x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF
1934
|
¨
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF
1934
|
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 September 30, 2010 and June 30, 2010
|
2
|
||
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|||
For
the Three Months Ended September 30, 2010 and 2009, and From
Inception on July 1, 1998 through September 30, 2010
|
3
|
||
CONDENSED
CONSOLIDATED STATEMENT OF STOCKHOLDERS’EQUITY
|
|||
For
the three months ended September 30, 2010
|
4
|
||
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|||
For
the Three Months Ended September 30, 2010 and 2009, and From
Inception on July 1, 1998 through September 30, 2010
|
5
|
||
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
6
|
||
Item
2. Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
13
|
||
Overview
|
13
|
||
Liquidity
and Capital Resources
|
24
|
||
Changes
to Critical Accounting Policies and Estimates
|
25
|
||
Results
of Operations
|
26
|
||
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.
|
47
|
||
Item
3. Defaults
Upon Senior Securities
|
47
|
||
Item
4. [REMOVED
AND RESERVED]
|
47
|
||
Item
5. Other
Information.
|
47
|
||
Item
6. Exhibits.
|
47
|
||
SIGNATURES
|
48
|
Item
1.
|
Financial
Statements (Unaudited).
|
September
30,
|
June
30,
|
|||||||
2010
|
2010
|
|||||||
ASSETS
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 6,290,995 | $ | 8,026,296 | ||||
Prepaid
research supplies and expenses
|
990,696 | 1,304,795 | ||||||
Total
Current Assets
|
7,281,691 | 9,331,091 | ||||||
Equipment,
furniture and fixtures, net
|
5,879 | 4,554 | ||||||
Intangibles,
net
|
4,662,960 | 4,568,895 | ||||||
Deferred
income tax assets, net
|
- | - | ||||||
Security
deposit
|
7,187 | 7,187 | ||||||
TOTAL
ASSETS
|
$ | 11,957,717 | $ | 13,911,727 | ||||
LIABILITIES AND STOCKHOLDERS'
EQUITY
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable
|
$ | 494,365 | $ | 557,420 | ||||
Accrued
expenses
|
744,497 | 576,857 | ||||||
Line
of credit
|
2,194,844 | 2,194,844 | ||||||
Deferred
rent
|
6,045 | - | ||||||
Total
Current Liabilities
|
3,439,751 | 3,329,121 | ||||||
Warrant
liabilities ($15,587 and $490,438 to related parties,
respectively)
|
1,207,452 | 2,493,794 | ||||||
Grant
payable
|
99,728 | 99,728 | ||||||
Deferred
rent
|
- | 8,060 | ||||||
TOTAL
LIABILITIES
|
4,746,931 | 5,930,703 | ||||||
STOCKHOLDERS'
EQUITY:
|
||||||||
Preferred
stock, $0.01 par value, authorized 5,000,000 shares
|
||||||||
Series
A 10,297 shares issued and 4,852 and 8,035 shares outstanding,
respectively
|
||||||||
(liquidation
preference of $5,094,600 and $8,235,875
|
||||||||
at
September 30, 2010 and June 30, 2010, respectively)
|
49 | 80 | ||||||
Series
B 1,200 shares issued and outstanding
|
||||||||
(liquidation
preference of $1,240,000 and $1,210,000
|
||||||||
at
September 30, 2010 and June 30, 2010, respectively)
|
12 | 12 | ||||||
Common
stock, $0.01 par value, authorized 250,000,000 shares,
|
||||||||
issued
and outstanding 64,302,322 and 50,092,204, respectively
|
643,022 | 500,922 | ||||||
Capital
in excess of par
|
60,430,744 | 58,321,169 | ||||||
Deficit
accumulated during the development stage
|
(53,863,041 | ) | (50,841,159 | ) | ||||
Total
Stockholders' Equity
|
7,210,786 | 7,981,024 | ||||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$ | 11,957,717 | $ | 13,911,727 |
Cumulative
|
||||||||||||
Three
months ended September 30,
|
Amounts
from
|
|||||||||||
2010
|
2009
|
Inception
|
||||||||||
Revenue
|
$ | - | $ | - | $ | 1,590,000 | ||||||
Operating
expenses:
|
||||||||||||
General
and administrative
|
668,884 | 494,955 | 26,949,195 | |||||||||
Research
and development
|
1,536,507 | 488,759 | 16,485,471 | |||||||||
Total
operating expenses
|
2,205,391 | 983,714 | 43,434,666 | |||||||||
Loss
from operations
|
(2,205,391 | ) | (983,714 | ) | (41,844,666 | ) | ||||||
Other
non-operating income (expense)
|
||||||||||||
Fair
value – warrant liability
|
319,476 | 1,888,133 | 7,567,904 | |||||||||
Sale
of state income tax loss – net
|
- | - | 586,442 | |||||||||
Other
noncash (expense) income, net
|
(111,265 | ) | - | 209,994 | ||||||||
Loss
on extinguishment of debt
|
- | (86,532 | ) | (361,877 | ) | |||||||
Amortization
of debt discount and financing costs
|
- | (807,914 | ) | (11,227,870 | ) | |||||||
Interest
expense – convertible notes
|
- | (199,616 | ) | (2,027,930 | ) | |||||||
Interest
(expense) income - net
|
(18,296 | ) | 347 | 480,882 | ||||||||
Net
loss
|
(2,015,476 | ) | (189,296 | ) | (46,617,121 | ) | ||||||
Preferred
dividends
|
(1,006,406 | ) | - | (7,245,920 | ) | |||||||
Loss
applicable to common shares
|
$ | (3,021,882 | ) | $ | (189,296 | ) | $ | (53,863,041 | ) | |||
Basic
and diluted net loss per common share
|
$ | (0.05 | ) | $ | (0.01 | ) | ||||||
Basic
and diluted weighted-average number
|
||||||||||||
of
common shares outstanding
|
56,930,150 | 22,046,718 |
Deficit
|
||||||||||||||||||||||||||||
Accumulated
|
||||||||||||||||||||||||||||
During
the
|
Stockholders'
|
|||||||||||||||||||||||||||
Capital
in Excess
|
Development
|
Equity
|
||||||||||||||||||||||||||
Preferred
Stock
|
Common
Stock
|
of
Par Value
|
Stage
|
(Deficiency)
|
||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
|||||||||||||||||||||||||
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 | |||||||||||||||
Preferred
stock converted into common stock
|
||||||||||||||||||||||||||||
during
the three months ended September 30, 2010
|
(3,183 | ) | (31 | ) | 9,946,875 | 99,468 | (99,437 | ) | - | - | ||||||||||||||||||
Issuance
of common stock in lieu of cash payment for
|
||||||||||||||||||||||||||||
dividends
during the three months ended September 30, 2010
|
- | - | 4,263,243 | 42,632 | 912,268 | (954,900 | ) | - | ||||||||||||||||||||
Fair
market value of options and warrants vested
|
||||||||||||||||||||||||||||
during
the three months ended September 30, 2010
|
- | - | - | - | 329,878 | - | 329,878 | |||||||||||||||||||||
Reclassification
of warrant liability during the three months
|
||||||||||||||||||||||||||||
ended
September 30, 2010
|
- | - | - | - | 966,866 | - | 966,866 | |||||||||||||||||||||
Dividends
accrued for the period from July 1, 2010
|
- | - | - | - | - | (51,506 | ) | (51,506 | ) | |||||||||||||||||||
through
September 30, 2010
|
||||||||||||||||||||||||||||
Net
loss for the three months ended September 30, 2010
|
- | - | - | - | - | (2,015,476 | ) | (2,015,476 | ) | |||||||||||||||||||
Balance
at September 30, 2010
|
6,052 | $ | 61 | 64,302,322 | $ | 643,022 | $ | 60,430,744 | $ | (53,863,041 | ) | $ | 7,210,786 |
Cumulative
|
||||||||||||
Three months ended September
30,
|
Amounts
from
|
|||||||||||
2010
|
2009
|
Inception
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$ | (2,015,476 | ) | $ | (189,296 | ) | $ | (46,617,121 | ) | |||
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
|
(319,476 | ) | (1,888,133 | ) | (7,889,163 | ) | ||||||
Noncash
charge for change in warrant terms
|
111,265 | - | 111,265 | |||||||||
Issuance
of common stock and warrants for interest
|
- | 199,616 | 2,003,386 | |||||||||
Issuance
of common stock for services
|
- | - | 53,800 | |||||||||
Stock-based
compensation expense
|
218,613 | 34,527 | 10,808,196 | |||||||||
Depreciation
and amortization
|
34,292 | 27,853 | 733,300 | |||||||||
Amortization
of convertible note discount
|
- | 663,637 | 10,000,000 | |||||||||
Amortization
of deferred financing costs
|
- | 144,278 | 1,227,869 | |||||||||
Loss
on extinguishment of debt
|
- | 86,532 | 361,877 | |||||||||
(Increase)
decrease in operating assets:
|
||||||||||||
Prepaid
expenses and other current assets
|
314,099 | 44,832 | (990,696 | ) | ||||||||
Security
deposit
|
- | - | (7,187 | ) | ||||||||
Increase
(decrease) in operating liabilities:
|
||||||||||||
Accounts
payable
|
(63,055 | ) | (375,592 | ) | 494,365 | |||||||
Accrued
expenses
|
116,134 | 205,271 | 637,117 | |||||||||
Other
liability
|
(2,015 | ) | (1,989 | ) | 6,045 | |||||||
Net
cash used in operating activities
|
(1,605,619 | ) | (1,048,464 | ) | (28,850,518 | ) | ||||||
Cash
flows from investing activities:
|
||||||||||||
Patent
costs
|
(127,656 | ) | (189,332 | ) | (5,221,934 | ) | ||||||
Redemption
of investments, net
|
- | 250,000 | - | |||||||||
Purchase
of equipment, furniture and fixtures
|
(2,026 | ) | (1,116 | ) | (180,205 | ) | ||||||
Net
cash (used in) provided by investing activities
|
(129,682 | ) | 59,552 | (5,402,139 | ) | |||||||
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
|
- | 883,638 | 20,442,006 | |||||||||
Net
cash provided by financing activities
|
- | 883,638 | 40,543,652 | |||||||||
Net
(decrease) increase in cash and cash equivalents
|
(1,735,301 | ) | (105,274 | ) | 6,290,995 | |||||||
Cash
and cash equivalents at beginning of period
|
8,026,296 | 380,569 | - | |||||||||
Cash
and cash equivalents at end of period
|
$ | 6,290,995 | $ | 275,295 | $ | 6,290,995 | ||||||
Supplemental
disclosure of non-cash transactions:
|
||||||||||||
Conversion
of convertible note into common stock
|
$ | - | $ | 653,400 | $ | 10,000,000 | ||||||
Conversion
of bridge notes into common stock
|
- | - | 534,316 | |||||||||
Conversion
of preferred stock into common stock
|
99,437 | - | 170,124 | |||||||||
Allocation
of preferred stock proceeds to warrants
|
||||||||||||
and
beneficial conversion feature
|
- | - | 7,089,047 | |||||||||
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
|
- | 199,616 | 2,003,386 | |||||||||
Issuance
of common stock for dividend payments on
|
||||||||||||
preferred
stock
|
954,900 | - | 1,632,900 | |||||||||
Issuance
of common stock in settlement of accounts payable
|
- | 175,000 | 175,000 | |||||||||
Dividends
accrued on preferred stock
|
51,506 | - | 282,381 | |||||||||
Supplemental
disclosure of cash flow information:
|
||||||||||||
Cash
paid for interest
|
26,671 | - | 117,619 |
|
·
|
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
|
||||||||
September
30,
|
||||||||
2010
|
2009
|
|||||||
Estimated
life in years
|
3.25-5.0 | 3.5-5.5 | ||||||
Risk-free
interest rate (1)
|
0.6%–1.3 | % | 1.3% – 1.8 | % | ||||
Volatility
|
104 | % | 100 | % | ||||
Dividend
paid
|
None
|
None
|
Fair
Value Measurement at
|
||||||||||||||||
Carrying
|
September 30, 2010
|
|||||||||||||||
Value
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Assets:
|
||||||||||||||||
Cash
and cash equivalents
|
$ | 6,290,995 | $ | 6,290,995 | $ | - | $ | - | ||||||||
Liabilities:
|
||||||||||||||||
Warrant
Liabilities
|
$ | 1,207,452 | $ | - | $ | 1,207,452 | $ | - | ||||||||
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 | $ | - |
September 30,
2010
|
June 30, 2010
|
|||||||
Warrants
issued on December 20, 2007
|
||||||||
Estimated
life in years
|
2.25 | 2.5 | ||||||
Risk-free
interest rate (1)
|
0.53 | % | 0.80 | % | ||||
Volatility
|
104 | % | 106 | % | ||||
Dividend
paid
|
None
|
None
|
||||||
Warrants
issued on June 30, 2008
|
||||||||
Estimated
life in years
|
2.75 | 3.0 | ||||||
Risk-free
interest rate (1)
|
0.53 | % | 1.00 | % | ||||
Volatility
|
104
|
% | 106 | % | ||||
Dividend
paid
|
None
|
None
|
||||||
Warrants
issued on April 1, 2010
|
||||||||
Estimated
life in years
|
4.5 | 4.75 | ||||||
Risk-free
interest rate (1)
|
1.27 | % | 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.
|
|
·
|
Performing
efficacy, toxicological and dose-finding studies in vitro in non-human
and human cells and in-vivo in mice and
dogs for our potential multiple myeloma drug candidate,
SNS01-T. SNS01-T is a potential treatment for cancer that
consists of a nano-encapsulated combination of an siRNA against the Factor
5A message and a DNA-plasmid for a closely related form of Factor
5A. Our efficacy studies in severe combined immune-deficient,
or SCID, mice with subcutaneous human multiple myeloma tumors tested
SNS01-T dose 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, compared to relevant controls, 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 SNS01-T treated mice
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 SNS01-T (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 SNS01-T 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.
|
|
·
|
demonstrating
significant tumor regression and diminished rate of tumor growth of
multiple myeloma tumors in SCID mice treated with Factor 5A technology
encapsulated in nanoparticles;
|
|
·
|
increasing
median survival by approximately 250% in a tumor model of mice injected
with melanoma cancer cells;
|
|
·
|
inducing
apoptosis in both human cancer cell lines derived from tumors and in lung
tumors in mice;
|
|
·
|
inducing
apoptosis of cancer cells in a human multiple myeloma cell line in the
presence of IL-6;
|
|
·
|
observing
a reduction in VEGF levels in mouse lung tumors as a result of
treatment with our genes;
|
|
·
|
decreasing
ICAM and activation of NFkB in cancer cells employing siRNA against Factor
5A;
|
|
·
|
increasing
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;
|
|
·
|
increasing
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, or iNOS,
an important indicator of inflammation;
and
|
|
·
|
increasing
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 in order to initiate a Phase 1/2
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 Phase 1/2
clinical trial in multiple myeloma. We estimate that it will
take approximately three (3) months from September 30, 2010 to complete
these objectives.
|
|
·
|
Other. We
may consider other human diseases 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, 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
|
3 - 5 years
|
More than
5 years
|
|||||||||||||||
Research
and Development Agreements (1)
|
$ | 697,242 | $ | 697,242 | $ | — | $ | — | $ | — | ||||||||||
Facility,
Rent and Operating Leases (2)
|
$ | 53,504 | $ | 53,504 | $ | — | $ | — | $ | — | ||||||||||
Employment,
Consulting
and
Scientific Advisory Board Agreements (3)
|
$ | 194,250 | $ | 189,250 | $ | 5,000 | $ | — | $ | — | ||||||||||
Total
Contractual Cash Obligations
|
$ | 944,996 | $ | 939,996 | $ | 5,000 | $ | — | $ | — |
(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 September 30,
|
||||||||||||||||
2010
|
2009
|
Change
|
%
|
|||||||||||||
(in
thousands, except % values)
|
||||||||||||||||
General
and administrative
|
$ | 669 | $ | 495 | $ | 174 | 35.2 | % | ||||||||
Research
and development
|
1,537 | 489 | 1,048 | 214.3 | % | |||||||||||
Total
operating expenses
|
$ | 2,206 | $ | 984 | $ | 1,222 | 124.2 | % |
Three
Months Ended September 30,
|
||||||||||||||||
2010
|
2009
|
Change
|
%
|
|||||||||||||
(in
thousands, except % values)
|
||||||||||||||||
Payroll
and benefits
|
$ | 149 | $ | 161 | $ | (12 | ) | (7.6 | )% | |||||||
Investor
relations
|
49 | 46 | 3 | 6.5 | % | |||||||||||
Professional
fees
|
105 | 122 | (17 | ) | (13.9 | )% | ||||||||||
Depreciation
and amortization
|
34 | 28 | 6 | 21.4 | % | |||||||||||
Director
fees
|
39 | 43 | (4 | ) | (9.3 | )% | ||||||||||
Other
general and administrative
|
90 | 57 | 33 | 57.9 | % | |||||||||||
466 | 457 | 9 | 2.0 | % | ||||||||||||
Stock-based
compensation
|
203 | 38 | 165 | 434.2 | % | |||||||||||
Total
general and administrative
|
$ | 669 | $ | 495 | $ | 174 | 35.2 | % |
|
·
|
Payroll
and benefits for the three months ended September 30, 2010 was lower than
the three months ended September 30, 2009 primarily due to the resignation
of the former VP-Corporate Development during Fiscal 2010. This
was partially offset by a bonus granted to the Chief Financial
Officer.
|
|
·
|
Investor
relations expense for the three months ended September 30, 2010 was lower
than the three months ended September 30, 2009 primarily as a result of a
decrease in investor relations consulting
costs.
|
|
·
|
Professional
fees for the three months ended September 30, 2010 was lower than the
three months ended September 30, 2009 primarily as a result of an decrease
in legal fees. Legal fees decreased primarily due to discounts
offered by the legal firm as well as lower fees in connection with the
review of our regulatory filings.
|
|
·
|
Depreciation
and amortization for the three months ended September 30, 2010 was higher
than the three months ended September 30, 2009 primarily as a result of an
increase in amortization of patent
costs.
|
|
·
|
Stock-based
compensation for the three months ended September 30, 2010 and 2009
consisted of the amortized portion of the Black-Sholes value of options,
restricted stock units and warrants granted to directors, employees and
consultants. There were no options granted during the three
month period ended September 30, 2010 and 2009. There were 300,000
warrants granted to consultants during the three months ended September
30, 2010 and no warrants granted during the three month period ended
September 30, 2009.
|
Three
Months Ended September 30,
|
||||||||||||||||
2010
|
2009
|
Change
|
%
|
|||||||||||||
(in
thousands, except % values)
|
||||||||||||||||
Stock-based
compensation
|
$ | 15 | $ | (3 | ) | $ | 18 | 600.0 | % | |||||||
Payroll
|
55 | 40 | 15 | 37.5 | % | |||||||||||
Research
contract with the University of Waterloo
|
164 | 160 | 4 | 2.5 | % | |||||||||||
Other
research and development
|
1,303 | 292 | 1,011 | 346.2 | % | |||||||||||
Total
research and development
|
$ | 1,537 | $ | 489 | $ | 1,048 | 214.3 | % |
|
·
|
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. Additionally, for the three
months ended September 30, 2010, it consisted of the amount of our
long-term incentive plan and for the three months ended September 30,
2009, it also consisted of the amount of our short-term incentive
plan.
|
|
·
|
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 three month period
ended September 30, 2010 we initiated our pivotal toxicology
study.
|
Three
Months Ended September 30,
|
||||||||||||||||
2010
|
%
|
2009
|
%
|
|||||||||||||
(in
thousands, except % values)
|
||||||||||||||||
Agricultural
|
$ | 146 | 10 | % | $ | 143 | 29 | % | ||||||||
Human
health
|
1,391 | 90 | % | 346 | 71 | % | ||||||||||
Total
research and development
|
$ | 1,537 | 100 | % | $ | 489 | 100 | % |
|
·
|
Agricultural
research expenses did not materially change during the three month period
ended September 30, 2010 as we have not materially changed the scope of
our agricultural research.
|
|
·
|
Human
health research expenses increased during the three month period ended
September 30, 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.
|
Item
4T.
|
Controls
and Procedures.
|
|
(a)
|
Evaluation
of disclosure controls and
procedures.
|
|
(b)
|
Changes
in internal controls.
|
|
·
|
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
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.
|
|
·
|
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 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.
|
|
·
|
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.
|
[REMOVED
AND RESERVED]
|
Item
5.
|
Other
Information
|
Item
6.
|
Exhibits.
|
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: November
15, 2010
|
By:
|
/s/ Leslie J. Browne
|
Leslie
J. Browne, President
|
||
and
Chief Executive Officer
|
||
(Principal
Executive Officer)
|
||
DATE: November
15, 2010
|
By:
|
/s/ Joel Brooks
|
Joel
Brooks, Chief Financial Officer
|
||
and
Treasurer
|
||
(Principal
Financial and Accounting
Officer)
|