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, 2005 |
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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
from to |
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 is not required to file reports
pursuant to Section 13 or 15(d) of the Exchange
Act. o
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
Indicate by a check mark whether the registrant is a shell
company (as defined in
Rule 12b-2 of the
Exchange
Act). Yes o No 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 March 27, 2006,
was $17,119,390.
As of March 27, 2006, the issuer had
107,992,148 shares of Common Stock outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the Proxy Statement for the issuers 2006
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
2
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. |
Medical Discoveries, Inc. was incorporated on November 20,
1991 as a Utah corporation and maintains its principal offices
at 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 useful and well tolerated
treatment for bacterial infections, viral infections and fungal
infections. We further believe that MDI-P will be a useful
therapy for the treatment of cystic fibrosis. 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. On November 10, 2004, we filed an Investigational 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 placed the proposed Phase I
clinical trials on clinical hold pending additional preclinical
testing. The preclinical testing has been completed and no
significant toxicities were noted. We have submitted this data
to the FDA. If the FDA lifts the clinical hold upon receipt of
the amended IND and allows us to proceed with Phase I
studies, we will begin human trials at St. Lukes Regional
Medical Center in Boise, Idaho using a protocol designed by
Dr. Henry Thompson. We hope to commence recruitment for
this study in June or July 2006. 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 preclinical
development.
We recently purchased SaveCream from a German biotechnology
company. 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, 2005,
we had incurred cumulative net losses since inception of
$20,840,714.
Cystic Fibrosis IND. We are continuing to pursue
our IND for cystic fibrosis with the FDA. In 2005 we concluded
large animal model testing to establish pharmacological safety
with relation to cardiovascular and central nervous system
toxicity as well as in-vitro work on genotoxicity for this IND.
The preclinical testing has been completed with positive
results. We recently submitted the data to the FDA in hopes of
being permitted to proceed with Phase I testing. We
anticipate that we may be able to start Phase I clinical
trials on cystic fibrosis as early as Q2 of 2006. While we
believe we have sufficient funds to begin Phase I clinical
trials of MDI-P for cystic fibrosis if and when the FDA allows
us to begin human trials under an amended IND, we will need to
raise additional funds to complete this testing.
More particularly, the clinical hold items established by the
FDA to which we responded included:
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Use of the same mode of nebulization administration of MDI-P in
small and large mammals as proposed for the Phase I cystic
fibrosis clinical trial, to develop: |
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Satisfactory safety pharmacology data from frank toxicity to
minimal toxicity for periods mimicking the proposed clinical
trial term; |
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Mouse safety pharmacology on potential central nervous system
involvement; and |
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Dog safety pharmacology on potential cardiovascular system
involvement; |
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A battery of genotoxicity studies; and |
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Data to support the safety of the maximum expected human
exposure to listed extractables in our prior IND submission. |
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We contracted with Ascentia Bio-Medical Technologies for the
cGMP, placebo-controlled, multi-dose mouse central nervous
system toxicology study. A specialized mouse nebulization system
was used, in order to mimic the mode of delivery slated for the
Phase I cystic fibrosis trial. We contracted with MPI
Research for the cGMP, placebo-controlled, multi-dose dog
cardiovascular toxoicology study. Again, specialized dog
nebulization masks with harnesses were used to mimic the mode of
delivery slated for the Phase I cystic fibrosis trial. We
contracted with NAMSA for the genotoxicity studies, including a
Mouse Peripheral Blood Micronucleus Study, a
Dose Range Study in Mouse Peripheral Blood
Micronucleus, an In-Vitro Chromosomal Aberration
Study in Mammalian Cells, and a Bacterial Reverse
Mutation Study. Finally, we contracted with
Dr. Robert Mastico for the data submission on the
extractables.
SaveCream. 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 anecdotal 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 $2.8 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. 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.
Before it ceased business in 2004, Savetherapeutics (SaveT) had
been developing SaveCream, a topical steroidal form of aromatase
inhibitor (AI) for breast cancer that never generated
revenues for SaveT. This promising cancer therapeutic product
has been tested in the European Union under a unique German
regulatory scheme that allows patients with limited treatment
options to receive novel treatments. In the study, over 100
women diagnosed with breast cancer received special permission
to be treated with SaveCream. A significant number of those
women experienced a significant reduction in tumor size of fifty
percent in two weeks. No follow up data was collected to permit
assessment of adverse events or benefits of treatment occurring
after the treatment period. We are in the process of developing
a global commercialization strategy for SaveCream, to include
certain preclinical studies including toxicology and
pharmacokinetics, as well as the development of future clinical
protocols.
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 purchase, pursuant to terms described
below.
We would like to initiate a preclinical development program for
SaveCream, however we do not currently have the funds to do so.
Should we be unable to fund preclinical testing necessary to
file an IND, we may instead seek a co-development partner or
out-licensing opportunities for this product.
We analyzed whether the intellectual property purchased was a
business within the contemplation of
Regulation S-X,
and concluded that no such business had been acquired.
Series A Preferred Stock Financings. On or
about March 14, 2005, we closed the second of two rounds of
Series A Preferred Stock financing with M.A.G. Capital, LLC
(formerly Mercator Advisory Group, LLC). In this round, 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 for this
round is 75% of the average of the lowest three intra-day
trading prices for our 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 our common stock on
or before the third anniversary of the issuance date of the
warrants at $0.1967 per
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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 our common stock 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 closed the first of two
rounds of Series A Preferred Stock financing with M.A.G.
Capital, LLC (formerly Mercator Advisory Group, LLC). In this
round, we sold 12,000 shares of Preferred Stock and
warrants to purchase 4,575,495 shares of common stock
for a total offering price of $1.2 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 for this round is 85% of the average of the
lowest three intra-day trading prices for our 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 4,575,495 shares of our common stock 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 our common stock on or
before the third anniversary of the issuance date of the
warrants at $0.1967 per share.
In connection with the Series A Preferred Stock financings,
we agreed with the investors to register the shares of common
stock into which the Preferred Stock is convertible and the
warrants are exercisable.
Our highest priorities are to:
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commence human clinical trials of MDI-P for cystic fibrosis; |
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file an IND for HIV; and |
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develop a commercialization strategy for SaveCream. |
Our second priorities are the completion of a longer-range
strategic business plan in which we utilize the intellectual
property that has been developed over the last decade and
determine an appropriate direction for future development of the
business over the next five to ten 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; and |
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projected long-term financing requirements. |
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MDI-P: Novel Anti-Infective Technology. |
MDI-P is an anti-infective drug that we believe will be useful
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 one month 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 |
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 preclinical 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 |
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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 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. |
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In 2005 and 2006 we conducted a battery of tests in response to
the FDAs clinical hold items for our cystic fibrosis IND.
Those studies included a mouse central nervous system toxicity
study conducted by Ascentia Bio-Medical Technologies, a dog
cardiovascular toxicity study conducted by MPI Research, and the
following genotoxicity studies conducted by NAMSA: Mouse
Peripheral Blood Micronucleus Study, Dose Range Study in Mouse
Peripheral Blood Micronucleus, In-Vitro Chromosomal Aberration
Study in Mammalian Cells, and Bacterial Reverse Mutation Study.
No adverse events were discovered in these studies. |
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Application of MDI-P to HIV. |
Overview. Our preclinical 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 preclinical
analysis. If these results can be replicated in human beings,
under appropriate clinical protocols, this compound 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. The most recent estimates of the World Health
Organization report that in 2003, between thirty-five and
forty-two million people were infected with the HIV virus
worldwide.
Existing Therapies for HIV. There are
approximately 24 HIV therapies currently on the market and
approved by the FDA with a market value in 2004 of approximately
$6 billion per year and a projected annual growth rate of
five and a half to six percent over the next ten years. The
current U.S. market is valued in excess of $3 billion
annually. The primary current therapies for HIV are
anti-retroviral products falling into four categories:
nucleoside reverse transcriptase inhibitors, non-nucleoside
reverse transcriptase inhibitors,
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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 exhibits a number of toxicities,
including: injection site reactions in approximately 98% of
patients treated, and on a less frequent basis, pneumonia,
diarrhea, nausea, fatigue, fever, increased hepatic enzymes,
neutropenia, thrombocytopenia, and renal failure.
Potential 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. In preliminary testing, MDI-P has been shown to be very
rapid in effect and to destroy viruses without destroying host
cells. |
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MDI-Ps broad-spectrum antiviral effects appear to make it
active 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. |
MDIs HIV Protocol. The HIV virus is known to
have a cell replication cycle of approximately ten 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. 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 the 400 copies/mL level
experienced by at least 34% of treatment-experienced patients in
trials of the best of breed therapeutics in HIV (e.g.
Fuzeon®).
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
preclinical 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. Some of our toxicity work
for cystic fibrosis (specifically, cardiovascular involvement in
dogs and central nervous system involvement in mice) may need to
be repeated via an infusion mode of delivery for HIV prior to
filing an IND for HIV.
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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
infections. 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.
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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, the increasing use of antibiotics to treat CF patients
has lead to an increased number of CF patients with
drug-resistant infection that can prove life-threatening. Since
CFs build-up of
mucus is genetically dependent, and the mucolytic agents and
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. 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 preliminary evidence from MDIs pre-clinical
studies, we are hopeful that MDI-P may offer CF patients the
following:
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to serve as a highly active anti-microbial agent for CF patients
with bacterial pulmonary infection, as well as viral pulmonary
infection, with low 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 potential benefits of using MDI-P as an adjunct therapy to
TOBI, based on preliminary data from our pre-clinical studies,
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 if TOBI was discontinued and MDI-P used
alone; and |
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to lessen the likelihood of adverse events due to endotoxin
reaction, due to the high level of activity MDI-P may exhibit in
killing pathogens. |
We are hopeful that MDI-P may, with CF patient compliance,
significantly improve both pulmonary function and longevity of
CF patients, due to its unique dual mechanism of action.
10
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 three times daily at home, and
will come into the CF clinic for weekly physicals, blood tests,
pulmonary function tests, and the like.
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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
for those indications and may in the future pursue opportunities
to commercialize MDI-P as a therapeutic for those indications.
MDI purchased intellectual property assets from the liquidation
estate of Savetherapeutics AG in March of 2005. The assets
related to SaveCream, a novel, topical steroidal form of
aromatase inhibitor (AI) indicated for breast cancer.
Because it is applied topically, SaveCream may be shown to
deliver substantially more therapeutic drug on the site of the
breast tumor, as contrasted with systemic ingestion of competing
AIs. If clinical research confirms the early evidence, SaveCream
may be found to promote 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 breast cancer received
special permission to be treated with SaveCream. Patients in
this preliminary study experienced an average reduction in tumor
size of fifty percent with two weeks treatment. No
follow-up data was
collected to permit assessment of adverse events or benefits of
treatment occuring after the treatment period. If these
preliminary results are confirmed in further clinical testing,
this compound may be a useful neoadjuvant therapy for reducing
tumor size to increase the potential for breast-saving surgery
in place of mastectomy.
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 40,000 per year. For the
25 percent 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), achieving $1.1 billion per
year in revenues in 2004, with an estimated annual growth rate
of 4%. 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
11
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. 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. Approximately 70% of women with breast
cancer 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.
While
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. Limiting
the amount of estrogen produced means there is less estrogen
available to reach cancer cells and make them 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 may affect 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.
In our preliminary European Union studies of SaveCream, we
observed an average fifty to eighty percent reduction in breast
tumor size within two weeks of treatment. If these preliminary
results are realized in further clinical testing, this compound
may be a useful neoadjuvant therapy for reducing tumor size,
increasing the potential for breast-saving surgery in place of
mastectomy. SaveCream was well tolerated in our limited clinical
studies, suggesting that it may offer a lower incidence of
toxicities that are less severe than those reported for oral
aromatase inhibitors. Other AIs are noted for musculoskeletal
complaints and increased risk of osteoporosis and bone fracture,
together with mastalagia. In our initial, limited clinical
experience with SaveCream, these common side-effects of other
AIs were not observed. Furthermore, the limited half-life of the
active product suggests that SaveCream may be shown to have an
improved side effect profile over existing oral formulations.
The safety and efficacy of SaveCream will require further
clinical evaluation, as the patients in the European Union
studies were not followed for collection of safety and efficacy
data beyond the treatment period.
The aromatase inhibitor in SaveCream is a known therapeutic
compound, for which we believe substantial published safety and
efficacy data are already available. The Food, Drug and Cosmetic
Act and its implementing regulations provide for the filing of a
paper NDA for certain products that are similar to
approved products, including those utilizing a new route of
administration of the approved product. An applicant filing a
paper NDA may rely upon the agencys finding of safety and
efficacy for the approved product, as well as on published data,
to show safety and efficacy, eliminating much of the clinical
testing required in a full NDA. Some clinical data is required
for a paper NDA submission, however, including clinical data
analyzing any differences between the known or approved product
and the new product. While we have not confirmed that sufficient
data is available to support a paper NDA for SaveCream, we
believe this abbreviated filing procedure may be available. If
this procedure can be utilized, the costs of clinical
development will be reduced and the product may be easier to
license.
SaveCreams unique mechanism of action suggests the product
may be shown to be useful in treating:
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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 existing chemistry,
manufacturing and control (CMC) data supporting SaveCream
will be sufficient, however additional preclinical data will
need to be obtained, including toxicology and pharmacokinetic
testing. While the Company plans to undertake a program to
expand SaveCreams preclinical data and expand the clinical
trial program, including revised protocols, additional funds
will need to be raised before this work can proceed. The
preclinical testing will likely take an additional three to six
months once it has begun, and expanded clinical trials will
likely take an additional year of work.
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Patents: 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. We believe that these patents, in combination with
our pending applications for patents covering additional uses of
MDI-P are sufficient to protect our proposed indications for
use, however additional patents may be sought if we pursue
additional uses for this product. 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 |
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This patent covers a method of treating antigen related
infections related to cardiomyopathy and multiple sclerosis in
humans and other warm blooded animals. It does not cover the
MDI-P Substance itself, but covers a particular use of the
substance. 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 |
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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.
This patent covers the equipment used to produce MDI-P, not the
substance itself. The duration of this patent is until
August 26, 2014. |
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Patent No. 5,560,816: Method for Electrolyzing
Fluids |
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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. This patent covers the method by which MDI-P is
produced, not the substance itself. The duration of this patent
is until August 26, 2014, subject to patent term extension
for clinical trial time. |
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Patent No. 5,622,848: Electrically Hydrolyzed
Saline Solution as Microbicides for In Vitro Treatment of
Contaminated Fluids Containing Blood |
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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. This patent
covers a particular use of MDI-P, not substance itself. 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 |
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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. This
patent covers the MDI-P substance. 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 |
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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. This patent covers a
method for using MDI-P, not the substance itself. 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 |
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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. This
patent covers a process by which MDI-P may be made for a
particular use, not the substance itself. 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 |
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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. This
patent covers a particular use of MDI-P, not the substance
itself. 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. These include:
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A patent application for the use of MDI-P in the treatment of
sepsis. This patent, if it is ultimately granted, would cover a
particular use of the MDI-P substance, not the substance itself. |
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A provisional patent application for the use of MDI-P in the
treatment of sepsis. A provisional patent application is an
abbreviated application intended to establish a priority filing
date for this technology. A full patent application will be
required before this patent application is reviewed by the
U.S. Patent and Trademark Office. This patent, if it is
ultimately granted, would cover a particular use of the MDI-P
substance, not the substance itself. |
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A provisional patent application for the use of MDI-P in the
treatment of asthma. A provisional patent application is an
abbreviated application intended to establish a priority filing
date for this technology. A full patent application will be
required before this patent application is reviewed by the
U.S. Patent and Trademark Office. This patent, if it is
ultimately granted, would cover a particular use of the MDI-P
substance, not the substance itself. |
As existing patents and pending patent applications are method
patents covering the use of MDI-P for particular indications, we
believe they are adequate to protect the proposed indications
for use.
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Patents: SaveCream and Related Technologies. |
The intellectual property assets we purchased from the
liquidation estate of Savetherapeutics A.G. include the
following four patent families:
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Substances and Agents for Positively Influencing
Collagen. This includes an EU patent application and a
Canadian patent. This patent covers the use of a substance such
as an aromatase inhibitor to inhibit the local formation of
estrogen to stabilize, multiply and/or restore collagen in the
skin for cosmetic purposes. It does not cover the SaveCream
substance itself. |
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Topical Treatment for Mastalgia. This
includes U.S. patent application 10/416,096 filed
October 30, 2001. A European Union patent application has
been filed as well. This patent application seeks to cover a
substance containing an aromatase inhibitor for topical
administration for medicinal treatment, including prevention and
treatment of mastalgia. |
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Medicament for Preventing and/or Treating a Mammary
Carcinoma Containing a Steroidal Aromatase Inhibitor.
This includes a U.S. patent application,
No. 09/646,355, filed November 16, 2000 and divisional
and continuation applications based upon the initial
application. These applications seek to cover a method or
prevention or treatment of breast cancer involving the local,
topical application of an aromatase inhibitor. These
applications seek to cover a particular use of the SaveCream
substance, not the substance itself. |
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Aromatase Marking. This includes a
U.S. Patent application, No. 10/487,953, filed
August 28, 2002, as well as a European Union patent
application. These patents seek to cover a group of compounds
that exhibit an inhibitory action toward the enzyme aromatase,
permitting them to be used for the medical diagnosis and
treatment of tumor diseases including breast cancer. |
We believe that these patents, if granted, will sufficiently
protect our proposed indications for use. We may, however, seek
additional patents to cover new uses of SaveCream that may be
discovered during the products development.
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 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. See Risk Factors We May Need
to Litigate to Secure Our Rights to SaveCream and Related
Assets.
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.
In particular, we face competition from the manufacturers of
products that would compete with MDI-P and SaveCream should they
be commercialized. Manufacturers of products currently available
for the treatment of HIV and cystic fibrosis would be among our
most significant competitors in the market for MDI-
15
P. While there are 24 HIV therapies currently on the market
(commonly used in three- or four-drug combinations), the primary
therapies currently in use are produced by Pfizer, Bristol-Myers
Squibb, Boehringer Ingelheim, GlaxoSmithKline, Gilead Sciences,
Hoffman-La Roche, Merck, Abbott Laboratories, Agouron
Pharmaceuticals, and Trimeris. Currently available
anti-infectives commonly used in the treatment of cystic
fibrosis are manufactured by Bayer Corporation, the maker of
Cipro; Pfizer, the maker of Zithromax; and Chiron, the maker of
tobramycin solution (TOBI); Bayer and Pfizer would compete with
us in the cystic fibrosis market, while MDI-P is being studied
as an adjunct to treatment with TOBI; thus we would be unlikely
to compete directly with Chiron. Producers of aromatase
inhibitors and other breast cancer treatments would compete with
SaveCream should we able to commercialize this product. These
companies include Astra-Zeneca, the maker of both Tamoxifen and
Arimidex; Novartis, the maker of Femara; and Pfizer, the maker
of Aromasin.
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.
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 preclinical 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.
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.
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.
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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 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
17
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.
The components of both MDI-P and SaveCream are readily available
from a number of sources. Therefore, once we are in the
production stage with respect to these drugs, we do not
anticipate raw materials acquisition difficulties or supplier
identification or relations problems.
|
|
|
Research and Development Expenditures. |
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, 2005, we spent $2,172,461 on
research and development of MDI-P. During fiscal year 2004, we
spent $550,093 on research and development. From inception
through December 31, 2005, we have recorded $5,721,199 in
research and development expenses including expenditures
relating to the purchase of the SaveCream intellectual property.
We are actively pursuing our research efforts of MDI-P and are
in the process of establishing a commercialization plan for
SaveCream.
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 preclinical development and all
capital resources have been devoted in that direction. At such
time as capital resources permit, we will hire a 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
18
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 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.
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 Consulting Group
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.
Dr. Henry R. Thompson, M.D.
Director, Cystic Fibrosis Program Therapeutics Center, St.
Lukes Health Center, Boise, Idaho
On September 23, 2004, Dr. Thompson agreed to serve as
Project Manager and Principal Investigator for MDIs
Phase I trials in late-term adult Cystic Fibrosis
(CF) patients. Dr. Thompson is a gastroentologist, and
received his M.D. from Oregon Health Sciences University. He
held a Fellowship in pediatric gastroenterology at
Childrens Hospital in Denver, at the University of
Colorado Health Sciences unit, where he also participated
in clinical studies. Dr. Thompson has been an Assistant
Professor at the University of Utahs Medical School, and
is a Board certified Fellow in the American Association of
Pediatrics. He has previously received grants from both the
Cystic Fibrosis Foundation and the NIH.
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
19
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 certain
intellectual property assets from the liquidation estate of
Savetherapeutics, A.G.
|
|
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.
|
|
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
|
|
ITEM 5. |
MARKET FOR COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND
SMALL BUSINESS ISSUER PURCHASES OF EQUITY SECURITIES. |
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.
|
|
|
|
|
|
|
|
|
Fiscal Year Ended December 31, 2005 |
|
High Bid | |
|
Low Bid | |
|
|
| |
|
| |
First Quarter
|
|
$ |
0.220 |
|
|
$ |
0.130 |
|
Second Quarter
|
|
|
0.170 |
|
|
|
0.082 |
|
Third Quarter
|
|
|
0.180 |
|
|
|
0.080 |
|
Fourth Quarter
|
|
|
0.135 |
|
|
|
0.090 |
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended December 31, 2004 |
|
High Bid | |
|
Low Bid | |
|
|
| |
|
| |
First Quarter
|
|
$ |
0.170 |
|
|
$ |
0.100 |
|
Second Quarter
|
|
|
0.300 |
|
|
|
0.115 |
|
Third Quarter
|
|
|
0.301 |
|
|
|
0.150 |
|
Fourth Quarter
|
|
|
0.260 |
|
|
|
0.180 |
|
20
SHAREHOLDERS
The approximate number of shareholders of record of our common
stock as of March 27, 2006 was 1500. 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, 2005.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of | |
|
|
|
|
|
|
Securities | |
|
|
|
|
|
|
Remaining Available | |
|
|
Number of | |
|
|
|
for Future Issuance | |
|
|
Securities to be | |
|
|
|
Under Equity | |
|
|
Issued Upon | |
|
|
|
Compensation Plans | |
|
|
Exercise of | |
|
Weighted-Average | |
|
(Excluding | |
|
|
Outstanding | |
|
Exercise Price of | |
|
Securities Reflected | |
|
|
Options, Warrants | |
|
Outstanding Options, | |
|
in the First | |
Plan Category |
|
and Rights | |
|
Warrants and Rights | |
|
Column) | |
|
|
| |
|
| |
|
| |
Equity compensation plans approved by security holders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1993 Incentive Plan
|
|
|
3,483,000 |
|
|
$ |
0.11 |
|
|
|
-0- |
|
|
2002 Stock Incentive Plan
|
|
|
16,000,000 |
|
|
$ |
0.02 |
|
|
|
4,000,000 |
|
Equity compensation plans not approved by security holders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
19,483,000 |
|
|
$ |
0.04 |
|
|
|
4,000,000 |
|
|
|
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 30 through 50.
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 did not book any revenue
for the year ended December 31, 2005. As we continue to
pursue preclinical and clinical testing of our pharmaceuticals,
we may not book significant revenues in the near future.
Operating Expenses and Operating Loss. We incurred
$2,172,461 in research and development expenses for the year
ended December 31, 2005, $1,345,000 of which is related to
our acquiring the patents and patent rights relating to
SaveCream. We incurred $550,093 in research and development
expenses for the same period of 2004. Our general and
administrative expenses were $1,878,027 during the year ended
21
December 31, 2005, as compared to $3,057,429 during the
year ended December 31, 2004. As a result of the foregoing,
we sustained an operating loss of $4,050,488 for the year ended
December 31, 2005, as compared with an operating loss of
$3,607,522 for the same period of 2004.
Other Income/ Expense and Net Loss. We booked $25,727 in
interest income and incurred interest expense of $38,264 for the
year ended December 31, 2005, as compared with interest
income of $6,165 and $131,526 in interest expenses during 2004.
During the year ended December 31, 2005, we also booked
foreign currency gain of $56,480. We had no foreign currency
risk in 2004. We recorded $2,300,191 as unrealized gain on
financial instrument to record the accounting of warrants
resulting from the issuance of the Series A Convertible
Preferred Stock entered into in October 2004 and March 2005. We
also recorded $196,353 in gain on forgiveness of debt. There was
no gain on forgiveness of debt during 2004. In sum, our net loss
applicable to common shareholders for the year ended 2005 was
$1,486,781 or a loss of $0.01 per fully diluted share. For
the year ended December 31, 2004 we incurred a net loss
applicable to common shareholders of $4,423,674, making a loss
of $0.05 per fully diluted share.
Future Expectations. We may operate at a loss for several
more years while we continue to research, gain regulatory
approval of, and commercialize our technologies. We will spend
more in 2006 in research and development expenses than we did
over the prior year as we continue to implement our
commercialization strategy. Similarly, we expect our general and
administrative expenses to continue to increase during 2006 as
we continue to expand the scope of our operations. As a result,
we may sustain a greater net loss in 2006 than we have in recent
years.
LIQUIDITY AND CAPITAL RESOURCES
As of December 31, 2005, we had $654,438 in cash and had a
working capital deficit of $5,893,077. Since our inception, we
have financed our operations primarily through private sales of
equity and the issuance of convertible and non-convertible
notes. We continue to require significant supplementary 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 private issuances
of equity.
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.
We have entered into fixed price contracts for all of the
services we expect will be required in connection with our
cystic fibrosis Phase I testing should the FDA allow us to
proceed to clinical trials. We have budgeted for these costs and
believe we have sufficient funds to initiate this trials.
However we will need to raise additional capital to complete
Phase I.
We have insufficient capital to file our IND for HIV. Once an
IND application for HIV is submitted, and assuming it is
approved, we also will need additional capital to initiate
Phase I clinical trials. We estimate the cost to complete
Phase I and Phase II clinical trials to be several
million dollars per indication and the cost to complete
Phase III testing and obtain approval of an NDA to be in
the tens of millions of dollars per indication. While our
ability to obtain financing may improve in the event our IND
application is approved, we cannot give assurances that we will
have 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.
22
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 Savetherapeutics
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. The results of our preclinical
and anecdotal 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 sale, during commercial use. Even if our drugs do
prove to be safe and effective and receive regulatory approvals,
we may be unable to successfully commercialize them.
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 approximately $22,240,291 as of
December 31, 2005. Our net losses were $1,486,781 for the
fiscal year ended December 31, 2005, and $20,840,714 from
inception through December 31, 2005. We will likely
continue to experience a net 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.
23
We May Not Be Able To Raise Sufficient Capital To Meet
Present And Future Obligations As of December 31, 2005,
we had $654,438 in cash and a working capital deficit of
$5,893,077. We need additional capital in order to satisfy our
current liabilities. However, because many of our creditors have
forebeared (including our CEO who we owed $877,636 in back
compensation as of December 31, 2005), we believe we have
sufficient funds to achieve our next developmental milestone for
MDI-P, that being commencing Phase I clinical trials for
cystic fibrosis.
More specifically, we believe we have sufficient capital on hand
to pay for the additional preclinical testing requested by the
FDA before it will remove the clinical hold on our IND and
permit us to begin Phase I clinical testing. That
preclinical testing has been completed. We entered into fixed
price contracts for each of the planned preclinical tests,
totaling $907,939. $865,311 of these contract charges have been
paid with $42,628 in preclinical testing fees outstanding
pending receipt of the preclinical study reports. We have
sufficient funds to make these payments and to fund overhead
expenses in the near term. While we believe we have sufficient
funds to begin Phase I clinical trials of MDI-P for cystic
fibrosis if and when the FDA allows use to begin human trials
under an amended IND, we may need to raise additional funds to
complete this testing. Should the FDA request further
preclinical testing beyond our current expectations, we will
need to expend additional funds beyond what is budgeted for our
MDI-P development activities. This could impact our ability to
commercialize this product.
We believe we have insufficient capital to file our IND for HIV.
In addition, once an IND application for HIV is submitted, and
assuming it is approved, we will need additional capital to
initiate Phase I clinical trials.
We estimate the cost to complete Phase I and Phase II
clinical trials to be several million dollars per indication and
the cost to complete Phase III testing and obtain approval
of a New Drug Application to be in the tens of millions of
dollars per indication. While our ability to obtain financing
may improve in the event our IND application is approved, we
cannot give assurances that we will have access to the
significant capital required to take a drug through regulatory
approvals and to market.
We do not currently have revenues that could be used to satisfy
our capital requirements. We may seek to obtain revenues at any
time, however, by partnering with another company to help us
co-develop, license, or even purchase some or all of our
technologies. Most likely, we will seek to raise additional
capital through equity and/or debt financings.
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; and |
|
|
|
the price, volatility and trading volume of our common shares. |
24
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.
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
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. Additionally, the existing
options, warrants and conversion rights, detailed in
Part III of this report, may hinder future equity
offerings, and the exercise of those options, warrants and
conversion rights may have an adverse effect on the value of our
stock. In particular, we have 19,483,000 options outstanding
with exercise prices ranging from $0.01 to $0.50 and a weighted
average exercise price of $0.04 per share; 40,923,861
warrants outstanding with exercise prices ranging from $0.09 to
$1.00 and a weighted average exercise price of $0.23 per
share; and 41,800 shares of Series A convertible
preferred stock outstanding, 11,800 of which can be exercised
into as many as 23,600,000 shares of common stock at the
exercise price of $0.05 per share and 30,000 of which can
be exercised into a theoretically unlimited number of shares of
common stock without a floor on the exercise price. If any such
options, warrants or conversion rights are exercised at a price
below the current market price of our shares, then the market as
a whole will experience dilution. Further, if any such options,
warrants or conversion rights are exercised at a price below the
price at which any particular shareholder purchased shares, then
that particular shareholder will experience dilution in his or
her investment.
Selling Pressure From Our Series A Convertible Preferred
Shareholders May Negatively Impact Our Stock Price, Our Market
Value, And Our Ability To Raise Additional Capital. Because
the conversion price of much of the Series A convertible
preferred stock has no floor, coupled with the fact that the
conversion price is at a discount to market, the holders of
those shares could realize a profit on selling common stock no
matter what price our common stock is trading at in the market
at the time. Because our trading volume is limited and our stock
price is subject to fluctuation, the market price of our stock
could decrease dramatically if the holders of those shares
decide to liquidate all or even some of their position. Even if
the Series A stockholders liquidate their position slowly
over time, because the overall number of shares into which they
could exercise is so large as a proportion to our shares
outstanding, the result could be a sustained market price for
our stock that is much lower than it would otherwise be without
such sustained selling pressure. If our stock price does suffer
due to this type of selling pressure, our market value will be
lower and our ability to raise much needed additional capital
will be negatively impacted. If the Series A shareholders
decide to liquidate their position in a market with very little
purchaser demand, the result could be to eliminate substantially
all of our market value, resulting in no meaningful opportunity
whatsoever to obtain additional financing that we need to
continue to develop our development-stage products.
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 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
25
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.
In particular, we face competition from the manufacturers of
products that would compete with MDI-P and SaveCream should they
be commercialized. Manufacturers of products currently available
for the treatment of HIV and cystic fibrosis would be among our
most significant competitors in the market for MDI-P. While
there are 24 HIV therapies currently on the market (commonly
used in three- or four-drug combinations), the primary therapies
currently in use are produced by Pfizer, Bristol-Myers Squibb,
Boehringer Ingelheim, GlaxoSmithKline, Gilead Sciences,
Hoffman-La Roche, Merck, Abbott Laboratories, Agouron
Pharmaceuticals, and Trimeris. Currently available
anti-infectives commonly used in the treatment of cystic
fibrosis are manufactured by Bayer Corporation, the maker of
Cipro; Pfizer, the maker of Zithromax; and Chiron, the maker of
tobramycin solution (TOBI). Bayer and Pfizer would compete with
us in the cystic fibrosis market, while MDI-P is being studied
as an adjunct to treatment with TOBI; thus we would be unlikely
to compete directly with Chiron. Producers of aromatase
inhibitors and other breast cancer treatments would compete with
SaveCream should we able to commercialize this product. These
companies include Astra-Zeneca, the maker of both Tamoxifen and
Arimidex; Novartis, the maker of Femara; and Pfizer, the maker
of Aromasin.
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. While we believe
that both MDI-P and SaveCream will be shown to be at least as
effective as existing therapies with more favorable risk
profiles, as described more fully in the Description of Business
section, clinical trials have not been conducted to prove these
potential competitive advantages. Additionally, given that
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.
26
The extensive financial and other resources of the major
pharmaceutical manufacturers who are our most likely competitors
may make it unlikely that we can successfully compete in the
HIV, cystic fibrosis or breast cancer markets on our own. As a
result, we may seek a development partner or pursue licensing
opportunities for these technologies.
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. We are unaware of
any current or past infringement of our patented technologies;
however, if such infringement were to occur, sufficient funds
may not be available to adequately pursue an action for
infringement. 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 patents outside 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 currently hold eight U.S. patents, two Japanese patents
and one Mexican patent related to MDI-P. These patents, detailed
in the Description of Business section, cover a specific
solution, methods of using this solution as an anti-infective,
and the equipment and processes necessary to produce it. The
durations of these patents range from May 2010 to August 2014.
We also have three pending U.S. patent applications
relating to methods of using MDI-P to treat cystic fibrosis,
sepsis and asthma. The intellectual property assets purchased
from Savetherapeutics include the intellectual property rights
in four patent families related to SaveCream. These patents and
the related international patents and patent applications are
detailed in the Description of Business section.
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 Savetherapeutics A.G.
(SaveT), SaveT had not yet obtained and filed with the
appropriate patent offices assignments of the inventors
rights to the underlying inventions. As a result, at the time
the SaveT assets were obtained, the two inventors of SaveCream,
Heinrich Wieland and Alfred Schmidt, were the record holders of
the U.S. patent rights related to this product. Each of
those inventors has agreed and is contractually bound to assign
such rights to SaveT. As of September 25, 2005, Heinrich
Wieland has executed assignments of his interests in the
SaveCream patents to Savetherapeutics and has provided us with a
declaration to the U.S. Patent and Trademark Office
detailing the agreements by which he and Mr. Schmidt, upon
receipt of consideration from SaveT, agreed and intended to
transfer these rights to SaveT. Those assignments, along with
assignments of Savetherapeutics rights in the patents to
us, have been filed with the U.S. Patent and Trademark
Office.
Despite his prior written agreements to do so, Mr. Schmidt
has refused to execute assignments of his rights in the
SaveCream patents. To our knowledge, Mr. Schmidts
refusal to undertake his contractual obligation to assign the
SaveCream patents has no basis in law. It may be necessary,
however, to litigate against Mr. Schmidt in all countries
in which patents are filed in order to obtain the assignment of
these rights. These countries include the U.S., Germany, Canada,
France, Great Britain, Italy, the Netherlands, Switzerland and
Spain. We may not have the funds necessary to effectively pursue
these claims.
Should we fail to obtain the assignment of
Mr. Schmidts rights in the SaveCream patents, it may
be more difficult to commercialize SaveCream should FDA approval
for such commercialization be granted. While the product would
remain subject to patent protection and we could pursue our
development and commercialization activities based upon
Dr. Wielands assignment, Mr. Schmidt, as a
co-inventor, may be
27
able to independently exploit his rights in the SaveCream
patents and could enter into competition with us or license his
rights to third parties. This would effectively preclude us from
pursing an exclusive licensing or co-development opportunity,
and would, therefore substantially reduce the value of this
intellectual property to us.
We Face Significant Product Liability. We face an
inherent business risk of exposure to product liability and
other claims in the event our products result in or are 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, and have incorporated the
costs of insurance coverage into our budget for the 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. Since our
inception, trading in our stock has been sporadic. During the
three months ended February 28, 2006, the daily trading
volume of our stock averaged 40,496 shares per day. This
thin trading market increases the volatility of our stock price
and allows trades of even small blocks of stock to have a
significant impact on our stock price. Our thin trading market
also increases the risk of illegal naked short selling which may
cause the stock price to decrease to as low as $0.001 and
shareholders to lose essentially all value in their stock. 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, 2005
|
|
|
0.135 |
|
|
|
0.090 |
|
Quarter ended September 30, 2005
|
|
|
0.180 |
|
|
|
0.080 |
|
Quarter ended June 30, 2005
|
|
|
0.170 |
|
|
|
0.082 |
|
Quarter ended March 31, 2005
|
|
$ |
0.220 |
|
|
$ |
0.130 |
|
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; and |
|
|
|
economic and other external market factors, such as poor
economic indicators or investor distrust. |
Penny stock rules may make buying or selling our
securities difficult which may make our stock less liquid and
make it harder for investors to buy and sell our shares.
Trading in our securities is subject to the SECs
penny stock rules and it is anticipated that trading
in our securities will continue to be subject to the penny stock
rules for the foreseeable future. The SEC has adopted
regulations that generally define a penny stock to be any equity
security that has a market price of less than $4.00 per
share, subject to certain exceptions. These rules require that
any broker-dealer who recommends our securities to persons other
than
28
prior customers and accredited investors must, prior to the
sale, make a special written suitability determination for the
purchaser and receive the purchasers written agreement to
execute the transaction. Unless an exception is available, the
regulations require the delivery, prior to any transaction
involving a penny stock, of a disclosure schedule explaining the
penny stock market and the risks associated with trading in the
penny stock market. In addition, broker-dealers must disclose
commissions payable to both the broker-dealer and the registered
representative and current quotations for the securities they
offer. The additional burdens imposed upon broker-dealers by
these requirements may discourage broker-dealers from
recommending transactions in our securities, which could
severely limit the liquidity of our securities and consequently
adversely affect the market price for our securities.
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.
29
|
|
ITEM 7. |
FINANCIAL STATEMENTS. |
FINANCIAL STATEMENTS TABLE OF CONTENTS
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Page | |
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|
No. | |
|
|
| |
|
|
|
31 |
|
FINANCIAL STATEMENTS
|
|
|
|
|
|
|
|
|
33 |
|
|
|
|
|
34 |
|
|
|
|
|
35 |
|
|
|
|
|
39 |
|
|
|
|
|
40 |
|
30
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Shareholders
Medical Discoveries, Inc.
We have audited the accompanying consolidated balance sheets of
Medical Discoveries, Inc. and subsidiaries (a development stage
company) as of December 31, 2005 and 2004, and the related
consolidated statements of operations, changes in
stockholders deficit, and cash flows for the years then
ended, and for the period from November 20, 1991 (date of
inception of the development stage) through December 31,
2005. These consolidated financial statements are the
responsibility of the Companys management. Our
responsibility is to express an opinion on these financial
statements based on our audits. We did not audit the 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 reports, dated February 18, 2004
(except Note K, not included herein, as to which the date
is November 15, 2004) and March 20, 2000, 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 audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audits to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by
management, as well as evaluating the overall financial
statement presentation. We believe that our audits and the
report of the other auditors provide a reasonable basis for our
opinion.
In our opinion, based on our audits 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, 2005 and 2004, and the results of their
operations and their cash flows for the years then ended and for
the period from November 20, 1991 through December 31,
2005, 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
deficit and the operating losses since inception raise
substantial doubt about the Companys ability to continue
as a going
31
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 3, 2006
32
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
December 31, | |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
ASSETS |
CURRENT ASSETS
|
|
|
|
|
|
|
|
|
|
Cash
|
|
$ |
654,438 |
|
|
$ |
1,455,397 |
|
|
Deposits
|
|
|
|
|
|
|
51,100 |
|
|
|
|
|
|
|
|
|
|
Total Current Assets
|
|
|
654,438 |
|
|
|
1,506,497 |
|
|
|
|
|
|
|
|
|
Note receivable
|
|
|
296,050 |
|
|
|
|
|
|
Property and equipment, net
|
|
|
80,635 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL ASSETS
|
|
$ |
1,031,123 |
|
|
$ |
1,506,497 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS DEFICIT |
CURRENT LIABILITIES
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
2,608,783 |
|
|
$ |
2,448,454 |
|
|
Accrued interest payable
|
|
|
237,836 |
|
|
|
415,262 |
|
|
Notes payable
|
|
|
56,000 |
|
|
|
336,717 |
|
|
Convertible notes payable
|
|
|
193,200 |
|
|
|
193,200 |
|
|
Research and development obligation
|
|
|
592,100 |
|
|
|
|
|
|
Financial instrument
|
|
|
2,859,596 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Current Liabilities
|
|
|
6,547,515 |
|
|
|
3,393,633 |
|
|
|
|
|
|
|
|
TOTAL LIABILITIES
|
|
|
6,547,515 |
|
|
|
3,393,633 |
|
|
|
|
|
|
|
|
STOCKHOLDERS DEFICIT
|
|
|
|
|
|
|
|
|
|
Preferred Stock undesignated, Series A,
convertible; no par value; 50,000 shares authorized; 42,000
and 12,000 shares issued and outstanding, respectively;
(aggregate liquidation preference of $4,200,000 and $1,200,000,
respectively)
|
|
|
523,334 |
|
|
|
523,334 |
|
|
Common stock, no par value; 250,000,000 shares authorized;
107,679,724 and 105,653,335 shares issued and outstanding,
respectively
|
|
|
15,211,895 |
|
|
|
14,918,657 |
|
|
Additional paid-in capital
|
|
|
988,670 |
|
|
|
3,424,383 |
|
|
Deficit accumulated prior to the development stage
|
|
|
(1,399,577 |
) |
|
|
(1,399,577 |
) |
|
Deficit accumulated during the development stage
|
|
|
(20,840,714 |
) |
|
|
(19,353,933 |
) |
|
|
|
|
|
|
|
|
|
Total Stockholders Deficit
|
|
|
(5,516,392 |
) |
|
|
(1,887,136 |
) |
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS DEFICIT
|
|
$ |
1,031,123 |
|
|
$ |
1,506,497 |
|
|
|
|
|
|
|
|
33
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF OPERATIONS
Years Ended December 31, 2005 and 2004, and
Cumulative Amounts Since November 20, 1991 (Date of
Inception)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
From Inception of the | |
|
|
For the Years Ended | |
|
Development Stage | |
|
|
December 31, | |
|
on November 20, 1991 | |
|
|
| |
|
through December 31, | |
|
|
2005 | |
|
2004 | |
|
2005 | |
|
|
| |
|
| |
|
| |
REVENUES
|
|
$ |
|
|
|
$ |
|
|
|
$ |
157,044 |
|
COST OF GOODS SOLD
|
|
|
|
|
|
|
|
|
|
|
14,564 |
|
|
|
|
|
|
|
|
|
|
|
|
GROSS PROFIT
|
|
|
|
|
|
|
|
|
|
|
142,480 |
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
|
1,878,027 |
|
|
|
3,057,429 |
|
|
|
17,054,997 |
|
|
Research and development
|
|
|
2,172,461 |
|
|
|
550,093 |
|
|
|
5,721,199 |
|
|
Inventory write-down
|
|
|
|
|
|
|
|
|
|
|
96,859 |
|
|
Impairment loss
|
|
|
|
|
|
|
|
|
|
|
9,709 |
|
|
License fees
|
|
|
|
|
|
|
|
|
|
|
1,001,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Expenses
|
|
|
4,050,488 |
|
|
|
3,607,522 |
|
|
|
23,884,264 |
|
|
|
|
|
|
|
|
|
|
|
LOSS FROM OPERATIONS
|
|
|
(4,050,488 |
) |
|
|
(3,607,522 |
) |
|
|
(23,741,784 |
) |
|
|
|
|
|
|
|
|
|
|
OTHER INCOME (EXPENSES)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on financial instrument
|
|
|
2,300,191 |
|
|
|
|
|
|
|
2,300,191 |
|
|
Interest income
|
|
|
25,727 |
|
|
|
6,165 |
|
|
|
55,298 |
|
|
Interest expense
|
|
|
(38,264 |
) |
|
|
(131,526 |
) |
|
|
(1,155,701 |
) |
|
Foreign currency transaction gain
|
|
|
56,480 |
|
|
|
|
|
|
|
56,480 |
|
|
Gain on forgiveness of debt
|
|
|
196,353 |
|
|
|
|
|
|
|
1,431,889 |
|
|
Other income
|
|
|
23,220 |
|
|
|
1,408 |
|
|
|
905,112 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Other Income (Expenses)
|
|
|
2,563,707 |
|
|
|
(123,953 |
) |
|
|
3,593,269 |
|
|
|
|
|
|
|
|
|
|
|
NET LOSS
|
|
|
(1,486,781 |
) |
|
|
(3,731,475 |
) |
|
|
(20,148,515 |
) |
|
|
|
|
|
|
|
|
|
|
|
Preferred stock dividend from beneficial conversion feature
|
|
|
|
|
|
|
(692,199 |
) |
|
|
(692,199 |
) |
|
|
|
|
|
|
|
|
|
|
NET LOSS APPLICABLE TO COMMON SHAREHOLDERS
|
|
$ |
(1,486,781 |
) |
|
$ |
(4,423,674 |
) |
|
$ |
(20,840,714 |
) |
|
|
|
|
|
|
|
|
|
|
BASIC AND DILUTED LOSS PER COMMON SHARE
|
|
$ |
(0.01 |
) |
|
$ |
(0.05 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING
|
|
|
107,398,164 |
|
|
|
93,947,646 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
34
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, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated | |
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
Deficit Prior | |
|
Accumulated |
|
|
|
|
|
|
Preferred Stock | |
|
Common Stock | |
|
Additional |
|
to | |
|
During the |
|
Escrow/ | |
|
|
|
|
| |
|
| |
|
Paid in |
|
Development | |
|
Development |
|
Subscription | |
|
|
|
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount | |
|
Capital |
|
Stage | |
|
Stage |
|
Receivables | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
|
|
|
| |
|
|
|
| |
|
| |
Balance at October 31,1991
|
|
|
|
|
|
|
|
|
|
|
1,750,000 |
|
|
$ |
252,997 |
|
|
$ |
|
|
|
$ |
(1,482,514 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
(1,229,517 |
) |
Restatement for reverse acquisition of WPI Pharmaceutical, Inc.
by Medical Discoveries, Inc.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(252,997 |
) |
|
|
|
|
|
|
252,997 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares issued in merger of WPI Pharmaceutical, Inc. Medical
Discoveries, Inc., $0.01 per share
|
|
|
|
|
|
|
|
|
|
|
10,000,000 |
|
|
|
135,000 |
|
|
|
|
|
|
|
(170,060 |
) |
|
|
|
|
|
|
|
|
|
|
(35,060 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at November 20,1991
(Date of Inception of 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 |
|
|
|
2003 $0.04 per share
|
|
|
|
|
|
|
|
|
|
|
20,162,500 |
|
|
|
790,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
790,300 |
|
|
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 |
|
35
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, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated | |
|
Deficit | |
|
|
|
|
|
|
|
|
|
|
|
|
Deficit Prior | |
|
Accumulated | |
|
|
|
|
|
|
Preferred Stock | |
|
Common Stock | |
|
Additional | |
|
to | |
|
During the | |
|
Escrow/ | |
|
|
|
|
| |
|
| |
|
Paid in | |
|
Development | |
|
Development | |
|
Subscription | |
|
|
|
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount | |
|
Capital | |
|
Stage | |
|
Stage | |
|
Receivables | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
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 |
|
|
2003 $0.06 per share
|
|
|
|
|
|
|
|
|
|
|
694,739 |
|
|
|
43,395 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
43,395 |
|
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 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
36
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, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated | |
|
Deficit | |
|
|
|
|
|
|
|
|
|
|
|
|
Deficit Prior | |
|
Accumulated | |
|
|
|
|
|
|
Preferred Stock | |
|
Common Stock | |
|
Additional | |
|
to | |
|
During the | |
|
Escrow/ | |
|
|
|
|
| |
|
| |
|
Paid in | |
|
Development | |
|
Development | |
|
Subscription | |
|
|
|
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount | |
|
Capital | |
|
Stage | |
|
Stage | |
|
Receivables | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
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 Issued for Servies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1998
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,336,303 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,336,303 |
|
|
|
1999
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
196,587 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
196,587 |
|
|
|
2001
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
159,405 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
159,405 |
|
|
|
2002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
124,958 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
124,958 |
|
|
|
2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
295,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
295,000 |
|
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, 2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(14,930,259 |
) |
|
|
|
|
|
|
(14,930,259 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
|
|
|
|
|
|
|
|
76,456,095 |
|
|
|
12,546,957 |
|
|
|
579,363 |
|
|
|
(1,399,577 |
) |
|
|
(14,930,259 |
) |
|
|
(227,300 |
) |
|
|
(3,430,816 |
) |
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 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
37
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, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated | |
|
Deficit | |
|
|
|
|
|
|
|
|
|
|
|
|
Deficit Prior | |
|
Accumulated | |
|
|
|
|
|
|
Preferred Stock | |
|
Common Stock | |
|
Additional | |
|
to | |
|
During the | |
|
Escrow/ |
|
|
|
|
| |
|
| |
|
Paid in | |
|
Development | |
|
Development | |
|
Subscription |
|
|
|
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount | |
|
Capital | |
|
Stage | |
|
Stage | |
|
Receivables |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
| |
|
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 |
) |
Issuance of common stock for services
|
|
|
|
|
|
|
|
|
|
|
104,167 |
|
|
|
11,312 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,312 |
|
Issuance of common stock for cash at $0.18 per share
|
|
|
|
|
|
|
|
|
|
|
1,922,222 |
|
|
|
281,926 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
281,926 |
|
Issuance of preferred stock and warrants for cash (net $340,000,
entire amount was reclassified to financial instrument liability)
|
|
|
30,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reclassification of warrants to a financial instrument liability
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,435,713 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,435,713 |
) |
Net loss for the year ended December 31, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,486,781 |
) |
|
|
|
|
|
|
(1,486,781 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
42,000 |
|
|
$ |
523,334 |
|
|
|
107,679,724 |
|
|
$ |
15,211,895 |
|
|
$ |
988,670 |
|
|
$ |
(1,399,577 |
) |
|
$ |
(20,840,714 |
) |
|
$ |
|
|
|
$ |
(5,516,392 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
38
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Consolidated Statements of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
From Inception of the | |
|
|
For the Year Ended | |
|
Development Stage on | |
|
|
December 31, | |
|
November 20, 1991 | |
|
|
| |
|
through Dec. 30, | |
|
|
2005 | |
|
2004 | |
|
2005 | |
|
|
| |
|
| |
|
| |
CASH FLOWS FROM OPERATING ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss
|
|
$ |
(1,486,781 |
) |
|
$ |
(3,731,475 |
) |
|
$ |
(20,148,515 |
) |
Adjustments to reconcile net loss to net cash used by operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency transaction gain
|
|
|
(56,480 |
) |
|
|
|
|
|
|
(56,480 |
) |
|
Gain on debt restructuring
|
|
|
(196,353 |
) |
|
|
|
|
|
|
(1,431,889 |
) |
|
Common stock issued for services, expenses, and litigation
|
|
|
|
|
|
|
66,501 |
|
|
|
4,267,717 |
|
|
Commitment for research and development obligation
|
|
|
665,700 |
|
|
|
|
|
|
|
665,700 |
|
|
Depreciation
|
|
|
8,515 |
|
|
|
|
|
|
|
108,786 |
|
|
Reduction of escrow receivable from research and development
|
|
|
|
|
|
|
|
|
|
|
272,700 |
|
|
Unrealized gain on financial instrument
|
|
|
(2,300,191 |
) |
|
|
|
|
|
|
(2,300,191 |
) |
|
Stock options and warrants granted for services
|
|
|
|
|
|
|
1,675,000 |
|
|
|
4,811,253 |
|
|
Reduction of legal costs
|
|
|
|
|
|
|
|
|
|
|
(130,000 |
) |
|
Write-off of subscriptions receivable
|
|
|
|
|
|
|
|
|
|
|
112,500 |
|
|
Impairment of loss on assets
|
|
|
|
|
|
|
|
|
|
|
9,709 |
|
|
Loss on disposal of equipment
|
|
|
|
|
|
|
|
|
|
|
30,364 |
|
|
Write-off of receivable
|
|
|
51,100 |
|
|
|
|
|
|
|
245,065 |
|
|
Note payable issued for litigation
|
|
|
|
|
|
|
|
|
|
|
385,000 |
|
Changes in operating assets and liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase in accounts receivable
|
|
|
|
|
|
|
|
|
|
|
(7,529 |
) |
|
Decrease in prepaid expenses
|
|
|
|
|
|
|
11,331 |
|
|
|
|
|
|
Decrease in deferred charges
|
|
|
|
|
|
|
12,077 |
|
|
|
|
|
|
Increase in accounts payable
|
|
|
171,641 |
|
|
|
381,727 |
|
|
|
2,464,186 |
|
|
Increase in accrued expenses
|
|
|
38,210 |
|
|
|
53,934 |
|
|
|
637,919 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash Used by Operating Activities
|
|
|
(3,104,639 |
) |
|
|
(1,530,905 |
) |
|
|
(10,063,705 |
) |
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase in deposits
|
|
|
|
|
|
|
(51,100 |
) |
|
|
(51,100 |
) |
|
Purchase of equipment
|
|
|
(89,150 |
) |
|
|
|
|
|
|
(221,334 |
) |
|
Issuance of note receivable
|
|
|
(313,170 |
) |
|
|
|
|
|
|
(313,170 |
) |
|
Payments received on note receivable
|
|
|
|
|
|
|
|
|
|
|
130,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash Used by Investing Activities
|
|
|
(402,320 |
) |
|
|
(51,100 |
) |
|
|
(455,604 |
) |
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock, preferred stock and warrants for cash
|
|
|
3,006,000 |
|
|
|
2,883,186 |
|
|
|
10,033,845 |
|
|
Contributed equity
|
|
|
|
|
|
|
|
|
|
|
131,374 |
|
|
Proceeds from notes payable
|
|
|
|
|
|
|
|
|
|
|
1,336,613 |
|
|
Payments on notes payable
|
|
|
(300,000 |
) |
|
|
(270,000 |
) |
|
|
(801,287 |
) |
|
Proceeds from convertible notes payable
|
|
|
|
|
|
|
|
|
|
|
571,702 |
|
|
Payments on convertible notes payable
|
|
|
|
|
|
|
|
|
|
|
(98,500 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash Provided by Financing Activities
|
|
|
2,706,000 |
|
|
|
2,613,186 |
|
|
|
11,173,747 |
|
|
|
|
|
|
|
|
|
|
|
|
NET INCREASE (DECREASE) IN CASH
|
|
|
(800,959 |
) |
|
|
1,031,181 |
|
|
|
654,438 |
|
|
CASH AT BEGINNING OF PERIOD
|
|
|
1,455,397 |
|
|
|
424,216 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH AT END OF PERIOD
|
|
$ |
654,438 |
|
|
$ |
1,455,397 |
|
|
$ |
654,438 |
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid
|
|
$ |
19,283 |
|
|
$ |
77,592 |
|
|
|
|
|
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
|
|
$ |
11,312 |
|
|
$ |
162,746 |
|
|
|
|
|
|
Preferred stock divedend as part of beneficial conversion feature
|
|
$ |
|
|
|
$ |
692,199 |
|
|
|
|
|
39
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Notes to Consolidated 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 $113,752 at
December 31, 2005.
Property and equipment are stated at cost. Depreciation is
computed using the straight-line method over the estimated lives
of the related assets. Estimated useful lives are 5 years.
Normal maintenance and repair items are charged to costs and
expensed as incurred. The cost and accumulated depreciation of
property and equipment sold or otherwise retired are removed
from the accounts and gain or loss on disposition is reflected
in net income.
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.
40
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Notes to Consolidated Financial
Statements (Continued)
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
$2,172,461 and $550,093 and $5,721,199 for the year ended
December 31, 2005 and 2004 and for the period
November 20, 1991 (date of inception of the development
stage) through December 31, 2005, respectively.
|
|
|
Fair Value of Financial Instruments |
The Company estimates that the fair value of all financial
instruments, at December 31, 2005, 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.
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.
The Company has no significant revenues and, therefore, no
significant trade receivables or extensions of credit.
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.
41
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Notes to Consolidated Financial
Statements (Continued)
These accounting policies resulted in the Company recognizing $0
and $1,675,000 in stock-based compensation cost during the years
ended December 31, 2005 and 2004, respectively. The effect
on net loss and 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, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Net loss applicable to common stockholders, as reported
|
|
$ |
(1,486,781 |
) |
|
$ |
(4,423,674 |
) |
Add: Stock-based employee compensation expense included in
reported net loss
|
|
|
|
|
|
|
1,675,000 |
|
Deduct: Total stock based employee compensation expense
determined under fair value based method for all awards
|
|
|
|
|
|
|
(1,979,237 |
) |
|
|
|
|
|
|
|
Pro forma net loss applicable to common shareholders
|
|
$ |
(1,486,781 |
) |
|
$ |
(4,727,911 |
) |
|
|
|
|
|
|
|
Basic and diluted loss per share, as reported
|
|
$ |
(0.01 |
) |
|
$ |
(0.05 |
) |
|
|
|
|
|
|
|
Basic and diluted loss per share, pro forma
|
|
$ |
(0.01 |
) |
|
$ |
(0.05 |
) |
|
|
|
|
|
|
|
|
|
|
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 annual periods beginning after
June 15, 2005, and will require the Company to record as an
expense all stock option grants issued to employees after
January 1, 2006.
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.
In May 2005, the FASB issued SFAS No. 154, Accounting
Changes and Error Corrections - a replacement of APB
Opinion No. 20 and FASB Statement No. 3. SFAS
No. 154 applies to all voluntary changes in accounting
principle or when an accounting pronouncement does not include
specific transition provisions and changes the requirements for
the accounting for and reporting of a change in accounting
principle. This statement requires retrospective application to
prior periods financial statements of changes in
accounting principle, unless it is impracticable to determine
either the period specific effects or the cumulative effect of
the change. The Company implemented this standard on
January 1, 2006 and will not have a material impact to the
company.
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
$1,486,781 during the year ended December 31, 2005 and has
incurred losses applicable to common shareholders since
inception of the development stage of $20,840,714. The Company
42
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Notes to Consolidated Financial
Statements (Continued)
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 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 PROPERTY AND EQUIPMENT
Property and equipment as of December 31, 2005 and 2004 are
detailed below:
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Equipment
|
|
$ |
168,468 |
|
|
$ |
79,318 |
|
Accumulated depreciation
|
|
|
(87,833 |
) |
|
|
(79,318 |
) |
|
|
|
|
|
|
|
|
|
$ |
80,635 |
|
|
$ |
|
|
|
|
|
|
|
|
|
Depreciation expense was $8,515 and $0 for the years ended
December 31, 2005 and 2004, respectively.
NOTE D 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,
2005:
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Federal income tax benefit at statutory rate (34%)
|
|
$ |
506,000 |
|
|
$ |
1,268,000 |
|
State income tax, net of federal benefit
|
|
|
89,000 |
|
|
|
224,000 |
|
Unrealized gain on financial instrument
|
|
|
920,000 |
|
|
|
|
|
Revaluation and expiration of options
|
|
|
|
|
|
|
(631,000 |
) |
Change in valuation allowance
|
|
|
(1,515,000 |
) |
|
|
(861,000 |
) |
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
The components of net deferred taxes are as follows at
December 31 using a combined deferred tax rate of 40%:
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Net operating loss carryforward
|
|
$ |
6,663,000 |
|
|
$ |
5,132,000 |
|
Research and development credits
|
|
|
80,000 |
|
|
|
80,000 |
|
Stock options
|
|
|
646,000 |
|
|
|
646,000 |
|
Accrued compensation
|
|
|
380,000 |
|
|
|
396,000 |
|
Valuation allowance
|
|
|
(7,769,000 |
) |
|
|
(6,254,000 |
) |
|
|
|
|
|
|
|
Net deferred tax asset
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
43
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Notes to Consolidated Financial
Statements (Continued)
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
$16,700,000 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 E NOTES PAYABLE
The Company has the following notes payable at December 31,
2005:
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Notes payable to shareholders, which are currently due and in
default. Interest is at 12%
|
|
$ |
56,000 |
|
|
$ |
336,717 |
|
On April 1, 2005, the Company negotiated a settlement
regarding notes payable totaling $280,717 and accrued interest
of $215,636, by payment of $300,000 in cash. The Company
recognized a gain on settlement of debt totaling $196,353.
NOTE F CONVERTIBLE NOTES PAYABLE
The Company has the following convertible notes payable at
December 31, 2005:
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Convertible notes payable to a trust, which is currently due and
in default. Interest is at 12%. Each $1,000 note is convertible
into 667 shares of Companys common stock
|
|
$ |
193,200 |
|
|
$ |
193,200 |
|
NOTE G STOCKHOLDERS EQUITY
During the year ended December 31, 2005, the Company issued
2,026,389 shares of restricted common stock, 104,167 of
which were issued to satisfy accrued liabilities valued at
$11,312 and 1,922,222 of which were issued for cash totaling
$346,000. In connection with the sales for cash, the Company
also issued warrants to purchase 1,922,222 shares of
restricted common stock at $0.18 per share, expiring
3 years from the date of issuance.
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.
During the year ended December 31, 2004, the Company
converted $487,503 of principal and $162,965 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.
44
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Notes to Consolidated Financial
Statements (Continued)
|
|
|
Preferred Stock and Warrants |
2005
During the year ended December 31, 2005, the Company issued
30,000 shares of Series A Convertible Preferred Stock
and warrants to purchase 22,877,478 shares of common
stock for a total offering price of $3.0 million. The
Company incurred $340,000 of offering costs and issued to the
placement agent warrants to purchase 1,220,132 shares
of common stock exercisable at $0.1967 per share which are
exercisable for a period 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 75% of the average of the three lowest
intra-day trading prices for the Companys common stock
during the 10 trading days immediately preceding the
conversion date. The conversion price may not exceed $0.1967.
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
22,877,478 shares of common stock of the Company at
$0.1967 per share. The warrants expire three years after
the date of issuance.
The Series A Convertible Preferred Stock has no voting
rights. In the event of liquidation, the holders are entitled to
a liquidating distribution of $100 per share. The Company
also entered into a Registration Rights Agreement with the
investors requiring the Company to use its best
efforts to timely 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. There are no significant liquidation
damages in the event the Company is unable to file its
registration statement.
The conversion feature of the Series A Convertible
Preferred Stock has more of the attributes of an equity
instrument than a liability instrument, and thus not considered
a derivative. However, the Company is unable to guarantee that
there will be enough shares of stock to settle other
freestanding instruments. Accordingly, the warrants
attached to the convertible preferred stock are measured at
their fair value and classified as liability in the financial
statements. The fair value of the warrants was $3,844,116 on the
date of issuance computed using the Black Scholes model with the
following assumptions: volatility of 170%, risk-free interest
rate of 3.9%, and an expected life of three years. The fair
value of the warrants exceeded the proceeds received by
$1,184,116, which was recorded as an expense on the statement of
operations. Due to the fact that the value of the warrants
exceeded the proceeds received, no value was assigned to the
preferred stock.
2004
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. 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
45
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Notes to Consolidated Financial
Statements (Continued)
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.
As noted above, all warrants and options outstanding on
March 11, 2005 (with the exception of stock options issued
to employees) were measured at their fair value and reclassified
as a liability in the financial statements. There were
16,215,100 warrants issued prior to March 11, 2005 had a
fair value of $2,435,713. The value of the warrants was computed
using the Black Scholes model with the following assumptions:
volatility of 170%, risk-free interest rate of 3.9%, and an
expected life of three years. As a result of the
reclassification, stockholders equity was decreased by the
fair value of the liability.
Subsequent to March 11, 2005, 611,110 warrants were issued
as part of common stock offerings of 611,110 shares. The
warrants have a fair value of $64,074 and are classified as a
liability on the financial statements. The value of the warrants
was computed using the Black Scholes model with the following
weighted assumptions: volatility of 165%, risk-free interest
rate of 3.8%, and an expected life of three years. The proceeds
received from this issuance exceeded the value of the warrants
by $45,926, which was attributed to the common stock.
The Company adjusted to market value the outstanding warrants as
of December 31, 2005. The fair value of the financial
instrument was $2,859,596. The Company used the Black-Scholes
model in calculating fair value with the following assumptions:
volatility of 152%, risk free interest rate of 4.41% and an
expected life of two years. The changes in fair market value
have been recorded as adjustments in the line Unrealized
gain on financial instrument in the statement of
operations for all periods presented.
|
|
|
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 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
46
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Notes to Consolidated Financial
Statements (Continued)
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.
NOTE H STOCK OPTIONS AND WARRANTS
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 did not grant any
options during 2005 and 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.
The following summarizes the option activity for the years ended
December 31, 2005 and 2004:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
|
|
|
Weighted- | |
|
|
|
Weighted- | |
|
|
|
|
Average | |
|
|
|
Average | |
|
|
Options | |
|
Exercise Price | |
|
Options | |
|
Exercise Price | |
|
|
| |
|
| |
|
| |
|
| |
Outstanding at beginning of year
|
|
|
19,483,000 |
|
|
$ |
0.04 |
|
|
|
18,783,000 |
|
|
$ |
0.04 |
|
Issued
|
|
|
|
|
|
|
|
|
|
|
700,000 |
|
|
|
0.05 |
|
Forfeited
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at end of year
|
|
|
19,483,000 |
|
|
|
0.04 |
|
|
|
19,483,000 |
|
|
|
0.04 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at end of year
|
|
|
19,483,000 |
|
|
$ |
0.04 |
|
|
|
19,483,000 |
|
|
$ |
0.04 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighed average fair value of options granted during the year
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
0.14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes information about fixed options
outstanding at December 31, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
7.6 |
|
|
$ |
0.02 |
|
|
|
16,000,000 |
|
|
$ |
0.02 |
|
$0.05
|
|
|
1,500,000 |
|
|
|
6.1 |
|
|
$ |
0.05 |
|
|
|
1,500,000 |
|
|
$ |
0.05 |
|
$0.15 to 0.50
|
|
|
1,983,000 |
|
|
|
6.1 |
|
|
$ |
0.02 |
|
|
|
1,983,000 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19,483,000 |
|
|
|
|
|
|
|
|
|
|
|
19,483,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
47
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Notes to Consolidated Financial
Statements (Continued)
Assumptions used to calculate the impact of stock options
granted as if the Company had adopted FAS 123 were as
follows:
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 | |
|
|
|
|
| |
Expected dividend yield
|
|
|
|
|
|
|
|
|
Risk free interest rate
|
|
|
|
|
|
|
3.8 |
% |
Expected volatility
|
|
|
|
|
|
|
220 |
% |
Expected life
|
|
|
|
|
|
|
7 years |
|
Weighted average fair value per share
|
|
$ |
|
|
|
$ |
0.10 |
|
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.
The following summarizes warrant activity for the years ended
December 31, 2005 and 2004:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
|
|
|
Weighted- | |
|
|
|
Weighted- | |
|
|
|
|
Average | |
|
|
|
Average | |
|
|
Warrants | |
|
Exercise Price | |
|
Warrants | |
|
Exercise Price | |
|
|
| |
|
| |
|
| |
|
| |
Outstanding at beginning of year
|
|
|
14,904,029 |
|
|
$ |
0.28 |
|
|
|
3,616,005 |
|
|
$ |
0.61 |
|
Issued
|
|
|
26,019,832 |
|
|
|
0.20 |
|
|
|
12,954,029 |
|
|
|
0.17 |
|
Expired
|
|
|
|
|
|
|
|
|
|
|
(1,666,005 |
) |
|
|
0.16 |
|
Exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at end of year
|
|
|
40,923,861 |
|
|
$ |
0.23 |
|
|
|
14,904,029 |
|
|
$ |
0.28 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes information about warrants
outstanding at December 31, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted | |
|
|
|
|
|
|
Average | |
|
|
|
|
|
|
Remaining | |
|
Weighted | |
|
|
|
|
Contractual | |
|
Average | |
|
|
Number | |
|
Life | |
|
Exercise | |
Range of Exercise Price |
|
Outstanding | |
|
(Years) | |
|
Price | |
|
|
| |
|
| |
|
| |
$0.09
|
|
|
2,356,700 |
|
|
|
1.5 |
|
|
$ |
0.09 |
|
$0.18 to 0.20
|
|
|
36,617,161 |
|
|
|
2.1 |
|
|
|
0.19 |
|
$1.00
|
|
|
1,950,000 |
|
|
|
1.0 |
|
|
|
1.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40,923,861 |
|
|
|
2.0 |
|
|
$ |
0.23 |
|
|
|
|
|
|
|
|
|
|
|
NOTE I RELATED PARTY TRANSACTIONS
At December 31, 2005 and 2004 the Company had accounts
payable to current and former officers and directors totaling
$1,550,898 and $1,491,586, respectively, for services performed
and costs incurred in behalf of the Company, including $877,636
and $902,636, respectively, payable to the Companys
President and CEO. Also at December 31, 2005 and 2004, the
Company had accounts payable to its controller of $73,000 and
$87,444, respectively.
48
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Notes to Consolidated Financial
Statements (Continued)
On July 15, 2005, the Company entered into an agreement to
grant a consultant a non-interest bearing loan in the amount of
500,000
(approximately $592,000 under current exchange rates) in
exchange for the transfer of certain patents in relation to
Savetherapeutics AG, and the performance of certain research
activities. The loan is payable as follows,
100,000 upon
closing, 150,000
after signature of consent to the transfer of patents, and
250,000 after
performance and acceptance of certain research activities. As of
December 31, 2005, the amount of the loan was
250,000 (approximately $296,000 under current exchange
rates). Settlement of the loan shall take place by offsetting
against profit claims, which accrue to the consultant from his
stake in the Company.
Subsequent to the transfer of the industrial property rights and
applications, the Company shall grant to the aforementioned
consultant a 6% stake in MDI Oncology, Inc. and assign to him 6%
of the shares. The Company deemed these shares to have no value
because it is a
start-up company, and
its success is contingent on several different factors. The
Company also entered into an employment contract with the
consultant for a period of 24 months. The consultant will
receive a fee of
120,000 per annum (approximately $142,000 using
current exchange rates.)
NOTE J OTHER SIGNIFICANT TRANSACTIONS
On March 16, 2005, 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-stage topical aromatase inhibitor treatment for
breast cancer. SaveCream never generated revenues for SaveT. The
Companys analysis as to whether the intellectual property
purchased constituted a business resulted in the conclusion that
no such business had been acquired.
The purchase price of the Assets was
2,350,000
(approximately $2.8 million under current exchange rates),
payable as follows:
500,000 at
closing, 500,000
(approximately $665,700 on the date of transaction, $592,000
using the December 31, 2005 exchange rates) upon conclusion
of certain pending transfers of patent and patent application
rights from SaveTs inventors to the Company, and the
remaining
1,350,000 (approximately $1.6 million at current
exchange rates) upon successful commercialization of the Assets.
The Companys source of funds for the acquisition was a
$3 million investment in the Companys Series A
Preferred Stock by an unrelated third party, as described in
Note G.
SaveT inventors have yet to assign the patent and application
rights to the Company, management has deemed the assignment of
the rights to be reasonably likely because the inventors are
contractually bound to execute and deliver the assignments;
therefore, the Company has recorded the second
500,000 payment
as a current liability in these financial statements. At present
it is undeterminable whether the intellectual property will ever
be commercialized; therefore, the final
1,350,000 under this acquisition has not been accrued as
a liability as of December 31, 2005. The Company determined
the intellectual property purchased should be expensed as
research and development costs
|
|
|
Formation of MDI Oncology, Inc. |
On March 22, 2005, the Company formed MDI Oncology, Inc., a
Delaware Corporation, as a wholly-owned subsidiary for the
purpose of acquiring and operating the assets and associated
business ventures associated with the SaveCream purchase.
49
MEDICAL DISCOVERIES, INC. AND SUBSIDIARIES
(A Development Stage Company)
Notes to Consolidated Financial
Statements (Continued)
NOTE K - SUBSEQUENT EVENTS
|
|
|
Exercise of Series A Convertible Preferred
Stock |
During the first quarter of 2006, Monarch Pointe Fund, Ltd.
converted 200 shares of Series A Convertible Preferred
Stock into 242,424 shares of common stock.
During the first quarter of 2006, the Company re-granted a stock
option to a former insider that had expired. The option is for
500,000 shares exercisable at $0.25 per share through
December 31, 2012. Because the prior option had expired
prior to the re-grant, the Company has treated this as a new
option grant. The Company will record the fair value of the
option grant as part of operations during the first quarter of
2006.
50
|
|
ITEM 8. |
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON
ACCOUNTING AND FINANCIAL DISCLOSURE. |
None.
ITEM 8A. CONTROLS AND
PROCEDURES.
Evaluation of Disclosure Controls and Procedures. Under
the supervision and with the participation of our management,
including our principal executive officer and principal
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), as of December 31,
2005. Based on this evaluation, our principal executive officer
and principal financial officer concluded that our disclosure
controls and procedures were effective as of December 31,
2005.
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 paragraph (a) above.
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. (filed as
Exhibit 2.1 to the Companys Annual Report on
Form 10-KSB for the fiscal year ended December 31,
2004, and incorporated herein by reference). |
|
|
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). |
51
|
|
|
|
|
Number |
|
Exhibit |
|
|
|
|
|
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. (filed as Exhibit 4.1 to the
Companys Annual Report on Form 10-KSB for the fiscal
year ended December 31, 2004, and incorporated herein by
reference). |
|
|
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.
(filed as Exhibit 4.2 to the Companys Annual Report
on Form 10-KSB for the fiscal year ended December 31,
2004, and incorporated herein by reference). |
|
|
4.3 |
|
|
Certificate of Designations of Preferences and Rights of
Series A Convertible Preferred Stock of Medical
Discoveries, Inc. (filed as Exhibit 4.1 to Registration
Statement No. 333-121635 filed on Form SB-2 on
December 23, 2004, and incorporated herein by reference). |
|
|
4.4 |
|
|
Amendment to Certificate of Designations of Preferences and
Rights of Series A Convertible Preferred Stock of Medical
Discoveries, Inc. (filed as Exhibit 4.2 to Registration
Statement No. 333-121635 filed on Form SB-2 on
December 23, 2004, and incorporated herein by reference). |
|
|
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). |
|
|
10.2 |
|
|
Subscription Agreement dated October 18, 2004 among Monarch
Pointe Fund, Ltd., Mercator Advisory Group, LLC, and Medical
Discoveries, Inc. (filed as Exhibit 10.2 to Amendment
No. 2 to Registration Statement No. 333-121635 filed
on Form SB-2 on June 2, 2005, and incorporated herein
by reference). |
|
|
10.3 |
|
|
Subscription Agreement dated December 3, 2004 among
Mercator Momentum Fund, LP, Mercator Momentum Fund III, LP,
Mercator Advisory Group, LLC, and Medical Discoveries, Inc.
(filed as Exhibit 10.3 to Amendment No. 2 to
Registration Statement No. 333-121635 filed on
Form SB-2 on June 2, 2005, and incorporated herein by
reference). |
|
|
10.4 |
|
|
Employment Agreement dated as of March 1, 2005 between
Medical Discoveries, Inc. and Judy M. Robinett (filed as
Exhibit 10.4 to Amendment No. 3 to Registration
Statement No. 333-121635 filed on Form SB-2 on
October 13, 2005, and incorporated herein by reference). |
|
|
21 |
|
|
Subsidiaries.* |
|
|
31.1 |
|
|
Rule 13a-14(a) Certification, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.* |
|
|
31.2 |
|
|
Rule 13a-14(a) Certification, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.* |
|
|
32.1 |
|
|
Certification pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002.* |
|
|
32.2 |
|
|
Certification pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002.* |
|
|
ITEM 14. |
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.
52
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, 2006
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 Officer) |
|
March 31, 2006 |
|
/s/ Deirdra J. Burgess
Deirdra J. Burgess |
|
Controller (Principal Financial Officer) |
|
March 31, 2006 |
|
/s/ David R. Walker
David R. Walker |
|
Chairman of the Board of Directors |
|
March 31, 2006 |
|
/s/ Larry Anderson
Larry Anderson |
|
Director |
|
March 31, 2006 |
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.
53
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. (filed as
Exhibit 2.1 to the Companys Annual Report on
Form 10-KSB for the fiscal year ended December 31,
2004, and incorporated herein by reference). |
|
|
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. (filed as Exhibit 4.1 to the
Companys Annual Report on Form 10-KSB for the fiscal
year ended December 31, 2004, and incorporated herein by
reference). |
|
|
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.
(filed as Exhibit 4.2 to the Companys Annual Report
on Form 10-KSB for the fiscal year ended December 31,
2004, and incorporated herein by reference). |
|
|
4 |
.3 |
|
Certificate of Designations of Preferences and Rights of
Series A Convertible Preferred Stock of Medical
Discoveries, Inc. (filed as Exhibit 4.1 to Registration
Statement No. 333-121635 filed on Form SB-2 on
December 23, 2004, and incorporated herein by reference). |
|
|
4 |
.4 |
|
Amendment to Certificate of Designations of Preferences and
Rights of Series A Convertible Preferred Stock of Medical
Discoveries, Inc. (filed as Exhibit 4.2 to Registration
Statement No. 333-121635 filed on Form SB-2 on
December 23, 2004, and incorporated herein by reference). |
|
|
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). |
|
|
10 |
.2 |
|
Subscription Agreement dated October 18, 2004 among Monarch
Pointe Fund, Ltd., Mercator Advisory Group, LLC, and Medical
Discoveries, Inc. (filed as Exhibit 10.2 to Amendment
No. 2 to Registration Statement No. 333-121635 filed
on Form SB-2 on June 2, 2005, and incorporated herein
by reference). |
|
|
10 |
.3 |
|
Subscription Agreement dated December 3, 2004 among
Mercator Momentum Fund, LP, Mercator Momentum Fund III, LP,
Mercator Advisory Group, LLC, and Medical Discoveries, Inc.
(filed as Exhibit 10.3 to Amendment No. 2 to
Registration Statement No. 333-121635 filed on
Form SB-2 on June 2, 2005, and incorporated herein by
reference). |
|
|
10 |
.4 |
|
Employment Agreement dated as of March 1, 2005 between
Medical Discoveries, Inc. and Judy M. Robinett (filed as
Exhibit 10.4 to Amendment No. 3 to Registration
Statement No. 333-121635 filed on Form SB-2 on
October 13, 2005, and incorporated herein by reference). |
|
21 |
|
|
Subsidiaries.* |
|
31 |
.1 |
|
Rule 13a-14(a) Certification, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.* |
|
31 |
.2 |
|
Rule 13a-14(a) Certification, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.* |
|
32 |
.1 |
|
Certification pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002.* |
|
32 |
.2 |
|
Certification pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002.* |
54