Statera Biopharma, Inc. - Quarter Report: 2008 March (Form 10-Q)
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(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 ____
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|
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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)
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|
||
(Registrant’s
telephone number, including area code) (716)
849-6810
_______________________________________________
(Former
name, former address and former fiscal year,
if
changed since last report)
|
Indicate
by check mark whether the registrant (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements
for
the past 90 days. Yes þ No
¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨
|
Smaller
reporting company þ
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes ¨
No
þ
As
of May 14, 2008 there were 13,479,432 shares outstanding of registrant's
common stock, par value $0.005 per share.
CLEVELAND
BIOLABS INC
10-Q
5/14/2008
TABLE
OF CONTENTS
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||||
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PAGE
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PART
I - FINANCIAL INFORMATION
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ITEM
1:
|
Financial
Statements
|
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Balance
Sheets as of March 31, 2008 and December 31, 2007
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|
3-4
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Statements
of Operations For Three Months Ended March 31, 2008 and
2007
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5
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Statements
of Cash Flows For Three Months Ended March 31, 2008 and
2007
|
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6
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|
Statement
of Stockholders' Equity from January 1, 2007 to December 31, 2007
and to
March 31, 2008
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7
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Notes
to Financial Statements
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10
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ITEM
2:
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
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21
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ITEM
3:
|
Quantitative
and Qualitative Disclosures About Market Risk
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35
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ITEM
4:
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Controls
and Procedures
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35
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PART
II - OTHER INFORMATION
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ITEM
1:
|
Legal
Proceedings
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36
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ITEM
2:
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Unregistered
Sales of Equity Securities and Use of Proceeds
|
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36
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ITEM
3:
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Defaults
Upon Senior Securities
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36
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ITEM
4:
|
Submission
of Matters to a Vote of Securities Holders
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36
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||
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ITEM
5:
|
Other
Information
|
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36
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ITEM
6:
|
Exhibits
|
|
36
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Signatures
|
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|
37
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In
this report, “Cleveland BioLabs,” “CBLI,” “we,” “us” and “our” refer to
Cleveland BioLabs, Inc. Our
common
stock, par value $0.005 per share
is
referred to as “common stock.”
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
|
3
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
|
4
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
|
5
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
|
$
|
-
|
6
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
|
7
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
|
8
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
|
9
CLEVELAND
BIOLABS, INC.
NOTES
TO FINANCIAL STATEMENTS
Note
1. Organization
Cleveland
BioLabs, Inc. (“CBLI” or the “Company”) is engaged in the discovery, development
and commercialization of products for cancer treatment and protection of normal
tissues from radiation and other stresses. The Company was incorporated under
the laws of the State of Delaware on June 5, 2003 and is headquartered in
Buffalo, New York. The Company's initial technological development efforts
are
intended to be used as powerful antidotes with a broad spectrum of applications
including protection from cancer treatment toxicities, radiation and hypoxia.
A
recent discovery found that one of its compounds increases the number of
progenitor (originator) stem cells in mouse bone marrow. To date, the Company
has not developed any commercial products. The Company has developed and
produced biological compounds under a single commercial development
contract.
Note
2. Summary of Significant Accounting Policies
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.
|
10
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.
|
A
portion of this intellectual property is owned by the Cleveland Clinic
Foundation, or CCF, and granted to the Company through an exclusive licensing
agreement. As part of the licensing agreement, CBLI agrees to bear the costs
associated with the preparation, filing and maintenance of patent applications
relating to this intellectual property. If the patent application is approved,
the costs paid by the Company are amortized on a straight-line basis over the
shorter of 17 years or the anticipated useful life of the patent. If the patent
application is not approved, the costs associated with the preparation, filing
and maintenance of the patent application by the Company on behalf of CCF will
be expensed as part of selling, general and administrative expenses. Gross
capitalized patents pending costs were $546,931 and $407,425 on behalf of CCF
for 13 patent applications as of March 31, 2008 and December 31, 2007,
respectively. All of the CCF patent applications are still pending
approval.
The
Company also has submitted three patent applications as a result of intellectual
property exclusively developed and owned by the Company. If the patent
applications are approved, costs paid by the Company associated with the
preparation, filing, and maintenance of the patents will be amortized on a
straight-line basis over the shorter of 17 years or the anticipated useful
life
of the patent. If the patent application is not approved, the costs associated
with the preparation, filing and maintenance of the patent application will
be
expensed as part of selling, general and administrative expenses at that time.
Gross capitalized patents pending costs were $62,915 and $51,677 on behalf
of
the Company for three patent applications as of March 31, 2008 and December
31,
2007, respectively. The patent applications are still pending
approval.
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.
|
In
September 2006, The Financial Accounting Standards Board (“FASB”) issued
Statement of Financial Accounting Standards (“SFAS”) No. 157, “Fair Value
Measurements.” SFAS No. 157 provides enhanced guidance for using fair value to
measure assets and liabilities and expands disclosure with respect to fair
value
measurements. This statement was originally effective for fiscal years beginning
after November 15, 2007. In February 2008, the FASB issued FSP157-2 which allows
companies to elect a one-year deferral of adoption of SFAS No. 157 for
non-recurring assets and non-financial liabilities that are recognized or
disclosed at fair value in the financial statements on a non-recurring basis.
The Company has adopted SFAS No. 157 as of January 1, 2008.
SFAS
No. 157 establishes a valuation hierarchy for disclosure of the inputs to
valuation used to measure fair value. This hierarchy prioritizes the inputs
into
three broad levels as follows: Level 1 inputs are quoted prices (unadjusted)
in
active markets for identical assets or liabilities; Level 2 inputs are quoted
prices for similar assets and liabilities in active markets or inputs that
are
observable for the asset or liability, either directly or indirectly; and,
Level
3 inputs are unobservable inputs in which little or no market data exists,
therefore requiring a company to develop its own assumptions. The Company does
not have any significant assets or liabilities measured at fair value using
Level 1 or Level 3 inputs as of March 31, 2008.
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.
|
11
Revenues
from government grants and contracts are for research and development purposes
and are recognized in accordance with the terms of the award and the government
agency per SAB 104. Grant revenue is recognized in one of two different ways
depending on the grant. Cost reimbursement grants require us to submit proof
of
costs incurred that are invoiced by us to the government agency, which then
pays
the invoice. In this case, grant revenue is recognized at the time of submitting
the invoice to the government agency. Fixed cost grants require no proof of
costs and are paid as a request for payment is submitted for expenses. The
grant
revenue under these fixed costs grants is recognized using a
percentage-of-completion method, which uses assumptions and estimates. These
assumptions and estimates are developed in coordination with the principal
investigator performing the work under the government fixed-cost grants to
determine key milestones, expenses incurred, and deliverables to perform a
percentage-of-completion analysis to ensure that revenue is appropriately
recognized. Critical estimates involved in this process include total costs
incurred and anticipated to be incurred during the remaining life of the grant.
Government
contract revenue is recognized periodically upon delivery of an invoice for
allowable R&D expenses according to the terms of the contract. The Company
has recognized grant revenue from the following agencies: the Defense Threat
Reduction Agency (DTRA), the U.S. Army (DARPA), National Aeronautics and Space
Administration (NASA), the National Institutes of Health (NIH) and the
Department of Health and Human Services (HHS).
The
Company recognizes revenue related to the funds received in 2007 from the State
of New York under the sponsored research agreement with the Roswell Park Cancer
Institute (RPCI) in accordance with SFAS 116. The principles of SFAS 116 result
in the recognition of revenue as allowable costs are incurred. The Company
recognizes revenue on research laboratory services and the purchase and
subsequent use of related equipment. The amount paid as a payment toward future
services related to the equipment is recognized as a prepaid asset and will
be
recognized as revenue as the services are performed and the prepaid asset is
recognized as expense.
Commercial
development revenues are recognized when the service or development is
delivered.
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.
|
The
Company received $2,000,000 in funds from the State of New York through the
Roswell Park Cancer Institute during the second quarter of 2007 and is
recognizing this revenue over the terms and conditions of the sponsored research
agreement. The Company recognizes revenue on research laboratory services and
the purchase and subsequent use of related equipment. The amount paid as a
payment toward future services related to the equipment is recognized as a
prepaid asset and will be recognized as revenue as the services are performed
and the prepaid asset is recognized as expense. For the three-months ended
March
31, 2008, the Company recognized $90,749 as revenue resulting in a balance
of
deferred revenue of $1,579,860 at March 31, 2008. At December 31, 2007, the
balance in deferred revenue was $1,670,610.
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.
|
12
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.
|
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 published
by
the St. Louis Federal Reserve at the time of the option grant, assumes a
forfeiture rate of zero, assumes an expected dividend yield rate of zero based
on the Company's intent not to issue a dividend in the foreseeable future,
uses
an expected life based on the safe harbor method, and computes an expected
volatility based on similar high-growth, publicly-traded, biotechnology
companies. In 2008, the Company began to include the use of its own stock in
the
volatility calculation and is layering in the volatility of the stock of the
Company with that of comparable companies since there is not adequate trading
history to rely solely on the volatility of the Company. The Company recognizes
the fair value of share-based compensation in net income on a straight-line
basis over the requisite service period.
The
assumptions used to value these option and warrant grants using the
Black-Scholes option valuation model are as follows:
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
|
%
|
During
the three-months ended March 31, 2008, the Company granted 719,948 additional
stock options pursuant to stock award agreements. The Company recognized a
total
of $728,077 in expense related to options for the three-months ended March
31,
2008. The Company also recaptured $1,459,425 of previously recognized expense
for stock options awarded under the 2007 Executive Compensation Plan. These
options were originally expensed based on the December 31, 2007 variables,
but
were not issued until February 4, 2008. The change in dates resulted in a
difference in valuation assumptions used in the Black-Scholes model causing
a
reduction in the grant date fair value. This reduction in the grant date fair
value from $5.34 to $2.44 per share resulted in the recapture of $1,459,425
in
expense and a net expense for options for the three-months ended March 31,
2008
of ($731,348).
The
weighted average, estimated grant date fair values of stock options granted
during the three-months ended March 31, 2008 was $2.86.
The
following tables summarize the stock option activity for the three-months ended
March 31, 2008 and March 31, 2007, respectively.
13
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
|
The
Company also recognized $521,000 in expense for shares issued under the Plan
to
an employee and a consultant during the three-months ended March 31, 2008.
In
addition, the Company recognized $17,722 in compensation expense related to
the
amortization of restricted shares.
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.
|
The
following table presents the calculation of basic and diluted net loss per
share
for the three-months ended March 31, 2008 and 2007:
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
|
The
Company has excluded all outstanding warrants and options from the calculation
of diluted net loss per share because all such securities are antidilutive
for
all applicable periods presented.
14
The
total number of shares excluded from the calculations of diluted net loss per
share, prior to application of the treasury stock method for warrants,
was 3,453,268 and 3,402,821 for the three-months ended March 31, 2008 and 2007,
respectively. Such securities, had they been dilutive, would have been included
in the computation of diluted earnings per share.
The
total number of shares excluded from the calculations of diluted net loss per
share, prior to the application of the treasury stock method for options,
was 1,720,589 and 582,990 for the three-months ended March 31, 2008 and 2007,
respectively. Such securities, had they been dilutive, would have been included
in the computation of diluted earnings per share.
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.
|
Financial
instruments that potentially subject us to a significant concentration of credit
risk consist primarily of cash and cash equivalents and securities
available-for-sale. The Company maintains deposits in federally insured
institutions in excess of federally insured limits. The Company does not believe
it is exposed to significant credit risk due to the financial position of the
depository institutions in which those deposits are held. Additionally, the
Company has established guidelines regarding diversification of its investment
portfolio and maturities of investments, which are designed to meet safety
and
liquidity.
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.
|
Note
3. Stock Transactions
On
February 1, 2006, the Company paid a common stock dividend of 91,776 shares
to
holders of the Series A preferred stock to satisfy the dividend requirement
of
the preferred stock issuance.
On
March 1, 2006, the Company issued 116,750 stock options to various employees
and
consultants of the Company under non-qualified stock option agreements. These
options allow for the purchase of 116,750 shares of common stock at a price
of
$4.50. These options have a three-year vesting schedule and expire on February
29, 2016.
On
June 21, 2006, after the expiration of the 115-day extension and an additional
30-day period, the Company incurred one additional penalty period in which
60,000 shares of Series A preferred stock were earned at $120,000 and 15,295
shares of common stock were earned at $30,590. The Company has not incurred
any
further obligation to issue penalty shares since these issuances.
On
July 20, 2006, the Company sold 1,700,000 shares of common stock in its initial
public offering at $6.00 per share. The net proceeds to the Company from this
offering were approximately $8,300,000. Beginning July 21, 2006, the Company’s
shares were quoted on the NASDAQ Capital Market and listed on the Boston Stock
Exchange under the symbols “CBLI” and “CFB” respectively. On August 28, 2007,
trading of the Company’s common stock moved from the NASDAQ Capital Market to
the NASDAQ Global Market. In September 2007, we ceased our listing on the Boston
Stock Exchange. In connection with its initial public offering, the Company
sold
warrants to purchase 170,000 shares of common stock to the underwriters and
their designees at a cost of $100.00. The warrants have an exercise price of
$8.70 per share.
15
On
July 20, 2006, the effective date of the Company’s initial public offering, the
Company issued 92,407 shares of common stock as accumulated dividends to the
Series A preferred stockholders. On the same date, all of the Company’s Series A
Preferred shares automatically converted on a one-for-one basis into 3,351,219
shares of common stock and notes of the Company in the principal amount of
$283,500 plus accrued interest of $29,503 automatically converted into 124,206
shares of common stock. In connection with their appointment to the Board,
the
Company issued to each of the Company’s three new independent directors, options
to purchase 15,000 shares of common stock with an exercise price of $6.00 per
share.
On
September 21, 2006, the SEC declared effective a registration statement of
the
Company registering up to 4,453,601 shares of common stock for resale from
time
to time by the selling stockholders named in the prospectus contained in the
registration statement. The Company will not receive any proceeds from the
sale
of the underlying shares of common stock, although to the extent the selling
stockholders exercise warrants for the underlying shares of common stock, the
Company will receive the exercise price of those warrants. The registration
statement was filed to satisfy registration rights that the Company had
previously granted.
On
November 16, 2006 the Company issued 50,000 warrants to an outside consultant.
These warrants are immediately exercisable into common shares of the Company
and
have an exercise price of $6.00 per share and an expiration date of November
16,
2011.
On
February 14, 2007, the Company issued 99,500 stock options to various employees
and consultants of the Company under non-qualified stock option agreements.
These options allow for the purchase of 99,500 shares of common stock at a
price
of $9.14. These options have various vesting schedules from immediate vesting
to
three years and expire on February 14, 2017.
On
February 26, 2007, the Company issued 55,000 warrants at an exercise price
of
$9.19 per share, to a placement agent as incentive for work on the private
placement offering.
On
March 16, 2007, the Company entered into a Securities Purchase Agreement with
various accredited investors (the Buyers), pursuant to which the Company agreed
to sell to the Buyers Series B Convertible Preferred Stock (Series B Preferred)
convertible into an aggregate of 4,288,712 shares of common stock and Series
B
Warrants that are exercisable for an aggregate of 2,144,356 shares of common
stock. The Series B Preferred have an initial conversion price of $7.00 per
share, and in the event of a conversion at such conversion price, one share
of
Series B Preferred would convert into one share of common stock. The Series
B
Warrants have an exercise price of $10.36 per share, the closing bid price
on
the day prior to the private placement. To the extent, however, that the
conversion price of the Series B Preferred or the exercise price of the Series
B
Warrants is reduced as a result of certain anti-dilution protections, the number
of shares of common stock into which the Series B Preferred are convertible
and
for which the Series B Warrants are exercisable may increase.
The
Company also issued to the placement agents in the private placement (the
Agents), as compensation for their services, Series B Preferred, Series B
Warrants, and Series C Warrants. The Agents collectively received Series B
Preferred that are convertible into an aggregate of 290,298 shares of common
stock, Series B Warrants that are exercisable for an aggregate of 221,172 shares
of the Company’s common stock, and Series C Warrants that are exercisable for
267,074 shares of the Company’s common stock. The Series C Warrants have an
exercise price of $11.00 per share, and are also subject to anti-dilution
protections that could increase the number of shares of common stock for which
they are exercisable.
In
total, the securities issued in the private placement were
convertible into, or exercisable for, up to approximately 7,211,612 shares
of
common stock, which amount is subject to adjustment in the event of certain
corporate events such as stock splits or issuances of securities at a price
below the conversion price of the Series B Preferred or exercise price of the
warrants, as the case may be. On September 13, 2007, the Company paid $807,913
to the Series B Preferred stockholders for the semiannual dividend.
On
March 19, 2007, the Company issued 20,000 stock options to members of the
Scientific Advisory Board of the Company under non-qualified stock option
agreements. These options are immediately exercisable and allow for the purchase
of 20,000 shares of common stock at a price of $8.82. These options expire
on
March 18, 2017.
On
April 6, 2007, the Company issued 152,500 stock options to officers and
consultants under non-qualified stock option agreements. These options are
immediately exercisable and allow for the purchase of 152,500 shares of common
stock at a price of $8.36. These options expire on April 5, 2017. The Company
also issued 115,000 shares of common stock to consultants under the
Plan.
16
On
June 12, 2007, the Company issued 140,000 stock options to four independent
members of the Board of Directors of the Company under non-qualified stock
option agreements. These options are immediately exercisable and allow for
the
purchase of 140,000 shares of common stock at a price of $9.40. These options
expire on June 11, 2017.
On
June 15, 2007, the Company issued 110,000 stock options to various key employees
and consultants under non-qualified stock option agreements. These options
have
various vesting schedules including immediate vesting, up to three year vesting,
and vesting upon the company stock price obtaining certain levels. These options
allow for the purchase of 110,000 shares of common stock at a price ranging
from
$9.93 to $17.00. These options expire on June 14, 2017. The Company also issued
30,000 shares of common stock to the same consultants under the
Plan.
On
June 21, 2007, the Company issued 3,000 stock options to a consultant under
a
non-qualified stock option agreement. These options vest over a six month period
and allow for the purchase of 3,000 shares of common stock at a price of $10.84.
These options expire on June 20, 2017.
On
June 27, 2007, the Company issued 30,000 shares of common stock to various
outside consultants under the Plan.
On
July 18, 2007, the Company issued 15,000 shares of common stock to an outside
consultant under the Plan. On that date, the Company also issued 18,000 stock
options to another consultant under a non-qualified stock option agreement.
These options are immediately exercisable and allow for the purchase of 18,000
shares of common stock at a price of $10.61. These options expire on December
31, 2012.
On
December 4, 2007, the Company issued 117,000 stock options to various key
employees and consultants under non-qualified stock option agreements. These
options have up to three year vesting. These options allow for the purchase
of
117,000 shares of common stock at an exercise price of $10.00 per share. These
options expire on or before December 3, 2017.
On
December 11, 2007, the SEC declared effective a registration statement of the
Company registering up to 5,514,999 shares of common stock for resale from
time
to time by the selling stockholders named in the prospectus contained in the
registration statement. This number represents 5,514,999 shares of common stock
issuable upon the conversion or exercise of the securities issued the Company’s
March 2007 private placement at the current conversion and exercise prices.
Of
these 5,514,999 shares of common stock, 3,717,515 shares are issuable upon
conversion of Series B Preferred and 1,797,484 shares are issuable upon exercise
of the Series B Warrants. The Company will not receive any proceeds from the
sale of the underlying shares of common stock, although to the extent the
selling stockholders exercise warrants for the underlying shares of common
stock, the Company will receive the exercise price of those warrants. The
registration statement was filed to satisfy registration rights that the Company
had previously granted. Subsequent to the effectiveness of the registration
statement, 708,743 Series B Preferred were converted and $61,418 in dividends
earned were paid as of December 31, 2007. At December 31, 2007, $396,469 in
dividends were accrued on the outstanding Series B Preferred.
On
January 1, 2008, the Company issued 100,000 options to a recently-hired employee
and 60,000 options to a key consultant of the Company under the Plan. The
options vest over a period from one to three years and allow for the purchase
of
160,000 shares of common stock at a price of $8.00 per share. These options
expire on December 31, 2017.
On
January 4, 2008, the Company issued 20,000 restricted shares of common stock
at
a price of $8.00 per share. These shares vest over a three-year period with
25%
vested on issuance and 25% vesting on the anniversary date of the agreement
for
each of the next three years.
On
February 4, 2008, the Company issued options to purchase 503,250 shares of
common stock under non-qualified stock option agreements to the executive
management team under the 2007 Executive Compensation Plan. These options were
originally expensed in 2007 at the December 31, 2007 closing price of $8.80.
These options vest immediately, contain an exercise price of $4.00 per share,
and expire on February 3,
2018. The Company also issued options to purchase 34,398 shares of common stock
to various employees under non-qualified stock option agreements under an
employee bonus program. These options vest immediately, contain an exercise
price of $4.00 per share, and expire on February 3, 2018. Finally, the Company
issued stock options to various key employees under non-qualified stock option
agreements. These options have up to three years vesting. These options allow
for the purchase of 21,300 shares of common stock at an exercise price of $4.00
per share. These options expire on February 3, 2018.
17
On
March 12, 2008, the Company issued 1,000 stock options to a consultant under
a
non-qualified stock option agreement. These options vest immediately and allow
for the purchase of 1,000 shares of common stock at an exercise price of $4.81
per share. These options expire on March 11, 2018.
On
March 14, 2008, the Company issued 100,000 unrestricted shares of common stock
to a key consultant under the Plan.
During
the three-months ended March 31, 2008 an additional 345,580 Series B Preferred
were converted and $661,295 in dividends were paid to Series B Preferred
stockholders. At March 31, 2008, there were 3,524,687 outstanding Series B
Preferred for which $51,462 in dividends had been accrued.
Note
4. Commitments and Contingencies
The
Company has entered into various agreements with third parties and certain
related parties in connection with the research and development activities
of
its existing product candidates as well as discovery efforts on potential new
product candidates. These agreements include costs for research and development
and license agreements that represent the Company's fixed obligations payable
to
sponsor research and minimum royalty payments for licensed patents. These
amounts do not include any additional amounts that the Company may be required
to pay under its license agreements upon the achievement of scientific,
regulatory and commercial milestones that may become payable depending on the
progress of scientific development and regulatory approvals, including
milestones such as the submission of an investigational new drug application
to
the FDA, similar submissions to foreign regulatory authorities and the first
commercial sale of the Company's products in various countries. These agreements
include costs related to manufacturing, clinical trials and preclinical studies
performed by third parties.
The
Company is also party to three agreements that require it to make milestone
payments, royalties on net sales of the Company's products and payments on
sublicense income received by the Company. As of March 31, 2008, $300,000 in
milestone payments have been made under one of these agreements and an
additional $50,000 has been accrued under one of these agreements.
From
time to time, the Company may have certain contingent liabilities that arise
in
the ordinary course of business. The Company accrues for liabilities when it
is
probable that future expenditures will be made and such expenditures can be
reasonably estimated. For all periods presented, the Company is not a party
to
any pending material litigation or other material legal
proceedings.
The
Company currently has operating lease commitments in place for facilities in
Buffalo, New York and Rosemont,
Illinois as well as office equipment. The Company recognizes rent expense on
a
straight-line basis over the term of the related operating leases. The operating
lease expenses recognized were $83,045, and $43,598 for the three-months ended
March 31, 2008 and 2007, respectively.
18
Annual
future minimum lease payments under present lease commitments are as
follows.
Operating
|
|||||||
Leases
|
|||||||
2008
|
Remaining
Three Quarters
|
$
|
249,539
|
||||
2009
|
349,782
|
||||||
2010
|
343,657
|
||||||
2011
|
311,803
|
||||||
2012
|
144,375
|
||||||
$
|
1,399,156
|
The
Company has entered into stock option agreements with key employees, board
members and consultants with exercise prices ranging from $0.66 to $17.00.
These
awards were approved by the Company’s Board of Directors. The options expire ten
years from the date of grant, subject to the terms applicable in the
agreement.
The
following tables summarize the stock option activity for the three-months ended
March 31, 2008 and 2007:
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
|
The
Company has entered into warrant agreements with strategic partners, consultants
and investors with exercise prices ranging from $1.13 to $11.00. These awards
were approved by the Company’s Board of Directors. The warrants expire between
five and six years from the date of grant, subject to the terms applicable
in
the agreement. A list of the total warrants awarded and exercised appears
below:
19
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
|
The
Company has entered into employment agreements with three key executives
who, if
terminated by the Company without cause as described in these agreements,
would
be entitled to severance pay.
The
Company is not currently a party to any pending legal actions. From time to
time
in the ordinary course of business, the Company may be subject to claims brought
against it. It is not possible to state the ultimate liability, if any, in
these
matters.
Note
5. Subsequent Events
On
April 29, 2008, at the Annual Meeting of Stockholders of the Company, the
stockholders of CBLI approved the amendment and restatement of the Cleveland
BioLabs, Inc. 2006 Equity Incentive Plan, or the Amended Plan. The Amended
Plan increased the number of shares available for issuance by an additional
2,000,000 shares, clarified other aspects of the Amended Plan, and added updates
that reflect changes and developments in federal tax laws.
20
Item
2: Management's Discussion and Analysis of Financial Condition and Results
of
Operations
This
management's discussion and analysis of financial condition and results of
operations and other portions of this filing contain forward-looking information
that involves risks and uncertainties. Our actual results could differ
materially from those anticipated by the forward-looking information. Factors
that may cause such differences include, but are not limited to, availability
and cost of financial resources, results of our research
and development, or R&D,
efforts and clinical trials, product demand, market acceptance and other factors
discussed in the Company's other SEC filings under the heading “Risk
Factors.”
This management's discussion and analysis of financial condition and results
of
operations should be read in conjunction with our financial statements and
the
related notes included elsewhere in this filing and in our Annual Report on
Form
10-K for the year ended December 31, 2007.
OVERVIEW
CBLI
was incorporated in Delaware and commenced business operations in June 2003
as a
development-stage, biotechnology company, with a very specific and targeted
focus on radiation drug discovery. We have devoted substantially all of our
resources to the identification, development and commercialization of new types
of drugs for protection of normal tissues from exposure to radiation and other
stresses, such as toxic chemicals and cancer treatments. CBLI’s pipeline
includes products from two primary families of compounds: protectans and
curaxins. We are developing protectans as drug candidates that protect healthy
tissues from acute stresses such as radiation, chemotherapy and ischemia
(pathologies developed as a result of blocking blood flow to a part of the
body). Curaxins are being developed as anticancer agents that could act as
mono-therapy drugs or in combination with other existing anticancer
agents.
On
July 20, 2006, we sold 1,700,000 shares of common stock, par value $0.005 per
share, in our initial public offering at a per share price of $6.00.
Our
common
stock is
currently
listed
on the NASDAQ Global
Market
under the symbol “CBLI”
Technology
Our
development efforts are based on discoveries made in connection with the
investigation of the cell-level process known as apoptosis. Apoptosis is a
highly specific and tightly regulated form of cell death that can occur in
response to external events such as exposure to radiation, toxic chemicals
or
internal stresses. Apoptosis is a major determinant of tissue damage caused
by a
variety of medical conditions including cerebral stroke, heart attack and acute
renal failure. Conversely, apoptosis is also an important protective mechanism
that allows the body to shed itself of defective cells, which otherwise can
cause cancerous growth.
Research
has demonstrated that apoptosis is sometimes suppressed naturally. For example,
most cancer cells develop resistance to apoptotic death caused by drugs or
natural defenses of the human body. Our research is geared towards identifying
the means by which apoptosis can be affected and manipulated depending on the
need.
If
the need is to protect healthy tissues against an external event such as
exposure to radiation, we focus our research efforts on attempting to
temporarily and reversibly suppress apoptosis in those healthy tissues, thereby
imitating the apoptotic-resistant tendencies displayed by cancer cells. A drug
with this effect would also be useful in ameliorating the often severe
toxicities
of anticancer drugs and radiation that cause collateral damage to healthy
tissues during cancer treatment. Because the severe toxicities
of anticancer drugs and radiation often limit their dosage in cancer patients,
an apoptosis suppressant drug may enable a more aggressive treatment regimen
using anticancer drugs and radiation and thereby increase their
effectiveness.
On
the other hand, if the need is to destroy cancerous cells, we focus our research
efforts on restoring apoptotic mechanisms that are suppressed in tumors, so
that
those cancerous cells will once again become vulnerable to apoptotic death.
In
this regard, we believe that our drug candidates could have significant
potential for improving, and becoming vital to, the treatment of cancer
patients.
We
have acquired rights to develop and commercialize the following prospective
drugs:
· |
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.
|
21
· |
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.
|
In
the area of radiation protection, we have achieved high levels of protection
in
animal models. With respect to cancer treatment, the biology of cancer is such
that there is no single drug that can be successfully used to treat 100% or
even
50% of all cancer patients. This means that there likely will be a need for
additional anticancer drugs for each type of cancer.
These
drug candidates demonstrate the value of our scientific foundation. Based on
the
expedited approval process currently available for non-medical applications
such
as protection from exposure to radiation, our most advanced drug candidate,
Protectan CBLB502, may be approved for such applications within 24 to 36 months.
Another drug candidate, Curaxin CBLC102, entered Phase IIa clinical trials
earlier last year. The results of this trial are anticipated to be available
in
the fourth quarter of 2008.
STRATEGIES
AND OBJECTIVES
Our
primary objective is to become a leading developer of drugs for the protection
of human tissues against radiation and other stresses and for cancer treatment.
Key elements of our strategy include:
· |
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.
|
22
PRODUCTS
IN DEVELOPMENT
Protectans
We
are exploring a new natural source of factors that suppress the programmed
cell
death (apoptosis) response in human cells, which can be rapidly developed into
therapeutic products. These inhibitors are anti-apoptotic factors developed
by
microorganisms of human microflora throughout millions of years of co-evolution
with mammalian host. We are using the same strategy that was applied for the
discovery of antibiotics, one of the biggest medical achievements of the
20th
century. We have established a technological pipeline for screening of such
factors, named protectans, and their rapid preclinical evaluation. These
inhibitors can be used as protection from cancer treatment toxicities and
antidotes against injuries induced by radiation and other stresses associated
with severe pathologies (i.e., heart attack or stroke).
Protectan
CBLB502
Protectan
CBLB502 is our leading radioprotectant molecule in the protectans series.
Protectan CBLB502 represents a rationally-designed derivative of the microbial
protein, flagellin. Flagellin is secreted by Salmonella
typhimurium and
many other Gram-negative bacteria, and in nature, arranges itself in a hollow
cylinder to form the filament in bacterial flagellum and
acts as a natural activator of NF-kB (nuclear factor-kappa B), a protein complex
widely used by cells as a regulator of genes that control cell proliferation
and
cell survival. Thus, Protectan CBLB502 reduces injury from acute stresses by
mobilizing several natural cell protecting mechanisms, including inhibition
of
apoptosis, reduction of oxidative damage and induction of factors (cytokines)
that induce protection and regeneration of stem cells in bone marrow and
intestine. Protectan CBLB502 is a single
agent anti-radiation therapy with significant survival benefits at a single
dose. Results indicate safety of Protectan CBLB502,
which protects animals without increasing the risk of radiation-induced cancer
development. The
remarkably strong radioprotective abilities of Protectan CBLB502 are the result
of a combination of several mechanisms of action, each of which is substantially
effective on its own. Potential
applications for Protectan CBLB502 include reduction of radiation therapy or
chemotherapy toxicities in cancer patients, protection from Acute Radiation
Syndrome (ARS) in defense scenarios, and protection from acute organ failure.
Protectan CBLB502 is administered through intramuscular injection.
Non-medical Applications
Our
scientists have demonstrated that injecting Protectan CBLB502 into mice, rats
and non-human primates protects them from lethal doses of total body gamma
radiation. An important advantage of Protectan CBLB502, above any other
radioprotectant known to us, is the ability to effectively protect not only
the
hematopoietic system, but also the gastrointestinal, or GI, tract, which are
among the most sensitive areas of the human body to radiation. High levels
of
radiation, among other effects, induce moderate to severe bone marrow damage.
The immune and blood stem cells are also depleted and death is caused by anemia,
infection, bleeding and poor wound healing. Protectan CBLB502’s ability to
effectively protect the hematopoietic system and GI tract may make Protectan
CBLB502 uniquely useful as a radioprotective antidote. Protectan CBLB502 was
shown to be safe at its therapeutic doses in rodents and non-human primates.
In
addition, Protectan CBLB502 has proved to be a stable compound for storage
purposes. It can be stored at temperatures close to freezing, room temperature
or extreme heat. Manufacture of Protectan CBLB502 is relatively inexpensive,
due
to its high yield bacterial producing strain and simple purification
process.
We
have successfully established cGMP quality manufacturing for
Protectan
CBLB502 and plan to initiate a first Phase I human safety study in 2008 for
Protectan CBLB502 in ARS, which is the only stage of human testing required
for
approval in this indication. The ARS indication follows an abbreviated approval
pathway through the FDA's two-animal rule, which requires efficacy in two
species and only safety in humans. This makes the start of the first Phase
I in
ARS especially important and although it will need to be followed with a much
larger cohort of volunteers prior to submission for FDA approval, this initial
trial will provide indications of human safety and therapeutic efficacy, through
the identification of predicted changes in certain cytokines, which function
as
biomarkers.
We
are working towards filing
a
Biologic License Application
for FDA approval of Protectan CBLB502 for non-medical applications in 18 months.
In
March 2008, the U.S. Department of Defense, or DoD, awarded us a letter contract
valued at up to $8.9 million through the Chemical Biological Medical Systems
(CBMS) Joint Project Management Office Broad Agency Announcement, or BAA, for
selected tasks in the advanced development of Protectan CBLB502 as a Medical
Radiation Countermeasure to treat radiation injury following exposure to
radiation from nuclear or radiological weapons.
23
We
also submitted a proposal for the BAA for "Therapies for Hematopoietic Syndrome,
Bone Marrow Stromal Cell Loss, and Vascular Injury Resulting from Acute Exposure
to Ionizing Radiation" published on March 6, 2008, by the Biomedical Advanced
Research and Development Authority (BARDA) of the Department of Health and
Human
Services (HHS). BARDA seeks to acquire developed medical countermeasures that
will be clinically useful in a civilian medical emergency situation that results
from or involves exposure of a large population to the effects of a nuclear
detonation, a radiologic dispersive device (such as a dirty bomb), or exposure
to radioactive material with or without combined injury or trauma. Among certain
other criteria, the BAA specified that any medical countermeasures submitted
must be efficacious when administered at or later than 24 hours after exposure.
According to the BAA, it is anticipated that multiple awards will result from
the announcement and those awards will be multi-year, cost-reimbursement,
completion type contracts. BARDA anticipates awarding 5-6 contracts on or about
September 16, 2008. BARDA estimates that the total cost (direct and indirect
cost combined) for these contracts (estimate to be 3 years in duration) will
be
up to $13.5 million per contract, out of which up to $3.4 million will be
available in fiscal year 2008.
Protectan
CBLB502 is a candidate for procurement by the DoD, HHS/BARDA and other countries
facing even more imminent threats. The HHS opportunity substantially expands
the
potential market, as its mandate is to protect the U.S. civilian population
in
the event of a radiological emergency, involving stockpiling of radiation
countermeasures for mass distribution. Our recent contract award from the DoD
and the solicitation from BARDA emphasize the government’s focus on acquiring
adequate protection against nuclear and radiation threats for military and
civilian populations. Upon FDA approval, our Protectan CBLB502 will be well
positioned to fulfill both of these needs, with its demonstrated unprecedented
efficacy and survival benefits, unique ability to address both hematopoietic
and
gastrointestinal damage, broad window of efficacy relative to radiation
exposure, and suitability for both military and civilian delivery scenarios.
We
believe that Protectan
CBLB502 is the only radiation countermeasure with these capabilities in advanced
development that can be self or buddy-administered, without the need of
additional supportive care in a battlefield or civilian community
setting.
Medical
Applications
In
addition to its military or other non-medical applications, we have found that
Protectan CBLB502 has been observed to dramatically increase the efficacy of
radiotherapy of experimental tumors in mice. Protectan CBLB502 appears to
increase the tolerance of mice to radiation while having no effect on the
radiosensitivity of tumors, thus opening the possibility of combining
radiotherapy with Protectan CBLB502 treatment to improve the overall anticancer
efficacy of radiotherapy. Our animal efficacy studies have demonstrated that
up
to 100% of mice treated with Protectan CBLB502 prior to being exposed to
radiation survived without any associated signs of toxicity. This compares
to a
100% mortality rate in the animal group that received a placebo drug.
Another
recent study demonstrated the ability of Protectan CBLB502 to reduce the
toxicities of a chemotherapeutic drug, Platinol (cisplatin), broadly used for
the treatment of ovarian, endometrial, head and neck, lung, stomach and other
types of cancer. Platinol treatment was used in the study as an example of
chemotherapy-associated toxicity. Platinol injected at toxic doses is known
to
induce myelosuppression (suppression of bone marrow) and nephrotoxicity (kidney
damage).
The
prospect of increasing patients' tolerance to chemotherapeutic drugs and
optimizing treatment regimens would be a significant paradigm shift in cancer
treatment. It is estimated that approximately 40% of the roughly $50 billion
annually spent on cancer treatment represents supportive care addressing
toxicities of various treatments, including chemotherapy.
We
plan to initiate a Phase I/II study in the second half of 2008 for Protectan
CBLB502 in head and neck cancer patients. The endpoint of the study will be
the
reduction of toxicities of radiation and chemotherapy, such as mucositis (a
painful inflammation and ulceration of oral mucosa causing difficulties with
speaking and eating). Mucositis weakens the patient by not allowing for the
oral
intake of nutrients and fluids and forces the temporary suspension of
radiotherapy and chemotherapy until the tissues of the mouth and throat have
healed. Due to the ability of head and neck cancer cells to regrow during
periods of interrupted treatment, any interruption in radiotherapy should be
avoided. Since the main cause of treatment interruptions in radiotherapy or
combinations of chemotherapy and radiotherapy treatment regimens of head and
neck cancer is acute mucositis, the ability to prevent mucositis, and therefore,
interruptions in treatment, could actually result in better outcomes for
patients with cancers of the head and neck.
24
Protectan
CBLB502 has also shown efficacy as a potential adjuvant for radiation therapy
in
mouse models of sarcoma and our researchers, in collaboration with investigators
from Cleveland Clinic, have demonstrated that a single injection of Protectan
CBLB502 effectively prevents acute renal failure and subsequent death in a
mouse
model of ischemia-reperfusion renal injury.
In
contrast to the non-medical applications of CBLB502, the use of Protectan
CBLB502 to ameliorate the toxicities of radiation treatment and anticancer
drugs
will be subject to the full FDA approval process.
Protectan
CBLB612
Protectan
CBLB612 is a modified lipopeptide mycoplasma that acts as a powerful stimulator
and mobilizer of hematopoietic (bone marrow/blood production) stem cells, or
HSC, to peripheral blood. Potential applications for Protectan CBLB612 include
accelerated hematopoietic recovery during chemotherapy and during donor
preparation for bone marrow transplantation.
Our
research indicates that Protectan CBLB612 is not only a potent stimulator of
bone marrow stem cells, but also causes their mobilization and proliferation
throughout the blood. A single administration of Protectan CBLB612 resulted
in a
three-fold increase in the number of progenitor stem cells in mouse bone marrow
within 24 hours after administration. Furthermore, the number of these stem
cells in peripheral blood was increased ten-fold within four days of
administration.
Protectan
CBLB612 was also found to be highly efficacious in stimulating proliferation
and
mobilization of hematopoietic stem cells into peripheral blood in primate model
(Rhesus macaques).
This
discovery opens a new and innovative way for us to address a broad spectrum
of
human diseases, some of which currently lack effective treatment. Direct
comparisons of Protectan CBLB612 and the market leading drug used for
stimulation of blood regeneration, G-CSF (Neupogen®, Amgen, Inc., Thousand Oaks,
California), demonstrated a stronger efficacy of Protectan CBLB612 as a
propagator and mobilizer of HSC in peripheral blood.
Protectan
CBLB612 also has been shown to provide protection in a mouse model from lethal
hematopoietic-induced ARS when administered between 48 hours prior or up to
24
hours after radiation exposure. Protectan CBLB612 does not display any
significant toxicity at its therapeutic doses in rodents and non-human primates.
With
efficacy and non-GLP safety already studied in mice and monkeys, Protectan
CBLB612 entered formal pre-clinical safety and manufacturing development in
February 2008. Its first human trials are projected for 2009. The development
of
our Protectan CBLB612 has been supported by a grant from the Defense Advanced
Research Projects Agency of the Department of Defense.
Curaxins
Curaxins
are small molecules that destroy tumor cells by simultaneously targeting two
regulators of apoptosis. Our initial test results indicate that curaxins can
be
effective against a number of malignancies, including renal cell carcinoma,
or
RCC, soft-tissue sarcoma, and hormone-refractory prostate cancer.
The
original focus of our drug development program was to develop drugs to treat
one
of the most treatment-resistant types of cancer, RCC. Unlike many cancer types
that frequently mutate or delete p53, one of the major tumor suppressor genes,
RCC belongs to a rare category of cancers that typically maintain a wild type
form of this protein. Nevertheless, RCC cells are resistant to apoptosis,
suggesting that in spite of its normal structure, p53 is functionally disabled.
The work of our founders has shown that p53 function is indeed inhibited in
RCC
by an unknown dominant factor. We have established a drug discovery program
to
identify small molecules that selectively destroy tumor cells by restoring
the
normal function to functionally impaired p53 in RCC. This program yielded a
series of chemicals with the desirable properties named curaxins (CBLC100
series). We have isolated three chemical classes of curaxins. One of them
includes relatives of 9-aminoacridine, the compound that is the core structure
of many existing drugs. Pre-existing information about this compound has allowed
us to bypass the preclinical development and Phase I studies and bring one
of
our drug candidates into Phase IIa clinical trials, saving years of R&D
efforts and improving the probability of success.
25
One
of the most important outcomes of this drug discovery program was the
identification of the mechanism by which curaxins deactivate NF-kB. This
mechanism of action makes curaxins potent inhibitors of the production and
the
activity of NF-kB not only in its stimulated form, but also in its basal form.
The level of active NF-kB is usually also increased in cancer cells. Moreover,
due to curaxin-dependent functional conversion of NF-kB-DNA complexes, the
cells
with the highest basal or induced NF-kB activity are supposed to be the most
significantly affected by curaxins. Clearly, this paradoxical activity makes
deactivation of NF-kB by curaxins more advantageous compared to conventional
strategies targeting NF-kB activators.
The
discovery of the mechanism of action of curaxins allowed us to predict and
later
experimentally verify that curaxins could be used for treatment of multiple
forms of cancers, including hormone-refractory prostate cancer, hepatocellular
carcinoma, multiple myeloma, acute lymphocytic leukemia, acute myeloid leukemia,
soft-tissue sarcomas and several others.
Curaxin
CBLC102
One
of the curaxins from the 9-aminoacridine group is a long-known, anti-infective
compound known as quinacrine, which we refer to as Curaxin CBLC102. It has
been
used for over 40 years to treat malaria, osteoarthritis and autoimmune
disorders. However, we have discovered new mechanisms of action for quinacrine
in the area of apoptosis. Through assay testing performed at Dr. Andrei Gudkov’s
laboratories at the Cleveland Clinic beginning in 2002, which included testing
in a variety of human tumor-derived cell lines representing cancers of different
tissue origin (including RCC, sarcomas, prostate, breast and colon carcinomas),
we have observed that Curaxin CBLC102 behaves as a potent NF-kB suppressor
and
activator of p53 in these types of cancer cells. It has favorable
pharmacological and toxicological profiles and demonstrates the anticancer
effect in transplants of human cancer cells into primates. These features make
Curaxin CBLC102 our prime IND drug candidate among other curaxins.
We
have applied for a patent covering the use of Curaxin CBLC102 as an anticancer
agent based on a newly-discovered mechanism of action. We
have an agreement with Regis Technologies, Inc., a GMP manufacturer, to produce
sufficient quantities of Curaxin CBLC102 according to the process previously
used for the production of this drug when it was in common use.
A
Phase II efficacy clinical trial using Curaxin CBLC102 in patients with advanced
hormone-refractory (androgen-independent) prostate cancer started in January
2007 at the University of Chicago, Cleveland Clinic, University of Pittsburgh
and Case Western Reserve University Hospitals. We are applying CBLC102 as the
monotherapy to patients who have failed to respond satisfactorily after
undergoing established cancer treatments and will use the suppression of tumor
growth and prolonged patient survival as major endpoints. Reducing the
prostate-specific antigen, or PSA, level is an additional endpoint (elevated
PSA
levels are indicative of the progression of prostate cancer).
The
planned enrollment of 32 patients was completed on April 29, 2008. The results
of this trial are anticipated to be available in the fourth quarter of 2008.
Other
Curaxins
As
mentioned above, screening of the chemical library for compounds capable of
restoring normal function to wild type p53 in the context of RCC yielded three
chemical classes of compounds. Generation of focused chemical libraries around
the hits from one of these classes and their structure-activity optimization
brought about a new generation of curaxins. As the part of this program
performed in the partnership with ChemBridge Corporation, more than 800
proprietary compounds were screened for p53 activation, efficacy in animal
tumor
models, selective toxicity and metabolic stability in the presence of rat and
human microsomes. The most active compounds were efficacious in preventing
tumor
growth in models for colon carcinoma, melanoma, ovarian cancer, RCC, and breast
cancer. In February 2008, three lead candidates were chosen for preclinical
development based on their efficacy, low toxicity profiles, high stability
and
suitability for human administration.
FINANCIAL
OVERVIEW
We
were incorporated
in Delaware and commenced business operations in June 2003. Beginning
July 21, 2006, our common stock was listed on the NASDAQ Capital Market and
on
the Boston Stock Exchange under the symbols “CBLI” and “CFB” respectively. On
August 28, 2007, trading of our stock moved from the NASDAQ Capital Market
to
the NASDAQ Global Market. In September 2007, we ceased our listing on the Boston
Stock Exchange.
26
On
March 16, 2007, we consummated a transaction with various accredited investors
pursuant to which we agreed to sell to the investors, in a private placement,
an
aggregate of approximately 4,288,712 shares of Series B Convertible Preferred
Stock, par value $0.005 per share, and Series B Warrants to purchase
approximately 2,144,356 shares of our common stock pursuant to a Securities
Purchase Agreement of the same date. The aggregate purchase price paid by the
investors for the Series B Preferred and Series B Warrants was approximately
$30,000,000. After related
fees and expenses, we received net proceeds of approximately $29,000,000. We
intend to use the proceeds for general corporate and working capital purposes.
The
Series B Preferred have an initial conversion price of $7.00 per share, and
in
the event of a conversion at such conversion price, one share of Series B
Preferred would convert into one share of common stock. Based on the closing
price of our common stock
on March 16, 2007 of $10.19, the Series B Preferred sold to investors and issued
to certain of the Agents had a market value of $46,660,112. The Series B
Warrants have an exercise price of $10.36 per share, the closing bid price
on
the day prior to the private placement. To the extent, however, that the
conversion price of the Series B Preferred or the exercise price of the Series
B
Warrants is reduced as a result of certain anti-dilution protections, the number
of shares of common stock into which the Series B Preferred are convertible
and
for which the Series B Warrants are exercisable may increase.
We
also issued to the placement agents in the private placement, as compensation
for their services, Series B Preferred, Series B Warrants, and Series C
Warrants. The Agents collectively received Series B Preferred that are
convertible into an aggregate of 290,298 shares of common stock, Series B
Warrants that are exercisable for an aggregate of 221,172 shares of our common
stock, and Series C Warrants that are exercisable for 267,074 shares of our
common stock. The Series C Warrants have an exercise price of $11.00 per share,
and are also subject to antidilution protections that could increase the number
of shares of common stock for which they are exercisable.
In
total, the securities issued in the private placement were convertible into,
or
exercisable for, up to approximately 7,211,612 shares of common stock (subject
to adjustments for stock splits, anti-dilution, etc.). As of March
31,
2008
the securities issued in the transaction, in the aggregate, were convertible
into or exercisable for approximately 6,157,289
shares of common stock (subject to adjustments for stock splits, anti-dilution,
etc.).
Proceeds
from these transactions, together with grants we have received, have supported
our R&D activities to date. We are actively seeking new grants and
co-development contacts with premier pharmaceutical partners to support further
development of other promising leads resulting from our R&D
program.
On
December 11, 2007, the SEC declared effective a registration statement of the
Company registering up to 5,514,999 shares of common stock for resale from
time
to time by the selling stockholders named in the prospectus contained in the
registration statement. This number represents 5,514,999 shares of common stock
issuable upon the conversion or exercise of the securities issued the Company’s
March 2007 private placement at the current conversion and exercise prices.
Of
these 5,514,999 shares of common stock, 3,717,515 shares are issuable upon
conversion of Series B Preferred and 1,797,484 shares are issuable upon exercise
of the Series B Warrants. We will not receive any proceeds from the sale of
the
underlying shares of common stock, although to the extent the selling
stockholders exercise warrants for the underlying shares of common stock, we
will receive the exercise price of those warrants. Subsequent to the
effectiveness of the registration statement, 708,743 Series B Preferred were
converted and $60,789 in dividends earned were paid as of December 31,
2007.
During
the three-months ended March 31, 2008 an additional 345,580 shares of the Series
B Preferred were converted and $661,295 in dividends were paid during the
three-months ended March 31, 2008. At March 31, 2008 there were 3,524,687
remaining outstanding Series B Preferred shares for which $51,462 in dividends
had been accrued.
Critical
Accounting Policies and the Use of Estimates
Our
management's discussion and analysis of our financial condition and results
of
operations is based upon our financial statements, which have been prepared
in
accordance with generally accepted accounting principles in the U.S., or GAAP.
The preparation of these financial statements requires us to make estimates
and
judgments that affect the reported amounts of our assets, liabilities, revenues,
expenses and other reported disclosures. We base our estimates on historical
experience and on various other assumptions that we believe are reasonable
under
the circumstances.
Note
2 to our financial statements includes disclosure of our significant accounting
policies. While all decisions regarding accounting policies are important,
we
believe that our policies regarding revenue recognition, R&D expenses,
intellectual property related costs and stock-based compensation expense could
be considered critical.
27
Revenue
Recognition
We
recognize revenue in accordance with Staff Accounting Bulletin No. 104, “Revenue
Recognition”, and Statement of Financial Accounting Standards No. 116, or SFAS
116. Our revenue sources consist of government grants, government contracts
and
a commercial development contract.
Grant
revenue is recognized using two different methods depending on the type of
grant. Cost reimbursement grants require us to submit proof of costs incurred
that are invoiced by us to the government agency, which then pays the invoice.
In this case, grant revenue is recognized at the time of submitting the invoice
to the government agency.
Fixed-cost
grants require no proof of costs and are paid as a request for payment is
submitted for expenses. The grant revenue under these fixed cost grants is
recognized using a percentage-of-completion method, which uses assumptions
and
estimates. These assumptions and estimates are developed in coordination with
the principal investigator performing the work under the government fixed-cost
grants to determine key milestones, expenses incurred, and deliverables to
perform a percentage-of-completion analysis to ensure that revenue is
appropriately recognized. Critical estimates involved in this process include
total costs incurred and anticipated to be incurred during the remaining life
of
the grant.
We
recognize revenue related to the funds received in 2007 from the State of New
York under the sponsored research agreement with the Roswell Park Cancer
Institute in accordance with SFAS 116. The principles of SFAS 116 result in
the
recognition of revenue as allowable costs are incurred. The Company recognizes
revenue on research laboratory services and the purchase and subsequent use
of
related equipment. The amount paid as a payment toward future services related
to the equipment is recognized as a prepaid asset and will be recognized as
revenue as the services are performed and the prepaid asset is recognized as
expense.
Government
contract revenue is recognized periodically upon delivery of an invoice for
allowable R&D expenses according to the terms of the contract. Commercial
development revenues are recognized when the service or development is
delivered.
R&D
Expenses
R&D
costs are expensed as incurred. These expenses consist primarily of our
proprietary R&D efforts, including salaries and related expenses for
personnel, costs of materials used in our R&D, costs of facilities and costs
incurred in connection with our third-party collaboration efforts. Pre-approved
milestone payments made by us to third parties under contracted R&D
arrangements are expensed when the specific milestone has been achieved. As
of
March
31,
2008,
$50,000 has been paid for milestone payments relating to the filing of an IND
with the FDA for Curaxin CBLC102 and $250,000 has been paid as a result of
commencing Phase II clinical trials for Curaxin CBLC102. An additional $50,000
has been accrued for a milestone payment relating to the filing of an IND with
the FDA for Protectan CBLB502. Once a drug receives regulatory approval, we
will
record any subsequent milestone payments in identifiable intangible assets,
less
accumulated amortization, and amortize them evenly over the remaining agreement
term or the expected drug life cycle, whichever is shorter. We expect our
R&D expenses to increase as we continue to develop our drug candidates.
Intellectual
Property Related Costs
We
capitalize costs associated with the preparation, filing and maintenance of
our
intellectual property rights. Capitalized intellectual property is reviewed
annually for impairment. If a patent application is approved, costs paid by
us
associated with the preparation, filing and maintenance of the patent will
be
amortized on a straight line basis over the shorter of 17 years or the
anticipated useful life of the patent. If the patent application is not
approved, costs paid by us associated with the preparation, filing and
maintenance of the patent will be expensed as part of selling, general and
administrative expenses at that time.
Through
December 31, 2007, we have capitalized $459,102 in expenditures associated
with
the preparation, filing and maintenance of certain of our patents, which were
incurred through the year ended December 31, 2007. We capitalized an additional
$150,744
relating to these costs incurred for the three months ended March 31, 2008,
totaling $609,846.
28
Stock-based
Compensation
We
value stock-based compensation pursuant to the provisions of SFAS 123(R).
Accordingly, effective January 1, 2005, all stock-based compensation, including
grants of employee stock options, are recognized in the statement of operations
based on their fair values.
The
Financial Accounting Standards Board (FASB) issued SFAS No. 123(R) requiring
all
share-based payments to employees, including grants of employee stock options,
be recognized in the statement of operations based at their fair values. The
Company values employee stock based compensation under the provisions of SFAS
123(R) and related interpretations.
The
fair value of each stock option granted is estimated on the grant date using
accepted valuation techniques such as the Black Scholes Option Valuation model
or Monte Carlo Simulation depending on the terms and conditions present within
the specific option being valued. The assumptions used to calculate the fair
value of options granted are evaluated and revised, as necessary, to reflect
our
experience. We use a risk-free rate based on published rates from the St. Louis
Federal Reserve at the time of the option grant; assume a forfeiture rate of
zero; assume an expected dividend yield rate of zero based on our intent not
to
issue a dividend in the foreseeable future; use an expected life based on the
safe harbor method; and presently compute an expected volatility based on a
method layering in the volatility of the Company along with that of similar
high-growth, publicly-traded, biotechnology companies due to the limited traded
history of the Company. Compensation expense is recognized using the
straight-line amortization method for all stock-based awards.
During
the three-months ended March 31, 2008, the Company granted 719,948 additional
stock options pursuant to stock award agreements. The Company recognized a
total
of $728,077 in expense related to options for the three months ended March
31,
2008. The Company also recaptured $1,459,425 of previously recognized expense
due to the stock options awarded under the 2007 Executive Compensation Plan.
These options were originally expensed based on the December 31, 2007 terms
and
conditions, but were not awarded until February 4, 2008. The change in dates
resulted in a difference in valuation assumptions used in the Black-Scholes
model causing a reduction in the grant date fair value. This reduction in the
grant date fair value from $5.34 to $2.44 per share necessitated the recapture
of the $1,459,425 in expense. This recapture resulted in a net expense for
options for the three-months ended March 31, 2008 of ($731,348).
During
the three-months ended March 31, 2007, the Company granted 119,500 options
pursuant to stock award agreements to employees and key consultants. We
recognized a total of $375,301 in expense for options for the three-months
ended
March 31, 2007. The weighted average, estimated grant date fair values of stock
options granted during the three-months ended March 31, 2008 and 2007 were
$2.86
and $5.88, respectively.
Impact
of Recently Issued Accounting Pronouncements
In
September 2006, the Financial Accounting Standards Board (“FASB”) issued
Statement of Financial Accounting Standard (“SFAS”) No. 157, “Fair Value
Measurements.”
SFAS No. 157 provides enhanced guidance for using fair value to measure assets
and liabilities and expands disclosure with respect to fair value measurement.
This statement was originally effective for fiscal years beginning after
November 15, 2007. In February 2008, the FASB issued Staff Position FSP 157-2
which allows companies to elect a one year deferral of adoption of SFAS No.
157
for non-financial assets and non-financial liabilities that are recognized
or
disclosed at fair values in the financial statements on a non-recurring basis.
The Company has adopted SFAS No. 157 as of January 1, 2008. There has been
no
material impact to our financial statements due to the adoptions of SFAS No.
157.
In
March
2008, the FASB issued SFAS No. 161. “Disclosures about Derivative
Instruments and Hedging Activities,” (SFAS No. 161). SFAS No. 161 amends
and expands the disclosure requirements of SFAS No. 133, “Accounting for
Derivative Instruments and Hedging Activities.” SFAS No. 161 requires
qualitative disclosures about objectives and strategies for using derivatives,
quantitative disclosures about fair value amounts of gains and losses on
derivative instruments and disclosures about credit-risk-related contingent
features in derivative agreements. SFAS No. 161 is intended to improve
financial reporting about derivative instruments and hedging activities by
requiring enhanced disclosures to enable investors to better understand their
effects on an entity's financial position, financial performance, and cash
flows. This statement is effective for financial statements issued for fiscal
years beginning after November 15, 2008. The adoption of SFAS No.161 will
not affect our consolidated financial condition and results of operations,
but
may require additional disclosures if we enter into derivative and hedging
activities.
29
Results
of Operations
Our
operating results for the past three fiscal years have been nominal. The
following table sets forth our statement of operations data for the quarters
ended March 31, 2008 and March 31, 2007, and the year ended December 31, 2007
and December 31, 2006, and should be read in conjunction with our financial
statements and the related notes appearing elsewhere in this filing and in
our
Annual Report on Form 10-K for the year ended December 31, 2007.
|
|
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
|
)
|
Three
Months Ended March 31, 2008 Compared to Three Months Ended March 31,
2007
Revenue
Revenue
increased from $321,445 for the three-months ended March 31, 2007 to $676,324
for the three-months ended March 31, 2008 representing an increase of $354,879
or 110.4% resulting primarily from an increase in revenue from various federal
grants and contracts including the Collaborative Research Agreement with the
Roswell Park Cancer Institute, the DTRA contract, and the NCI contract.
See
the table below for further details regarding the sources of our government
grant and contract revenue:
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
|
We
anticipate our revenue over the next year to be derived mainly from government
grants and contracts. In addition, it is common in our industry for companies
to
enter into licensing agreements with large pharmaceutical companies. To the
extent we enter into such licensing arrangements, we may receive additional
revenue from licensing fees.
30
Operating
Expenses
Operating
expenses have historically consisted of costs relating to R&D and general
and administrative expenses. R&D expenses have consisted mainly of
supporting our R&D teams, process development, sponsored research at the
Roswell Park Cancer Institute and Cleveland Clinic, clinical trials and
consulting fees. General and administrative expenses include all corporate
and
administrative functions that serve to support our current and future operations
while also providing an infrastructure to support future growth. Major items
in
this category include management and staff salaries, rent/leases, professional
services and travel-related expenses. We anticipate these expenses to increase
as a result of increased legal and accounting fees anticipated in connection
with our compliance with ongoing reporting and accounting requirements of the
SEC and the expansion of our business.
Operating
expenses increased from $4,522,919 for the three-months ended March 31, 2007
to
$4,744,500 for the three-months ended March 31, 2008, an increase of $221,581
or
4.9%. We recognized a total of ($192,626) of non-cash, stock-based compensation
for the three-months ended March 31, 2008 compared to $375,301 for the
three-months ended March 31, 2007. If these non-cash, stock-based compensation
expenses were excluded, operating expenses would have increased from
$4,147,618
for
the three-months ended March 31, 2007 to $4,937,126 for the three-months ended
March 31, 2008. This represents an increase in operating expenses of $789,508
or
19.0%.
Research
and development costs increased from $3,528,600 for the three-months ended
March
31, 2007 to $3,551,386 for the three-months ended March 31, 2008. This
represents an increase of $22,786 or 0.6%. We recognized a total of $315,630
of
R&D non-cash, stock based compensation for the three-months ended March 31,
2007 compared to $46,862 for the three-months ended March 31, 2008. Without
the
non-cash, stock-based compensation, the R&D expenses increased from
$3,212,970 for the three-months ended March 31, 2007 to $3,504,524 for the
three-months ended March 31, 2008; an increase of $291,554 or 9.1%.
Selling,
general and administrative costs increased from $994,319 for the three-months
ended March 31, 2007 to $1,193,114 for the three-months ended March 31, 2008.
This represents an increase of $198,795 or 20.0%. We recognized a total of
$59,670 of non-cash, stock-based compensation under selling, general and
administrative costs for the three-months ended March 31, 2007 compared to
($239,488) for the three-months ended March 31, 2008. Without the non-cash,
stock-based compensation, the selling, general and administrative expenses
increased from $934,649 for the three-months ended March 31, 2007 to $1,432,602
for the three months ended March 31, 2008; an increase of $497,953 or 53.3%.
The
higher general and administrative expenses were incurred as a result of
increased investor relations activities and continuing to improve the
infrastructure of the Company
Until
we introduce a product to the market, we expect these expenses in the categories
mentioned above will be the largest categories in our income
statement.
Year
Ended December 31, 2007 Compared to Year Ended December 31,
2006
Revenue
Revenue
increased from $1,708,214 for the year ended December 31, 2006 to $2,018,558
for
the year ended December 31, 2007, representing an increase of $310,344 or 18.2%,
resulting primarily from an increase in revenue from various grants including
the sponsored research agreement with RPCI, the DTRA contract, and the NCI
contract. As the term of the BioShield grant ended, the proceeds from the
BioShield grant were $0 for the year ended December 31, 2007 as compared to
$1,100,293 for the year ended December 31, 2006.
31
Operating
Expenses
Operating
expenses have historically consisted of costs relating to R&D and general
and administrative expenses. R&D expenses have consisted mainly of
supporting our R&D teams, process development, sponsored research at the
Roswell Park Cancer Institute and the Cleveland Clinic, clinical trials and
consulting fees. General and administrative expenses include all corporate
and
administrative functions that serve to support our current and future operations
while also providing an infrastructure to support future growth. Major items
in
this category include management and staff salaries, rent/leases, professional
services and travel-related expenses. We expect these expenses to increase
as a
result of increased legal and accounting fees anticipated in connection with
our
compliance with ongoing reporting and accounting requirements of the SEC and
also to support the expansion of our business.
Operating
expenses increased from $9,126,315 for the year ended December 31, 2006 to
$27,960,590 for the year ended December 31, 2007. This represents an increase
of
$18,834,275 or 206.4%. We recognized a total of $7,789,305 of non-cash
compensation for stock based compensation for the year December 31, 2007
compared to $506,078 for the year ended December 31, 2006. If these non-cash
stock based compensation expenses were excluded, operating expenses would have
increased from $8,620,237 for the year ended December 31, 2006 to $20,171,285
for the year ended December 31, 2007. This represents an increase in operating
expenses of $11,551,048 or 134.0%.
This
increase resulted primarily from an increase in R&D expenses from $6,989,804
for the year ended December 31, 2006 to $17,429,652 for the year ended December
31, 2007, an increase of $10,439,848 or 149.4%. The higher R&D expenses were
incurred as a result of increasing the number of research and development
personnel, commencing clinical trials for CBLC102 and completing the cGMP
manufacturing of CBLB502. We recognized a total of $250,682 of non-cash
compensation for R&D stock based compensation for the year ended December
31, 2006 compared to $1,836,787 for the year ended December 31, 2007. Without
the non-cash stock based compensation, the R&D expenses increased from
$6,739,122 for the year ended December 31, 2006 to $15,592,865 for the year
ended December 31, 2007; an increase of $8,853,743 or 131.4%.
In
addition, general and administrative expenses increased from $2,136,511 for
the
year ended December 31, 2006 to $10,530,938, for the year ended December 31,
2007. This represents an increase of $8,394,427 or 392.9%. These higher general
and administrative expenses were incurred as a result of creating and improving
the infrastructure of the company and the costs associated with being a publicly
traded company. We recognized a total of $255,396 of non-cash stock-based
compensation for general and administrative compensation for the year ended
December 31, 2006 compared to $5,952,517 for the year ended December 31, 2007.
Without the non-cash stock based compensation, the general and administrative
expenses increased from $1,881,115 for the year ended December 31, 2006 to
$4,578,421 for the year ended December 31, 2007; an increase of $2,697,306
or
143.4%.
Liquidity
and Capital Resources
We
have incurred annual operating losses since our inception, and, as of March
31,
2008, we had an accumulated deficit of $45,324,549. Our principal sources of
liquidity have been cash provided by sales of our securities and government
grants, contracts and agreements. Our principal uses of cash have been R&D
and working capital. We expect our future sources of liquidity to be primarily
government grants, equity financing, licensing fees and milestone payments
in
the event we enter into licensing agreements with third parties, and research
collaboration fees in the event we enter into research collaborations with
third
parties.
Net
cash used in operating activities totaled $4,243,435 for the three-months ended
March 31, 2008, compared to $3,030,466 used in operating activities for the
three-months ended March 31, 2007. Net cash used in operating activities totaled
$16,607,922 for the year ended December 31, 2007, compared to $6,653,602 used
in
operating activities for the same period in 2006. For all periods, the increase
in cash used was primarily attributable to increased R&D activities and
maintaining and improving the infrastructure necessary to support these R&D
activities.
Net
cash used in investing activities was $205,813 for the three months ended March
31, 2008 and net cash used in investing activities was $17,054,798 for the
three
months ended March 31, 2007. The decrease in cash used in investing activities
resulted primarily from a reduction in the purchase of short term investments
of
$17,999,965 from the funds received from the issuance of Series B Preferred
in
connection with our private placement offering that took place in the first
quarter of 2007. Net cash used in investing activities was $442,523 for the
year
ended December 31, 2007 and $14,281 used for the same period in 2006. The
increase in cash used for investing activities resulted primarily from the
maturing of short-term investments that converted to cash.
32
Net
cash used in financing activities totaled $660,558 for the three-months ended
March 31, 2008, compared to net cash provided by financing activities of
$28,991,288 for the three-months ended March 31, 2007. The decrease in cash
provided by financing activities was attributed to the payment of dividends
in
the first three months of 2008 as compared to the proceeds from the issuance
of
preferred stock and warrants in the private placement offering which occurred
during the first three months of 2007. Net cash provided by financing activities
totaled $28,200,591 for the year ended December 31, 2007, compared to $8,523,414
provided by financing activities for the year ended December 31, 2006. The
increase in cash provided by financing activities was attributed to the proceeds
from the issuance of Series B Preferred in connection with our private placement
offering.
Under
our exclusive license agreement with CCF, we may be responsible for making
milestone payments to CCF in amounts ranging from $50,000 to $4,000,000. The
milestones and corresponding payments for Protectan CBLB502 and Curaxin CBLC102
are set forth below:
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
|
As
of March 31, 2008, we have paid $50,000 for the milestone payment relating
to
the filing of the IND application for Curaxin CBLC102 and $250,000 for
commencing Phase II clinical trials for Curaxin CBLC102. The $50,000 milestone
payment was made May 3, 2007 and the $250,000 milestone was paid on August
21,
2007 as per the terms of the agreement. In addition, the Company has accrued
an
additional $50,000 related to the filing of an IND application related
to Protectan CBLB502 that occurred in February 2008.
Our
agreement with the CCF also provides for payment by us to CCF of royalty
payments calculated as a percentage of the net sales of the drug candidates
ranging from 1-2%, and sublicense royalty payments calculated as a percentage
of
the royalties received from the sublicenses ranging from 5-35%. However, any
royalty payments and sublicense royalty payments assume that we will be able
to
commercialize our drug candidates, which are subject to numerous risks and
uncertainties, including those associated with the regulatory approval process,
our R&D process and other factors. Each of the above milestone payments,
royalty payments and sublicense royalty payments was accrued until CCF owns
less
than five percent of our common stock on a fully-diluted basis or we receive
more than $30,000,000 in funding and/or revenues from sources other than CCF,
which have occurred with the completion of the private offering.
Although
we believe that existing cash resources will be sufficient to finance our
currently planned operations for the near-term (6-18 months), such amounts
will
not be sufficient to meet our longer-term cash requirements, including our
cash
requirements for the commercialization of certain of our drug candidates
currently in development. We may be required to issue equity or debt securities
or enter into other financial arrangements, including relationships with
corporate and other partners, in order to raise additional capital. Depending
upon market conditions, we may not be successful in raising sufficient
additional capital for our long-term requirements. In such event, our business,
prospects, financial condition and results of operations could be materially
adversely affected.
The
following factors, among others, could cause actual results to differ from
those
indicated in the above forward-looking statements: the results of our R&D
efforts, the timing and success of preclinical testing, the timing and success
of any clinical trials we may commence in the future, the timing of and
responses to regulatory submissions, the amount of cash generated by our
operations, the amount of competition we face and how successful we are in
obtaining any required licenses and entering into collaboration
arrangements.
33
Impact
of Inflation
We
believe that our results of operations are not dependent upon moderate changes
in inflation rates.
Impact
of Exchange Rate Fluctuations
We
believe that our results of operations are somewhat dependent upon moderate
changes in foreign currency exchange rates. We have entered into a manufacturing
agreement with a foreign third party to produce one of its drug compounds and
are required to make payments in the foreign currency. We also expect to enter
into additional agreements with foreign third parties, increasing the risk.
As a
result, our financial results could be affected by changes in foreign currency
exchange rates. Currently, our exposure primarily exists with the Euro and
the
Great British Pound or GBP. As of March 31, 2008, we are obligated to make
payments under the agreement of 74,350 Euros and 144,323 GBP. We have
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
Off-Balance
Sheet Arrangements
We
have not entered into any off-balance sheet arrangements.
34
Item
3: Quantitative
and Qualitative Disclosures About Market Risk
Not
applicable.
Item
4: Controls
and Procedures
Effectiveness
of Disclosure
Our
management, with the participation of our chief executive officer and chief
financial officer, evaluated the effectiveness of our disclosure controls and
procedures as of March 31, 2008 as defined in Rules 13a-15(e) and 15d-15(e)
under the Securities Exchange Act of 1934, as amended, (the “Exchange Act”). Our
management recognizes that any controls and procedures, no matter how well
designed and operated, can provide only reasonable assurance of achieving their
objectives and management necessarily applies its judgment in evaluating the
cost-benefit relationship of possible controls and procedures. Based on the
evaluation of our disclosure controls and procedures as of March 31, 2008,
our
chief executive officer and chief financial officer concluded that, as of such
date, our disclosure controls and procedures were effective to assure that
information required to be declared by us in reports that we file or submit
under the Exchange Act is (1) recorded, processed, summarized, and reported
within the periods specified in the SEC's rules and forms and (2) accumulated
and communicated to our management, including our chief executive officer and
chief financial officer, as appropriate, to allow timely decisions regarding
required disclosure.
Changes
in Internal Control over Financial Reporting
No
change in our internal control over financial reporting (as defined in Rules
13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the fiscal
quarter ended March 31, 2008 that has materially affected, or is reasonably
likely to materially affect, our internal control over financial
reporting.
35
PART
II -
Other
Information
Item
1. Legal Proceedings
As
of
March
31, 2008,
we
were
not
a
party to any litigation or other legal proceeding.
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
None.
Item
3. Defaults Upon Senior Securities
None.
Item
4. Submission of Matters to a Vote of Security Holders
None.
Item
5. Other Information
None.
Item
6. Exhibits
(a)
The following exhibits are included as part of this report:
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
|
36
Signatures
In
accordance with the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly
authorized.
|
|
|
|
|
|
|
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)
|