UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 10-KSB

 

(Mark One)

 

ý

 

ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934.

 

 

 

 

 

For the fiscal year ended June 30, 2005

 

 

 

OR

 

 

 

o

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934.

 

 

 

 

 

For the transition period from                  to                       

 

Commission File No. 001-31326

 

SENESCO TECHNOLOGIES, INC.

(Name of Small Business Issuer 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

(Issuer’s Telephone Number,
Including Area Code)

 

Securities registered under Section 12(b) of the Exchange Act:

 

Title of each class

 

Name of each exchange on which registered

Common Stock, $0.01 par value per share.

 

American Stock Exchange

 

Securities registered under Section 12(g) of the Exchange Act:

 

None.

 

Check whether the issuer: (1) filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act during the past 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:

ý

 

No:

o

 

Check if there is no disclosure of delinquent filers in response to Item 405 of Regulation S-B contained in this form, and no disclosure will 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-KSB or any amendment to this Form 10-KSB. ý

 

State issuer’s revenues for fiscal year ended June 30, 2005:  $125,000

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

 

Yes:

o

 

No:

ý

 

State the aggregate market value of the voting common stock held by non-affiliates of the Registrant: $23,691,116 at August 31, 2005 based on the closing sales price on that date.

 

Indicate the number of shares outstanding of each of the Registrant’s classes of common stock, as of August 31, 2005:

 

Class

 

Number of Shares

 

 

 

Common Stock, $0.01 par value

 

15,467,388

 

Transitional Small Business Disclosure Format:

 

Yes:

o

 

No:

ý

 

The following documents are incorporated by reference into the Annual Report on Form 10-KSB:  Portions of the registrant’s definitive Proxy Statement for its 2005 Annual Meeting of Stockholders are incorporated by reference into Part III of this Report.

 

 



 

TABLE OF CONTENTS

 

 

Item

 

 

 

 

 

 

PART I

1.

Business

 

 

 

 

 

 

2.

Properties

 

 

 

 

 

 

3.

Legal Proceedings

 

 

 

 

 

 

4.

Submission of Matters to a Vote of Security Holders

 

 

 

 

 

PART II

5.

Market for Our Common Equity and Related Stockholder Matters

 

 

 

 

 

 

6.

Management’s Discussion and Analysis or Plan of Operation

 

 

 

 

 

 

7.

Financial Statements

 

 

 

 

 

 

8.

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

 

 

 

 

 

 

8A.

Controls and Procedures

 

 

 

 

 

PART III

9.

Directors and Executive Officers

 

 

 

 

 

 

10.

Executive Compensation

 

 

 

 

 

 

11.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

 

 

 

 

 

 

12.

Certain Relationships and Related Transactions

 

 

 

 

 

 

13.

Exhibits

 

 

 

 

 

 

14.

Principal Accountant Fees and Services

 

 

 

SIGNATURES

 

 

 

EXHIBIT INDEX

 

 

 

FINANCIAL STATEMENTS

 

 

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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 the research, development and commercial exploitation of a potentially significant platform technology involving the identification and characterization of genes that we believe control programmed cell death in plants, also known as senescence, and human cells, also known as apoptosis.

 

Agricultural Applications

 

Our goal for the agricultural applications of our technology is to enhance the quality and productivity of fruits, flowers, vegetables and agronomic crops by:

 

                  extending the shelf life of perishable produce;

 

                  producing larger and leafier crops;

 

                  increasing yield in horticultural and agronomic crops; and

 

                  reducing the harmful effects of environmental stresses and pathogens.

 

Senescence is the natural aging of plant tissues.  Loss of cellular membrane integrity is an early event during the senescence of all plant tissues that prompts the deterioration of fresh flowers, fruits and vegetables.  A decline in cell function ensues, leading to deterioration and eventual death, or spoilage, of the tissue.  A delay in senescence increases shelf life and extends the plant’s growth timeframe, which allows the plant to devote more time to the photosynthetic process.  In our greenhouse testing, we have shown that the additional energy gained during this period leads directly to increased seed and starch production, and therefore increases crop yield.  Seed production is a vital agricultural function.  For example, oil-bearing crops, such as corn, canola, soy and others, store oil in their seeds.  We have also shown that this reduction in premature senescence leads to larger plants, with increased biomass, and more leafy crops.  We have demonstrated that reducing premature senescence also results in crops which exhibit increased resilience to water deprivation and salt stress and require less fertilizer.  Most recently, we have shown that our technology confers increased disease resistance to fungal pathogens by preventing premature cell death.  These crops may ultimately be more cost effective due to reduced loss in the field and fewer resources devoted to crop management.

 

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 hence only has application to the limited number of plants that are ethylene-sensitive.  Our 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, deoxyhypusine synthase, or DHS, gene and Factor 5A gene in certain species of plants. Our goal is to inhibit the expression of, or silence, these genes to delay senescence, in order to achieve such traits as extended shelf

 

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life, increased biomass, increased yield and increased resistance to environmental stress and disease, thereby demonstrating proof of concept in each category of crop.  We have licensed this technology to various strategic partners and have entered into a joint venture, and we intend to continue to license this technology to additional strategic partners and/or enter into additional joint ventures.

 

We are currently working with lettuce, turfgrass, tomato, canola, Arabidopsis (a model plant that is similar to canola), banana, alfalfa, and certain species of trees and bedding plants, and we have obtained proof of concept for the use of the Factor 5A, DHS and lipase genes in several of these plants.  We have ongoing field trials of certain bedding plants, trees, lettuce and bananas with our respective partners.  The first round of lettuce field trials showed that our technology reduced browning of cut lettuce.  The banana field trials have shown that our technology can extend the shelf life of banana fruit by 100%.  In addition to the shelf life benefits, field trials conducted during the 2004-2005 winter generated encouraging disease resistance data specific to Black Sigatoka (Black Leaf Streak Disease), for banana plants.  Commercialization may require a combination of traits in a crop, such as both shelf life and disease resistance, or other traits.  Our near-term research and development initiatives include silencing or reducing the expression of DHS and Factor 5A genes in these plants and propagation and testing of plants with our silenced genes.

 

Human Health Applications

 

Inhibiting Apoptosis

 

Our preliminary research reveals that DHS and Factor 5A genes may regulate apoptosis in human cells.  In humans, there are two different isoforms of Factor 5A: the apoptosis isoform, which carries out cell death and the growth isoform, which carries out cell proliferation. We believe that our Factor 5A technology may have potential application as a means for controlling a broad range of apoptotic diseases, both inflammatory/ischemic diseases and cancers. We have commenced preclinical in-vivo and in-vitro research to determine Factor 5A’s ability to regulate key execution genes, inflammatory cytokines, receptors, and transcription factors, which are implicated in numerous apoptotic diseases.

 

We believe that our technology’s down-regulation of the cell death isoform of Factor 5A may have potential application as a means for controlling a broad range of diseases that are attributable to either premature apoptosis, ischemia, or inflammation. Apoptotic diseases include glaucoma, heart disease, and certain inflammatory diseases such as Crohn’s disease, sepsis and rheumatoid arthritis, among others.  We have commenced preclinical research on a variety of these diseases. Using small inhibitory RNAs, or siRNAs against the apoptosis isoform of Factor 5A to inhibit its expression, we have reduced pro-inflammatory cytokine formation and formation of receptors for LPS, interferon gamma and TNF-alpha.   In-vitro experiments have shown that siRNAs against Factor 5A protected human lamina cribrosa (optic nerve) and colon epithelial (HT-29) cells from TNF alpha induced apoptosis.  In-vivo mouse studies have shown that the siRNAs against Factor 5A (i) protect thymocyte cells from apoptosis and decreases formation of myeloperoxidase, TNF, MIP-1alpha, and IL-1 in the lungs of mice challenged with LPS; and (ii) increases the survival rate in which sepsis had been induced by a lethal injection of LPS.  We have also determined that inhibiting the apoptosis isoform of Factor 5A down-regulates NFkB and JAK1 and decreases the inflammatory cytokines formed through the NFkB

 

2



 

and JAK/STAT pathways.  The siRNAs against Factor 5A are currently being tested in several preclinical in-vivo inflammatory disease models.

 

Proteins required for cell death include p53, interleukins, caspases, and TNF-a. Expression of these cell death proteins is required for the execution of apoptosis.  We have found that blocking 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, down-regulation of Factor 5A up-regulates Bcl-2, a major suppressor of apoptosis.  Blocking Factor 5A also reduces the number of cells undergoing apoptosis.  These data were collected in tests in human lamina cribrosa cells grown from human optic nerve heads and from human intestinal epithelial cells.  The use of primary human cells and cell lines has direct application to the study of glaucoma and inflammatory bowel disease.  By inhibiting Factor 5A, we were able to reduce TNF-a induced apoptosis by 80% in lamina cribrosa cells.  TNF-a is strongly up-regulated in the optic nerve head of the glaucomatous eye, and TNF-a induced apoptosis appears to be an important determinant of the progressive neurodegeneration characteristic of glaucoma. Thus, inhibition of TNF-a induced apoptosis may reduce damage to the optic nerve during glaucoma.  Crohn’s disease can lead to apoptosis of intestinal epithelial cells and destruction of the lining of the bowel through production of cytokines, such as TNF-a.  We have found that inhibition of Factor 5A in a human intestinal epithelial cell line not only protects these cells from cytokine induced apoptosis, but it also decreases production of TNF-a protein by 90%.  This dual effect of our inhibitor of Factor 5A has led us to study Inflammatory Bowel Disease in an animal model.

 

In addition to this in vitro work, several preclinical mouse studies showed a reduction of inflammation and general protection of the immune system.  In one experiment, we pretreated mice intranasally with an inhibitor of Factor 5A and then introduced lipopolysaccharide, or LPS, a toxic agent that triggers inflammation through the immune system in response to bacterial infections. The mice that had been pretreated with the inhibitor of Factor 5A had approximately 90% lower levels of myeloperoxidase, or MPO, in their lung tissue, indicating that inflammation of the lung was correspondingly reduced.  MPO is a marker of inflammation and has been associated with inflammatory disease of organs such as the heart, lungs and bowels.  In another experiment, we similarly pretreated mice with an inhibitor of Factor 5A and introduced LPS to induce inflammation and an immune system response. Under control conditions, LPS kills thymocytes, which are important immune system precursor cells, known as T cells, created in the thymus to fend off infection. Senesco’s technology allowed for approximately 90% greater survival of these thymocytes in the presence of LPS.  In another study designed to test Factor 5A’s ability to protect mice from death due to sepsis, a condition in which the immune system’s rapid inflammatory response to a severe infection can cause organ damage and result in death, we treated mice with Factor 5A inhibitor using different dosing schedules.  In the groups that received Factor 5A inhibitor, survival ranged from 20% to 100% of the mice, depending upon the mouse strain and dosing regime, while none of the untreated mice survived.

 

Accelerating Apoptosis

 

Conversely, we have also established in preclinical studies that up-regulation of the apoptosis Factor 5A isoform carries out cell death in cancer cells through both the p53 (intrinsic) and cell death receptor (extrinsic) immune pathways. Tumors arise when cells that have been targeted by the immune system to undergo apoptosis are unable to do so because of an inability

 

3



 

to activate the apoptotic pathways. When our apoptosis Factor 5A gene was introduced into RKO cells, a cell line derived from human carcinoma and COS-7 cells, an immortal, cancer-like cell line from monkeys, virtually all cells expressing the Factor 5A gene underwent apoptosis. Moreover, just as the senescence Factor 5A gene appears to facilitate expression of the entire suite of genes required for programmed cell death in plants, the apoptosis Factor 5A gene appears to regulate expression of a suite of genes required for programmed cell death in humans. 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.  We have found that up-regulating the apoptosis isoform of Factor 5A results in the up-regulation of p53, an important tumor suppressor gene that promotes apoptosis in cells with damaged DNA, inflammatory cytokine production, increased cell death receptor formation and caspase activity.  These features, coupled with a simultaneous down-regulation Bcl-2, a suppressor of apoptosis, and telomerase, result in apoptosis of cancer cells.  In in-vitro studies, 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.  We believe that our data in mouse cancer models support this theory.  Preclinical studies using mice with the same genetic defect that causes lung cancer in humans showed that we can induce apoptosis in cancerous cells while leaving healthy cells unaffected.  Factor 5A, without any targeted delivery technologies, was injected into the blood stream of the mice, and the lung tissue was subsequently analyzed for apoptosis. The data from this study revealed that the lung tumor cells underwent cell death, while the surrounding healthy tissue was unaffected. Additionally, there was no evidence of systemic toxicity in the mice as evidenced by no weight loss, mortality or any signs of abnormal apoptosis in any of the vital organs.  This study has recently been successfully repeated with testing taking place over an extended period of time.  In a separate study, we have shown that when mice with a type of melanoma that has an affinity for lung tissue, which results in aggressive metastatic lung tumors, were treated with Factor 5A, there was a 41% reduction in tumor weight relative to the untreated mice.  Furthermore, nearly half of the treated mice had lung weights that were statistically comparable to the control (healthy) mice that did not have any tumors. Additional studies are planned in which dosing and delivery mechanisms will be addressed.

 

Agricultural Target Markets

 

Our technology embraces crops that are reproduced both through seeds and propagation, which are the only two means of commercial crop reproduction.  Propagation is a process whereby the plant does not produce fertile seeds and must reproduce through cuttings from the parent plant which are planted and become new plants.  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 plan to enter into licensing agreements or other strategic relationships with a variety of companies or other entities on a crop-by-crop basis.

 

In November 2001, we entered into a worldwide exclusive development and license agreement with the Harris Moran Seed Company, referred to herein as the Harris Moran License, to commercialize our technology in lettuce and certain melons for an indefinite term, unless terminated by either party pursuant to the terms of the agreement.  To date, the development steps performed by Harris Moran and us have all been completed in accordance with the protocol set forth in the Harris Moran License.  There has been extensive

 

4



 

characterization of our genes in lettuce in a laboratory setting. The initial lab work has produced genetically modified seed under greenhouse containment, which has been followed by substantial field trials for evaluation.  These field trials represent a vital step in the process necessary to develop a commercial product. While additional laboratory and field experiments and development are necessary for development of cut, bagged lettuce, we believe that these field trials have yielded data sufficient to initiate contact with potential marketing partners.  Harris Moran is in the process of performing additional field trials of our technology.  Under the Harris Moran License, we have received an upfront payment and we may receive benchmark payments upon achievement of certain research and marketing milestones.

 

In June 2002, we entered into a three-year worldwide exclusive development and option agreement with ArborGen, LLC, referred to herein as the ArborGen Agreement, to develop our technology in certain species of trees.  The ArborGen Agreement also grants ArborGen an option to acquire an exclusive worldwide license to commercialize our technology in various other forestry products.  To date, the research being conducted by ArborGen has proceeded according to schedule.  ArborGen has seen promising positive growth responses in greenhouse-grown seedlings.  These initial greenhouse data led to the initiation of field trials by ArborGen in the second half of calendar 2004.  In March, 2005, in accordance with the terms of the agreement, ArborGen extended the ArborGen Agreement through June 2006.  Under the ArborGen Agreement, we have received an upfront and a benchmark payment and we may receive additional benchmark payments upon achievement of certain development milestones.

 

In September 2002, we entered into an exclusive development and license agreement with Cal/West Seeds, referred to herein as the Cal/West License, to commercialize our technology in certain varieties of alfalfa.  The Cal/West License will continue until the expiration of the patents set forth in the agreement, unless terminated earlier by either party pursuant to the terms of the agreement.  The Cal/West License also grants Cal/West an exclusive option to develop our technology in various other forage crops.  The Cal/West development effort successfully incorporated our technology into their alfalfa plants as of July 2004.  Greenhouse trait analysis is ongoing.  Under the Cal/West License, we have received an upfront payment and we may receive benchmark payments as certain development milestones are achieved and a royalty upon commercialization based upon the volume of alfalfa seed sold that contains our technology.

 

In October 2002, we entered into a non-exclusive sales representative agreement to market and promote our technology in the People’s Republic of China.  Under the terms of the agreement, we will pay a commission to the sales representative based on a percentage of any gross license fees we may receive.  With the assistance of the sales representative, in November 2002, we executed a non-binding letter of intent with the Tianjin Academy of Agricultural Sciences for the exclusive use of our technology in a large variety of fruit and vegetable crops in China.  Discussions were held with representatives of the Academy as well as government representatives from the city of Tianjin and from the central government of China.  We also initiated discussions with several Asian biotechnology companies to secure the financing for the proposed agreement with the Academy and to commercialize the seeds developed with our technology under the proposed license.  Because of the number of crops the Academy has expressed interest in, the letter of intent called for significant licensing and milestone fees to be paid to us by a commercial partner if the project were successful.  The size of the proposed

 

5



 

financial terms in the letter of intent have made attracting such a commercial partner difficult.  As such, we have asked the Academy to reduce the number of crops selected so that the financial terms may correspondingly be reduced.  Because of the long effort to assist the Academy in finding an appropriate commercial partner, we have shifted our focus to Asian companies that could directly commercialize our technology without government or research academy involvement.  Such discussions with Asian companies are currently in process, however, we cannot assure you that any final agreements may be consummated.

 

In March 2004, we entered into an exclusive development and license agreement with The Scotts Company, referred to herein as the Scotts Agreement, to commercialize our technology in turfgrass and certain species of bedding plants.  Scotts is working on incorporating our technology to enhance a variety of traits in these plants, including environmental stress resistance, disease resistance and enhanced bloom properties.  Specifically, Scotts is currently performing field trials on certain species of bedding plants and greenhouse trials on turfgrass that incorporates our technology.  Under the Scotts Agreement, we have received an upfront payment and a benchmark payments and we may receive additional benchmark payments and royalties upon commercialization from the net sales of turfgrass seed and bedding plants containing our technology .

 

In October 2005, we entered into a license agreement with the Broin Companies to license our proprietary gene technology to Broin to improve aspects of Broin’s ethanol production capabilities.  We are currently working on incorporating our technology into those aspects of Broin’s ethanol production.  We will receive an annual payment for each Broin facility that incorporates our technology.  If Broin incorporates our technology into each of its facilities, we would receive an annual payment in excess of $1,000,000.

 

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.

 

Human Health Target Markets

 

We believe that our gene technology could have broad applicability in the human health field, by either inhibiting or accelerating apoptosis.  Inhibiting apoptosis may be useful in preventing or treating a wide range of inflammatory and ischemic diseases attributed to premature apoptosis, including heart disease, arthritis, ocular diseases, such as glaucoma, and neurodegenerative diseases among others.  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.

 

6



 

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:

 

                  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 owned by 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, among others: Icora (formerly Paradigm Genetics); Bayer Crop Science; Mendel Biotechnology; Renessen LLC; Exelixis Plant Sciences, Inc.; PlantGenix, Inc.; Syngenta International AG; and Eden Bioscience.

 

There are many large and development stage companies working in the field of apoptosis research including: Amgen; Centocor; Genzyme; OSI Pharmaceuticals, Inc.; Idun Pharmaceuticals; Novartis; Introgen Therapeutics, Inc.; Genta, Inc.; and Vertex Pharmaceuticals, Inc.

 

Marketing Program

 

We presently license our technology to agricultural companies capable of incorporating our technology into crops grown for commercial agriculture.  We anticipate revenues from these relationships in the form of licensing fees and royalties from our partners, usage fees in the case of the agreement with the Broin Company, or sharing gross profits in the case of the joint venture with Rahan Meristem.  In addition, we anticipate payments from our partners upon our achievement of certain research and development benchmarks.  This commercialization strategy allows us to generate revenues 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.  Through June 30, 2005, we have entered into five license and development agreements and one joint venture with established agricultural biotechnology companies.  Generally, projects with our license and joint venture partners begin by transforming seed or germplasm to incorporate our technology.  Those seeds or germplasm are then grown in a greenhouse.  After greenhouse trials, the plants are then transferred to the field.  The 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.

 

7



 

The estimated timeline below indicates the stage of development we are currently in for each of our respective licenses and joint venture.

 

Project

 

1-2 Years

/

1-2 Years

/

2-5+ Years

 

 

 

 

Seed Transformation

/

Greenhouse

/

Field Trials

/

Commercialization

 

 

 

 

 

 

 

 

 

Banana

 

 

Shelf Life

 

--------------------------------------------------------------------/

Disease

 

--------------------------------------------------------------------/

 

 

 

Lettuce

 

 

Browning

 

--------------------------------------------------------------------/

Disease

 

--------------------------------------------------------------------/

 

 

 

Trees

 

 

Growth

 

--------------------------------------------------------------/

 

 

 

Alfalfa

 

--------------------------------------/

 

 

 

Turfgrass

 

--------------------------------------/

 

 

 

Bedding Plants

 

--------------------------------------------------------------/

 

 

 

Ethanol

 

----/ Modify Inputs

 

 

 

Test

 

Implementation

 

Commercialization 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.

 

We plan to employ the same partnering strategy in both the human health and agricultural target markets.  Our preclinical 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 of our technology.  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 and other related revenues.  Successful future operations will depend on our ability to transform our research and development activities into a commercially feasible technology.

 

Research Program

 

Our subsequent research and development initiatives include: (i) further developing and implementing the DHS and Factor 5A gene technology in lettuce, banana, and a variety of other commercially important agricultural crops such as oil seed crops, turfgrass, bedding plants, tomato, alfalfa and trees; (ii) testing the resultant crops for new beneficial traits such as increased yield, increased tolerance to environmental stress and disease resistance; and (iii) assessing the

 

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role of the Factor 5A genes in human diseases through the accumulation of additional data from preclinical experiments with cell lines and animal models. Our strategy for agriculture focuses on various plants to maximize possible future market penetration among the different sectors of the broad agricultural and horticultural markets.

 

Our research and development is performed by third party researchers at our direction, pursuant to various research and license agreements.  The primary research and development effort, which is performed by approximately 26 researchers that are funded in whole or in part by us, takes place at the University of Waterloo in Ontario, Canada, where the technology was discovered, the Mayo Clinic, the University of Virginia, the University of Pittsburgh, the University of Colorado and previously at two research hospitals in Toronto, Ontario. Additional research and development is performed by our partners in connection with the Harris Moran License, the Scotts Agreement, the ArborGen Agreement, the Cal/West License, the Broin License, and through the Rahan Joint Venture, referenced below.

 

Joint Venture

 

On May 14, 1999, we entered into a joint venture agreement with Rahan Meristem Ltd., or Rahan Meristem, an Israeli company engaged in the worldwide export marketing of banana germplasm, referred to herein as the Rahan Joint VentureIn general, bananas are grown either for local domestic consumption or grown for export.  According to the Food and Agriculture Organization of the United Nations, there were 12 million metric tons of bananas exported in 2002.  The level of production equates to the fruit of approximately 480 million banana plants.  A percentage of these plants are replaced each year with new banana seedlings.  Rahan Meristem accounts for approximately 10% of the worldwide export of enhanced banana seedlings.

 

We have contributed, by way of a limited, exclusive, worldwide license to the Rahan Joint Venture, access to our technology, discoveries, inventions and know-how, whether patentable or otherwise, pertaining to plant genes and their cognate expressed proteins that are induced during senescence for the purpose of developing, on a joint basis, genetically enhanced banana plants which will result in a banana that has a longer shelf life.  Rahan Meristem has contributed its technology, inventions and know-how with respect to banana plants.  Rahan Meristem and Senesco equally own the Rahan Joint Venture and have equally shared the expense of field trials.

 

The Rahan Joint Venture applied for and received a conditional grant that totals approximately $340,000, which constituted 50% of the Rahan Joint Venture’s research and development budget over the five-year period, ending on May 31, 2005, from the Israel - U.S. Binational Research and Development Foundation, or BIRD Foundation, referred to herein as the BIRD Grant.  Such grant, along with certain royalty payments, shall only be repaid to the BIRD Foundation upon the commercial success of the Rahan Joint Venture’s technology. The commercial success is measured based upon certain benchmarks and/or milestones achieved by the Rahan Joint Venture.  The Rahan Joint Venture reports these benchmarks periodically to the BIRD Foundation.

 

All aspects of the Rahan Joint Venture’s research and development initiative are proceeding on time, or are ahead of the original schedule laid out at the inception of the Rahan Joint Venture.  Both the DHS and lipase genes have been identified and isolated in banana, and

 

9



 

the Rahan Joint Venture is currently in the process of silencing these genes.  Two Israeli field trials indicated that Senesco’s proprietary technology extends the shelf life of the banana fruit up to 100%, while allowing the banana fruit to ripen normally.  Later field trials have shown promising disease resistance results and we are currently performing additional field trials to further assess disease resistance.  We believe that these field trials have yielded data sufficient to initiate contact with potential marketing partners.

 

Consistent with our commercialization strategy, we intend to attract other companies interested in strategic partnerships, joint ventures or licensing our technology.  The Harris Moran License, the ArborGen Agreement, the Cal/West License, the Broin Agreement and the Rahan Joint Venture are the first successes toward the execution of our strategy.

 

Intellectual Property

 

Research and Development

 

The inventor 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 3.7% of the outstanding shares of our common stock, $0.01 par value, as of June 30, 2005.  On September 1, 1998, we entered into, and subsequently have extended, a research and development agreement with the University of Waterloo and Dr. Thompson as the principal inventor, referred to herein as the First Research and Development Agreement.  The First Research and Development Agreement is currently set to expire on August 31, 2006.  Also, effective May 1, 2002, we entered into another research and development agreement, for a period of one year, with the University of Waterloo and Dr. Thompson, referred to herein as the Second Research and Development Agreement.  The First Research and Development Agreement and the Second Research and Development Agreement are collectively referred to herein as the Research and Development Agreements.  The Research and Development Agreements provide 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.

 

Effective May 1, 1999, we entered into a consulting agreement for research and development with Dr. Thompson.  On July 1, 2001, we renewed the consulting agreement with Dr. Thompson for an additional three-year term as provided for under the terms and conditions of the agreement.  On July 1, 2004, the agreement automatically renewed for an additional three-year term.  In July 2004, Richard Dondero was hired as our Vice President of Research and Development allowing Dr. Thompson to become our Chief Scientific Officer.

 

In September 2002, we entered into an exclusive worldwide collaboration agreement with Anawah, Inc., formerly Tilligen, Inc., referred to herein as the Anawah Agreement, to establish a research alliance to develop and commercialize certain genetically enhanced species of produce.  Under the Anawah Agreement, Anawah licensed its proprietary technology to us and also performed certain transformation functions in order to develop seeds in certain species of produce that had been enhanced with our technology.  In January 2005, we terminated the

 

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Anawah Agreement.  Under the terms of the agreement, we will retain our exclusive license to Anawah’s DHS Gene Mutation technology in the specific field of use at an annual fee of $50,000.

 

Our research and development expenses incurred on human health applications were approximately 50% for the fiscal year ended June 30, 2005 and approximately 43% for the fiscal year ended June 30, 2004.  Since our inception the proportion of research and development expenses on human health applications has increased, as compared to plant 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 research partners.

 

Our future research and development program focuses on the discovery and development of certain gene technologies which intend to extend shelf life and to confer other positive traits on fruits, flowers, vegetables and agronomic row crops and on expanding our human health research programs.  Over the next twelve months, we plan to continue the following research and development initiatives:

 

                  the development of plants that possess new beneficial traits, such as protection against drought and disease, with emphasis on lettuce, corn, forestry products, alfalfa and the other species described below with several entities;

 

                  the development of enhanced lettuce plants through the Harris Moran License;

 

                  the development of enhanced trees through the ArborGen Agreement;

 

                  the development of enhanced alfalfa through the Cal/West License;

 

                  the isolation of new genes in the Arabidopsis, tomato, lettuce, soybean, canola seed and melon plants, among others, at the University of Waterloo;

 

                  the development of enhanced banana plants through the Rahan Joint Venture;

 

                  the transformation of seeds enhanced with our technology;

 

                  improving aspects of ethanol production through the Broin License;

 

                  the development of enhanced turfgrass and bedding plants through the Scotts Agreement; and

 

                  assessing the function of the Factor 5A genes in human diseases at the University of Waterloo, the University of Colorado, the Mayo Clinic, the University of Virginia and the University of Pittsburgh.

 

We may further expand our research and development program beyond the initiatives listed above to include other research centers.

 

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Patent and Patent Applications

 

We have eight issued patents from the United States Patent and Trademark Office, or PTO, and two issued patents from foreign countries as follows:

 

Patent #

 

 

 

Date Issued

 

Expiration
Date

 

 

 

 

 

 

 

Agricultural

 

 

 

 

 

 

 

 

 

 

 

 

 

United States

 

 

 

 

 

 

 

 

 

 

 

 

 

6,538,182

 

DNA Encoding a Plant Deoxyhypusine Synthase, A Plant Eukaryotic Initiation Factor 5A, Transgenic Plants and A Method For Controlling Senescence and Programmed Cell Death in Plants

 

3/23/2004

 

7/06/2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6,774,284

 

DNA Encoding A Plant Lipase, Transgenic Plants and A Method For Controlling Senescence In Plants

 

8/10/2004

 

7/22/2018

 

 

 

 

 

 

 

6,849,782

 

Arabidopsis Antisense Deoxyhypusine Synthase Molecule and Method of Inhibiting Deoxyhypusine Expression in Plants

 

2/01/2005

 

7/06/2019

 

 

 

 

 

 

 

6,855,529

 

DNA Encoding a Plant Deoxyhypusine Synthase, a Plant Eukaryotic Initiation Factor 5A, Transgenic Plants and a Method for Controlling Senescence Programmed and Cell Death in Plants

 

2/15/2005

 

8/05/2019

 

 

 

 

 

 

 

6,878,860

 

DNA Encoding a Plant Deoxyhypusine Synthase, a Plant Eukaryotic Initiation Factor 5A, Transgenic Plants and a Method For Controlling Senescence Programmed and Cell Death in Plants

 

4/12/2005

 

7/06/2019

 

 

 

 

 

 

 

6,897,359

 

Carnation Antisense Deoxyhypusine Synthase Molecule and Method of Inhibiting Deoxyhypusine Synthase Expression in Plants

 

5/24/2005

 

11/11/2019

 

 

 

 

 

 

 

6,900,368

 

Tomato Antisense Deoxyhypusine Synthase Molecule and Method of Inhibiting Deoxyhypusine Synthase Expression in Plants

 

5/31/2005

 

7/06/2019

 

 

 

 

 

 

 

Commonwealth of Australia

 

 

 

 

 

 

 

 

 

 

 

778437

 

DNA encoding a plant lipase, transgenic plants and a method for controlling senescence in plants

 

3/24/2005

 

2/14/2020

 

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New Zealand

 

 

 

 

 

 

 

 

 

 

 

 

 

523280

 

DNA encoding a plant lipase, transgenic plants and a method for controlling senescence in plants

 

6/09/2005

 

6/19/2021

 

 

 

 

 

 

 

Human Health

 

 

 

 

 

 

 

 

 

 

 

 

 

United States

 

 

 

 

 

 

 

 

 

 

 

 

 

6,867,237

 

DNA Encoding Apoptosis-Induced Eukaryotic Initiation Factor-5A and Deoxyhypusine Synthase and a Method for Controlling Apoptosis in Animals and Humans

 

3/15/2005

 

7/23/2021

 

In addition to our ten 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.

 

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 Food and Drug Administration 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.

 

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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, or our licensees, may be required to obtain such licensing or approval from governmental regulatory agencies prior to the commercialization of our genetically transformed plants and the application of our human health technology.

 

Employees

 

In addition to the 26 scientists performing funded research for us at the University of Waterloo, the University of Toronto, Mayo Clinic, the University of Pittsburgh, the University of Virginia and the University of Colorado, we have five employees and one consultant, four of whom are executive officers and 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.  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.  Russell L. Jones, Ph.D., who serves as a member of the Scientific Advisory Board, is a professor at the University of California, Berkeley and an expert in plant cell biology and cell death.  Dr. Jones is also an editor of Planta, Annual Review of Plant Physiology and Plant Molecular Biology, as well as Research Notes in Plant Science. Additionally, he has held positions on the editorial boards of Plant Physiology and Trends in Plant Science.

 

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 substantial research staff including graduate and post-graduate researchers.

 

We have also undertaken preclinical apoptosis research at the University of Colorado under the supervision of Dr. Dinarello.  In addition to the research being conducted at the University of Colorado, we have also undertaken preclinical apoptosis research at the Mayo Clinic, the University of Pittsburgh and the University of Virginia.  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.

 

All agricultural and human health research is monitored by Richard Dondero, our Vice President of Research.

 

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Safe Harbor Statement

 

The statements contained in this Annual Report on Form 10-KSB 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 the Harris Moran License, the ArborGen Agreement, the Cal/West License, The Scotts License, the Broin License and the Research and Development Agreements, the successful implementation of the Rahan Joint Venture, the conversion of the letter of intent with the Tianjin Academy of Agricultural Sciences into an executed agreement, statements relating to our patent applications, the anticipated longer term growth of our business, the results of our preclinical studies 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, the timing of revenues due to the variability in size, scope and duration of research projects, regulatory delays, research study results which lead to cancellations of research projects, and other factors, including general economic conditions and regulatory developments, not within our control.  The factors discussed herein and expressed from time to time in our filings with the Securities and Exchange Commission could cause actual results and developments to be materially different from those expressed in or implied by such statements.  The forward-looking statements are made only as of the date of this filing, and we undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

 

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 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 have an accumulated deficit of $14,763,907 at June 30, 2005.  We have generated minimal revenues by licensing certain of our technology to companies willing to share in our development costs. However, our technology may not be ready for widespread commercialization for several years. We expect to continue to incur losses over the next two to three years because we anticipate that

 

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our expenditures on research and development, commercialization and administrative activities will significantly exceed our revenues during that period. We cannot predict when, if ever, we will become profitable.

 

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 commercial exploitation of technology to identify, isolate, characterize and silence genes which control the death of cells in plants and humans.  Our future revenue and profitability critically depend upon our ability to successfully develop senescence and apoptosis gene technology and later market and license such technology at a profit.  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 plants or humans or reduced benefits in terms of crop yield or protection.  Our failure to obtain market acceptance of our technology or to successfully commercialize such technology or develop a commercially viable product 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 primary research and development efforts take place at the University of Waterloo in Ontario, Canada, where our technology was discovered, the University of Colorado, the Mayo Clinic, the University of Virginia, the University of Pittsburgh, a research hospital in Canada, and with our commercial partners.  At this time, we do not have the internal capabilities to perform our research and development activities. Accordingly, the failure of third-party research partners, such as the University of Waterloo, 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.

 

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, 2005, we had cash and highly-liquid investments valued at $4,481,253 and working capital of $3,959,125.  Using our available reserves as of June 30, 2005, we believe that we can operate according to our current business plan for at least the next twelve 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 may be required to raise additional capital in the future in order to operate according to our current business plan, and this funding may not be available on favorable terms, if at all.  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

 

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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, as of June 30, 2005, we had 6,517,021 shares of common stock authorized but unissued, 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 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.

 

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 agricultural and biotechnology 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.

 

We have been issued eight patents by the U.S. Patent and Trademark Office, or PTO, and two patents from foreign countries.  We have also filed 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 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

 

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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 that 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 require licensing and the payment of significant fees or royalties to third parties for the use of their intellectual property in order to enable us to conduct our business.

 

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 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 that 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.

 

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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, we require all employees to agree to a confidentiality provision that prohibits the disclosure of confidential information to anyone outside of our company, during the term of employment and 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.

 

We occasionally provide information to research collaborators in academic institutions and request the collaborators to 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 will 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 intend to conduct research and development activities in-house, we may undertake those activities in the future.  Expanding our business will 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 changes may make it difficult for us to manage our growth and expand our operations.

 

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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 also 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 we fail to successfully establish distribution channels, or if our marketing partners fail to provide adequate levels of sales, our commercialization efforts will be delayed or limited and we will not be able to generate revenue.

 

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 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 agricultural and human health 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 agricultural and human health biotechnology companies are engaged in research and development activities relating to senescence and apoptosis.  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: Icoria (formerly Paradigm Genetics); Bayer Crop Science; Mendel Biotechnology; Renessen LLC; Exelixis Plant Sciences, Inc.; PlantGenix, Inc; Syngenta International AG; and Eden Bioscience, among others.  Some of our competitors that are involved in apoptosis research include:  Amgen; Centocor; Genzyme; OSI Pharmaceuticals, Inc.; Idun Pharmaceuticals; Novartis; 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

 

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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.

 

Our business is subject to various government regulations and, if we 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 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, 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.

 

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Preclinical studies and clinical trials 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 clinical trials 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. 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.

 

Even if we receive regulatory approval, consumers may not accept 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 consumer products.  The adverse consequences from heightened consumer concern in this regard could affect the markets for 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.

 

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 employment agreements with all of our key employees and a research agreement with Dr. Thompson, these agreements may be terminated upon no or short notice.  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 American Stock 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

 

22



 

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 outstanding options or issue equivalent options, our board of directors is required to provide accelerated vesting of outstanding options.

 

Increasing political and social turmoil, such as terrorist and military actions, increase the difficulty for us and our strategic partners to forecast accurately and plan future business activities.

 

Recent political and social turmoil, including the conflict in Iraq and the current crisis in the Middle East, can be expected to put further pressure on economic conditions in the United States and worldwide.  These political, social and economic conditions may make it difficult for us to plan future business activities.  Specifically, if the current crisis in Israel continues to escalate, our joint venture with Rahan Meristem Ltd. could be adversely affected.

 

Risks Related to Our Common Stock

 

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, 2005, our executive officers, directors and affiliated entities together beneficially own approximately 40.6% 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, 2005, 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.

 

Our stockholders may experience substantial dilution as a result of the exercise of outstanding options and warrants to purchase our common stock.

 

As of June 30, 2005, we have granted options outside of our stock option plan to purchase 10,000 shares of our common stock and outstanding warrants to purchase 5,894,091 shares of our common stock.  In addition, as of June 30, 2005, we have reserved 3,000,000 shares of our common stock for issuance upon the exercise of options granted pursuant to our stock option plan, 2,201,500 of which have been granted. 90,000 of which have been exercised, 2,111,500 of which are outstanding, and 798,500 of which may be granted in the future.  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.

 

23



 

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, 2005, we had 15,467,388 shares of our common stock issued and outstanding, of which approximately 1,595,651 and 1,536,922 shares are registered pursuant to registration statements on Form S-3, which were declared effective on June 17, 2005 and May 14, 2004, respectively, and the remainder of which are either eligible to be sold under SEC Rule 144 or are in the public float.  In addition, we registered 3,000,000 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 American Stock Exchange and currently has a limited trading market.  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.

 

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.

 

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.

 

24



 

If our common stock is delisted from the American Stock Exchange, it may be subject to the “penny stock” regulations which may affect the ability of our stockholders to sell their shares.

 

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 the American Stock Exchange delists our common stock, it could be deemed a penny stock, which imposes additional sales practice requirements 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 common stock were subject to the rules on penny stocks, the market liquidity for our common stock could be severely and adversely affected.  Accordingly, the ability of holders of our common stock to sell their shares in the secondary market may also be adversely affected.

 

25



 

Item 2.          Properties.

 

We lease office space in New Brunswick, New Jersey for a current monthly rental fee of $2,838, subject to certain escalations for our proportionate share of increases, over the base year of 2001, in the building’s operating costs.  In June, 2005, we moved to larger office space in the same building.  Accordingly, beginning in May 2006, the monthly rental fee will increase to $6,384 and 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.          Submission of Matters to a Vote of Security Holders.

 

None.

 

26



 

PART II

 

Item 5.          Market for Our Common Equity and Related Stockholder Matters.

 

Our common stock trades on the American Stock 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, 2003, as reported on the American Stock Exchange.

 

Quarter
Ended

 

Common
Stock

 

 

 

High

 

Low

 

 

 

 

 

 

 

September 30, 2003

 

$

3.99

 

$

2.05

 

December 31, 2003

 

$

3.83

 

$

2.75

 

March 31, 2004

 

$

3.50

 

$

2.46

 

June 30, 2004

 

$

4.50

 

$

2.60

 

September 30, 2004

 

$

3.15

 

$

2.30

 

December 31, 2004

 

$

3.75

 

$

2.40

 

March 31, 2005

 

$

3.95

 

$

2.75

 

June 30, 2005

 

$

3.45

 

$

1.60

 

 

As of September 20, 2005, the approximate number of holders of record of our common stock was 314.

 

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.

 

27



 

Item 6.          Management’s Discussion and Analysis or Plan of Operation.

 

Overview

 

We do not expect to generate significant revenues for approximately the next one to three years, during which time we will engage in significant research and development efforts. However, we have entered into the Harris Moran License, the ArborGen Agreement, the Cal/West License, the Scotts License and the Broin Agreement to develop and commercialize our technology in certain varieties of lettuce, melons, trees, alfalfa, bedding plants, turf grass and ethanol.  The Harris Moran License, the Cal/West License, and the Scotts License also provide for royalty payments to us upon commercial introduction.  The ArborGen Agreement contains an option for ArborGen to execute a license to commercialize developed products, and upon the execution of a license agreement, we will receive a license fee and royalties from ArborGen.  The Cal/West License contains an option for Cal/West to develop our technology in various other forage crops. The Broin License provides for annual payments for each of Broin’s ethanol production facilities that incorporates our technology.  We also have entered into the Rahan Joint Venture to develop and commercialize our technology in banana plants.  In connection with the Rahan Joint Venture, we will receive 50% of the profits from the sale of enhanced banana plants.

 

Consistent with our commercialization strategy, we intend to attract other companies interested in strategic partnerships or licensing our technology 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 preclinical 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 of 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.

 

28



 

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.

 

Valuation Allowances and Carrying Values

 

We have recorded valuation allowances against our entire deferred tax assets of $4,355,000 at June 30, 2005.  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, 2005, we have determined that the estimated future undiscounted cash flows related to our patent applications will be sufficient to recover their carrying value.

 

We do not have any off-balance sheet arrangements.

 

Research Program

 

We do not expect to generate significant revenues for approximately the next one to three 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;

 

29



 

                  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.

 

Liquidity and Capital Resources

 

Overview

 

As of June 30, 2005, our cash balance and investments totaled $4,481,253, and we had working capital of $3,959,125.  As of June 30, 2005, we had a federal tax loss carryforward of approximately $11,692,000 and a state tax loss carry-forward of approximately $4,222,000 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, 2005:

 

 

 

Payments Due by Period

 

Contractual Obligations

 

Total

 

Less than
1 year

 

1 - 3 years

 

4 - 5 years

 

More than
5 years

 

Research and Development Agreements (1)

 

$

762,807

 

$

660,845

 

$

101,962

 

$

 

$

 

Facility, Rent and Operating Leases (2)

 

$

425,156

 

$

39,380

 

$

154,280

 

$

157,928

 

$

73,568

 

Employment, Consulting and Scientific Advisory Board Agreements (3)

 

$

926,201

 

$

673,808

 

$

252,393

 

$

 

$

 

Total Contractual Cash Obligations

 

$

2,114,164

 

$

1,374,033

 

$

508,635

 

$

157,928

 

$

73,568

 

 


(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.

 

30



 

(3)   Certain of our employment and 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.

 

Effective September 1, 2004, we extended our research and development agreement with the University of Waterloo for an additional two-year period through August 31, 2006, in the amount of Can $1,529,430 or approximately U.S. $1,140,000. Research and development expenses under this agreement for the years ended June 30, 2005 and 2004 aggregated U.S. $628,341 and U.S. $560,308 respectively, and U.S. $2,634,853 for the cumulative period through June 30, 2005.

 

Capital Resources

 

Since inception, we have generated revenues of $351,667 in connection with the initial fees and milestone payments received under the Harris Moran License, the ArborGen Agreement, the Cal/West License and the Scotts License.  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 in the near future, 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.

 

In October 2004, we entered into a license agreement with the Broin Companies to license our proprietary gene technology to Broin to improve aspects of Broin’s ethanol production capabilities.  We will receive an annual payment for each Broin facility that incorporates our technology.

 

In December 2004, pursuant to the New Jersey Technology Tax Credit Transfer Program, we sold our entire New Jersey net operating loss tax benefit for the fiscal year ended June 30, 2003 in the amount of $177,063 and received net proceeds of $153,160.

 

In May 2005, we completed a private placement to certain accredited investors for an aggregate amount of 1,595,651 shares of our common stock and warrants to purchase 797,836 shares of our common stock for the aggregate gross cash consideration of $3,366,829.  The private placement offered units of one share of common stock and a five-year warrant to purchase 0.50 shares of common stock at a price equal to $2.11 per unit.  The warrant was offered with an exercise price equal to $3.38 per share, with such warrant vesting on the date of grant.  The costs associated with the private placement totaled $428,863.

 

31



 

We anticipate that, based upon our current cash and investments, we will be able to fund our operations for at least the next twelve months. Over the next twelve months, 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 and through the execution of additional licensing agreements for our technology.

 

Market Risk

 

Foreign Currency Risk

 

Except for our Research and Development Agreements with the University of Waterloo, which is payable in Canadian dollars, we have no other agreements or transactions denominated in foreign currency.  Thus, we do not believe that any fluctuations in foreign currency exchange rates would have a material impact on our financial condition or results of operations.

 

Interest Rate Risk

 

We have approximately $4.5 million in cash and investments as of June 30, 2005.  Our cash is invested primarily in short-term investments, which we plan to hold until maturity.  We do not believe that any fluctuations in interest rates would have a material impact on our financial condition or results of operations.

 

Results of Operations

 

Fiscal Years ended June 30, 2005 and June 30, 2004

 

The net loss for the years ended June 30, 2005 and June 30, 2004 was $2,188,966 and $3,078,282, respectively, a decrease of $889,316, or 28.9%.  This decrease was primarily the result of a decrease in stock-based compensation related to general and administrative expenses (i.e. – noncash), which was partially offset by an increase in research and development expenses and other general and administrative expenses.

 

Revenue for the year ended June 30, 2005 was $125,000, which represented milestone payments and the amortized portion of the initial fee on a development and license agreement. Revenue for the year ended June 30, 2004 was $16,667, which also represented the amortized portion of the initial fee in connection with the same development and license agreement.

 

Operating expenses for the years ended June 30, 2005 and June 30, 2004 were $2,656,785 and $3,405,302, respectively, a decrease of $748,517, or 22.0%.  This decrease in operating expenses was primarily the result of a decrease in stock-based compensation related to general and administrative expenses, which was partially offset by an increase in research and development expenses and other general and administrative expenses.  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.

 

32



 

General and administrative expenses for the years ended June 30, 2005 and June 30, 2004 were $1,390,825 and $2,333,432, respectively, a decrease of $942,607, or 40.4%.

 

 

 

Year ended June 30,

 

 

 

2005

 

2004

 

Stock-based compensation

 

$

53,268

 

$

1,083,921

 

Other general and administrative expenses

 

1,337,557

 

1,249,511

 

Total general and administrative expenses

 

$

1,390,825

 

$

2,333,432

 

 

                  The decrease in stock-based compensation was primarily the result of a warrant being granted in connection with a financial advisory agreement during the year ended June 30, 2004.

 

                  The increase in other general and administrative expenses was primarily due to an increase in investor relation expenses, accounting fees, amortization of patent costs and payroll and benefits, which was partially offset by a decrease in legal fees and corporate insurance.

 

                  Investor relation expenses increased during the year ended June 30, 2005, primarily as a result of an increase in financial advisory fees in connection with a financial advisory agreement entered into in January 2005.

 

                  Accounting fees increased primarily as a result of an increase in consulting fees. During the year ended June 30, 2005, we had incurred additional consulting fees related to implementation of the internal control assessment required under Sarbanes-Oxley section 404.

 

                  Amortization of patent costs increased due to the issuance of six new patents during the year ended June 30, 2005.

 

                  Payroll and benefits increased primarily as a result of salary increases.

 

                  Legal fees decreased primarily as a result of greater efficiencies in the preparation and review of our forms and filings with the Securities and Exchange Commission.

 

                  Insurance costs decreased primarily because of a decrease in the premium for our directors’ and officers’ liability insurance policy.

 

We expect general and administrative expenses to modestly increase over the next twelve months primarily due to an increase in legal and accounting fees related to the increased regulatory environment and an increase in rent due to moving into larger space in June 2005.

 

Research and development expenses for the years ended June 30, 2005 and June 30, 2004 were $1,265,960 and $1,071,870, respectively, an increase of $194,090, or 18.1%. This increase was primarily the result of the expanded research program performed by the University of Waterloo and other institutions, the weakness of the U.S currency against the Canadian currency and the expansion of our human health research programs, as well as an increase stock-based compensation, which was due to previously issued options becoming exercisable and new options being issued during the year ended June 30, 2005.

 

33



 

 

 

Year ended June 30,

 

 

 

2005

 

2004

 

Stock-based compensation

 

$

131,015

 

$

93,924

 

Other research and development expenses

 

1,134,945

 

977,946

 

Total research and development expenses

 

$

1,265,960

 

$

1,071,870

 

 

The breakdown of our research and development expenses between our agricultural and human health research programs are as follows:

 

 

 

Year ended June 30,

 

 

 

2005

 

2004

 

Agricultural research programs

 

$

635,386

 

$

614,312

 

Human health research programs

 

630,574

 

457,558

 

Total research and development expenses

 

$

1,265,960

 

$

1,071,870

 

 

From Inception on July 1, 1998 through June 30, 2005

 

From inception of operations on July 1, 1998 through June 30, 2005, we had revenues of $351,667, 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 approximately the next one to three 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 $14,763,907 at June 30, 2005.  We expect to continue to incur losses as a result of expenditures on research, product development and administrative activities.

 

34



 

Item 7.          Financial Statements.

 

The financial statements required to be filed pursuant to this Item 7 are included in this Annual Report on Form 10-KSB.  A list of the financial statements filed herewith is found at “Item 13. Exhibits.”

 

Item 8.          Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.

 

None.

 

Item 8A.       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 June 30, 2005.  Based on this evaluation, our chief executive officer and chief financial officer concluded that as of June 30, 2005, our disclosure controls and procedures were (1) designed to ensure that material information relating to us, including our consolidated subsidiaries, is made known to our chief executive officer and chief financial officer by others within those entities, particularly during the period in which this report was being prepared and (2) effective, in that they provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.

 

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, 2005 that has materially affected, or is reasonably likely to materially affect, our internal controls over financial reporting.

 

35



 

PART III

 

Item 9.                    Directors and Executive Officers.

 

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 2005 Annual Meeting of Stockholders is incorporated herein by reference to such proxy statement.

 

Item 10.                 Executive Compensation.

 

The discussion under the heading “Executive Compensation” in our definitive proxy statement for the 2005 Annual Meeting of Stockholders is incorporated herein by reference to such proxy statement.

 

Item 11.                 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 2005 Annual Meeting of Stockholders is incorporated herein by reference to such proxy statement.

 

Item 12.                 Certain Relationships and Related Transactions.

 

The discussion under the heading “Certain Relationships and Related Transactions” in our definitive proxy statement for the 2005 Annual Meeting of Stockholders is incorporated herein by reference to such proxy statement.

 

Item 13.                 Exhibits.

 

(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 35.

 

(b)                                                                                 Reports on Form 8-K.

 

None.

 

Item 14.                 Principal Accountant Fees and Services.

 

The discussion under the heading “Principal Accountant Fees and Services” in our definitive proxy statement for the 2005 Annual Meeting of Stockholders is incorporated herein by reference to such proxy statement.

 

36



 

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 2005.

 

 

 

SENESCO TECHNOLOGIES, INC.

 

 

 

 

 

By:

/s/ Bruce C. Galton

 

 

 

Bruce C. Galton, President and

 

 

Chief Executive Officer

 



 

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/ Ruedi Stalder

 

Chairman and Director

 

September 28, 2005

Ruedi Stalder

 

 

 

 

 

 

 

 

 

 

 

 

 

 

/s/ Bruce C. Galton

 

President and Chief Executive

 

September 28, 2005

Bruce C. Galton

 

Officer (principal executive officer)

 

 

 

 

and Director

 

 

 

 

 

 

 

 

 

 

 

 

/s/ Joel Brooks

 

Chief Financial Officer

 

September 28, 2005

Joel Brooks

 

and Treasurer (principal financial

 

 

 

 

and accounting officer)

 

 

 

 

 

 

 

 

 

 

 

 

/s/ John E. Thompson

 

Executive Vice President, Chief

 

September 28, 2005

John E. Thompson

 

Scientific Officer and Director

 

 

 

 

 

 

 

 

 

 

 

 

/s/ Christopher Forbes

 

Director

 

September 28, 2005

Christopher Forbes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

/s/ Thomas C. Quick

 

Director

 

September 28, 2005

Thomas C. Quick

 

 

 

 

 

 

 

 

 

 

 

 

 

 

/s/ David Rector

 

Director

 

September 28, 2005

David Rector

 

 

 

 

 

 

 

 

 

 

 

 

 

 

/s/ John Braca

 

Director

 

September 28, 2005

John Braca

 

 

 

 

 



 

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 December 26, 2002. (Incorporated by reference to Senesco Technologies, Inc. quarterly report on Form 10-QSB for the period ended December 31, 2002.)

 

 

 

 

 

3.2

 

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.)

 

 

 

 

 

4.1

 

Form of Warrant with Forbes, Inc. (Incorporated by reference to Senesco Technologies, Inc. quarterly report on Form 10-QSB for the period ended September 30, 1999.)

 

 

 

 

 

4.2

 

Form of Option Agreement with Kenyon & Kenyon. (Incorporated by reference to Senesco Technologies, Inc. quarterly report on Form 10-QSB for the period ended September 30, 1999.)

 

 

 

 

 

4.3

 

Form of Warrant with Parenteau Corporation. (Incorporated by reference to Senesco Technologies, Inc. quarterly report on Form 10-QSB for the period ended December 31, 1999.)

 

 

 

 

 

4.4

 

Form of Warrant with Strategic Growth International, Inc. (Incorporated by reference to Senesco Technologies, Inc. quarterly report on Form 10-QSB for the period ended December 31, 1999.)

 

 

 

 

 

4.5

 

Form of Warrant Agreement with Fahnestock & Co. Inc., dated October 2, 2000. (Incorporated by reference to Senesco Technologies, Inc. quarterly report on Form 10-QSB for the period ended December 31, 2000.)

 

 

 

 

 

4.6

 

Warrant Agreement by and between Senesco Technologies, Inc. and Christenson, Hutchinson, McDowell, LLC. (Incorporated by reference to Senesco Technologies, Inc. quarterly report on Form 10-QSB for the period ended September 30, 2001.)

 



 

Exhibit
No.

 

Description of Exhibit

 

 

 

 

4.7

 

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.)

 

 

 

 

 

4.8

 

Form of Warrant issued to certain accredited investors (with attached schedule of parties and terms thereto). (Incorporated by reference to Exhibit 4.2 of Senesco Technologies, Inc. quarterly report on Form 10-QSB for the period ended March 31, 2002.)

 

 

 

 

 

4.9

 

Form of Warrant issued to Pond Equities, Inc. (with attached schedule of terms thereto). (Incorporated by reference to Exhibit 4.3 of Senesco Technologies, Inc. quarterly report on Form 10-QSB for the period ended March 31, 2002.)

 

 

 

 

 

4.10

 

Form of Warrant issued to Perrin, Holden & Davenport Capital Corp. and certain principals thereof (with attached schedule of parties and terms thereto). (Incorporated by reference to Exhibit 4.4 of Senesco Technologies, Inc. quarterly report on Form 10-QSB for the period ended March 31, 2002.)

 

 

 

 

 

4.11

 

Form of Warrant issued to certain accredited investors (with attached schedule of parties and terms thereto). (Incorporated by reference to Exhibit 4.2 of Senesco Technologies, Inc. quarterly report on Form 10-QSB for the period ended December 31, 2002.)

 

 

 

 

 

4.12

 

Form of Warrant issued to certain third parties for services rendered (with attached schedule of parties and terms thereto). (Incorporated by reference to Exhibit 4.3 of Senesco Technologies, Inc. quarterly report on Form 10-QSB for the period ended December 31, 2002.)

 

 

 

 

 

4.13

 

Warrant issued to Sands Brothers International Ltd. dated September 25, 2003. (Incorporated by reference to Exhibit 4.1 of Senesco Technologies, Inc. quarterly report on Form 10-QSB for the period ended September 30, 2003.)

 

 

 

 

 

4.14

 

Warrant issued to Sands Brothers International Ltd. Dated September 25, 2003. (Incorporated by reference to Exhibit 4.1 of Senesco Technologies, Inc. quarterly report on From 10-QSB for the period ended September 30, 2003.)

 

 

 

 

 

4.15

 

Form of Warrant issued to certain accredited investors (with attached schedule of parties and terms thereto). (Incorporated by reference to Exhibit 4.1 of Senesco Technologies, Inc. Current Report on Form 8-K, filed on February 3, 2004.)

 

 

 

 

 

4.16

 

Form of Warrant issued to certain accredited investors (with attached schedule of parties and terms thereto). (Incorporated by reference to Exhibit 4.1 of Senesco Technologies, Inc. Current Report on Form 8-K, filed on May 4, 2005.)

 

 

 

 

 

4.17

 

Form of Warrant issued to Oppenheimer & Co. Inc. or its designees, dated as of May 9, 2005. (Incorporated by reference to Exhibit 4.2 of Senesco Technologies, Inc. quarterly report on From 10-QSB for the period ended March 31, 2005.)

 



 

Exhibit
No.

 

Description of Exhibit

 

 

 

 

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.) (Incorporated by reference to Exhibit 4.1 of Senesco Technologies, Inc. Current Report on Form 8-K, filed on February 3, 2004.)

 

 

 

 

 

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 *

 

Employment Agreement by and between Senesco, Inc. and Sascha P. Fedyszyn, dated January 21, 1999. (Incorporated by reference to Senesco Technologies, Inc. quarterly report on Form 10-QSB for the period ended December 31, 1998.)

 

 

 

 

 

10.5

 

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.)

 

 

 

 

 

10.6 *

 

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.)

 

 

 

 

 

10.7

 

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.)

 

 

 

 

 

10.8 †

 

First amendment of office lease by and between Senesco Technologies, Inc. and Matrix/AEW NB, LLC, dated May 13, 2005.

 

 

 

 

 

10.9 *

 

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.)

 

 

 

 

 

10.10 +

 

License Agreement by and between Senesco Technologies, Inc. and Harris Moran Seed Company, dated November 19, 2001. (Incorporated by reference to Exhibit 10.8 of Senesco Technologies, Inc. quarterly report on Form 10-QSB for the period ended December 31, 2001.)

 

 

 

 

 

10.11 *

 

Employment Agreement by and between Senesco Technologies, Inc. and Bruce C. Galton, dated October 4, 2001. (Incorporated by reference to Exhibit 10.9 of Senesco Technologies, Inc. quarterly report on Form 10-QSB for the period ended December 31, 2001.)

 



 

Exhibit
No.

 

Description of Exhibit

 

 

 

 

10.12

 

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 period ended December 31, 2001.)

 

 

 

 

 

10.13

 

Agreement for Service on Senesco Technologies, Inc. Scientific Advisory Board by and between Senesco Technologies, Inc. and Dr. Russell A. Jones, dated February 12, 2002. (Incorporated by reference to Exhibit 10.5 of Senesco Technologies, Inc. quarterly report on Form 10-QSB for the period ended March 31, 2002.)

 

 

 

 

 

10.14

 

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.)

 

 

 

 

 

10.15

 

Research Agreement by and among Senesco Technologies, Inc., Dr. John E. Thompson and the University of Waterloo, dated May 1, 2002. (Incorporated by reference to Exhibit 10.29 of Senesco Technologies, Inc. annual report on Form 10-KSB for the year ended June 30, 2002.)

 

 

 

 

 

10.16 +

 

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.)

 

 

 

 

 

10.17 +

 

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.)

 

 

 

 

 

10.18

 

Collaboration Agreement by and between Senesco Technologies, Inc. and Tilligen, Inc. (currently known as Anawah, Inc.), dated September 20, 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.)

 

 

 

 

 

10.19

 

Sales Representative Agreement by and between Senesco Technologies, Inc. and DP, Inc., dated October 14, 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.)

 

 

 

 

 

10.20 *

 

Amendment to Consulting Agreement of July 12, 1999, as modified on February 8, 2001, by and between Senesco Technologies, 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.)

 

 

 

 

 

10.21 *

 

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 From 10-KSB for the period ended June 30, 2003.)

 



 

Exhibit
No.

 

Description of Exhibit

 

 

 

 

10.21

 

Form of Securities Purchase Agreement by and between Senesco Technologies, Inc. and certain accredited investors (with attached schedule of parties and terms thereto). (Incorporated by reference to Exhibit 10.1 of Senesco Technologies, Inc. Current Report on Form 8-K, filed on February 3, 2004.)

 

 

 

 

 

10.22

 

Form of Registration Rights Agreement by and between Senesco Technologies, Inc. and certain accredited investors (with attached schedule of parties and terms thereto). (Incorporated by reference to Exhibit 10.2 of Senesco Technologies, Inc. Current Report on Form 8-K, filed on February 3, 2004.)

 

 

 

 

 

10.23

 

Amendment No. 1 to the Securities Purchase Agreement by and between Senesco Technologies, Inc. and Crestview Capital Master, L.L.C. (Incorporated by reference to Exhibit 10.1 of Senesco Technologies, Inc. Current Report on Form 8-K, filed on February 13, 2004.)

 

 

 

 

 

10.24

 

Amendment No. 1 to the Registration Rights Agreement by and between Senesco Technologies, Inc. and Crestview Capital Master, L.L.C. (Incorporated by reference to Exhibit 10.2 of Senesco Technologies, Inc. Current Report on Form 8-K, filed on February 13, 2004.)

 

 

 

 

 

10.25 +

 

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.)

 

 

 

 

 

10.26

 

Amendment to Research Agreement by and among the University of Waterloo, Senesco Technologies, Inc. and Dr. John E. Thompson, dated March 11, 2004. (Incorporated by reference to Exhibit 10.2 of Senesco Technologies, Inc. quarterly report on Form 10-QSB for the period ended March 31, 2004.)

 

 

 

 

 

10.27

 

Extension to Research Agreement by and among the University of Waterloo, Senesco Technologies, Inc. and Dr. John E. Thompson, dated August 1, 2004. (Incorporated by reference to Exhibit 10.37 of Senesco Technologies, Inc. annual report on Form 10-KSB for the period ended June 30, 2004.)

 

 

 

 

 

10.28

 

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.)

 

 

 

 

 

10.29 *

 

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.)

 

 

 

 

 

10.30

 

Indemnification Agreement with 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.)

 



 

Exhibit
No.

 

Description of Exhibit

 

 

 

 

10.31 +

 

Development and License Agreement with Broin and Associates, Inc. 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.)

 

 

 

 

 

10.32

 

Form of Securities Purchase Agreement by and between the Company and certain accredited investors (with schedule of parties and terms thereto). (Incorporated by reference to Exhibit 10.1 of Senesco Technologies, Inc. Current Report on Form 8-K filed on May 4, 2005.)

 

 

 

 

 

10.33

 

Placement Agent Agreement by and between the Company and Oppenheimer & Co. Inc. dated as of February 15, 2005 (with attachments thereto). (Incorporated by reference on Exhibit 10.2 of Senesco Technologies, Inc. Current Report on Form 8-K, filed on May 4, 2005.)

 

 

 

 

 

10.34

 

Consulting Agreement by and between the Company and Michael Berry, Ph.D. dated as of January 3, 2005 and Warrant issued to Michael Berry, Ph.D. dated as of January 3, 2005. (Incorporated by reference to Exhibit 10.3 of Senesco Technologies, Inc. quarterly report on Form 10-QSB for the period ended March 31, 2005.)

 

 

 

 

 

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 Goldstein Golub Kessler 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-KSB.

 

                  Filed herewith.

 

+                 The SEC granted Confidential Treatment for portions of this Exhibit.

 



 

SENESCO TECHNOLOGIES, INC.

 AND SUBSIDIARY

(a development stage company)

 

CONSOLIDATED FINANCIAL STATEMENTS

 

JUNE 30, 2005

 



 

SENESCO TECHNOLOGIES, INC. AND SUBSIDIARY

(a development stage company)

 

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

 

Report of Independent Registered Public Accounting Firm

 

 

 

Consolidated Financial Statements:

 

 

 

Balance Sheet

 

Statement of Operations

 

Statement of Stockholders’ Equity

 

Statement of Cash Flows

 

Notes to Consolidated Financial Statements

 

 

F-1



 

 

GOLDSTEIN GOLUB KESSLER LLP

 

Certified Public Accountants and Consultants

 

 

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Board of Directors of

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, 2005, and the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the two years in the period ended and cumulative amounts from inception to June 30, 2005. 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, 2005 and the results of their operations and their cash flows for each of the two years in the period ended and cumulative amounts from inception to June 30, 2005 in conformity with United States generally accepted accounting principles.

 

/s/ GOLDSTEIN GOLUB KESSLER LLP

 

GOLDSTEIN GOLUB KESSLER LLP

New York, New York

 

August 17, 2005

 

1185 Avenue of the Americas Suite 500 New York, NY 10036-2602

TEL 212 372 1800 FAX 212 372 1801 www.ggkllp.com

NEXIA INTERNATIONAL IS A WORLDWIDE NETWORK OF INDEPENDENT ACCOUNTING AND CONSULTING FIRMS

 

F-2



 

SENESCO TECHNOLOGIES, INC. AND SUBSIDIARY

(a development stage company)

 

CONSOLIDATED BALANCE SHEET

 

June 30, 2005

 

ASSETS

 

 

 

 

 

 

 

Current Assets:

 

 

 

Cash and cash equivalents

 

$

291,858

 

Short-term investments

 

3,941,627

 

Prepaid expenses and other current assets

 

156,544

 

 

 

 

 

Total current assets

 

4,390,029

 

 

 

 

 

Long-term Investments

 

247,768

 

 

 

 

 

Property and Equipment, net

 

30,038

 

 

 

 

 

Intangibles, net

 

1,438,119

 

 

 

 

 

Deferred Income Tax Asset, net of valuation allowance of $4,355,000

 

 

 

 

 

 

Security Deposit

 

7,187

 

Total Assets

 

$

6,113,141

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

Current Liabilities:

 

 

 

Accounts payable

 

$

217,569

 

Accrued expenses

 

180,002

 

Deferred revenue

 

33,333

 

Total current liabilities

 

430,904

 

 

 

 

 

Grant Payable

 

90,150

 

 

 

 

 

Other Liability

 

2,336

 

Total liabilities

 

523,390

 

 

 

 

 

 

 

 

 

Commitments

 

 

 

 

 

 

 

Stockholders’ Equity:

 

 

 

Preferred stock - $0.01 par value; authorized 5,000,000 shares, no shares issued

 

 

Common stock - $0.01 par value; authorized 30,000,000 shares, issued and outstanding 15,467,388 shares

 

154,674

 

Capital in excess of par

 

20,198,984

 

Deficit accumulated during the development stage

 

(14,763,907

)

Stockholders’ equity

 

5,589,751

 

Total Liabilities and Stockholders’ Equity

 

$

6,113,141

 

 

See Notes to Consolidated Financial Statements

 

F-3



 

SENESCO TECHNOLOGIES, INC. AND SUBSIDIARY

(a development stage company)

 

CONSOLIDATED STATEMENT OF OPERATIONS

 

 

 

Year ended June 30,

 

Cumulative
Amounts from

 

 

 

2005

 

2004

 

Inception

 

 

 

 

 

 

 

 

 

Revenue

 

$

125,000

 

$

16,667

 

$

351,667

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

General and administrative

 

1,390,825

 

2,333,432

 

11,300,228

 

Research and development

 

1,265,960

 

1,071,870

 

4,929,076

 

Total operating expenses

 

2,656,785

 

3,405,302

 

16,229,304

 

 

 

 

 

 

 

 

 

Loss from operations

 

(2,531,785

)

(3,388,635

)

(15,877,637

)

 

 

 

 

 

 

 

 

Noncash income

 

135,632

 

185,627

 

321,259

 

 

 

 

 

 

 

 

 

Sale of state income tax loss - net

 

153,160

 

91,448

 

586,442

 

 

 

 

 

 

 

 

 

Interest income - net

 

54,027

 

33,278

 

206,029

 

Net loss

 

$

(2,188,966

)

$

(3,078,282

)

$

(14,763,907

)

 

 

 

 

 

 

 

 

Basic and diluted net loss per common share

 

$

(.16

)

$

(.24

)

 

 

 

 

 

 

 

 

 

Basic and diluted weighted-average number of common shares outstanding

 

14,053,808

 

12,668,396

 

 

 

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, 1998 (date of inception) to June 30, 2005

 

 

 

 

 

 

 

 

 

 

 

Deferred

 

 

 

 

 

 

 

 

 

 

 

Deficit

 

Compensation

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

Related to

 

Total

 

 

 

Common Stock

 

Capital

 

During the

 

Issuance of

 

Stockholders'

 

 

 

Number

 

 

 

in Excess

 

Development

 

Options and

 

Equity

 

 

 

of Shares

 

Amount

 

of Par

 

Stage

 

Warrants

 

(Deficiency)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 for $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 for $2.867647 per share

 

17,436

 

174

 

49,826

 

 

 

50,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock for cash on January 31, 2000 for $2.87875 per share

 

34,737

 

347

 

99,653

 

 

 

100,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock for cash on February 4, 2000 for $2.924582 per share

 

85,191

 

852

 

249,148

 

 

 

250,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock for cash on March 15, 2000 for $2.527875 per share

 

51,428

 

514

 

129,486

 

 

 

130,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock for cash on June 22, 2000 for $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 granted during the year ended June 30, 2000

 

 

 

755,084

 

 

$

(180,732

)

574,352

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

(2,444,916

)

 

(2,444,916

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at June 30, 2000

 

7,873,292

 

78,733

 

5,234,468

 

(3,613,911

)

(180,732

)

1,518,558

 

 

See Notes to Consolidated Financial Statements

 

F-5



 

 

 

 

 

 

 

 

 

 

 

Deferred

 

 

 

 

 

 

 

 

 

 

 

Deficit

 

Compensation

 

 

 

 

 

 

 

 

 

Accumulated

 

Related to

 

Total

 

 

 

Common Stock

 

Capital

 

During the

 

Issuance of

 

Stockholders'

 

 

 

Number

 

 

 

in Excess

 

Development

 

Options and

 

Equity

 

 

 

of Shares

 

Amount

 

of Par

 

Stage

 

Warrants

 

(Deficiency)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fair market value of warrants granted on October 2, 2000

 

 

 

$

80,700

 

 

 

$

80,700

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Change in fair market value of options and warrants granted

 

 

 

154,583

 

 

$

(83,563

)

71,020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

$

(1,876,991

)

 

(1,876,991

)

Balance at June 30, 2001

 

7,873,292

 

$

78,733

 

5,469,751

 

(5,490,902

)

(264,295

)

(206,713

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock and warrants for cash from November 30, 2001 through April 17, 2002 at $1.75 per unit

 

3,701,430

 

37,014

 

6,440,486

 

 

 

6,477,500

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock and warrants associated with bridge loan conversion on December 3, 2001

 

305,323

 

3,053

 

531,263

 

 

 

534,316

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Commissions, legal and bank fees associated with issuances for the year ended June 30, 2002

 

 

 

(846,444

)

 

 

(846,444

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fair market value of options and warrants vested during the year ended June 30, 2002

 

 

 

577,708

 

 

 

577,708

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fair value of options and warrants vested and change in fair market value of options and warrants granted

 

 

 

(15,085

)

 

203,813

 

188,728

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

(1,939,419

)

 

(1,939,419

)

Balance at June 30, 2002

 

11,880,045

 

118,800

 

12,157,679

 

(7,430,321

)

(60,482

)

4,785,676

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fair market value of warrants vested during the year ended June 30, 2003

 

 

 

97,497

 

 

 

97,497