Form 10-QSB GenoMed, Inc.
U.S. SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-QSB
[X] QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the quarterly period ended March 31, 2004
[ ] TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT
Commission File Number: 000-49720
GenoMed, Inc.
(Exact name of Small Business Issuer as specified in its Charter)
Florida
(State or other jurisdiction of incorporation or organization)
43-1916702
(I.R.S. Employer Identification No.)
909 South Taylor Avenue, St. Louis, Missouri 63110
(Address of principal executive offices) (Zip Code)
(314) 652-0500
(Issuer's telephone number)
Check mark whether the Issuer (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the past 12
months (or for such shorter period that the registrant was required to file such
reports), and (2) has been subject to such filing requirements for the past 90
days. Yes [X] No [ ]
APPLICABLE ONLY TO CORPORATE ISSUERS
As of March 31, 2004, we had 187,716,591 shares of our Common Stock outstanding.
INDEX
PART 1. CONSOLIDATED FINANCIAL INFORMATION
Item 1. Consolidated Financial Statements............................... 3-7
Item 2. Management's Discussion and Analysis and Plan of operation...... 8-14
Item 3. Controls and Procedures......................................... 14
PART II. OTHER INFORMATION
Item 1. Legal Proceedings............................................... 15
Item 2. Changes in Securities and Use of Proceeds....................... 15
Item 3. Default Upon Senior Securities.................................. 16
Item 4. Submission of Matters to a Vote of Securities................... 16
Item 5. Other Information............................................... 16
Item 6. Exhibits and Reports on Form 8-K................................ 17
PART 1.
Item 1. Consolidated Financial Information
GenoMed, Inc.
(A Development Stage Company)
Consolidated Balance Sheet
March 31, 2004
(Unaudited)
Assets
Current assets:
Cash $ 1,473,796
-------------
Property and equipment, net 130,278
-------------
$ 1,604,074
=============
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 16,056
Due to shareholders 190,868
-------------
Total current liabilities 206,924
-------------
Stockholders' equity:
Common stock, $.001 par value,
1,000,000,000 shares authorized,
187,716,591 shares issued and outstanding 187,717
Additional paid in capital 10,248,313
Subscribed common shares 34,749
(Deficit) accumulated during the development stage (9,073,629)
-------------
1,397,150
-------------
$ 1,604,074
=============
See the accompanying notes to the consolidated financial statements.
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GenoMed, Inc.
(A Development Stage Company)
Consolidated Statements of Operations
Three Months Ended March 31, 2004 and 2003, and
the Period From Inception (January 3, 2001) to March 31, 2004
(Unaudited)
Three Months Three Months
Ended Ended Inception to
March 31, March 31, March 31,
2004 2003 2004
--------------- -------------- -------------
Revenue $ 669 $ 1,000 $ 7,079
--------------- -------------- -------------
Operating expenses:
Research and development - - 333,264
Selling, general and administrative expenses 5,677,116 69,921 8,587,627
--------------- -------------- -------------
5,677,116 69,921 8,920,891
--------------- -------------- -------------
(Loss) from operations (5,676,447) (68,921) (8,913,812)
Other (income) and expenses:
Interest income (248) - (248)
Impairment of web site - - 6,939
Interest expense - 20,000 153,126
---------------- --------------- -------------
(248) 20,000 159,817
--------------- -------------- -------------
Net (loss) $ (5,676,199) $ (88,921) $ (9,073,629)
=============== ============== =============
Per share information - basic and fully diluted:
Weighted average shares outstanding 163,608,201 121,079,231 242,944,833
=============== ============== =============
Net (loss) per share $ (0.03) $ (0.00) $ (0.04)
=============== ============== =============
See the accompanying notes to the consolidated financial statements.
-4-
GenoMed, Inc.
(A Development Stage Company)
Consolidated Statements of Cash Flows
Three Months Ended March 31, 2004 and 2003, and
the Period From Inception (January 3, 2001) to March 31, 2004
(Unaudited)
Three Months Three Months
Ended Ended Inception to
March 31, March 31, March 31,
2004 2003 2004
------------- ------------- -------------
Cash flows from operating activities:
Net cash (used in) operating activities $ (161,335) $ (12,159) $ (1,042,612)
------------- ------------- -------------
Cash flows from investing activities:
Net cash (used in) investing activities - - (210,254)
------------- ------------- -------------
Cash flows from financing activities:
Net cash provided by financing activities 1,623,662 1,500 2,726,662
------------- ------------- -------------
Net increase (decrease) in cash 1,462,327 (10,659) 1,473,796
Beginning - cash balance 11,469 13,031 -
------------- ------------- -------------
Ending - cash balance $ 1,473,796 $ 2,372 $ 1,473,796
============= ============= =============
See the accompanying notes to the consolidated financial statements.
-5-
GenoMed, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements
March 31, 2004
(Unaudited)
(1) Basis Of Presentation
The accompanying unaudited consolidated financial statements have been prepared
in accordance with accounting principles generally accepted in the United States
of America ("GAAP") for interim financial information. They do not include all
of the information and footnotes required by GAAP for complete financial
statements. In the opinion of management, all adjustments (consisting only of
normal recurring adjustments) considered necessary for a fair presentation have
been included. The results of operations for the periods presented are not
necessarily indicative of the results to be expected for the full year. For
further information, refer to the financial statements of the Company as of
December 31, 2003 the years ended December 31, 2003 and 2002 and the period from
inception (January 3, 2001) to December 31, 2003 including notes thereto
included in Form 10-KSB.
(2) Earnings Per Share
The Company calculates net income (loss) per share as required by SFAS No. 128,
"Earnings per Share." Basic earnings (loss) per share is calculated by dividing
net income (loss) by the weighted average number of common shares outstanding
for the period. Diluted earnings (loss) per share is calculated by dividing net
income (loss) by the weighted average number of common shares and dilutive
common stock equivalents outstanding. During the periods presented common stock
equivalents were not considered as their effect would be anti-dilutive.
(3) Note Payable - Affiliate
At December 31, 2003 the Company had outstanding notes aggregating $1,000,000,
which has been advanced to the Company by an affiliated entity by virtue of
stock ownership in the Company. The note bears interest at 8% per annum and is
due on January 1, 2005. The note may be converted into common shares of the
Company as follows:
a. The unpaid principal in whole or in part together with accrued
interest shall at the option of the holder be converted into the class
of the Company's shares on the same terms and conditions applicable to
any investors in a financing agreement. The holder may elect to
negotiate separate terms and conditions however the unpaid balance
will not be payable in cash, but convertible only into shares of the
Company. For the purposes of this calculation the aggregate value of
the Company's shares received by the holder in conversion shall be
determined by subtracting $1,000,000 from the unpaid original
principal balance of the note, which remains unpaid at the time of
conversion. A financing agreement is defined as the receipt by the
Company of a least $1,500,000 of net cash proceeds from the sale of
capital stock.
b. The unpaid principal in whole or in part together with accrued
interest shall be converted into shares if the Company realizes
revenue of $1,500,000 during the period commencing April 9, 2003 and
ending on December 31, 2004. The price per share shall be determined
as provided in c below. The unpaid balance will not be payable in cash
but convertible only into shares of the Company. For the purposes of
this calculation the aggregate value of the Company's shares received
by the holder in conversion shall be determined by subtracting
$1,000,000 from the unpaid original principal balance of the note,
which remains unpaid at the time of conversion.
c. If no financing agreement has occurred by December 31, 2004 and/or the
Company has not realized the requirements of a and b above the holder
may elect to convert the unpaid principal balance and accrued interest
into the number of common shares of the Company determined by dividing
the unpaid balance by the average bid price of the Company's common
stock for the previous 30 trading days. The unpaid balance will not be
payable in cash but convertible only into shares of the Company.
During March 2004 the holder contributed the $1,000,000 principal balance of the
note to the capital of the Company and converted the unpaid interest into the
Company's common shares (see Note 4).
-6-
(4) Stockholders' Equity
During the period ended March 2004 the Company charged $11,250 to operations
pursuant to its agreement to issue 300,000 shares of common stock on December
31, 2004 in accordance with the terms of advisory board contracts. As of March
31, 2004, 75,000 shares had been earned and had not been issued. The shares have
been valued at the trading price of $.15 of the Company's common stock on March
31, 2004, the measurement date. The above amount has been included as subscribed
common shares. Through March 31, 2004 an aggregate of 675,000 shares with a
value of $26,249 have been earned pursuant to the advisory board contracts.
During March 2002 the Company granted an officer options to purchase 37,500,000
shares of common stock at an exercise price of 20% of the fair market value of
the common stock on the exercise date. The options may be exercised after May 6,
2002 for a period of 10 years as to 12,500,000 options and after November 6,
2002 for a period of 10 years as to 25,000,000 options. The change in the
discount from the fair market value of the common stock related to the options
will be charged to operations as general and administrative expenses during the
period of the grant date to the exercise date. During the three months ended
March 31, 2004, $3,300,000 was charged to operations related to the these
options.
During the period ended March 31, 2004 the Company issued an aggregate of
10,716,327 shares of common stock to the affiliate which held the note described
in Note 3 for cash aggregating $480,000. In addition, the Company issued
12,737,995 shares of common stock to this affiliate related to the conversion of
$333,738 in debt. The discount on these shares of $2,222,757 has been charged to
operations during the period. In addition, this affiliate forgave the balance of
$1,000,000 due on the note payable described in Note 3 which has been recorded
as a contribution to capital.
During the period ended March 31, 2004 the Company issued 33,464,230 shares of
common stock to Advanced Optics Electronics for $900,000 in cash. These shares
were sold at a discount from the trading price of the Company's common stock.
During the period ended March 31, 2004 the Company issued 4,337,783 shares of
common stock to Pierpoint Investments and its affiliates for $195,200 in cash.
These shares were sold at a discount from the trading price of the Company's
common stock.
During the period ended March 31, 2004 a former board member exercised 769,231
options and received 769,231 common shares for cash of $38,462.
(5) Subsequent Events
Through May 11, 2004 the Company issued 2,460,002 shares of common stock for
cash aggregating $109,950, 10,000 shares of common stock for services and
1,000,000 shares of common stock which were subscribed for at March 31, 2004.
-7-
Item 2. Management's Discussion and Analysis of Financial Condition and Plan of
Operations
Forward-Looking Statements.
The following discussion and analysis contains forward looking statements and
should be read in conjunction with our financial statements and related notes.
For purposes of this plan of operations, GenoMed, Inc. is referred to herein as
"we," "us," or "our." This discussion and analysis contains forward-looking
statements based on our current expectations, assumptions, estimates and
projections overview. The words or phrases "believe," "expect," "may," "should,"
"anticipates" or similar expressions are intended to identify "forward-looking
statements". Actual results could differ materially from those projected in the
forward-looking statements as a result of the following risks and uncertainties,
which are more fully discussed in our periodic filings which are available for
review at www.sec.gov: (a) during 2003, our Plan of Operations was
substantially delayed due to lack of financing; (b) if we are not awarded
patents or licenses, we will never market potential products and our potential
revenues will be negatively affected; (c) our business may be adversely affected
by regulatory costs which would negatively affect our potential profitability;
(d) because our genomics method of gene identification is a relatively new gene
identification method, the public or prospective strategic partners may not
accept it as an acceptable gene identification method, which would negatively
affect our operations and potential revenues; (e) our competitors may develop
and respond to gene procedures and products before us due to their superior
financial and technical resources and superior technologies; (f) we may be
subject to medical or product liability claims that will negatively affect our
potential profitability and may lead to losses; (g) because we will lack control
over the outsourcing of sample collection, genotyping and data analysis, our
quality control and brand name reputation may be negatively affected; (h) if we
fail to recruit test patients for our clinical trials, our development of
potential products will be delayed which would negatively affect our potential
revenues; (i) if our strategic partners fail to obtain Federal Drug
Administration approval, our costs may increase and our revenues may decrease;
(j) our business plan is dependent upon forming strategic alliances or
acquisitions or partnership alliances with others for which there are no
assurances, and if we fail to do so we will never generate any revenues; (k) if
we fail to abide by the terms of our acquisition agreement in which we acquired
Genomic Medicine, LLC, the acquisition could be rescinded and we would have no
business or ability to generate revenues; (l) if we fail to conduct adequate due
diligence regarding our strategic alliances or acquisitions and partnership
alliances, we will be subject to increased costs and operational difficulties;
(m) our management decisions are made by our President/Chief Executive
Officer/Chairman of the Board/ Chief Medical Officer, Dr. David Moskowitz and if
we lose his services, our operations will be negatively impacted; (n) we have
issued a substantial amount of our common stock in connection with funding that
we obtained, which substantially dilutes the value of your shares; and (o) we
have a substantial amount of options outstanding, which if exercised, will
result in the issuance of shares of our common stock, which will substantially
dilute the value of your shares.
PLAN OF OPERATIONS:
We plan on funding the following estimated expenses totaling $1,403,907 over the
next year from the funding that we have received from Advanced Optics and
Pierpoint Investments, and from revenues, if any, that we generate.
Annual
Type Expenditures Estimated Amount
------------------- ------------------
Salaries $ 328,907*
------------------- ------------------
Operating Expenses** $ 125,000
------------------- ------------------
Genotyping $ 800,000
------------------- ------------------
Sample
Collection $ 100,000
------------------- ------------------
Marketing $ 50,000
------------------- ------------------
Total $ 1,403,907
==================
*Salaries include: (a) $183,907 for our Chief Executive Officer, David
Moskowitz, which represents a base salary of $135,000 plus deferred salary of
$146,720 from the period November 1, 2002 through December 31, 2003, of which
one-third or $48,907 is to be paid in cash in 2004, one-third or $48,907 is to
be paid in cash in 2005, and the balance of $48,907 is to be paid in shares of
our common stock priced at a 25% discount from the average closing price of the
period of salary deferral November 1, 2002 through December 31, 2003; and (b)
$60,000 annual salary and $15,000 of benefits for a Chief Financial Officer; and
(c) $60,000 annual salary and $10,000 of benefits for a Chief Technical Officer.
** Operating Expenses include office rent, utilities, and legal and accounting
expenses.
-8-
We intend to satisfy these estimated total expenditures of $1,403,907 for our
Plan of Operations through our cash as of June 1, 2004 of $1,485,800 and
revenues or a private placement of our equity Securities.
If we have additional expenses that exceed our estimates and we have
insufficient funds at the time or we are unable to obtain sufficient financing,
then we will be unable to conduct our Plan of Operations, which may negatively
impact development of our brand name and reputation. In the event that we do not
obtain adequate financing we may have to liquidate our business and undertake
any or all of the following actions:
o Sell or dispose of our assets, if any;
o Pay our liabilities in order of priority, if we have available cash to
pay such liabilities;
o If any cash remains after we satisfy amounts due to our creditors,
distribute any remaining cash to our shareholders in an amount equal
to the net market value of our net assets;
o File a Certificate of Dissolution with the State of Florida to
dissolve our corporation and close our business;
o Make the appropriate filings with the Securities and Exchange
Commission so that we will no longer be required to file periodic and
other required reports with the Securities and Exchange Commission,
if, in fact, we are a reporting company at that time; and
o Make the appropriate filings with the National Association of Security
Dealers to affect a delisting of our common stock, if, in fact, our
common stock is trading on the OTC Bulletin Board at that time.
Based upon our current assets, however, we will not have the ability to
distribute any cash to our shareholders. If we have any liabilities that we are
unable to satisfy and we qualify for protection under the U.S. Bankruptcy Code,
we may voluntarily file for reorganization under Chapter 11 or liquidation under
Chapter 7. Our creditors may also file a Chapter 7 or Chapter 11 bankruptcy
action against us. If our creditors or we file for Chapter 7 or Chapter 11
bankruptcy, our creditors will take priority over our shareholders. If we fail
to file for bankruptcy under Chapter 7 or Chapter 11 and we have creditors, such
creditors may institute proceedings against us seeking forfeiture of our assets,
if any.
We do not know and cannot determine which, if any, of these actions we will be
forced to take.
If any of these foregoing events occur, you could lose your entire investment in
our shares.
OUR PLAN OF OPERATIONS TO DATE
To date, we have accomplished the following in our Plan of Operations:
November 2001
Dr. David Moskowitz became our Chairman of the Board and Chief Medical Officer.
Jerry E. White became our President, Chief Executive Officer, and a Director.
Jerry White resigned on October 21, 2002, and our Board of Directors appointed
Dr. David Moskowitz as our President and Chief Executive Officer as of October
22, 2002 to fill the vacancies created by Jerry White's resignation.
Dr. Scott Williams became the first member of our Scientific Advisory Board.
Filed Provisional Patent Application: "Modifications of Serum Potassium
Concentration in Patients for Whom ACE Inhibition is Indicated." Patent
application number pending. This patent concerns patients with chronic kidney
disease that cannot tolerate ACE inhibitors because their serum potassium
concentration is already high. ACE inhibitors make this problem worse. ACE
inhibitors block the action of the ACE enzyme, and as a class have been used as
anti-hypertensive drugs since the late 1970s. This provisional patent
application describes the use of a second medication to control serum potassium,
allowing the use of ACE inhibitors in such patients.
-9-
Filed Provisional Patent Application: "Clinical Trials Illustrating New Uses for
an Existing ACE Inhibitor." Patent application number 60/347,013. This
provisional patent application describes how to test ACE inhibitors for new
disease indications.
Re-filed Provisional Patent Application: "Promoter SNPs." Patent application
number pending. This provisional patent application specifies nearly 12,000 SNPs
culled from the regulatory region of some 5,000 genes. The specific region of
the gene involved is the promoter, which sits upstream of the coding portion of
the gene.
December 2001
Dr. Tony Frudakis joins our Scientific Advisory Board. Filed Provisional Patent
Application: "New Formulation of an Existing ACE Inhibitor." Patent Application
Number 60/350,563. This provisional patent application outlines the
reformulation of a particular ACE inhibitor at the higher doses required for
minimal clinical effectiveness.
Letter of Intent with DNAPrint Genomics, Inc. and Orchid BioSciences, Inc. to
perform 400,000 SNP-genotypes at $0.40 per genotype.
Approval obtained from American Diabetes Association to utilize its bank of DNA
samples from patients with Type 2 Diabetes.
Disease Management Consultants Vince Kuraitis and Alan Kaul engaged to develop a
marketing plan to form relationships with disease management firms and health
care plans to commercialize our clinical research findings.
Second contract for Regulatory SNPs signed with Sequence Sciences, LLC to find
more regulatory SNPs.
Filed tenth Provisional Patent Application involving a method to delay or
prevent altogether most common serious diseases. Patent application number
pending.
Added Peter C. Brooks and Richard A. Kranitz as members of our Board of
Directors.
January 2002
Dr. Jason Moore joins our Scientific Advisory Board.
HealthChip trademark filed with United States Patent and Trademark Office.
Purchased one SNP Stream UHT (Ultrahigh Throughput) SNP Genotyping system from
Orchid BioSciences, Inc. that will enable us to perform as many as 100,000
genotypes a day. Beta Test Agreement with Orchid BioSciences, Inc. completed for
the SNP stream UHT system, which will permit us to operate this equipment
through a joint venture with DNA Print, Inc. in Sarasota, Florida. The Beta Test
Agreement involves the following: In return for providing Orchid BioSciences
with information regarding their systems genotyping accuracy, the agreement
allows GenoMed to perform the first 50,000 genotypes at no charge.
February 2002
Orchid BioSciences, Inc. installed our UHT SNP-stream genotyping system at
DNAPrint Genomics, Inc., a company with one year's experience using the Orchid
genotyping platform.
Personnel with DNAPrint Genomics began training on SNP stream-UHT system
equipment. DNAPrint Genomics personnel have been trained by Orchid BioSciences
to operate the new system. In return for hosting the machine, we are allowing
DNAPrint Genomics to use our UHT SNP-stream machine for DNAPrint's genotyping
needs during times when the machine would otherwise be idle.
Our first board meeting was held in Sarasota, Florida. Board members also
visited DNAPrint Genomics to see the UHT SNP-stream technology in operation.
-10-
March 2002 - August 2002
Data analysis and manuscript preparation
We conducted data analysis in conjunction with our preparation of the following
publications:
From Pharmacogenomics to Improved Patient Outcomes: Angiotensin
I-Converting Enzyme as an Example
Is Angiotensin I-Converting Enzyme a "Master" Disease Gene?
Is "Somatic" Angiotensin I-Converting Enzyme a Mechanosensor?
September 2002
In September 2002, we published an article in Diabetes Technology; Therapeutics,
demonstrating our efforts to prevent end-stage kidney disease in diabetes and
hypertension. We also published case reports showing better outcomes than with
conventional treatment for emphysema and peripheral vascular disease or poor
circulation.
October 2002
We published an article in Diabetes Technology and Therapeutics describing how
our patent-pending treatment regarding inhibition of angiotensin II production
and/or activity might benefit a total of some 160 common diseases associated
with aging, such as all cardiovascular diseases, all common cancers, except
prostate, several psychiatric diseases, autoimmune diseases, and viral diseases,
including infection with HIV and progression to AIDS.
December 2002
We published an article in Diabetes Technology and Therapeutics describing the
molecular mechanism for aging.
January 2003
We began to seek elderly volunteers in nursing homes to test ACE inhibitors, in
addition to their current medications, for the purpose of delaying progression
of age-related diseases.
We began to seek collaborators in a trial to treat acute kidney failure with an
intravenous drug, rather than with the kidney machine. The trial would be for
patients with new, sudden loss of kidney function, not for chronic dialysis
patients.
We began to seek collaborators in Neonatal Intensive Care Units to test a new
treatment for lung immaturity in newborns. Lung immaturity is common in babies
more than a month premature.
We began to seek volunteers with glaucoma to test a new medication in addition
to their current medications.
February 2003
We signed a Letter of Intent to collaborate with Dr. Huseyin Abali of Turkey to
use ACE inhibitors to help treat cancer. We plan to collaborate with Dr. Abali
using our ACE inhibitor treatment in lung cancer, colorectal cancer, mesenchymal
tumors, and lymphomas.
March 2003
Alopecia areata, an autoimmune disease, responded dramatically in a patient with
active disease to our patent pending treatment approach of inhibiting
angiotensin II.
-11-
April 2003
We announced a novel anti-viral therapy that may decrease mortality in the SARS
epidemic and that we were seeking patient and physician collaborators to
collaborate in a world-wide trial of the efficacy of this therapy. On April 25,
2003, we filed a patent application for the use of "sartans" for SARS. A
"sartan" is a drug that specifically inhibits the angiotensin II type 1
receptor. It appears that angiotensin II operates through the AT1 receptor to
activate lymphocytes and macrophages, but that type 2 angiotensin II receptor
promotes death of these cells and thus, an AT1 receptor blocker might be ideal
for selectively turning off an overly exuberant host immune response.
On April 30, 2003, our Chief Executive Officer, Dr. David Moskowitz, presented
our patient outcomes data to help stop the epidemic of end-stage kidney disease
to Blue Cross/Blue Shield of Tennessee.
May 2003
We announced the granting of a license of our aminophylline treatment to Dr.
Mehmet Sukru Sever. Aminophylline is an existing, generic drug that we have used
to restore kidney function and avoid dialysis in the setting of acute kidney
failure. Dr. Sever coordinated kidney dialysis for survivors of the earthquake
in Bingol in Eastern Turkey.
June 2003
We announced that we were launching a clinical trial against age-related macular
degeneration using drugs to inhibit angiotensin II, as well as other causes of
blindness, such as retinitis pigmentosa.
We reported that over 300 patients had expressed interest in our clinical
trials, but that less than a dozen patients with diabetes or high blood pressure
had signed up to use our treatment to prevent kidney dialysis and other
complications of diabetes and high blood pressure.
We announced a clinical trial using inhibitors of angiotensin II against all
neurodegenerative diseases, including common ones such as Alzheimer's disease,
Parkinson's disease, and rare ones like amyotrophic lateral sclerosis, which is
known as "Lou Gehrig's disease", and spinal muscular atrophy.
July 2003
Our Chief Executive Officer, Dr. David Moskowitz, was invited to speak at the
Nucleic Acid World Summit to be held in Boston, Massachusetts from September
15-17, 2003. The conference's subject is "Transforming Cutting-Edge Science into
Business" and will focus on uses of RNA and DNA to understand and treat
diseases, including viral scourges such as SARS, HIV, and West Nile virus. Dr.
Moskowitz's speech is entitled "Improving the Odds of Therapeutic Efficacy:
Blocking Angiotensin II." The conference is hosted by the Strategic Research
Institute.
We announced that we were still seeking volunteers for our treatment to avoid
complications of West Nile virus based on our belief that inhibiting angiotensin
II would decrease signaling by T cells and macrophage/monocyte/microglial cells,
which should in turn decrease the number of encephalitis cases due to West Nile
virus.
August 2003
We acquired 10,000 more promoter SNPs for our Disease GeneNet(tm) from Sequence
Sciences, LLC. This brought the number of promoter SNPs to 23,000 that we have
to interrogate each disease.
We proposed our patent-pending approach, namely inhibiting angiotensin II, as a
possible treatment to halt any further troop deaths due to pneumonia cases which
appear to be an unusually intense allergic reaction to the anthrax vaccine.
Our Chief Executive Officer, Dr. David Moskowitz was invited to speak at an
anti-aging conference sponsored by the American Academy of Anti-Aging Medicine
to be held December 11-14, 2003. It is anticipated that over 4,000 scientists
and physicians interested in anti-aging medicine will attend the conference. Dr.
Moskowitz will discuss our clinical findings that ACE inhibitors and angiotensin
II receptor blockers may be effective against almost all age-related diseases.
-12-
Our Chief Executive Officer, Dr. David Moskowitz, was asked to serve as the
Chairperson and speak at the Cancer Drug Research and Development Conference in
San Diego, California on November 20-21, 2003. Dr. Moskowitz will speak on the
topic, "Is Angiotensin II Behind Most Cancers (Except Prostrate)?"
October 2003
We announced that we have partnered with PhenoMed, a development stage disease
management and medical pharmaceutical company based in Kuala Lumpur, Malaysia,
to expand GenoMed's Next Generation Disease Management(tm) services into Asia.
January 2004
We launched a free clinical trial available to anybody with the common cold. We
have accumulated clinical evidence that blocking the major product of ACE, which
is a small eight amino acid hormone named angitensin II, can decrease
inflammation in a number of diseases, including viral disease.
We entered into a stock sale agreement with Advanced Optics Electronics, in
which Advanced Optics agreed to purchase a total of $900,000 of our shares of
common stock at a discount of 25% from the average closing bid price of our
common stock for the month of December 2003. In accordance with the agreement
terms, we issued 33,464,230 of our common stock to Advanced Optics during the
period from January 2004 to March 2004.
During January 2004 and March 2004, Research Capital purchased an aggregate of
10,716,327 shares of our common stock for cash totaling $480,000 and also
forgave $1,000,000 of the note payable discussed in Note 4 to our 2003 year end
financial statements. In addition, $153,081 in accrued interest and $180,657 in
other advances were converted into 12,737,995 shares of our common stock.
February 2004
We announced we launched a web-based course on genomics for practicing
physicians. This course is aimed at 650,000 physicians who require continuing
medical education credits to keep their medical license active. The course is
worth 50 hours of such credit.
We announced that our treatment approach to viruses, which tones down the host's
immune response rather than trying to kill the virus, should be effective
against the bird flu.
March 2004
We joined the Leadership Circle of St. Louis Regional Commerce and Growth
Association, which serves as the Chamber of Commerce and Economic Development
Organization for the 12-county, bi-state region.
We executed an agreement with Pierpoint Investissements SA, a Swiss-based
venture capital group that is registered in the British Virgin Islands, which
provides for minimum funding of $500,000 and a maximum of $2,000,000 annually
for up to 10 years.
The United States Patent and Trademark Office awarded us two the following two
trademarks for use in our marketing: (a) "Next Generation Disease Management";
and (b) "Clinical Outcomes Improvement Program."
May 2004
Chief Financial Officer
In May 2004, we hired Ms. Robyn L. Owens as our Chief Financial Officer. Ms.
Owens will be responsible for directing our financial operations.
Vice President for Marketing
In May 2004, we hired Ms. Ellen Jones as our Vice President for Marketing.
Chief Technical Officer
In May 2004, we hired Mr. Andy O'Guin as our Chief Technical Officer. Our Chief
Technical Officer will be responsible for the following:
o Bioinformatics of our operations, which is the science of developing
computer databases and algorithms to facilitate and expedite our
genomics research;
o perform DNA extraction from whole blood;
o supervise shipment of samples and SNPs to our genotyping partner;
o receive data from our genotyping partner and assist with data
analysis; and
o assist with writing patents.
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OUR PLAN OF OPERATIONS
Our Plan of Operations over the next twelve months will focus on common cancers
such as lung, prostate, colon, breast and pancreas. We will conduct screening
genotyping, followed by validation genotyping. In addition, our Plan of
Operations includes the following:
Market to Health Care Plans
We will contact health care plans for the purpose of establishing agreements
with these companies to provide our patent-pending cost-saving medical
treatments. We do not yet have such an agreement in place.
Data Analysis
The computational demands expand when you consider that some of the many SNPs we
genotype for may work together to produce the disease. Sorting through all the
combinations of 10,000 SNPs, that is, one SNP at a time, then any two SNPs out
of 10,000, then any three SNPs out of the same 10,000, then any four SNPs out of
10,000, and so on, will take advanced software and considerable computing power.
Therefore, we will lease a computer or network of computers which will cost
approximately $100,000.
Patent Writing
As in every aspect of this project, high throughput patent application is
required. A template patent application has been prepared by our Chairman of the
Board and Chief Medical Officer, Dr. David Moskowitz. As data becomes available,
it will be incorporated into the existing template patent application.
Marketing IP
We will attempt to recruit personnel with research pharmaceutical and healthcare
industry experience to market our disease-gene associations to the research
pharmaceutical industry and our cost-saving treatments to the healthcare
industry.
Liquidity and Capital Resources
Cash at June 1, 2004 amounted to $1,485,800. We have experienced significant
losses from our operations. For the period ended December 31, 2003, we incurred
a net loss of $1,299,347. Since our inception to March 31, 2004, we incurred a
net loss of $9,073,629.
Item 3. Controls and Procedures
As of March 31, 2004, the end of the period covered by this report, an
evaluation was performed under the supervision and with the participation of our
management, including our Chief Executive Officer and Chief Financial Officer,
of the effectiveness of the design and operation of our disclosure controls and
procedures. Based on that evaluation, our management, including our Chief
Executive Officer and Chief Financial Officer, concluded that our disclosure
controls and procedures were effective as of March 31, 2004.
There were no changes in our internal control over financial reporting during
the last quarter, which ended March 31, 2004, that have materially affected or
are reasonably likely to materially affect, our internal control over financial
reporting.
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PART II
OTHER INFORMATION
Item 1. Legal Proceedings
Not applicable.
Item 2. Changes in Securities and Use of Proceeds
On February 20, 2004, in connection with our agreement with Pierpoint
Investments, we sold 1,266,669 shares of our common stock to Robin Carr at
$0.045 per share or an aggregate of $57,000.
On April 7, 2004, in connection with our agreement with Pierpoint Investments,
we sold 200,000 shares of our common stock to F. Saier at $0.045 per share or an
aggregate of $9,000.
On April 7, 2004, in connection with our agreement with Pierpoint Investments,
we sold 200,000 shares of our common stock to L. Cooke at $0.045 per share or an
aggregate of $9,000.
On April 7, 2004, in connection with our agreement with Pierpoint Investments,
we sold 200,000 shares of our common stock to I. Crawford at $0.045 per share or
an aggregate of $9,000.
On April 7, 2004, in connection with our agreement with Pierpoint Investments,
we sold 200,000 shares of our common stock to N. Shah at $0.045 per share or an
aggregate of $9,000.
On April 7, 2004, in connection with our agreement with Pierpoint Investments,
we sold 25,000 shares of our common stock to H. Peterman at $0.045 per share or
an aggregate of $1,125.
On April 7, 2004, in connection with our agreement with Pierpoint Investments,
we sold 25,000 shares of our common stock to D. Paerse at $0.045 per share or an
aggregate of $1,125.
On April 14, 2004, we issued 1,000,000 shares of our common stock to Peter
Brooks in connection with his exercise of options granted to him. The options
were exercised at $0.006 per share or an aggregate of $6,000.
On May 4, 2004, in connection with our agreement with Pierpoint Investments, we
sold 122,223 shares of our common stock to G. Clarke at $0.045 per share or an
aggregate of $5,500.
On May 4, 2004, in connection with our agreement with Pierpoint Investments, we
sold 111,112 shares of our common stock to M. Saier at $0.045 per share or an
aggregate of $5,500.
On May 4, 2004, in connection with our agreement with Pierpoint Investments, we
sold 255,556 shares of our common stock to W. Clark at $0.045 per share or an
aggregate of $5,500.
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On May 5, 2004, we issued 10,000 shares of our common stock at $0.20 per share
or an aggregate of $2,000 to Josh Finer in exchange for services that Mr. Finer
rendered to us.
On May 13, 2004, in connection with our agreement with Pierpoint Investments, we
sold 367,647 shares of our common stock to J. Hadley at $0.045 per share or an
aggregate of $16,544.
On May 13, 2004, in connection with our agreement with Pierpoint Investments, we
sold 743,464 shares of our common stock to Pierpoint Investments at $0.045 per
share or an aggregate of $33,456.
As to the above sales and issuances, we relied upon Section 4(2) of the
Securities Act of 1933, as amended for the above issuances. None of these
issuance involved underwriters, underwriting discounts or commissions or any
public offer in the United States. We placed restrictive legends on all
certificates issued. We believed that Section 4(2) were available because:
o We are an operational company and not a blank check company;
o Sales were not made by general solicitation or advertising;
o The sales did not involve a public offering;
o Sales were made only to an accredited investor or investor who
represented that he or she was a sophisticated enough investor to
evaluate the risks of the investment;
o We placed legends on the certificates stating that the securities were
not registered under the Securities Act of 19933 and set forth the
restrictions on their transferability and sale.
Item 3. Default Upon Senior Securities
Not applicable
Item 4. Submission of Matters to a Vote of Securities
Not applicable
Item 5 Other Information
Subsequent Event
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Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits required by Item 601 of Regulation S-B
EXHIBIT
NUMBER DESCRIPTION
2 In re: e-Miracle Network, Inc. - Amended Plan of reorganization 1)
3.1 Articles of Incorporation - E-Kids Network, Inc. (1)
3.2 Articles of Amendment of the Articles of Incorporation of E-Kids
Network, Inc. (1)
3.3 Amended and Restated By Laws of GenoMed, Inc. (1)
10.1 Agreement and Plan of Exchange by and Between GenoMed, Inc. and
Genomic Medicine, LLC and its sole owner (1)
10.2 Amendment to the Agreement and Plan of Exchange 1)
10.3 Agreement with Research Capital, LLC (1)
10.4 Amendment to Agreement with Research Capital, LLC (1)
10.5 Agreement with DNAPrint Genomics, Inc. (1)
10.6 Agreement with Muna, Inc. (1)
10.7 Agreement with Sequence Sciences, LLC 1)
10.8 Agreement with Better Health Technologies, Inc. (1)
10.9 Employment Agreement with Jerry E. White (1)
10.10 Employment Agreement with David Moskowitz (1)
10.11 Option Agreement with David Moskowitz (1)
10.12 Scientific Advisory Board Agreement with Jason Moore (1)
10.13 Scientific Advisory Board Agreement with Scott Williams (1)
10.14 Scientific Advisory Board Agreement with Tony Frudakis (1)
10.15 Resignation of Jerry E. White (3)
10.16 Settlement Agreement with Jerry E. White (3)
10.17 Convertible Promissory Note dated April 9, 2003 payable to Research
Capital, LLC (4)
10.18 Scientific Advisory Board Agreement with Frank Johnson (4)
10.19 Scientific Advisory Board Agreement with Sergio Danilov (4)
10.20 Scientific Advisory Board Agreement with Geoffrey Boner (4)
10.21 Stock Option Agreement with Peter C. Brooks (4)
10.22 Stock Option Agreement with David W Moskowitz (4)
10.23 Stock Option Award Letter to Jason Moore (4)
10.24 Stock Option Award Letter to Scott Williams (4)
10.25 Stock Option Award Letter to Tony Frudakis (4)
10.26 Stock Option Agreement with Richard A. Kranitz (4)
10.27 Agreement with Advanced Optics Electronics (5)
10.28 Agreement with Pierpoint Investments (5)
10.29 Agreement with E & E Communications (5)
21 List of subsidiaries (1)
23 Consent of Stark Winter Schenkein & Co., LLP, Certified Public
Accountants (2)
31.1 Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2 Certification 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
(1) Previously filed on April 4, 2002, as exhibit to Form 10-SB Registration
Statement, hereby incorporated by reference.
(2) Previously filed on July 19, 2001, as exhibit to Form 10-SB Registration
Statement, hereby incorporated by reference.
(3) Previously filed on October 31, 2002, as exhibit to Form 10-SB Registration
Statement, hereby incorporated by reference.
(4) Previously filed on May 6, 2003 - Form 10-KSB Annual Report
(5) Previously filed on April 22, 2004 - Form 10-KSB Annual Report
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We hereby incorporate the following additional documents by reference: (a) our
Form 10-KSB for the year ended December 31, 2003 which was filed on April 22,
2004, and our Form 10-KSB for the year ended December 31, 2002 which was filed
on May 6, 2003; (b) our Registration Statement on Form 10SB and all amendments
thereto which was filed on April 4, 2002 and amended on June 26, 2002, July 19,
2002, July 22, 2002, August 22, 2002, October 2, 2002, and October 31, 2002; (c)
our Forms 10-QSB for the periods ended: June 30, 2002 which was filed on August
19, 2002 and amended on October 1, 2002 and on October 31, 2002; September 30,
2002 which was filed on November 14, 2002; March 31, 2002 which was filed on May
22, 2003; June 30, 2003 which was filed on August 18, 2003; and September 30,
2003 which was filed on November 20, 2003.
(b) Reports on Form 8-K
On March 18, 2004, we filed Form 8-K, Item 5. Other Events, to disclose
that we completed the sale of 33,364,230 shares of our restricted common stock
to Advanced Optics Electronics, Inc. on March 9, 2004 for the purchase price of
$900,000, in accordance with the terms of a January 8, 2004 Stock Sale Agreement
we have with Advanced Optics Electronics, Inc.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned as duly authorized officers of the Registrant.
GenoMed, Inc.
By:/s/ Dr. David Moskowitz
Dr. David Moskowitz
President/Chief Executive Officer/Chairman of the Board/Chief
Financial Officer/Chief Accounting Officer
DATED: June 3, 2004
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