Correspondence 0001903596-23-000489 from LUDWIG ENTERPRISES, INC. (LUDG)
LUDWIG ENTERPRISES, INC.
Date: June 21, 2023 · CIK: 0001960262 · Accession: 0001903596-23-000489
AI Filing Summary & Sentiment
File numbers found in text: 333-271439
Referenced dates: May 9, 2023
Letter
Office of Industrial Applications and Services Division of Corporation Finance Securities and Exchange Commission Re: Ludwig Enterprises, Inc. Registration Statement on Form S-1 Filed April 26, 2023 File No. 333-271439
Dear Ms. Lochhead:
This is in response to the letter of comment of the Staff dated May 9, 2023, relating to the captioned Registration Statement on Form S-1 of Ludwig Enterprises, Inc. (the “Company”). The comments of the Staff is addressed below, seriatim:
Registration Statement on Form S-1
Use of Proceeds, page 23
1. We note your response to comment 8 and your revisions to your disclosure here. You state on page 26 that “[y]our management has determined that expenditures for clinical trials and marketing would be the last expenditure items to be reduced” if you were required to prioritize your expenditures in the case you do not sell all of the offered shares. We also note, however, that you intend to purchase equipment with which you expect to analyze mRNA samples.
Please clarify whether these purchases of equipment are necessary to conducting your clinical trials and whether or not you will prioritize these equipment purchases.
Revisions to the subject disclosure that provide clarification have been made, in response to such comment. Also, the disclosure with respect to prioritization of expenditures is presented in the next to last paragraph of the section.
Additionally, with respect to the funds you intend to put towards your research and clinical trials, please provide further details with respect to what aspects of your research and clinical development you intend to support with these funds, including reference to how far into the research and development processes the proceeds will enable you to reach. For example, please discuss how far into the development and execution of your current research study and additional planned research studies as described on pages 39 through 41 you expect the proceeds will enable you to reach.
Disclosure with respect to the Company’s planned clinical trials has been added, in response to such comment.
2. We note your statement here that “[y]our plan is to develop specific antibodies that bind to these genes and market them to biotech- and pharma-companies to treat chronic inflammatory diseases, such as cancer, diabetes and heart disease.”
Please clarify whether your current and planned clinical research studies will support your plan to develop these antibodies.
Revisions to the subject disclosure in that provide clarification have been made, in response to such comment.
Please also expand your disclosure in your “Our Strategy” section on page 40 to discuss your plans to develop and market antibodies to treat chronic inflammatory diseases, including your plan to “organize an antibody research lab.”
Additional disclosure as been added under “Our Strategy,” in response to such comment.
Business
Background, page 36
3. We note your response to comment 12 and your revised disclosure on page 36. Please expand your disclosure to briefly discuss why the April 2019 acquisition of Direct Mortgage Investors, Inc. was rescinded in September 2021 and why the management team decided at that time to move in the direction of the current business plan.
Additional disclosure has been added, in response to such comment.
Please also expand your disclosure to briefly explain how the business plan “gained clarity” in late 2021.
Additional disclosure has been added, in response to such comment.
My RNA for Life Home Test Kits, page 38
4. We note your response to comment 15 and we reissue the comment in part. We note that you have revised your disclosure to state that you have "developed, internally, a variety of statistical and data analysis approaches, all centering around a combined representation of machine learning and clustering methodology." Please expand your discussion here to clearly explain what your machine learning approach and clustering methodology are and then to discuss how you have used these to develop the various statistical and data analysis approaches that you use. Please also clarify your disclosure in your discussion of your clinical research studies starting on page 39 to explain how these combined approaches will be applied in your studies, including if the three models you discuss here will be examined in each study.
Additions to the subject disclosure have been made, in response to such comment.
Current Research Study, page 39
5. We note your response to comment 13 and your revised disclosure on page 39. Please define “Elisa-based protein cellular biomarkers” and “Elisa technology.”
Additions to the subject disclosure have been made, in response to such comment.
Please also revise to clarify what "unique bioinformatics strategy" you will use in addition to the Elisa technology.
Additions to the subject disclosure have been made, in response to such comment.
We also note that you plan to perform statistical analysis. Please revise your disclosure to discuss when measurements will be taken using your My RNA for Life test kits and to clarify how the measurements may then be used to develop an "L-genomic bladder cancer risk score." It may be helpful to discuss step-by-step how the study will be conducted, including at what stages measurements will be taken and then how those measurements will be used to perform a statistical analysis and generate a cancer risk score.
Additions to the subject disclosure have been made, in response to such comment.
Dietary Supplement Formula License, page 39
6. We note your response to comment 16 and your inclusion of the agreement with Xikoz, Inc. as Exhibit 10.8. We note that the December 6, 2022 press release stated that “[t]he compounds within this formula have the potential to modulate inflammatory conditions that are the root causes of many chronic diseases.” Please expand your disclosure to discuss how this dietary supplement, “FlamaBlue,” is different from your My RNA for Life™ Genetic Centric Supplement and discuss how it will fit into your overall business strategy. For example, please discuss whether you plan to market FlamaBlue to the same customers as your My RNA for Life™ Genetic Centric Supplement.
Additions to the subject disclosure have been made, in response to such comment.
Intellectual Property, page 42
7. We note your response to comment 20 and reissue the comment in part. Please revise to include the type of patent protection for which you have applied.
Revisions to the subject disclosure have been made, in response to such comment.
Manufacturing and Distribution, page 45
8. We note your response to comment 23 and your revised disclosure on page 45. We note that Designer Genomics Inc serves as one of your two CROs. We also note your disclosure on page F-15 that in July 2022 you acquired the assets of Designer Genomics International, Inc. and that those assets "consisted solely of the technological know-how of its owners." You also state that Designer Genomics International, Inc. "was a dormant inactive entity at the time of the asset purchase." Please clarify whether there is any relation between the Designer Genomics Inc that serves as your CRO and Designer Genomics International, Inc., the entity whose assets you acquired in July 2022. To the extent that you have a material agreement in place with Designer Genomics Inc as your CRO, please revise your disclosure to include the material terms of that agreement. Please also file the agreement as an exhibit to the registration statement, or, n the alternative, please tell us why you believe that you are not required to file the agreement. Refer to Item 601(b)(10) of Regulation S-K.
Please be advised that references in the prior disclosure to Designer Genomics, Inc.’s being one of the Company’s CRO’s was in error. Designer Genomics International, Inc. is, and always has been, the Company’s only CRO.
In July 2022, the Company acquired assets (that consisted solely of the technological know-how) from Designer Genomics, a partnership of parties not affiliated with the Company. Designer Genomics, the partnership, is now defunct. The Company’s agreement with Designer Genomics has been included in the amended filing as Exhibit 10.9.
Management, page 47
9. We note your response to comment 26 and your revised disclosure here. With respect to your consulting agreement with Homeopathic Partners, Inc., please clarify the termination provisions, including whether there is any connection between this agreement and Dr. Hausman’s consulting agreement. Additionally, please file an executed version of the consulting agreement dated July 1, 2022 with Homeopathic Partners, Inc. as Exhibit 10.4. The current agreement filed as Exhibit 10.4 only appears to be executed by the Registrant.
Please be advised that the reference to Dr. Hausman in the paragraph relating to Homeopathic Partners was the result of scrivener’s error. The reference is now made properly to Homeopathic Partners.
A fully signed copy of the agreement with Homeopathic Partners, Inc. is included in the amended filing as Exhibit 10.4.
Executive Compensation, page 49
10. We note there appears to be a footnote number 5 following the name of Jean Cherubin, however, there is no corresponding footnote below in this section. Please revise to include the missing footnote.
Please be advised the “5” was a typographical error and has been removed.
Item 16. Exhibits and Financial Statement Schedules, page II-2
11. We note your response to comment 29 and reissue the comment. Please file your Bylaws as Exhibit 3.3.
Please be advised that the Company’s Bylaws have been included in the amended filing as Exhibit 3.3.
12. We note that you state that Exhibits 4.1 through 4.25, with the exception of Exhibit 4.19, have been "Filed previously." However, we also note that in your prior Draft Registration Statement filed on February 15, 2023 you stated that Exhibits 4.1 through 4.25 were "To be filed by amendment" and the exhibits were not filed at that time. Please file the exhibits or revise to clarify that they will be filed by future amendment.
Please be advised that the amended filing includes all referenced exhibits, which references are now accurate.
General
13. We note various publicly available press releases, including on your official Twitter page, discussing recent strategic steps, including partnerships and product launches, which do not appear to be discussed in your registration statement. These press releases include:
• A May 3, 2023 press release titled, “Ludwig Enterprises to Launch New Nutraceutical in Hair Loss Market” discussing your plans “to expand [your] direct to consumer and direct to professional sales and marketing strategies to include individuals facing hair loss associated with inflammation.”
A new section entitled “Recent Developments” has been added under “Business.” Disclosure associated with the May 3, 2023, press release is included.
• An April 25, 2023 press release titled, “Ludwig Enterprises Announces Launch of New Nutraceutical and Strategic Marketing Plan” discussing the launch of your “ground-breaking nutraceutical, NuGenea™” and the release of your “strategic sales and marketing plan” for NuGenea.
Please be advised that the overall disclosure in the amended filing embodies the information described in the April 25, 2023, press release.
• A March 23, 2023 press release titled, “Ludwig Enterprises Announces Agreement with Summit Bancorp to Assist with Cross Listing on the Canadian Stock Exchange” announcing you signed an agreement with Summit Bancorp of Ontario Canada to assist you with cross listing on the Canadian Stock Exchange.
• A March 21, 2023 press release titled, “Ludwig Enterprises Announces Intention to List on the Canadian Stock Exchange” and a March 21, 2023 Tweet, each announcing your intention to file a Non-Offering Prospectus in the second quarter of 2023 to enable you to be listed on the Canadian Stock Exchange.
In the new section entitled “Recent Developments,” disclosure associated with the press releases of March 23, 2023, and March 21, 2023, is included.
• A
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CORRESP
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filename1.htm
NEWLAN
LAW FIRM, PLLC
2201
Long Prairie Road, Suite 107-762
Flower
Mound, Texas 75022
June
21, 2023
Kristin
Lochhead
Office
of Industrial Applications and Services
Division
of Corporation Finance
Securities
and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Re: Ludwig
Enterprises, Inc.
Registration
Statement on Form S-1
Filed
April 26, 2023
File
No. 333-271439
Dear
Ms. Lochhead:
This
is in response to the letter of comment of the Staff dated May 9, 2023, relating to the captioned Registration Statement on Form S-1
of Ludwig Enterprises, Inc. (the “Company”). The comments of the Staff is addressed below, seriatim:
Registration
Statement on Form S-1
Use
of Proceeds, page 23
1. We
note your response to comment 8 and your revisions to your disclosure here. You state on
page 26 that “[y]our management has determined that expenditures for clinical trials
and marketing would be the last expenditure items to be reduced” if you were required
to prioritize your expenditures in the case you do not sell all of the offered shares. We
also note, however, that you intend to purchase equipment with which you expect to analyze
mRNA samples.
Please
clarify whether these purchases of equipment are necessary to conducting your clinical trials and whether or not you will prioritize
these equipment purchases.
Revisions
to the subject disclosure that provide clarification have been made, in response to such comment. Also, the disclosure with respect to
prioritization of expenditures is presented in the next to last paragraph of the section.
Additionally,
with respect to the funds you intend to put towards your research and clinical trials, please provide further details with respect to
what aspects of your research and clinical development you intend to support with these funds, including reference to how far into the
research and development processes the proceeds will enable you to reach. For example, please discuss how far into the development and
execution of your current research study and additional planned research studies as described on pages 39 through 41 you expect the proceeds
will enable you to reach.
Disclosure
with respect to the Company’s planned clinical trials has been added, in response to such comment.
2. We
note your statement here that “[y]our plan is to develop specific antibodies that bind
to these genes and market them to biotech- and pharma-companies to treat chronic inflammatory
diseases, such as cancer, diabetes and heart disease.”
Please
clarify whether your current and planned clinical research studies will support your plan to develop these antibodies.
Revisions
to the subject disclosure in that provide clarification have been made, in response to such comment.
Please
also expand your disclosure in your “Our Strategy” section on page 40 to discuss your plans to develop and market antibodies
to treat chronic inflammatory diseases, including your plan to “organize an antibody research lab.”
Additional
disclosure as been added under “Our Strategy,” in response to such comment.
Business
Background,
page 36
3. We
note your response to comment 12 and your revised disclosure on page 36. Please expand your
disclosure to briefly discuss why the April 2019 acquisition of Direct Mortgage Investors,
Inc. was rescinded in September 2021 and why the management team decided at that time to
move in the direction of the current business plan.
Additional
disclosure has been added, in response to such comment.
Please
also expand your disclosure to briefly explain how the business plan “gained clarity” in late 2021.
Additional
disclosure has been added, in response to such comment.
My
RNA for Life Home Test Kits, page 38
4. We
note your response to comment 15 and we reissue the comment in part. We note that you have
revised your disclosure to state that you have "developed, internally, a variety of
statistical and data analysis approaches, all centering around a combined representation
of machine learning and clustering methodology." Please expand your discussion here
to clearly explain what your machine learning approach and clustering methodology are and
then to discuss how you have used these to develop the various statistical and data analysis
approaches that you use. Please also clarify your disclosure in your discussion of your clinical
research studies starting on page 39 to explain how these combined approaches will be applied
in your studies, including if the three models you discuss here will be examined in each
study.
Additions
to the subject disclosure have been made, in response to such comment.
Current
Research Study, page 39
5. We
note your response to comment 13 and your revised disclosure on page 39. Please define “Elisa-based
protein cellular biomarkers” and “Elisa technology.”
Additions
to the subject disclosure have been made, in response to such comment.
Please
also revise to clarify what "unique bioinformatics strategy" you will use in addition to the Elisa technology.
Additions
to the subject disclosure have been made, in response to such comment.
We
also note that you plan to perform statistical analysis. Please revise your disclosure to discuss when measurements will be taken using
your My RNA for Life test kits and to clarify how the measurements may then be used to develop an "L-genomic bladder cancer risk
score." It may be helpful to discuss step-by-step how the study will be conducted, including at what stages measurements will be
taken and then how those measurements will be used to perform a statistical analysis and generate a cancer risk score.
Additions
to the subject disclosure have been made, in response to such comment.
Dietary
Supplement Formula License, page 39
6. We
note your response to comment 16 and your inclusion of the agreement with Xikoz, Inc. as
Exhibit 10.8. We note that the December 6, 2022 press release stated that “[t]he compounds
within this formula have the potential to modulate inflammatory conditions that are the root
causes of many chronic diseases.” Please expand your disclosure to discuss how this
dietary supplement, “FlamaBlue,” is different from your My RNA for Life™
Genetic Centric Supplement and discuss how it will fit into your overall business strategy.
For example, please discuss whether you plan to market FlamaBlue to the same customers as
your My RNA for Life™ Genetic Centric Supplement.
Additions
to the subject disclosure have been made, in response to such comment.
Intellectual
Property, page 42
7. We
note your response to comment 20 and reissue the comment in part. Please revise to include
the type of patent protection for which you have applied.
Revisions
to the subject disclosure have been made, in response to such comment.
Manufacturing
and Distribution, page 45
8. We
note your response to comment 23 and your revised disclosure on page 45. We note that Designer
Genomics Inc serves as one of your two CROs. We also note your disclosure on page F-15 that
in July 2022 you acquired the assets of Designer Genomics International, Inc. and that those
assets "consisted solely of the technological know-how of its owners." You also
state that Designer Genomics International, Inc. "was a dormant inactive entity at the
time of the asset purchase." Please clarify whether there is any relation between the
Designer Genomics Inc that serves as your CRO and Designer Genomics International, Inc.,
the entity whose assets you acquired in July 2022. To the extent that you have a material
agreement in place with Designer Genomics Inc as your CRO, please revise your disclosure
to include the material terms of that agreement. Please also file the agreement as an exhibit
to the registration statement, or, n the alternative, please tell us why you believe that
you are not required to file the agreement. Refer to Item 601(b)(10) of Regulation S-K.
Please
be advised that references in the prior disclosure to Designer Genomics, Inc.’s being one of the Company’s CRO’s was
in error. Designer Genomics International, Inc. is, and always has been, the Company’s only CRO.
In
July 2022, the Company acquired assets (that consisted solely of the technological know-how) from Designer Genomics, a partnership of
parties not affiliated with the Company. Designer Genomics, the partnership, is now defunct. The Company’s agreement with Designer
Genomics has been included in the amended filing as Exhibit 10.9.
Management,
page 47
9. We
note your response to comment 26 and your revised disclosure here. With respect to your consulting
agreement with Homeopathic Partners, Inc., please clarify the termination provisions, including
whether there is any connection between this agreement and Dr. Hausman’s consulting
agreement. Additionally, please file an executed version of the consulting agreement dated
July 1, 2022 with Homeopathic Partners, Inc. as Exhibit 10.4. The current agreement filed
as Exhibit 10.4 only appears to be executed by the Registrant.
Please
be advised that the reference to Dr. Hausman in the paragraph relating to Homeopathic Partners was the result of scrivener’s error.
The reference is now made properly to Homeopathic Partners.
A
fully signed copy of the agreement with Homeopathic Partners, Inc. is included in the amended filing as Exhibit 10.4.
Executive
Compensation, page 49
10. We
note there appears to be a footnote number 5 following the name of Jean Cherubin, however,
there is no corresponding footnote below in this section. Please revise to include the missing
footnote.
Please
be advised the “5” was a typographical error and has been removed.
Item
16. Exhibits and Financial Statement Schedules, page II-2
11. We
note your response to comment 29 and reissue the comment. Please file your Bylaws as Exhibit
3.3.
Please
be advised that the Company’s Bylaws have been included in the amended filing as Exhibit 3.3.
12. We
note that you state that Exhibits 4.1 through 4.25, with the exception of Exhibit 4.19, have
been "Filed previously." However, we also note that in your prior Draft Registration
Statement filed on February 15, 2023 you stated that Exhibits 4.1 through 4.25 were "To
be filed by amendment" and the exhibits were not filed at that time. Please file the
exhibits or revise to clarify that they will be filed by future amendment.
Please
be advised that the amended filing includes all referenced exhibits, which references are now accurate.
General
13. We
note various publicly available press releases, including on your official Twitter page,
discussing recent strategic steps, including partnerships and product launches, which do
not appear to be discussed in your registration statement. These press releases include:
• A
May 3, 2023 press release titled, “Ludwig Enterprises to Launch New Nutraceutical in
Hair Loss Market” discussing your plans “to expand [your] direct to consumer
and direct to professional
sales and marketing strategies to include individuals facing hair loss associated with inflammation.”
A
new section entitled “Recent Developments” has been added under “Business.” Disclosure associated with the May
3, 2023, press release is included.
• An
April 25, 2023 press release titled, “Ludwig Enterprises Announces Launch of New Nutraceutical
and Strategic Marketing Plan” discussing the launch of your “ground-breaking
nutraceutical, NuGenea™” and the release of your “strategic sales and marketing
plan” for NuGenea.
Please
be advised that the overall disclosure in the amended filing embodies the information described in the April 25, 2023, press release.
• A
March 23, 2023 press release titled, “Ludwig Enterprises Announces Agreement with Summit
Bancorp to Assist with Cross Listing on the Canadian Stock Exchange” announcing you
signed an agreement with Summit Bancorp of Ontario Canada to assist you with cross listing
on the Canadian Stock Exchange.
• A
March 21, 2023 press release titled, “Ludwig Enterprises Announces Intention to List
on the Canadian Stock Exchange” and a March 21, 2023 Tweet, each announcing your intention
to file a Non-Offering Prospectus in the second quarter of 2023 to enable you to be listed
on the Canadian Stock Exchange.
In
the new section entitled “Recent Developments,” disclosure associated with the press releases of March 23, 2023, and March
21, 2023, is included.
• A