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.)
|
|
|
PAGE
|
|
PART
I - FINANCIAL INFORMATION
|
|
|
|
|
|
|
|
ITEM
1:
|
Financial
Statements
|
|
|
|
|
|
|
|
Balance
Sheets as of June 30, 2007 and December 31, 2006
|
|
3-4
|
|
|
|
|
|
Statements
of Operations For Three and Six Months Ended June 30, 2007 and
2006
|
|
5
|
|
|
|
|
|
Statements
of Cash Flows For Six Months Ended June 30, 2007 and 2006
|
|
6
|
|
|
|
|
|
Statement
of Stockholders' Equity January 1, 2006 to December 31, 2006 and
to
June
30, 2007
|
|
7
|
|
|
|
|
|
Notes
to Financial Statements
|
|
10
|
|
|
|
|
ITEM
2:
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
|
19
|
|
|
|
|
ITEM
3:
|
Controls
and Procedures
|
|
30
|
|
|
|
|
PART
II - OTHER INFORMATION
|
|
|
|
|
|
|
|
ITEM
1:
|
Legal
Proceedings
|
|
31
|
|
|
|
|
ITEM
2:
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
|
31
|
|
|
|
|
ITEM
3:
|
Defaults
Upon Senior Securities
|
|
31
|
|
|
|
|
ITEM
4:
|
Submission
of Matters to a Vote of Securities Holders
|
|
31
|
|
|
|
|
ITEM
5:
|
Other
Information
|
|
32
|
|
|
|
|
ITEM
6:
|
Exhibits
|
|
32
|
|
|
|
|
Signatures
|
|
33
|
June
30
|
|
December
31
|
|
||||
|
|
2007
|
|
2006
|
|
||
|
(unaudited)
|
|
|
||||
ASSETS
|
|||||||
CURRENT
ASSETS
|
|||||||
Cash
and equivalents
|
$
|
9,587,660
|
$
|
3,061,993
|
|||
Short-term
investments
|
17,999,965
|
1,995,836
|
|||||
Accounts
receivable:
|
|||||||
Trade
|
669,204
|
159,750
|
|||||
Interest
|
271,665
|
42,479
|
|||||
Notes
Receivable - Orbit Brands
|
300,000
|
50,171
|
|||||
Other
prepaid expenses
|
532,925
|
434,675
|
|||||
Total
current assets
|
29,361,419
|
5,744,904
|
|||||
EQUIPMENT
|
|||||||
Computer
equipment
|
181,471
|
132,572
|
|||||
Lab
equipment
|
487,313
|
347,944
|
|||||
Furniture
|
72,497
|
65,087
|
|||||
741,281
|
545,603
|
||||||
Less
accumulated depreciation
|
203,692
|
142,011
|
|||||
537,589
|
403,592
|
||||||
OTHER
ASSETS
|
|||||||
Intellectual
Property
|
372,016
|
252,978
|
|||||
Deposits
|
16,477
|
15,055
|
|||||
388,493
|
268,033
|
||||||
TOTAL
ASSETS
|
$
|
30,287,501
|
$
|
6,416,529
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
June
30
2007
(unaudited)
|
December
31
2006
|
|||||
CURRENT
LIABILITIES
|
|||||||
Accounts
payable:
|
|||||||
Trade
|
$
|
1,151,831
|
$
|
644,806
|
|||
Milestone
payable (current)
|
250,000
|
-
|
|||||
Deferred
revenue
|
2,000,000
|
-
|
|||||
Accrued
expenses
|
292,008
|
128,569
|
|||||
Total
current liabilities
|
3,693,839
|
773,375
|
|||||
LONG-TERM
LIABILITIES
|
|||||||
Milestone
payable (long-term)
|
-
|
50,000
|
|||||
Total
long-term liabilities
|
-
|
50,000
|
|||||
STOCKHOLDERS'
EQUITY
|
|||||||
Series
B convertible preferred stock, $.005 par value
|
|||||||
Authorized
- 10,000,000 shares at June 30, 2007
|
|||||||
and
December 31, 2006
|
22,895
|
-
|
|||||
Issued
and outstanding 4,579,010 and 0
|
|||||||
shares
at June 30, 2007 and December 31, 2006, respectively
|
|||||||
Additional
paid-in capital
|
28,845,232
|
-
|
|||||
Common
stock, $.005 par value
|
|||||||
Authorized
- 40,000,000 shares at June 30, 2007
|
|||||||
and
December 31, 2006
|
|||||||
Issued
and outstanding 12,114,152 and 11,826,389
|
|||||||
shares
at June 30, 2007 and December 31, 2006, respectively
|
60,571
|
59,132
|
|||||
Additional
paid-in capital
|
22,362,732
|
18,314,097
|
|||||
Accumulated
other comprehensive income (loss)
|
-
|
(4,165
|
)
|
||||
Accumulated
deficit
|
(24,697,768
|
)
|
(12,775,910
|
)
|
|||
Total
stockholders' equity
|
26,593,662
|
5,593,154
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
30,287,501
|
$
|
6,416,529
|
|||
Three
Months Ended
|
Six
Months Ended
|
||||||||||||
June
30
|
|
June
30
|
|
June
30
|
|
June
30
|
|
||||||
|
|
2007
|
|
2006
|
|
2007
|
|
2006
|
|
||||
|
|
(unaudited)
|
|
(unaudited)
|
|
(unaudited)
|
|
(unaudited)
|
|||||
REVENUES
|
|||||||||||||
Grant
|
$
|
516,007
|
$
|
554,996
|
$
|
787,453
|
$
|
1,008,420
|
|||||
Service
|
120,000
|
20,000
|
170,000
|
145,000
|
|||||||||
636,007
|
574,996
|
957,453
|
1,153,420
|
||||||||||
OPERATING
EXPENSES
|
|||||||||||||
Research
and Development
|
3,966,711
|
1,558,117
|
7,557,726
|
3,060,480
|
|||||||||
Selling,
general and administrative
|
4,782,257
|
305,782
|
5,776,577
|
658,681
|
|||||||||
Total
operating expenses
|
8,748,968
|
1,863,899
|
13,334,303
|
3,719,161
|
|||||||||
LOSS
FROM OPERATIONS
|
(8,112,961
|
)
|
(1,288,903
|
)
|
(12,376,850
|
)
|
(2,565,741
|
)
|
|||||
OTHER
INCOME
|
|||||||||||||
Interest
Income
|
359,651
|
15,390
|
456,080
|
44,529
|
|||||||||
OTHER
EXPENSE
|
|||||||||||||
Interest
Expense
|
-
|
4,495
|
1,087
|
8,941
|
|||||||||
NET
LOSS
|
$
|
(7,753,310
|
)
|
$
|
(1,278,008
|
)
|
$
|
(11,921,857
|
)
|
$
|
(2,530,153
|
)
|
|
DIVIDENDS
ON CONVERTIBLE PREFERRED STOCK
|
-
|
(98,644
|
)
|
-
|
(162,800
|
)
|
|||||||
NET
LOSS AVAILABLE TO COMMON STOCKHOLDERS
|
$
|
(7,753,310
|
)
|
$
|
(1,376,652
|
)
|
$
|
(11,921,857
|
)
|
$
|
(2,692,953
|
)
|
|
NET
LOSS AVAILABLE TO COMMON STOCKHOLDERS PER SHARE OF COMMON STOCK
- BASIC
AND DILUTED
|
$
|
(0.64
|
)
|
$
|
(0.21
|
)
|
$
|
(1.00
|
)
|
$
|
(0.41
|
)
|
|
WEIGHTED
AVERAGE NUMBER OF SHARES USED IN CALCULATING NET LOSS PER SHARE,
BASIC AND
DILUTED
|
12,024,549
|
6,544,150
|
11,939,759
|
6,519,913
|
June
30
|
|
June
30
|
|
||||
|
|
2007
|
|
2006
|
|
||
|
|
(unaudited)
|
|
(unaudited)
|
|||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
|||||||
Net
loss
|
$
|
(11,921,857
|
)
|
$
|
(2,530,153
|
)
|
|
Adjustments
to reconcile net loss to net cash
|
|||||||
used
by operating activities:
|
|||||||
Depreciation
|
61,681
|
43,692
|
|||||
Noncash
interest expense
|
-
|
8,941
|
|||||
Noncash
salaries and consulting expense
|
3,891,458
|
367,197
|
|||||
Deferred
compensation
|
-
|
4,569
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Accounts
receivable - trade
|
(509,454
|
)
|
-
|
||||
Accounts
receivable - interest
|
(229,014
|
)
|
13,798
|
||||
Other
prepaid expenses
|
(98,250
|
)
|
2,556
|
||||
Deposits
|
(1,422
|
)
|
(2,488
|
)
|
|||
Accounts
payable
|
507,024
|
235,690
|
|||||
Deferred
revenue
|
2,000,000
|
21,110
|
|||||
Accrued
expenses
|
163,440
|
13,666
|
|||||
Milestone
payments
|
200,000
|
50,000
|
|||||
Total
adjustments
|
5,985,463
|
758,730
|
|||||
Net
cash (used in) provided by operating
|
|||||||
activities
|
(5,936,394
|
)
|
(1,771,423
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
|||||||
Sale/(purchase)
of short-term investments
|
(15,999,965
|
)
|
1,000,000
|
||||
Issuance
of notes receivable
|
(250,000
|
)
|
-
|
||||
Purchase
of equipment
|
(195,679
|
)
|
(124,418
|
)
|
|||
Costs
of patents pending
|
(119,038
|
)
|
(13,540
|
)
|
|||
Net
cash (used in) provided by investing activities
|
(16,564,682
|
)
|
862,042
|
||||
CASH
FLOWS FROM FINANCING ACTIVITIES
|
|||||||
Issuance
of preferred stock
|
30,020,984
|
-
|
|||||
Financing
costs
|
(1,152,857
|
)
|
(312,053
|
)
|
|||
Dividends
|
-
|
(23
|
)
|
||||
Issuance
of common stock
|
158,616
|
-
|
|||||
Net
cash (used in) provided by financing activities
|
29,026,743
|
(312,076
|
)
|
||||
|
|||||||
INCREASE
(DECREASE) IN CASH AND EQUIVALENTS
|
6,525,667
|
(1,221,456
|
)
|
||||
|
|||||||
CASH
AND EQUIVALENTS AT BEGINNING OF
|
3,061,993
|
1,223,600
|
|||||
PERIOD
|
|||||||
|
|||||||
CASH
AND EQUIVALENTS AT END OF PERIOD
|
$
|
9,587,660
|
$
|
2,144
|
|||
|
|||||||
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
|
$
|
2,350,158
|
$
|
367,197
|
|||
Issuance
of common stock dividend to preferred shareholders
|
$
|
-
|
$
|
-
|
|||
Issuance
of shares to consultants
|
$
|
1,541,300
|
$
|
-
|
Stockholders'
Equity
|
|||||||||||||
Common
Stock
|
|||||||||||||
Shares
|
Amount
|
Additional
Paid-in
Capital
|
Penalty
Shares
|
||||||||||
Balance
at January 1, 2006
|
6,396,801
|
31,984
|
3,338,020
|
81,125
|
|||||||||
Issuance
of shares - previously accrued penalty shares
|
54,060
|
270
|
80,855
|
(81,125
|
)
|
||||||||
Issuance
of shares - stock dividend
|
184,183
|
922
|
367,445
|
-
|
|||||||||
Issuance
of penalty shares
|
15,295
|
76
|
(76
|
)
|
-
|
||||||||
Issuance
of shares - initial public offering
|
1,700,000
|
8,500
|
10,191,500
|
-
|
|||||||||
Fees
associated with initital public offering
|
-
|
-
|
(1,890,444
|
)
|
-
|
||||||||
Conversion
of preferred stock to common stock
|
3,351,219
|
16,756
|
5,291,385
|
-
|
|||||||||
Conversion
of notes payable to common stock
|
124,206
|
621
|
312,382
|
-
|
|||||||||
Issuance
of options
|
-
|
-
|
506,078
|
-
|
|||||||||
Exercise
of options
|
625
|
3
|
2,810
|
-
|
|||||||||
Issuance
of warrants
|
-
|
-
|
114,032
|
-
|
|||||||||
Proceeds
from sales of warrants
|
-
|
-
|
110
|
-
|
|||||||||
Net
loss
|
-
|
-
|
-
|
-
|
|||||||||
Other
comprehensive income
|
|||||||||||||
Unrealized
gains (losses) on short term investments
|
|||||||||||||
Changes
in unrealized holding gains (losses)
|
|||||||||||||
arising
during period
|
-
|
-
|
-
|
-
|
|||||||||
Less
reclassification adjustment for (gains) losses
|
|||||||||||||
included
in net loss
|
-
|
-
|
-
|
-
|
|||||||||
Comprehensive
loss
|
|||||||||||||
Balance
at December 31, 2006
|
11,826,389
|
$
|
59,132
|
$
|
18,314,097
|
$
|
-
|
||||||
Issuance
of options
|
-
|
-
|
2,350,158
|
-
|
|||||||||
Issuance
of Series B Preferred Shares
|
-
|
-
|
-
|
-
|
|||||||||
Fees
associated with Series B Preferred offering
|
-
|
-
|
-
|
-
|
|||||||||
Issuance
of restricted shares
|
175,000
|
875
|
1,540,425
|
-
|
|||||||||
Exercise
of options
|
67,505
|
338
|
67,763
|
-
|
|||||||||
Exercise
of warrants
|
45,258
|
226
|
90,289
|
-
|
|||||||||
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, 2007
|
12,114,152
|
$
|
60,571
|
$
|
22,362,732
|
$
|
-
|
Stockholders'
Equity
|
|||||||||||||
Preferred
Stock
|
|||||||||||||
Shares
|
Amount
|
Additional
Paid-in
Capital
|
Penalty
Shares
|
||||||||||
Balance
at January 1, 2006
|
3,051,219
|
15,256
|
4,932,885
|
360,000
|
|||||||||
Issuance
of shares - previously accrued penalty shares
|
240,000
|
1,200
|
358,800
|
(360,000
|
)
|
||||||||
Issuance
of shares - stock dividend
|
-
|
-
|
-
|
-
|
|||||||||
Issuance
of penalty shares
|
60,000
|
300
|
(300
|
)
|
-
|
||||||||
Issuance
of shares - initial public offering
|
-
|
-
|
-
|
-
|
|||||||||
Fees
associated with initital public offering
|
-
|
-
|
-
|
-
|
|||||||||
Conversion
of preferred stock to common stock
|
(3,351,219
|
)
|
(16,756
|
)
|
(5,291,385
|
)
|
-
|
||||||
Conversion
of notes payable to common stock
|
-
|
-
|
-
|
-
|
|||||||||
Issuance
of options
|
-
|
-
|
-
|
-
|
|||||||||
Exercise
of options
|
-
|
-
|
-
|
-
|
|||||||||
Issuance
of warrants
|
-
|
-
|
-
|
-
|
|||||||||
Proceeds
from sales of warrants
|
-
|
-
|
-
|
-
|
|||||||||
Net
loss
|
-
|
-
|
-
|
-
|
|||||||||
Other
comprehensive income
|
|||||||||||||
Unrealized
gains (losses) on short term investments
|
|||||||||||||
Changes
in unrealized holding gains (losses)
|
|||||||||||||
arising
during period
|
-
|
-
|
-
|
-
|
|||||||||
Less
reclassification adjustment for (gains) losses
|
|||||||||||||
included
in net loss
|
-
|
-
|
-
|
-
|
|||||||||
Comprehensive
loss
|
|||||||||||||
Balance
at December 31, 2006
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||
Issuance
of options
|
-
|
-
|
-
|
-
|
|||||||||
Issuance
of Series B Preferred Shares
|
4,288,712
|
21,444
|
29,999,540
|
-
|
|||||||||
Fees
associated with Series B Preferred offering
|
290,298
|
1,451
|
(1,154,308
|
)
|
-
|
||||||||
Issuance
of restricted shares
|
-
|
-
|
-
|
-
|
|||||||||
Exercise
of options
|
-
|
-
|
-
|
-
|
|||||||||
Exercise
of warrants
|
-
|
-
|
-
|
-
|
|||||||||
Net
Loss
|
-
|
-
|
-
|
-
|
|||||||||
Other
comprehensive income
|
|||||||||||||
Unrealized
gains (losses) on short term investments
|
|||||||||||||
Changes
in unrealized holding gains (losses)
|
|||||||||||||
arising
during period
|
-
|
-
|
-
|
-
|
|||||||||
Less
reclassification adjustment for (gains) losses
|
|||||||||||||
included
in net loss
|
-
|
-
|
-
|
-
|
|||||||||
Comprehensive
loss
|
|
|
|
|
|||||||||
Balance
at June 30, 2007
|
4,579,010
|
$
|
22,895
|
$
|
28,845,232
|
$
|
-
|
Stockholders'
Equity
|
|||||||||||||
Other
Comprehensive
Income/(Loss)
|
Accumulated
Deficit
|
Total
|
Comprehensive
Income
(Loss)
|
||||||||||
Balance
at January 1, 2006
|
(17,810
|
)
|
(5,184,856
|
)
|
3,556,604
|
||||||||
Issuance
of shares - previously accrued penalty shares
|
-
|
-
|
-
|
||||||||||
Issuance
of shares - stock dividend
|
-
|
(368,410
|
)
|
(43
|
)
|
||||||||
Issuance
of penalty shares
|
-
|
-
|
-
|
||||||||||
Issuance
of shares - initial public offering
|
-
|
-
|
10,200,000
|
||||||||||
Fees
associated with initital public offering
|
-
|
-
|
(1,890,444
|
)
|
|||||||||
Conversion
of preferred stock to common stock
|
-
|
-
|
-
|
||||||||||
Conversion
of notes payable to common stock
|
-
|
-
|
313,003
|
||||||||||
Issuance
of options
|
-
|
-
|
506,078
|
||||||||||
Exercise
of options
|
-
|
-
|
2,813
|
||||||||||
Issuance
of warrants
|
-
|
-
|
114,032
|
||||||||||
Proceeds
from sales of warrants
|
-
|
-
|
110
|
||||||||||
Net
loss
|
-
|
(7,222,644
|
)
|
(7,222,644
|
)
|
(7,222,644
|
)
|
||||||
Other
comprehensive income
|
|||||||||||||
Unrealized
gains (losses) on short term investments
|
|||||||||||||
Changes
in unrealized holding gains (losses)
|
|||||||||||||
arising
during period
|
6,678
|
-
|
6,678
|
$
|
6,678
|
||||||||
Less
reclassification adjustment for (gains) losses
|
|||||||||||||
included
in net loss
|
6,967
|
-
|
6,967
|
$
|
6,967
|
||||||||
Comprehensive
loss
|
$
|
(7,208,999
|
)
|
||||||||||
Balance
at December 31, 2006
|
$
|
(4,165
|
)
|
$
|
(12,775,910
|
)
|
$
|
5,593,154
|
|||||
Issuance
of options
|
-
|
-
|
2,350,158
|
||||||||||
Issuance
of Series B Preferred Shares
|
-
|
-
|
30,020,984
|
||||||||||
Fees
associated with Series B Preferred offering
|
-
|
-
|
(1,152,857
|
)
|
|||||||||
Issuance
of restricted shares
|
-
|
-
|
-
|
||||||||||
Exercise
of options
|
-
|
-
|
68,101
|
||||||||||
Exercise
of warrants
|
-
|
-
|
90,515
|
||||||||||
Net
Loss
|
-
|
(11,921,858
|
)
|
(11,921,858
|
)
|
(11,921,858
|
)
|
||||||
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
|
$
|
(11,917,693
|
)
|
||||||||||
Balance
at June 30, 2007
|
$
|
-
|
$
|
(24,697,768
|
)
|
$
|
26,593,662
|
A.
|
Basis
of Presentation - The information at June 30, 2007 and June 30, 2006,
and
for the quarter and six-month periods ended June 30, 2007 and June
30,
2006, 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 CBL’s audited financial statements for the year ended
December 31, 2006, which were contained in the Company’s Annual Report on
Form 10-KSB 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 maturity to be
short-term investments and has classified these securities as
available-for-sale. Such investments are carried at fair value, with
unrealized gains and losses included as accumulated other comprehensive
income (loss) in stockholders' equity. The cost of available-for-sale
securities sold is determined based on the specific identification
method.
|
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, 2007 and December 31, 2006.
.
|
E.
|
Notes
Receivable - On December 7, 2006 the Company entered into an agreement
with the Orbit Brands Corporation (Borrower) and its subsidiaries
whereby
the Company would lend up to $150,000 each on two promissory notes
to the
Borrower at a rate of 5% per annum with a maturity date of one year.
The
proceeds of the loans shall be used by the Borrower solely to cover
expenses associated with converting the notes into common stock and
preparing the lending motions for the bankruptcy case involving the
Borrower. The loans are convertible into common stock of the Borrower
and
its subsidiaries. As of June 30, 2007 the balance outstanding was
$300,000
plus accrued interest of $5,479.
|
F.
|
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 $34,016, and $23,451 for
the
quarters ended June 30, 2007 and 2006 respectively. Depreciation
expense
was $61,861 and $43,692 for the six months ended June 30, 2007 and
2006,
respectively.
|
G.
|
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.
|
H.
|
Intellectual
Property - The Company capitalizes the costs associated with the
preparation, filing, and maintenance of certain intellectual property
rights. Capitalized intellectual property is reviewed annually for
impairment.
|
I.
|
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
$500,000, and expires on August 30, 2007. At June 30, 2007, there
were no
outstanding borrowings under this credit
facility.
|
J.
|
Fair
Value of Financial Instruments - Financial instruments, including
cash and
equivalents, accounts receivable, notes receivable, accounts payable
and
accrued liabilities, are carried at net realizable value. The carrying
amounts of the convertible notes payable approximate their respective
fair
values as they bear terms that are comparable to those available
under
current market conditions.
|
K.
|
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.
|
L.
|
Revenue
Recognition - The Company recognizes revenue in accordance with Staff
Accounting Bulletin No. 104, “Revenue Recognition.” Revenue sources
consist of government grants, government contracts and commercial
development contracts.
|
M.
|
Deferred
Revenue - Deferred Revenue results when payment is received in advance
of
revenue being earned. When cash is received, the Company makes a
determination as to whether the revenue has been earned by applying
a
percentage-of-completion analysis to compute the need to recognize
deferred revenue. The percentage of completion method is based upon
(1)
the total income projected for the project at the time of completion
and
(2) the expenses incurred to date. The percentage-of-completion can
be
measured using the proportion of costs incurred versus the total
estimated
cost to complete the contract.
|
N.
|
Research
and Development - Research and development expenses consist primarily
of
costs associated with the clinical trials of drug candidates, compensation
and other expenses for research and development, personnel, supplies
and
development materials, costs for consultants and related contract
research
and facility costs. Expenditures relating to research and development
are
expensed as incurred.
|
O.
|
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 provides for up to 2,000,000 shares of stock to be awarded.
For the year ended December 31, 2006, 45,000 options were granted
to
independent board members. On February 14, 2007, these 2,000,000
shares
were registered with the SEC by filing a Form S-8 registration statement.
For the quarter ended June 30, 2007, there were 405,500 options and
175,000 shares granted under the Plan, and as of June 30, 2007 there
were
570,000 stock options and 175,000 shares granted under the Plan totaling
745,000 equity instruments awarded under the Plan.
|
P.
|
Stock-Based
Compensation - The FASB issued SFAS No. 123(R) (revised December
2004),
Share Based Payment, which is a revision of SFAS No. 123 Accounting
for
Stock-Based Compensation. SFAS 123(R) requires all share-based payments
to
employees, including grants of employee stock options, to be recognized
in
the statement of operations based on their fair values. The Company
values
employee stock based compensation under the provisions of SFAS 123(R)
and
related interpretations.
|
|
The
fair value of each stock option granted is estimated on the grant
date.
The Black Scholes model is used for standard stock options, but if
market
conditions are present within the stock options, the company utilizes
Monte Carlo simulation to value the stock options The assumptions
used to
calculate the fair value of options granted are evaluated and revised,
as
necessary, to reflect the Company's experience. The Company uses
a
risk-free rate based on published rates from the St. Louis Federal
Reserve
at the time of the option grant, assumes a forfeiture rate of zero,
assumes an expected dividend yield rate of zero based on the Company's
intent not to issue a dividend in the foreseeable future, uses an
expected
life based on safe harbor method, and computes an expected volatility
based on similar high-growth, publicly-traded, biotechnology companies.
The Company does not include the use of its own stock in the volatility
calculation at this time because of the brief history of the stock
as a
publicly traded security on a listed exchange. The Company recognizes
the
fair value of share-based compensation in net income on a straight-line
basis over the requisite service
period.
|
Quarter
Ended June 30, 2007
|
||||
Risk-free
interest rate
|
4.67
- 5.18%
|
|||
Expected
dividend yield
|
0%
|
|||
Expected
life - Black-Scholes
|
5
-
6 years
|
|||
Expected
volatility
|
72.48
- 73.56%
|
|
Shares
|
Weighted
Average
Exercise
Price
per
Share
|
Weighted
Average
Remaining
Contractual
Term
(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
|
|
Shares
|
Weighted
Average
Exercise
Price
per
Share
|
Weighted
Average
Remaining
Contractual
Term
(in
Years)
|
|||||||
Outstanding,
December 31, 2005
|
324,240
|
$
|
.82
|
|||||||
Granted
|
116,750
|
$
|
4.50
|
|||||||
Exercised
|
0
|
n/a
|
||||||||
Forfeited,
Canceled
|
0
|
n/a
|
||||||||
Outstanding,
June 30, 2006
|
440,990
|
$
|
1.79
|
9.19
|
||||||
Exercisable,
June 30, 2006
|
195,058
|
$
|
1.87
|
9.10
|
Q.
|
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
|
Six-Months
Ended
|
Six-Months
Ended
|
|||||||||
|
June
30, 2007
|
June
30, 2006
|
June
30, 2007
|
June
30, 2006
|
|||||||||
|
|
|
|
|
|||||||||
Net
loss available to common shareholders
|
$
|
(7,753,310
|
)
|
$
|
(1,376,652
|
)
|
$
|
(11,921,857
|
)
|
$
|
(2,692,953
|
)
|
|
|
|||||||||||||
Net
loss per share, basic and diluted
|
$
|
(.64
|
)
|
$
|
(.21
|
)
|
$
|
(1.00
|
)
|
$
|
(.41
|
)
|
|
|
|||||||||||||
Weighted-average
shares used in computing
|
12,024,549
|
6,544,150
|
11,939,759
|
6,519,913
|
R.
|
Concentrations
of Risk - Grant revenue was comprised wholly from grants and contracts
issued by the federal government and accounted for 81.1% and 96.5%
of
total revenue for the quarter ended June 30, 2007 and 2006, respectively.
Grant revenue accounted for 82.2% and 87.4% for the six months ended
June
30, 2007 and 2006, respectively. Although the Company anticipates
ongoing
federal grant revenue, there is no guarantee that this revenue stream
will
continue in the future.
|
S.
|
Foreign
Currency Exchange Rate Risk - The Company has entered into a manufacturing
agreement with a foreign third party to produce one of its drug compounds
and is required to make payments in the foreign currency. As a result,
the
Company's financial results could be affected by changes in foreign
currency exchange rates. Currently, the Company's exposure primarily
exists with the Euro Dollar. As of June 30, 2007, the Company is
obligated
to make payments under the agreement of 527,500 Euros. The Company
has
established means to purchase forward contracts to hedge against this
risk. As of June 30, 2007, no hedging transactions have been
consummated.
|
T.
|
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
|
|||
2007
(from July 1, 2007 through December 31, 2007)
|
$
|
166,240
|
||
2008
|
332,995
|
|||
2009
|
347,214
|
|||
2010
|
339,155
|
|||
2011
|
307,300
|
|||
2012
|
144,000
|
|||
Total
|
$
|
1,636,904
|
|
Number of
Options
|
Weighted Average
Exercise
Price
|
|||||
Outstanding
at December 31, 2006
|
483,490
|
$
|
2.17
|
||||
Granted
|
525,000
|
$
|
9.79
|
||||
Exercised
|
69,000
|
$
|
1.28
|
||||
Forfeited
|
0
|
n/a
|
|||||
Outstanding
at June 30, 2007
|
939,490
|
$
|
6.50
|
|
Number of
Options
|
Weighted Average
Exercise
Price
|
|||||
Outstanding
at December 31, 2005
|
324,240
|
$
|
.82
|
||||
Granted
|
116,750
|
$
|
4.50
|
||||
Exercised
|
—
|
n/a
|
|||||
Forfeited
|
—
|
n/a
|
|||||
Outstanding
at June 31, 2006
|
440,990
|
$
|
1.79
|
|
Number of
Warrants
|
Weighted Average
Exercise
Price
|
|||||
Outstanding
at December 31, 2006
|
814,424
|
$
|
3.36
|
||||
Granted
|
2,687,602
|
$
|
10.40
|
||||
Exercised
|
45,258
|
$
|
2.00
|
||||
Forfeited
|
—
|
n/a
|
|||||
Outstanding
at June 30, 2007
|
3,456,768
|
$
|
8.85
|
|
Number of
Warrants
|
Weighted Average
Exercise
Price
|
|||||
Outstanding
at December 31, 2005
|
594,424
|
1.61
|
|||||
Granted
|
—
|
$
|
n/a
|
||||
Exercised
|
—
|
n/a
|
|||||
Forfeited
|
—
|
n/a
|
|||||
Outstanding
at June 30, 2006
|
594,424
|
$
|
1.61
|
|
Quarter
Ended
June
30,
2007 |
|
Quarter
Ended
June
30,
2006 |
|
Six
Months
Ended
June
30,
2007 |
|
Six
Months
Ended
June
30,
2006 |
|
Year
Ended December 31, 2006
|
|
Year
Ended December 31, 2005
|
|
|||||||
|
|
(unaudited)
|
|
(unaudited)
|
|
(unaudited)
|
|
(unaudited)
|
|
|
|
||||||||
Revenues
|
$
|
636,007
|
$
|
574,996
|
$
|
957,453
|
$
|
1,153,420
|
$
|
1,708,214
|
$
|
1,138,831
|
|||||||
Operating
expenses
|
8,748,968
|
1,863,899
|
13,334,303
|
3,719,161
|
9,126,315
|
3,626,664
|
|||||||||||||
Net
interest expense (income)
|
(359,651
|
)
|
(10,895
|
)
|
(454,993
|
)
|
(35,588
|
)
|
(195,457
|
)
|
(101,378
|
)
|
|||||||
Net
income (loss)
|
$
|
(7,753,310
|
)
|
$
|
(1,278,008
|
)
|
$
|
(11,921,857
|
)
|
$
|
(2,530,153
|
)
|
$
|
(7,222,644
|
)
|
$
|
(2,386,455
|
)
|
Agency
|
Program
|
Amount
|
Period
of
Performance
|
Revenue
2007
(thru
June
30)
|
Revenue
2006
(thru
June
30)
|
Revenue
2006
|
|||||||||||||
|
|
|
|
(unaudited)
|
(unaudited)
|
|
|||||||||||||
NIH
|
Phase
I NIH SBIR program
|
$
|
100,000
|
08/2004-04/2005
|
|||||||||||||||
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
|
|||||||||||||||
NIH
|
Phase
I NIH SBIR program
|
$
|
100,000
|
06/2005-01/2006
|
|||||||||||||||
NIH
|
BioShield
program (NIAID)
|
|
$
|
1,500,000
|
07/2005-01/2007
|
$
|
941,890
|
$
|
1,100,293
|
||||||||||
NIH
|
Phase
I NIH SBIR program
|
$
|
100,000
|
08/2005-01/2006
|
$
|
33,334
|
$
|
33,334
|
|||||||||||
NIH
|
Phase
I NIH SBIR program
|
$
|
100,000
|
09/2005-02/2006
|
|||||||||||||||
NASA
|
Phase
I NASA STTR program
|
$
|
100,000
|
01/2006-01/2007
|
$
|
33,196
|
$
|
33,196
|
$
|
66,393
|
|||||||||
NIH
|
Phase
II NIH SBIR program
|
$
|
750,000
|
07/2006-06/2008
|
$
|
140,594
|
$
|
212,713
|
|||||||||||
NIH
|
NCI
Contract
|
$
|
750,000
|
09/2006-08/2008
|
$
|
262,293
|
$
|
90,481
|
|||||||||||
DoD
|
DTRA
Contract
|
$
|
$1,300,000
|
03/2007-02/2009
|
$
|
351,370
|
|||||||||||||
Totals
|
$
|
787,453
|
$
|
1,008,420
|
$
|
1,503,214
|
File
IND application for Protectan CBLB502
|
$
|
50,000
|
||
Complete
Phase I studies for Protectan CBLB502
|
$
|
100,000
|
||
File
NDA application for Protectan CBLB502
|
$
|
350,000
|
||
Receive
regulatory approval to sell Protectan CBLB502
|
$
|
1,000,000
|
||
File
IND application for Curaxin CBLC102 (completed May 2006)
|
$
|
50,000
|
||
Commence
Phase II clinical trials for Curaxin CBLC102 (completed January
2007)
|
$
|
250,000
|
||
Commence
Phase III clinical trials for Curaxin CBLC102
|
$
|
700,000
|
||
File
NDA application for Curaxin CBLC102
|
$
|
1,500,000
|
||
Receive
regulatory approval to sell Curaxin CBLC102
|
$
|
4,000,000
|
Votes
Cast
|
|||||||
For
|
Withheld
|
||||||
James
J. Antal
|
10,755,965
|
76,236
|
|||||
Paul
E. DiCorleto
|
10,760,965
|
71,236
|
|||||
Michael
Fonstein
|
10,760,640
|
71,561
|
|||||
Andrei
Gudkov
|
10,760,640
|
71,561
|
|||||
Bernard
L. Kasten
|
10,760,965
|
71,236
|
|||||
Yakov
Kogan
|
10,760,965
|
71,236
|
|||||
H.
Daniel Perez
|
10,760,965
|
71,236
|
Votes
Cast
|
||
For
|
Against
|
Abstain
|
10,805,147
|
6,115
|
20,939
|
Votes
Cast
|
||
For
|
Against
|
Abstain
|
8,358,040
|
148,891
|
21,685
|
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 14, 2007
|
By: |
/s/ MICHAEL
FONSTEIN.
|
Michael
Fonstein
Chief
Executive Officer
(Principal
Executive Officer)
|
Dated:
August 14, 2007
|
By: |
/s/ JOHN
A. MARHOFER, JR.
|
John
A. Marhofer, Jr.
Chief
Financial Officer
(Principal
Financial Officer)
|
Dated:
August 14, 2007
|
By: |
/s/ Michael
Fonstein
|
Michael
Fonstein
Chief
Executive Officer
(Principal
Executive 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.
|