,958
|
1,367,457
|
778,638
|
|||||||||
Total
operating expenses
|
1,989,831
|
1,253,412
|
5,708,992
|
2,285,678
|
|||||||||
LOSS
FROM OPERATIONS
|
(1,666,463
|
)
|
(687,218
|
)
|
(4,232,205
|
)
|
(1,521,553
|
)
|
|||||
OTHER
INCOME
|
|||||||||||||
Interest
Income
|
81,189
|
37,315
|
125,719
|
83,952
|
|||||||||
OTHER
EXPENSE
|
|||||||||||||
Interest
Expense
|
2,257
|
4,287
|
11,198
|
13,558
|
|||||||||
NET
LOSS
|
$
|
(1,587,530
|
)
|
$
|
(654,190
|
)
|
$
|
(4,117,684
|
)
|
$
|
(1,451,159
|
)
|
|
DIVIDENDS
ON CONVERTIBLE PREFERRED STOCK
|
(22,035
|
)
|
(92,289
|
)
|
(215,933
|
)
|
(199,625
|
)
|
|||||
NET
LOSS AVAILABLE TO COMMON SHAREHOLDERS
|
$
|
(1,609,565
|
)
|
$
|
(746,479
|
)
|
$
|
(4,333,617
|
)
|
$
|
(1,650,784
|
)
|
|
NET
LOSS AVAILABLE TO COMMON SHAREHOLDERS
|
|||||||||||||
PER
SHARE OF COMMON STOCK - BASIC AND
|
|||||||||||||
DILUTED
|
$
|
(0.15
|
)
|
$
|
(0.12
|
)
|
$
|
(0.55
|
)
|
$
|
(0.27
|
)
|
|
WEIGHTED
AVERAGE NUMBER OF SHARES USED
|
|||||||||||||
IN
CALCULATING NET LOSS PER SHARE, BASIC AND
|
|||||||||||||
DILUTED
|
10,681,032
|
6,314,531
|
7,922,195
|
6,201,126
|
September
30
2006
|
September
30
2005
|
||||||
(unaudited)
|
(unaudited)
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
|||||||
Net
loss
|
$
|
(4,117,684
|
)
|
$
|
(1,451,159
|
)
|
|
Adjustments
to reconcile net loss to net cash
|
|||||||
used
by operating activities:
|
|||||||
Depreciation
|
68,204
|
27,720
|
|||||
Noncash
interest expense
|
9,929
|
11,120
|
|||||
Noncash
salaries and consulting expense
|
439,684
|
225,944
|
|||||
Deferred
compensation
|
4,852
|
(165,000
|
)
|
||||
Changes
in operating assets and liabilities:
|
|||||||
Accounts
receivable - trade
|
(76,644
|
)
|
20,485
|
||||
Accounts
receivable - interest
|
(5,170
|
)
|
-
|
||||
Other
prepaid expenses
|
(132,729
|
)
|
6,616
|
||||
Deposits
|
(3,055
|
)
|
(4,551
|
)
|
|||
Accounts
payable
|
308,797
|
(60,821
|
)
|
||||
Deferred
revenue
|
(100,293
|
)
|
-
|
||||
Accrued
expenses
|
15,596
|
(33,011
|
)
|
||||
Milestone
payments
|
50,000
|
-
|
|||||
Total
adjustments
|
579,172
|
28,502
|
|||||
Net
cash used in operating activities
|
$
|
(3,538,512
|
)
|
$
|
(1,422,657
|
)
|
|
CASH
FLOWS FROM INVESTING ACTIVITIES
|
|||||||
Sale
(purchase) of short-term investments
|
(500,000
|
)
|
(1,600,000
|
)
|
|||
Purchase
of equipment
|
(143,693
|
)
|
(293,145
|
)
|
|||
Costs
of patents pending
|
(106,059
|
)
|
-
|
||||
Net
cash provided by (used in) investing activities
|
$
|
(749,752
|
)
|
$
|
(1,893,145
|
)
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES
|
|||||||
Issuance
of preferred stock
|
-
|
6,000,000
|
|||||
Financing
costs
|
(1,679,456
|
)
|
(48,939
|
)
|
|||
Dividends
|
(43
|
)
|
(31
|
)
|
|||
Issuance
of common stock - IPO
|
10,200,000
|
-
|
|||||
Exercise
of stock options
|
2,813
|
||||||
Issuance
of warrants
|
100
|
||||||
Proceeds
from convertible notes payable
|
-
|
(50,000
|
)
|
||||
Net
cash provided by (used in) financing activities
|
8,523,413
|
5,901,030
|
|||||
NET
INCREASE IN CASH AND EQUIVALENTS
|
4,235,149
|
2,585,228
|
|||||
CASH
AND EQUIVALENTS AT BEGINNING OF PERIOD
|
1,206,462
|
94,741
|
|||||
CASH
AND EQUIVALENTS AT END OF PERIOD
|
$
|
5,441,611
|
$
|
2,679,969
|
September
30
2006
|
September
30
2005
|
||||||
(unaudited)
|
(unaudited)
|
||||||
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:
|
|||||||
Issuance
of stock options to employees and consultants
|
$
|
439,684
|
$
|
345,144
|
|||
Conversion
of notes payable and accrued interest to common stock
|
$
|
313,003
|
- | ||||
Conversion
of preferred stock to common stock
|
$
|
5,308,142
|
- | ||||
Issuance
of common stock dividend to preferred shareholders
|
$
|
368,366
|
$
|
138,402
|
|||
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
|
|||
Exercise
of stock options into 59,600 common shares by consultant
|
$
|
-
|
$
|
119,200
|
Common
Stock
|
|||||||||||||
Shares
|
Amount
|
Additional
Paid-in Capital
|
Penalty
Shares
|
||||||||||
Balance
at January 1, 2005
|
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
|
- | |||||||||
Unrealized
loss on investments
|
-
|
- | |||||||||||
Accrue
unissued shares
|
-
|
-
|
(81,125
|
)
|
81,125
|
||||||||
Net
loss
|
-
|
-
|
-
|
- | |||||||||
Balance
at December 31, 2005
|
6,396,801
|
31,984
|
3,338,020
|
81,125
|
|||||||||
Issuance
of shares - previously accrued penalty shares (unaudited)
|
54,060
|
270
|
80,855
|
(81,125
|
)
|
||||||||
Issuance
of shares - stock dividend (unaudited)
|
184,183
|
922
|
367,445
|
- | |||||||||
Issue
penalty shares (unaudited)
|
15,295
|
76
|
(76
|
)
|
- | ||||||||
Issuance
of shares - initial public offering (unaudited)
|
1,700,000
|
8,500
|
10,191,500
|
||||||||||
Fees
associated with initital public offering (unaudited)
|
(1,890,444
|
)
|
|||||||||||
Conversion
of preferred stock to common stock (unaudited)
|
3,351,219
|
16,756
|
5,291,385
|
||||||||||
Conversion
of notes payable to common stock (unaudited)
|
124,206
|
621
|
312,382
|
||||||||||
Issuance
of options (unaudited)
|
-
|
-
|
439,684
|
- | |||||||||
Exercise
of options (unaudited)
|
625
|
3
|
2,810
|
||||||||||
Issuance
of warrants (unaudited)
|
100
|
||||||||||||
Unrealized
gain/(loss) on investments (unaudited)
|
-
|
-
|
-
|
- | |||||||||
Net
loss (unaudited)
|
-
|
-
|
-
|
- | |||||||||
Balance
at September 30, 2006 (unaudited)
|
11,826,389
|
$
|
59,132
|
$
|
18,133,661
|
$
|
-
|
Preferred
Stock
|
||||||||||||||||||||||
Shares
|
Amount
|
Additional
Paid-in
Capital
|
Penalty
Shares
|
Other
Comprehensive
Loss
|
Accumulated
Deficit
|
Total
|
||||||||||||||||
Balance
at January 1, 2005
|
-
|
-
|
-
|
-
|
-
|
(2,659,968
|
)
|
(374,214
|
)
|
|||||||||||||
Issuance
of shares - Series A financing
|
3,051,219
|
15,256
|
5,292,885
|
-
|
-
|
-
|
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
|
|||||||||||||||
Unrealized
loss on investments
|
-
|
-
|
-
|
-
|
(17,810
|
)
|
-
|
(17,810
|
)
|
|||||||||||||
Accrue
unissued shares
|
- | - |
(360,000
|
)
|
360,000
|
-
|
-
|
-
|
||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
(2,386,455
|
)
|
(2,386,455
|
)
|
|||||||||||||
Balance
at December 31, 2005
|
3,051,219
|
15,256
|
4,932,885
|
360,000
|
(17,810
|
)
|
(5,184,856
|
)
|
3,556,604
|
|||||||||||||
Issuance
of shares - previously accrued penalty shares (unaudited)
|
240,000
|
1,200
|
358,800
|
(360,000
|
)
|
-
|
-
|
-
|
||||||||||||||
Issuance
of shares - stock dividend (unaudited)
|
-
|
-
|
-
|
-
|
-
|
(368,410
|
)
|
(43
|
)
|
|||||||||||||
Issue
penalty shares (unaudited)
|
60,000
|
300
|
(300
|
)
|
-
|
-
|
-
|
-
|
||||||||||||||
Issuance
of shares - initial public offering (unaudited)
|
- | - | - | - | - | - |
10,200,000
|
|||||||||||||||
Fees
associated with initital public offering (unaudited)
|
- | - | - | - | - | - |
(1,890,444
|
)
|
||||||||||||||
Conversion
of preferred stock to common stock (unaudited)
|
(3,351,219
|
)
|
(16,756
|
)
|
(5,291,385
|
)
|
- | - | - |
-
|
||||||||||||
Conversion
of notes payable to common stock (unaudited)
|
313,003
|
|||||||||||||||||||||
Compensation
for stock options (unaudited)
|
-
|
-
|
-
|
-
|
-
|
-
|
439,684
|
|||||||||||||||
Exercise
of stock options (unaudited)
|
- | - | - | - | - | - |
2,813
|
|||||||||||||||
Issuance
of warrants (unaudited)
|
- | - | - | - | - | - |
100
|
|||||||||||||||
Unrealized
gain/(loss) on investments (unaudited)
|
-
|
-
|
-
|
-
|
10,257
|
-
|
10,257
|
|||||||||||||||
Net
loss (unaudited)
|
-
|
-
|
-
|
-
|
-
|
(4,117,684
|
)
|
(4,117,684
|
)
|
|||||||||||||
Balance
at September 30, 2006 (unaudited)
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
(7,553
|
)
|
$
|
(9,670,950
|
)
|
$
|
8,514,290
|
A.
|
Basis
of Presentation - The information at September 30, 2006 and September
30,
2005, and for the three and nine-month periods ended September
30, 2006
and September 30, 2005, is unaudited. In the opinion of management,
these
financial statements include all adjustments, consisting of normal
recurring adjustments, necessary for a fair presentation of the
results
for the interim periods presented. Interim results are not necessarily
indicative of results for a full year. These financial statements
should
be read in conjunction with Cleveland BioLabs, Inc.’s (“CBL” or the
“Company”) audited financial statements for the year ended December 31,
2005, which was contained in the Company’s Form SB-2 registration
statement filed with the United States Securities and Exchange
Commission.
|
B.
|
Use
of Estimates - The preparation of the unaudited financial statements
in
conformity with accounting principles generally accepted in the
United
States of America 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.
|
C.
|
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 $24,514 and $16,055
for the
quarters ended September 30, 2006 and 2005, respectively. Depreciation
expense was $68,206 and $27,720 for the nine months ended September
30,
2006 and 2005, respectively.
|
D.
|
Intellectual
Property - As a result of ongoing research and development efforts,
there
have been additional capitalized costs since December 31, 2005
associated
with the preparation, filing, and maintenance of certain intellectual
property rights. Gross capitalized patents pending costs are
$173,031 on
behalf of the Cleveland Clinic Foundation (“CCF”) for 12 patent
applications as of September 30, 2006. All of the 12 CCF patent
applications are still pending approval. The Company also has
submitted
two patent applications as a result of intellectual property
exclusively
developed and owned by the Company. Gross capitalized patents
pending
costs were $9,385 for the two patent applications as of September
30,
2006. These patent applications are still pending approval. If
these
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 17 years
or the
anticipated useful life of the patent. If the patent applications
are not
approved, the costs associated with the preparation and filing
of the
patent application will be expensed as part of selling, general
and
administrative expenses at that time.
|
E.
|
Working
Capital Line of Credit - To more effectively match short-term
investment
maturities with cash flow requirements, the Company has obtained
a working
capital line of credit which is fully-secured by the short-term
investments. This fully-secured, working capital line of credit
has a rate
of Prime minus 1%, a borrowing limit of $500,000, and an expiration
date
of July 1, 2007. At September 30, 2006, there were no outstanding
borrowings under this credit facility.
|
F.
|
Stock-Based
Compensation - The FASB issued SFAS No. 123 (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 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 safe-harbor
method
as described in SEC Staff Accounting Bulletin No. 107; and computes
an expected volatility based on similar high-growth, publicly-traded,
biotechnology companies. Compensation expense is recognized using
the
straight-line amortization method for all stock-based awards.
|
On
March 1, 2006, the Company granted 116,750 options pursuant to
stock award
agreements to certain employees and key consultants. On July
20, 2006 the
Company granted 45,000 fully-vested, stock options to independent
board
members pursuant to stock award agreements. The assumptions used
to value
these option grants using the Black-Scholes option valuation
model are as
follows:
|
March 1, 2006
|
July
20, 2006
|
||||||
Risk-free
interest rate
|
4.66
|
%
|
5.04
|
%
|
|||
Expected
dividend yield
|
0
|
%
|
0
|
%
|
|||
Expected
life
|
5
years
|
5
years
|
|||||
Expected
volatility
|
75.11
|
%
|
71.43
|
%
|
For
the quarter ended September 30, 2006, the Company recognized
$72,489 in
expense for stock based compensation under SFAS No. 123 (R).
The Company
recognized a total of $439,684 and $345,144 in expense for options
for the
nine-months ended September 30, 2006, and 2005, respectively.
|
The
weighted average, estimated fair values of stock options granted
during
the nine-month period ended September 30, 2006 was
$3.14.
|
The
following tables summarize the stock option activity for the
nine-months
ended September 30, 2006 and 2005.
|
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,
September 30, 2006
|
483,490
|
$
|
2.17
|
9.02
|
||||||
Exercisable,
September 30, 2006
|
239,433
|
$
|
2.27
|
9.03
|
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
|
294,240
|
0.66
|
||||||||
Exercised
|
-
|
-
|
||||||||
Forfeited,
Canceled
|
-
|
-
|
||||||||
Outstanding,
September 30, 2005
|
304,240
|
$
|
0.74
|
9.74
|
||||||
Exercisable,
September 30, 2005
|
83,560
|
$
|
3.00
|
9.71
|
Three
Months Ended
|
Nine
Months Ended
|
||||||||||||
September
30 2006
|
September
30 2005
|
September
30 2006
|
September
30 2005
|
||||||||||
(unaudited)
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
||||||||||
NET
LOSS AVAILABLE TO COMMON SHAREHOLDERS
|
$
|
(1,609,565
|
)
|
$
|
(746,479
|
)
|
$
|
(4,333,617
|
)
|
$
|
(1,650,784
|
)
|
|
NET
LOSS AVAILABLE TO COMMON SHAREHOLDERS PER SHARE OF COMMON STOCK
- BASIC
AND DILUTED
|
$
|
(0.15
|
)
|
$
|
(0.12
|
)
|
$
|
(0.55
|
)
|
$
|
(0.27
|
)
|
|
WEIGHTED
AVERAGE NUMBER OF SHARES USED
|
|||||||||||||
IN
CALCULATING NET LOSS PER SHARE, BASIC AND DILUTED
|
10,681,032 | 6,314,531 | 7,922,195 | 6,201,126 |
|
Operating
Leases
|
|||
2006
balance of year
|
$
|
43,745
|
||
2007
|
155,997
|
|||
2008
|
53,137
|
|||
2009
and
Beyond
|
1,935
|
|||
|
$
|
254,814
|
|
Number of
Options
|
Weighted Average
Exercise
Price
|
|||||
Outstanding
at December 31,
2003
|
—
|
N/A
|
|||||
Granted
|
—
|
N/A
|
|||||
Exercised
|
—
|
N/A
|
|||||
Forfeited
|
—
|
N/A
|
|||||
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 September 30, 2006
|
483,490
|
$
|
2.17
|
|
Outstanding
|
Exercisable
|
|||||||||
Exercise
Price
|
Number
of
Options
|
Weighted
Average
Years
to
Expiration
|
Number
of
Options
|
||||||||
$ |
0.66
|
190,000
|
8.75
|
95,000
|
|||||||
0.67
|
104,240
|
8.75
|
52,120
|
||||||||
2.00
|
20,000
|
9.17
|
8,750
|
||||||||
3.00
|
10,000
|
8.42
|
10,000
|
||||||||
4.50
|
114,250
|
9.42
|
28,563
|
||||||||
6.00
|
45,000
|
9.80
|
45,000
|
||||||||
Total
|
483,490
|
9.02
|
239,433
|
· |
Protectans
(CBLB500 and CBLB600 series) are modified proteins of microbes
and tumors
that protect cells from apoptosis, and, as a result, have a broad
spectrum
of potential applications. These 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 side effects.
|
· |
Curaxins
(CBLC100 series) are 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 renal cell carcinoma, or RCC (a highly fatal form of
kidney
cancer), soft-tissue sarcoma and hormone refractory prostate
cancer.
|
|
Quarter
Ended Sept. 30,
2006
|
Quarter
Ended Sept. 30,
2005
|
Nine
Months Ended Sept. 30,
2006
|
Nine
Months Ended Sept. 30,
2005
|
Year
Ended
December 31,
2005
|
|||||||||||
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
||||||||||||
Revenues
|
$
|
323,368
|
$
|
566,194
|
$
|
1,476,787
|
$
|
764,125
|
$
|
1,138,831
|
||||||
Operating
expenses
|
1,989,831
|
1,253,412
|
5,708,992 | 2,285,678 |
3,626,664
|
|||||||||||
Net
interest expense (income)
|
(78,933
|
)
|
(33,028
|
)
|
(114,521 | ) | (70,394 | ) |
(101,378
|
)
|
||||||
Net
income (loss)
|
$
|
(1,587,530
|
)
|
$
|
(654,190
|
)
|
$
|
(4,117,684
|
)
|
$
|
(1,451,159
|
)
|
$
|
(2,386,455
|
)
|
Agency
|
Program
|
Amount
|
Period
of
Performance
|
Revenue
2006
(thru
Sept.
30)
|
Revenue
2005
(thru
Sept.
30)
|
Revenue
2005
|
|||||||||||||
|
|
|
|
(unaudited)
|
(unaudited)
|
|
|||||||||||||
NIH
|
Phase
I NIH SBIR program
|
$
|
100,000
|
08/2004-04/2005
|
—
|
$
|
49,999
|
$
|
49,998
|
||||||||||
NIH
|
NIH
SBIR Contract, Topic 186
|
$
|
100,000
|
09/2004-03/2005
|
—
|
—
|
—
|
||||||||||||
NIH
|
Phase
I NIH STTR program
|
$
|
100,000
|
08/2004-04/2005
|
—
|
—
|
—
|
||||||||||||
DARPA
|
DARPA,
program BAA04-12
|
$
|
475,000
|
11/2004-08/2005
|
—
|
$
|
283,185
|
$
|
283,185
|
||||||||||
NIH
|
Phase
I NIH SBIR program
|
$
|
100,000
|
06/2005-01/2006
|
—
|
$
|
100,000
|
$
|
100,000
|
||||||||||
NIH
|
BioShield
program (NIAID)
|
|
$
|
1,500,000
|
07/2005-01/2007
|
$
|
1,100,293
|
$
|
150,000
|
$
|
399,707
|
||||||||
NIH
|
Phase
I NIH SBIR program
|
$
|
100,000
|
08/2005-01/2006
|
$
|
33,334
|
$
|
16,666
|
$
|
66,666
|
|||||||||
NIH
|
Phase
I NIH SBIR program
|
$
|
100,000
|
09/2005-02/2006
|
—
|
$
|
25,000
|
$
|
100,000
|
||||||||||
NASA
|
Phase
I NASA STTR program
|
$
|
100,000
|
01/2006-01/2007
|
$
|
33,197
|
$
|
—
|
$
|
—
|
|||||||||
NIH
|
Phase
II NIH SBIR program
|
$
|
750,000
|
07/2006-06/2008
|
$ |
88,320
|
$ |
—
|
$ |
—
|
|||||||||
NIH
|
NCI
Contract
|
$
|
750,000
|
09/2006-08/2008
|
$
|
16,643
|
|||||||||||||
Totals
|
$
|
1,271,787
|
$
|
624,850
|
$
|
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
|
$
|
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
|
Exhibit
Number
|
|
Description
of Document
|
31.1
|
Certification
of Michael Fonstein, Chief Executive Officer, pursuant to Section
302 of
the Sarbanes Oxley Act of 2002.
|
|
31.2
|
Certification
of John A. Marhofer, Jr., Chief Financial Officer, pursuant to
Section 302
of the Sarbanes Oxley Act of 2002.
|
|
32.1
|
Certification
Pursuant To 18 U.S.C. Section 1350
|
CLEVELAND
BIOLABS, INC.
|
||
|
|
|
Dated: November 13, 2006 | By: | /s/ JOHN A. MARHOFER, JR. |
John
A. Marhofer, Jr.
Chief
Financial Officer
(Principal
Financial Officer)
|
CLEVELAND
BIOLABS, INC.
|
||
|
|
|
Dated:
November 13, 2006
|
By: | /s/ MICHAEL FONSTEIN. |
Michael
Fonstein
Chief
Executive Officer
(Principal
Executive Officer)
|
Date: November 13, 2006 | By: | /s/ Michael Fonstein |
Michael
Fonstein
Chairman
and Chief Executive Officer
(Principal
Executive Officer)
|
Date:
November 13, 2006
|
By: | /s/ John A. Marhofer, Jr. |
John
A. Marhofer, Jr.
Chief
Financial Officer
(Principal
Financial Officer)
|
Dated:
November 13, 2006
|
By: | /s/ Michael Fonstein |
Michael Fonstein
Chairman
and Chief Executive Officer
(Principal
Executive Officer)
|
Dated:
November 13, 2006
|
By: | /s/ John A. Marhofer, Jr |
John
A. Marhofer, Jr.
Chief
Financial Officer
(Principal
Financial Officer)
|
*
|
This
certification accompanies the Periodic 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 Periodic
Report), irrespective of any general incorporation language contained
in
such filing.
|