DELAWARE
|
41-1505029
|
|
(State
or other jurisdiction of incorporation or organization)
|
(I.R.S.
Employer Identification Number)
|
|
850
Bear Tavern Road, Suite 201
Ewing,
NJ
|
08628
|
|
(Address
of principal executive offices)
|
(Zip
Code)
|
|
(609)
538-8200
|
||
(Issuer’s
telephone number, including area code)
|
2007
|
2006
|
|||||||||
Assets
Current
assets:
|
||||||||||
Cash
|
$
|
2,220,128
|
$
|
119,636
|
||||||
Grants
receivable
|
97,845
|
89,933
|
||||||||
Prepaid
expenses
|
119,178
|
94,470
|
||||||||
Total
current assets
|
2,437,151
|
304,039
|
||||||||
Office
and laboratory equipment, net
|
25,941
|
29,692
|
||||||||
Intangible
assets, net
|
1,320,787
|
1,073,239
|
||||||||
Total
assets
|
$
|
3,783,879
|
$
|
1,406,970
|
||||||
Liabilities and shareholders’ equity
(deficiency)
|
||||||||||
Current
liabilities:
|
||||||||||
Accounts
payable
|
$
|
847,610
|
$
|
2,112,479
|
||||||
Accrued
compensation
|
345,903
|
402,947
|
||||||||
Total
current liabilities
|
1,193,513
|
2,515,426
|
||||||||
Shareholders’
equity (deficiency):
|
|
|||||||||
Common
stock, $.001 par value. Authorized 250,000,000
|
|
|||||||||
shares;
94,996,547 and 68,855,794, respectively issued and
outstanding
|
94,996
|
68,855 | ||||||||
Additional
paid-in capital
|
101,391,090
|
91,553,766 | ||||||||
Accumulated
deficit
|
(
98,895,720
|
) |
(
92,731,077
|
) | ||||||
|
||||||||||
Total
shareholders’ equity (deficiency)
|
2,590,366
|
(
1,108,456
|
) | |||||||
Total
liabilities and shareholders’ equity (deficiency)
|
$
|
3,783,879
|
1,406,970 | |||||||
|
2007 |
2006
|
||||||
Revenues
|
$
|
1,258,017
|
$
|
2,313,020
|
|||
Cost
of revenues
|
(
943,385
|
)
|
(
1,965,074
|
)
|
|||
Gross profit
|
314,632
|
347,946
|
|||||
Operating
expenses:
|
|||||||
Research and development
|
3,099,944
|
3,638,493
|
|||||
General and administrative | 2,864,370 | 2,553,700 | |||||
Stock based compensation research and development | 230,668 | 219,895 | |||||
Stock based compensation general and administrative | 446,733 | 337,287 | |||||
In-process research and development
|
-
|
981,819
|
|||||
Impairment of intangible assets
|
-
|
816,300
|
|||||
Total operating expenses
|
6,641,715
|
8,547,494
|
|||||
Loss
from operations
|
(
6,327,083
|
)
|
(
8,199,548
|
)
|
|||
Other
income (expense):
|
|||||||
Interest income
|
164,847
|
41,510
|
|||||
Interest (expense) | ( 1,020 | ) | ( 5,308 | ) | |||
Other (expense)
|
(
1,387
|
)
|
-
|
||||
Total other income (expense)
|
162,440
|
36,202
|
|||||
Net
loss
|
$
|
(
6,164,643
|
)
|
$
|
(
8,163,346
|
)
|
|
BasicnBasic
and diluted net loss per share
|
$
|
(
0.07
|
)
|
$
|
(
0.13
|
)
|
|
Basic Basic
and diluted weighted average common shares outstanding
|
90,687,677
|
63,759,092
|
Common
Stock
|
Additional
Paid-In capital
|
AccumulatedDeficit
|
|||||||||||
Shares
|
Par
Value
|
||||||||||||
Balance,
January
1, 2006
|
50,612,504
|
$50,612
|
$86,045,192
|
(
$84,567,731
|
)
|
||||||||
Issuance
of common stock
|
13,429,504
|
13,430
|
3,521,570
|
-
|
|||||||||
Issuance
of common stock for exercise of options
|
504,100
|
|
504
|
|
112,816
|
|
-
|
||||||
Issuance of common stock to vendors | 506,942 | 507 | 134,171 | - | |||||||||
Issuance of warrants to vendors | - | - | 121,965 | - | |||||||||
Issuance of common stock for an equity commitment fee | 512,500 | 512 | ( 512 | ) | - | ||||||||
Issuance of common stock to employees | 222,061 | 222 | 82,632 | - | |||||||||
Issuance of common stock to minority shareholders | 3,068,183 | 3,068 | 978,750 | - | |||||||||
Stock
option expense
|
-
|
-
|
557,182
|
|
-
|
||||||||
Net
loss
|
-
|
-
|
-
|
(
8,163,346
|
)
|
||||||||
Balance,
December
31, 2006
|
68,855,794
|
68,855
|
91,553,766
|
(
92,731,077
|
)
|
||||||||
Issuance
of common stock
|
15,745,891
|
15,746
|
6,219,658
|
-
|
|||||||||
Issuance
of common stock for exercise of options and warrants
|
8,195,487
|
8,195
|
2,128,088
|
-
|
|||||||||
Issuance
of common stock to vendors
|
829,821
|
830
|
329,670
|
-
|
|||||||||
Issuance
of stock to investors by contract as dilution protection
|
995,947
|
996
|
307,747
|
-
|
|||||||||
Issuance
of common stock to employees
|
373,607
|
374
|
84,759
|
-
|
|||||||||
Stock
option expense
|
-
|
-
|
677,401
|
-
|
|||||||||
Net
loss
|
-
|
-
|
-
|
(
6,164,643
|
)
|
||||||||
Balance,
December
31, 2007
|
94,996,547
|
$94,996
|
$101,391,090
|
(
$98,895,720
|
)
|
||||||||
2007
|
2006
|
||||||
Operating
activities
|
|||||||
Net loss
|
$
|
(
6,164,643
|
)
|
$
|
(
8,163,346
|
)
|
|
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
|||||||
Amortization and depreciation
|
119,565
|
137,044
|
|||||
Non-cash stock compensation
|
1,401,777
|
896,680
|
|
||||
Non-cash stock purchase of in-process research and
development
|
-
|
981,819
|
|||||
Impairment expense for intangibles
|
-
|
816,300
|
|||||
Change
in operating assets and liabilities:
|
|||||||
Grants receivable
|
(
7,912
|
) |
474,397
|
||||
Prepaid expenses
|
(
24,708
|
) |
44,324
|
|
|||
Accounts payable
|
(
1,264,868
|
) |
476,605
|
|
|||
Accrued compensation
|
(57,044
|
) |
254,347
|
||||
Accrued royalties
|
-
|
|
(
60,000
|
)
|
|||
Total
adjustments
|
166,810
|
4,021,516
|
|||||
Net cash used by operating activities
|
(
5,997,833
|
)
|
(
4,141,830
|
)
|
|||
Investing
activities:
|
|||||||
Purchases
of office and laboratory equipment
|
(
7,170
|
)
|
(
2,552
|
)
|
|||
Acquisition
of intangible assets
|
(
356,192
|
)
|
(
206,004
|
)
|
|||
Net cash used by investing activities
|
(
363,362
|
)
|
(
208,556
|
)
|
|||
Financing
activities:
|
|||||||
Net
proceeds from issuance of common stock
|
6,235,404
|
3,535,000
|
|||||
Proceeds
from exercise of warrants
|
1,592,263
|
-
|
|
||||
Proceeds
from exercise of stock options
|
634,020
|
113,320
|
|||||
Net cash provided by financing activities
|
8,461,687
|
3,648,320
|
|||||
Net
increase (decrease) in cash and cash equivalents
|
2,100,492
|
|
(
702,066
|
)
|
|||
Cash and cash equivalents at beginning of period
|
119,636
|
821,702
|
|||||
Cash and cash equivalents at end of period
|
$
|
2,220,128
|
$
|
119,636
|
|||
Supplemental
disclosure of cash flow:
|
|||||||
Cash paid for interest
|
$
|
1,020
|
$
|
3,170
|
|||
Non-cash
transactions:
|
|||||||
Non-cash payment to an institutional investor
|
$ |
-
|
$
|
220,374
|
·
|
The
Company secured a new $8,000,000 equity line from Fusion Capital and the
Company expects that the registration statement supporting this facility
will become effective by April
2008.
|
·
|
The
Company will manage its expenditures very closely and proceed with
Clinical programs with the use of the equity
facility.
|
·
|
The
Company plans to continue seeking grant funds and responding to requests
for proposals from governmental
sources.
|
·
|
The
Company will utilize Named Patient Sales (Compassionate Use programs)
wherever possible in countries outside the United States to generate
revenues from orBec®.
The Company already has letters of intent for Named Patient programs in
place in South Korea, Australia, New Zealand and South Africa and expects
to receive modest revenues from these programs in the second half of
2008.
|
·
|
The
Company is exploring outlicensing opportunities for orBec®
and for its BioDefense programs both in the US and
Europe.
|
·
|
The
Company has engaged Investment Bankers to assist in exploring
mergers and acquisitions
opportunities.
|
|
2007 | 2006 | ||||
Office
equipment
|
$ 125,328
|
$ 117,660
|
||||
Laboratory
equipment
|
23,212
|
23,212
|
||||
Total
|
148,540
|
140,872
|
||||
Accumulated
depreciation
|
( 122,599
|
)
|
( 111,180
|
)
|
||
$
25,941
|
$
29,692
|
Weighted
Average Amortization period
(years)
|
Cost
|
Accumulated
Amortization
|
Net Book Value
|
|||
December
31, 2007
|
||||||
Licenses
|
12.7
|
$
462,234
|
$ 115,681
|
$
346,553
|
||
Patents
|
9.7
|
1,633,490
|
659,256
|
974,234
|
||
Total
|
10.4
|
$
2,095,724
|
$
774,937
|
$
1,320,787
|
||
December
31, 2006
|
||||||
Licenses
|
13.7
|
$
462,234
|
$
88,443
|
$ 373,791
|
||
Patents
|
8.8
|
1,277,157
|
577,709
|
699,448
|
||
Total
|
10.1
|
$
1,739,391
|
$
666,152
|
$
1,073,239
|
Year |
Amortization Amount
|
2008
|
$ 125,000
|
2009
|
126,000
|
2010
|
127,000
|
2011
|
128,000
|
2012
|
129,000
|
2007
|
2006
|
||||
Shares
available for grant at beginning of year
|
3,236,032
|
7,000,000
|
|||
Increase
in shares available
|
10,000,000
|
-
|
|||
Options
granted
|
( 3,375,000
|
)
|
( 4,360,000
|
)
|
|
Options
forfeited or expired
|
1,140,000
|
1,325,000
|
|||
Common
stock payment for services
|
( 388,071
|
)
|
( 728,968
|
)
|
|
Shares
available for grant at end of year
|
10,612,961
|
3,236,032
|
Options
|
Weighted
Average
Options Exercise Price
|
|||||
Balance
at January 1, 2006
|
10,014,339
|
$ 0.59
|
||||
Granted
|
4,360,000
|
0.30
|
||||
Forfeited
|
( 2,230,900
|
)
|
0.83
|
|||
Exercised
|
( 504,100
|
)
|
0.22
|
|||
Balance
at December 31, 2006
|
11,639,339
|
0.59
|
||||
Granted
|
3,375,000
|
0.46
|
||||
Forfeited
|
( 2,927,300
|
)
|
0.73
|
|||
Exercised
|
( 1,737,200
|
)
|
0.36
|
|||
Balance
at December 31, 2007
|
10,349,839
|
$ 0.44
|
Price
Range
|
Weighted
Average Remaining
Contractual Life in Years
|
Outstanding
Options
|
Exercisable
Options
|
||||
$0.20-$0.50
|
8.12
|
9,020,000
|
5,884,756
|
||||
$0.51-$1.00
|
2.69
|
962,839
|
962,839
|
||||
$1.01-$6.00
|
3.17
|
367,000
|
367,000
|
||||
Total
|
7.53
|
10,349,839
|
7,214,595
|
Warrants
|
Weighted
Average
Warrant Exercise Price
|
|||||
Balance
at January 1, 2006
|
22,167,118
|
$ 0.92
|
||||
Granted
|
14,961,672
|
0.25
|
||||
Balance
at December 31, 2006
|
37,128,790
|
0.65
|
||||
Granted
|
560,106
|
0.59
|
||||
Expired
|
(
2,178,909
|
) |
1.90
|
|||
Exercised
|
(
6,458,287
|
) |
0.25
|
|||
Balance
at December 31, 2007
|
29,051,700
|
$ 0.70
|
Price
Range
|
Weighted
Average Remaining
Contractual Life in Years
|
Outstanding
Warrants
|
Exercisable
Warrants
|
||||
$0.24-$0.50
|
1.23
|
8,503,386
|
8,503,386
|
||||
$0.505-$1.00
|
1.67
|
18,328,622
|
18,328,622
|
||||
$1.01-$2.00
|
0.29
|
2,012,622
|
2,012,622
|
||||
$8.11
|
0.86
|
207,070
|
207,070
|
||||
Total
|
1.44
|
29,051,700
|
29,051,700
|
2007 | 2006 | |||||||
Deferred tax assets:
|
||||||||
Net operating loss carry forwards | $ 25,000,000 | $25,000,000 | ||||||
Orphan
drug and research and development credit carry forwards
|
2,000,000
|
3,000,000
|
||||||
Other
|
3,000,000
|
3,000,000
|
||||||
Total
|
30,000,000
|
31,000,000
|
||||||
Valuation
allowance
|
( 30,000,000
|
) |
( 31,000,000
|
) | ||||
Net
deferred tax assets
|
$
-
|
$ -
|
2008
|
$ 910,000
|
2009
|
1,330,000
|
2010
|
1,410,000
|
2011
|
870,000
|
2012
|
3,870,000
|
2007
|
2006
|
||
Income
tax loss at federal statutory rate
|
(34.00)%
|
(34.00)%
|
|
State
taxes, net of federal benefit
|
(4.29)
|
(3.63)
|
|
Permanent
differences, principally purchased
in-process
research and development
|
-
|
3.30
|
|
Valuation
allowance
|
38.29
|
34.33
|
|
Provision
for income taxes (benefit)
|
-
%
|
-
%
|
December
31,
|
|||||||
2007
|
2006
|
||||||
Net
Revenues
|
|||||||
BioDefense
|
$
|
1,258,017
|
$
|
2,173,128
|
|||
BioTherapeutics
|
-
|
139,892
|
|||||
Total
|
$
|
1,258,017
|
$
|
2,313,020
|
|||
Loss
from Operations
|
|||||||
BioDefense
|
$
|
( 109,698
|
)
|
$
|
(
1,973,732
|
)
|
|
BioTherapeutics
|
(
2,748,764
|
)
|
(
5,061,664
|
)
|
|||
Corporate
|
(
3,468,620
|
)
|
(
1,164,152
|
)
|
|||
Total
|
$
|
(
6,327,082
|
)
|
$
|
(
8,199,548
|
)
|
|
Identifiable
Assets
|
|||||||
BioDefense
|
$
|
896,383
|
$
|
849,295
|
|||
BioTherapeutics
|
552,248
|
343,876
|
|||||
Corporate
|
2,335,248
|
213,799
|
|||||
Total
|
$
|
3,783,879
|
$
|
1,406,970
|
|||
Amortization
and Depreciation Expense
|
|||||||
BioDefense
|
$
|
90,185
|
$
|
103,855
|
|||
BioTherapeutics
|
24,312
|
24,395
|
|||||
Corporate
|
5,068
|
8,794
|
|||||
Total
|
$
|
119,565
|
$
|
137,044
|
|||
Interest Income | |||||||
Corporate | $ | 164,847 | $ | 41,510 | |||
Total | $ | 164,847 | $ | 41,510 | |||
Stock Option Compensation | |||||||
BioDefense | $ | 69,591 | $ | 98,937 | |||
BioTherapeutic | 161,077 | 120,958 | |||||
Corporate | 446,733 | 337,287 | |||||
Total | $ | 677,401 | $ | 557,182 | |||
Signature
|
Title
|
Date
|
||
/s/
Christopher J.
Schaber
Christopher
J. Schaber
|
Director,
President and Chief Executive Officer (Principal Executive
Officer)
|
April 24,
2008
|
||
/s/ Evan Myrianthopoulos
Evan
Myrianthopoulos
|
Director,
Chief Financial Officer (Principal Financial and Accounting
Officer)
|
April 24,
2008
|
||
/s/
James
S.
Kuo
James
S. Kuo
|
Chairman
of the Board
|
April 25,
2008
|
||
/s/ Cyrille
F. Buhrman
Cyrille
F. Buhrman
|
Director
|
April 27,
2008
|
||
/s/ James
Clavijo
James Clavijo
|
Controller,
Treasurer, and Corporate Secretary
|
April 24,
2008
|
Exhibit
No.
|
Description
|
|
31.1
|
Certification
of the Chief Executive Officer pursuant to Section 302 of the
Sarbanes Oxley Act of 2002.
|
|
31.2
|
Certification
of the Chief Financial Officer pursuant to Section 302 of the Sarbanes
Oxley Act of 2002.
|
|
32.1
|
Certification
of the Chief Executive Officer pursuant to Section 906 of the Sarbanes
Oxley Act of 2002.
|
|
32.2
|
Certification
of the Chief Financial Officer pursuant to Section 906 of the Sarbanes
Oxley Act of 2002.
|