Eloxx Pharmaceuticals, Inc. - Annual Report: 2010 (Form 10-K)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
(Mark
One)
x
|
ANNUAL REPORT UNDER
SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF
1934.
|
For
the fiscal year ended June 30, 2010
OR
¨
|
TRANSITION REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF
1934.
|
|
For
the transition period from ___________ to
_____________
|
Commission
file number: 001-31326
SENESCO TECHNOLOGIES,
INC.
|
(Exact
name of registrant as specified in its
charter)
|
Delaware
|
84-1368850
|
|
(State
or other jurisdiction of
incorporation
or organization)
|
(I.R.S.
Employer Identification
No.)
|
303
George Street, Suite 420, New Brunswick, New Jersey
|
08901
|
(Address
of principal executive offices)
|
(Zip
Code)
|
(732)
296-8400
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(Registrant’s
telephone number,
|
including
area code)
|
Securities
registered under Section 12(b) of the Act:
Title of each class
|
Name of each exchange on which
registered
|
Common
Stock, $0.01 par value per share.
|
NYSE
Amex
|
Securities
registered under Section 12(g) of the Act:
None.
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act.Yes ¨ No x
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or 15(d) of the Exchange Act . Yes ¨ No x
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days. Yes x No ¨
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T ((§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files). Yes ¨ No ¨
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained herein, and will not be contained, to the best
of registrant's knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K. ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer or a smaller reporting
company. See definitions of “accelerated filer”, “large accelerated
filer” and “smaller reporting company” in Rule 12b-2 of the Exchange
Act.
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes ¨ No x
As of
December 31, 2009, the aggregate market value of the registrant’s common stock
held by non-affiliates of the registrant was $7,253,840, based on the
closing sales price as reported on the NYSE Amex on that date.
Indicate
the number of shares outstanding of each of the registrant's classes of common
stock, as of September 26, 2010:
Class
|
Number of Shares
|
|||
Common
Stock, $0.01 par value
|
63,596,073 | |||
Preferred
Stock, $0.01 par value
|
6,191 |
TABLE OF
CONTENTS
Item
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Page
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||
PART
I
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1.
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Business
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1
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1A.
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Risk
Factors
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15
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1B.
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Unresolved
Staff Comments
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30
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2.
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Properties
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30
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3.
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Legal
Proceedings
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30
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4.
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Removed
and Reserved
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30
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PART
II
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5.
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Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
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31
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6.
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Selected
Financial Data
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34
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7.
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Management's
Discussion and Analysis of Financial Condition and Results of
Operations
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35
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7A.
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Quantitative
and Qualitative Disclosures About Market Risk
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46
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8.
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Financial
Statements and Supplementary Data
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47
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9.
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Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
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47
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9A.
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Controls
and Procedures
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47
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9B.
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Other
Information
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48
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PART III
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10.
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Directors,
Executive Officers and Corporate Governance
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49
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11.
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Executive
Compensation
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49
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12.
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
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49
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13.
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Certain
Relationships and Related Transactions and Director
Independence
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49
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14.
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Principal
Accounting Fees and Services
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49
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PART
IV
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15.
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Exhibits
and Financial Statement Schedules
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50
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SIGNATURES
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51
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FINANCIAL
STATEMENTS
|
F-1
|
- i
-
PART
I
Item
1. Business.
Our
Business
The
primary business of Senesco Technologies, Inc., a Delaware corporation
incorporated in 1999, and its wholly-owned subsidiary, Senesco, Inc., a New
Jersey corporation incorporated in 1998, collectively referred to as “Senesco,”
“we,” “us” or “our,” is to utilize our patented and patent-pending genes,
primarily eucaryotic translation initiation Factor 5A, or Factor 5A, and
deoxyhypusine synthase, or DHS, and related technologies for inhibition in human
health applications to develop novel approaches to treat cancer and inflammatory
diseases.
In
agricultural applications we are developing and licensing Factor 5A, DHS and
Lipase to enhance the quality and productivity of fruits, flowers, and
vegetables and agronomic crops through the control of cell death, referred to
herein as senescence, and growth in plants.
Human
Health Applications
We
believe that our gene technology could have broad applicability in the human
health field, by either inducing or inhibiting apoptosis. Inducing
apoptosis may be useful in treating certain forms of cancer because the
cancerous cells have failed to initiate apoptosis on their own due to damaged or
inhibited apoptotic pathways. Inhibiting apoptosis may be useful in
preventing or treating a wide range of inflammatory and ischemic diseases
attributed to premature apoptosis.
We have
commenced preclinical in-vivo and in-vitro research to
determine the ability of Factor 5A to regulate key execution genes,
pro-inflammatory cytokines, receptors, and transcription factors, which are
implicated in numerous apoptotic diseases.
Certain
preclinical human health results to date include:
|
·
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Performing
efficacy, toxicological and dose-finding studies in mice for our potential
multiple myeloma drug candidate, SNS-01-T. SNS-01-T 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-T 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-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
SNS-01-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;
|
1
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·
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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;
|
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·
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Increased
median survival by approximately 250% in a tumor model of mice injected
with melanoma cancer cells;
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·
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Induced
apoptosis in both human cancer cell lines derived from tumors and in lung
tumors in mice;
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·
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Induced
apoptosis of cancer cells in a human multiple myeloma cell line in the
presence of IL-6;
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·
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Measured
VEGF reduction in mouse lung tumors as a result of treatment with our
genes;
|
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·
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Decreased
ICAM and activation of NFkB in cancer cells employing siRNA against Factor
5A;
|
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·
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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;
|
|
·
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Increased
the survival, while maintaining functionality, of mouse pancreatic islet
cells isolated for transplantation, using intraperitoneal 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.
|
Accelerating
Apoptosis
The data
from our pre-clinical studies indicate that the up-regulation of Factor 5A
induces cell death in cancer cells through both the p53 (intrinsic) and cell
death receptor (extrinsic) apoptotic pathways. Tumors arise when abnormal cells
fail to undergo apoptosis due to an inability to activate their apoptotic
pathways. Just as the Factor 5A gene appears to facilitate expression of the
entire suite of genes required for programmed cell death in plants, the Factor
5A gene appears to regulate expression of a suite of genes required for
programmed cell death in human cells. Because the Factor 5A gene appears to
function at the initiation point of the apoptotic pathways, both intrinsic and
extrinsic, we believe that our gene technology has potential application as a
means of combating a broad range of cancers. Based on the results
obtained through our in-vitro studies, we have
found that up-regulating Factor 5A results in: (i) the up-regulation of p53;
(ii) increased inflammatory cytokine production; (iii) increased cell death
receptor formation; and (iv) increased caspase activity. These
features, coupled with a simultaneous down-regulation Bcl-2, result in apoptosis
of cancer cells. In addition, our in-vitro studies have shown
that the up-regulation of Factor 5A also down-regulates VEGF, a growth factor
which allows tumors to develop additional vascularization needed for growth
beyond a small mass of cells.
2
Inhibiting
Apoptosis
Our
preclinical studies indicate that down-regulation of our proprietary Factor 5A
gene may have potential application as a means for controlling the effects of a
broad range of diseases that are attributable to premature cell death, ischemia,
or inflammation. Such inflammatory diseases include glaucoma, heart disease, and
other certain inflammatory diseases such as Crohn’s disease, sepsis and diabetic
retinopathy. We have performed preclinical research of certain
inflammatory diseases. Using small inhibitory RNA’s, or siRNA’s, against Factor
5A to inhibit its expression, the results of our studies have indicated a
reduction in pro-inflammatory cytokine formation and the formation of receptors
for LPS, interferon-gamma and TNF-alpha. Our studies have also
indicated that by inhibiting Factor 5A, iNOS, MAPK, NFkB, JAK1 and ICAM are
downregulated, which decreases the inflammatory cytokines formed through these
pathways. Additionally, a mouse study has indicated that our siRNA is comparable
to a steroid and to a prescription anti-TNF drug in its ability to reduce
cytokine response to LPS. Other mouse studies have also indicated
that the siRNA against Factor 5A (i) protects thymocyte cells from apoptosis and
decreases formation of MPO, TNF-a, MIP-1alpha, and IL-1 in the lungs of mice
challenged with LPS and (ii) increases the survival rate in which sepsis was
induced by a lethal injection of LPS and (iii) reduces blood serum levels of
inflammatory proteins, such as IL-1, IL-2, IL-6, IL-12, TNF-a, IFNg and
MIP-1alpha, while not effecting IL-10, an anti-inflammatory
cytokine. Other experiments utilizing siRNA to Factor 5A include
inhibition of or apoptosis during the processing of mouse pancreatic beta islet
cells for transplantation, and the inhibition of early inflammatory changes
associated with type-1 diabetes in an in-vivo rat model.
Proteins
required for cell death include p53, interleukins, TNF-a and other cytokines and
caspases. Expression of these cell death proteins is required for the
execution of apoptosis. Based on our studies, we believe that
down-regulating Factor 5A by treatment with siRNA inhibits the expression of
p53, a major cell death transcription factor that in turn controls the formation
of a suite of other cell death proteins. In addition, we believe that
the down-regulation of Factor 5A up-regulates Bcl-2, a suppressor of
apoptosis.
Human
Health Target Markets
We
believe that our gene technology may have broad applicability in the human
health field, by either accelerating or inhibiting
apoptosis. Accelerating apoptosis may be useful in treating certain
forms of cancer because the body’s immune system is not able to force cancerous
cells to undergo apoptosis. Inhibiting apoptosis may be useful in
preventing or treating a wide range of inflammatory and ischemic diseases
attributed to premature apoptosis, including diabetes, diabetic retinopathy and
lung inflammation, among others.
3
We are
advancing our research in multiple myeloma with the goal of initiating a Phase I
clinical trial, and may select additional human health indications to bring into
clinical trials. We believe that the success of our future operations will
likely depend on our ability to transform our research and development
activities into a commercially feasible technology.
Human
Health Research Program
Our human
health research program, which has consisted of pre-clinical in-vitro and in-vivo experiments designed
to assess the role and method of action of the Factor 5A genes in human
diseases, is being performed by approximately nine (9) third party researchers,
at our direction, at Mayo Clinic, our contract research organization (Cato
Research) and the University of Waterloo. Additionally, we outsource
certain projects, such as our pivotal toxicity studies, to other third party
research organizations.
Our
research and development expenses incurred on human health applications were
approximately 79% of our total research and development expenses for the year
ended June 30, 2010. Our research and development expenses incurred
on human health applications were approximately 74% of our total research and
development expenses for the year ended June 30, 2009. Our research
and development expenses incurred on human health applications were
approximately 56% of our total research and development expenses for the year
ended June 30, 2008. Since inception, the proportion of our research
and development expenses on human health applications has increased, as compared
to our research and development expenses on agricultural
applications. This change is primarily due to the fact that our
research focus on human health has increased and some of our research costs for
plant applications have shifted to our license partners.
Our
planned future research and development initiatives for human health
include:
|
·
|
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 six (6)
months from June 30, 2010 to complete these
objectives.
|
|
·
|
Other. We
may continue to look at other disease states in order to determine the
role of Factor 5A.
|
In order
to pursue the above research initiatives, as well as other research initiatives
that may arise, we completed a private placement of convertible preferred stock
and warrants on April 1, 2010 and June 2, 2010. However, it may be
necessary for us to raise a significant amount of additional working capital in
the future. If we are unable to raise the necessary funds, we may be
required to significantly curtail the future development of some of our research
initiatives and we will be unable to pursue other possible research
initiatives.
4
We may
further expand our research and development program beyond the initiatives
listed above to include other research centers.
Human
Health Suppliers
The
materials for our SNT-01T therapeutic for multiple myeloma consists of three
parts: Factor 5A plasmid, siRNA against Factor 5A, and a
nano-particle. We have entered into supply agreements for the
components as follows:
On June 27, 2008, the Company entered
into a supply agreement with VGXI, Inc. (“VGXI”) under which VGXI will supply
the Company with the plasmid portion of the Company’s combination therapy
consisting of the Factor 5A gene and siRNA against Factor 5A (the “Plasmid
Product”). The agreement has an initial term that
commences on the date of the agreement and runs for a period of five (5)
years. The agreement shall, upon mutual agreement, renew for
consecutive one (1) year periods thereafter. The Company’s financial
obligation under the agreement is dependent upon the amount of Plasmid Product
ordered by the Company.
On June 30, 2008, the Company entered
into a supply agreement with POLYPLUS under which POLYPLUS will supply the
Company with its “in vivo-jetPEI” (the “Product”), which is used for systemic
delivery of the Company’s combination therapy of siRNA against Factor 5A and a
plasmid of the Factor 5A gene. The agreement has an initial term
which commences on the date of the agreement and runs until the eighth
anniversary of the first sale of the Product. The agreement shall
automatically renew for consecutive one (1) year periods thereafter, except if
terminated by either party upon six (6) months written notice prior to the
initial or any subsequent renewal term. The Company’s financial
obligation under the agreement is dependent upon the amount of Product ordered
by the Company.
On September 4, 2008, the Company
entered into a supply agreement with AVECIA under which AVECIA will supply the
Company with the siRNA portion of the Company’s combination therapy consisting
of the Factor 5A gene and siRNA against Factor 5A (the “Plasmid
Product”). The agreement has a term which commences on the date of
the agreement and terminates on the later of the completion of all services to
be provided under the agreement or 30 days following delivery of the final
shipment of product.
Human
Health Competition
Our
competitors in human health that are presently attempting to distribute their
technology have generally utilized one of the following distribution
channels:
|
·
|
Entering
into strategic alliances, including licensing technology to major
marketing and distribution partners;
or
|
|
·
|
Developing
in-house production and marketing
capabilities.
|
In
addition, some competitors are established distribution companies, which
alleviates the need for strategic alliances, while others are attempting to
create their own distribution and marketing channels.
5
There are
many large companies and development stage companies working in the field of
apoptosis research including: Amgen Inc., Centocor, Inc., Genzyme Corporation,
OSI Pharmaceuticals, Inc., Novartis AG, Introgen Therapeutics, Inc., Genta,
Incorporated, and Vertex Pharmaceuticals, Inc., amongst others.
We do not
currently have any commercialized products, and therefore, it is difficult to
assess our competitive position in the market. However, we believe
that if we are able to develop and commercialize a product or products under our
patents to our Factor 5A platform technology, we will have a competitive
position in the markets in which we will operate.
Agricultural
Applications
Our
agricultural research focuses on the discovery and development of certain gene
technologies, which are designed to confer positive traits on fruits, flowers,
vegetables, forestry species and agronomic crops. To date, we have
isolated and characterized the senescence-induced Lipase gene, DHS, and Factor
5A in certain species of plants. Our goal is to modulate the expression of these
genes in order to achieve such traits as extended shelf life, increased biomass,
increased yield and increased resistance to environmental stresses and disease,
thereby demonstrating proof of concept in each category of crop.
Certain
agricultural results to date include:
|
·
|
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.
|
The
technology presently utilized by the industry for increasing the shelf life in
certain flowers, fruits and vegetables relies primarily on reducing ethylene
biosynthesis, and therefore only has application to the crops that are
ethylene-sensitive. Because Factor 5A, DHS and Lipase are already
present in all plant cells, our technology may be incorporated into crops by
using either conventional breeding methods (non-genetically modified) or
biotechnology techniques.
We have
licensed this technology to various strategic partners and have entered into a
joint collaboration. We may continue to license this technology, as
opportunities present themselves, to additional strategic partners and/or enter
into additional joint collaborations or ventures. Our commercial
partners have licensed our technology for use in turfgrass, canola, corn,
soybean, cotton, banana, alfalfa, rice and certain species of trees and bedding
plants, and we have obtained proof of concept for enhanced post harvest shelf
life, seed yield, biomass, and resistance to disease in several of these plant
species.
6
We have
ongoing field trials of certain trees and bananas with our respective
partners. The initial field trials conducted with ArborGen over a
five year period in certain species of trees have concluded and the trees have
been harvested for wood quality assessment. Preliminary data from our
joint field trials show significantly enhanced growth rates in some of the trees
relative to controls. Selected trees from the field trials were
harvested and their wood chemistry and density was assessed. There
were no differences in key economic characteristics of wood, such as lignin,
cellulose and specific gravity, between the trees with the enhanced growth
attributes and untreated control trees, which indicates that the faster growth
does not result in lower wood quality. Additional field trials for
enhanced growth rates and other traits are currently being performed with
ArborGen.
To date,
banana field trials have indicated that our technology extends the shelf life of
banana fruit by 100%. In addition to the post harvest shelf life
benefits, an additional field trial generated encouraging disease tolerance data
specific to Black Sigatoka (Black Leaf Streak Disease), for banana plants.
Additional field trials for banana plants are ongoing for the combined traits of
disease resistance and shelf life extension.
Commercialization
by our partners may require a combination of traits in a crop, such as both post
harvest shelf life and disease resistance, or other traits. Our
near-term research and development initiatives include modulating the expression
of DHS and Factor 5A genes in these plants and then propagation and phenotype
testing of such plants.
Our
ongoing research and development initiatives for agriculture include assisting
our license and joint collaboration partners to:
|
·
|
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.
|
Agricultural
Target Markets
In order
to address the complexities associated with marketing and distribution in the
worldwide market, we have adopted a multi-faceted commercialization strategy, in
which we have entered into and plan to enter into, as the opportunities present
themselves, additional licensing agreements or other strategic relationships
with a variety of companies or other entities on a crop-by-crop
basis. We anticipate revenues from these relationships in the form of
licensing fees, royalties, usage fees, or the sharing of gross
profits. In addition, we anticipate payments from certain of our
partners upon their achievement of certain research and development
benchmarks. This commercialization strategy allows us to generate
revenue at various stages of product development, while ensuring that our
technology is incorporated into a wide variety of crops. Our optimal
partners combine the technological expertise to incorporate our technology into
their product line along with the ability to successfully market the enhanced
final product, thereby eliminating the need for us to develop and maintain a
sales force.
7
Because
the agricultural market is dominated by privately held companies or subsidiaries
of foreign owned companies, market size and market share data for the crops
under our license and development agreements is not readily
available. Additionally, because we have entered into confidentiality
agreements with our license and development partners, we are unable to report
the specific financial terms of the agreements as well as any market size and
market share data that our partners may have disclosed to us regarding their
companies.
Agricultural
Development and License Agreements
Through
June 30, 2010, we have entered into eight (8) license agreements and one (1)
joint collaboration with established agricultural biotechnology companies and an
established ethanol company.
On August
6, 2007, we entered into a license agreement with Monsanto Company for the
development and commercialization of corn and soy. Under the terms of
the agreement, we received an upfront payment, are entitled to royalty payments
in the low single digits and potential milestone payments upon achievement of
certain development milestones. The agreement contains standard
termination provisions, and the term of the agreement runs until the expiration
of the patents licensed under the agreement (2019 in the United States and 2025
outside the United States).
On
December 21, 2006, we entered into a license agreement with Arborgen, LLC
regarding the growth and development of trees (other than edible fruit and nut
production). Under the terms of the agreement, we received three
fixed payments and are entitled to royalty payments in the mid single
digits. The agreement contains standard termination provisions, and
the term of the agreement runs until the expiration of the patents licensed
under the agreement (2019 in the United States and 2025 outside the United
States).
On March
8, 2004, we entered into a development and license agreement with The Scotts
Company for the development and commercialization of garden plants, potted
plants and turf grass (excluding forage grasses). Under the terms of
the agreement, we are entitled to certain benchmark payments upon various
anniversaries of the date of execution as well as upon achievement of certain
commercial milestones. We are also entitled to royalty payments in
the low to mid single digits. The agreement contains standard
termination provisions, and the term of the agreement runs until the expiration
of the patents licenses under the agreement (2019 in the United States and 2024
outside of the United States).
On July
17, 2007, we entered into a license agreement with Bayer CropScience AG for the
development and commercialization of rice. Under the terms of the
agreement, we are entitled to royalty payments of a dollar value per unit and
potential milestone payments upon the achievement of certain development
milestones. The agreement contains standard termination provisions,
and the term of the agreement runs until the expiration of the patents licensed
under the agreement (2019 in the United States and 2025 outside the United
States).
On August
30, 2007, we entered into a license agreement with Bayer CropScience AG for the
development and commercialization of cotton. Under the terms of the
agreement, we are entitled to royalty payments in the low to mid single digits
and potential milestone payments upon the achievement of certain development
milestones. The agreement contains standard termination provisions,
and the term of the agreement runs until the expiration of the patents licensed
under the agreement (2019 in the United States and 2025 outside the United
States).
8
On
November 8, 2006, we entered into a license agreement with Bayer CropScience
GmbH for the development and commercialization of Brassica. Under the
terms of the agreement, we are entitled to receive potential milestone payments
upon the achievement of certain development and commercialization milestones and
a share of Bayer’s income related to our license. The agreement
contains standard termination provisions, and the term of the agreement runs
until the expiration of the patents licensed under the agreement (2019 in the
United States and 2024 outside the United States).
On
October 14, 2004, we entered into a development and license agreement with Broin
and Associates, Inc. for the development and commercialization of
certain inputs in connection with the manufacturing process for
ethanol. Under the terms of the agreement, we are entitled to
payments based on the usage of our intellectual property at Broin’s
facilities. The agreement contains standard termination provisions,
and the term of the agreement runs until the expiration of the patents licensed
under the agreement (2019 in the United States and 2021 outside the United
States).
On
September 14, 2002, we entered into a development and license agreement
withCal/West Seeds for the development and commercialization of alfalfa,
medicago species. Under the terms of the agreement, we are entitled
to potential milestone payments upon the achievement of certain development and
commercialization milestones and a dollar amount of royalties based upon
production. The agreement contains standard termination provisions,
and the term of the agreement runs until the expiration of the patents licensed
under the agreement (2019 in the United States and 2021 outside the United
States).
On May 14, 1999, we entered into an agreement with Rahan Meristem,
an Israeli partnership that is engaged in the worldwide marketing of tissue
culture plants. The purpose of the agreement is to develop enhanced banana
plants which will result in banana fruit with improved consumer and
grower-driven traits. The program has been performed as a joint
collaboration whereby we pay for 50% of the research costs of the program and
upon successful commercialization of banana fruit, we will receive 50% of the
profits, as defined by the agreement.
Agricultural
Research Program
Our
agricultural research and development is performed by four (4) researchers, at
our direction, at the University of Waterloo, where the technology was
developed. Additional agricultural research and development is
performed by our license or joint collaboration partners.
The
discoverer of our technology, John E. Thompson, Ph.D., is the Associate Vice
President, Research and former Dean of Science at the University of Waterloo in
Ontario, Canada, and is our Executive Vice President and Chief Scientific
Officer. Dr. Thompson is also one of our directors and owns 1.8% of
the outstanding shares of our common stock, $0.01 par value, as of June 30,
2010.
On
September 1, 1998, we entered into, and have extended through November 30, 2010,
a research and development agreement with the University of Waterloo and Dr.
Thompson as the principal inventor. The Research and Development
Agreement provides that the University of Waterloo will perform research and
development under our direction, and we will pay for the cost of this work and
make certain payments to the University of Waterloo. In return for
payments made under the Research and Development Agreements, we have all rights
to the intellectual property derived from the research.
Agricultural
Competition
Our
competitors in both human health and agriculture that are presently attempting
to distribute their technology have generally utilized one of the following
distribution channels:
9
|
·
|
licensing
technology to major marketing and distribution
partners;
|
|
·
|
entering
into strategic alliances; or
|
|
·
|
developing
in-house production and marketing
capabilities.
|
In
addition, some competitors are established distribution companies, which
alleviates the need for strategic alliances, while others are attempting to
create their own distribution and marketing channels.
Our competitors in the field of
delaying plant senescence are companies that develop and produce transformed
plants with a variety of enhanced traits. Such companies include:
Mendel Biotechnology; Renessen LLC; Exelixis Plant Sciences, Inc.; and Syngenta
International AG; among others.
We do not currently have any
commercialized products, and therefore, it is difficult to assess our
competitive position in the market. However, we believe that if we or
our licensee’s are able to develop and commercialize a product or products using
our technology, we will have a competitive position in the markets in which we
or our licensee’s operate.
Agricultural Development
Program
Generally,
projects with our licensees and joint venture partner begin by transforming seed
or germplasm to incorporate our technology. Those seeds or germplasm
are then grown in our partners’ greenhouses. After successful
greenhouse trials, our partners will transfer the plants to the field for field
trials. After completion of successful field trials, our partners may
have to apply for and receive regulatory approval prior to initiation of any
commercialization activities.
Generally,
the approximate time to complete each sequential development step is as
follows:
Seed
Transformation
|
approximately
1 to 2 years
|
|
Greenhouse
|
approximately
1 to 2 years
|
|
Field
Trials
|
approximately
2 to 5 years
|
The
actual amount of time spent on each development phase depends on the crop, its
growth cycle and the success of the transformation achieving the desired
results. As such, the amount of time for each phase of development
could vary, or the time frames may change.
The
development of our technology with Poet is different than our other licenses in
that we are modifying certain production inputs for ethanol. That
process involves modifying the inputs, testing such inputs in Poet’s production
process and if successful, implementing such inputs in Poet’s production process
on a plant by plant basis.
10
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
|
||
The
Scotts Company
|
Greenhouse
|
|||
Ethanol
|
Poet
|
Modify
inputs
|
Commercialization
by our partners may require a combination of traits in a crop, such as both
shelf life and disease resistance, or other traits.
Based
upon our commercialization strategy, we anticipate that there may be a
significant period of time before plants enhanced using our technology reach
consumers. Thus, we have not begun to actively market our technology
directly to consumers, but rather, we have sought to establish ourselves within
the industry through presentations at industry conferences, our website and
direct communication with prospective licensees.
Consistent
with our commercialization strategy, we intend to attract other companies
interested in strategic partnerships or licensing our technology, which may
result in additional license fees, revenues from contract research, royalty fees
and other related revenues. Successful future operations will depend
on our ability to transform our research and development activities into a
commercially feasible technology.
Intellectual
Property
We have twenty-one (21) issued patents
from the United States Patent and Trademark Office, or PTO, and fifty-seven (57)
issued patents from foreign countries, fifty-three (53) of which are for the use
of our technology in agricultural applications and twenty-five (25) of which
relate to human health applications.
In
addition to our seventy-eight (78) patents, we have a wide variety of patent
applications, including divisional applications and continuations-in-part, in
process with the PTO and internationally. We intend to continue our
strategy of enhancing these new patent applications through the addition of data
as it is collected.
Our
agricultural patents are generally set to expire in 2019 in the United States
and 2025 outside the United States. Our core human health technology
patents are set to expire in 2021 in the United States and 2025 outside the
United States, and our patents related to multiple myeloma are set to expire,
both in and outside the United States in 2026. To the extent our
patents have different expiration dates abroad than in the United States, we are
currently developing a strategy to extend the United States expiration dates to
the foreign expiration dates.
11
Government Regulation
At
present, the U.S. federal government regulation of biotechnology is divided
among three agencies: (i) the U.S. Department of Agriculture regulates the
import, field-testing and interstate movement of specific types of genetic
engineering that may be used in the creation of transformed plants; (ii) the
Environmental Protection Agency regulates activity related to the invention of
plant pesticides and herbicides, which may include certain kinds of transformed
plants; and (iii) the FDA regulates foods derived from new plant
varieties. The FDA requires that transformed plants meet the same
standards for safety that are required for all other plants and foods in
general. Except in the case of additives that significantly alter a
food’s structure, the FDA does not require any additional standards or specific
approval for genetically engineered foods but expects transformed plant
developers to consult the FDA before introducing a new food into the market
place.
In
addition, our ongoing preclinical research with cell lines and lab animal models
of human disease is not currently subject to the FDA requirements that govern
clinical trials. However, use of our technology, if developed for
human health applications, will also be subject to FDA
regulation. Generally, the FDA must approve any drug or biologic
product before it can be marketed in the United States. In addition,
prior to being sold outside of the U.S., any products resulting from the
application of our human health technology must be approved by the regulatory
agencies of foreign governments. Prior to filing a new drug
application or biologics license application with the FDA, we would have to
perform extensive clinical trials, and prior to beginning any clinical trial, we
need to perform extensive preclinical testing which could take several years and
may require substantial expenditures.
We
believe that our current activities, which to date have been confined to
research and development efforts, do not require licensing or approval by any
government regulatory agency. However, we are planning on performing
clinical trials, which would be subject to FDA
approval. Additionally, federal, state and foreign regulations
relating to crop protection products and human health applications developed
through biotechnology are subject to public concerns and political
circumstances, and, as a result, regulations have changed and may change
substantially in the future. Accordingly, we may become subject to
governmental regulations or approvals or become subject to licensing
requirements in connection with our research and development efforts. We may
also be required to obtain such licensing or approval from the governmental
regulatory agencies described above, or from state agencies, prior to the
commercialization of our genetically transformed plants and human health
technology. In addition, our marketing partners who utilize our
technology or sell products grown with our technology may be subject to
government regulations. If unfavorable governmental regulations are
imposed on our technology or if we fail to obtain licenses or approvals in a
timely manner, we may not be able to continue our operations.
12
Employees
In
addition to the twelve (12) scientists performing funded research for us at Mayo
Clinic, our contract research organization (Cato Research) the University of
Waterloo, and other commercial research facilities, we have four (4) employees
and one (1) consultant, four (4) of whom are executive officers and who are
involved in our management. We do not anticipate hiring any
additional employees over the next twelve months.
The
officers are assisted by a Scientific Advisory Board that consists of prominent
experts in the fields of plant and human cell biology as follows:
|
·
|
Alan
Bennett, Ph.D., who serves as the Chairman of the Scientific Advisory
Board, is the Associate Vice Chancellor of the Office of Technology
Transfer at the University of California. His research
interests include the molecular biology of tomato fruit development and
ripening, the molecular basis of membrane transport, and cell wall
disassembly.
|
|
·
|
Charles
A. Dinarello, M.D., who serves as a member of the Scientific Advisory
Board, is a Professor of Medicine at the University of Colorado School of
Medicine, a member of the U.S. National Academy of Sciences and the author
of over 500 published research articles. In addition to his
active academic research career, Dr. Dinarello has held advisory positions
with two branches of the National Institutes of Health and positions on
the Board of Governors of both the Weizmann Institute and Ben Gurion
University.
|
|
·
|
James
E. Mier, who serves as a member of the Scientific Advisory Board, is an
Associate Professor of Medicine at Beth Israel Deaconess Medical Center, a
teaching hospital of Harvard Medical School. He is also a practicing
physician in the Division of Hematology-Oncology at Beth Israel. Dr.
Mier’s research is funded by the NIH and he is a member of numerous
professional societies.
|
Furthermore,
pursuant to the Research and Development Agreements, a substantial amount of our
research and development activities are conducted at the University of Waterloo
under the supervision of Dr. Thompson, our Executive Vice President and Chief
Scientific Officer. We utilize the University’s research staff including
graduate and post-graduate researchers.
We have
also undertaken preclinical apoptosis research at Mayo Clinic. This
research is performed pursuant to specific project proposals that have
agreed-upon research outlines, timelines and budgets. We may also
contract research to additional university laboratories or to other companies in
order to advance the development of our technology.
13
Safe
Harbor Statement
The
statements contained in this Annual Report on Form 10-K that are not historical
facts are forward-looking statements within the meaning of Section 21E of the
Securities Exchange Act of 1934, as amended, and the Private Securities
Litigation Reform Act of 1995. Such forward-looking statements may be identified
by, among other things, the use of forward-looking terminology such as
“believes,” “expects,” “may,” “will,” “should,” or “anticipates” or the negative
thereof or other variations thereon or comparable terminology, or by discussions
of strategy that involve risks and uncertainties. In particular, our
statements regarding the anticipated growth in the markets for our technologies,
the continued advancement of our research, the approval of our patent
applications, the possibility of governmental approval in order to sell or offer
for sale to the general public a genetically engineered plant or plant product,
the successful implementation of our commercialization strategy, including the
success of our agricultural partners and the successful implementation of the
Rahan Joint Collaboration, statements relating to our patent applications, the
anticipated long term growth of our business, the results of our preclinical
studies, if any, our ability to comply with the continued listing standards of
the NYSE Amex, and the timing of the projects and trends in future operating
performance are examples of such forward-looking statements. The
forward-looking statements include risks and uncertainties, including, but not
limited to, our limited operating history, our need for additional
capital to fund our operations until we are able to generate a profit, the
current economic environment, our dependence on a single principal technology,
our outsourcing of our research and development activities, our significant
future capital needs, our dependence on our patents and proprietary rights and
the enforcement of these rights, the potential for our competitors or third
parties to allege that we are infringing upon their intellectual property
rights, the potential that our security measures may not adequately protect our
unpatented technology, potential difficulty in managing our growth and expanding
our operations, our lack of marketing or sales history and dependence on
third-party marketing partners, our potential future dependence on joint
ventures and strategic alliances to develop and market our technology, the
intense competition in the human health and agricultural biotechnology
industries, the various government regulations that our business is subject to,
the potential that our preclinical studies and clinical trials of our human
health applications may be unsuccessful, any inability to license from third
parties their proprietary technologies or processes which we use in connection
with the development of our technology, the length, expense and uncertainty
associated with clinical trials for our human health technology, the
potential that, even if we receive regulatory approval, consumers may not accept
products containing our technology, our dependence on key personnel, the
potential that certain provisions of our charter, by-laws and Delaware law could
make a takeover difficult, increasing political and social turmoil, the
potential that our management and other affiliates, due to their significant
control of our common stock have the ability to significantly influence our
actions, the potential that a significant portion of our total outstanding
shares of common stock may be sold in the market in the near future, the limited
trading market of our common stock, the potential that our common stock may be
delisted from the NYSE Amex Exchange, fluctuations in the market price of our
common stock, our dividend policy and potential for our stockholders to be
diluted.
14
ITEM
1A: Factors That May Affect Our Business, Future
Operating Results and Financial Condition
The more
prominent risks and uncertainties inherent in our business are described below.
However, additional risks and uncertainties may also impair our business
operations. If any of the following risks actually occur, our
business, financial condition or results of operations may suffer.
Risks Related to Our
Business
We have a limited operating history
and have incurred substantial losses and expect to incur future
losses.
We are a
development stage biotechnology company with a limited operating history and
limited assets and capital. We have incurred losses each year since inception
and had an accumulated deficit of $50,841,159 at June 30, 2010. We have
generated minimal revenues by licensing our technology for certain crops to
companies willing to share in our development costs. In addition, our technology
may not be ready for commercialization for several years. We expect to continue
to incur losses for the next several years because we anticipate that our
expenditures on research and development and administrative activities will
significantly exceed our revenues during that period. We cannot predict when, if
ever, we will become profitable.
We
may need additional capital to fund our operations until we are able to generate
a profit.
Our
operations to date have required significant cash expenditures. Our
future capital requirements will depend on the results of our research and
development activities, preclinical and clinical studies, and competitive and
technological advances.
We will
need to obtain more funding in the future through collaborations or other
arrangements with research institutions and corporate partners, or public and
private offerings of our securities, including debt or equity
financing. We may not be able to obtain adequate funds for our
operations from these sources when needed or on acceptable terms. Future
collaborations or similar arrangements may require us to license valuable
intellectual property to, or to share substantial economic benefits with, our
collaborators. If we raise additional capital by issuing additional
equity or securities convertible into equity, our stockholders may experience
dilution and our share price may decline. Any debt financing may
result in restrictions on our spending.
If we are
unable to raise additional funds, we will need to do one or more of the
following:
|
·
|
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.
|
15
We
believe that at the projected rate of spending we should have sufficient cash to
maintain our present operations for at least the next twelve (12)
months.
We
may be adversely affected by the current economic environment.
Our
ability to obtain financing, invest in and grow our business, and meet our
financial obligations depends on our operating and financial performance, which
in turn is subject to numerous factors. In addition to factors
specific to our business, prevailing economic conditions and financial, business
and other factors beyond our control can also affect our business and ability to
raise capital. We cannot anticipate all of the ways in which the
current economic climate and financial market conditions could adversely impact
our business.
We depend on a single principal
technology and, if our technology is not commercially successful, we will have
no alternative source of revenue.
Our
primary business is the development and licensing of technology to identify,
isolate, characterize and promote or silence genes which control the death of
cells in humans and plants. Our future revenue and profitability critically
depend upon our ability, or our licensees’ ability, to successfully develop
apoptosis and senescence gene technology and later license or market such
technology. We have conducted experiments on certain crops with
favorable results and have conducted certain preliminary cell-line and animal
experiments, which have provided us with data upon which we have designed
additional research programs. However, we cannot give any assurance that our
technology will be commercially successful or economically viable for any crops
or human health applications.
In
addition, no assurance can be given that adverse consequences might not result
from the use of our technology such as the development of negative effects on
humans or plants or reduced benefits in terms of crop yield or
protection. Our failure to obtain market acceptance of our technology
or of our current or potential licensees to successfully commercialize such
technology would have a material adverse effect on our business.
We
outsource all of our research and development activities and, if we are
unsuccessful in maintaining our alliances with these third parties, our research
and development efforts may be delayed or curtailed.
We rely
on third parties to perform all of our research and development
activities. Our research and development efforts take place at the
University of Waterloo in Ontario, Canada, where our technology was discovered,
at the Mayo Clinic, at other commercial research facilities and with our
commercial partners. At this time, we do not have the internal
capabilities to perform our own research and development activities.
Accordingly, the failure of third-party research partners to perform under
agreements entered into with us, or our failure to renew important research
agreements with these third parties, may delay or curtail our research and
development efforts.
16
We
have significant future capital needs and may be unable to raise capital when
needed, which could force us to delay or reduce our research and development
efforts.
As of
June 30, 2010, we had cash of $8,026,296 and working capital of
$6,001,970. Using our available reserves as of June 30, 2010, we
believe that we can operate according to our current business plan for at least
the next twelve (12) months. To date, we have generated minimal
revenues and anticipate that our operating costs will exceed any revenues
generated over the next several years. Therefore, we will be required
to raise additional capital in the future in order to operate in accordance with
our current business plan, and this funding may not be available on favorable
terms, if at all. If we are unable to raise additional funds, we will
need to do one or more of the following:
|
·
|
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.
|
In
addition, in connection with any funding, if we need to issue more equity
securities than our certificate of incorporation currently authorizes, or more
than 20% of the shares of our common stock outstanding, we may need stockholder
approval. If stockholder approval is not obtained or if adequate
funds are not available, we may be required to curtail operations significantly
or to obtain funds through arrangements with collaborative partners or others
that may require us to relinquish rights to certain of our technologies, product
candidates, products or potential markets. Investors may experience
dilution in their investment from future offerings of our common
stock. For example, if we raise additional capital by issuing equity
securities, such an issuance would reduce the percentage ownership of existing
stockholders. In addition, assuming the exercise of all options and
warrants outstanding and the conversion of the preferred stock into common
stock, as of June 30, 2010, we had 64,783,361 shares of common stock authorized
but unissued and unreserved, which may be issued from time to time by our board
of directors without stockholder approval. Furthermore, we may need
to issue securities that have rights, preferences and privileges senior to our
common stock. Failure to obtain financing on acceptable terms would
have a material adverse effect on our liquidity.
Since our
inception, we have financed all of our operations through private equity and
debt financings. Our future capital requirements depend on numerous factors,
including:
|
·
|
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.
|
17
Our
business depends upon our patents and proprietary rights and the enforcement of
these rights. Our failure to obtain and maintain patent protection
may increase competition and reduce demand for our technology.
As a
result of the substantial length of time and expense associated with developing
products and bringing them to the marketplace in the biotechnology and
agricultural industries, obtaining and maintaining patent and trade secret
protection for technologies, products and processes is of vital
importance. Our success will depend in part on several factors,
including, without limitation:
|
·
|
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.
|
As of
June 30, 2010, we have been issued twenty one (21) patents by the PTO and
fifty-seven (57) patents from foreign countries. We have also filed
numerous patent applications for our technology in the United States and in
several foreign countries, which technology is vital to our primary business, as
well as several continuations in part on these patent
applications. Our success depends in part upon the grant of patents
from our pending patent applications.
Although
we believe that our technology is unique and that it will not violate or
infringe upon the proprietary rights of any third party, we cannot assure you
that these claims will not be made or if made, could be successfully defended
against. If we do not obtain and maintain patent protection, we may
face increased competition in the United States and internationally, which would
have a material adverse effect on our business.
Since
patent applications in the United States are maintained in secrecy until patents
are issued, and since publication of discoveries in the scientific and patent
literature tend to lag behind actual discoveries by several months, we cannot be
certain that we were the first creator of the inventions covered by our pending
patent applications or that we were the first to file patent applications for
these inventions.
In
addition, among other things, we cannot assure you that:
|
·
|
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.
|
18
Our
competitors may allege that we are infringing upon their intellectual property
rights, forcing us to incur substantial costs and expenses in resulting
litigation, the outcome of which would be uncertain.
Patent
law is still evolving relative to the scope and enforceability of claims in the
fields in which we operate. We are like most biotechnology companies
in that our patent protection is highly uncertain and involves complex legal and
technical questions for which legal principles are not yet firmly
established. In addition, if issued, our patents may not contain
claims sufficiently broad to protect us against third parties with similar
technologies or products, or provide us with any competitive
advantage.
The PTO
and the courts have not established a consistent policy regarding the breadth of
claims allowed in biotechnology patents. The allowance of broader
claims may increase the incidence and cost of patent interference proceedings
and the risk of infringement litigation. On the other hand, the
allowance of narrower claims may limit the scope and value of our proprietary
rights.
The laws
of some foreign countries do not protect proprietary rights to the same extent
as the laws of the United States, and many companies have encountered
significant problems and costs in protecting their proprietary rights in these
foreign countries.
We could
become involved in infringement actions to enforce and/or protect our
patents. Regardless of the outcome, patent litigation is expensive
and time consuming and would distract our management from other
activities. Some of our competitors may be able to sustain the costs
of complex patent litigation more effectively than we could because they have
substantially greater resources. Uncertainties resulting from the
initiation and continuation of any patent litigation could limit our ability to
continue our operations.
If
our technology infringes the intellectual property of our competitors or other
third parties, we may be required to pay license fees or damages.
If any
relevant claims of third-party patents that are adverse to us are upheld as
valid and enforceable, we could be prevented from commercializing our technology
or could be required to obtain licenses from the owners of such
patents. We cannot assure you that such licenses would be available
or, if available, would be on acceptable terms. Some licenses may be
non-exclusive and, therefore, our competitors may have access to the same
technology licensed to us. In addition, if any parties successfully
claim that the creation or use of our technology infringes upon their
intellectual property rights, we may be forced to pay damages, including treble
damages.
Our
security measures may not adequately protect our unpatented technology and, if
we are unable to protect the confidentiality of our proprietary information and
know-how, the value of our technology may be adversely affected.
Our
success depends upon know-how, unpatentable trade secrets, and the skills,
knowledge and experience of our scientific and technical
personnel. As a result, all employees agreed to a confidentiality
provision in their employment agreement that prohibited the disclosure of
confidential information to anyone outside of our company, during the term of
employment and for 5 years thereafter. We also require all employees
to disclose and assign to us the rights to their ideas, developments,
discoveries and inventions. We also attempt to enter into similar
agreements with our consultants, advisors and research
collaborators. We cannot assure you that adequate protection for our
trade secrets, know-how or other proprietary information against unauthorized
use or disclosure will be available.
19
We
occasionally provide information to research collaborators in academic
institutions and request that the collaborators conduct certain
tests. We cannot assure you that the academic institutions will not
assert intellectual property rights in the results of the tests conducted by the
research collaborators, or that the academic institutions will grant licenses
under such intellectual property rights to us on acceptable terms, if at
all. If the assertion of intellectual property rights by an academic
institution is substantiated, and the academic institution does not grant
intellectual property rights to us, these events could limit our ability to
commercialize our technology.
As
we evolve from a company primarily involved in the research and development of
our technology into one that is also involved in the commercialization of our
technology, we may have difficulty managing our growth and expanding our
operations.
As our
business grows, we may need to add employees and enhance our management, systems
and procedures. We may need to successfully integrate our internal
operations with the operations of our marketing partners, manufacturers,
distributors and suppliers to produce and market commercially viable
products. We may also need to manage additional relationships with
various collaborative partners, suppliers and other
organizations. Although we do not presently conduct research and
development activities in-house, we may undertake those activities in the
future. Expanding our business may place a significant burden on our
management and operations. We may not be able to implement
improvements to our management information and control systems in an efficient
and timely manner and we may discover deficiencies in our existing systems and
controls. Our failure to effectively respond to such changes may make
it difficult for us to manage our growth and expand our operations.
We
have no marketing or sales history and depend on third-party marketing
partners. Any failure of these parties to perform would delay or
limit our commercialization efforts.
We have
no history of marketing, distributing or selling biotechnology products and we
are relying on our ability to successfully establish marketing partners or other
arrangements with third parties to market, distribute and sell a commercially
viable product both here and abroad. Our business plan envisions
creating strategic alliances to access needed commercialization and marketing
expertise. We may not be able to attract qualified sub-licensees,
distributors or marketing partners, and even if qualified, these marketing
partners may not be able to successfully market agricultural products or human
health applications developed with our technology. If our current or
potential future marketing partners fail to provide adequate levels of sales,
our commercialization efforts will be delayed or limited and we may not be able
to generate revenue.
20
We
will depend on joint ventures and strategic alliances to develop and market our
technology and, if these arrangements are not successful, our technology may not
be developed and the expenses to commercialize our technology will
increase.
In its
current state of development, our technology is not ready to be marketed to
consumers. We intend to follow a multi-faceted commercialization
strategy that involves the licensing of our technology to business partners for
the purpose of further technological development, marketing and
distribution. We have and are seeking business partners who will
share the burden of our development costs while our technology is still being
developed, and who will pay us royalties when they market and distribute
products incorporating our technology upon commercialization. The
establishment of joint ventures and strategic alliances may create future
competitors, especially in certain regions abroad where we do not pursue patent
protection. If we fail to establish beneficial business partners and
strategic alliances, our growth will suffer and the continued development of our
technology may be harmed.
Competition
in the human health and agricultural biotechnology industries is intense and
technology is changing rapidly. If our competitors market their
technology faster than we do, we may not be able to generate revenues from the
commercialization of our technology.
Many
human health and agricultural biotechnology companies are engaged in research
and development activities relating to apoptosis and senescence. The
market for plant protection and yield enhancement products is intensely
competitive, rapidly changing and undergoing consolidation. We may be
unable to compete successfully against our current and future competitors, which
may result in price reductions, reduced margins and the inability to achieve
market acceptance for products containing our technology. Our
competitors in the field of plant senescence gene technology are companies that
develop and produce transgenic plants and include major international
agricultural companies, specialized biotechnology companies, research and
academic institutions and, potentially, our joint venture and strategic alliance
partners. These companies include: Mendel Biotechnology, Inc.,
Renessen LLC, Exelixis Plant Sciences, Inc., and Syngenta International AG,
among others. Some of our competitors that are involved in apoptosis
research include: Amgen Inc.; Centocor, Inc.; Genzyme Corporation;
OSI Pharmaceuticals, Inc.; Novartis AG; Introgen Therapeutics, Inc.; Genta,
Inc.; and Vertex Pharmaceuticals, Inc. Many of these competitors have
substantially greater financial, marketing, sales, distribution and technical
resources than us and have more experience in research and development, clinical
trials, regulatory matters, manufacturing and marketing. We
anticipate increased competition in the future as new companies enter the market
and new technologies become available. Our technology may be rendered
obsolete or uneconomical by technological advances or entirely different
approaches developed by one or more of our competitors, which will prevent or
limit our ability to generate revenues from the commercialization of our
technology.
21
Our
business is subject to various government regulations and, if we or our
licensees are unable to obtain regulatory approval, we may not be able to
continue our operations.
At
present, the U.S. federal government regulation of biotechnology is divided
among three agencies:
|
·
|
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.
|
The FDA
requires that transgenic plants meet the same standards for safety that are
required for all other plants and foods in general. Except in the
case of additives that significantly alter a food’s structure, the FDA does not
require any additional standards or specific approval for genetically engineered
foods, but expects transgenic plant developers to consult the FDA before
introducing a new food into the marketplace.
Use of
our technology, if developed for human health applications, will also be subject
to FDA regulation. The FDA must approve any drug or biologic product
before it can be marketed in the United States. In addition, prior to
being sold outside of the U.S., any products resulting from the application of
our human health technology must be approved by the regulatory agencies of
foreign governments. Prior to filing a new drug application or
biologics license application with the FDA, we would have to perform extensive
clinical trials, and prior to beginning any clinical trial, we would need to
perform extensive preclinical testing which could take several years and may
require substantial expenditures.
We
believe that our current activities, which to date have been confined to
research and development efforts, do not require licensing or approval by any
governmental regulatory agency. However, we are planning on performing clinical
trials, which would be subject to FDA approval. Additionally,
federal, state and foreign regulations relating to crop protection products and
human health applications developed through biotechnology are subject to public
concerns and political circumstances, and, as a result, regulations have changed
and may change substantially in the future. Accordingly, we may
become subject to governmental regulations or approvals or become subject to
licensing requirements in connection with our research and development efforts.
We may also be required to obtain such licensing or approval from the
governmental regulatory agencies described above, or from state agencies, prior
to the commercialization of our genetically transformed plants and human health
technology. In addition, our marketing partners who utilize our
technology or sell products grown with our technology may be subject to
government regulations. If unfavorable governmental regulations are
imposed on our technology or if we fail to obtain licenses or approvals in a
timely manner, we may not be able to continue our operations.
22
Preclinical
studies of our human health applications may be unsuccessful, which could delay
or prevent regulatory approval.
Preclinical
studies may reveal that our human health technology is ineffective or harmful,
and/or may be unsuccessful in demonstrating efficacy and safety of our human
health technology, which would significantly limit the possibility of obtaining
regulatory approval for any drug or biologic product manufactured with our
technology. The FDA requires submission of extensive preclinical,
clinical and manufacturing data to assess the efficacy and safety of potential
products. We are currently in the process of conducting preclinical toxicology
studies for our multiple myeloma product candidate. Any delay in this
toxicology study, or any potential negative findings in this toxicology study,
will delay our ability to file an IND for our multiple myeloma product
candidate. Furthermore, the success of preliminary studies does not
ensure commercial success, and later-stage clinical trials may fail to confirm
the results of the preliminary studies.
Our success will
depend on the success of our clinical trials that have not yet
begun.
It may take several years to complete
the clinical trials of a product, and failure of one or more of our clinical
trials can occur at any stage of testing. We believe that the
development of our product candidate involves significant risks at each stage of
testing. If clinical trial difficulties and failures arise, our
product candidate may never be approved for sale or become commercially
viable.
There are a number of difficulties and
risks associated with clinical trials. These difficulties and risks
may result in the failure to receive regulatory approval to sell our product
candidate or the inability to commercialize our product
candidate. The possibility exists that:
|
·
|
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.
|
23
Clinical
trials for our human health technology will be lengthy and expensive and their
outcome is uncertain.
Before
obtaining regulatory approval for the commercial sales of any product containing
our technology, we must demonstrate through clinical testing that our technology
and any product containing our technology is safe and effective for use in
humans. Conducting clinical trials is a time-consuming, expensive and
uncertain process and typically requires years to complete. In our
industry, the results from preclinical studies and early clinical trials often
are not predictive of results obtained in later-stage clinical
trials. Some products and technologies that have shown promising
results in preclinical studies or early clinical trials subsequently fail to
establish sufficient safety and efficacy data necessary to obtain regulatory
approval. At any time during clinical trials we or the FDA might
delay or halt any clinical trial for various reasons, including:
|
·
|
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.
|
Any
failure or substantial delay in successfully completing clinical trials and
obtaining regulatory approval for our product candidates could severely harm our
business.
If
our clinical trials for our product candidates are delayed, we would be unable
to commercialize our product candidates on a timely basis, which would
materially harm our business.
Planned clinical trials may not begin
on time or may need to be restructured after they have
begun. Clinical trials can be delayed for a variety of reasons,
including delays related to:
|
·
|
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 availablility 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.
|
24
We
believe that our product candidate has significant milestones to reach,
including the successful completion of clinical trials, before
commercialization. If we have significant delays in or termination of
clinical trials, our financial results and the commercial prospects for our
product candidates or any other products that we may develop will be adversely
impacted. In addition, our product development costs would increase
and our ability to generate revenue could be impaired.
Any
inability to license from third parties their proprietary technologies or
processes which we use in connection with the development of our technology may
impair our business.
Other
companies, universities and research institutions have or may obtain patents
that could limit our ability to use our technology in a product candidate or
impair our competitive position. As a result, we would have to obtain
licenses from other parties before we could continue using our technology in a
product candidate. Any necessary licenses may not be available on
commercially acceptable terms, if at all. If we do not obtain
required licenses, we may not be able to develop our technology into a product
candidate or we may encounter significant delays in development while we
redesign methods that are found to infringe on the patents held by
others.
Even
if we receive regulatory approval, consumers may not accept products containing
our technology, which will prevent us from being profitable since we have no
other source of revenue.
We cannot
guarantee that consumers will accept products containing our
technology. Recently, there has been consumer concern and consumer
advocate activism with respect to genetically-engineered agricultural consumer
products. The adverse consequences from heightened consumer concern
in this regard could affect the markets for agricultural products developed with
our technology and could also result in increased government regulation in
response to that concern. If the public or potential customers perceive our
technology to be genetic modification or genetic engineering, agricultural
products grown with our technology may not gain market acceptance.
25
We
depend on our key personnel and, if we are not able to attract and retain
qualified scientific and business personnel, we may not be able to grow our
business or develop and commercialize our technology.
We are
highly dependent on our scientific advisors, consultants and third-party
research partners. Our success will also depend in part on the
continued service of our key employees and our ability to identify, hire and
retain additional qualified personnel in an intensely competitive
market. Although we have a research agreement with Dr. John Thompson,
this agreement may be terminated upon short or no
notice. Additionally, we do not have employment agreements with our
key employees. We do not maintain key person life insurance on any
member of management. The failure to attract and retain key personnel
could limit our growth and hinder our research and development
efforts.
Certain
provisions of our charter, by-laws and Delaware law could make a takeover
difficult.
Certain
provisions of our certificate of incorporation and by-laws could make it more
difficult for a third party to acquire control of us, even if the change in
control would be beneficial to stockholders. Our certificate of
incorporation authorizes our board of directors to issue, without stockholder
approval, except as may be required by the rules of the NYSE Amex Exchange,
5,000,000 shares of preferred stock with voting, conversion and other rights and
preferences that could adversely affect the voting power or other rights of the
holders of our common stock. Similarly, our by-laws do not restrict
our board of directors from issuing preferred stock without stockholder
approval.
In
addition, we are subject to the Business Combination Act of the Delaware General
Corporation Law which, subject to certain exceptions, restricts certain
transactions and business combinations between a corporation and a stockholder
owning 15% or more of the corporation’s outstanding voting stock for a period of
three years from the date such stockholder becomes a 15% owner. These
provisions may have the effect of delaying or preventing a change of control of
us without action by our stockholders and, therefore, could adversely affect the
value of our common stock.
Furthermore,
in the event of our merger or consolidation with or into another corporation, or
the sale of all or substantially all of our assets in which the successor
corporation does not assume our outstanding equity awards or issue equivalent
equity awards, our current equity plans require the accelerated vesting of such
outstanding equity awards.
26
Risks Related to Our Common
Stock
We
currently do not meet the NYSE Amex Exchange continued listing
standards. If our common stock is delisted from the NYSE Amex
Exchange, we may not be able to list on any other stock exchange, and our common
stock may be subject to the “penny stock” regulations which may affect the
ability of our stockholders to sell their shares.
The NYSE
Amex Exchange requires us to meet minimum financial requirements in order to
maintain our listing. Although we currently meet the $6,000,000
minimum net worth continued listing requirement of the NYSE Amex Exchange, we
have not met the $6,000,000 minimum net worth continued listing requirement of
the NYSE Amex Exchange for two consecutive quarters and have received a
notice of noncompliance from the NYSE Amex Exchange. We submitted a
plan of compliance to the NYSE Amex Exchange discussing how we intend to regain
compliance with the continued listing requirements. The NYSE Amex
Exchange has accepted our plan of compliance and granted us an extension until
April 29, 2011 to regain compliance with the NYSE's continued listing
standards. During the extension period, we remain subject to periodic
review by NYSE Staff. Failure to make progress consistent with the plan or to
regain compliance with the continued listing standards by the end of the
extension period could result in our company being delisted from the
NYSE. If we are delisted from the NYSE Amex Exchange, our common
stock likely will become a “penny stock.” In general, regulations of
the SEC define a “penny stock” to be an equity security that is not listed on a
national securities exchange or the NASDAQ Stock Market and that has a market
price of less than $5.00 per share or with an exercise price of less than $5.00
per share, subject to certain exceptions. If our common stock becomes
a penny stock, additional sales practice requirements would be imposed on
broker-dealers that sell such securities to persons other than certain qualified
investors. For transactions involving a penny stock, unless exempt, a
broker-dealer must make a special suitability determination for the purchaser
and receive the purchaser’s written consent to the transaction prior to the
sale. In addition, the rules on penny stocks require delivery, prior
to and after any penny stock transaction, of disclosures required by the
SEC.
If our
stock is not accepted for listing on the NYSE Amex Exchange, we will make every
possible effort to have it listed on the Over the Counter Bulletin Board, or the
OTC Bulletin Board. If our common stock were to be traded on the OTC
Bulletin Board, the Securities Exchange Act of 1934, as amended, and related
Securities and Exchange Commission (SEC) rules would impose additional sales
practice requirements on broker-dealers that sell our
securities. These rules may adversely affect the ability of
stockholders to sell our common stock and otherwise negatively affect the
liquidity, trading market and price of our common stock.
We
believe that the listing of our common stock on a recognized national trading
market, such as the NYSE Amex Exchange, is an important part of our business and
strategy. Such a listing helps our stockholders by providing a
readily available trading market with current quotations. Without
that, stockholders may have a difficult time getting a quote for the sale or
purchase of our stock, the sale or purchase of our stock would likely be made
more difficult and the trading volume and liquidity of our stock would likely
decline. The absence of such a listing may adversely affect the
acceptance of our common stock as currency or the value accorded it by other
parties. In that regard, the absence of a listing on a recognized
national trading market will also affect our ability to benefit from the use of
our operations and expansion plans, including for use in licensing agreements,
joint ventures, the development of strategic relationships and acquisitions,
which are critical to our business and strategy and none of which is currently
the subject of any agreement, arrangement or understanding, with respect to any
future financing or strategic relationship we may undertake. A
delisting from the NYSE Amex Exchange could result in negative publicity and
could negatively impact our ability to raise capital in the future.
27
Our
management and other affiliates have significant control of our common stock and
could significantly influence our actions in a manner that conflicts with our
interests and the interests of other stockholders.
As of
June 30, 2010, our executive officers, directors and affiliated entities
together beneficially own approximately 53.3% of the outstanding shares of our
common stock, assuming the exercise of options and warrants which are currently
exercisable or will become exercisable within 60 days of June 30, 2010, held by
these stockholders. As a result, these stockholders, acting together, will
be able to exercise significant influence over matters requiring approval by our
stockholders, including the election of directors, and may not always act in the
best interests of other stockholders. Such a concentration of
ownership may have the effect of delaying or preventing a change in control of
us, including transactions in which our stockholders might otherwise receive a
premium for their shares over then current market prices.
A
significant portion of our total outstanding shares of common stock may be sold
in the market in the near future, which could cause the market price of our
common stock to drop significantly.
As of
June 30, 2010, we had 50,092,204 shares of our common stock issued and
outstanding and 9,235 shares of convertible preferred stock outstanding which
can convert into 28,859,375 shares of common stock. Approximately
34,164,431 shares of such shares are registered pursuant to registration
statements on Form S-3 and 44,787,148 of which are either eligible to be sold
under SEC Rule 144 or are in the public float. In addition, we have
registered 35,890,007 shares of our common stock underlying warrants previously
issued on Form S-3 registration statements and we registered 11,137,200 shares
of our common stock underlying options granted or to be granted under our stock
option plan. Consequently, sales of substantial amounts of our common
stock in the public market, or the perception that such sales could occur, may
have a material adverse effect on our stock price.
Our
common stock has a limited trading market, which could limit your ability to
resell your shares of common stock at or above your purchase price.
Our
common stock is quoted on the NYSE Amex Exchange and currently has a limited
trading market. The NYSE Amex Exchange requires us to meet minimum
financial requirements in order to maintain our listing. Currently,
we do not meet the continued listing requirements of the NYSE Amex
Exchange. As we do not meet the continued listing standards, we could
be delisted. We cannot assure you that an active trading market will
develop or, if developed, will be maintained. As a result, our
stockholders may find it difficult to dispose of shares of our common stock and,
as a result, may suffer a loss of all or a substantial portion of their
investment.
28
The
market price of our common stock may fluctuate and may drop below the price you
paid.
We cannot
assure you that you will be able to resell the shares of our common stock at or
above your purchase price. The market price of our common stock may
fluctuate significantly in response to a number of factors, some of which are
beyond our control. These factors include:
|
·
|
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.
|
For
example, during the year ended June 30, 2010, our common stock traded between
$0.25 per share and $0.83 per share.
Because
we do not intend to pay, and have not paid, any cash dividends on our shares of
common stock, our stockholders will not be able to receive a return on their
shares unless the value of our common stock appreciates and they sell their
shares.
We have
never paid or declared any cash dividends on our common stock, and we intend to
retain any future earnings to finance the development and expansion of our
business. We do not anticipate paying any cash dividends on our
common stock in the foreseeable future. Therefore, our stockholders
will not be able to receive a return on their investment unless the value of our
common stock appreciates and they sell their shares.
Our
stockholders may experience substantial dilution as a result of the conversion
of convertible preferred stock, the exercise of options and warrants to purchase
our common stock, or due to anti-dilution provisions relating to any on the
foregoing.
As of
June 30, 2010, we have outstanding 9,235 shares of convertible preferred stock
which may convert into 28,859,375 shares of our common stock and warrants to
purchase 55,171,226 shares of our common stock. In addition, as of June
30, 2010, we have reserved 15,204,884 shares of our common stock for issuance
upon the exercise of options granted or available to be granted pursuant to our
stock option plan, all of which may be granted in the future. The
conversion of the convertible preferred stock and the exercise of these options
and warrants will result in dilution to our existing stockholders and could have
a material adverse effect on our stock price. The conversion price of the
convertible preferred stock and certain warrants are also subject to certain
anti-dilution adjustments.
29
Item
1B. Unresolved Staff
Comments.
None.
Item
2. Properties.
We lease
office space in New Brunswick, New Jersey for a current monthly rental fee of
$6,612, subject to certain escalations for our proportionate share of increases,
over the base year of 2001, in the building's operating costs. The
monthly rental fee will continue to increase by one percent each year through
the expiration date of the lease. The lease expires in May
2011. The space is in good condition, and we believe it will
adequately serve as our headquarters over the term of the lease. We
also believe that this office space is adequately insured by the
lessor.
Item
3. Legal
Proceedings.
We are
not currently a party to any legal proceedings; however, we may become involved
in various claims and legal actions arising in the ordinary course of
business.
Item
4. Removed and
Reserved.
30
PART
II
Item
5.
|
Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities.
|
Our
common stock trades on the NYSE Amex Exchange under the symbol SNT.
The
following table sets forth the range of the high and low sales price for our
common stock for each of the quarters since the quarter ended September 30,
2008, as reported on the NYSE Amex Exchange.
Quarter
Ended
|
Common
Stock
|
|||||||
High
|
Low
|
|||||||
September
30, 2008
|
$ | 1.81 | $ | 0.88 | ||||
December
31, 2008
|
$ | 1.25 | $ | 0.50 | ||||
March
31, 2009
|
$ | 0.87 | $ | 0.33 | ||||
June
30, 2009
|
$ | 0.97 | $ | 0.43 | ||||
September
30, 2009
|
$ | 0.83 | $ | 0.43 | ||||
December
31, 2009
|
$ | 0.49 | $ | 0.30 | ||||
March
31, 2010
|
$ | 0.51 | $ | 0.25 | ||||
June
30, 2010
|
$ | 0.75 | $ | 0.30 |
As of
September 26, 2010, the approximate number of holders of record of our common
stock was 277. This number does
not include “street name” or beneficial holders, whose shares are held of record
by banks, brokers and other financial institutions.
We have
neither paid nor declared dividends on our common stock since our inception, and
we do not plan to pay dividends on our common stock in the foreseeable future.
We expect that any earnings, which we may realize, will be retained to finance
the growth of our company.
31
The
following table provides information about the securities authorized for
issuance under our equity compensation plans as of June 30, 2010.
EQUITY
COMPENSATION PLAN INFORMATION
Number
of securities
to
be issued upon
exercise
of outstanding
options,
warrants
and rights and restricted
stock
units
|
Weighted-average
exercise
price of
outstanding
options,
warrants and rights and
restricted
stock units
|
Number of securities
remaining
available
for future
issuance
under
equity
compensation plans
|
||||||||||
Equity
compensation plans approved by security holders
|
7,319,172 |
(1)
|
$ | 1.13 | 7,935,712 |
(2)
|
||||||
Equity
compensation plans not approved by security holders
|
— | — | — | |||||||||
Total
|
7,319,172 |
(1)
|
$ | 1.13 | 7,935,712 |
(2)
|
(1) Issued
pursuant to our 1998 Stock Plan and 2008 Stock Plan.
(2) Available
for future issuance pursuant to our 2008 Stock Plan.
RECENT
SALES OF UNREGISTERED SECURITIES; USE OF PROCEEDS FROM REGISTERED
SECURITIES
None,
except as previously disclosed on our Quarterly reports on Forms 10-Q and
Current Reports on Forms 8-K.
32
PERFORMANCE GRAPH
The
following graph compares the cumulative total stockholder return on our common
stock with the cumulative total return on the NYSE Amex Market Value (U.S.)
Index and the RDG Microcap Biotechnology Index for the period beginning
July 1, 2005 and ending on the last day of our last completed fiscal year.
The stock performance shown on the graph below is not indicative of future price
performance.
7/1/05
|
6/30/06
|
6/30/07
|
6/30/08
|
6/30/09
|
6/30/10
|
|||||||||||||||||||
Senesco Technologies,
Inc.
|
$ | 100.00 | $ | 106.15 | $ | 64.25 | $ | 103.35 | $ | 46.37 | $ | 17.60 | ||||||||||||
NYSE Amex Composite
Index
|
$ | 100.00 | $ | 124.41 | $ | 155.25 | $ | 152.02 | $ | 112.25 | $ | 133.12 | ||||||||||||
RDG Microcap Biotechnology
Index
|
$ | 100.00 | $ | 85.27 | $ | 69.67 | $ | 36.79 | $ | 30.04 | $ | 23.56 |
33
Item 6.Selected Financial
Data.
The following Selected Financial Data
should be read in conjunction with “Item 7. Management’s Discussion and Analysis
of Financial Condition and Results of Operations” and “Item 8. Financial
Statements and Supplementary Data” included elsewhere in this Annual Report on
Form 10-K.
SELECTED FINANCIAL
DATA
Year Ended June
30,
|
||||||||||||||||||||
2010
|
2009
|
2008
|
2007
|
2006
|
||||||||||||||||
(In thousands, except per share
data)
|
||||||||||||||||||||
Statement of Operations
Data:
|
||||||||||||||||||||
Revenue
|
$ | 140 | $ | 275 | $ | 457 | $ | 300 | $ | 67 | ||||||||||
Operating
expenses:
|
||||||||||||||||||||
General and
administrative
|
2,349 | 2,206 | 2,291 | 2,413 | 1,920 | |||||||||||||||
Research and
development
|
2,637 | 2,354 | 1,765 | 1,208 | 1,566 | |||||||||||||||
Total operating
expenses
|
4,986 | 4,560 | 4,056 | 3,621 | 3,486 | |||||||||||||||
Loss from
operations
|
(4,846 | ) | (4,285 | ) | (3,599 | ) | (3,321 | ) | (3,419 | ) | ||||||||||
Fair value – warrant
liability
|
2,517 | - | - | - | - | |||||||||||||||
Loss on extinguishment of
debt
|
(362 | ) | - | - | - | - | ||||||||||||||
Amortization of debt discount and
financing costs
|
(10,081 | ) | (478 | ) | (668 | ) | - | - | ||||||||||||
Interest expense – convertible
notes
|
(587 | ) | (1,007 | ) | (434 | ) | - | - | ||||||||||||
Interest (expense) income,
net
|
(24 | ) | 43 | 100 | 69 | 104 | ||||||||||||||
Net loss
|
(13,383 | ) | (5,727 | ) | (4,601 | ) | (3,252 | ) | (3,315 | ) | ||||||||||
Preferred dividends including
beneficial conversion feature of $5,330
|
(6,240 | ) | - | - | - | - | ||||||||||||||
Net loss available to common
shares
|
$ | (19,623 | ) | $ | (5,727 | ) | $ | (4,601 | ) | $ | (3,252 | ) | $ | (3,315 | ) | |||||
Basic and diluted net loss
per
|
||||||||||||||||||||
common
share
|
$ | (0.67 | ) | $ | (0.30 | ) | $ | (0.26 | ) | $ | (0.19 | ) | $ | (0.21 | ) | |||||
Basic and diluted weighted average
number of common shares outstanding
|
29,113 | 18,888 | 17,660 | 16,917 | 15,469 | |||||||||||||||
Balance Sheet
Data:
|
||||||||||||||||||||
Cash, cash equivalents and
investments
|
$ | 8,026 | $ | 1,431 | $ | 6,176 | $ | 658 | $ | 1,168 | ||||||||||
Working
capital
|
6,002 | 1,259 | 5,673 | 259 | 859 | |||||||||||||||
Total
assets
|
13,912 | 7,122 | 10,643 | 3,322 | 3,535 | |||||||||||||||
Accumulated
deficit
|
(50,841 | ) | (35,950 | ) | (30,223 | ) | (25,622 | ) | (22,370 | ) | ||||||||||
Total stockholders’
equity
|
7,981 | 5,668 | 9,836 | 2,690 | 2,952 |
34
Item 7.
|
Management's Discussion and
Analysis of Financial Condition and Results of
Operations.
|
The discussion in “Management’s
Discussion and Analysis of Financial Condition and Results of Operations”
contains trend analysis, estimates and other forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. These
forward-looking statements include, without limitation, statements containing
the words “believes,” “anticipates,” “expects,” “continue,” and other words of
similar import or the negative of those terms or expressions. Such
forward-looking statements are subject to known and unknown risks,
uncertainties, estimates and other factors that may cause our actual results,
performance or achievements, or industry results, to be materially different
from any future results, performance or achievements expressed or implied by
such forward-looking statements. Actual results could differ
materially from those set forth in such forward-looking statements as a result
of, but not limited to, the “Risk Factors” described in Part I, Item
1A. You should read the following discussion and analysis along with
the “Selected Financial Data” and the financial statements and notes attached to
those statements included elsewhere in this report.
Overview
We are a development stage
company. We do not expect to generate significant revenues for
several years, during which time we will engage in significant research and
development efforts. However, we have eight active agricultural
license agreements to develop and commercialize our technology in corn, soy,
cotton, rice, canola, trees, alfalfa, bedding plants, turf grass, and
ethanol. Seven of the licenses provide for upfront payments,
milestone payments and royalty payments to us upon commercial
introduction. The ethanol license provides for annual payments for
each of the licensee’s ethanol production facilities that incorporate our
technology. We also have entered into a joint collaboration to
develop and commercialize our technology in banana plants. In
connection with the joint collaboration, we will receive 50% of the profits from
the sale of enhanced banana plants.
Consistent with our commercialization
strategy, we intend to license our technology for additional crops, as the
opportunities may arise, that may result in additional license fees, revenues
from contract research and other related revenues. Successful future
operations will depend on our and our partners’ ability to transform our
research and development activities into a commercially feasible
technology.
We plan to employ the same partnering
strategy in both the human health and agricultural target
markets.
Our human health research program, which
has consisted of pre-clinical in-vitro and in-vivo experiments designed to
assess the role and method of action of the Factor 5A genes in human diseases,
is performed by approximately twelve (12) third party researchers at our direction, at
the University of Waterloo, Mayo Clinic and other commercial research
facilities.
Our
primary human health initiative 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 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 and
have contracted with a third party laboratory to conduct toxicology
studies, Together with the assistance of our CRO, we will have the
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 review and consideration in order to initiate a clinical
trial. We estimate that it will take approximately six (6) months
from June 30, 2010 to complete these objectives.
35
Our preclinical human health research has yielded data that we have
presented to various biopharmaceutical companies that may be prospective
licensees for the development and marketing of potential applications for our
technology.
Critical Accounting Policies and
Estimates
Revenue Recognition
We record revenue under technology
license and development agreements related to the following. Actual
fees received may vary from the recorded estimated revenues.
|
·
|
Nonrefundable upfront license fees
that are received in exchange for the transfer of our technology to
licensees, for which no further obligations to the licensee exist with
respect to the basic technology transferred, are recognized as revenue on
the earlier of when payments are received or collections are
assured.
|
|
·
|
Nonrefundable upfront license fees
that are received in connection with agreements that include time-based
payments are, together with the time-based payments, deferred and
amortized ratably over the estimated research period of the
license.
|
|
·
|
Milestone payments, which are
contingent upon the achievement of certain research goals, are recognized
as revenue when the milestones, as defined in the particular agreement,
are achieved.
|
The effect of any change in revenues
from technology license and development agreements would be reflected in
revenues in the period such determination was made. Historically, no such
adjustments have been made.
Estimates of
Expenses
Our research and development agreements
with third parties provide for an estimate of our expenses and costs, which are
variable and are based on the actual services performed by the third
party. We estimate the aggregate amount of the expenses based upon
the projected amounts that are set forth in the agreements, and we accrue the
expenses for which we have not yet been invoiced. In estimating the
expenses, we consider, among other things, the following
factors:
|
·
|
the
existence of any prior relationship between us and the third party
provider;
|
|
·
|
the
past results of prior research and development services performed by the
third party provider; and
|
|
·
|
the
scope and timing of the research and development services set forth in the
agreement with the third party
provider.
|
After the
research services are performed
and we are invoiced, we make any adjustments that are necessary to accurately
report research and development expense for the period.
36
Valuation Allowances and Carrying
Values
We have recorded valuation allowances
against our entire deferred tax assets of $17,923,000 at June 30, 2010
and $11,520,000 at June 30, 2009. The valuation allowances relate
primarily to the net operating
loss carryforward deferred tax asset where the tax benefit of such asset is not
assured.
As of June 30, 2010 and 2009, we have
determined that the estimated future discounted cash flows related to our patent
applications will be sufficient to recover their carrying
value.
We have determined that we are receiving
the economic benefit of the agricultural patent applications as well
as all of the issued patents and are amortizing the agricultural patent application costs and all of the issued patents over
seventeen (17) years on a straight-line basis.
We do not have any off-balance sheet
arrangements.
Stock-Based
Compensation
The fair value of each stock option and
warrant is estimated on the date of grant using the Black-Scholes option-pricing
model. Expected volatility is based on the historical volatility of
our stock and of similar companies. The expected term of stock
options and warrants granted is based upon the simplified method whereby
expected term is calculated using the weighted average term of the vesting
period of such options and warrants. The expected term is calculated
for and applied to all groups of stock options and warrants as we do not expect
substantially different exercise or post-vesting termination behavior amongst
our employee population. The risk-free rate of stock options is based
on the U.S. Treasury rate in effect at the time of grant for the expected term
of the stock options and warrants. Expected forfeitures are based on
historical data.
In connection with our short-term and
long-term incentive plans, our management reviews the specific goals of such
plans to determine if such goals have been achieved or are probable that they
will be achieved. If the goals have been achieved or are probable of
being achieved, then the amount of compensation expense determined on the date
of grant related to those specific goals is charged to compensation expense at
such time.
Convertible Notes
During the year ended June 30, 2008, we
issued convertible notes and warrants for gross proceeds in the amount of
$10,000,000. The proceeds have been allocated between convertible
notes and warrants based upon their fair values, whereby the fair value of the
warrants have been determined using the Black-Scholes model. The
remaining amounts were allocated to the beneficial conversion feature based upon
the effective conversion price compared to the fair value of the common stock on
the date of issuance of the convertible notes and warrants. As such,
all of the proceeds of the convertible notes and warrants were recorded as
equity. The convertible notes were being amortized to interest
expense using the effective yield method over the term of the
notes.
37
Convertible Preferred
Stock
During the year ended June 30, 2010, we
issued convertible preferred stock and warrants for gross proceeds in the amount
of $11,497,000. The proceeds have been allocated between convertible
preferred stock and warrants based upon their fair values, whereby the fair
value of the warrants have been determined using the Black-Scholes
model. Such amount was recorded as a liability. The
remaining amounts were allocated to the convertible preferred stock and were
recorded as equity.
Research Program
We do not expect to generate significant
revenues for approximately the next several years, during which time we will
engage in significant research and development efforts. We expect to
spend significant amounts on the research and development of our
technology. We also expect our research and development costs to
increase as we continue to develop and ultimately commercialize our
technology. However, the successful development and commercialization
of our technology is highly uncertain. We cannot reasonably estimate
or know the nature, timing and expenses of the efforts necessary to complete the
development of our technology, or the period in which material net cash inflows
may commence from the commercialization of our technology, including the
uncertainty of:
|
·
|
the scope, rate of progress and
expense of our research
activities;
|
|
·
|
the interim results of our
research;
|
|
·
|
the expense of additional research
that may be required after review of the interim
results;
|
|
·
|
the terms and timing of any
collaborative, licensing and other arrangements that we may
establish;
|
|
·
|
the expense and timing of
regulatory approvals;
|
|
·
|
the effect of competing
technological and market developments;
and
|
|
·
|
the expense of filing,
prosecuting, defending and enforcing any patent claims or other
intellectual property
rights.
|
38
Liquidity and Capital
Resources
Overview
As of June 30, 2010, our cash
balance totaled $8,026,296, and we had working capital
of $6,001,970. As of June 30, 2010, we had a federal tax loss
carryforward of approximately $41,466,000 and a state tax loss carry-forward of
approximately $34,101,000 to offset future taxable income. We cannot assure you that we will be
able to take advantage of any or all of such tax loss carryforwards, if at all,
in future fiscal years.
Contractual
Obligations
The following table lists our cash
contractual obligations as of June 30, 2010:
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)
|
$ | 911,401 | $ | 911,401 | $ | — | $ | — | $ | — | ||||||||||
Facility, Rent and Operating
Leases (2)
|
$ | 73,568 | $ | 73,568 | $ | — | $ | — | $ | — | ||||||||||
Employment, Consulting and
Scientific Advisory Board Agreements (3)
|
$ | 224,542 | $ | 217,042 | $ | 7,500 | $ | — | $ | — | ||||||||||
Total Contractual Cash
Obligations
|
$ | 1,209,511 | $ | 1,202,011 | $ | 7,500 | $ | — | $ | — |
(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.
|
We expect our capital requirements to
increase significantly over the next several years as we commence new research
and development efforts, increase our business and administrative infrastructure
and embark on developing in-house business capabilities and facilities. Our
future liquidity and capital funding requirements will depend on numerous
factors, including, but not limited to, the levels and costs of our research and
development initiatives and the cost and timing of the expansion of our business
development and administrative staff.
39
Effective September 1, 2010, we
extended our research and development agreement with the University of Waterloo
for an additional three-month period through November 30, 2010, in the amount of
CAD $164,200 or approximately USD $164,200, which is not included in the above
table of contractual obligations. Research and development expenses under this
agreement aggregated $672,693 for the year ended June 30, 2010, USD $653,104 for
the year ended June 30, 2009, USD $730,960 for the year ended June 30, 2008 and
USD $5,953,061 for the cumulative period from inception through June 30, 2010.
Total research and development expenses aggregated $2,637,407 for the year ended
June 30, 2010, $2,353,962 for the year ended June 30, 2009, $1,767,741 for the
year ended June 30, 2008 and $14,948,964 for the cumulative period from
inception through June 30, 2010.
Capital
Resources
Since inception, we have generated
revenues of $1,590,000 in
connection with the initial fees and milestone payments received under our
license and development agreements. We have not been profitable since
inception, we will continue to incur additional operating losses in the future,
and we will require additional financing to continue the development and
subsequent commercialization of our technology. While we do not
expect to generate significant revenues from the licensing of our technology for
several years, we may enter into additional
licensing or other agreements with marketing and distribution partners that may
result in additional license fees, receive revenues from contract research, or
other related revenue.
License Agreements
On July 17, 2007 we entered into a
license agreement with Bayer CropScience AG for the development and
commercialization of cotton. Under the terms of the license agreement, we received an upfront payment, will
receive milestone payments upon the achievement of certain development
milestones, and additionally, upon commercialization, a royalty on net
sales.
On August 6, 2007 we entered into a license agreement with
Monsanto for the development and commercialization of corn and soy. Under the terms of the license agreement, we received an upfront payment, will
receive milestone payments upon the achievement of certain development
milestones, and additionally, upon commercialization, a royalty on net
sales.
On September 11, 2007 we entered into a
license agreement with Bayer CropScience AG for the development and
commercialization of rice. Under the terms of the agreement, we
received an upfront payment, will receive milestone payments upon the
achievement of certain development milestones, and additionally, upon
commercialization, a royalty on net sales.
Financing
On April 1, 2010, we entered into
securities purchase agreements with non-affiliated and affiliated investors for
the issuance of 10% convertible preferred stock and warrants and received
aggregate gross proceeds of $11,497,000.
On July 9, 2009, we entered into
securities purchase agreements with Partlet Holdings Ltd., for the issuance of
common stock and warrants and received gross proceeds of
$1,000,000.
On July 29, 2009, we entered into
securities purchase agreements with each of Robert Forbes, Timothy Forbes and
certain insiders and affiliates for the issuance of common stock and warrants
and received gross proceeds of $530,000.
On July 29, 2009, we entered into a
securities purchase agreement with Cato Holding Company for the issuance of
common stock and warrants in exchange for amounts owed by us to Cato Research
Ltd. in the amount of $175,000.
40
We anticipate that, based upon our
current cash balance, we will be able to fund our operations
for at least the next twelve (12) months from June 30, 2010. Over the next twelve months from June 30, 2010, we plan to fund our research and
development and commercialization activities by:
|
·
|
utilizing our current cash balance
and investments,
|
|
·
|
achieving some of the milestones
set forth in our current licensing
agreements,
|
|
·
|
through the execution of
additional licensing agreements for our technology,
and
|
|
·
|
through the placement of equity or debt
instruments.
|
We cannot assure you that we will be
able to raise money through any of the foregoing transactions, or on favorable
terms, if at all.
Results of
Operations
Fiscal Years
ended June 30, 2010, 2009 and 2008
Revenue
Total revenues consisted of initial fees
and milestone payments on our agricultural development and license
agreements. During the fiscal year ended June 30, 2010, we earned
revenue in the amount of $140,000, which consisted of milestone payments
in connection with certain agricultural license agreements. During
the fiscal year ended June 30, 2009, we earned revenue in the amount of
$275,000, which consisted of milestone payments received in connection with
certain agricultural license agreements. During the year ended June
30, 2008, we earned revenue in the amount of $456,667, which consisted of the
initial payments and the amortized portion of previous milestone payments in
connection with certain agricultural license agreements.
We anticipate that we will continue to
receive milestone payments in connection with our current agricultural
development and license agreements while we continue to pursue our goal of
attracting other companies to license our technologies in various other
crops. Additionally, we anticipate that we will receive royalty
payments from our license agreements when our partners commercialize their crops
containing our technology. However, it is difficult for us to
determine our future revenue expectations because we are a development stage
biotechnology company. As such, the timing and outcome of our
experiments, the timing of signing new partners and the timing of our partners
moving through the development process into commercialization is difficult to
accurately predict.
Operating expenses
Year Ended June 30,
|
||||||||||||||||||||||||||||||||
2010
|
2009
|
Change
|
%
|
2009
|
2008
|
Change
|
%
|
|||||||||||||||||||||||||
(In thousands, except % values)
|
||||||||||||||||||||||||||||||||
General
and administrative
|
$ | 2,349 | $ | 2,206 | $ | 143 | 6 | % | $ | 2,206 | $ | 2,291 | $ | (85 | ) | (4 | ) % | |||||||||||||||
Research
and development
|
2,637 | 2,354 | 283 | 12 | % | 2,354 | 1,765 | 589 | 33 | % | ||||||||||||||||||||||
Total
operating expenses
|
$ | 4,986 | $ | 4,560 | $ | 426 | 9 | % | $ | 4,560 | $ | 4,056 | $ | 504 | 12 | % |
41
We expect operating expenses to increase
over the next twelve months as we anticipate that research and development
expenses and other general and administrative expenses will increase as we
continue to expand our research and development activities.
General and administrative
expenses
General and administrative expenses
consist of the following:
Year ended June 30,
|
||||||||||||
2010
|
2009
|
2008
|
||||||||||
(In thousands)
|
||||||||||||
Stock-based
compensation
|
$ | 433 | $ | 445 | $ | 749 | ||||||
Payroll and
benefits
|
656 | 690 | 669 | |||||||||
Investor
relations
|
251 | 245 | 305 | |||||||||
Professional
fees
|
510 | 416 | 261 | |||||||||
Depreciation and
amortization
|
127 | 112 | 97 | |||||||||
Other general and administrative
expenses
|
372 | 298 | 210 | |||||||||
Total general and administrative
expenses
|
$ | 2,349 | $ | 2,206 | $ | 2,291 |
|
·
|
Stock-based compensation in Fiscal
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. During Fiscal 2010 and 2009, the
following options, warrants and restricted stock units were granted to
such individuals:
|
Fiscal 2010
|
Fiscal 2009
|
|||||||
Options
|
2,951,760 | 834,812 | ||||||
Warrants
|
- | 500 | ||||||
Restricted Stock
Units
|
- | 136,000 |
Stock-based compensation in Fiscal 2010
was lower than in Fiscal 2009 primarily due to a lower Black-Sholes value of the
options granted due to a lower average stock price during Fiscal
2010.
Stock-based compensation in Fiscal 2009
was lower than in Fiscal 2008 primarily due to the extension and repricing of
warrants in connection with a financial advisory agreement in Fiscal 2008. The
Black-Sholes value of the extension and repricing of warrants amounted to $385
in Fiscal 2008.
|
·
|
Payroll and benefits in Fiscal
2010 was lower than in Fiscal 2009 primarily due to the resignation of the
former President and CEO and the VP-Corporate Development during Fiscal
2010.
|
Payroll and benefits in Fiscal 2009 was
higher than in Fiscal 2008 primarily as a result of salary and health insurance
rate increases.
|
·
|
Investor relations expense in
Fiscal 2010 was higher than in Fiscal 2009 primarily as a result of an
increase in investor relations consulting
costs.
|
Investor relations expense in Fiscal
2009 was lower than in Fiscal 2008 primarily as a result of a decrease in the
cost of the annual report and investor relations consulting
costs.
42
|
·
|
Professional fees in Fiscal 2010
was higher than in Fiscal 2009 primarily as a result of an increase in
legal fees. Legal fees increased primarily due to the
resignation of our former President and CEO and the VP-Corporate
Development, the redemption of our convertible notes, the Stanford
bankruptcy and other regulatory
issues.
|
|
·
|
Professional fees in Fiscal 2009
was higher than in Fiscal 2008 primarily as a result of an increase in
accounting and legal fees. Legal fees increased primarily due to our
multiple myeloma project and employee compensation review. Accounting and
legal fees also increased primarily due to the review and filing of our
annual report.
|
|
·
|
Depreciation and amortization in
Fiscal 2010 was higher than in Fiscal 2009 primarily as a result of an
increase in amortization of patent
costs.
|
|
·
|
Depreciation and amortization in
Fiscal 2009 was higher than in Fiscal 2008 primarily as a result of an
increase in amortization of patent
costs.
|
We expect general and administrative
expenses to modestly increase over the next twelve months primarily due to an
increase in payroll and benefits and insurance costs related to our multiple
myeloma project.
Research and development
expenses
Year
Ended June 30,
|
||||||||||||||||||||||||||||||||
2010
|
2009
|
Change
|
%
|
2009
|
2008
|
Change
|
%
|
|||||||||||||||||||||||||
(In
thousands, except % values)
|
||||||||||||||||||||||||||||||||
Stock-based
compensation
|
$ | 7 | $ | 62 | $ | (55 | ) | (89 | )% | $ | 62 | $ | 148 | $ | (86 | ) | (58 | )% | ||||||||||||||
Other
research and development
|
2,630 | 2,292 | 338 | 15 | % | 2,292 | 1,617 | 675 | 38 | % | ||||||||||||||||||||||
Total
research and development
|
$ | 2,637 | $ | 2,354 | $ | 283 | 12 | % | $ | 2,354 | $ | 1,765 | $ | 589 | 33 | % |
|
·
|
Stock-based compensation in Fiscal
2010 was lower than in Fiscal 2009 primarily because the Black-Sholes
calculated fair value of the options and warrants granted during Fiscal
2010 were lower than in Fiscal 2009 because the number of options vested
were lower in Fiscal 2010.
|
|
·
|
Stock-based compensation in Fiscal
2009 was lower than in Fiscal 2008 primarily because the Black-Sholes
calculated fair value of the options and warrants granted during Fiscal
2009 were lower than in Fiscal 2008 because the number of options granted
were lower in Fiscal 2009.
|
|
·
|
Other research and development
costs in Fiscal 2010 was higher than in Fiscal 2009 primarily as a result
of the expansion of our human health programs, specifically our multiple
myeloma project and an increase in the cost of our research agreement with
the University of Waterloo due to the weakening of the U.S. dollar against
the Canadian dollar.
|
|
·
|
Other research and development in
Fiscal 2009 was higher than in Fiscal 2008 primarily as a result of the
expansion of our human health programs, specifically our multiple myeloma
project, which was partially offset by a decrease in the cost of our
research agreement with the University of Waterloo due to the
strengthening of the U.S. dollar against the Canadian
dollar.
|
43
The breakdown of our research and
development expenses between our agricultural and human health research programs
are as follows:
Year ended June
30,
|
||||||||||||||||||||||||
2010
|
%
|
2009
|
%
|
2008
|
%
|
|||||||||||||||||||
(In thousands, except %
values)
|
||||||||||||||||||||||||
Agricultural research
programs
|
$ | 553 | 21 | % | $ | 617 | 26 | % | $ | 771 | 44 | % | ||||||||||||
Human health research
programs
|
2,084 | 79 | % | 1,737 | 74 | % | 994 | 56 | % | |||||||||||||||
Total research and development
expenses
|
$ | 2,637 | 100 | % | $ | 2,354 | 100 | % | $ | 1,765 | 100 | % |
|
·
|
Agricultural research expenses in
Fiscal 2010 was lower than in Fiscal 2009 primarily as a result of a
decrease in the allocation of payroll from agriculture to human
health.
|
|
·
|
Agricultural research expenses in
Fiscal 2009 was higher than in Fiscal 2008 primarily as a result
of a decrease in the
allocation of resources from agriculture to human health at the University
of Waterloo and the strengthening of the U.S. dollar against the Canadian
dollar.
|
|
·
|
Human health research expenses
in Fiscal 2010 was higher than in Fiscal 2009 primarily as a result
of the progress of
the ongoing multiple
myeloma project.
|
|
·
|
Human health research expenses
in Fiscal 2009 was higher than in Fiscal 2008 primarily as a result
of the ongoing
multiple myeloma project.
|
We expect the percentage of human health
research programs to increase as a percentage of the total research and
development expenses as we continue to expand our human health
initiatives.
Amortization of debt discount and
financing costs
During Fiscal 2008, we issued
$10,000,000 of convertible notes and warrants. The discount on the
convertible notes was being amortized, using the effective yield method over the
term of the convertible notes. The related costs of issuance were
recorded as deferred financing costs and were being amortized on a straight line
basis over the term of the convertible notes. As of June 30, 2010,
all of the notes had been converted or redeemed and the unamortized portion of
the convertible notes and deferred financing costs were fully
amortized. As of June 30, 2009, there were $9,455,000 of the
convertible notes outstanding.
Interest expense – convertible
notes
Interest expense – convertible notes
represents the fair value of the common stock issued in lieu of paying cash for
the 8% coupon rate of interest related to the convertible notes issued during
Fiscal 2008.
44
Interest (expense)
income
Year Ended June 30,
|
||||||||||||||||||||||||||||||||
2010
|
2009
|
Change
|
%
|
2009
|
2008
|
Change
|
%
|
|||||||||||||||||||||||||
(In thousands, except % values)
|
||||||||||||||||||||||||||||||||
Interest
expense
|
$ | (35 | ) | - | $ | (35 | ) | - | - | - | - | - | ||||||||||||||||||||
Interest
income
|
11 | $ | 43 | (32 | ) | (57 | )% | $ | 43 | $ | 100 | $ | (57 | ) | (57 | )% | ||||||||||||||||
Interest (expense)income,
net
|
$ | (24 | ) | $ | 43 | $ | (67 | ) | (156 | )% | $ | 43 | $ | 100 | $ | (57 | ) | (57 | )% |
Interest expense in Fiscal 2010 was
higher than in Fiscal 2009 due to the interest incurred on the $3,000,000 line
of credit, of which approximately $2,200,000 was utilized during Fiscal
2010.
Interest income in Fiscal 2010 was lower
than in Fiscal 2009 and Fiscal 2009 was lower than Fiscal 2008 due to a lower
average cash and investments balance during the year and lower interest
rates.
From
Inception on July 1, 1998 through June 30, 2010
From inception of operations on July 1,
1998 through June 30, 2010, we earned revenues in the amount of $1,590,000,
which consisted of the initial license fees and milestone payments in connection
with our various development and license agreements. We do not expect
to generate significant revenues for several years, during which time we will
engage in significant research and development efforts.
We have incurred losses each year since
inception and have an accumulated deficit of $50,841,159 at June 30, 2010. We expect to
continue to incur losses as a result of expenditures on research, product
development and administrative activities.
45
Item 7A.
|
Quantitative and Qualitative
Disclosures About Market
Risk.
|
Foreign Currency
Risk
Our financial statements are denominated
in United States dollars and, except for our agreement with the University of
Waterloo, which is denominated in Canadian dollars, all of our contracts are
denominated in United States dollars. Therefore, we believe that
fluctuations in foreign currency exchange rates will not result in any material
adverse effect on our financial condition or results of
operations. In the event we derive a greater portion of our revenues
from international operations or in the event a greater portion of our expenses
are incurred internationally and denominated in a foreign currency, then changes
in foreign currency exchange rates could effect our results of operations and
financial condition.
Interest Rate Risk
We invest in high-quality financial
instruments, primarily money market funds, with an effective duration of the
portfolio of less than one year which we believe are subject to limited credit
risk. We currently do not hedge our interest rate
exposure. Due to the short-term nature of our investments, which we
plan to hold until maturity, we do not believe that we have any material
exposure to interest rate risk arising from our
investments.
46
Item 8.
|
Financial Statements and
Supplementary Data.
|
The financial statements required to be
filed pursuant to this Item 8 are included in this Annual Report on Form
10-K. A list of the financial statements filed herewith is found at
"Item 15. Exhibits, Financial Statement Schedules."
Item 9.
|
Changes in and Disagreements with
Accountants on Accounting and Financial
Disclosure.
|
None.
Item 9A.
|
Controls and
Procedures.
|
Disclosure Controls and
Procedures
Our management, with the participation
of our chief executive officer and chief financial officer, evaluated the
effectiveness of our disclosure controls and procedures (as defined in Rules
13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period
covered by this Annual Report on Form 10-K. Based on this evaluation,
our chief executive officer and chief financial officer have concluded that, as
of the end of such period, our disclosure controls and procedures were
effective.
Internal Control Over Financial
Reporting
Management’s Annual Report on Internal
Control Over Financial Reporting
Our company’s management is responsible
for establishing and maintaining adequate internal control over financial
reporting. Internal control over financial reporting is defined in
Rules 13a-15(f) and 15d-15(f) under the Exchange Act as a process designed by,
or under the supervision of, our company’s principle executive and principal
financial officers and effected by our company’s board of directors, management
and other personnel to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles in the U.S.
and includes those policies and procedures that:
|
·
|
Pertain to the maintenance of
records that in reasonable detail accurately and fairly reflect the
transactions and dispositions of the assets of our
company;
|
|
·
|
Provide reasonable assurance that
transactions are recorded as necessary to permit preparation of financial
statements in accordance with generally accepted accounting principles,
and that receipts and expenditures of our company are being made only in
accordance with authorization of management and directors of our company;
and
|
|
·
|
Provide reasonable assurance
regarding prevention or timely detection of unauthorized acquisition, use
or disposition of our company’s assets that could have a material effect
on the financial statements.
|
Because of its inherent limitations,
internal control over financial reporting may not prevent or detect
misstatements. Projections of any evaluation of effectiveness to
future periods are subject to the risks that controls may become inadequate
because of changes in conditions, or that the degree of compliance with the
policies or procedures may deteriorate.
47
Management assessed the effectiveness of
our company’s internal control over financial reporting as of June 30,
2010. In making this assessment, management used the criteria
established in Internal
Control-Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission, or COSO.
Based on this assessment, management has
concluded that, as of June 30, 2010 our company’s internal control over
financial reporting is effective.
Management’s report was not subject to
attestation by the company’s registered public accounting firm pursuant to
applicable law that permit the Company to provide only management’s report in
this annual report.
Changes in Internal Controls Over
Financial Reporting
No change in our internal controls over
financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the
Exchange Act) occurred during the fiscal year ended June 30, 2010 that has
materially affected, or is reasonably likely to materially affect, our internal
controls over financial reporting.
Item 9B.
|
Other
Information.
|
None.
48
PART III
Item 10.
|
Directors, Executive Officers and
Corporate Governance.
|
The information relating to our
directors, nominees for election as directors and executive officers under the
headings "Election of Directors" and "Executive Officers" in our definitive
proxy statement for the 2010 Annual Meeting of Stockholders is incorporated
herein by reference to such proxy statement.
Item 11.
|
Executive
Compensation.
|
The discussion under the heading
"Executive Compensation" in our definitive proxy statement for the 2010 Annual
Meeting of Stockholders is incorporated herein by reference to such proxy
statement.
Item 12.
|
Security Ownership of Certain
Beneficial Owners and Management and Related Stockholder
Matters.
|
The discussion under the heading
"Security Ownership of Certain Beneficial Owners and Management" in our
definitive proxy statement for the 2010 Annual Meeting of Stockholders is
incorporated herein by reference to such proxy statement.
Item 13.
|
Certain Relationships and Related
Transactions, and Director
Independence.
|
The discussion under the heading
"Certain Relationships and Related Transactions" in our definitive proxy
statement for the 2010 Annual Meeting of Stockholders is incorporated herein by
reference to such proxy statement.
Item 14.
|
Principal Accounting Fees and
Services.
|
The discussion under the heading
"Principal Accountant Fees and Services" in our definitive proxy statement for
the 2010 Annual Meeting of Stockholders is incorporated herein by reference to
such proxy statement.
49
PART IV
|
|||
Item 15.
|
Exhibits and Financial Statement
Schedules.
|
||
(a)
|
(1)
|
Financial
Statements.
|
|
Reference is made to the Index to
Financial Statements on Page F-1.
|
|||
(a)
|
(2)
|
Financial Statement
Schedules.
|
|
None.
|
|||
(a)
|
(3)
|
Exhibits.
|
|
Reference is made to the Exhibit
Index on Page
53.
|
50
SIGNATURES
Pursuant to the requirements of Section
13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized this 28th day of September 2010.
SENESCO TECHNOLOGIES,
INC.
|
||
By:
|
/s/ Leslie J.
Browne
|
|
Leslie J. Browne, President
and
|
||
Chief Executive
Officer
|
||
(principal executive
officer)
|
||
By:
|
/s/ Joel
Brooks
|
|
Joel Brooks, Chief Financial
Officer
|
||
(principal financial and
accounting
officer)
|
51
Pursuant to the requirements of the
Securities Exchange Act of 1934, this report has been signed below by the
following persons on behalf of the Registrant and in the capacities and on the
dates indicated.
Signature
|
Title
|
Date
|
||
/s/ Harlan W. Waksal,
M.D
|
Chairman and
Director
|
September 28,
2010
|
||
Harlan W. Waksal,
M.D.
|
||||
/s/ Leslie J.
Browne
|
President and Chief
Executive
|
September 28,
2010
|
||
Leslie J.
Browne
|
Officer (principal executive
officer)
|
|||
/s/ Joel
Brooks
|
Chief Financial Officer and
Treasurer
|
September 28,
2010
|
||
Joel Brooks
|
(principal financial and
accounting officer)
|
|||
/s/ John E.
Thompson
|
Executive Vice President,
Chief
|
September 28,
2010
|
||
John E.
Thompson
|
Scientific Officer and
Director
|
|||
/s/ John
Braca
|
Director
|
September 28,
2010
|
||
John Braca
|
||||
/s/ Christopher
Forbes
|
Director
|
September 28,
2010
|
||
Christopher
Forbes
|
||||
/s/ Warren J.
Isabelle
|
Director
|
September 28,
2010
|
||
Warren J.
Isabelle
|
||||
/s/ Thomas C.
Quick
|
Director
|
September 28,
2010
|
||
Thomas C.
Quick
|
||||
/s/ David
Rector
|
Director
|
September 28,
2010
|
||
David
Rector
|
||||
/s/ Rudolf
Stalder
|
Director
|
September 28,
2010
|
||
Rudolf
Stalder
|
||||
/s/ Jack Van
Hulst
|
Director
|
September 28,
2010
|
||
Jack Van
Hulst
|
52
EXHIBIT
INDEX
Exhibit
No.
|
Description of Exhibit
|
|
2.1
|
Merger
Agreement and Plan of Merger by and among Nava Leisure USA, Inc., an Idaho
corporation, the Principal Stockholders (as defined therein), Nava Leisure
Acquisition Corp., and Senesco, Inc., dated October 9,
1998. (Incorporated by reference to Senesco Technologies, Inc.
definitive proxy statement on Schedule 14A dated January 11,
1999.)
|
|
2.2
|
Merger
Agreement and Plan of Merger by and between Senesco Technologies, Inc., an
Idaho corporation, and Senesco Technologies, Inc., a Delaware corporation,
dated September 30, 1999. (Incorporated by reference to Senesco
Technologies, Inc. quarterly report on Form 10-QSB for the period ended
September 30, 1999.)
|
|
3.1
|
Amended
and Restated Certificate of Incorporation of Senesco Technologies, Inc.
filed with the State of Delaware on January 22,
2007. (Incorporated by reference to Senesco Technologies, Inc.
quarterly report on Form 10-Q for the period ended December 31,
2006.)
|
|
3.2
|
Certificate
of Amendment to the Amended and Restated Certificate of Incorporation of
Senesco Technologies, Inc. filed with the State of Delaware on January 22,
2008. (Incorporated by reference to Exhibit 3.1 of Senesco Technologies,
Inc. quarterly report on Form 10-Q for the period ended December 31,
2007.)
|
|
3.3
|
Certificate
of Amendment to the Amended and Restated Certificate of Incorporation of
Senesco Technologies, Inc. filed with the State of Delaware on September
22, 2009. (Incorporated by reference to Exhibit 3.3 of Senesco
Technologies, Inc. annual report on Form 10-K/A for the period ended June
30, 2009.)
|
|
3.4
|
Certificate
of Amendment to the Amended and Restated Certificate of Incorporation of
Senesco Technologies, Inc. filed with the State of Delaware on May 25,
2010. (Incorporated by reference to Exhibit 3.1 to Senesco Technologies,
Inc. current report on Form 8-K filed on May 28, 2010.)
|
|
3.5
|
Amended
and Restated By-laws of Senesco Technologies, Inc. as adopted on October
2, 2000. (Incorporated by reference to Senesco Technologies, Inc.
quarterly report on Form 10-QSB for the period ended December 31,
2000.)
|
|
3.6
|
Certificate
of Designations to the Company’s Certificate of Incorporation (Series
A)(Incorporated by reference to Exhibit 3.1 to Senesco Technologies, Inc.
current report on Form 8-K filed on March 29, 2010)
|
|
3.7
|
Certificate
of Designations to the Company’s Certificate of Incorporation (Series
B)(Incorporated by reference to Exhibit 3.2 to Senesco Technologies, Inc.
current report on Form 8-K filed on March 29, 2010)
|
|
4.1
|
|
Form
of Warrant issued to Stanford Venture Capital Holdings, Inc. and certain
officers of Stanford Venture Capital Holdings, Inc. (with attached
schedule of parties and terms thereto). (Incorporated by reference to
Exhibit 4.1 of Senesco Technologies, Inc. quarterly report on Form 10-QSB
for the period ended December 31,
2001.)
|
53
Exhibit
No.
|
Description of Exhibit
|
|
4.2
|
Form
of Warrant issued to H.C. Wainwright & Co., Inc., or its designees,
dated as of October 10, 2006 (Incorporated by reference to Exhibit 10.42
of Senesco Technologies, Inc. annual report on Form 10-K for the period
ended June 30, 2006.)
|
|
4.3
|
Form
or Warrant issued to certain accredited investors dated October 10, 2006
(with attached schedule of parties and terms
thereto). (Incorporated by reference to Exhibit 10.40 of
Senesco Technologies, Inc. annual report on Form 10-K for the period ended
June 30, 2006.)
|
|
4.4
|
Form
of Series A Warrant issued to YA Global Investments, L.P. (Incorporated by
reference to Exhibit 4.15 of Senesco Technologies, Inc. annual report on
Form 10-K for the period ended June 30, 2007.)
|
|
4.5
|
Form
of Series A Warrant issued to Stanford Venture Capital Holdings, Inc.
(Incorporated by reference to Exhibit 4.16 of Senesco Technologies, Inc.
annual report on Form 10-K for the period ended June 30,
2007.)
|
|
4.6
|
Form
of Series B Warrant issued to YA Global Investments, L.P. (Incorporated by
reference to Exhibit 4.19 of Senesco Technologies, Inc. annual report on
Form 10-K for the period ended June 30, 2007.)
|
|
4.7
|
Form
of Series B Warrant issued to Stanford Venture Capital Holdings, Inc.
(Incorporated by reference to Exhibit 4.20 of Senesco Technologies, Inc.
annual report on Form 10-K for the period ended June 30,
2007.)
|
|
4.8
|
Form
of Warrant issued to H.C. Wainwright & Co., Inc or its designees.
(Incorporated by reference to Exhibit 4.21 of Senesco Technologies, Inc.
annual report on Form 10-K for the period ended June 30,
2008.)
|
|
4.9
|
Form
of Series A Warrant issued to Partlet Holdings Ltd. (Incorporated by
reference to Exhibit 4.1 of Senesco Technologies, Inc. current report on
Form 8-K, filed on July 10, 2009.)
|
|
4.10
|
Form
of Series B Warrant issued to Partlet Holdings Ltd. (Incorporated by
reference to Exhibit 4.1 of Senesco Technologies, Inc. current report on
Form 8-K, filed on July 10, 2009.)
|
|
4.11
|
Form
of Series A Warrant issued to each of Robert Forbes, Timothy Forbes,
Harlan W. Waksal, M.D., Rudolf Stalder, Christopher Forbes, David Rector,
John N. Braca, Jack Van Hulst, Warren Isabelle and the Thomas C. Quick
Charitable Foundation. (Incorporated by reference to Exhibit 4.1 of
Senesco Technologies, Inc. current report on Form 8-K, filed on July 30,
2009.)
|
|
4.12
|
|
Form
of Series B Warrant issued to each of Robert Forbes, Timothy Forbes,
Harlan W. Waksal, M.D., Rudolf Stalder, Christopher Forbes, David Rector,
John N. Braca, Jack Van Hulst, Warren Isabelle and the Thomas C. Quick
Charitable Foundation. (Incorporated by reference to Exhibit 4.1 of
Senesco Technologies, Inc. current report on Form 8-K, filed on July 30,
2009.)
|
54
Exhibit
No.
|
Description of Exhibit
|
|
4.13
|
Form
of Series A Warrant issued to Cato Holding Company. (Incorporated by
reference to Exhibit 4.1 of Senesco Technologies, Inc. current report on
Form 8-K, filed on July 30, 2009.)
|
|
4.14
|
Form
of Series B Warrant issued to Cato Holding Company. (Incorporated by
reference to Exhibit 4.1 of Senesco Technologies, Inc. current report on
Form 8-K, filed on July 30, 2009.)
|
|
4.15
|
Form
of Series A Common Stock Purchase Warrant issued to certain accredited
investors (Incorporated by reference to Exhibit 4.1 of Senesco
Technologies, Inc. current report on Form 8-K filed on March 29,
2010.)
|
|
4.16
|
Form
of Series B Common Stock Purchase Warrant issued to certain affiliated
investors (Incorporated by reference to Exhibit 4.2 of Senesco
Technologies, Inc. current report on Form 8-K filed on March 29,
2010.)
|
|
10.1
|
Indemnification
Agreement by and between Senesco Technologies, Inc. and Christopher
Forbes, dated January 21, 1999. (Incorporated by reference to
Senesco Technologies, Inc. quarterly report on Form 10-QSB for the period
ended December 31, 1998.)
|
|
10.2
|
Indemnification
Agreement by and between Senesco Technologies, Inc. and Thomas C. Quick,
dated February 23, 1999. (Incorporated by reference to Senesco
Technologies, Inc. quarterly report on Form 10-QSB for the period ended
March 31, 1999.)
|
|
10.3
|
Indemnification
Agreement by and between Senesco Technologies, Inc. and Ruedi Stalder,
dated March 1, 1999. (Incorporated by reference to Senesco
Technologies, Inc. quarterly report on Form 10-QSB for the period ended
March 31, 1999.)
|
|
10.4
|
Indemnification
Agreement by and between Senesco Technologies, Inc. and Bruce C. Galton,
dated October 4, 2001. (Incorporated by reference to Exhibit 10.10 of
Senesco Technologies, Inc. quarterly report on Form 10-QSB for the
quarterly period ended December 31, 2001.)
|
|
10.5
|
Indemnification
Agreement by and between Senesco Technologies, Inc. and Jack Van Hulst,
dated January 16, 2007. (Incorporated by reference to Exhibit 10.13 of
Senesco Technologies, Inc. annual report on Form 10-K for the period ended
June 30, 2007)
|
|
10.6
|
Indemnification
Agreement by and between Senesco Technologies, Inc. and John Braca, dated
October 8, 2003. (Incorporated by reference to Exhibit 10.38 of
Senesco Technologies, Inc. annual report on Form 10-KSB for the period
ended June 30, 2004.)
|
|
10.7
|
Indemnification
Agreement by and between Senesco Technologies, Inc. and David Rector dated
as of April, 2002. (Incorporated by reference to Exhibit 10.1
of Senesco Technologies, Inc. quarterly report on Form 10-QSB for the
period ended September 30, 2004.)
|
|
10.8
|
|
Indemnification
Agreement by and between Senesco Technologies, Inc. and Harlan W. Waksal,
M.D. dated as of October 24, 2008. (Incorporated by reference
to Exhibit 10.8 of Senesco Technologies, Inc. annual report on Form 10-K
for the period ended June 30,
2009.)
|
55
Exhibit
No.
|
Description of Exhibit
|
|
10.
9
|
Indemnification
Agreement by and between Senesco Technologies, Inc. and Warren Isabelle
dated as of June 8, 2009. (Incorporated by reference to Exhibit
10.9 of Senesco Technologies, Inc. annual report on Form 10-K for the
period ended June 30, 2009.)
|
|
10.10
|
Indemnification
Agreement by and between Senesco Technologies, Inc. and Leslie J. Browne,
Ph.D. dated as of May 25, 2010. (Incorporated by reference to
Exhibit 10.2 of Senesco Technologies, Inc. current report on Form 8-K
filed on May 25, 2010.)
|
|
10.11*
|
Employment
Agreement by and between Senesco Technologies, Inc. and Joel Brooks, dated
July 1, 2003. (Incorporated by reference to Exhibit 10.29 of
Senesco Technologies, Inc. annual report on Form 10-KSB for the period
ended June 30, 2003.)
|
|
10.12*
|
Employment
Agreement by and between Senesco Technologies, Inc. and Richard Dondero,
dated July 19, 2004. (Incorporated by reference to Exhibit
10.39 of Senesco Technologies, Inc. annual report on Form 10-KSB for the
period ended June 30, 2004.)
|
|
10.13*
|
Offer
Letter by and between Senesco Technologies, Inc. and Leslie J. Browne,
Ph.D. dated May 25, 2010. (Incorporated by reference
to Exhibit 10.1 of Senesco Technologies, Inc. current report on Form 8-K
filed on May 25, 2010.)
|
|
10.14
|
Nondisclosure,
Noncompetition and Invention Assignment Agreement by and between Leslie J.
Browne, Ph.D. and Senesco Technologies, Inc. dated May 25, 2010.
(Incorporated by reference to Exhibit 10.3 of Senesco Technologies, Inc.
current report on Form 8-K filed on May 25, 2010.)
|
|
10.15*
|
Confidential
Separation Agreement and General Release by and between the Company and
Bruce C. Galton dated as of November 23, 2009. (Incorporated by reference
to Exhibit 10.1 of Senesco Technologies, Inc. current report on Form 8-K
filed on November 25, 2010.)
|
|
10.16*
|
Confidential
Separation Agreement and General Release by and between the Company and
Sascha P. Fedyszyn dated as of February 2, 2010. (Incorporated by
reference to Exhibit 10.1 of Senesco Technologies, Inc. current report on
Form 8-K filed on February 4, 2010.)
|
|
10.17*
|
Consulting
Agreement by and between Senesco Technologies, Inc. and John E. Thompson,
Ph.D., dated July 12, 1999. (Incorporated by reference to
Senesco Technologies, Inc. annual report on Form 10-KSB for the period
ended June 30, 2000.)
|
|
10.18*
|
|
Amendment
to Consulting Agreement of July 12, 1999, as modified on February 8, 2001,
by and between Senesco, Inc. and John E. Thompson, Ph.D., dated December
13, 2002. (Incorporated by reference to Exhibit 10.1 of Senesco
Technologies, Inc. quarterly report on Form 10-QSB for the period ended
December 31,
2002.)
|
56
Exhibit
No.
|
Description of Exhibit
|
|
10.19
*
|
Amendment
# 5 to Consulting Agreement of July 12, 1999, as modified, by and between
Senesco, Inc. and John E. Thompson, Ph.D., dated June 15, 2007.
(Incorporated by reference to Exhibit 10.49 of Senesco Technologies, Inc.
annual report on Form 10-K for the period ended June 30,
2007.)
|
|
10.20
*
|
Amendment
# 6 to Consulting Agreement of July 12, 1999, as modified, by and between
Senesco, Inc. and John E. Thompson, Ph.D., dated June 25, 2009.
(Incorporated by reference to Exhibit 10.17 of Senesco Technologies, Inc.
annual report on Form 10-K for the period ended June 30,
2009.)
|
|
10.21
+
|
Development
Agreement by and between Senesco Technologies, Inc. and ArborGen, LLC,
dated June 28, 2002. (Incorporated by reference to Exhibit
10.31 of Senesco Technologies, Inc. annual report on Form 10-KSB for the
year ended June 30, 2002.)
|
|
10.22
+
|
Commercial
License Agreement by and between Senesco Technologies, Inc. and ArborGen,
LLC dated as of December 21, 2006. (Incorporated by reference
to Senesco Technologies, Inc. quarterly report on Form 10-Q for the period
ended December 31, 2006.)
|
|
10.23
+
|
Development
and License Agreement by and between Senesco Technologies, Inc. and
Calwest Seeds, dated September 14, 2002. (Incorporated by
reference to Exhibit 10.1 of Senesco Technologies, Inc. quarterly report
on Form 10-QSB for the period ended September 30,
2002.)
|
|
10.24
+
|
Development
and License Agreement by and between Senesco Technologies, Inc. and The
Scotts Company, dated March 8,
2004. (Incorporated by reference to Exhibit 10.1 of Senesco
Technologies, Inc. quarterly report on Form 10-QSB for the period ended
March 31, 2004.)
|
|
10.25
+
|
Development
and License Agreement with Broin and Associates, Inc. (currently known as
Poet) dated as of October 14, 2004. (Incorporated by reference
to Exhibit 10.2 of Senesco Technologies, Inc. quarterly report on Form
10-QSB for the period ended September 30, 2004.)
|
|
10.26
+
|
License
Agreement by and between Senesco Technologies, Inc. and Bayer CropScience
GmbH, dated as of November 8, 2006. (Incorporated by reference
to Senesco Technologies, Inc. quarterly report on Form 10-Q for the
quarterly period ended December 31, 2006.)
|
|
10.27
+
|
License
Agreement with Bayer CropScience AG dated as of July 23, 2007.
(Incorporated by reference to Exhibit 10.1 of Senesco Technologies, Inc.
quarterly report on Form 10-Q for the period ended September 30,
2007.)
|
|
10.28
+
|
Patent
License Agreement with Monsanto Company dated as of August 6, 2007.
(Incorporated by reference to Exhibit 10.2 of Senesco Technologies, Inc.
quarterly report on Form 10-Q for the period ended September 30,
2007.)
|
|
10.29
+
|
|
License
Agreement with Bayer CropScience AG dated as of September 17, 2007.
(Incorporated by reference to Exhibit 10.3 of Senesco Technologies, Inc.
quarterly report on Form 10-Q for the period ended September 30,
2007.)
|
57
Exhibit
No.
|
Description of Exhibit
|
|
10.30
|
Research
Agreement by and among Senesco Technologies, Inc., Dr. John E. Thompson
and the University of Waterloo, dated September 1, 1998, as amended.
(Incorporated by reference to Senesco Technologies, Inc. quarterly report
on Form 10-QSB for the period ended December 31, 1998.)
|
|
10.31
|
Amendment
to Research Agreement by and among the University of Waterloo, Senesco,
Inc. and Dr. John E. Thompson, Ph.D., dated August 27, 2009. (Incorporated
by reference to Exhibit 10.2 of Senesco Technologies, Inc. annual report
on Form 10-K for the period ended June 30, 2009.)
|
|
10.32
†
|
Amendment
to Research Agreement by and among the University of Waterloo, Senesco,
Inc. and Dr. John E. Thompson, Ph.D., dated September 1,
2010.
|
|
10.33 +
|
Master
Product Sale Agreement with VGXI, Inc. dated as of June 27, 2008.
(Incorporated by reference to Exhibit 10.29 of Senesco Technologies, Inc.
annual report on Form 10-K for the period ended June 30,
2008.)
|
|
10.34
|
Master
Product Sale Agreement with Polyplus-transfection dated as of June 30,
2008. (Incorporated by reference to Exhibit 10.30 of Senesco Technologies,
Inc. annual report on Form 10-K for the period ended June 30,
2008.)
|
|
10.35
|
Proposal
for Manufacture and Supply by and between Avecia Biotechnology, Inc. and
Senesco Technologies, Inc. dated as of September 4, 2008. (Incorporated by
reference to Exhibit 10.1 of Senesco Technologies, Inc. quarterly report
on Form 10-Q for the period ended September 30, 2008.)
|
|
10.36
|
Proposal
for Biodistribution and Repeat Dose Toxicity Studies in Mice by and
between BioReliance and Senesco Technologies, Inc. dated as of September
5, 2008. (Incorporated by reference to Exhibit 10.2 of Senesco
Technologies, Inc. quarterly report on Form 10-Q for the period ended
September 30, 2008.)
|
|
10.37
|
Services
Agreement by and between KBI BioPharma, Inc. and Senesco Technologies,
Inc. dated as of September 15, 2008. (Incorporated by reference to Exhibit
10.3 of Senesco Technologies, Inc. quarterly report on Form 10-Q for the
period ended September 30, 2008.)
|
|
10.38
|
Agreement
for Service on Senesco Technologies, Inc. Scientific Advisory Board by and
between Senesco Technologies, Inc. and Dr. Charles A. Dinarello, dated
February 12, 2002. (Incorporated by reference to Exhibit 10.6
of Senesco Technologies, Inc. quarterly report on Form 10-QSB for the
period ended March 31, 2002.)
|
|
10.39
|
Agreement
for Service on Senesco Technologies, Inc. Scientific Advisory Board by and
between Senesco Technologies, Inc. and James W. Mier, M.D., dated April 2,
2007. (Incorporated by reference to Exhibit 10.43 of Senesco Technologies,
Inc. annual report on Form 10-K for the period ended June 30,
2007.)
|
|
10.40
|
|
Registration
Rights Agreement by and among Senesco Technologies, Inc., Stanford Group
Company, Stanford Venture Capital Holdings, Inc., Stanford International
Bank, Ltd., Ronald Stein, Daniel Bogar, Osvaldo Pi and William Fusselmann
dated October 11, 2006. (Incorporated by reference to Exhibit
10.36 of Senesco Technologies, Inc. annual report on Form 10-K for the
period ended June 30,
2006.)
|
58
Exhibit
No.
|
Description of Exhibit
|
|
10.41
|
Form
of Securities Purchase Agreement by and between Senesco Technologies, Inc.
and certain accredited investors dated October 10, 2006 (with attached
schedule of parties and terms thereto). (Incorporated by
reference to Exhibit 10.38 of Senesco Technologies, Inc. annual report on
Form 10-K for the period ended June 30, 2006.)
|
|
10.42
|
Form
of Registration Rights Agreement by and between Senesco Technologies, Inc
and certain accredited investors dated October 10, 2006 (with attached
schedule of parties and terms thereto). (Incorporated by
reference to Exhibit 10.39 of Senesco Technologies, Inc. annual report on
Form 10-K for the period ended June 30, 2006.)
|
|
10.43
|
Securities
Purchase Agreement by and between Senesco Technologies, Inc. and YA Global
Investments, L.P. (Incorporated by reference to Exhibit 10.44 of Senesco
Technologies, Inc. annual report on Form 10-K for the period ended June
30, 2007.)
|
|
10.44
|
Registration
Rights Agreement by and between Senesco Technologies, Inc. and YA Global
Investments, L.P. (Incorporated by reference to Exhibit 10.45 of Senesco
Technologies, Inc. annual report on Form 10-K for the period ended June
30, 2007.)
|
|
10.45
|
Securities
Purchase Agreement by and between Senesco Technologies, Inc. and Stanford
Venture Capital Holdings, Inc. (Incorporated by reference to Exhibit 10.46
of Senesco Technologies, Inc. annual report on Form 10-K for the period
ended June 30, 2007.)
|
|
10.46
|
Registration
Rights Agreement by and between Senesco Technologies, Inc. and Stanford
Venture Capital Holdings, Inc. (Incorporated by reference to Exhibit 10.47
of Senesco Technologies, Inc. annual report on Form 10-K for the period
ended June 30, 2007.)
|
|
10.47
|
Securities
Purchase Agreement by and between Senesco Technologies, Inc. and Partlet
Holdings Ltd. Dated as of July 9, 2009. (Incorporated by reference to
Exhibit 10.1 of Senesco Technologies, Inc. current report on Form 8-K,
filed on July 10, 2009.)
|
|
10.48
|
Securities
Purchase Agreement by and between Senesco Technologies, Inc. and each of
Robert Forbes, Timothy Forbes, Harlan W. Waksal, M.D., Rudolf Stalder,
Christopher Forbes, David Rector, John N. Braca, Jack Van Hulst, Warren
Isabelle and the Thomas C. Quick Charitable Foundation dated as of July
29, 2009. (Incorporated by reference to Exhibit 10.1 of Senesco
Technologies, Inc. current report on Form 8-K , filed on July 30,
2009.)
|
|
10.49
|
Securities
Purchase Agreement by and between Senesco Technologies, Inc. and Cato
Holding Company dated as of July 29, 2009. (Incorporated by reference to
Exhibit 10.2 of Senesco Technologies, Inc. current report on Form 8-K ,
filed on July 30, 2009.)
|
|
10.50
|
|
Securities
Purchase Agreement by and between Senesco Technologies, Inc. and certain
investors (Non-Affiliates). (Incorporated by reference to Exhibit 10.2 of
Senesco Technologies, Inc. current report on Form 8-K filed on March 29,
2010.)
|
59
Exhibit
No.
|
Description of Exhibit
|
|
10.51
|
Securities
Purchase Agreement by and between Senesco Technologies, Inc. and certain
investors (Non-Affiliates). (Incorporated by reference to Exhibit 10.3 of
Senesco Technologies, Inc. current report on Form 8-K filed on March 29,
2010.)
|
|
10.52
|
Securities
Purchase Agreement by and between Senesco Technologies, Inc. and certain
investors (Affiliates). (Incorporated by reference to Exhibit 10.4 of
Senesco Technologies, Inc. current report on Form 8-K filed on March 29,
2010.)
|
|
10.53
|
Registration
Rights Agreement dated March 26, 2010 by and between Senesco Technologies,
Inc. and certain investors. (Incorporated by reference to Exhibit 10.1 of
Senesco Technologies, Inc. current report on Form 8-K filed on March 29,
2010.)
|
|
10.54
|
Office
lease by and between Senesco Technologies, Inc. and Matrix/AEW NB, LLC,
dated March 16, 2001. (Incorporated by reference to Senesco
Technologies, Inc. quarterly report on Form 10-QSB for the period ended
March 31, 2001.)
|
|
10.55
|
Credit
Agreement dated as of February 17, 2010 by and between Senesco
Technologies, Inc. and JMP Securities. (Incorporated by reference to
Exhibit 10.1 of Senesco Technologies, Inc. quarterly report on Form 10-Q
for the period ended March 31, 2010.)
|
|
10.56
|
Letter
Agreement dated as of March 3, 2010 by and between the Company and YA
Global Investments L.P. (Incorporated by reference to Exhibit 10.1 of
Senesco Technologies, Inc. current report on Form 8-K filed on March 4,
2010.)
|
|
10.57
|
Letter
Agreement dated as of March 4, 2010 sent to the Company by certain of its
insiders relating to the conversion of convertible debentures.
(Incorporated by reference to Exhibit 10.1 of Senesco Technologies, Inc.
current report on Form 8-K filed on March 5, 2010.)
|
|
10.58
|
First
amendment of office lease by and between Senesco Technologies, Inc. and
Matrix/AEW NB, LLC, dated May 13, 2005 (Incorporated by reference to
Exhibit 10.8 of Senesco Technologies, Inc annual report on Form 10-KSB for
the period ended June 30, 2005.)
|
|
|
||
10.59
*
|
1998
Stock Incentive Plan, as amended on December 13, 2002. (Incorporated by
reference to Exhibit 10.7 of Senesco Technologies, Inc. quarterly report
on Form 10-QSB for the period ended December 31, 2002.)
|
|
10.60*
|
Senesco
Technologies, Inc. 2008 Incentive Compensation Plan. (Incorporated by
reference to Exhibit 10.1 of Senesco Technologies, Inc. quarterly report
on Form 10-Q for the period ended December 31, 2008.)
|
|
10.61*
|
Amendment
to Senesco Technologies, Inc. 2008 Incentive Compensation Plan.
(Incorporated by reference to Exhibit 10.1 of Senesco Technologies, Inc.
current report on Form 8-K filed on May 28, 2010.)
|
|
10.62*
|
|
Form
of Stock Option Agreement under the Senesco Technologies, Inc. 2008 Stock
Incentive Plan. (Incorporated by reference to Exhibit 10.5 of Senesco
Technologies, Inc. quarterly report on Form 10-Q for the period ended
September 30, 2009.)
|
60
Exhibit
No.
|
Description of Exhibit
|
|
10.63*
|
Form
of Restricted Stock Unit Issuance Agreement under the Senesco
Technologies, Inc. 2008 Stock Incentive Plan. (Incorporated by reference
to exhibit 10.6 of Senesco Technologies, Inc. quarterly report on Form
10-Q for the period ended September 30, 2009.)
|
|
17.1
|
Resignation
Letter of Jack Van Hulst dated May 24, 2010. (Incorporated by reference to
Exhibit 17.1 of Senesco Technologies, Inc. current report on Form 8-K
filed on May 25, 2010.)
|
|
21
|
Subsidiaries
of the Registrant. (Incorporated by reference to Senesco Technologies,
Inc. annual report on Form 10-KSB for the period ended June 30,
1999.)
|
|
23.1
†
|
Consent
of McGladrey & Pullen, LLP.
|
|
31.1
†
|
Certification
of the principal executive officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
31.2
†
|
Certification
of the principal financial and accounting officer pursuant to Section 302
of the Sarbanes-Oxley Act of 2002.
|
|
32.1 †
|
Certification
of the principal executive officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
|
32.2 †
|
|
Certification
of the principal financial and accounting officer pursuant to Section 906
of the Sarbanes-Oxley Act of
2002.
|
*
|
A management contract or
compensatory plan or arrangement required to be filed as an exhibit
pursuant to Item 13(a) of Form
10-K.
|
†
|
Filed
herewith.
|
+ The SEC granted
Confidential Treatment for portions of this
Exhibit.
|
61
SENESCO
TECHNOLOGIES, INC.
AND
SUBSIDIARY
(a
development stage company)
CONSOLIDATED
FINANCIAL STATEMENTS
JUNE
30, 2010
SENESCO
TECHNOLOGIES, INC AND SUBSIDIARY
(a
development stage company)
INDEX
TO CONSOLIDATED FINANCIAL STATEMENTS
Reports
of Independent Registered Public Accounting Firm
|
F-2
|
Consolidated
Financial Statements:
|
|
Balance
Sheets
|
F-3
|
Statements
of Operations
|
F-4
|
Statements
of Stockholders' Equity
|
F-5
- F-9
|
Statements
of Cash Flows
|
F-10
|
Notes
to Consolidated Financial Statements
|
F-11
- F-32
|
F-1
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the
Board of Directors and Stockholders
Senesco
Technologies, Inc.
We have
audited the accompanying consolidated balance sheet of Senesco Technologies,
Inc. and Subsidiary (a development stage company) as of June 30, 2010 and June
30, 2009, and the related consolidated statements of operations, stockholders'
equity and cash flows for each of the three years in the period ended June 30,
2010 and cumulative amounts from July 1, 1998 (inception) to June 30, 2010.
These financial statements are the responsibility of the Company's management.
Our responsibility is to express an opinion on these financial statements based
on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our
opinion, the consolidated financial statements referred to above present fairly,
in all material respects, the financial position of Senesco Technologies, Inc.
and Subsidiary as of June 30, 2010 and June 30, 2009, and the results of their
operations and their cash flows for each of the three years in the period ended
June 30, 2010 and cumulative amounts from July 1, 1998 (inception) to June 30,
2010, in conformity with U.S. generally accepted accounting
principles.
As
discussed in Note 10 to the financial statements, Senesco Technologies, Inc. has
changed its method of accounting for derivative instruments as of July 1, 2009
due to the adoption of Financial Accounting Standards Board Accounting
Codification Topic 815-40, “Evaluating Whether an Instrument Involving a
Contingency is Considered Indexed to an Entity’s Own Stock”.
We were
not engaged to examine management’s assertion about the effectiveness of Senesco
Technologies, Inc.'s internal control over financial reporting as of June 30,
2010, included in the accompanying Item 9A. Report on Internal Control Over
Financial Reporting and, accordingly, we do not express an opinion
thereon.
/s/
McGladrey & Pullen, LLP
|
|
New
York, New York
|
|
September
28, 2010
|
F-2
SENESCO TECHNOLOGIES, INC.
AND SUBSIDIARY
(A DEVELOPMENT STAGE
COMPANY)
CONSOLIDATED BALANCE
SHEETS
June
30,
|
June
30,
|
|||||||
2010
|
2009
|
|||||||
ASSETS
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 8,026,296 | $ | 380,569 | ||||
Short-term
investments
|
- | 1,050,000 | ||||||
Prepaid
research supplies and expenses
|
1,304,795 | 1,161,348 | ||||||
Total
Current Assets
|
9,331,091 | 2,591,917 | ||||||
Equipment,
furniture and fixtures, net
|
4,554 | 5,986 | ||||||
Deferred
financing costs, net of accumulated amortization of $592,308 as of June
30, 2009
|
- | 632,324 | ||||||
Intangibles,
net
|
4,568,895 | 3,884,999 | ||||||
Deferred
income tax assets, net
|
- | - | ||||||
Security
deposit
|
7,187 | 7,187 | ||||||
TOTAL
ASSETS
|
$ | 13,911,727 | $ | 7,122,413 | ||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable
|
$ | 557,420 | $ | 976,680 | ||||
Accrued
expenses
|
576,857 | 355,937 | ||||||
Line
of credit
|
2,194,844 | - | ||||||
Total
Current Liabilities
|
3,329,121 | 1,332,617 | ||||||
Warrant
liabilities ($490,438 to related parties)
|
2,493,794 | - | ||||||
Convertible
notes, net of discount of $9,448,783 as of June 30, 2009
|
- | 6,217 | ||||||
Grant
payable
|
99,728 | 99,728 | ||||||
Deferred
rent
|
8,060 | 16,017 | ||||||
TOTAL
LIABILITIES
|
5,930,703 | 1,454,579 | ||||||
STOCKHOLDERS'
EQUITY:
|
||||||||
Preferred
stock, $0.01 par value, authorized 5,000,000 shares
|
||||||||
Series
A 10,297 shares issued and 8,035 shares outstanding
|
80 | - | ||||||
(liquidation
preference of $8,235,875 at June 30, 2010)
|
||||||||
Series
B 1,200 shares issued and outstanding
|
12 | - | ||||||
(liquidation
preference of $1,210,000 at June 30, 2010)
|
||||||||
Common
stock, $0.01 par value, authorized 250,000,000 shares,
|
||||||||
issued
and outstanding 50,092,204 and 19,812,043, respectively
|
500,922 | 198,120 | ||||||
Capital
in excess of par
|
58,321,169 | 41,419,613 | ||||||
Deficit
accumulated during the development stage
|
(50,841,159 | ) | (35,949,899 | ) | ||||
Total
Stockholders' Equity
|
7,981,024 | 5,667,834 | ||||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$ | 13,911,727 | $ | 7,122,413 |
See notes
to consolidated financial statements
F-3
SENESCO TECHNOLOGIES, INC.
AND SUBSIDIARY
(A DEVELOPMENT STAGE
COMPANY)
CONSOLIDATED STATEMENTS OF
OPERATIONS
Cumulative
|
||||||||||||||||
Year
ended June 30,
|
Amounts
from
|
|||||||||||||||
2010
|
2009
|
2008
|
Inception
|
|||||||||||||
Revenue
|
$ | 140,000 | $ | 275,000 | $ | 456,667 | $ | 1,590,000 | ||||||||
Operating
expenses:
|
||||||||||||||||
General
and administrative
|
2,349,116 | 2,205,739 | 2,291,263 | 26,280,311 | ||||||||||||
Research
and development
|
2,637,407 | 2,353,962 | 1,764,426 | 14,948,964 | ||||||||||||
Total
operating expenses
|
4,986,523 | 4,559,701 | 4,055,689 | 41,229,275 | ||||||||||||
Loss
from operations
|
(4,846,523 | ) | (4,284,701 | ) | (3,599,022 | ) | (39,639,275 | ) | ||||||||
Other
non-operating income (expense)
|
||||||||||||||||
Fair
value – warrant liability
|
2,516,661 | - | - | 7,248,428 | ||||||||||||
Sale
of state income tax loss – net
|
- | - | - | 586,442 | ||||||||||||
Other
noncash income
|
- | - | - | 321,259 | ||||||||||||
Loss
on extinguishment of debt
|
(361,877 | ) | - | - | (361,877 | ) | ||||||||||
Amortization
of debt discount and financing costs
|
(10,081,107 | ) | (478,000 | ) | (668,763 | ) | (11,227,870 | ) | ||||||||
Interest
expense – convertible notes
|
(586,532 | ) | (1,007,244 | ) | (434,154 | ) | (2,027,930 | ) | ||||||||
Interest
(expense) income - net
|
(24,135 | ) | 43,076 | 100,449 | 499,178 | |||||||||||
Net
loss
|
(13,383,513 | ) | (5,726,869 | ) | (4,601,490 | ) | (44,601,645 | ) | ||||||||
Preferred
dividends including beneficial conversion feature of
$5,330,039
|
(6,239,514 | ) | - | - | (6,239,514 | ) | ||||||||||
Loss
applicable to common shares
|
$ | (19,623,027 | ) | $ | (5,726,869 | ) | $ | (4,601,490 | ) | $ | (50,841,159 | ) | ||||
Basic
and diluted net loss per common share
|
$ | (0.67 | ) | $ | (0.30 | ) | $ | (0.26 | ) | |||||||
Basic
and diluted weighted-average number of common shares
outstanding
|
29,112,976 | 18,888,142 | 17,660,466 |
See notes
to consolidated financial statements
F-4
SENESCO TECHNOLOGIES, INC.
AND SUBSIDIARY
(A DEVELOPMENT STAGE
COMPANY)
CONSOLIDATED STATEMENT OF
STOCKHOLDERS’ EQUITY
Period from July 1, 1998
(date of inception) to June 30, 2010
Deficit
|
||||||||||||||||||||||||||||
Accumulated
|
||||||||||||||||||||||||||||
During
the
|
Stockholders'
|
|||||||||||||||||||||||||||
Capital
in Excess
|
Development
|
Equity
|
||||||||||||||||||||||||||
Preferred Stock
|
Common Stock
|
of Par Value
|
Stage
|
(Deficiency)
|
||||||||||||||||||||||||
Shares
|
Amount
|
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 | ) | - | - | ||||||||||||||||||||
Net
loss
|
- | - | - | - | - | (1,168,995 | ) | (1,168,995 | ) | |||||||||||||||||||
Balance
at June 30, 1999
|
- | - | 6,212,800 | 62,128 | 2,019,033 | (1,168,995 | ) | 912,166 | ||||||||||||||||||||
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 $2.924582 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 | |||||||||||||||||||||
Net
loss
|
- | - | - | - | - | (3,346,491 | ) | (3,346,491 | ) | |||||||||||||||||||
Balance
at June 30, 2000
|
- | - | 7,873,292 | 78,733 | 5,955,311 | (4,515,486 | ) | 1,518,558 | ||||||||||||||||||||
Fair
market value of options and warrants vested during the year ended June 30,
2001
|
- | - | - | - | 308,619 | - | 308,619 | |||||||||||||||||||||
Net
loss
|
- | - | - | - | - | (2,033,890 | ) | (2,033,890 | ) | |||||||||||||||||||
Balance
at June 30, 2001
|
- | - | 7,873,292 | 78,733 | 6,263,930 | (6,549,376 | ) | (206,713 | ) |
continued
See notes
to consolidated financial statements
F-5
SENESCO TECHNOLOGIES, INC.
AND SUBSIDIARY
(A DEVELOPMENT STAGE
COMPANY)
CONSOLIDATED STATEMENT OF
STOCKHOLDERS’ EQUITY
Period from July 1, 1998
(date of inception) to June 30, 2010
Deficit
|
||||||||||||||||||||||||||||
Accumulated
|
||||||||||||||||||||||||||||
During
the
|
Stockholders'
|
|||||||||||||||||||||||||||
Capital
in Excess
|
Development
|
Equity
|
||||||||||||||||||||||||||
Preferred Stock
|
Common Stock
|
of Par Value
|
Stage
|
(Deficiency)
|
||||||||||||||||||||||||
Shares
|
Amount
|
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 during 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 | |||||||||||||||||||||
Net
loss
|
- | - | - | - | - | (3,021,709 | ) | (3,021,709 | ) | |||||||||||||||||||
Balance
at June 30, 2002
|
- | - | 11,880,045 | 118,800 | 14,237,961 | (9,571,085 | ) | 4,785,676 | ||||||||||||||||||||
Fair
market value of options and warrants vested during the year ended
June 30, 2003
|
- | - | - | - | 848,842 | - | 848,842 | |||||||||||||||||||||
Net
loss
|
- | - | - | - | - | (2,778,004 | ) | (2,778,004 | ) | |||||||||||||||||||
Balance
at June 30, 2003
|
- | - | 11,880,045 | 118,800 | 15,086,803 | (12,349,089 | ) | 2,856,514 | ||||||||||||||||||||
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 to $3.25
|
- | - | 370,283 | 3,704 | 692,945 | - | 696,649 | |||||||||||||||||||||
Net
loss
|
- | - | - | - | - | (3,726,951 | ) | (3,726,951 | ) | |||||||||||||||||||
Balance
at June 30, 2004
|
- | - | 13,787,250 | 137,873 | 20,669,142 | (16,076,040 | ) | 4,730,975 |
continued
See notes
to consolidated financial statements
F-6
SENESCO TECHNOLOGIES, INC.
AND SUBSIDIARY
(A DEVELOPMENT STAGE
COMPANY)
CONSOLIDATED STATEMENT OF
STOCKHOLDERS’ EQUITY
Period from July 1, 1998
(date of inception) to June 30, 2010
Deficit
|
||||||||||||||||||||||||||||
Accumulated
|
||||||||||||||||||||||||||||
During
the
|
Stockholders'
|
|||||||||||||||||||||||||||
Capital
in Excess
|
Development
|
Equity
|
||||||||||||||||||||||||||
Preferred Stock
|
Common Stock
|
of Par Value
|
Stage
|
(Deficiency)
|
||||||||||||||||||||||||
Shares
|
Amount
|
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 the 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 | |||||||||||||||||||||
Net
loss
|
- | - | - | - | - | (2,978,918 | ) | (2,978,918 | ) | |||||||||||||||||||
Balance
at June 30, 2005
|
- | - | 15,467,388 | 154,674 | 24,490,035 | (19,054,958 | ) | 5,589,751 | ||||||||||||||||||||
Warrants
exercised during the year ended June 30, 2006 at an exercise price of
$0.01
|
- | - | 10,000 | 100 | - | - | 100 | |||||||||||||||||||||
Fair
market value of options and warrants vested during the year ended
June 30, 2006
|
- | - | - | - | 677,000 | - | 677,000 | |||||||||||||||||||||
Net
loss
|
- | - | - | - | - | (3,314,885 | ) | (3,314,885 | ) | |||||||||||||||||||
Balance
at June 30, 2006
|
- | - | 15,477,388 | 154,774 | 25,167,035 | (22,369,843 | ) | 2,951,966 | ||||||||||||||||||||
Issuance
of common stock and warrants for cash on October 10, 2006 at $1.135
per unit
|
- | - | 1,986,306 | 19,863 | 2,229,628 | - | 2,249,491 | |||||||||||||||||||||
Commissions,
legal and bank fees associated with the issuance on October 10,
2006
|
- | - | - | - | (230,483 | ) | - | (230,483 | ) | |||||||||||||||||||
Warrants
exercised during the year ended June 30, 2007 at an exercise price of
$0.01
|
- | - | 10,000 | 100 | - | - | 100 | |||||||||||||||||||||
Fair
market value of options and warrants vested during the year ended
June 30, 2007
|
- | - | - | - | 970,162 | - | 970,162 | |||||||||||||||||||||
Net
loss
|
- | - | - | - | - | (3,251,697 | ) | (3,251,697 | ) | |||||||||||||||||||
Balance
at June 30, 2007
|
- | - | 17,473,694 | 174,737 | 28,136,342 | (25,621,540 | ) | 2,689,539 |
continued
See notes
to consolidated financial statements
F-7
SENESCO TECHNOLOGIES, INC.
AND SUBSIDIARY
(A DEVELOPMENT STAGE
COMPANY)
CONSOLIDATED STATEMENT OF
STOCKHOLDERS’ EQUITY
Period from July 1, 1998
(date of inception) to June 30, 2010
Deficit
|
||||||||||||||||||||||||||||
Accumulated
|
||||||||||||||||||||||||||||
During the
|
Stockholders'
|
|||||||||||||||||||||||||||
Capital in Excess
|
Development
|
Equity
|
||||||||||||||||||||||||||
Preferred Stock
|
Common Stock
|
of Par Value
|
Stage
|
(Deficiency)
|
||||||||||||||||||||||||
Shares
|
Amount
|
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, net of fees paid to holder, from the issuance of
convertible notes and warrants on September 21, 2007, October 16,
2007, December 20, 2007, and June 30, 2008
|
- | - | - | - | 9,340,000 | - | 9,340,000 | |||||||||||||||||||||
Convertible
notes converted into common stock during the year ended June 30,
2008
|
- | - | 555,556 | 5,556 | 430,952 | - | 436,508 | |||||||||||||||||||||
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 | |||||||||||||||||||||
Net
loss
|
- | - | - | - | - | (4,601,490 | ) | (4,601,490 | ) | |||||||||||||||||||
Balance
at June 30, 2008
|
- | - | 18,375,117 | 183,751 | 39,874,958 | (30,223,030 | ) | 9,835,679 | ||||||||||||||||||||
Fair
market value of options and warrants vested during the year ended
June 30, 2009
|
- | - | - | - | 506,847 | - | 506,847 | |||||||||||||||||||||
Warrants
exercised during the year ended June 30, 2009 at an exercise price of
$0.01
|
- | - | 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 Short-Term Incentive Plan during
the year ended June 30, 2009
|
- | - | 112,700 | 1,127 | (1,127 | ) | - | - | ||||||||||||||||||||
Net
loss
|
- | - | - | - | - | (5,726,869 | ) | (5,726,869 | ) | |||||||||||||||||||
Balance
at June 30, 2009
|
- | - | 19,812,043 | 198,120 | 41,419,613 | (35,949,899 | ) | 5,667,834 |
continued
See notes
to consolidated financial statements
F-8
SENESCO TECHNOLOGIES, INC.
AND SUBSIDIARY
(A DEVELOPMENT STAGE
COMPANY)
CONSOLIDATED STATEMENT OF
STOCKHOLDERS’ EQUITY
Period from July 1, 1998
(date of inception) to June 30, 2010
Deficit
|
||||||||||||||||||||||||||||
Accumulated
|
||||||||||||||||||||||||||||
During
the
|
Stockholders'
|
|||||||||||||||||||||||||||
Capital
in Excess
|
Development
|
Equity
|
||||||||||||||||||||||||||
Preferred Stock
|
Common Stock
|
of Par Value
|
Stage
|
(Deficiency)
|
||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
|||||||||||||||||||||||||
Cumulative
effect of change in accounting principle- implementation of FASB ASC
Topic 815-40
|
- | $ | - | - | $ | - | $ | (7,931,875 | ) | $ | 4,731,767 | $ | (3,200,108 | ) | ||||||||||||||
Issuance
of common stock and warrants for cash on July 9, 2009 and September
30, 2009 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 on
September 30, 2009
|
- | - | 194,444 | 1,944 | 259,588 | - | 261,532 | |||||||||||||||||||||
Legal
and regulatory fees associated with the issuances on July 9, 2009 and
September 30, 2009
|
- | - | - | - | (180,862 | ) | - | (180,862 | ) | |||||||||||||||||||
Issuance
of preferred stock and warrants for cash on April 1, 2010 and June 2,
2010
|
11,497 | 115 | - | - | 11,496,885 | - | 11,497,000 | |||||||||||||||||||||
Deemed
dividend- Preferred Stock
|
- | - | - | - | 5,330,039 | (5,330,039 | ) | - | ||||||||||||||||||||
Legal
and regulatory fees associated with the issuances of preferred stock
and warrants on April 1, 2010 and June 2, 2010
|
- | - | - | - | (793,498 | ) | - | (793,498 | ) | |||||||||||||||||||
Fair
value of warrants issued on April 1, 2010 and June 2, 2010
|
- | - | - | - | (1,759,008 | ) | - | (1,759,008 | ) | |||||||||||||||||||
Preferred
stock converted into common stock during the year ended June 30,
2010
|
(2,262 | ) | (23 | ) | 7,068,750 | 70,688 | (70,665 | ) | - | - | ||||||||||||||||||
Warrants
exercised during the year ended June 30, 2010 at an exercise price of
$0.01
|
- | - | 1,005,000 | 10,050 | - | - | 10,050 | |||||||||||||||||||||
Issuance
of common stock in lieu of cash payment for interest during the year
ended June 30, 2010
|
- | - | 1,353,132 | 13,531 | 539,142 | - | 552,673 | |||||||||||||||||||||
Issuance
of common stock in lieu of cash payment for dividends during the year
ended June 30, 2010
|
- | - | 3,029,465 | 30,295 | 648,305 | (678,600 | ) | - | ||||||||||||||||||||
Convertible
notes converted into common stock during the year ended June 30,
2010
|
- | - | 15,659,186 | 156,592 | 7,462,768 | - | 7,619,360 | |||||||||||||||||||||
Issuance
of common stock in connection with Short-Term Incentive Plan during
the year ended June 30, 2010
|
- | - | 116,000 | 1,160 | (1,160 | ) | - | - | ||||||||||||||||||||
Issuance
of common stock for services during the year ended June 30,
2010
|
- | - | 154,184 | 1,542 | 52,258 | - | 53,800 | |||||||||||||||||||||
Fair
market value of options and warrants vested during the year ended
June 30, 2010
|
- | - | - | - | 386,639 | - | 386,639 | |||||||||||||||||||||
Repurchase
of warrants during the year ended June 30, 2010
|
- | - | - | - | (50,000 | ) | - | (50,000 | ) | |||||||||||||||||||
Dividends
accrued at June 30, 2010
|
- | - | - | - | - | (230,875 | ) | (230,875 | ) | |||||||||||||||||||
Net
loss
|
- | - | - | - | - | (13,383,513 | ) | (13,383,513 | ) | |||||||||||||||||||
Balance
at June 30, 2010
|
9,235 | $ | 92 | 50,092,204 | $ | 500,922 | $ | 58,321,169 | $ | (50,841,159 | ) | $ | 7,981,024 |
See notes to consolidated financial
statements
F-9
SENESCO TECHNOLOGIES, INC.
AND SUBSIDIARY
(A DEVELOPMENT STAGE
COMPANY)
CONSOLIDATED STATEMENT OF
CASH FLOWS
Cumulative
|
||||||||||||||||
Year
ended June 30,
|
Amounts
from
|
|||||||||||||||
2010
|
2009
|
2008
|
Inception
|
|||||||||||||
Cash
flows from operating activities:
|
||||||||||||||||
Net
loss
|
$ | (13,383,513 | ) | $ | (5,726,869 | ) | $ | (4,601,490 | ) | $ | (44,601,645 | ) | ||||
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
|
(2,516,661 | ) | (7,569,687 | ) | ||||||||||||
Issuance
of common stock and warrants for interest
|
552,673 | 1,007,244 | 434,154 | 2,003,386 | ||||||||||||
Issuance
of common stock for services
|
53,800 | - | - | 53,800 | ||||||||||||
Stock-based
compensation expense
|
386,639 | 506,847 | 897,321 | 10,589,583 | ||||||||||||
Depreciation
and amortization
|
126,567 | 111,753 | 96,847 | 699,008 | ||||||||||||
Amortization
of convertible note discount
|
9,448,783 | 51,160 | 500,057 | 10,000,000 | ||||||||||||
Amortization
of deferred financing costs
|
632,324 | 426,839 | 168,706 | 1,227,869 | ||||||||||||
Loss
on extinguishment of debt
|
361,877 | - | - | 361,877 | ||||||||||||
(Increase)
decrease in operating assets:
|
||||||||||||||||
Prepaid
expenses and other current assets
|
(143,447 | ) | (980,792 | ) | (76,030 | ) | (1,304,795 | ) | ||||||||
Security
deposit
|
- | - | - | (7,187 | ) | |||||||||||
Increase
(decrease) in operating liabilities:
|
||||||||||||||||
Accounts
payable
|
(419,260 | ) | 606,513 | 260,909 | 557,420 | |||||||||||
Accrued
expenses
|
165,046 | 41,670 | (63,092 | ) | 520,983 | |||||||||||
Deferred
revenue
|
- | - | (16,667 | ) | - | |||||||||||
Other
liability
|
(7,957 | ) | (7,045 | ) | (6,134 | ) | 8,060 | |||||||||
Net
cash used in operating activities
|
(4,743,129 | ) | (3,962,680 | ) | (2,405,419 | ) | (27,244,899 | ) | ||||||||
Cash
flows from investing activities:
|
||||||||||||||||
Patent
costs
|
(807,915 | ) | (779,563 | ) | (761,093 | ) | (5,094,278 | ) | ||||||||
Redemption
(purchase) of investments, net
|
1,050,000 | (550,000 | ) | (250,000 | ) | - | ||||||||||
Purchase
of equipment, furniture and fixtures
|
(1,116 | ) | (4,173 | ) | (2,783 | ) | (178,179 | ) | ||||||||
Net
cash provided by (used in) investing activities
|
240,969 | (1,333,736 | ) | (1,013,876 | ) | (5,272,457 | ) | |||||||||
Cash
flows from financing activities:
|
||||||||||||||||
Proceeds
from grant
|
- | - | - | 99,728 | ||||||||||||
Proceeds
from draw-down on line of credit
|
2,194,844 | - | - | 2,194,844 | ||||||||||||
Proceeds
from issuance of bridge notes
|
- | - | - | 525,000 | ||||||||||||
Proceeds
from issuance of preferred stock and warrants, net
|
10,754,841 | - | - | 10,754,841 | ||||||||||||
Redemption
of convertible notes and warrants
|
(2,160,986 | ) | - | - | (2,160,986 | ) | ||||||||||
Proceeds
from issuance of convertible notes
|
- | - | 9,340,000 | 9,340,000 | ||||||||||||
Deferred
financing costs
|
- | - | (651,781 | ) | (651,781 | ) | ||||||||||
Proceeds
from issuance of common stock and warrants, net and exercise of warrants
and options
|
1,359,188 | - | - | 20,442,006 | ||||||||||||
Net
cash provided by financing activities
|
12,147,887 | - | 8,688,219 | 40,543,652 | ||||||||||||
Net
(decrease) increase in cash and cash equivalents
|
7,645,727 | (5,296,416 | ) | 5,268,924 | 8,026,296 | |||||||||||
Cash
and cash equivalents at beginning of period
|
380,569 | 5,676,985 | 408,061 | - | ||||||||||||
Cash
and cash equivalents at end of period
|
$ | 8,026,296 | $ | 380,569 | $ | 5,676,985 | $ | 8,026,296 |
See notes
to consolidated financial statements
F-10
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
1.
|
Principle
Business Activity:
|
The
Company
The
Company is a development stage biotechnology company whose mission is to develop
novel approaches to treat programmed cell death diseases in humans (apoptosis),
and to enhance the quality and productivity of fruits, flowers, vegetables and
agronomic crops through the control of cell death in plants
(senescence).
SI, a New
Jersey corporation, was incorporated on November 24, 1998 and is the successor
entity to Senesco, L.L.C., a New Jersey limited liability company that was
formed on June 25, 1998 but commenced operations on July 1, 1998.
Liquidity
As shown
in the accompanying consolidated financial statements, the Company has a history
of losses with a deficit accumulated during the development stage from July 1,
1998 (inception) through June 30, 2010 of $50,841,159. Additionally,
the Company has generated minimal revenues by licensing its technology for
certain crops to companies willing to share in its development costs. In
addition, the Company’s technology may not be ready for commercialization for
several years. The Company expects to continue to incur losses for the next
several years because it anticipates that its expenditures on research and
development, and administrative activities will significantly exceed its
revenues during that period. The Company cannot predict when, if ever, it will
become profitable.
As of
June 30, 2010, the Company had cash and cash equivalents in the amount of
$8,026,296, which consisted of checking accounts and money market
funds. The Company estimates that such amount will cover its expenses
for at least the next twelve months from June 30, 2010.
The
Company will need additional capital and plans to raise additional capital
through the placement of debt instruments or equity or both. However,
the Company may not be able to obtain adequate funds for its operations when
needed or on acceptable terms. If the Company is unable to raise
additional funds, it will need to do one or more of the following:
|
·
|
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.
|
Risks
and Uncertainties
The
Company operates in an industry that is subject to intense competition,
government regulation and rapid technological change. The Company's operations
are subject to significant risk and uncertainties including financial,
operational, technological, regulatory and other risks, including the potential
risk of business failure.
2.
|
Summary
of Significant Accounting Policies:
|
Principles
of consolidation
The
accompanying consolidated financial statements include the accounts of Senesco
Technologies, Inc. ("ST") and its wholly owned subsidiary, Senesco, Inc. ("SI")
(collectively, the "Company"). All significant intercompany accounts
and transactions have been eliminated in consolidation.
F-11
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
Management
Estimates and Judgments
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and judgments that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenue and expenses during
the reporting period. The critical accounting policies that require
management's most significant estimate and judgment are the assessment of the
recoverability of intangible assets, the variables and method used to calculate
stock-based compensation and warrant liabilities, and the valuation allowance on
deferred tax assets. Actual results experienced by the Company may
differ from management's estimates.
Pursuant
to Statement of Financial Accounting Standard No. 168, The FASB Accounting Standards
Codification and the Hierarchy of Generally Accepted Accounting Principles,
issued by
the Financial Accounting Standards Board (FASB) in June 2009 and effective for
the Company beginning July 1, 2009, the Financial Accounting Standards
Board Accounting Standards Codification (referred to as the Codification or the
ASC) officially became the single source of authoritative nongovernmental
generally accepted accounting principles (GAAP), superseding existing FASB,
American Institute of Certified Public Accountants, Emerging Issues Task Force
(EITF), and related accounting literature. Only one level of authoritative GAAP
now exists and all other accounting literature is considered non-authoritative.
The Codification reorganizes the thousands of GAAP pronouncements into roughly
90 accounting topics and displays them using a consistent structure. Also
included in the Codification is relevant SEC guidance organized using the same
topical structure in separate sections within the Codification. This has an
impact on the disclosures in the Company’s financial statements since all
references to authoritative accounting literature will be through the
Codification.
Cash
and Cash Equivalents and Short-Term Investments
The
Company considers all highly liquid instruments with an original maturity of 90
days or less at the time of purchase to be cash equivalents. Cash and cash
equivalents consist of deposits that are readily convertible into
cash.
Short-term
investments consisted primarily of U.S. Treasury Notes. For financial
reporting purposes, short-term investments were classified as held-to-maturity
and were stated at amortized cost. As of June 30, 2009, all short-term
investments mature within one year of the balance sheet date. Realized gains and
losses are determined based on the specific-identification method. The
investments are reviewed on a periodic basis for other-than-temporary
impairments. (See note 3 and 4).
Fair
Value Measurements
ASC Topic
820, Fair Value Measurements, defines fair value, establishes a framework for
measuring fair value and expands the related disclosure requirements. The
guidance applies under other accounting pronouncements that require or permit
fair value measurements. The statement indicates, among other things, that a
fair value measurement assumes that the transaction to sell an asset or transfer
a liability occurs in the principal market for the asset or liability or, in the
absence of a principal market, the most advantageous market for the asset or
liability. ASC 820 defines fair value based upon an exit price
model.
The
Company categorizes our financial instruments into a three-level fair value
hierarchy that prioritizes the inputs to valuation techniques used to measure
fair value into three broad levels. The fair value hierarchy gives the highest
priority to quoted prices in active markets for identical assets or liabilities
(Level 1) and the lowest priority to unobservable inputs (Level 3). If the
inputs used to measure fair value fall within different levels of the hierarchy,
the category level is based on the lowest priority level input that is
significant to the fair value measurement of the instrument. Financial assets
recorded at fair value on our consolidated balance sheets are categorized as
follows:
F-12
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
•
|
Level
1: Observable inputs such as quoted prices in active
markets;
|
|
•
|
Level
2: Inputs, other than the quoted prices in active markets, that are
observable either directly or indirectly;
and
|
|
•
|
Level
3: Unobservable inputs in which there is little or no market data, which
require the reporting entity to develop its own
assumptions.
|
Short-term
investments reported at fair value on our consolidated balance sheet are based
on quoted prices in active markets for identical or comparable assets (Level 1).
(See note 4).
The fair
value of the warrant liabilities is based on the Black-Scholes Merton option
pricing model (“Black-Scholes model”) (Level 2). (See note 4).
The
carrying value of prepaid expenses and other current assets, accounts payable,
accrued expenses, and line of credit reported in the consolidated balance sheets
equal or approximate fair value due to their short maturities. The fair value of
the convertible notes approximated the amortized portion of the principal amount
as such instruments were at market rates available to the Company.
Concentrations
of Credit Risk
The
Company maintains its cash primarily in investment accounts within one large
financial institution. The Federal Deposit Insurance Corporation insures these
balances up to $250,000 per bank. The Company has not experienced any losses on
its bank deposits and believes these deposits do not expose the Company to any
significant credit risk.
Prepaid
Research Services and Supplies
Prepaid
research services and supplies are carried at cost and are included in prepaid
expenses and other current assets on the accompanying consolidated balance
sheet. When such services are performed and supplies are used, the
carrying value of the supplies are expensed in the period that they are
performed or used for the development of proprietary applications and
processes.
Deferred
Financing Costs
Deferred
financing costs represented the costs related to the placement of convertible
notes during the year ended June 30, 2008. Such costs were being
amortized ratably over the term of the convertible notes. During the
year ended June 30, 2010, all of the convertible notes were either redeemed or
converted into common stock. Accordingly, the remaining unamortized
deferred financing costs were fully amortized during the year ended June 30,
2010. (See note 9)
Equipment,
Furniture and fixtures
Equipment,
furniture and fixtures are recorded at cost. Depreciation is calculated on a
straight-line basis over the estimated useful life of each asset, generally four
to seven years. Expenditures for major renewals and improvements are
capitalized, and expenditures for maintenance and repairs are charged to
operations as incurred. (See note 5)
Intangibles
The
Company conducts research and development activities, the cost of which is
expensed as incurred, in order to generate patents that can be licensed to third
parties in exchange for license fees and royalties. Because the
patents are the basis of the Company’s future revenue, the patent costs are
capitalized. The capitalized patent costs represent the outside
legal fees incurred by the Company to submit and undertake all necessary efforts
to have such patent applications issued as patents.
F-13
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
The
length of time that it takes for an initial patent application to be approved is
generally between four to six years. However, due to the unique
nature of each patent application, the actual length of time may
vary. If a patent application is denied, the associated cost of that
application would be written off. However, the Company has not had
any patent applications denied as of June 30, 2010. Additionally,
should a patent application become impaired during the application process, the
Company would write down or write off the associated cost of that patent
application.
Issued
patents and agricultural patent applications pending are being amortized over a
period of 17 years, the expected economic life of the patent. (See note
6).
Impairment
of Long-lived Assets
The
Company assesses the impairment in value of intangible assets whenever events or
circumstances indicate that their carrying value may not be
recoverable. Factors the Company considers important which could
trigger an impairment review include the following:
• 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.
If the
Company's review determines that the future discounted cash flows related to
these assets will not be sufficient to recover their carrying value, the Company
will reduce the carrying values of these assets down to its estimate of fair
value and continue amortizing them over their remaining useful
lives. To date, the Company has not recorded any impairment of
intangible assets.
Net
Loss per Common Share
Basic
earnings (loss) per share is computed by dividing net income (loss) available to
common shareholders by the weighted average number of common shares assumed to
be outstanding during the period of computation. Diluted earnings per share is
computed similar to basic earnings per share except that the denominator is
increased to include the number of additional common shares that would have been
outstanding if the potential common shares had been issued and if the additional
common shares were dilutive.
For all
periods presented, basic and diluted loss per share are the same, as any
additional common stock equivalents would be anti-dilutive. Potentially dilutive
shares of common stock that have been excluded from the calculation of the
weighted average number of dilutive common shares.
For the
year ended June 30, 2010, there were 91,299,773 additional potentially dilutive
shares of common stock. These additional shares include 28,859,375 shares
issuable upon conversion of the Preferred Stock, and 62,440,398 outstanding
options and warrants. For the year ended June 30, 2009, there were
33,779,411 additional potentially dilutive shares of common stock. These
additional shares include 10,505,556 shares issuable upon conversion of the 8%
Convertible Notes and 23,273,855 outstanding options and
warrants. For the year ended June 30, 2008, there were 34,078,081
additional potentially dilutive shares of common stock. These additional shares
include 10,555,555 shares issuable upon conversion of the 8% Convertible Notes
and 23,522,526 outstanding options and warrants.
F-14
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
Income
Taxes
Income
taxes are accounted for under the asset and liability method. Deferred tax
assets and liabilities are recognized for the future tax consequences
attributable to the differences between the financial statement carrying amounts
of existing assets and liabilities and their respective tax bases and operating
loss and tax credit carryforwards. Deferred tax assets and liabilities are
measured using enacted tax rates expected to apply to taxable income in the
years in which those temporary differences are expected to be recovered or
settled. The effect on deferred tax assets and liabilities of a change in tax
rates is recognized in income in the period that includes the enactment
date.
The asset
and liability method requires that deferred tax assets and liabilities be
recorded without consideration as to their realizability. The deferred tax asset
primarily includes net operating loss carryforwards. The portion of any deferred
tax asset for which it is more likely than not that a tax benefit will not be
realized must then be offset by recording a valuation allowance. A valuation
allowance has been established against all of the deferred tax assets as it is
more likely than not that these assets will not be realized given the history of
operating losses.
While the
Company believes that its tax positions are fully supportable, there is a risk
that certain positions could be challenged successfully. In these
instances, the Company looks to establish reserves. If the Company
determined that a tax position is more likely than not of being sustained upon
audit, based solely on the technical merits of the position, the Company would
recognize the benefit. The Company measures the benefit by
determining the amount that has a likelihood greater than 50% of being realized
upon settlement. The Company presumes that all tax positions will be
examined by a taxing authority with full knowledge of all relevant
information. The Company regularly monitors its tax positions,
tax assets and tax liabilities. The Company reevaluates the technical
merits of its tax positions and would recognize an uncertain tax benefit or
derecognize a previously recorded tax benefit when (i) there is a completion of
a tax audit, (ii) there is a change in applicable tax law including a tax case
or legislative guidance, or (iii) there is an expiration of the statute of
limitations. Significant judgment is required in accounting for tax
reserves. As of June 30, 2010, the Company determined that it
had no liability for uncertain income taxes. The Company’s policy is to
recognize potential accrued interest and penalties related to the liability for
uncertain tax benefits, if applicable, in income tax expense. The
Company’s tax returns for the years ended June 30, 2010, 2009, 2008 and 2007 are
open for examination. (See note 13).
Revenue
Recognition
The
Company has received certain nonrefundable upfront fees in exchange for the
transfer of its technology to licensees. Upon delivery of the
technology, the Company had no further obligations to the licensee with respect
to the basic technology transferred and, accordingly, recognized revenue at that
time. The Company has and may continue to receive additional payments
from its licensees in the event such licensees achieve certain development or
commercialization milestones in their particular field of
use. Milestone payments, which are contingent upon the achievement of
certain research goals, are recognized as revenue when the milestones, as
defined in the particular agreement, are achieved.
Stock-based
Payments
The
Company accounts for stock-based compensation under the provisions of FASB ASC
Topic 718, Compensation—Stock Compensation (“ASC
718”), which requires the measurement and recognition of compensation expense
for all stock-based awards made to employees and directors based on estimated
fair values on the grant date. The Company adopted ASC 718 on January 1, 2006.
The Company estimates the fair value of stock-based awards on the date of grant
using the Black-Scholes model. The value of the portion of the award
that is ultimately expected to vest is recognized as expense over the requisite
service periods using the straight-line method. The Company estimates
forfeitures at the time of grant and revise our estimate in subsequent periods
if actual forfeitures differ from those estimates.
F-15
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
The
Company accounts for stock-based compensation awards to non-employees in
accordance with FASB ASC Topic 505-50, Equity-Based Payments to
Non-Employees (“ASC 505-50”). Under ASC 505-50, the Company
determines the fair value of the warrants or stock-based compensation awards
granted as either the fair value of the consideration received or the fair value
of the equity instruments issued, whichever is more reliably
measurable.
All
issuances of stock options or other equity instruments to non-employees as
consideration for goods or services received by the Company are accounted for
based on the fair value of the equity instruments issued. Any stock options
issued to non-employees are recorded as an expense and additional paid-in
capital in stockholders’ equity over the applicable service periods using
variable accounting through the vesting dates based on the fair value of the
options at the end of each period.
The
following table sets forth the total stock-based compensation expense and
issuance of common stock for services included in the consolidated statements of
operations for the years ended June 30, 2010, 2009 and 2008 and from inception
to date.
Year Ended June 30,
|
Cummulative
|
|||||||||||||||
2010
|
2009
|
2008
|
From Inception
|
|||||||||||||
General
and administrative
|
433,414 | 445,255 | 749,100 | 9,164,710 | ||||||||||||
Research
and development
|
7,025 | 61,592 | 148,221 | 1,478,673 | ||||||||||||
Total
|
$ | 440,439 | $ | 506,847 | $ | 897,321 | $ | 10,643,383 |
The
Company estimated the fair value of each option grant throughout the year using
the Black-Scholes option-pricing model using the following assumptions for the
Plan:
Year Ended June 30,
|
||||||||||||
2010
|
2009
|
2008
|
||||||||||
Risk-free
interest rate (2)
|
2.0%-3.9%
|
1.3%-2.1%
|
1.9%-4.1%
|
|||||||||
Expected
volatility
|
100-106%
|
100%
|
100%
|
|||||||||
Dividend
yield
|
None
|
None
|
None
|
|||||||||
Expected
life (1)
|
3.5-6.2
|
3.0-5.5
|
4-6
|
|||||||||
(1) Expected
life was estimated using the “simplified” method, as allowed under the
provisions of the Securities and Exchange Commission Staff Accounting Bulletin
No. 110.
(2) Represents
the interest rate on a U.S. Treasury security with a maturity date corresponding
to that of the option term.
The
economic values of the options will depend on the future price of the Company's
common stock, par value $0.01 (the “Common Stock”), which cannot be forecast
with reasonable accuracy.
Research
and Development
Research
and development costs are expensed as incurred.
F-16
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
Supplemental
Cash Flow Information
Cumulative
|
||||||||||||||||
Year Ended June 30,
|
Amounts
from
|
|||||||||||||||
2010
|
2009
|
2008
|
Inception
|
|||||||||||||
Supplemental
disclosure of non-cash transactions:
|
||||||||||||||||
Conversion
of convertible note into common stock
|
$ | 9,455,000 | $ | 45,000 | $ | 500,000 | $ | 10,000,000 | ||||||||
Conversion
of bridge notes into common stock
|
- | - | - | 534,316 | ||||||||||||
Conversion
of preferred stock into common stock
|
70,687 | - | - | 70,687 | ||||||||||||
Allocation
of preferred stock proceeds to warrants and beneficial conversion
feature
|
7,089,047 | - | - | 7,089,047 | ||||||||||||
Allocation
of convertible debt proceeds to warrants and beneficial conversion
feature
|
- | - | 9,340,000 | 9,340,000 | ||||||||||||
Warrants
issued for financing costs
|
51,339 | - | 639,645 | 690,984 | ||||||||||||
Issuance
of common stock for interest payments on convertible notes
|
552,673 | 1,007,244 | 434,154 | 2,003,386 |
Recent
Accounting Pronouncements Applicable to the Company
In
January 2010, the Financial Accounting Standards Board (FASB) issued guidance
that amends ASC Topic 820, Fair Value Measurements and Disclosures, that
requires reporting entities to make new disclosures about recurring or
nonrecurring fair-value measurements including significant transfers into and
out of Level 1 and Level 2 fair-value measurements and information about
purchases, sales, issuances, and settlements on a gross basis in the
reconciliation of Level 3 fair-value measurements. This guidance also clarifies
existing fair-value measurement disclosure guidance about the level of
disaggregation, inputs, and valuation techniques. Except for the detailed Level
3 roll forward disclosures, the guidance is effective for reporting periods
beginning after December 15, 2009 and did not have an impact on the Company’s
consolidated financial statements.
In March
2010, the FASB issued new guidance that updates ASC Topic 605, Revenue
Recognition, which addresses accounting for arrangements in which a vendor
satisfies its performance obligations over time, with all or a portion of the
consideration contingent on future events, referred to as “milestones.” The
Milestone Method of Revenue Recognition is limited to arrangements which involve
research or development activities. A milestone is defined as an event for
which, at the date the arrangement is entered into, there is substantive
uncertainty whether the event will be achieved, and the achievement of the event
is based in whole or in part on either the vendor’s performance or a specific
outcome resulting from the vendor’s performance. In addition, the achievement of
the event would result in additional payments being due to the vendor. The
Milestone Method of Revenue Recognition allows a vendor to adopt an accounting
policy to recognize arrangement consideration that is contingent on the
achievement of a substantive milestone in its entirety in the period the
milestone is achieved. The Milestone Method of Revenue Recognition is effective
on a prospective basis, with an option for retrospective application for
milestones achieved in fiscal years and interim periods within those fiscal
years beginning on or after June 15, 2010. Early adoption is permitted. If an
entity elects early application in a period that is not the first reporting
period of its fiscal year, then the guidance must be applied retrospectively
from the beginning of that fiscal year. The Company will determine the impact of
the new accounting standard as it enters into new revenue arrangements that
include the achievement of milestones and earns payments under either new or
existing revenue arrangements.
F-17
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
3.
|
Investments:
|
At June
30, 2009, the amortized cost basis, aggregate fair value, gross unrealized gains
and maturity by majority security type were as follows:
Gross Unrealized
|
||||||||||||||||
Amortized Cost
|
Gains
|
Losses
|
Fair Market Value
|
|||||||||||||
June
30, 2009:
|
||||||||||||||||
Held-to-maturity
securities:
|
||||||||||||||||
U.S.
Treasury Notes
|
$ | 1,050,000 | $ | - | $ | - | $ | 1,050,000 |
4.
|
Fair Value
Measurements:
|
The
following tables provide the assets and liabilities carried at fair value
measured on a recurring basis as of June 30, 2010 and 2009:
Fair
Value Measurement at June
30,
|
||||||||||||||||
Carrying
|
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 | $ | - | ||||||||
Fair
Value Measurement at June
30,
|
||||||||||||||||
Carrying
|
2009
|
|||||||||||||||
Value
|
Level
1
|
Level
2
|
Level
3
|
|||||||||||||
Assets:
|
||||||||||||||||
Cash
and cash equivalents
|
$ | 380,569 | $ | 380,569 | ||||||||||||
U.S.
Treasury Notes
|
1,050,000 | 1,050,000 | $ | - | $ | - | ||||||||||
$ | 1,430,569 | $ | 1,430,569 | $ | - | $ | - |
F-18
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
5.
|
Equipment, Furniture and
Fixtures:
|
Equipment,
Furniture and Fixtures consist of the following:
June 30,
|
||||||||
2010
|
2009
|
|||||||
Equipment
|
$ | 24,566 | $ | 39,909 | ||||
Furniture
and fixtures
|
67,674 | 67,674 | ||||||
92,240 | 107,583 | |||||||
Less—Accumulated
depreciation
|
(87,686 | ) | (101,597 | ) | ||||
$ | 4,554 | $ | 5,986 |
Depreciation
expense aggregated $2,548, $3,646, $4,850 and $173,625 for the years ended June
30, 2010, 2009, 2008, and cumulatively from inception through June 30, 2010,
respectively.
6.
|
Intangible
assets:
|
Intangible
assets consist of the following:
June 30,
|
||||||||
2010
|
2009
|
|||||||
Patents
approved
|
$ | 850,419 | $ | 830,152 | ||||
Patents
pending
|
4,243,859 | 3,456,211 | ||||||
5,094,278 | 4,286,363 | |||||||
Accumulated
amortization
|
(525,383 | ) | (401,364 | ) | ||||
$ | 4,568,895 | $ | 3,884,999 |
Amortization
expense amounted to $124,019, $108,107, $91,997 and $525,383 for the years ended
June 30, 2010, 2009, 2008, and cumulatively from inception through June 30,
2010, respectively.
Estimated
amortization expense for the next five years is as follows:
Year
ended June 30,
|
||||
2011
|
$ | 175,000 | ||
2012
|
175,000 | |||
2013
|
175,000 | |||
2014
|
175,000 | |||
2015
|
175,000 |
F-19
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
7.
|
Accrued
Expenses:
|
Accrued
expenses were comprised of the following:
June 30,
|
||||||||
2010
|
2009
|
|||||||
Accrued
research
|
$ | 218,514 | $ | 152,226 | ||||
Accrued
dividends payable
|
230,875 | - | ||||||
Accrued
director fees
|
29,041 | 44,800 | ||||||
Accrued
patent costs
|
36,962 | 96,313 | ||||||
Accrued
legal
|
29,682 | 43,216 | ||||||
Accrued
other
|
31,783 | 19,382 | ||||||
$ | 576,857 | $ | 355,937 |
8.
|
Line
of Credit:
|
On
February 17, 2010, the Company entered into a credit agreement with JMP
Securities LLC. The agreement provides the Company with, subject to
certain restrictions, including the existence of suitable collateral, up to a
$3.0 million line of credit upon which the Company may draw at any time (the
“Line of Credit”). Any draws upon the Line of Credit accrue at a
monthly interest rate of (i) the broker rate in effect at the time of the draw
(which was 2.0% at June 30, 2010), plus (ii) 2.75%. There are no
other conditions or fees associated with the Line of Credit. The Line
of Credit is not secured by any assets of the Company, but it is secured by
certain assets of one of the Company’s Board of Directors, Harlan W. Waksal,
M.D., which is currently held by JMP Securities. The balance
outstanding as of June 30, 2010 is $2,194,844.
9.
|
Convertible
Notes:
|
On August
1, 2007 and August 29, 2007, the Company entered into a binding Securities
Purchase Agreement to issue $5,000,000 of 8% Convertible Notes to YA
Global Investments L.P. (“YA Global”) and $5,000,000 of 8%
Convertible Notes to Stanford Venture Capital Holdings, Inc. (“Stanford”) for
aggregate gross proceeds of $10,000,000. The convertible notes were
originally convertible into the Company’s common stock at a fixed price of $0.90
per share, subject to certain adjustments through August 1, 2009 and December
20, 2009, respectively, at which time the convertible notes could convert into
shares of the Company’s common stock at the lower of the fixed conversion price
or 80% of the lowest daily volume-weighted average price (the “VWAP”), of the
common stock during the five trading days prior to the conversion date. The
maturity date of each of the convertible notes for YA Global and Stanford was
December 30, 2010 and December 31, 2010, respectively.
The
convertible notes accrued interest on their outstanding principal balances at an
annual rate of 8%. The Company had the option to pay interest in cash
or, upon certain conditions, common stock. If the Company paid
interest in common stock, the stock would be valued at a 10% discount to the
average daily VWAP for the five day trading period prior to the interest payment
date (the “Interest Shares”).
The
agreements with YA Global and Stanford provided for the issuance of warrants to
purchase an aggregate of 5,550,000 and 8,333,333, respectively, of the Company’s
Common Stock, exercisable six months and one day from the date of issuance until
their expiration on the date that is five years from the date of
issuance. The warrants have been issued in two series. The exercise
price of the Series A warrants is $1.01 per share, and the exercise price of the
Series B warrants was $0.90 per share, subject to certain
adjustments. The warrants provide a right of cashless exercise if, at
the time of exercise, there is no effective registration statement registering
the resale of the shares underlying the warrants.
F-20
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
The
conversion rate of each convertible note and the exercise price of the Series B
warrants are subject to adjustment for certain events, including dividends,
stock splits, combinations and the sale of the Company’s Common Stock or
securities convertible into or exercisable for the Company’s Common Stock at a
price less than the then applicable conversion or exercise price. As
of June 30, 2010, the exercise price of the Series B warrants has been adjusted
to $0.50 per share.
During
the year ended June 30, 2008, $7,931,875 of the total net proceeds of $9,340,000
from the convertible notes was allocated to the warrants based upon the fair
value of the warrants which was determined using the Black-Scholes
model. The remaining $1,408,125 was allocated to the beneficial
conversion feature based upon the effective conversion price of the Convertible
Notes compared to the fair value of the common stock on the date of issuance of
the convertible notes and warrants.
Debt
discount associated with the Convertible Notes which amounted to $10,000,000 was
being amortized to interest expense, using the effective yield method, over the
remaining life of the Convertible Notes. Upon conversion or
redemption of the Convertible Notes into Common Stock, any unamortized debt
discount relating to the portion converted or redeemed was charged to interest
expense.
The
material factors incorporated in the Black-Scholes model in estimating the value
of the warrants include the following:
Estimated
life in years
|
5.0
|
Risk-free
interest rate
|
3.5%
- 4.4%
|
Volatility
|
100%
|
Dividend
paid
|
None
|
In
connection with the issuance of the Convertible Notes, the Company incurred
costs in the amount of $1,291,427 which was recorded as deferred financing costs
and was being amortized ratably over the term of the convertible
notes. During the year ended June 30, 2010, as a result of the
conversion and redemption of the Convertible Notes, the remaining balance of the
deferred financing costs which amounted to $632,324 was fully
amortized.
During
the year ended June 30, 2010, YA Global converted $2,619,360 of their
convertible notes into 9,635,093 shares of common stock. From the
inception of the convertible notes, YA Global converted $3,164,360 of the
convertible notes into 10,250,648 shares of common stock. On March 3,
2010, YA Global and the Company entered into a letter agreement pursuant to
which the Company purchased from YA Global all of its remaining outstanding
convertible notes, which in the aggregate totaled $1,835,640, for an aggregate
purchase price of $2,144,844, including accrued interest of $33,859 on the
convertible notes. As a result of this transaction, the Company
recorded a loss on the extinguishment of debt in the amount of
$275,345. In addition, the Company purchased from YA Global warrants
to purchase 2,775,000 shares of the Company’s common stock at an exercise price
of $1.01 per share, for a purchase price of $50,000.
During
the year ended June 30, 2010, certain members of the Company’s board of
directors acquired all of the $5,000,000 of convertible notes and warrants
previously issued to Stanford and converted the $5,000,000 of convertible notes
into 6,024,096 shares of common stock at a conversion price of
$0.83.
Total
charges to interest for amortization of debt discount were $9,448,783, $51,160,
$500,057 and $10,000,000 for the years ended June 30, 2010, June 30, 2009 and
June 30, 2008 and from inception through June 30, 2010,
respectively.
F-21
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
10.
|
Warrant
Liabilities:
|
Effective
July 1, 2009, the Company adopted the provisions of FASB Topic ASC 815-40,
Determining Whether an Instrument (or Embedded Feature) is Indexed to an
Entity's Own Stock (“ASC 815-40”). FASB ASC 815-40 applies to any
freestanding financial instruments or embedded features that have the
characteristics of a derivative, and to any freestanding financial instruments
that are potentially settled in an entity’s own common stock. As a
result of adopting FASB ASC 815-40, as of July 1, 2009, 6,941,666 of the
Company’s issued and outstanding common stock warrants previously accounted for
as equity pursuant to the derivative treatment exemption should no longer be
accounted for as equity. As such, effective July 1, 2009, the Company
reclassified the fair value of these common stock purchase warrants, which have
exercise price reset features, from equity to a liability. On July 1,
2009, using the Black Sholes model, the Company reclassified, as a cumulative
effect adjustment, a total of the difference in fair value of $4,731,767, which
represents the difference between the fair value on the dates of issuance of
$7,931,875 and the fair value on July 1, 2009 of $3,200,108 from additional paid
in capital to deficit accumulated during the development
stage. Additionally, the Company recorded a warrant liability in the
amount of $3,200,108 to recognize the fair value of such warrants at July 1,
2009.
The
effect on the net loss for the year ending June 30, 2009 would have been a
reduction of $7,080,499, which would have resulted in net income of
$1,353,630. The effect on the basic net loss per common share would
have been a reduction of $0.38 which would have resulted in basic net income per
common share of $0.08.
As
discussed in note 11, in connection with a private placement of preferred stock
and warrants, on April 1, 2010 and June 2, 2010 the Company issued 33,257,813
warrants and 3,750,000 warrants, respectively. In accordance with ASC
480-10, Distinguishing Liabilities from Equity, the Company determined that such
warrants are to be accounted for as liabilities. Using the Black
Sholes valuation model, the Company recorded a warrant liability in the amount
of $1,581,409 and $228,938, respectively related to the warrants on the issuance
date.
On June
30, 2010, the Company revalued all of the warrant liabilities, using the Black
Scholes model and recorded a gain on the change in fair value of the warrant
liabilities amounting to $2,516,661 in the Consolidated Statement of Operations
for the year ended June 30, 2010. The fair value of the warrant
liabilities at June 30, 2010 was $2,493,794.
F-22
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
The
assumptions used to value the warrants were as follows:
July 1, 2009
|
June 30, 2010
|
|||
Warrants
issued on December 20, 2007
|
||||
Estimated
life in years
|
3.5
|
2.5
|
||
Risk-free
interest rate (1)
|
1.64%
|
0.80%
|
||
Volatility
|
100%
|
106%
|
||
Dividend
paid
|
None
|
None
|
||
July 1, 2009
|
June 30, 2010
|
|||
Warrants
issued on June 30, 2008
|
||||
Estimated
life in years
|
4.0
|
3.0
|
||
Risk-free
interest rate (1)
|
1.64%
|
1.00%
|
||
Volatility
|
100%
|
106%
|
||
Dividend
paid
|
None
|
None
|
||
April 1, 2010
|
June 30, 2010
|
|||
Warrants
issued on April 1, 2010
|
||||
Estimated
life in years
|
5.0
|
4.75
|
||
Risk-free
interest rate (1)
|
2.59%
|
1.79%
|
||
Volatility
|
100%
|
106%
|
||
Dividend
paid
|
None
|
None
|
||
June 2, 2010
|
June 30, 2010
|
|||
Warrants
issued on June 2, 2010
|
||||
Estimated
life in years
|
5.0
|
4.9
|
||
Risk-free
interest rate (1)
|
2.14%
|
1.79%
|
||
Volatility
|
106%
|
106%
|
||
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.
|
11.
|
Stockholders’
Equity:
|
Preferred
Stock
Series
A Preferred Stock
On April
1, 2010, the Company sold 10,297 shares of 10% Series A preferred stock to
non-affiliated purchasers for cash. The Company received gross proceeds in the
amount of $10,297,000 and net proceeds in the amount of $9,554,841.
Pursuant
to the Agreements, the Series A Preferred Stock is convertible into
approximately 32,178,125 shares of the Company’s common stock. In addition, the
Series A Preferred shareholders received immediately exercisable warrants to
purchase up to approximately 32,178,125 shares.
F-23
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
Series
B Preferred Stock
On June
2, 2010, the Company sold 1,200 shares of 10% Series B Preferred Stock to
affiliated purchasers for cash. The Company received proceeds in the
amount of $1,200,000.
Pursuant
to the agreement, the Series B Preferred Stock is convertible into approximately
3,750,000 shares of Common Stock. In addition, the Series B Preferred
Shareholders received immediately exercisable warrants to purchase up to
approximately 3,750,000 shares of Common Stock.
Each
share of Preferred Stock has a stated value of $1,000 (the “Stated Value”). Each
holder of shares of Preferred Stock is entitled to receive semi-annually
dividends at the rate of 10% per annum of the Stated Value for each share of
Preferred Stock held by such holder. Except in limited circumstances, the
Company can elect to pay the dividends in cash or shares of Common
Stock. If the dividends are paid in shares of Common Stock, such
shares will be priced at the lower of 90% of the average VWAP for the 20 days
immediately preceding the payment date or $0.224. The dividends are
subject to a 30% make whole provision.
The
shares of Preferred Stock are convertible into shares of Common Stock at an
initial conversion price of $0.32 per share and are convertible at any time, The
conversion price is subject to adjustment if the Company sells or grants any
common stock or common stock equivalents, subject to certain exclusions, at an
effective price per share that is lower than the conversion price of the
Preferred Stock. After 18 months from the date of issuance of the
Preferred Stock, if the Company’s Common Stock trades above $0.80 for 20 out of
30 consecutive trading days, the Preferred Stock will no longer be subject to
adjustment.
The
Company may force conversion of the Preferred Stock if the Company’s Common
Stock trades above $0.80 for 20 out of 30 consecutive trading days and there is
an effective registration statement for the underlying Common Stock or such
underlying Common Stock is freely tradable under rule 144.
Warrants
Pursuant
to the Purchase Agreements, the Company delivered a Series A Warrant to the
Non-Affiliate Investors and a Series B Warrant to the Affiliate Investors (the
“Warrants”). Each Warrant has an initial exercise price of $0.35 per
share of Common Stock. The Warrants are immediately exercisable and have a five
year term. The Series A Warrants also contain a provision which limits the
holder’s beneficial ownership to a maximum of 4.99% (which percentage may be
increased to 9.99% upon 60 days notice to the Company).
Placement Agent
Warrants
On April
1, 2010, in connection with the issuance of the Series A Preferred Stock, the
Company issued warrants to purchase 1,079,688 shares of the Company’s common
stock as partial compensation for services related to the raising of the
capital. Each Warrant has an initial exercise price of $0.35 per
share of Common Stock. The Warrants are immediately exercisable and have a five
year term. In accordance with ASC 480-10, Distinguishing Liabilities
from Equity, the Company determined that such warrants are to be accounted for
as a liability. Accordingly, using the Black Scholes model, the
Company recorded a warrant liability in the amount of $51,339 related to the
warrants on the issuance date. The Company recorded a charge to
additional paid in capital as an additional cost of capital.
Registration Rights
Agreement
The
Company also entered into a Registration Rights Agreement by and among the
Company and the Series A Preferred shareholders (the “Registration Rights
Agreement”). The Series B Preferred shareholders are not a
party to the Registration Rights Agreement. Pursuant to the
Registration Rights Agreement, the Company agreed to file a registration
statement (the “Registration Statement”) with the Securities and Exchange
Commission within, except for certain limited exceptions, 30 days of closing the
offering (the “Filing Deadline”) to register the shares of Common Stock issuable
upon conversion or exercise of the shares of Series A Preferred Stock and the
Warrants, as the case may be (collectively, the “Underlying Shares”). In the
event the Company did not file the Registration Statement on or before the
Filing Deadline, the Company would have been required to pay liquidated damages
in an amount equal to 1% of the aggregate amount purchase price paid by the
holder for any unregistered securities then held by such Investor up to a
maximum of 3%. The Company filed such registration statement on April 23, 2010
and such registration statement was declared effective on June 23,
2010. The Company must file additional registration statements until
all of the securities may be sold pursuant to an effective registration
statement or the securities become eligible for sale under Rule 144 of the
Securities Act of 1933, as amended.
F-24
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
As
discussed in note 10 above, the Company is required to record the warrants as
liabilities. As a result, the Company must allocate the proceeds to
the warrants based upon their fair value with the remainder of the proceeds
allocated to the preferred stock. The Company allocated the gross
proceeds of the offering as follows:
Series
A
|
Series
B
|
|||||||||||
Preferred Stock
|
Preferred Stock
|
Total
|
||||||||||
Total
gross proceeds
|
$ | 10,297,000 | $ | 1,200,000 | $ | 11,497,000 | ||||||
Allocated
to warrants
|
(1,530,070 | ) | (228,938 | ) | (1,759,008 | ) | ||||||
Allocated
to preferred stock
|
$ | 8,766,930 | $ | 971,062 | $ | 9,737,992 |
Due to
the allocation of the proceeds to the fair value of the warrant at the issuance
dates, the convertible feature of the Preferred Stock was below market value.
Such feature, as it specifically relates to the convertible feature of the
Preferred Stock, is characterized as a “Beneficial Conversion Feature” (“BCF”).
Pursuant to existing accounting standards, FASB ASC topic 470.20 – Debt with
Conversion and Other Options”, the estimated relative fair value of the BCF was
$15,068,031. The value of the BCF which amounted to $5,330,039 was determined
utilizing an intrinsic value method with the fair value of the warrants
determined using the Black-Scholes model at the date of issuance. Per the
guidance of accounting standards, the value of the BCF is treated as a deemed
dividend to the Preferred stockholders and, due to the potential immediate
convertibility of the Preferred stock at issuance, this value is recorded as an
increase to both additional-paid-in-capital and accumulated deficit at the time
of issuance.
Common
Stock
On
September 22, 2009, the stockholders approved a proposal to increase the
authorized Common Stock of the Company from 100,000,000 shares to 120,000,000
shares. On May 25, 2010, the stockholders approved a proposal to
increase the authorized Common Stock of the Company from 120,000,000 shares to
250,000,000 shares.
In July
2009 and September 2009, the Company issued 1,555,555 shares of common stock in
a private placement to unaffiliated investors. The Company received
total gross proceeds in the amount of $1,400,000.
In
connection with the private placement to the unaffiliated investors in July and
September 2009, the Company issued Series A warrants to purchase 1,400,000
shares of the Company’s common stock at $0.01 per warrant share. The
Series A Warrants have a term of seven years and were exercisable immediately
after the date of grant. The Company also issued Series B Warrants to
purchase 2,461,110 shares of the Company’s common stock at $0.60 per warrant
share. The Series B Warrants have a term of seven years and were not
exercisable until after the six-month anniversary from the date of
grant.
Additionally,
on September 30, 2009, the Company issued 144,444 shares of common stock in a
private placement to affiliated investors. The Company received total
gross proceeds in the amount of $130,000.
In
connection with the private placement to the affiliated investors on September
30, 2009, the Company issued Series A warrants to purchase 130,000 shares of the
Company’s common stock at $0.01 per warrant share. The Series A
Warrants have a term of seven years and were exercisable immediately after the
date of grant. The Company also issued Series B Warrants to purchase
131,807 shares of the Company’s common stock at $0.60 per warrant
share. The Series B Warrant has a term of seven years and was not
exercisable until after the six-month anniversary from the date of
grant.
F-25
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
Also, on
September 30, 2009, the Company issued 194,444 Shares of the Company’s common
stock at $0.90 per share, a Series A warrant and a Series B warrant in exchange
for the extinguishment of an accounts payable due to the vendor amounting to
$175,000.
The
Series A Warrant entitles the holder to purchase in the aggregate, up to 175,000
shares of the Company’s common stock at $0.01 per warrant share, has a term of
seven years and was exercisable immediately after the date of grant. The Series
B Warrant entitles the holder to purchase, up to 177,431 shares of the Company’s
common stock at $0.60 per warrant share, has a term of seven years and was not
exercisable until after the six-month anniversary from the date of
grant.
The
transaction was accounted for as an extinguishment of debt. The
Company valued the common stock and warrants issued at fair value on the date of
the closing which amounted to $261,532 and recorded a loss on the extinguishment
of debt in the amount of $86,532 for the year ended June 30, 2010.
In
connection with the July 2009 and September 2009 private placements, the Company
incurred $180,862 in issuance costs which has been recorded as a charge to
Capital in Excess of Par Value.
12.
|
Stock-Based
Compensation
|
In
December 2008, the Company adopted the 2008 Incentive Compensation Plan (the
"2008 Plan"), which provides for the grant of stock options, stock grants and
stock purchase rights to certain designated employees and certain other persons
performing services for the Company, as designated by the board of
directors. Pursuant to the 2008 Plan, an aggregate of 5,137,200
shares of common stock had been reserved for issuance. On May 25,
2010, the Company increased the aggregate shares of common stock reserved for
issuance under the 2008 Plan to 11,137,200. The 2008 Plan is intended
to serve as a successor to the Amended and Restated 1998 Stock Incentive Plan
(the “1998 Plan”), which terminated in December 2008. To the extent
that any of the 4,548,384 options or restricted stock units issued under the
1998 Plan subsequently expire unexercised or without the issuance of shares
thereunder, the number of shares of common stock subject to those expired
options and restricted stock units will be added to the share reserve available
for issuance under the 2008 Plan, up to an additional 1,000,000
shares. On February 19, 2009, the Company filed a registration
statement with the SEC to register all of the 6,137,200 shares of Common Stock
underlying the 2008 Plan. On June 8, 2010, the Company filed with the
SEC an amendment to the registration statement to register the additional
5,000,000 shares of Common Stock underlying the 2008 Plan. The registration
statement and amendment was deemed effective upon filing.
The terms
and vesting schedules for share-based awards vary by type of grant and the
employment status of the grantee. Generally, the awards vest based
upon time-based conditions or achievement of specified goals and
milestones.
F-26
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
Stock
option activity under the 2008 Plan and 1998 Plan is summarized as
follows:
Weighted
|
||||||||
Aggregate
|
Average
|
|||||||
Number
|
Exercise Price
|
|||||||
Outstanding,
July 31, 2007
|
2,646,000 | $ | 2.33 | |||||
Granted
|
1,069,600 | 0.99 | ||||||
Exercised
|
- | - | ||||||
Cancelled
|
- | - | ||||||
Expired
|
- | - | ||||||
Outstanding,
June 30, 2008
|
3,715,600 | 1.95 | ||||||
Granted
|
834,812 | 0.59 | ||||||
Exercised
|
- | - | ||||||
Cancelled
|
- | - | ||||||
Expired
|
- | - | ||||||
Outstanding,
June 30, 2009
|
4,550,412 | 1.70 | ||||||
Granted
|
2,951,760 | 0.43 | ||||||
Exercised
|
- | - | ||||||
Cancelled
|
- | - | ||||||
Expired
|
(233,000 | ) | 3.45 | |||||
Outstanding,
June 30, 2010
|
7,269,172 | $ | 1.13 | |||||
Options
exercisable at June 30, 2010
|
5,146,671 | $ | 1.34 | |||||
Options
exercisable at June 30, 2009
|
3,667,412 | $ | 1.90 | |||||
Options
exercisable at June 30, 2008
|
2,778,336 | $ | 2.25 | |||||
Weigthed
average fair value of options granted during the year ended June 30,
2010
|
$ | 0.33 | ||||||
Weigthed
average fair value of options granted during the year ended June 30,
2009
|
$ | 0.45 | ||||||
Weigthed
average fair value of options granted during the year ended June 30,
2008
|
$ | 0.76 |
Non-vested
stock option activity under the Plan is summarized as follows:
Weighted-average
|
||||||||
Number
of
|
Grant-Date
|
|||||||
Options
|
Fair Value
|
|||||||
Non-vested
stock options at July 1, 2009
|
883,000 | $ | 0.66 | |||||
Granted
|
2,951,760 | 0.33 | ||||||
Vested
|
(1,708,259 | ) | 0.32 | |||||
Forfeited
|
(4,000 | ) | 0.60 | |||||
Outstanding,
June 30, 2010
|
2,122,501 | $ | 0.48 |
F-27
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
As of
June 30, 2010, the aggregate intrinsic value of stock options outstanding was
$28,825, with a weighted-average remaining term of 7 years. The
aggregate intrinsic value of stock options exercisable at that same date was
$18,025, with a weighted-average remaining term of 6 years. As of
June 30, 2010, the Company has 7,935,712 shares available for future stock
option grants.
As of
June 30, 2010, total estimated compensation expense not yet recognized related
to stock option grants amounted to $607,770, which will be recognized over the
next 48 months, and an additional $467,500 which may be recognized as
achievement of certain target goals under the Company’s Long-Term Incentive
Program become probable over the next 6 months.
Warrants
Total
outstanding warrants at June 30, 2010 were as follows:
Strike Price
|
Warrants
|
|||||
$ | 7.00 | 10,000 | ||||
$ | 3.45 | 15,000 | ||||
$ | 3.15 | 20,000 | ||||
$ | 2.35 | 15,000 | ||||
$ | 2.15 | 110,000 | ||||
$ | 1.40 | 5,000 | ||||
$ | 1.18 | 993,153 | ||||
$ | 1.08 | 2,500 | ||||
$ | 1.07 | 139,041 | ||||
$ | 1.01 | 5,900,000 | ||||
$ | 0.99 | 1,000 | ||||
$ | 0.90 | 388,889 | ||||
$ | 0.74 | 151,314 | ||||
$ | 0.60 | 2,770,850 | ||||
$ | 0.50 | 6,941,666 | ||||
$ | 0.35 | 37,007,813 | ||||
$ | 0.01 | 700,000 | ||||
55,171,226 |
As of
June 30, 2010, 55,171,060 of the above warrants are exercisable expiring at
various dates through 2016. At June 30, 2010, the weighted-average
exercise price on the above warrants was $0.47.
Short-Term
Incentive Program
Year
ended June 30, 2009
In
November 2008, the Company adopted a Short-Term Equity Incentive Program for key
employees in which shares of the Company’s Common Stock, or options to acquire
shares of the Company’s Common Stock would be awarded, if the Company achieved
certain target goals relating to research, financing, licensing, investor
relations and other administrative items during the fiscal year ending June 30,
2009. The number of eligible shares and options to be awarded to the employees
was based upon certain performance criteria as defined in the incentive
program.
F-28
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
As of
June 30, 2009, the Company had determined that the achievement of the target
goals was probable and issued 116,000 Restricted Stock Units (“RSU”) and 124,000
options to purchase common stock with a fair value based upon the Black Scholes
model of $140,480. As a result, the Company recognized the fair
value of the awards as compensation expense ratably over the seven and one-half
month period from November 19, 2008 through June 30, 2009. In October
2009, it was determined that the executive officers had partially achieved the
previously granted short-term performance milestones and the number of RSU’s and
options to purchase common stock which vested were reduced. As a result,
compensation expense was reduced by $13,840 during the year ended June 30,
2010.
Year
ended June 30, 2008
In
December 2007, the Company adopted a Short-Term Equity Incentive Program for key
employees in which shares of the Company’s Common Stock, or options to acquire
shares of the Company’s Common Stock would be awarded, if the Company achieved
certain target goals relating to research, financing, licensing, investor
relations and other administrative items during the fiscal year ending June 30,
2008. The number of eligible shares and options to be awarded to the employees
was based upon certain performance criteria as defined in the incentive
program.
As of
June 30, 2008, the target goals were achieved and the Company issued 112,700
shares of the Company’s common stock and 124,600 options to purchase common
stock with a fair value based upon the Black Scholes model of
$206,269. As a result, the Company recognized the fair value of
the awards as compensation expense ratably over the seven and one-half month
period from December 19, 2007 through June 30, 2008.
Long-Term
Incentive Program
On
December 13, 2007, the Company adopted a Long-Term Equity Incentive Program for
the members of the executive management team in which key employees will be
awarded shares of the Company’s Common Stock and options to acquire shares of
the Company’s Common Stock if the Company achieves certain target goals relating
to its Multiple Myeloma research project over the three fiscal year period from
the date of adoption.
As of
June 30, 2010, the Company was not able to determine if the achievement of the
target goals under the Long-Term Equity Incentive Program are probable and,
therefore, has not yet begun to recognize any of the $467,500, net of
forfeitures, of compensation expense that was computed on the date of adoption
of the Long-Term Equity Incentive Program. The Company will begin
recognizing such compensation expense ratably over the remaining term of the
Long-Term Equity Incentive Program at such time that the Company is able to
determine if the achievement of the target goals are probable.
13.
|
Income
Taxes:
|
The
provision for income taxes consists of the following:
Year Ended June 30,
|
||||||||||||
2010
|
2009
|
2008
|
||||||||||
Current
|
$ | - | $ | - | $ | - | ||||||
Deferred
|
17,923,000 | 11,520,000 | 9,152,000 | |||||||||
17,923,000 | 11,520,000 | 9,152,000 | ||||||||||
Valuation
allowance
|
(17,923,000 | ) | (11,520,000 | ) | (9,152,000 | ) | ||||||
Income
tax benefit
|
$ | - | $ | - | $ | - |
F-29
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
The
Company files a consolidated federal income tax return. The
subsidiary files separate state and local income tax returns.
The
reconciliation of the effective income tax rate to the federal statutory rate is
as follows:
June
30,
|
||||||||||||
2010
|
2009
|
2008
|
||||||||||
Federal
income tax provision at statutory rate
|
(34.0 | )% | (34.0 | )% | (34.0 | )% | ||||||
Fair
value - warrant liability
|
(6.4 | )% | - | - | ||||||||
Stock-based
compensation
|
1.1 | % | 0.5 | % | 0.5 | % | ||||||
Amortization
of debt discount and finance costs
|
1.5 | % | 5.8 | % | 2.9 | % | ||||||
Other
|
0.6 | % | 0.1 | % | 0.1 | % | ||||||
Change
in valuation allowance
|
37.2 | % | 27.6 | % | 30.5 | % | ||||||
Actual
income tax provision (benefit) effective tax rate
|
- | % | - | % | - | % |
The
deferred income tax asset consists of the following at:
June 30,
|
||||||||
2010
|
2009
|
|||||||
Deferred
tax assets:
|
||||||||
Net
operating loss carryforwards
|
$ | 16,144,000 | $ | 9,791,000 | ||||
Stock-based
compensation
|
1,797,000 | 1,698,000 | ||||||
Other
|
(18,000 | ) | 31,000 | |||||
17,923,000 | 11,520,000 | |||||||
Valuation
allowance
|
(17,923,000 | ) | (11,520,000 | ) | ||||
Net
deferred tax asset
|
$ | - | $ | - |
At June
30, 2010, the Company has federal and state net operating loss carryforwards of
approximately $41,466,000 and $34,101,000, respectively, available to offset
future taxable income expiring on various dates through 2030. The
timing and extent to which the Company can utilize future tax deductions in any
year may be limited by provisions of the Internal Revenue Code regarding changes
in ownership of Corporations (i.e. IRS Code Section 382).
14.
|
Commitments:
|
Research
Agreement
Effective
September 1, 1998, the Company entered into a research and development
agreement, which has subsequently been renewed, with The University of Waterloo
which Dr. John Thompson, who is an officer, director and stockholder of the
Company, is affiliated with. Pursuant to the agreement, the
university provides research and development under the direction of the
researcher and the Company. The agreement is renewable annually by
the Company which has the right of termination upon 30 days' advance written
notice. Effective September 1, 2009, the Company extended the
research and development agreement for an additional one-year period through
August 31, 2010, in the amount of Can $650,400, or approximately U.S.
$650,400. Effective September 1, 2010, the Company extended the
research and development agreement for an additional three-month period through
November 30, 2010, in the amount of Can $164,200, or approximately U.S.
$164,200. Research and development expenses under this agreement for
the years ended June 30, 2010, 2009 and 2008 aggregated U.S. $672,693, U.S.
$653,104 and U.S. $730,960, respectively, and U.S. $5,953,061 for the cumulative
period through June 30, 2010. Future obligations to be paid under the
agreement through November 30, 2010 equal approximately U.S.
$383,000.
F-30
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
Supply
and service agreements
On June
27, 2008, the Company entered into a supply agreement with VGXI, Inc. (“VGXI”)
under which VGXI will supply the Company with the plasmid portion of the
Company’s combination therapy consisting of the Factor 5A gene and siRNA against
Factor 5A (the “Plasmid Product”). The agreement has an
initial term that commences on the date of the agreement and runs for a period
of five (5) years. The agreement shall, upon mutual agreement, renew
for consecutive one (1) year periods thereafter. The Company’s
financial obligation under the agreement is dependent upon the amount of Plasmid
Product ordered by the Company.
On June
30, 2008, the Company entered into a supply agreement with POLYPLUS under which
POLYPLUS will supply the Company with its “in vivo-jetPEI” (the “Product”),
which is used for systemic delivery of the Company’s combination therapy of
siRNA against Factor 5A and a plasmid of the Factor 5A gene. The
agreement has an initial term which commences on the date of the agreement and
runs until the eighth anniversary of the first sale of the
Product. The agreement shall automatically renew for consecutive one
(1) year periods thereafter, except if terminated by either party upon six (6)
months written notice prior to the initial or any subsequent renewal
term. The Company’s financial obligation under the agreement is
dependent upon the amount of Product ordered by the Company.
On
September 4, 2008, the Company entered into a supply agreement with AVECIA under
which AVECIA will supply the Company with the siRNA portion of the Company’s
combination therapy consisting of the Factor 5A gene and siRNA against Factor 5A
(the “Plasmid Product”). The agreement has a term which commences on
the date of the agreement and terminates on the later of the completion of all
services to be provided under the agreement or 30 days following delivery of the
final shipment of product.
On April
8, 2010, the Company entered into a service agreement with BIORELIANCE under
which BIORELIANCE will perform a pivotal single dose and repeat dose toxicity
and biodistribution study. The agreement has a term which commences
on the date of the agreement and terminates when all of the services to be
provided under the agreement have been provided.
On May 7,
2010, the Company entered into a service agreement with CHARLES RIVER
LABORATORIES, INC. (“CHARLES RIVER”) under which CHARLES RIVER will perform a
pivotal single dose and repeat dose toxicity and histopathology
study. The agreement has a term which commences on the date of the
agreement and continues for five (5) years unless terminated earlier as defined
in the agreement.
In
the aggregate, the Company anticipates that it will pay approximately $660,000
under the terms of the supply and service agreements over to the next 12
months.
Consulting
and other Agreements
Effective
May 1, 1999, the Company entered into a consulting agreement for research and
development with Dr. John Thompson. The agreement was
renewed for an additional two-year term through June 30, 2011. Future
obligations to be paid under the agreement equal $65,000.
On May
25, 2010, the Company entered into an agreement with its current President and
CEO whereby, the Company will pay six months of severance in the event that the
President and CEO is terminated without cause within the first year of
employment, which would amount to $125,000.
The
Company is obligated under a non-cancelable operating lease of office space
expiring on May 31, 2011. The aggregate minimum future payments are
$73,568. Rent expense charged to operations aggregated $86,215, $84,768, $75,602
and $756,792 for the years ended June 30, 2010, 2009, 2008, and from inception
through June 30, 2010, respectively.
The lease
provides for scheduled increases in base rent. Rent expense is
charged to operations ratably over the term of the lease, which results in
deferred rent payable and represents the cumulative rent expense charged to
operations from inception of the lease in excess of the required lease
payments.
F-31
SENESCO
TECHNOLOGIES, INC. AND SUBSIDIARY
(A
DEVELOPMENT STAGE COMPANY)
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
15.
|
Collaborative
Arrangements:
|
On May
14, 1999, the Company entered into an agreement ("Collaboration") with an
Israeli partnership that is engaged in the worldwide marketing of tissue culture
plants. The purpose of the Collaboration is to develop enhanced
banana plants which will result in banana fruit with improved consumer- and
grower-driven traits. The program has been performed as a joint
collaboration whereby the Company pays for 50% of the research costs of the
program. The Company's portion of the expenses of the collaboration
approximated $214,000, $210,000 and $205,000 for the years ended June 30, 2010,
2009 and 2008, respectively, and is included in research and development
expenses.
In July
1999, the Collaboration applied for and received a conditional grant from the
Israel - United States Binational Research and Development Foundation (the "BIRD
Foundation"). This agreement, as amended, allowed the Collaboration
to receive $340,000 over a five-year period ending May 31,
2004. Grants received from the BIRD Foundation will be paid back only
upon the commercial success of the Collaborations technology, as
defined. The Company has received a total of $99,728, all of which
was received prior to the years ended June 30, 2010, June 30, 2009 and June 30,
2008.
F-32