Annual Statements Open main menu

AngioGenex, Inc. - Annual Report: 2008 (Form 10-K)

AngioGenex 10-K 04-10-09

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549


FORM 10-K


[X]  Annual report under Section 13 or 15(d) of the Securities Exchange Act of 1934 for the fiscal year ended December 31, 2008.


[   ]  Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from _____ to _____.


Commission File Number 000-26181


AngioGenex, Inc.

(Exact name of small business issuer as specified in its charter)


Nevada

(State or other jurisdiction of

incorporation or organization)

86-0945116

(I.R.S. employer

identification number)


425 Madison Ave., Suite 902, New York, New York, 10017

(Address of principal executive offices and zip code)

  

(212) 874-6008

(Registrant’s telephone number, including area code)


Securities registered pursuant to Section 12(b) of the Act: NONE


Securities registered pursuant to Section 12(g) of the Act:

Common Stock, $0.001 par value


Check whether the issuer is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. [  ]


Check mark whether the issuer (1) has filed all reports required to be filed by Section 13 or 15(d) of the 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 [X] NO [  ]


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-K or any amendment to this Form 10-K. [X]


Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).   YES [  ]  NO [X]


The issuer had no revenues for its fiscal year ended December 31, 2008.


 

- 1 -


Aggregate market value of the common equity held by non-affiliates of the issuer as of March 24, 2009 was $5,687,116.


Number of shares outstanding of the issuer’s common stock as of March 24, 2009: 21,302,906 shares.

 

- 2 -


  

TABLE OF CONTENTS


  

  

  

Page   

PART I

  

  

  

Item 1.   

Business

  

4

Item 1A

Risk Factors

  

15

Item 2.

Description of Property

  

27

Item 3.

Legal Proceedings

  

27

Item 4.

Submission of Matters to a Vote of Security Holders

  

27

PART II

 

  

28

Item 5.

Market for Common Equity and Related Stockholder Matters

  

28

Item 6.

Selected Financial Data

  

29

Item 7.

Management’s Discussion and Analysis or Plan of Operation

  

29

Item 8.

Financial Statements

  

34

Item 9.

Changes in and Disagreements With Accountants on Accounting and Financial Disclosure

  

54

Item 9A.

Controls and Procedures

  

54

PART III

  

  

  

Item 10.

Directors, Executive Officers, Promoters and Control Persons; Compliance with Section 16(a) of the Securities Exchange Act

  

56

Item 11.

Executive Compensation

  

58

Item 12.    

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

  

60

Item 13.

Certain Relationships and Related Transactions

  

62

Item 14.

Principal Accountant Fees and Services

  

62

PART IV

 

 

 

Item 15

Exhibit Index

  

63

SIGNATURES   

  

64



- 3 -


PART I


CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS


This annual report on Form 10-K and the documents incorporated by reference include “forward-looking statements.” To the extent that the information presented in this report discusses financial projections, information or expectations about our business plans, results of operations, products or markets, or otherwise makes statements about future events, such statements are forward-looking. Such forward-looking statements can be identified by the use of words such as “may,” “will,” “should,” “might,” “would,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” and “proposes.” Although we believe that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. These include, among others, the cautionary statements in the “Risk Factors” and “Management’s Discussion and Analysis and Plan of Operation” sections of this report. These cautionary statements identify important factors that could cause actual results to differ materially from those described in the forward-looking statements. When considering forward-looking statements in this report, you should keep in mind the cautionary statements in the “Risk Factors” section above and “Management’s Discussion and Analysis or Plan of Operation” section below, and other sections of this report.

  

The statements contained in this Registration Statement that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including, without limitation, statements regarding our expectations, objectives, anticipations, plans, hopes, beliefs, intentions or strategies regarding the future.


All forward-looking statements included in this document are based on information available to us on the date hereof, and we assume no obligation to update any such forward-looking statements. It is important to note that our actual results could differ materially from those included in such forward-looking statements. For a more detailed explanation of such risks, please see “Risk Factors” below. Such risks, as well as such other risks and uncertainties as are detailed in our SEC reports and filings for a discussion of the factors that could cause actual results to differ materially from the forward-looking statements.


The following discussion should be read in conjunction with the audited consolidated financial statements and the notes included in this report on Form 10-K and the section entitled “Management’s Discussion and Analysis of Financial Condition and Plan of Operation” included in this report on Form 10-K.

  

ITEM 1.  BUSINESS


History and Background


AngioGenex is a development stage biopharmaceutical company focused on creating products that are uniquely useful for the treatment, diagnosis and prognosis of cancer. Our development programs focus on (1) the discovery and development of orally active anti-cancer drugs that act by modulating the action of the Id (inhibitor of differentiation) proteins, (2) the measurement of Id proteins in tumors and blood to create products for the diagnosis and prognosis of cancer and (3) generating proof-of-concept data in relevant preclinical models to establish that modulation of Id genes and proteins is useful to treat non-oncologic diseases in which a surplus or deficit in the growth of blood vessels is an important part of the underlying pathology. Our proprietary technology is based on the research work of Dr. Robert Benezra and his colleagues at Memorial Sloan Kettering Cancer Center (MSKCC), who discovered the Id, or inhibitor of differentiation genes and corresponding Id proteins and established their role in the formation of new blood vessels (angiogenesis) required for tumor growth and metastasis. Our intellectual property includes the rights to biotechnology in the Id field, which we acquired under exclusive worldwide licenses from

 

- 4 -


MSKCC, and our own patented and proprietary technology and molecules that we have generated while developing our Id based anti-angiogenesis anti-cancer and other strategies.


AngioGenex, Inc. was incorporated in the State of Nevada on April 2, 1999.


On April 3, 2000, in exchange for $30,000 we obtained from MSKCC an exclusive worldwide license two patent applications relating to a method for modulating tumor growth and metastasis of tumor cells based on the Id technology and Id knockout mice useful for testing and developing useful products for the treatment, diagnosis and prognosis of cancer. The license agreement provides that an additional $200,000 shall be paid to MSKCC upon the submission to any regulatory authority of the first new drug application for any licensed product and $500,000 to be paid upon the first regulatory authority approval. In addition, the agreement also provides for royalty payments to MSKCC ranging from 2.5% - 4% of net sales and 15% of gross revenues from sub-license fees.


We licensed our intellectual property relating to Id related diagnostic, bio-analytical or prognostic products to BioCheck Inc. pursuant to a Development and Marketing Agreement entered into on December 15, 2003. AngioGenex has licensed the rights to develop Id based prognostics and diagnostics to BioCheck in exchange for milestones, royalties and the right to use internally, any developed technology (such as new assays or monoclonal antibodies). BioCheck, a subsidiary of OXIS International, Inc., is a leading producer of clinical diagnostic assays, including high quality enzyme immunoassay research services and immunoassay kits for cardiac and tumor markers, infectious diseases, thyroid function, steroids, and fertility hormones designed to improve the accuracy, efficiency, and cost-effectiveness of in vitro (outside the body) diagnostic testing in clinical laboratories. BioCheck focuses primarily on the immunoassay segment of the clinical diagnostics market. BioCheck offers over 40 clinical diagnostic assays manufactured in its 15,000 square foot, U.S. Food and Drug Administration, or FDA, certified Good Manufacturing Practices device-manufacturing facility in Foster City, California.

  

AngioGenex is a development stage company and has incurred significant losses since inception. We had an accumulated deficit of approximately $4,510,246 as of December 31, 2008. These losses have resulted principally from costs incurred in connection with research and development activities, license fees, patent expenses and general and administrative expenses.


RESEARCH AND DEVELOPMENT PROGRAMS


Anti-Cancer Therapeutics


Our main focus is the discovery and development of one or more anti-cancer drug product candidates that act by preventing the formation of blood vessels (angiogenesis) into tumors that act by modulating the action of the Id (inhibitor of differentiation) proteins.


Scientific Background


Cancer is a genetic disease resulting in deregulated cell growth. Tumor suppressor genes and oncogenes inhibit or stimulate cell growth or proliferation and are normally in balance. Mutations in either or both of these gene classes can lead to cancer. Over the past 20 years, much research has focused on inhibiting the growth of tumor cells by either altering the activity of oncogenes or tumor suppressors so that normal cell growth properties are restored. This approach has met with limited success for several reasons. Tumor cells can acquire mutations rapidly and drugs designed to kill the tumor cell or alter protein activity are often countered with further mutations leading to drug resistance. In addition, many of the oncogenes and tumor suppressors have normal healthy counterparts that are required for normal cell functions so that inhibiting their activity often causes serious side effects and toxicities. Finally, the mechanisms of action of some oncogene and tumor suppressors are poorly understood limiting the development of more specific drug therapies. For these reasons, alternate approaches to the management and cure for cancer have been actively pursued.

 

- 5 -


The Anti-Angiogenic Approach.


One anti-cancer approach that has received much attention in recent years involves targeting the blood supply of the tumor. If tumors are prevented from recruiting new blood vessels for nutrients (through a process called angiogenesis) they cannot grow beyond a very small size and cannot spread (metastasize) to other parts of the body, rendering them essentially harmless to the patient. This approach is attractive because unlike tumor cells, the cells that form blood vessels do not acquire mutations at any appreciable rate and, therefore, it is unlikely that they would acquire drug resistance. In addition, certain research indicates that the growth of blood vessels around tumors is a different process than normal angiogenesis in adults suggesting it is possible to develop non-toxic drug regimens for treating cancer. Normal angiogenesis occurs in adults primarily in wound healing and certain reproductive functions. Finally, the molecular steps that result in angiogenesis are becoming better understood, thereby providing new targets for anti-angiogenic drug design. Among these, the Id genes and Id proteins have been demonstrated to play a key role in tumor angiogenesis.


The Id genes act early in fetal development to promote the growth of cells and blood vessels but are turned off prior to birth and are usually inactive in adult life. The Id gene is reactivated in many tumor cells in the early stages of the disease and, importantly, it is also expressed in the blood vessels that infiltrate tumors. Through genetic manipulations in mice it has been shown that partial loss of Id gene function leads to an inhibition of the growth and metastasis of tumors. This inhibition can be attributed to the failure of the animals to develop an intact vasculature (network of blood vessels) within the tumor mass resulting in significant cancer cell death. Importantly, animals with reduced Id levels show no other obvious physiological abnormalities. Thus, the Id genes and proteins become attractive drug targets for the following reasons:

 

The Id proteins have been shown to be a key component for tumor angiogenesis.

 

 

 

 

The Id proteins are fetal specific and are only re-expressed during tumor vascularization but not in normal adult vasculature (with the exception of wound healing and reproductive functions) making it possible to design drugs that are not expected to cause side-effects

 

 

 

 

Only partial reduction in Id activity causes a significant inhibition of tumor angiogenesis.

 

 

  

 

The mechanism of Id action is well understood-thus allowing high-throughput screening and rational design of drug candidates.

 

 

  

 

Inactivation of Id before or after tumor formation is effective in preventing or limiting tumor growth in animal models that we believe is reasonably predictive of human activity.

 

 

  

 

Compounds of a known chemical class have been identified that bind and inhibit the Id protein in a biochemical and a cell culture screen.


We are pursuing strategies to inactivate either the Id genes or Id proteins to inhibit the growth and metastasis of tumors. We are funding ongoing research concerning their activity for the design of more potent and efficient Id protein inhibitors.


Id-Based Oncology Therapeutics .


The discovery and development of one or more anticancer drugs that act by preventing the formation of blood vessels (angiogenesis) into tumors by either by blocking the action of the Id genes or Id proteins is the primary corporate goal of AngioGenex. The validation of the usefulness of inhibiting blood vessel formation in cancer has been shown in man using drugs such as Avastin{trademark} whose target is vascular endothelial growth factor. While these drugs appear to be only modestly effective, they

 

- 6 -


demonstrate the potential value of treating cancer by this approach and suggest that a more potent and selective agent would be an even more important addition to cancer therapy.


There is considerable evidence to demonstrate the effects of several Id proteins (Id1, Id2, and Id3) on different aspects of cellular growth. The participation of Id proteins in advanced human malignancy has been supported by the discovery that they exert pivotal contributions to essential cellular alterations that collectively cause malignant growth. The Id proteins support the formation of blood vessels into tumors that results in growth and metastasis. These proteins comprise a particularly compelling target for drug discovery because they are either absent or present in very low concentration in normal adult tissues. They are normally required only for wound healing and certain reproductive functions in adults. As a result, inhibition of Id proteins would be limited to the tumor and would not be expected to affect normal cellular functions and cause toxicity like other anti-angiogenic drugs that are less selective. Dr. Robert Benezra of Memorial Sloan Kettering has shown that mice that are deficient in one or more copies of the Id proteins (Id1 and/or Id3) are unable to support the growth and metastasis of tumors caused by the injection of several different types of cancer cells. Negative effects of Id deletion on preformed tumors have also been demonstrated. The evidence for the lack of growth of tumors with Id deficiency has been extended by using genetically modified mice that harbor either activated oncogenes or mutated tumor suppressor genes that are commonly found in human cancers including breast and prostate. The inhibition of tumor growth in these animals is especially important since they are the most challenging models available and, as a result, are not often used by others to identify anti-cancer drugs. These are compelling models that mimic the human course of the disease because these animals are immune competent and the tumors develop spontaneously rather than grow from tumor cells that are injected into the mouse.


We conducted research to identify other inhibitors with superior characteristics for development as anti-cancer drugs using a rational computational drug design approach , at a number of contract research organizations and collaborating laboratories. Cengent Therapeutics, Inc commenced a collaborative effort in June 2004. Part of this effort involved the screening, using an assay developed by AngioGenex, of both large and small libraries of small organic and naturally occurring molecules for their ability to inhibit the Id proteins. Rational drug design was employed using the most advanced research technology. For example, the crystal structure of Id1 has been identified and computational analysis was used to determine the site of binding of a known anti-Id drug with modest inhibitory activity. The initial findings have led to the selection of approximately 350 small molecules and 12 peptides that were acquired for further winnowing through additional screening with the objective of selecting one or more compounds for more advanced testing. Two compounds with the desired anti-Id property were identified and tested in established animal tumor models for their ability to block blood vessel formation and to inhibit tumor growth, designated AGX8 and AGX51. Based on these findings, screening results and other information that has been accrued, we identified a number of more potent anti-Id molecules, including AGX8 and AGX51, which were the subject of a recently filed patent application.  We conducted further pre-clinical research with these molecules at the Southern Research Institute, a contracting research organization the results of which demonstrated both the retardation of tumor formation and the prevention of metastasis.  We presented those results at a number of important scientific conferences.


We are also pursuing the potential in-licensing from Memorial Sloan Kettering Cancer Center of a patent application filed in January 2008 covering a targeted peptide conjugated anti-sense oligonucleotide compound that prevents angiogenesis by inhibiting Id gene expression and blocks both tumor formation and metastasis in mice. Although our licensed patent position with regard to our previous license from MSKCC creates unique synergies, we cannot give assurance that we will be successful in licensing this new patent application from MSKCC.


Our lead compounds AGX8 and AGX51 will be subjected to further testing in animals to obtain preliminary knowledge of their properties including safety and then they will be subjected to the more stringent tests required to complete the FDA requirements for an IND (Investigational New Drug Application). Clinical studies will then be conducted first in normal volunteers and then in cancer patients to obtain preliminary results regarding the safety and efficacy of the drugs (Phase I & II). If the results of both the animal and clinical studies indicate that the drugs has potential as an anti-cancer agent, we will

 

- 7 -


attempt to identify a partner willing to assume financial responsibility while sharing clinical development responsibility for completing the requirements for an NDA (New Drug Application) and marketing.

  

While progress in the identification of an anti-Id molecule is proceeding with some success, we are acutely aware of the difficulties that are usually encountered in finding a drug that is effective in treating cancer. The major obstacle is the heterogeneity of tumors. That is, while cancer is thought to begin with the mutation of a single cell, the tumors that are formed are made up of numerous cellular cousins. As a result, drug treatment does not usually eliminate all the tumor cells (resistance) and the recurrence and metastasis of a tumor can be fatal. A major advantage of our technology is that it is expected to circumvent this problem; anti-Id therapy is not aimed at the heterogeneous tumor cells but at the source of the formation of blood vessels. The latter are necessary if a tumor is to survive beyond the size of a pencil eraser. Elimination of the action of the Id proteins has been shown to block tumor formation in genetically modified animals that carry the human form of tumors with an effectiveness that is unequaled in the scientific literature. We expect to out-license the rights to our lead product candidates at some point prior to initiation of Phase III clinical trials to a licensor capable of funding and efficiently executing such clinical trials, and undertaking the manufacturing and marketing of the licensed drug compound.


Id-Related Ocular Therapeutics.


There are other important diseases besides cancer in which the abnormal growth of blood vessels contributes to the underlying pathology. These include ARMD (age related macular degeneration) and diabetic retinopathy where growth of blood vessels has been implicated in the loss of vision and blindness. These are major diseases for which existing treatments are unsatisfactory. Medical experts in these diseases believe, and there is some experimental evidence to suggest, that blocking the growth of blood vessels would be therapeutic. All research in the ocular was conducted for us at the University of Florida in 2004 and supervised by Glenn Stoller MD, the principal investigator and a practicing ophthalmologist and Patricia D'Amore, PhD (Schepens Eye Institute, Harvard), an expert in angiogenesis in the eye. Promising results were obtained in two animal models used routinely to identify drugs useful to treat these diseases. The first model involves subjecting very young mice to high oxygen concentrations (hyperoxia), a procedure that causes growth of blood vessels in the eye. This model is used routinely to screen for agents to treat ARMD. The absence of Id genes and proteins prevented the growth of blood vessels into the eye in this animal model. A second mouse model of ARMD that employs argon laser injury was also used to investigate the role of the Id genes and proteins in ocular angiogenesis. The argon laser model is the most predictive of a beneficial action of a drug or procedure for the treatment of ARMD. As in the hyperoxia model, Id deletion resulted in a failure of growth of new blood vessels into the eye.


Additional research is planned subject to available capital resources to confirm and extend these findings and anti-Id molecules will be used in an attempt to reproduce these results. An anti-sense molecule that is known to block blood vessel formation in one in vivo model would be tested in the eye models and, if active, additional investigations would be initiated to identify a chemically related compound with more desirable properties that could be considered for development as a therapeutic for ARMD.

After selection of a molecule suitable for development as a drug, we plan to seek a partner in the ocular area who will assume responsibility for completing the work to market.


We have spent approximately $146,000 on research and development within the last two fiscal years (2007 and 2008)


OUT-LICENSED TECHNOLOGY


BioCheck, Inc.: Id-based Products for Diagnosis/Prognosis of Cancer.


We licensed our intellectual property relating to Id related diagnostic, bio-analytical or prognostic products to BioCheck Inc. pursuant to a Development and Marketing Agreement entered into on December 15, 2003. AngioGenex licensed the rights to develop Id based prognostics and diagnostics to BioCheck in exchange for milestones, royalties and the right to use internally any developed technology (such as new

 

- 8 -


assays or monoclonal antibodies). BioCheck, a subsidiary of OXIS International, Inc., is a leading producer of clinical diagnostic assays including high quality enzyme immunoassay research services and immunoassay kits for cardiac and tumor markers, infectious diseases, thyroid function, steroids, and fertility hormones designed to improve the accuracy, efficiency, and cost-effectiveness of in vitro (outside the body) diagnostic testing in clinical laboratories. BioCheck has a proven record in the field having created a number of successfully marketed diagnostic kits including EPT ™ (Early Pregnancy Test). BioCheck focuses primarily on the immunoassay segment of the clinical diagnostics market. BioCheck offers over 40 clinical diagnostic assays manufactured in its 15,000 square foot, U.S. Food and Drug Administration, or FDA, certified Good Manufacturing Practices device-manufacturing facility in Foster City, California.   


License Agreement with BioCheck


We licensed our intellectual property relating to Id related diagnostic, bio-analytical or prognostic products to BioCheck Inc. pursuant to a Development and Marketing Agreement entered into on December 15, 2003. AngioGenex has licensed the rights to develop Id based prognostics and diagnostics to BioCheck in exchange for milestones, royalties and the right to use internally, any developed technology (such as new assays or monoclonal antibodies). BioCheck,  is a leading producer of clinical diagnostic assays. BioCheck, in collaboration with AngioGenex. has been investigating the Id technology for its potential for the diagnosis and prognosis of various types of cancers. .


BioCheck and AngioGenex have developed monoclonal antibodies for both human and mouse Id1, Id2 and Id3. Currently, BioCheck is developing monoclonal antibodies for all four Id proteins (Id1, Id2, Id3 and Id4) for use in standard ELISA type tests and for kits for detection of the proteins in tumors and other tissues. These monoclonal antibodies are critical to the development of diagnostics and other research in the Id area. These antibodies will also be used to identify those tumors in which Id proteins are expressed that may be amenable to anti-Id therapy.  The monoclonal antibodies to the Id1 and Id3 proteins are the subject of a patent application jointly owned by AngioGenex and BioCheck. Their availability is expected to provide AngioGenex multiple opportunities to answer key questions regarding the action of the Id proteins that could not be addressed heretofore with certainty since only polyclonal antibodies are commercially obtainable. Their availability is expected to have a positive impact on progress of our product development programs.


The development of a serum test for breast cancer using a standard ELISA format is the second diagnostic product that is under development by BioCheck. The ability to detect the presence of breast cancer at a very early stage would allow early intervention and a much better opportunity to treat this disease successfully. The test would also provide early detection of reemergence of the disease following therapy and signal the need to re-institute therapy. Pilot measurements of serum Id proteins from patients with breast cancer suggest the possibility of developing a highly sensitive test that will allow early detection and the ability to monitor the progress of the disease during and after therapy. A small number of serum samples comparing age matched normal individuals and breast cancer patients were assayed blindly using the ELISA assay developed at BioCheck. This diagnostic test correctly identified the breast cancer patients and gave no false positives or false negatives. Additional clinical testing will be conducted to confirm these findings.


Recent reports in the scientific literature suggest that Id measurements could also be useful in the prognosis of melanoma and cervical cancer. As testing for Id proteins progresses in breast cancer patients, it is likely that other tumors will eventually be made part of BioCheck’s efforts in the diagnostic prognostic area. The development of highly sensitive diagnostic and prognostic tests of the ELISA type is aided by the use of monoclonal antibodies to the Id proteins.

 

- 9 -


COMPETITION


We believe that there is no other company developing an Id-based therapeutic, diagnostic or prognostic product. However, there are a large number of competitors developing cancer therapeutics based on an anti-angiogenic approach. There are also, a significant number of companies developing therapeutics and diagnostics based on other technologies. The table below presents our competitors' principal anti-angiogenic drug and biologic candidates currently in clinical trials. The table is representative and not all-inclusive, and reflects information publicly available in 2008.

  

PRINCIPAL ANTI-ANGIOGENIC DRUGS IN CLINICAL TRIALS FOR CANCER

  

Drug

  

Company

  

Action(s)

  

Clinical status

Avastin

  

Genentech, Inc.

  

Monoclonal

  

Market approval first-line or previously untreated metastatic cancer of the antibody to VEGF colon or rectum received Q1/04 Phase III for adjuvant colorectal cancer, renal cell carcinoma, prostate cancer, and metastatic and locally advanced pancreatic cancer

  

  

  

  

  

  

  

Neovastat AE-941

  

NCI, Aeterna,

Zentaris Inc.,

  

Multiple

  

Phase III for NSCLC mechanisms, eg inhibits MMPs, blocks binding of

VEGF to its receptor, promotes apoptosis of endothelial cells and increases levels of angiostatin, a naturally occurring anti- angiogenic agent.

  

  

  

  

  

  

  

Thalidomide

  

Celgene

  

Immunomodulation

  

NDA submitted for multiple myeloma, Phase III for renal cell cancer, Phase II for prostate

  

  

  

  

  

  

  

Revlimid/Actimed

  

Celgene

  

Immunomodulatory

  

Phase II/III for prostate thalidomide and multiple myeloma, analogs Phase III for metastaic melanoma, Phase II for solid tumors and MDS

  

  

  

  

  

  

  

Combrestatin-A4

  

OXiGene

  

Directly inhibits

  

Phase I/II for advanced endothelial cells colorectal cancer, Phase II for breast, Phase I for cervical, Phase I/II for head/neck cancer, Phase II for lung cancer, Phase II for ovarian cancer, Phase I/II prostate cancer, Phase II for advanced regional or metastatic anaplastic thryoid cancer

  

  

  

  

  

  

  

PTK787

ZK222584

  

Schering AG

  

Inhibits VEGF receptor tyrosine

kinases

  

Phase III for colorectal

  

  

  

  

  

  

  

BMS-275291

  

Bristol Meyers Squibb Co.

  

MMP inhibitor

  

Phase III combination with Paclitaxel and Carboplatin for for NSCL

  

  

  

  

  

  

  

Cilengitide

(EMD121974)

  

Merck KGaA

  

Integrin inhibitor

  

Phase I for solid tumors or lymphoma

 

- 10 -


 

  

  

  

  

  

  

  

Panzem

  

EntreMed, Inc.

  

Steroid (2- Methoxy estradiol)

  

Phase II for various solid tumors

  

  

  

  

  

  

  

LY317615

  

Eli Lilly & Co.

  

Protein kinase C Inhibitor

  

Phase II for gliomas & lymphomas

  

  

  

  

  

  

  

IL-12 + IL-2

  

NCI, Chiron, Wyeth

  

Multiple mechanisms

  

Phase I for lymphoma, Phase I for neuroblastoma

  

  

  

  

  

  

  

IL-12

  

Wyeth, NCI

  

Multiple Mechanisms

  

Phase II for lymphoma, Phase II for ovarian, Phase

I for kidney, Phase I for solid tumors

  

  

  

  

  

  

  

Fragmin

  

Pfizer, Inc.

  

Blocks matrix

  

Phase II/III for pancreatic breakdown

  

  

  

  

  

  

  

Suramin

  

Pfizer, Inc.

  

Blocks matrix

  

Kidney Phase I/II, breast cancer Phase I/II Phase   I for bladder breakdown

  

  

  

  

  

  

  

VEGF-Trap AVE0005

  

Sanofi-Aventis

  

Blocks VEGF

  

Phase I for solid tumors,

  

  

  

  

  

  

  

  

  

Regeneron Pharmaceuticals Inc.

  

  

  

Phase I for non-Hodgkin's lymphoma

  

  

  

  

  

  

  

Vitaxin

  

Medimmune, Inc. inhibits key

integrin

  

Antibody that

  

Phase II for melanoma and prostate cancer

  

  

  

  

  

  

  

ZD6474

  

AstraZeneca Plc

  

Blocks VEGF and EGF receptors

  

  Phase III for myeloma, SCLC and NSCLC, Phase II for solid tumors

  

  

  

  

  

  

  

PI-88

  

Progen Industries Ltd.

  

Mechanism not established

  

Phase II for myeloma, liver and lung cancer

  

  

  

  

  

  

  

IMC-1121b

  

Imclone

  

Inhibition of VEGFR-2

  

Phase I for solid tumors

  

  

  

  

  

  

  

CDP791

  

Imclone

  

Inhibition of VEGFR-2

  

Phase II for solid tumors

  

Most of the drugs in the above table are directed at biochemicals that are growth factors such as VEGF, fibroblast growth factor, and others, or important remodeling chemicals such as integrins, matrix metallo-proteinase inhibitors, and others.


Various efforts are being made to deliver the growth factors noted above using gene therapy approaches.

 

- 11 -


GOVERNMENT REGULATION


The Food and Drug Administration or “FDA” and comparable regulatory agencies in foreign countries, as well as drug regulators in state and local jurisdictions, impose substantial requirements upon the clinical development, manufacture and marketing of pharmaceutical products. These agencies and other federal, state and local entities regulate research and development activities and the human testing, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping, approval, advertising, and promotion of AngioGenex’ lead product and any other products we may develop, acquire, or in-license).

  

The process required by the FDA under the drug provisions of the United States Food, Drug, and Cosmetic Act before AngioGenex’ initial products may be marketed in the U.S. generally involves the following:


 

·

Preclinical laboratory and animal tests;

 

·

Submission of an Investigational New Drug application or “IND”, which must become effective before human clinical trials may begin;

 

·

Adequate and well-controlled human clinical trials to establish the safety and efficacy of the product candidate for its intended use;

 

·

Submission to the FDA of an New Drug Application or “NDA” and

 

·

FDA review and approval of an NDA.


The testing and approval process requires substantial time, effort, and financial resources, and we cannot be certain that any approval will be granted on a timely basis, if at all. Preclinical tests include laboratory evaluation of the product candidate, its chemistry, formulation and stability, as well as animal studies to assess the potential safety and efficacy of the product candidate. Certain preclinical tests must be conducted in compliance with good laboratory practice regulations. Violations of these regulations can, in some cases, lead to invalidation of the studies, requiring such studies to be replicated. In some cases, long-term preclinical studies are conducted while clinical studies are ongoing.


The company submits the results of the preclinical tests, together with manufacturing information and analytical data, to the FDA as part of an IND, which must become effective before we may begin human clinical trials.


The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the trials as outlined in the IND and imposes a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can begin. The submission of an IND may not result in FDA authorization to commence clinical trials. All clinical trials must be conducted under the supervision of a qualified investigator in accordance with good clinical practice regulations. These regulations include the requirement that all subjects provide informed consent.


Further, an independent Institutional Review Board ("IRB") at each medical center proposing to conduct the clinical trials must review and approve any clinical study. The IRB also continues to monitor the study and must be kept aware of the study's progress, particularly as to adverse events and changes in the research. Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if adverse events occur.

 

- 12 -


Human clinical trials are typically conducted in three sequential phases that may overlap:


·  Phase I: The drug is initially introduced into healthy human subjects or patients and tested for safety, dosage tolerance, absorption, metabolism, distribution, and excretion.


·  Phase II: The drug is studied in a limited patient population to identify possible adverse effects and safety risks, to determine the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.


·  Phase III: When Phase II evaluations demonstrate that a dosage range of the drug is effective and has an acceptable safety profile, Phase III trials are undertaken to further evaluate dosage and clinical efficacy and to further test for safety in an expanded patient population, often at geographically dispersed clinical study sites.


The FDA or the Institutional Review Board or the IND sponsor may suspend clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.


Concurrent with clinical trials and pre-clinical studies, the company must also develop information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the product in accordance with good manufacturing practice ("GMP") requirements. The manufacturing process must be capable of consistently producing quality batches of the product, and management must develop methods for testing the quality, purity, and potency of the final products. Additionally, appropriate packaging must be selected and tested and chemistry stability studies must be conducted to demonstrate that the product does not undergo unacceptable deterioration over its shelf-life.


The results of product development, pre-clinical studies, and clinical studies are submitted to the FDA as part of an NDA for approval of the marketing and commercial shipment of the product. The FDA reviews each NDA submitted and may request additional information, rather than accepting the NDA for filing. In this event, the application must be resubmitted with the additional information. The resubmitted application is also subject to review before the FDA accepts it for filing. Once the FDA accepts the NDA for filing, the agency begins an in-depth review of the NDA. The FDA has substantial discretion in the approval process and may disagree with AngioGenex' interpretation of the data submitted in the NDA.


The review process may be significantly extended by FDA requests for additional information or clarification regarding information already provided. Also, as part of this review, the FDA may refer the application to an appropriate advisory committee, typically a panel of clinicians, for review, evaluation and a recommendation. The FDA is not bound by the recommendation of an advisory committee. Manufacturing establishments often also are subject to inspections prior to NDA approval to assure compliance with GMPs and with manufacturing commitments made in the relevant marketing application.


Submission of an NDA with clinical data requires payment of a fee. For fiscal year 2005, that fee was $672,000. In return, the FDA assigns a goal often months for standard NDA reviews from acceptance of the application to the time the agency issues its "complete response," in which the FDA may approve the NDA, deny the NDA if the applicable regulatory criteria are not satisfied, or require additional clinical data. Even if these data are submitted, the FDA may ultimately decide that the NDA does not satisfy the criteria for approval. If the FDA approves the NDA, the product becomes available for physicians to prescribe. Even if the FDA approves the NDA, the agency may decide later to withdraw product approval if compliance with regulatory standards is not maintained or if safety problems occur after the product reaches the market. The FDA may also require post-marketing studies, also known as Phase IV studies, as a condition of approval to develop additional information regarding the safety of a product. In addition, the FDA requires surveillance programs to monitor approved products that have been commercialized, and the agency has the power to require changes in labeling or to prevent further marketing of a product based on the results of these post-marketing programs.  The FDA regulates drug labeling and promotion activities.

 

- 13 -


The FDA has actively enforced regulations prohibiting the marketing of products for unapproved uses. Under the FDA Modernization Act of 1997, the FDA will permit the promotion of a drug for an unapproved use in certain circumstances, but subject to very stringent requirements.


Whether or not FDA approval has been obtained, approval of a pharmaceutical product by comparable governmental regulatory authorities in foreign countries must be obtained prior to the commencement of clinical trials and subsequent sales and marketing efforts in those countries. The approval procedure varies in complexity from country to country, and the time required may be longer or shorter than that required for FDA approval. We may incur significant costs to comply with these laws and regulations now or in the future.


Marketing and Sales

  

We do not intend to manufacture the products we may develop. We intend to license to, or enter into strategic alliances with companies like BioCheck, Inc. and larger companies in the pharmaceutical business which are equipped to manufacture and/or market our products, if any, through their well developed distribution networks. We intend to license some or all of our worldwide patent rights to more than one company to achieve the fullest development, marketing and distribution of our products, if any.


Patents, Trademarks, and Copyrights


We are substantially dependent on our ability to obtain and maintain patents and proprietary rights for our product candidates, particularly those relating to our proprietary anti-Id compounds, and to avoid infringing the proprietary rights of others. We have interests in three patents issued by the United States Patent and Trademark Office. We obtained exclusive worldwide licenses to two patent applications, we jointly own the rights to two patent applications with our licensee, BioCheck, and we have filed a patent application which we own exclusively. We licensed our intellectual property, including certain rights to two of the five patent applications below, relating to Id related diagnostic, bio-analytical or prognostic products to BioCheck. Additional patent applications may be forthcoming from our ongoing research and development.


AngioGenex Patent Application


U. S. Patent Application No. 60/980,296 filed October 16, 2007 entitled “Chemical Inhibitors of Inhibitors of Differentiation.” Inventors: Jaideep Chaudhary and Bill Garland.


Licensed Patent Applications


U.S. Patent Application No. 01/07379 filed September 13, 2001 entitled “Method for Modulating Tumor Growth And Metastasis of Tumor Cells.”


U.S. Patent Application No. 01/07378 filed September 13, 2001 entitled “Inhibitor of Differentiation Knockout Mammals and Methods of Use Thereof.”


Jointly Owned Patent Applications


U.S. Patent Application No. 11/453,156 filed June 13, 2006 filed 6/13/2006 entitled “Novel Rabbit Monoclonal Antibody Against Id1 Protein.”


U.S. Patent Application No. 11/657,426 filed January 23, 2007 [filed January 27, 2006??] entitled “Rabbit Monoclonal Antibody Against Mouse/Human Id3 Protein.”


We have not filed for any copyright or trademark protection to date.

 

- 14 -



Employees


AngioGenex, Inc. has no current employees. Employee-like services are provided by William Garland, Chief Executive Officer and Chief Operating Officer, Richard Salvador, President, and by Michael Strage, Vice President of Business Development.. Both of these individuals devote over 30 hours a week to AngioGenex, Inc.  Martin Murray, CFO is not paid for his CFO services rendered to AngioGenex, but his firm Murray and Josephson, CPAs LLC , is paid for doing the accounting and tax work. All three individuals have additional responsibilities outside of AngioGenex, Inc. It is anticipated that all three of these individuals will become full-time employees for AngioGenex, Inc. when sufficient capital resources are available.


ITEM 1A.  RISK FACTORS


RISKS RELATED TO OUR BUSINESS

  

We operate in a rapidly changing environment that involves a number of risks, some of which are beyond our control. The following discussion highlights some of these risks and others are discussed elsewhere in this report.


We will need to raise additional capital to fund our general and administrative expenses, and if we are unable to raise such capital, we will have to curtail or cease operations.


Our product development programs and the potential commercialization of our product candidates require substantial working capital, including expenses for in house and third party testing. Our future working capital needs will depend on many factors, including:


·

the progress and magnitude of our product development programs,

·

the scope and results of product development testing,

·

the costs under current and future license agreements for our product candidates, including the costs of obtaining and maintaining patent protection for our product candidates,

·

the costs of acquiring any technologies or additional product candidates,

·

the rate of technological advances,

·

the commercial potential of our product candidates,

·

the magnitude of our administrative and legal expenses, including office and research development facilities rent, and

·

the amount of revenues we may generate from our license agreement with BioCheck, Inc..


We have incurred negative cash flow from operations since we incorporated and we may not generate positive cash flow from our operations within the next several years. Therefore, we will need additional future financings in order to carry out our plan of operations beyond the next six months.


We may not be able to obtain adequate financing to fund our operations and any additional financing we obtain may be on terms that are not favorable to us. In addition, any future financings could substantially dilute our stockholders. If adequate funds are not available we will be required to delay, reduce or eliminate one or more of our product development programs, to enter into new collaborative arrangements on terms that are not favorable to us (i.e., the collaborative arrangements could result in the transfer to third parties of rights that we consider valuable), or to cease operations altogether.


We have no products currently available for sale and we may never be successful in developing products suitable for commercialization.


Some of our product candidates are at an early stage of development and all of our product candidates will require expensive and lengthy testing and regulatory clearances. None of our product

 

- 15 -


candidates have been approved by regulatory authorities. We have no products available for sale. There can be no assurance that our research will lead to the discovery of any commercially viable battery chargers or power generation devices. There are many reasons that we may fail in our efforts to develop commercially viable product candidates, including that:


We have a limited operating history. We have a large accumulated deficit and may never become profitable.


AngioGenex is a development stage company that has generated no revenues and a loss of $4,510,246 from March 31, 1999 (inception) to December 31, 2008. Management expects to incur significant operating losses for the foreseeable future. AngioGenex may not be able to validate and market products in the future that will generate significant revenues. In addition, any revenues that AngioGenex may generate may be insufficient for AngioGenex to become profitable. In particular, there are no assurances that AngioGenex can:


·

raise sufficient capital in the public and/or private markets;

·

obtain the regulatory approvals necessary to commence selling its therapeutic drugs or diagnostic products in the U.S., Europe or elsewhere;

·

develop and manufacture drugs in a manner that enables AngioGenex to be profitable and meets regulatory, strategic partner and customer requirements;

·

develop and maintain relationships with key vendors and strategic partners that will be necessary to optimize the market value of the drugs AngioGenex plans to develop

·

respond effectively to competitive pressures; or

·

recruit and build a management team to accomplish AngioGenex' business plan.


If AngioGenex is unable to accomplish these goals, its business is unlikely to succeed.


AngioGenex has a limited product and technology portfolio at the current time.


AngioGenex does not have any products in clinical trials. Although its products might ultimately show effectiveness against multiple disease states, AngioGenex has validated its technology only in animal models.


There can be no assurance that any of AngioGenex' other product ideas will be successfully developed, prove to be safe and efficacious in clinical trials, meet applicable regulatory standards, be capable of being produced in commercial quantities at acceptable costs or be successfully marketed.


There can be no assurance that any programs or technologies that AngioGenex might license in or acquire in the future will be successfully developed, prove to be safe and efficacious in clinical trials, meet applicable regulatory standards, be capable of being produced in commercial quantities at acceptable costs or be successfully marketed.


We must obtain governmental approval for each of our product candidates.


The development, production and marketing of AngioGenex' potential products are subject to extensive regulation by government authorities in the United States and most other developed countries. The process of obtaining approval from the Food and Drug Administration (FDA) in the United States requires conducting extensive pre-clinical and clinical testing.


AngioGenex has limited experience in, and limited resources available for, regulatory activities. Failure to comply with applicable regulations can, among other things, result in non-approval, suspensions of regulatory approvals, fines, product seizures and recalls, operating restrictions, injunctions and criminal prosecution.

 

- 16 -


Any of the following events can occur and, if any did occur, any one could have a material adverse effect on AngioGenex' business, financial conditions and results of operations:


·

difficulty in securing centers to conduct trials;

·

difficulty in enrolling patients in conformity with required protocols or projected timelines;

·

unexpected adverse reactions by patients or a temporary suspension or complete ban on trials of AngioGenex' products due to adverse side effects;

·

clinical trials may not yield sufficiently conclusive results for regulatory agencies to approve the use of AngioGenex' lead product, other products in development, or any other products AngioGenex may acquire or in-license;

·

there can be delays, sometimes long delays, in obtaining approval for its product candidates;

·

the rules and regulations governing product candidates can change during the review process, which can result in the need to spend time and money for further testing or review;

·

if approval for commercialization is granted, it is possible the authorized use will be more limited than we believe is necessary for commercial success, or that approval may be conditioned on completion of further clinical trials or other activities; and

·

once granted, approval can be withdrawn, or limited, if previously unknown problems arise with AngioGenex’ human-use product or data arising from its use.


These and other factors could delay marketing approval from the FDA or cause AngioGenex to fail to receive any approval from the FDA or other governmental authorities. Trials are expensive, time-consuming and difficult to design and implement.


Human clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. Further, the medical, regulatory and commercial environment for pharmaceutical products changes quickly and often in ways that we may not be able to accurately predict. The clinical trial process is also time- consuming, and we do not know whether planned clinical trials will begin on time or whether AngioGenex will complete any of its clinical trials on schedule or all. Significant delays may adversely affect AngioGenex' financial results and the commercial prospects for potential products or any other products AngioGenex may acquire or in-license, and delay the ability to become profitable. Product development costs and collaborators will increase if AngioGenex has delays in testing or approvals or if AngioGenex needs to perform more or larger clinical trials than planned. Furthermore, as failure can occur at any stage of the trials, we could encounter problems that cause AngioGenex to abandon or repeat clinical trials. The commencement and completion of clinical trials may be delayed by several factors, including:


·

changes to applicable regulatory requirements;

·

unforeseen safety issues;

·

determination of dosing issues;

·

lack of effectiveness in the clinical trials;

·

slower than expected rates of patient recruitment;

·

inability to monitor patients adequately during or after treatment;

·

inability or unwillingness of medical investigators to follow AngioGenex' clinical protocols;

·

inability to maintain a supply of the investigational drug in sufficient quantities to support the trials; and

·

suspension or termination of clinical trials for various reasons, including noncompliance with regulatory requirements or changes in the clinical care protocols and standards of care within the institutions in which AngioGenex' trials take place.

 

In addition, AngioGenex or the FDA may suspend the clinical trials at any time if it appears that AngioGenex are exposing participants to unacceptable health risks or if the FDA finds deficiencies in any Investigational New Drug Applications ("IND") or the conduct of these trials. A number of companies in the biotechnology and drug development industries have suffered significant setbacks in advanced clinical trials despite promising results in earlier trials. In the end, AngioGenex may be unable to develop marketable products.

 

- 17 -


  

The results of our future clinical trials may not support the product candidate claims.


Even if AngioGenex' clinical trials are completed as planned, their results may not support the product-candidate claims, or the FDA or government authorities may not agree with the conclusions regarding such results. Success in preclinical testing and early clinical trials does not ensure that will be successful, and the results from any later clinical trials may not replicate the results of prior clinical trials and pre- clinical testing. The clinical trial process may fail to demonstrate that product candidates are safe for humans and effective for indicated uses. This failure would cause us to abandon a product candidate and may delay development of other product candidates. Any delay in, or termination of, AngioGenex' clinical trials will delay the filing of the NDAs with the FDA and, ultimately, AngioGenex' ability to commercialize its product candidates and generate product revenues.


Delays in patient enrollment for clinical trials could increase costs and delay regulatory approvals.


The rate of completion of AngioGenex' clinical trials will depend on the rate of patient enrollment. There may be substantial competition to enroll patients in clinical trials for AngioGenex' product and any other products AngioGenex may develop or in-license. This competition has delayed the clinical trials of other biotechnology and drug development companies in the past. In addition, recent improvements in existing drug therapy may make it more difficult for us to enroll patients in the clinical trials as the patient population may choose to enroll in clinical trials sponsored by other companies or choose alternative therapies. Delays in patient enrollment can result in increased development costs and delays in regulatory approvals.


AngioGenex' lead product candidate requires several additional processes before it is ready for an initial IND filing with the FDA; we may not successfully perform such processes, or the results from such processes may not support the filing of an IND.


The industry is highly competitive, so, even if AngioGenex' products ultimately get approved by the FDA, the success depends on management's ability to sustain competitive advantages.


The pharmaceutical, biopharmaceutical and biotechnology industries are very competitive, fast moving and intense, and expected to be increasingly so in the future. Other larger and well funded companies have developed and are developing drugs that, if not similar in type to AngioGenex' drugs, are designed to address the same patient or subject population. Therefore, AngioGenex' lead product, other products in development, or any other products AngioGenex may acquire or in-license may not be the best, the safest, the first to market, or the most economical to make or use. If a competitor's product is better than AngioGenex', for whatever reason, then AngioGenex could make less money from sales, if Angiogenex is able to generate sales at all.


There are many reasons why a competitor might be more successful than AngioGenex, including:


·

Most competitors have greater financial resources and can afford more technical and development setbacks than we can.

·

Most competitors have been in the drug-discovery and drug-development business longer than we have. They have greater experience than us in critical areas like clinical testing, obtaining regulatory approval, and sales and marketing. This experience and their name recognition give them a competitive advantage over AngioGenex.

·

Some competitors may have a better patent position protecting their technology than AngioGenex has or will have to protect its technology. If AngioGenex cannot use AngioGenex’ proprietary rights to prevent others from copying AngioGenex’ technology or developing similar technology, then AngioGenex’ competitive position will be harmed.

 

- 18 -


 

·

Some companies with competitive technologies may move through stages of development, approval, and marketing faster than we do. If a competitor receives FDA approval before AngioGenex, then it will be authorized to sell its products before AngioGenex can sell its products. The first company "to market" often has a significant advantage over latecomers; a second-place position could result in less-than-anticipated sales.

·

The recent completion of the sequencing of the human genome may result in an acceleration of competing products due to enhanced information about disease states and the factors that contribute to the disease.


If AngioGenex is unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any products we may develop, we may not be able to generate product revenue.


We do not currently have an organization for the sales, marketing and distribution of pharmaceutical products. In order to market any products that may be approved by the FDA, management must build sales, marketing, managerial and other non-technical capabilities or make arrangements with third parties to perform these services. In addition, our management has no experience in developing, training or managing a sales force and will incur substantial additional expenses in doing so. The cost of establishing and maintaining a sales force may exceed its cost effectiveness. Furthermore, we will compete with many companies that currently have extensive and well-funded marketing and sales operations. Our marketing and sales efforts may be unable to compete successfully against these companies. If our management is unable to establish adequate sales, marketing and distribution capabilities, whether independently or with third parties, we may not be able to generate product revenue and may not become profitable.

  

We do not have any manufacturing facilities and expect to rely on one or more third-party manufacturers to properly manufacture any products we may develop or in-license and may not be able to quickly replace manufacturing capacity without the use of a third party's manufacturing facilities as a result of a fire, natural disaster (including an earthquake), equipment failure or other difficulty, or if such facilities are deemed not in compliance with the GMP requirements, and the noncompliance could not be rapidly rectified.


Our inability or reduced capacity to have any products we may develop or in-license manufactured would prevent us from successfully commercializing our proposed products. Our dependence upon third parties for the manufacture of its proposed products may adversely affect our profit margins and our ability to develop and deliver proposed products on a timely and competitive basis. Any delays in formulation and manufacturing objectives may cause a delay in our clinical program, and could have an adverse effect on any potential sales or profits.


We could occasionally become subject to commercial disputes that might harm our business by distracting our management from the operation of the business, by increasing expenses and, if we do not prevail, it is subject to potential monetary damages and other remedies.


From time to time we can become engaged in disputes regarding its commercial transactions. These disputes could result in monetary damages or other remedies that could adversely impact of its financial position or operations. Even if we prevail in these disputes, they may distract our management from operating the business and the cost of defending these disputes would reduce operating results.


We may be subject to product liability claims. The development, manufacture, and sale of pharmaceutical products would expose us to the risk of significant losses resulting from product liability claims. Although management intends to obtain and maintain product liability insurance to offset some of this risk, we may be unable to secure such insurance or we may not cover certain potential claims.


We may not be able to afford to obtain product liability insurance due to rising costs in insurance premiums in recent years. If our management is able to secure insurance coverage, we may be faced with a successful claim in excess of our product liability coverage that could result in a material adverse impact on our business. If insurance coverage is too expensive or is unavailable, we may be forced to self-insure

 

- 19 -


against product-related claims. Without insurance coverage, a successful claim against us and any defense costs incurred in defending us may have a material adverse impact on operations.


As a result of our limited operating history, we may not be able to correctly estimate the future operating expenses, which could lead to cash shortfalls.   


AngioGenex was incorporated in 1999 and has only a limited operating history from which to evaluate its business. We have generated only $464,688 in other income and we have not received FDA approval for marketing any of its product candidates. Failure to obtain FDA approval for its products would have a material adverse effect on our ability to continue operating. Accordingly, these prospects must be considered in light of the risks, expenses, and difficulties frequently encountered by companies in an early stage of development. We may not be successful in addressing such risks, and the failure to do so could have an adverse effect on the business, operating results and financial condition.


Because of this limited operating history and because of the emerging nature of the markets in which we compete, the historical financial data is of limited value in estimating future operating expenses. Our budgeted expense levels are affected based on our expectations concerning future revenues. However, our ability to generate any revenues beyond grants depends largely on receiving marketing approval from the FDA. Moreover, if FDA approval is obtained, the size of any future revenues depends on the choices and demand of individuals, which are difficult to forecast accurately. We may be unable to adjust its operations in a timely manner to compensate for any unexpected shortfall in revenues. Accordingly, a significant shortfall in demand for its products could have an immediate and material adverse effect on the business, results of operations, and financial condition.


Our operating results may fluctuate as a result of a number of factors, many of which are outside of our control. For these reasons, comparing our operating results on a period-to-period basis may not be meaningful, and no one should rely on the past results as any indication of our future performance. Our quarterly and annual expenses are likely to increase substantially over the next several years, and revenues from the SBIR grants may not continue at the current levels. Our operating results in future quarters may fall below expectations. Any of these events could adversely impact business prospects and make it more difficult to raise additional equity capital at an acceptable price per share. Each of the risk factors listed in this "Risk Factors" section may affect our operating results.

  

Our business and its industry are constantly changing and evolving over time. Furthermore, we compete in an unpredictable industry and regulatory environment. Our ability to succeed depends on its ability to compete in this fluctuating market. As such, the actual operating results may differ substantially from projections.

  

We may be unable to maintain an effective system of internal controls and accurately report its financial results or prevent fraud, which may cause current and potential stockholders to lose confidence in our financial reporting and adversely impact the business and the ability to raise additional funds in the future.

  

Effective internal controls are necessary for us to provide reliable financial reports and effectively prevent fraud, if we cannot provide reliable financial reports or prevent fraud, its operating results and reputation could be harmed as a result, causing stockholders and/or prospective investors to lose confidence in management and making it more difficult for us to raise additional capital in the future.


In-licensing of drug-development programs could result in operating difficulties, dilution and other harmful consequences.


We may seek to in- license certain technologies, but have only limited experience in these types of transactions. From time-to- time, management may engage in discussions regarding in-licensing or certain technologies management believes critical to our business. Any one of these transactions could have a material effect on our financial condition and operating results.

 

- 20 -


If we lose the services of key management personnel, we may not be able to execute our business strategy effectively.


Our future success depends in a large part upon the continued service of key members of its senior management team. In particular, Chairman Richard Salvador, CEO William Garland, Ph.D., and COO and Vice President of R&D, are critical to our overall management as well as the development of the technology, the culture and the strategic direction for our company. All of the executive officers and key employees are at-will employees, and we do not maintain any key-person life insurance policies. Any loss of management or key personnel could materially harm the business.


We rely on highly skilled personnel and, if unable to retain or motivate key personnel or hire additional qualified personnel, we may not be able to grow effectively.


Our performance is largely dependent on the talents and efforts of highly skilled individuals. The future success depends on the continuing ability to identify, hire, develop, motivate, and retain highly skilled personnel for all areas of the organization. Competition in the industry for qualified employees is intense and it is likely that certain competitors will directly target some of our employees. The continued ability to compete effectively depends on the ability to retain and motivate existing employees.


Management may also need to hire additional qualified personnel with expertise in preclinical testing, clinical research and testing, government regulation, formulation and manufacturing and sales and marketing. We compete for qualified individuals with numerous biopharmaceutical companies and other emerging entrepreneurial companies, as well as universities and research institutions. Competition for such individuals is intense, and may not be able to successfully recruit or retain such personnel. Attracting and retaining qualified personnel will be critical to our success.

  

Our future profitability is uncertain.

  

We cannot predict our ability to increase our revenues or achieve profitability. We may be required to increase our research and development expenses in order to develop potential new products. As evidenced by the substantial net losses during and 2008 and 2007, losses and expenses may increase and fluctuate from quarter to quarter. There can be no assurance that we will ever achieve profitable operations.


We may not successfully manage any experienced growth.   


Our success will depend upon the expansion of its operations and the effective management of any such growth, which will place a significant strain on management and on administrative, operational, and financial resources. To manage any such growth, management must expand the facilities, augment it's operational, financial and management systems, and hire and train additional qualified personnel. If management is unable to manage its growth effectively, its business would be harmed.


Our drug-development programs depend upon third-party researchers who are outside our control.


We depend upon independent investigators and collaborators, such as universities, medical institutions, and clinical research organizations to conduct pre-clinical and clinical trials under agreements. These collaborators are not our employees, and management cannot control the amount or timing of resources that they devote to our programs. These investigators may not assign as great a priority to the programs or pursue them as diligently as we would if it were undertaking such programs. If outside collaborators fail to devote sufficient time and resources to our drug-development programs, or if their performance is substandard, the approval of our FDA applications, if any, and the introduction of new drugs, if any, will be delayed. These collaborators may also have relationships with other commercial entities, some of whom may compete with us. If our collaborators assist the competitors at our expense, any competitive position would be harmed. If conflicts arise with our collaborators, they may act in their self-interests, which may be adverse to our interests. Conflicts may arise in our collaborations due to one or more of the following:

 

- 21 -


·

disputes with respect to payments that we believe are due under a collaboration agreement;

·

disagreements with respect to ownership of intellectual property rights;

·

unwillingness on the part of a collaborator to keep us informed regarding the progress of its development and commercialization activities, or to permit public disclosure of these activities;

·

delay of a collaborator's development or commercialization efforts with respect to drug candidates; or

·

termination or non-renewal of the collaboration.


In addition, with our collaborations, we may be required to agree not to conduct independently, or with any third party, any research that is competitive with the research conducted under our collaborations. Our collaborations may have the effect of limiting the areas of research that management may pursue, either alone or with others. Our collaborators, however, may be able to develop, either alone or with others, products in related fields that are competitive with the products or potential products that are the subject of these collaborations.


RISKS RELATED TO OUR INTELLECTUAL PROPERTY


Our intellectual property rights are valuable, and its inability to protect them could reduce the value of our products, services and brand. Our patents, trademarks, trade secrets, copyrights and other intellectual property rights are critically important assets.


Events outside of management's control could jeopardize our ability to protect its intellectual property rights. For example, effective intellectual property protection may not be available in every country in which the products and services are distributed. In addition, the efforts management has taken to protect its intellectual property rights may not be sufficient or effective. Any significant impairment of its intellectual property rights could harm its business or its ability to compete. Protecting our intellectual property rights is costly and time consuming, and the unauthorized use of our intellectual property could cause these costs to rise significantly and materially affect the operating results.


While our goal is to obtain patent protection for its innovations, they may not be patentable or management may choose not to protect certain innovations that later turn out to be important for its business.


Even if we do obtain protection for its potential innovations, the scope of protection gained may be insufficient or a patent issued may be deemed invalid or unenforceable, as the issuance of a patent is not conclusive as to its validity or as to the enforceable scope of the claims of the patent. The patenting process, enforcement of issued patents, and defense against claims of infringement are inherently costly and risky. We may not have the financial resources to defend its patents, thereby reducing our competitive position and its business prospects. Specific risks associated with the patent process include the following:


·

The United States or foreign patent offices may not grant patents of meaningful scope based on the applications we have already filed and those we intend to file. If our current patents do not adequately protect its drug molecules and the indications for their use, then management will not be able to prevent imitation and any product may not be commercially viable.


·

Some of the issued patents we now license may be determined to be invalid. If we have to defend the validity of its patents the costs of such defense could be substantial, and there is no guarantee of a successful outcome. In the event any of the patents in-licensed is found to be invalid, we may lose its competitive position and may not be able to receive royalties for products covered in part or whole by that patent under license agreements.


 

- 22 -


 

·

In addition, changes in or different interpretations of patent laws in the United States and foreign countries may permit others to use discoveries or to develop and commercialize technology and products without providing any compensation to us. The laws of some countries do not protect intellectual property rights to the same extent as U.S. laws and those countries may lack adequate rules and procedures for defending the intellectual property rights. For example, some countries, including many in Europe, do not grant patent claims directed to methods of treating humans, and in these countries patent protection may not be available at all to protect


Although we try to avoid infringement, there is the risk that patented technology owned by another person or entity and/or that we may be sued for infringement.


For example, U.S. patent applications are confidential while pending in the Patent and Trademark Office, and patent offices in foreign countries often publish patent applications for the first time six months or more after filing. Further, we may not be aware of published or granted conflicting patent rights. Any conflicts resulting from patent applications and patents of others could significantly reduce the coverage of its patents and limit its ability to obtain meaningful patent protection. In addition, defending or indemnifying a third party against a claim of infringement can involve lengthy and costly other legal actions, and there can be no guarantee of a successful outcome.


Our management also seeks to maintain certain intellectual property as trade secrets. The secrecy of this information could be compromised by third parties, or intentionally or accidentally disclosed to others by our employees, which may cause us to lose any competitive advantage we enjoy from maintaining these trade secrets.


We are, and may in the future be, subject to intellectual property rights claims, which are costly to defend, which could require us to pay damages, and which could limit our ability to use certain technologies in the future.   


Companies in the pharmaceutical, biopharmaceutical and biotechnology industries own large numbers of patents, copyrights, trademarks, and trade secrets and frequently enter into litigation based on allegations of infringement or other violations by others of intellectual property rights. As our products get closer to commercialization, there is greater possibility that we may become subject to an infringement claim based on use of the technology such that we would be unable to continue using the technology without obtaining a license or settlement from third parties.


Any intellectual property claims, whether merited or not, could be time- consuming and expensive to litigate and could us to divert critical management and financial resources to the resolution of such claims. We may not be able to afford the costs of litigation. Any legal action against us or our collaborators could lead to:


·

payment of damages, potentially treble damages, if we are found to have willfully infringed a party's patent rights;

·

injunctive or other equitable relief that may effectively block the ability to further develop, commercialize and sell products; or

·

we or our collaborators having to enter into license arrangements that may not be available on commercially acceptable terms, if at all.

 

Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect our intellectual property.


Because we operate in the highly technical field of drug discovery and development, we rely in part on trade secret protection in order to protect the proprietary technology and processes. However, trade secrets are difficult to protect. We enter into confidentiality and intellectual property assignment

 

- 23 -


agreements with corporate partners, employees, consultants, outside scientific collaborators, sponsored researchers and other advisors. These agreements generally require that the other party keep confidential and not disclose to third parties all confidential information developed by the party or made known to the party during the course of the party's relationship with us. These agreements also generally provide that inventions conceived by the party in the course of rendering services to us will be our exclusive property. However, these agreements may not be honored and may not effectively assign intellectual property rights to us. Enforcing a claim that a party illegally obtained and is using our trade secrets is difficult, expensive and time consuming and the outcome is unpredictable. In addition, courts outside the United States may be less willing to protect trade secrets. The failure to obtain or maintain trade secret protection could adversely affect our competitive position.


RISKS RELATED TO OUR COMMON STOCK

  

Our common stock is traded on the OTCBB, our stock price is highly volatile, and you may not be able to sell your shares of our common stock at a price greater than or equal to the price you paid for such shares.


Our shares of common stock are currently traded on the Over the Counter Bulletin Board, or OTCBB. Stocks traded on the OTCBB generally have limited trading volume and exhibit a wide spread between bid and ask quotations. The market price of our common stock is extremely volatile. To demonstrate the volatility of our stock price, during 2008, our common stock traded as low as $0.05 per share and as high as $0.65 per share. This may impact an investor’s decision to buy or sell our common stock. As of December 31, 2008 there were approximately 217 holders of our common stock. Factors affecting our stock price include:

  

  

·

our financial results;

  

·

fluctuations in our operating results;

  

·

announcements of technological innovations or new commercial health care products or therapeutic products by us or our competitors;

  

·

government regulation;

  

·

developments in patents or other intellectual property rights;

  

·

developments in our relationships with customers and potential customers; and

  

·

general market conditions.

  

Furthermore, volatility in the stock price of other companies has often led to securities class action litigation against those companies. Any such securities litigation against us could result in substantial costs and divert management’s attention and resources, which could seriously harm our business and financial condition.


Our common stock may be subject to “penny stock” rules which may be detrimental to investors.


Our common stock may be, or may become, subject to the regulations promulgated by the SEC for “penny stock.” SEC regulation relating to penny stock is presently evolving, and the OTCBB may react to such evolving regulation in a way that adversely affects the market liquidity of our common stock. Penny stock currently includes any non-NASDAQ equity security that has a market price of less than $5.00 per share, subject to certain exceptions. The regulations require that prior to any non-exempt buy/sell transaction in a penny stock, a disclosure schedule set forth by the SEC relating to the penny stock market must be delivered to the purchaser of such penny stock. This disclosure must include the amount of commissions payable to both the broker-dealer and the registered representative and current price quotations for the common stock. The regulations also require that monthly statements be sent to holders of penny stock that disclose recent price information for the penny stock and information of the limited market for penny stocks. These requirements may adversely affect the market liquidity of our common stock.

 

- 24 -


Sales of our common stock may require broker-dealers to make special suitability determinations regarding prospective purchasers.


Our common stock may be, or may become, subject to Rule 15g-1 through 15g-9 under the Exchange Act, which imposes certain sales practice requirements on broker-dealers which sell our common stock to persons other than established customers and “accredited investors” (generally, individuals with a net worth in excess of $1,000,000 or an annual income exceeding $200,000 (or $300,000 together with their spouses)). For transactions covered by this rule, a broker-dealer must make a special suitability determination for the purchaser and have received the purchaser’s written consent to the transaction prior to the sale. Applicability of this rule would adversely affect the ability of broker-dealers to sell our common stock and purchasers of our common stock to sell their shares of such common stock. Accordingly, the market for our common stock may be limited and the value negatively impacted.

  

Potential investors in the Registrant's common stock are urged to obtain and read such disclosure carefully before purchasing any shares that are deemed to be "penny stock." Moreover, Rule 15g-9 requires broker-dealers in penny stocks to approve the account of any investor for transactions in such stocks before selling any penny stock to that investor. This procedure requires the broker-dealer to (i) obtain from the investor information concerning his or her financial situation, investment experience and investment objectives; (ii)reasonably determine, based on that information, that transactions in penny stocks are suitable for the investor and that the investor has sufficient knowledge and experience as to be reasonably capable of evaluating the risks of penny stock transactions; (iii) provide the investor with a written statement setting forth the basis on which the broker-dealer made the determination in (ii) above; and (iv) receive a signed and dated copy of such statement from the investor, confirming that it accurately reflects the investor's financial situation, investment experience and investment objectives. Compliance with these requirements may make it more difficult for holders of the Registrant's common stock to resell their shares to third parties or to otherwise dispose of them in the market or otherwise.


If we fail to maintain the adequacy of our internal controls, our ability to provide accurate financial statements and comply with the requirements of the Sarbanes-Oxley Act of 2002 could be impaired, which could cause our stock price to decrease substantially.


We are continuing to take measures to address and improve our financial reporting and compliance capabilities and we are in the process of instituting changes to satisfy our obligations in connection with being a public company. We plan to obtain additional financial and accounting resources to support and enhance our ability to meet the requirements of being a public company. We will need to continue to improve our financial and managerial controls, reporting systems and procedures, and documentation thereof. If our financial and managerial controls, reporting systems or procedures fail, we may not be able to provide accurate financial statements on a timely basis or comply with the Sarbanes-Oxley Act of 2002 as it applies to us. Any failure of our internal controls or our ability to provide accurate financial statements could cause the trading price of our common stock to decrease substantially.


Our common shares are thinly traded and, if you are a holder of shares, you may be unable to sell at or near ask prices or at all if you need to convert your options, warrants or other convertible securities into common stock and sell your shares to raise money or otherwise desire to liquidate such shares.


We cannot predict the extent to which an active public market for our common stock will develop or be sustained. Our common shares have historically been sporadically or “thinly-traded” on the “Over-The-Counter Bulletin Board,” meaning that the number of persons interested in purchasing our common shares at or near bid prices at any given time may be relatively small or non-existent. This situation is attributable to a number of factors, including the fact that we are a small company which is relatively unknown to stock analysts, stock brokers, institutional investors and others in the investment community that generate or influence sales volume, and that even if we came to the attention of such persons, they tend to be risk-averse and would be reluctant to follow an unproven company such as ours or purchase or recommend the purchase of our shares until such time as we became more seasoned and viable. As a consequence, there may be periods of several days or more when trading activity in our shares is minimal

 

- 25 -


or non-existent, as compared to a seasoned issuer which has a large and steady volume of trading activity that will generally support continuous sales without an adverse effect on share price. We cannot give you any assurance that a broader or more active public trading market for our common stock will develop or be sustained, or that current trading levels will be sustained.

  

The market price for our common stock is particularly volatile given our status as a relatively small company with a small and thinly traded “float” and lack of current revenues that could lead to wide fluctuations in our share price. The price at which you convert your debentures into our common stock many be indicative of the price that will prevail in the trading market. You may be unable to sell your common stock at or above your purchase price if at all, which may result in substantial losses to you.


The market for our common shares is characterized by significant price volatility when compared to seasoned issuers, and we expect that our share price will continue to be more volatile than a seasoned issuer for the indefinite future. The volatility in our share price is attributable to a number of factors. First, as noted above, our common shares are sporadically and/or thinly traded. As a consequence of this lack of liquidity, the trading of relatively small quantities of shares by its shareholders may disproportionately influence the price of those shares in either direction. The price for its shares could, for example, decline precipitously in the event that a large number of our common shares are sold on the market without commensurate demand, as compared to a seasoned issuer which could better absorb those sales without adverse impact on its share price. Secondly, an investment in us is a speculative or “risky” investment due to our lack of revenues or profits to date and uncertainty of future market acceptance for current and potential products. As a consequence of this enhanced risk, more risk-adverse investors may, under the fear of losing all or most of their investment in the event of negative news or lack of progress, be more inclined to sell their shares on the market more quickly and at greater discounts than would be the case with the stock of a seasoned issuer.


Investors should be aware that, according to SEC Release No. 34-29093, the market for penny stocks has suffered in recent years from patterns of fraud and abuse. Such patterns include (1) control of the market for the security by one or a few broker-dealers that are often related to the promoter or issuer; (2) manipulation of prices through prearranged matching of purchases and sales and false and misleading press releases; (3) boiler room practices involving high-pressure sales tactics and unrealistic price projections by inexperienced sales persons; (4) excessive and undisclosed bid-ask differential and markups by selling broker-dealers; and (5) the wholesale dumping of the same securities by promoters and broker-dealers after prices have been manipulated to a desired level, along with the resulting inevitable collapse of those prices and with consequent investor losses. Our management is aware of the abuses that have occurred historically in the penny stock market. Although we do not expect to be in a position to dictate the behavior of the market or of broker-dealers who participate in the market, management will strive within the confines of practical limitations to prevent the described patterns from being established with respect to our securities. The occurrence of these patterns or practices could increase the volatility of our share price.


We do not anticipate paying any cash dividends.


We presently do not anticipate that we will pay any dividends on any of our capital stock in the foreseeable future. The payment of dividends, if any, would be contingent upon our revenues and earnings, if any, capital requirements, and general financial condition. The payment of any dividends will be within the discretion of our board of directors. We presently intend to retain all earnings, if any, to implement our business plan; accordingly, we do not anticipate the declaration of any dividends in the foreseeable future.

 

- 26 -


ITEM 2.  DESCRIPTION OF PROPERTY


AngioGenex does not presently own or lease any real property. Our executive and administrative offices are located in New York at 425 Madison Avenue Suite 902, New York, New York 10017, in space provided to the company by our Chief Financial Officer. AngioGenex maintains no laboratories of its own. Our research and development programs including drug screening, animal breeding are performed at contract research organizations and academic facilities pursuant to contract.


ITEM 3.  LEGAL PROCEEDINGS


We are not aware of any material pending legal proceedings to which AngioGenex is a party or of which any of its property is subject.


To our knowledge, no director, officer or affiliate of ours and no owner of record or beneficial owner of more than five percent (5%) of our securities, or any associate of any such director, officer or security holder is a party adverse to us or has a material interest adverse to us in reference to pending litigation.


ITEM 4.  SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS


We held our Annual Meeting of Stockholders on December 29, 2008.  Set forth below is a summary of each matter voted upon at the meeting and the number of votes cast for, against, withheld or abstained.


Proposal #1 : The election William Garland, Martin Murray, Richard Salvador and Michael Stage to serve on the Board of Directors:


Nominee

  

Total Votes For All Nominees

  

Total Votes Withheld From All Nominees

William Garland

  

14,448,005

  

0

Martin Murray

  

14,448,005

  

0

Richard Salvador

  

14,448,005

  

0

Michael Strage

  

14,448,005

  

0


       Proposal #2 : Ratification of the appointment of Williams & Webster, P.S. as our independent auditors for the year ending December 31, 2008:


Total Votes For

  

Total Votes Against

  

Abstained

14,448,005

  

0

  

  



- 27 -



PART II


ITEM 5.  MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES


Our common stock began to be traded in the Over-The-Counter Bulletin Board on May 7, 2007 under the stock symbol AGGX.OB. It is also listed in Germany on the Frankfurt Stock Exchange.


The market represented by the OTCBB is limited and the price for our common stock quoted on the OTCBB is not necessarily a reliable indication of the value of our common stock. The following table sets forth the high and low closing prices for shares of our common stock for the periods noted, as reported on the OTCBB. Quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not represent actual transactions.

   

  YEAR

  

PERIOD

  

HIGH   

  

LOW   

  

Fiscal Year 2007

  

  

Second Quarter

  

$

0.54 

  

$

0.31 

  

 

  

  

Third Quarter

  

$

0.85 

  

$

0.51 

  

 

  

  

Fourth Quarter

  

$

0.85 

  

$

0.65 

  

 

 

 

 

 

 

 

 

 

 

 

Fiscal Year 2008

  

  

Second Quarter

  

$

0.44 

  

$

0.40 

  

 

  

  

Third Quarter

  

$

0.40 

  

$

0.20 

  

 

  

  

Fourth Quarter

  

$

0.20 

  

$

0.15 

  

  

Stockholders

  

As of December 31, 2008, we had approximately 21,302,906 shares of common stock issued and outstanding which were held by approximately 217 stockholders of record, which total does not include stockholders who hold their shares in street name. The transfer agent for our common stock is Nevada Agency and Trust Company.


DIVIDEND POLICY

  

Our board of directors determines any payment of dividends. We utilize our assets to develop our business and, consequently, we have never paid a dividend and do not expect to pay dividends in the foreseeable future. Any future decision with respect to dividends will depend on future earnings, operations, capital requirements and availability, restrictions in future financing agreements and other business and financial considerations.


Recent Sales of Unregistered Securities


In April 2006, we sold an aggregate of 310,000 shares to five accredited investors in a private placement with the shares sold at $0.25 per share for gross proceeds of $77,500. The issuance of shares was exempt from registration pursuant to Section 4(2) of the Securities Act of 1933, as amended.

  

In September 2006, we sold 150,000 units, with each unit consisting of 2 shares of common stock and one warrant with an exercise price of $1 per share to Kleen Capital, A.G for gross proceeds of $100,000. The issuance of shares upon conversion of the notes was exempt from registration pursuant to Section 4(2) of the Securities Act of 1933, as amended.

  

In October 2006, holders of convertible pay in kind note converted their notes into an aggregate of 7,050,285 shares of common stock. The convertible notes were issued in March 2004 with a maturity date of December 31, 2004, later extended to December 31, 2005. Detachable warrants were also granted to the note holders exercisable at an aggregate of 6,391,876 shares at an exercise price of $0.155 per share.

 

- 28 -


                Holders included Richard Salvador, our President and CEO ($75,000 in principal), Michael Strage, our Vice President for Business Development ($25,000 in principal) and George Gould, our former Vice President and General Counsel ($25,000 in principal). The issuance of shares upon conversion of the notes was exempt from registration pursuant to Section 4(2) of the Securities Act of 1933, as amended.


In March 2007, we began a private placement of up to 5 million units for $1.00 per unit, with each unit consisting of two shares and one warrant to purchase a share of common stock for $1.00 per share. In 2007 we sold 39,000 units (78,000 shares and 39,000 warrants) at $0.50 per share and 8,000 units (16,000 shares and 8,000 warrants) at $0.65 per share for an aggregate amount of $34,690, net of expenses of $14,710. The issuance of shares and warrants was exempt from registration pursuant to Section 4(2) of the Securities Act of 1933, as amended.


In March and April 2007, we issued convertible notes to seven unrelated parties for gross proceeds of $85,000. The convertible notes began to accrue annual interest on the outstanding principal 60 days after the date of the note at a rate of 6%, with a maturity date of June 30, 2007. The notes were convertible into shares of common stock at $0.35 per share. On July 5, 2007 the holders of these convertible notes converted the notes into an aggregate of 242,859 shares of common stock. The issuance of shares upon conversion of the notes was exempt from registration pursuant to Section 4(2) of the Securities Act of 1933, as amended.

  

In December 2007, we sold 169,262 shares at $0.50 per share in a private placement for $68,860 in cash, net of expenses of $18,271, to two unrelated investors. The issuance of shares was exempt from registration pursuant to Section 4(2) of the Securities Act of 1933, as amended.


In February 2008, we sold 19,500 shares to an unrelated third party for gross proceeds of $6,500. In June 2008 we sold 150,000 shares of common stock at $0.333 per share with net proceeds of $50,000. In September 2008 we sold 30,000 shares of common stock at $0.333 per share with net proceeds of $10,000. These private placements were exempt from registration pursuant to Section 4(2) of the Securities Act. In October 2008, 50,000 shares were issued in exchange for reduction of note payable from related party of $12,500.


ITEM 6.  SELECTED FINANCIAL DATA


Not required.


ITEM 7.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.


THE FOLLOWING SECTION SHOULD BE READ IN CONJUNCTION WITH OUR FINANCIAL STATEMENTS AND THE NOTES THERETO INCLUDED ON PAGES F-1 THROUGH F-27 FOLLOWING THE SIGNATURE PAGES OF THIS ANNUAL REPORT. THIS ANNUAL REPORT ON FORM 10-K CONTAINS “FORWARD-LOOKING STATEMENTS” WITHIN THE MEANING OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 AND INVOLVE A HIGH DEGREE OF RISK AND UNCERTAINTY. ALL STATEMENTS, OTHER THAN STATEMENTS OF HISTORICAL FACTS, INCLUDED IN OR INCORPORATED BY REFERENCE INTO THIS FORM 10-K ARE FORWARD-LOOKING STATEMENTS. IN ADDITION, WHEN USED IN THIS DOCUMENT, THE WORDS “ANTICIPATE,” “ESTIMATE,” “PROJECT,” AND SIMILAR EXPRESSIONS ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS. OUR ACTUAL RESULTS MAY DIFFER MATERIALLY FROM THOSE PROJECTED IN THE FORWARD-LOOKING STATEMENTS DUE TO RISKS AND UNCERTAINTIES THAT EXIST IN OUR OPERATIONS. THESE FORWARD-LOOKING STATEMENTS ARE SUBJECT TO CERTAIN RISKS, UNCERTAINTIES AND ASSUMPTIONS INCLUDING AMONG OTHERS, THE RISK THAT OUR PRODUCT DEVELOPMENT PROGRAMS WILL NOT PROVE SUCCESSFUL, THAT WE WILL NOT BE ABLE TO OBTAIN FINANCING TO COMPLETE ANY FUTURE PRODUCT DEVELOPMENT, THAT OUR PRODUCTS WILL NOT PROVE COMPETITVE IN THEIR MARKETS SHOULD ONE OR MORE OF THESE RISKS OR UNCERTAINTIES MATERIALIZE, OR SHOULD UNDERLYING ASSUMPTIONS

 

- 29 -


PROVE INCORRECT, ACTUAL RESULTS MAY VARY MATERIALLY FROM THOSE ANTICIPATED, ESTIMATED OR PROJECTED.


ALTHOUGH WE BELIEVE THAT THE EXPECTATIONS INCLUDED IN SUCH FORWARD-LOOKING STATEMENTS ARE REASONABLE, WE CANNOT GIVE ANY ASSURANCES THAT THESE EXPECTATIONS WILL PROVE TO BE CORRECT. WE UNDERTAKE NO OBLIGATION TO PUBLICLY RELEASE THE RESULT OF ANY REVISIONS TO SUCH FORWARD-LOOKING STATEMENTS THAT MAY BE MADE TO REFLECT EVENTS OR CIRCUMSTANCES AFTER THE DATE HEREOF OR TO REFLECT THE OCCURRENCE OF UNANTICIPATED EVENTS.


The following discussion and analysis should be read in conjunction with our financial statements and the notes thereto appearing in Part I, Item 1.


Company Overview


AngioGenex is an early stage biotechnology company focused on the discovery and development of compounds useful for the diagnosis and treatment of cancer. Our proprietary technology is based on the research work of Dr. Robert Benezra and his colleagues at Memorial Sloan Kettering Cancer Center, who established the role of the Id (inhibition of differentiation) genes and corresponding Id proteins in the formation of new blood vessels (angiogenesis) required for tumor growth and metastasis. This intellectual property includes the exclusive worldwide rights to certain patent pending Id based anti-angiogenesis anti-cancer biotechnology that we acquired in 2000 from the Sloan Kettering Institute for Cancer Research and subsequently from sponsored research. In addition, our intellectual property includes molecules that were generated as a result of in-house screening and out-sourced contract research concerning organic molecules that appear to inhibit the Id related process responsible for the formation of new blood vessels and consequent tumor growth, as well as other “know-how” and trade secrets which resulted from other out-sourced research.


Our therapeutic focus is on the identification and development of orally active molecules capable of inhibiting Id activity and preventing the formation of blood vessels that support the growth of cancerous tumors. In addition, we have sponsored other research on the modulation of Id genes and proteins that may be useful in the treatment of non-oncological diseases, such as age related macular degeneration and diabetic retinopathy, in which a surplus in the growth of blood vessels is an important part of the underlying pathology of such diseases.


AngioGenex has out-licensed its rights to develop Id-based prognostics and diagnostics to BioCheck, Inc., a leading producer of clinical diagnostic assays. In June 2004 AngioGenex signed a Development and Marketing Agreement with BioCheck under which AngioGenex assigned BioCheck the exclusive rights to develop and market cancer prognostic and diagnostics in return for certain limited royalties and milestone payments. Pursuant to this sub-license BioCheck has been developing monoclonal antibodies for all four Id proteins (Id1, Id2, Id3, and Id4) for use in standard enzyme linked immunoassay or ELISA type assay tests and for kits for the detection of the proteins in tumors and other tissues.


Since commencement of operations in 1999, our efforts have been principally devoted to in-licensing our intellectual property, research and development activities, entering into collaborative agreements, recruiting management personnel and advisors, and raising capital.


Our current business strategy is to concentrate our financial resources primarily on the further development of our proprietary potential anti-cancer lead drug compounds.

  

Product Research and Development Plans


For the year ended December 31, 2008 we incurred $80,787 on research and development costs as compared to $64,834 for the year ended December 31, 2007. The increase was due to cost of experiments and availability of working capital.

 

- 30 -


Our current plan of operation for the next 12 months primarily involves out-sourced contract research and development activities on the design of more potent and efficient Id protein inhibitors based on two organic molecules which have exhibited anti-Id protein properties. Given sufficient capital resources, we plan to continue to test these organic molecules in established animal tumor models for their ability to block blood vessel formation and inhibit tumor growth. This testing as well as further refinement of the structure of active molecules is expected to result in the identification of a lead therapeutic drug compound. The lead compound would then be subjected to further testing in animals to obtain preliminary knowledge of its properties including safety. After the receiving promising preliminary data on the lead compound, it would be subjected to the more stringent tests required to complete the FDA requirements for an IND (Investigational New Drug Application). Such additional research and testing necessary for an IND application will require significant capital expenditures of approximately $1.5 million and will only be possible if we raise additional capital through equity financings.


We intend to contract out substantially all of the research and development work on our potential anti-cancer lead drug compounds. No employees were hired in 2008. We do not expect to hire employees during the next twelve months unless we raise substantial additional capital in the range of $5 million.


Our actual research and development and related activities may vary significantly from current plans depending on numerous factors, including changes in the costs of such activities from current estimates, the results of our research and development programs, technological advances, determinations as to commercial viability and the status of competitive products. The focus and direction of our operations will also be dependent on the establishment of our collaborative arrangements with other companies, the availability of financing and other factors. We expect our development costs to increase as   any future lead anti-cancer drug compound or compounds enter the later stages of development.

  

Liquidity and Capital Resources


Since inception, we have financed our operations through the private placement of equity and debt securities, as well as loans from certain of our officers and directors. During the period ended December 31, 2008, we sold 199,500 shares  at $0.33 per share for an aggregate amount of $65,850, net of expenses of $650  During the fourth quarter of 2008 we issued 50,000 shares in exchange for a $12,500 reduction of note payable to related party. We received $28,500 from issuance of notes payable from related parties.

  

As of December 31, 2008, we had $3,493 in cash and cash equivalents as compared to $45,406 as of December 31, 2007. We do not have any available lines of credit. Since inception we have financed our operations from private placements of equity securities and loans from shareholders and officers.

  

Net cash used in operating activities during the fiscal year ended December 31, 2008 was $136,263 resulting in a net loss of $400,763, after taking into account significant non-cash charges for operating expenses during the year and other adjustments. We pay no rent to Murray and Josephson CPAs LLC, whose principal is Martin Murray, a director and our Chief Financial Officer, Secretary and Treasurer, for the use of office space for file keeping and other business purposes.


Net cash from financing activities for the fiscal year ended December 31, 2008 was $94,350.


We are pursuing potential equity financing that may generate additional capital for us. We may need to raise additional capital or generate additional revenue to complete our development. We cannot assure you that we will generate sufficient additional capital or revenues, if any, to fund our operations beyond the twelve month period ending December 31, 2009, that any future equity financings will be successful, or that other potential financings through bank borrowings, debt or equity offerings, or otherwise, will be available on acceptable terms or at all.

  

As of December 31, 2008, our current liabilities exceeded our current assets by $604,996. We anticipate that our minimum cash requirements to continue as a going concern for the next twelve months will be at least $70,000.

 

- 31 -


We plan to finance our needs principally from the following:

·

our existing capital resources and interest earned on that capital;

·

royalty income, if any, from licensed product sales by BioCheck, Inc.;

·

annual minimum royalty payments from BioCheck if aggregate royalty income received by AngioGenex during the twelve months ending in the second quarter of 2009 is less than $50,000;

·

through future private placement financing.


The current rate of our cash usage raises substantial doubt about our ability to continue as a going concern, absent any new sources of significant cash flows. We believe that we have sufficient capital resources to finance our plan of operation for at least the next six months. However, this is a forward-looking statement, and there may be changes that could consume available resources before such time. Our long term capital requirements and the adequacy of our available funds will depend on many factors, including the eventual reporting company costs, public relations fees, patent costs for filing, prosecuting, maintaining and defending our patent rights, among others.


We do not currently have sufficient capital resources to finance our plan of operation through the second quarter of 2009. We will need to raise additional capital prior to the third quarter of 2009 in order to fund our plan of operation through 2009. Our long term capital requirements and the adequacy of our available funds will depend on many factors, including our reporting company costs, patent costs for filing, prosecuting, maintaining and defending our patent rights, among others.


We will need to raise substantial additional capital through equity or debt financings or generate additional revenue to complete our development of lead anti-cancer drug compounds. We cannot assure you that we will generate sufficient additional capital or revenues, if any, to fund our operations through 2009, that any future equity financings will be successful, or that other potential financings through equity offerings, or otherwise, will be available on acceptable terms or at all. Having insufficient funds may require us to delay, scale back, or eliminate some or all of our development programs, relinquish some or even all rights to product candidates at an earlier stage of development, or renegotiate less favorable terms that we would otherwise. If we are unable to raise additional capital prior to the third quarter 2009 we may have to further curtail or cease operations.


Critical Accounting Policies and Estimates.


This discussion and analysis of our financial condition and results of operations are based on our financial statements that have been prepared under accounting principles generally accepted in the United States of America. The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires our management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could materially differ from those estimates. We have disclosed all significant accounting policies in note 2 to the financial statements included in our Form 10-K. Our critical accounting policies are:


Revenue recognition : Royalties will be recognized as revenue when the amounts are contractually earned, fixed and determinable, and there is substantial probability of collection.


Research, development costs: Research and development costs are expensed as incurred.


Estimates. The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

 

- 32 -


Off Balance Sheet Arrangements


We do not have any off-balance sheet arrangements.


Lawsuit


In July 2006, Comparative BioSciences Inc. (“CompBio”), a company that we had previously hired to breed and house a colony of its proprietary “Id-Knockout” mice, sued us in state court in California claiming approximately $200,000 in unpaid invoices. We removed the case from state court to federal court and responded to CompBio’s claims by pointing to over charges from a) keeping a colony of mice much larger than we specifically requested, b) continuing to breed and house the mice for several years after we had demanded that CompBio cease performing any work or incurring any charges. Our response also included counter-claims for CompBio’s breach of contract, as well as a number of business torts arising out of their refusal to return the proprietary mice to us so that we could perform important anti-cancer experiments as part of our drug development program and business plan. At a hearing on December 22, 2006, the judge granted our request for injunctive relief in the form of the return of our proprietary experimental mice. However the judge ruled that CompBio would only be required to return our proprietary Id-knockout mice if we first posted a bond for $200,000, which we have not posted to date. On November 6, the parties agreed to a disposition of the suit under a stipulated judgment and settlement agreement pursuant to which: CompBio must return the laboratory mice and all scientific data from the research, CompBio agrees to forego all intellectual property rights in the mice and in the research, that it acknowledges belong to us, and we agreed to pay the CompBio $55,000 in installments over a 5-year period. We have made $17,500 payments to CompBio pursuant to the settlement agreement.  The outstanding balance as of December 31, 2008 is $39,906, including accrued interest.. The stipulated judgment and settlement agreement was filed with the court on November 15, 2007  The Company has not made the required payment for the fourth quarter of 2008, and is in default of this settlement agreement. Under the terms of the agreement upon receipt of written notification of default from CompBio the Company has five days to cure. Failure by the Company to cure the default results in an increase in the settlement amount to $75,000 plus retroactive interest of 5% on the balance. The Company has not received any notification of default from CompBio.

 

- 33 -



ITEM 8.  FINANCIAL STATEMENTS



ANGIOGENEX, INC.

INDEX TO FINANCIAL STATEMENTS

Report of Independent Registered Public Accounting Firm

 

35

Balance Sheets for December 31, 2007 and December 31, 2008

 

36

Statements of Operations for twelve months ended December 31, 2008

 

37

Statement of Stockholder’s Equity as of December 31, 2008

 

38-40

Statements of Cash Flows for twelve months ended December 31, 2008

 

41-42

Notes to Financial Statements for period ended December 31, 2008

 

43-53


 

- 34 -


AngioGenex, Inc.

New York, New York


REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM



We have audited the accompanying balance sheets of AngioGenex, Inc. as of December 31, 2008 and 2007, and the related statements of operations, stockholders’ equity and cash flows for the years then ended and for the period from March 31, 1999 (inception) through December 31, 2008.  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 audit.


We conducted our audit 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.  The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. 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 audit provides a reasonable basis for our opinion.


In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of AngioGenex, Inc. as of December 31, 2008 and 2007 and the results of its operations, stockholders equity and its cash flows for the years then ended and for the period from March 31, 1999 (inception) through December 31, 2008 in conformity with accounting principles generally accepted in the United States of America.


The accompanying financial statements have been prepared assuming that the Company will continue as a going concern.  As discussed in Note 2 to the financial statements, the Company has no revenues, limited resources and a large accumulated deficit. These factors raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans are also discussed in Note 2.  The financial statements do not include any adjustments that might result from the outcome of this uncertainty.





Williams & Webster, P.S.

Certified Public Accountants

Spokane, Washington

April 9, 2009




- 35 -




ANGIOGENEX, INC.

(A DEVELOPMENT STAGE ENTERPRISE)

BALANCE SHEETS

 

 

 

 

 

 

December 31,

 

 

December 31,

 

ASSETS

 

 

 

 

2008

 

 

2007

 

 

CURRENT ASSETS

 

 

 

 

 

 

 

 

 

Cash

 

$

               3,493

 

$

             45,406

 

 

 

Prepaid expenses

 

 

               8,928

 

 

               6,122

 

 

 

Receivable

 

 

                    -   

 

 

             50,000

 

 

 

 

TOTAL CURRENT ASSETS

 

 

             12,421

 

 

           101,528

 

 

PROPERTY AND EQUIPMENT

 

 

 

 

 

 

 

 

 

 

Equipment, net of depreciation of $7,280 and $6,659, respectively

 

 

                  569

 

 

               1,190

 

 

 

 

TOTAL PROPERTY AND EQUIPMENT

 

 

                  569

 

 

               1,190

 

 

 

TOTAL ASSETS

 

$

             12,990

 

$

           102,718

 

LIABILITIES AND STOCKHOLDERS' DEFICIT

 

 

 

 

 

 

 

 

CURRENT LIABILITIES

 

 

 

 

 

 

 

 

 

Accrued expenses

 

$

           353,546

 

$

           273,442

 

 

 

Accrued expenses - related parties

 

 

           218,837

 

 

           148,793

 

 

 

Notes payable

 

 

             11,000

 

 

             11,000

 

 

 

Notes payable, related parties

 

 

             22,500

 

 

             35,000

 

 

 

Accrued interest

 

 

               9,958

 

 

               4,859

 

 

 

Other liabilities

 

 

               1,576

 

 

                    -   

 

 

 

 

TOTAL CURRENT LIABILITIES

 

 

           617,417

 

 

           473,094

 

 

LONG-TERM LIABILITIES

 

 

 

 

 

 

 

 

 

Notes payable, related parties

 

 

             28,500

 

 

                    -   

 

 

 

Settlement payable

 

 

             25,000

 

 

             35,000

 

 

 

 

 

 

 

             53,500

 

 

             35,000

 

 

COMMITMENTS AND CONTINGENCIES

 

 

 

 

 

 

 

 

STOCKHOLDERS' DEFICIT

 

 

 

 

 

 

 

 

 

Preferred stock, 5,000,000 shares authorized, $0.001 par value;

 

 

 

 

 

 

 

 

 

 

no shares issued and outstanding

 

 

                    -   

 

 

                    -   

 

 

 

Common stock, 70,000,000 shares authorized, $0.001 par value;

 

 

 

 

 

 

 

 

 

 

21,302,906 and 21,053,406 shares issued and outstanding, respectively

 

 

             21,303

 

 

             21,053

 

 

 

Additional paid-in capital

 

 

        2,848,775

 

 

        2,770,675

 

 

 

Stock options, warrants, and beneficial conversion rights

 

 

           982,241

 

 

           912,379

 

 

 

Accumulated deficit during development stage

 

 

      (4,510,246)

 

 

      (4,109,483)

 

 

 

 

TOTAL STOCKHOLDERS' DEFICIT

 

 

         (657,927)

 

 

         (405,376)

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT

 

$

             12,990

 

$

           102,718

 

 

 

 

 

 

 

                    -   

 

 

                    -   

 


The accompanying condensed notes are an integral part of these interim financial statements.

 

- 36 -



ANGIOGENEX, INC

(A DEVELOPMENT STAGE ENTERPRISE)

STATEMENTS OF OPERATIONS

 

 

 

 

 

 

 

 

March , 1999

 

 

 

 

Year Ended

 

(Inception) to

 

 

 

 

December 31,

 

December 31,

 

 

 

 

2008

 

2007

 

2008

 

 

 

 

 

 

 

 

 

REVENUES

$

                  -   

$

          50,000

$

               50,000

 

 

 

 

 

 

 

 

 

EXPENSES

 

 

 

 

 

 

 

Research and development

 

           80,787

 

          64,834

 

          1,748,602

 

Consulting

 

                    -

 

                   -

 

             109,666

 

Licenses and fees

 

                    -

 

                   -

 

             155,000

 

Professional fees

 

         220,839

 

        228,260

 

          1,597,711

 

General and administrative

 

           89,142

 

          52,836

 

             362,013

 

 

TOTAL OPERATING EXPENSES

 

         390,768

 

        345,930

 

          3,972,992

 

 

 

 

 

 

 

 

 

LOSS FROM OPERATIONS

 

       (390,768)

 

      (295,930)

 

        (3,922,992)

 

 

 

 

 

 

 

 

        (3,922,992)

OTHER INCOME  (EXPENSES)

 

 

 

 

 

 

 

Other income

 

                  -   

 

                 -   

 

             464,688

 

Interest income

 

                  21

 

                 -   

 

                 7,257

 

Finance costs

 

         (10,016)

 

        (68,475)

 

        (1,059,199)

 

 

TOTAL OTHER INCOME (EXPENSES)

 

           (9,995)

 

        (68,475)

 

           (587,254)

 

 

 

 

 

 

 

 

 

LOSS BEFORE INCOME TAXES

 

       (400,763)

 

      (364,405)

 

        (4,510,246)

 

 

 

 

 

 

 

 

 

INCOME TAXES

 

                  -   

 

                 -   

 

                      -   

 

 

 

 

 

 

 

 

 

NET LOSS

$

       (400,763)

$

      (364,405)

$

        (4,510,246)

 

 

 

 

 

 

 

 

 

 

NET LOSS PER COMMON SHARE,

 

 

 

 

 

 

 

 

BASIC AND DILUTED

$

          (0.02)

$

         (0.02)

 

 

 

 

 

 

 

 

 

 

 

 

WEIGHTED AVERAGE NUMBER OF

 

 

 

 

 

 

 

 

COMMON STOCK SHARES OUTSTANDING,

 

 

 

 

 

 

 

 

BASIC AND DILUTED

 

    21,180,375

 

   20,673,474

 

 

 

 

 

 

 

 

 

 

 

The accompanying condensed notes are an integral part of these interim financial statements.

 

- 37 -


 

ANGIOGENEX, INC.

(A DEVELOPMENT STAGE ENTERPRISE)

STATEMENT OF STOCKHOLDERS' EQUITY (DEFICIT)

 

 

 

 

 

 

 

 

 

 

 

 

Deficit

 

 

 

 

 

 

 Common Stock

 

 

 

 

 Stock options /

 Accumulated

 

 

 

 

 

 

 

 

 

 

 Warrants /

 During

 

 Total

 

 

 

 Number

 

 

 

Additional

 

 

 Beneficial

 Development

 

 Stockholders'

 

 

 

 of Shares

 

Amount

 

Paid-in Capital

 

 

 conversion

 Stage

 

 Equity (Deficit)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of founders' common stock at $0.01 per share

 

           8,100,000

 

$

           8,100

 $

                 900

 

 $

                         -   

$

                        -   

 

$

                  9,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock at $0.17 per share

 

              729,000

 

 

              729

 

          120,271

 

 

                         -   

 

                        -   

 

 

              121,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss for the year ended March 31, 2000

 

                        -   

 

 

                 -   

 

                    -   

 

 

                         -   

 

            (104,357)

 

 

            (104,357)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, March 31, 2000

 

           8,829,000

 

 

           8,829

 

          121,171

 

 

                         -   

 

            (104,357)

 

 

                25,643

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock at $0.17 per share

 

              171,000

 

 

              171

 

            28,829

 

 

                         -   

 

                        -   

 

 

                29,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock and warrants (net of  cash and

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

non cash expenses of $146,000) at $12,500 per unit

 

              144,000

 

 

              144

 

          347,856

 

 

                         -   

 

                        -   

 

 

              348,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock options vested

 

                        -   

 

 

                 -   

 

                    -   

 

 

                 22,845

 

                        -   

 

 

                22,845

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss for the year ended March 31, 2001

 

                        -   

 

 

                 -   

 

                    -   

 

 

                         -   

 

            (181,811)

 

 

            (181,811)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance March 31, 2001

 

           9,144,000

 

 

           9,144

 

          497,856

 

 

                 22,845

 

            (286,168)

 

 

              243,677

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock and warrants (net of cash and

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

non cash expenses of $118,000) at $12,500 per unit

 

                62,000

 

 

                62

 

            75,149

 

 

                         -   

 

                        -   

 

 

                75,211

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock options vested

 

                        -   

 

 

                 -   

 

                    -   

 

 

                 82,875

 

                        -   

 

 

                82,875

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss for the year ended March 31, 2002

 

                        -   

 

 

                 -   

 

                    -   

 

 

                         -   

 

            (482,903)

 

 

            (482,903)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance March 31, 2002

 

           9,206,000

 

 

           9,206

 

          573,005

 

 

               105,720

 

            (769,071)

 

 

              (81,140)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock for services at $0.25 per share

 

              510,000

 

 

              510

 

          124,490

 

 

                         -   

 

                        -   

 

 

              125,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock at $0.25 per share  (net of

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

cash and non cash expenses of $14,989)

 

              216,000

 

 

              216

 

            38,795

 

 

                         -   

 

                        -   

 

 

                39,011

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock options vested

 

                        -   

 

 

                 -   

 

                    -   

 

 

                 74,280

 

                        -   

 

 

                74,280

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss for the year ended March 31, 2003

 

                        -   

 

 

                 -   

 

                    -   

 

 

                         -   

 

            (469,897)

 

 

            (469,897)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, March 31, 2003

 

           9,932,000

 

 

           9,932

 

          736,290

 

 

               180,000

 

         (1,238,968)

 

 

            (312,746)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock for services  at $0.25 per share

 

           1,255,000

 

 

           1,255

 

          312,495

 

 

                         -   

 

                        -   

 

 

              313,750

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Private placement costs from prior year offering

 

                        -   

 

 

                 -   

 

            (2,300)

 

 

                         -   

 

                        -   

 

 

                (2,300)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

- 38 -


 

ANGIOGENEX, INC.

(A DEVELOPMENT STAGE ENTERPRISE)

STATEMENT OF STOCKHOLDERS' EQUITY (DEFICIT) CONTINUED

 

 

 

 

 

 

 

 

 

 

 

 

Deficit

 

 

 

 

 

 

 Common Stock

 

 

 

 

 Stock options /

 Accumulated

 

 

 

 

 

 

 

 

 

 

 Warrants /

 During

 

 Total

 

 

 

 Number

 

 

 

Additional

 

 

 Beneficial

 Development

 

 Stockholders'

 

 

 

 of Shares

 

Amount

 

Paid-in Capital

 

 

 conversion

 Stage

 

 Equity (Deficit)

Stock options vested

 

                        -   

 

 

                 -   

 

                    -   

 

 

                 35,653

 

                        -   

 

 

                35,653

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of warrants attached to convertible bridge loan

 

                        -   

 

 

                 -   

 

                    -   

 

 

               586,551

 

                        -   

 

 

              586,551

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Beneficial conversion rights of convertible bridge loan

 

                        -   

 

 

                 -   

 

                    -   

 

 

               288,449

 

                        -   

 

 

              288,449

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss for the year ended March 31, 2004

 

                        -   

 

 

                 -   

 

                    -   

 

 

                         -   

 

            (356,061)

 

 

            (356,061)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, March 31, 2004

 

         11,187,000

 

 

         11,187

 

       1,046,485

 

 

            1,090,653

 

         (1,595,029)

 

 

              553,296

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock options vested

 

                        -   

 

 

                 -   

 

                    -   

 

 

                 21,614

 

                        -   

 

 

                21,614

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss for the year ended March 31, 2005

 

                        -   

 

 

                 -   

 

                    -   

 

 

                         -   

 

         (1,396,914)

 

 

         (1,396,914)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, March 31, 2005

 

         11,187,000

 

 

         11,187

 

       1,046,485

 

 

            1,112,267

 

         (2,991,943)

 

 

            (822,004)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock options granted for prepaid offering costs

 

                        -   

 

 

                 -   

 

                    -   

 

 

                 14,822

 

                        -   

 

 

                14,822

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock options vested

 

                        -   

 

 

                 -   

 

                    -   

 

 

                 36,954

 

                        -   

 

 

                36,954

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock issued in recapitalization and

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

reverse merger

 

           1,500,000

 

 

           1,500

 

            (1,500)

 

 

                         -   

 

                        -   

 

 

                        -   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss for the nine months ended December 31, 2005

 

                        -   

 

 

                 -   

 

                    -   

 

 

                         -   

 

            (409,997)

 

 

            (409,997)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2005

 

                12,687,000

 

$

               12,687

$

               1,044,985

 

 $

                  1,164,043

$

                (3,401,940)

 

$

         (1,180,225)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock at $0.25 per share

 

                     310,000

 

 

                    310

 

                    77,190

 

 

                         -   

 

                        -   

 

 

                77,500

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock at $0.33 per share

 

                     300,000

 

 

                    300

 

                    80,200

 

 

                       19,500

 

                        -   

 

 

              100,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock options vested

 

                        -   

 

 

                 -   

 

                          -   

 

 

                            514

 

                        -   

 

 

                     514

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares issued in connection to conversion of notes payable

7,050,285

 

 

 7050

 

1,246,513

 

 

(288,449)

 

                        -   

 

 

              965,114

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss for the year ended December 31, 2006

 

 

 

 

 

 

 

 

 

 

 

(343,138)

 

 

            (343,138)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2006

 

                20,347,285

 

 

               20,347

 

               2,448,888

 

 

                      895,608

 

                (3,745,078)

 

 

            (380,235)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock at $0.50 per share

 

                       78,000

 

 

                      78

 

                    17,266

 

 

                        13,086

 

                        -   

 

 

                30,430

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock for services at $0.45 per share

 

200,000

 

 

200

 

89,800

 

 

                         -   

 

                        -   

 

 

                90,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares issued in connection to conversion of notes payable

                     242,859

 

 

                    243

 

                  145,471

 

 

                         -   

 

                        -   

 

 

              145,714



- 39 -


 

ANGIOGENEX, INC.

(A DEVELOPMENT STAGE ENTERPRISE)

STATEMENT OF STOCKHOLDERS' EQUITY (DEFICIT) CONTINUED

 

 

 

 

 

 

 

 

 

 

 

 

Deficit

 

 

 

 

 

 

 Common Stock

 

 

 

 

 Stock options /

 Accumulated

 

 

 

 

 

 

 

 

 

 

 Warrants /

 During

 

 Total

 

 

 

 Number

 

 

 

Additional

 

 

 Beneficial

 Development

 

 Stockholders'

 

 

 

 of Shares

 

Amount

 

Paid-in Capital

 

 

 conversion

 Stage

 

 Equity (Deficit)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock at $0.65 per share

 

                16,000

 

 

                16

 

              3,059

 

 

                   3,685

 

                        -   

 

 

                  6,760

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock at $0.50 per share

 

              169,262

 

 

              169

 

            84,191

 

 

                         -   

 

 

 

 

                84,360

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortized private placement costs

 

                        -   

 

 

                 -   

 

          (18,000)

 

 

                         -   

 

                        -   

 

 

              (18,000)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss for the year ended December 31, 2007

 

                        -   

 

 

                 -   

 

                    -   

 

 

                         -   

 

(364,405)

 

 

            (364,405)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2007

 

         21,053,406

 

$

         21,053

$

       2,770,675

 

 $

               912,379

 $

         (4,109,483)

 

$

            (405,376)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock at $0.33 per share

 

              199,500

 

 

              200

 

            65,650

 

 

                         -   

 

                        -   

 

 

                65,850

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares issued in connection to conversion of note payable

                50,000

 

 

                50

 

            12,450

 

 

                         -   

 

                        -   

 

 

                12,500

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock options vested

 

                        -   

 

 

                 -   

 

                    -   

 

 

                 69,862

 

                        -   

 

 

                69,862

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss for the year ended December 31, 2008

 

                        -   

 

 

                 -   

 

                    -   

 

 

                         -   

 

0

 

 

                        -   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2008

 

         21,302,906

 

$

         21,303

$

       2,848,775

 

 $

               982,241

 $

         (4,109,483)

 

$

            (257,164)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The accompanying condensed notes are an integral part of these interim financial statements.

 

- 40 -



ANGIOGENEX, INC.

(A DEVELOPMENT STAGE ENTERPRISE)

STATEMENTS OF CASH FLOWS

 

 

 

 

 

 

 

 

 

 

 

 

 

March, 1999

 

 

 

 

 

 

 

Year Ended

 

(Inception) to

 

 

 

 

 

 

 

December 31,

 

December 31,

 

 

 

 

 

 

 

2008

 

2007

 

2008

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

$

            (400,763)

 

$

          (364,405)

 

$

          (4,510,246)

 

Adjustments to reconcile net loss

 

 

 

 

 

 

 

 

 

 

 

 

to net cash used by operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation

 

 

 

                   621

 

 

                  620

 

 

                  7,280

 

 

 

Services paid by issuance of common stock

 

 

                     -   

 

 

             90,000

 

 

              526,450

 

 

 

Services paid by issuance of common stock options

 

 

               69,862

 

 

                    -   

 

 

              359,419

 

 

 

Amortization of warrants and beneficial conversion

 

 

                     -   

 

 

             54,429

 

 

              948,929

 

 

 

Non cash financing and other charges

 

 

                     -   

 

 

               6,285

 

 

                  6,285

 

 

(Increase) decrease in prepaid expenses

 

 

 

               (2,806)

 

 

              (5,383)

 

 

                (8,928)

 

 

(Increase) decrease in prepaid offering costs

 

 

                     -   

 

 

             15,000

 

 

                        -

 

 

(Increase) decrease in receivables

 

 

 

               50,000

 

 

            (50,000)

 

 

                        -

 

 

Increase (decrease) in accrued expenses

 

 

               80,104

 

 

             37,607

 

 

              352,124

 

 

Increase (decrease) in accrued expenses, related party

 

 

               70,044

 

 

             21,087

 

 

              220,259

 

 

Increase (decrease) in accrued interest

 

 

 

                 5,099

 

 

               2,230

 

 

              100,072

 

 

Increase (decrease) in other liabilities

 

 

 

                 1,576

 

 

                    -   

 

 

                  1,576

 

 

Increase (decrease) in settlement payable

 

 

             (10,000)

 

 

             35,000

 

 

                25,000

 

Net cash used in operating activities

 

 

 

            (136,263)

 

 

          (157,530)

 

 

          (1,971,780)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

Purchase of equipment

 

 

 

                     -   

 

 

                    -   

 

 

                (7,849)

 

Net cash used in investing activities

 

 

 

                     -   

 

 

                    -   

 

 

                (7,849)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

Proceeds from bridge loan

 

 

 

                     -   

 

 

                    -   

 

 

              875,000

 

Payment of notes payable - related party

 

 

 

                     -   

 

 

                    -   

 

 

               (25,000)

 

Payment of notes payable

 

 

 

                     -   

 

 

                    -   

 

 

               (35,000)

 

Proceeds from notes payable

 

 

 

               28,500

 

 

             95,000

 

 

              219,500

 

Issuance of stock for cash - net

 

 

 

               65,850

 

 

            103,550

 

 

              948,622

 

Net cash provided by financing activities

 

 

 

               94,350

 

 

            198,550

 

 

            1,983,122

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net increase (decrease)  in cash

 

 

 

             (41,913)

 

 

             41,020

 

 

                  3,493

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash, beginning of period

 

 

 

               45,406

 

 

               4,386

 

 

                        -

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

- 41 -


 

ANGIOGENEX, INC.

(A DEVELOPMENT STAGE ENTERPRISE)

STATEMENTS OF CASH FLOWS CONTINUED

 

 

 

 

 

 

 

 

 

 

 

 

 

March, 1999

 

 

 

 

 

 

 

Year Ended

 

(Inception) to

 

 

 

 

 

 

 

December 31,

 

December 31,

 

 

 

 

 

 

 

2008

 

2007

 

2008

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash, end of period

 

 

$

                 3,493

 

$

             45,406

 

$

                  3,493

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SUPPLEMENTAL CASH FLOW DISCLOSURES:

 

 

 

 

 

 

 

 

 

 

Cash paid for interest and income taxes:

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

$

 

 

$

                    -   

 

$

                        -

 

 

Income taxes

 

 

$

                     -   

 

$

                    -   

 

$

                        -

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NON-CASH INVESTING AND FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

 

Services paid by issuance of stock

 

 

$

                     -   

 

$

             90,000

 

$

              526,450

 

Services paid by issuance of stock options

 

 

$

               69,862

 

$

                    -   

 

$

              344,597

 

Offering costs paid by issuance of stock options

 

$

                     -   

 

$

                    -   

 

$

                14,822

 

Conversion of debt to equity

 

 

$

               12,500

 

$

             85,000

 

$

              972,500

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The accompanying condensed notes are an integral part of these interim financial statements.

- 42 -


ANGIOGENEX, INC.

(A DEVELOPMENT STAGE COMPANY)

NOTES TO FINANCIAL STATEMENTS

DECEMBER 31, 2008


NOTE 1 – ORGANIZATION AND DESCRIPTION OF BUSINESS


AngioGenex, Inc. (“AngioGenex” or the “Company”) incorporated in the State of New York on March 31, 1999. The Company is a biopharmaceutical company founded to create products that are uniquely useful for the treatment, diagnosis and prognosis of cancer. Company programs focus on (1) the discovery and development of orally active anti-cancer drugs that act by modulating the action of the Id proteins, (2) the measurement of Id proteins in tumors and blood to create products for the diagnosis and prognosis of cancer, (3) generating proof-of-concept data in relevant preclinical models to establish that modulation of Id proteins is useful to treat non-oncologic diseases in which an overgrowth of blood vessels is an important part of the underling pathology and (4) collaborating in respect to treatments of diseases in which blood vessel proliferation is desirable. The Company’s proprietary technology is based on the research work of Dr. Robert Benezra and his colleagues at Memorial Sloan Kettering Cancer Center (MSKCC), NYC, who discovered the Id (inhibitor of differentiation) genes and corresponding Id proteins and established their role in the formation of new blood vessels (angiogenesis) required for tumor growth and metastasis.  The Company’s intellectual property includes the rights to biotechnology in the Id field, which it acquired under exclusive worldwide licenses from MSKCC and the Albert Einstein College of Medicine (“AECOM”), and its own patentable findings that it has generated while developing its Id based anti-angiogenesis anti-cancer strategies.


On December 30, 2005, AngioGenex merged into eClic Acquisition, Inc., a wholly owned subsidiary of eClic, Inc. incorporated in the state of Nevada, eClic Acquisition, Inc. then changed its name to AngioGenex Therapeutics, Inc. and concurrently eClic, Inc, a fully reporting shell changed its name to AngioGenex, Inc.  For accounting purposes, the acquisition has been treated as a recapitalization of AngioGenex, with AngioGenex as the acquirer in a reverse acquisition.  The transaction was compliant with Rule 12g-3 of the Securities and Exchange Commission.  The historical financial statements prior to December 30, 2005 are those of AngioGenex while the legal structure of eClic remains in place.  eClic had no assets or liabilities at the time of the acquisition.


The Company has been in the development stage since inception and as of December 31, 2008 has had $50,000 of revenues from its planned operations.  At time of the merger, the Company’s year-end changed from March 31 to December 31.


NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES


This summary of significant accounting policies of AngioGenex, Inc. is presented to assist in understanding the Company’s financial statements.  The financial statements and notes are representations of the Company’s management, which is responsible for their integrity and objectivity.  These accounting policies conform to accounting principles generally accepted in the United States of America, and have been consistently applied in the preparation of the financial statements.


Accounting Method

The Company uses the accrual method of accounting in accordance with accounting principles generally accepted in the United States of America.


Basic and Diluted Loss Per Share

Statement of Financial Accounting Standards No.128, “Earnings Per Share” (hereinafter “SFAS No. 128”), requires the reporting of basic and diluted earnings/loss per share. Basic loss per share is calculated by dividing net loss by the weighted average number of outstanding common shares during the year. As all potential common shares are anti-dilutive, the effects of options and warrants (totaling approximately 6,800,000 additional shares) are not included in the calculation of diluted loss per share.


Cash and Cash Equivalents

For purposes of its statement of cash flows, the Company considers all short-term debt securities purchased with a maturity of three months or less to be cash equivalents.

 

- 43 -


ANGIOGENEX, INC.

(A DEVELOPMENT STAGE COMPANY)

NOTES TO FINANCIAL STATEMENTS

DECEMBER 31, 2008


Derivative Instruments

The Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 133, “Accounting for Derivative Instruments and Hedging Activities” (hereinafter “SFAS No. 133”), as amended by SFAS No. 137, “Accounting for Derivative Instruments and Hedging Activities – Deferral of the Effective Date of FASB No. 133”, SFAS No. 138, “Accounting for Certain Derivative Instruments and Certain Hedging Activities”, SFAS No. 149, “Amendment of Statement 133 on Derivative Instruments and Hedging Activities”, SFAS No. 150, “Accounting for Certain Financial Instruments with Characteristics of Both Liabilities and Equity”, and SFAS No. 155, “Accounting for Certain Hybrid Financial Instruments, an amendment of FASB Standards No. 133 and 140”.  These statements establish accounting and reporting standards for derivative instruments, including certain derivative instruments embedded in other contracts, and for hedging activities. They require that an entity recognize all derivatives as either assets or liabilities in the balance sheet and measure those instruments at fair value.


If certain conditions are met, a derivative may be specifically designated as a hedge, the objective of which is to match the timing of gain or loss recognition on the hedging derivative with the recognition of (i) the changes in the fair value of the hedged asset or liability that are attributable to the hedged risk or (ii) the earnings effect of the hedged forecasted transaction. For a derivative not designated as a hedging instrument, the gain or loss is recognized in income in the period of change.


Historically, the Company has not entered into derivatives contracts to hedge existing risks or for speculative purposes.


At December 31, 2008 and 2007 the Company has not engaged in any transactions that would be considered derivative instruments or hedging activities.


Development Stage Activities

The Company is currently and has been a development stage company as defined under Statements of Financial Accounting Standards (“FAS”) No. 7 since its formation on March 31, 1999.  It is primarily engaged in the research to develop anti-cancer strategies using the field of antiangiogenesis.  In 2003, the Company entered into an agreement to provide certain properties to an unrelated outside company. The Company recognized $50,000 of royalty revenue under this agreement for the year ended December 31, 2007, however the Company did not deem this revenue sufficient to move the Company from development stage to a fully reporting company. See Note 4.


Equipment

Equipment is carried at cost less an allowance for depreciation.  Depreciation is recorded using the straight- line method over an estimated useful life of five years.  Depreciation expense for the year ended December 31, 2008 and 2007 was $621 and $620, respectively.


Fair Value Measurement

The Company's financial instruments as defined by SFAS No. 107, "Disclosures about Fair Value of Financial Instruments," include cash, accounts payable and accrued expenses and short-term borrowings.  All instruments are accounted for on a historical cost basis, which, due to the short maturity of these financial instruments, approximates fair value at December 31, 2008 and 2007.


In September 2006, the FASB issued FASB Statement No. 157, "Fair Value Measurements" ("SFAS 157"). SFAS 157 defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles, and expands disclosures about fair value measurements. The provisions of SFAS 157 were adopted January 1, 2008.

 

SFAS 157 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy under SFAS 157 are described below: 

 

- 44 -


ANGIOGENEX, INC.

(A DEVELOPMENT STAGE COMPANY)

NOTES TO FINANCIAL STATEMENTS

DECEMBER 31, 2008


Level 1 - Unadjusted quoted prices in active markets that are accessible at the measurement date for identical unrestricted assets or liabilities.

Level 2 - Quoted prices in markets that are not active, or inputs that are observable, either directly or indirectly, for substantially the full term of the asset or liability.

Level 3 - Prices or valuation techniques that require inputs that are both significant to fair value measurement and unobservable (supported by little or no market activity).


The Company's cash instruments are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices. The cash instruments that are valued based on quoted market prices in active markets are primarily money market securities.


Going Concern

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern.


As shown in the accompanying financial statements, the Company has incurred substantial net losses since inception.  The future of the Company is dependent upon additional financing and revenue to fund its research and development activities and to support operations. However, there is no assurance that the Company will be able to obtain additional financing. Furthermore, there is no assurance that the Food and Drug Administration will grant future approval of the Company’s prospective products or that profitable operations can be attained as a result thereof.


The Company anticipates that its principal source of funds for the next year will be the issuance for cash of additional equity instruments.  The financial statements do not include any recoverability and classification of recorded assets, or the amounts and classification of liabilities that might be necessary in the event the Company cannot continue in existence.  Management plans to seek additional capital from new equity securities issuances that will provide funds needed to increase liquidity, fund internal growth and fully implement its business plan.  The Company anticipates that its minimum cash requirements to continue as a going concern for the next twelve months will be at least $70,000 for administrative costs.


Research, Development and Patent

Research and development costs, including certain costs related to patent applications, are charged to operations as incurred.


Stock-based Compensation

In December 2004, the Financial Accounting Standards Board issued a revision to Statement of Financial Accounting Standards No. 123R, “Accounting for Stock Based Compensations.” This statement supersedes APB Opinion No. 25, “Accounting for Stock Issued to Employees,” and its related implementation guidance. This statement establishes standards for the accounting for transactions in which an entity exchanges its equity instruments for goods or services. It also addresses transactions in which an entity incurs liabilities in exchange for goods or services that are based on the fair value of the entity’s equity instruments or that may be settled by the issuance of those equity instruments. This statement focuses primarily on accounting for transactions in which an entity obtains employee services in share-based payment transactions. This statement does not change the accounting guidance for share based payment transactions with parties other than employees provided in Statement of Financial Accounting Standards No. 123.


Statement of Financial Accounting Standards No. 123, “Accounting for Stock-Based Compensation”, defines a fair value-based method of accounting for stock options and other equity instruments. The Company has adopted this method, which measures compensation costs based on the estimated fair value of the award and recognizes that cost over the service period.


Provision for Taxes

Income taxes are provided based upon the liability method of accounting pursuant to Statement of Financial Accounting Standards No. 109, “Accounting for Income Taxes” (hereinafter “SFAS No. 109”).  Under this

 

- 45 -


ANGIOGENEX, INC.

(A DEVELOPMENT STAGE COMPANY)

NOTES TO FINANCIAL STATEMENTS

DECEMBER 31, 2008


approach, deferred income taxes are recorded to reflect the tax consequences in future years of differences between the tax basis of assets and liabilities and their financial reporting amounts at each year-end.  A valuation allowance is recorded against deferred tax assets if management does not believe the Company has met the “more likely than not” standard imposed by SFAS No. 109 to allow recognition of such an asset. The Company evaluates tax positions to determine whether the benefits of tax positions are more likely than not of being sustained upon audit based on the technical merits of the tax position. For tax positions that are more likely than not of being sustained, the Company recognizes the largest amount that is greater than 50% likely of being realized upon ultimate settlement in the financial statements. For tax positions that are not more likely than not of being sustained upon audit, the Company does not recognize any portion of the benefit.


At December 31, 2008, the Company had net deferred tax assets (calculated at an expected rate of 40%, to include local, state and federal taxes) of approximately $1,872,000 principally arising from net operating loss carryforwards for income tax purposes and other accumulated temporary differences.  As management of the Company cannot determine that it is more likely than not that the Company will realize the benefit of the net deferred tax asset, a valuation allowance equal to the net deferred tax asset has been established at December 31, 2008.  The significant components of the income tax and deferred tax asset at December 31, 2008 and 2007 were as follows:



 

December 31,

 2008

 

December 31,

2007

Operating Loss

$

        401,000

$

     364,000

 

 

 

 

 

Permanent Differences:

 

 

 

 

 Nondeductible meals and entertainment

 

1,000

 

            1,000

Temporary Differences:

 

 

 

 

 Stock options issued under a non-qualified plan:

 

          70,000

 

           

-

 Financing costs

 

                   -

 

61,000    

 Deferred research and development costs:

 

         18,000

 

       9,000

Operating loss after permanent and temporary differences

$

 

$

       

    312,000

    293,000

 

 

 

 

 

Accumulated Net Operating Loss Carryforward

$

2,229,000

$

 1,917,000

Other accumulated temporary differences

2,237,000

2,149,000

Accumulated net operating loss carryforward after all temporary and permanent differences

$

 

$

 

4,466,000

 4,066,000

  Research and development tax credit

$

86,000

$

         85,000


 

 

 

 

Deferred tax asset

$

      1,872,000

$

     1,711,000

Deferred tax asset valuation allowance

 

     (1,872,000)

 

(1,711,000)

     Net deferred tax asset

$

               -

$

               -


 

- 46 -


ANGIOGENEX, INC.

(A DEVELOPMENT STAGE COMPANY)

NOTES TO FINANCIAL STATEMENTS

DECEMBER 31, 2008


At December 31, 2008 the Company has estimated net operating loss carryforward and deferred charges of approximately $4,466,000 which expire in the years 2018 through 2028. The Company also recognized a research and development tax credit that is included in the above calculation of deferred tax assets. The change in valuation allowance for the year ended December 31, 2008 was $161,000.


Use of Estimates

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that effect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reported period. Actual results could differ from those estimates.


Recent Accounting Pronouncements

FAS 163 “Accounting for Financial Guarantee Insurance Contracts” is effective January 1, 2009 except for disclosures about the risk-management activities of the insurance enterprise be effective for the first period (including interim periods) beginning after issuance of this Statement. Except for those disclosures, earlier application is not permitted. FAS 163 requires that an insurance enterprise recognize a claim liability prior to an event of default (insured event) when there is evidence that credit deterioration has occurred in an insured financial obligation. FAS 163 also clarifies how Statement 60 applies to financial guarantee insurance contracts, including the recognition and measurement to be used to account for premium revenue and claim liabilities. The effect of adoption of FAS 163 on the Company’s financial position and results of operations is not expected to be material.

 

FAS 162 “The Hierarchy of Generally Accepted Accounting Principles” is effective 60 days following the SEC’s approval of the Public Company Accounting Oversight Board amendments to AU Section 411, The Meaning of Present Fairly in Conformity With Generally Accepted Accounting Principles. FAS 162 identifies the sources of accounting principles and the framework for selecting the principles to be used in the preparation of financial statements of nongovernmental entities that are presented in conformity with generally accepted accounting principles in the United States. The effect of adoption of FAS 162 on the Company’s financial position and results of operations is not expected to be material.


FAS 161 “Disclosures about Derivative Instruments and Hedging Activities”, which is effective January 1, 2009 requires enhanced disclosures about derivative instruments and hedging activities to allow for a better understanding of their effects on an entity’s financial position, financial performance, and cash flows. Among other things, FAS 161 requires disclosure of the fair values of derivative instruments and associated gains and losses in a tabular format. The adoption of FAS 161 will not affect the Company’s financial position or results of operations.


In December 2007, the SEC issued Staff Accounting Bulletin (SAB) No. 110 regarding the use of a "simplified" method, as discussed in SAB No. 107 (SAB 107), in developing an estimate of expected term of "plain vanilla" share options in accordance with SFAS No. 123 (R), Share-Based Payment.  In particular, the staff indicated in SAB 107 that it will accept a company's election to use the simplified method, regardless of whether the company has sufficient information to make more refined estimates of expected term. At the time SAB 107 was issued, the staff believed that more detailed external information about employee exercise behavior (e.g., employee exercise patterns by industry and/or other categories of companies) would, over time, become readily available to companies. Therefore, the staff stated in SAB 107 that it would not expect a company to use the simplified method for share option grants after December 31, 2007. The staff understands that such detailed information about employee exercise behavior may not be widely available by December 31, 2007. Accordingly, the staff will continue to accept, under certain circumstances, the use of the simplified method beyond December 31, 2007. The Company currently uses the simplified method for “plain vanilla” share options and warrants, and will assess the impact of SAB 110 for fiscal year 2009. It is not believed that this will have an impact on the Company’s financial position, results of operations or cash flows.

 

- 47 -


ANGIOGENEX, INC.

(A DEVELOPMENT STAGE COMPANY)

NOTES TO FINANCIAL STATEMENTS

DECEMBER 31, 2008


Reclassification

Certain amounts from prior periods have been reclassified to conform to the current period presentation.  This reclassification has resulted in no changes to the Company’s accumulated deficit or net losses presented.


Revenue recognition

Royalties will be recognized as revenue when the amounts are contractually earned, fixed and determinable, and there is substantial probability of collection. The Company recognized $50,000 royalty revenue at December 31, 2007.


Net Loss Per Share

In June of 1999 the Company adopted Statement of Financial Accounting Standards Statement No. 128, “Earnings Per Share.” Basic earnings (net loss) per share is computed using the weighted average number of common shares outstanding. Diluted net loss per share for FASC is the same as basic net loss per share, as the inclusion of the common stock equivalents would be antidilutive.


NOTE 3 – AGREEMENT WITH SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH (“SKICR”)


On January 1, 2001, the Company signed a two-year industrial research agreement with SKICR to sponsor the research to determine if Id proteins are useful targets for antiangiogenic drug design, which may be highly specific for the inhibition of tumor vasculature thereby blocking the growth and/or metastasis of a majority of neoplasms with few side effects. The research agreement provided that the Company would fund the project on a quarterly basis. The Company was committed to pay for legal costs in connection with related patent applications and protection. The Company paid $308,000 to SKICR in connection with this research project.


In March of 2000, in exchange for $30,000 the Company obtained from SKICR an exclusive worldwide right and license in the field of use, including to make, have made, use, lease, commercialize and sell licensed products and to use licensed processes derived from the invention. The agreement provides that an additional $200,000 shall be paid to SKICR upon the submission to any regulatory authority of the first new drug application for any licensed product and $500,000 to be paid upon the first regulatory authority approval. In addition, agreement also provides for royalty payments to SKICR ranging from 2.5% - 4% of net sales and 15% of gross revenues from sub-license fees.


At December 31, 2008, the Company has no products for sale that would fall under the licensing agreement, and no fees, aside from the original license fee, has been paid or accrued.


NOTE 4 – AGREEMENT WITH BIOCHECK, INC.


On December 15, 2003, the Company entered into a development and marketing agreement with BioCheck Inc. for the development and marketing of diagnostic, prognostic, or bio-analytical products.  The agreement was modified as of July 21,2008. Under the agreement, the Company will receive license fees equal to 9% of the gross revenue of the direct sale by BioCheck, Inc. of any products and 25% of any sublicensing revenue received by BioCheck, Inc. As of December 31, 2008 no revenues were generated. Prior to its modification the agreement provided certain minimum annual royalty to be paid to the Company. The provision for minimum royalty payments has been eliminated. Therefore the receivable of $50,000 that was recognized was charged to bad debt as in 2008.


NOTE 5 – RELATED PARTY TRANSACTIONS


An officer of the Company allows the Company to use space in his offices for file keeping and other business purposes.  The Company pays no rent for this space.  This same officer also provides services to the Company in the form of bookkeeping and tax preparation, for which the Company is billed.

 

- 48 -


ANGIOGENEX, INC.

(A DEVELOPMENT STAGE COMPANY)

NOTES TO FINANCIAL STATEMENTS

DECEMBER 31, 2008


At December 31, 2008 and 2007 the Company owed the officer’s business $100,842 and $53,793, respectively, which is included in accrued expenses – related parties in the financial statements.


At December 31, 2008 the Company owed an officer $95,000 for unpaid salary pursuant to an agreement to pay $5,000 per month through September 30, 2006.  See Note 11.


For additional related party transactions, see Notes 6 and 11.


NOTE 6 – NOTES PAYABLE


On September 1, 2005, the Company obtained an unsecured loan in the amount of $25,000 from a corporate officer, $12,500 of which was repaid during 2008. The agreement provides for repayment of principal and interest accrued at 6% per annum at September 1, 2008. At December 31, 2008 the principal balance and accrued interest of $4,537 were unpaid.


On November 25, 2005, the Company obtained an unsecured loan in the amount of $1,000 from an unrelated third party. The agreement provides for repayment of principal and interest accrued at 6% per annum at December 1, 2008.  At December 31, 2008 the principal balance and accrued interest of $186 were unpaid.


On November 29, 2005, the Company obtained an unsecured loan in the amount of $10,000 from a corporate officer. The agreement provides for repayment of principal and interest accrued at 6% per annum at December 1, 2008.  At December 31, 2008, the principal balance and accrued interest of $1,854 were unpaid.


On November 19, 2007, the Company obtained an unsecured loan in the amount of $10,000 from an unrelated third party. The agreement provides for repayment of principal and interest accrued at 6% per annum at November 19, 2009.  At December 31, 2008 the Company had accrued interest of $671.


On October16, 2008, the Company obtained an unsecured loan in the amount of $16,000 from a corporate officer. The agreement provides for repayment of principal and interest accrued at 6% per annum at October 16, 2011. At December 31, 2008, the Company had accrued interest of $203.


On October 28, 2008, the Company obtained an unsecured loan in the amount of $5,000 from a related party. The agreement provides for repayment of principal and interest accrued at 6% per annum at October 28, 2011.  At December 31, 2008, the Company had accrued interest of $53.


On November 3, 2008, the Company obtained an unsecured loan in the amount of $4,000 from a related party. The agreement provides for repayment of principal and interest accrued at 6% per annum at November 3, 2011.  At December 31, 2008, the Company had accrued interest of $32.


On December 1, 2008, the Company obtained an unsecured loan in the amount of $3,500 from a corporate officer. The agreement provides for repayment of principal and interest accrued at 6% per annum at December 1, 2011.  At December 31, 2008, the Company had accrued interest of $17.


NOTE 7 – CONVERTIBLE DEBT AND BENEFICIAL CONVERSION


During 2007, the Company issued convertible notes to unrelated parties for $85,000. According to the terms of the agreement interest began to accrue on the outstanding principal 60 days after the date of the note at rate of 6% annually. Full payment of principal and interest was due June 30, 2007. The notes were convertible into shares of common stock at rate of $0.35 per share prior to payment in full of principal balance of a note. On July 5, 2007 the holders of these notes converted notes payable into 242,859 shares of common stock and the Company incurred additional costs of conversion of $6,235.

 

- 49 -


ANGIOGENEX, INC.

(A DEVELOPMENT STAGE COMPANY)

NOTES TO FINANCIAL STATEMENTS

DECEMBER 31, 2008


In accordance with EITF 00-27, “Application of Issue No. 98-5 to Certain Convertible Instruments”, the Company calculated the value of the warrants and the beneficial conversion feature of the note and recorded the value as a finance cost. The beneficial conversion expense was valued and recorded at $54,429.


NOTE 8 – ACQUISITION OF ECLIC, INC.


On December 30, 2005, the Company cancelled, as part of a plan of merger and recapitalization, approximately 10,000,000 shares of eClic’s outstanding common stock. This cancellation had the effect of reducing the 11,515,000 shares of eClic common stock issued and outstanding immediately prior to the merger to 1,500,000 shares outstanding after the merger. After the aforementioned cancellation of shares the Company cancelled the outstanding shares of AngioGenex, Inc. and issued 11,187,000 new shares of common stock to AngioGenex‘s shareholders of record in compliance with a transaction pursuant to Rule 12g-3 of the Securities and Exchange Commission.  For accounting purposes, the acquisition has been treated as a recapitalization of AngioGenex, with AngiogGenex as the acquirer (reverse acquisition). The 1,500,000 outstanding shares of eClic that were not canceled in the merger were accounted for as the cost of the acquisition. The historical financial statements prior to December 30, 2005 are those of AngioGenex, while the legal structure of eClic, Inc. remains in place.   eCLic, Inc. had no assets or liabilities at the time of the acquisition.


NOTE 9 – CAPITAL STOCK


Common Stock


The Company is authorized to issue 70,000,000 shares of $0.001 par value common stock.


During the year ended December 31, 2008 the Company sold 199,500 shares of common stock for $65,850, net of expenses of $650. Also the Company issued 50,000 shares of common stock in exchange for reduction note payable from a related party of $12,500.


During the year ended December 31, 2007, the Company sold in private placement 169,262 shares of common stock at $0.50 per share for $66,360 in cash, net of expenses of $18,271. The Company also sold 47,000 units for consisting of 2 shares of common stock and 1 warrant to purchase common stock, for $37,190, net of expenses of $12,210. The warrants allow the stockholder to purchase 1 share of common stock for $1.00 per share for the next five years.


The assumptions used to value these warrants were: risk-free rate of 4.5%; no dividends to be paid; expected life of warrants is 5 years; and volatility of 100%. The value ascribed to the warrants attached to the issuances was $16,771.


The Company issued 242,859 shares of common stock in exchange for convertible notes payable of $85,000 (see Note 7).


The Company issued 200,000 shares as a compensation for legal services rendered. The shares exchanged for these services were valued at $0.45 per share and a charge of $90,000 is included with professional fees expense.


Preferred Stock


The Company is authorized to issue 5,000,000 shares of $0.001 par value preferred stock.  The Company has not issued any preferred stock.

 

- 50 -


ANGIOGENEX, INC.

(A DEVELOPMENT STAGE COMPANY)

NOTES TO FINANCIAL STATEMENTS

DECEMBER 31, 2008


NOTE 10 – STOCK OPTIONS AND WARRANTS


During 2001, the board of directors and the stockholders of the Company approved a stock option plan which provides for the granting of options to purchase up to 2,000,000 shares of common stock, pursuant to which officers, directors, advisers and consultants are eligible to receive incentive and/or non-statutory stock options. The options are exercisable for a period of up to 10 years from date of grant at an exercise price which is not less than the fair value on date of grant, except that the exercise period of options granted to a stockholder owning more then 10% of the outstanding capital stock may not exceed 5 years with the exercise option price not less then 110% of the fair value of the common stock at date of grant. The options granted vest between 2 and 5 years. At December 31, 2008, the Company had granted all 2,000,000 options permitted under this plan and of which 300,000 expired in 2008.


On July 13, 2004, the board of directors and the stockholders of the Company approved a stock option plan which provides for the granting of options to purchase up to 5,000,000 shares of common stock, pursuant to which officers, directors, advisers and consultants are eligible to receive incentive and/or non-statutory stock options. The options are exercisable for a period of up to 10 years from date of grant at an exercise price which is not less than the fair value on date of grant, except that the exercise period of options granted to a stockholder owning more then 10% of the outstanding capital stock may not exceed 5 years with the exercise option price not less then 110% of the fair value of the common stock at date of grant. The options granted vest between 2 and 5 years.  At December 31, 2005, the Company has granted 90,000 options under this plan.


During the year ended December 31, 2008, the Company granted 200,000 options to a consultant and 300,000 options to a director. In accordance with FAS No. 123R, in the year ended December 31, 2008, the Company recorded expense of $69,862 for vested portion of share-based compensation relating to the issuance of these stock options.


Stock options activity under the plans is summarized as follows:

 

Number of Stock Options

 

Weighted Average Exercise Price

 

 

 

 

Options at December 31, 2006

2,090,000

 

$0.77

Options issued (2004 Plan)

-

 

-

Options at December 31, 2007

2,090,000

 

$0.77


Options exercisable at December 31, 2007

2,090,000

 

$0.77

 

 

 

 

Weighted average fair value of

    options granted at December 31, 2007

 

 


$0.25


 

Number of Stock Options

 

Weighted Average Exercise Price

 

 

 

 

Options at December 31, 2007

   2,090,000

 

$0.77

Options issued (2004 Plan)

      500,000

 

$0.20

Options expired (2001 Plan)

(300,000)

 

$1.47

Options at December 31, 2008

2,290,000

 

$0.55


Options exercisable at December 31, 2008

2,290,000

 

$0.55

 

 

 

 

Weighted average fair value of

    options granted at December 31, 2008

 

 


$0.25



- 51 -


ANGIOGENEX, INC.

(A DEVELOPMENT STAGE COMPANY)

NOTES TO FINANCIAL STATEMENTS

DECEMBER 31, 2008






As of December 31, 2008 4,410,000 options are available for future grant under 2004 Plan and 300,000 options are available under 2001 Plan.  A summary of the options outstanding and exercisable as of December 31, 2008 is as follows:


 

 

 

Weighted

 

 

Weighted

Average

 

Number of

Average

Remaining

 

Stock

Exercise

Contractual

 

Options

Price

Life in Years

 

 

 

 

Options outstanding

2,290,000

$

0.55

5.2

Options exercisable

2,290,000

$

0.55

5.2


The weighted average grant-date fair value of stock options granted during the year ended December 31, 2008 was $0.14.  


Following is a summary of the status of the Company's nonvested stock options as of December 31, 2008 and the changes during the year ended December 31, 2008:


 

 

Weighted

 

Number of

Average

 

Stock

Grant-Date

Nonvested Stock Options

Options

Fair Value

 

 

 

Nonvested at January 1, 2008

0

$

0.00

Granted

500,000

$

0.14

Vested

   (500,000)

$

0.14

Forfeited

0       

$

0.00

 

 

 

Nonvested at December 31, 2008

0

$

0.00


The fair value of each option granted was estimated on the date of grant using the Black-Scholes option-pricing model with the following weighted average assumptions:


 

2008

 

 

Expected life (years)

5 years

Risk-free interest rate

2.98%

Expected dividend yield

0%

Expected volatility

88%


At December 31, 2008 the Company had 6,799,876 warrants outstanding

 

- 52 -


ANGIOGENEX, INC.

(A DEVELOPMENT STAGE COMPANY)

NOTES TO FINANCIAL STATEMENTS

DECEMBER 31, 2008


Warrants activity is summarized as follows:

 

Number of Warrants

 

Weighted Average Exercise Price

 

 

 

 

Warrants at December 31, 2006

6,752,876

 

$0.26

Warrants granted

47,000

 

$1.00

Warrants at December 31, 2007

6,799,876

 

$0.18


Warrants exercisable at December 31, 2007

6,799,876

 

$0.18

 

 

 

 


 

Number of Stock Options

 

Weighted Average Exercise Price

 

 

 

 

Warrants at December 31, 2007

   6,799,876

 

$0.18

Warrants granted

-

 

-

Warrants at December 31, 2008

6,799,876

 

$0.18


Warrants exercisable at December 31, 2008

6,799,876

 

$0.18

 

 

 

 


NOTE 11 — COMMITMENTS AND CONTINGENCIES


On August 1, 2001, the Company entered into an agreement with William Garland, PhD. In exchange for his services as the Company’s vice president and chief operating officer, he will receive a salary of $5,000 per month.  Additionally, he was to receive options to purchase 5,000 shares of the Company’s common stock exercisable at $3.00 each per month.  The Company granted to Mr. Garland 30,000 options on August 1, 2001 under this agreement.  Subsequently, the Company and Mr. Garland amended this agreement eliminating the monthly options but the Company has continued to pay $5,000 plus expense reimbursements and has also granted to Mr. Garland 440,000 options under the 2001 stock option plan. The agreement was terminated September 30, 2006. However Mr. Garland is still providing services to the Company.


In July 2006, Comparative Biosciences Inc. (“CompBio”) , a company that AngioGenex hired to breed and house a colony of its proprietary “ID-Knockout” mice, sued the Company claiming approximately $200,000 in unpaid invoices. AngioGenex’s response included counter-claims for CompBio’s breaches of contract, as well as a number of business torts. On November 6, 2007 the parties agreed to a disposition of the suit under a stipulated judgment and settlement agreement pursuant to which: CompBio must return the laboratory mice and all scientific data from the research, CompBio agrees to forego all intellectual property rights in the mice and in the research, that it acknowledges belong to AngioGenex, and AngioGenex agreed to pay the CompBio $55,000 in installments over a 5-year period, plus accumulated interest at 5% per annum. The stipulated judgment and settlement agreement was filed with the court by November 15. At December 31, 2008 the Company has made $17,500 payments to CompBio pursuant to the settlement agreement, and had accrued interest of $2,406. The Company has not made the required payment for the fourth quarter of 2008, and is in default of this settlement agreement. Under the terms of the agreement upon receipt of written notification of default from CompBio the Company has five days to cure. Failure by the Company to cure the default results in an increase in the settlement amount to $75,000 plus retroactive interest of 5% on the balance. The Company has not received any notification of default from CompBio.

 

- 53 -


 

ITEM 9.  CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.


None.


ITEM 9A.  CONTROLS AND PROCEDURES


Evaluation of Disclosure Controls and Procedures .


Our management, including our principal executive officer and our principal financial officer, has evaluated the effectiveness of our “disclosure controls and procedures” (as such term is defined in Rules 13a-15(e) and 15d-15(e) of the United States Securities Exchange Act of 1934, as amended), as of December 31, 2008. As described below in the Management’s Report on Internal Control over Financial Reporting, management has reported material weaknesses in the internal control over financial reporting as of December 31, 2008. Based on that evaluation, our principal executive officer and our principal financial officer have concluded that our disclosure controls and procedures were not effective as of December 31, 2008 due to the reported material weakness.


Management’s Report on Internal Control over Financial Reporting


Management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rule 13a-15(f) or 15d-15(f) promulgated under the Securities Exchange Act of 1934, as amended, as a process designed by, or under the supervision of, a company’s principal executive and principal financial officers and effected by a company’s board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:


  

·

Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the company;

  

·

Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and

  

·

Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the financial statements.


All internal control systems, no matter how well designed, have inherent limitations and can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our company have been detected. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.   

  

   Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, assessed the effectiveness of our internal control over financial reporting as of December 31, 2008. In making this assessment, our management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control — Integrated Framework .


A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.

 

- 54 -


 

We identified a material weakness in our internal control over financial reporting as of December 31, 2008 because fundamental elements of an effective control environment were not present as of December 31, 2008, including a code of conduct or ethics, independent oversight and review of financial reporting, the financial reporting processes and procedures and internal control procedures by the Board of Directors, as we have not established an audit committee and our full board has not been adequately performing those functions. Other deficiencies, such as communication breakdowns between the individuals executing transactions and the individuals accounting for those transactions led to the identification by the auditors of certain required material adjustments to the financial statements. In addition, management has not established with appropriate rigor the procedures for reconciliation between transfer agent and Company records of shares issued and outstanding, including the actions required upon identification of inconsistencies or reconciling items between those two sets of records. Additionally, due to insufficient staffing and the lack of full time personnel, it was not possible to ensure appropriate segregation of duties between incompatible functions, and formalized monitoring procedures have not been established or implemented.

  

These deficiencies represent a material weakness in our internal control over financial reporting given that it results in a reasonable possibility that a material misstatement to the annual or interim financial statements would not have been prevented or detected. Based on this assessment and the material weakness described above, management has concluded that internal control over financial reporting was not effective as of December 31, 2008.

  

This annual report does not include an attestation report of the company’s registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the company’s registered public accounting firm pursuant to temporary rules of the Securities and Exchange Commission that permit the company to provide only management’s report in this annual report.

  

We intend to take the following steps as soon as practicable to remediate the material weakness we identified as follows:


  

·

We will segregate incompatible functions using existing personnel where possible or, given sufficient capital resources, we will hire additional personnel to perform those functions.

  

·

We will increase the oversight and review procedures of the board of directors with regard to financial reporting, financial reporting processes and procedures and internal control procedures.

  

·

To the extent we can attract outside directors, we will nominate an audit committee to review and assist the board with its oversight responsibilities.

  

·

We will adopt a code of conduct and ethics

  

·

We will remedy the deficiencies in communication between those executing transactions and those who are responsible for accounting for such transactions by adopting written procedures and implementing a monitoring mechanism to ensure that transactions are recorded appropriately

  

·

We will remedy the deficiencies in reconciliation and disposition of reconciling items related to shares issued and outstanding.


Changes in Internal Control Over Financial Reporting   


There has been no change in our internal control over financial reporting that occurred during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

- 55 -


PART III


ITEM 10.  DIRECTORS, EXECUTIVE OFFICERS , PROMOTERS AND CONTROL PERSONS; COMPLIANCE WITH SECTION 16(a) OF THE EXCHANGE ACT   


 The following table sets forth certain information with respect to each of our directors and executive officers as of March 24, 2009.

  

  

Name

  

  

Age

  

  

Principal Occupation

  

Served as

Director Since

Richard Salvador

  

80

  

President, Director

  

1999

William Garland

  

62

  

Chief Executive Officer, Chief Operating Officer, Director

  

2007

Martin Murray

  

42

  

Chief Financial Officer, Treasurer, Secretary, Director

  

1999

Michael Strage

  

49

  

Vice President Business Development, Director

  

1999


William A. Garland, Ph.D.,   Chief Executive Officer and Chief Operating Officer. Dr. Garland, joined AngioGenex as Chief Operating Officer in July 2001 and has served as our Chief Executive Officer since June 2008. From 1994 to 2000, Dr. Garland was Executive Vice President Pharmaceutical Development with Centaur Pharmaceuticals Incorporated, a Silicon Valley development stage biopharmaceutical company. At Centaur, he was responsible for all aspects of pre-clinical drug testing, the design and execution of clinical studies, quality assurance, quality control, pilot manufacturing, interactions with the FDA and international drug regulatory authorities along with presentation of Centaur’s development efforts to potential corporate partners and investors. While at Centaur he progressed three projects from discovery stage to Phase II clinical testing, and helped manage the growth of Centaur from fewer than a dozen employees to more than 100 employees in a six-year period. At Centaur, Dr. Garland also co-invented a compound, CPI-1189, that demonstrated efficacy in two Phase II clinical trials, and was a key participant in the successful negotiation of an $80 million corporate alliance with Arcus, Astra AB’s neuroscience company, and the successful negotiation of a $30 million corporate alliance with Lundbeck A/S. CPI-1189 is currently in Phase III clinical development as REN-1654 (Renovis Inc.). Dr. Garland was with Hoffmann-La Roche, Inc. from 1974-1994, most recently as Senior Director and U.S. Head of International Project Management. During his 20-year tenure at Roche, he managed groups consisting of as many as 100 scientific and administrative personnel. Immediately prior to joining AngioGenex, he was Vice President Scientific Affairs of Atairgin Technologies, Inc. an emerging healthcare technology company, where he was responsible for all aspects of R&D, quality and clinical effort associated with the Company’s oncology-related diagnostic and therapeutic efforts. Dr. Garland received a BS in chemistry from the University of San Francisco and a Ph.D. in medicinal chemistry from the University of Washington. He has authored or co-authored over 100 scientific publications .


Michael M. Strage, Vice President Business Development . Mr. Strage has been our VP of Business Development since 1999. Mr. Strage was a co-founder of Axonyx Inc., a publicly traded biotechnology company (NASDAQ:TPTX) engaged in the development of drugs to treat Alzheimer's disease. As a founding Officer and Director he was responsible for all business and administrative aspects of Axonyx from its inception in 1996 to its listing on the NASDAQ-NMS in January 2001. As Vice President and Chief Administrative Officer of Axonyx, Mr. Strage was responsible for negotiating all of the company's major corporate transactions including the agreements under which Axonyx first acquired its intellectual property portfolio that includes the commercial rights to the pre-clinical research and development programs at New York University School of Medicine and the National Institute on Aging, and subsequently out-licensed some of those rights through pharmaceutical joint development agreements, including a major world-wide licensing agreement with Serono International S.A. (NYSE:SRA) In addition, Mr. Strage directed all aspects of the administrative operations of Axonyx including finance, where he participated actively in each of the multiple phases of the company's capital formation, budgeting, human resources, infrastructure, corporate communications and investor relations. As Chairman and founder of AngioGenex, Mr. Strage recruited and assembled the AngioGenex management team and its Scientific Advisory Board. On the company's behalf, he acquired the exclusive rights to Dr. Benezra's anti-

 

- 56 -



cancer work by negotiating the Company's Industrial Research and Commercial licenses with MSKCC. Mr. Strage was responsible for raising the seed capital used to create the company and that funded the collaboration with Memorial Sloan Kettering Cancer Center. Prior to joining Axonyx in 1996, Mr. Strage was an associate at the Los Angeles law firm of Hancock, Rothert & Bunschoft and prior thereto an assistant district attorney at the Manhattan District Attorney's office.


Richard A. Salvador, Ph.D., President, and Cairman of the Board. Dr. Salvador was our Chief Executive Officer, President and has been a director of our company since 1999 until June 2008 when Dr. Salvador resigned as our Chief Executive Officer. At that time he became Chairman of the Board and continues to serve as acting President of the company. Dr. Salvador was with Hoffmann-La Roche, Inc. from 1970 to 1997, most recently as Vice-President and Director of International Pre-clinical Development and Deputy to the President, International Research and Development. The three major departments reporting to him worldwide were Toxicology and Pathology, Drug Metabolism, and Pharmaceutical Research and Development. In the U.S., Dr. Salvador was responsible for approximately 350 personnel and an annual budget in excess of $60 million. Dr. Salvador was also a member of key international Hoffman-La Roche (ROG.VX) R&D committees. Dr. Salvador is on the Board of Directors of Suntory Pharmaceutical Research Laboratories, Cambridge, MA, and was a Senior Scientific Advisor to Axonyx Inc. which recently merged with TorreyPines Therapeuitcs (NASDAQ: TPTX), New York, NY. He has served as a consultant to the biotechnology industry in recent years. Dr. Salvador has a Ph.D. in Pharmacology from George Washington University, Washington, DC.


Martin F. Murray, CPA, MBA, Secretary, Chief Financial Officer, Treasurer, Director . Mr. Murray has been our Secretary, Treasurer, CFO and Director since 1999. Mr. Murray is a founder and managing partner of Murray and Josephson, CPAs, LLC. He previously held the position of managing partner at the accounting firm of Leeds & Murray, and audit manager with Eisner, LLP. His experience includes providing accounting, auditing, tax, and consulting services for publicly-traded and privately-owned companies, including: professional organizations, biotechnology companies, creative artists, and manufacturing firms. Mr. Murray has appeared on television news as a guest expert and has led a series of Continuing Professional Education seminars. He is a member of the tax section of the American Institute of Certified Public Accountants, and the New York State Society of Certified Public Accountants where he served on the health care committee. He earned his MBA in taxation from Baruch College where he also earned his BBA in Accountancy.


There are no family relationships among any of our directors or officers.


Section 16(a) Beneficial Ownership Reporting Compliance


The members of the Board of Directors, our executive officers and persons who hold more than 10% of our outstanding common stock are subject to the reporting requirements of Section 16(a) of the Securities Exchange Act of 1934, as amended, which require them to file reports with respect to their ownership of our common stock and their transactions in such common stock. Based solely upon the review of the Forms 3, 4 and 5 furnished to our company and certain representations made to our company, we believe that during 2006, the following members of the Board of Directors, our executive officers and person(s) who hold more than 10% of our outstanding common stock failed to timely file all reports required to be filed pursuant to Section 16(a) of the Securities Exchange Act of 1934 with respect to transactions in equity securities of our company.  We believe that in 2008 none of the members of the Board of Directors, our executive officers and person(s) who hold more than 10% of our outstanding common stock failed to timely file all reports required to be filed pursuant to Section 16(a) of the Securities Exchange Act of 1934 with respect to transactions in equity securities of our company


Code of Ethics


We adopted a code of ethics that applies to our President and CEO (principal executive officer), and our Chief Financial Officer (principal accounting officer).

 

- 57 -


Audit Committee and Audit Committee Financial Expert

  

We are not a “listed company” under SEC rules and are therefore not required to have an audit committee comprised of independent directors. As we are a development stage company with minimal revenues from operations, few employees, and relatively simple financial statements, we have not, at this stage, constituted any board committees, including an audit committee. Consequently we do not have an audit committee financial expert who is an outside director. As our business grows and our financial statements become more complicated, we intend to seek an outside director who can qualify as an audit committee financial expert.


ITEM 11.  EXECUTIVE COMPENSATION


The following table sets forth compensation information for services rendered to us by the two individuals who served as our chief executive officer in 2008 (collectively, our company’s “Named Executive Officers”) in all capacities, other than as directors, during each of the prior two fiscal years. Other than as set forth below, no executive officer’s salary and bonus exceeded $100,000 for the fiscal year 2008. The following information includes the dollar value of base salaries, bonus awards, the number of stock options granted and certain other compensation, if any, whether paid or deferred. Shares issued in lieu of compensation are listed in the year the salary was due.


SUMMARY COMPENSATION TABLE


Name and

Principal

Position

(a)

  

Year

(b)

  

Salary

($)

(c)

  

Bonus

($)

(d)

  

Stock

Awards

($)

(e)

  

Option Awards

($)

(f)

  

Non-Equity Incentive Plan Compensation ($)

(g)

  

Non-Qualified Deferred Compen-sation Earnings ($)

(h)

  

All other Compen-sation

($)

(i)

  

  

  

Total

($)

(j)

  

William Garland

CEO, COO, Dir.

  

  

2008

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

  

  

  

2007

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

Richard Salvador

Pres. & former CEO, Dir. Chairman of the Board of Directors

  

  

2008

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

  

  

  

2007

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  


A. Narrative Disclosure to Summary Compensation Table


The current CEO, William Garland and the former CEO Richard Salvador have not entered into a formal written employment agreements with AngioGenex. They are employed on an at will basis with equity compensation at the discretion of the uninterested members of the board of directors.

 

- 58 -


 

B. Outstanding Equity Awards at Fiscal Year End

  

  

  

  

Option Awards

  

  

Stock Awards

  

  Name

  

  

Number of

Securities

Underlying

Unexercised

Options

(#)

Exercisable  

  

  

  

Number of

Securities

Underlying

Unexercised

Options

(#)

Unexercisable

  

  

Equity

Incentive

Plan

Awards

Number of

Securities

Underlying

Unexer cised

Unearned

Options

(#)   

  

  

Option

Exercise

Price

($)   

  

  

Option

Expiration

Date   

  

  

Number

of Shares

or Units of

Stock

That

Have Not

Vested

(#)   

  

  

Market

Value of

Shares or

Units

That

Have Not

Vested

($)   

  

  

Equity

Incentive

Plan

Awards:

Number of

Unearned

Shares,

Units or

Other

Rights That

Have Not

Vested

(#)   

  

  

Equity

Incentive

Plan

Awards:

Market or

Payout

Value of

Unearned

Shares

Units or

Other

Rights

That Have

Not Vested

($)

  

  (a)

  

  

(b)

  

  

(c)   

  

  

(d)   

  

  

(e)   

  

  

(f)   

  

  

(g)   

  

  

(h)   

  

  

(i)

  

  

(j)

  

Garland

  

  

30,000

  

  

-

  

  

-

  

$

3.00

  

  

7/31/2011

  

  

-

  

  

-

  

  

-

  

$

-

  

  

  

  

200,000

  

  

-

  

  

-

  

$

1.00

  

  

12/31/2011

  

  

-

  

  

-

  

  

-

  

$

-

  

  

  

  

240,000

  

  

-

  

  

-

  

$

0.01

  

  

7/30/2015

  

  

-

  

  

-

  

  

-

  

$

-

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Salvador

  

  

90,000

  

  

-

  

  

-

  

$

1.50

  

  

5/31/2010

  

  

-

  

  

-

  

  

-

  

$

-

  

  

  

  

200,000

  

  

-

  

  

-

  

$

1.00

  

  

1/1/2012

  

  

-

  

  

-

  

  

-

  

$

-

  

  

  

  

120,000

  

  

-

  

  

-

  

$

0.01

  

  

7/31/2015

  

  

-

  

  

-

  

  

-

  

$

-

  

  

There were no option grants to our Named Executive Officers in 2008.


D. Compensation of Directors


We did not pay our directors fees in 2008 and have not paid such fees in the past for attending scheduled and special meetings of our board of directors. In the future, we may adopt a policy of paying independent director a fee for their attendance at board meetings. We do reimburse each director for reasonable travel expenses related to such   director's attendance at board of directors meetings.

  

Name

  

Fees Earned   or Paid in   Cash

($)

  


Stock Awards  

($)

  

Option  Awards   ($)

  

  Non-Equity   

incentive  

Plan Com pensation  

($)

 

Change in   

Pension   

Value and   

Nonqualified   

Deferred   

Compensation 

Earnings

($)

  


All other   Compensa tion   

($)

  

Total

($)

  

(a)

  

(b)

  

(c)

  

(d)

  

(e)

  

(f)

  

(g)

  

(h)

  

Murray

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

Strage

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

  

0

  

  

Employment Contracts with Executive Officers and Termination of Employment and Change-in-Control Arrangements


AngioGenex does not have employment contracts with its Named Executive Officers.

 

- 59 -


ITEM 12.  SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT


The following table sets forth certain information known by us with respect to the beneficial ownership of our common stock as of March 24, 2009 by (i) each person who is known by us to own beneficially more than 5% of common stock, (ii) each of our Chief Executive Officers and our Chief Financial Officer, (iii) each of our directors and (iv) all of our current executive officers and directors as a group. Except as otherwise listed below, the address of each person is c/o AngioGenex, Inc. 425 Madison Avenue, Suite 902, New York NY 10017.


The percentage of shares beneficially owned is based on 21,302,906 shares of common stock outstanding as of March 24, 2009. Shares of common stock subject to stock options and warrants that are currently exercisable or exercisable within 60 days of March 24, 2009 are deemed to be outstanding for the purpose of computing the percentage ownership of that person but are not treated as outstanding for the purpose of computing the percentage ownership of any other person. Unless indicated below, the persons and entities named in the table have sole voting and sole investment power with respect to all shares beneficially owned, subject to community property laws where applicable.


Information with respect to beneficial ownership has been furnished by each director, officer or beneficial owner of 5% or more of our voting Common Stock. Except as noted the persons named in the table have sole voting and investment power with respect to all shares of common stock shown as beneficially owned by them. The number of shares of common stock used to calculate the percentage ownership of each listed person includes the shares of common stock underlying options or warrants. Percentage ownership information is based on 21,302,906 shares of Common Stock outstanding as of March 24, 2009. Percentage information for each person assumes that no other individual will exercise any warrants and/or options. Unless otherwise noted, we believe that all persons named in the table have sole voting and investment power with respect to all the shares beneficially owned by them.

  


Name and, as Appropriate, Address of Beneficial Owner (1)

  

Amount and Nature of

Beneficial Owner

  


Percent of

Common Stock

  

Michael Strage (2)

  

  

3,075,639

  

  

14.24

%

Richard Salvador(3)

  

  

2,288,364

  

  

10.28

%

William Garland (4)

  

  

1,265,000

  

  

5.81

%

Martin Murray (5)

  

  

189,000

  

  

*

  

All directors and executive officers (four persons) as a group

  

  

  

  

  

30.33

%

Atypical BioVentures Fund LLC (6)

c/o Aurora Capital LLC

200 Park Avenue South, Suite 1301

New York, NY 10003

  

  

3,652,505

  

  

14.64

%

* Less than 1%.

 

 

 

 

 

 

 


(1)

Unless otherwise indicated, the address of each of the listed beneficial owners identified above is c/o 425 Madison Avenue, Suite 902, New York, New York 10017 .

(2)

Michael Strage, Chairman, Vice President. Includes 2,773,014 shares held by Mr. Strage, , 120,000 options exercisable at $0.01 per share, and warrants to purchase 182,625 shares exercisable at $0.15 per share.

(3)

Richard Salvador, President, Chairman. Includes 1,290,488 shares held by Mr. Salvador, 32,000 shares held by his wife, a warrant to purchase 8,000 shares at $6.00 per share held by Dick Salvador’s wife, 90,000 options exercisable at $1.50 per share, 200,000 options exercisable at $1.00 per share and 120,000 options exercisable at $0.01 per share and 547,876 warrants exercisable at $0.15 per share.

 

- 60 -


 

(4)

William Garland, Chief Executive Officer, Chief Operating Officer, director. Includes 795,000 shares held by Mr. Garland, 30,000 options exercisable at $3.00 per share, 200,000 options exercisable at $1.00 per share, 240,000 exercisable at $0.01 per share.

(5)

Martin Murray, Chief Financial Officer, Secretary, Treasurer, director. Includes 129,000 shares held by Mr. Murray, 45,000 options exercisable at $1.50 per share, 5,000 options exercisable at $1.00 per share, and 10,000 options exercisable at $0.01 per share.

(6)

Atypical BioVentures Fund LLC. Includes 3,652,505 warrants exercisable at $0.15 per share.


Equity Compensation Plan Information


The following table sets forth information about the common stock available for issuance under compensatory plans and arrangements as of December 31, 2008.


  

  

(a)

  

(b)

  

(c)

  

Plan Category

  

Number of securities to be issued upon exercise of outstanding options, warrants and rights.

  

Weighted-average exercise price of outstanding options, warrants, and rights

  

Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))

  

Equity compensation plan approved by security holders (1)

  

  

1,700,000

  

$

0.65

  

  

300,000

  

Equity compensation plan approved by security holders (2)

  

  

590,000

  

$

0.17

  

  

4,410,000

  

Total

  

  

2,290,000

  

$

0.55

  

  

4,710,000

  


(1)

The AngioGenex 2000 Stock Option Plan had 2,000,000 shares of common stock reserved for issuance under the Plan under which the board of directors may grant incentive or non-statutory stock options to officers, directors, employees, consultants and advisors of AngioGenex.

 (2)

The AngioGenex 2004 Stock Option Plan has 5,000,000 shares of common stock reserved for issuance under the Plan under which the board of directors may grant incentive or non-statutory stock options to officers, directors, employees, consultants and advisors of AngioGenex.

 

- 61 -


ITEM 13.  CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDPENDENCE


Accounting Services


Since its inception, AngioGenex has employed Murray Josephson, CPAs, LLC to provide outside bookkeeping, accounting and tax filing services, but not audit services. Martin Murray, our Chief Financial Officer, Secretary and Treasurer, as well as a member of the board of directors, is a principal of Murray Josephson, CPAs, LLC. We owed Martin Murray approximately $101,000 for accounting services as of December 31, 2008.


Director Independence


Our Board of Directors has determined that none of its members are currently “independent directors” as that term is defined in Rule 4200(a)(15) of the Marketplace Rules of the National Association of Securities Dealers as all members of the board of directors are also officers of the company.


ITEM 14.  PRINCIPAL ACCOUNTANT FEES AND SERVICES


Fees Billed to AngioGenex by Williams & Webster, P.S. during Fiscal Year 2008.


Audit Fees. Aggregate fees billed for professional services rendered by Williams & Webster in connection with its audit of AngioGenex’ financial statements as of and for the years ended December 31, 2008, and 2007, its reviews of AngioGenex’ unaudited condensed consolidated interim financial statements, and for SEC consultations and filings were $39,480 and $33,467, respectively.


Tax Fees - We did not pay Williams & Webster, P.S. for professional services for tax compliance, tax advice and tax planning in 2007 or 2008.


All Other Fees - We did not incur any other fees and expenses from Williams & Webster, P.S. for the fiscal years 2007 and 2008 annual audits.


Audit Committee Pre-Approval.


The Company does not have a standing audit committee. Therefore, all services provided to the Company by Williams & Webster, P.S. were pre-approved by the Company’s board of directors. Williams & Webster, P.S. performed all work only with their permanent full time employees.

 

- 62 -


PART IV


ITEM 15.  EXHIBITS AND FINANCIAL STATEMENT SCHEDULES


Exhibits

Description of Document

 

2.1

Acquisition Agreement and Plan of Reorganization between AngioGenex, Inc. and eClic, Inc. dated December 1, 2005 (Incorporated by reference to the corresponding exhibit to the Form 8-K previously filed by AngioGenex on December 30, 2005 (File No. 000-26181))

  

3.1

Amended Articles of Incorporation dated December 30, 2005 (Incorporated by reference to exhibit 3.4 to the Form 8-K previously filed by AngioGenex on December 30, 2005 (File No. 000-26181))

  

10.2

Exclusive License Agreement between AngioGenex, Inc. and Sloan Kettering Institutes for Cancer Research, dated April 3, 2000. (Incorporated by reference to the corresponding exhibit to the Form 8-K/A previously filed by AngioGenex on January 9, 2006 (File No. 000-26181))

  

31.1

Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer

  

31.2

Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer

  

32.1

Section 1350 Certifications

 

- 63 -


 

SIGNATURES


In accordance with 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.


 Dated: April 10, 2009

AngioGenex, Inc.

  
  

  
  

  
  

 

By:  

/s/ Richard Salvador     

  

Richard Salvador

President and Chief Executive Officer


  

  

  

 

 

/s/ Martin Murray   

  

Martin Murray

Chief Financial Officer

Principal Financial and Accounting Officer




POWER OF ATTORNEY


KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints each of Richard Salvador and Martin Murray as his true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him and in his name, place and stead, in any and all capacities, to sign any and all amendments (including post-effective amendments) to this Report on Form 10-K, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of them, or their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.


In accordance with the Exchange Act, this report has been signed below by the following directors on behalf of the registrant.


/s/ Richard Salvador

  

April 10, 2009

  

/s/ Michael M. Strage*

  

April 10, 2009

Richard Salvador

  

Date

  

Michael M. Strage

  

Date

  

  

  

  

  

  

  

/s/ Martin Murray

  

April 10, 2009

  

/s/ William Garland*

  

April 10, 2009

Martin Murray

  

Date

  

William Garland

  

Date

  

*By: 

/s/ Martin Murray

  

April 10, 2009

  

Martin Murray

As Attorney-in-Fact

  

 


 

- 64 -