Delaware
|
84-1368850
|
|
(State
or other jurisdiction of incorporation or organization)
|
(IRS
Employer Identification No.)
|
Large accelerated filer
¨
|
Accelerated filer ¨
|
Smaller reporting company
x
|
Non-accelerated filer
¨
|
Page
|
||
PART
I. FINANCIAL
INFORMATION.
|
||
Item
1.
|
Financial
Statements (Unaudited)
|
1
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
||
as
of March 31, 2010 and June 30, 2009
|
2
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
||
For
the Three Months Ended March 31, 2010 and 2009,
|
||
For
the Nine Months Ended March 31, 2010 and 2009
|
||
and
From Inception on July 1, 1998 through March 31, 2010
|
3
|
|
CONDENSED
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
|
||
From
Inception on July 1, 1998 through March 31, 2010
|
4
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
||
For
the Nine Months Ended March 31, 2010 and 2009,
|
||
and
From Inception on July 1, 1998 through March 31, 2010
|
9
|
|
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
10
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial
|
|
Condition
and Results of Operations
|
25
|
|
Overview
|
25
|
|
Liquidity
and Capital Resources
|
35
|
|
Changes
to Critical Accounting Policies and Estimates
|
37
|
|
Results
of Operations
|
38
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
46
|
Item
4T.
|
Controls
and Procedures
|
46
|
PART
II. OTHER
INFORMATION.
|
||
Item
1A.
|
Risk
Factors.
|
47
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds.
|
63
|
Item
3.
|
Defaults
Upon Senior Securities
|
65
|
Item
4.
|
[RESERVED]
|
65
|
Item
5.
|
Other
Information.
|
66
|
Item
6.
|
Exhibits.
|
66
|
SIGNATURES
|
68
|
Item
1.
|
Financial
Statements.
|
March 31,
|
June 30,
|
|||||||
2010
|
2009
|
|||||||
|
(unaudited)
|
|||||||
ASSETS
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 39,707 | $ | 380,569 | ||||
Short-term
investments
|
- | 1,050,000 | ||||||
Deferred
financing costs
|
177,279 | - | ||||||
Prepaid
expenses and other current assets
|
1,269,488 | 1,161,348 | ||||||
Total
Current Assets
|
1,486,474 | 2,591,917 | ||||||
Property
and equipment, net
|
5,581 | 5,986 | ||||||
Intangibles,
net
|
4,483,750 | 3,884,999 | ||||||
Deferred
financing costs
|
- | 632,324 | ||||||
Security
deposit
|
7,187 | 7,187 | ||||||
TOTAL
ASSETS
|
$ | 5,982,992 | $ | 7,122,413 | ||||
LIABILITIES AND STOCKHOLDERS’
EQUITY
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable
|
$ | 1,401,135 | $ | 976,680 | ||||
Accrued
expenses
|
621,614 | 355,937 | ||||||
Line
of credit
|
2,198,609 | - | ||||||
Convertible
note, net of discount
|
82,047 | - | ||||||
Total
Current Liabilities
|
4,303,405 | 1,332,617 | ||||||
Convertible
note, net of discount
|
- | 6,217 | ||||||
Warrant
liability ($416,667 to related parties)
|
1,388,333 | - | ||||||
Grant
payable
|
99,728 | 99,728 | ||||||
Other
liability
|
10,049 | 16,017 | ||||||
TOTAL
LIABILITIES
|
5,801,515 | 1,454,579 | ||||||
STOCKHOLDERS’
EQUITY:
|
||||||||
Preferred
stock, $0.01 par value; authorized 5,000,000 shares, no shares
issued
|
— | — | ||||||
Common
stock, $0.01 par value; authorized 120,000,000 shares, issued and
outstanding 33,584,121 and 19,812,043, respectively
|
335,841 | 198,120 | ||||||
Capital
in excess of par,
|
38,240,964 | 36,687,846 | ||||||
Deficit
accumulated during the development stage
|
(38,395,328 | ) | (31,218,132 | ) | ||||
TOTAL
STOCKHOLDERS’ EQUITY
|
181,477 | 5,667,834 | ||||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$ | 5,982,992 | $ | 7,122,413 |
For the Three
Months Ended
March 31,
|
For the Three
Months Ended
March 31,
|
For the Nine
Months Ended
March 31,
|
For the Nine
Months Ended
March 31,
|
From Inception on
July 1, 1998
through
March 31,
|
||||||||||||||||
2010
|
2009
|
2010
|
2009
|
2010
|
||||||||||||||||
Revenue
|
$ | — | $ | 75,000 | $ | 140,000 | $ | 275,000 | $ | 1,590,000 | ||||||||||
Operating
Expenses:
|
||||||||||||||||||||
General
and administrative
|
554,953 | 532,245 | 1,735,317 | 1,711,166 | 25,666,510 | |||||||||||||||
Research
and development
|
566,307 | 540,494 | 1,522,610 | 1,624,166 | 13,834,169 | |||||||||||||||
Total
Operating Expenses
|
1,121,260 | 1,072,739 | 3,257,927 | 3,335,332 | 39,500,679 | |||||||||||||||
Loss
From Operations
|
(1,121,260 | ) | (997,739 | ) | (3,117,927 | ) | (3,060,332 | ) | (37,910,679 | ) | ||||||||||
Sale
of state income tax loss, net
|
— | — | — | — | 586,442 | |||||||||||||||
Loss
on extinguishment of debt
|
(275,345 | ) | — | (361,877 | ) | — | (361,877 | ) | ||||||||||||
Fair
value – warrant liability
|
(527,566 | ) | — | 1,811,775 | — | 6,543,542 | ||||||||||||||
Other
noncash income
|
— | — | — | — | 321,259 | |||||||||||||||
Interest
income (expense), net
|
(7,375 | ) | 737 | (6,349 | ) | 41,788 | 516,964 | |||||||||||||
Amortization
of debt discount and financing costs
|
(3,206,049 | ) | (107,240 | ) | (4,973,909 | ) | (319,637 | ) | (6,120,672 | ) | ||||||||||
Interest
expense on convertible notes
|
(146,640 | ) | (227,235 | ) | (528,909 | ) | (799,043 | ) | (1,970,307 | ) | ||||||||||
Net
Loss
|
$ | (5,284,235 | ) | $ | (1,331,477 | ) | $ | (7,177,196 | ) | $ | (4,137,224 | ) | $ | (38,395,328 | ) | |||||
Basic
and Diluted Net Loss Per Common Share
|
$ | (0.17 | ) | $ | (0.07 | ) | $ | (0.27 | ) | $ | (0.22 | ) | ||||||||
Basic
and Diluted Weighted Average Number of Common
|
||||||||||||||||||||
Shares
Outstanding
|
31,650,371 | 19,033,091 | 26,610,925 | 18,678,109 |
Common Stock
|
Capital in
Excess of
Par Value
|
Deficit
Accumulated
During the
Development
Stage
|
Total
|
|||||||||||||||||
Shares
|
Amount
|
|||||||||||||||||||
Common
stock outstanding
|
2,000,462 | $ | 20,005 | $ | (20,005 | ) | — | — | ||||||||||||
Contribution
of capital
|
— | — | 85,179 | — | $ | 85,179 | ||||||||||||||
Issuance
of common stock in reverse merger on January 22, 1999 at $0.01 per
share
|
3,400,000 | 34,000 | (34,000 | ) | — | — | ||||||||||||||
Issuance
of common stock for cash on May 21, 1999 at $2.63437 per
share
|
759,194 | 7,592 | 1,988,390 | — | 1,995,982 | |||||||||||||||
Issuance
of common stock for placement fees on May 21, 1999 at $0.01 per
share
|
53,144 | 531 | (531 | ) | — | — | ||||||||||||||
Issuance
of common stock for cash on January 26, 2000 at $2.867647 per
share
|
17,436 | 174 | 49,826 | — | 50,000 | |||||||||||||||
Issuance
of common stock for cash on January 31, 2000 at $2.87875 per
share
|
34,737 | 347 | 99,653 | — | 100,000 | |||||||||||||||
Issuance
of common stock for cash on February 4, 2000 at $2.934582 per
share
|
85,191 | 852 | 249,148 | — | 250,000 | |||||||||||||||
Issuance
of common stock for cash on March 15, 2000 at $2.527875 per
share
|
51,428 | 514 | 129,486 | — | 130,000 | |||||||||||||||
Issuance
of common stock for cash on June 22, 2000 at $1.50 per
share
|
1,471,700 | 14,718 | 2,192,833 | — | 2,207,551 | |||||||||||||||
Commissions,
legal and bank fees associated with issuances for the year ended June 30,
2000
|
— | — | (260,595 | ) | — | (260,595 | ) | |||||||||||||
Fair
market value of options and warrants vested during the year ended June 30,
2000
|
— | — | 1,475,927 | — | 1,475,927 | |||||||||||||||
Fair
market value of options and warrants vesting during the year ended June
30, 2001
|
— | — | 308,619 | — | 308,619 |
Common Stock
|
Capital in
Excess of
Par Value
|
Deficit
Accumulated
During the
Development
Stage
|
Total
|
|||||||||||||||||
Shares
|
Amount
|
|||||||||||||||||||
Issuance
of common stock and warrants for cash from November 30, 2001 through April
17, 2002 at $1.75 per unit
|
3,701,430 | $ | 37,014 | $ | 6,440,486 | — | $ | 6,477,500 | ||||||||||||
Issuance
of common stock and warrants associated with bridge loan conversion on
December 3, 2001
|
305,323 | 3,053 | 531,263 | — | 534,316 | |||||||||||||||
Commissions,
legal and bank fees associated with issuances for the year ended June 30,
2002
|
— | — | (846,444 | ) | — | (846,444 | ) | |||||||||||||
Fair
market value of options and warrants vested during the year ended June 30,
2002
|
— | — | 1,848,726 | — | 1,848,726 | |||||||||||||||
Fair
market value of options and warrants vested during the year ended June 30,
2003
|
— | — | 848,842 | — | 848,842 | |||||||||||||||
Issuance
of common stock and warrants for cash from January 15, 2004 through
February 12, 2004 at $2.37 per unit
|
1,536,922 | 15,369 | 3,627,131 | — | 3,642,500 | |||||||||||||||
Allocation
of proceeds to warrants
|
— | — | (2,099,090 | ) | — | (2,099,090 | ) | |||||||||||||
Reclassification
of warrants
|
— | 1,913,463 | — | 1,913,463 | ||||||||||||||||
Commissions,
legal and bank fees associated with issuances for the year ended June 30,
2004
|
— | (378,624 | ) | — | (378,624 | ) | ||||||||||||||
Fair
market value of options and warrants vested during the year ended June 30,
2004
|
- | — | 1,826,514 | — | 1,826,514 | |||||||||||||||
Options
and warrants exercised during the year ended June 30, 2004 at exercise
prices ranging from $1.00 - $3.25
|
370,283 | $ | 3,704 | 692,945 | — | 696,649 | ||||||||||||||
Issuance
of common stock and warrants for cash on May 9, 2005 at $2.11 per
unit
|
1,595,651 | 15,957 | 3,350,872 | — | 3,366,829 |
Common Stock
|
Capital in
Excess of Par
Value
|
Deficit
Accumulated
During the
Development
Stage
|
Total
|
|||||||||||||||||
Shares
|
Amount
|
|||||||||||||||||||
Issuance
of common stock and warrants for cash on May 9, 2005 at $2.11 per
unit
|
1,595,651 | $ | 15,957 | $ | 3,350,872 | — | $ | 3,366,829 | ||||||||||||
Allocation
of proceeds to warrants
|
— | — | (1,715,347 | ) | — | (1,715,347 | ) | |||||||||||||
Reclassification
of warrants
|
— | — | 1,579,715 | — | 1,579,715 | |||||||||||||||
Commissions,
legal and bank fees associated with issuance on May 9,
2005
|
— | — | (428,863 | ) | — | (428,863 | ) | |||||||||||||
Options
and warrants exercised during the year ended June 30, 2005 at exercise
prices ranging from $1.50 to $3.25
|
84,487 | 844 | 60,281 | — | 61,125 | |||||||||||||||
Fair
market value of options and warrants vested during the year ended June 30,
2005
|
— | — | 974,235 | — | 974,235 | |||||||||||||||
Fair
market value of options and Warrants granted and vested During the year
ended June 30,2006
|
— | — | 677,000 | — | 677,000 | |||||||||||||||
Warrants
exercised during the year ended June 30, 2006 at an exercise price of
$0.01
|
10,000 | 100 | — | — | 100 | |||||||||||||||
Issuance
of common stock and warrants for cash on October 11, 2006 at $1.135 per
unit
|
1,986,306 | 19,863 | 2,229,628 | — | 2,249,491 | |||||||||||||||
Commissions,
legal and bank fees associated with issuance on October 11,
2006
|
— | — | (230,483 | ) | — | (230,483 | ) | |||||||||||||
Fair
market value of options and warrants vested during the year ended June 30,
2007
|
— | — | 970,162 | — | 970,162 | |||||||||||||||
Warrants
exercised during the year ended June 30, 2007 at an exercise price of
$0.01
|
10,000 | 100 | — | — | 100 |
Common
Stock
|
Capital
in
Excess
of
Par
Value
|
Deficit
Accumulated
During
the
Development
Stage
|
Total
|
|||||||||||||||||
Shares
|
Amount
|
|||||||||||||||||||
Fair
market value of options and warrants vested during the year ended June 30,
2008
|
— | — | $ | 1,536,968 | — | $ | 1,536,968 | |||||||||||||
Allocation
of proceeds from issuance of convertible notes and warrants from September
21, 2007 through June 30, 2008
|
— | — | 9,340,000 | — | 9,340,000 | |||||||||||||||
Issuance
of common stock in lieu of cash payment for interest during the year ended
June 30, 2008
|
345,867 | $ | 3,458 | 430,696 | — | 434,154 | ||||||||||||||
Convertible
notes converted into common stock during the year ended June 30,
2008
|
555,556 | 5,556 | 430,952 | — | 436,508 | |||||||||||||||
Fair
market value of options and warrants vested during the
year ended June 30, 2009
|
— | — | 506,847 | — | 506,847 | |||||||||||||||
Cashless
exercise of warrants during the year ended June 30, 2009 at an exercise
price of $0.74
|
2,395 | 24 | (24 | ) | — | — | ||||||||||||||
Issuance
of common stock in lieu of cash payment for interest during the year ended
June 30,2009
|
1,271,831 | 12,718 | 994,526 | — | 1,007,244 | |||||||||||||||
Convertible
notes converted into common stock during the year ended June 30,
2009
|
50,000 | 500 | 44,433 | — | 44,933 | |||||||||||||||
Issuance
of common stock in connection with the Company’s short term incentive plan
during the year ended June 30, 2009
|
112,700 | 1,127 | (1,127 | ) | — | — | ||||||||||||||
Cumulative
net loss from inception through June 30, 2009
|
— | — | — | $ | (35,949,899 | ) | (35,949,899 | ) | ||||||||||||
Cumulative
effect of change in accounting principle –implementation of FASB ASC
815.40
|
— | — | (7,931,875 | ) | 4,731,767 | (3,200,108 | ) |
Common Stock
|
Capital in
Excess of
Par Value
|
Deficit
Accumulated
During the
Development
Stage
|
Total
|
|||||||||||||||||
Shares
|
Amount
|
|||||||||||||||||||
Issuance
of common stock and warrants for cash during the nine months ended March
31, 2010 at $0.90 per unit
|
1,700,000 | $ | 17,000 | $ | 1,513,000 | — | $ | 1,530,000 | ||||||||||||
Issuance
of common stock and warrants for satisfaction of accounts payable during
the nine months ended March 31, 2010
|
194,444 | 1,944 | 259,588 | — | 261,532 | |||||||||||||||
Warrants
exercised for cash during the nine months ended March 31, 2010 at an
exercise price of $0.01
|
1,003,000 | 10,030 | — | — | 10,030 | |||||||||||||||
Legal
and regulatory fees associated with issuances during the nine
months ended March 31, 2010
|
— | — | (175,862 | ) | — | (175,862 | ) | |||||||||||||
Issuance
of common stock in lieu of cash payment for interest during the nine
months ended March 31, 2010
|
969,360 | 9,694 | 372,575 | — | 382,269 | |||||||||||||||
Convertible
notes converted into common stock during the nine months ended March 31,
2010
|
9,635,090 | 96,351 | 2,511,043 | — | 2,607,394 | |||||||||||||||
Issuance
of common stock in connection with the Company’s short term incentive plan
during the nine months ended March 31, 2010
|
116,000 | 1,160 | (1,160 | ) | — | — | ||||||||||||||
Issuance
of common stock for services during the nine months ended March 31,
2010
|
154,184 | 1,542 | 52,258 | — | 53,800 | |||||||||||||||
Fair
market value of options and warrants vested during the nine months ended
March 31, 2010
|
— | — | 271,784 | — | 271,784 | |||||||||||||||
Warrants
repurchased during the nine months ended March 31, 2010
|
— | — | (50,000 | ) | — | (50,000 | ) | |||||||||||||
Net
loss for the nine months ended March 31, 2010
|
— | — | — | $ | (7,177,196 | ) | (7,177,196 | ) | ||||||||||||
Balance
at March 31, 2010
|
33,584,121 | $ | 335,841 | $ | 38,240,964 | $ | (38,395,328 | ) | $ | 181,477 |
For
the Nine Months Ended
March
31,
|
From
Inception on
July
1, 1998 through
March
31,
|
|||||||||||
2010
|
2009
|
2010
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$ | (7,177,196 | ) | $ | (4,137,224 | ) | $ | (38,395,328 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Noncash
capital contribution
|
— | — | 85,179 | |||||||||
Noncash
conversion of accrued expenses into equity
|
— | — | 131,250 | |||||||||
Noncash
income related to change in fair value of
warrant liability
|
(1,811,775 | ) | — | (6,864,801 | ) | |||||||
Issuance
of common stock and warrants for interest
|
382,269 | 799,043 | 1,832,982 | |||||||||
Issuance
of common stock for services
|
53,800 | — | 53,800 | |||||||||
Share-based
compensation expense
|
271,784 | 358,347 | 10,474,728 | |||||||||
Depreciation
and amortization
|
92,613 | 81,054 | 665,053 | |||||||||
Amortization
of convertible note discount
|
4,518,864 | 1,869 | 5,070,081 | |||||||||
Amortization
of deferred financing costs
|
455,045 | 317,768 | 1,050,591 | |||||||||
Loss
on extinguishment of debt
|
361,877 | — | 361,877 | |||||||||
(Increase)
decrease in operating assets:
|
||||||||||||
Prepaid
expense and other current assets
|
(108,140 | ) | (709,266 | ) | (1,269,488 | ) | ||||||
Security
deposit
|
— | — | (7,187 | ) | ||||||||
Increase
(decrease) in operating liabilities:
|
||||||||||||
Accounts
payable
|
599,455 | 102,208 | 1,576,135 | |||||||||
Accrued
expenses
|
265,677 | 186,505 | 621,614 | |||||||||
Other
liability
|
(5,968 | ) | (5,284 | ) | 10,049 | |||||||
Net
cash used in operating activities
|
(2,101,695 | ) | (3,004,980 | ) | (24,603,465 | ) | ||||||
Cash
flows from investing activities:
|
||||||||||||
Patent
costs
|
(689,843 | ) | (490,251 | ) | (4,976,206 | ) | ||||||
Redemptions
(Purchases) of investments, net
|
1,050,000 | (1,799,388 | ) | — | ||||||||
Purchase
of property and equipment
|
(1,116 | ) | (4,173 | ) | (178,179 | ) | ||||||
Net
cash provided by (used in) investing activities
|
359,041 | (2,293,812 | ) | (5,154,385 | ) | |||||||
Cash
flows from financing activities:
|
||||||||||||
Proceeds
from grant
|
— | — | 99,728 | |||||||||
Proceeds
from issuance of loan payable
|
2,198,609 | — | 2,198,609 | |||||||||
Proceeds
from issuance of bridge notes
|
— | — | 525,000 | |||||||||
Proceeds
from issuance of common stock, net and exercise of options and
warrants
|
1,364,169 | — | 20,446,987 | |||||||||
Proceeds
from issuance of convertible notes and warrants, net
|
— | — | 9,340,000 | |||||||||
Redemption
of convertible notes and warrants
|
(2,160,986 | ) | — | (2,160,986 | ) | |||||||
Deferred
financing costs
|
— | — | (651,781 | ) | ||||||||
Net
cash provided by financing activities
|
1,401,792 | — | 29,787,557 | |||||||||
Net
increase (decrease) in cash and cash equivalents
|
(340,862 | ) | (5,298,792 | ) | 39,707 | |||||||
Cash
and cash equivalents at beginning of period
|
380,569 | 5,676,985 | — | |||||||||
Cash
and cash equivalents at end of period
|
$ | 39,707 | $ | 378,193 | $ | 39,707 | ||||||
Supplemental
disclosure of cash flow information:
|
||||||||||||
Cash
paid during the period for interest
|
$ | 33,859 | $ | — | $ | 56,176 | ||||||
Supplemental
schedule of noncash financing activity:
|
||||||||||||
Conversion
of convertible notes into common stock, net
|
$ | 2,619,360 | $ | — | $ | 3,164,360 | ||||||
Conversion
of bridge notes into stock
|
$ | — | $ | — | $ | 534,316 | ||||||
Allocation
of convertible debt proceeds to warrants and beneficial conversion
feature
|
$ | — | $ | — | $ | 9,340,000 | ||||||
Warrants
issued for financing costs
|
$ | — | $ | — | $ | 639,645 | ||||||
Issuance
of common stock for interest on convertible notes
|
$ | 382,269 | $ | 799,043 | $ | 1,832,982 | ||||||
Issuance
of common stock in settlement of accounts payable
|
$ | 175,000 | $ | — | $ | 175,000 |
|
·
|
delay,
scale-back or eliminate some or all of its research and product
development programs;
|
|
·
|
license
third parties to develop and commercialize products or technologies that
it would otherwise seek to develop and commercialize
itself;
|
|
·
|
seek
strategic alliances or business
combinations;
|
|
·
|
attempt
to sell the Company;
|
|
·
|
cease
operations; or
|
|
·
|
declare
bankruptcy.
|
|
·
|
significant
negative industry trends;
|
|
·
|
significant
underutilization of the assets;
|
|
·
|
significant
changes in how the Company uses the assets or its plans for their use;
and
|
|
·
|
changes
in technology and the appearance of competing
technology.
|
Three Months Ended
|
Nine Months Ended
|
|||||||||||||||
March 31,
|
March 31,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Estimated
life in years (1)
|
5-5.7 | 3.5-5.5 | 3.5-5.7 | 3.5-5.5 | ||||||||||||
Risk-free
interest rate (2)
|
2.5%–3.9 | % | 1.3% – 1.8 | % | 2.2%-3.9 | % | 1.1%-3.9 | % | ||||||||
Volatility
|
100 | % | 100 | % | 100 | % | 100 | % | ||||||||
Dividend
paid
|
None
|
None
|
None
|
None
|
Number of Options
|
Weighted-Average
Exercise Price
|
|||||||
Outstanding
at July 1, 2009
|
4,550,412 | $ | 1.70 | |||||
Granted
|
1,748,399 | 0.33 | ||||||
Exercised
|
— | — | ||||||
Expired
|
(233,000 | ) | 3.50 | |||||
Outstanding
at March 31, 2010
|
6,065,811 | $ | 1.24 | |||||
Exercisable
at March 31, 2010
|
4,823,310 | $ | 1.40 |
Weighted-Average
|
||||||||
Number of Options
|
Grant-Date
Fair Value
|
|||||||
Non-vested
stock options at July 1, 2009
|
883,000 | $ | 0.66 | |||||
Granted
|
1,748,399 | 0.25 | ||||||
Vested
|
(1,384,898 | ) | (0.31 | ) | ||||
Expired
|
(4,000 | ) | (0.46 | ) | ||||
Non-vested
stock options at March 31, 2010
|
1,242,501 | $ | 0.48 |
|
1.
|
25%
of eligible shares and options for contributions relating to the Company’s
Human Health Objectives;
|
|
2.
|
15%
of eligible shares and options for contributions relating to the Company’s
Finance Objectives;
|
|
3.
|
20%
of eligible shares and options for contributions relating to the Company’s
Agricultural Licensing Objectives;
|
|
4.
|
25%
of eligible shares and options for contributions relating to the Company’s
Investor Relations, Intellectual Property and Website Administration;
and
|
|
5.
|
15%
of the eligible shares and options relating to the Company’s
Organizational Objectives.
|
Number of Shares
|
Number of Options (1)
|
|||||||
Bruce
C. Galton
|
66,000 | — | ||||||
John
E. Thompson, Ph.D.
|
— | 48,000 | ||||||
Joel
Brooks
|
28,000 | — | ||||||
Richard
Dondero
|
— | 80,000 | ||||||
Sascha
P. Fedyszyn
|
42,000 | — | ||||||
Total
|
136,000 | 128,000 |
(1)
|
Such
options are exercisable at a strike price of $0.60, which represents the
closing price of the common stock on November 18,
2008.
|
|
1.
|
20%
of the eligible shares upon the execution of a research agreement to
conduct a phase I/II clinical trial at a research
facility;
|
|
2.
|
20%
of the eligible shares upon the filing and acceptance by the FDA of an
investigational new drug application;
and
|
|
3.
|
60%
of the eligible shares upon the successful completion of a FDA approved
phase I/II clinical trial.
|
Goal 1
|
Goal 2
|
Goal 3
|
||||||||||
Number
of Shares
|
||||||||||||
Joel
Brooks
|
10,000 | 10,000 | 30,000 | |||||||||
Number of
Options (1)
|
||||||||||||
John
E. Thompson, Ph.D.
|
50,000 | 50,000 | 150,000 | |||||||||
Richard
Dondero
|
60,000 | 60,000 | 180,000 | |||||||||
Total
number of options
|
110,000 | 110,000 | 330,000 |
(1)
|
Such
options are exercisable at a strike price of $0.99, which represents the
closing price of the common stock on December 12,
2007.
|
July 1,
2009
|
March 31, 2010
|
|||||||
Estimated
life in years
|
3 | 3 | ||||||
Risk-free
interest rate (1)
|
1.57 | % | 1.60 | % | ||||
Volatility
|
100 | % | 100 | % | ||||
Dividend
paid
|
None
|
None
|
(1)
|
Represents
the interest rate on a U.S. Treasury security with a maturity date
corresponding to that of the option
term.
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
|
|
·
|
Performing
efficacy, toxicological and dose-finding studies in mice for our potential
multiple myeloma drug candidate, SNS-01. SNS-01 is a
nano-encapsulated combination therapy of Factor 5A and an siRNA against
Factor 5A. Our efficacy study in severe combined
immune-deficient (“SCID”) mice with subcutaneous human multiple myeloma
tumors tested SNS-01 dosages ranging from 0.15 mg/kg to 1.5
mg/kg. In these studies, mice treated with a dose of either
0.75 mg/kg or 1.5 mg/kg both showed a 91% reduction in tumor volume and a
decrease in tumor weight of 87% and 95%, respectively. For mice
that received smaller doses of either 0.38 mg/kg or 0.15 mg/kg, there was
also a reduction in tumor volume (73% and 61%, respectively) and weight
(74% and 36%, respectively). All of the treated mice,
regardless of dose, survived. This therapeutic dose range study
provided the basis for an 8-day maximum tolerated dose study in which
normal mice received two intravenous doses of increasing amounts of SNS-01
(from 2.2 mg/kg). Body weight, organ weight and serum levels of
liver enzymes were used as clinical indices to assess
toxicity. A dose between 2.2 mg/kg and 2.9 mg/kg was well
tolerated with respect to these clinical indices, and the survival rate at
2.9 mg/kg was 80%. Those mice receiving above 2.9 mg/kg of
SNS-01 showed evidence of morbidity and up to 80%
mortality. The 2.9 mg/kg threshold, twice the upper end of the
proposed therapeutic dose range, was therefore determined to be the
maximum tolerated dose in mice.
|
|
·
|
demonstrated
significant tumor regression and diminished rate of tumor growth of
multiple myeloma tumors in SCID mice treated with Factor 5A technology
encapsulated in nanoparticles;
|
|
·
|
increased
median survival by approximately 250% in a tumor model of mice injected
with melanoma cancer cells;
|
|
·
|
induced
apoptosis in both human cancer cell lines derived from tumors and in lung
tumors in mice;
|
|
·
|
induced
apoptosis of cancer cells in a human multiple myeloma cell line in the
presence of IL-6;
|
|
·
|
measured
VEGF reduction in mouse lung tumors as a result of treatment with our
genes;
|
|
·
|
decreased
ICAM and activation of NFkB in cancer cells employing siRNA against Factor
5A;
|
|
·
|
increased
the survival rate in H1N1 mouse influenza survival studies from 14% in
untreated mice to 52% in mice treated with our siRNA against Factor
5A. Additionally, the treated mice reversed the weight loss
typically seen in infected mice and had other reduced indicators of
disease severity as measured by blood glucose and liver
enzymes;
|
|
·
|
increased
the survival, while maintaining functionality, of mouse pancreatic islet
cells isolated for transplantation, using intraperitaneal administration
of our technology. Initial animal studies have shown that our
technology administered prior to harvesting beta islet cells from a mouse,
has a significant impact not only on the survival of the beta islet cells,
but also on the retention of the cells’ functionality when compared to the
untreated beta islet cells. Additional studies have shown that
the treated beta islet cells survive a pro-inflammatory cytokine
challenge, while maintaining their functionality with respect to insulin
production. These further studies also revealed Factor-5A’s
involvement in the modulation of inducible nitric oxide synthase (iNOS),
an important indicator of inflammation;
and
|
|
·
|
increased
the survival rate of mice in a lethal challenge sepsis
model. Additionally, a broad spectrum of systemic
pro-inflammatory cytokines were down-regulated, while not effecting the
anti-inflammatory cytokine IL-10.
|
|
·
|
Multiple
Myeloma. Our objective is to advance our technology for the
potential treatment of multiple myeloma with the goal of initiating a
clinical trial. In connection with the potential clinical
trial, we have engaged a clinical research organization, or CRO, to assist
us through the process. We have also determined the delivery
system for our technology, contracted for the supply of pharmaceutical
grade materials to be used in toxicology and human studies, performed
certain toxicology studies, and have contracted with a third party
laboratory to conduct additional toxicology studies. Together
with the assistance of our CRO, we will have additional toxicology studies
performed with the goal of filing an investigational new drug application,
or IND application, with the U.S. Food and Drug Administration, or FDA,
for their review and consideration in order to initiate a clinical
trial. We estimate that it will take approximately nine (9)
months from March 31, 2010 to complete these
objectives.
|
|
·
|
Other. We
may continue to look at other disease states in order to determine the
role of Factor 5A.
|
|
·
|
Entering
into strategic alliances, including licensing technology to major
marketing and distribution partners;
or
|
|
·
|
developing
in-house production and marketing
capabilities.
|
|
·
|
longer
shelf life of perishable produce;
|
|
·
|
increased
biomass and seed yield;
|
|
·
|
greater
tolerance to environmental stresses, such as drought and soil
salinity;
|
|
·
|
greater
tolerance to certain fungal and bacterial
pathogens;
|
|
·
|
more
efficient use of fertilizer; and
|
|
·
|
advancement
to field trials in banana, and
trees.
|
|
·
|
further
develop and implement the DHS and Factor 5A gene technology in banana,
canola, cotton, turfgrass, bedding plants, rice, alfalfa, corn, soybean
and trees; and
|
|
·
|
test
the resultant crops for new beneficial traits such as increased yield,
increased tolerance to environmental stress, disease resistance and more
efficient use of fertilizer.
|
|
·
|
licensing
technology to major marketing and distribution
partners;
|
|
·
|
entering
into strategic alliances; or
|
|
·
|
developing
in-house production and marketing
capabilities.
|
Seed
Transformation
|
approximately
1 to 2 years
|
Greenhouse
|
approximately
1 to 2 years
|
Field
Trials
|
approximately
2 to 5 years
|
Project
|
Partner
|
Status
|
||
Banana
|
Rahan
Meristem
|
|||
-
Shelf Life
|
|
Field
trials
|
||
-
Disease Resistance
|
|
Field
trials
|
||
Trees
|
Arborgen
|
|||
-
Growth
|
|
Field
trials
|
||
Alfalfa
|
Cal/West
|
Greenhouse
|
||
Corn
|
Monsanto
|
Proof
of concept ongoing
|
||
Cotton
|
Bayer
|
Seed
transformation
|
||
Canola
|
Bayer
|
Seed
transformation
|
||
Rice
|
Bayer
|
Proof
of concept ongoing
|
||
Soybean
|
Monsanto
|
Proof
of concept ongoing
|
||
Turfgrass
|
The
Scotts Company
|
Greenhouse
|
||
Ethanol
|
|
Poet
|
|
Modify
inputs
|
Payments Due by Period
|
||||||||||||||||||||
Contractual Obligations
|
Total
|
Less than
1 year
|
1 - 3 years
|
4 - 5 years
|
More than
5 years
|
|||||||||||||||
Research
and Development Agreements (1)
|
$ | 480,049 | $ | 480,049 | $ | — | $ | — | $ | — | ||||||||||
Facility,
Rent and Operating Leases (2)
|
$ | 93,480 | $ | 80,104 | $ | 13,376 | $ | — | $ | — | ||||||||||
Employment,
Consulting and Scientific Advisory Board Agreements (3)
|
$ | 221,842 | $ | 211,842 | $ | 10,000 | $ | — | $ | — | ||||||||||
Total
Contractual Cash Obligations
|
$ | 795,371 | $ | 771,995 | $ | 23,376 | $ | — | $ | — |
(1)
|
Certain
of our research and development agreements disclosed herein provide that
payment is to be made in Canadian dollars and, therefore, the contractual
obligations are subject to fluctuations in the exchange
rate.
|
(2)
|
The
lease for our office space in New Brunswick, New Jersey is subject to
certain escalations for our proportionate share of increases in the
building’s operating costs.
|
(3)
|
Certain
of our consulting agreements provide for automatic renewal, which is not
reflected in the table, unless terminated earlier by the parties to the
respective agreements.
|
|
·
|
utilizing
our current cash balance and
investments;
|
|
·
|
the
placement of additional equity or debt
instruments;
|
|
·
|
achieving
some of the milestones set forth in our current licensing agreements;
and
|
|
·
|
the
possible execution of additional licensing agreements for our
technology.
|
Three Months Ended March 31,
|
||||||||||||||||
2010
|
2009
|
Change
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
General
and administrative
|
$ | 555 | $ | 532 | $ | 23 | 4.3 | % | ||||||||
Research
and development
|
566 | 541 | 25 | 4.6 | % | |||||||||||
Total
operating expenses
|
$ | 1,121 | $ | 1,073 | $ | 48 | 4.5 | % |
Three Months Ended March 31,
|
||||||||||||||||
2010
|
2009
|
Change
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
Share-based
compensation
|
$ | 141 | $ | 120 | $ | 21 | 17.5 | % | ||||||||
Payroll
and benefits
|
142 | 177 | (35 | ) | (19.8 | )% | ||||||||||
Investor
relations
|
34 | 45 | (11 | ) | (24.4 | )% | ||||||||||
Professional
fees
|
122 | 74 | 48 | 64.9 | % | |||||||||||
Depreciation
and amortization
|
32 | 27 | 5 | 18.5 | % | |||||||||||
Director
fees
|
9 | 14 | (5 | ) | (35.7 | )% | ||||||||||
Other
general and administrative
|
75 | 75 | — | — | % | |||||||||||
Total
general and administrative
|
$ | 555 | $ | 532 | $ | 23 | 4.3 | % |
|
·
|
Share-based
compensation for the three months ended March 31, 2010 consisted primarily
of the amortized portion of the Black-Scholes value of options granted to
directors, employees and consultants and the value of 74,184 shares of
common stock issued to consultants. Share based compensation
for the three months ended March 31, 2009 consisted primarily of the
amortized portion of the Black-Scholes value of options granted to
directors, employees and consultants and the amount of our short-term
incentive program for the year ended June 30, 2009. During the
three month periods ended March 31, 2010 and 2009, there were 1,015,000
and 127,836 options granted,
respectively.
|
|
·
|
Payroll
and benefits decreased primarily due to a reduction in the amount of
compensation for our President and CEO, which was partially offset by the
costs associated with severance agreement with our former Vice-President
of Corporate Development.
|
|
·
|
Investor
relations decreased primarily due to a reduction in the amount of fees
being paid to our previous investor relations
firm.
|
|
·
|
Professional
fees increased primarily due to legal fees in connection with the
redemption of the YA Global convertible notes, the purchase of the
Stanford convertible notes and warrants by certain of our board members
and the execution of the severance agreement with our former
Vice-President of Corporate
Development.
|
Three Months Ended March 31,
|
||||||||||||||||
2010
|
2009
|
Change
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
Share-based
compensation
|
$ | 2 | $ | 23 | $ | (21 | ) | (91.3 | )% | |||||||
Other
research and development
|
564 | 518 | 46 | 8.8 | % | |||||||||||
Total
research and development
|
$ | 566 | $ | 541 | $ | 25 | 4.6 | % |
|
·
|
Share-based
compensation consists primarily of the amortized portion of Black-Scholes
value of options and warrants granted to research and development
consultants and employees. Additionally, for the three
months ended March 31, 2009, it also consisted of the amount of our
short-term incentive plan for the year ended June 30,
2009.
|
|
·
|
Other
research and development costs increased primarily due to an increase in
the costs incurred in connection with our development of SNS01 for
multiple myeloma due to the timing of certain aspects of the development
and the cost of the research performed at the University of Waterloo as a
result of a negative exchange rate variance during the three months ended
March 31, 2010.
|
Three Months Ended March 31,
|
||||||||||||||||
2010
|
%
|
2009
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
Agricultural
|
$ | 138 | 24 | % | $ | 146 | 27 | % | ||||||||
Human
health
|
428 | 76 | % | 395 | 73 | % | ||||||||||
Total
research and development
|
$ | 566 | 100 | % | $ | 541 | 100 | % |
|
·
|
Agricultural
research expenses decreased during the three month period ended March 31,
2010 primarily due to a decrease in the amount of share- based
compensation.
|
|
·
|
Human
health research expenses increased during the three month period ended
March 31, 2010 primarily as a result of the timing of certain aspects of
the development of SNS01 for multiple
myeloma.
|
Nine Months Ended March 31,
|
||||||||||||||||
2010
|
2009
|
Change
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
General
and administrative
|
$ | 1,735 | $ | 1,711 | $ | 24 | 1.4 | % | ||||||||
Research
and development
|
1,523 | 1,624 | (101 | ) | (6.2 | )% | ||||||||||
Total
operating expenses
|
$ | 3,258 | $ | 3,335 | $ | (77 | ) | (2.3 | )% |
Nine Months Ended March 31,
|
||||||||||||||||
2010
|
2009
|
Change
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
Share-based
compensation
|
$ | 324 | $ | 323 | $ | 1 | 0.3 | % | ||||||||
Payroll
and benefits
|
542 | 522 | 20 | 3.8 | % | |||||||||||
Investor
relations
|
125 | 200 | (75 | ) | (37.5 | )% | ||||||||||
Professional
fees
|
384 | 349 | 35 | 10.0 | % | |||||||||||
Depreciation
and amortization
|
93 | 81 | 12 | 14.8 | % | |||||||||||
Director
fees
|
62 | 58 | 4 | 6.9 | % | |||||||||||
Other
general and administrative
|
205 | 178 | 27 | 15.2 | % | |||||||||||
Total
general and administrative
|
$ | 1,735 | $ | 1,711 | $ | 24 | 1.4 | % |
|
·
|
Share-based
compensation for the nine months ended March 31, 2010 consisted primarily
of the amortized portion of the Black-Scholes value of options granted to
directors, employees and consultants and the value of 154,184 shares of
common stock issued to consultants. Share based compensation
for the nine months ended March 31, 2009 consisted primarily of the
amortized portion of the Black-Scholes value of options granted to
directors, employees and consultants and the amount of our short-term
incentive program for the year ended June 30,
2009. During the nine month periods ended March 31,
2010 and 2009, there were 1,748,399 and 849,420 options granted,
respectively.
|
|
·
|
Payroll
and benefits increased primarily due to the severance agreement with our
former Vice-President of Corporate
Development.
|
|
·
|
Investor
relations decreased primarily because we have not yet incurred the costs
of holding our annual meeting for the current year. Our annual
meeting was held in December 2008 in the previous year and incurred such
costs during the nine month period ended March 31,
2009. Additionally, there was a reduction in the amount of fees being
paid to our previous investor relations firm beginning on December 1,
2009.
|
|
·
|
Professional
fees increased primarily due to legal fees in connection with our
redemption of the YA Global convertible notes, the purchase of the
Stanford convertible notes and warrants by certain of our board members
and the execution of the severance agreements with our former President
and CEO and Vice-President of Corporate Development. Such
increase was partially offset by a decrease in accounting
fees.
|
Nine Months Ended March 31,
|
||||||||||||||||
2010
|
2009
|
Change
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
Share-based
compensation
|
$ | 2 | $ | 35 | $ | (33 | ) | (94.3 | )% | |||||||
Other
research and development
|
1,521 | 1,589 | (68 | ) | (4.3 | )% | ||||||||||
Total
research and development
|
$ | 1,523 | $ | 1,624 | $ | (101 | ) | (6.2 | )% |
|
·
|
Share-based
compensation consists primarily of the amortized portion of Black-Scholes
value of options and warrants granted to research and development
consultants and employees. Additionally, for the three
months ended March 31, 2009, it also consisted of the amount of our
short-term incentive plan for the year ended June 30,
2009.
|
|
·
|
Other
research and development costs decreased primarily due to a decrease in
the costs incurred in connection with our development of SNS01 for
multiple myeloma due to the timing of certain aspects of the development
and the cost of the research performed at the University of Waterloo as a
result of a decrease in the annual budget that began on September 1,
2009.
|
Nine Months Ended March 31,
|
||||||||||||||||
2010
|
%
|
2009
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
Agricultural
|
$ | 404 | 27 | % | $ | 457 | 28 | % | ||||||||
Human
health
|
1,119 | 73 | % | 1,167 | 72 | % | ||||||||||
Total
research and development
|
$ | 1,523 | 100 | % | $ | 1,624 | 100 | % |
|
·
|
Agricultural
research expenses decreased during the nine month period ended March 31,
2010 primarily due to a decrease in the cost of the research performed at
the University of Waterloo as a result of a decrease in the annual budget
beginning on September 1, 2009 .
|
|
·
|
Human
health research expenses decreased during the nine month period ended
March 31, 2010 primarily as a result of the timing of certain projects
related to the development of SNS01 for multiple
myeloma.
|
Item
3.
|
Quantitative and Qualitative
Disclosures about Market
Risk.
|
Item
4T.
|
Controls
and Procedures.
|
|
·
|
delay,
scale-back or eliminate some or all of our research and product
development programs;
|
|
·
|
license
third parties to develop and commercialize products or technologies that
we would otherwise seek to develop and commercialize
ourselves;
|
|
·
|
seek
strategic alliances or business
combinations;
|
|
·
|
attempt
to sell our company;
|
|
·
|
cease
operations; or
|
|
·
|
declare
bankruptcy.
|
|
·
|
delay,
scale back or eliminate some or all of our research and development
programs;
|
|
·
|
provide
a license to third parties to develop and commercialize our technology
that we would otherwise seek to develop and commercialize
ourselves;
|
|
·
|
seek
strategic alliances or business
combinations;
|
|
·
|
attempt
to sell our company;
|
|
·
|
cease
operations; or
|
|
·
|
declare
bankruptcy.
|
|
·
|
the
scope of our research and
development;
|
|
·
|
our
ability to attract business partners willing to share in our development
costs;
|
|
·
|
our
ability to successfully commercialize our
technology;
|
|
·
|
competing
technological and market
developments;
|
|
·
|
our
ability to enter into collaborative arrangements for the development,
regulatory approval and commercialization of other products;
and
|
|
·
|
the
cost of filing, prosecuting, defending and enforcing patent claims and
other intellectual property rights.
|
|
·
|
our
ability to obtain patent protection for our technologies and
processes;
|
|
·
|
our
ability to preserve our trade secrets;
and
|
|
·
|
our
ability to operate without infringing the proprietary rights of other
parties both in the United States and in foreign
countries.
|
|
·
|
our
patent applications will result in the issuance of
patents;
|
|
·
|
any
patents issued or licensed to us will be free from challenge and if
challenged, would be held to be
valid;
|
|
·
|
any
patents issued or licensed to us will provide commercially significant
protection for our technology, products and
processes;
|
|
·
|
other
companies will not independently develop substantially equivalent
proprietary information which is not covered by our patent
rights;
|
|
·
|
other
companies will not obtain access to our
know-how;
|
|
·
|
other
companies will not be granted patents that may prevent the
commercialization of our technology;
or
|
|
·
|
we
will not incur licensing fees and the payment of significant other fees or
royalties to third parties for the use of their intellectual property in
order to enable us to conduct our
business.
|
|
·
|
the
USDA regulates the import, field testing and interstate movement of
specific types of genetic engineering that may be used in the creation of
transgenic plants;
|
|
·
|
the
EPA regulates activity related to the invention of plant pesticides and
herbicides, which may include certain kinds of transgenic plants;
and
|
|
·
|
the
FDA regulates foods derived from new plant
varieties.
|
•
|
we
may discover that the product candidate does not exhibit the expected
therapeutic results in humans, may cause harmful side effects or have
other unexpected characteristics that may delay or preclude regulatory
approval or limit commercial use if approved;
|
||
•
|
the
results from early clinical trials may not be statistically significant or
predictive of results that will be obtained from expanded, advanced
clinical trials;
|
||
•
|
institutional
review boards or regulators, including the FDA, may hold, suspend or
terminate our clinical research or the clinical trials of our product
candidate for various reasons, including noncompliance with regulatory
requirements or if, in their opinion, the participating subjects are being
exposed to unacceptable health risks;
|
||
•
|
subjects
may drop out of our clinical trials;
|
||
•
|
our
preclinical studies or clinical trials may produce negative, inconsistent
or inconclusive results, and we may decide, or regulators may require us,
to conduct additional preclinical studies or clinical trials;
and
|
||
•
|
the
cost of our clinical trials may be greater than we currently
anticipate.
|
•
|
obtaining
an effective investigational new drug application, or IND, or regulatory
approval to commence a clinical trial;
|
||
•
|
negotiating
acceptable clinical trial agreement terms with prospective trial
sites;
|
||
•
|
obtaining
institutional review board approval to conduct a clinical trial at a
prospective site;
|
||
•
|
recruiting
qualified subjects to participate in clinical trials;
|
||
•
|
competition
in recruiting clinical investigators;
|
||
•
|
shortage
or lack of availability of supplies of drugs for clinical
trials;
|
||
•
|
the
need to repeat clinical trials as a result of inconclusive results or
poorly executed testing;
|
||
•
|
the
placement of a clinical hold on a study;
|
||
•
|
the
failure of third parties conducting and overseeing the operations of our
clinical trials to perform their contractual or regulatory obligations in
a timely fashion; and
|
||
•
|
exposure
of clinical trial subjects to unexpected and unacceptable health risks or
noncompliance with regulatory requirements, which may result in suspension
of the trial
|
|
·
|
occurrence
of unacceptable toxicities or side
effects;
|
|
·
|
ineffectiveness
of the product candidate;
|
|
·
|
negative
or inconclusive results from the clinical trials, or results that
necessitate additional studies or clinical
trials;
|
|
·
|
delays
in obtaining or maintaining required approvals from institutions, review
boards or other reviewing entities at clinical
sites;
|
|
·
|
delays
in patient enrollment; or
|
|
·
|
insufficient
funding or a reprioritization of financial or other
resources.
|
|
·
|
quarterly
variations in operating results;
|
|
·
|
the
progress or perceived progress of our research and development
efforts;
|
|
·
|
changes
in accounting treatments or
principles;
|
|
·
|
announcements
by us or our competitors of new technology, product and service offerings,
significant contracts, acquisitions or strategic
relationships;
|
|
·
|
additions
or departures of key personnel;
|
|
·
|
future
offerings or resales of our common stock or other
securities;
|
|
·
|
stock
market price and volume fluctuations of publicly-traded companies in
general and development companies in particular;
and
|
|
·
|
general
political, economic and market
conditions.
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of
Proceeds.
|
Item
3.
|
Defaults
Upon Senior Securities
|
Item
4.
|
[RESERVED]
|
Item
5.
|
Other
Information
|
Item
6.
|
Exhibits.
|
Exhibit No.
|
Description
|
||
3.1
|
Certificate
of Designations to the Company’s Certificate of Incorporation (Series A)
(Filed as exhibit 3.1 to Form 8-K filed on March 29,
2010)
|
||
3.2
|
Certificate
of Designations to the Company’s Certificate of Incorporation (Series B)
(Filed as exhibit 3.2 to Form 8-K filed on March 29,
2010)
|
||
4.1
|
Form
of Series A Common Stock Purchase Warrant (Filed as exhibit 4.1 to Form
8-K filed on March 29, 2010)
|
||
4.2
|
Form
of Series B Common Stock Purchase Warrant (Filed as exhibit 4.2 to Form
8-K filed on March 29, 2010)
|
||
10.1
|
Credit
Agreement dated as of February 17, 2010 by and between Senesco
Technologies, Inc. and JMP Securities (filed herewith)
|
||
10.2
|
Letter
Agreement dated as of March 3, 2010 by and between the Company and YA
Global Investments L.P. (Filed as exhibit 10.1 to Form 8-K filed on March
4, 2010
|
||
10.3
|
Letter
dated as of March 4, 2010 sent to the Company by certain of its insiders
relating to the conversion of convertible debentures (Filed as exhibit
10.1 to Form 8-K filed on March 5, 2010)
|
||
10.4
|
Registration
Rights Agreement dated March 26, 2010 by and between the Company and
certain investors (Filed as exhibit 10.1 to Form 8-K filed on March 29,
2010)
|
||
10.5
|
Securities
Purchase Agreement dated March 26, 2010 by and between the Company and
certain investors (Non-Affiliates) (Filed as exhibit 10.2 to Form 8-K
filed on March 29, 2010)
|
||
10.6
|
Securities
Purchase Agreement dated March 26, 2010 by and between the Company and
certain investors (Non-Affiliates) (Filed as exhibit 10.3 to Form 8-K
filed on March 29, 2010)
|
||
10.7
|
Securities
Purchase Agreement dated March 26, 2010 by and between the Company and
certain investors thereto (Affiliates) (Filed as exhibit 10.4 to Form 8-K
filed on March 29, 2010)
|
Exhibit No.
|
Description
|
||
31.1
|
Certification
of principal executive officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. (filed herewith)
|
||
31.2
|
Certification
of principal financial and accounting officer pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002. (filed herewith)
|
||
32.1
|
Certification
of principal executive officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, 18 U.S.C. 1350. (furnished
herewith)
|
||
32.2
|
|
Certification
of principal financial and accounting officer pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002, 18 U.S.C. 1350. (furnished
herewith)
|
SENESCO
TECHNOLOGIES, INC.
|
||
DATE: May
17, 2010
|
By:
|
/s/ Jack Van Hulst
|
Jack
Van Hulst, President
|
||
and
Chief Executive Officer
|
||
(Principal
Executive Officer)
|
||
DATE: May
17, 2010
|
By:
|
/s/ Joel Brooks
|
Joel
Brooks, Chief Financial Officer
|
||
and
Treasurer
|
||
(Principal
Financial and Accounting
Officer)
|