SEC Comment Letter 0000000000-25-001779 to YD Bio Ltd (YDES)
YD Bio Ltd
Date: Feb. 14, 2025 · CIK: 0002011674 · Accession: 0000000000-25-001779
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File numbers found in text: 333-283428
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February 14, 2025
Ethan Shen, Ph.D
Chief Executive Officer
YD Bio Limited
12F., No. 3, Xingnan St.
Nangang Dist.
Taipei City 115001, Taiwan
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. 3 to Registration Statement on Form F-4
Filed January 30, 2025
File No. 333-283428
Dear Ethan Shen Ph.D and Ethan Shen Ph.D:
We have reviewed your amended registration statement and have the following
comment(s).
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 January 16, 2025 letter.
February 14, 2025
Page 2
Amendment No. 3 to Registration Statement on Form F-4 filed January 30, 2025
Summary of the Proxy Statement/Prospectus, page 1
1.We note your revised Summary disclosure in response to prior comment 8. Please
revise to balance your disclosure with equally prominent disclosure of YD
Biopharma’s reliance on licensing partnerships and the Company’s competition from
diagnostic and pharmaceutical companies focused on cancer blood tests. In your
revised disclosure, please also clarify that the Company itself has not conducted any
clinical trials or prepared any FDA submissions to date and these tests have not
received FDA approval or clearance.
Unaudited Pro Forma Condensed Combined and Consolidated Financial Information, page
79
2.We have reviewed your revised disclosure in response to comment 20. Please disclose
in tabular form each type of potentially dilutive security with the related number of
potentially dilutive common shares.
Comparative Per Share Data, page 89
3.We note your revised disclosure in response to prior comment 21. We note your
revisions to the “Comparative Per Share Data” table on page 90 to include the various
redemption scenarios and the tables on pages 13-14. Please revise to include a
separate dilution table and related disclosure that addresses each disclosure item
required by Item 1604(c) of Regulation S-K, including subsections (c)(1) and (2).
Please ensure the tabular disclosure reflects all material probable or consummated
transactions and other material effects on Breeze's net tangible book value per share
from the business combination, including the PIPE financing, loan repayment, and
estimated transaction expenses. Outside of the table, please describe each material
potential source of future dilution that non-redeeming shareholders may experience if
they elect not to tender their shares in connection with the business combination,
including sources not included in the table with respect to the determination of net
tangible book value per share, as adjusted. Please also disclose the effective
underwriting fee on a percentage basis for shares at each redemption level presented
in your sensitivity analysis related to dilution.
Background of the Business Combination, page 99
4.We acknowledge your revised disclosure in response to prior comment 22, which we
reissue in part. Please expand your disclosure of the 24 potential business combination
targets the Breeze Board considered to discuss the industries these companies
operated in. For the companies for which negotiations advanced the most, including
any that you entered into letters of intent or other arrangements with, please revise to
provide additional detail about the potential targets on an individual basis, such as the
reason for terminating negotiations. We also note your disclosure on page F-67
relating to the business combination agreement that Breeze entered into with D-Orbit
S.p.A. Please revise your disclosure in this section to describe in greater detail the
Board’s reason for terminating this agreement with D-Orbit S.p.A.
February 14, 2025
Page 3
5.We note your revised disclosure on page 99 identifying certain representatives of
Breeze and YD Biopharma and their financial and legal advisors in response to prior
comment 23. Please revise your disclosure to identify such individuals and/or parties
who participated in the meetings and discussions described throughout this section.
For example, we continue to note references to “senior members” and of the Breeze
management team and “principals” of Breeze and YD Biopharma.
6.We note your revised disclosure in response to prior comments 24 and 25, which we
reissue in part. We refer to your disclosure on page 102 that the preliminary equity
value of YD Biopharma of $647.3 million was determined through arms-length
negotiations between the management teams and that the Breeze Board considered the
valuation reports, various methodologies, and discount rates in arriving at this
valuation of YD Biopharma. Please revise to discuss the evolution of the negotiations
of the preliminary equity value and other material terms of the letter of intent,
including which party proposed which terms.
Breeze's Board of Directors' Reasons for the Approval of the Business Combination, page
102
7.We note your revised disclosure in response to prior comment 35, which we reissue in
part. Please revise your disclosure in this section to address the following
comments:
•Please expand your disclosure in this section to describe in greater detail the
comparable companies analysis performed by BDO Taiwan and the Breeze
Board, including how the criteria for each of the comparable companies was
chosen, the names of the companies, and whether any companies meeting the
selection criteria were excluded from the analysis. Please also provide the
disclosure requested with respect to the comparable transaction analysis
performed by CIAA. We also note the Breeze Board considered several other
companies not included in the BDO Report or CIAA Report, including Belite Bio.
Please revise to describe and name the other companies considered.
•In your revised disclosure, discuss the valuations of the comparable companies
and the analyses provided by BDO Taiwan and how the Breeze Board applied the
comparable companies analysis to determine the valuation for YD Biopharma in
greater detail.
•Please file a consent for BDO Taiwan pursuant to Securities Act Rule 436.
We note that page 104 states that the BDO Report included prospective financial
information through 2038, as shown on Annex D-29, and we note revenue forecasts
through 2039 were provided to CIAA, as shown on Annex E-31. To the extent these
projections were considered and relied upon by the Board, please revise to
describe the material bases and assumptions for the projections, including
assumptions regarding regulatory approvals and any growth or discount rates used in
preparing the projections. Explicitly discuss how the Board determined these
projections were reasonable, particularly in light of the length of time reflected in the 8.
February 14, 2025
Page 4
projections and considering 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. To the extent the Board did not rely upon these projections, please revise
to explain the basis for such determination and how it separated these projections (or
projections for certain years) from the valuation provided in the reports produced by
BDO and CIAA. See Item 1606(b) of Regulation S-K.
9.We note the general descriptions of the types of valuation methodologies used in the
BDO Report. Please revise to explain how these were applied to YD Biopharma and
this transaction specifically. For example, the comparable transactions method should
note the "transaction price" and "value multiples" used, and for the income approach
you should quantify the "future income stream" and the "capitalization or discount."
The same should be revised with respect to each of the methodologies used in the
CIAA Report. For example, disclose the "cost" that was calculated for the two cost
methods described.
Material U.S. Federal Income Tax Considerations, page 131
10.We note your revised disclosure in response to prior comment 41, which we reissue.
Your disclosure continues to state that the exchange of Breeze common stock for
Pubco ordinary shares pursuant to the merger agreement is expected to “qualify as a
tax-free exchange for U.S. federal income tax purposes,” but we also refer to your
disclosure on page 134 that your counsel, Woolery & Co, “is unable to opine on the
application of Section 367(a) of the Code to the exchange by a U.S. Holder of Breeze
Common Stock in the Business Combination” as a result of “the inherently factual
nature of the tests under the applicable Treasury Regulations, and the fact that these
tests are generally applied based on the relevant facts at the time of, and following, the
completion of the Business Combination.” Please revise your disclosure in this section
to clearly state the tax consequences of the transaction. If there is uncertainty
regarding the tax treatment of the transactions, counsel may (1) issue a “should” or
“more likely than not” opinion to make clear that the opinion is subject to a degree of
uncertainty and (2) explain why it cannot give a firm opinion (for example, the facts
are currently unknown or the law is unclear). For further guidance, see Staff Legal
Bulletin No. 19.
Information about YD Biopharma, page 172
11.We note your revised disclosure in response to prior comment 42, which we reissue in
part. Please revise to disclose the termination provisions of the EG BioMed License
Agreements and the royalty term (if different than the term of the agreement).
We note your revised disclosure in response to prior comment 44 that clinical studies
for the breast and pancreatic cancer tests were initiated in 2017 and have continued to
date at Taipei Medical University under the approval of the Institutional Review
Board of Taiwan. Please expand your disclosure relating to these clinical trials to
clarify whether YD Biopharma or EG BioMed sponsored the clinical trials and who
conducted the trials; discuss the scope, size and design of the trials; specify the
primary endpoints and whether they were met for any past trials; the criteria used for
the enrollment of participants; whether the trials were powered to show statistical 12.
February 14, 2025
Page 5
significance, and if so, the p-values; any serious adverse events and the number of
patients who experienced them and the role of Taipei Medical University or its
employees in conducting the trials, if any (we note that, based on Annex E-11, it
appears EG BioMed spun off from Taipei Medical University, if so please revise to
explain this relationship). Please also revise to disclose who conducted the
“comprehensive statistical analysis” using the Cancer Genome Atlas (TCGA)
database as disclosed on page 176. Please also revise to clarify whether YD
Biopharma or EG BioMed has conducted any clinical trials regarding these diagnostic
tests in the U.S.
13.We refer to your disclosure on page 172 that EG BioMed leverages AI using the
Infinium MethylationEPIC v2.0 BeadChip to analyze DNA methylation patterns in
plasma. Please clarify whether EG BioMed developed the Infinium MethylationEPIC
v2.0 BeadChip platform and revise to provide greater detail relating to such platform,
including the application of AI and the analyses of DNA methylation patterns.
14.We note your revised disclosure on page 177 in response to prior comment 46,
including that “the FDA application was originally prepared by EG Biomed because
EG Biomed collected, organized, and managed the clinical data that is included in the
application.” Please revise to clearly specify the clinical trials and data that EG
BioMed included in its FDA application.
15.We note your revised disclosure in response to prior comment 49, which we reissue in
part. We refer to your statements on pages 1 and 2 that YD Biopharma collaborates
with international pharmaceutical companies to provide competitors’ drugs and
develop high-quality nutritional products, such as calcium supplements and other
health supplements to be sold alongside eye drops. Your disclosure on page 215
continues to refer to the sale of drugs and medical products to corporate customers
and nutritional products to retail customers. Please revise to describe in greater detail
each drug, medical and nutritional products and supplements that YD Biopharma
manufactures and/or sells, including a breakdown of YD Biopharma’s top individual
products by revenue, where applicable. Please also specify the types of products from
the “post COVID-19 era” and clarify whether YD Biopharma expects the continued
increase in the sales demand for these products.
16.We acknowledge your revised disclosure in response to prior comment 50, which we
reissue in part. Please revise to identify your top corporate customers and specify the
relevant jurisdictions within the Asia region, as applicable. Refer to Item 101(h)(4)(vi)
of Regulation S-K. In addition, amend your risk factor disclosure to discuss the risks
related to this customer concentration.
17.We note your revised disclosure in response to prior comment 51, which we reissue in
part. Please revise to identify your top supplier, which you disclosed as responsible
for 72.1% of the Group's purchases for the six months ended June 30, 2024, the terms
of any agreement with this supplier and the sources and availability of raw materials
for your products. Refer to Item 101(h)(4)(v) of Regulation S-K. To the extent
applicable, please also tell us what consideration you gave to filing your agreement
with your top supplier as a material contract pursuant to Item 601(b)(10) of
Regulation S-K.
February 14, 2025
Page 6
18.We note your revised disclosure in response to prior comment 53, which we reissue in
part. Please revise to discuss any material assumptions underlying the anticipated
compound annual growth rates for each market.
Our Eye Disease Treatment Business, page 180
19.We note your revised disclosure in response to prior comment 56, which we reissue in
part. Please revise your narrative disclosure relating to each eye product to provide
greater detail of the mechanisms of action, key ingredients, timeline of development,
and any regulatory requirements and/or approvals including the applicable
jurisdiction. In your revised disclosure, please clearly state that any approvals or
certifications that you have not yet obtained may not be obtained in the timeframe you
have suggested and may never be obtained.
3D Global License Agreement, page 181
20.We note your response to prior comment 47 and refer to your disclosure on page 212
that YD Biopharma recently entered into an exclusive licensed patent and know-how
agremeent with 3D Global to “pioneer the application of corneal mesenchymal stem
cells and their exosomes for treating eye diseases.” Please revise to discuss in greater
detail the development and current status of the application of corneal mesenchymal
stem cells and their exosomes for treating eye diseases, including additional detail
concerning any trials conducted with respect to eye disease indications and any
significant regulatory or other requirements the Company must satisfy to
commercialize product candidates for these indications, as well as the timing for any
additional planned trials.
21.We note your revised disclosure in response to prior comment 57. We refer to your
statement that “[a]s of the date of this proxy statement/prospectus, the Group paid
$1,000,000 including VAT or $952,381 net of VAT to 3D Global for the patent,
formula and know-how of the technology, which is not for use in particu