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SEC Comment Letter 0000000000-22-013931 to Advanced Biomed Inc. (ADVB)

Advanced Biomed Inc.
Date: Dec. 27, 2022 · CIK: 0001941029 · Accession: 0000000000-22-013931

AI Filing Summary & Sentiment

Date
December 27, 2022
Author
Not clearly detected
Form
UPLOAD
Company
Advanced Biomed Inc.

Letter

United States securities and exchange commission logo December 27, 2022 Hung To Pau, Ph.D. Chief Executive Officer Advanced Biomed Inc. 689-87 Xiaodong Road Yongkang District Tainan, Taiwan Re:Advanced Biomed Inc. Draft Registration Statement on Form S-1 Submitted November 30, 2022 CIK No. 0001941029 Dear Hung To Pau: We have reviewed your draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and your amended draft registration statement or filed registration statement, we may have additional comments. Draft Registration Statement on Form S-1 submitted November 30, 2022 Cover Page 1.We note your cover page disclosure that you "face various legal and operational risks and uncertainties relating to [y]our subsidiaries’ operations in China." We also note your prospectus convention on page 13 that while “China” refers to the People’s Republic of China, including Hong Kong and Macau, "the only time such jurisdictions are not included in the definition of PRC and China is when [you] reference to the specific laws that have been adopted by the PRC." Please revise your cover page disclosure to state that the legal and operational risks associated with operating in China also apply to your operations in Hong Kong.

FirstName LastNameHung To Pau, Ph.D. Comapany NameAdvanced Biomed Inc. December 27, 2022 Page 2 FirstName LastNameHung To Pau, Ph.D. Advanced Biomed Inc. December 27, 2022 Page 2 2.We note your disclosure on page 15 that you will issue underwriters warrants for 4.0% of the aggregate number of shares of common stock sold in this offering. Please reference these warrants in the table included in the cover page of the Prospectus. 3.We note your statement that any audit reports not issued by auditors that are completely inspected or investigated by the PCAOB, or a lack of PCAOB inspections of audit work undertaken in China that prevents the PCAOB from regularly evaluating your auditors’ audits and their quality control procedures, could result in limitation or restriction to your access to the U.S. capital markets, and trading of your securities, including trading on the national exchange and trading on “over-the-counter” markets, may be prohibited under the HFCAA. Please also revise to explicitly state that an exchange may determine to delist your securities. 4.We note your discussion on page 4 about how cash can be transferred through your organization. Please revise to include a cross-reference to the consolidated finanical statements. Market, Industry and Other Data, page 8 5.We note your statement on page 8 that although you believe these third-party sources are reliable as of their respective dates, neither you nor the underwriters have independently verified the accuracy or completeness of this information. Please delete this language or clarify that you are liable for all such information included in your registration statement. Our Company Overview, page 9 6.We note your statement that you have developed three automated devices and "have initially applied the devices in clinic trials." Please provide additional detail regarding the testing of these devices and clarify if you have engaged in any clinical trials. To the extent you have engaged in any clinical trials for any of your products, please provide complete disclosure regarding these trials here or elsewhere in the prospectus. 7.On page 9 please revise to briefly further describe your products and clarify the approvals required for each in order to begin sales in China and the current regulatory status of each. For example, please explain what an application for localization registration is. We also note on page 9 you say your immunochromogenic kits "are ready to be transformed into commercialization" and on page 10 you state you "completed production registration for A+Pre and AC-1000 in China," please explain what this means. Please also explain whether, and if so, how, your products are used with or dependent on each other. Briefly explain what an immunochromogenic kit is, how it is used and the differences between your kits. Provide comparable disclosure in the Business section as appropriate. 8.We note your statements that "[your] three microfluidic biochips, A+Pre Chip and AC1000 CTC enrichment chip can be mass-produced" and that "A+Cellscan chip have completed the development plan." Please state the basis for your statement that these chips

FirstName LastNameHung To Pau, Ph.D. Comapany NameAdvanced Biomed Inc. December 27, 2022 Page 3 FirstName LastNameHung To Pau, Ph.D. Advanced Biomed Inc. December 27, 2022 Page 3 can be mass-produced and note, if true, that to date none of the chips have been mass- produced by the Company or any third party. Additionally, please clarify what the development plan for the A+Cellscan chip entailed, when it was completed and the next steps for the development or commercialization of that product. 9.We note your statements that "[i]n the future, [you] plan to set up a subsidiary in the United States for business operations in North America" and that you "also plan to develop the European market and conduct localized management and operation in the region in compliance with European rules and regulations." Please specify if you have a timeframe for establishing North American or European operations and note what actions, if any, you have taken to date with respect to business in these jurisdictions. Please also include risk factor disclosure regarding the operational and regulatory risks and uncertainties surrounding potential expansion into these markets, including the need for regulatory approvals in these jurisdictions and the risk that regulators in the United States and European Union may not accept clinical data from trials conducted in China. Prospectus Summary, page 9 10.We note that your Prospectus Summary appears to only discuss the positive aspects of your business. The prospectus summary should provide a brief, but balanced, description of the key aspects of the company as of the latest practicable date. Please revise the summary to balance the positive aspects of your business with a similarly prominent discussion of risks and challenges you face. For example, please note that you do not currently have any products approved for sale, have not generated any revenue from the sale of products, and do not expect to generate revenue from the sale of your product candidates until you complete clinical development, submit regulatory filings and receive approvals from the applicable regulatory bodies for such product candidates. 11.Please include a series of concise, bulleted or numbered statements that is no more than two pages summarizing the principal factors that make an investment in the Company or offering speculative or risky as it appears the Risk Factors section beginning on page 18 is longer than 15 pages. Please refer to Item 105(b) of Regulation S-K. Additionally, in your summary of risk factors, disclose the risks that your corporate structure and being based in or having the majority of the company’s operations in China poses to investors. In particular, describe the significant regulatory, liquidity, and enforcement risks with cross- references to the more detailed discussion of these risks in the prospectus. For example, specifically discuss risks arising from the legal system in China, including risks and uncertainties regarding the enforcement of laws and that rules and regulations in China can change quickly with little advance notice; and the risk that the Chinese government may intervene or influence your operations at any time, or may exert more control over offerings conducted overseas and/or foreign investment in China-based issuers, which could result in a material change in your operations and/or the value of the securities you are registering for sale. Acknowledge any risks that any actions by the Chinese government to exert more oversight and control over offerings that are conducted overseas

FirstName LastNameHung To Pau, Ph.D. Comapany NameAdvanced Biomed Inc. December 27, 2022 Page 4 FirstName LastName Hung To Pau, Ph.D. Advanced Biomed Inc. December 27, 2022 Page 4 and/or foreign investment in China-based issuers could significantly limit or completely hinder your ability to offer or continue to offer securities to investors and cause the value of such securities to significantly decline or be worthless. Finally, include summary risk factor disclosure and disclosure in the Enforceability of Civil Liabilities section concerning whether your directors and officers are located in China and, if so, that it will be even more difficult to enforce liabilities against them. 12.Disclose each permission or approval that you or your subsidiaries are required to obtain from Chinese authorities to operate your business and to offer the securities being registered to foreign investors. State whether you or your subsidiaries are covered by permissions requirements from the China Securities Regulatory Commission (CSRC), Cyberspace Administration of China (CAC) or any other governmental agency that is required to approve your operations, and state affirmatively whether you have received all requisite permissions or approvals and whether any permissions or approvals have been denied. Please also describe the consequences to you and your investors if you or your subsidiaries: (i) do not receive or maintain such permissions or approvals, (ii) inadvertently conclude that such permissions or approvals are not required, or (iii) applicable laws, regulations, or interpretations change and you are required to obtain such permissions or approvals in the future. 13.Provide a clear description of how cash is transferred through your organization. Disclose your intentions to distribute earnings. Quantify any cash flows and transfers of other assets by type that have occurred between the holding company and its subsidiaries, and direction of transfer. Quantify any dividends or distributions that a subsidiary have made to the holding company and which entity made such transfer, and their tax consequences. Similarly quantify dividends or distributions made to U.S. investors, the source, and their tax consequences. Your disclosure should make clear if no transfers, dividends, or distributions have been made to date. Describe any restrictions on foreign exchange and your ability to transfer cash between entities, across borders, and to U.S. investors. Describe any restrictions and limitations on your ability to distribute earnings from the company, including your subsidiaries, to the parent company and U.S. investors. Commercialization Preparation, page 10 14.We note your statement that you "have been cooperating with the injection molding machine manufacturer Riva Machinery Co., Ltd. and the mold manufacturer Unimold Technology Inc. to conduct mass production mode testing and trial production." Please expand on this statement to note the current status of the mode testing and trial production. Additionally, please note if you have entered into any contracts with these entities with respect to mass production. If so, please file these agreements as exhibits to the Registration Statement or provide us your basis for not doing so. If you have not entered into contracts with these entities, please clarify the nature of your relationship.

FirstName LastNameHung To Pau, Ph.D. Comapany NameAdvanced Biomed Inc. December 27, 2022 Page 5 FirstName LastName Hung To Pau, Ph.D. Advanced Biomed Inc. December 27, 2022 Page 5 Market Opportunities, page 10 15.Please balance your disclosure of these estimated global and United States markets by noting that you intend to initially focus on developing your cancer screening market in China. To the extent available, please provide corresponding estimates of the Chinese market for comparison. In this regard, we note your risk factor disclosure on page 18 that "Taiwan and China’s precision oncology detection market is still in its early stage of development and rapidly evolving." Please revise page 10 to state the date of the Goldman Sachs and Piper Jaffray data, and if more recent data is available for the 2015 JP Morgan report. Also, it says this data is based “pending substantial clinical support for the use of liquid biopsy as a routine means of early screening,” revise to state the current and necessary levels of clinical support. Competitive Strengths, page 11 16.On page 11 you state your technology enables a fast and inexpensive method for early cancer diagnosis. Please revise to state the basis for your technology being inexpensive. Our Platform, page 11 17.We note your statement that you can "also provide application services in tumor screening, auxiliary diagnosis, treatment evaluation, prognosis evaluation, recurrence and metastasis detection, individualized medication guidance, and companion diagnosis" including to third parties for a fee. Please revise to note the basis for your ability to provide these services and state whether you have provided such services to date or if these applications are potential, but speculative, uses for your platform. Note whether you consider these services to third parties will be a material part of your operations in the future. Risk Factors Risks associated with numerous government regulations, page 23 18.We note your statements here that "[d]ue to the relatively short history of the cancer screening industry in China, a comprehensive regulatory framework to regulate the industry has not yet been established" and that "[a]ll significant aspects of the development and commercialization of [y]our products are strictly regulated in China." Please reconcile these two statements. If our existing and new products fail to meet the quality standards required by applicable laws, our business and reputation..., page 25 19.This risk factor includes a cross-reference to a section titled “Business — Quality Control” that does not appear to be included in the Prospectus. Please revise your disclosure to include a discussion of your quality control systems or remove this cross reference. In this regard, we note your disclosure on page 85 that under applicable

FirstName LastNameHung To Pau, Ph.D. Comapany NameAdvanced Biomed Inc. December 27, 2022 Page 6 FirstName LastName Hung To Pau, Ph.D. Advanced Biomed Inc. December 27, 2022 Page 6 regulations in the PRC, "an enterprise engaged in the production of medical devices shall establish and effectively maintain a quality control system in accordance to the requirements of the Standards on Production and Quality Management of Medical Devices." Risks Related to Doing Business in Taiwan, page 31 20.We note your disclosure in this section regarding certain R&D contracts between Advanced Biomed Taiwan and other legal persons in Taiwan, such as National Cheng Kung University Hospital, National Applied Research Laboratories and your research projects collaborated with Chenggong University Hospital in two written contracts. Please expand on your disclosure to note the material terms of these contracts. Additionally, please file these contracts as exhibits to the Registration Statement or provide us with your basis for not filing them. Please refer to Item 601 of Regulation S-K. Any lack of requisite approvals, licenses, permits or filings or failure to comply with any requirements of Taiwan laws

Show Raw Text
United States securities and exchange commission logo
December 27, 2022
Hung To Pau, Ph.D.
Chief Executive Officer
Advanced Biomed Inc.
689-87 Xiaodong Road
Yongkang District
Tainan, Taiwan
Re:Advanced Biomed Inc.
Draft Registration Statement on Form S-1
Submitted November 30, 2022
CIK No. 0001941029
Dear Hung To Pau:
            We have reviewed your draft registration statement and have the following comments.  In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
            Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR.  If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
            After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1 submitted November 30, 2022
Cover Page
1.We note your cover page disclosure that you "face various legal and operational risks and
uncertainties relating to [y]our subsidiaries’ operations in China." We also note your
prospectus convention on page 13 that while “China” refers to the People’s Republic of
China, including Hong Kong and Macau, "the only time such jurisdictions are not
included in the definition of PRC and China is when [you] reference to the specific laws
that have been adopted by the PRC." Please revise your cover page disclosure to state that
the legal and operational risks associated with operating in China also apply to your
operations in Hong Kong.

 FirstName LastNameHung To Pau, Ph.D.
 Comapany NameAdvanced Biomed Inc.
 December 27, 2022 Page 2
 FirstName LastNameHung To Pau, Ph.D.
Advanced Biomed Inc.
December 27, 2022
Page 2
2.We note your disclosure on page 15 that you will issue underwriters warrants for 4.0% of
the aggregate number of shares of common stock sold in this offering. Please reference
these warrants in the table included in the cover page of the Prospectus.
3.We note your statement that any audit reports not issued by auditors that are completely
inspected or investigated by the PCAOB, or a lack of PCAOB inspections of audit work
undertaken in China that prevents the PCAOB from regularly evaluating your auditors’
audits and their quality control procedures, could result in limitation or restriction to your
access to the U.S. capital markets, and trading of your securities, including trading on the
national exchange and trading on “over-the-counter” markets, may be prohibited under the
HFCAA. Please also revise to explicitly state that an exchange may determine to delist
your securities.
4.We note your discussion on page 4 about how cash can be transferred through your
organization. Please revise to include a cross-reference to the consolidated finanical
statements.
Market, Industry and Other Data, page 8
5.We note your statement on page 8 that although you believe these third-party sources are
reliable as of their respective dates, neither you nor the underwriters have independently
verified the accuracy or completeness of this information. Please delete this language or
clarify that you are liable for all such information included in your registration statement.
Our Company
Overview, page 9
6.We note your statement that you have developed three automated devices and "have
initially applied the devices in clinic trials." Please provide additional detail regarding the
testing of these devices and clarify if you have engaged in any clinical trials. To the extent
you have engaged in any clinical trials for any of your products, please provide complete
disclosure regarding these trials here or elsewhere in the prospectus.
7.On page 9 please revise to briefly further describe your products and clarify the approvals
required for each in order to begin sales in China and the current regulatory status of
each. For example, please explain what an application for localization registration is. We
also note on page 9 you say your immunochromogenic kits "are ready to be transformed
into commercialization" and on page 10 you state you "completed production registration
for A+Pre and AC-1000 in China," please explain what this means. Please also explain
whether, and if so, how, your products are used with or dependent on each other. Briefly
explain what an immunochromogenic kit is, how it is used and the differences between
your kits. Provide comparable disclosure in the Business section as appropriate.
8.We note your statements that "[your] three microfluidic biochips, A+Pre Chip and
AC1000 CTC enrichment chip can be mass-produced" and that  "A+Cellscan chip have
completed the development plan." Please state the basis for your statement that these chips

 FirstName LastNameHung To Pau, Ph.D.
 Comapany NameAdvanced Biomed Inc.
 December 27, 2022 Page 3
 FirstName LastNameHung To Pau, Ph.D.
Advanced Biomed Inc.
December 27, 2022
Page 3
can be mass-produced and note, if true, that to date none of the chips have been mass-
produced by the Company or any third party. Additionally, please clarify what the
development plan for the A+Cellscan chip entailed, when it was completed and the next
steps for the development or commercialization of that product.
9.We note your statements that "[i]n the future, [you] plan to set up a subsidiary in the
United States for business operations in North America" and that you "also plan to
develop the European market and conduct localized management and operation in the
region in compliance with European rules and regulations." Please specify if you have a
timeframe for establishing North American or European operations and note what actions,
if any, you have taken to date with respect to business in these jurisdictions. Please also
include risk factor disclosure regarding the operational and regulatory risks and
uncertainties surrounding potential expansion into these markets, including the need for
regulatory approvals in these jurisdictions and the risk that regulators in the United States
and European Union may not accept clinical data from trials conducted in China.
Prospectus Summary, page 9
10.We note that your Prospectus Summary appears to only discuss the positive aspects of
your business. The prospectus summary should provide a brief, but balanced, description
of the key aspects of the company as of the latest practicable date. Please revise the
summary to balance the positive aspects of your business with a similarly prominent
discussion of risks and challenges you face. For example, please note that you do not
currently have any products approved for sale, have not generated any revenue from the
sale of products, and do not expect to generate revenue from the sale of your product
candidates until you complete clinical development, submit regulatory filings and receive
approvals from the applicable regulatory bodies for such product candidates.
11.Please include a series of concise, bulleted or numbered statements that is no more than
two pages summarizing the principal factors that make an investment in the Company or
offering speculative or risky as it appears the Risk Factors section beginning on page 18 is
longer than 15 pages. Please refer to Item 105(b) of Regulation S-K. Additionally, in your
summary of risk factors, disclose the risks that your corporate structure and being based in
or having the majority of the company’s operations in China poses to investors. In
particular, describe the significant regulatory, liquidity, and enforcement risks with cross-
references to the more detailed discussion of these risks in the prospectus. For example,
specifically discuss risks arising from the legal system in China, including risks and
uncertainties regarding the enforcement of laws and that rules and regulations in China
can change quickly with little advance notice; and the risk that the Chinese government
may intervene or influence your operations at any time, or may exert more control over
offerings conducted overseas and/or foreign investment in China-based issuers, which
could result in a material change in your operations and/or the value of the securities you
are registering for sale. Acknowledge any risks that any actions by the Chinese
government to exert more oversight and control over offerings that are conducted overseas

 FirstName LastNameHung To Pau, Ph.D.
 Comapany NameAdvanced Biomed Inc.
 December 27, 2022 Page 4
 FirstName LastName
Hung To Pau, Ph.D.
Advanced Biomed Inc.
December 27, 2022
Page 4
and/or foreign investment in China-based issuers could significantly limit or completely
hinder your ability to offer or continue to offer securities to investors and cause the value
of such securities to significantly decline or be worthless. Finally, include summary risk
factor disclosure and disclosure in the Enforceability of Civil Liabilities section
concerning whether your directors and officers are located in China and, if so, that it will
be even more difficult to enforce liabilities against them.
12.Disclose each permission or approval that you or your subsidiaries are required to obtain
from Chinese authorities to operate your business and to offer the securities being
registered to foreign investors. State whether you or your subsidiaries are covered by
permissions requirements from the China Securities Regulatory Commission (CSRC),
Cyberspace Administration of China (CAC) or any other governmental agency that is
required to approve your operations, and state affirmatively whether you have received all
requisite permissions or approvals and whether any permissions or approvals have been
denied. Please also describe the consequences to you and your investors if you or your
subsidiaries: (i) do not receive or maintain such permissions or approvals, (ii)
inadvertently conclude that such permissions or approvals are not required, or (iii)
applicable laws, regulations, or interpretations change and you are required to obtain such
permissions or approvals in the future.
13.Provide a clear description of how cash is transferred through your organization. Disclose
your intentions to distribute earnings. Quantify any cash flows and transfers of other
assets by type that have occurred between the holding company and its subsidiaries, and
direction of transfer. Quantify any dividends or distributions that a subsidiary have made
to the holding company and which entity made such transfer, and their tax consequences.
Similarly quantify dividends or distributions made to U.S. investors, the source, and their
tax consequences. Your disclosure should make clear if no transfers, dividends, or
distributions have been made to date. Describe any restrictions on foreign exchange and
your ability to transfer cash between entities, across borders, and to U.S. investors.
Describe any restrictions and limitations on your ability to distribute earnings from the
company, including your subsidiaries, to the parent company and U.S. investors.
Commercialization Preparation, page 10
14.We note your statement that you "have been cooperating with the injection molding
machine manufacturer Riva Machinery Co., Ltd. and the mold manufacturer Unimold
Technology Inc. to conduct mass production mode testing and trial production." Please
expand on this statement to note the current status of the mode testing and trial
production. Additionally, please note if you have entered into any contracts with these
entities with respect to mass production. If so, please file these agreements as exhibits to
the Registration Statement or provide us your basis for not doing so. If you have not
entered into contracts with these entities, please clarify the nature of your relationship.

 FirstName LastNameHung To Pau, Ph.D.
 Comapany NameAdvanced Biomed Inc.
 December 27, 2022 Page 5
 FirstName LastName
Hung To Pau, Ph.D.
Advanced Biomed Inc.
December 27, 2022
Page 5
Market Opportunities, page 10
15.Please balance your disclosure of these estimated global and United States markets by
noting that you intend to initially focus on developing your cancer screening market in
China. To the extent available, please provide corresponding estimates of the Chinese
market for comparison. In this regard, we note your risk factor disclosure on page 18 that
"Taiwan and China’s precision oncology detection market is still in its early stage of
development and rapidly evolving." Please revise page 10 to state the date of the Goldman
Sachs and Piper Jaffray data, and if more recent data is available for the 2015 JP Morgan
report. Also, it says this data is based “pending substantial clinical support for the use of
liquid biopsy as a routine means of early screening,” revise to state the current and
necessary levels of clinical support.
Competitive Strengths, page 11
16.On page 11 you state your technology enables a fast and inexpensive method for early
cancer diagnosis. Please revise to state the basis for your technology being inexpensive.
Our Platform, page 11
17.We note your statement that you can "also provide application services in tumor
screening, auxiliary diagnosis, treatment evaluation, prognosis evaluation, recurrence and
metastasis detection, individualized medication guidance, and companion diagnosis"
including to third parties for a fee. Please revise to note the basis for your ability to
provide these services and state whether you have provided such services to date or if
these applications are potential, but speculative, uses for your platform. Note whether you
consider these services to third parties will be a material part of your operations in the
future.
Risk Factors
Risks associated with numerous government regulations, page 23
18.We note your statements here that "[d]ue to the relatively short history of the cancer
screening industry in China, a comprehensive regulatory framework to regulate the
industry has not yet been established" and that "[a]ll significant aspects of the
development and commercialization of [y]our products are strictly regulated in China."
Please reconcile these two statements.
If our existing and new products fail to meet the quality standards required by applicable laws,
our business and reputation..., page 25
19.This risk factor includes a cross-reference to a section titled “Business — Quality
Control” that does not appear to be included in the Prospectus. Please revise your
disclosure to include a discussion of your quality control systems or remove this cross
reference. In this regard, we note your disclosure on page 85 that under applicable

 FirstName LastNameHung To Pau, Ph.D.
 Comapany NameAdvanced Biomed Inc.
 December 27, 2022 Page 6
 FirstName LastName
Hung To Pau, Ph.D.
Advanced Biomed Inc.
December 27, 2022
Page 6
regulations in the PRC, "an enterprise engaged in the production of medical devices shall
establish and effectively maintain a quality control system in accordance to the
requirements of the Standards on Production and Quality Management of Medical
Devices."
Risks Related to Doing Business in Taiwan, page 31
20.We note your disclosure in this section regarding certain R&D contracts between
Advanced Biomed Taiwan and other legal persons in Taiwan, such as National Cheng
Kung University Hospital, National Applied Research Laboratories and your research
projects collaborated with Chenggong University Hospital in two written contracts. Please
expand on your disclosure to note the material terms of these contracts. Additionally,
please file these contracts as exhibits to the Registration Statement or provide us with your
basis for not filing them. Please refer to Item 601 of Regulation S-K.
Any lack of requisite approvals, licenses, permits or filings or failure to comply with any
requirements of Taiwan laws