Select Agent
|
Currently Available Countermeasure
|
DOR Biodefense Vaccine
|
|
|
|
Ricin Toxin
|
No vaccine or antidote currently
FDA approved
|
Injectable Ricin Vaccine
|
Ricin Toxin
|
No vaccine or antidote currently
FDA approved
|
Nasal Ricin Vaccine
|
Botulinum Toxin
|
No vaccine or antidote currently
FDA approved
|
Oral/Nasal Botulinum Vaccine
|
|
|
|
Product
|
Therapeutic Indication
|
Stage of Development
|
|
|
|
orBec
Ò
|
Treatment of acute Graft-versus-Host Disease with intestinal involvement
|
Phase III
|
|
|
|
Price Range
|
|
|
||||
|
Period
|
|
High
|
Low
|
|
|
|
||
Fiscal Year Ending December 31, 2002
:
|
|
|
||
|
First Quarter
|
|
$2.10
|
$0.95
|
|
Second Quarter
|
|
$1.25
|
$0.25
|
|
Third Quarter
|
|
$0.44
|
$0.11
|
|
Fourth Quarter
|
|
$0.60
|
$0.35
|
|
|
|
|
|
Fiscal Year Ending December 31, 2003:
|
|
|
||
|
First Quarter
|
|
$1.67
|
$0.52
|
|
Second Quarter
|
|
$1.30
|
$0.82
|
|
Third Quarter
|
|
$1.11
|
$0.56
|
|
Fourth Quarter
|
|
$0.83
|
$0.60
|
|
|
|
|
|
|
|
2004 Expenditures
|
||||||||||||||
Licensor
|
Description
|
1
st
quarter
|
2
nd
quarter
|
3
rd
quarter
|
4
th
Quarter
|
|||||||||||
|
|
|
|
|
|
|||||||||||
Thomas Jefferson University
|
License fee
|
$
|
10,000
|
$
|
$ 10,000
|
$
|
--
|
|||||||||
Thomas Jefferson University
|
Sponsored research
|
74,500
|
74,500
|
75,000
|
75,000
|
|||||||||||
University of Texas
|
License fee
|
--
|
200,000
|
--
|
100,000
|
|||||||||||
University of Texas
|
Sponsored research
|
25,000
|
25,000
|
--
|
--
|
|||||||||||
Southern Research Institute
|
Sponsored research
|
120,000
|
--
|
--
|
--
|
|||||||||||
Southern Research Institute
|
Patent Maintenance
|
15,000
|
15,000
|
15,000
|
15,000
|
|||||||||||
|
|
|
|
|||||||||||||
Total
|
$
|
244,500
|
$
|
314,500
|
$
|
100,000
|
$
|
190,000
|
||||||||
|
|
|
|
Name
|
Age
|
Position
|
Director Since
|
General Alexander M. Haig, Jr.
|
79
|
Chairman of the Board
|
2003
|
Steve H. Kanzer, CPA., Esq.
|
40
|
Vice Chairman of the Board
|
1996
|
Ralph M. Ellison, M.D., M.B.A.
|
42
|
Chief Executive Officer, President and Director
|
2003
|
Robert N. Brey, Ph.D.
|
53
|
Chief Scientific Officer
|
__
|
Geoff Green
|
30
|
Chief Operating Officer
|
__
|
Larry J. Kessel, M.D.
|
49
|
Director
|
2002
|
Arthur Asher Kornbluth, M.D.
|
43
|
Director
|
2002
|
James S. Kuo M.D. M.B.A.
|
39
|
Director
|
2004
|
Evan Myrianthopoulos
|
39
|
Director
|
2002
|
Peter Salomon, M.D., FACG
|
43
|
Director
|
2002
|
Stuart Sedlack
|
39
|
Director
|
2004
|
|
Annual Compensation
|
Long term Compensation Awards
|
|||||||||||
Name and Principal Position
|
Year
|
Salary($)
|
Bonus($)
|
Securities Underlying Options
|
|||||||||
|
|
|
|
|
|||||||||
Ralph Ellison
|
2003
|
$
|
200,000
|
-
|
2,000,000
|
||||||||
President & CEO (1)
|
2002
|
-
|
-
|
-
|
|||||||||
|
2001
|
-
|
-
|
-
|
|||||||||
David Kent,
|
2003
|
$
|
103,124
|
-
|
200,000
|
||||||||
Former President & CEO(2)
|
2002
|
-
|
-
|
-
|
|||||||||
|
2001
|
-
|
-
|
-
|
|||||||||
Robert Brey
|
2003
|
$
|
155,000
|
-
|
-
|
||||||||
Chief Science Officer (3)
|
2002
|
$
|
254,600
|
-
|
-
|
||||||||
|
2001
|
-
|
-
|
-
|
|||||||||
|
|
|
|
|
|||||||||
(1)
Dr. Ellison joined our company in March 2003.
|
|||||||||||||
(2) Mr. Kent joined our company in January 2003 and resigned from our company in March 2003 | |||||||||||||
(3) Dr. Brey joined our company in December 2002. |
|
|
|
|
Number of Securities
Underlying Unexercised
Options at 12/31/03 (#)
|
|||||||||
Name
|
Shares Acquired Upon Exercise
|
Value Realized
|
|||||||||||
Exercisable/Unexercisable
|
|||||||||||||
Ralph Ellison
|
|
|
|
1,333,333/666,667
|
|||||||||
David Kent
|
200,000
|
$
|
85,000
|
|
-/-
|
||||||||
Robert Brey
|
|
|
|
115,000/-
|
Plan Category
|
Number of Securities to be Issued Upon Exercise of Outstanding Options, Warrants and Rights (a)
|
Weighted-Average Exercise Price of Outstanding Options, Warrants and Rights (b)
|
Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in Column (a)) (c)
|
|
|
|
|
Equity Compensation Plans Approved by Security Holders
|
8,496,844
|
$0.72
|
1,503,156
|
|
|
|
|
Equity Compensation Plans Not Approved by Security Holders
|
0
|
0
|
0
|
|
|
|
|
Total
|
8,496,844
|
$0.72
|
1,503,156
|
|
|
|
|
|
||
|
||
|
||
F-1 | ||
|
||
|
December 31,
|
||||||
|
2003
|
2002
|
|||||
|
|
||||||
Assets
|
|
|
|||||
Current assets:
|
|
|
|||||
Cash and cash equivalents
|
$
|
4,117,539
|
$
|
4,147,164
|
|||
Receivable
|
20,954
|
|
|||||
Prepaid expenses
|
155,844
|
104,333
|
|||||
|
|
||||||
Total current assets
|
4,294,337
|
4,251,497
|
|||||
|
|
|
|||||
Equipment, net of accumulated amortization of $141,650 and $1,162,247
|
60,795
|
262,921
|
|||||
Licenses and patent costs, net of accumulated amortization of $384,333
and $193,810
|
1,896,934
|
1,323,782
|
|||||
|
|
||||||
Total assets
|
$
|
6,252,066
|
$
|
5,838,200
|
|||
|
|
||||||
|
|
|
|||||
Liabilities and stockholders equity
|
|
|
|||||
Current liabilities:
|
|
|
|||||
Accounts payable
|
$
|
211,587
|
$
|
568,120
|
|||
Accrued royalties
|
320,000
|
130,000
|
|||||
Accrued compensation and other expenses
|
116,638
|
124,480
|
|||||
Current portion of long-term debt
|
359,067
|
382,122
|
|||||
|
|
||||||
Total current liabilities
|
1,007,292
|
1,204,722
|
|||||
|
|
||||||
Long-term debt
|
|
347,845
|
|||||
|
|
||||||
Total liabilities
|
1,007,292
|
1,552,567
|
|||||
|
|
||||||
|
|
|
|||||
Stockholders equity:
|
|
|
|||||
Preferred stock, $.001 par value. Authorized 4,600,000 shares; none issued
and outstanding
|
|
|
|||||
Series B convertible preferred stock, $.05 par value. Authorized 200,000 shares; 126,488 and 117,118 issued and outstanding, at liquidation value
|
12,648,768
|
11,711,822
|
|||||
Common stock, $.001 par value. Authorized 100,000,000 shares; 34,893,765 and 26,794,642 issued, 34,721,423 and 26,622,300 outstanding
|
34,894
|
26,795
|
|||||
Additional paid-in capital
|
67,005,276
|
61,315,985
|
|||||
Common stock to be issued, 375,498 shares in 2002
|
|
436,812
|
|||||
Unearned compensation
|
|
(50,148
|
)
|
||||
(73,975,897
|
)
|
(68,687,366
|
)
|
||||
|
|
||||||
|
5,713,041
|
4,753,900
|
|||||
Less: Cost of 172,342 shares of common stock in treasury
|
(468,267
|
)
|
(468,267
|
)
|
|||
|
|
||||||
Total stockholders equity
|
5,244,774
|
4,285,633
|
|||||
|
|
||||||
Total liabilities and stockholders equity
|
$
|
6,252,066
|
$
|
5,838,200
|
|||
|
|
|
||
F-2 | ||
|
||
|
||
F-3 | ||
|
||
|
|
|
|
|
(Deficit)
|
|
|
|
|
|||||||||||||||||||||||||||||||
|
|
|
|
|
Accumulated
|
|
|
|
|
|||||||||||||||||||||||||||||||
|
|
Common Stock
|
Series B and C Convertible
|
Additional
|
During the
|
Other
|
|
|
|
|||||||||||||||||||||||||||||||
|
Common Stock
|
to be Issued
|
Preferred Stock
|
Paid-In
|
Development
|
Comprehensive
|
Treasury Stock
|
Unearned
|
Subscription
|
|||||||||||||||||||||||||||||||
|
|
|
|
|||||||||||||||||||||||||||||||||||||
|
Shares |
|
|
Par Value
|
|
|
Shares
|
|
|
Stated Value
|
|
|
Shares
|
|
|
Stated Value
|
|
|
Capital
|
|
|
Stage
|
|
|
Income
|
|
|
Shares
|
|
|
Cost
|
|
|
Compensation
|
|
|
Receivable
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Common stock issued for cash in
February 1985 at $1.50 per share
|
667
|
$ |
1
|
|
$ |
|
|
$ |
|
$ |
999
|
$ |
|
$ |
|
|
$ |
|
$ |
|
$ |
|
||||||||||||||||||
Common Stock issued for cash in
October 1986 at $750.00 per share
|
666
|
1
|
|
|
|
|
499,999
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Excess of fair market value over option price of nonqualified stock option granted in 1986
|
|
|
|
|
|
|
13,230
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Common stock issued in May 1987 at $750.00 per share for legal services performed for the company
|
7
|
|
|
|
|
|
5,000
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Net Proceeds from initial public stock offering in June 1987 at $6,000 per share, less insurance costs
|
333
|
|
|
|
|
|
1,627,833
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Nonqualified stock options exercised
in 1987
|
48
|
|
|
|
|
|
33,808
|
|
|
|
|
(28,188
|
)
|
|
||||||||||||||||||||||||||
Amortization of unearned
compensation in 1987
|
|
|
|
|
|
|
|
|
|
|
|
7,425
|
|
|||||||||||||||||||||||||||
Excess of fair market value over
option price of nonqualified stock options granted in 1987
|
|
|
|
|
|
|
75,063
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||
Balance at 12-31-1987
|
1,721
|
$
|
2
|
|
$
|
|
|
$
|
|
$
|
2,255,932
|
$
|
|
$
|
|
|
$
|
|
$
|
(20,763
|
)
|
$
|
|
F-4 | ||
|
||
|
|
|
|
|
|
|
|
(Deficit)
|
|
|
|
|
|
|||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|||||||||||||||||||||||||||
|
|
|
Common Stock
|
Series B and C Convertible
|
Additional
|
During the
|
Other
|
|
|
|
|
|||||||||||||||||||||||||||||
|
Common Stock
|
to be Issued
|
Preferred Stock
|
Paid-In
|
Development
|
Comprehensive
|
Treasury Stock
|
Unearned
|
Subscription
|
|||||||||||||||||||||||||||||||
|
Shares
|
Par Value
|
Shares
|
Stated Value
|
Shares
|
Stated Value
|
Capital
|
Stage
|
Income
|
Equity
|
Cost
|
Compensation
|
Receivable
|
|||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Nonqualified stock options exercised in
1988
|
18
|
$
|
|
$
|
|
$
|
$ 256
|
$
|
$
|
|
$
|
$
|
$
|
|||||||||||||||||||||||||||
Stock warrants exercised in 1988
|
1
|
|
|
|
|
|
12,000
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Common stock redeemed and retired in 1988
|
(10
|
)
|
|
|
|
|
|
(150
|
)
|
|
|
|
|
|
|
|||||||||||||||||||||||||
Excess of fair market value over option price of nonqualified stock options granted in 1988
|
|
|
|
|
|
|
36,524
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Amortization of unearned compensation in 1988
|
|
|
|
|
|
|
|
|
|
|
|
19,113
|
|
|||||||||||||||||||||||||||
Nonqualified stock options exercised in
1989
|
71
|
|
|
|
|
|
1,060
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Common stock redeemed and retired in
1989
|
(12
|
)
|
|
|
|
|
|
(175
|
)
|
|
|
|
|
|
|
|||||||||||||||||||||||||
Excess of fair market value over option price of nonqualified stock options granted in 1989
|
|
|
|
|
|
|
113,037
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Net proceeds from secondary public stock offering in April 1989 at $525 per share, less issuance cost
|
2,174
|
2
|
|
|
|
|
980,178
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Amortization of unearned compensation in 1989
|
|
|
|
|
|
|
|
|
|
|
|
1,650
|
|
|||||||||||||||||||||||||||
Common stock issued for cash in October 1990 through January 1991 at $9.00 per share
|
5,694
|
6
|
|
|
|
|
51,244
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Excess of fair market value over option price of nonqualified stock options granted in 1990
|
|
|
|
|
|
|
30,635
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||
Balance at 12-31-1990
|
9,657
|
$
|
10
|
|
$
|
|
|
$
|
|
$
|
3,480,541
|
$
|
|
$
|
|
|
$
|
|
$
|
|
$
|
|
F-5 | ||
|
||
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|||||||||||||||||||||||||||
|
|
|
Common Stock
|
Series B and C Convertible
|
Additional
|
During the
|
Other
|
|
|
|
|
|||||||||||||||||||||||||||||
Common Stock
|
to be Issued
|
Preferred Stock
|
Preferred Stock
|
Paid-In
|
Comprehensive
|
Treasury Stock
|
Unearned
|
Subscription
|
||||||||||||||||||||||||||||||||
Shares
|
Par Value
|
Shares
|
Stated Value
|
Capital
|
Stated Value
|
Capital
|
Stage
|
Income
|
Shares
|
Cost
|
Compensation
|
Receivable
|
||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Common stock issued for cash in February
1991 through April 1991 at $9.00 per share
|
2,772
|
$ 3
|
|
$
|
|
$
|
$ 24,947
|
$
|
$
|
|
$
|
$
|
$
|
|||||||||||||||||||||||||||
Common stock issued for cash and services in November 1991 at $1.50 per share
|
15,333
|
15
|
|
|
|
|
22,985
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Common stock issued for cash and note in December 1991 at $0.75 per share
|
296,949
|
297
|
|
|
|
|
200,018
|
|
|
|
|
|
(50,315
|
)
|
||||||||||||||||||||||||||
Excess of fair market value over option price of nonqualified stock options granted in 1991
|
|
|
|
|
|
|
16,570
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Nonqualified stock options exercised in 1991
|
1
|
|
|
|
|
|
1
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Payments on note receivable in 1992
|
|
|
|
|
|
|
|
|
|
|
|
|
11,300
|
|||||||||||||||||||||||||||
Net proceeds from secondary public stock offering in August 1992 at $112.50 per share, less issuance costs
|
66,666
|
66
|
|
|
|
|
6,230,985
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Nonqualified stock options exercised in 1992
|
2,000
|
2
|
|
|
|
|
28
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Excess of fair market value over option price of nonqualified stock options granted in 1993
|
|
|
|
|
|
|
126,000
|
|
|
|
|
(126,000
|
)
|
|
||||||||||||||||||||||||||
Amortization of unearned compensation in 1993
|
|
|
|
|
|
|
|
|
|
|
|
40,750
|
|
|||||||||||||||||||||||||||
Nonqualified stock options exercised in 1993
|
67
|
|
|
|
|
|
57
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Collection of note receivable in 1993
|
|
|
|
|
|
|
|
|
|
|
|
|
39,015
|
|||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||
Balance at 12-31-1993
|
393,445
|
$
|
393
|
|
$
|
|
|
$
|
|
$
|
10,102,132
|
$
|
|
$
|
|
|
$
|
|
$
|
(85,250
|
)
|
$
|
|
F-6 | ||
|
||
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||
|
|
|
|
|
(Deficit
|
|
|
|
|
|||||||||||||||||||||||||||||||
|
|
Common Stock
|
Series B and C Convertible
|
|
Accumulated
|
|
|
|
||||||||||||||||||||||||||||||||
|
Common Stock
|
to be Issued
|
Preferred Stock
|
Additional
|
During the
|
Other
|
Treasury Stock
|
|
||||||||||||||||||||||||||||||||
|
|
|
Paid-In
|
Development | Comprehensive |
|
Unearned
|
Subscription | ||||||||||||||||||||||||||||||||
|
Shares
|
Par Value
|
Shares
|
Stated Value
|
Shares
|
Stated Value
|
Capital
|
Stage
|
Income
|
Shares
|
Cost
|
Compensation
|
Receivable
|
|||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Acquisition of treasury stock in 1994
|
|
$
|
|
|
$
|
|
|
$
|
|
$
|
|
$
|
|
$
|
|
41,975
|
$
|
(300,000
|
)
|
$
|
|
$
|
|
|||||||||||||||||
Forfeiture of nonqualified stock options granted in 1994
|
|
|
|
|
|
|
(22,402
|
)
|
|
|
|
|
22,402
|
|
||||||||||||||||||||||||||
Amortization of unearned compensation in 1994
|
|
|
|
|
|
|
|
|
|
|
|
49,348
|
|
|||||||||||||||||||||||||||
Acquisition of treasury stock in 1995
|
|
|
|
|
|
|
|
|
|
76,667
|
(143,750
|
)
|
|
|
||||||||||||||||||||||||||
Forfeiture of nonqualified stock options granted in 1995
|
|
|
|
|
|
|
(1,379
|
)
|
|
|
|
|
1,379
|
|
||||||||||||||||||||||||||
Amortization of unearned compensation in 1995
|
|
|
|
|
|
|
|
|
|
|
|
12,121
|
|
|||||||||||||||||||||||||||
Common stock issued at $0.975 per share in 1996
|
333,333
|
333
|
|
|
|
|
324,667
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Common stock issued at $3.00 per share in 1996
|
333,333
|
333
|
|
|
|
|
999,667
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Nonqualified stock options exercised in 1996
|
145,283
|
146
|
|
|
|
|
379,003
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Warrants exercised at $1.20 per share in 1997
|
1,173
|
1
|
|
|
|
|
1,407
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Proceeds on exercise of stock options in 1997
|
|
|
|
|
|
|
5,000
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Warrants issued in 1997
|
|
|
|
|
|
|
5,407,546
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Net proceeds for private placement at $2.3125 per share, less issuance cost in 1997
|
8,648,718
|
8,650
|
|
|
|
|
15,122,943
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||
Balance at 12-31-1997
|
9,955,285
|
$
|
9,955
|
|
$
|
|
|
$
|
|
$
|
32,318,584
|
$
|
|
$
|
|
118,642
|
$
|
(443,760
|
)
|
$
|
|
$
|
|
F-7 | ||
|
||
|
|
|
|
|
|
|
|
(Deficit) |
|
|
|
|
|
|||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|||||||||||||||||||||||||||
|
|
|
Common Stock
|
Series B and C Convertible
|
Additional
|
During the
|
Other
|
|
|
|
|
|||||||||||||||||||||||||||||
|
common stock |
to be Issued
|
Preferred Stock
|
Paid-In
|
Development
|
Comprehensive
|
Treasury Stock
|
Unearned
|
Subscription
|
|||||||||||||||||||||||||||||||
|
Shares |
Par Value
|
Shares
|
Stated Value
|
Shares
|
Stated Value
|
Capital
|
Stage
|
Income
|
Shares
|
Cost
|
Compensation
|
Receivable
|
|||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Net proceeds from issuance of common stock and warrants in January 1998
|
307,692
|
$ 308
|
|
$
|
|
$
|
$ 1,871,537
|
$
|
$
|
$
|
$
|
$
|
$
|
|||||||||||||||||||||||||||
Proceeds from exercise of stock options in 1998
|
25,000
|
25
|
|
|
|
|
61,725
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Purchase and retirement of common stock in 1998
|
(133,335
|
)
|
(134
|
)
|
|
|
|
|
(129,866
|
)
|
|
|
|
|
|
|
||||||||||||||||||||||||
Net proceeds from issuance of Series B preferred stock at $100 per share in March 1998
|
|
|
|
|
80,100
|
8,010,000
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Accrued preferred stock dividends in 1998
|
|
|
|
|
5,986
|
598,666
|
(713,187
|
)
|
|
|
|
|
|
|
||||||||||||||||||||||||||
Proceeds from exercise of stock options in 1999
|
334
|
4
|
|
|
|
|
347
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Common stock dividends issued in 1999
|
819,319
|
819
|
|
|
|
|
1,535,403
|
(1,536,222
|
)
|
|
|
|
|
|
||||||||||||||||||||||||||
Accrued preferred stock dividends in 1999
|
|
|
|
|
6,887
|
688,634
|
(1,285,412
|
)
|
|
|
|
|
|
|
||||||||||||||||||||||||||
Net proceeds from private placement at $4.725 per share, less issuance costs in 2000
|
1,809,520
|
1,810
|
|
|
|
|
7,772,738
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Issuance of options issued in exchange for financial advisory services in 2000
|
|
|
|
|
|
|
87,373
|
|
|
|
|
(87,373
|
)
|
|
||||||||||||||||||||||||||
Issuance of options issued in exchange for consulting services in 2000
|
|
|
|
|
|
|
12,787
|
|
|
|
|
(12,787
|
)
|
|
||||||||||||||||||||||||||
Amortization of unearned compensation in 2000
|
|
|
|
|
|
|
|
|
|
|
|
95,307
|
|
|||||||||||||||||||||||||||
Proceeds from exercise of stock options in 2000
|
71,722
|
69
|
|
|
|
|
215,685
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Noncash exercise of warrants in 2000
|
104,963
|
104
|
|
|
|
|
(104
|
)
|
|
|
|
|
|
|
||||||||||||||||||||||||||
Accrued preferred stock dividends in 2000
|
|
|
|
|
7,437
|
743,700
|
(1,382,200
|
)
|
|
|
|
|
|
|
||||||||||||||||||||||||||
Net loss from inception, February 15, 1985 to December 31, 2000
|
|
|
|
|
|
|
|
(47,553,888
|
)
|
|
|
|
|
|
||||||||||||||||||||||||||
Unrealized gain on marketable securities in 2000
|
|
|
|
|
|
|
|
|
75
|
|
|
|
|
|||||||||||||||||||||||||||
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||
Balance at December 31, 2000
|
12,860,500
|
$
|
12,861
|
|
$
|
|
100,410
|
$
|
10,041,000
|
$
|
40,365,410
|
$
|
(49,090,110
|
)
|
$
|
75
|
$
|
118,642
|
$
|
(443,750
|
)
|
$
|
(4,853
|
)
|
$
|
|
F-8 | ||
|
||
|
|
|
|
|
|
|
|
(Deficit |
|
|
|
|
|
|||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|||||||||||||||||||||||||||
|
|
Common Stock |
Series B and C Convertible
|
Additional
|
During the
|
Other
|
|
|
|
|
||||||||||||||||||||||||||||||
|
Common Stock |
to be Issued
|
Preferred Stock
|
Paid-In
|
Development
|
Comprehensive
|
Treasury Stock
|
Unearned
|
Subscription
|
|||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||
Shares |
Par Value
|
Shares
|
Stated Value
|
Shares
|
Stated Value
|
Capital
|
Stage
|
Income
|
Shares
|
Cost
|
Compensation
|
Receivable
|
||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||
Issuance of common stock for the acquisition of CTD
|
8,083,884
|
$ 8,084
|
1,350,000
|
$ 1,687,500
|
|
$
|
$10,100,771
|
$
|
$
|
|
$
|
$
|
$
|
|||||||||||||||||||||||||||
Additional costs related to 2000 private placement
|
|
|
|
|
|
|
(21,871
|
)
|
|
|
|
|
|
|
||||||||||||||||||||||||||
Issuance of options issued in exchange for advisory services and consulting fees
|
|
|
|
|
|
|
25,552
|
|
|
|
|
(25,552
|
)
|
|
||||||||||||||||||||||||||
Amortization of unearned compensation
|
|
|
|
|
|
|
|
|
|
|
|
30,405
|
|
|||||||||||||||||||||||||||
Accrued preferred stock dividends
|
|
|
|
|
8,033
|
803,280
|
(1,486,501
|
)
|
|
|
|
|
|
|
||||||||||||||||||||||||||
Net loss
|
|
|
|
|
|
|
|
(14,631,175
|
)
|
|
|
|
|
|
||||||||||||||||||||||||||
Unrealized loss on marketable securities
|
|
|
|
|
|
|
|
|
(75
|
)
|
|
|
|
|
||||||||||||||||||||||||||
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Balance at December 31, 2001
|
20,944,384
|
20,945
|
1,350,000
|
1,687,500
|
108,443
|
10,844,280
|
48,983,361
|
(63,721,285
|
)
|
|
118,642
|
(443,750
|
)
|
|
|
|||||||||||||||||||||||||
Issuance of common stock, net
|
3,593,569
|
3,593
|
|
|
|
|
1,220,476
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Issuance of options issued in exchange for advisory services and consulting fees
|
|
|
|
|
|
|
368,836
|
|
|
|
|
(368,836
|
)
|
|
||||||||||||||||||||||||||
Amortization of unearned compensation
|
|
|
|
|
|
|
|
|
|
|
|
318,688
|
|
|||||||||||||||||||||||||||
Accrued preferred stock dividends
|
|
|
|
|
8,675
|
867,542
|
(1,456,385
|
)
|
|
|
|
|
|
|
||||||||||||||||||||||||||
Conversion of redeemable preferred stock to common stock
|
1,245,187
|
1,245
|
|
|
|
|
10,936,331
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Issuance of restricted stock for consulting services
|
|
|
37,000
|
13,690
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Acquisition of treasury stock
|
|
|
|
|
|
|
|
|
|
53,700
|
(24,517
|
)
|
|
|
||||||||||||||||||||||||||
Release of shares to be issued
|
1,011,502
|
1,012
|
(1,011,502
|
)
|
(1,264,378
|
)
|
|
|
1,263,366
|
|
|
|
|
|
|
|||||||||||||||||||||||||
Net loss
|
|
|
|
|
|
|
|
(4,966,081
|
)
|
|
|
|
|
|
||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||
Balance at December 31, 2002
|
26,794,642
|
26,795
|
375,498
|
436,812
|
117,118
|
11,711,822
|
61,315,985
|
(68,687,366
|
)
|
|
172,342
|
(468,267
|
)
|
(50,148
|
)
|
|
||||||||||||||||||||||||
Issuance of Common Stock, from private placement
|
6,796,912
|
6,797
|
|
|
|
|
4,748,125
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Issuance of Common Stock other
|
40,974
|
41
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Issuance of options issued in exchange for Technology Licenses
|
391,305
|
391
|
|
|
|
|
329,609
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Amortization of unearned compensation
|
|
|
|
|
|
|
|
|
|
|
|
50,148
|
|
|||||||||||||||||||||||||||
Issuance of shares from Options/Warrants
|
494,434
|
494
|
|
|
|
|
187,217
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Accrued preferred stock dividends
|
|
|
|
|
9,370
|
936,946
|
(936,946
|
)
|
|
|
|
|
|
|
||||||||||||||||||||||||||
Release of shares to be issued
|
375,498
|
376
|
(375,498
|
)
|
(436,812
|
)
|
|
|
436,
436
|
|
|
|
|
|
|
|||||||||||||||||||||||||
Non-cash stock Compensation
|
|
|
|
|
|
|
954,850
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Net Loss
|
|
|
|
|
|
|
|
(5,288,531
|
)
|
|
|
|
|
|
||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||
Balance at December 31, 2003
|
34,893,765
|
$
|
34,894
|
|
$
|
|
126,488
|
$
|
12,648,768
|
$
|
67,035,652
|
$
|
(73,975,897
|
)
|
$
|
|
172,342
|
$
|
(468,267
|
)
|
$
|
|
$
|
|
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these Financial Statements
|
||
F-9 | ||
|
||
|
Year ended
December 31,
|
Cumulative Period
February 15, 1985 (Inception) to December 31,
|
||||||||
|
2003
|
2002
|
2003
|
|||||||
|
||||||||||
Operating activities:
|
|
|
|
|||||||
$
|
(5,288,531
|
)
|
$
|
(4,966,081
|
)
|
$
|
(72,439,676
|
)
|
||
Adjustments to reconcile net loss to cash used in operating activities:
|
|
|
|
|||||||
Depreciation and amortization
|
226,140
|
345,495
|
2,134,741
|
|||||||
Gain on sale of marketable securities
|
|
|
(110,244
|
)
|
||||||
Noncash stock compensation
|
1,004,998
|
332,378
|
2,123,554
|
|||||||
Equity in (earnings) losses of joint ventures
|
|
(868,859
|
)
|
22,179,091
|
||||||
Amortization of fair value of warrants
|
|
|
3,307,546
|
|||||||
Gain on sale of assets
|
26,389
|
|
21,859
|
|||||||
Write-off patent issuance cost
|
59,340
|
|
499,065
|
|||||||
Write-off of acquired research and
development
|
|
|
10,181,000
|
|||||||
Change in operating assets and liabilities:
|
|
|
|
|||||||
Receivables
|
(20,954
|
)
|
|
(20,954
|
)
|
|||||
Receivable from related party
|
|
44,447
|
|
|||||||
Prepaid expenses
|
(51,511
|
)
|
(54,392
|
)
|
(151,822
|
)
|
||||
Accounts payable and accrued expenses
|
(78,897
|
)
|
(158,067
|
)
|
564,269
|
|||||
Accrued compensation
|
(95,480
|
)
|
(81,489
|
)
|
29,000
|
|||||
Due to joint ventures
|
|
(594,232
|
)
|
(1,635,466
|
)
|
|||||
|
||||||||||
Total adjustments
|
1,070,025
|
(1,034,719
|
)
|
39,121,639
|
||||||
|
|
|
||||||||
Net cash used in operating activities
|
(4,218,506
|
)
|
(6,000,800
|
)
|
(33,318,037
|
)
|
||||
|
|
|
|
|||||||
Investing activities:
|
|
|
|
|||||||
Cash received in acquisition of CTD, net
|
|
|
1,392,108
|
|||||||
Patent issuance costs
|
(438,845
|
)
|
(593,931
|
)
|
(1,827,272
|
)
|
||||
Investment in joint ventures
|
|
|
(3,638,171
|
)
|
||||||
Organizational costs incurred
|
|
|
(135
|
)
|
||||||
Purchases of leasehold improvements and equipment
|
(17,854
|
)
|
(83,089
|
)
|
(1,888,052
|
)
|
||||
Proceeds from assets sold
|
103,407
|
|
108,197
|
|||||||
Purchases of marketable securities
|
|
|
(11,004,080
|
)
|
||||||
Proceeds from sale of marketable securities
|
|
|
11,114,324
|
|||||||
|
|
|
||||||||
Net cash provided by (used in) investing
activities
|
(353,292
|
)
|
(677,020
|
)
|
(5,743,041
|
)
|
F-10 | ||
|
||
|
Year ended
December 31,
|
Cumulative Period
February 15, 1985 (Inception) to December 31,
|
||||||||
|
2003
|
2002
|
2003
|
|||||||
|
|
|
||||||||
Financing activities:
|
|
|
|
|||||||
Net proceeds from issuance (costs incurred related
to issuance) of common stock
|
$4,724,849
|
$974,069
|
$43,477,317
|
|||||||
Proceeds from exercise of options
|
187,217
|
|
604,711
|
|||||||
Proceeds from borrowings under line of credit
|
|
|
1,150,913
|
|||||||
Repayment of amounts due under line of credit, notes payable and capital lease obligations
|
(370,900
|
)
|
(66,621
|
)
|
(1,434,404
|
)
|
||||
Repayment of long-term receivable
|
|
|
50,315
|
|||||||
Repayment of note payable issued in exchange for legal services
|
|
|
(71,968
|
)
|
||||||
Purchase and retirement of common stock
|
|
|
(130,000
|
)
|
||||||
Purchase of common stock for treasury
|
|
(24,517
|
)
|
(468,267
|
)
|
|||||
|
|
|
||||||||
Net cash provided by (used in) financing activities
|
4,542,166
|
882,931
|
43,178,617
|
|||||||
|
|
|
||||||||
Net increase (decrease) in cash and cash
equivalents
|
(29,625
|
)
|
(5,794,889
|
)
|
4,117,539
|
|||||
Cash and cash equivalents at beginning of period
|
4,147,164
|
9,942,053
|
|
|||||||
|
|
|
||||||||
Cash and cash equivalents at end of year
|
$
|
4,117,539
|
$
|
4,147,164
|
$
|
4,117,539
|
||||
|
|
|
||||||||
|
|
|
|
|||||||
Supplemental disclosure of cash flow:
|
|
|
|
|||||||
Cash paid for interest
|
$
|
5,330
|
$
|
9,103
|
|
|||||
Non-cash transactions:
|
|
|
|
|||||||
Non-cash stock option expense
|
$
|
1,004,998
|
|
|
||||||
Issuance of preferred stock dividends in kind
|
936,945
|
$
|
1,456,385
|
|
||||||
Issuance of note payable for joint venture termination
|
|
$
|
579,742
|
|
||||||
Issuance of common stock for patent rights
|
$
|
320,000
|
$
|
250,000
|
|
F-11 | ||
|
||
|
||
F-12 | ||
|
||
F-13 | ||
|
||
F-14 | ||
|
||
|
Year ended December 31,
|
|
|
2003
|
2002
|
|
|
|
Net loss applicable to common stockholders:
|
|
|
As reported
|
$(6,225,476)
|
$(6,422,466)
|
Add Stock-based employee compensation expense related to stock options determined under fair value method
|
(1,919,282)
|
(577,326)
|
Deduct amounts charged to expense
|
645,850
|
--
|
|
|
|
Pro forma net income available to common stock holders
|
$(7,490,708)
|
$(6,999,792)
|
|
|
|
Net loss per share:
|
|
|
As reported, basic and diluted
|
$(0.21)
|
$(0.29)
|
Pro forma, , basic and diluted
|
$(0.25)
|
$(0.31)
|
F-15 | ||
|
||
F-16 | ||
|
||
F-17 | ||
|
||
|
December 31,
|
||||||
|
2003
|
2002
|
|||||
|
|
||||||
|
|
|
|||||
Leasehold improvements
|
$
|
|
$
|
262,985
|
|||
Laboratory equipment
|
117,588
|
927,189
|
|||||
Office equipment
|
84,857
|
234,994
|
|||||
|
|
||||||
|
202,445
|
1,425,168
|
|||||
Accumulated depreciation
|
(141,650
|
)
|
(1,162,247
|
)
|
|||
|
|
||||||
|
$
|
60,795
|
$
|
262,921
|
|||
|
|
F-18 | ||
|
||
December, 31 2003
|
Weighted Average Amortization period (years)
|
Cost
|
Accumulated Amortization
|
Net
|
|
|
|
|
|
Patents and Licenses
|
11.85 years
|
$2,281,267
|
$ 384,333
|
$1,896,934
|
Year
|
Amortization Amount
|
|||
2004
|
$
|
254,802
|
||
2005
|
134,791
|
|||
2006
|
134,791
|
|||
2007
|
134,791
|
|||
2008
|
134,791
|
|
December 31,
|
||||||
|
2003
|
2002
|
|||||
|
|
||||||
|
|
|
|||||
Note payable to Elan (see Note 4)
|
$
|
348,845
|
$
|
579,742
|
|||
Note payable to a bank
|
11,222
|
150,225
|
|||||
|
|
||||||
|
359,067
|
729,967
|
|||||
Less current portion
|
359,067
|
382,122
|
|||||
|
|
||||||
$ | -- |
$
|
347,845
|
||||
|
|
F-19 | ||
|
||
F-20 | ||
|
||
|
December 31,
|
|
|
2003
|
2002
|
|
|
|
|
|
|
Shares available for grant at beginning of year
|
4,474,443
|
1,101,238
|
Increase in shares available
|
-
|
208,257
|
Amendment to increase shares available in plan
|
-
|
5,291,743
|
Options granted under the Plan
|
(4,520,000)
|
(3,087,420)
|
Options forfeited
|
1,676,144
|
960,625
|
Shares available for grant at end of year
|
1,630,587
|
4,474,443
|
|
|
|
|
|
|
|
Options
|
Weighted-Average Options Exercise Price
|
|
|
|
|
|
|
Balance at December 31, 2001
|
3,411,667
|
$1.69
|
Granted
|
3,626,000
|
0.33
|
Forfeited
|
(960,625)
|
1.27
|
|
|
|
Balance at December 31, 2002
|
6,077,042
|
0.95
|
Granted
|
4,520,000
|
0.80
|
Forfeited
|
(1,676,144)
|
1.85
|
Exercised
|
(424,054)
|
0.39
|
|
|
|
Balance at December 31, 2003
|
8,496,844
|
$0.72
|
|
|
|
|
|
|
|
Weighted-Average Remaining Contractual Life
|
Outstanding Options
|
Exercisable Warrants
|
|
|
|
|
Price Range $0.20 $0.40
|
8.92
|
3,250,000
|
3,162,500
|
Price Range $0.71 $0.99
|
8.70
|
4,681,844
|
2,138,506
|
Price Range $1.25 $2.00
|
5.11
|
180,000
|
180,000
|
Price Range $2.47 $6.75
|
3.71
|
385,000
|
385,000
|
|
Weighted-Average Remaining Contractual Life
|
Outstanding Warrants
|
Exercisable Warrants
|
|
|
|
|
Price Range $0.75 $1.00
|
4.41
|
11,952,000
|
11,952,000
|
Price Range $1.50 $2.00
|
2.36
|
1,944,000
|
1,944,000
|
Price Range $5.25 $8.50
|
2.11
|
885,000
|
885,000
|
F-21 | ||
|
||
|
December 31,
|
||||||
|
2003
|
2002
|
|||||
|
|
||||||
Deferred tax assets:
|
|
|
|||||
Net operating loss carryforwards
|
$
|
22,893,000
|
$
|
21,712,000
|
|||
Research and development credit carryforwards
|
1,988,000
|
1,910,000
|
|||||
Work opportunity credit carryforwards
|
260,000
|
260,000
|
|||||
Orphan drug credit carryforwards
|
2,595,000
|
2,552,000
|
|||||
|
|
||||||
|
27,736,000
|
26,434,000
|
|||||
Valuation allowance
|
(27,736,000
|
)
|
(26,434,000
|
)
|
|||
|
|
||||||
Net deferred tax assets
|
$
|
|
$
|
|
|||
|
|
Year of expiration
|
Amount
|
|||
|
|
|||
2004
|
$
|
893,000
|
||
2005
|
544,000
|
|||
2006
|
222,000
|
|||
2007
|
981,000
|
|||
2008
|
910,000
|
F-22 | ||
|
||
Year
|
Lease Payments
|
|
|
2004
|
$64,502
|
2005
|
$66,914
|
2006
|
$52,628
|
|
||
DOR BIOPHARMA, INC.
|
|
By:
/s/ Ralph M. Ellison
Ralph M. Ellison, Chief Executive
Officer and President
|
|
|
Signature
|
Title
|
|
|
/s/ General Alexander M. Haig, Jr.
General Alexander M. Haig, Jr.
|
Chairman of the Board
|
|
|
/s/ Ralph M. Ellison
Ralph M. Ellison
|
Chief Executive Officer, President and Director (principal executive officer)
|
|
|
/s/ Steve M. Kanzer
Steve M. Kanzer
|
Vice-Chairman of the Board
|
|
|
/s/ William D. Milling
William D. Milling
|
Controller, Treasurer and Corporate Secretary (principal financial and accounting officer)
|
|
|
/s/ Larry Kessel
Larry Kessel
|
Director
|
|
|
/s/ Arthur Asher Kornbluth
Arthur Asher Kornbluth
|
Director
|
|
|
/s/ Evan Myrianthopoulos
Evan Myrianthopoulos
|
Director
|
|
|
/s/ Peter Salomon
Peter Salomon
|
Director
|
|
|
/s/ James S. Kuo
James S. Kuo
|
Director
|
|
|
/s/ Stuart Sedlack
Stuart Sedlack
|
Director
|
|
|
||
DOR BioPharma, Inc. | ||
|
|
|
Date: 03/30/2004 | By: | /s/ Ralph M. Ellsion |
Chief Executive Officer |
||
Title |
DOR BioPharma, Inc. | ||
|
|
|
Date: 03/30/2004 | By: | /s/ William D. Milling |
Chief Accounting Officer |
||
Title |
DOR BioPharma, Inc. | ||
|
|
|
Date: 03/30/2004 | By: | /s/ Ralph M. Ellison |
Chief Executive Offocer |
||
Title |
DOR BioPharma, Inc. | ||
|
|
|
Date: 03/30/2004 | By: | /s/ William D. Milling |
Chief Accounting Officer |
||
Title |
Due Date
|
Amount
|
|
|
12 months from the EFFECTIVE
DATE
|
$100,000
|
|
|
18 months from the EFFECTIVE
DATE
|
$100,000
|
|
|
Milestone Event
|
Milestone Fee
|
|
|
Initiation of manufacture of first LICENSED PRODUCTS to be for SALE
|
$100,000
|
|
|
Filing NDA or BLA
|
$250,000
|
|
|
REGULATORY APPROVAL
|
$500,000
|
|
|
|
||