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ENDOVASC INC - 10KSB - 20041013 - PART_I
PART I
Item 1. BUSINESS.
HISTORY
We incorporated as a biopharmaceutical company under the laws of the State
of Nevada on June 10, 1996, under the name Endovasc, Inc. Upon our initial
incorporation, we were authorized to issue an aggregate of 25,000 shares of
capital stock with a par value of $0.001 per share. On September 5, 1996, we
amended our articles of incorporation to increase our authorized shares to
100,000,000 shares of common stock, par value $0.001 per share. On May 28,
1997, we amended our articles of incorporation to change our name to Endovasc
Ltd., Inc. On June 2, 1997, we amended our articles of incorporation to
authorize a total of 120,000,000 shares of capital stock, par value $0.001 per
share, of which 100,000,000 shares are common shares and 20,000,000 shares are
preferred shares.
On April 30, 2002 our Board of Directors authorized its former Chairman,
David P. Summers, to pursue a plan of reorganization that would allow us to meet
its obligations to our creditors and the Series A Convertible Preferred
Shareholders. This plan involved the issuance of up to 3,000,000 shares of
Series B Convertible Stock and a reverse domicile merger from Nevada to
Delaware. On or about May 6, 2002 an information statement was filed with the
SEC and simultaneously sent to our shareholders. On July 5, 2002 a meeting of
shareholders representing 52.6% of the total outstanding voting authority
approved the resolution to adopt the plan of reorganization. It was made
effective July 9, 2002. This reorganization resulted in an increase in the
authorized capital stock to 220,000,000 shares.
Effective April 1, 2003, our Board of Directors and holders of shares
representing a majority of the voting rights of the outstanding shares of our
common stock and preferred stock approved a reincorporation of the Company from
the State of Delaware to the State of Nevada. This reincorporation was
accomplished by a merger of the Company into a new Nevada corporation under the
name Endovasc, Inc.
On December 16, 2003, a special meeting of the Board of Directors of
Endovasc, Inc, was called by the former Chairman David P. Summers. At this
meeting Dr. Diane Dottavio, Ph.D. was nominated and elected to serve as
President and Chief Executive Officer of the Company for the coming year, as
reported on the December 31, 2003 8-K.
We have not been subject to bankruptcy, receivership or any similar
proceeding.
We develop, market and license biopharmaceutical products, particularly
liposomal drug delivery methods, for the human healthcare industry. We develop
liposomes, which are microscopic cell-like spheres composed of a thin, durable
lipid membrane surrounding a hollow compartment. Liposomes entrap and protect
drugs from degradation in the blood stream and can be engineered to regulate the
transport of molecules across their outer membrane. Using this technology, we
are developing products that deliver drugs to their intended target and release
them with efficiency and control.
Currently, our product development is focused on three product lines--
Liprostin(TM), Angiogenix(TM) and Nutraceuticals. Although we hold patents and
patents pending for products in the process of clinical testing, our products
have not been approved for general sales. Consequently, we have not generated
any revenues from the sale of these products and have historically operated with
significant losses. Although our current development efforts focus on vascular
(heart and lung) applications of our products, we intend to develop our
technologies for use in many medical treatment applications. We believe that
our unique and highly adaptable technologies will put our products at the
forefront of the multi-billion dollar drug market.
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LIPROSTIN(TM) TECHNOLOGY
Our Liprostin(TM) products provide targeted delivery of Prostaglandin E-1
to blood vessels in connection with angioplasty procedures. Angioplasty is a
common medical procedure that utilizes a small balloon-like structure to expand
and clear blocked cardio-pulmonary blood vessels. Prostaglandin E1, a naturally
occurring hormone, is used to prevent common secondary blockages from occurring
after angioplasty treatment; these blockages are known as restenosis. Restenosis
following balloon angioplasty or stent placement is the most common problem
occurring in the over 1,000,000 patients undergoing angioplasty procedures
annually worldwide, according to the American Heart Association. According to
the American Heart Association, the incidence of restenosis can be as high as
40-50%, within six months of the procedure (slightly less with stents) and only
a few drugs tested have been preliminarily proven to reduce restenosis
significantly in clinical trials. Similarly, Prostaglandin E1's short lifespan
in the blood stream can render it ineffective in preventing restenosis.
Liprostin(TM) delivery system utilizes liposomal encapsulation of Prostaglandin
E1 to provide a longer and more controlled release of Prostaglandin E1 and to
improve therapeutic effectiveness of the drug. Liprostin(TM), as an adjunct
therapy for the treatment of critical limb ischemic (CLI) complications is
administered as an intra-arterial bolus prior to, and immediately after PTA and
followed by intravenous infusion with indications of early success. We intend to
develop our Liprostin(TM) product lines further to treat conditions such as
restenosis, myocardial infarction, veno-occlusive disease, diabetic ischemic
ulcers, CLI (limb salvage), claudicants, liver disease, arthritis, and as a
topical solution for wound healing.
We have successfully completed Phase II clinical trials of Liprostin(TM),
and are preparing for Phase III clinical trials for Critical Limb Ischemia (CLI)
in a large patient base including clinical sites in the U.S., Europe and Mexico.
We have protected our proprietary rights to Liprostin(TM) technology
through US Patent 4,820,732, US Patent 4,955,878 and Notice of Allowance to US
Patent 5,980,551 received on November 9, 1999, and Trademark Application Ser.
No. 75/632,736 (Liprostin) and various patents pending.
STENT COATING TECHNOLOGY
We are developing Prostaglandin E-1 and Nicotine coated stents for varied
vascular applications. As described above, balloon catheters are utilized to
physically expand and clear blocked blood vessels in vascular surgical
procedures. Conversely, stents are small scaffolds used during and after
vascular surgery to support vessels and deliver agents that promote healing.
This technology accomplishes the opening and maintenance of a blood vessel by
mechanical means (stent) while providing medicinal drug treatment from the
gradual release of Prostaglandin E1, NRA or other drugs from the slowly
degrading, biocompatible substrate of the intravascular stent.
We have protected our proprietary rights to our stent coating technology
through patents and patents pending.
ANGIOGENIX(TM)
Our Angiogenix(TM) technology promotes new growth of blood vessels (known
as angiogenesis and vasculogenesis), and has applications in the treatment of
heart disease, stroke, limb circulatory disease, and wound healing. Researches
at Stanford University discovered the technology during a 1999 study funded by
the Tobacco-Related Diseases Research Program of the University of California,
the American Heart Association, the National Institutes of Health and the
Deutsche Froschungsgemeinschkaft. While studying the damaging effects of tobacco
smoke, researchers discovered that smokers appeared less susceptible to deaths
due to infarction as compared to non-smokers. This counterintuitive discovery
suggested that low-dose (non-smoked) nicotine had extraordinary angiogenic
growth factor potential. To develop technology based on this unique discovery,
we obtained a worldwide exclusive right to the patent application for Nicotine
Receptor Agonist in February 2000.
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Further study of our Nicotine technology revealed more conclusive results.
Experiments have shown that nicotine promotes angiogenesis and vasculogenesis in
areas of the body that are deprived of proper blood supply. Blockages of the
arteries that feed an organ, often caused by build-up of fatty material,
cholesterol and plaques in arterial walls, may deprive the tissue of proper
blood supply. These blockages reduce the body's ability to supply organs and
surrounding tissue with nutrients, particularly oxygen, which results in a
condition called ischemia. Ischemia reduces cells' ability to function and in
severe cases causes rapid cell death. The body naturally defends against
ischemia by reducing the work required from the affected area and attempting to
grow new blood vessels into the ischemic area. Stanford researchers found
tobacco smokers had significantly more growth of new vessels around such
blockages than non-smokers, apparently due to the therapeutic effects of
nicotine. Upon further analysis, researchers determined that nicotine could
recruit and mobilize the body's own quiescent stem cells that might provide a
method of treating and preventing a range of diseases and ailments involving
angiogenesis. These diseases, such as myocardial and cerebral infarction,
mesenteric or limb ischemia, common wounds, vascular occlusion, and vascular
stenosis, commonly called "hardening of the arteries", affect millions of
persons every year in the United States alone (American Heart Association).
We estimate that the market for treatment of these diseases is over $5
billion. For example, we estimate that a course of treatment for coronary
ischemia utilizing Angiogenix(TM) drugs would cost approximately $10,000 to
$15,000. This type of treatment would be significantly less expensive and
intensive than current alternatives of angioplasty and/or open heart surgery,
providing a "biological bypass." We hope to market a commercially viable
product using this Nicotine Receptor Agonist technology within three years.
NDC SUBSIDIARY
In June of 2003 the Board of Directors approved a nutraceutical subsidiary,
named Nutraceutical Development Corporation (NDC) for the purpose of expanding
our product line into the nutraceutical industry. We have one patented product
which has been transferred to a major nutraceutical manufacturer. The product
is currently under development with a potential release date of December 2004.
JOINT VENTURE AGREEMENTS
Effective August 12, 2003, we entered into a joint venture agreement with
TissueGen, Inc. named Endovasc-TissueGen Research Sponsors, L.L.C. (the
"Partnership"). The purpose of the Partnership is to develop a bioresorbable
drug-eluting cardiovascular stent for the advanced treatment of coronary artery
disease. The Company and TissueGen agreed to co-license certain intellectual
property to the Partnership for an initial 49.9% and 51.1% interest,
respectively, in the Partnership. In addition to its license contribution, we
are required to purchase a convertible promissory note from the Partnership in
the maximum principal amount of $150,000. The convertible promissory note is
convertible at our option into Class B Membership interests in the Partnership.
As of June 30, 2004 we have not purchased the promissory note.
In November 2003, we entered into a joint venture agreement with TissueGen,
Inc. and Dr. Nathan Blumberg named Endovasc-TissueGen-Blumberg Research
Sponsors, L.L.C. (the "Joint Venture"). The purpose of the Joint Venture is to
develop biodegradable stents for ureteral and prostate applications. The Company
and TissueGen agreed to co-license certain intellectual property to the Joint
Venture for an initial 39.9% and 50.1% interest, respectively, in the Joint
Venture. Dr. Blumberg owns the remaining 10% interest. In addition to its
license contribution, we are required to purchase a convertible promissory note
from the Joint Venture in the principal amount of approximately $137,000. The
convertible promissory note is convertible at our option into Class B membership
interests in the Joint Venture. As of June 30, 2004, we have not purchased the
promissory note.
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DISTRIBUTION METHODS
Upon receipt of necessary governmental regulatory consent, we intend to
distribute products utilizing our Liprostin(TM), stent-coating, and Nicotine
Receptor Agonist technologies worldwide. As previously described, we are
developing our products for varied vascular applications.
In addition to peer review, seminars, journals and direct sales, we intend
to market and distribute our products in conjunction with business partners
experienced in marketing and distribution in the biopharmaceutical and medical
industries. If we are unable to reach an agreement with marketing and
distribution partners that is acceptable to us, we may raise the funds necessary
to create our own production, marketing and distribution infrastructure through
a public offering of our securities.
PATENTS AND PROPRIETARY RIGHTS
We believe that adequate protection of our proprietary technology is a
vital aspect of our business operations. Consequently, we pursue patent
protection for our proprietary technology in the United States and in foreign
countries, as deemed necessary to protect development of our operations.
We have patent protection for several products and are pursuing patent and
trademark applications for additional products. In August 1996, Dr. Jackie R.
See transferred and assigned patent rights in the United States, Germany and
Canada for two of our products. The first patent, United States Patent No.
4,820,732, was issued on April 11, 1989, and protects our proprietary technology
regarding a "Method and Composition for Reducing Dysfunction in Angioplasty
Procedures". The second patent, United States Patent No. 4,955,878, was issued
on September 11, 1990, and protects our proprietary technology regarding a "Kit
for Treating Arterial Dysfunction Resulting from Angioplasty Procedures". We
have not maintained the application of this second patent and intend to let its
protections expire to the benefit of the public domain, except as limited by
patent applications described below.
In addition to these assigned patents, we obtained a United States patent
for our proprietary technology regarding a "Composition and Method for Making a
Biodegradable Drug Delivery Stent", on November 9, 1999. Similarly, we have
filed a patent application for this technology under the Patent Cooperation
Treaty, as well as with the European Patent office and European Union. These
applications seek patent protection in France, Germany and the United Kingdom.
We have United States patent applications pending for several other
technologies. In June 1997, we filed a United States patent application for our
proprietary technology regarding a "Method and Apparatus for Treating Vascular
Disease with PGE-1 Bearing Liposomes". In May 1999, we filed a United States
patent application for our proprietary technology regarding "Prosthesis with
Biodegradable Surface Coating and Method for Making Same". The May 1999
application is a "continuation in part" of our patent application regarding
"Composition and Method for Making a Biodegradable Drug Delivery Stent," and, if
granted, will protect this technology's application in various medical products.
In June 1999, we filed a United States patent application for our proprietary
technology regarding "Sterically Stabilized Liposomes with Improvement of Blood
Retention Times and Targeting of Sites of Disease by Prostaglandins in
Particulate Drug Carriers." In May 2000, we filed a United States patent
application for proprietary technology regarding "Resorbable Prosthesis with
Biodegradable Surface Coating and Method for Making Same."
We received trademark protection Liprostin(TM) under Trademark Application
Ser. No. 75/632,736. In May of 1999, the United States Patent and Trademark
Office notified us that our pending Patent US Ser. No. 09/309,949 would be
allowed (Notice of Allowance). We also own rights to several trademarks
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employed in our business, including our logo, the registered domain name of
www.endovasc.com, and other trade and service marks identifying our products and
services.
In February 2000, we obtained exclusive worldwide licensing of patent
rights to develop, manufacture, use and sell products incorporating nicotine and
nicotine agonists for therapeutic angiogenesis. Pursuant to our acquisition of
these patent rights from the Leland Stanford Junior University, we agreed to pay
royalties to the university on sales of any products incorporating the nicotine
agonist technology. Our licensing rights may be terminated in the event that we
default on payment of royalties, in addition to certain other circumstances.
It is important to note that other public and private institutions may have
obtained, or filed applications for, patents that we may need for development of
our products. We cannot know the scope or validity of such patents, the extent
that we may desire to acquire licenses under such patents, or the availability
of such licenses upon terms that are acceptable to us.
GOVERNMENTAL REGULATION
United States and international governmental regulation of the
biopharmaceutical industry is a significant factor in our operations,
particularly our research and development activities. In the United States the
Food and Drug Administration oversees clinical testing, production and marketing
of our products for human therapeutic use through rigorous mandatory procedures
and safety.
The Food & Drug Administration requires satisfaction of several procedures
prior to approving marketing and distribution of pharmaceutical products in the
United States. These include (i) preclinical tests, (ii) submission of an
application for an Investigational New Drug, which must become effective before
commencing human clinical trials, (iii) thoroughly documented and supervised
human clinical trials to determine drug safety and efficacy in its intended
application, (iv) submission and acceptance of an Investigational New Drug
Application, in the case of drugs, or a Product License Application, in the case
of biologics, and (v) approval of the Investigational New Drug Application or
Product License Application prior to commercial sale or shipment of the drug or
biologic. In addition to this process, each domestic drug manufacturing
establishment must be registered or licensed with the Food and Drug
Administration. Domestic manufacturing establishments are also subject to
inspections by the FDA and by other federal, state and local agencies and must
comply with Good Manufacturing Practices as required.
Clinical trials are typically conducted in three sequential phases, which
may overlap. Phase I clinical studies test dosage and tolerance upon initial
introduction of the drug to humans. Phase II clinical studies document
evaluation of drug safety and efficacy. Phase III trials document large scale
evaluation of drug safety and efficacy and may utilize larger patient pools,
depending on the type of marketing approval that is sought.
Clinical testing and the Food and Drug Administration approval process for
a new product often involve significant time and resources. The Food and Drug
Administration may grant an unconditional approval of a drug for a particular
indication or may grant approval pending further post-marketing testing. In
addition, further clinical studies may be required to provide additional safety
data or to gain approval for an alternative product application than was
originally approved.
International biopharmaceutical product sales and distribution are subject
to widely varying regulatory requirements. Generally, the European Union has
coordinated its member states' common standards for clinical testing of new
drugs. Due to difference in regulatory restrictions in the European Union and
other foreign jurisdictions the time required to obtain regulatory approval from
a foreign country's regulatory agencies may be longer or shorter than that
required for Food and Drug Administration approval.
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In addition to these regulations, our operation is subject to regulations
under state and federal law regarding occupational safety, laboratory practices,
the use and handling of radioisotopes, environmental protection and hazardous
substance control as well as other present and possible future local, state,
federal and foreign regulation.
COMPETITION
Competition in the biopharmaceutical industry and the liposome and
lipid-based product area is intense. Factors such as product performance,
patient compliance, physician acceptance, ease of use, safety, pricing,
marketing, distribution and adaptability of administration are crucial to
capturing market position in our industry. Competition may also be based on
other company's development of alternative products and approaches aimed at the
treatment, diagnoses or prevention of the same diseases as our products.
Competition from other companies is based on scientific and technological
factors, the availability of patent protection, the ability to commercialize
technological developments, the ability to obtain government approval for
testing, manufacturing and marketing and the economic factors resulting from the
use of those products. Many companies, both public and private, including
well-known pharmaceutical and chemical companies, many of which have greater
capital resources than we do, are seeking to develop lipid and liposome based
products, as well as stent-coating technologies similar to our own. In addition,
colleges, universities, and public and private research institutions are
similarly seeking to establish proprietary rights to these product technologies.
We face established and well-funded competition from other companies
developing liposome based drug delivery systems. These liposome competitors
include Eli Lilly, The Liposome Company and Schering-Plough. These companies
generally use liposome for the delivery of anti-tumor drugs, while our products
are primarily intended for use in vascular treatments. To our knowledge,
current competition in the vascular treatment area is limited to ReoPro(R) (Eli
Lilly) and Agratroban(R) (Texas Biotech) as a treatment used for angioplasty.
Remodulin (United Therapeutics) and CGT003 (Corgentech) are being tested in
Phase III trials for treatment of Peripheral Vascular Disease.
We also face established and well-funded competition from medical device
manufacturers in the development of stent-coating technologies. These
competitors include major medical device manufacturers such as, Guidant, Inc.,
Cook, Inc., Cordis and Boston Scientific, Inc. To our knowledge current
competition in this technology is limited to the use of drugs used in cancer
therapies, as opposed to our Prostaglandin E1, which is a naturally occurring,
chemically related fatty acid shown to be a potent vasodilator, platelet
inhibitor and anti-thrombotic.
RESEARCH AND DEVELOPMENT
We maintain 1,100 square feet of lab space equipped with customary wet
laboratory equipment at our headquarters in Montgomery, Texas.
Our research and development efforts are focused on our core products -
Liprostin(TM) and Angiogenix(TM). We are conducting clinical trial testing of
Liprostin(TM) and Angiogenix(TM) to obtain the Federal Drug Administration
approval of its sale in the United States. Phase I clinical trials to test
product safety and tolerance levels using a small group of healthy subjects, as
well as providing information about the product's effectiveness and dosage
levels was successfully completed in January 2001. With this success, we
determined to proceed to Phase III clinical trials as suggested by the FDA in
late 1999. An IND and protocol for a Phase III, "Randomized, multi-center study
of Liposomal prostaglandin E1 (Liprostin(TM)) and Angiogenix(TM) in conjunction
with percutaneous transluminal angioplasty in patients with critical limb
ischemia" was filed with the FDA in August 2001.
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Concurrently, we conducted a series of Phase II trials. The IND for
Angiogenix(TM) is pending final animal data for a protocol change that was made
due to the unavailability of a critical piece of equipment supplied by a third
party. Also, we filed an Orphan Drug application with the FDA on July 2001.
Orphan Drug is a designation of the FDA to indicate a therapy developed to treat
a rare disease (one which afflicts a U.S. population of less than 200,000
people). Because there are few financial incentives for drug companies to
develop therapies for diseases that afflict so few people, the U.S. government
offers additional incentives to drug companies that develop these drugs, which
include: 1) eligibility for an FDA grant of up to $300,000 per year for a
maximum of 3 years; 2) a tax credit equal to 50% of the qualified clinical
testing expenses for the taxable year in which the clinical study(s) were
conducted; and most importantly, 3) a 7 year exclusivity to market the drug as
adjunct treatment for the rare disease. Our first orphan drug application for
critical limb ischemia (CLI) was denied based on greater than 200,000 patient
eligibility. However, FDA granted us a second indication for peripheral
occlusive artery disease (POAD) which included severe intermittent claudication
(walking pain, which doubled our potential market). We expect to enter phase III
clinical trials in 2005.
In addition, we are conducting feasibility studies with prospective
strategic partners to find practical collaborative products that incorporate
Liprostin(TM) and Angiogenix(TM) with other technologies. We intend to develop
new uses for our core product Liprostin(TM), including applications in hip or
bone prostheses, cancer treatment, inflammatory disease, liver disease, and
wound healing.
We have successfully completed preclinical trials in rabbits for Nicotine
receptor agonist at Stanford University, and have completed animal studies in
dogs and pigs at Columbia University to continue safety and efficacy studies of
this technology. We are currently carrying out animal trials at Washington
Hospital Center in Washington, DC in preparation for an amended IND to FDA for
use of minimal invasive angioplasty catheters with Angiogenix(TM) for chronic
myocardial ischemia and severe intermittent angina.
We successfully completed a feasibility study of our stent-coating
technology using our patented Prostaglandin E1 with a major medical device
manufacturer in early 2001; and we have continued that work with other medical
device companies, as well.
In 2002 we began experimentation with Angiogenix(TM) compound for use in
the Nutraceutical Field. Our finding in mice demonstrate that when fed very low
doses of the Angiogenix(TM), in drinking water, the compound which is a potent
natural plant alkaloid, produced accelerated muscle mass when combined with
extensive exercise during a 3 week regime, the mice fed low (10-6 mole to 10-8
mole) developed a significant muscle increase compared to the control mice.
A scientifically controlled double blind, double placebo study in healthy
weight lifters confirmed our earlier animal results and we subsequently filed a
patent application relating to this discovery. A patent license was proposed
from a large international Nutraceutical supplier, Basic Research, LLC, of Salt
Lake City Utah and subsequently closed on or about July 1, 2003. We will be
compensated for this license with a 10% royalty on all revenues generated by the
licensed products during the first contract year. In subsequent years, the
contract stipulates compensation to us of the greater of 10% of revenues or
$2,000,000 per year. This contract includes a clause allowing termination of
the contract by Basic Research, LLC, for cause including Basic Research's
decision to discontinue selling the licensed product or decision not to bring
the licensed product to market. In October, 2004, the contract we have with
basic Research, LLC, will become non-exclusive.
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EMPLOYEES
As of June 30, 2004, we employed seven full time employees and two contract
consultants. None of our employees are subject to a collective bargaining
agreement and we believe that our relations with our employees are good.
Item 2. PROPERTY.
We maintain 6,800 square feet of executive offices and research and
development facilities at 550 Club Drive Suite 440, Montgomery, Texas 77316. In
May of 2003 we entered into a lease agreement for five years at an aggregate
monthly rental rate of $11,379 per month.
We believe that our facilities are adequate for our current levels of
operations.
Item 3. LEGAL PROCEEDINGS
In March 2003, Francis C. Pizzulli ("Pizzulli") filed a lawsuit styled
Geotermica, LTD., Francis C. Pizzulli, Inc., and Francis C. Pizzulli vs.
Endovasc, Inc., against Endovasc and others in the Los Angeles Superior Court
Case No. BC291463 seeking damages for alleged breach of contract, damages for
alleged misrepresentations, and to invalidate a merger/reverse stock split of
Endovasc Inc. We denied any and all liability in the lawsuit. Without the
admission of any liability by either Pizzulli or Endovasc, in February 2004, we
agreed to issue to Pizzulli 500,000 shares of common stock of the Company valued
at $125,000to settle the lawsuit.
On August 28, 2003, Cause No. 03-08-0681-CV, styled The Dow Chemical
Company vs. Endovasc Inc., was filed against us in the District Court of
Montgomery County, Texas, 359th Judicial District. Dow Chemical Company ("Dow")
filed a complaint against us for an alleged breach of contract and damages. The
amount of damages sought is approximately $230,000. This case is being
vigorously defended against the allegations made by Dow. We have also filed our
own counter-claim against Dow for breach of contract and damages. On June 30,
2004 a prediction cannot be made as to the final outcome of the complaint and
damages allegedly owed to Dow or to Endovasc. As a result, no amounts have been
accrued for this contingency.
On November 7, 2003, Cause No. 03-11-08112-CV, styled Greg Creekmore vs.
Endovasc, Inc. and Endovasc, LTD., Inc., was filed against the Company in the
District Court of Montgomery County, Texas, 284th Judicial District. Greg
Creekmore ("Creekmore") filed a complaint against Endovasc for alleged breach of
an employment contract between the parties. Creekmore seeks payment of $114,000
plus interest, 1 million shares of Endovasc's common stock and reimbursement of
court costs including reasonable attorney's fees allowed by law. This case is
being vigorously defended against the allegations made by Creekmore. On June
30, 2004, a prediction cannot be made as to the final outcome of the complaint
and damages allegedly owed to Creekmore. As a result, no amounts have been
accrued for this contingency.
On January 13, 2004, Case No. H-03-5226, styled Lorenz M. Hofmann, Ph.D.
and LMH Associates, Inc. vs. Endovasc, LTD., Inc., Endovasc, Inc., David P.
Summers, Ph.D. and M. Dwight Cantrell was filed against the Company in the
United States District Court for the Southern District of Texas Houston
Division. Lorenz M. Hofmann, Ph.D. and LMH Associates, Inc. ("LMH") filed a
complaint against us for alleged breach of contract and damages. LMH seeks
payment of $91,859. This case is being vigorously defended against the
allegations made by LMH. We have also filed our own counter-claim against LMH
for breach of contract and damages. On June 30, 2004, a prediction cannot be
made as to the final outcome of the complaint and damages allegedly owed to LMH.
As a result, no amounts have been accrued for this contingency.
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During the year ended June 30, 2004, a counterclaim under cause No
03-04-02939-CV (AAA Arbitration no. 79-181-0037-03TMS), styled Marco D.
Carnevale vs. Endovasc Corporation was filed against us in the 359th Judicial
District Court of Montgomery County, Texas. Carnevale filed a complaint against
us for alleged breach of contract and damages. Without the admission of any
liability, subsequent to June 30, 2004, we agreed to issue to Carnevale $33 of
cash or shares of common stock of the Company valued at $33 to settle the claim.
We are subject to certain other legal proceedings and claims which arose in
the ordinary course of its business. In the opinion of management, the amount
of ultimate liability with respect to these actions will not materially affect
the financial position, results of operations or cash flows of the Company.
Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
None.
PART II
Item 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS.
Our common stock trades on the NASDAQ Over the Counter Bulletin Board under
the symbol "EVSC." The following table sets forth for the quarters indicated the
range of high and low closing prices of our Common Stock as reported by NASDAQ
and the Electronic Bulletin Board but does not include retail markups, markdowns
or commissions.
Fiscal Quarter Ending Common Stock Price
(rounded to the nearest penny)
High Low
June 30, 2004 .33 .14
March 31, 2004 .39 .19
December 31, 2003 .33 .25
September 30, 2003 .54 .25
June 30, 2003 .75 .32
March 31, 2003 1.28 .65
December 31, 2002 2.74 .60
September 30, 2002 1.80 .05
June 30, 2002 .11 .04
March 31, 2002 .22 .05
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As of June 30, 2004, we have approximately 7,800 record and beneficial
stockholders.
DIVIDEND POLICY
Endovasc has never paid cash dividends on its common stock and intends to
retain earnings, if any, for use in the operation and expansion of its business.
The amount of future dividends, if any, will be determined by the Board of
Directors based upon our earnings, financial condition, capital requirements and
other conditions.
On April 1, 2003 in conjunction with our re-domicile to the State of
Nevada, a stock dividend representing 20% to the holders of record on that date
was declared by the Board of Directors.
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RECENT SALES OF UNREGISTERED SECURITIES
We effected the following transactions in reliance upon Regulation S, Rules
Governing Offers and Sales made Outside the United States without Registration,
under the Securities Act of 1933 as amended (the "Act"). Each certificate
issued for unregistered securities contained a legend stating that the
securities have not been registered under the Act and setting forth the
restrictions on the transferability and the sale of the securities. We believe
that each person had knowledge and experience in financial and business matters,
which allowed them to evaluate the merits and risk of the receipt of our
securities. We believe that each person was knowledgeable about our operations
and financial condition.
During the year ended June 30, 2004 we received $1,223,256 for the sale of
7,615,737 restricted shares of common stock from one investor pursuant to
Regulation S of the Act. A net of 8% commission was paid on this transaction.
Item 6. MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATION
The statements contained in this prospectus that are not historical are
forward-looking statements, including statements regarding our expectations,
intentions, beliefs or strategies regarding the future. Forward-looking
statements include our statements regarding liquidity, anticipated cash needs
and availability and anticipated expense levels. All forward-looking statements
included in this prospectus are based on information available to us on the date
hereof, and the we assume no obligation to update any such forward-looking
statement. It is important to note that our actual results could differ
materially from those in such forward-looking statements. Additionally, the
following discussion and analysis should be read in conjunction with the
Financial Statements and notes thereto appearing elsewhere in this prospectus.
CRITICAL ACCOUNTING POLICIES
We believe that of the significant accounting policies used in the
preparation of our financial statements (See Note 1 to the financial
statements), the following are critical accounting policies, which may involve a
higher degree of judgment, complexity and estimates.
SIGNIFICANT 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 dates of the financial statements and the reported amounts of revenues and
expenses during the periods. Actual results could differ from estimates making
it reasonably possible that a change in the estimates could occur in the near
term.
RESEARCH AND DEVELOPMENT
Research and development costs are expensed as incurred. These costs
consist of direct and indirect costs associated with specific projects.
STOCK-BASED COMPENSATION
We account for employee stock options using the intrinsic value method in
accordance with Accounting Principles Board Opinion ("AFB") No. 25, Accounting
for Stock Issued to Employees, and has adopted the disclosure-only alternative
of SFAS No. 123, Accounting for Stock-Based Compensation-Transition and
Disclosure. Under the intrinsic value method, we have only recorded stock-based
compensation resulting from options granted at below fair market value.
12
CONCENTRATION OF CREDIT RISK
Our financial instruments that potentially subject us to concentration of
credit risk consist principally of accounts receivable from a sponsor under an
external research agreement. Accounts receivable from this sponsor represented
100% of our accounts receivable outstanding at June 30, 2004.
RESULTS OF OPERATIONS
We are in the development stage and have had limited operating revenues
since our inception on June 10, 1996. From June 10, 1996 through June 30, 2004,
we had an accumulated deficit $25,593,000.
Endovasc filed an Investigational New Drug (IND) application for
Liprostin(TM) in October 1999. In support of the application a protocol was
submitted for the use of Liprostin(TM) in combination with angioplasty for
patients suffering from intermittent claudication or critical limb ischemia. In
accordance with this protocol, a small pilot study was conducted in 2003. Based
on this pilot study, a new protocol was designed and submitted to the FDA in
September 2003 for a Phase II clinical trial for patients with Peripheral
Arterial Occlusive Disease who are not candidates for angioplasty.
The Phase II clinical trial consisting of 73 patients was initiated in
December 2003 and concluded in August 2004. The results of this trial for
peripheral arterial occlusive disease will be presented to the FDA in the fall
of 2004. We intend to move forward with Phase III in the first quarter of 2005.
In November 2000, we submitted an application for consideration of a major
research grant for animal studies of Nicotine Receptor Agonist. In April 2001,
we were notified of the grant approval for $512,000 with an option to extend for
an additional year. The option to extend this agreement for an additional one
year term was exercised. The extension increased the maximum funding to
$730,000. The agreement was verbally extended subsequent to June 30, 2003 to
allow us to receive the maximum funding allowed under the agreement. Identity
of the grantor was requested to remain anonymous until such time as release of
the results from the studies. Due to delays pertaining to the animal research,
extensions were granted until October 2004.
We submitted Phase I and animal data to the FDA in February 2002 on trials
carried out at Stanford University and Columbia University; with its nicotinic
acetylcholine receptor (nAChR) agonist trademarked Angiogenix(TM). We also
sponsored research which was completed during the fiscal year 2004. The first
was conducted by Dr. Yong-Jian Geng at the Texas Heart Institute to study the
effects of nicotine on stem cell development. The second was conducted by Dr.
Liping Tang at the University of Texas at Arlington, Texas to study the
angiogenic effect of a new nicotine delivery system in two mouse models of
ischemia. Currently we are focusing our research on alternative site-specific
delivery methods for our drug candidates.
In September 2003, the Company's Board of Directors authorized the creation
of a new class of common stock, called Series NDC common stock, $0.001 par value
per share, whose rights and distributions would be based on the performance of
NDC. During the twelve months ended June 30, 2004, the Company issued a
dividend of one share of the Series NDC common stock for each four shares of the
Company's common stock. As of June 30, 2004, 14,158,593 shares of Endovasc
Series NDC common stock were issued and outstanding.
During the fiscal year ended June 30, 2004, our net revenues decreased to
$71,000 compared with revenues of $287,000 for the previous fiscal year ended
June 30, 2003. The decrease in revenue is the result of fewer billings toward
research grants.
13
During the fiscal year ending June 30, 2004 and 2003, costs and operating
expenses were $4,779,000 and $9,965,000, respectively. The decrease in costs
and operating expenses for the year is primarily due to the decrease in stock
based compensation.
Cash flows used in operating activities for the fiscal year ending June 30,
2004 increased $509,000 to $1,987,000, compared to $1,478,000 for the previous
fiscal year ending June 30, 2003, primarily due to the increase in cash used to
fund research and development and clinical trials, and a reduction in the use of
stock based compensation to consultants.
Interest expense decreased for the fiscal year ending June 30, 2004 by
$38,000. This was primarily due to a decrease in the average balance
outstanding of capital leases and notes payable to financial institutions during
the year ended June 30, 2004.
Research and development expenses totaled $1,647,000 during the fiscal year
ending June 30, 2004, a decrease of $1,162,000 from $2,809,000 for the fiscal
year ended June 30, 2003. This decrease is due primarily to our focus on the
clinical trials of only one of our major products during the year ended June
30, 2004.
LIQUIDITY AND CAPITAL RESOURCES
We had a working capital deficit on June 30, 2004 of $425,000, compared to
a working capital deficit of $541,000 at June 30, 2003. This decrease was
primarily due to a reduction of short term notes payable to shareholders.
Endovasc requires significant additional funds to enable it to continue its
Liprostin(TM) product development and to complete its Food and Drug
Administration required clinical trials, as well as research and development of
its licensed product nicotine receptor agonist (NRA) and its stent coating
technology.
We continue to actively pursue additional financing, collaborations with
firms, and other arrangements aimed at increasing our capital resources.
Failure to acquire such funds may adversely impact the scheduled marked
introduction of Liprostin(TM) and Angiogenix(TM) and possibly adversely affect
our operations. In order to continue as a going concern, we must raise
additional funds as noted above and ultimately achieve profit from its
operations.
OFF BALANCE SHEET ARRANGEMENTS
None.
Item 7. FINANCIAL STATEMENTS
The response to this item is set forth at the end of this report.
Item 8. CHANGES IN OR DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
None.
14
Item 8A. CONTROLS AND PROCEDURES
Under the supervision and with the participation of our management,
including the Chief Executive Officer and Chief Financial Officer, we have
evaluated the effectiveness of the design and operation of our disclosure
controls and procedures pursuant to Exchange Act Rule 13a-14(c) as of the end of
the period covered by this report. Based on that evaluation, the Chief
Executive Officer and Chief Financial Officer have concluded that these
disclosure controls and procedures are effective. There were no changes in our
internal control over financial reporting during the quarter ended June 30, 2004
that have materially affected, or are reasonably likely to materially affect,
our internal controls over financial reporting.
PART III
Item 9. DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS;
COMPLIANCE WITH SECTION 16(a) OF THE EXCHANGE ACT AND THE CODE OF ETHICS
Our executive officers, directors and key employees and their ages and
positions with us as of June 30, 2004 are as follows:
Name Age Position Period Officer/Director/Key Employee
---------------------------------------------------------------------------------------------------
Diane Dottavio, Ph.D. 58 President/Chief Executive Officer March 2000 - present
Chairman of the Board
M. Dwight Cantrell 58 Chief Financial Officer, January 1997 - present
Treasurer and Director
Robert Johnson 33 Vice President of Business February 2003 - present
Development
|
Set forth below is a brief background of the executive officers, directors
and key employees of Endovasc based on information supplied by them.
Dr. Diane Dottavio serves as our President, Chief Executive Officer and
Chairman of the Board of Directors. Dr. Dottavio served as our Vice President
of Research and Development from March 2000 to December 2003. Prior to joining
us in March of 2000, Dr. Dottavio served as Senior Scientist with Leukosite,
Inc., from 1994 to 1996, and as Director of Laboratory Instruction and Research
at the University of Houston, from 1996 to 2001. Dr. Dottavio holds a B.S. in
Biology and a M.S. in Organic Chemistry from the University of New Mexico, as
well as a Ph.D. in Biochemistry from the University of Texas.
M. Dwight Cantrell has served as our Chief Financial Officer, Treasurer and
Director since 1997. He has an extensive background in the banking and venture
capital markets and is a member of the Association of Biotech Financial
officers.
Robert Johnson has served as our Vice President of Business Development
since February 2003. He has over 11 years of progressive experience in a
corporate and franchise business environment. From 1992 to 2003, Mr. Johnson
held several management positions with the Alderwoods Group Inc.
Our Directors are elected for a three year term with certain members coming
up for re-election annually. Executive officers are elected by our Board of
Directors annually and serve at the discretion of the Board. We have no
standing committees.
15
Directors receive no salary for their services and receive no fee from us
for their participation in meetings, although all Directors are reimbursed for
reasonable travel and other out-of-pocket expenses incurred in attending
meetings of the Board.
Section 16(a) Beneficial Ownership Reporting Compliance
Based solely upon a review of Forms 3 and 4 submitted to us during the fiscal
year ending June 30, 2004, we believe that all reporting persons have complied
with the reporting requirements of Section 16(a) of the Exchange Act.
CODE OF ETHICS
We have adopted a Code of Ethics for our Principal Executive and Senior
Financial Officers which is attached hereto as Exhibit 14.1.
Item 10. EXECUTIVE COMPENSATION.
The following table sets forth certain summary information with respect to
the compensation paid to the executive officers for services rendered to us, in
all capacities, for the fiscal years ended June 30, 2004, 2003 and 2002. Other
than as listed below, we had no executive officers whose total annual salary and
bonus exceeded $100,000 for that fiscal year:
SUMMARY COMPENSATION TABLE
ANNUAL COMPENSATION LONG TERM COMPENSATION
-------------------------- ---------------------------------
AWARDS Payouts
----------------------- --------
SECURITIES
OTHER UNDER- ALL
ANNUAL RESTRICTED LYING OTHER
NAME AND COMP- STOCK OPTIONS LTIP COMP-
PRINCIPAL SALARY BONUS ENSATION AWARDS SARS PAYOUTS ENSATION
POSITION YEAR $ $ $ $ # $ $
------------------- ---- ------- ------ --------- ----------- ---------- -------- ---------
Summers, David P. 2004 44,000 -0- -0- -0- -0- -0- -0-
President/CEO 2003 82,000 -0- 44,000 -0- -0- -0- -0-
Chairman of the 2002 79,000 -0- -0- -0- -0- -0- -0-
Board
------------------- ---- ------- ------ --------- ----------- ---------- -------- ---------
Dottavio, Diane 2004 72,399 -0- -0- -0- -0- -0- -0-
President/CEO 2003 72,000 -0- 65,100 -0- -0- -0- -0-
Chairman of the 2002 25,915 -0- 55,160 -0- -0- -0- -0-
Board
------------------- ---- ------- ------ --------- ----------- ---------- -------- ---------
Cantrell, M. Dwight 2004 72,199 -0- -0- -0- -0- -0- -0-
Chief Financial 2003 72,000 -0- 35,020 -0- -0- -0- -0-
Officer/Treasurer 2002 72,000 -0- -0- -0- -0- -0- -0-
---------------------------------------------------------------------------------------------------
16
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---------------------------------------------------------------------------------------------------
Johnson, Robert 2004 7,596 -0- 72,000 54,612 -0- -0- -0-
Vice President of
Business
Development
---------------------------------------------------------------------------------------------------
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STOCK OPTION PLANS
In May 2002, we adopted the 2002 Directors, Officers and Consultants Stock
Option, Stock Warrant and Stock Award Plan (the "Plan"). The Plan was
discontinued in May 2003, for new issuances but still has 339,252
options/warrants outstanding under the Plan. The purpose of the Plan was to
maintain the ability of the Company to attract and retain highly qualified and
experienced directors, employees and consultants and to give such directors,
employees and consultants a continued proprietary interest in the success of the
Company. In addition, the Plan was intended to encourage ownership of common
stock of the Company by the directors, employees and consultants of the Company
and to provide increased incentive for such persons to render services and to
exert maximum effort for the success of the Company's business. Subject to
adjustment so that the total number of shares issuable under the Plan would
equal 15% of the total number of issued and outstanding common stock of the
Company, the aggregate number of shares of common stock that could be optioned,
subject to conversion or issued under the Plan was 18,750,000 which has not been
adjusted for the 40 to 1 reverse split of the Company's common stock.
The maximum term of options granted under the Plan is ten years. The
aggregate fair market value of the stock with respect to which incentive stock
options are first exercisable in any calendar year may not exceed $1,000,000.
The exercise price of incentive stock options must be equal or greater than the
fair market value of common stock on the date of grant. The exercise price of
incentive stock options granted to any person who at the time of grant owns
stock possessing more than 10% of the total combined voting power of all classes
of stock must be at least 110% of the fair market value of such stock on the
date of grant, and the term of these options cannot exceed five years.
Non-qualified stock options or warrants, restricted common stock and/or
convertible preferred stock could be granted under the Plan. The terms of these
issuances were determined based on the sole discretion of the Company's
Compensation Committee, and the Board of Directors. As of June 30, 2004,
3,068,990 options/warrants have been issued under the Plan.
In May 2003, we adopted the 2003 Stock Compensation Plan (the "2003 Plan")
in order to attract and retain highly qualified and experienced directors,
employees and consultants and to give such directors, employees and consultants
a continued proprietary interest in the success of the Company. Under the 2003
Plan, the Company may award up to 10,000,000 shares of its common stock or
options to purchase its common stock to the directors, employees and consultants
of the Company. All terms of the common stock options or warrants granted under
the 2003 Plan are at the discretion of the Board of Directors but will expire
not more than ten years from the date of grant.
As of June 30, 2004, 2,850,758 shares of common stock or options/warrants
have been issued under the 2003 Plan.
OPTION/SAR GRANT
We did not grant any options or SARS to any of our directors or officers
during the year ended June 30, 2004.
17
AGGREGATE OPTIONS EXERCISED IN LAST FISCAL YEAR
AND FISCAL YEAR END OPTION VALUES
-----------------------------------------------------------------------
NUMBER OF
UNEXERCISED
SECURITIES
SHARES UNDERLYING VALUE OF UNEXERCISED
ACQUIRED OPTIONS AT FYE IN THE MONEY OPTIONS AT
ON VALUE EXERCISABLE/ FISCAL YEAR END
NAME EXERCISE REALIZED UNEXERCISABLE EXERCISABLE/UNEXERCISABLE
-------- -------- -------- -------------- -------------------------
Summers -0- -0- -0- -0-
-------- -------- -------- -------------- -------------------------
Dottavio -0- -0- -0- -0-
-----------------------------------------------------------------------
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Long-term Incentive Plan Awards Table
We issued no long-term incentive plan awards to any of our officers during the
year ended June 30 2004.
Item 11. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS
Securities authorized for issuance under equity compensation plans.
The following table reflects all equity compensation plans to date that have not
been approved specifically by security holders. We have a Stock and Stock Option
Plan and several Individual Compensation Arrangements established by the Board
of Directors.
============================================================================================
EQUITY COMPENSATION PLAN INFORMATION
--------------------------------------------------------------------------------------------
NUMBER OF SECURITIES
REMAINING AVAILABLE
FOR FUTURE ISSUANCE
NUMBER OF SECURITIES UNDER EQUITY
TO BE ISSUED UPON WEIGHTED-AVERAGE COMPENSATION PLANS
EXERCISE OF EXERCISE PRICE OF (EXCLUDING SECURITIES
OUTSTANDING OPTIONS, OUTSTANDING OPTIONS, REFLECTED IN COLUMN
WARRANTS AND RIGHTS WARRANTS AND RIGHTS (a)
PLAN CATEGORY (a) (b) (c)
--------------------- --------------------- ---------------------- ----------------------
Equity compensation
plans approved by 339,252 $ 1.30 9,660,748
security holders
--------------------- --------------------- ---------------------- ----------------------
Equity compensation
plans not approved by -0- -0- -0-
security holders
--------------------- --------------------- ---------------------- ----------------------
TOTAL
============================================================================================
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The following table sets forth certain information at September 15, 2004
with respect to the beneficial ownership of shares of Common Stock by (1) each
person who owns beneficially more than 5% of the outstanding shares of Common
Stock, (2) each of our directors, (3) each of our executive officers, and (4)
all of our executive officers and directors as a group. As of September 15,
2004, we had 72,553,634 shares of Common stock-Endovasc Series issued and
outstanding and 14,158,593 shares of Common stock-NDC Series issued and
outstanding.
18
SERIES
ENDOVASC PERCENT SERIES NDC PERCENT TOTAL PERCENT
NAME OF COMMON OF COMMON OF VOTING OF
INDIVIDUAL OR GROUP (1) STOCK CLASS(2) STOCK CLASS(3) INTERESTS CLASS(4)
----------------------------------- ---------- -------- ---------- -------- ---------- --------
5% STOCKHOLDERS
David P. Summers, Ph.D.
3158 Canterbury Lane
Montgomery, TX 77356 (5) 7,449,206 10.27% 2,450,131 17.3% 9,899,337 11.42%
INDIVIDUAL DIRECTORS,
OFFICERS AND NOMINEES
Diane Dottavio, Ph.D.
Chief Executive Officer, Director 984,144 1.36% 234,786 1.7% 1,218,930 1.41%
M. Dwight Cantrell
Chief Financial Officer, Treasurer
and Secretary, Director (6) 3,689,828 5.09% 953,171 6.7% 4,642,999 5.35%
Robert G. Johnson
Vice President, Business
Development 419,262 .58% 18,458 .1% 437,720 .50%
ALL OFFICERS AND
DIRECTORS AS A GROUP 5,093,234 7.02% 1,206,415 8.52% 6,299,649 7.27%
|
(1) The securities "beneficially owned" by a person are determined in
accordance with the definition of "beneficial ownership" set forth in the rules
and regulations promulgated under the Securities Exchange Act of 1934, as
amended, and accordingly, may include securities owned by and for, among others,
the spouse and/or minor children of an individual and any other relative who has
the same home as such individual, as well as other securities as to which the
individual has or shares voting or investment power or which such person has the
right to acquire within 60 days after the Record Date pursuant to the conversion
of convertible equity, exercise of options, or otherwise. Beneficial ownership
may be disclaimed as to certain of the securities.
(2) Based upon 72,553,634 shares of Common stock-Endovasc Series
outstanding as of September 15, 2004, assuming no other changes in the
beneficial ownership of our securities.
(3) Based upon 14,158,593 shares of Common stock-NDC Series outstanding as
of September 15, 2004, assuming no other changes in the beneficial ownership of
our securities.
(4) Based upon the total shares of common stock outstanding as of September
15, 2004 of 86,712,227, assuming no other changes in the beneficial ownership of
our securities.
(5) Dr. Summer's beneficially owned shares include approximately 291,600
shares beneficially owned by his wife, Dorothy Summers. Dr. Summers exercises no
investment or voting power over any of the shares owned by his wife, and
disclaims beneficial ownership of those shares.
(6) Dwight Cantrell's beneficially owned shares include approximately
211,656 shares beneficially owned by his wife Janie Cantrell. Dwight Cantrell
exercises no investment or voting power over any of the shares owned by his
wife, and disclaims beneficial ownership of those shares.
19
Item 12. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS.
As of June 30, 2004, we have not entered into a transaction during the past
two years with a value in excess of $60,000 with a Director, officer, or
beneficial owner of 5% or more of our capital stock, or members of their
immediate families that had, or is to have, a direct or indirect material
interest in us, except as follows:
During the year ended June 30, 2003, the former Chief Executive Officer of
the Company advanced $793,000 to the Company in the form of a note payable to
stockholder and received $171,000 for partial repayment of this note payable to
stockholder. During the year ended June 30, 2004, the former Chief Executive
Officer of the Company advanced an additional $205,000 to the Company under the
existing note payable which had a balance of $680,000 as of June 30, 2003.
During the year ended June 30, 2004, the Company repaid $885,000 of the note
through a $49,000 cash payment to the shareholder, payments totaling $149,000 on
behalf of the shareholder to third parties, and through issuance of common stock
with a value of $687,000. The balance of this note of $-0- and $680,000 as of
June 30, 2004 and 2003, respectively, is due on demand, non-interest bearing and
is not collateralized.
During the year ended June 30, 2004, the current Chief Executive Officer
and the Chief Financial Officer of the Company advanced the Company $55,000 and
$50,000 respectively. The balances of the notes of $55,000 and $50,000 as of
June 30, 2004 are due on demand, non-interest bearing and are not
collateralized.
During the year ended June 30, 2004, a stockholder of the Company advanced
the Company $185,000. The balance outstanding at June 30, 2004 of $185,000 is
due on demand, non-interest bearing and is not collateralized.
Item 13. EXHIBITS
(a) INDEX TO EXHIBITS
Exhibit No. Exhibit
14.1 Code of Ethics For Principal Executive and Senior
Financial Officers
31.1 Certifications of Chief Executive Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act
of 2002
31.2 Certifications of Chief Financial Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act
of 2002
32.1 Certifications of Chief Executive Officer Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
32.2 Certifications of Chief Financial Officer Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
|
20
(b) Reports on Form 8-K:
As noted in the Form 8-K filed May 18, 2004, on April 27, 2004 the Company
terminated its agreement with MIV Therapeutics, Inc. The Company entered into
an agreement with MIV Therapeutics in November, 2002, to develop Endovasc's
Angiogenix(TM) and a biodegradable stent. Under this agreement the Company was
to contribute certain technology while MIV Therepautics Inc, was to provide
funding for the research. On November 17, 2003, MIV Therepautics, Inc. was
placed on notice that they were in default in the funding of the agreement;
because of this default, Endovasc, Inc did not transfer the technology. MIV
Therepeutics, Inc. has not been able to cure this default, and the agreement was
terminated April 27, 2004.
As noted in the Form 8-K filed June 4, 2004, on Wednesday May 26, 2004
David P. Summers tendered his resignation, in writing, from all positions with
Endovasc, Inc., effective close of the business day, May 27, 2004. A special
meeting of the Board of Directors was duly noticed, called and held. The
resignation of Dr. David P. Summers was accepted by the Board of Directors,
effective May 27, 2004.
Item 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
AUDIT FEES
Ham, Langston & Brezina billed us in the aggregate amount of $48,000 and
$54,000 for professional services rendered for their audit of our annual
financial statements and their reviews of the financial statements included in
our Forms 10-KSB for the years ended June 30, 2004 and June 30, 2003,
respectively.
AUDIT RELATED FEES
Ham, Langston & Brezina did not bill us for, nor perform professional
services rendered for assurance and related services that were reasonably
related to the performance of audit or review of the Company's financial
statements for the years ended June 30, 2004 and June 30, 2003 but were not
reportable as audit fees.
FINANCIAL INFORMATION SYSTEMS DESIGN AND IMPLEMENTATION FEES
For the fiscal years ended June 30, 2004 and June 30, 2003, Ham, Langston &
Brezina did not bill us for, nor perform, any financial information systems
design or implementation. For the fiscal years ended June 30, 2004 and June 30,
2003, we were not billed for professional services from any other accounting
firm for information systems design or implementation.
TAX FEES
Ham, Langston & Brezina did not bill us for professional accounting
services rendered for tax related services for the years ended June 30, 2004 and
June 30, 2003.
ALL OTHER FEES
We were not billed for any other professional accounting services for the
fiscal years ended June 30, 2004 and 2003.
21
AUDITOR INDEPENDENCE
Our Board of Directors considers that the work done for us in the year
ended June 30, 2004 by Ham, Langston & Brezina is compatible with maintaining
Ham, Langston & Brezina's independence.
SIGNATURES
In accordance with Section 13 or 15(d) of the Exchange Act, the registrant
caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
ENDOVASC, INC.
Date: October 13, 2004 By: /s/ Diane Dottavio
---------------------------
Diane Dottavio, Ph.D.
Chief Executive Officer and
Chairman of the Board
|
In accordance with the Exchange Act, this report has been signed below by
the following persons on behalf of the registrant and in the capacities and on
the dates indicated.
Date: October 13, 2004 /s/ Diane Dottavio
---------------------------
Diane Dottavio, Ph.D.
Chief Executive Officer and
Chairman of the Board
Date: October 13, 2004 /s/ M. Dwight Cantrell
---------------------------
M. Dwight Cantrell
Chief Financial Officer and
Director
|
22
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
FINANCIAL STATEMENTS
WITH REPORT OF INDEPENDENT ACCOUNTANTS
AS OF AND FOR THE YEARS ENDED JUNE 30, 2004 AND 2003,
AND FOR THE PERIOD FROM INCEPTION, JUNE 10, 1996,
TO JUNE 30, 2004
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
TABLE OF CONTENTS
PAGE(S)
Report of Independent Accountants F-2
Financial Statements:
Balance Sheet as of June 30, 2004 and 2003 F-3
Statement of Operations for the years ended June 30, 2004
and 2003, and for the period from inception, June 10,
1996, to June 30, 2004 F-4
Statement of Stockholders' Deficit for the years ended
June 30, 2004 and 2003, and for the period from inception,
June 10, 1996, to June 30, 2004 F-5
Statement of Cash Flows for the years ended June 30, 2004
and 2003, and for the period from inception, June 10, 1996,
to June 30, 2004 F-11
Notes to Financial Statements F-12
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F-1
REPORT OF INDEPENDENT ACCOUNTANTS
To the Stockholders of
Endovasc, Inc.
We have audited the accompanying balance sheet of Endovasc, Inc. (a corporation
in the development stage) as of June 30, 2004 and 2003, and the related
statements of operations, stockholders' deficit and cash flows for the years
then ended, and for the period from inception, June 10, 1996, to June 30, 2004.
These financial statements are the responsibility of the Company's management.
Our responsibility is to express an opinion on these financial statements based
upon our audits.
We conducted our audits in accordance with standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we
plan and perform the audits to obtain reasonable assurance about whether the
financial statements are free of material misstatement. An audit includes
examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the accounting
principles used and significant estimates made by management, as well as
evaluating the overall financial statement presentation. We believe that our
audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the financial position of Endovasc, Inc. as of June 30,
2004 and 2003, and the results of its operations and its cash flows for the
years then ended, and for the period from inception, June 10, 1996, to June 30,
2004, in conformity with accounting principles generally accepted in the United
States of America.
The accompanying financial statements have been prepared assuming that Endovasc,
Inc. will continue as a going concern. As shown in the financial statements and
discussed in Note 16, the Company has incurred significant recurring losses from
operations since inception, is in a negative working capital and stockholders'
deficit position at June 30, 2004, and is dependent on outside sources of
financing for the continuation of its operations. These factors raise
substantial doubt about the Company's ability to continue as a going concern.
Management's plans with regard to this matter are also discussed in Note 16.
These financial statements do not include any adjustments that might result from
the outcome of this uncertainty.
/s/ Ham, Langston & Brezina, L.L.P.
Houston, Texas
September 30, 2004
|
F-2
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
BALANCE SHEET
JUNE 30, 2004 AND 2003
-----------
(IN THOUSANDS, EXCEPT SHARE DATA)
ASSETS 2004 2003
------ --------- ---------
Current assets:
Cash and cash equivalents $ 116 $ 120
Accounts receivable 22 98
Other current assets 375 365
--------- ---------
Total current assets 513 583
Property and equipment, net 114 175
Other assets, net 102 112
--------- ---------
Total assets $ 729 $ 870
========= =========
LIABILITIES AND STOCKHOLDERS' DEFICIT
-------------------------------------
Current liabilities:
Current maturities of long-term debt $ 52 $ 41
Current portion of obligations under capital leases 30 47
Notes payable to shareholders 290 680
Accounts payable 539 339
Accrued liabilities 27 17
--------- ---------
Total current liabilities 938 1,124
Long-term debt, net of current maturities - 29
Long-term obligations under capital leases 28 58
Convertible debentures 1 1
Deferred liabilities 53 -
--------- ---------
Total liabilities 1,020 1,212
--------- ---------
Commitment and contingencies
Stockholders' deficit:
Common stock, $.001 par value, 200,000,000 shares authorized
Common stock-Endovasc Series, 70,203,634 and 50,933,138
shares issued and outstanding at June 30, 2004 and 2003,
respectively 70 51
Common stock-NDC Series, 14,158,593 and -0- shares issued
and outstanding at June 30, 2004 and 2003, respectively 14 -
Preferred stock, $.001 par value, 20,000,000 shares authorized,
208 and 330 shares of Series A 8% cumulative convertible
preferred stock issued and outstanding at June 30, 2004 and
2003, respectively, stated value $100 per share - -
Additional paid-in capital 25,218 20,521
Losses accumulated during the development stage (25,593) (20,914)
--------- ---------
Total stockholders' deficit (291) (342)
--------- ---------
Total liabilities and stockholders' deficit $ 729 $ 870
========= =========
|
The accompanying notes are an integral
part of these financial statements.
F-3
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
STATEMENT OF OPERATIONS
FOR THE YEARS ENDED JUNE 30, 2004 AND 2003 AND
FOR THE PERIOD FROM INCEPTION, JUNE 10, 1996, TO JUNE 30, 2004
__________
(IN THOUSANDS, EXCEPT SHARE DATA)
YEAR ENDED
-------------------------- INCEPTION
JUNE 30, JUNE 30, TO JUNE 30,
2004 2003 2004
------------ ------------ -------------
Income:
Revenue $ 71 $ 287 $ 1,127
Interest income 1 1 30
Other income - 33 47
------------ ------------ -------------
Total income 72 321 1,204
------------ ------------ -------------
Costs and expenses:
Operating, general and administrative expenses 3,115 7,101 16,131
Research and development costs 1,647 2,809 9,457
Interest expense 17 55 644
Settlement with former employee - - 408
------------ ------------ -------------
Total costs and expenses 4,779 9,965 26,640
------------ ------------ -------------
Loss attributed to minority interest 28 - 28
------------ ------------ -------------
Net loss before extraordinary item (4,679) (9,644) (25,408)
Extraordinary loss on extinguishment of
convertible debentures - - (127)
------------ ------------ -------------
Net loss $ (4,679) $ (9,644) $ (25,535)
============ ============ =============
Net loss available to common stockholders $ (4,679) $ (9,684)
============ ============
Weighted average shares outstanding 76,721,885 37,774,518
============ ============
Basic and diluted net loss per common share $ (0.06) $ (0.26)
============ ============
|
The accompanying notes are an integral
part of these financial statements.
F-4
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
STATEMENT OF STOCKHOLDERS' EQUITY (DEFICIT)
FOR THE YEARS ENDED JUNE 30, 2004 AND 2003, AND
FOR THE PERIOD FROM INCEPTION, JUNE 10, 1996 TO JUNE 30, 2004
__________
(IN THOUSANDS, EXCEPT SHARE DATA)
COMMON STOCK COMMON STOCK SERIES A SERIES B SERIES C
ENDOVASC SERIES NDC SERIES PREFERRED STOCK PREFERRED STOCK PREFERRED STOCK ADDITIONAL
------------------ --------------- --------------- --------------- --------------- PAID-IN
AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES CAPITAL
------- --------- ------- ------ ------- ------ ------- ------ ------- ------ --------
Balance at inception, June
10, 1996 $ - - $ - - $ - - $ - - $ - - $ -
Stock issued for equity
securities in 1996 2 2,332,000 - - - - - - - - 300
Stock issued for purchase
of patent rights in 1996 2 2,188,000 - - - - - - - - 282
Stock issued for services
in 1997 2 1,702,000 - - - - - - - - 354
Stock issued for cash in
1997 1 304,571 - - - - - - - - 205
Stock issued for purchase
of patent rights in 1997 - 200,000 - - - - - - - - 200
Stock issued for services
in 1998 - 77,380 - - - - - - - - 56
Stock subject to rescission - - - - - - - - - - -
Conversion of debentures to
common stock 1 1,208,077 - - - - - - - - 444
Stock issued for services - 362,462 - - - - - - - - 285
Losses accumulated during
the period from inception,
June 10, 1996, to June 30,
1999 - - - - - - - - - - -
------- --------- ------- ------ ------- ------ ------- ------ ------- ------ --------
Balance at June 30, 1999 8 8,374,490 - - - - - - - - 2,126
LOSSES
ACCUMULATED
DURING THE
TREASURY DEVELOPMENT
STOCK STAGE TOTAL
---------- ------------ --------
Balance at inception, June
10, 1996 $ - $ - $ -
Stock issued for equity
securities in 1996 - - 302
Stock issued for purchase
of patent rights in 1996 - - 284
Stock issued for services
in 1997 - - 356
Stock issued for cash in
1997 - - 206
Stock issued for purchase
of patent rights in 1997 - - 200
Stock issued for services
in 1998 - - 56
Stock subject to rescission (17) - (17)
Conversion of debentures to
common stock - - 445
Stock issued for services - - 285
Losses accumulated during
the period from inception,
June 10, 1996, to June 30,
1999 - (2,777) (2,777)
---------- ------------ --------
Balance at June 30, 1999 (17) (2,777) (660)
|
The accompanying notes are an integral part of these financial statements.
Continued
F-5
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
STATEMENT OF STOCKHOLDERS' EQUITY (DEFICIT), CONTINUED
FOR THE YEARS ENDED JUNE 30, 2004 AND 2003, AND
FOR THE PERIOD FROM INCEPTION, JUNE 10, 1996 TO JUNE 30, 2004
__________
(IN THOUSANDS, EXCEPT SHARE DATA)
COMMON STOCK COMMON STOCK SERIES A SERIES B SERIES C
ENDOVASC SERIES NDC SERIES PREFERRED STOCK PREFERRED STOCK PREFERRED STOCK ADDITIONAL
------------------ -------------- -------------- -------------- -------------- PAID-IN TREASURY
AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES CAPITAL STOCK
------ ---------- ------ ------ ------ ------ ------ ------ ------ ------ ------- ---------
Conversion of debentures
to common stock 3 2,569,546 - - - - - - - - 841 -
Stock issued for services 2 1,869,334 - - - - - - - - 1,388 -
Conversion of note payable
to shareholder to common
stock 1 1,250,000 - - - - - - - - 147 -
Issue of common stock in
connection with license
agreement - 190,000 - - - - - - - - 63 -
Issue of common stock in
settlement of lawsuit 1 300,000 - - - - - - - - 192 -
Issuance of preferred
stock - - - - - 15,000 - - - - 1,040 -
Net loss - - - - - - - - - - - -
------ ---------- ------ ------ ------ ------ ------ ------ ------ ------ ------- ---------
Balance at June 30, 2000 15 14,553,370 - - - 15,000 - - - - 5,797 (17)
Issue of common stock upon
exercise of warrants 1 1,250,000 - - - - - - - - 34 -
Issue of common stock upon
exercise of options 1 1,100,000 - - - - - - - - 274 -
Issue of common stock for
services 2 1,770,301 - - - - - - - - 300 -
Issue of warrants for ser-
vices - - - - - - - - - - 162 -
Issue of preferred stock - - - - - 15,000 - - - - 1,061 -
LOSSES
ACCUMULATED
DURING THE
DEVELOPMENT
STAGE TOTAL
---------- -------
Conversion of debentures
to common stock - 844
Stock issued for services - 1,390
Conversion of note payable
to shareholder to common
stock - 148
Issue of common stock in
connection with license
agreement - 63
Issue of common stock in
settlement of lawsuit - 193
Issuance of preferred
stock - 1,040
Net loss (2,975) (2,975)
---------- -------
Balance at June 30, 2000 (5,752) 43
Issue of common stock upon
exercise of warrants - 35
Issue of common stock upon
exercise of options - 275
Issue of common stock for
services - 302
Issue of warrants for ser-
vices - 162
Issue of preferred stock - 1,061
|
The accompanying notes are an integral part of these financial statements.
Continued
F-6
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
STATEMENT OF STOCKHOLDERS' EQUITY (DEFICIT), CONTINUED
FOR THE YEARS ENDED JUNE 30, 2004 AND 2003, AND
FOR THE PERIOD FROM INCEPTION, JUNE 10, 1996 TO JUNE 30, 2004
__________
(IN THOUSANDS, EXCEPT SHARE DATA)
COMMON STOCK COMMON STOCK SERIES A SERIES B SERIES C
ENDOVASC SERIES NDC SERIES PREFERRED STOCK PREFERRED STOCK PREFERRED STOCK
--------------------- -------------- ---------------- ----------------- ---------------
AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES
------- ------------ ------ ------ ------ -------- ------ --------- ------ -------
Conversion of preferred
stock to common stock 16 16,501,251 - - - (14,240) - - - -
Dividends declared on pre-
ferred stock - - - - - - - - - -
Issue of common stock as
payment of dividends on
preferred stock 1 840,383 - - - - - - - -
Conversion of note payable
to shareholder to common
stock 4 4,210,526 - - - - - - - -
Issue of common stock for
cash - 27,500 - - - - - - - -
Net loss - - - - - - - - - -
------- ------------ ------ ------ ------ -------- ------ --------- ------ -------
Balance at June 30, 2001 40 40,253,331 - - - 15,760 - - - -
Exchange of common and trea-
sury stock for Series B
preferred stock (24) (24,008,545) - - - - 2 2,400,855 - -
Issue of Series C preferred
stock for services - - - - - - - - - 350,000
Issue of common stock for
services and financing
costs 14 14,012,130 - - - - - - - -
Issue of common stock for
lawsuit settlement 8 8,000,000 - - - - - - - -
Purchase of treasury stock - - - - - - - - - -
Purchase of treasury stock
for note payable to stock-
holders - - - - - - - - - -
LOSSES
ACCUMULATED
ADDITIONAL DURING THE
PAID-IN TREASURY DEVELOPMENT
CAPITAL STOCK STAGE TOTAL
-------- --------- ------------- -------
Conversion of preferred
stock to common stock (16) - - -
Dividends declared on pre-
ferred stock - - (135) (135)
Issue of common stock as
payment of dividends on
preferred stock 64 - - 65
Conversion of note payable
to shareholder to common
stock 439 - - 443
Issue of common stock for
cash 6 - - 6
Net loss - - (2,842) (2,842)
-------- --------- ------------- -------
Balance at June 30, 2001 8,121 (17) (8,729) (585)
Exchange of common and trea-
sury stock for Series B
preferred stock 17 5 - -
Issue of Series C preferred
stock for services 210 - - 210
Issue of common stock for
services and financing
costs 875 - - 889
Issue of common stock for
lawsuit settlement 400 - - 408
Purchase of treasury stock - (5) - (5)
Purchase of treasury stock
for note payable to stock-
holders - (560) - (560)
|
The accompanying notes are an integral part of these financial statements.
Continued
F-7
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
STATEMENT OF STOCKHOLDERS' EQUITY (DEFICIT), CONTINUED
FOR THE YEARS ENDED JUNE 30, 2004 AND 2003, AND
FOR THE PERIOD FROM INCEPTION, JUNE 10, 1996 TO JUNE 30, 2004
__________
(IN THOUSANDS, EXCEPT SHARE DATA)
COMMON STOCK COMMON STOCK SERIES A SERIES B SERIES C
ENDOVASC SERIES NDC SERIES PREFERRED STOCK PREFERRED STOCK PREFERRED STOCK ADDITIONAL
--------------------- -------------- --------------- ----------------- --------------- PAID-IN
AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES CAPITAL
------- ------------ ------ ------ ------ ------- ------ --------- ------ ------- --------
Issue of treasury stock for
conversion of preferred
stock to common stock - - - - - (240) - - - - (182)
Conversion of preferred
stock to common stock 27 26,546,674 - - - (7,651) - - - - (27)
Dividends declared on pre-
ferred stock - - - - - - - - - - -
Issue of common stock as
payment of dividends on
preferred stock 2 2,379,913 - - - - - - - - 64
Conversion of debentures to
common stock 6 5,945,870 - - - - - - - - 166
Issue of treasury stock for
conversion of debentures
to common stock - - - - - - - - - - (324)
Conversion of note payable
to stockholder to common
stock 13 12,650,000 - - - - - - - - 913
Issue of common stock as
payment of interest on
debentures - 317,433 - - - - - - - - 9
Issue of common stock for
cash 1 1,245,800 - - - - - - - - 68
Effect of the beneficial
conversion feature of the
convertible debentures - - - - - - - - - - 171
Effect of 40 to 1 reverse
common stock split (85) (85,159,031) - - - - - - - - 85
Net loss - - - - - - - - - - -
------- ------------ ------ ------ ------ ------- ------ --------- ------ ------- --------
Balance at June 30, 2002 2 2,183,575 - - - 7,869 2 2,400,855 - 350,000 10,566
Issue of common stock for
services and financing
costs 5 3,888,186 - - - - - - - - 4,131
LOSSES
ACCUMULATED
DURING THE
TREASURY DEVELOPMENT
STOCK STAGE TOTAL
--------- ----------- -------
Issue of treasury stock for
conversion of preferred
stock to common stock 182 - -
Conversion of preferred
stock to common stock - - -
Dividends declared on pre-
ferred stock - (103) (103)
Issue of common stock as
payment of dividends on
preferred stock - - 66
Conversion of debentures to
common stock - - 172
Issue of treasury stock for
conversion of debentures
to common stock 378 - 54
Conversion of note payable
to stockholder to common
stock - - 926
Issue of common stock as
payment of interest on
debentures - - 9
Issue of common stock for
cash - - 69
Effect of the beneficial
conversion feature of the
convertible debentures - - 171
Effect of 40 to 1 reverse
common stock split - - -
Net loss - (2,398) (2,398)
--------- ----------- -------
Balance at June 30, 2002 (17) (11,230) (677)
Issue of common stock for
services and financing
costs - - 4,136
|
The accompanying notes are an integral part of these financial statements.
Continued
F-8
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
STATEMENT OF STOCKHOLDERS' EQUITY (DEFICIT), CONTINUED
FOR THE YEARS ENDED JUNE 30, 2004 AND 2003, AND
FOR THE PERIOD FROM INCEPTION, JUNE 10, 1996 TO JUNE 30, 2004
__________
(IN THOUSANDS, EXCEPT SHARE DATA)
COMMON STOCK COMMON STOCK SERIES A SERIES B SERIES C
ENDOVASC SERIES NDC SERIES PREFERRED STOCK PREFERRED STOCK PREFERRED STOCK
------------------- -------------- --------------- -------------------- -----------------
AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES
------ ----------- ------ ------ ------ ------- ------- ----------- ------ ---------
Issue of common stock for
assets - 185,000 - - - - - - - -
Conversion of preferred
stock to treasury stock - 121,000 - - - - - (12,100) - -
Conversion of preferred
stock to common stock 31 31,320,592 - - - (7,594) (2) (2,388,755) - (350,000)
Dividends declared on pre-
ferred stock - - - - - - - - - -
Issue of common stock as
payment of dividends on
preferred stock - 100,753 - - - - - - - -
Conversion of convertible
debentures to common
stock - 363,900 - - - - - - - -
Conversion of liabilities
to common stock 1 873,530 - - - - - - - -
Issue of warrants for ser-
vices - - - - - - - - - -
Issue of common stock for
exercise of warrants 3 2,579,562 - - - - - - - -
Issue of common stock for
cash 1 1,236,335 - - - - - - - -
Retirement of treasury
stock - (52,125) - - - - - - - -
Effect of a 6 to 5 for-
ward stock split 8 8,132,830 - - - 55 - - - -
Net loss - - - - - - - - - -
------ ----------- ------ ------ ------ ------- ------- ----------- ------ ---------
Balance at June 30, 2003 51 50,933,138 - - - 330 - - - -
LOSSES
ACCUMULATED
ADDITIONAL DURING THE
PAID-IN TREASURY DEVELOPMENT
CAPITAL STOCK STAGE TOTAL
----------- --------- ----------- -------
Issue of common stock for
assets 197 - - 197
Conversion of preferred
stock to treasury stock 5 (5) - -
Conversion of preferred
stock to common stock (29) - - -
Dividends declared on pre-
ferred stock - - (40) (40)
Issue of common stock as
payment of dividends on
preferred stock 47 - - 47
Conversion of convertible
debentures to common
stock 170 - - 170
Conversion of liabilities
to common stock 726 - - 727
Issue of warrants for ser-
vices 3,682 - - 3,682
Issue of common stock for
exercise of warrants 610 - - 613
Issue of common stock for
cash 446 - - 447
Retirement of treasury
stock (22) 22 - -
Effect of a 6 to 5 for-
ward stock split (8) - - -
Net loss - - (9,644) (9,644)
----------- --------- ----------- -------
Balance at June 30, 2003 20,521 - (20,914) (342)
|
The accompanying notes are an integral part of these financial statements.
F-9
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
STATEMENT OF STOCKHOLDERS' EQUITY (DEFICIT), CONTINUED
FOR THE YEARS ENDED JUNE 30, 2004 AND 2003, AND
FOR THE PERIOD FROM INCEPTION, JUNE 10, 1996 TO JUNE 30, 2004
__________
(IN THOUSANDS, EXCEPT SHARE DATA)
COMMON STOCK COMMON STOCK SERIES A SERIES B SERIES C
ENDOVASC SERIES NDC SERIES PREFERRED STOCK PREFERRED STOCK PREFERRED STOCK
------------------- ------------------- ---------------- --------------- ---------------
AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES
------- ---------- ------- ---------- ------- ------- ------- ------ ------- ------
Issuance of common stock for
services 6 5,774,322 - - - - - - - -
Issuance of common stock for
lawsuit settlement - 500,000 - - - - - - - -
Conversion of liabilities to
common stock - 674,161 - - - - - - - -
Conversion of note payable
to stockholder to common
stock 2 1,800,000 - - - - - - - -
Issuance of common stock for
cash 8 7,615,737 - - - - - - - -
Issuance of common stock for
exercise of warrants and
options 3 2,850,758 - - - - - - - -
Conversion of preferred stock
to common stock - 55,518 - - - (122) - - - -
4 to 1 stock dividend through
issuance of common stock-
NDC Series - - 14 14,158,593 - - - - - -
Issuance of stock options/
warrants for services - - - - - - - - - -
Net loss - - - - - - - - - -
------- ---------- ------- ---------- ------- ------- ------- ------ ------- ------
Balance at June 30, 2004 $ 70 70,203,634 $ 14 14,158,593 $ - 208 $ - - $ - -
======= ========== ======= ========== ======= ======= ======= ====== ======= ======
LOSSES
ACCUMULATED
ADDITIONAL DURING THE
PAID-IN TREASURY DEVELOPMENT
CAPITAL STOCK STAGE TOTAL
---------- --------- ------------ --------
Issuance of common stock for
services 1,614 - - 1,620
Issuance of common stock for
lawsuit settlement 125 - - 125
Conversion of liabilities to
common stock 163 163
Conversion of note payable
to stockholder to common
stock 685 - - 687
Issuance of common stock for
cash 1,215 - - 1,223
Issuance of common stock for
exercise of warrants and
options 556 - - 559
Conversion of preferred stock
to common stock - - - -
4 to 1 stock dividend through
issuance of common stock-
NDC Series (14) - - -
Issuance of stock options/
warrants for services 353 - - 353
Net loss - - (4,679) (4,679)
---------- --------- ------------ --------
Balance at June 30, 2004 $ 25,218 $ - $(25,593) $ (291)
========== ========= ============ ========
|
The accompanying notes are an integral part of these financial statements.
F-10
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
STATEMENT OF CASH FLOWS
FOR THE YEARS ENDED JUNE 30, 2004 AND 2003, AND
FOR THE PERIOD FROM INCEPTION, JUNE 10, 1996, TO JUNE 30, 2004
__________
(IN THOUSANDS)
YEAR ENDED
---------------------- INCEPTION
JUNE 30, JUNE 30, TO JUNE 30,
2004 2003 2004
---------- ---------- -------------
Cash flows from operating activities:
Net loss $ (4,679) $ (9,644) $ (25,535)
Adjustments to reconcile net loss to net cash used
in operating activities:
Common stock, preferred stock and warrants
issued as compensation for services, financing
costs and lawsuit settlement 2,098 7,818 13,833
Extraordinary loss - - 127
Write down of long-lived assets to fair value - - 285
Depreciation and amortization expense 77 75 294
Deferred income tax expense - - 8
Amortization of discount on convertible debentures - - 421
Changes in operating assets and liabilities:
Decrease (increase) in accounts receivable 76 116 (22)
Decrease (increase) in other assets 15 (100) (220)
Increase in accounts payable and
accrued liabilities 373 257 1,757
Increase in deferred liabilities 53 - 53
---------- ---------- -------------
Net cash used in operating activities (1,987) (1,478) (8,999)
---------- ---------- -------------
Cash flows from investing activities:
Capital expenditures (1) (10) (158)
Proceeds received from repayment of loan to
stockholder - - 72
---------- ---------- -------------
Net cash used in investing activities (1) (10) (86)
---------- ---------- -------------
Cash flows from financing activities:
Proceeds from sale of equity securities - - 337
Proceeds from sale of common stock 1,223 447 1,916
Proceeds from exercise of warrants 529 613 1,177
Proceeds from sale of convertible debenture and
related conversion feature - - 1,437
Net proceeds from issuance of preferred stock - - 2,263
Issuance of long-term debt and notes payable 398 287 1,099
Repayment of long-term debt and notes payable (416) (341) (874)
Payments of obligations under capital leases (47) (21) (129)
Proceeds from advances from stockholders 495 793 2,371
Repayments of notes to stockholder (198) (171) (374)
Purchase of treasury stock - - (22)
---------- ---------- -------------
Net cash provided by financing activities 1,984 1,607 9,201
---------- ---------- -------------
Net (decrease) increase in cash and cash equivalents (4) 119 116
Cash and cash equivalents at beginning of year 120 1 -
---------- ---------- -------------
Cash and cash equivalents at end of year $ 116 $ 120 $ 116
========== ========== =============
Supplemental disclosure of cash flow information:
Cash paid for interest expense $ 17 $ 52 $ 185
========== ========== =============
Cash paid for income taxes $ - $ - $ -
========== ========== =============
|
The accompanying notes are an integral
part of these financial statements.
F-11
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS
(IN THOUSANDS, EXCEPT SHARE DATA)
1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Endovasc, Inc. (the "Company") is incorporated under the laws of the State
of Nevada. The Company's principal business is the production of various
drugs that can be administered using an advanced drug delivery system. The
Company believes that its drug delivery system will ultimately be widely
used by cardiologists, interventional radiologists and vascular surgeons.
The Company is considered a development stage enterprise because it has not
yet generated significant revenue from sale of its products and has devoted
substantially all of its efforts in raising capital.
Effective June 27, 2003, the Company's board of directors approved the
creation of a wholly-owned subsidiary named Nutraceutical Development
Corporation ("NDC") to manage its Nutraceutical product line (Note 20). In
addition, during the year ended June 30, 2004, the Company acquired a
controlling interest in two joint ventures that have been consolidated in
the accompanying financial statements (Note 21). The consolidated financial
statements include the accounts of the Company, its subsidiary and its
majority owned joint venture investments. All intercompany accounts and
transactions are eliminated in consolidation.
SIGNIFICANT 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 dates of the financial statements and the reported
amounts of revenues and expenses during the periods. Actual results could
differ from estimates making it reasonably possible that a change in the
estimates could occur in the near term.
CASH AND CASH EQUIVALENTS
The Company considers all highly liquid short-term investments with an
original maturity of three months or less when purchased to be cash
equivalents.
The Company maintains cash deposits in banks which may occasionally exceed
the amount of federal deposit insurance available. Management periodically
assesses the financial condition of the institutions and believes that any
possible deposit loss is minimal.
PROPERTY AND EQUIPMENT
Property and equipment are recorded at cost. Depreciation is provided on
the straight-line method over the estimated useful lives of the assets,
which range from five to seven years. Expenditures for major renewals and
betterments that extend the original estimated economic useful lives of the
applicable assets are capitalized. Expenditures for normal repairs and
maintenance are charged to expense as incurred. The cost and related
accumulated depreciation of assets sold or otherwise disposed of are
removed from the accounts, and any gain or loss is included in operations.
DEBT ISSUANCE COSTS
Debt issuance costs are deferred and recognized, using the interest method,
over the term of the related debt.
Continued
F-12
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS, CONTINUED
(IN THOUSANDS, EXCEPT SHARE DATA)
1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, CONTINUED
INCOME TAXES
The Company uses the liability method of accounting for income taxes. Under
this method, deferred income taxes are recorded to reflect the tax
consequences on future years of temporary differences between the tax basis
of assets and liabilities and their financial amounts at year-end. The
Company provides a valuation allowance to reduce deferred tax assets to
their net realizable value.
RESEARCH AND DEVELOPMENT
Research and development costs are expensed as incurred. These costs
consist of direct and indirect costs associated with specific projects.
STOCK-BASED COMPENSATION
The Company accounts for employee stock options using the intrinsic value
method in accordance with Accounting Principles Board Opinion ("APB") No.
25, Accounting for Stock Issued to Employees, and has adopted the
disclosure-only alternative of SFAS No. 123, Accounting for Stock-Based
Compensation, as amended by SFAS No. 148, Accounting for Stock-Based
Compensation-Transition and Disclosure. Under the intrinsic value method,
the Company has only recorded stock-based compensation resulting from
options granted at below fair market value.
LOSS PER SHARE
Basic and diluted loss per share is computed on the basis of the weighted
average number of shares of common stock outstanding during each period.
Common equivalent shares from common stock options and warrants and Series
A, B and C convertible preferred stock are excluded from the computation
(See Note 14) as their effect would dilute the loss per share for all
periods presented.
If the Company had reported net income for the years ended June 30, 2004 or
2003, the calculation of diluted net income per share would not have
included any additional common equivalent shares.
FAIR VALUE OF FINANCIAL INSTRUMENTS
The Company includes fair value information in the notes to financial
statements when the fair value of its financial instruments is different
from the book value. When the book value approximates fair value, no
additional disclosure is made.
LONG-LIVED ASSETS INCLUDING GOODWILL AND OTHER ACQUIRED INTANGIBLE ASSETS
The Company reviews property and equipment and certain identifiable
intangibles, excluding goodwill, for impairment whenever events or changes
in circumstances indicate the carrying amount of an asset may not be
recoverable. Recoverability of these assets is measured by comparison of
its carrying amounts to future undiscounted cash flows the assets are
expected to generate. If property and equipment and certain identifiable
intangibles are considered to be impaired, the impairment to be recognized
equals the amount by which the carrying value of the asset exceeds its fair
market value. There was no impairment of long-lived assets in the years
ended June 30, 2004 and 2003.
Continued
F-13
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS, CONTINUED
(IN THOUSANDS, EXCEPT SHARE DATA)
1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, CONTINUED
LONG-LIVED ASSETS INCLUDING GOODWILL AND OTHER ACQUIRED INTANGIBLE ASSETS,
CONTINUED
The Company has adopted SFAS No. 142, Goodwill and Other Intangible Assets.
SFAS No. 142 requires that goodwill and intangible assets with indefinite
useful lives no longer be amortized, but instead be tested for impairment
at least annually or sooner whenever events or changes in circumstances
indicate that they may be impaired. The Company was not affected by this
requirement as it does not have any goodwill or intangible assets with
indefinite useful lives as of June 30, 2004 or 2003.
SFAS No. 142 also requires that intangible assets with definite lives be
amortized over their estimated useful lives and reviewed for impairment
whenever events or changes in circumstances indicate an asset's carrying
value may not be recoverable in accordance with SFAS No. 144. The Company
is currently amortizing its acquired intangible assets with definite lives
over periods ranging from 1 to 10 years. The Company believes no events or
changes in circumstances have occurred that would require an impairment
test for these assets during the years ended June 30, 2004 and 2003.
CONCENTRATION OF CREDIT RISK
The Company's financial instruments that potentially subject the Company to
concentration of credit risk consist principally of accounts receivable
from a sponsor under an external research agreement. Accounts receivable
from this sponsor represented 100% of the Company's accounts receivable
outstanding at June 30, 2004 and June 30, 2003. In addition, the sponsor
under the external research agreement represented 100% of the Company's
revenues for the year ended June 30, 2004.
2. LICENSE AGREEMENTS
In February 2000 the Company entered into an exclusive license agreement
with Stanford University to assist in the development of the Nicotine
Receptor Agonist technology. For the exclusive rights to this license, the
Company paid a non-refundable license fee of $100 plus 190,000 shares of
the Company's common stock to Stanford University and the inventors of the
technology. The term of the agreement is for 10 years or five years from
the first commercial sale of a licensed product by the Company, whichever
occurs first. The Company is also required to pay an annual royalty of $100
beginning February 1, 2001 and each year thereafter and a 6% royalty on net
sales of any licensed product. The Company is required to pay to Stanford
an additional $100 upon FDA approval of Phase I clinical trials, $300 upon
FDA approval of Phase III clinical trials and $500 within six months after
FDA marketing approval.
The costs of obtaining the license of $163 were capitalized and included in
other assets in the accompanying balance sheet. These costs are being
amortized on a straight line basis over the term of the agreement.
Amortization expense during each of the years ended June 30, 2004 and 2003
was $15.
Continued
F-14
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS, CONTINUED
(IN THOUSANDS, EXCEPT SHARE DATA)
2. LICENSE AGREEMENTS, CONTINUED
In May 2002 the Company entered into a perpetual agreement with another
company ("Licensee") whereby the Company granted the Licensee an exclusive
world-wide license to manufacture, market and distribute various products
using the Company's stent coating technology. In consideration for this
license, the Company received a non-refundable initial fee of $200, of
which $50 was used by the Licensee to purchase 1,000,000 shares of the
Company's common stock. The Company was also to receive an additional
$2,000, payable to the Company by the Licensee, at the sole and absolute
discretion of the Licensee in cash or common stock of the Licensee with
$1,000 due within 12 months and $1,000 due within 24 months from the
execution date of the agreement with the provision that at least $300 of
each $1,000 payment must be payable in cash. In addition, the Company was
to receive the greater of a royalty fee of 8% of all gross product sales or
an additional $2,000 payable in cash for each 10-year period the agreement
remains in effect. During the year ended June 30, 2002, the Company
collected $50 in cash, $50 upon the sale of 1,000,000 shares of the
Company's common stock and recorded $100 in accounts receivable, which was
collected during the year ended June 30, 2003. During the year ended June
30, 2003, $140 of revenue was recognized under the agreement. No additional
amounts have been recognized due to the Licensee exercising its rights to
cancel this agreement prior to the payment of the initial $1,000 payment on
May 13, 2003.
3. RESEARCH AGREEMENT
Effective July 1, 2001, the Company entered into an External Research
Agreement with another company (the "Sponsor") whereby the Sponsor agreed
to assist in the funding of the Company's research and development related
to its Nicotine Receptor Agonist technology for one year with the option to
extend the agreement for an additional one year term. The Sponsor agreed to
fund $512 which was recorded as revenue in the statement of operations for
the year ended June 30, 2002. The option to extend this agreement for an
additional one year term was exercised. The extension increased the funding
to $730 and resulted in $147 of revenue for the year ended June 30, 2003.
The agreement was verbally extended subsequent to July 1, 2003 to extend
the time allowed to receive the maximum funding, resulting in additional
revenue of $71 during the year ended June 30, 2004.
4. OTHER CURRENT ASSETS
Other current assets at June 30, 2004 and 2003 consists of the following
(in thousands):
2004 2003
----- -----
Other receivable $ 30 $ 29
Prepaid license 58 58
Prepaid supplies 278 278
Prepaid insurance 9 -
----- -----
$ 375 $ 365
===== =====
|
Continued
F-15
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS, CONTINUED
(IN THOUSANDS, EXCEPT SHARE DATA)
5. PROPERTY AND EQUIPMENT
Property and equipment at June 30, 2004 and 2003 consists of the following
(in thousands):
2004 2003
------ ------
Office furniture, fixtures and equipment $ 319 $ 321
Less accumulated depreciation (205) (146)
------ ------
$ 114 $ 175
====== ======
|
Depreciation expense during the years ended June 30, 2004 and 2003 was $62
and $59, respectively. Included in property and equipment at June 30, 2004
and 2003 is equipment under capital leases of $182.
6. CONVERTIBLE DEBENTURES
During the year ended June 30, 2002, the Company issued $400 in convertible
debentures. The debentures bear interest at 8% per year payable quarterly
in arrears. The debentures mature in September 2004 and are convertible, at
the option of the holder, to shares of the Company's common stock at a
conversion price per share equal to the lower of (i) 85% of the average of
the three lowest closing prices for the common stock for the thirty days
prior to the closing date of the debentures; or (ii) 70% of the average of
the three lowest closing prices for the common stock for the thirty days
prior to the conversion date. Accordingly, the actual weighted average
interest rate on these debentures, including the effect of the cost of the
beneficial conversion feature is approximately 23%.
During the year ended June 30, 2003, 363,900 shares of common stock were
issued upon the conversion of $170 of the convertible debentures and 6,100
shares of common stock were issued as payment of $3 of interest owed on the
convertible debentures.
During the year ended June 30, 2002, 8,045,870 shares of common stock
(including treasury stock) were issued upon the conversion of $229 of the
convertible debentures and 317,433 shares of common stock were issued as
payment of $9 of interest owed on the convertible debentures.
Continued
F-16
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS, CONTINUED
(IN THOUSANDS, EXCEPT SHARE DATA)
7. NOTES PAYABLE
Notes payable at June 30, 2004 and 2003 consist of the following (in
thousands):
2004 2003
------ ------
Note payable to a financial institution, bearing
interest at prime (4% at June 30, 2004) with
interest due monthly and principal due on demand.
Note is uncollateralized but is guaranteed by two
stockholders of the Company. $ 46 $ 56
Note payable to a financial institution, bearing
interest at prime (4% at June 30, 2004) plus
1.5% or an annual rate of 6%, whichever is higher,
principal and interest due on demand, with monthly
interest payments due until demand is made or at
maturity on November 7, 2003. This note is
collateralized by personal property of a stockholder
of the Company. - 14
Note payable to a financial institution, bearing
interest at rates ranging from 16% to 18%
and due in 9 monthly installments of $924. 6 -
Notes are uncollateralized.
Notes payable to stockholders, non-interest bearing
and due on demand. These notes are uncollateralized. 290 680
------ ------
Total notes payable 342 750
Less current maturities (342) (721)
------ ------
$ - $ 29
====== ======
|
8. ACCRUED LIABILITIES
Accrued liabilities at June 30, 2004 and 2003 consist of the following (in
thousands):
2004 2003
----- -----
Accrued payroll and related taxes $ 20 $ 6
Dividends payable 7 7
Other accrued expenses - 4
----- -----
$ 27 $ 17
===== =====
|
Continued
F-17
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS, CONTINUED
(IN THOUSANDS, EXCEPT SHARE DATA)
9. INCOME TAX
The composition of deferred tax assets and the related tax effects at June
30, 2004 and 2003 are as follows (in thousands):
2004 2003
-------- --------
Benefit from carryforward of net operating losses $ 4,803 $ 3,925
Less valuation allowance (4,803) (3,925)
-------- --------
Net deferred tax asset $ - $ -
======== ========
|
The difference between the income tax benefit in the accompanying statement
of operations and the amount that would result if the U.S. Federal
statutory rate of 34% were applied to pre-tax loss is as follows (in
thousands):
2004 2003
--------------------- ---------------------
PERCENTAGE PERCENTAGE
OF PRE-TAX OF PRE-TAX
AMOUNT LOSS AMOUNT LOSS
------------ ------- ------------ --------
Benefit for income tax at
federal statutory rate $ 1,591 34.0% $ 3,279 34.0%
Non-deductible expenses (713) (15.2%) (1,559) (16.2)
Increase in valuation
allowance (878) (18.8%) (1,720) (17.8)
------------ ------- ------------ --------
Total $ - -% $ - -%
============ ======= ============ ========
|
The non-deductible expenses relate primarily to the issuance of common
stock for services using different valuation methods for financial and tax
reporting purposes.
At June 30, 2004, for federal income tax and alternative minimum tax
reporting purposes, the Company has approximately $14,140 of unused net
operating losses available for carryforward to future years. The benefit
from carryforward of such net operating losses will expire in various years
between 2016 and 2024 and could be subject to severe limitations if
significant ownership changes occur in the Company.
10. COMMON STOCK
During the year ended June 30, 2003, the board of directors approved the
purchase by the Company of up to 2% of the outstanding shares of its common
stock. No purchase of common stock of the Company was made by the Company
during the years ended June 30, 2004 or 2003.
Continued
F-18
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS, CONTINUED
(IN THOUSANDS, EXCEPT SHARE DATA)
11. STOCK OPTIONS AND WARRANTS
The Company periodically issues incentive stock options and warrants to key
employees, officers, directors and outside consultants to provide
additional incentives to promote the success of the Company's business and
to enhance the ability to attract and retain the services of qualified
persons. The issuance of such options are approved by the Board of
Directors. The exercise price of an option or warrant granted is determined
by the fair market value of the stock on the date of grant. All of the
following have been adjusted for the effect of the 5 to 6 forward stock
split and the 40 to 1 reverse stock split (See Note 13), unless otherwise
noted.
During the year ended June 30, 2000, the Company issued stock warrants to
acquire 8,320 shares of the Company's common stock to certain companies for
their role in the completion of the Company's preferred stock offering.
These warrants have a three year term and an exercise price of $75.60 per
share, which approximated market value at the date of grant. During the
years ended June 30, 2000 and 2001, the Company also issued stock warrants
to acquire 12,500 and 25,000 shares, respectively, of the Company's common
stock to a company as a finder's fee for the placement of the preferred
stock offering. The warrants have a five year term and an exercise price of
$4.00 and $0.40 per share, respectively. The costs associated with these
stock warrants did not effect the Company's statement of operations as all
costs were offset against the offering proceeds and recorded through
stockholders' equity.
During the year ended June 30, 2001, the Company granted options to various
consultants and employees, with a term of 3 years, to purchase 39,766
shares of the Company's common stock at a price ranging from $13.33 to
$33.33 per share, which was greater than the market price of the stock at
the grant date.
In May 2002, the Company adopted the 2002 Directors, Officers and
Consultants Stock Option, Stock Warrant and Stock Award Plan (the "Plan").
The purpose of the Plan is to maintain the ability of the Company to
attract and retain highly qualified and experienced directors, employees
and consultants and to give such directors, employees and consultants a
continued proprietary interest in the success of the Company. In addition,
the Plan is intended to encourage ownership of common stock of the Company
by the directors, employees and consultants of the Company and to provide
increased incentive for such persons to render services and to exert
maximum effort for the success of the Company's business. Subject to
adjustment so that the total number of shares issuable under the Plan will
equal 15% of the total number of issued and outstanding common stock of the
Company, the aggregate number of shares of common stock that may be
optioned, subject to conversion or issued under the Plan is 18,750,000
which has not been adjusted for the 40 to 1 reverse split of the Company's
common stock (See Note 13).
Continued
F-19
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS, CONTINUED
(IN THOUSANDS, EXCEPT SHARE DATA)
11. STOCK OPTIONS AND WARRANTS, CONTINUED
The maximum term of options granted under this Plan is ten years. The
aggregate fair market value of the stock with respect to which incentive
stock options are first exercisable in any calendar year may not exceed
$1,000,000. The exercise price of incentive stock options must be equal or
greater than the fair market value of common stock on the date of grant.
The exercise price of incentive stock options granted to any person who at
the time of grant owns stock possessing more than 10% of the total combined
voting power of all classes of stock must be at least 110% of the fair
market value of such stock on the date of grant, and the term of these
options cannot exceed five years.
Non-qualified stock options or warrants, restricted common stock and/or
convertible preferred stock may be granted under the Plan. The terms of
these issuances are determined based on the sole discretion of the
Company's Compensation Committee.
During the year ended June 30, 2002, the Company issued stock warrants,
which were subject to the 40 to 1 reverse stock split, to acquire 58,750
shares of the Company's common stock to various consultants for services
provided to the Company. Of these warrants, 56,250 have a 6 month term and
exercise prices ranging from $5.20 to $20.00 per share, which was greater
than market value at the date of grant. The remaining 2,500 of warrants
have a 5 year term and an exercise price of $2.40 per share, which
approximated market value at the date of grant.
During November 2002, the Company entered into an agreement with a warrant
holder to exclude their warrants from the effects of the 40 to 1 reverse
stock split. This resulted in a change in the number of warrants granted by
2.2 million warrants with an exercise price of $0.13 to $0.50. This change
in the terms of these warrants resulted in an additional expense to the
Company of $3,549, which was recorded in operating, general and
administrative expenses in the accompanying statement of operations for the
year ended June 30, 2003.
During the year ended June 30, 2003, the Company issued stock warrants to
acquire 816,490 shares of the Company's common stock. Of these warrants,
316,490 (379,788 after the 6 to 5 forward stock split) of them were to
individuals purchasing stock as an incentive for the purchase and have an
exercise price of $1.50 per share ($1.80 after the 6 to 5 forward split)
and expiration dates ranging from one to three years from the issuance
date. The costs associated with these stock warrants did not effect the
Company's statement of operations as the value of $61 as determined by the
Black-Scholes valuation model was offset against the offering proceeds and
recorded through stockholders' equity. The remaining 500,000 warrants were
issued to a consultant for services provided to the Company and have an
exercise price of 70% of the stock price on the date of exercise and expire
two months from issuance. The cost of these warrants of $133 has been
included in the accompanying statement of operations for the year ended
June 30, 2003.
Continued
F-20
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS, CONTINUED
(IN THOUSANDS, EXCEPT SHARE DATA)
11. STOCK OPTIONS AND WARRANTS, CONTINUED
In May 2003, the Company adopted the 2003 Stock Compensation Plan (the
"Plan") in order to attract and retain highly qualified and experienced
directors, employees and consultants and to give such directors, employees
and consultants a continued proprietary interest in the success of the
Company. Under the Plan, the Company may award up to 10,000,000 shares of
its common stock or options to purchase its common stock to the directors,
employees and consultants of the Company. All terms of the common stock,
stock options or warrants granted under the Plan are at the discretion of
the board of directors but will expire not more than ten years from the
date of grant. During the year ended June 30, 2004, the Company issued
stock options and warrants to two consultants to acquire 2,850,758 shares
of the Company's common stock at prices ranging from $0.15-$0.29, all of
which were exercised during the year.
The Company has issued stock options to employees and non-employee
consultants as follows:
NUMBER OF SHARES WEIGHTED
---------------------- AVERAGE
NON- EXERCIS- EXERCISE EXERCISE
EMPLOYEE EMPLOYEE TOTAL ABLE PRICE PRICE
--------- ----------- ----------- ----------- ------------- --------
Options outstanding
at June 30, 2002 10,516 29,250 39,766 39,766 $13.33-$33.33 $ 14.00
Options expired - - - -
--------- ----------- ----------- -----------
Options outstanding
at June 30, 2003 10,516 29,250 39,766 39,766 $13.33-$33.33 $ 14.00
Options expired (10,516) (29,250) (39,766) (39,766) $13.33-$33.00 $ 14.00
Options issued - 1,850,758 1,850,758 1,850,758 $ 0.17-$0.29 $ 0.22
Options exercised - (1,850,758) (1,850,758) (1,850,758) $ 0.17-$0.29 $ 0.22
--------- ----------- ----------- -----------
Options outstanding
at June 30, 2004 - - - -
========= =========== =========== ===========
|
During the year ended June 30, 2004 and 2003, the Company issued stock
warrants to certain companies in payment of stock offering costs and for
consulting services, some of which were subsequently exercised, as follows:
Continued
F-21
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS, CONTINUED
(IN THOUSANDS, EXCEPT SHARE DATA)
11. STOCK OPTIONS AND WARRANTS, CONTINUED
WEIGHTED
AVERAGE
NUMBER OF EXERCISE EXERCISE
SHARES EXERCISABLE PRICE PRICE
----------- ------------ -------------- ---------
Warrants outstanding at
June 30, 2002 73,325 73,325 $ 2.40-$75.60 $ 16.00
Effect of change in warrant
agreement 2,193,750 2,193,750 $ 0.13-$0.50 $ 0.23
Warrants issued 816,490 816,490 70% of market $ 0.96
price-$1.50
Warrants exercised (2,579,562) (2,579,562) $ 0.13-$0.39 $ 0.24
Warrants expired (178,763) (178,763) $ 0.50-$75.60 $ 3.99
Effect of 6:5 stock split 65,048 65,048 $ 1.25-$3.33 $ 1.30
----------- ------------
Warrants outstanding at
June 30, 2003 390,288 390,288 $ 1.25-$3.33 $ 1.30
Warrants issued 1,000,000 1,000,000 $ 0.15-$0.20 $ 0.17
Warrants exercised (1,000,000) (1,000,000) $ 0.15-$0.20 $ 0.17
Warrants expired (51,036) (51,036) $ 1.25 $ 1.25
----------- ------------
Warrants outstanding at
June 30, 2004 339,252 339,252 $ 1.25-$3.33 $ 1.30
=========== ============
|
Following is a summary of outstanding warrants at June 30, 2004:
NUMBER OF SHARES VESTED EXPIRATION DATE EXERCISE PRICE
---------------- ------- --------------- ---------------
7,500 7,500 May 2005 $ 3.33
9,600 9,600 October 2005 $ 1.25
319,152 319,152 January 2006 $ 1.25
3,000 3,000 August 2006 $ 2.00
---------------- -------
339,252 339,252
================ =======
|
The Company has elected to follow Accounting Principles Board Opinion No.
25, "Accounting for Stock Issued to Employees" (APB 25) and related
Interpretations in accounting for its employee stock options because, as
discussed below, the alternative fair value accounting provided for under
FASB Statement No. 123, "Accounting for Stock-Based Compensation", requires
use of option valuation models that were not developed for use in valuing
employee stock options.
Continued
F-22
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS, CONTINUED
(IN THOUSANDS, EXCEPT SHARE DATA)
11. STOCK OPTIONS AND WARRANTS, CONTINUED
Proforma information regarding net income and earnings per share is
required by SFAS No. 123 and No. 148, and has been determined as if the
Company had accounted for its employee stock options under the fair value
method of that Statement. The fair value for these options was estimated at
the date of grant using a Black-Scholes option pricing model with the
following weighted-average assumptions for 2004 and 2003.
2004 2003
--------- -------
Risk-free interest rate 3.75% 5.00%
Dividend yield - -
Volatility 190% 50%
Weighted average and expected life 2 months 1 year
|
The Black-Scholes option valuation model was developed for use in
estimating fair value of traded options which have no vesting restrictions
and are fully transferable. In addition, option valuation models require
the input of highly subjective assumptions including the expected stock
price volatility. Because the Company's stock options have characteristics
significantly different from those of traded options, and because changes
in the subjective input assumptions can materially affect the fair value
estimate, in management's opinion, the existing models do not necessarily
provide a reliable single measure of the fair value of its stock options.
For purposes of proforma disclosures, the estimated fair value of the
options is included in expense at the date of issuance. The Company's
proforma information is as follows (in thousands, except per share data):
2004 2003
-------- --------
Net loss available to common stockholders $(4,679) $(9,644)
Proforma net loss available to common stockholders $(4,679) $(9,644)
Proforma basic and dilutive loss per share $ (0.06) $ (0.26)
|
12. PREFERRED STOCK
The Company's articles of incorporation authorize the issuance of up to
20,000,000 shares of preferred stock with characteristics determined by the
Company's board of directors. Effective May 5, 2000, the board of directors
authorized the issuance and sale of up to 55,000 shares of Series A 8%
convertible preferred stock. The following information excludes the effect
of the 40 to 1 reverse stock split. The conversion features of all classes
of preferred stock were not subject to the effects of the split.
Continued
F-23
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS, CONTINUED
(IN THOUSANDS, EXCEPT SHARE DATA)
12. PREFERRED STOCK, CONTINUED
On May 9, 2000, the Company issued 15,000 shares of $0.001 par value and
$100 per share liquidation value Series A 8% non-voting convertible
preferred stock for $1,500. The actual proceeds received by the Company
were $1,040, which are net of related offering costs. During the year ended
June 30, 2001, the Company issued an additional 15,000 shares of the Series
A preferred stock for cash proceeds to the Company of $1,223, which is net
of related offering costs of $277. In addition, the Company issued as a
finders fee, warrants to purchase 1,000,000 shares of common stock at $0.01
per share, which resulted in additional offering costs of $162.
The Series A convertible preferred stock can be converted to common stock
at any time at the option of the holder. The conversion rate is the stated
value per share plus any accrued and unpaid dividends divided by 85% of the
average of the three lowest closing bid prices of the Company's common
stock for the thirty trading days immediately preceding May 9, 2000, or 70%
of the average of the three lowest closing bid prices for the thirty days
immediately preceding the conversion date of the respective preferred
stock. During the years ended June 30, 2004, 2003, 2002 and 2001, 122,
7,594, 7,651 and 14,240 shares of preferred stock were converted to 55,518,
1,737,798, 26,546,674 and 16,501,251 shares of common stock, respectively.
In addition, in 2002, 1,000,000 shares of treasury stock were issued for
the conversion of 240 shares of preferred stock. The preferred stock shares
outstanding increased by 55 during the year ended June 30, 2003 as a result
of the forward stock split.
In addition, the Series A preferred stockholders were originally obligated
to purchase an additional 30,000 shares (of which 15,000 shares were
purchased during the year ended June 30, 2001) of Series A 8% convertible
preferred stock at the option of the Company subject to the Company's
compliance with various covenants. The Company has violated certain of
these covenants but the stockholders retain the right to waive any
violations. The purchase price of additional shares is $100 per share. If
the conversion price is lower than the initial price at the date of issue,
the Company has the right to redeem the shares of Series A preferred stock
at 130% of its liquidation value per share.
In May 2002, the Company's board of directors authorized the issuance of up
to 3,000,000 shares of Series B convertible preferred stock with a par
value of $0.001 per share. Each share of Series B preferred stock is
convertible into 10 shares of common stock at the option of the holder.
Upon the occurrence of a recapitalization of the Company, each share of
Series B preferred stock is automatically converted to 10 shares of the
Company's common stock. Each share of Series B preferred stock includes
voting rights equal to 500 shares of common stock. The shares of the Series
B preferred stock rank senior to the common stock both in payment of
dividends and liquidation preference.
As of June 30, 2002, the Company had entered into Exchange Agreements with
certain stockholders, whereby these stockholders exchanged 24,008,545
shares of the Company's common stock for 2,400,855 shares of Series B
convertible preferred stock. An additional 2,305,259 shares of the
Company's common stock were exchanged for 230,526 shares of Series B
convertible preferred stock during the year ended June 30, 2003.
Continued
F-24
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS, CONTINUED
(IN THOUSANDS, EXCEPT SHARE DATA)
12. PREFERRED STOCK, CONTINUED
In May 2002, the Company's board of directors authorized the issuance of up
to 370,000 shares of Series C convertible preferred stock with no par
value. Each share of Series C preferred stock is convertible into 10 shares
of common stock at the option of the holder. Upon the occurrence of an
increase in authorized common stock of the Company, each share of Series C
preferred stock is automatically converted into 10 shares of the Company's
common stock. Holders of the Series C preferred stock have voting rights,
dividend rights and liquidation preference equal to those of the common
stockholders.
In May 2002, 350,000 shares of the Series C convertible preferred stock
were issued to two consultants for services performed for the Company. The
cost associated with the issuance of these shares was $210.
During the year ended June 30, 2003, all shares of Series B and Series C
preferred stock were automatically converted back to the shares of common
stock originally exchanged and such conversion had a significant dilutive
effect on the owners of common stock (See Note 13).
13. REINCORPORATION
Effective July 9, 2002, the Company's board of directors and holders of
shares representing a majority of the voting rights of the outstanding
shares of the Company's common stock and preferred stock approved a
reincorporation of the Company from the State of Nevada to the State of
Delaware. This reincorporation was accomplished by a merger of the Company
into a new Delaware corporation of the same name. Under the terms of the
merger, holders of the Company's common stock received one share of the new
Delaware corporation common stock in exchange for 40 shares of the
Company's common stock, resulting in a 40 to 1 reverse split for all common
stockholders. All holders of the outstanding shares of Series A, B and C
convertible preferred stock were not subject to the 40 to 1 reverse split,
because under the terms of the merger agreement, each share of preferred
stock was converted into one share of preferred stock in the new Delaware
corporation with identical conversion rights, which resulted in significant
dilution to all common stockholders.
As a result of this reincorporation, each share of Series B and Series C
convertible preferred stock was automatically converted to 10 shares of the
Company's new common stock (See Note 12) resulting in the issuance of
29,813,804 post-split shares of common stock in the new Delaware
corporation. Accordingly, the reincorporation process resulted in a
preferential stock dividend of 29,068,459 shares of common stock issued to
holders of Series B and Series C convertible preferred stock in July 2002.
Continued
F-25
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS, CONTINUED
(IN THOUSANDS, EXCEPT SHARE DATA)
13. REINCORPORATION, CONTINUED
Each share of Series A convertible preferred stock was not automatically
converted to common stock upon reincorporation and was not subject to the
40 to 1 reverse split. Accordingly, holders of Series A convertible
preferred stock received a preferential dividend of 23,469,792 shares of
common stock based on the conversion rate on July 9, 2002.
This reincorporation resulted in an increase in authorized shares of the
Company's common stock to 200,000,000 shares with all other terms of the
common and preferred stock remaining the same except as otherwise noted.
The Company's treasury stock was cancelled and retired as a result of this
reincorporation and all shares held in treasury resumed the status of
authorized and unissued common stock.
The effect of the 40 to 1 reverse stock split has been recognized
retroactively in the stockholders' equity accounts on the balance sheet at
June 30, 2002, with the exception of 2,247,628 shares which were recognized
during the year ended June 30, 2003, and in all share and per share data in
the accompanying financial statements and notes to the financial statements
unless otherwise noted. Stockholders' equity accounts have been restated to
reflect the reclassification of an amount equal to the par value of the
decrease in issued common shares from the common stock account to the
additional paid-in capital account.
Effective March 31, 2003, the Company's board of directors and holders of
shares representing a majority of the voting rights of the outstanding
shares of the Company's common stock and preferred stock approved a
reversal of the previous reincorporation in Delaware and a new
reincorporation from the State of Delaware back into the State of Nevada.
This new reincorporation was accomplished by a merger of the Company into
Endovasc, Inc., a new Nevada corporation. Under the terms of the merger,
holders of the Company's common and preferred stock received 1.20 shares of
Endovasc, Inc. common and preferred stock in exchange for one share of the
Company's common and preferred stock resulting in a 6 to 5 forward stock
split. The effect of the 6 to 5 forward stock split was recognized
retroactively in the stockholders' equity accounts. Stockholders' equity
accounts have been restated to reflect the reclassification of an amount
equal to the par value of the decrease in issued common shares from the
common and preferred stock account to the additional paid-in capital
account.
14. LOSS PER COMMON SHARE
The following table sets forth the computation of basic and diluted net
loss per common share:
2004 2003
-------- --------
Basic and diluted loss per common share:
Net loss before extraordinary item $(4,679) $(9,644)
Preferred stock dividends - (40)
-------- --------
Net loss available for common shareholders $(4,679) $(9,684)
======== ========
|
Continued
F-26
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS, CONTINUED
(IN THOUSANDS, EXCEPT SHARE DATA)
15. COMMITMENTS AND CONTINGENCIES
LEGAL PROCEEDINGS
In March 2003, Francis C. Pizzulli ("Pizzulli") filed a lawsuit against the
Company and others in the Los Angeles Superior Court Case No. BC291463
seeking damages for alleged breach of contract, damages for alleged
misrepresentations, and to invalidate a merger/reverse stock split of the
Company. The Company denied any and all liability in the lawsuit. Without
the admission of any liability by either Pizzulli or the Company, in
February 2004, the Company agreed to issue to Pizzulli 500,000 shares of
common stock of the Company valued at $125 to settle the lawsuit. The
common stock was issued during the year ended June 30, 2004.
On August 28, 2003, Cause No. 03-08-0681-CV, "The Dow Chemical Company vs.
Endovasc LTD., Inc.," was filed against the Company in the District Court
of Montgomery County, Texas, 359th Judicial District. Dow Chemical Company
("Dow") filed a complaint against the Company for breach of contract and
damages. The amount of damages sought is approximately $230,000. This case
is being vigorously defended against the allegations made by Dow. The
Company has also filed its own counter-claim against Dow for breach of
contract and damages. On June 30, 2004, a prediction cannot be made as to
the final outcome of the complaint and damages allegedly owed to Dow or to
the Company. However, management believes it will prevail and accordingly,
no amounts have been accrued for this contingency.
On November 7, 2003, Cause No. 03-11-08112-CV, "Greg Creekmore vs.
Endovasc, Inc. and Endovasc, LTD., Inc.," was filed against the Company in
the District Court of Montgomery County, Texas, 284th Judicial District.
Greg Creekmore ("Creekmore") filed a complaint against the Company for
breach of an employment contract between the parties. Creekmore seeks
payment of $114,000 plus interest, one million shares of the Company's
common stock and reimbursement of court costs including reasonable
attorneys' fees allowed by law. This case is being vigorously defended
against the allegations made by Creekmore. On June 30, 2004, a prediction
cannot be made as to the final outcome of the complaint and damages
allegedly owed to Creekmore. However, management believes it will prevail
and accordingly, no amounts have been accrued for this contingency.
On January 13, 2004, Case No. H-03-5226, "Lorenz M. Hofmann, Ph.D. and LMH
Associates, Inc. vs. Endovasc, LTD., Inc., Endovasc, Inc., David P.
Summers, Ph.D. and M. Dwight Cantrell" was filed against the Company in the
United States District Court for the Southern District of Texas, Houston
Division. Lorenz M. Hofmann, Ph.D. and LMH Associates, Inc. ("LMH") filed a
complaint against the Company for breach of contract and damages. LMH seeks
payment of $91,859. This case is being vigorously defended against the
allegations made by LMH. The Company has also filed its own counter-claim
against LMH for breach of contract and damages. On June 30, 2004, a
prediction cannot be made as to the final outcome of the complaint and
damages allegedly owed to LMH. However, management believes it will prevail
and accordingly, no amounts have been accrued for this contingency.
During the year ended December 31, 2004, a counterclaim under Cause No.
03-04-02939-CV (AAA Arbitration No. 79-181-00037-03TMS), "Marco D.
Carnevale vs. Endovasc Corporation" was filed against the Company in the
359th Judicial District Court of Montgomery County, Texas. Carnevale filed
a complaint against the Company for alleged breach of contract and damages.
Without the admission of any liability, subsequent to June 30, 2004, the
Company agreed to issue to Carnevale $33 of cash or shares of common stock
of the Company valued at $33 to settle the claim.
Continued
F-27
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS, CONTINUED
(IN THOUSANDS, EXCEPT SHARE DATA)
15. COMMITMENTS AND CONTINGENCIES, CONTINUED
The Company is a defendant in an arbitration proceeding entitled vFinance
Investments and vFinance Capital and Endovasc, Ltd., Inc., AAA No. 32 M 181
0011602. vFinance claims an entitlement to certain fees and an unspecified
amount of damages for the value of the warrants to which they claim
entitlement. This matter was scheduled for mediation on September 27, 2004.
The Company intends to defend its position vigorously as it believes it
will prevail and, accordingly, has not accrued any liability associated
with this case in the accompanying financial statements.
LEASES
The Company has entered into a five year lease agreement for office space
which is accounted for as an operating lease. Lease payments of $11 are due
monthly until May 2008. Rent expense for the years ended June 30, 2004 and
2003 was $144 and $50, respectively. In addition, the Company leases
equipment under capital leases which expire at various dates through 2007.
Future minimum lease payments having initial or noncancellable lease terms
in excess of one year are as follows:
OPERATING CAPITAL
LEASE LEASES
---------- ---------
2005 $ 137 $ 39
2006 137 28
2007 137 1
2008 125 -
---------- ---------
Total payments $ 536 $ 68
==========
Less amount representing interest (10)
---------
Present value of minimum lease payments 58
Less current portion (30)
---------
Obligations under capital lease, net of current portion $ 28
==========
|
16. GOING CONCERN CONSIDERATIONS
Since its inception as a development stage enterprise, the Company has not
generated significant revenue and has been dependent on debt and equity
raised from individual investors to sustain its operations. The Company has
conserved cash by issuing its common stock and preferred stock to satisfy
obligations, to compensate individuals and vendors and to settle disputes
that have arisen. However, during the years ended June 30, 2004 and 2003,
the Company incurred net losses (in thousands) of $(4,679) and $(9,644),
respectively, and negative cash flows from operations of $(1,987) and
$(1,478), respectively. These factors, along with a $(425) negative working
capital position at June 30, 2004, raise substantial doubt about the
Company's ability to continue as a going concern.
Management plans to take specific steps to address its difficult financial
situation as follows:
- In the near term the Company plans additional private sales of debt
and common and preferred stock to qualified investors to fund its
current operations.
Continued
F-28
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS, CONTINUED
(IN THOUSANDS, EXCEPT SHARE DATA)
16. GOING CONCERN CONSIDERATIONS, CONTINUED
- The Company originally anticipated the generation of approximately
$500 in revenue from its Nutraceutical product in the third and fourth
quarters of the year ending June 30, 2004. The anticipated revenue to
be generated by the launch of the Nutraceutical product line has been
delayed pending certain problems with formulation. The Company has
made the required changes and anticipates launching the product during
the year ending June 30, 2005.
- In the long-term, the Company believes that cash flows from
commercialization of its products will provide the resources for
continued operations.
There can be no assurance that the Company's planned private sales of debt
and equity securities or its planned public registration of common stock
will be successful or that the Company will have the ability to
commercialize its products and ultimately attain profitability. The
Company's long-term viability as a going concern is dependent upon three
key factors, as follows:
- The Company's ability to obtain adequate sources of debt or equity
funding to meet current commitments and fund the commercialization of
its products.
- The ability of the Company to obtain positive test results of its
products in clinical trials.
- The ability of the Company to ultimately achieve adequate
profitability and cash flows to sustain its operations.
17. NON-CASH INVESTING AND FINANCING ACTIVITIES
During the years ended June 30, 2004 and 2003, and for the period of
inception, June 10, 1996 to June 30, 2004 the Company engaged in certain
non-cash investing and financing activities as follows (in thousands):
INCEPTION
2004 2003 TO DATE
----- ----- ----------
Common stock issued in exchange for
equity securities $ - $ - $ 302
===== ===== ==========
Common and treasury stock issued upon
conversion of debentures and interest on
debentures $ - $ 173 $ 1,697
===== ===== ==========
Common and preferred stock issued for ser-
vices and license and patent rights $ - $ - $ 2,634
===== ===== ==========
Common stock issued in settlement of
lawsuit and related liabilities $ - $ - $ 601
===== ===== ==========
Common stock issued for payment of accounts
payable and accrued liabilities $ 163 $ 724 $ 887
===== ===== ==========
Common stock issued for assets $ - $ 197 $ 197
===== ===== ==========
Conversion of note payable to shareholder
to common stock $ 687 $ - $ 2,190
===== ===== ==========
Conversion of dividends payable to
common stock $ - $ 47 $ 178
===== ===== ==========
|
Continued
F-29
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS, CONTINUED
(IN THOUSANDS, EXCEPT SHARE DATA)
17. NON-CASH INVESTING AND FINANCING ACTIVITIES, CONTINUED
Reduction of note payable to stockholder
and accrued liabilities through exercise
of stock options $ - $ - $275
====== ====== ====
Issuance of notes payable for insurance $ - $ - $ 37
====== ====== ====
Issuance of notes payable for the purchase
of equipment $ - $ 56 $180
====== ====== ====
Dividends declared on preferred stock $ - $ 40 $143
====== ====== ====
Receipt of treasury stock for note payable
to stockholders $ - $ - $560
====== ====== ====
Issuance of common stock for receivable $ 30 $ - $ 30
====== ====== ====
|
18. 401(K) PLAN
The Endovasc, Inc. 401(k) Plan (the "Plan"), which was implemented in June
2001 was terminated in November of 2003. The Plan covered all of the
Company's employees who are United States citizens, at least 21 years of
age and have completed at least six months of service with the Company.
Pursuant to the Plan, employees could elect to reduce their current
compensation by up to the statutorily prescribed annual limit and have the
amount of such reduction contributed to the Plan. The Plan provided for the
Company to make discretionary contributions as authorized by the board of
directors; however, no Company contributions were made in the years ended
June 30, 2004 and 2003.
19. RELATED PARTY TRANSACTIONS
During the year ended June 30, 2003, the former Chief Executive Officer of
the Company advanced $793 to the Company in the form of a note payable to
stockholder and received $171 for partial repayment of this note payable to
stockholder. During the year ended June 30, 2004, the former Chief
Executive Officer of the Company advanced an additional $205 to the Company
under the existing note payable which had a balance of $680 as of June 30,
2003. During the year ended June 30, 2004, the Company repaid $885 of the
note through a $49 cash payment to the shareholder, payments totaling $149
on behalf of the shareholder to third parties, and through issuance of
common stock with a value of $687. The balance of this note of $-0- and
$680 as of June 30, 2004 and 2003, respectively, is due on demand,
non-interest bearing and is not collateralized.
During the year ended June 30, 2004, the current Chief Executive Officer
and the Chief Financial Officer of the Company advanced the Company $55 and
$50, respectively. The balances of the notes of $55 and $50 as of June 30,
2004 are due on demand, non-interest bearing and are not collateralized.
During the year ended June 30, 2004, a stockholder of the Company advanced
the Company $185. The balance outstanding at June 30, 2004 of $185 is due
on demand, non-interest bearing and is not collateralized.
Continued
F-30
ENDOVASC, INC.
(A CORPORATION IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS, CONTINUED
(IN THOUSANDS, EXCEPT SHARE DATA)
20. NDC SUBSIDIARY
During the year ended June 30, 2004, the Company's board of directors
authorized the creation of a new class of common stock, called Series NDC
common stock, $0.001 par value per share, whose rights and distributions
would be based on the performance of NDC. During the year ended June 30,
2004, the Company issued a dividend of one share of the Series NDC common
stock for each four shares of the Company's common stock. As of June 30,
2004, 14,158,593 shares of Endovasc Series NDC common stock were issued and
outstanding. Included in operating, general and administrative expenses for
the year ended June 30, 2004 is $33 of expenses of NDC.
21. JOINT VENTURES
Effective August 12, 2003, the Company entered into a joint venture
agreement with TissueGen, Inc. named Endovasc-TissueGen Research Sponsors,
L.L.C. (the "Partnership"). The purpose of the Partnership is to develop a
bioresorbable drug-eluting cardiovascular stent for the advanced treatment
of coronary artery disease. The Company and TissueGen agreed to co-license
certain intellectual property to the Partnership for an initial 49.9% and
51.1% interest, respectively, in the Partnership. In addition to its
license contribution, Endovasc is required to purchase a convertible
promissory note from the Partnership in the maximum principal amount of
$150. The convertible promissory note is convertible at Endovasc's option
into Class B Membership interests in the Partnership. As of June 30, 2004,
the Company has not purchased the promissory note. The Company has a 56%
controlling interest in the Partnership as the result of additional
contributions to the Partnership; as a result, the activity of the
Partnership has been consolidated in the accompanying financial statements
for the period from August 12, 2003 to June 30, 2004. The activity that was
consolidated includes $129 of costs and expenses and $64 of current
liabilities.
In November 2003, the Company entered into a joint venture agreement with
TissueGen, Inc. and Dr. Nathan Blumberg named Endovasc-TissueGen-Blumberg
Research Sponsors, L.L.C. (the "Joint Venture"). The purpose of the Joint
Venture is to develop biodegradable stents for ureteral and prostate
applications. The Company and TissueGen agreed to co-license certain
intellectual property to the Joint Venture for an initial 39.9% and 50.1%
interest, respectively, in the Joint Venture. Dr. Blumberg owns the
remaining 10% interest. In addition to its license contribution, the
Company is required to purchase a convertible promissory note from the
Joint Venture in the principal amount of approximately $137. The
convertible promissory note is convertible at Endovasc's option into Class
B membership interests in the Joint Venture. As of June 30, 2004, the
Company has not purchased the promissory note. The Company has a 63%
controlling interest in the Joint Venture as the result of additional
contributions to the Joint Venture; as a result, the activity of the
Partnership has been consolidated in the accompanying financial statements
for the period from November 2003 to June 2004. The activity that was
consolidated includes $221 of costs and expenses, $2 of cash and $186 of
current liabilities.
22. SUBSEQUENT EVENTS
On September 17, 2004, the Company made the election to become a business
development company. As part of this election, the Company has certified
that it will be operated for the purpose of making investments in
securities described in sections 55(a) (1) through (3) of the Investment
Company Act of 1940 and that it will make available significant managerial
assistance with respect to issuers of such securities to the extent
required by the Act.
F-31
EXHIBIT 14.1
ENDOVASC, INC
CODE OF ETHICS FOR PRINCIPAL EXECUTIVE
AND SENIOR FINANCIAL OFFICERS
I.
INTRODUCTION AND PURPOSE
This Code of Ethics for Principal Executive and Senior Financial Officers
(hereinafter referred to as the "Code") helps maintain standards of business
conduct and ensures compliance with legal requirements, specifically, but not
limited to, Section 406 of the Sarbanes-Oxley Act of 2002 and SEC rules
promulgated thereby for Endovasc, Inc (hereinafter referred to as the
"Company").
In addition to securing compliance with legal requirements, the purpose of
the Code is to deter wrongdoing and promote ethical conduct, and full, fair,
accurate, timely, and understandable disclosure of financial information in the
periodic reports of the Company. The matters covered in this Code are of the
utmost importance to the Company, our stockholders and our business partners,
and are essential to our ability to conduct our business in accordance with our
stated values.
Financial executives hold an important and elevated role in corporate
governance and are uniquely capable and empowered to ensure that stockholders'
interests are appropriately balanced, protected and preserved. Accordingly, this
Code provides principles to which financial executives are expected to adhere
and advocate. This Code embodies rules regarding individual and peer
responsibilities, as well as responsibilities to the company, the public and
others.
II.
APPLICATION
This Code is applicable to the following persons (hereinafter referred to
as the "Officers"):
1. The Company's principal executive officers;
2. The Company's principal financial officers;
3. The Company's principal accounting officer or controller; and
4. Persons performing similar functions.
III.
CODE OF ETHICS:
Each Officer shall adhere to and advocate the following principles and
responsibilities governing professional and ethical conduct:
1. Act with honesty and integrity, avoiding actual or apparent conflicts of
interest in personal and professional relationships.
2. Provide information that is full, fair, accurate, complete, objective,
relevant, timely, and understandable to the Company's Board of Directors,
the Securities and Exchange Commission, the Company's stockholders, and the
public.
3. Comply with applicable governmental laws, rules, and regulations.
4. Act in good faith, responsibly, with due care, competence and diligence,
without misrepresenting material facts or allowing your independent
judgment to be subordinated.
5. Take all reasonable measures to protect the confidentiality of non-public
information about the Company acquired in the course of your work except
when authorized or otherwise legally obligated to disclose such information
and to not use such confidential information for personal advantage.
6. Assure responsible use of and control over all assets and resources
employed or entrusted to you.
7. Promptly report to the Chairman of the Board:
a. any information you may have regarding any violation of this Code;
b. any actual or apparent conflict of interest between personal and/or
professional relationships involving management or any other employee
with a role in financial reporting disclosures or internal controls;
c. any information you might have concerning evidence of a material
violation of the securities or other laws, rules or regulations
applicable to the Company and its operations;
d. significant deficiencies in the design or operation of internal
controls that could adversely affect the Company's ability to record,
process, summarize or report financial data; or
e. any fraud, whether or not material, that involves management or other
employees who have a significant role in the Company's financial
reporting, disclosures or internal controls.
IV.
REPORTING PROCEDURE, PROCESS AND ACCOUNTABILITY
As discussed above, Officers shall promptly report any violation of this
Code to the Chairman of the Board of Directors.
Reports of violations under this Code received by the Chairman of the Board
shall be investigated by the Board of Directors. If the Board of Directors finds
a violation of this Code, it shall refer the matter to the full Board of
Directors.
In the event of a finding that a violation of this Code has occurred,
appropriate action shall be taken that is reasonably designed to deter
wrongdoing and to promote accountability for adherence to this Code, and may
include written notices to the individual involved of the determination that
there has been a violation, censure by the Board, demotion or re-assignment of
the individual involved, suspension with or without pay or benefits, and up to
and including, if appropriate, termination of the individual's employment. In
determining what action is appropriate in a particular case, the Board of
Directors (or the independent directors of the Board as the case may be) shall
take into account all relevant information, including the nature and severity of
the violation, whether the violation was a single occurrence or repeated
occurrences, whether the violation appears to have been intentional or
inadvertent, whether the individuals in question had been advised prior to the
violation as to the proper course of action and whether or not the individual in
question had committed other violations in the past.
V.
ANONYMOUS REPORTING
Any violation of this Code and any violation by the Company or its
directors or officers of the securities laws, rules, or regulations, or other
laws, rules, or regulations applicable to the Company may be reported to the
Chairman of the Board anonymously.
VI.
NO RETALIATION
It is against the Company's policy to retaliate in any way against an
Officer for good faith reporting of violations of this Code.
VII.
WAIVER AND AMENDMENT
The Company is committed to continuously reviewing and updating its
policies and procedures. Therefore, this Code is subject to modification. Any
amendment or waiver of any provision of this Code must be approved in writing by
the Company's Board of Directors and promptly disclosed pursuant to applicable
laws and regulations.
VIII.
ACKNOWLEDGMENT OF RECEIPT OF CODE OF ETHICS FOR
PRINCIPAL EXECUTIVE AND SENIOR FINANCIAL OFFICERS
I have received and read the Company's Code of Ethics for Principal
Executive and Senior Financial Officers (the "Code"). I understand the standards
and policies contained in the Code and understand that there may be additional
policies or laws applicable to my job. I agree to comply with the Code in all
respects.
If I have questions concerning the meaning or application of the Code, any
Company policies, or the legal and regulatory requirements applicable to my job,
I know that I can consult with the Chairman of the Board, knowing that my
questions or reports will remain confidential to the fullest extent possible.
I understand that my agreement to comply with this Code does not constitute
a contract of employment.
Officer Name
Signature
Date
EXHIBIT 31.1
CERTIFICATION OF CEO PURSUANT TO SECTION 302
OF THE SARBANES-OXLEY ACT OF 2002
I, Diane Dottavio, certify that:
1. I have reviewed this annual report on Form 10-KSB of Endovasc, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of
a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial
information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of
Endovasc, Inc. as of, and for, the periods presented in this report;
4. Endovasc, Inc.'s other certifying officer and I:
a) are responsible for establishing and maintaining disclosure controls
and procedures (as defined in Exchange Act rules 13a-15(e) and
15d-15(e)) for Endovasc, Inc and have:
b) designed such disclosure controls and procedures, or caused such
disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to Endovasc,
Inc., including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which
this report is being prepared;
c) evaluated the effectiveness of Endovasc, Inc.'s disclosure controls
and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end
of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in Endovasc, Inc.'s internal
control over financial reporting that occurred during Endovasc, Inc.'s
most recent fiscal year that has materially affected, or is reasonably
likely to materially affect, Endovasc, Inc.'s internal control over
financial reporting; and
5. Endovasc, Inc.'s other certifying officer and I have disclosed, based on
our most recent evaluation of internal control over financial reporting, to
Endovasc, Inc.'s auditors and the audit committee of Endovasc, Inc.'s Board
of Directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect Endovasc, Inc.'s ability to
record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other
employees who have a significant role in Endovasc, Inc.'s internal
control over financial reporting.
Date: October 13, 2004 /s/ Diane Dottavio
----------------------------
Diane Dottavio,
Chief Executive Officer
|
EXHIBIT 31.2
CERTIFICATION OF CFO PURSUANT TO SECTION 302
OF THE SARBANES-OXLEY ACT OF 2002
I, M. Dwight Cantrell, certify that:
1. I have reviewed this annual report on Form 10-KSB of Endovasc, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of
a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial
information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of
Endovasc, Inc. as of, and for, the periods presented in this report;
4. Endovasc, Inc.'s other certifying officer and I:
a) are responsible for establishing and maintaining disclosure controls
and procedures (as defined in Exchange Act rules 13a-15(e) and
15d-15(e)) for Endovasc, Inc and have:
b) designed such disclosure controls and procedures, or caused such
disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to Endovasc,
Inc., including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which
this report is being prepared;
c) evaluated the effectiveness of Endovasc, Inc.'s disclosure controls
and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end
of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in Endovasc, Inc.'s internal
control over financial reporting that occurred during Endovasc, Inc.'s
most recent fiscal year that has materially affected, or is reasonably
likely to materially affect, Endovasc, Inc.'s internal control over
financial reporting; and
5. Endovasc, Inc.'s other certifying officer and I have disclosed, based on
our most recent evaluation of internal control over financial reporting, to
Endovasc, Inc.'s auditors and the audit committee of Endovasc, Inc.'s Board
of Directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect Endovasc, Inc.'s ability to
record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other
employees who have a significant role in Endovasc, Inc.'s internal
control over financial reporting.
Date: October 13, 2004 /s/ M. Dwight Cantrell
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M. Dwight Cantrell,
Chief Financial Officer
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EXHIBIT 32.1
CERTIFICATION OF CEO PURSUANT TO RULE 13a-14(b) OR
RULE 15d-14(b) and 18 U.S.C. Sec.1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the annual report of Endovasc, Inc. (the "Company") on
Form 10-KSB for the period ended June 30, 2004 as filed with the Securities and
Exchange Commission on the date hereof (the "Report"), I, Diane Dottavio, Chief
Executive Officer of the Company, certify, pursuant to 18 U.S.C. Sec.1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of Section 13(a) or
15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all
material respects, the financial condition and results of operations
of the Company.
Date: October 13, 2004 /s/ Diane Dottavio
----------------------------
Diane Dottavio, Ph.D.
Chief Executive Officer
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EXHIBIT 32.2
CERTIFICATION OF CFO PURSUANT TO RULE 13a-14(b) OR
RULE 15d-14(b) and 18 U.S.C. Sec.1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the annual report of Endovasc, Inc. (the "Company") on
Form 10-KSB for the period ended June 30, 2004 as filed with the Securities and
Exchange Commission on the date hereof (the "Report"), I, M. Dwight Cantrell,
Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Sec.1350,
as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of Section 13(a) or
15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all
material respects, the financial condition and results of operations
of the Company.
Date: October 13, 2004 /s/ M. Dwight Cantrell
------------------------
M. Dwight Cantrell
Chief Financial Officer
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A SIGNED ORIGINAL OF THIS WRITTEN STATEMENT REQUIRED BY SECTION 906 HAS BEEN
PROVIDED TO ENDOVASC, INC. AND WILL BE RETAINED BY ENDOVASC, INC. AND FURNISHED
TO THE SECURITIES AND EXCHANGE COMMISSION OR ITS STAFF UPON REQUEST.
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