e10ksb
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-KSB
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934 |
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For the fiscal period ended December 31, 2004 |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE EXCHANGE ACT |
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For the transition period
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Commission file number 0-12627
MEDICAL DISCOVERIES, INC.
(Exact name of Small Business Issuer as specified in its
charter)
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Utah
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87-0407858 |
(State or other jurisdiction of
incorporation or organization) |
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(I.R.S. Employer
Identification No.) |
1338 S. Foothill Drive, #266, Salt Lake City,
Utah 84108
(Address of principal executive offices)
(801) 582-9583
(Issuers telephone number, including area code)
Securities registered pursuant to Section 12(b) of the
Act:
None
Securities registered pursuant to Section 12(g) of the
Act:
Common Stock, no par value
(Title of Class)
Check whether the issuer: (1) filed all reports required to
be filed by Section 13 or 15(d) of the Exchange Act during
the past 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has
been subject to such filing requirements for the past
90 days. Yes þ No o
Check if there is no disclosure of delinquent filers in response
to Item 405 of Regulation S-B contained in this form,
and no disclosure will be contained, to the best of
registrants knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this
Form 10-KSB or any amendment to this
Form 10-KSB. þ
The issuer had no revenues for its most recent fiscal
year.
The aggregate market value of the voting and non-voting common
equity held by non-affiliates computed by reference to the price
at which the common equity was sold, as of the last business day
of the issuers most recently completed second fiscal
quarter, June 30, 2004, was $25,523,334.
As of March 16, 2005, the issuer had
105,653,337 shares of Common Stock outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the Proxy Statement for the issuers 2005
Annual Meeting of Shareholders are incorporated by reference in
Part III of this Form 10-KSB.
Transitional Small Business Disclosure Format (check
one): Yes o No þ
TABLE OF CONTENTS
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DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS
This Report, including the documents incorporated by
reference into this Report, contains Forward-Looking
Statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, including, without
limitation, statements regarding our products still being in the
developmental stage, our lack of operating revenues or profits,
our dependence on raising significant additional capital, our
auditors expression of substantial doubt as to our ability
to continue as a going concern, the government regulation to
which we are subject, our exposure to pricing and reimbursement
risks, the competition we face, the potential that our
intellectual property is not adequately protected, the fact that
we may need to litigate to secure certain of our intellectual
property rights, our risk of product liability, our stock being
thinly traded and subject to manipulation, the volatility of our
stock price, the risk that shareholders could suffer substantial
dilution, and the fact that we have not paid dividends to date.
All statements other than statements of historical fact are
Forward-Looking Statements for purposes of these
provisions, including any projections of earnings, revenues or
other financial items, any statements of the plans and
objectives of management for future operations, any statements
concerning proposed new products or services, any statements
regarding future economic conditions or performance, and any
statements of assumptions underlying any of the foregoing. All
Forward-Looking Statements included in this document are made as
of the date hereof and are based on information available to us
as of such date. We assume no obligation to update any
Forward-Looking Statement. In some cases, Forward-Looking
Statements can be identified by the use of terminology such as
may, will, expects,
plans, anticipates, intends,
believes, estimates,
potential, or continue, or the negative
thereof or other comparable terminology. Although we believe
that the expectations reflected in the Forward-Looking
Statements contained herein are reasonable, there can be no
assurance that such expectations or any of the Forward-Looking
Statements will prove to be correct, and actual results could
differ materially from those projected or assumed in the
Forward-Looking Statements. Future financial condition and
results of operations, as well as any Forward-Looking Statements
are subject to inherent risks and uncertainties, including any
other factors referred to in the Companys press releases
and reports filed with the Securities and Exchange Commission.
All subsequent Forward-Looking Statements attributable to the
Company or persons acting on its behalf are expressly qualified
in their entirety by these cautionary statements. Additional
factors that may have a direct bearing on the Companys
operating results are described under Managements
Discussion and Analysis of Financial Condition and Results of
Operations Cautionary Statement for Forward-Looking
Information and Factors Affecting Future Results and
elsewhere in this report.
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PART I
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ITEM 1. |
DESCRIPTION OF BUSINESS. |
OVERVIEW
Medical Discoveries, Inc. is a Utah corporation incorporated on
November 20, 1991. Our address is
1338 S. Foothill Drive, #266, Salt Lake City,
Utah 84108, our telephone number is (801) 582-9583 and our
web address is www.medicaldiscoveries.com.
We are a developmental-stage bio-pharmaceutical company engaged
in the research, validation, development and ultimate
commercialization of two drugs: MDI-P and SaveCream. MDI-P is an
anti-infective drug that we believe will be a safe and effective
treatment for bacterial infections, viral infections and fungal
infections. SaveCream is a breast cancer medication that is
applied topically to reduce breast cancer tumors. Both of these
drugs are still in development and have not been approved by the
U.S. Food and Drug Administration (FDA).
Our initial target indications for MDI-P are Cystic Fibrosis and
HIV. We have filed an Investigatory New Drug application
(IND) with the FDA seeking permission to begin Phase I
human clinical trials of MDI-P as a treatment for Cystic
Fibrosis. The FDA has responded to our IND and we are hopeful
that we can satisfactorily answer the FDAs questions and
satisfy the FDAs follow-up requests for further animal
testing, resulting in the FDA approving the application. If the
FDA approves that IND, we will begin human trials at St.
Lukes Regional Medical Center in Boise, Idaho using a
protocol designed by Dr. Henry Thompson. If our
Phase I IND for Cystic Fibrosis is successful, we intend to
file an IND for Phase I testing of MDI-P as a treatment for
HIV at Harvard School of Medicine using a protocol designed by
Dr. Bruce Dezube. We also expect to add additional
indications for the use of MDI-P in the future as we further our
pre-clinical development.
We recently purchased SaveCream from a German biotechnology
company. In a European Union study of SaveCream used by over 100
women diagnosed with Stage 4 breast cancer, a significant
number of those women experienced a significant tumor reduction.
This study, while preliminary, indicates that SaveCream may be
substantially more effective and faster acting than similar
drugs already on the market. We are in the process of developing
a global commercialization strategy for SaveCream.
To date, we have not generated significant revenues from
operations or realized a profit. Through December 31, 2004,
we had incurred a cumulative net loss since inception of
$19,353,933.
RECENT DEVELOPMENTS
Savetherapeutics Asset Acquisition. On March 16,
2005 we announced the completed acquisition of the intellectual
property assets of Savetherapeutics AG, a German biotechnology
company headquartered in Hamburg. The purchase price
was 2,350,000
(approximately $3.1 million). Savetherapeutics (SaveT) has
been developing SaveCream, a topical steroidal form of aromatase
inhibitor (AI) for breast cancer.
This promising cancer therapeutic product has been tested in the
European Union under a unique German regulatory scheme that
allows terminal patients to receive novel treatments. In the
study, over 100 women diagnosed with Stage 4 breast
cancer received special permission to be treated with SaveCream.
A significant number of those women experienced significant
tumor reduction. This study indicates substantially improved
efficacy in reduction of breast tumors, in shorter time frames
than the three approved AIs currently on the market. We are in
the process of developing a global commercialization strategy
for SaveCream.
M.A.G. Capital, LLC (formerly Mercator Advisory Group, LLC),
through its designated funds, Mercator Momentum Fund, L.P., and
Mercator Momentum Fund III, L.P., provided us with
$3 million for the acquisition.
We expect to perform additional CMC (chemistry manufacturing and
control) work and expand the clinical trials over 2005, and
believe this will open the door to commercialization
opportunities for SaveCream
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by late 2006, which may be quicker than we can commercialize
MDI-P. This acquisition also allows us to diversify our product
base.
Cystic Fibrosis IND. We are continuing to prosecute our
IND for Cystic Fibrosis with the FDA. We have agreed with the
FDA on a large animal model protocol to establish
pharmacological safety with relation to cardio and central
nervous system toxicity for this IND. We expect to begin that
phase of testing in the very near future and to start
Phase I clinical trials on Cystic Fibrosis in Q4 of 2005.
BUSINESS STRATEGY
Our highest priorities are to:
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gain FDA approval of our IND for Cystic Fibrosis and commence
human clinical trials; |
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file an IND for HIV; and |
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develop a commercialization strategy for SaveCream. |
Our secondary priorities are the completion of a longer-range
strategic business plan in which we utilize the intellectual
property and analysis that has been developed over the last
decade and determine an appropriate direction for future
development of the business over the next five years. Some of
the issues we will be dealing with will include:
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Listing the Companys common stock on a stock exchange or
NASDAQ |
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How to provide shareholders with liquidity, transparency and a
return on investment |
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A decision on whether or when to relocate the Company or
maintain its current location |
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A decision as to what staffing requirements the Company will
have, when to bring additional permanent staff on board and the
best route for recruiting those staff members |
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Additional target indications and the formulation and
development process required for those target indications |
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A comprehensive intellectual property strategy |
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A potential partnering strategy |
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Projected long-term financing requirements |
MDI-P: NOVEL ANTI-INFECTIVE TECHNOLOGY
MDI-P is an anti-effective drug that we believe will be a safe
and effective treatment for bacterial infections, viral
infections and fungal infections. MDI-P appears to work by
virtue of the direct virus-, bacteria- and fungus-killing effect
of several of the powerful oxidants present in the MDI-P
solution. The MDI-P solution contains oxidants such as various
hypochlorous acid chains, ozone and dilute hydrogen peroxide.
These oxidants, traditionally believed to have a very short
half-life in their natural state, seem to exhibit stability of
several months or longer in MDI-P.
During the past nine years, we have conducted a variety of cell
line testing at the following university and medical research
institutions, among others:
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Stratton V.A. Medical Center, Albany, New York |
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Albany Medical College, Albany, New York |
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Indiana University School Of Medicine And Dentistry |
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University of California, Los Angeles |
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Baylor College of Medicine and Dentistry, Dallas, Texas |
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Dana-Farber Cancer Institute, Boston, Massachusetts |
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University of Washington Medical School |
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Highlights from those tests include the following:
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In 1998, we initiated in vitro testing, conducted at
the Dana-Farber Cancer Institute in Boston, Massachusetts, a
major teaching affiliate of the Harvard Medical School. The
results of this independent testing confirmed that MDI-P
achieved destruction of more than 90% of the HIV virus in cell
cultures, with no toxicity to the cells. |
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In 2000, data and results published by Dr. Aldonna
Baltch, M.D., of the Stratton V.A. Medical Center and
Albany Medical College, Albany NY, indicated that MDI-P is a
potent antibacterial and anti-fungal agent.
Dr. Baltchs work demonstrated that MDI-P was
effective in destroying the fungi Candida albicans and
Legionella pneumophillia (Legionnaires Disease) within
60 seconds of exposure to the fungi with no evidence of
cell toxicity. This work was published in The American Journal
of Infection Control in 2000 and as abstracts of the American
Society of Microbiology meetings in 1997 and 1998. |
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Toxicity tests completed in 2001 by WIL Research Laboratories
demonstrated that various strengths of MDI-P (up to a 50%
solution strength) produced no systemic toxicity in laboratory
animal tests used to assess potential problems for human
application. These studies were conducted following FDA
guidelines and have helped establish that MDI-P is reasonably
safe for human clinical trials. |
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In 2004, Dr. Emil Chi, Chairman of the Department of
Histopathology at the University of Washington Medical School
conducted a mouse study focused on MDI-P as a potential
therapeutic agent for the treatment of sepsis. The results
reaffirmed the anti-infective strength and low toxicity profile
in preclinical models of MDI-P. |
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In 2004, we also commissioned a mouse study by Dr. Chi
focused on MDI-P as a potential therapeutic agent for the
treatment of the symptoms of asthma. In the study, 36 female
mice were examined in a chronic asthma model, using various
doses of MDI-P as a therapeutic agent as measured against a
saline control. Samples of bronchial lavage lung fluid and
tissue were taken from all mice, with assays performed in airway
mucus build-up and eosinophil infiltration, a prime blood cell
measure of asthmatic attacks. More than 70% of the MDI-P treated
mice exhibited no increase in mucus secretions, comparable with
saline control animals, with a marked reduction in eosinophil
infiltration. Untreated asthmatic mice, in contrast, had more
than a nine-fold increase in mucus build-up as compared with
saline controls. Further, no toxicity was found in the MDI-P
treated mice. |
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On July 15, 2004, we announced our receipt from Clagett
Consulting of a large mammal toxicity report for MDI-P. The
study found no sign of any toxicity from MDI-P in the anatomy,
behavior, clinical chemical, hematological, or histopathological
measures of adverse events. The study was conducted in a rabbit
species (New Zealand white rabbits) because of their
acknowledged hyper-reactivity to toxicity in drugs. These
results, when combined with our prior toxicological work,
suggest that MDI-P should not cause toxic events in humans. Also
included in the Clagett Consulting report was a further genomic
analysis for toxicology of MDI-P. This genomics analysis
indicated that MDI-P had no effect on any of the following: bone
marrow function, hematocrit levels in peripheral blood, serum
levels for alanine aminotransferase levels and aspartate
aminotransferase levels, both of which provide sensitive
measures of hepatic toxicity, serum protein and albumin levels,
bound urinary nitrogen levels, serum calcium levels or blood
glucose levels. In addition, this genomics analysis provided
confirmation that various measures of impact on the hundreds of
genes controlling toxicity as well as the immuno-regulatory
system were neither up-or-down regulated by MDI-P. |
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In 2004 Dr. Chi also studied MDI-P as a potential
therapeutic agent for the treatment of the symptoms of Cystic
Fibrosis. In this study of 48 mice, it was found that MDI-P is a
useful agent to reduce primary measures of disease in Cystic
Fibrosis, including bacterial infection, mucus secretion,
cellular infiltration, lung edema (swelling with excess fluid),
lung hemorrhage, and lung infiltration by neutrophils and
eosinophils, the principal white blood cells responding to
allergic and infectious pathogens. Excessive presence of
neutrophils and eosinophils can lead to cell death in surrounding |
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tissues, causing serious health problems from their
over-expression. No overt signs of toxicity were found in the
primary organs (lungs, liver, spleen, kidneys, brain) of mice
treated with MDI-P. |
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In 2004 we conducted a chronic toxicity study of MDI-P. The
study involved the weekly injection of MDI-P into the body
cavity of test mice for six-months. No statistically relevant
changes in body weight, or morphometry or histopathology of
vital organs were observed, when compared with mice receiving
saline control injections or with untreated animals. The study
resulted in no dose-dependency and no toxic effects. |
Application of MDI-P to HIV:
Overview. Our pre-clinical research has demonstrated that
MDI-P is capable of rapidly killing HIV upon direct contact and
preventing infection of cells in a cell culture. MDI-P has also
shown it is capable of rapidly killing the HIV virus in an
acutely infected cell line. Furthermore, the destruction of the
HIV virus by MDI-P in a cell culture or a cell line does not
require any additional combination of drugs, and appears to have
a low toxicity profile in pre-clinical analysis. If these
results can be replicated in human beings, under appropriate
clinical protocols, this therapy may represent a significant
clinical advance over existing therapies.
Background of HIV/ AIDS. HIV is a retrovirus whose
genetic information is encoded by ribonucleic acid
(RNA) instead of deoxyribonucleic acid (DNA). It spreads
through the body by invading host cells and using the human
cells own protein synthesis process to replicate itself.
As the virus replicates, it slowly destroys the immune system by
infecting and killing T lymphocytes, so-called T
cells, which are critical for the function of the human
immune system.
Existing Therapies for HIV. There are approximately 83
HIV therapies currently on the market and approved by the FDA
with a market value of approximately $9.5 billion per year.
The primary current therapies for HIV are anti-retroviral
products falling into four categories: nucleoside reverse
transcriptase inhibitors, non-nucleoside reverse transcriptase
inhibitors, protease inhibitors, and anti-fusion of HIV-1 with
CD4 cells (Fuzeon®, or enfuvirtide). These therapies are
typically taken in combination under a protocol called Highly
Active Antiretroviral Therapy (HAART). HAART is effective in
controlling the levels of virus and in increasing the number of
T cells. However, these combination therapies are also
associated with significant toxicity and viral resistance. As a
result, current therapy management is characterized by a set of
complex issues: when to initiate therapy, what regimen to use,
which drugs within each class to use, and when to change
therapies. Due to limitations of chronic use of anti-retroviral
drug therapies, guidelines issued by the National Institutes of
Health suggest starting these therapies later in the disease.
Therefore, a need exists for therapies that are useful early in
the disease process, that are non-toxic, that are active against
resistant strains and that do not give rise to rapid resistance.
Even the new best-of-breed therapeutic, Fuzeon®, requires
administration with other standard combination antiretroviral
therapies, and still exhibits a number of toxicities, including:
inflammation/cysts at site of injection (9%/26%), erythema
(22%), proritus (4%), ecchymosis (8%), and on a less frequent
basis, rashes, fever, nausea, vomiting, chills, hypotension,
increased hepatic enzymes, neutropenia, thrombocytomeia, and
renal failure.
Benefits of MDI-P. MDI-P appears to have several
important characteristics that could provide benefits to both
patients and providers alike:
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MDI-Ps mechanism of action is not accomplished by enzyme
or nucleic acid inhibition, but rather by direct intra-cellular
effects. MDI-P is very rapid in effect and destroys viruses
without destroying host cells. |
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MDI-Ps broad-spectrum antiviral effects appear to make it
effective against even highly resistant viral strains and not
subject to rapid resistance. |
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The destruction of bacterial organisms by exposure to MDI-P does
not appear to produce any potential harmful effects. |
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MDI-P appears to have a low toxicity profile and therefore may
be better tolerated by patients. |
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MDIs HIV Protocol. The HIV virus is known to have a
cell replication cycle of approximately 10 days to two
weeks. For this reason, the Phase I protocol designed by
Dr. Bruce Dezube planned at Harvard Medical School will use
daily infusions over fourteen-day infusion cycles of MDI-P,
followed by a rest period, followed by subsequent two-week
infusions. The selection of the appropriate human dosing regimen
will be based upon the dose curve data currently being
established at the University of Washington Medical School.
Since the best-of-breed therapeutics in HIV (e.g., Fuzeon®)
establish an ability to bring the HIV RNA cell count below 400
copies per ml for as much as 65% of HIV patients, the Harvard
Phase I studies will be examining toxicity, together with
early signs of efficacy in bringing HIV RNA cell copies in blood
tests down to or below this level with statistical significance.
In order to expedite MDIs IND for HIV, the Company may
pursue an adjunct therapy program for its therapeutic, as in
joint dosing with an approved HAART HIV therapeutic with MDI-P
as an adjunct therapy to clinically manage the effects of fungal
infections which frequently plague HIV patients. Specific
pre-clinical studies in common fungi associated with HIV
patients would be undertaken to support such a filing, together
with the improved toxicity profile for MDI-P currently being
established for the Cystic Fibrosis indication.
Application of MDI-P to Cystic Fibrosis:
Overview. Cystic Fibrosis (CF) is a recessive
genetic disease that manifests itself in multiple systems of the
body. Individuals who suffer from CF produce excessive amounts
of thick, sticky mucus that obstructs the airways of the CF
patient. If mucus is not reduced in the CF patient, then
respiratory failure can occur. Due to the fact that mucus serves
as a medium for the growth of bacteria, the CF patient faces a
high risk of morbidity and mortality due to frequent pulmonary
infection. Currently, there are no FDA approved CF therapeutics
that provide a statistically significant mucus-clearing effect.
The prospective ability of MDI-P to remove CF patient mucus
accumulation may, in fact, provide a significant extension of
life for CF patients.
Background of Existing Therapies. With CF being a
genetically-determined illness, there is presently no known
cure for CF. Current treatment standards, which may
entail 3-4 hours of treatment per day for the CF patient,
include:
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Dietary control to lessen the build-up of fats, proteins (and to
a lesser extent, carbohydrates) which can not be readily
absorbed and metabolized. Typically, such dietary control is
augmented with oral pancreatic enzymes to assist in fat
metabolism. |
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Treatment of bacterial infection with erythromycin,
Tobramycin® (TOBI), and in severe infection cases,
vancomycin to eradicate or control the infection. In some cases,
daily use of oral antibiotics may be prescribed due to the high
frequency of lung infection in CF patients and its risk of
mortality. |
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Frequent use of mucolytic agents such as N-acetylcysteine and
bronchodilator therapy with Pulmozyme®. Clinical response
may further indicate bronchial drainage through recombinant
human Dnase or flutter devices to assist in mucus airway
clearance, together with clapping of the chest to dislodge
mucus. In extreme cases, broncho-alveolar lavage may be used,
and if necessary, lung transplantation. |
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Periodic corticosteroid tablets and inhaled anti-asthma
medications (e.g., Advair®, Singulair®, etc.) to
combat lung inflammation (frequently resulting from the presence
of infection), together with high doses of ibuprofen for its
anti-inflammatory effect. |
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In addition, the CF patient may have insulin prescribed for
CF-related diabetes, as well as medications for CF-associated
liver disease, supplements of vitamins A and D, and medication
to treat constipation. Oxygen therapy may also be prescribed. |
At present, current therapies tend to be more effective in
controlling pulmonary infection than in clearance of mucus.
However, even with the use of antibiotics, there may be as many
as 45% of CF patients with drug-resistant infection that can
prove life-threatening. Further, should the more common
bacterial infection be complicated through a simultaneous viral
infection, the odds of mortality can increase for the infected
CF patient. Since CFs build-up of mucus is genetically
dependent, and the mucolytic agents and
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therapies limited in total mucus-clearing effect, the CF patient
lives with a serious threat of respiratory failure from any of
the various frequent pulmonary infections. This risk tends to be
compounded with the increasing age of the CF patient. Even with
the use of all such therapies administered through approved CF
disease centers, the common prognosis for life expectancy of a
CF patient is currently 31-32 years.
Prospective Benefits of MDI-P. New anti-microbial
therapies that would reduce continued mucus build-up would be
beneficial to the CF patient to help prevent airway obstruction
and frequent pulmonary infection. Should such new anti-microbial
therapies also prove less susceptible to drug resistance,
together with efficacy on viruses, their value in extending the
quality of life and life span of CF patients would be
substantial.
Based upon MDIs pre-clinical studies, MDI-P offers CF
patients the following:
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to serve as a highly effective anti-microbial agent for CF
patients with bacterial pulmonary infection, as well as viral
pulmonary infection, with little or no drug resistance
probability; and |
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to serve as the best-of-breed mucolytic agent in clearing the
continuous mucus build-up in CF, when applied by nebulization
into the lungs, as an adjunct therapy to TOBI. |
The benefit of using MDI-P as an adjunct therapy to TOBI are as
follows:
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to avoid the possibility of significant clinical risk of adverse
events with CF patients that a lengthy drug-clearance period
might introduce through a rebound of the degree of infection
with Pseudomonas aeruginosa or other bacterial pulmonary
infection; and |
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to lessen the likelihood of adverse events due to endotoxin
reaction, due to the unparalleled efficacy of MDI-P in killing
pathogens, including Pseudomanas. |
MDI-P is believed to have the potential, with CF patient
compliance, of significantly improving both pulmonary function
and longevity of CF patients, due to its unique and potent dual
mechanism of action.
MDIs CF Protocols. MDI has established its planned
Phase I CF trials at St. Lukes Regional Medical
Center, Boise, Idaho, under the supervision of Dr. Henry
Thompson, Principal Investigator, who is Director of the Idaho
CF Clinic. The Phase I trial is planned on adult CF
patients in the latter term of life expectancy (age 21+).
There are two arms to the study:
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Arm I-a: a clinical trial will be conducted on a healthy normal
adult population consisting of 10-15 individuals to
establish the safety of MDI-P as a prospective adjunct therapy, |
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Arm I-b: a clinical trial will be conducted on a TOBI-dependent
adult CF population consisting of 30 individuals, in which
MDI-P is used as an adjunct therapy during TOBIs 28-day
rest period on a dose-rising regimen. Fifteen of the
30 patients will undergo each dose regimen, to determine if
greater efficacy is achieved on the higher dose of MDI-P. |
Nebulization of MDI-P through Pari Research Institutes new
FDA-approved e-Flow device is planned. All patients will be
hospitalized during the initial 24-hour start of nebulization,
to allow monitoring for endotoxic reactions. Patients will then
self-nebulize 3 times daily at home, and will come into the CF
clinic for weekly physicals, blood tests, pulmonary function
tests, and the like.
Other Indications for MDI-P:
Our preclinical testing has also shown efficacy of MDI-P in
treating sepsis and asthma. We have filed patent applications on
those indications and may in the future pursue opportunities to
commercialize MDI-P as a therapeutic for those indications.
SAVECREAM
Overview. MDI acquired substantially all of the assets of
a Hamburg, Germany-based biotech company, Savetherapeutics, AG,
in March of 2005. The principal assets of Savetherapeutics are
its intellectual property, pre-clinical data, and clinical trial
data on SaveCream, a novel, topical steroidal form of aromatase
inhibitor (AI) indicated for breast cancer. The principal value
of SaveCream is its ability to deliver
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substantially more therapeutic drug on the site of the breast
tumor, as contrasted with systemic ingestion of competing AIs,
thereby promoting faster and greater breast tumor reduction with
fewer side effects.
This promising cancer therapeutic product has been tested in the
European Union under a unique German regulatory scheme that
allows terminal patients to receive novel treatments. In the
study, over 100 women diagnosed with Stage 4 breast
cancer positive for the estrogen receptor received special
permission to be treated with SaveCream. A significant number of
those women experienced significant tumor reduction. This study
indicates substantially improved efficacy in reduction of breast
tumors, in shorter time frames than the three approved AIs
currently on the market.
Background on the Breast Cancer Market. Breast cancer is
one of the leading cancer indications, with an annual incidence
in the U.S. of 211,000 new cases per year, with annual
mortality of 43,000 per year. For the one third of such
breast cancers that are positive for human epidermal growth
factor receptor-2, the standard treatment therapies are
Herceptin®, followed by doxorubicin or epirubicin.
For the remaining two thirds of breast cancers which are
positive for the estrogen receptor (ER), the leading
therapies over the past several years have become the aromatase
inhibitors (AIs), recently achieving an estimated
$2 billion per year in revenues in 2004. The current three
approved AIs on the U.S. market are: Novartis
Femara®, AstraZenecas Arimidex®, and
Pfizers Aromatase®. All are oral in dosage. Because
of significantly improved efficacy and reduced toxicity as
compared with the former leading first-line ER-positive therapy,
Astra Zenecas Tamoxifen, the AIs became the preferred
first-line therapy for most breast cancers in the fall of 2004.
Background on Aromatase Inhibitors. An aromatase
inhibitor is an anti-estrogen therapy, blocking estrogens
ability to activate cancer cells. Aromatase is the enzyme that
converts other naturally occurring hormones (such as androgen)
into estrogen. The way aromatase inhibitors work is to limit the
production of estrogen by blocking its catalysis from other
hormones. Approximately 70% of women test positive for estrogen
receptors (ER) or progesterone receptors (PR) to which
estrogen can dock, activating cancer cells. For this 70% ER/ PR
positive patient grouping, the results of anti-estrogen therapy
through AIs is strongest.
Aromatase inhibitors represent a preferred approach to
anti-estrogen therapy by lowering the amount of estrogen being
produced by the body. This method contrasts with that of
Tamoxifen and related therapies, which block estrogens
ability to turn on cancer cells. Limiting the amount
of estrogen produced means there is less estrogen available to
reach cancer cells and make them grow.
In post-menopausal women, estrogen is no longer produced by the
ovaries, but is converted from androgen, another hormone.
Aromatase inhibitors keep androgen from being converted to
estrogen. That means less estrogen in the bloodstream, and less
estrogen reaching estrogen receptors to trigger a breast tumor.
In about 70-80% of breast cancer cases, the cancer cells have
areas on their surface called receptors to which hormones such
as estrogen and progesterone attach, providing fuel for the
cells growth into a tumor. Tamoxifen® and AIs both
interfere with cancer cells use of hormones to help them
grow, but the drugs work in different ways. Tamoxifen®
interferes directly with cancer cells ability to use
estrogen for fuel. AIs block the action of a substance called
aromatase, which helps the body to produce estrogen.
Testing at the time breast cancer is diagnosed can determine
whether the cancer cells are sensitive to estrogen or
progesterone. Neither Tamoxifen® nor AIs are effective in
treating breast cancer that is not hormone sensitive, that is,
cancer that does not use hormones to help the tumor grow.
Following reduction in tumor size by AI treatment, current
treatment regimens usually proscribe surgery to remove the
tumor(s), which if tumor size reduction has been substantial,
may obviate the need for a mastectomy.
Potential Benefits of SaveCream in Treating ER-Positive
Breast Cancers. SaveT has formulated its AI therapeutic in a
topical steroidal cream (SaveCream), applied twice daily, unlike
the current AI oral formulations. By local administration on the
breast, SaveCream effects a stronger down-regulation of estrogen
in the local breast tissue now believed to be key to
reduction in ER-positive breast tumors as contrasted
with oral forms, which are constrained to systemic blood levels
of active product under recommended dosing.
10
SaveCream evidenced an average 50%-80% reduction in breast
tumor size within two weeks of treatment under its European
Union trials, versus 24% over 3-months for the other AI
competitor products.
SaveCream appears to offer much less severe, and lower incidence
of toxicities (likely due to the limited half-life of the active
product). This favorable therapeutic index (efficacy/toxicity
ratio) should make the therapeutic amenable to registration with
a paper NDA, thereby making the product easier to license. Other
AIs are still noted for musculoskeletal complaints and increased
risk of osteoporosis and bone fracture, together with
mastalagia. Initial clinical experience with SaveCream indicates
that these common side-effects of other AIs are largely avoided
with this novel AI therapeutic.
SaveCream, because of its higher efficacy and unique mechanism
of action, may also prove amenable to:
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pre-menopausal breast cancer patients, thereby expanding the
targeted breast cancer indication substantially; |
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other cancer indications, including ovarian, uterine,
endometrial and skin cancers; and |
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osteoporosis, effectively turning the therapeutic into a
technology platform for drug development. |
MDIs Commercialization Program for SaveCream. MDI
believes that the supporting chemistry, manufacturing and
control (CMC) data supporting SaveCream may need to be
expanded and amplified, particularly in reference to the topical
vehicle used as the carrier for its therapeutic agent. While
undertaking a program to expand SaveCreams CMC data, the
Company will also undertake to expand the clinical trial
program, including revised protocols. The CMC expansion is
expected to require at least 3-6 months, while newly
expanded clinical trials may require an additional year of
testing.
PATENTS
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MDI-P and Related Technologies. |
We hold eight United States Patents, two Japanese patents and a
Mexican patent covering various applications for MDI-P, the
machinery that manufactures it and the method by which it is
manufactured. The U.S. Patents are as follows:
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Patent No. 5,334,383: Electrically Hydrolyzed Salines
as In Vivo Microbicides for the Treatment of Cardiomyopathy and
Multiple Sclerosis |
This patent covers a method of treating antigen related
infections related to cardiomyopathy and multiple sclerosis in
humans and other warm blooded animals. This method of treatment
includes the use of an electrolyzed saline solution in
conjunction with one or more modulating agents such as ascorbic
acid (Vitamin C), with or without concurrent colchicine, to
mimic or enhance the bodys naturally occurring immune
response to bacterial, viral or fungal infection. The duration
of this patent is until August 2, 2011, subject to patent
term extension for clinical trial time.
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Patent No. 5,507,932: Apparatus for Electrolyzing
Fluids |
This patent covers equipment that exposes a liquid solution to
an electrical current, creating an electrolyzed solution. This
equipment may be used to produce an electrolyzed saline
solution, capable of killing bacterial, viral and fungal agents,
for use in medical applications such as the treatment of antigen
related infections in humans and other warm blooded animals. The
duration of this patent is until August 26, 2014.
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Patent No. 5,560,816: Method for Electrolyzing
Fluids |
This patent covers a method for electrolyzing fluids, by using
specialized equipment to expose liquid solutions to an
electrical current. Saline, for example, may be treated by this
process to yield an electrolyzed saline solution, capable of
killing bacterial, viral and fungal agents, for the treatment of
antigen related infection in humans and other warm blooded
animals. The duration of this patent is until August 26,
2014, subject to patent term extension for clinical trial time.
11
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Patent No. 5,622,848: Electrically Hydrolyzed Saline
Solution as Microbicides for In Vitro Treatment of Contaminated
Fluids Containing Blood |
This patent covers a method of treating whole blood and other
blood products with an electrolyzed saline solution to reduce
infection with bacterial, viral and fungal agents. The duration
of this patent is until April 22, 2014, subject to patent
term extension for clinical trial time.
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Patent No. 5,674,537: An Electrolyzed Saline Solution
Containing Concentrated Amount of Ozone and Chlorine
Species |
This patent covers a specific electrolyzed saline solution
containing a regulated amount of microbicidal agents including
ozone and active chlorine species. This solution is intended for
use in the treatment of infections in the body of humans and
other warm blooded animals, or in blood or blood products. The
duration of this patent is until October 7, 2014, subject
to patent term extension for clinical trial time.
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Patent No. 5,731,008: Electrically Hydrolyzed Salines
as Microbicides |
This patent covers a method of using a specific electrolyzed
saline solution containing a regulated amount of microbicidal
agents including ozone and active chlorine species for the
treatment of microbial infections, including HIV infection. The
method includes intravenous administration of the solution along
with one or more modulating agents such ascorbic acid (Vitamin
C), with or without concurrent colchicine. The duration of this
patent is until May 23, 2010, subject to patent term
extension for clinical trial time.
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Patent No. 6,007,686: System for Electrolyzing Fluids
for Use as Antimicrobial Agents |
This patent covers a system for electrolyzing fluids, such as a
saline solution, for use in sterilizing dental and medical
instruments and other health care equipment. The patent covers
the necessary equipment for generating and circulating the
electrolyzed saline solution around the instruments to be
sterilized, and includes specific claims for equipment designed
for use with dental drill handpieces and flexible tubing. The
duration of this patent is until August 26, 2014.
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Patent No. 6,117,285: System for Carrying Out
Sterilization of Equipment |
This patent covers a system for cleaning and sterilizing
medical and dental instruments to prevent the spread of
infection from one patient to another. The covered system bathes
the instrument in an electrolyzed saline solution and causes the
solution to flow into and sterilize any openings in the
equipment. It includes specific claims for systems designed
specifically for the sterilization of dental drills and flexible
tubing. The duration of this patent is until August 26,
2014.
The Japanese and Mexican patents provide coverage in those
countries for various of the U.S. patents. We also have
pending applications with the US Patent and Trademark Office for
patents on MDI-P as a pharmaceutical treatment for cystic
fibrosis, sepsis and asthma.
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SaveCream and Related Technologies. |
The assets we purchased from Savethearpeutics A.G. included the
following patents and patent applications:
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Medicament for Preventing and/or Treating a mammary
Carcinoma Containing a Steroidal Aromatase Inhibitor |
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Aromatase Marking |
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Topical Treatment for Mastalgia |
The purchased assets also include U.S. patents on cosmetic
products and various international patent applications.
We are in the process of transferring the patents and
applications to MDIs subsidiary. At the time we purchased
SaveCream and the other intellectual property assets from SaveT,
SaveT had not yet obtained and filed with the appropriate patent
offices assignments of the various inventors rights to the
underlying
12
inventions. Each of those inventors has agreed and is
contractually bound to assign such rights. We are currently in
the process of securing the applicable assignments. However, we
may need to initiate litigation against the inventors to secure
such assignments.
COMPETITION
The biotechnology and pharmaceutical industries are
characterized by rapidly evolving technologies and intense
competition. Our competitors include major pharmaceutical, and
specialized biotechnology companies, many of which have
financial, technical, and marketing resources significantly
greater than ours. Fully integrated pharmaceutical companies,
due to their expertise in research and development,
manufacturing, testing, obtaining regulatory approvals, and
marketing, as well as their substantially greater financial and
other resources, may be our most formidable competitors. In
addition, acquisitions by such pharmaceutical companies could
enhance the financial and marketing resources of smaller
competitors. Furthermore, colleges, universities, governmental
agencies, and other public and private research organizations
will continue to conduct research and possibly market
competitive commercial products on their own or through joint
ventures. These institutions are becoming more active in seeking
patent protection and licensing arrangements to collect
royalties for use of technology that they have developed. These
institutions also will compete with us in recruiting and
retaining highly qualified scientific personnel.
If and when we obtain regulatory approval for any of the
potential uses of our technology which require them, we must
then compete for acceptance in the marketplace. Given that such
regulatory approval, especially in the United States, may take a
number of years, the timing of the introduction of our
technology and other products to the market is critical. Other
safe and effective drugs and treatments may be introduced into
the market prior to the time that we are able to obtain approval
for the commercialization of our technology. In addition, even
after such regulatory approval is obtained, competition among
products approved for sale may be affected by, among other
things, product efficacy, safety, reliability, availability,
price, and patent position. There can be no assurance that our
technology will be competitive if and when introduced into the
marketplace for any of its possible uses.
GOVERNMENT REGULATIONS
Overview. Our use of MDI-P and SaveCream as
pharmaceuticals is subject to extensive regulation by United
States and foreign governmental authorities. In particular,
pharmaceutical treatments are subject to rigorous pre-clinical
and clinical testing and other approval requirements by the FDA
in the United States under the federal Food, Drug and Cosmetic
Act and by comparable agencies in most foreign countries.
Various federal, state and foreign statutes also govern or
influence the manufacture, labeling, storage, record keeping,
and marketing of such products. Pharmaceutical manufacturing
facilities are also regulated by state, local, and other
authorities. Obtaining approval from the FDA and other
regulatory authorities for a new drug or treatment may take
several years and involve substantial expenditures. Moreover,
ongoing compliance with these requirements can require the
expenditure of substantial resources. Difficulties or
unanticipated costs may be encountered by us in our efforts to
secure necessary governmental approvals, which could delay or
preclude us from marketing MDI-P or SaveCream.
FDA. The FDA imposes substantial requirements upon and
conditions precedent to the introduction of therapeutic drug
products, such as MDI-P or SaveCream, through lengthy and
detailed laboratory and clinical testing procedures, sampling
activities and other costly and time consuming procedures to
demonstrate that such products are both safe and effective in
treating the indications for which approval is sought. After
testing in animals, an Investigational New Drug, or IND,
application must be filed with the FDA to obtain authorization
for human testing. When the clinical testing has been completed
and analyzed, final manufacturing processes and procedures are
in place, and certain other required information is available to
the manufacturer, a manufacturer may submit a new drug
application, or NDA, to the FDA. No action can be taken to
market any therapeutic drug product in the United States until
an NDA has been approved by the FDA.
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The IND process in the United States is governed by regulations
established by the FDA which strictly control the use and
distribution of investigational drugs in the United States. The
guidelines require that an application contain sufficient
information to justify administering the drug to humans, that
the application include relevant information on the chemistry,
pharmacology and toxicology of the drug derived from chemical,
laboratory and animal or in vitro testing, and that
a protocol be provided for the initial study of the new drug to
be conducted on humans.
In order to conduct a clinical trial of a new drug in humans, a
sponsor must prepare and submit to the FDA a comprehensive IND.
The focal point of the IND is a description of the overall plan
for investigating the drug product and a comprehensive protocol
for each planned study. The plan is carried out in three phases:
Phase I clinical trials, which involve the administration
of the drug to a small number of healthy subjects to determine
safety, tolerance, absorption and metabolism characteristics;
Phase II clinical trials, which involve the administration
of the drug to a limited number of patients for a specific
disease to determine dose response, efficacy and safety; and
Phase III clinical trials, which involve the study of the
drug to gain confirmatory evidence of efficacy and safety from a
wide base of investigators and patients.
Phase I testing typically takes at least one year,
Phase II trials typically take from
11/2
to
21/2 years,
and Phase III trials generally take from 2 to 5 years
to complete. Should the FDA grant fast-track status
to MDI-P based upon its safety profile and early signs of
efficacy in Phase I clinical trials, the overall timeline
for completion of Phase II-III clinical trials can be
compacted to as little as 2-3 years. We can give no
assurance that Phase I, Phase II or Phase III
testing for MDI-P or SaveCream will be completed successfully
within any specified time period, if at all. While we are
hopeful that fast-track status might be provided
MDI-P, there is no assurance that such status will, in fact, be
provided. Furthermore, the FDA may suspend clinical trials at
any time if the patients are believed to be exposed to a
significant health risk.
An investigators brochure must be included in the IND and
the IND must commit the sponsor to obtain initial and continual
review and approval of the clinical investigation. A section
describing the composition, manufacture and control of the drug
substance and the drug product is included in the IND.
Sufficient information is required to be submitted to assure the
proper identification, quality, purity and strength of the
investigational drug. A description of the drug substance,
including its physical, chemical, and biological
characteristics, must also be included in the IND. The general
method of preparation of the drug substance must be included. A
list of all components including inactive ingredients must also
be submitted. There must be adequate information about
pharmacological and toxicological studies of the drug involving
laboratory animals and in vitro tests on the basis
of which the sponsor has concluded that it is reasonably safe to
conduct the proposed clinical investigation. Where there has
been widespread use of the drug outside of the United States or
otherwise, it is possible in some limited circumstances to use
well documented clinical experience as a substitute for other
pre-clinical work.
The FDA typically takes several months to consider and act on an
IND application. We can give no assurance that our IND
application will be approved or, if approved following comments
or subject to modifications, the length of FDA approval time.
After the FDA approves the IND, the investigation is permitted
to proceed, during which the sponsor must keep the FDA informed
of new studies, including animal studies, make progress reports
on the study or studies covered by the IND, and also be
responsible for alerting FDA and clinical investigators
immediately of unforeseen serious side effects or injuries.
When all clinical testing has been completed and analyzed, final
manufacturing processes and procedures are in place, and certain
other required information is available to the manufacturer, a
manufacturer may submit an NDA to the FDA. An NDA must be
approved by the FDA covering the drug before its manufacturer
can commence commercial distribution of the drug. The NDA
contains a section describing the clinical investigations of the
drug which section includes, among other things, the following:
a description and analysis of each clinical pharmacology study
of the drug; a description and analysis of each controlled
clinical study pertinent to a proposed use of the drug; a
description of each uncontrolled clinical study including a
summary of the results and a brief statement explaining why the
study is classified as uncontrolled; and a description and
analysis of any other data or information relevant to an
evaluation of the safety and
14
effectiveness of the drug product obtained or otherwise received
by the applicant from any source foreign or domestic. The NDA
also includes an integrated summary of all available information
about the safety of the drug product including pertinent animal
and other laboratory data, demonstrated or potential adverse
effects of the drug, including clinically significant potential
adverse effects of administration of the drug contemporaneously
with the administration of other drugs and other related drugs.
A section is included describing the statistical controlled
clinical study and the documentation and supporting statistical
analysis used in evaluating the controlled clinical studies.
Another section of the NDA describes the data concerning the
action of a drug in the human body over a period of time and
data concerning the extent of drug absorption in the human body
or information supporting a waiver of the submission of such
data. Also included in the NDA is a section describing the
composition, manufacture and specification of the drug substance
including the following: a full description of the drug
substance, its physical and chemical characteristics; its
stability; the process controls used during manufacture and
packaging; and such specifications and analytical methods as are
necessary to assure the identity, strength, quality and purity
of the drug substance as well as the availability of the drug
products made from the substance. NDAs contain lists of all
components used in the manufacture of the drug product and a
statement of the specifications and analytical methods for each
component. Also included are studies of the toxicological
actions of the drug as they relate to the drugs intended
uses.
The data in the NDA must establish that the drug has been shown
to be safe for use under its proposed labeling conditions and
that there is substantial evidence that the drug is effective
for its proposed use(s). Substantial evidence is defined by
statute and FDA regulation to mean evidence consisting of
adequate and well-controlled investigations, including clinical
investigations by experts qualified by scientific training and
experience, to evaluate the effectiveness of the drug involved.
We can give no assurance that even if we complete clinical
testing that our NDA will be approved.
RESEARCH AND DEVELOPMENT
Our research and development efforts to date have consisted
primarily of pre-clinical development of and preparing
applications for regulatory approvals for MDI-P for our initial
target indications, HIV and Cystic Fibrosis. Our research and
development is accomplished by outside scientific researchers
under the coordination of Craig Palmer, Ph.D. During the
fiscal year ended December 31, 2004, we spent $550,093 on
research and development of MDI-P. During fiscal 2003, we spent
$100,423 on research and development. From inception through
December 31, 2004, we have recorded $3,548,738 in research
and development expenses. We are actively pursuing our research
efforts of MDI-P and are in the process of establishing a
commercialization plan for SaveCream. See Business
Strategy above.
EMPLOYEES
We currently have two employees, our President and CEO, Judy M.
Robinett, and our controller. We have engagements with a number
of consultants for communications, investor relations, website
development, accounting and other services. Over the past
several years, our priority has been the advancement of our
therapeutic technology through pre-clinical development and all
capital resources have been devoted in that direction. At such
time as capital resources permit, we will hire a larger
full-time staff of employees.
SCIENTIFIC ADVISORY BOARD
We have a scientific advisory board consisting of the following
individuals:
Bruce I. Dezube, M.D.
Director of AIDS Oncology, Beth Israel Deaconess Medical
Center, Boston
Associate Professor of Medicine, Harvard Medical School
We retained Dr. Dezube to oversee medical testing, FDA
protocol alignment and approvals planning for MDI-P.
Dr. Dezube will be the principal investigator for our IND
in HIV. Dr. Dezube is a member of the
15
AIDS Clinical Trial Group (ACTG) where he is principal
investigator in more than seven studies involving the testing
and evaluation of interferon and newer anti-HIV agents.
Additionally, Dr. Dezube has been involved in
industry-sponsored studies of other anti-HIV agents, assisting
with required FDA approvals. In one such action, Dr. Dezube
assisted Fuji Immuno Pharmaceuticals, Inc. in receiving the
quickest FDA approval for Phase 1 clinical trials ever
granted an anti-HIV drug. Dr. Dezube received his M.A. from
Harvard University and his M.D. from Tufts University.
Dr. Dezube was a research fellow in hematology and oncology
and is board certified in internal medicine, hematology, and
oncology.
Robert A. Mastico, Ph.D.
Physical Chemist, Independent Consultant
Dr. Mastico specializes in the chemistry, manufacturing and
control of new drug substances required for FDA approval. He has
experience submitting INDs to the FDA, handling the
manufacturing and analytical data (CMC section) for
investigational therapeutics. We have retained Dr. Mastico
to determine the chemical characterization requirements for
MDI-P, and for planning and compliance with all FDA and other
required certifications involving chemical analyses.
Dr. Mastico received his Ph.D. from the University of Leeds
in genetic biochemistry and has fifteen years experience in the
fields of biotherapeutics and pharmaceutical production.
Craig R. Palmer, Ph.D.
Principal, Palmer Capital Group, LLC
Dr. Palmer has served over the past twenty years as a
strategic financial advisor to a wide variety of technology
platform and biotech companies in their capital formation,
management and product licensing arenas. We have retained
Dr. Palmer to assist us in managing the pre-clinical and
clinical development of MDI-P as well as commercialization. He
serves as a director on several biotech and biomedical
companies, and has successfully licensed major ethical drugs and
biomedical devices. Prior to his involvement as a Principal in
Palmer Capital Group LLC, and its predecessor The Palmer Group,
he served as a manager and principal in the consulting
operations of Ernst & Young (10 years), followed
by a brief stint as a VP of Investments for a regional bank and
its SBIC. Dr. Palmer has assisted a number of his clients
in securing underwriters for their IPOs or secondary offerings.
He has also assisted several clients in establishing major
strategic partnerships for product development. Dr. Palmer
received his Ph.D. from the University of Washington.
ORGANIZATIONAL HISTORY
Medical Discoveries, Inc. was incorporated under the laws of the
State of Utah on November 20, 1991. Effective as of
August 6, 1992, the Company merged with and into WPI
Pharmaceutical, Inc., a Utah corporation (WPI), pursuant to
which WPI was the surviving corporation. Pursuant to the MDI-WPI
merger, the name of the surviving corporation was changed to
Medical Discoveries, Inc. WPI was incorporated under the laws of
the State of Utah on February 22, 1984 under the name
Westport Pharmaceutical, Inc. Effective as of May 8, 1984,
Westport Pharmaceutical, Inc. merged with and into Euripides
Technology, Inc., a Utah corporation (Euripides), pursuant to
which Euripides was the surviving corporation. Pursuant to the
Westport-Euripides merger, the name of the surviving corporation
was changed to Westport Pharmaceutical, Inc. Westport
Pharmaceutical, Inc. subsequently changed its name to WPI
Pharmaceutical, Inc. Euripides was incorporated under the laws
of the State of Utah on November 9, 1983.
On July 6, 1998, we incorporated a wholly-owned subsidiary,
Regenere, Inc., in the State of Nevada. On October 2, 1998,
we incorporated another wholly-owned subsidiary, MDI Healthcare
Systems, Inc., in the State of Nevada. Both subsidiaries were
incorporated to undertake special purposes, neither of which
were pursued by us in recent years. As of December 31,
2003, we dissolved those subsidiaries.
On March 22, 2005, we formed MDI Oncology, Inc., a Delaware
corporation, as a wholly-owned subsidiary to acquire and operate
the assets and business associated with the Savetherapeutics
transaction.
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We file annual, quarterly, and current reports, proxy
statements, and other information with the Securities and
Exchange Commission. You may read and copy any reports,
statements, or other information that we file at the
Commissions Public Reference Room at 450 Fifth
Street, N.W., Washington, D.C. 20549. Please call the
Commission at 1-800-SEC-0330 for further information on the
Public Reference Room. The Commission also maintains an Internet
site (http://www.sec.gov) that makes available to the public
reports, proxy statements, and other information regarding
issuers, such as us, that file electronically with the
Commission. Reports, proxy statements and other information
concerning us can be inspected and copied at the Public
Reference Room of the National Association of Securities
Dealers, 1735 K Street, N.W., Washington, D.C.
20006. We are not required to deliver annual reports to security
holders, but we plan to deliver an annual report to all
shareholders this year prior to our annual meeting of
shareholders.
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ITEM 2. |
DESCRIPTION OF PROPERTY. |
We do not currently own or lease any real property. Currently,
we operate out of the President and CEOs home office. We
do not pay any rent to the President and CEO. Over the past
several years, our priority has been the advancement of our
therapeutic technology through pre-clinical development and all
capital resources have been devoted in that direction. At such
time as capital resources permit, we will lease dedicated office
and laboratory space.
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ITEM 3. |
LEGAL PROCEEDINGS. |
None.
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ITEM 4. |
SUBMISSION OF MATTERS TO A VOTE OF SECURITY
HOLDERS. |
No matters were submitted to a vote of security holders during
the fourth quarter of the fiscal year covered by this report.
PART II
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ITEM 5. |
MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER
MATTERS. |
MARKET INFORMATION
Our common stock is traded on the NASD OTC Bulletin Board
under the symbol MLSC. The following table sets
forth the range of bid quotations for our common stock for the
quarters indicated according to data provided by The NASDAQ
Stock Market, Inc. Such quotations reflect inter-dealer prices,
without retail mark-ups, markdowns or commissions, and may not
represent actual transactions.
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Fiscal Year Ended December 31, 2004 |
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High Bid | |
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Low Bid | |
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First Quarter
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$ |
0.170 |
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$ |
0.100 |
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Second Quarter
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0.300 |
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0.115 |
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Third Quarter
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0.301 |
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0.150 |
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Fourth Quarter
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0.260 |
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0.180 |
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Fiscal Year Ended December 31, 2003 |
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High Bid | |
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Low Bid | |
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First Quarter
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$ |
0.085 |
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$ |
0.035 |
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Second Quarter
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0.090 |
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0.055 |
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Third Quarter
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0.075 |
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0.045 |
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Fourth Quarter
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0.395 |
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0.060 |
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SHAREHOLDERS
The approximate number of shareholders of record of our common
stock as of March 16, 2005 was 1,458. This number does not
include shareholders whose shares are held in securities
position listings.
DIVIDENDS
We have never paid any cash dividends on our common stock and do
not anticipate paying dividends in the foreseeable future. We
presently intend to retain any future earnings for financing our
growth and expansion.
SECURITIES AUTHORIZED FOR ISSUANCE UNDER EQUITY COMPENSATION
PLANS
The following table contains information regarding our equity
compensation plans as of December 31, 2004.
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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 | |
|
|
Outstanding Options, | |
|
Outstanding Options, | |
|
Securities Reflected | |
Plan Category |
|
Warrants and Rights | |
|
Warrants and Rights | |
|
in the First Column) | |
|
|
| |
|
| |
|
| |
Equity compensation plans approved by security holders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1993 Incentive Plan
|
|
|
3,483,000 |
|
|
$ |
0.14 |
|
|
|
-0- |
|
|
2002 Stock Incentive Plan
|
|
|
16,000,000 |
|
|
$ |
0.02 |
|
|
|
4,700,000 |
|
Equity compensation plans not approved by security holders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
19,483,000 |
|
|
$ |
0.04 |
|
|
|
4,700,000 |
|
UNREGISTERED SALES OF SECURITIES
We sold the following unregistered securities in the past three
years. None of the sales involved an underwriter. We believe
these sales were exempt from registration pursuant to
Section 4(2) of the Securities Act of 1933 because the
sales did not involve a public offering.
|
|
|
|
|
On or about March 14, 2005, we sold 30,000 shares of
Preferred Stock and warrants to
purchase 22,877,478 shares of common stock for a total
offering price of $3 million. Each share of Preferred Stock
entitles the holder to convert the share of Preferred Stock into
the number of shares of common stock resulting from multiplying
$100 by the conversion price. The conversion price is 75% of the
average of the lowest three intra-day trading prices for the
Companys common stock during the 10 trading days
immediately preceding the conversion date, but the conversion
price may not exceed $0.1967. The number of shares of common
stock subject to the warrants and the exercise price are subject
to equitable adjustment in connection with a stock split, stock
dividend or similar transaction. The warrants entitle the holder
to purchase up to 22,877,478 shares of common stock of the
Company on or before the third anniversary of the issuance date
of the warrants at $0.1967 per share. The number of shares
of common stock subject to the warrants and the exercise price
are subject to equitable adjustment in connection with a stock
split, stock dividend or similar transaction. In connection with
this financing, we issued to a placement agent warrants that
entitle the holder to purchase up to 1,220,132 shares of common
stock of the Company on or before the third anniversary of the
issuance date of the warrants at $0.1967 per share. |
|
|
|
On or about October 18, 2004, we sold 12,000 shares of
Preferred Stock and warrants to
purchase 4,575,496 shares of common stock for a total
offering price of $1.2 million. Each share of |
18
|
|
|
|
|
Preferred Stock entitles the holder to convert the share of
Preferred Stock into the number of shares of common stock
resulting from multiplying $100 by the conversion price. The
conversion price is 85% of the average of the lowest three
intra-day trading prices for the Companys common stock
during the 10 trading days immediately preceding the
conversion date, but the conversion price may not exceed $0.1967
or be lower than $0.05. The number of shares of common stock
subject to the warrants and the exercise price are subject to
equitable adjustment in connection with a stock split, stock
dividend or similar transaction. The warrants entitle the holder
to purchase up to 4,575,496 shares of common stock of the
Company on or before the third anniversary of the issuance date
of the warrants at $0.1967 per share. The number of shares
of common stock subject to the warrants and the exercise price
are subject to equitable adjustment in connection with a stock
split, stock dividend or similar transaction. In connection with
this financing, we issued to a placement agent
350,000 shares of restricted common stock and warrants that
entitle the holder to purchase up to 488,052 shares of common
stock of the Company on or before the third anniversary of the
issuance date of the warrants at $0.1967 per share. |
|
|
|
During 2004 we sold 5,551,011 shares of restricted common
stock at $0.18 per share to various private investors
pursuant to a private placement, further terms of which are
disclosed in Form D filed with the Commission. |
|
|
|
During 2004 we sold 714,286 shares of restricted common
stock at $0.14 per share to various private investors
pursuant to a private placement, further terms of which are
disclosed in Form D filed with the Commission. |
|
|
|
During 2004 we sold 2,272,727 shares of restricted common
stock at $0.11 per share to various private investors
pursuant to a private placement, further terms of which are
disclosed in Form D filed with the Commission. |
|
|
|
During 2004 we sold 11,600,000 shares of restricted common
stock at $0.04 per share to various private investors
pursuant to a private placement, further terms of which are
disclosed in Form D filed with the Commission. |
|
|
|
During 2004 we issued 9,875,951 shares of common stock upon
conversion of certain promissory notes with an aggregate
outstanding principal and interest amount of $650,468. |
|
|
|
During 2004 we issued 1,189,465 shares of restricted common
stock in lieu of cash finders fees in connection with
equity financings. |
|
|
|
During the fourth quarter of 2003, we sold
26,862,500 shares of restricted common stock at
$0.04 per share to various private investors pursuant to a
private placement, further terms of which are disclosed in
Form D filed with the Commission. |
|
|
|
$195,000 secured promissory note dated February 20, 2003,
bearing interest at the rate of 12%. |
|
|
|
$25,000 secured promissory note dated October 25, 2002,
bearing interest at the rate of 15%, 12% of which is payable in
cash and 3% of which is payable in common stock at a rate equal
to the 15-day average market price determined at the date of
maturity. |
|
|
|
$125,000 secured promissory note dated October 24, 2002,
bearing interest at the rate of 15%, 12% of which is payable in
cash and 3% of which is payable in common stock at a rate equal
to the 15-day average market price determined at the date of
maturity. This note has subsequently been retired. |
|
|
|
$50,000 secured promissory note dated October 24, 2002,
bearing interest at the rate of 15%, 12% of which is payable in
cash and 3% of which is payable in common stock at a rate equal
to the 15-day average market price determined at the date of
maturity. |
|
|
|
$50,000 unsecured convertible promissory note dated
February 8, 2002, bearing interest at the rate of 18%,
convertible to common stock of the Company at the rate of
$0.06 per share. This note was subsequently refinanced with
a 15% interest rate. |
19
|
|
|
|
|
$50,000 unsecured convertible promissory note dated
April 8, 2002, bearing interest at the rate of 18%,
convertible to common stock of the Company at the rate of
$0.06 per share. This note was subsequently refinanced with
a 15% interest rate. |
|
|
|
$50,000 unsecured convertible promissory note dated
July 12, 2002, bearing interest at the rate of 18%,
convertible to common stock of the Company at the rate of
$0.06 per share. This note was subsequently refinanced with
a 15% interest rate. |
|
|
|
$50,000 unsecured convertible promissory note dated
April 21, 2002, bearing interest at the rate of 18%,
convertible to common stock of the Company at the rate of
$0.125 per share. This note was subsequently refinanced
with a conversion rate of $0.06 per share. |
|
|
|
$55,000 unsecured convertible promissory note dated
February 22, 2002, bearing interest at the rate of 18%,
convertible to common stock of the Company at the rate of
$0.125 per share. This note was subsequently refinanced
with a conversion rate of $0.06 per share. |
|
|
ITEM 6. |
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS. |
The purpose of this section is to discuss and analyze our
consolidated financial condition, liquidity and capital
resources, and results of operations. This analysis should be
read in conjunction with the financial statements and notes
thereto at pages 27 through 43.
This section contains certain forward-looking statements that
involve risks and uncertainties, including statements regarding
our plans, objectives, goals, strategies and financial
performance. Our actual results could differ materially from the
results anticipated in these forward-looking statements as a
result of factors set forth under Cautionary Statement for
Forward-Looking Information and Factors Affecting Future
Results below and elsewhere in this report.
RESULTS OF OPERATIONS
Revenues and Gross Profit. We booked no revenues for the
year ended December 31, 2004 or for the prior year ended
December 31, 2003. As we continue to pursue pre-clinical
and clinical testing of our pharmaceuticals, we do not
anticipate booking significant revenues in the near future.
Operating Expenses and Operating Loss. We booked $550,093
in research and development expenses during the year ended
December 31, 2004, as compared with $100,423 in such
expenses for the same period in 2003. Our increased research and
development activity reflects our success is raising capital to
fund pre-clinical studies of MDI-P. We have continued to be
successful in raising capital in 2005 and will likely incur
substantially higher research and development expenses during
2005. Our general and administrative expenses were $3,057,429 in
2004, as compared with $1,206,484 during the year ended
December 31, 2003. Of that amount, we recorded non-cash
charges of $1,741,501 for stock and stock options issued for
services, expenses and interest. As a result of the foregoing,
we sustained an operating loss of $3,607,522 for the year ended
December 31, 2004, as compared with a loss of $1,306,907
for the same period of 2003.
Other Income/ Expense and Net Loss. We recorded other
income during 2004 in the amount of $1,408. During 2003, we
recorded $611,558 in other income, $610,828 of which was on
account of writing off certain liabilities from our balance
sheet. We incurred interest expenses of $131,526 in 2004, as
compared with $256,694 in such expenses in 2003. Our interest
expenses have decreased as we have paid down or converted to
equity relatively short-term, high-interest debt incurred in
past periods in order to finance operations, research and
development. We also recorded $6,165 in interest income in 2004.
In sum, our net loss available to common stockholders for 2004
was $4,423,674, or a loss of approximately $0.05 per fully
diluted share. In 2003, we sustained a net loss of $952,043, or
a loss of approximately $0.02 per fully diluted share.
Income Taxes. We have available net operating losses of
approximately $12,830,000 which can be utilized to offset future
earnings. See Note C to the Financial Statements for a
further explanation of this analysis.
20
Future Commitment and Expectations. We expect to operate
at a loss for several more years while we continue to study,
gain regulatory approval of and commercialize our technologies.
We will spend more in 2005 in research and development expenses
as we continue to implement our commercialization strategy.
Similarly, we expect our general and administrative expenses to
increase in 2005 as we assimilate the Savetherapeutics assets
into our organization and commercialize SaveCream. As a result,
we may sustain a greater net loss in 2005, than we have in
recent years.
Recently Issued Accounting Statements. In December 2004,
the FASB issued SFAS No. 123 (revised 2004),
Share-Based Payment, which is an amendment to
SFAS No. 123, Accounting for Stock-Based
Compensation. This new standard eliminates the ability to
account for share-based compensation transactions using
Accounting Principles Board (APB) No. 25,
Accounting for Stock Issued to Employees
(APB 25) and requires such transactions to be accounted for
using a fair-value-based method and the resulting cost
recognized in the Companys financial statements. This new
standard is effective for interim and annual periods beginning
after June 15, 2005. The Company intends to implement
SFAS No. 123 in the third quarter of 2005 and it will
not currently have any effect on the Companys financial
statements.
In December 2004, the FASB issued SFAS Statement
No. 153, Exchanges of Non-monetary Assets
an amendment of APB Opinion No. 29. This
Statement amends APB Opinion 29 to eliminate the exception for
non-monetary exchanges of similar productive assets and replaces
it with a general exception for exchanges of non-monetary assets
that do not have commercial substance. A non-monetary exchange
has commercial substance if the future cash flows of the entity
are expected to change significantly as a result of the
exchange. The Statement will be effective in January 2006. The
Company does not expect that the adoption of
SFAS No. 153 will have a material impact on its
Consolidated Financial Statements.
LIQUIDITY AND CAPITAL RESOURCES
As of December 31, 2004, we had $1,455,397 in cash and had
a working capital deficit of $1,887,136. Since our inception, we
have financed our operations primarily through private sales of
equity and the issuance of convertible and non-convertible
notes. We will require significant additional funding to
continue to develop, research and seek regulatory approval of
our technologies. We do not currently generate any cash from
operations and have no credit facilities in place or available.
Currently, we are funding operations through issuances of
private equity.
We are seeking to raise substantial additional funds in private
stock offerings in order to meet our mid-term funding
requirements. While we are optimistic that we can raise such
funds, we have not always been successful in doing so in recent
years. Given that we are still in an early development stage and
do not have revenues from operations, raising equity financing
is difficult. In addition, any additional equity financing will
have a substantial dilutive effect to our current shareholders.
Pursuant to our commercialization strategy, we estimate we will
need to expend an additional $550,000 in research and
development to conduct additional pre-clinical testing and gain
acceptance of our IND as a therapy for Cystic Fibrosis. (See
Description of Business Commercialization
Strategy above.) In addition, we estimate we will need to
expend an additional $300,000 to $350,000 in debt service and
general and administrative costs between now and when we hope to
receive acceptance of that IND in Q4 2005. Assuming that IND is
accepted, we estimate we will need to expend an additional
$830,000 in conducting Phase I clinical trials (including
general and administrative expenses through our projected
completion date of such trials in Q1 of 2006). Additionally,
upon acceptance of the Cystic Fibrosis IND, we estimate we will
need to expend an additional $300,000 in completing and filing
our IND for HIV. Therefore, in total, in order to advance MDI-P
through our immediate developmental goals, we estimate to incur
expenses of $1,980,000 to $2,030,000. As of the date of this
report, we nearly have adequate cash for these purposes.
However, we have not yet completed our commercialization
strategy for SaveCream or our projections of the associated
costs. Clearly, therefore, the near-term costs of advancing
MDI-P and SaveCream to the next developmental milestones and
funding the remaining
1,850,000 of our
SaveCream purchase price obligation, when taken together, exceed
our current cash.
21
Furthermore, we estimate the cost to complete Phase II
clinical trials in any one indication to be several million
dollars and the cost to complete Phase III testing and
obtain approval of an NDA to be in the tens of millions of
dollars. While our ability to obtain financing may improve as we
continue to advance our technologies, we cannot give assurances
that we will have the access to the significant capital required
to take a drug through regulatory approvals and to market. We
may seek a partner in the global pharmaceutical industry to help
us co-develop, license, or even purchase some or all of our
technologies.
OFF-BALANCE SHEET ARRANGEMENTS
We have no off-balance sheet arrangements as defined in
Item 303(c) of Regulation S-B.
FOREIGN CURRENCY RISK
The Company bears foreign currency exchange risk because our
remaining purchase price obligation for the Savetherapeutic
assets is stated in Euros.
CAUTIONARY STATEMENT FOR FORWARD LOOKING INFORMATION
AND FACTORS AFFECTING FUTURE RESULTS
Certain information set forth in this report contains
forward-looking statements within the meaning of
federal securities laws. Forward looking statements include
statements concerning our plans, objectives, goals, strategies,
future events, future revenues or performance, capital
expenditures, and financing needs and other information that is
not historical information. When used in this report, the words
estimates, expects,
anticipates, forecasts,
plans, intends, believes and
variations of such words or similar expressions are intended to
identify forward-looking statements. Additional forward-looking
statements may be made by us from time to time. All such
subsequent forward-looking statements, whether written or oral
and whether made by us or on our behalf, are also expressly
qualified by these cautionary statements.
Our forward-looking statements are based upon our current
expectations and various assumptions. Our expectations, beliefs
and projections are expressed in good faith and are believed by
us to have a reasonable basis, including without limitation, our
examination of historical operating trends, data contained in
our records and other data available from third parties, but
there can be no assurance that our expectations, beliefs and
projections will result or be achieved or accomplished. Our
forward-looking statements apply only as of the date made. We
undertake no obligation to publicly update or revise
forward-looking statements which may be made to reflect events
or circumstances after the date made or to reflect the
occurrence of unanticipated events. There are a number of risks
and uncertainties that could cause actual results to differ
materially from those set forth in, contemplated by, or
underlying the forward-looking statements contained in this
report. In addition to the other factors and matters discussed
elsewhere in this report, the following factors are among the
factors that could cause actual results to differ materially
from the forward-looking statements. Any forward-looking
statements made by us or on our behalf should be considered in
light of these factors.
We Are A Development-Stage Company That Has Not Yet
Commercialized A Product. We have not commercialized MDI-P,
SaveCream or any other product and our failure to commercialize
our drugs would likely cause us to cease operations. While we
believe MDI-P and SaveCream may have very broad commercial
applications, we do not have any other products under
development, nor do we have scientific personnel on staff to
develop any further technologies. While our pre-clinical studies
of MDI-P and SaveCream to date have been quite favorable, there
is no certainty that our drugs will be successful. The results
of our pre-clinical studies may not be indicative of future
clinical trials. Moreover, unacceptable side effects could occur
at any time in the course of human trials or, if our drugs are
approved for sales, during commercial use. Even if our drugs do
prove to be safe and effective and receive regulatory approvals,
we may be unable to successfully.
We Have Incurred Substantial Losses Since Our Inception And
May Continue To Operate At A Loss. We have experienced net
losses in each twelve-month period since inception, with a
retained deficit of
22
approximately $20,753,510 as of December 31, 2004. Our
losses from operations in 2004 were $3,731,475 and our
cumulative losses from operations since inception through
December 31, 2004 were $18,661,734. We will likely continue
to experience a net operating loss until, and if, we can fully
commercialize our technologies, which may not be for several
years. We are presently investing all of our resources in the
testing, development and commercialization of MDI-P and
Save-Cream. If MDI-P and SaveCream do not generate revenues or
if the revenues do not exceed the costs of research,
development, testing, regulatory approval and other costs, then
we may never realize a profit from operations.
We May Not Be Able To Raise Sufficient Capital To Meet
Present And Future Obligations. As of December 31,
2004, our current liabilities exceeded our current assets by
$1,887,136 and we had cash of only $1,455,397. We need
substantial additional capital to fund regulatory approvals and
to fully commercialize our technologies. We do not anticipate
that revenues will satisfy these capital requirements.
Furthermore, we may not to be able to obtain the amount of
additional capital needed or may be forced to pay an extremely
high price for capital.
The timing and amount of our future capital requirements will
depend on many factors, including, without limitation the
following:
|
|
|
|
|
our ability to raise additional funding and the amounts raised,
if any; |
|
|
|
the time and costs involved in obtaining regulatory approvals; |
|
|
|
the results of pre-clinical studies and clinical trials; |
|
|
|
the cost of manufacturing scale-up; |
|
|
|
competing technological and market developments; |
|
|
|
the costs of filing, prosecuting and enforcing patent
claims; and |
|
|
|
the effectiveness of our commercialization activities. |
Factors affecting the availability and price of capital may
include, without limitation, the following:
|
|
|
|
|
market factors affecting the availability and cost of capital
generally; |
|
|
|
our performance; |
|
|
|
the size of our capital needs; |
|
|
|
the markets perception and acceptance of our technologies; |
|
|
|
the price, volatility and trading volume of our common
shares; and |
|
|
|
the effect of the exercise of outstanding options and warrants
exercisable into approximately 58 million shares of common
stock. |
If we are unable to obtain sufficient capital or are forced to
pay a high price for capital, we may be unable to complete
testing, regulatory approval and commercialization of our
technologies and may never achieve consistent revenues or
profitability. In addition, because of their size, resources and
other factors, our competitors may have better access to capital
than we do and, as a result, may be able to exploit
opportunities more rapidly, easily or thoroughly than we can.
Our Independent Auditors Have Expressed Substantial Doubt As
To Our Ability To Continue As A Going Concern. Our auditors
have expressed substantial doubt about our ability to continue
as a going concern because of our recurring losses from our
development-stage activities in current and prior years. We have
not generated any significant revenues to date. We expect to
continue to incur substantial net operating losses over the next
several years. We may not be able to generate sufficient
revenues to become profitable and do not expect to generate any
revenues for several years. We struggle with operating and
liquidity issues due to our negative cash flows from operations
and we have had difficulty in the past with raising capital. As
a result of these and other factors, our independent auditors
have expressed substantial doubt about our ability to
23
continue as a going concern. The financial statements do not
include any adjustments that might be necessary if the Company
is unable to continue as a going concern.
Our Operations Are And Will Be Subject To Extensive
Regulation. Our use of MDI-P and SaveCream in the treatment
of humans is subject to extensive regulation by United States
and foreign governmental authorities. In particular,
pharmaceutical treatments are subject to rigorous pre-clinical
and clinical testing and other approval requirements by the FDA
in the United States under the federal Food, Drug and Cosmetic
Act and by comparable agencies in most foreign countries.
Various federal, state and foreign statutes also govern or
influence the manufacture, labeling, storage, record keeping,
and marketing of such products. Pharmaceutical manufacturing
facilities are also regulated by state, local, and other
authorities. Obtaining approval from the FDA and other
regulatory authorities for a new drug or treatment may take
several years and involve substantial expenditures. Moreover,
ongoing compliance with these requirements can require the
expenditure of substantial resources. Difficulties or
unanticipated costs may be encountered by us in our efforts to
secure necessary governmental approvals, which could delay or
preclude us from marketing our products.
Our Products Will Be Exposed To Pricing And Reimbursement
Risks. Our ability to earn revenue will depend in part on
the extent to which reimbursement for the costs of the products
and related treatments will be available from government health
administration authorities, private health coverage and managed
care organizations. Third-party payers are increasingly
challenging the prices of drugs and medical services. If
purchasers or users of MDI-P or SaveCream are not able to obtain
adequate reimbursement, they may forego or reduce their use.
We Face Intense Competition And Competing Products.
Competition in the markets for MDI-P and SaveCream is intense
and will likely further intensify. The biotechnology and
pharmaceutical industries are characterized by rapidly evolving
technologies and intense competition. Our competitors include
major pharmaceutical, and specialized biotechnology companies,
many of which have financial, technical, and marketing resources
significantly greater than ours. Fully integrated pharmaceutical
companies, due to their expertise in research and development,
manufacturing, testing, obtaining regulatory approvals, and
marketing, as well as their substantially greater financial and
other resources, may be our most formidable competitors. In
addition, acquisitions by such pharmaceutical companies could
enhance the financial and marketing resources of smaller
competitors. Furthermore, colleges, universities, governmental
agencies, and other public and private research organizations
will continue to conduct research and possibly market
competitive commercial products on their own or through joint
ventures. These institutions are becoming more active in seeking
patent protection and licensing arrangements to collect
royalties for use of technology that they have developed. These
institutions also will compete with us in recruiting and
retaining highly qualified scientific personnel.
If and when we obtain regulatory approval for any of the
potential uses of our technology which require them, we must
then compete for acceptance in the marketplace. Given that such
regulatory approval, especially in the United States, may take a
number of years, the timing of the introduction of our
technology and other products to the market is critical. Other
safe and effective drugs and treatments may be introduced into
the market prior to the time that we are able to obtain approval
for the commercialization of our technology. In addition, even
after such regulatory approval is obtained, competition among
products approved for sale may be affected by, among other
things, product efficacy, safety, reliability, availability,
price, and patent position.
Our Intellectual Property May Not Be Adequately
Protected. We rely heavily on our patent protection to
prevent others from using the human therapeutic applications of
our technology. It is our policy to protect our intellectual
property and proprietary technologies by, among other means,
filing patent applications to protect technology that we
consider important to the development of our business. We also
rely on trade secrets and improvements, unpatented know-how, and
continuing technological innovation to develop and maintain our
competitive position. Despite our policy to seek patent
protection wherever appropriate, we cannot be sure that our
patent applications will result in further patents being issued
or that, if issued, the patents will afford protection against
competitors with similar technology. While we have obtained
several United States patents, persons in jurisdictions outside
of the United States in which no application has been filed, or
which do not honor United States patents, may develop and market
infringing technologies. Also, the cost of enforcing
24
patents outside of North America, as well as other obstacles,
may limit our ability to enforce any patents outside of the
United States. Finally, our products and processes may infringe
on patents of others. If relevant claims of third-party patents
are upheld as valid and enforceable, we could be prevented from
practicing the subject matter claimed in the claims, or be
required to obtain licenses or redesign our products or
processes to avoid infringement.
We May Need to Litigate to Secure Our Rights to SaveCream And
Related Assets. At the time we purchased SaveCream and the
other intellectual property assets from Savethearpeutics A.G.
(SaveT), SaveT had not yet obtained and filed with the
appropriate patent offices assignments of the various
inventors rights to the underlying inventions. Each of
those inventors has agreed and is contractually bound to assign
such rights. We are currently in the process of securing the
applicable assignments. However, we may need to initiate
litigation against the inventors to secure such assignments.
We Face Significant Product Liability. We face an
inherent business risk of exposure to product liability and
other claims in the event our products results in or is alleged
to result in harmful effects. We may not be able to avoid
significant liability exposure. We may not have or be able to
obtain or maintain sufficient insurance coverage at a reasonable
cost. An inability to obtain sufficient insurance coverage at a
reasonable cost could prevent or inhibit the commercialization
of our technology. Even if we avoid liability exposure, we could
incur significant costs that hurt our financial performance. We
currently do not have and have not applied for product liability
insurance. We intend to purchase product liability insurance
prior to commencing clinical trials.
The Market For Our Stock Is Thin And Subject To
Manipulation. Our common stock is traded on the NASD OTC
Bulletin Board under the symbol MLSC. The
following table sets forth the range of bid quotations for our
common stock for the quarters indicated according to data
provided by The NASDAQ Stock Market, Inc. Such quotations
reflect inter-dealer prices, without retail mark-ups, markdowns
or commissions, and may not represent actual transactions.
|
|
|
|
|
|
|
|
|
Period |
|
High Bid | |
|
Low Bid | |
|
|
| |
|
| |
Quarter ended December 31, 2004
|
|
$ |
0.260 |
|
|
$ |
0.180 |
|
Quarter ended September 30, 2004
|
|
|
0.301 |
|
|
|
0.150 |
|
Quarter ended June 30, 2004
|
|
|
0.300 |
|
|
|
0.115 |
|
Quarter ended March 31, 2004
|
|
|
0.170 |
|
|
|
0.100 |
|
The Market Price For Our Common Stock Will Likely Be Volatile
And May Change Dramatically At Any Time. The market price of
our common stock, like that of the securities of other
early-stage companies, may be highly volatile. Our stock price
may change dramatically as the result of announcements of our
quarterly results, the execution or termination of significant
customer contracts, significant litigation or other factors or
events that would be expected to affect our business or
financial condition, results of operations and other factors
specific to our business and future prospects. In addition, the
market price for our common stock may be affected by various
factors not directly related to our business, including the
following:
|
|
|
|
|
intentional manipulation of our stock price by existing or
future stockholders; |
|
|
|
short selling of our common stock or related derivative
securities; |
|
|
|
the interest, or lack of interest, of the market in our business
sector, without regard to our financial condition or results of
operations; |
|
|
|
the adoption of governmental regulations and similar
developments in the United States or abroad that may affect our
ability to develop our products or affect our cost structure; |
|
|
|
economic and other external market factors, such as poor
economic indicators or investor distrust. |
Obtaining Additional Capital Though The Sale Of Common Stock
Will Result In Dilution Of Stockholder Interests. We plan to
raise additional funds in the future by issuing additional
shares of common stock, or securities such as convertible notes,
options, warrants or preferred stock that are convertible into
25
common stock. Any such sale of common stock or other securities
will lead to further dilution of the equity ownership of
existing holders of our common stock.
We Are Unlikely To Pay Dividends On Our Common Stock In the
Foreseeable Future. We have never declared or paid dividends
on our stock. We currently intend to retain all available funds
and any future earnings for use in the operation and expansion
of our business. We do not anticipate paying any cash dividends
in the foreseeable future, and it is unlikely that investors
will derive any current income from ownership of our stock. This
means that your potential for economic gain from ownership of
our stock depends on appreciation of our stock price and will
only be realized by a sale of the stock at a price higher than
your purchase price.
26
|
|
ITEM 7. |
FINANCIAL STATEMENTS. |
FINANCIAL STATEMENTS TABLE OF CONTENTS
|
|
|
|
|
|
|
|
Page No. | |
|
|
| |
|
|
|
28 |
|
|
|
|
29 |
|
FINANCIAL STATEMENTS
|
|
|
|
|
|
|
|
|
30 |
|
|
|
|
|
31 |
|
|
|
|
|
32 |
|
|
|
|
|
34 |
|
|
|
|
|
35 |
|
27
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Shareholders
Medical Discoveries, Inc.
We have audited the accompanying consolidated balance sheet of
Medical Discoveries, Inc. and subsidiaries (a development stage
company) as of December 31, 2004, and the related
consolidated statements of operations, changes in
stockholders deficit, and cash flows for the year then
ended, and for the period from November 20, 1991 (date of
inception of the development stage) through December 31,
2004. These financial statements are the responsibility of the
Companys management. Our responsibility is to express an
opinion on these financial statements based on our audit. We did
not audit the consolidated financial statements of the Company
from November 20, 1991 through December 31, 2003,
which statements reflect total revenues and deficit accumulated
during the development stage of $157,044 and $14,930,259,
respectively. Those statements were audited by other auditors
whose report, dated February 18, 2004 (except Note K
as to which the date is November 15, 2004), included an
explanatory paragraph stating there was substantial doubt
regarding the Companys ability to continue as a going
concern. Our opinion, insofar as it relates to the consolidated
financial statements for the period from November 20, 1991
through December 31, 2003, is based solely on the report of
the other auditors.
We conducted our audit in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by
management, as well as evaluating the overall financial
statement presentation. We believe that our audit and the report
of the other auditors provide a reasonable basis for our opinion.
In our opinion, based on our audit and the report of the other
auditors, the consolidated financial statements referred to
above present fairly, in all material respects, the financial
position of Medical Discoveries, Inc. and subsidiaries as of
December 31, 2004, and the results of their operations and
their cash flows for the year then ended and for the period from
November 20, 1991 through December 31, 2004, in
conformity with U.S. generally accepted accounting
principles.
The accompanying consolidated financial statements have been
prepared assuming that the Company will continue as a going
concern. The Company is a development stage enterprise engaged
in developing bio-pharmaceutical research. As discussed in
Note B to the financial statements, the stockholders
deficiency and the operating losses since inception raise
substantial doubt about the Companys ability to continue
as a going concern. Managements plans concerning these
matters are also described in Note B. The financial
statements do not include any adjustments that might result from
the outcome of these uncertainties.
|
|
|
/s/ HANSEN, BARNETT & MAXWELL |
|
|
Salt Lake City, Utah
March 28, 2005
28
INDEPENDENT AUDITORS REPORT
To the Board of Directors and Stockholders
Medical Discoveries, Inc. and Subsidiaries
Boise, Idaho
We have audited the accompanying consolidated statements of
operations, changes in stockholders deficit, and cash
flows of Medical Discoveries, Inc. and Subsidiaries (a
development stage company) for the year ended December 31,
2003, and for the period from inception (November 20, 1991)
to December 31, 2003. These consolidated financial
statements are the responsibility of the Companys
management. Our responsibility is to report on these
consolidated financial statements based on our audit. The
Companys financial statements for the period from
inception (November 20, 1991) through December 31,
1999 were audited by other auditors whose report, dated
March 20, 2000, expressed an unqualified opinion on those
statements. The financial statements for the period from
inception (November 20, 1991) through December 31,
1999 reflect total revenues and net loss of $150,015 and
$9,951,404, respectively, of the related totals. The other
auditors report has been furnished to us, and our report,
insofar as it relates to the amounts included for such prior
period, is based solely on the report of such other auditors.
We conducted our audit in accordance with U.S. generally
accepted auditing standards. Those standards require that we
plan and perform the audit to obtain reasonable assurance about
whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis,
evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting
principles used and significant estimates made by management, as
well as evaluating the overall financial statement presentation.
We believe that our audit provides a reasonable basis for our
opinion.
In our opinion, based on our audit and the report of other
auditors, such consolidated financial statements present fairly,
in all material respects, the results of operations and cash
flows of Medical Discoveries, Inc. and Subsidiaries for the year
ended December 31, 2003, and for the period from inception
(November 20, 1991) to December 31, 2003, in
conformity with U.S. generally accepted accounting
principles.
The accompanying 2003 consolidated financial statements have
been prepared assuming the Company will continue as a going
concern. The Company is a development stage enterprise engaged
in developing biopharmaceutical research. As discussed in
Note B to the financial statements, the stockholders
deficiency and the operating losses since inception raise
substantial doubt about its ability to continue as a going
concern. Managements plans concerning these matters are
also described in Note B. The financial statements do not
include any adjustments that might result from the outcome of
these uncertainties.
|
|
|
/s/ EIDE BAILLY, LLP (formerly
BALUKOFF, LINDSTROM & CO., P.A.
joined Eide Bailly November 1, 2004) |
Boise, Idaho
February 18, 2004, except Note K as to which the date
is November 15, 2004
29
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED BALANCE SHEET
December 31, 2004
|
|
|
|
|
|
|
|
December 31, | |
|
|
2004 | |
|
|
| |
ASSETS |
Current assets
|
|
|
|
|
|
Cash
|
|
$ |
1,455,397 |
|
|
Deposit
|
|
|
51,100 |
|
|
|
|
|
Total current assets
|
|
|
1,506,497 |
|
|
|
|
|
Total assets
|
|
$ |
1,506,497 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS DEFICIT |
Current liabilities
|
|
|
|
|
|
Accounts payable
|
|
$ |
2,448,454 |
|
|
Accrued interest
|
|
|
415,262 |
|
|
Notes payable
|
|
|
336,717 |
|
|
Convertible notes payable
|
|
|
193,200 |
|
|
|
|
|
Total current liabilities
|
|
|
3,393,633 |
|
|
|
|
|
Stockholders deficit
|
|
|
|
|
|
Preferred stock, no par value, 50,000 shares authorized
Series A, convertible; 12,000 shares issued and outstanding
(aggregate liquidation preference of $1,200,000)
|
|
|
523,334 |
|
|
Common stock, no par value; 250,000 shares authorized;
105,653,335 shares issued and outstanding
|
|
|
14,918,657 |
|
|
Additional paid-in capital
|
|
|
3,424,383 |
|
|
Deficit accumulated prior to the development stage
|
|
|
(1,399,577 |
) |
|
Deficit accumulated during the development stage
|
|
|
(19,353,933 |
) |
|
|
|
|
Total stockholders deficit
|
|
|
(1,887,136 |
) |
|
|
|
|
Total liabilities and stockholders deficit
|
|
$ |
1,506,497 |
|
|
|
|
|
See Notes to Consolidated Financial Statements
30
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF OPERATIONS
Years Ended December 31, 2004 and 2003, and
Cumulative Amounts Since November 20, 1991 (Date of
Inception of the Development Stage)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative Amounts | |
|
|
For the Years Ended | |
|
Since November 20, | |
|
|
December 31, | |
|
1991 (Date of | |
|
|
| |
|
Inception of | |
|
|
2004 | |
|
2003 | |
|
Development Stage) | |
|
|
| |
|
| |
|
| |
Revenues
|
|
$ |
|
|
|
$ |
|
|
|
$ |
157,044 |
|
Cost of revenues
|
|
|
|
|
|
|
|
|
|
|
14,564 |
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
|
|
|
|
|
|
|
|
142,480 |
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses
|
|
|
550,093 |
|
|
|
100,423 |
|
|
|
3,548,738 |
|
|
Inventory write-down
|
|
|
|
|
|
|
|
|
|
|
96,859 |
|
|
Impairment loss
|
|
|
|
|
|
|
|
|
|
|
9,709 |
|
|
License
|
|
|
|
|
|
|
|
|
|
|
1,001,500 |
|
|
General and administrative expenses
|
|
|
3,057,429 |
|
|
|
1,206,484 |
|
|
|
15,176,970 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
(3,607,522 |
) |
|
|
(1,306,907 |
) |
|
|
(19,691,296 |
) |
Other income (expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
6,165 |
|
|
|
|
|
|
|
29,571 |
|
|
Other income
|
|
|
1,408 |
|
|
|
611,558 |
|
|
|
881,892 |
|
|
Interest expense
|
|
|
(131,526 |
) |
|
|
(256,694 |
) |
|
|
(1,117,437 |
) |
|
Forgiveness of debt
|
|
|
|
|
|
|
|
|
|
|
1,235,536 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(123,953 |
) |
|
|
354,864 |
|
|
|
1,029,562 |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(3,731,475 |
) |
|
|
(952,043 |
) |
|
|
(18,661,734 |
) |
Preferred stock dividend from beneficial conversion feature
|
|
|
(692,199 |
) |
|
|
|
|
|
|
(692,199 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stockholders
|
|
$ |
(4,423,674 |
) |
|
$ |
(952,043 |
) |
|
$ |
(19,353,933 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share
|
|
$ |
(0.05 |
) |
|
$ |
(0.02 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares outstanding
|
|
|
93,947,646 |
|
|
|
59,302,562 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See Notes to Consolidated Financial Statements
31
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS
DEFICIT
Period From November 20, 1991 (Date of Inception of the
Development Stage) through
December 31, 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated | |
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
Deficit | |
|
Accumulated |
|
|
|
|
|
|
Preferred Stock | |
|
Common stock | |
|
Additional |
|
Prior to | |
|
During the |
|
Escrow/ | |
|
|
|
|
| |
|
| |
|
Paid In |
|
Development | |
|
Development |
|
Subscription | |
|
|
|
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount | |
|
Capital |
|
Stage | |
|
Stage |
|
Receivables | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
|
|
|
| |
|
|
|
| |
|
| |
Balance at November 20, 1991 (Date of Inception of the
Development Stage)
|
|
|
|
|
|
|
|
|
|
|
11,750,000 |
|
|
$ |
135,000 |
|
|
$ |
|
|
|
$ |
(1,399,577 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
(1,264,577 |
) |
Issuance of common stock for:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1992 $0.50 per share
|
|
|
|
|
|
|
|
|
|
|
200,000 |
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
1992 $1.50 per share
|
|
|
|
|
|
|
|
|
|
|
40,000 |
|
|
|
60,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
60,000 |
|
|
|
1993 $0.97 per share
|
|
|
|
|
|
|
|
|
|
|
542,917 |
|
|
|
528,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
528,500 |
|
|
|
1994 $1.20 per share
|
|
|
|
|
|
|
|
|
|
|
617,237 |
|
|
|
739,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
739,500 |
|
|
|
1995 $0.67 per share
|
|
|
|
|
|
|
|
|
|
|
424,732 |
|
|
|
283,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
283,200 |
|
|
|
1996 $0.66 per share
|
|
|
|
|
|
|
|
|
|
|
962,868 |
|
|
|
635,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(60,000 |
) |
|
|
575,000 |
|
|
|
1997 $0.43 per share
|
|
|
|
|
|
|
|
|
|
|
311,538 |
|
|
|
135,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
60,000 |
|
|
|
195,000 |
|
|
|
1998 $0.29 per share
|
|
|
|
|
|
|
|
|
|
|
2,236,928 |
|
|
|
650,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
650,000 |
|
|
|
1999 $0.15 per share
|
|
|
|
|
|
|
|
|
|
|
13,334 |
|
|
|
2,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,000 |
|
|
|
2001 $0.15 per share
|
|
|
|
|
|
|
|
|
|
|
660,000 |
|
|
|
99,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
99,000 |
|
|
Services and Interest
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1992 $0.50 per share
|
|
|
|
|
|
|
|
|
|
|
500,000 |
|
|
|
250,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
250,000 |
|
|
|
1993 $0.51 per share
|
|
|
|
|
|
|
|
|
|
|
251,450 |
|
|
|
127,900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
127,900 |
|
|
|
1993 $0.50 per share
|
|
|
|
|
|
|
|
|
|
|
800,000 |
|
|
|
400,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
400,000 |
|
|
|
1994 $1.00 per share
|
|
|
|
|
|
|
|
|
|
|
239,675 |
|
|
|
239,675 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
239,675 |
|
|
|
1995 $0.39 per share
|
|
|
|
|
|
|
|
|
|
|
4,333,547 |
|
|
|
1,683,846 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(584,860 |
) |
|
|
1,098,986 |
|
|
|
1996 $0.65 per share
|
|
|
|
|
|
|
|
|
|
|
156,539 |
|
|
|
101,550 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101,550 |
|
|
|
1997 $0.29 per share
|
|
|
|
|
|
|
|
|
|
|
12,500 |
|
|
|
3,625 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,625 |
|
|
|
1998 $0.16 per share
|
|
|
|
|
|
|
|
|
|
|
683,000 |
|
|
|
110,750 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
110,750 |
|
|
|
1999 $0.30 per share
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
30,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
30,000 |
|
|
|
2001 $0.14 per share
|
|
|
|
|
|
|
|
|
|
|
1,971,496 |
|
|
|
284,689 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
284,689 |
|
|
|
2002 $0.11 per share
|
|
|
|
|
|
|
|
|
|
|
2,956,733 |
|
|
|
332,236 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
332,236 |
|
|
Conversion of Debt
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1996 $0.78 per share
|
|
|
|
|
|
|
|
|
|
|
239,458 |
|
|
|
186,958 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
186,958 |
|
|
|
1997 $0.25 per share
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
25,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,000 |
|
|
|
1998 $0.20 per share
|
|
|
|
|
|
|
|
|
|
|
283,400 |
|
|
|
56,680 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
56,680 |
|
|
|
2002-Debt-$0.03 per share
|
|
|
|
|
|
|
|
|
|
|
17,935,206 |
|
|
|
583,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
583,500 |
|
|
Other Issuances
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1993 License $0.50 share
|
|
|
|
|
|
|
|
|
|
|
2,000,000 |
|
|
|
1,000,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,000,000 |
|
|
|
1997 Settlement of contract
|
|
|
|
|
|
|
|
|
|
|
800,000 |
|
|
|
200,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
200,000 |
|
|
|
1998 Issuance of common stock from exercise of
warrants, $0.001 per share
|
|
|
|
|
|
|
|
|
|
|
200,000 |
|
|
|
200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
200 |
|
|
|
2000 Reversal of shares issued
|
|
|
|
|
|
|
|
|
|
|
(81,538 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See Notes to Consolidated Financial Statements
32
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS
DEFICIT (Continued)
Period From November 20, 1991 (Date of Inception of the
Development Stage) through December 31, 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated | |
|
Deficit | |
|
|
|
|
|
|
|
|
|
|
|
|
Deficit | |
|
Accumulated | |
|
|
|
|
|
|
Preferred Stock | |
|
Common Stock | |
|
Additional | |
|
Prior to | |
|
During the | |
|
Escrow/ | |
|
|
|
|
| |
|
| |
|
Paid In | |
|
Development | |
|
Development | |
|
Subscription | |
|
|
|
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount | |
|
Capital | |
|
Stage | |
|
Stage | |
|
Receivables | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
Escrow and Subscription Receivables
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1996 Common stock
canceled $.34 per share
|
|
|
|
|
|
|
|
|
|
|
(1,400,000 |
) |
|
$ |
(472,360 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
472,360 |
|
|
$ |
|
|
|
|
2000 Issuance for escrow receivable $0.09 per
share
|
|
|
|
|
|
|
|
|
|
|
5,500,000 |
|
|
|
500,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(500,000 |
) |
|
|
|
|
|
|
2000 Write-off of subscription receivable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
112,500 |
|
|
|
112,500 |
|
|
|
2000 Research and development costs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
115,400 |
|
|
|
115,400 |
|
|
|
2001 Research and development costs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
132,300 |
|
|
|
132,300 |
|
|
|
2001 Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,000 |
|
|
|
25,000 |
|
|
Exercise of Options and Warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1997 $0.25 per share
|
|
|
|
|
|
|
|
|
|
|
87,836 |
|
|
|
21,959 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21,959 |
|
|
|
1999 Waived option price $0.14 per share
|
|
|
|
|
|
|
|
|
|
|
170,000 |
|
|
|
24,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24,000 |
|
Value of Options Issued for Services
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1998
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,336,303 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,336,303 |
|
|
|
1999
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
196,587 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
196,587 |
|
|
|
2001
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
159,405 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
159,405 |
|
|
|
2002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
124,958 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
124,958 |
|
Other
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1994 Cash contributed
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
102,964 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
102,964 |
|
|
|
1995 Issuance of common stock option to satisfy
debt restructuring
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,000 |
|
Net loss from inception through December 31, 2002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(13,978,216 |
) |
|
|
|
|
|
|
(13,978,216 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2002
|
|
|
|
|
|
|
|
|
|
|
55,598,856 |
|
|
|
11,713,262 |
|
|
|
284,363 |
|
|
|
(1,399,577 |
) |
|
|
(13,978,216 |
) |
|
|
(227,300 |
) |
|
|
(3,607,468 |
) |
Value of options issued for services
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
295,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
295,000 |
|
Issuance of common stock for:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash $0.04 per share
|
|
|
|
|
|
|
|
|
|
|
20,162,500 |
|
|
|
790,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
790,300 |
|
|
|
Services and interest $0.06 per share
|
|
|
|
|
|
|
|
|
|
|
694,739 |
|
|
|
43,395 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
43,395 |
|
Net loss for the year ended December 31, 2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(952,043 |
) |
|
|
|
|
|
|
(952,043 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
|
|
|
|
|
|
|
|
76,456,095 |
|
|
|
12,546,957 |
|
|
|
579,363 |
|
|
|
(1,399,577 |
) |
|
|
(14,930,259 |
) |
|
|
(227,300 |
) |
|
|
(3,430,816 |
) |
Issuance and extension of options for services
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,675,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,675,000 |
|
Termination of escrow agreement
|
|
|
|
|
|
|
|
|
|
|
(2,356,200 |
) |
|
|
(227,300 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
227,300 |
|
|
|
|
|
Issuance of preferred stock and warrants for cash (net $130,000,
common stock and warrants issued to placement agent)
|
|
|
12,000 |
|
|
|
523,334 |
|
|
|
350,000 |
|
|
|
68,845 |
|
|
|
477,821 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,070,000 |
|
Convertible preferred stock beneficial conversion dividend
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
692,199 |
|
|
|
|
|
|
|
(692,199 |
) |
|
|
|
|
|
|
|
|
Issuance of common stock for:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash $0.09 per share
|
|
|
|
|
|
|
|
|
|
|
20,138,024 |
|
|
|
1,813,186 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,813,186 |
|
|
Debt and interest $0.07 per share
|
|
|
|
|
|
|
|
|
|
|
9,875,951 |
|
|
|
650,468 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
650,468 |
|
|
Services $0.06 per share
|
|
|
|
|
|
|
|
|
|
|
1,189,465 |
|
|
|
66,501 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
66,501 |
|
Net loss for the year ended December 31, 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,731,475 |
) |
|
|
|
|
|
|
(3,731,475 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
12,000 |
|
|
$ |
523,334 |
|
|
|
105,653,335 |
|
|
$ |
14,918,657 |
|
|
$ |
3,424,383 |
|
|
$ |
(1,399,577 |
) |
|
$ |
(19,353,933 |
) |
|
$ |
|
|
|
$ |
(1,887,136 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See Notes to Consolidated Financial Statements
33
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF CASH FLOWS
Years Ended December 31, 2004 and 2003, and
Cumulative Amounts Since November 20, 1991 (Date of
Inception of the Development Stage)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative Amounts | |
|
|
For the Year Ended | |
|
Since November 20, | |
|
|
December 31, | |
|
1991 (Date of | |
|
|
| |
|
Inception of | |
|
|
2004 | |
|
2003 | |
|
Development Stage) | |
|
|
| |
|
| |
|
| |
Cash flows from operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(3,731,475 |
) |
|
$ |
(952,043 |
) |
|
$ |
(18,661,734 |
) |
|
Adjustments to reconcile net loss to net cash from operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock options issued for services
|
|
|
1,675,000 |
|
|
|
295,000 |
|
|
|
4,811,253 |
|
|
|
Common stock issued for services, expenses, and litigation
|
|
|
66,501 |
|
|
|
43,395 |
|
|
|
4,267,717 |
|
|
|
Reduction of escrow receivable from research and development
|
|
|
|
|
|
|
|
|
|
|
272,700 |
|
|
|
Reduction of legal costs
|
|
|
|
|
|
|
|
|
|
|
(130,000 |
) |
|
|
Notes payable issued for litigation
|
|
|
|
|
|
|
|
|
|
|
385,000 |
|
|
|
Depreciation
|
|
|
|
|
|
|
|
|
|
|
100,271 |
|
|
|
Write-off of subscription receivables
|
|
|
|
|
|
|
|
|
|
|
112,500 |
|
|
|
Impairment loss on assets
|
|
|
|
|
|
|
|
|
|
|
9,709 |
|
|
|
Loss on disposal of equipment
|
|
|
|
|
|
|
|
|
|
|
30,364 |
|
|
|
Gain on debt restructuring
|
|
|
|
|
|
|
|
|
|
|
(1,235,536 |
) |
|
|
Write-off of receivables
|
|
|
|
|
|
|
|
|
|
|
193,965 |
|
|
|
Changes in assets and liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid expenses
|
|
|
11,331 |
|
|
|
24,929 |
|
|
|
|
|
|
|
|
Deferred charges
|
|
|
12,077 |
|
|
|
48,305 |
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
|
|
|
|
|
|
|
|
(7,529 |
) |
|
|
|
Inventory
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
|
381,727 |
|
|
|
(211,311 |
) |
|
|
2,292,545 |
|
|
|
|
Accrued expenses
|
|
|
53,934 |
|
|
|
176,086 |
|
|
|
599,709 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash from operating activities
|
|
|
(1,530,905 |
) |
|
|
(575,639 |
) |
|
|
(6,959,066 |
) |
Cash flows from investing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase in deposit
|
|
|
(51,100 |
) |
|
|
|
|
|
|
(51,100 |
) |
|
Purchase of equipment
|
|
|
|
|
|
|
|
|
|
|
(132,184 |
) |
|
Payments received on note receivable
|
|
|
|
|
|
|
|
|
|
|
130,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash from investing activities
|
|
|
(51,100 |
) |
|
|
|
|
|
|
(53,284 |
) |
Cash flows from financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contributed equity
|
|
|
|
|
|
|
|
|
|
|
131,374 |
|
|
Issuance of common stock, preferred stock and warrants
|
|
|
2,883,186 |
|
|
|
790,300 |
|
|
|
7,027,845 |
|
|
Payments on notes payable
|
|
|
(270,000 |
) |
|
|
(25,000 |
) |
|
|
(501,287 |
) |
|
Proceeds from notes payable
|
|
|
|
|
|
|
220,000 |
|
|
|
1,336,613 |
|
|
Payments on convertible notes payable
|
|
|
|
|
|
|
|
|
|
|
(98,500 |
) |
|
Proceeds from convertible notes payable
|
|
|
|
|
|
|
|
|
|
|
571,702 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash from financing activities
|
|
|
2,613,186 |
|
|
|
985,300 |
|
|
|
8,467,747 |
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash
|
|
|
1,031,181 |
|
|
|
409,661 |
|
|
|
1,455,397 |
|
Cash, beginning of period
|
|
|
424,216 |
|
|
|
14,555 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, end of period
|
|
$ |
1,455,397 |
|
|
$ |
424,216 |
|
|
$ |
1,455,397 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid
|
|
$ |
77,592 |
|
|
$ |
80,608 |
|
|
|
|
|
Noncash investing and financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Retirement of notes payable and interest through issuance of
common stock
|
|
$ |
650,468 |
|
|
|
|
|
|
|
|
|
|
Release of shares as part of Perrigrine settlement
|
|
$ |
227,300 |
|
|
|
|
|
|
|
|
|
|
Common stock and warrants issued to placement agent
|
|
$ |
162,746 |
|
|
|
|
|
|
|
|
|
|
Preferred stock dividend as part of beneficial conversion feature
|
|
$ |
692,199 |
|
|
|
|
|
|
|
|
|
See Notes to Consolidated Financial Statements
34
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS
NOTE A SIGNIFICANT ACCOUNTING POLICIES
Medical Discoveries, Inc. (MDI or the
Company) was incorporated under the laws of the
State of Utah on November 20, 1991. Effective as of
August 6, 1992, the Company merged with and into WPI
Pharmaceutical, Inc., a Utah corporation (WPI),
pursuant to which WPI was the surviving corporation. Pursuant to
the MDI-WPI merger, the name of the surviving corporation was
changed to Medical Discoveries, Inc.
On July 6, 1998, the Company incorporated a wholly owned
subsidiary, Regenere, Inc., in the State of Nevada. On
October 2, 1998, the Company incorporated another wholly
owned subsidiary, MDI Healthcare Systems, Inc., in the State of
Nevada. As of December 31, 2003, the Company dissolved
those subsidiaries.
On March 22, 2005, the Company formed MDI Oncology, Inc., a
Delaware corporation, as a wholly-owned subsidiary to acquire
and operate the assets and business associated with the
Savetherapeutics transaction, discussed further in Note J.
Principles of Consolidation
The consolidated financial statements include the accounts of
Medical Discoveries, Inc. and subsidiaries. All significant
intercompany transactions have been eliminated in consolidation.
Development Stage Company
The Company has not generated any significant revenue and is,
therefore, considered a development stage company as defined in
the Financial Accounting Standards Board (FASB) Statement
of Financial Accounting Standards (SFAS) No. 7. The Company
has, at the present time, not paid any dividends. Any dividends
that may be paid in the future will depend upon the financial
requirements of the Company. The primary purpose of the business
is the research and development of pharmaceuticals.
Cash and Cash Equivalents
For purposes of the statement of cash flows, the Company
considers all highly liquid debt instruments maturing in three
months or less to be cash equivalents. At year end, the Company
has cash deposits in excess of federally insured limits. The
Company had an insured bank balance of $114,564 at
December 31, 2004.
Income Taxes
The Company utilizes the liability method of accounting for
income taxes. Under the liability method, deferred tax assets
and liabilities are determined based on differences between
financial reporting and tax bases of assets and liabilities and
the carryforward of operating losses and tax credits and are
measured using the enacted tax rates and laws that will be in
effect when the differences are expected to reverse. An
allowance against deferred tax assets is recorded when it is
more likely than not that such tax benefits will not be
realized. Research tax credits are recognized as utilized.
Research and Development
Research and development has been the principal function of the
Company. Expenses in the accompanying financial statements
include certain costs which are directly associated with the
Companys research and development of the Companys
anti-infective pharmaceutical, MDI-P. These costs, which consist
primarily of pre-clinical testing activities, amounted to
$550,093 and $100,423 and $3,548,738 for the year ended
December 31, 2004 and 2003 and for the period
November 20, 1991 (date of inception of the development
stage) through December 31, 2004, respectively.
35
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS (Continued)
Fair Value of Financial Instruments
The Company estimates that the fair value of all financial
instruments, at December 31, 2004, do not differ materially
from the aggregate carrying values of its financial instruments
recorded in the accompanying balance sheet. The estimated fair
value amounts have been determined by the Company using
available market information and appropriate valuation
methodologies. Considerable judgment is required in interpreting
market data to develop the estimates of fair value, and
accordingly, the estimates are not necessarily indicative of the
amounts that the Company could realize in a current market
exchange.
Estimates
Management uses estimates and assumptions in preparing financial
statements. Those estimates and assumptions affect the reported
amounts of assets and liabilities, the disclosure of contingent
assets and liabilities, and reported revenues and expenses.
Significant estimates used in preparing these financial
statements include those assumed in determining the valuation of
common stock and stock options. It is at least reasonably
possible that the significant estimates used will change within
the next year.
Basic and Diluted Loss per Share
Basic loss per share is computed on the basis of the
weighted-average number of common shares outstanding during the
year. Diluted loss per share is computed on the basis of the
weighted-average number of common shares and all dilutive
potentially issuable common shares outstanding during the year.
Common stock equivalents, stock options and stock warrants have
not been included as they are anti-dilutive.
Concentration of Credit
The Company has no significant revenues and, therefore, no
significant trade receivables or extensions of credit.
Stock Based Compensation
The Company accounts for its stock-based compensation issued to
non-employees using the fair value method in accordance with
SFAS No. 123, Accounting for Stock-Based
Compensation. Under SFAS No. 123, stock-based
compensation is determined as either the fair value of the
consideration received or the fair value of the equity
instruments issued, whichever is more reliably measurable. The
measurement date for these issuances is the earlier of the date
at which a commitment for performance is reached or the date at
which the recipients performance is complete.
The Company accounts for employee stock option and award plans
under the recognition method and measurement principles of APB
Opinion No. 25, Accounting for Stock Issued to
Employees, and the related Interpretations. Under APB
Opinion No. 25, compensation related to stock options, if
any, is recorded if an options exercise price on the
measurement date is below the fair value of the Companys
common stock. The compensation is amortized to expense over the
vesting period.
These accounting policies resulted in the Company recognizing
$1,675,000 and $295,000 in stock-based compensation cost during
the years ended December 31, 2004 and 2003. The effect on
net loss and
36
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS (Continued)
net loss per common share if the Company had applied the fair
value recognition provisions of SFAS No. 123 to
employee stock-based compensation is as follows:
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Net loss applicable to common stockholders, as reported
|
|
$ |
(4,423,674 |
) |
|
$ |
(952,043 |
) |
Add: Stock-based employee compensation expense included in
reported net loss
|
|
|
1,675,000 |
|
|
|
295,000 |
|
Deduct: Total stock based employee compensation expense
determined under fair value based method for all awards
|
|
|
(1,979,237 |
) |
|
|
(473,200 |
) |
|
|
|
|
|
|
|
Pro forma net loss applicable to common shareholders
|
|
$ |
(4,727,911 |
) |
|
$ |
(1,130,243 |
) |
|
|
|
|
|
|
|
Basic and diluted loss per share, as reported
|
|
$ |
(0.05 |
) |
|
$ |
(0.02 |
) |
Basic and diluted loss per share, pro forma
|
|
$ |
(0.05 |
) |
|
$ |
(0.02 |
) |
Recently Issued Accounting Statements
In December 2004, the FASB issued SFAS No. 123
(revised 2004), Share-Based Payment, which is an
amendment to SFAS No. 123, Accounting for
Stock-Based Compensation. This new standard eliminates the
ability to account for share-based compensation transactions
using Accounting Principles Board (APB) No. 25,
Accounting for Stock Issued to Employees
(APB 25) and requires such transactions to be accounted for
using a fair-value-based method and the resulting cost
recognized in the Companys financial statements. This new
standard is effective for interim and annual periods beginning
after June 15, 2005. The Company intends to implement
SFAS No. 123 in the third quarter of 2005 and it will
not currently have any effect on the Companys financial
statements.
In December 2004, the FASB issued SFAS Statement
No. 153, Exchanges of Non-monetary Assets
an amendment of APB Opinion No. 29. This
Statement amends APB Opinion 29 to eliminate the exception for
non-monetary exchanges of similar productive assets and replaces
it with a general exception for exchanges of non-monetary assets
that do not have commercial substance. A non-monetary exchange
has commercial substance if the future cash flows of the entity
are expected to change significantly as a result of the
exchange. The Statement will be effective in January 2006. The
Company does not expect that the adoption of
SFAS No. 153 will have a material impact on its
Consolidated Financial Statements.
Reclassifications
Certain 2003 amounts have been reclassified to conform to the
2004 presentation. These reclassifications had no effect on the
previously reported net loss.
NOTE B BASIS OF PRESENTATION AND GOING CONCERN
As shown in the accompanying financial statements, the Company
incurred a net loss applicable to common shareholders of
$4,423,674 during the year ended December 31, 2004 and has
incurred losses applicable to common shareholders since
inception of the development stage of $19,353,933. The Company
has not had significant revenues and is still in the process of
testing and commercializing its technologies. The Company is
hopeful, but there is no assurance, that the current product
development and research will be economically viable. Those
factors raise substantial doubt about the Companys ability
to continue as a going concern.
Management plans to meet its cash needs through the issuance of
equity or debt securities and the potential licensure of its
technologies. The ability of the Company to continue as a going
concern is dependent
37
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS (Continued)
on that plans success. The financial statements do not
include any adjustments that might be necessary if the Company
is unable to continue as a going concern.
NOTE C INCOME TAXES
Income taxes are provided for temporary differences between
financial and tax basis income. The following is a
reconciliation of the amount of benefit that would result from
applying the federal statutory rate to pretax loss with the
benefit from income taxes for the year ended December 31,
2004:
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Federal income tax benefit at statutory rate (34%)
|
|
$ |
1,268,000 |
|
|
$ |
327,000 |
|
State income tax, net of federal benefit
|
|
|
224,000 |
|
|
|
38,000 |
|
Revaluation and expiration of options
|
|
|
(631,000 |
) |
|
|
(108,000 |
) |
Change in valuation allowance
|
|
|
(861,000 |
) |
|
|
(257,000 |
) |
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
The components of net deferred taxes are as follows at
December 31 using a combined deferred tax rate of 40%:
|
|
|
|
|
|
|
2004 | |
|
|
| |
Net operating loss carryforward
|
|
$ |
5,132,000 |
|
Research and development credits
|
|
|
80,000 |
|
Stock options
|
|
|
646,000 |
|
Accrued compensation
|
|
|
396,000 |
|
Valuation allowance
|
|
|
(6,254,000 |
) |
Net deferred tax asset
|
|
$ |
|
|
|
|
|
|
Inasmuch as it is not possible to determine when or if the net
operating losses will be utilized, a valuation allowance has
been established to offset the benefit of the utilization of the
net operating losses.
The Company has available net operating losses of approximately
$12,830,000 which can be utilized to offset future earnings of
the Company. The Company also has available approximately
$80,000 in research and development credits which expire in
2008. The utilization of the net operating losses and research
and development credits are dependent upon the tax laws in
effect at the time such losses can be utilized. The losses begin
to expire between the years 2007 and 2023. Should the Company
experience a change of ownership the utilization of net
operating losses could be reduced.
NOTE D NOTES PAYABLE
The Company has the following notes payable at December 31,
2004:
|
|
|
|
|
Notes payable to shareholders, which are currently due and in
default. Interest is at 12%. The notes are unsecured
|
|
$ |
336,717 |
|
38
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS (Continued)
NOTE E CONVERTIBLE NOTES PAYABLE
The Company has the following convertible notes payable at
December 31, 2004:
|
|
|
|
|
Convertible notes payable to a trust, which are currently due
and in default. Interest is at 12%. Each $1,000 note is
convertible into 667 shares of the Companys common
stock
|
|
$ |
193,200 |
|
NOTE F STOCKHOLDERS EQUITY
Series A Convertible Preferred Stock
On October 18, 2004, the Company issued 12,000 shares
of Series A Convertible Preferred Stock and warrants to
purchase 4,575,495 shares of common stock for a total
offering price of $1.2 million. The Company incurred
$130,000 of offering costs and issued to the placement agent
350,000 shares of common stock (valued at $0.20 per
share) and warrants to purchase 488,052 shares of
common stock exercisable at $0.1967 per share which are
exercisable for a period of three years. The Company valued
these warrants at $0.19 per share using a Black Scholes
option pricing model with the following assumptions: risk free
rate 2.82%, volatility of 171% and an expected life of three
years.
Each share of Preferred Stock entitles the holder to convert the
share of Preferred Stock into the number of shares of common
stock resulting from multiplying $100 by the conversion price.
The conversion price is 85% of the average of the lowest three
intra-day trading prices for the Companys common stock
during the 10 trading days immediately preceding the conversion
date, but the conversion price may not exceed $0.1967 or be
lower than $0.05 per share. The warrants are subject to
equitable adjustment in connection with a stock split, stock
dividend or similar transaction. The warrants entitle the holder
to purchase up to 4,575,495 shares of common stock of the
Company on or before the third anniversary of the issuance date
of the warrants at $0.1967 per share.
The Company has allocated the proceeds from the issuance of the
Series A Convertible Preferred Stock and warrants, based on
their relative fair values on the date of issuance which are as
follows: $1,200,000 to the Series A Convertible Preferred
and $880,325 to the warrants. The warrants were valued using the
Black Scholes Pricing model using the following assumptions:
volatility of 171%, risk-free interest rate of 2.82% and a term
of three years. The allocation of the net proceeds resulted in
$523,334 being allocated to the Series A Convertible
Preferred Stock and $383,920 being allocated to the warrants.
The Company recognized a beneficial conversion dividend of
$692,199 on the date of issuance equal to the value allocated to
the Series A Convertible Preferred Stock (before offering
costs). The actual value of the beneficial conversion option was
$719,177, but the dividend was limited to the amount of gross
proceeds allocated to the Series A Convertible Preferred
Stock.
The Series A Convertible Preferred Stock has no dividend or
voting rights. In the event of liquidation, the holders are
entitled to a liquidating distribution of $100 per share.
The number of shares of common stock subject to the warrants and
the exercise price are subject to equitable adjustment in
connection with a stock split, stock dividend or similar
transaction. The Company also entered into a Registration Rights
Agreement with Monarch Pointe Fund, Ltd. and Mercator Advisory
Group, LLC, requiring the Company to file a registration
statement with the Securities and Exchange Commission
registering the shares of common stock issuable upon conversion
of the Preferred Stock and exercise of the warrants.
Commitment Regarding Peregrine Stock
Peregrine Properties, LLC, a Utah limited liability company
(Peregrine), has entered into an agreement to
provide $500,000 to the Company to fund testing and research
steps necessary to continue
39
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS (Continued)
development of MDI-P. The studies are funded through an escrow
agent. As of December 31, 2000, the Company had deposited
in escrow a single certificate for 5.5 million shares of
common stock for these purposes. Through December 31, 2003,
Peregrine had funded $275,800 to the escrow, of which $272,700
had been disbursed and recorded as research and development
expense on the financial statements of the Company. The
remaining $227,300 to be expended under the agreement was
recorded in equity under the caption escrow receivable. As
expenditures are made from the escrow for research and
development, the expenses are recorded by the Company with a
corresponding reduction in the escrow receivable. Under the
original agreement, upon completion of the studies, the escrow
agent was to disburse the 5.5 million shares to Peregrine
and to disburse the research results to the Company. On
March 22, 2002, the parties entered into an agreement to
partially close the escrow agreement to the extent of
Peregrines funding to date. On that date,
3,143,800 shares were distributed to Peregrine and all
research conducted to date was disbursed to the Company. As of
February 20, 2004, the Company held Peregrine in breach
with respect to its remaining funding obligation and terminated
the Peregrine research agreement. The Company and Peregrine
resolved the matter during 2004 by the Company agreeing to grant
Peregrine a warrant to purchase 2,356,200 shares of
restricted common stock at an exercise price of $0.09 per
share, exercisable at any time within 3 years. The exchange
of the escrow receivable for the warrants was considered a
financing transaction, with no additional expense being
recorded. The Company reversed the $227,300 escrow receivable
and cancelled the remaining 2,356,200 shares held in escrow.
Common Stock and Warrants Issued for Cash
During 2004, as part of a private placement offering, the
Company issued 5,551,011 shares of common stock for
$0.18 per share or $999,180. In conjunction with the
private placement, the Company issued to these investors
warrants to purchase 5,551,011 shares of common stock
at $0.18 per share. These warrants expire three years from
the date of issuance.
Conversion of Notes Payable and Convertible
Notes Payable to Common Stock
During the year ended December 31, 2004, the Company
converted $487,503 of principal and $162,964 of interest related
to notes payable and convertible notes payable into
9,875,951 shares of common stock. The conversion prices
ranged from $0.06 to $0.21 per share.
NOTE G STOCK OPTIONS AND WARRANTS
Stock Options
The Company has two incentive stock option plans wherein
24,000,000 shares of the Companys common stock are
reserved for issuance thereunder. The Company granted 700,000
fully vested stock options during the year ended
December 31, 2004 to consultants with an exercise price of
$0.05. These options were valued at $98,000 using the Black
Scholes pricing model using the following weighted average
assumptions: risk free interest of 3.8%, expected dividend yield
of 0%, volatility of 220% and an expected life of 7 years.
During the year ended December 31, 2003, the Company
granted 14,800,000 fully vested stock options to an officer and
directors with exercise prices ranging from $0.01 to $0.05, the
Company recognized stock compensation expense of $295,000
related to this issuance.
40
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS (Continued)
The following summarizes option activity for the years ended
December 31, 2004 and 2003:
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of | |
|
Option Price | |
|
|
Options | |
|
per Share | |
|
|
| |
|
| |
Outstanding at January 1, 2003
|
|
|
4,583,000 |
|
|
$ |
0.01 to 0.50 |
|
|
|
Granted
|
|
|
14,800,000 |
|
|
|
0.01 to 0.05 |
|
|
|
Expired
|
|
|
(600,000 |
) |
|
|
0.25 |
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2003
|
|
|
18,783,000 |
|
|
$ |
0.01 to 0.50 |
|
|
|
Granted
|
|
|
700,000 |
|
|
|
0.05 |
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2004
|
|
|
19,483,000 |
|
|
$ |
0.01 to 0.50 |
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2003
|
|
|
18,783,000 |
|
|
$ |
0.01 to 0.50 |
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2004
|
|
|
19,483,000 |
|
|
$ |
0.01 to 0.50 |
|
|
|
|
|
|
|
|
The following table summarizes information about fixed stock
options outstanding at December 31, 2004:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding | |
|
Options Exercisable | |
|
|
| |
|
| |
|
|
|
|
Weighted | |
|
|
|
|
|
|
|
|
Average | |
|
|
|
|
|
|
|
|
Remaining | |
|
Weighted | |
|
|
|
Weighted | |
|
|
|
|
Contractual | |
|
Average | |
|
|
|
Average | |
|
|
Number | |
|
Life | |
|
Exercise | |
|
Number | |
|
Exercise | |
Range of Exercise Prices |
|
Outstanding | |
|
(Years) | |
|
Price | |
|
Exercisable | |
|
Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
$0.01 to 0.02
|
|
|
16,000,000 |
|
|
|
8.7 |
|
|
$ |
0.02 |
|
|
|
16,000,000 |
|
|
$ |
0.02 |
|
$0.05
|
|
|
1,500,000 |
|
|
|
7.1 |
|
|
$ |
0.05 |
|
|
|
1,500,000 |
|
|
$ |
0.05 |
|
$0.15 to 0.50
|
|
|
1,983,000 |
|
|
|
7.1 |
|
|
$ |
0.23 |
|
|
|
1,983,000 |
|
|
$ |
0.23 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19,483,000 |
|
|
|
|
|
|
|
|
|
|
|
19,483,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assumptions used to calculate the impact of stock options
granted as if the Company had adopted FAS 123 were as
follows:
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Expected dividend yield
|
|
|
|
|
|
|
|
|
Risk free interest rate
|
|
|
3.8 |
% |
|
|
5.0 |
% |
Expected volatility
|
|
|
220 |
% |
|
|
511 |
% |
Expected life
|
|
|
7 years |
|
|
|
10 years |
|
Weighted average fair value per share
|
|
$ |
0.10 |
|
|
$ |
0.04 |
|
During 2004, the Company extended the expiration date of options
to purchase an aggregate amount of 18,603,000 shares of
stock. As a result of such extension, such options expire from
between 2011 to 2013. These options are subject to a one-time
remeasurement of the options as if they were newly granted. The
expense associated with the change in expiration date was
$1,577,000.
41
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS (Continued)
Stock Warrants
The following summarizes warrant activity for the years ended
December 31, 2004 and 2003:
|
|
|
|
|
|
|
|
|
|
|
|
Number of | |
|
Warrant Price | |
|
|
Warrants | |
|
per Share | |
|
|
| |
|
| |
Outstanding at January 1, 2003
|
|
|
3,616,005 |
|
|
$ |
0.10 to 1.00 |
|
|
|
|
|
|
|
|
Outstanding at December 31, 2003
|
|
|
3,616,005 |
|
|
|
0.10 to 1.00 |
|
|
Granted
|
|
|
12,920,751 |
|
|
|
0.09 to 0.20 |
|
|
Forfeited
|
|
|
(1,666,005 |
) |
|
|
0.10 to 0.40 |
|
|
|
|
|
|
|
|
Outstanding at December 31, 2004
|
|
|
14,870,751 |
|
|
$ |
0.09 to 1.00 |
|
|
|
|
|
|
|
|
The following table summarizes information about warrants
outstanding at December 31, 2004:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted | |
|
|
|
|
|
|
Average | |
|
|
|
|
|
|
Remaining | |
|
Weighted | |
|
|
|
|
Contractual | |
|
Average | |
|
|
Number | |
|
Life | |
|
Exercise | |
Range of Exercise Prices |
|
Outstanding | |
|
(Years) | |
|
Price | |
|
|
| |
|
| |
|
| |
$0.09
|
|
|
2,356,200 |
|
|
|
3.0 |
|
|
$ |
0.09 |
|
$0.18 to 0.20
|
|
|
10,564,551 |
|
|
|
2.8 |
|
|
$ |
0.19 |
|
$1.00
|
|
|
1,950,000 |
|
|
|
2.0 |
|
|
$ |
1.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,870,751 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOTE H RELATED PARTY TRANSACTIONS
At December 31, 2004 the Company had accounts payable to
current and former officers and directors totaling $1,491,586
for services performed and costs incurred in behalf of the
Company, including $902,636 payable to the Companys
President and CEO. Also at December 31, 2004, the Company
had an account payable to its controller of $87,444.
NOTE I COMMITMENT REGARDING CONSULTING
AGREEMENT
The Company entered into a consulting agreement with
Craig R. Palmer (d/b/a Palmer Consulting Group) dated
April 7, 2003 and amended as of September 16, 2004,
pursuant to which Palmer is to render certain services to the
Company relating to the development and commercialization of the
Companys technology. Under the agreement, Palmer was paid
a consulting fee equal to $20,000 in cash and
500,000 shares of stock. From October 1, 2004, he also
accrues a consulting fee of $8,000 per month, $3,500 per month
of which is paid monthly and the balance of which is paid in the
CEOs discretion as the Companys cash flow permits.
The agreement also provides Palmer with the opportunity to earn
a contingent fee of 5% of the value of any out-licensing,
distribution or co-marketing agreements Palmer secures for the
Company and an opportunity to earn 1,500,000 shares of
stock upon the successful filing of an investigational new drug
application in HIV with the U.S. Food and Drug
Administration. The Company has not recorded a liability for the
contingent fees due to the uncertainty that such events will
occur.
42
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS (Continued)
NOTE J SUBSEQUENT EVENTS
Formation of MDI Oncology, Inc.
On March 22, 2005, the Company formed MDI Oncology, Inc., a
Delaware corporation, as a wholly-owned subsidiary to acquire
and operate the assets and business associated with the
Savetherapeutics transaction.
Savetherapeutics A.G. Asset Acquisition
On March 16, 2005, Medical Discoveries, Inc. (the
Company) completed the purchase of the intellectual
property assets (the Assets) of Savetherapeutics AG,
a German corporation in liquidation in Hamburg, Germany
(SaveT). The Assets consist primarily of patents,
patent applications, pre-clinical study data and clinical trial
data concerning SaveCream, SaveTs developmental topical
aromatase inhibitor treatment for breast cancer.
The purchase price of the Assets
is 2,350,000
(approximately $3.1 million under current exchange rates)
payable as
follows: 500,000
at closing,
500,000 upon
conclusion of certain pending transfers of patent and patent
application rights from SaveTs inventors to the Company,
and 1,350,000
upon successful commercialization of the Assets. The
Companys source of funds for the acquisition is a
$3 million equity investment by Mercator Momentum
Fund LP and Mercator Momentum Fund III LP, as
described below. Neither SaveT nor any employee of SaveT has a
material relationship with the Company or any of its affiliates,
any director or officer of the Company or any associate of any
such director or officer.
Issuance of Series A Preferred Stock
On or about March 14, 2005, the Company issued
30,000 shares of Preferred Stock and warrants to
purchase 22,877,478 shares of common stock for a total
offering price of $3 million. Each share of Preferred Stock
entitles the holder to convert the share of Preferred Stock into
the number of shares of common stock resulting from multiplying
$100 by the conversion price. The conversion price is 75% of the
average of the lowest three intra-day trading prices for the
Companys common stock during the 10 trading days
immediately preceding the conversion date, but the conversion
price may not exceed $0.1967. The number of shares of common
stock subject to the warrants and the exercise price are subject
to equitable adjustment in connection with a stock split, stock
dividend or similar transaction. The warrants entitle the holder
to purchase up to 22,877,478 shares of common stock of the
Company on or before the third anniversary of the issuance date
of the warrants at $0.1967 per share.
NOTE K CUMULATIVE NET LOSS
The Statements of Operations was amended to correct a previously
reported error in the cumulative net loss amount since inception
through December 31, 2003 (not presented herein). While the
Company previously reported the correct cumulative net loss on
the Statements of Cash Flows through December 31, 2003 (not
presented herein), the same figure as reported on the Statements
of Operations through December 31, 2003 (not presented
herein) was erroneous based on an apparent incorrect calculation
in the 1999 annual report, which error had been carried forward.
The previously reported cumulative net loss amount through
December 31, 2003 (not presented herein) of $14,141,763 was
corrected to $14,930,259.
|
|
ITEM 8. |
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON
ACCOUNTING AND FINANCIAL DISCLOSURE. |
None.
43
PART III
|
|
ITEM 9. |
DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL
PERSONS; COMPLIANCE WITH SECTION 16(a) OF THE EXCHANGE
ACT. |
The information required by this Item is incorporated by
reference to the section entitled Election of
Directors in our definitive proxy statement to be filed
with the Commission.
|
|
ITEM 10. |
EXECUTIVE COMPENSATION. |
The information required by this Item is incorporated by
reference to the section entitled Executive
Compensation in our definitive proxy statement to be filed
with the Commission.
|
|
ITEM 11. |
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND
MANAGEMENT AND RELATED STOCKHOLDER MATTERS. |
The information required by this Item is incorporated by
reference to the section entitled Security Ownership of
Certain Beneficial Owners and Management in our definitive
proxy statement to be filed with the Commission.
|
|
ITEM 12. |
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS. |
The information required by this Item is incorporated by
reference to the section entitled Certain Relationships
and Related Transactions in our definitive proxy statement
to be filed with the Commission.
The following documents are furnished as exhibits to this
Form 10-KSB. Exhibits marked with an asterisk are filed
herewith. The remainder of the exhibits previously have been
filed with the Commission and are incorporated herein by
reference.
|
|
|
|
|
Number |
|
Exhibit |
|
|
|
|
2 |
.1 |
|
Sale and Purchase Agreement between Attorney Hinnerk-Joachim
Müller as liquidator of Savetherapeutics AG i.L. and
Medical Discoveries, Inc. regarding the purchase of the
essential assets of Savetherapeutics AG i.L. (Exhibits
referenced therein will be provided upon request.)* |
|
|
3 |
.1 |
|
Amended and Restated Articles of Incorporation of the Company
(filed as Exhibit 3.1 to the Companys Annual Report
on Form 10-KSB for the fiscal year ended December 31,
1994, and incorporated herein by reference). |
|
|
3 |
.2 |
|
Amended Bylaws of the Company (filed as Exhibit 3.2 to the
Companys Annual Report on Form 10-KSB for the fiscal
year ended December 31, 1994, and incorporated herein by
reference). |
|
|
4 |
.1 |
|
Registration Rights Agreement dated October 18, 2004 among
Monarch Pointe Fund, Ltd., Mercator Advisory Group, LLC and
Medical Discoveries, Inc.* |
|
|
4 |
.2 |
|
Registration Rights Agreement dated December 3, 2004 among
Mercator Momentum Fund, LP, Mercator Momentum Fund III, LP,
Mercator Advisory Gropu, LLC and Medical Discoveries, Inc.* |
|
|
10 |
.1 |
|
2002 Stock Incentive Plan adopted by the Board of Directors as
of July 11, 2002 (filed as Exhibit 10.5 to the
Companys Quarterly Report on Form 10-QSB for
the quarter ended June 30, 2002, and incorporated herein by
reference). |
|
|
21 |
|
|
Subsidiaries.* |
|
|
31 |
|
|
Rule 13a-14(a) Certification, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.* |
|
|
32 |
|
|
Certification pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002.* |
44
|
|
ITEM 14. |
CONTROLS AND PROCEDURES |
Evaluation of Disclosure Controls and Procedures. Under
the supervision and with the participation of our management,
including our principal executive and financial officer, we
conducted an evaluation of our disclosure controls and
procedures, as such term is defined under Rule 13a-14(c)
promulgated under the Securities Exchange Act of 1934, as
amended (the Exchange Act), within 90 days of
the filing date of this report. Based on this evaluation, our
principal executive and financial officer concluded that our
disclosure controls and procedures are effective in alerting her
on a timely basis to material information relating to our
Company (including its consolidated subsidiaries) required to be
included in our reports filed or submitted under the Exchange
Act.
Changes in Internal Controls. There have been no
significant changes (including corrective actions with regard to
significant deficiencies or material weaknesses) in our internal
controls or in other factors that could significantly affect
these controls subsequent to the date of the evaluation
referenced in the preceding paragraph.
|
|
ITEM 15. |
PRINCIPAL ACCOUNTANT FEES AND SERVICES. |
The information required by this Item is incorporated by
reference to the section entitled Principal Accountant
Fees and Services in our definitive proxy statement to be
filed with the Commission.
45
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.
|
|
|
MEDICAL DISCOVERIES, INC. |
|
|
/s/ Judy M. Robinett |
|
|
|
Judy M. Robinett |
|
President and Chief Executive Officer |
Date: March 31, 2004
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.
|
|
|
|
|
|
|
Name |
|
Position |
|
Date |
|
|
|
|
|
|
/s/ Judy M. Robinett
Judy
M. Robinett |
|
President, Chief Executive Officer and Director (Principal
Executive and Financial Officer) |
|
March 31, 2005 |
|
/s/ David R. Walker
David
R. Walker |
|
Chairman of the Board of Directors |
|
March 31, 2005 |
|
/s/ Larry Anderson
Larry
Anderson |
|
Director |
|
March 31, 2005 |
Fuzeon is a registered trademark of Roche Laboratories, Inc. and
Timeris Inc.
Tobramycin is a registered trademark of Chiron Corporation or
its subsidiaries.
Pulmozyme is a registered trademark of Genetech, Inc.
Advair is a registered trademark of GlaxoSmithKline.
Singulair is a registered trademark of Merck & Co., Inc.
Herceptin is a registered trademark of Genetech, Inc.
Femara is a registered trademark of Novartis Pharma AG.
Arimidex is a registered trademark of AstraZeneca
Pharmaceuticals LP.
Aromasin is a registered trademark of Pfizer, Inc.
46
INDEX TO EXHIBITS
|
|
|
|
|
Number |
|
Exhibit |
|
|
|
|
2 |
.1 |
|
Sale and Purchase Agreement between Attorney Hinnerk-Joachim
Müller as liquidator of Savetherapeutics AG i.L. and
Medical Discoveries, Inc. regarding the purchase of the
essential assets of Savetherapeutics AG i.L. (Exhibits
referenced therein will be provided upon request.)* |
|
|
3 |
.1 |
|
Amended and Restated Articles of Incorporation of the Company
(filed as Exhibit 3.1 to the Companys Annual Report
on Form 10-KSB for the fiscal year ended December 31,
1994, and incorporated herein by reference). |
|
|
3 |
.2 |
|
Amended Bylaws of the Company (filed as Exhibit 3.2 to the
Companys Annual Report on Form 10-KSB for the fiscal
year ended December 31, 1994, and incorporated herein by
reference). |
|
|
4 |
.1 |
|
Registration Rights Agreement dated October 18, 2004 among
Monarch Pointe Fund, Ltd., Mercator Advisory Group, LLC and
Medical Discoveries, Inc.* |
|
|
4 |
.2 |
|
Registration Rights Agreement dated December 3, 2004 among
Mercator Momentum Fund, LP, Mercator Momentum Fund III, LP,
Mercator Advisory Gropu, LLC and Medical Discoveries, Inc.* |
|
|
10 |
.1 |
|
2002 Stock Incentive Plan adopted by the Board of Directors as
of July 11, 2002 (filed as Exhibit 10.5 to the
Companys Quarterly Report on Form 10-QSB for
the quarter ended June 30, 2002, and incorporated herein by
reference). |
|
|
21 |
|
|
Subsidiaries.* |
|
|
31 |
|
|
Rule 13a-14(a) Certification, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.* |
|
|
32 |
|
|
Certification pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002.* |
47