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SEC Comment Letter 0000000000-25-003620 to YD Bio Ltd (YDES)

YD Bio Ltd
Date: April 3, 2025 · CIK: 0002011674 · Accession: 0000000000-25-003620

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File numbers found in text: 333-283428

Date
April 3, 2025
Author
Marc Rivera, Esq.
Form
UPLOAD
Company
YD Bio Ltd

Letter

Re: YD Bio Limited Amendment No. 4 to Registration Statement on Form F-4 Filed March 17, 2025 File No. 333-283428 Dear J. Douglas Ramsey Ph.D and Ethan Shen Ph.D:

April 3, 2025

J. Douglas Ramsey, Ph.D Chief Executive Officer YD Bio Limited 955 West John Carpenter Freeway Suite 100-929 Irving, TX, 75039

Ethan Shen, Ph.D Chief Executive Officer YD Biopharma Limited 12F., No. 3, Xingnan St. Nangang Dist. Taipei City 115001, Taiwan

We have reviewed your amended registration statement and have the following comments.

Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe a comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response.

After reviewing any amendment to your registration statement and the information you provide in response to this letter, we may have additional comments. Unless we note otherwise, any references to prior comments are to comments in our February 14, 2025 letter. April 3, 2025 Page 2 Amendment No. 4 to Form F-4 filed March 17, 2025 The Business Combination Background of the Business Combination, page 102

1. We refer to your revised disclosure in response to prior comment 6, which we reissue in part. Please revise to discuss in greater detail the evolution of the negotiations of preliminary equity value and other material terms of the letter of intent, including the proposals and counter-proposals made during the course of negotiations and which party proposed which terms, and how you reached agreement on the final terms. 2. We note your disclosure on the cover page, page xii, and elsewhere in the proxy statement/prospectus that Pubco has received commitments of $10 million in respect of the PIPE financing to date. You also disclose that the letter of intent entered into on September 6, 2024, included up to $15 million in PIPE financing. Please expand your disclosure here and throughout the proxy statement/prospectus to discuss the material details of the negotiation and marketing processes for the PIPE financing, including who selected the PIPE investors, what relationships the PIPE investors have to Breeze, the Sponsor, YD Biopharma and its affiliates, the placement agent and advisors, if any, and how the terms of the PIPE transaction were determined. Please also clarify the current status of discussions and negotiations regarding the PIPE transaction, including whether such processes for the PIPE financing remain ongoing. 3. We note your statements on page 114: "given the uncertainty surrounding regulatory approvals for YD Biopharma s cancer detection technology, the Breeze Board chose not to incorporate these long-term projections into its final valuation models. Instead, it relied on comparable company data, which provided a more conservative, market- validated valuation basis" and "[a]lthough these projections were prepared... the Breeze Board did not rely on them for its final valuation. Rather, the Board regarded these forecasts as part of YD Biopharma s internal management planning." Revise to clarify if the projections used for the Enterprise Valuation by CIAA were the same as those used by CIAA for the Breast Cancer License. In your revised disclosure, please also clarify how the Board considered the CIAA Enterprise Valuation, given your disclosure on page 115 that CIAA s determination of YD Biopharma s enterprise value using the income approach was based on long-term projections provided by YD Biopharma. 4. We note your statement on page 106: "Throughout these negotiations, both parties utilized extensive financial analyses and industry benchmarks to ensure that each term down to the specific dollar amounts and percentage thresholds was fully understood and agreed upon." Please revise to further describe and quantify these financial analyses and industry benchmarks, to the extent not part of the valuation reports described elsewhere. Breeze s Board of Directors Reasons for the Approval of the Business Combination, page

5. We are still considering your response to prior comment 7 and may have additional comments. April 3, 2025 Page 3 6. We note your revised disclosure in response to prior comments 8 and 9. Regarding the financial projections through 2038 that were provided by YD Biopharma to CIAA, please revise to provide additional detail relating to the material assumptions underlying YD Biopharma s projected revenues, including assumptions regarding the timing of regulatory approvals and any growth or discount rates used in preparing the projections. Additionally, revise to specify which figures from the projections CIAA used to calculate YD Biopharma's valuation and disclose how CIAA selected the growth and discount rates used in calculating the valuation. Please also explicitly discuss how the Breeze Board determined that YD Biopharma's projections were reasonable, particularly in light of the length of time reflected in the projections and considering that the company does not have regulatory approvals for its cancer screening tests or any product candidates related to eye diseases that it intends to develop. See Item 1606(b) of Regulation S-K. 7. We note your disclosure concerning CIAA's Breast Cancer License Valuation. Please address the following comments:

You state that "CIAA looked at Grail s valuation without revenue in 2019 and 2020, which were $6 billion and $7.1 billion respectively, and applied a market size adjustment of 145.85% to such valuation when determining a market valuation range for YD Biopharma of between $747 million and $884 million." We note Grail s value is from "cbinsights." Clarify how Grail s valuation was calculated and why CIAA did not use more recent figures. Revise to explain why the adjustment of 145.85% was selected. We note your statement that "[t]he comparable companies analyzed in the CIAA Breast Cancer License Valuation were identified for use in the report based on discussions between YD Biopharma management and CIAA personnel and were selected because such companies possessed similar technologies or a similar service nature." A similar statement appears on page 115 with respect to the CIAA Enterprise Valuation. For both reports, please revise to provide more detail for the basis of comparison, such as the scope of the companies geographic operations, size and operating history. With respect to both CIAA reports, please revise to provide a quantification of the "transaction prices, value multiples and relevant transaction information" for each comparable company. We note your statement that "the CIAA Breast Cancer License Valuation compared the detection technology capabilities of EG BioMed with those of other comparable companies. The analysis evaluated factors such as the methodology employed by each detection method, its intended use (e.g. tracking versus screening), clinical data sensitivity, product specifications, and pricing." Please revise to clarify how these other companies' metrics were quantified and considered in the valuation analysis. 8. You state that CIAA used the market approach to determine YD Biopharma s enterprise value using Grail's valuation. Further down the page you also list other comparable companies. Please revise to state how these other comparable companies were analyzed and whether they were factored into the enterprise value calculation. April 3, 2025 Page 4 Industry Background and Market Trends, page 183

9. We note your response to prior comment 18 and refer to your revised disclosure on pages 183-185 relating to the market sizes and anticipated compound annual growth rates for each of the pancreatic cancer diagnostics, breast cancer diagnostics, contact lens, glaucoma, and dry eye markets. Please revise your disclosure to address the following:

We note your disclosure on page 184 that the U.S. pancreatic cancer diagnostics market was valued at $1.5 billion in 2023 according to a Grand View report. You also state that the "global pancreatic cancer diagnostics market size in the U.S. was valued at over $870 million in 2023." Please reconcile your disclosures; and

We refer to your statements that the "dry eye disease market will grow due to aging populations, increased screen time, rising awareness " and that "the trend toward personalized medicine and improvements in non-invasive screening methods are expected to further drive market expansion" in the breast cancer diagnostics market. Please revise to provide support for these and other similar statements about the growth of your markets or characterize the same as management s opinions or beliefs. Information about YD Biopharma, page 183

10. We note your revised disclosure in response to prior comment 12, which we reissue in part. Please revise to disclose when the pancreatic cancer study was conducted by EG BioMed. Please also expand your disclosure to discuss the data and results of the clinical studies for the breast and pancreatic cancer tests, including the p-values, if applicable. Disclose also the specificity, selectivity and accuracy observed in these studies. For example, we refer to your discussion of the results of the study detecting biomarkers for breast cancer progression for the breast cancer blood test on page Annex D-13. Our Eye Disease Treatment Business, page 194

11. We note your response to prior comment 19 and your statements on pages 194-198 concerning your eye-related products. We note statements referencing "FDA OTC Final Monograph M018," completing "the CMC documentation and the required safety studies," and filing "for FDA DMF for the Active Pharmaceutical Ingredient (API)." Please revise to briefly describe these approvals and processes. We also note your statement that you expect to complete Phase III clinical trials in the U.S. by 2030 for two of your drug candidates, please disclose whether you have completed Phase I and II trials for these candidates and, if so, revise to describe the relevant trials. YD Biopharma Management's Discussion and Analysis of Financial Condition and Results of Operations, page 230

12. We note your revised disclosure in response to prior comment 20 that you initiated an Institutional Review Board application for your study in collaboration with Shuang- Ho Hospital and that you plan to initiate applications for clinical trials evaluating the April 3, 2025 Page 5

efficacy of exosome-based contact lenses and artificial tears in alleviating dry eye symptoms in 2025. Please clarify the scope of your collaboration with Shuang-Ho Hospital and whether you plan to conduct these clinical trials in 2025 in collaboration with Shuang-Ho Hospital s Department of Ophthalmology. If you have entered into a collaboration agreement with Shuang-Ho Hospital please provide a brief description of the material terms of the agreement, where appropriate, and file the agreement as an exhibit to the registration statement or explain to us why you believe you are not required to do so. Refer to Item 601(b)(10) of Regulation S-K. Exhibits

13. We note your disclosure in the footnote to Exhibit 10.13 in the exhibit index that "certain of the exhibits and schedules to this exhibit have been omitted in accordance with Regulation S-K Item 601(b)(2)." Please revise the applicable footnote to state that certain identified information has been excluded from the exhibit because it is both not material and the type of information that you treat as private or confidential. Please also include a similar statement at the top of the first page of the redacted exhibit and include brackets indicating where the information is omitted from the filed version of the exhibit. Refer to Item 601 of Regulation S-K. Please contact Christie Wong at 202-551-3684 or Michael Fay at 202-551-3812 if you have questions regarding comments on the financial statements and related matters. Please contact Jane Park at 202-551-7439 or Margaret Sawicki at 202-551-7153 with any other questions.

Sincerely,
Division of
Corporation Finance
Office of
Industrial Applications and
Services
cc: Mathew J. Saur, Esq.
Marc Rivera, Esq.

Show Raw Text
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 April 3, 2025

J. Douglas Ramsey, Ph.D
Chief Executive Officer
YD Bio Limited
955 West John Carpenter Freeway
Suite 100-929
Irving, TX, 75039

Ethan Shen, Ph.D
Chief Executive Officer
YD Biopharma Limited
12F., No. 3, Xingnan St.
Nangang Dist.
Taipei City 115001, Taiwan

 Re: YD Bio Limited
 Amendment No. 4 to Registration Statement on Form F-4
 Filed March 17, 2025
 File No. 333-283428
Dear J. Douglas Ramsey Ph.D and Ethan Shen Ph.D:

 We have reviewed your amended registration statement and have the
following
comments.

 Please respond to this letter by amending your registration statement
and providing
the requested information. If you do not believe a comment applies to your
facts and
circumstances or do not believe an amendment is appropriate, please tell us why
in your
response.

 After reviewing any amendment to your registration statement and the
information
you provide in response to this letter, we may have additional comments. Unless
we note
otherwise, any references to prior comments are to comments in our February 14,
2025 letter.
 April 3, 2025
Page 2
Amendment No. 4 to Form F-4 filed March 17, 2025
The Business Combination
Background of the Business Combination, page 102

1. We refer to your revised disclosure in response to prior comment 6,
which we reissue
 in part. Please revise to discuss in greater detail the evolution of the
negotiations of
 preliminary equity value and other material terms of the letter of
intent, including the
 proposals and counter-proposals made during the course of negotiations
and which
 party proposed which terms, and how you reached agreement on the final
terms.
2. We note your disclosure on the cover page, page xii, and elsewhere in
the proxy
 statement/prospectus that Pubco has received commitments of $10 million
in respect
 of the PIPE financing to date. You also disclose that the letter of
intent entered into on
 September 6, 2024, included up to $15 million in PIPE financing. Please
expand your
 disclosure here and throughout the proxy statement/prospectus to discuss
the material
 details of the negotiation and marketing processes for the PIPE
financing, including
 who selected the PIPE investors, what relationships the PIPE investors
have to
 Breeze, the Sponsor, YD Biopharma and its affiliates, the placement
agent and
 advisors, if any, and how the terms of the PIPE transaction were
determined. Please
 also clarify the current status of discussions and negotiations
regarding the PIPE
 transaction, including whether such processes for the PIPE financing
remain ongoing.
3. We note your statements on page 114: "given the uncertainty surrounding
regulatory
 approvals for YD Biopharma s cancer detection technology, the Breeze
Board chose
 not to incorporate these long-term projections into its final valuation
models. Instead,
 it relied on comparable company data, which provided a more
conservative, market-
 validated valuation basis" and "[a]lthough these projections were
prepared... the
 Breeze Board did not rely on them for its final valuation. Rather, the
Board regarded
 these forecasts as part of YD Biopharma s internal management
planning." Revise to
 clarify if the projections used for the Enterprise Valuation by CIAA
were the same as
 those used by CIAA for the Breast Cancer License. In your revised
disclosure, please
 also clarify how the Board considered the CIAA Enterprise Valuation,
given your
 disclosure on page 115 that CIAA s determination of YD Biopharma s
enterprise
 value using the income approach was based on long-term projections
provided by YD
 Biopharma.
4. We note your statement on page 106: "Throughout these negotiations, both
parties
 utilized extensive financial analyses and industry benchmarks to ensure
that each term
 down to the specific dollar amounts and percentage thresholds
was fully
 understood and agreed upon." Please revise to further describe and
quantify these
 financial analyses and industry benchmarks, to the extent not part of
the valuation
 reports described elsewhere.
Breeze s Board of Directors Reasons for the Approval of the Business
Combination, page
108

5. We are still considering your response to prior comment 7 and may have
additional
 comments.
 April 3, 2025
Page 3
6. We note your revised disclosure in response to prior comments 8 and 9.
Regarding
 the financial projections through 2038 that were provided by YD
Biopharma to CIAA,
 please revise to provide additional detail relating to the material
assumptions
 underlying YD Biopharma s projected revenues, including assumptions
regarding the
 timing of regulatory approvals and any growth or discount rates used in
preparing the
 projections. Additionally, revise to specify which figures from the
projections CIAA
 used to calculate YD Biopharma's valuation and disclose how CIAA
selected the
 growth and discount rates used in calculating the valuation. Please also
explicitly
 discuss how the Breeze Board determined that YD Biopharma's projections
were
 reasonable, particularly in light of the length of time reflected in the
projections and
 considering that the company does not have regulatory approvals for its
cancer
 screening tests or any product candidates related to eye diseases that
it intends to
 develop. See Item 1606(b) of Regulation S-K.
7. We note your disclosure concerning CIAA's Breast Cancer License
Valuation. Please
 address the following comments:

 You state that "CIAA looked at Grail s valuation without revenue
in 2019 and
 2020, which were $6 billion and $7.1 billion respectively, and
applied a market
 size adjustment of 145.85% to such valuation when determining a
market
 valuation range for YD Biopharma of between $747 million and $884
 million." We note Grail s value is from "cbinsights." Clarify how
Grail s
 valuation was calculated and why CIAA did not use more recent
figures. Revise
 to explain why the adjustment of 145.85% was selected.
 We note your statement that "[t]he comparable companies analyzed
in the CIAA
 Breast Cancer License Valuation were identified for use in the
report based on
 discussions between YD Biopharma management and CIAA personnel and
were
 selected because such companies possessed similar technologies or a
similar
 service nature." A similar statement appears on page 115 with
respect to the
 CIAA Enterprise Valuation. For both reports, please revise to
provide more detail
 for the basis of comparison, such as the scope of the companies
geographic
 operations, size and operating history. With respect to both CIAA
reports, please
 revise to provide a quantification of the "transaction prices, value
multiples and
 relevant transaction information" for each comparable company.
 We note your statement that "the CIAA Breast Cancer License
Valuation
 compared the detection technology capabilities of EG BioMed with
those of other
 comparable companies. The analysis evaluated factors such as the
methodology
 employed by each detection method, its intended use (e.g. tracking
versus
 screening), clinical data sensitivity, product specifications, and
pricing." Please
 revise to clarify how these other companies' metrics were quantified
and
 considered in the valuation analysis.
8. You state that CIAA used the market approach to determine YD Biopharma
s
 enterprise value using Grail's valuation. Further down the page you also
list other
 comparable companies. Please revise to state how these other comparable
companies
 were analyzed and whether they were factored into the enterprise value
calculation.
 April 3, 2025
Page 4
Industry Background and Market Trends, page 183

9. We note your response to prior comment 18 and refer to your revised
disclosure on
 pages 183-185 relating to the market sizes and anticipated compound
annual growth
 rates for each of the pancreatic cancer diagnostics, breast cancer
diagnostics, contact
 lens, glaucoma, and dry eye markets. Please revise your disclosure to
address the
 following:

 We note your disclosure on page 184 that the U.S. pancreatic
cancer diagnostics
 market was valued at $1.5 billion in 2023 according to a Grand View
report. You
 also state that the "global pancreatic cancer diagnostics market
size in the U.S.
 was valued at over $870 million in 2023." Please reconcile your
disclosures; and

 We refer to your statements that the "dry eye disease market will
grow due to
 aging populations, increased screen time, rising awareness " and
that "the trend
 toward personalized medicine and improvements in non-invasive
screening
 methods are expected to further drive market expansion" in the
breast cancer
 diagnostics market. Please revise to provide support for these and
other similar
 statements about the growth of your markets or characterize the same
as
 management s opinions or beliefs.
Information about YD Biopharma, page 183

10. We note your revised disclosure in response to prior comment 12, which
we reissue in
 part. Please revise to disclose when the pancreatic cancer study was
conducted by EG
 BioMed. Please also expand your disclosure to discuss the data and
results of the
 clinical studies for the breast and pancreatic cancer tests, including
the p-values, if
 applicable. Disclose also the specificity, selectivity and accuracy
observed in these
 studies. For example, we refer to your discussion of the results of the
study detecting
 biomarkers for breast cancer progression for the breast cancer blood
test on page
 Annex D-13.
Our Eye Disease Treatment Business, page 194

11. We note your response to prior comment 19 and your statements on pages
194-198
 concerning your eye-related products. We note statements referencing
"FDA OTC
 Final Monograph M018," completing "the CMC documentation and the
required
 safety studies," and filing "for FDA DMF for the Active Pharmaceutical
Ingredient
 (API)." Please revise to briefly describe these approvals and processes.
We also note
 your statement that you expect to complete Phase III clinical trials in
the U.S. by 2030
 for two of your drug candidates, please disclose whether you have
completed Phase
 I and II trials for these candidates and, if so, revise to describe the
relevant trials.
YD Biopharma Management's Discussion and Analysis of Financial Condition and
Results of
Operations, page 230

12. We note your revised disclosure in response to prior comment 20 that you
initiated an
 Institutional Review Board application for your study in collaboration
with Shuang-
 Ho Hospital and that you plan to initiate applications for clinical
trials evaluating the
 April 3, 2025
Page 5

 efficacy of exosome-based contact lenses and artificial tears in
alleviating dry eye
 symptoms in 2025. Please clarify the scope of your collaboration with
Shuang-Ho
 Hospital and whether you plan to conduct these clinical trials in 2025
in collaboration
 with Shuang-Ho Hospital s Department of Ophthalmology. If you have
entered into a
 collaboration agreement with Shuang-Ho Hospital please provide a brief
description
 of the material terms of the agreement, where appropriate, and file the
agreement as
 an exhibit to the registration statement or explain to us why you
believe you are not
 required to do so. Refer to Item 601(b)(10) of Regulation S-K.
Exhibits

13. We note your disclosure in the footnote to Exhibit 10.13 in the exhibit
index that
 "certain of the exhibits and schedules to this exhibit have been omitted
in accordance
 with Regulation S-K Item 601(b)(2)." Please revise the applicable
footnote to
 state that certain identified information has been excluded from the
exhibit because it
 is both not material and the type of information that you treat as
private or
 confidential. Please also include a similar statement at the top of the
first page of the
 redacted exhibit and include brackets indicating where the information
is omitted
 from the filed version of the exhibit. Refer to Item 601 of Regulation
S-K.
 Please contact Christie Wong at 202-551-3684 or Michael Fay at
202-551-3812 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jane Park at 202-551-7439 or Margaret Sawicki at 202-551-7153 with any
other
questions.

 Sincerely,

 Division of
Corporation Finance
 Office of
Industrial Applications and
 Services
cc: Mathew J. Saur, Esq.
 Marc Rivera, Esq.
</TEXT>
</DOCUMENT>