Correspondence 0001903596-23-000542 from LUDWIG ENTERPRISES, INC. (LUDG)
LUDWIG ENTERPRISES, INC.
Date: July 18, 2023 · CIK: 0001960262 · Accession: 0001903596-23-000542
AI Filing Summary & Sentiment
File numbers found in text: 333-271439
Referenced dates: July 11, 2023
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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
July
__, 2023
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.
Amendment
No. 1 to
Registration
Statement on Form S-1
Filed
June 21, 2023
File
No. 333-271439
Ladies
and Gentlemen:
This
is in response to the letter of comment of the Staff dated July 11, 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:
Amendment
No. 1 to Form S-1 filed on June 21, 2023
Cover
Page
1. Please
revise your cover page to highlight that each share of your Convertible Preferred Stock (i)
is convertible into 100 shares of your common stock at any time, (ii) votes on all matters
as a class with the holders of common stock and (iii) shall be entitled to 100 votes per
share.
Revisions
to the disclosure on the cover page have been made, in response to such comment.
Use
of Proceeds, page 25
2. We
note your response to prior comment 1 and your revised disclosure here including details
of your three planned clinical trials. Please revise your disclosure related to each of these
three planned clinical trials on pages 39-40 under your Business section to include the level
of detail you have included here, in particular for your Preeclampsia and Cardiovascular/Heart
Diseases studies. For each planned clinical trial, please revise your disclosure to specify,
to the extent known, the primary and secondary endpoints. For your studies that have not
yet received Institutional Review Boards (IRB) approval, please briefly describe the process
for obtaining IRB approval and state that there is no guarantee of approval on the timeline
you anticipate or at all.
Revisions
to the subject disclosure in the “Additional Planned Research Studies” section under “Business” have been made,
in response to such comment.
Item
7. Management's Discussion and Analysis of Financial Condition and Results of Operations
Results
of Operations, Three Months Ended March 31, 2023, compared to the Three Months
Ended
March 31, 2022, page 30
3. Revise
to include a discussion within Results of Operations of research and development expense
recorded for the three months ended March 31, 2023. In that regard, we see that in February
2023 you issued 1,000,000 shares of common stock, at a fair value of $370,0000, in exchange
for the right to license, manufacture and market nutraceutical products. Please revise your
financial statements to disclose the accounting basis for the point in time recognition of
the expense for research and development at inception of the agreement. Discuss the accounting
literature upon which you relied.
In
response to such comment, revisions to the subject disclosure in “Results of Operations” section have been made. Additionally,
Note 4 to the March 31, 2023, financials statements has been revised.
Further,
please be advised that, during the Three Months Ended March 31, 2023, the Company expensed the entire amount of $370,000 related to the
issuance of common stock as a component of research and development due to the lack of viability of the right to license, manufacture
and market certain nutraceutical products. The Company believes that the rights acquired are related to products that have never been
launched and would require significant additional capital to commercialize.
In
this case, the Company was attempting to obtain intellectual property that may become usable in the future, but that has no current value.
This intellectual property currently serves as a basis for the Company’s research and development activities. The Company also
understands it does not have functional intellectual property in its current form.
As a result, expensing of the costs associated
with the license is akin to an impairment, due to there being no identifiable future economic benefit and lacking the substance of the
definition of an asset.
From an accounting policy perspective,
Accounting Standard Codification (“ASC”) 350 “Goodwill and Other Intangible Assets” requires that assets with
indefinite lives no longer be amortized, but instead be subject to annual impairment tests.
Following the guidelines contained in ASC
350, the Company tests goodwill and intangible assets that are not subject to amortization for impairment annually or more frequently
if events or circumstances indicate that impairment is possible. The Company has elected to conduct its annual test during the first quarter.
During the quarter ended March 31, 2023, management qualitatively assessed goodwill to determine whether testing was necessary. Factors
that management considered in this assessment included macroeconomic conditions, industry and market considerations, overall financial
performance (both current and projected), changes in management and strategy, and changes in the composition and carrying amounts of net
assets. If this qualitative assessment indicates that it is more likely than not that the fair value of a reporting unit is less than
its carrying value, a quantitative assessment is then performed. Based on the qualitative analysis conducted during the quarter, management
performed a quantitative analysis determining that the asset was not recoverable and would need to be expensed on the grant date.
Pursuant to the guidance in ASC 350-30-35-1,
the Company considered capitalizing this license based on its useful life. ASC 350-30-35-2 discusses the useful life of an intangible
asset to an entity as the period over which the asset is expected to contribute directly or indirectly to the future cash flows of that
entity.
In reaching its conclusion to expense the
issuance on the grant date and in accordance with ASC 350-30-35-3, the Company evaluated pertinent factors in trying to arrive at this
estimate. Ultimately, the Company concluded that, since the intellectual property cannot be commercialized at this time, the expected
use of the asset, as well as the Company’s historical experience (very limited), would not support capitalizing an asset that would
have been deemed non-recoverable on the acquisition date. Finally, shortly after the acquisition of the license, the Company determined
that it would not pursue the commercialization of any products under the agreement.
The filing has been revised to reflect
the foregoing discussion.
Recent
Developments, page 37
4. We
note your response to prior comment 13 and your revised disclosure here. We also note that
you intended to apply for OTCQB listing in June 2023. Please revise your disclosure to discuss
the current status of this application. Additionally, with respect to the agreements you
have entered into with the Fannon Group as well as with Dr. Kim Farahay and Dr. Jeff Lee,
please revise your "Our Planned Marketing and Distribution" and "Our Planned
Programs and Services" sections to discuss each of these agreements, including all material
provisions, and how they impact your planned marketing strategy and your planned services.
Please also file each of these agreements as an exhibit, or, in the alternative, please tell
us why you believe that you are not required to file the agreements. Refer to Item 601(b)(10)
of Regulation S-K. Last, as your filing review progresses, please consider updating the recent
developments disclosures accordingly.
Please
be advised that the disclosure regarding the OTCQB application has been updated, along with the entire section’s having been updated.
Additionally,
disclosure regarding the agreements with Fannon Group and Drs. Farahay and Lee has been added to the “Business” section.
Finally, these agreements have been filed as exhibits.
Dietary
Supplement Formula License, page 39
5. We
note your response to prior comment 6 and your revised disclosure stating that you "have
chosen, however, not to sell FlamaBlue, opting instead to market a similar, though differently
formulated product known as "NuGenea."" Please revise your disclosure to discuss
when and on what basis you determined not to develop and market FlamaBlue after entering
the license agreement in December 2022.
Revisions
to the subject disclosure have been made, in response to such comment.
Intellectual
Property, page 42
6. We
note your response to prior comment 7 and reissue the comment. For each of your pending patents,
please disclose the type of patent protection for which you have applied (for example, composition
of matter, use, or process).
Revisions
to the subject disclosure have been made, in response to such comment.
Manufacturing
and Distribution, page 45
7. We
note your response to prior comment 8 and reissue the comment in part. We also note your
response that "Designer Genomics International, Inc. is and always has been, the Company's
only CRO." You continue to state, however, on page 45 that you "use Grace Health
Technology Inc. and Designer Genomics International Inc. as [y]our Clinical Research Organization
(“CRO”)." Please revise to clarify whether you use both of these entities
as CROs and to clarify the specific services provided to you by Designer Genomics International,
Inc. 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, in 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.
The
subject disclosure has been revised to provide a clear explanation of the contractual relationship between Grace Health Technology and
Designer Genomics International and between the Company and each of these companies.
Management,
page 47
8. We
note your response to prior comment 9 and your revised disclosure here. We also note your
response that a fully signed version of the agreement with Homeopathic Partners, Inc. has
been filed with the amendment as Exhibit 10.4. However, it appears that the current agreement
filed Exhibit 10.4 is only executed by the Registrant. Please file a fully executed version
of the consulting agreement dated July 1, 2022 with Homeopathic Partners, Inc. as Exhibit
10.4.
Please
be advised that a fully-executed copy of the Homeopathic Partners, Inc. agreement has been filed as Exhibit 10.4.
Security
Ownership of Certain Beneficial Owners and Management, page 50
9. We
note your disclosure that Mr. Rubin is the "authorized agent" of Worthington Financial
Services, Inc. and has dispositive power with respect to the shares it owns. Please amend
your disclosure to identify all natural persons with voting and/or dispositive power over
the shares owned by Worthington Financial Services, Inc. Please also provide the address
of the entity. See Item 403(a) of Regulation S-K.
In
response to such comment, the disclosure regarding Worthington Financial Services has been revised.
Item
16. Exhibits and Financial Statement Schedules, page II-2
10. We
note your response to comment 11 and reissue the comment. We also note that the Company's
Bylaws are listed in the list of Exhibits as Exhibit 3.3, however, the Bylaws do not appear
to have been filed. Please filed the Bylaws as Exhibit 3.3.
Please
be advised that the Bylaws of the Company have been filed as Exhibit 3.3.
11. Please
ensure each exhibit is in the proper text-searchable format. See Item 301 of Regulation S-T.
Please re-file the respective exhibits to your registration statement.
Please
be advised that the Company has re-filed such exhibits as necessary to satisfy such comment.
_____________________________
The
Company believes that this filing is now in order for effectiveness.
Please
feel free to contact the undersigned at (940) 367-6154, should you have any questions regarding any of the Company’s responses.
Thank
you for your attention in this matter.
Sincerely,
NEWLAN
LAW FIRM, PLLC
By:
/s/ Eric Newlan
Eric
Newlan
Managing
Member
cc:
Ludwig Enterprises, Inc.