Form 10QSB 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, 2003
[ ] 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 May 22, 2003, we had 121,079,231 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...... 9-18
Item 3. Controls and Procedures......................................... 18
PART II. OTHER INFORMATION
Item 1. Legal Proceedings............................................... 19
Item 2. Changes in Securities and Use of Proceeds....................... 19
Item 3. Default Upon Senior Securities.................................. 19
Item 4. Submission of Matters to a Vote of Securities................... 19
Item 5. Other Information............................................... 19
Item 6. Exhibits and Reports on Form 8-K................................ 19
Signatures............................................................... 20
-2-
Item 1. Consolidated Financial Information
GenoMed, Inc.
(A Development Stage Company)
Consolidated Balance Sheet
March 31, 2003
(Unaudited)
Assets
Current assets:
Cash $ 2,372
---------
Property and equipment, net 165,676
---------
$ 168,048
=========
Liabilities and stockholders' (deficit)
Current liabilities:
Accounts payable $ 48,349
Due to shareholders 250,318
---------
Total current liabilities 298,667
---------
Note payable - affiliate 1,077,581
Stockholders' (deficit):
Common stock, $.001 par value,
1,000,000,000 shares authorized,
121,079,231 shares issued and outstanding 121,079
Additional paid in capital 852,474
Subscribed common shares 5,250
(Deficit) accumulated during the development stage (2,187,003)
---------
(1,208,200)
---------
$ 168,048
=========
See the accompanying notes to the consolidated financial statements.
-3-
GenoMed, Inc.
(A Development Stage Company)
Consolidated Statements of Operations
Three Months Ended March 31, 2003 and 2002, and
the Period From Inception (January 3, 2001) to March 31, 2003
(Unaudited)
Three Months Three Months
Ended Ended Inception to
March 31, March 31, March 31,
2003 2002 2003
----------- ----------- ------------
(Restated)
Revenue $ 1,000 $ - $ 1,000
----------- ----------- ------------
Operating expenses:
Research and development - - 333,264
Selling, general and
administrative expenses 69,921 471,800 1,760,674
----------- ----------- ------------
69,921 471,800 2,093,938
----------- ----------- ------------
(Loss) from operations (68,921) (471,800) (2,092,938)
Other expenses:
Impairment of web site - - 6,939
Interest 20,000 11,000 87,126
----------- ----------- ------------
20,000 11,000 94,065
----------- ----------- ------------
Net (loss) $ (88,921) $ (482,800) $ (2,187,003)
=========== =========== ============
Per share information -
basic and fully diluted:
Weighted average shares outstanding 121,079,231 120,310,000 291,839,196
=========== =========== ============
Net (loss) per share $ (0.00) $ (0.00) $ (0.01)
=========== =========== ============
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, 2003 and 2002, and
the Period From Inception (January 3, 2001) to March 31, 2003
(Unaudited)
Three Months Three Months
Ended Ended Inception to
March 31, March 31, March 31,
2003 2002 2003
------------ ------------ -------------
(Restated)
Cash flows from operating activities:
Net cash (used in) operating activities $ (12,159) $ (241,528) $ (820,374)
------------ ------------ -------------
Cash flows from investing activities:
Net cash (used in) investing activities - (200,000) (210,254)
------------ ------------ -------------
Cash flows from financing activities:
Net cash provided by financing activities 1,500 350,000 1,033,000
------------ ------------ -------------
Net increase (decrease) in cash (10,659) (91,528) 2,372
Beginning - cash balance 13,031 269,892 -
------------ ------------ -------------
Ending - cash balance $ 2,372 $ 178,364 $ 2,372
============ ============ =============
See the accompanying notes to the consolidated financial statements.
-5-
GenoMed, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements
March 31, 2003
(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, 2002 and the period from inception (January 3, 2001) to December
31, 2002 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) Stockholders' (Deficit)
During January 2003 the Company issued 769,231 shares of common stock pursuant
to a subscription agreement entered into in December 2002 for cash aggregating
$10,000. In addition, the Company accepted a subscription for 187,500 shares of
common stock during February 2003 in exchange for cash aggregating $1,500.
During the period ended March 2003 the Company charged $750 to operations
pursuant to its agreement to issue 300,000 shares of common stock on December
31, 2003 in accordance with the terms of advisory board contracts. As of March
31, 2003, 75,000 shares had been earned and had not been issued. The shares have
been valued at the trading price of $.01 of the Company's common stock on March
31, 2003, the measurement date. The above amount has been included as subscribed
common shares.
During the period ended
March 31, 2003 the Company charged $12,000 to operations related to the vesting
of stock options granted in 2002.
During the period ended March 31, 2003 the Company granted options to purchase
956,731 shares of common stock to purchasers of 956,731 shares of its common
stock in December 2002 and February 2003 for an aggregate of $11,500. The
options are exercisable at $.05 per share and expire when the trading price of
the Company's common stock is at least $.07 for a period of ten days.
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. There is no material
difference between the reported net loss and the pro-forma net loss had the fair
values of the options granted during 2003 been included in operations.
-6-
(4) 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 March 31, 2003 the Company incurred a net loss of
$88,921 and has a working capital deficit of $296,295 and a stockholders'
deficit of $1,208,200 at March 31, 2003. In addition, the Company has no
significant revenue generating operations.
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.
(5) Note Payable - Affiliate
On April 9, 2003 the Company converted $1,010,500 in advances and $67,081 of
accrued interest into a convertible promissory note in the amount of $1,077,581.
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:
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.
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.
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.
-7-
(6) Correction of An Error
During August 2002 the Company determined that the value assigned to 37,500,000
options issued to an officer should have been recorded at the discount from the
fair market value of the common shares for the options vested on the measurement
date of $.032 per share or an aggregate of $153,000 through March 31, 2002. The
Company charged this amount to general and administrative expenses during the
period ended March 31, 2002.
In addition, during August 2002 the Company determined that the value assigned
to certain common shares to be issued pursuant to an employment contract and
advisory board contracts should have been valued at the trading prices of the
Company's common shares on the measurement date of $.005 for the shares
related to the employment contract and $.04 for the shares related to the
advisory board contracts. The correction of the previous valuation resulted in a
decrease in general and administrative expenses of $84,500.
The accompanying financial statements have been restated to reflect these
corrections. The adjustment increased the net loss for the period ended March
31, 2002 as previously reported from $(414,300) to $(482,800) or $(.00) per
share.
-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," "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, 2002, 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.
Management's Discussion and Analysis of Financial Condition and Results of
Operation.
The discussion contained in this Quarterly Report contains "forward-looking
statements" that involve risk 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 prospectus should be read as being applicable to all related
forward-looking statements wherever they appear in this prospectus. Our actual
results could differ materially from those discussed in this prospectus.
Important factors that could cause or contribute to such differences, including
the following risk factors:
BECAUSE WE ARE A DEVELOPMENT STAGE COMPANY WITH A LIMITED OPERATING HISTORY AND
A POOR FINANCIAL CONDITION, YOU WILL BE UNABLE TO DETERMINE WHETHER WE WILL EVER
BECOME PROFITABLE.
You cannot determine if we will ever become profitable. Future losses are likely
before we become profitable, if ever. We are a development stage company with
limited operations and no revenues through May 5, 2003. From our inception to
March 31, 2003, we incurred a net loss of $(2,187,003) and a working capital
deficit of $(296,295). We anticipate our losses to continue.
OUR INDEPENDENT ACCOUNTANTS, STARK WINTER SCHENKEIN & CO., LLP, HAVE ISSUED AN
OPINION RAISING SUBSTANTIAL DOUBT ABOUT OUR ABILITY TO CONTINUE AS A GOING
CONCERN.
Our independent accountants, Stark Winter Schenkein & Co., LLP, have issued an
opinion 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 note 4 of 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.
-9-
OUR PLAN OF OPERATIONS HAS BEEN SUBSTANTIALLY DELAYED DUE TO LACK OF FINANCING;
IF WE ARE UNABLE TO OBTAIN FINANCING TO PURSUE OUR PLAN OF OPERATIONS WE WILL NO
LONGER BE ABLE TO CONDUCT BUSINESS AND YOU WILL LOSE YOUR ENTIRE INVESTMENT.
Our plan of operations involves substantial marketing and personnel costs. In
addition, our plan of operations involved substantial costs associated with
services which we wish to obtain. Our plan of operations, however, has already
been delayed by one year because we do not have sufficient funds to accomplish
the steps in our plan of operations. If we are unable to obtain traditional bank
financing or financing from a debt or equity offering or we are unable to obtain
financing when needed on favorable terms, we may be forced to terminate our
business and you will lose your entire investment.
IF WE ARE NOT AWARDED PATENTS OR LICENSES, WE WILL NEVER MARKET POTENTIAL
PRODUCTS AND OUR POTENTIAL REVENUES WILL BE NEGATIVELY AFFECTED.
Although we have filed 13 provisional patent applications with the U.S. Patent
and Trademark Office, there are no assurances that such patents will be approved
for commercial use. Our future business is contingent upon the patents being
awarded. Accordingly, if we are unsuccessful in having our patents approved, our
potential revenues will be negatively affected or we will never develop any
revenues.
OUR BUSINESS MAY BE ADVERSELY AFFECTED BY REGULATORY COSTS WHICH WOULD
NEGATIVELY AFFECT OUR POTENTIAL PROFITABILITY.
Our attempt to patent disease associated genes or our processes are subject to
regulations by the United States Patent and Trademark Office. Our attempt to
develop drugs based upon the disease associated genes we identify is subject to
regulations by the Federal Drug Administration. Government regulations may
result in increased costs and delays which will increase our costs and may have
an adverse affect on our potential profitability and operations.
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.
Our method of gene identification is a relatively new method. If our potential
strategic partners do not accept our gene identification methods, our operations
and potential revenues will be negatively affected.
OUR COMPETITORS MAY DEVELOP AND RESPOND TO GENE PROCEDURES AND PRODUCTS BEFORE
US DUE TO THEIR SUPERIOR FINANCIAL AND TECHNICAL RESOURCES AND SUPERIOR
TECHNOLOGIES.
Because our competitors have financial and technical resources that are superior
to ours, they may succeed in developing procedures for automated sequencing of
genes or develop and market drug products before us. The markets for our
potential products are subject to rapidly evolving technological change and
unanticipated changes in customer needs and preferences. Accordingly, our
competitors' superior financial and technical resources may allow them to
respond to technological changes in a more timely or cost-effective manner than
us.
WE MAY BE SUBJECT TO MEDICAL OR PRODUCT LIABILITY CLAIMS THAT WILL NEGATIVELY
AFFECT OUR POTENTIAL PROFITABILITY AND MAY LEAD TO LOSSES.
If we or our strategic partners develop drug products based on our
identification of disease associated genes, we may be subject to medical or
product liability claims. We do not intend to acquire product liability
insurance until drug products receive the necessary regulatory approvals to be
marketed. There are no assurances that we will have sufficient capital to
acquire product liability insurance. Moreover, even if we obtain product
liability insurance, there are no assurances that we will obtain insurance
coverage with limits that will adequately cover any claims brought against us.
As a result, we may be subject to judgments that exceed our assets and which
would lead to losses.
-10-
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.
We plan to outsource our services pertaining to sampling, collection,
genotyping, and data analysis, all of which are essential components of our gene
identification process. Because we will contract with other companies to provide
these services, we may have little or no control over the quality of these
services. If poor quality control leads to errors in these processes, our
quality control and brand name reputation will be negatively affected.
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.
Our ability to identify and qualify patients for testing in our clinical trials
is critical to our success in bringing products to market. Delays or other
operational problems in recruiting or enrolling patients will result in
increased costs, delays in the development of our products, or termination of
our clinical trials.
IF OUR STRATEGIC PARTNERS FAIL TO OBTAIN FEDERAL DRUG ADMINISTRATION APPROVAL,
OUR COSTS MAY INCREASE AND OUR REVENUES MAY DECREASE.
Obtaining Federal Drug Administration approval is a costly and time-consuming
process which may take as long as three to five years. We may not obtain such
approvals in a timely manner, or at all, or we may encounter significant delays
or excessive costs in efforts to secure necessary approvals or licenses, which
may lead to increased costs and negatively affect our revenues.
OUR ENTIRE BUSINESS PLAN IS DEPENDENT UPON FORMING STRATEGIC ALLIANCES OR
ACQUISITIONS OR PARTNERSHIP ALLIANCES WITH OTHERS FOR WHICH THERE ARE NO
ASSURANCES; IF WE FAIL TO DO SO, WE WILL NEVER GENERATE ANY REVENUES.
Whether we ever develop any products and thereafter generate any revenue is
dependent upon our forming strategic alliances with pharmaceutical or
biotechnology companies, health maintenance organizations, and clinical
diagnostic laboratories; however, we may be unsuccessful in establishing such
alliances.
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.
Under the terms of our acquisition of Genomic Medicine, LLC, we are required to:
(a) make a $1,000,000 investment in Genomic Medicine, LLC; and (b) issue an
additional 37,500,000 shares of our common stock to our Chairman of the Board,
David W. Moskowitz, if he elects to exercise the 37,500,000 options issued to
him. Should we fail to abide by these terms, that agreement may be rescinded or
breach of contract actions could be brought against us. This could lead to
cessation of our business and the loss of your entire investment.
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.
Our future plans involve entering into strategic alliances or acquiring
companies that have businesses complementary to ours. If we fail to perform
adequate due diligence regarding these acquisitions or alliances, we may acquire
or enter into arrangements with a company or technology that is uncomplimentary
to our business, which subjects us to possible liability for product defects, or
involves substantial additional costs exceeding our estimated costs. In
addition, management time and resources devoted to due diligence efforts may
divert attention away from our current operations and negatively affect our
operations.
-11-
OUR MANAGEMENT DECISIONS ARE MADE BY OUR PRESIDENT/CHIEF EXECUTIVE OFFICER/
CHAIRMAN OF THE BOARD/CHIEF MEDICAL OFFICER, DR. DAVID MOSKOWITZ; IF WE LOSE HIS
SERVICES, OUR OPERATIONS WILL BE NEGATIVELY IMPACTED.
The success of our business is dependent upon the expertise of our
President/Chief Executive Officer/Chairman of the Board/Chief Medical Officer,
Dr. David Moskowitz. Because Dr. David Moskowitz is essential to our operations,
you must rely on his management decisions. We have not entered into any
agreement with Dr. David Moskowitz that would prevent him from leaving our
company; however, as of April 1, 2002, we have obtained a $2,000,000 key man
insurance policy for Dr. Moskowitz. There is no assurance that we would be able
to hire and retain another Chairman of the Board/President/Chief Executive
Officer/Chief Medical Officer with comparable experience. As a result, the loss
of Dr. Moskowitz's services would have a materially adverse affect upon our
business.
OUR CHAIRMAN OF THE BOARD, DR. DAVID MOSKOWITZ, HAS SIGNIFICANT CONTROL OVER
STOCKHOLDER MATTERS, WHICH MAY AFFECT THE ABILITY OF MINORITY STOCKHOLDERS TO
INFLUENCE OUR ACTIVITIES.
Dr. David Moskowitz beneficially owns approximately 12.5% of our outstanding
common stock. As such, he may be able to control the outcome of matters
submitted to a vote by the holders of our common stock, including the election
of our directors, amendments to our certificate of incorporation and approval of
significant corporate transactions. Additionally, his control could delay, deter
or prevent a change in our control that might be beneficial to our other
stockholders.
WE PLAN TO ISSUE OUR COMMON STOCK AS COMPENSATION TO OUR OFFICERS/DIRECTORS
WHICH WILL SUBSTANTIALLY DILUTE THE VALUE OF YOUR SHARES.
We have numerous agreements with our officers, directors and our scientific
advisory board members to compensate them with shares of our restricted common
stock and options to purchase our common stock. These include a grant to our
Chairman of the Board, Dr. David Moskowitz, of options to purchase up to 100
million shares of our common stock. These stock issuances will negatively affect
the value of your investment by substantially diluting the value of an
investment in our common stock. In addition, because our agreement with Dr.
Moskowitz provides that shares may be issued for the next ten years, should the
shares be issued, the value of your investment will be negatively affected
during that ten year period. For further information regarding these agreements,
please see our Material Agreements Section at page 6 and our Executive
Compensation Section at page 36.
BECAUSE OUR COMMON STOCK IS CONSIDERED A PENNY STOCK, ANY INVESTMENT IN OUR
COMMON STOCK IS CONSIDERED A HIGH-RISK INVESTMENT AND IS SUBJECT TO RESTRICTIONS
ON MARKETABILITY; YOU MAY BE UNABLE TO SELL YOUR SHARES.
If our common stock becomes tradable in the secondary market, we may be subject
to the penny stock rules adopted by the Securities and Exchange Commission that
require brokers to provide extensive disclosure to its customers prior to
executing trades in penny stocks. These disclosure requirements may cause a
reduction in the trading activity of our common stock, which in all likelihood
would make it difficult for our shareholders to sell their securities. For
additional details concerning the disclosure requirements under the penny stock
rules, see the section entitled Penny Stock Considerations at page 19 below.
-12-
PLAN OF OPERATIONS:
Delayed Operations
Our Plan of Operations was originally scheduled to occur from March 2002 to
March 2003; however, as of May 22, 2003, we have insufficient funds to continue
our Plan of Operations. Because we have insufficient funds to conduct our
operations as originally planned, we have ceased conducting our operations, as
follows:
o Dismissed two of our three employees, our Administrative Assistant and
Director of Research and Development; therefore, we have only one
employee, our President/Chairman of the Board/Chief Medical Officer,
David Moskowitz;
o We have not paid the $135,000 salary due to our President/Chairman of
the Board/Chief Medical Officer;
o We have no financial resources by which to pay for genotypes and for
the collection of blood from Hispanic patients with documented
disease;
o We have no financial resources to begin the collection of Caucasian,
African American, Asian and Hispanic samples for 52 diseases;
o We have no financial resources to conduct genotyping of Type 2 NIDDM
samples from patients with Type 2 Diabetes;
o We have no financial resources by to lease laboratory space; and
o We have no financial resources by which to hire a research assistant.
Accordingly, our Plan of Operations will be delayed until such time that we
obtain sufficient funding, as follows:
Annual
Type Expenditures Estimated Amount
------------------- ------------------
Salaries $ 500,000
------------------- ------------------
Operating Expenses* $ 200,000
------------------- ------------------
Genotyping $ 2,000,000
------------------- ------------------
Data Analysis $ 100,000
------------------- ------------------
Marketing $ 150,000
------------------- ------------------
Patents $ 30,000
------------------- ------------------
Total $ 2,980,000
==================
* Operating Expenses include office rent, utilities, and legal and accounting
expenses.
-13-
We intend to satisfy these estimated total expenditures of $2,980,000 for our
Plan of Operations through revenues or 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:
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.
-14-
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.
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 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.
-15-
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. 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.
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 with 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.
-16-
December 2002
We published in 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.
OUR PLAN OF OPERATIONS PENDING SUFFICIENT FINANCIAL RESOURCES
We intend to accomplish the following regarding our plan of operations over a
period of twelve months, when we have sufficient resources to do so.
Collections
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 GenoMed in St. Louis, Missouri for conversion to DNA. The
total approximate cost will be $125 per sample.
Establish Laboratory for Purpose of Collecting DNA from Blood
We plan to we lease space for a laboratory to conduct our testing and research
and development.
Hire Research Assistant
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.
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.
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.
-17-
Market to Health Care Plans
We have begun contacting 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.
Hispanic Collection of Blood Samples
We will arrange for the collection of blood from Hispanic patients with
documented disease. We will hire a firm to provide samples and to conduct
DNA preparation. The total anticipated estimated cost is $36,000.
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.
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, and Polster Lieder located in St. Louis, Missouri to help with
writing specific claims.
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.
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.
-18-
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
None
-19-
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: May 22, 2003
-20-
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: May 22, 2003
/s/ Dr. David Moskowitz
Dr. David Moskowitz
President/Chief Executive Officer/Chairman of the Board/Chief Financial
Officer/Chief Accounting Officer
-21-