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SEC Comment Letter for GENETHERA INC (CIK 0001017110) — Oct 7, 2004

GENETHERA INC (CIK 0001017110)
Date: Oct. 7, 2004 · CIK: 0001017110 · Accession: 0000000000-04-032282

AI Filing Summary & Sentiment

File numbers found in text: 333-118937

Date
October 7, 2004
Author
Not clearly detected
Form
UPLOAD
Company
GENETHERA INC (CIK 0001017110)

Letter

Mail Stop 3-09 October 7, 2004 Tony Milici, MD, Ph.D GeneThera, Inc. 3930 Youngfield Street Wheat Ridge, CO 80033

Re: GeneThera, Inc. Registration Statement on Form SB-2 File No. 333-118937

Dear Dr. Milici:

We have reviewed your filing only from a legal perspective and have the following comments. Where indicated, we think you should revise your documents in response to these comments. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary. Please be as detailed as necessary in your explanation. In some of our comments, we may ask you to provide us with supplemental information so we may better understand your disclosure. After reviewing this information, we may or may not raise additional comments.

Please understand that the purpose of our review process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or on any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter.

Form SB-2

General 1. In your next amendment, please update the disclosure, including updated financial information, and in your Risk Factor section, as of a recent date practicable. 2. Please provide updated interim financial information in accordance with Item 310(g) of Regulation S-B.

Registration Statement Cover Page 3. Although Form SB-2 does not contain a space to indicate that the securities are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, please revise to include this disclosure.

Prospectus Cover Page 4. Please revise the third line where you disclose the number of shares of common stock to say "up to 4,249,236 shares of common stock." 5. Please provide the information requested by Item 501 (a)(9)(iv) of Regulation S-B. 6. Please revise the cover page to delete the last sentence of the first paragraph and the three bullet paragraphs that follow. This information is not required by Item 501. Consideration should be given to relocating this information to the selling security holder section.

Prospectus summary, page 1 7. Please expand the discussion to briefly identify your second subsidiary and the nature of its business. 8. Please reconcile the reference to GeneThera (Colorado) as a subsidiary with the discussion in the last sentence on page 23 under "Certain Relationships and Related Transactions" which suggests the acquisition has not yet been completed. 9. Please file the InvestLinc Securities and NVO Solutions agreements as exhibits.

Risk Factors, page 3 10. We note your disclosure in the Recent Development sections that you are in default on notes payable in the amount of $44,517, including accrued interest. Please add a separate risk factor disclosing the risk and consequences of such default. In your discussion, please disclose the holders of such notes payable, and if you expect such parties to commence legal action. In the alternative, advise us as to why you do not believe a risk factor is necessary. 11. Given that insiders of the Company own approximately 64 % of the equity stock of GeneThera, please add a risk factor that discusses the risk and potential consequences to your market price of future sales of by these individuals. In your discussion, please include the number of your presently outstanding shares, the number that is freely tradable and the number that is subject to Rule 144. 12. Given the fluctuations in price that your shares have experienced in the last two years, please consider adding a quantified risk factor so that investors can appreciate the risk stemming from the volatility of your common stock. If you decide to add a risk factor discussing the volatility of your stock, please disclose the price range of your common stock during the most recent two fiscal years and interim period. Note that it is not necessary to replicate the table included on page 23 of your document under the subheading "Market for Common Equity and Related Stockholder Matters." Instead, you may disclose the high and low price during this period. In addition, please explain if any one particular factor has resulted or is anticipated in causing volatility in your stock price, if any. 13. Please include a risk factor that discusses your charter and bylaw provisions and how such provisions would prevent a change of control in management. In the alternative, advise us as to why you do not believe a risk factor is necessary. 14. Many of your subheadings currently either merely state a fact about your business, such as " We do not have a sales, marketing, or distribution capabilities and no experience in those areas," and "Many of our competitors and potential competitors have resources superior to ours," or describe an event that may occur in the future, such as "Our technology may conflict with patents held by others." Succinctly state in your subheadings the risks that result from the facts or uncertainties.

"We are not currently profitable and may never become profitable," page 3 15. Please revise your heading and accompanying discussion to include disclosure concerning the "going concern" opinion set forth in your accountants` consent.

We will continue to have significant capital needs and may not be able to obtain sufficient funding," page 3 16. Please revise the subheading to include the risk in the event additional funding is not obtained. 17. Please expand the discussion to indicate the additional funding required and when these funds are needed. In this regard, we note the discussion under "Liquidity and capital resources" on page 10.

"We may not obtain the necessary regulatory approvals to commercialize . . . .," page 3 18. Please briefly describe whether you have any applications before the USDA or other approvals for your key products, the stage of the approvals of your products in process, and the amount you have spent on research and development. You should provide more detailed disclosure in the "Business" section of your document. "Many of our competitors and potential competitors have resources superior . . . .," page 4 19. Please consider discussing your competitive position vis-.-vis other companies that are in your specific industry. If available, please identify your primary competitors.

"We are highly dependent on the services of our key personnel for our potential . . . .," page 6 20. Please identify the key personnel with whom you maintain employment agreements. We note your description of two employment agreements in your document.

"Current litigation involving the company," page 6 21. Please revise the subheading of this risk factor to clearly identify the risk and potential consequences. At present, this risk factor heading does not appear to adequately describe the risk to investors. Your reader should be able to understand the nature of the risk to the investment by reading the caption to your discussion. Please revise your subheading to clearly identify a risk.

"You may experience dilution in your ownership of shares of our common stock . . . .," page 7 22. Please disclose the dilution shareholders would experience if shares of your common stock were sold at a price as of a recent date. Please provide similar disclosure in the section of your document entitled "Dilution" on page 8. 23. Please expand the discussion to clarify how you determined the calculations used in the second paragraph. If the risk is to potential purchasers of the shares that are the subject of the current registration statement, at what price are the shares to be sold to potential purchasers? 24. Please revise the discussion in the prospectus where appropriate to discuss in greater detail the agreement with InvestLinc.

"We have never paid dividends on our common stock, and we do not anticipate . . . .," page 7 25. Revise this risk factor to express the risk to investors, for example, that investors will only see a return on their investment if the value of the shares appreciates.

Management`s Discussion and Analysis or Plan of Operation, page 9

Overview, page 9 26. Please address the topics required by Item 303 of Regulation S-B, including expected significant infrastructure changes during this period (e.g. increase/decrease in number of employees and plant start up) and a discussion of off-balance sheet arrangements that are reasonably likely to have a current or future effect on the Company`s financial condition, revenues, results of operations, liquidity, capital expenditures that is material to investors or state that none exist. 27. Please expand the discussion in the prospectus to address the specifics of your business plan referred to on page 10. 28. Please include a table of contractual obligations.

Three-month period ending June 30, 2004 Compared to Three-month period Ending June 30, 2003, page 9 29. We note your disclosure that you experienced a decline in gross profits from the same period last year "due to the research and development state the company is in at the present time." Please expand your description to specifically disclose what state the company is at present. For example, have you halted testing of certain proposed products or services? How was the state of your company different in this period as compared to the same period last year. 30. In addition, please clarify the product and/or services for which you received revenue in the 2003 period. 31. Please explain the reasons for the decrease in personnel (salaries) expenses.

Liquidity and Capital Resources, page 10 32. We note your have filed several agreements related to equity line credit agreements in your registration statement. Please describe the material terms of such agreements in this section.

Convertible Notes, page 10 33. Please identify the investors to whom you issued convertible promissory notes. 34. Please disclose the expiration date for each of the notes. In addition, indicate if you are currently in default on any of these notes. In this regard, we note your disclosure in the Recent Development sections that you are currently in default on a notes payable. 35. Please explain the discrepancies in the conversions that have occurred. For example, the May 16, 2003 note in the principle amount of $60,000 was convertible at a rate of $0.25 per share and was converted into 240,000 shares of common stock. However, the notes issued between May 17, 2003 and September 19, 2003 in the principle amount of $215,000 were convertible into common stock at a rate of $0.50 per share and the notes were converted into 436,926 shares, a number that exceeds the conversion ratio. Please advise or revise. 36. Please expand the discussion to clarify whether the consideration received in each note sale equaled the principal amount of the note issued. In this regard, we note the reference to the January 12, 2003 note sale in the principal amount of $120,000 and the fact only $36,900 was raised. In addition, we note the conversion ratio was $0.50 per share, yet the note was converted into 80,000 shares. Please advise or revise.

R&D Services, page 12 37. Please explain what the "Molecular Biology Potential Agreement Structure" is. In addition, please briefly describe what each of the stages you list entail. 38. Please provide supplemental support for the statement that your senior scientists have more than 100 years of research and development experience. In addition, please provide the information requested by Item 401(b) of Regulation SB.

Business model - page 13 39. Please expand the discussion to explain the absence of any revenues in 2004. If the products and services referred to in this section were available in 2003 and revenues were derived from such products and services, why were there no similar revenues in 2004?

Integrated Technology Platform (ITP), page 14 40. Please expand the discussions to identify the vaccines you have developed using the platform and the amount of time required to develop each of these vaccines. We may have additional comment.

GEA(tm) System, page 14 41. Please expand the discussion to clarify whether the GEA system is intended solely for your use or for sale to other laboratories. If the system can be sold to other laboratories, please indicate the number of units you have sold to date, indicating when such sales began. 42. Please expand the discussion to provide a balanced presentation including, any disadvantages to the GEA system and any advantages to other systems or methods available to test for veterinary diseases or food contamination. In this regard, we note your discussion concerning the methods use by "most labs" which phrase suggests alternatives are available. 43. Please expand the discussion to indicate when the GEA system was developed and the extent of its utilization to date.

Field Collection System, page 15 44. Please expand the discussion to indicate when the system was developed, when sales began, and the extent of sales to date. In this regard, we note your intent to begin a marketing campaign to achieve higher volume sales. Business, page 16 45. Please note that Item 101 of Regulation S-B requires the description of a small business issuer`s business during the last three years. Please revise your Business section to comply with this requirement. 46. Please provide disclosure of the background of the reverse acquisition by and between you and Hand Brand Distribution as well as the reverse acquisition of GeneThera. For example, discuss:

* the steps that led to the acquisition; * the reasons of the acquisition; * whether the negotiations were conducted on an "arms-length" basis; and * the assets and liabilities you acquired as a result of the acquisition. 47. For each product/service that is still in development, please disclose the status of any regulatory review or clinical trials; the estimated amounts required to complete development, testing and regulatory approval process; and when you anticipate commencement of the marketing efforts.

Competition, page 17 48. Please expand the discussion to include the development of emerging technologies or products that may compete with you and the current stage of development of these technologies or products.

Employees, page 19 49. Please disclose the status of your employee relations.

Properties, page 19 50. Please file your lease agreement as an exhibit.

Legal Matters, page 19 51. Please expand the discussion concerning each proceeding and counterclaim to include a description of the facts underlying the proceeding. For example, what is the specific nature of the fraud, breach of contract, and violation of state consumer protection law alleged in the counterclaim described in the first paragraph.

Directors and Executive Officers, page 19 52. Please disclose when you held your last annual meeting, and when you plan to hold your next annual meeting. 53. Please note that Item 401(a)(4) of Regulation S-B requires a brief description of the business experience of your officers and directors during each of the last five years. Many of your officer/director disclosure do not include the applicable dates. Please revise the discussion to provide the applicable dates that the officers/directors held their various positions. 54. Please also disclose the composition of your director committees.

Compensation of Directors and Executive Compensation, page 21

Employment Agreements, page 21 55. Your description of the employment agreements is too limited. Please revise your disclosure to include the following to the extent applicable:

* Do the employment agreements have renewable terms beyond the initial periods? * Are the annual salaries of each of execu

Show Raw Text
<DOCUMENT>
<TYPE>LETTER
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<TEXT>

Mail Stop 3-09

									October 7, 2004

Tony Milici, MD, Ph.D
GeneThera, Inc.
3930 Youngfield Street
Wheat Ridge, CO  80033

Re:	GeneThera, Inc.
	Registration Statement on Form SB-2
	File No. 333-118937

Dear Dr. Milici:

	We have reviewed your filing only from a legal perspective and
have the following comments.  Where indicated, we think you should
revise your documents in response to these comments.  If you
disagree, we will consider your explanation as to why our comment is
inapplicable or a revision is unnecessary.  Please be as detailed as
necessary in your explanation.  In some of our comments, we may ask
you to provide us with supplemental information so we may better
understand your disclosure.  After reviewing this information, we may
or may not raise additional comments.

	Please understand that the purpose of our review process is to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.
We look forward to working with you in these respects.  We welcome
any questions you may have about our comments or on any other aspect
of our review.  Feel free to call us at the telephone numbers listed
at the end of this letter.

Form SB-2

General
1. In your next amendment, please update the disclosure, including
updated financial information, and in your Risk Factor section, as of
a recent date practicable.
2. Please provide updated interim financial information in accordance
with Item 310(g) of Regulation S-B.

Registration Statement Cover Page
3. Although Form SB-2 does not contain a space to indicate that the
securities are to be offered on a delayed or continuous basis
pursuant to Rule 415 under the Securities Act of 1933, please revise
to include this disclosure.

Prospectus Cover Page
4. Please revise the third line where you disclose the number of
shares of common stock to say "up to 4,249,236 shares of common
stock."
5. Please provide the information requested by Item 501 (a)(9)(iv) of
Regulation S-B.
6. Please revise the cover page to delete the last sentence of the
first paragraph and the three bullet paragraphs that follow.  This
information is not required by Item 501.  Consideration should be
given to relocating this information to the selling security holder
section.

Prospectus summary, page 1
7. Please expand the discussion to briefly identify your second
subsidiary and the nature of its business.
8. Please reconcile the reference to GeneThera (Colorado) as a
subsidiary with the discussion in the last sentence on page 23 under
"Certain Relationships and Related Transactions" which suggests the
acquisition has not yet been completed.
9. Please file the InvestLinc Securities and NVO Solutions agreements
as exhibits.

Risk Factors, page 3
10. We note your disclosure in the Recent Development sections that
you are in default on notes payable in the amount of $44,517,
including accrued interest.  Please add a separate risk factor
disclosing the risk and consequences of such default.  In your
discussion, please disclose the holders of such notes payable, and if
you expect such parties to commence legal action. In the alternative,
advise us as to why you do not believe a risk factor is necessary.
11. Given that insiders of the Company own approximately 64 % of the
equity stock of GeneThera, please add a risk factor that discusses
the risk and potential consequences to your market price of future
sales of by these individuals.  In your discussion, please include
the number of your presently outstanding shares, the number that is
freely tradable and the number that is subject to Rule 144.
12. Given the fluctuations in price that your shares have experienced
in the last two years, please consider adding a quantified risk
factor so that investors can appreciate the risk stemming from the
volatility of your common stock. If you decide to add a risk factor
discussing the volatility of your stock, please disclose the price
range of your common stock during the most recent two fiscal years
and interim period.  Note that it is not necessary to replicate the
table included on page 23 of your document under the subheading
"Market for Common Equity and Related Stockholder Matters."  Instead,
you may disclose the high and low price during this period. In
addition, please explain if any one particular factor has resulted or
is anticipated in causing volatility in your stock price, if any.
13. Please include a risk factor that discusses your charter and
bylaw provisions and how such provisions would prevent a change of
control in management. In the alternative, advise us as to why you do
not believe a risk factor is necessary.
14. Many of your subheadings currently either merely state a fact
about your business, such as " We do not have a sales, marketing, or
distribution capabilities and no experience in those areas," and
"Many of our competitors and potential competitors have resources
superior to ours,"  or describe an event that may occur in the
future, such as "Our technology may conflict with patents held by
others."  Succinctly state in your subheadings the risks that result
from the facts or uncertainties.

"We are not currently profitable and may never become profitable,"
page 3
15. Please revise your heading and accompanying discussion to include
disclosure concerning the "going concern" opinion set forth in your
accountants` consent.

We will continue to have significant capital needs and may not be
able to obtain sufficient funding," page 3
16. Please revise the subheading to include the risk in the event
additional funding is not obtained.
17. Please expand the discussion to indicate the additional funding
required and when these funds are needed.  In this regard, we note
the discussion under "Liquidity and capital resources" on page 10.

"We may not obtain the necessary regulatory approvals to
commercialize . . . .," page 3
18. Please briefly describe whether you have any applications before
the USDA or other approvals for your key products, the stage of the
approvals of your products in process, and the amount you have spent
on research and development.  You should provide more detailed
disclosure in the "Business" section of your document.
"Many of our competitors and potential competitors have resources
superior . . . .," page 4
19. Please consider discussing your competitive position vis-.-vis
other companies that are in your specific industry.  If available,
please identify your primary competitors.

"We are highly dependent on the services of our key personnel for our
potential . . . .," page 6
20. Please identify the key personnel with whom you maintain
employment agreements. We note your description of two employment
agreements in your document.

"Current litigation involving the company," page 6
21. Please revise the subheading of this risk factor to clearly
identify the risk and potential consequences.  At present, this risk
factor heading does not appear to adequately describe the risk to
investors.  Your reader should be able to understand the nature of
the risk to the investment by reading the caption to your discussion.
Please revise your subheading to clearly identify a risk.

"You may experience dilution in your ownership of shares of our
common stock . . . .," page 7
22. Please disclose the dilution shareholders would experience if
shares of your common stock were sold at a price as of a recent date.
Please provide similar disclosure in the section of your document
entitled "Dilution" on page 8.
23. Please expand the discussion to clarify how you determined the
calculations used in the second paragraph.  If the risk is to
potential purchasers of the shares that are the subject of the
current registration statement, at what price are the shares to be
sold to potential purchasers?
24. Please revise the discussion in the prospectus where appropriate
to discuss in greater detail the agreement with InvestLinc.

"We have never paid dividends on our common stock, and we do not
anticipate . . . .," page 7
25. Revise this risk factor to express the risk to investors, for
example, that investors will only see a return on their investment if
the value of the shares appreciates.

Management`s Discussion and Analysis or Plan of Operation, page 9

Overview, page 9
26. Please address the topics required by Item 303 of Regulation S-B,
including expected significant infrastructure changes during this
period (e.g. increase/decrease in number of employees and plant start
up) and a discussion of off-balance sheet arrangements that are
reasonably likely to have a current or future effect on the Company`s
financial condition, revenues, results of operations, liquidity,
capital expenditures that is material to investors or state that none
exist.
27. Please expand the discussion in the prospectus to address the
specifics of your business plan referred to on page 10.
28. Please include a table of contractual obligations.

Three-month period ending June 30, 2004 Compared to Three-month
period Ending June 30, 2003, page 9
29. We note your disclosure that you experienced a decline in gross
profits from the same period last year "due to the research and
development state the company is in at the present time."  Please
expand your description to specifically disclose what state the
company is at present.  For example, have you halted testing of
certain proposed products or services?  How was the state of your
company different in this period as compared to the same period last
year.
30. In addition, please clarify the product and/or services for which
you received revenue in the 2003 period.
31. Please explain the reasons for the decrease in personnel
(salaries) expenses.

Liquidity and Capital Resources, page 10
32. We note your have filed several agreements related to equity line
credit agreements in your registration statement.  Please describe
the material terms of such agreements in this section.

Convertible Notes, page 10
33. Please identify the investors to whom you issued convertible
promissory notes.
34. Please disclose the expiration date for each of the notes.  In
addition, indicate if you are currently in default on any of these
notes.  In this regard, we note your disclosure in the Recent
Development sections that you are currently in default on a notes
payable.
35. Please explain the discrepancies in the conversions that have
occurred.  For example, the May 16, 2003 note in the principle amount
of $60,000 was convertible at a rate of $0.25 per share and was
converted into 240,000 shares of common stock.  However, the notes
issued between May 17, 2003 and September 19, 2003 in the principle
amount of $215,000 were convertible into common stock at a rate of
$0.50 per share and the notes were converted into 436,926 shares, a
number that exceeds the conversion ratio.  Please advise or revise.
36. Please expand the discussion to clarify whether the consideration
received in each note sale equaled the principal amount of the note
issued.  In this regard, we note the reference to the January 12,
2003 note sale in the principal amount of $120,000 and the fact only
$36,900 was raised.  In addition, we note the conversion ratio was
$0.50 per share, yet the note was converted into 80,000 shares.
Please advise or revise.

R&D Services, page 12
37. Please explain what the "Molecular Biology Potential Agreement
Structure" is.  In addition, please briefly describe what each of the
stages you list entail.
38. Please provide supplemental support for the statement that your
senior scientists have more than 100 years of research and
development experience.  In addition, please provide the information
requested by Item 401(b) of Regulation SB.

Business model - page 13
39. Please expand the discussion to explain the absence of any
revenues in 2004.  If the products and services referred to in this
section were available in 2003 and revenues were derived from such
products and services, why were there no similar revenues in 2004?

Integrated Technology Platform (ITP), page 14
40. Please expand the discussions to identify the vaccines you have
developed using the platform and the amount of time required to
develop each of these vaccines.  We may have additional comment.

GEA(tm) System, page 14
41. Please expand the discussion to clarify whether the GEA system is
intended solely for your use or for sale to other laboratories.  If
the system can be sold to other laboratories, please indicate the
number of units you have sold to date, indicating when such sales
began.
42. Please expand the discussion to provide a balanced presentation
including, any disadvantages to the GEA system and any advantages to
other systems or methods available to test for veterinary diseases or
food contamination.  In this regard, we note your discussion
concerning the methods use by "most labs" which phrase suggests
alternatives are available.
43. Please expand the discussion to indicate when the GEA system was
developed and the extent of its utilization to date.

Field Collection System, page 15
44. Please expand the discussion to indicate when the system was
developed, when sales began, and the extent of sales to date.  In
this regard, we note your intent to begin a marketing campaign to
achieve higher volume sales.
Business, page 16
45. Please note that Item 101 of Regulation S-B requires the
description of a small business issuer`s business during the last
three years. Please revise your Business section to comply with this
requirement.
46. Please provide disclosure of the background of the reverse
acquisition by and between you and Hand Brand Distribution as well as
the reverse acquisition of GeneThera.  For example, discuss:

* the steps that led to the acquisition;
* the reasons of the acquisition;
* whether the negotiations were conducted on an "arms-length" basis;
and
* the assets and liabilities you acquired as a result of the
acquisition.
47. For each product/service that is still in development, please
disclose the status of any regulatory review or clinical trials; the
estimated amounts required to complete development, testing and
regulatory approval process; and when you anticipate commencement of
the marketing efforts.

Competition, page 17
48. Please expand the discussion to include the development of
emerging technologies or products that may compete with you and the
current stage of development of these technologies or products.

Employees, page 19
49. Please disclose the status of your employee relations.

Properties, page 19
50. Please file your lease agreement as an exhibit.

Legal Matters, page 19
51. Please expand the discussion concerning each proceeding and
counterclaim to include a description of the facts underlying the
proceeding.  For example, what is the specific nature of the fraud,
breach of contract, and violation of state consumer protection law
alleged in the counterclaim described in the first paragraph.

Directors and Executive Officers, page 19
52. Please disclose when you held your last annual meeting, and when
you plan to hold your next annual meeting.
53. Please note that Item 401(a)(4) of Regulation S-B requires a
brief description of the business experience of your officers and
directors during each of the last five years.  Many of your
officer/director disclosure do not include the applicable dates.
Please revise the discussion to provide the applicable dates that the
officers/directors held their various positions.
54. Please also disclose the composition of your director committees.

Compensation of Directors and Executive Compensation, page 21

Employment Agreements, page 21
55. Your description of the employment agreements is too limited.
Please revise your disclosure to include the following to the extent
applicable:

* Do the employment agreements have renewable terms beyond the
initial periods?
* Are the annual salaries of each of execu