(Mark
One)
|
|
þ
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For
the quarterly period ended March 31, 2008
OR
|
|
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
|
|
For
the transition period from ____ to ____
|
|
|
|
Commission
file number 001-32954
CLEVELAND
BIOLABS, INC.
(Exact
name of registrant as specified in its
charter)
|
DELAWARE
|
|
20-0077155
|
(State
or other jurisdiction of incorporation or organization)
|
|
(I.R.S.
Employer Identification No.)
|
|
|
|
73
High Street, Buffalo, New
York
|
|
14203
|
(Address
of principal executive offices)
|
|
(Zip
Code)
|
|
||
(Registrant’s
telephone number, including area code) (716)
849-6810
_______________________________________________
(Former
name, former address and former fiscal year,
if
changed since last report)
|
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨
|
Smaller
reporting company þ
|
TABLE
OF CONTENTS
|
||||
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|
PAGE
|
PART
I - FINANCIAL INFORMATION
|
|
|
||
|
|
|
|
|
ITEM
1:
|
Financial
Statements
|
|
|
|
|
|
|
|
|
|
Balance
Sheets as of March 31, 2008 and December 31, 2007
|
|
3-4
|
|
|
|
|
|
|
|
Statements
of Operations For Three Months Ended March 31, 2008 and
2007
|
|
5
|
|
|
|
|
|
|
|
Statements
of Cash Flows For Three Months Ended March 31, 2008 and
2007
|
|
6
|
|
|
|
|
|
|
|
Statement
of Stockholders' Equity from January 1, 2007 to December 31, 2007
and to
March 31, 2008
|
|
7
|
|
|
|
|
|
|
|
Notes
to Financial Statements
|
|
10
|
|
|
|
|
|
|
ITEM
2:
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
|
21
|
|
|
|
|
|
|
ITEM
3:
|
Quantitative
and Qualitative Disclosures About Market Risk
|
|
35
|
|
|
|
|
|
|
ITEM
4:
|
Controls
and Procedures
|
|
35
|
|
|
|
|
|
|
PART
II - OTHER INFORMATION
|
|
|
||
|
|
|
|
|
ITEM
1:
|
Legal
Proceedings
|
|
36
|
|
|
|
|
|
|
ITEM
2:
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
|
36
|
|
|
|
|
|
|
ITEM
3:
|
Defaults
Upon Senior Securities
|
|
36
|
|
|
|
|
|
|
ITEM
4:
|
Submission
of Matters to a Vote of Securities Holders
|
36
|
||
|
|
|
|
|
ITEM
5:
|
Other
Information
|
|
36
|
|
|
|
|
|
|
ITEM
6:
|
Exhibits
|
|
36
|
|
|
|
|
|
|
Signatures
|
|
|
37
|
CLEVELAND
BIOLABS, INC.
|
|||||||
BALANCE
SHEETS
|
March
31, 2008 (unaudited) and December 31,
2007
|
March
31
|
December
31
|
||||||
2008
|
2007
|
||||||
ASSETS
|
(unaudited)
|
||||||
CURRENT
ASSETS
|
|||||||
Cash
and equivalents
|
$
|
9,102,383
|
$
|
14,212,189
|
|||
Short-term
investments
|
1,000,000
|
1,000,000
|
|||||
Accounts
receivable:
|
|||||||
Trade
|
527,476
|
163,402
|
|||||
Interest
|
42,634
|
50,042
|
|||||
Other
prepaid expenses
|
440,020
|
325,626
|
|||||
Total
current assets
|
11,112,513
|
15,751,259
|
|||||
EQUIPMENT
|
|||||||
Computer
equipment
|
263,344
|
258,089
|
|||||
Lab
equipment
|
1,016,331
|
966,517
|
|||||
Furniture
|
274,904
|
274,903
|
|||||
1,554,579
|
1,499,509
|
||||||
Less
accumulated depreciation
|
390,298
|
313,489
|
|||||
1,164,281
|
1,186,020
|
||||||
OTHER
ASSETS
|
|||||||
Intellectual
property
|
609,846
|
459,102
|
|||||
Deposits
|
26,327
|
25,445
|
|||||
636,173
|
484,547
|
||||||
TOTAL
ASSETS
|
$
|
12,912,967
|
$
|
17,421,826
|
CLEVELAND
BIOLABS, INC.
|
|||||||
BALANCE
SHEETS
|
|||||||
March
31, 2008 (unaudited) and December 31,
2007
|
March
31
|
December
31
|
||||||
2008
|
2007
|
||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
(unaudited)
|
||||||
CURRENT
LIABILITIES
|
|||||||
Accounts
payable
|
$
|
1,266,391
|
$
|
710,729
|
|||
Milestone
payable
|
50,000
|
-
|
|||||
Deferred
revenue
|
1,579,860
|
1,670,610
|
|||||
Dividends
payable
|
51,462
|
396,469
|
|||||
Accrued
expenses
|
249,236
|
449,774
|
|||||
Total
current liabilities
|
3,196,949
|
3,227,582
|
|||||
STOCKHOLDERS'
EQUITY
|
|||||||
Series
B convertible preferred stock, $.005 par value Authorized -
10,000,000 shares at March 31, 2008 and December 31,
2007
|
|||||||
Issued
and outstanding 3,524,687 and 3,870,267 shares at March 31, 2008
and December 31, 2007, respectively
|
17,623
|
19,351
|
|||||
Additional
paid-in capital
|
22,208,269
|
24,383,695
|
|||||
Common
stock, $.005 par value Authorized - 40,000,000 shares at March 31,
2008 and December 31, 2007
|
|||||||
Issued
and outstanding 13,355,657 and 12,899,241shares at March 31, 2008
and December 31, 2007, respectively
|
66,778
|
64,496
|
|||||
Additional
paid-in capital
|
32,747,897
|
30,764,914
|
|||||
Accumulated
other comprehensive income (loss)
|
-
|
-
|
|||||
Accumulated
deficit
|
(45,324,549
|
)
|
(41,038,212
|
)
|
|||
Total
stockholders' equity
|
9,716,018
|
14,194,244
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
12,912,967
|
$
|
17,421,826
|
CLEVELAND
BIOLABS, INC.
|
|||||
STATEMENT
OF OPERATIONS
|
|||||
Three
Months Ending March 31, 2008 and 2007 (unaudited)
|
|||||
Three
Months Ended
|
|||||||
March
31
|
March
31
|
||||||
2008
|
2007
|
||||||
(unaudited)
|
(unaudited)
|
||||||
REVENUES
|
|||||||
Grant
and contract
|
$
|
556,324
|
$
|
271,445
|
|||
Service
|
120,000
|
50,000
|
|||||
676,324
|
321,445
|
||||||
OPERATING
EXPENSES
|
|||||||
Research
and development
|
3,551,386
|
3,528,600
|
|||||
Selling,
general and administrative
|
1,193,114
|
994,319
|
|||||
Total
operating expenses
|
4,744,500
|
4,522,919
|
|||||
LOSS
FROM OPERATIONS
|
(4,068,176
|
)
|
(4,201,474
|
)
|
|||
OTHER
INCOME
|
|||||||
Interest
income
|
145,127
|
96,429
|
|||||
Sublease
revenue
|
2,656
|
-
|
|||||
Gain
on disposal of fixed assets
|
1,394
|
-
|
|||||
Gain
on investment
|
3,292
|
-
|
|||||
Total
other income
|
152,469
|
96,429
|
|||||
OTHER
EXPENSE
|
|||||||
Corporate
relocation
|
54,344
|
-
|
|||||
Interest
expense
|
-
|
1,088
|
|||||
Total
other expense
|
54,344
|
1,088
|
|||||
NET
LOSS
|
$
|
(3,970,051
|
)
|
$
|
(4,106,133
|
)
|
|
DIVIDENDS
ON CONVERTIBLE PREFERRED STOCK
|
(316,286
|
)
|
-
|
||||
NET
LOSS AVAILABLE TO COMMON SHAREHOLDERS
|
$
|
(4,286,337
|
)
|
$
|
(4,106,133
|
)
|
|
NET
LOSS AVAILABLE TO COMMON SHAREHOLDERS PER SHARE OF COMMON STOCK -
BASIC AND DILUTED
|
$
|
(0.33
|
)
|
$
|
(0.35
|
)
|
|
WEIGHTED
AVERAGE NUMBER OF SHARES USED IN CALCULATING NET LOSS PER SHARE,
BASIC AND DILUTED
|
13,143,686
|
11,854,027
|
CLEVELAND
BIOLABS, INC.
|
|||||
STATEMENTS
OF CASH FLOWS
|
|||||
For
the Three Months Ended March 31, 2008 and 2007
(unaudited)
|
|||||
March
31
|
March
31
|
||||||
2008
|
2007
|
||||||
(unaudited)
|
(unaudited)
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
|||||||
Net
loss
|
$
|
(3,970,051
|
)
|
$
|
(4,106,133
|
)
|
|
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
|||||||
Depreciation
|
76,809
|
27,666
|
|||||
Noncash
salaries and consulting expense
|
(192,626
|
)
|
375,301
|
||||
Changes
in operating assets and liabilities:
|
|||||||
Accounts
receivable - trade
|
(364,074
|
)
|
(54,298
|
)
|
|||
Accounts
receivable - interest
|
7,407
|
(10,605
|
)
|
||||
Other
prepaid expenses
|
(114,394
|
)
|
(78,293
|
)
|
|||
Deposits
|
(881
|
)
|
-
|
||||
Accounts
payable
|
555,663
|
467,030
|
|||||
Deferred
revenue
|
(90,749
|
)
|
-
|
||||
Accrued
expenses
|
(200,539
|
)
|
98,866
|
||||
Milestone
payments
|
50,000
|
250,000
|
|||||
Total
adjustments
|
(273,384
|
)
|
1,075,667
|
||||
Net
cash (used in) provided by operating activities
|
(4,243,435
|
)
|
(3,030,466
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
|||||||
Sale
of short-term investments
|
-
|
1,300,000
|
|||||
Purchase
of short-term investments
|
-
|
(17,999,965
|
)
|
||||
Issuance
of notes receivable
|
-
|
(250,000
|
)
|
||||
Purchase
of equipment
|
(55,070
|
)
|
(11,640
|
)
|
|||
Costs
of patents pending
|
(150,743
|
)
|
(93,193
|
)
|
|||
Net
cash (used in) provided by investing activities
|
(205,813
|
)
|
(17,054,798
|
)
|
|||
CASH
FLOWS FROM FINANCING ACTIVITIES
|
|||||||
Issuance
of preferred stock
|
-
|
30,020,984
|
|||||
Financing
costs
|
-
|
(1,148,106
|
)
|
||||
Dividends
|
(661,295
|
)
|
-
|
||||
Issuance
of common stock
|
-
|
118,410
|
|||||
Exercise
of stock options
|
737
|
-
|
|||||
Net
cash (used in) provided by financing activities
|
(660,558
|
)
|
28,991,288
|
||||
|
|||||||
INCREASE
(DECREASE) IN CASH AND EQUIVALENTS
|
(5,109,806
|
)
|
8,906,024
|
||||
|
|||||||
CASH
AND EQUIVALENTS AT BEGINNING OF PERIOD
|
14,212,189
|
3,061,993
|
|||||
|
|||||||
CASH
AND EQUIVALENTS AT END OF PERIOD
|
$
|
9,102,383
|
$
|
11,968,017
|
|||
|
|||||||
|
|||||||
|
|||||||
Supplemental
disclosures of cash flow information:
|
|||||||
Cash
paid during the period for interest
|
$
|
-
|
$
|
-
|
|||
Cash
paid during the year for income taxes
|
$
|
-
|
|||||
Supplemental
schedule of noncash financing activities:
|
|||||||
Issuance
of stock options to employees, consultants, and independent board
members
|
$
|
728,077
|
$
|
375,301
|
|||
Conversion
of preferred stock to common stock
|
$
|
2,177,154
|
$
|
-
|
|||
Expense
recapture of expense for options expensed in 2007 but issued in
2008
|
$
|
(1,459,425
|
)
|
$
|
-
|
||
Issuance
of shares to consultants and employees
|
$
|
521,000
|
$
|
-
|
|||
Accrual
of preferred stock dividends
|
$
|
316,287
|
$
|
-
|
|||
Amortization
of restricted shares issued to employees
|
$
|
17,722
|
$
|
-
|
CLEVELAND
BIOLABS, INC.
|
||||||||
STATEMENTS
OF STOCKHOLDERS' EQUITY AND COMPREHENSIVE LOSS
|
||||||||
Period
From January 1, 2007 to December 31, 2007 and to
|
||||||||
March
31, 2008 (unaudited)
|
Stockholders'
Equity
|
||||||||||
Common
Stock
|
||||||||||
Additional
|
||||||||||
Paid-in
|
||||||||||
Shares
|
Amount
|
Capital
|
||||||||
Balance
at January 1, 2007
|
11,826,389
|
$
|
59,132
|
$
|
18,314,097
|
|||||
Issuance
of options
|
-
|
-
|
3,401,499
|
|||||||
Options
to be issued in 2008
|
-
|
-
|
2,687,355
|
|||||||
Issuance
of shares - Series B financing
|
-
|
-
|
-
|
|||||||
Fees
associated with Series B Preferred offering
|
-
|
-
|
-
|
|||||||
Issuance
of restricted shares
|
190,000
|
950
|
1,699,500
|
|||||||
Exercise
of options
|
126,046
|
630
|
110,650
|
|||||||
Exercise
of warrants
|
48,063
|
240
|
90,275
|
|||||||
Conversion
of Series B Preferred Shares to Common
|
708,743
|
3,544
|
4,461,537
|
|||||||
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
|
$
|
30,764,914
|
|||||
Issuance
of options
|
-
|
-
|
728,077
|
|||||||
Partial
recapture of expense for options expensed in 2007 but issued in
2008
|
-
|
-
|
(1,459,425
|
)
|
||||||
|
||||||||||
Issuance
of restricted shares
|
105,000
|
525
|
520,475
|
|||||||
Amortization
of restricted shares
|
-
|
-
|
17,722
|
|||||||
Exercise
of options
|
5,836
|
29
|
708
|
|||||||
Conversion
of Series B Preferred Shares to Common
|
345,580
|
1,728
|
2,175,426
|
|||||||
Dividends
on Series B Preferred shares
|
-
|
-
|
-
|
|||||||
Net
Loss
|
-
|
-
|
-
|
|||||||
|
||||||||||
|
||||||||||
Other
comprehensive income Unrealized gains (losses) on short term
investmentsChanges
in unrealized holding gains (losses) arising
during period
|
-
|
-
|
-
|
|||||||
Less
reclassification adjustment for (gains) lossesincluded
in net loss
|
-
|
-
|
-
|
|||||||
Comprehensive
loss
|
||||||||||
Balance
at March 31, 2008
|
13,355,657
|
$
|
66,778
|
$
|
32,747,897
|
CLEVELAND
BIOLABS, INC.
|
||||||||
STATEMENTS
OF STOCKHOLDERS' EQUITY AND COMPREHENSIVE LOSS
|
||||||||
Period
From January 1, 2007 to December 31, 2007 and to
|
||||||||
March
31, 2008 (unaudited)
|
Stockholders'
Equity
|
||||||||||
Preferred
Stock
|
||||||||||
Additional
|
||||||||||
Paid-in
|
||||||||||
Shares
|
Amount
|
Capital
|
||||||||
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
|
32,030,175
|
|||||||
Fees
associated with Series B Preferred offering
|
-
|
-
|
(3,184,943
|
)
|
||||||
Issuance
of restricted shares
|
-
|
-
|
-
|
|||||||
Exercise
of options
|
-
|
-
|
-
|
|||||||
Exercise
of warrants
|
-
|
-
|
-
|
|||||||
Conversion
of Series B Preferred Shares to Common
|
(708,743
|
)
|
(3,544
|
)
|
(4,461,537
|
)
|
||||
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
|
$
|
24,383,695
|
|||||
Issuance
of options
|
-
|
-
|
-
|
|||||||
Partial
recapture of expense for options expensed in 2007 but issued in
2008
|
-
|
-
|
-
|
|||||||
Issuance
of restricted shares
|
-
|
-
|
-
|
|||||||
Amortization
of restricted shares
|
-
|
-
|
-
|
|||||||
Exercise
of options
|
-
|
-
|
-
|
|||||||
Conversion
of Series B Preferred Shares to Common
|
(345,580
|
)
|
(1,728
|
)
|
(2,175,426
|
)
|
||||
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 March 31, 2008
|
3,524,687
|
$
|
17,623
|
$
|
22,208,269
|
CLEVELAND
BIOLABS, INC.
|
|||||||||||||
STATEMENTS
OF STOCKHOLDERS' EQUITY AND COMPREHENSIVE LOSS
|
|||||||||||||
Period
From January 1, 2007 to December 31, 2007 and to
|
|||||||||||||
March
31, 2008 (unaudited)
|
|||||||||||||
Stockholders'
Equity
|
|||||||||||||
Other
|
Comprehensive
|
||||||||||||
Comprehensive
|
Accumulated
|
Income
|
|||||||||||
Income/(Loss)
|
Deficit
|
Total
|
(Loss)
|
||||||||||
Balance
at January 1, 2007
|
$
|
(4,165
|
)
|
$
|
(12,775,910
|
)
|
$
|
5,593,154
|
|||||
Issuance
of options
|
-
|
-
|
3,401,499
|
||||||||||
Options
to be issued in 2008
|
-
|
-
|
2,687,355
|
||||||||||
Issuance
of shares - Series B financing
|
-
|
-
|
32,053,070
|
||||||||||
Fees
associated with Series B Preferred offering
|
-
|
-
|
(3,184,943
|
)
|
|||||||||
Issuance
of restricted shares
|
-
|
-
|
1,700,450
|
||||||||||
Exercise
of options
|
-
|
-
|
111,280
|
||||||||||
Exercise
of warrants
|
-
|
-
|
90,515
|
||||||||||
Conversion
of Series B Preferred Shares to Common
|
-
|
-
|
-
|
||||||||||
Dividends
on Series B Preferred shares
|
-
|
(1,265,800
|
)
|
(1,265,800
|
)
|
||||||||
Net
Loss
|
-
|
(26,996,502
|
)
|
(26,996,502
|
)
|
(26,996,502
|
)
|
||||||
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
|
4,165
|
-
|
4,165
|
$
|
4,165
|
||||||||
Comprehensive
loss
|
$
|
(26,992,337
|
)
|
||||||||||
Balance
at December 31, 2007
|
$
|
-
|
$
|
(41,038,212
|
)
|
$
|
14,194,244
|
||||||
Issuance
of options
|
-
|
-
|
728,077
|
||||||||||
Partial
recapture of expense for options expensed in 2007
but
issued in 2008
|
-
|
-
|
(1,459,425
|
)
|
|||||||||
|
|||||||||||||
Issuance
of restricted shares
|
-
|
-
|
521,000
|
||||||||||
Amortization
of restricted shares
|
-
|
-
|
17,722
|
||||||||||
Exercise
of options
|
-
|
-
|
737
|
||||||||||
Conversion
of Series B Preferred Shares to Common
|
-
|
-
|
-
|
||||||||||
Dividends
on Series B Preferred shares
|
-
|
(316,286
|
)
|
(316,286
|
)
|
||||||||
Net
Loss
|
-
|
(3,970,051
|
)
|
(3,970,051
|
)
|
(3,970,051
|
)
|
||||||
Other
comprehensive income
|
|||||||||||||
Unrealized
gains (losses) on short term investments
|
|||||||||||||
Changes
in unrealized holding gains (losses)
arising
during person
|
-
|
-
|
-
|
$
|
-
|
||||||||
Less
reclassification adjustment for (gains) losses
|
|||||||||||||
included
in net loss
|
-
|
-
|
-
|
$
|
-
|
||||||||
Comprehensive
loss
|
$
|
(3,970,051
|
)
|
||||||||||
Balance
at March 31, 2008
|
$
|
-
|
$
|
(45,324,549
|
)
|
$
|
9,716,018
|
A.
|
Basis
of Presentation - The information at March 31, 2008 and March 31,
2007,
and for the three-months ended March 31, 2008 and March 31, 2007,
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
CBLI’s audited financial statements for the year ended December 31, 2007,
which were contained in the Company’s Annual Report on Form 10-K filed
with the U.S. Securities and Exchange
Commission.
|
B.
|
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.
|
C.
|
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.
|
D.
|
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 March 31, 2008 and December 31,
2007.
|
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 $76,809, and $27,666 for
the
three-months ended March 31, 2008 and 2007, 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.
|
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.
|
H.
|
Line
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 $1,000,000, and expires on September 25, 2008. At March
31, 2008
and December 31, 2007, there were no outstanding borrowings under
this
credit facility.
|
I.
|
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.
|
J.
|
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.
|
K.
|
Revenue
Recognition - The Company recognizes revenue in accordance with Staff
Accounting Bulletin No. 104, “Revenue Recognition”, or SAB 104, and
Statement of Financial Accounting Standards No. 116, or SFAS 116.
Revenue
sources consist of government grants, government contracts and commercial
development contracts.
|
L.
|
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.
|
M.
|
Research
and Development - Research and development expenses consist primarily
of
costs associated with salaries and related expenses for personnel,
costs
of materials used in R&D, costs of facilities and costs incurred in
connection with third-party collaboration efforts. Expenditures relating
to research and development are expensed as
incurred.
|
N.
|
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 the aggregate number of shares of stock which may be
delivered under the Plan shall 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. For the three-months ended March
31,
2008, there were 719,948 options and 120,000 shares granted under
the
Plan, and as of March 31, 2008 there were 1,424,948 stock options
and
310,000 shares granted under the Plan leaving 265,052 shares of stock
to
be awarded under the Plan.
A
proposed amendment and restatement of the Plan, which among other
things,
reserved an additional 2,000,000 shares, was submitted to the stockholders
for approval at the 2008 Annual
Meeting.
|
O.
|
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.
|
2008
YTD
|
2007
|
||||||
Risk-free
interest rate
|
2.61-3.58
|
%
|
3.38-5.11
|
%
|
|||
Expected
dividend yield
|
0
|
%
|
0
|
%
|
|||
Expected
life
|
5-6
years
|
2.74-6
years
|
|||||
Expected
volatility
|
53.44-80.25
|
%
|
71.86-76.29
|
%
|
Weighted
|
Weighted
|
|||||||||
Average
|
Average
|
|||||||||
Exercise
|
Remaining
|
|||||||||
Price
per
|
Contractual
|
|||||||||
Shares
|
Share
|
Term
(in Years)
|
||||||||
Outstanding,
December 31, 2007
|
1,011,740
|
$
|
7.29
|
|||||||
Granted
|
719,948
|
$
|
4.89
|
|||||||
Exercised
|
11,099
|
$
|
1.87
|
|||||||
Forfeited,
Canceled
|
0
|
n/a
|
||||||||
Outstanding,
March 31, 2008
|
1,720,589
|
$
|
6.32
|
9.09
|
||||||
Exercisable,
March 31, 2008
|
1,256,747
|
$
|
5.75
|
9.13
|
Weighted
|
Weighted
|
|||||||||
Average
|
Average
|
|||||||||
Exercise
|
Remaining
|
|||||||||
Price
per
|
Contractual
|
|||||||||
Shares
|
Share
|
Term
(in Years)
|
||||||||
Outstanding,
December 31, 2006
|
483,490
|
$
|
2.17
|
|||||||
Granted
|
119,500
|
$
|
9.09
|
|||||||
Exercised
|
20,000
|
$
|
2.50
|
|||||||
Forfeited,
Canceled
|
0
|
n/a
|
||||||||
Outstanding,
March 31, 2007
|
582,990
|
$
|
3.58
|
8.81
|
||||||
Exercisable,
March 31, 2007
|
301,120
|
$
|
3.57
|
8.81
|
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.
|
Quarter
Ended
|
Quarter
Ended
|
||||||
March
31, 2008
|
March
31, 2007
|
||||||
Net
loss available to common stockholders
|
$
|
(4,286,337
|
)
|
$
|
(4,106,133
|
)
|
|
Net
loss per share, basic and diluted
|
$
|
(0.33
|
)
|
$
|
(0.35
|
)
|
|
Weighted-average
shares used in computing net
|
13,143,686
|
11,854,027
|
|||||
loss
per share, basic and diluted
|
Q.
|
Concentrations
of Risk - Grant and contract revenue was comprised wholly from grants
and
contracts issued by the federal government and accounted for 82.3%
and
84.4% of total revenue for the three-months ended March 31, 2008
and 2007,
respectively. Although the Company anticipates ongoing federal grant
and
contract 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 and into an agreement
for
assay development and validation with foreign third parties 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 and the Great British Pound, or GBP. As of March
31,
2008, the Company is obligated to make payments under the agreements
of
74,350 Euros and 144,323 GBP. The Company has established means to
purchase forward contracts to hedge against this risk. As of March
31,
2008, the Company has no commitments for Euros or GBP.
|
S.
|
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.
|
Operating
|
|||||||
Leases
|
|||||||
2008
|
Remaining
Three Quarters
|
$
|
249,539
|
||||
2009
|
349,782
|
||||||
2010
|
343,657
|
||||||
2011
|
311,803
|
||||||
2012
|
144,375
|
||||||
$
|
1,399,156
|
Weighted
Average
|
|||||||
Shares
|
Exercise
Price Per Share
|
||||||
Outstanding,
December 31, 2007
|
1,011,740
|
$
|
7.29
|
||||
Granted
|
719,948
|
$
|
4.89
|
||||
Exercised
|
11,099
|
$
|
1.87
|
||||
Forfeited,
Canceled
|
0
|
n/a
|
|||||
Outstanding,
March 31, 2008
|
1,720,589
|
$
|
6.32
|
Weighted
Average
|
|||||||
Shares
|
Exercise
Price Per Share
|
||||||
Outstanding,
December 31, 2006
|
483,490
|
$
|
2.17
|
||||
Granted
|
119,500
|
$
|
9.09
|
||||
Exercised
|
20,000
|
$
|
2.50
|
||||
Forfeited,
Canceled
|
0
|
n/a
|
|||||
Outstanding,
March 31, 2007
|
582,990
|
$
|
3.58
|
Weighted
Average
|
|||||||
Warrants
|
Exercise
Price Per Share
|
||||||
Outstanding,
December 31, 2007
|
3,453,268
|
$
|
8.86
|
||||
Granted
|
0
|
n/a
|
|||||
Exercised
|
0
|
n/a
|
|||||
Forfeited,
Canceled
|
0
|
n/a
|
|||||
Outstanding,
March 31, 2008
|
3,453,268
|
$
|
8.86
|
Weighted
Average
|
|||||||
Warrants
|
Exercise
Price Per Share
|
||||||
Outstanding,
December 31, 2006
|
814,424
|
$
|
3.36
|
||||
Granted
|
2,632,602
|
$
|
10.42
|
||||
Exercised
|
44,205
|
$
|
2.00
|
||||
Forfeited,
Canceled
|
-
|
n/a
|
|||||
Outstanding,
March 31, 2007
|
3,402,821
|
$
|
8.84
|
· |
Protectans
- modified factors of microbes and tumors 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 renal
cell
carcinoma, or RCC (a highly fatal form of kidney cancer), soft-tissue
sarcoma, and hormone-refractory prostate
cancer.
|
· |
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
anticipate having a developed drug submitted for FDA approval for
these
non-medical applications within 18-30 months.
|
· |
Leveraging
our relationship with leading research and clinical development
institutions.
The Cleveland Clinic Foundation, 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 clinical trials 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 and
help fund our programs.
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,
as well as an additional resource for funding.
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.
|
· |
Utilizing
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.
|
|
|
Quarter
|
|
Quarter
|
|
Year
Ended
|
|
Year
Ended
|
|
||||
|
|
Ended
|
|
Ended
|
|
December
31,
|
|
December
31,
|
|
||||
|
|
31-Mar-08
|
|
31-Mar-07
|
|
2007
|
|
2006
|
|
||||
(unaudited)
|
(unaudited)
|
||||||||||||
Revenues
|
$
|
676,324
|
$
|
321,445
|
$
|
2,018,558
|
$
|
1,708,214
|
|||||
Operating
expenses
|
4,744,500
|
4,522,919
|
27,960,590
|
9,126,315
|
|||||||||
Other
expense (income)
|
47,002
|
-
|
2,058,236
|
-
|
|||||||||
Net
interest expense (income)
|
(145,127
|
)
|
(95,341
|
)
|
(1,003,766
|
)
|
(195,457
|
)
|
|||||
Net
income (loss)
|
$
|
(3,970,051
|
)
|
$
|
(4,106,133
|
)
|
$
|
(26,996,502
|
)
|
$
|
(7,222,644
|
)
|
Revenue
|
Revenue
|
Revenue
|
|||||||||||||||||
2008
|
2007
|
2007
|
|||||||||||||||||
Period
of
|
(thru
|
(thru
|
|||||||||||||||||
Agency
|
Program
|
Amount
|
Performance
|
March
31)
|
March
31)
|
||||||||||||||
(unaudited)
|
(unaudited)
|
||||||||||||||||||
DoD
|
DTRA
Contract
|
$
|
1,263,836
|
03/2007-02/2009
|
$
|
323,826
|
$
|
-
|
$
|
466,322
|
|||||||||
NY
State/RPCI
|
Sponsored
Research Agreement
|
$
|
3,000,000
|
03/2007-02/2012
|
$
|
90,749
|
$
|
-
|
$
|
329,390
|
|||||||||
NIH
|
Phase
II NIH SBIR program
|
$
|
750,000
|
07/2006-06/2008
|
$
|
77,971
|
$
|
$140,593
|
$
|
459,621
|
|||||||||
NIH
|
NCI
Contract
|
$
|
750,000
|
09/2006-08/2008
|
$
|
63,778
|
$
|
130,852
|
$
|
440,028
|
|||||||||
NASA
|
Phase
I NASA STTR program
|
$
|
100,000
|
01/2006-01/2007
|
$
|
-
|
$
|
-
|
$
|
33,197
|
|||||||||
Totals
|
$
|
556,324
|
$
|
271,445
|
$
|
1,728,558
|
File
IND application for Protectan CBLB502 (completed February
2008)
|
$
|
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
|
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:
May 14, 2008
|
By:
|
/s/
MICHAEL FONSTEIN.
|
|
Michael Fonstein Chief
Executive Officer
(Principal
Executive Officer)
|
|
|
||
|
|
|
Dated:
May 14, 2008
|
By:
|
/s/
JOHN A. MARHOFER, JR.
|
|
John A. Marhofer, Jr. Chief
Financial Officer
(Principal
Financial Officer)
|