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)
|
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨
|
Smaller
reporting company x
|
PAGE
|
||||
PART
I - FINANCIAL INFORMATION
|
||||
ITEM
1:
|
Financial
Statements
|
|||
Balance
Sheets as of June 30, 2008 and December 31, 2007
|
3
|
|||
Statements
of Operations For Three and Six Months Ended June 30, 2008 and
2007
|
5
|
|||
Statements
of Cash Flows For Six Months Ended June 30, 2008 and 2007
|
6
|
|||
Statement
of Stockholders' Equity from January 1, 2007 to December 31, 2007and
to
June 30, 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
|
36
|
||
ITEM
4:
|
Controls
and Procedures
|
36
|
||
PART
II - OTHER INFORMATION
|
||||
ITEM
1:
|
Legal
Proceedings
|
37
|
||
ITEM
2:
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
37
|
||
ITEM
3:
|
Defaults
Upon Senior Securities
|
37
|
||
ITEM
4:
|
Submission
of Matters to a Vote of Securities Holders
|
37
|
||
ITEM
5:
|
Other
Information
|
38
|
||
ITEM
6:
|
Exhibits
|
38
|
||
Signatures
|
39
|
June
30 2008
|
December
31 2007
|
||||||
ASSETS |
(unaudited)
|
||||||
CURRENT
ASSETS
|
|||||||
Cash
and equivalents
|
$
|
6,252,471
|
$
|
14,212,189
|
|||
Short-term
investments
|
1,000,000
|
1,000,000
|
|||||
Accounts
receivable:
|
|||||||
Trade
|
912,980
|
163,402
|
|||||
Interest
|
38,016
|
50,042
|
|||||
Other
prepaid expenses
|
306,223
|
325,626
|
|||||
Total
current assets
|
8,509,690
|
15,751,259
|
|||||
EQUIPMENT
|
|||||||
Computer
equipment
|
279,136
|
258,089
|
|||||
Lab
equipment
|
1,073,705
|
966,517
|
|||||
Furniture
|
274,903
|
274,903
|
|||||
1,627,744
|
1,499,509
|
||||||
Less
accumulated depreciation
|
470,554
|
313,489
|
|||||
1,157,190
|
1,186,020
|
||||||
OTHER
ASSETS
|
|||||||
Intellectual
property
|
679,083
|
459,102
|
|||||
Deposits
|
26,327
|
25,445
|
|||||
705,410
|
484,547
|
||||||
TOTAL
ASSETS
|
$
|
10,372,290
|
$
|
17,421,826
|
June
30
|
December
31
|
||||||
2008
|
2007
|
||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
(unaudited)
|
||||||
CURRENT
LIABILITIES
|
|||||||
Accounts
payable
|
$
|
588,306
|
$
|
710,729
|
|||
Milestone
payable
|
50,000
|
—
|
|||||
Deferred
revenue
|
2,515,898
|
1,670,610
|
|||||
Dividends
payable
|
305,251
|
396,469
|
|||||
Accrued
expenses
|
301,870
|
449,774
|
|||||
Total
current liabilities
|
3,761,325
|
3,227,582
|
|||||
STOCKHOLDERS'
EQUITY
|
|||||||
Series
B convertible preferred stock, $.005 par value
|
|||||||
Authorized
- 10,000,000 shares at June 30, 2008
|
|||||||
and
December 31, 2007
|
|||||||
Issued
and outstanding 3,315,973 and 3,870,267
|
|||||||
shares
at June 30, 2008 and December 31, 2007, respectively
|
16,580
|
19,351
|
|||||
Additional
paid-in capital
|
20,894,414
|
24,383,695
|
|||||
Common
stock, $.005 par value
|
|||||||
Authorized
- 40,000,000 shares at June 30, 2008
|
|||||||
and
December 31, 2007
|
|||||||
Issued
and outstanding 13,575,146 and 12,899,241
|
|||||||
shares
at June 30, 2008 and December 31, 2007, respectively
|
67,876
|
64,496
|
|||||
Additional
paid-in capital
|
35,028,355
|
30,764,914
|
|||||
Accumulated
other comprehensive income (loss)
|
—
|
—
|
|||||
Accumulated
deficit
|
(49,396,260
|
)
|
(41,038,212
|
)
|
|||
Total
stockholders' equity
|
6,610,965
|
14,194,244
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
10,372,290
|
$
|
17,421,826
|
Three
Months Ended
|
Six
Months Ended
|
||||||||||||
June
30
|
June
30
|
June
30
|
June
30
|
||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
(unaudited)
|
(unaudited)
|
(unaudited)
|
(unaudited)
|
||||||||||
REVENUES
|
|||||||||||||
Grant
and contract
|
$
|
674,376
|
$
|
516,007
|
$
|
1,230,700
|
$
|
787,453
|
|||||
Service
|
—
|
120,000
|
120,000
|
170,000
|
|||||||||
674,376
|
636,007
|
1,350,700
|
957,453
|
||||||||||
OPERATING
EXPENSES
|
|||||||||||||
Research
and development
|
2,682,703
|
3,966,711
|
6,234,089
|
7,557,726
|
|||||||||
Selling,
general and administrative
|
1,992,536
|
4,782,257
|
3,185,650
|
5,776,577
|
|||||||||
Total
operating expenses
|
4,675,239
|
8,748,968
|
9,419,739
|
13,334,303
|
|||||||||
LOSS
FROM OPERATIONS
|
(4,000,863
|
)
|
(8,112,961
|
)
|
(8,069,039
|
)
|
(12,376,850
|
)
|
|||||
OTHER
INCOME
|
|||||||||||||
Interest
income
|
50,016
|
359,651
|
195,143
|
456,080
|
|||||||||
Buffalo
relocation reimbursement
|
220,000
|
—
|
220,000
|
—
|
|||||||||
Sublease
revenue
|
2,657
|
—
|
5,313
|
—
|
|||||||||
Gain
on disposal of fixed assets
|
—
|
—
|
1,394
|
—
|
|||||||||
Gain
on investment
|
—
|
—
|
3,292
|
—
|
|||||||||
Total
other income
|
272,673
|
359,651
|
425,142
|
456,080
|
|||||||||
OTHER
EXPENSE
|
|||||||||||||
Corporate
relocation
|
79,361
|
—
|
133,705
|
—
|
|||||||||
Interest
expense
|
—
|
—
|
—
|
1,087
|
|||||||||
Total
other expense
|
79,361
|
—
|
133,705
|
1,087
|
|||||||||
NET
LOSS
|
$
|
(3,807,551
|
)
|
$
|
(7,753,310
|
)
|
$
|
(7,777,602
|
)
|
$
|
(11,921,857
|
)
|
|
DIVIDENDS
ON CONVERTIBLE PREFERRED STOCK
|
(264,160
|
)
|
—
|
(580,446
|
)
|
—
|
|||||||
NET
LOSS AVAILABLE TO COMMON SHAREHOLDERS
|
$
|
(4,071,711
|
)
|
$
|
(7,753,310
|
)
|
$
|
(8,358,048
|
)
|
$
|
(11,921,857
|
)
|
|
NET
LOSS AVAILABLE TO COMMON SHAREHOLDERS
|
|||||||||||||
PER
SHARE OF COMMON STOCK - BASIC AND
|
|||||||||||||
DILUTED
|
$
|
(0.30
|
)
|
$
|
(0.64
|
)
|
$
|
(0.63
|
)
|
$
|
(1.00
|
)
|
|
WEIGHTED
AVERAGE NUMBER OF SHARES USED
|
|||||||||||||
IN
CALCULATING NET LOSS PER SHARE, BASIC AND
|
|||||||||||||
DILUTED
|
13,491,493
|
12,024,549
|
13,318,744
|
11,939,759
|
June
30
|
June
30
|
||||||
2008
|
2007
|
||||||
(unaudited)
|
(unaudited)
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
|||||||
Net
loss
|
$
|
(7,777,602
|
)
|
$
|
(11,921,857
|
)
|
|
Adjustments
to reconcile net loss to net cash
|
|||||||
used
by operating activities:
|
|||||||
Depreciation
|
157,066
|
61,681
|
|||||
Noncash
salaries and consulting expense
|
770,931
|
3,891,458
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Accounts
receivable - trade
|
(749,578
|
)
|
(509,454
|
)
|
|||
Accounts
receivable - interest
|
12,026
|
(229,014
|
)
|
||||
Other
prepaid expenses
|
19,403
|
(98,250
|
)
|
||||
Deposits
|
(881
|
)
|
(1,422
|
)
|
|||
Accounts
payable
|
(122,423
|
)
|
507,024
|
||||
Deferred
revenue
|
845,288
|
2,000,000
|
|||||
Accrued
expenses
|
(147,904
|
)
|
163,440
|
||||
Milestone
payments
|
50,000
|
200,000
|
|||||
Total
adjustments
|
833,928
|
5,985,463
|
|||||
Net
cash (used in) provided by operating
|
|||||||
activities
|
(6,943,674
|
)
|
(5,936,394
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
|||||||
Sale
of short-term investments
|
—
|
2,000,000
|
|||||
Purchase
of short-term investments
|
—
|
(17,999,965
|
)
|
||||
Issuance
of notes receivable
|
—
|
(250,000
|
)
|
||||
Purchase
of equipment
|
(128,236
|
)
|
(195,679
|
)
|
|||
Costs
of patents pending
|
(219,980
|
)
|
(119,038
|
)
|
|||
Net
cash (used in) provided by investing activities
|
(348,216
|
)
|
(16,564,682
|
)
|
|||
CASH
FLOWS FROM FINANCING ACTIVITIES
|
|||||||
Issuance
of preferred stock
|
—
|
30,020,984
|
|||||
Financing
costs
|
—
|
(1,152,857
|
)
|
||||
Dividends
|
(671,664
|
)
|
—
|
||||
Issuance
of common stock
|
—
|
158,616
|
|||||
Exercise
of stock options
|
3,836
|
—
|
|||||
Net
cash (used in) provided by financing activities
|
(667,828
|
)
|
29,026,743
|
||||
INCREASE
(DECREASE) IN CASH AND EQUIVALENTS
|
(7,959,718
|
)
|
6,525,667
|
||||
CASH
AND EQUIVALENTS AT BEGINNING OF PERIOD
|
14,212,189
|
3,061,993
|
|||||
CASH
AND EQUIVALENTS AT END OF PERIOD
|
$
|
6,252,471
|
$
|
9,587,660
|
|||
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:
|
|||||||
Conversion
of preferred stock to common stock
|
$
|
3,492,052
|
$
|
—
|
|||
Issuance
of stock options to employees, consultants, and independent board
members
|
$
|
1,573,632
|
$
|
2,350,158
|
|||
Expense
recapture of expense for options expensed in 2007 but issued in
2008
|
$
|
1,459,425
|
$
|
—
|
|||
Issuance
of shares to consultants and employees
|
$
|
563,200
|
$
|
1,541,300
|
|||
Accrual
of preferred stock dividends
|
$
|
305,251
|
$
|
—
|
|||
Amortization
of restricted shares issued to employees and consultants
|
$
|
93,525
|
$
|
—
|
Stockholders'
Equity
|
||||||||||
Common
Stock
|
||||||||||
|
Paid-in
|
Additional
|
||||||||
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
|
—
|
—
|
1,573,633
|
|||||||
Partial
recapture of expense for options expensed in 2007
|
—
|
—
|
(1,459,425
|
)
|
||||||
but
issued in 2008
|
||||||||||
Issuance
of restricted shares
|
115,000
|
575
|
562,625
|
|||||||
Amortization
of restricted shares
|
—
|
—
|
93,525
|
|||||||
Exercise
of options
|
6,611
|
33
|
3,803
|
|||||||
Conversion
of Series B Preferred Shares to Common
|
554,294
|
2,771
|
3,489,281
|
|||||||
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 June 30, 2008
|
13,575,146
|
$
|
67,876
|
$
|
35,028,355
|
|
|
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
|
(554,294
|
)
|
(2,771
|
)
|
(3,489,281
|
)
|
||||
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 June 30, 2008
|
3,315,973
|
$
|
16,580
|
$
|
20,894,414
|
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
|
—
|
—
|
1,573,633
|
||||||||||
Partial
recapture of expense for options expensed in 2007
|
—
|
—
|
(1,459,425
|
)
|
|||||||||
but
issued in 2008
|
|||||||||||||
Issuance
of restricted shares
|
—
|
—
|
563,200
|
||||||||||
Amortization
of restricted shares
|
—
|
—
|
93,525
|
||||||||||
Exercise
of options
|
—
|
—
|
3,836
|
||||||||||
Conversion
of Series B Preferred Shares to Common
|
—
|
—
|
—
|
||||||||||
Dividends
on Series B Preferred shares
|
—
|
(580,446
|
)
|
(580,446
|
)
|
||||||||
Net
Loss
|
—
|
(7,777,602
|
)
|
(7,777,602
|
)
|
(7,777,602
|
)
|
||||||
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
|
$
|
(7,777,602
|
)
|
||||||||||
Balance
at June 30, 2008
|
$
|
—
|
$
|
(49,396,260
|
)
|
$
|
6,610,965
|
A.
|
Basis
of Presentation - The information at June 30, 2008 and June 30, 2007,
and
for the quarter and six-months ended June 30, 2008 and June 30, 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 June 30, 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 $80,256, and $34,016 for
the
quarters ended June 30, 2008 and 2007, respectively. Depreciation
expense
was $157,066 and $61,861 for the six months ended June 30, 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 June 30,
2008,
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.
|
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. On April 29, 2008, the stockholders
of
the Company approved an amendment and restatement of the Plan (the
“Amended Plan”). The Amended Plan increases the number of shares available
for issuance by an additional 2,000,000 shares, clarifies other aspects
of
the 2006 Plan, and contains updates that reflect changes and developments
in federal tax laws. For the quarter ended June 30, 2008, there were
194,976 stock options and 25,000 shares granted under the Amended
Plan,
and as of June 30, 2008 there were 1,619,924 stock options and 335,000
shares granted under the Amended Plan leaving 2,045,076 shares of
stock to
be awarded under the Amended Plan.
|
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
|
64.31-80.25
|
%
|
71.86-76.29
|
%
|
|
|
|
|
|
|
|||||
|
|
|
|
Weighted
|
|
Weighted
|
|
|||
|
|
|
|
Average
|
|
Average
|
|
|||
|
|
|
|
Exercise
|
|
Remaining
|
|
|||
|
|
|
|
Price
|
|
Contractual
|
|
|||
per
|
Term
|
|||||||||
|
|
Shares
|
|
Share
|
|
(in
Years)
|
|
|||
|
|
|
|
|
|
|
||||
Outstanding,
December 31, 2007
|
1,011,740
|
$
|
7.29
|
|||||||
Granted
|
914,924
|
$
|
4.93
|
|||||||
Exercised
|
11,874
|
$
|
1.75
|
|||||||
Forfeited,
Canceled
|
0
|
n/a
|
||||||||
Outstanding,
June 30, 2008
|
1,914,790
|
$
|
6.20
|
8.94
|
||||||
Exercisable,
June 30, 2008
|
1,559,503
|
$
|
5.44
|
8.91
|
|
|
Weighted
|
|
Weighted
|
|
|||||
|
|
|
|
Average
|
|
Average
|
|
|||
|
|
|
|
Exercise
|
|
Remaining
|
|
|||
|
|
|
|
Price
|
|
Contractual
|
|
|||
per
|
Term
|
|||||||||
|
|
Shares
|
|
Share
|
|
(in
Years)
|
||||
Outstanding,
December 31, 2006
|
483,490
|
$
|
2.17
|
|||||||
Granted
|
525,000
|
$
|
9.79
|
|||||||
Exercised
|
69,000
|
$
|
1.28
|
|||||||
Forfeited,
Canceled
|
0
|
n/a
|
||||||||
Outstanding,
June 30, 2007
|
939,490
|
$
|
6.50
|
9.02
|
||||||
Exercisable,
June 30, 2007
|
637,680
|
$
|
6.02
|
9.03
|
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
June
30, 2008
|
|
Quarter
Ended
June
30, 2007
|
|
Six-Months
Ended
June
30, 2008
|
|
Six-Months
Ended
June
30, 2007
|
|||||||
Net
loss available to common stockholders
|
$
|
(4,071,711
|
)
|
$
|
(7,753,310
|
)
|
$
|
(8,358,048
|
)
|
$
|
(11,921,857
|
)
|
|
Net
loss per share, basic and diluted
|
$
|
(0.30
|
)
|
$
|
(0.64
|
)
|
$
|
(0.63
|
)
|
$
|
(1.00
|
)
|
|
Weighted-average
shares used in computing net
|
13,491,493
|
12,024,549
|
13,318,744
|
11,939,759
|
|||||||||
loss
per share, basic and diluted
|
Q.
|
Concentrations
of Risk - Grant revenue was comprised wholly from grants and contracts
issued by the federal and NY state government and accounted for 100.0%
and
81.1% of total revenue for the quarter ended June 30, 2008 and 2007,
respectively. Grant revenue accounted for 91.1% and 82.2% for the
six
months ended June 30, 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 June
30,
2008, the Company is obligated to make payments under the agreements
of
49,250 Euros and 144,323 GBP. The Company has established means to
purchase forward contracts to hedge against this risk. As of June
30,
2008, the Company has not
purchased any forward contracts 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
Two Quarters
|
$
|
166,531
|
||||
2009
|
349,782
|
||||||
2010
|
343,657
|
||||||
2011
|
311,803
|
||||||
2012
|
144,375
|
||||||
$
|
1,316,148
|
Shares
|
Weighted
Average
Exercise
Price Per Share
|
||||||
Outstanding,
December 31, 2007
|
1,011,740
|
$
|
7.29
|
||||
Granted
|
914,924
|
$
|
4.93
|
||||
Exercised
|
11,874
|
$
|
1.75
|
||||
Forfeited,
Canceled
|
0
|
n/a
|
|||||
Outstanding,
June 30, 2008
|
1,914,790
|
$
|
6.20
|
Shares
|
|
Weighted
Average
Exercise
Price Per Share
|
|||||
Outstanding,
December 31, 2006
|
483,490
|
$
|
2.17
|
||||
Granted
|
525,000
|
$
|
9.79
|
||||
Exercised
|
69,000
|
$
|
1.28
|
||||
Forfeited,
Canceled
|
0
|
n/a
|
|||||
Outstanding,
June 30, 2007
|
939,490
|
$
|
6.50
|
Warrants
|
|
Weighted
Average
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,
June 30, 2008
|
3,453,268
|
$
|
8.86
|
Warrants
|
Weighted
Average
Exercise
Price Per Share
|
||||||
Outstanding,
December 31, 2006
|
814,424
|
$
|
3.36
|
||||
Granted
|
2,687,602
|
$
|
10.40
|
||||
Exercised
|
45,258
|
$
|
2.00
|
||||
Forfeited,
Canceled
|
-
|
n/a
|
|||||
Outstanding,
June 30, 2007
|
3,456,768
|
$
|
8.85
|
· |
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
Ended
30-Jun-08
|
|
Quarter
Ended
30-Jun-07
|
|
Six
Months
Ended
30-Jun-08
|
|
Six
Months
Ended
30-Jun-07
|
|
Year
Ended December 31, 2007
|
|
Year
Ended December 31, 2006
|
|
||||||||
|
|
(unaudited)
|
|
(unaudited)
|
|
(unaudited)
|
|
(unaudited)
|
|
||||||||||
Revenues
|
$
|
674,376
|
$
|
636,007
|
$
|
1,350,700
|
$
|
957,453
|
$
|
2,018,558
|
$
|
1,708,214
|
|||||||
Operating
expenses
|
4,675,239
|
8,748,968
|
9,419,739
|
13,334,303
|
27,960,590
|
9,126,315
|
|||||||||||||
Other
expense (income)
|
(143,296
|
)
|
-
|
(96,294
|
)
|
-
|
2,058,236
|
-
|
|||||||||||
Net
interest expense (income)
|
(50,016
|
)
|
(359,651
|
)
|
(195,143
|
)
|
(454,993
|
)
|
(1,003,766
|
)
|
(195,457
|
)
|
|||||||
Net
income (loss)
|
$
|
(3,807,551
|
)
|
$
|
(7,753,310
|
)
|
$
|
(7,777,602
|
)
|
$
|
(11,921,857
|
)
|
$
|
(26,996,502
|
)
|
$
|
(7,222,644
|
)
|
Agency
|
Program
|
Amount
|
Period
of Performance
|
Revenue
2008
(April
1 thru
June
30)
|
Revenue
2007
(April
1 thru
June
30)
|
Revenue
2007
|
|||||||||||||
|
|
|
|
unaudited)
|
(unaudited)
|
||||||||||||||
DoD
|
DTRA
Contract
|
$
|
1,263,836
|
03/2007-02/2009
|
$
|
290,075
|
$
|
351,370
|
$
|
466,322
|
|||||||||
NY
State/RPCI
|
Sponsored
Research Agreement
|
$
|
3,000,000
|
03/2007-02/2012
|
$
|
63,962
|
$ | - |
$
|
329,390
|
|||||||||
NIH
|
Phase
II NIH SBIR program
|
$
|
750,000
|
07/2006-06/2008
|
$
|
0
|
$
|
$0
|
$
|
459,621
|
|||||||||
NIH
|
NCI
Contract
|
$
|
750,000
|
09/2006-08/2008
|
$
|
93,438
|
$
|
131,441
|
$
|
440,028
|
|||||||||
NASA
|
Phase
I NASA STTR program
|
$
|
100,000
|
01/2006-01/2007
|
$ |
$
|
33,196
|
$
|
33,197
|
||||||||||
DOD
|
DOD
Contract
|
$
|
8,900,000
|
05/2008
- 09/2009
|
$
|
226,901
|
$ | - |
$
|
0
|
|||||||||
|
Totals
|
$
|
674,376
|
$
|
516,007
|
$
|
1,728,558
|
Revenue
|
Revenue
|
||||||||||||||||||
2008
|
2007
|
||||||||||||||||||
Period
of
|
(thru
|
(thru
|
Revenue
|
||||||||||||||||
Agency
|
Program
|
Amount
|
Performance
|
June
30)
|
June
30)
|
2007
|
|||||||||||||
(unaudited)
|
(unaudited)
|
||||||||||||||||||
DoD
|
DTRA
Contract
|
$
|
1,263,836
|
03/2007-02/2009
|
$
|
323,826
|
$
|
351,370
|
$
|
466,322
|
|||||||||
NY
State/RPCI
|
Sponsored
Research Agreement
|
$
|
3,000,000
|
03/2007-02/2012
|
$
|
154,711
|
$
|
-
|
$
|
329,390
|
|||||||||
NIH
|
Phase
II NIH SBIR program
|
$
|
750,000
|
07/2006-06/2008
|
$
|
77,971
|
$
|
140,594
|
$
|
459,621
|
|||||||||
NIH
|
NCI
Contract
|
$
|
750,000
|
09/2006-08/2008
|
$
|
157,216
|
$
|
262,293
|
$
|
440,028
|
|||||||||
NASA
|
Phase
I NASA STTR program
|
$
|
100,000
|
01/2006-01/2007
|
$
|
290,075
|
$
|
33,196
|
$
|
33,197
|
|||||||||
DOD
|
DOD
Contract
|
$
|
8,900,000
|
05/2008
- 09/2009
|
$
|
226,901
|
$
|
-
|
$
|
0
|
|||||||||
|
Totals
|
$
|
1,230,700
|
$
|
787,453
|
$
|
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
|
|
For
|
Withheld
|
||
James
J. Antal
|
13,510,123
|
28,308
|
||
Paul
E. DiCorleto
|
13,510,828
|
27,603
|
||
Michael
Fonstein
|
13,511,125
|
27,306
|
||
Andrei
Gudkov
|
13,511,730
|
26,701
|
||
Bernard
L. Kasten
|
13,511,018
|
27,413
|
||
Yakov
Kogan
|
13,510,725
|
27,706
|
||
H.
Daniel Perez
|
13,511,833
|
26,598
|
For
|
Against
|
Abstain
|
||
13,520,849
|
4,759
|
12,823
|
For
|
Against
|
Abstain
|
Broker
Non-Votes
|
|||
9,540,824
|
456,196
|
34,345
|
3,507,066
|
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:
August 12, 2008
|
By:
|
/s/
MICHAEL FONSTEIN
|
|
Michael
Fonstein
Chief
Executive Officer
(Principal
Executive Officer)
|
|
|
||
|
|
|
Dated:
August 12, 2008
|
By:
|
/s/
JOHN A. MARHOFER, JR.
|
|
John
A. Marhofer, Jr.
Chief
Financial Officer
(Principal
Financial Officer)
|