Delaware
|
84-1368850
|
(State
or other jurisdiction of incorporation or organization)
|
(IRS
Employer Identification No.)
|
Yes:
x
|
No:
¨
|
Yes:
¨
|
No:
¨
|
Large accelerated filer
¨
|
Accelerated filer ¨
|
Smaller reporting company
x
|
Non-accelerated filer
¨
|
Yes:
¨
|
No:
x
|
Page
|
||||
PART
I. FINANCIAL
INFORMATION.
|
||||
Item
1.
|
Financial
Statements (Unaudited)
|
1
|
||
CONDENSED
CONSOLIDATED BALANCE SHEETS
as
of December 31, 2010 and June 30, 2010
|
2
|
|||
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
For
the Three Months and Six Months Ended December 31, 2010 and 2009, and
From Inception on July 1, 1998 through December 31, 2010
|
3
|
|||
CONDENSED
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
For
the Six Months Ended December 31, 2010
|
4
|
|||
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
For
the Six Months Ended December 31, 2010 and 2009, and From Inception
on July 1, 1998 through December 31, 2010
|
5
|
|||
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
6
|
|||
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
14
|
||
Overview
|
14
|
|||
Liquidity
and Capital Resources
|
18
|
|||
Changes
to Critical Accounting Policies and Estimates
|
20
|
|||
Results
of Operations
|
21
|
|||
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
31
|
||
Item
4T.
|
Controls
and Procedures
|
31
|
||
PART
II. OTHER
INFORMATION.
|
||||
Item
1.
|
Legal
Proceedings.
|
32
|
||
Item
1A.
|
Risk
Factors.
|
32
|
||
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds.
|
48
|
||
Item
3.
|
Defaults
Upon Senior Securities
|
48
|
||
Item
4.
|
[REMOVED
AND RESERVED]
|
48
|
||
Item
5.
|
Other
Information.
|
48
|
||
Item
6.
|
Exhibits.
|
48
|
||
SIGNATURES
|
49
|
Item
1.
|
Financial
Statements (Unaudited).
|
December 31,
|
June 30,
|
|||||||
2010
|
2010
|
|||||||
ASSETS
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 4,837,477 | $ | 8,026,296 | ||||
Prepaid
research supplies and expenses
|
1,307,976 | 1,304,795 | ||||||
Total
Current Assets
|
6,145,453 | 9,331,091 | ||||||
Equipment,
furniture and fixtures, net
|
5,179 | 4,554 | ||||||
Intangibles,
net
|
4,759,268 | 4,568,895 | ||||||
Deferred
income tax assets, net
|
- | - | ||||||
Security
deposit
|
7,187 | 7,187 | ||||||
TOTAL
ASSETS
|
$ | 10,917,087 | $ | 13,911,727 | ||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable
|
$ | 625,995 | $ | 557,420 | ||||
Accrued
expenses
|
371,467 | 576,857 | ||||||
Line
of credit
|
2,194,844 | 2,194,844 | ||||||
Deferred
rent
|
4,030 | - | ||||||
Total
Current Liabilities
|
3,196,336 | 3,329,121 | ||||||
Warrant
liabilities ($0 and $490,438 to related parties,
respectively)
|
902,675 | 2,493,794 | ||||||
Deferred
rent
|
- | 8,060 | ||||||
Grant
payable
|
99,728 | 99,728 | ||||||
TOTAL
LIABILITIES
|
4,198,739 | 5,930,703 | ||||||
STOCKHOLDERS'
EQUITY:
|
||||||||
Preferred
stock, $0.01 par value, authorized 5,000,000 shares
|
||||||||
Series
A 10,297 shares issued and 4,125 and 8,035 shares outstanding,
respectively (liquidation preference of $4,228,125 and $8,235,875 at
December 31, 2010 and June 30, 2010, respectively)
|
41 | 80 | ||||||
Series
B 1,200 shares issued and outstanding (liquidation preference of
$1,230,000 and $1,210,000 at December 31, 2010 and June 30, 2010,
respectively)
|
12 | 12 | ||||||
Common
stock, $0.01 par value, authorized 250,000,000 shares, issued and
outstanding 69,255,399 and 50,092,204, at December 31, 2010 and June 30,
2010, respectively
|
692,554 | 500,922 | ||||||
Capital
in excess of par
|
61,700,953 | 58,321,169 | ||||||
Deficit
accumulated during the development stage
|
(55,675,212 | ) | (50,841,159 | ) | ||||
Total
Stockholders' Equity
|
6,718,348 | 7,981,024 | ||||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$ | 10,917,087 | $ | 13,911,727 |
Cumulative
|
||||||||||||||||||||
Three months ended December 31,
|
Six months ended December 31,
|
Amounts from
|
||||||||||||||||||
2010
|
2009
|
2010
|
2009
|
Inception
|
||||||||||||||||
Revenue
|
$ | - | $ | 140,000 | $ | - | $ | 140,000 | $ | 1,590,000 | ||||||||||
Operating
expenses:
|
||||||||||||||||||||
General
and administrative
|
706,685 | 685,409 | 1,375,569 | 1,180,364 | 27,655,880 | |||||||||||||||
Research
and development
|
798,352 | 467,544 | 2,334,859 | 956,303 | 17,283,823 | |||||||||||||||
Total
operating expenses
|
1,505,037 | 1,152,953 | 3,710,428 | 2,136,667 | 44,939,703 | |||||||||||||||
Loss
from operations
|
(1,505,037 | ) | (1,012,953 | ) | (3,710,428 | ) | (1,996,667 | ) | (43,349,703 | ) | ||||||||||
Other
non-operating income (expense)
|
||||||||||||||||||||
Grant
income
|
244,479 | - | 244,479 | - | 244,479 | |||||||||||||||
Fair
value – warrant liability
|
149,910 | 451,208 | 469,386 | 2,339,341 | 7,717,814 | |||||||||||||||
Sale
of state income tax loss – net
|
- | - | - | - | 586,442 | |||||||||||||||
Other
noncash (expense) income, net
|
(4,604 | ) | - | (115,869 | ) | - | 205,390 | |||||||||||||
Loss
on extinguishment of debt
|
- | - | - | (86,532 | ) | (361,877 | ) | |||||||||||||
Amortization
of debt discount and financing costs
|
- | (959,946 | ) | - | (1,767,860 | ) | (11,227,870 | ) | ||||||||||||
Interest
expense – convertible notes
|
- | (182,653 | ) | - | (382,269 | ) | (2,027,930 | ) | ||||||||||||
Interest
(expense) income - net
|
(21,311 | ) | 679 | (39,607 | ) | 1,026 | 459,571 | |||||||||||||
Net
loss
|
(1,136,563 | ) | (1,703,665 | ) | (3,152,039 | ) | (1,892,961 | ) | (47,753,684 | ) | ||||||||||
Preferred
dividends
|
(675,608 | ) | - | (1,682,014 | ) | - | (7,921,528 | ) | ||||||||||||
Loss
applicable to common shares
|
$ | (1,812,171 | ) | $ | (1,703,665 | ) | $ | (4,834,053 | ) | $ | (1,892,961 | ) | $ | (55,675,212 | ) | |||||
Basic
and diluted net loss per common share
|
$ | (0.03 | ) | $ | (0.06 | ) | $ | (0.08 | ) | $ | (0.08 | ) | ||||||||
Basic
and diluted weighted-average number of common shares
outstanding
|
67,978,776 | 26,250,566 | 62,733,481 | 24,146,382 |
Deficit
|
||||||||||||||||||||||||||||
Accumulated
|
||||||||||||||||||||||||||||
During the
|
Stockholders'
|
|||||||||||||||||||||||||||
Preferred Stock
|
Common Stock
|
Capital in Excess
|
Development
|
Equity
|
||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
of Par Value
|
Stage
|
(Deficiency)
|
||||||||||||||||||||||
Balance
July 1, 1998 (inception) through June 30, 2010
|
9,235 | $ | 92 | 50,092,204 | $ | 500,922 | $ | 58,321,169 | $ | (50,841,159 | ) | $ | 7,981,024 | |||||||||||||||
Issuance
of common stock at $0.30 per share
|
- | - | 599,185 | 5,992 | 174,722 | - | 180,714 | |||||||||||||||||||||
Commissions
and other fees related to the issuance of common stock
|
- | - | - | - | (31,437 | ) | - | (31,437 | ) | |||||||||||||||||||
Preferred
stock converted into common stock
|
(3,910 | ) | (39 | ) | 12,218,750 | 122,187 | (122,148 | ) | - | - | ||||||||||||||||||
Issuance
of common stock in lieu of cash payment for dividends
|
- | - | 6,335,260 | 63,353 | 1,355,678 | (1,188,156 | ) | 230,875 | ||||||||||||||||||||
Fair
market value of options and warrants vested and amended
|
- | - | - | - | 520,603 | - | 520,603 | |||||||||||||||||||||
Reclassification
of warrant liability
|
- | - | - | - | 1,121,733 | - | 1,121,733 | |||||||||||||||||||||
Issuance
of common stock under the Company's the Company's long-term incentive
plan
|
- | - | 10,000 | 100 | (100 | ) | - | - | ||||||||||||||||||||
Deemed
dividend - Preferred Stock
|
- | - | - | - | 360,733 | (360,733 | ) | - | ||||||||||||||||||||
Dividends
accrued and unpaid at December 31, 2010
|
- | - | - | - | - | (133,125 | ) | (133,125 | ) | |||||||||||||||||||
Net
loss
|
- | - | - | - | - | (3,152,039 | ) | (3,152,039 | ) | |||||||||||||||||||
Balance
at December 31, 2010
|
5,325 | $ | 53 | 69,255,399 | $ | 692,554 | $ | 61,700,953 | $ | (55,675,212 | ) | $ | 6,718,348 |
Cumulative
|
||||||||||||
Six months ended December 31,
|
Amounts from
|
|||||||||||
2010
|
2009
|
Inception
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$ | (3,152,039 | ) | $ | (1,892,961 | ) | $ | (47,753,684 | ) | |||
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
|
(469,386 | ) | (2,339,341 | ) | (8,039,073 | ) | ||||||
Noncash
charge for change in warrant terms
|
115,869 | - | 115,869 | |||||||||
Issuance
of common stock and warrants for interest
|
- | 382,269 | 2,003,386 | |||||||||
Issuance
of common stock for services
|
- | 28,800 | 53,800 | |||||||||
Stock-based
compensation expense
|
404,734 | 153,542 | 10,994,317 | |||||||||
Depreciation
and amortization
|
69,304 | 60,535 | 768,312 | |||||||||
Deferred
rent
|
(4,030 | ) | (3,979 | ) | 4,030 | |||||||
Amortization
of convertible note discount
|
- | 1,496,593 | 10,000,000 | |||||||||
Amortization
of deferred financing costs
|
- | 271,267 | 1,227,869 | |||||||||
Loss
on extinguishment of debt
|
- | 86,532 | 361,877 | |||||||||
(Increase)
decrease in operating assets:
|
||||||||||||
Accounts
receivable
|
- | (140,000 | ) | - | ||||||||
Prepaid
expenses and other current assets
|
(3,181 | ) | 29,344 | (1,307,976 | ) | |||||||
Security
deposit
|
- | - | (7,187 | ) | ||||||||
Increase
(decrease) in operating liabilities:
|
||||||||||||
Accounts
payable
|
68,575 | 196,512 | 625,995 | |||||||||
Accrued
expenses
|
(107,640 | ) | 96,434 | 413,343 | ||||||||
Net
cash used in operating activities
|
(3,077,794 | ) | (1,574,453 | ) | (30,322,693 | ) | ||||||
Cash
flows from investing activities:
|
||||||||||||
Patent
costs
|
(258,276 | ) | (467,382 | ) | (5,352,554 | ) | ||||||
Redemption
of investments, net
|
- | 1,050,000 | - | |||||||||
Purchase
of equipment, furniture and fixtures
|
(2,026 | ) | (1,116 | ) | (180,205 | ) | ||||||
Net
cash (used in) provided by investing activities
|
(260,302 | ) | 581,502 | (5,532,759 | ) | |||||||
Cash
flows from financing activities:
|
||||||||||||
Proceeds
from grant
|
- | - | 99,728 | |||||||||
Proceeds
from draw-down on line of credit
|
- | - | 2,194,844 | |||||||||
Proceeds
from issuance of bridge notes
|
- | - | 525,000 | |||||||||
Proceeds
from issuance of preferred stock and warrants, net
|
- | - | 10,754,841 | |||||||||
Redemption
of convertible notes and warrants
|
- | - | (2,160,986 | ) | ||||||||
Proceeds
from issuance of convertible notes
|
- | - | 9,340,000 | |||||||||
Deferred
financing costs
|
- | - | (651,781 | ) | ||||||||
Proceeds
from issuance of common stock and warrants, net and exercise of warrants
and options
|
149,277 | 1,364,169 | 20,591,283 | |||||||||
Net
cash provided by financing activities
|
149,277 | 1,364,169 | 40,692,929 | |||||||||
Net
(decrease) increase in cash and cash equivalents
|
(3,188,819 | ) | 371,218 | 4,837,477 | ||||||||
Cash
and cash equivalents at beginning of period
|
8,026,296 | 380,569 | - | |||||||||
Cash
and cash equivalents at end of period
|
$ | 4,837,477 | $ | 751,787 | $ | 4,837,477 | ||||||
Supplemental
disclosure of non-cash transactions:
|
||||||||||||
Conversion
of convertible note into common stock
|
$ | - | $ | 1,457,460 | $ | 10,000,000 | ||||||
Conversion
of bridge notes into common stock
|
- | - | 534,316 | |||||||||
Conversion
of preferred stock into common stock
|
122,148 | - | 308,111 | |||||||||
Allocation
of preferred stock proceeds to warrants and beneficial conversion
feature
|
360,733 | - | 7,449,780 | |||||||||
Allocation
of convertible debt proceeds to warrants and beneficial conversion
feature
|
- | - | 9,340,000 | |||||||||
Warrants
issued for financing costs
|
- | - | 690,984 | |||||||||
Issuance
of common stock for interest payments on convertible notes
|
- | 382,269 | 2,003,386 | |||||||||
Issuance
of common stock for dividend payments on preferred stock
|
1,188,156 | - | 2,607,187 | |||||||||
Issuance
of common stock in settlement of accounts payable
|
- | 175,000 | 175,000 | |||||||||
Dividends
accrued on preferred stock
|
133,125 | - | 133,125 | |||||||||
Supplemental
disclosure of cash flow information:
|
||||||||||||
Cash
paid for interest
|
53,387 | - | 179,872 |
|
·
|
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.
|
Three
Months Ended
|
Six
Months Ended
|
|||||||||||||||
December
31,
|
December
31,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Warrants
granted
|
5,000 |
None
|
305,000 |
None
|
||||||||||||
Options
granted
|
4,115,892 | 733,399 | 4,115,892 | 733,399 | ||||||||||||
Estimated
life in years
|
5.0-10.0 | 3.5-5.5 | 5.0-10.0 | 3.5-5.5 | ||||||||||||
Risk-free
interest rate (1)
|
1.5%-2.9 | % | 1.9%-3.9 | % | 1.3%-2.9 | % | 1.3% – 1.8 | % | ||||||||
Volatility
|
104 | % | 100 | % | 104 | % | 100 | % | ||||||||
Dividend
paid
|
None
|
None
|
None
|
None
|
Number of Options
|
Weighted-Average
Exercise Price
|
|||||||
Outstanding
at July 1, 2010
|
7,269,172 | $ | 1.13 | |||||
Granted
|
4,115,892 | 0.26 | ||||||
Exercised
|
— | — | ||||||
Expired
|
(500,000 | ) | 1.14 | |||||
Outstanding
at December 31, 2010
|
10,885,064 | $ | 0.80 | |||||
Exercisable
at December 31, 2010
|
6,413,394 | $ | 1.13 | |||||
Not
Exercisable at December 31, 2010
|
4,471,670 | $ | 0.26 |
Fair
Value Measurement at
|
||||||||||||||||
Carrying
|
December 31, 2010.
|
|||||||||||||||
Value
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Assets:
|
||||||||||||||||
Cash
and cash equivalents
|
$ | 4,837,477 | $ | 4,837,477 | $ | - | $ | - | ||||||||
Liabilities:
|
||||||||||||||||
Warrant
Liabilities
|
$ | 902,675 | $ | - | $ | 902,675 | $ | - |
Fair
Value Measurement at
|
||||||||||||||||
Carrying
|
June 30, 2010.
|
|||||||||||||||
Value
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Assets:
|
||||||||||||||||
Cash
and cash equivalents
|
$ | 8,026,296 | $ | 8,026,296 | $ | - | $ | - | ||||||||
Liabilities:
|
||||||||||||||||
Warrant
Liabilities
|
$ | 2,493,794 | $ | - | $ | 2,493,794 | $ | - |
December 31,
|
|
|||||||
2010
|
June 30, 2010
|
|||||||
Warrants
issued on December 20, 2007
|
||||||||
Estimated
life in years
|
2.00 | 2.50 | ||||||
Risk-free interest
rate (1)
|
0.61 | % | 0.80 | % | ||||
Volatility
|
104 | % | 106 | % | ||||
Dividend
paid
|
None
|
None
|
||||||
Warrants
issued on June 30, 2008
|
||||||||
Estimated
life in years
|
2.50 | 3.00 | ||||||
Risk-free interest
rate (1)
|
1.02 | % | 1.00 | % | ||||
Volatility
|
104 | % | 106 | % | ||||
Dividend
paid
|
None
|
None
|
||||||
Warrants
issued on April 1, 2010
|
||||||||
Estimated
life in years
|
4.25 | 4.75 | ||||||
Risk-free interest
rate (1)
|
1.52 | % | 1.79 | % | ||||
Volatility
|
104 | % | 106 | % | ||||
Dividend
paid
|
None
|
None
|
||||||
Warrants
issued on June 2, 2010
|
||||||||
Estimated
life in years
|
- | 4.9 | ||||||
Risk-free interest
rate (1)
|
- | 1.79 | % | |||||
Volatility
|
- | 106 | % | |||||
Dividend
paid
|
- |
None
|
(1)
|
Represents
the interest rate on a U.S. Treasury security with a maturity date
corresponding to that of the warrant
term.
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
|
|
·
|
further
develop and implement the DHS and Factor 5A gene technology in banana,
canola, cotton, turfgrass, 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.
|
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
|
Discontinued
|
Payments Due by Period
|
||||||||||||||||||||
Less than
|
More than
|
|||||||||||||||||||
Contractual Obligations
|
Total
|
1 year
|
1 - 3 years
|
3 - 5 years
|
5 years
|
|||||||||||||||
Research
and Development Agreements (1)
|
$ | 738,257 | $ | 738,257 | $ | — | $ | — | $ | — | ||||||||||
Facility,
Rent and Operating Leases (2)
|
$ | 33,440 | $ | 33,440 | $ | — | $ | — | $ | — | ||||||||||
Employment,
Consulting and Scientific Advisory Board Agreements (3)
|
$ | 184,000 | $ | 181,500 | $ | 2,500 | $ | — | $ | — | ||||||||||
Total
Contractual Cash Obligations
|
$ | 955,697 | $ | 953,197 | $ | 2,500 | $ | — | $ | — |
(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 December 31,
|
||||||||||||||||
2010
|
2009
|
Change
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
Payroll
and benefits
|
$ | 136 | $ | 239 | $ | (103 | ) | (43.1 | )% | |||||||
Investor
relations
|
57 | 45 | 12 | 26.7 | % | |||||||||||
Professional
fees
|
160 | 141 | 19 | 13.5 | % | |||||||||||
Depreciation
and amortization
|
35 | 33 | 2 | 6.1 | % | |||||||||||
Director
fees
|
(14 | ) | 10 | (24 | ) | (240.0 | )% | |||||||||
Other
general and administrative
|
163 | 69 | 94 | 136.2 | % | |||||||||||
537 | 537 | - | - | |||||||||||||
Stock-based
compensation
|
170 | 148 | 22 | 14.9 | % | |||||||||||
Total
general and administrative
|
$ | 707 | $ | 685 | $ | 22 | 3.2 | % |
|
·
|
Payroll
and benefits for the three months ended December 31, 2010 was lower than
for the three months ended December 31, 2009, primarily due to the
severance package recorded for the former President and CEO during Fiscal
2010. This was partially offset by a bonus granted to the Chief
Financial Officer during Fiscal
2011.
|
|
·
|
Investor
relations expense for the three months ended December 31, 2010 was higher
than for the three months ended December 31, 2009, primarily as a result
of an increase in investor relations consulting
costs.
|
|
·
|
Professional
fees for the three months ended December 31, 2010 was higher than for the
three months ended December 31, 2009, primarily as a result of an increase
in accounting fees. Accounting fees increased primarily due to
the use of a consultant to assist with the preparation of our quarterly
filings.
|
|
·
|
Depreciation
and amortization for the three months ended December 31, 2010 was higher
than for the three months ended December 31, 2009, primarily as a result
of an increase in amortization of patent
costs.
|
|
·
|
Director
fees for the three months ended December 31, 2010 was lower than for the
three months ended December 31, 2009 primarily due to the termination of
the Finance Committee that was in place from November 2009 through May
2010 and fewer board meetings being held during the three months ended
December 31, 2010 than during the three months ended December 31,
2009.
|
|
·
|
Other
general and administration expenses for the three months ended December
31, 2010 was higher than for the three months ended December 31, 2009
primarily due to an increase in attendance at various financial and
industry conferences and certain consulting
costs.
|
|
·
|
Stock-based
compensation for the three months ended December 31, 2010 and 2009
consisted of the amortized portion of the Black-Scholes value of options,
restricted stock units and warrants granted to directors, employees and
consultants. There were 4,115,892 and 733,399 options granted
during the three months ended December 31, 2010 and 2009, respectively.
There were 5,000 warrants granted to consultants during the three months
ended December 31, 2010 and no warrants granted during the three months
ended December 31, 2009.
|
Three Months Ended December 31,
|
||||||||||||||||
2010
|
2009
|
Change
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
Payroll
|
$ | 40 | $ | 40 | $ | - | - | |||||||||
Research
contract with the University of Waterloo
|
150 | 155 | (5 | ) | (3.2 | )% | ||||||||||
Other
research and development
|
592 | 270 | 322 | 119.3 | % | |||||||||||
782 | 465 | 317 | 68.2 | % | ||||||||||||
Stock-based
compensation
|
16 | 3 | 13 | 433.3 | % | |||||||||||
Total
research and development
|
$ | 798 | $ | 468 | $ | 330 | 70.5 | % |
|
·
|
Other
research and development costs increased primarily due to an increase in
the costs incurred in connection with our development of SNS01-T for
multiple myeloma. Specifically, during the three months ended
December 31, 2010, we were conducting our pivotal toxicology study and
preparing for the filing of an IND for the treatment of multiple myeloma
with SNS01-T.
|
|
·
|
Stock-based
compensation consists primarily of the amortized portion of Black-Scholes
value of options and warrants granted to research and development
consultants and employees. Stock-based compensation for
the three months ended December 31, 2010 was higher than for the three
months ended December 31, 2009, primarily due to an increase in the number
of options granted during the three months ended December 31, 2010 as
compared to the number of options granted during the three months ended
December 31, 2009.
|
Three Months Ended December 31,
|
||||||||||||||||
2010
|
%
|
2009
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
Agricultural
|
$ | 139 | 17 | % | $ | 127 | 27 | % | ||||||||
Human
health
|
659 | 83 | % | 341 | 73 | % | ||||||||||
Total
research and development
|
$ | 798 | 100 | % | $ | 468 | 100 | % |
|
·
|
Agricultural
research expenses did not materially change during the three months ended
December 31, 2010 from the three months ended December 31, 2009, as we
have not materially changed the scope of our agricultural
research.
|
|
·
|
Human
health research expenses increased during the three months ended December
31, 2010, primarily as a result of the timing of certain aspects of the
development of our potential drug candidate, SNS01-T, for treating
multiple myeloma. Specifically, during the three months ended
December 31, 2010, we incurred costs related to the performance of our
pivotal toxicology studies and the preparation of an
IND.
|
Six Months Ended December 31,
|
||||||||||||||||
2010
|
2009
|
Change
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
Payroll
and benefits
|
$ | 286 | $ | 400 | $ | (114 | ) | (28.5 | )% | |||||||
Investor
relations
|
106 | 91 | 15 | 16.5 | % | |||||||||||
Professional
fees
|
265 | 263 | 2 | 0.8 | % | |||||||||||
Depreciation
and amortization
|
69 | 61 | 8 | 13.1 | % | |||||||||||
Director
fees
|
24 | 53 | (29 | ) | (54.7 | )% | ||||||||||
Other
general and administrative
|
251 | 130 | 121 | 93.1 | % | |||||||||||
1,001 | 998 | 3 | 0.3 | % | ||||||||||||
Stock-based
compensation
|
374 | 182 | 192 | 105.5 | % | |||||||||||
Total
general and administrative
|
$ | 1,375 | $ | 1,180 | $ | 195 | 16.5 | % |
|
·
|
Payroll
and benefits for the six months ended December 31, 2010 was lower than for
the six months ended December 31, 2009, primarily due to the severance
package recorded for the former President and CEO during Fiscal
2010. This was partially offset by a bonus granted to the Chief
Financial Officer during Fiscal 2011.
|
|
·
|
Investor
relations expense for the six months ended December 31, 2010 was higher
than for the six months ended December 31, 2009, primarily as a result of
an increase in investor relations consulting
costs.
|
|
·
|
Depreciation
and amortization for the six months ended December 31, 2010 was higher
than for the six months ended December 31, 2009, primarily as a result of
an increase in amortization of patent
costs.
|
|
·
|
Director
fees for the six months ended December 31, 2010 was lower than for the six
months ended December 31, 2009, primarily due to the termination of the
Finance Committee that was in place from November 2009 through May 2010
and fewer board meetings being held during the six months ended December
31, 2010 than during the six months ended December 31,
2009.
|
|
·
|
Other
general and administration expenses for the six months ended December 31,
2010 was higher than for the six months ended December 31, 2009, primarily
due to an increase in attendance at various financial and industry
conferences and certain consulting
costs.
|
|
·
|
Stock-based
compensation for the six months ended December 31, 2010 and 2009 consisted
of the amortized portion of the Black-Scholes value of options, restricted
stock units and warrants granted to directors, employees and
consultants. There were 4,115,892 and 733,399 options granted
during the six months ended December 31, 2010 and 2009, respectively.
There were 305,000 warrants granted to consultants during the six months
ended December 31, 2010 and no warrants granted during the six months
ended December 31, 2009.
|
Six Months Ended December 31,
|
||||||||||||||||
2010
|
2009
|
Change
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
Payroll
|
$ | 95 | $ | 80 | $ | 15 | 18.8 | % | ||||||||
Research
contract with the University of Waterloo
|
315 | 315 | - | - | ||||||||||||
Other
research and development
|
1,894 | 562 | 1,332 | 237.0 | % | |||||||||||
2,304 | 957 | 1,347 | 140.8 | % | ||||||||||||
Stock-based
compensation
|
31 | - | 31 | - | ||||||||||||
Total
research and development
|
$ | 2,335 | $ | 957 | $ | 1,378 | 144.0 | % |
|
·
|
Payroll
increased primarily due to a bonus grant to the VP-Research and
Development.
|
|
·
|
Other
research and development costs increased primarily due to an increase in
the costs incurred in connection with our development of SNS01-T for
multiple myeloma. Specifically, during the six months ended
December 31, 2010, we incurred costs related to the performance of our
pivotal toxicology studies and the preparation of an
IND.
|
|
·
|
Stock-based
compensation consists primarily of the amortized portion of Black-Scholes
value of options and warrants granted to research and development
consultants and employees. Stock-based compensation for
the six months ended December 31, 2010 was higher than for the six months
ended December 31, 2009, primarily due to an increase in the number of
options granted during the six months ended December 31, 2010 as compared
to the number of options granted during the three months ended December
31, 2009. Additionally, for the six months ended December 31, 2010,
stock-based compensation consisted of the amount of awards under our
long-term incentive plan and for the six months ended December 31, 2009,
stock-based compensation also consisted of the amount of awards under our
short-term incentive plan.
|
Six Months Ended December 31,
|
||||||||||||||||
2010
|
%
|
2009
|
%
|
|||||||||||||
(in thousands, except % values)
|
||||||||||||||||
Agricultural
|
$ | 285 | 12 | % | $ | 247 | 26 | % | ||||||||
Human
health
|
2,050 | 88 | % | 710 | 74 | % | ||||||||||
Total
research and development
|
$ | 2,335 | 100 | % | $ | 957 | 100 | % |
|
·
|
Agricultural
research expenses did not materially change during the six months ended
December 31, 2010 from the six months ended December 31, 2009, as we have
not materially changed the scope of our agricultural
research.
|
|
·
|
Human
health research expenses increased during the six months ended December
31, 2010, primarily as a result of the timing of certain aspects of the
development of our potential drug candidate, SNS01-T, for treating
multiple myeloma. Specifically, during the three months ended
December 31, 2010, we incurred costs related to the performance of our
pivotal toxicology studies and the preparation of an
IND.
|
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;
|
|
·
|
provide
licenses to 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
United States Department of Agriculture, or 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
United States Environmental Protection Agency, or 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.
|
|
·
|
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.
|
|
·
|
obtaining
an effective 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.
|
|
·
|
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.
|
Exhibit No.
|
Description
|
|
10.1
|
Amendment
to Research Agreement by and among the University of Waterloo, Senesco,
Inc. and Dr. John E. Thompson, Ph.D., dated December 1, 2010. (filed
herewith)
|
|
10.2
|
At
Market Issuance Sales Agreement by and between Senesco Technologies Inc.
and McNicoll, Lewis & Vlak LLC dated December 22, 2010. (Incorporated
by reference to Exhibit 10.1 of Senesco Technologies, Inc. Form 8-K filed
on December 22, 2010.)
|
|
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: February
10, 2011
|
By:
|
/s/
Leslie J. Browne
|
Leslie
J. Browne, Ph.D., President
|
||
and
Chief Executive Officer
|
||
(Principal
Executive Officer)
|
||
DATE: February
10, 2011
|
By:
|
/s/
Joel Brooks
|
Joel
Brooks, Chief Financial Officer,
Secretary
and Treasurer
|
||
(Principal
Financial and Accounting
Officer)
|