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 September 30, 2002
[ ] 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.)
4560 Clayton Avenue, St. Louis, Missouri 63110
(Address of principal executive offices) (Zip Code)
(314) 977-0115
(877) 436-6603
(Issuer's telephone number)
All Correspondence to:
Brenda Lee Hamilton, Esquire
Hamilton, Lehrer and Dargan, P.A.
2 East Camino Real, Suite 202
Boca Raton Florida 33432
561-416-8956
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 September 30, 2002, we had 120,310,000 shares of our Common Stock
outstanding.
INDEX
PART 1. CONSOLIDATED FINANCIAL INFORMATION
Item 1. Consolidated Financial Statements............................... 3-8
Item 2. Management's Discussion and Analysis and Plan of operation...... 9-16
Item 3. Controls and Procedures......................................... 17
PART II. OTHER INFORMATION
Item 1. Legal Proceedings............................................... 18
Item 2. Changes in Securities and Use of Proceeds....................... 18
Item 3. Default Upon Senior Securities.................................. 18
Item 4. Submission of Matters to a Vote of Securities................... 18
Item 5. Other Information............................................... 18
Item 6. Exhibits and Reports on Form 8-K................................ 18
Signatures............................................................... 19
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Item 1. Consolidated Financial Information
GenoMed, Inc.
(A Development Stage Company)
Consolidated Balance Sheet
September 30, 2002
(Unaudited)
Assets
Current assets:
Cash $ 17,184
Other current assets 4,464
-----------
Total current assets 21,648
-----------
Property and equipment, net 203,173
-----------
Other assets 6,939
-----------
$ 231,760
===========
Liabilities and stockholders' (deficit)
Current liabilities:
Accounts payable $ 49,930
Accrued expenses 48,947
Due to shareholder 46,023
Advances payable - affiliates 1,096,375
Advances payable 20,000
-----------
Total current liabilities 1,261,275
-----------
Stockholders' (deficit):
Common stock, $.001 par value,
1,000,000,000 shares authorized,
120,310,000 shares issued and outstanding 120,310
Additional paid in capital 872,723
Subscribed common shares 23,500
Deferred compensation (20,000)
(Deficit) accumulated during the development stage (2,026,048)
-----------
(1,029,515)
-----------
$ 231,760
===========
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 September 30, 2001 and 2002,
Period From Inception (January 3, 2001)
to September 30, 2001, the Nine Months Ended September 30, 2002 and
the Period From Inception (January 3, 2001) to September 30, 2002
(Unaudited)
Nine Months
Three Months Ended Inception to Ended Inception to
September 30, September 30, September 30, September 30, September 30,
2001 2002 2001 2002 2002
------------- ------------- -------------- ------------- -------------
Revenue $ - $ - $ - $ - $ -
------------- ------------- -------------- ------------- -------------
Operating expenses:
Research and development - - - - 333,264
Selling, general and
administrative expenses 1,208 200,062 8,750 1,466,452 1,645,784
------------- ------------- -------------- ------------- -------------
1,208 200,062 8,750 1,466,452 1,979,048
------------- ------------- -------------- ------------- -------------
(Loss) from operations (1,208) (200,062) (8,750) (1,466,452) (1,979,048)
Other expense:
Interest - 18,000 - 43,000 47,000
------------- ------------- -------------- ------------- -------------
Net (loss) $ (1,208) $ (218,062) $ (8,750) $ (1,509,452) $ (2,026,048)
============= ============= ============== ============= =============
Per share information - basic
and fully diluted:
Weighted average shares
outstanding 603,810,000 120,310,000 581,263,150 120,310,000 340,662,210
============= ============= ============== ============= =============
Net (loss) per share $ (0.00) $ (0.00) $ (0.00) $ (0.01) $ (0.01)
============= ============= ============== ============= =============
See the accompanying notes to the consolidated financial statements.
-4-
GenoMed, Inc.
(A Development Stage Company)
Consolidated Statements of Cash Flows
Period From Inception (January 3, 2001) to September 30, 2001,
the Nine Months Ended September 30, 2002 and
the Period From Inception (January 3, 2001) to September 30, 2002
(Unaudited)
Nine Months
Inception to Ended Inception to
September 30, September 30, September 30,
2001 2002 2002
------------- ------------- ------------
Cash flows from operating activities:
Net cash (used in) operating activities $ (10,000) $ (656,666) $ (842,930)
------------- ------------- ------------
Cash flows from investing activities:
Net cash (used in) investing activities - (201,042) (211,296)
------------- ------------- ------------
Cash flows from financing activities:
Net cash provided by financing activities 10,000 605,000 1,071,410
------------- ------------- ------------
Net increase (decrease) in cash - (252,708) 17,184
Beginning - cash balance - 269,892 -
------------- ------------- ------------
Ending - cash balance $ - $ 17,184 $ 17,184
============= ============= ============
Supplemental cash flow information:
Cash paid for income taxes $ - $ - $ -
Cash paid for interest $ - $ - $ -
See the accompanying notes to the consolidated financial statements.
-5-
GenoMed, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements
September 30, 2002
(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 restated financial statements of the Company
as of December 31, 2001 and the period from inception (January 3, 2001) to
December 31, 2001 including notes thereto.
(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) Property and Equipment
During the period ended September 30, 2002 the Company expended $201,042 for
lab equipment.
(4) Advances Payable - affiliates
During the period ended September 30, 2002 the Company received an additional
$605,000 pursuant to a funding agreement entered into during 2001. In addition,
this affiliate paid the Company's suppliers an aggregate of $55,465 during the
period.
(5) Stockholders' (Deficit)
During November 2001 the Company acquired all of the issued and outstanding
shares of Genomic Medicine, LLC ("LLC"), a development stage company involved in
research and development, with no revenue generating operations from its current
president. The business combination has been accounted for as a purchase. In
exchange for the membership interest of LLC the Company issued 12,500,000 shares
of its common stock valued at $62,500 and agreed to issue an additional
37,500,000 shares of its common stock during May and November 2002 valued at
$187,500. The agreement was amended in March 2002 to reduce the purchase price
to require the issuance of 12,500,000 shares of common stock and the payment of
$46,023 to effect the acquisition. The reduction of the purchase price of
$141,477 has been recorded as a capital contribution during March 2002.
-6-
GenoMed, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements
September 30, 2002
(Unaudited)
During November 2001 the Company agreed to issue 4,000,000 shares of common
stock valued at $240,000 pursuant to a one year consulting agreement. The shares
were issued during the period ended March 31, 2002. The shares were valued at
their fair market value on the measurement date of $.06 per share and the value
of the services is being amortized over the one year period at a rate of $20,000
per month. The Company charged $40,000 to operations during the period ended
December 31, 2001 and $180,000 to operations during the period ended September
30, 2002. The balance of $20,000 has been recorded as deferred compensation at
September 30, 2002.
The Company also charged $18,750 to operations during the period ended September
30, 2002 pursuant to its agreement to issue 5,000,000 shares of common stock for
the year ended December 31, 2002 in accordance with the terms of an employment
agreement. As of September 30, 2002, 3,750,000 shares had been earned and had
not been issued. The shares have been valued at the their trading price of $.005
of the Company's common stock on November 15, 2001, the measurement date. The
above amount has been included as subscribed common shares.
In addition, the Company charged $4,750 to operations during the period ended
September 30, 2002 pursuant to its agreement to issue 50,000 shares of common
stock during January 2002 and 250,000 shares of common stock on December 31,
2002 in accordance with the terms of advisory board contracts. As of September
30, 2002, 237,500 shares had been earned and had not been issued. The shares
have been valued at the trading price of $.02 of the Company's common stock on
September 30, 2002, the measurement date. The above amount has been included as
subscribed common shares.
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. In addition, this
officer was granted a performance option to purchase up to 100,000,000 common
shares for a period of 10 years at an exercise price of 20% of the fair market
value of the common stock on the exercise date. The performance options will
only be granted to the officer upon the occurrence of future specified events.
The discount from the fair market value of the common stock related to the
37,500,000 options will be charged to operations as general and administrative
expenses during the period from the grant date to November 6, 2002. During the
period ended September 30, 2002 $536,480 was charged to operations.
The effect of applying SFAS No. 123 pro forma net (loss) is not necessarily
representative of the effects on reported net income (loss) for future years due
to, among other things, the vesting period of the stock options and the fair
value of additional stock options in future years. The fair values of the
options granted during 2002 are estimated at $.004 on the date of grant using
the Black-Scholes option pricing model with the following assumptions: no
dividend yield, volatility of 508%, a risk-free interest rate of 4%, and
expected lives of 10 years from date of vesting.
-7-
GenoMed, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements
September 30, 2002
(Unaudited)
For purpose of pro forma disclosure, the estimated fair value of the options is
charged to expense in the period that the options were granted. The Company's
pro forma information is as follows:
September 30,
2002 2001
Pro forma net (loss) $ (1,685,452) $ -
Pro forma (loss) per share -
Basic and diluted $ (.01) $ -
(6) Going Concern
The Company's financial statements are presented on a going concern basis, which
contemplates the realization of assets and satisfaction of liabilities in the
normal course of business.
The Company has experienced a significant loss from operations as a result of
its investment necessary to achieve its operating plan, which is long-range in
nature. For the period ended September 30, 2002 the Company incurred a net loss
of $1,509,452 and has a working capital deficit of $1,239,627 and a
stockholders' deficit of $1,029,515 at September 30, 2002.
The Company's ability to continue as a going concern is contingent upon its
ability to attain profitable operations and secure financing. In addition, the
Company's ability to continue as a going concern must be considered in light of
the problems, expenses and complications frequently encountered by entrance into
established markets and the competitive environment in which the Company
operates.
The Company is pursuing equity financing for its operations. Failure to secure
such financing or to raise additional capital or borrow additional funds may
result in the Company depleting its available funds and not being able pay its
obligations.
The financial statements do not include any adjustments to reflect the possible
future effects on the recoverability and classification of assets or the amounts
and classification of liabilities that may result from the possible inability of
the Company to continue as a going concern.
(7) Subsequent Event
On October 25, 2002 the Company entered into a settlement agreement with its
former president who resigned on October 21, 2002. In conjunction with the
resignation the Company granted this former employee options to purchase
6,000,000 shares of common stock at an exercise price of 20% of the average bid
and ask price of the Company's common stock on October 25, 2002. The options
vested on the date of the agreement and expire after a period of 10 years. The
Company will record the fair value of the options as a charge to operations
during the fourth quarter of 2002.
-8-
Item 2. Management's Discussion and Analysis of Financial Condition and Plan of
Operations
The following discussion pertaining to our Plan of Operations, as contained in
this Form 10-QSB, contains "forward-looking statements" that involve risks and
uncertainties. These statements may be identified by the use of terminology such
as "believes," "expects," "may," "will," "should," or "anticipates," or
expressing this terminology negatively or similar expressions or by discussions
of strategy. The cautionary statements made in this Form 10-QSB should be read
as being applicable to all related forward-looking statements wherever they
appear in this Form 10-QSB. Our actual results could differ materially from
those discussed in this Form 10-QSB. Important factors that could cause or
contribute to such differences include those discussed under the caption
entitled "Risk Factors," in our Form 10SB. Our independent accountants, Stark
Winter Schenkein & Co., LLP, have issued an opinion in conjunction with their
audit of our consolidated balance sheet as of December 31, 2001, raising
substantial doubt about our ability to continue as a going concern based on the
losses that we have suffered from our operations, our working capital and
stockholders' deficiencies, and the developmental stage nature of our business.
In addition, our auditors have noted in our financial statements that our
ability to continue as a going concern is contingent upon our ability to attain
profitable operations by securing financing and implementing our business plan.
We can continue to satisfy our estimated current cash requirements of
approximately $32,550 until December 31, 2002 through our existing cash of
$20,600 as of November 8, 2002, which is subsequent to this quarterly period
ended September 30, 2002. We anticipate that our total estimated
expenditures of $14,550 through December 31, 2002, will include the following:
November 2002
Our remaining expenses of approximately $5,500 for the month of November 2002
will be allocated exclusively to payroll. During our last quarterly report for
the period ended June 30, 2002, we reported that we would have payroll expenses
of $16,000; however, because we do not have sufficient funds, our Chief
Executive Officer is deferring approximately $11,000 of compensation owed to him.
December 2002
We anticipate total expenses of approximately $9,050 during December 2002
consisting of the following:
Payroll ----------- $ 2,850
Rent -------------- $ 500
Phone ------------- $ 200
Travel ------------ $ 2,000
Genotyping -------- $ 2,500
Sample collection - $ 1,000
Because we have only $20,600 as of November 8, 2002, we will only spend $2,500
on genotyping rather than $10,000 as anticipated in our last quarterly report
for the period ended June 30, 2002. In addition, our Chief Executive Officer
will defer compensation of approximately $11,000 due to him during December
2002.
-9-
On January 1, 2003, we will have remaining cash of approximately $6,050, which
is insufficient to satisfy our estimated cash requirements of approximately
$148,198 for the period from January 2003 to March 2003. We anticipate that our
total estimated expenditures of $148,198 for the period of January 2003 to March
2003 will be:
Total for
Type Expenditures Monthly Amount Three Month Period
------------------- ------------------- ------------------
Salaries $ 31,248 $ 93,744
------------------- ------------------- ------------------
Operating Expenses* $ 5,818 $ 17,454
------------------- ------------------- ------------------
Genotyping $ 4,000 $ 12,000
------------------- ------------------- ------------------
Data Analysis $ 5,000 $ 15,000
------------------- ------------------- ------------------
Marketing $ 0 $ 0
------------------- ------------------- ------------------
(March only)
Patents (March only) $ 10,000 $ 10,000
------------------- ------------------- ------------------
Total $ 56,066 $ 148,198
=================== ==================
* Operating Expenses include office rent, utilities, and legal and accounting
expenses.
We intend to satisfy these estimated total expenditures of $148,198 for the
period from January 2003 to March 2003 through a private placement of our equity
securities or, if necessary, possibly through traditional bank financing or a
debt offering; however, because we are a development stage company with no
operating history and a poor financial condition, we may be unsuccessful in
conducting a private placement of equity or debt securities or in obtaining bank
financing. If we are unsuccessful in obtaining funding through these means, our
President/Chief Executive Officer, Dr. David Moskowitz, plans to loan us funds;
however, we have no agreement with our President/Chief Executive Office to loan
us funds and he is under no obligation to do so. Accordingly, there are no
assurances that we will receive loans from our President/Chief Executive
Officer. Moreover, there are no assurances that our President/Chief Executive
Officer will have sufficient funds to make these loans. If our President/Chief
Executive Officer is unable or unwilling to make loans to us necessary to
implement our plan of operations and we are unable to obtain financing through
any other means or the amount of the financing is minimal, we will be unable to
complete our plan of operations. In addition, if we only have nominal funds by
which to conduct our operations, we may have to curtail our research and
development activities, which will negatively impact development of our possible
products, brand name and reputation. We have no alternative plan of operations.
In the event that we do not obtain adequate financing to complete our plan of
operations or if we do not adequately implement an alternative plan of
operations that enables us to conduct operations without having received
adequate financing, we may have to liquidate our business and undertake any or
all of the following actions:
-10-
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 Over-the-Counter 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
We have accomplished the following in our plan of operations to date:
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.
-11-
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.
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 DW Coordinating Center located in Los Altos, California
signed for samples in Moscow and St. Petersburg, Russia. We have signed a Letter
of Intent and anticipate that we will sign a definitive agreement by April 2002.
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.
-12-
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.
Letter of Intent to acquire Caucasian samples for fifty common diseases from DW
Coordinating Center, a Clinical Research Organization based in Los Altos,
California. We anticipate signing a definitive agreement by April 2002.
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. Purchased one SNP stream UHT system and the software from
Orchid BioSciences, Inc. of Princeton, New Jersey, that will further 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. We are outsourcing our high-throughput genotyping needs to
DNAPrint Genomics, Inc.
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 driving 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.
-13-
OUR PLAN OF OPERATIONS OVER THE NEXT YEAR FROM MARCH 2002 TO MARCH 2003
We intend to accomplish the following regarding our plan of operations over the
next twelve months, from March 2002 to March 2003:
March 2002
Move into Office and Lab Space
In March 2002, we moved into approximately 1200 square feet of space and are
contemplating 2000 square feet of laboratory space in St. Louis, Missouri to
conduct our research. Although we have not yet been provided with lease
quotations, we estimate that the cost involved in renting this space will range
from $800 to $1200 per month. We will attempt to negotiate a one (1) year term
for the lease. Our president, Dr. David Moskowitz will be responsible for
conducting inquiries regarding a potential lease for our laboratory purposes.
Begin collections of Caucasian, African American, Asian and Hispanic samples for
52 diseases in accordance with our agreement with Bio Collections, Inc. The
blood samples will be obtained from clinics and hospitals in Florida. The blood
will be shipped to DNAPrint in Sarasota, Florida for conversions to DNA. The
total approximate cost will be $125 per sample.
Begin collection of Caucasian samples for 52 diseases in accordance with our
agreement with DW Coordinating Center, Inc.
We signed a Letter of Intent with DW Coordinating Center for Caucasian patient
samples representing a variety of common disease. The blood samples will be
obtained with full informed consent and local Institutional Review Board
approval from participating clinics and hospitals in Moscow and St. Petersburg,
Russia. The blood will be converted to DNA by a laboratory in Moscow and shipped
to our offices in St. Louis, Missouri. The total approximate cost will be $45.35
per sample and a total approximate cost of $54,420. The collection of an initial
set of 1200 samples will commence in March and last approximately six months.
Additional Caucasian patient samples will be collected by DW Coordinating Center
in the future.
Establish Laboratory for Purpose of Collecting DNA from Blood
Assuming that we lease space for our laboratory, beginning in approximately
April or May 2002 we will purchase a refrigerator for approximately $1,000 to
store whole blood and a freezer for approximately $1,000 to store DNA. We
estimate that the laboratory will become operational during June 2002.
We will hire a research assistant for $30,000 per year that will prepare DNA
from the white blood cells present in blood samples.
Genotyping Type 2 NIDDM Samples
DNA samples from patients with Type 2 Diabetes and controls have been obtained
from the American Diabetes Association and the Coriell Cell Repository. Each DNA
sample will be genotyped at a reasonably large number of potentially functional
SNPs (single nucleotide polymorphism) using the Orchid UHT SNP-stream machine
housed at DNAPrint Genomics, Inc. We will start with several hundred SNPs and
scale-up to 10,000 SNPs over the next eight months.
-14-
The frequency of each SNP will be determined for patients ("cases") and
controls. Where the SNP differs significantly in frequency between the "cases"
and "control" groups, the SNP is said to be associated with the disease under
consideration, in this case Type 2 Diabetes.
The first 1,000 SNPs will be genotyped by September 2002. Personnel at DNAPrint
Genomics, under the direction of its Chief Executive Officer, Tony Frudakis, and
its Project Manager, Matt Thomas, will be responsible for executing the
genotyping. The project will be overseen by David Moskowitz, our Chairman of the
Board/Chief Medical Officer.
Market to Disease Management Companies and Health Care Providers
We plan to attempt to negotiate an agreement with Better Health Technology, a
consulting firm located in Boise, Idaho, to contact disease management companies
and health care providers for the purpose of establishing agreements with these
companies to provide cost saving medical procedures. The terms of this potential
agreement have not been determined.
April 2002
Obtain Hispanic Collection of Blood Samples
In accordance with our joint venture agreement with Muna, Inc. located in
Coconut Creek, Florida. Muna, Inc. will arrange for the collection of blood from
Hispanic patients with documented disease. Muna, Inc. will provide samples at
approximately $50 per sample total cost; including the cost of DNA preparation.
The total anticipated estimated cost is $36,000.
SNP Genotyping
DNA samples from patients with Type 2 Diabetes and controls have been obtained
from the American Diabetes Association and the Coriell Cell Repository located
in Camden, New Jersey. Each DNA sample will be genotyped at a reasonably large
number of potentially functional SNPs using the Orchid UHT SNP-stream machine
housed at DNAPrint Genomics, Inc.
The frequency of each SNP will be determined for patients ("cases") and
controls. Where the SNP differs significantly in frequency between the "cases"
and "control" groups the SNP is said to be associated with the disease under
consideration, in this case Type 2 Diabetes.
The first 1,000 SNPs will be genotyped by September 2002. Personnel at DNAPrint
Genomics, under the direction of Tony Frudakis, CEO, and Matt Thomas, Project
Manger, will be responsible for executing the genotyping. The project will be
overseen by David Moskowitz, our Chief Executive Officer.
Data Analysis
Once genotype results are known for 384 samples, there will be too much data to
keep track of, so it will take a computer or network of computers to process the
results. The computational demands expand when you consider that some of these
1,000 SNPs may work with each other to produce the disease. Sorting through all
the combinations of 1,000 SNPs, that is, one SNP at a time, then any two SNPs
out of 1,000, then any three SNPs out of the same 1,000, then any four SNPs out
of 1,000, 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.
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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,
such as SNPs and genes associated with our first disease target, Type 2
Diabetes, it will be incorporated into the existing template patent application.
We have retained the law firms of Holland and Knight located in Boston,
Massachusetts, Thompson Coburn located in St. Louis, Missouri, and Polster
Lieder located in St. Louis, Missouri to help with writing specific claims.
Marketing
We will attempt to recruit personnel with research pharmaceutical industry
experience to market our disease-gene associations to the research
pharmaceutical industry. Resumes are now being assembled for this purpose.
May 2002 to March 2003
SNP Genotyping
DNA samples from patients with Type 2 Diabetes and controls have been obtained
from the American Diabetes Association and the Coriell Cell Repository located
in Camden, New Jersey. Each DNA sample will be genotyped at a reasonably large
number of potentially functional SNPs using the Orchid UHT SNP-stream machine
housed at DNAPrint Genomics, Inc.
The frequency of each SNP will be determined for patients ("cases") and
controls. Where the SNP differs significantly in frequency between the "cases"
and control groups, the SNP is said to be associated with the disease under
consideration, in this case Type 2 Diabetes.
The first 1,000 SNPs will be genotyped by September 2002. Personnel at DNAPrint
Genomics, under the direction of Tony Frudakis, CEO, and Matt Thomas, Project
Manger, will be responsible for executing the genotyping. The project will be
overseen by Dr. David Moskowitz, our Chairman of the Board and Chief Medical
Officer.
Data Analysis
Once genotype results are known for 384 samples, because there will be too much
data to keep track of, it will take a computer or network of computers to
process the results. The computational demands expand when you consider that
some of these 1,000 SNPs may work with each other to produce the disease.
Sorting through all the combinations of 1,000 SNPs, that is, one SNP at a time,
then any two SNPs out of 1,000, and so on, will take advanced software and
considerable computing power. Therefore, we will purchase 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. As data becomes available, such as SNPs and genes associated with our
first disease target, Type 2 Diabetes, it will be incorporated into each new
patent application. We have retained the law firms of Holland and Knight located
in Boston, MA, Thompson Coburn located in St. Louis, MO, and Polster Lieder
located in St. Louis, MO to help with writing specific claims.
Marketing IP
We will attempt to recruit personnel with research pharmaceutical industry
experience to market GenoMed's disease-gene associations to the research
pharmaceutical industry. Resumes are now being assembled for this purpose.
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Item 3. Controls and Procedures
The Company's Chief Executive Officer and Chief Financial Officer evaluated the
Company's disclosure controls and procedures within the 90 days preceding the
filing date of this quarterly report. Based upon this evaluation, the Chief
Executive Officer and Chief Financial Officer concluded that the Company's
disclosure controls and procedures are effective in ensuring that material
information required to be disclosed is included in the reports that it files
with the Securities and Exchange Commission.
There were no significant changes in the Company's internal controls or, to the
knowledge of the management of the Company, in other factors that could
significantly affect these controls subsequent to the evaluation date.
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PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Not applicable.
Item 2. Changes in Securities and Use of Proceeds
Not applicable
Item 3. Default Upon Senior Securities
Not applicable
Item 4. Submission of Matters to a Vote of Securities
Not applicable
Item 5. Other Information
Not Applicable.
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits required by Item 601 of Regulation S-B
EXHIBIT DESCRIPTION
NUMBER
2 In re: e-Miracle Network, Inc. - Amended Plan of reorganization*
3.1 Articles of Incorporation - E-Kids Network, Inc.*
3.2 Articles of Amendment of the Articles of Incorporation of E-Kids
Network, Inc.*
3.3 Amended and Restated By Laws of GenoMed, Inc.*
10.1 Agreement and Plan of Exchange by and Between GenoMed, Inc. and
Genomic Medicine, LLC and its sole owner*
10.2 Amendment to the Agreement and Plan of Exchange*
10.3 Agreement with Research Capital, LLC*
10.4 Amendment to Agreement with Research Capital, LLC*
10.5 Agreement with DNAPrint Genomics, Inc.*
10.6 Agreement with Muna, Inc.*
10.7 Agreement with Sequence Sciences, LLC*
10.8 Agreement with Better Health Technologies, Inc.*
10.9 Employment Agreement with Jerry E. White*
10.10 Employment Agreement with David Moskowitz*
10.11 Option Agreement with David Moskowitz*
10.12 Scientific Advisory Board Agreement with Jason Moore*
10.13 Scientific Advisory Board Agreement with Scott Williams*
10.14 Scientific Advisory Board Agreement with Tony Frudakis*
10.15 Resignation of Jerry E. White***
10.16 Settlement Agreement with Jerry E. White***
21 List of subsidiaries*
23 Consent of Stark Winter Schenkein & Co., LLP, Certified Public
Accountants**
99.1 Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002.
*Previously filed on April 4, 2002, as exhibit to Form 10-SB Registration
Statement, hereby incorporated by reference.
**Previously filed on July 19, 2001, as exhibit to Form 10-SB Registration
Statement, hereby incorporated by reference.
***Previously filed on October 31, 2002, as exhibit to Form 10-SB Registration
Statement, hereby incorporated by reference.
(b) Reports on Form 8-K
We filed a Form 8-K on August 16, 2002 in connection with Item 9, Regulation FD
Disclosure, with an attached exhibit, Exhibit 99.1 - the Certification of Jerry
White, our prior President, Chief Executive Officer, Chief Financial Officer,
and Principal Accounting Officer, in response to the new legislation that
requires our Chief Executive Officer and Chief Financial Officer to certify
periodic reports that contain financial statements.
-18-
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: November 12, 2002
CERTIFICATION ACCOMPANYING PERIODIC REPORT PURSUANT TO SECTION 302 OF THE
SARBANES-OXLEY ACT OF 2002
I, Dr. David Moskowitz, certify that:
1. I have reviewed this quarterly report on Form 10-QSB of GenoMed, Inc.;
2. Based on my knowledge, this quarterly report does not contain any untrue
statement of a material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this quarterly
report;
3. Based on my knowledge, the financial statements, and other financial
information included in this quarterly report, fairly present in all material
respects the financial condition, results of operations and cash flows of
GenoMed, Inc. as of, and for, the periods presented in this quarterly report.
4. I am responsible for establishing and maintaining disclosure controls and
procedures (as defined in Exchange Act Rules 13a-14 and 15d-14)for GenoMed, Inc.
and have:
a) designed such disclosure controls and procedures to ensure that material
information relating to GenoMed, Inc., including its consolidated subsidiaries,
is made known to us by others within those entities, particularly during the
period in which this quarterly report is being prepared;
b) evaluated the effectiveness of GenoMed, Inc.'s disclosure controls and
procedures as of a date within 90 days prior to the filing date of this
quarterly report (the "Evaluation Date"); and
c) presented in this quarterly report our conclusions about the effectiveness of
the disclosure controls and procedures based on our evaluation as of the
Evaluation Date;
5. I have disclosed, based on my most recent evaluation, to GenoMed, Inc.'s
auditors and the audit committee of GenoMed, Inc.'s board of directors (or
persons performing the equivalent functions):
a) all significant deficiencies in the design or operation of internal controls
which could adversely affect GenoMed, Inc.'s ability to record, process,
summarize and report financial data and have identified for the registrant's
auditors any material weaknesses in internal controls; and
b) any fraud, whether or not material, that involves management or other
employees who have a significant role in GenoMed, Inc.'s internal controls; and
6. I have indicated in this quarterly report whether there were significant
changes in internal controls or in other factors that could significantly affect
internal controls subsequent to the date of our most recent evaluation,
including any corrective actions with regard to significant deficiencies and
material weaknesses.
Date: November 12, 2002
/s/ Dr. David Moskowitz
Dr. David Moskowitz
President/Chief Executive Officer/Chairman of the Board/Chief Financial
Officer/Chief Accounting Officer
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