SEC Comment Letter 0000000000-23-002720 to Advanced Biomed Inc. (ADVB)
Advanced Biomed Inc.
Date: March 17, 2023 · CIK: 0001941029 · Accession: 0000000000-23-002720
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United States securities and exchange commission logo
March 17, 2023
Hung To Pau, Ph.D.
Chief Executive Officer
Advanced Biomed Inc.
689-87 Xiaodong Road
Yongkang District
Tainan, Taiwan
Re:Advanced Biomed Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted March 6, 2023
CIK No. 0001941029
Dear Hung To Pau:
We have reviewed your amended 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.
FirstName LastNameHung To Pau, Ph.D.
Comapany NameAdvanced Biomed Inc.
March 17, 2023 Page 2
FirstName LastName
Hung To Pau, Ph.D.
Advanced Biomed Inc.
March 17, 2023
Page 2
Amendment No. 1 to Draft Registration Statement on Form S-1 submitted March 6, 2023
Prospectus Summary
Overview, page 9
1.We note your revisions in response to our prior comment 6 and reissue. Your
disclosure on pages 9, 58 and 66 appears to indicate that the testing completed between
July 17, 2019 and December 2021 was for your A+Pre, AC-1000 and A+SCDrop.
However, you then present the results for A+LCGuard without mentioning the
involvement of A+Pre, AC-1000 or A+SCDrop. Please revise to connect your statements
about A+Pre, AC-1000 and A+SCDrop to the results of A+LCGuard. We also note that
page 75 provides that the 123 case studies took place during the August 2020 – September
2022 timeframe. Please clarify what developmental tests and studies were conducted for
each of your products, specify which products were tested in each of these studies, and
when these studies each took place. Please also revise references to “clinic trials” and
certain values “obtained through clinical trials” so as to not draw an inference to clinical
trials as defined by the FDA and other comparable regulators. Revise to state explicitly
that you have not conducted any clinical trials.
2.We note your revisions in response to our prior comment 7 and reissue in part. Please
disclose here the role of single cell targeting in CTC capturing. We also note your
statement that you will need to "complete the registration application and obtain the
corresponding license in accordance with the local regulations before engaging in
commercial activities in the respective regions/countries" and that you have "applied for
product registration in China in accordance with relevant Chinese laws and regulations."
For each of China, the U.S. and Europe, please disclose the governmental authority
holding regulatory jurisdiction over the commercialization of your products and the
regulatory requirements you must satisfy to receive licensure or approval, including the
steps you have completed and those that remain to be completed. We note, for example,
your statements that A+Cellscan chip has completed a "development plan" and
"performance study," A+SCDrop samples have been "produced for product
registration," your CTC identification and counting application is “ready for
commercialization," your A+LCGuard has completed a "prospective study" and your
immunochromogenic kits "are ready to be transformed into commercialization." Please
disclose what each of these steps mean in the context of registering your products for
licensure or approval. Finally, we note your statement that your "products and devices
work together to achieve the designed result." Please clearly state whether, if approved,
your products could be sold individually, or whether they are only designed to work
together and not with any third-party products.
FirstName LastNameHung To Pau, Ph.D.
Comapany NameAdvanced Biomed Inc.
March 17, 2023 Page 3
FirstName LastName
Hung To Pau, Ph.D.
Advanced Biomed Inc.
March 17, 2023
Page 3
3.We note your response to prior comment 12 regarding permissions or approvals and
reissue. 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. Please also identify your PRC counsel in the
prospectus summary. Note that even if you disclose that you are not subject to any
permissions or approvals you must still revise your summary to include the consequences
to you and your offering if you: (i) inadvertently conclude that such permissions or
approvals are not required, or (ii) applicable laws, regulations, or interpretations change
and you are required to obtain such permissions or approvals in the future.
4.We note your response to our prior comment 13 and reissue. Please include disclosure in
your prospectus summary that provides 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
5.We note your revisions in response to our prior comment 8 and reissue in part. Please
disclose what the development plan and performance study for your A+CellScan entailed,
the purpose of the development plan and performance study, and when each was
completed. Please also discuss the pre-mass production test in more detail and what
factors will need to be satisfied to achieve mass production.
FirstName LastNameHung To Pau, Ph.D.
Comapany NameAdvanced Biomed Inc.
March 17, 2023 Page 4
FirstName LastName
Hung To Pau, Ph.D.
Advanced Biomed Inc.
March 17, 2023
Page 4
6.We note your revisions in response to our prior comment 14 and reissue in part. We note
from your response that you "currently cooperate with Unimold Technology Inc. for
small-scale trial production." Please clearly disclose this information in your prospectus
and describe the terms and parameters of this arrangement. To the extent that you have
entered into any contracts with Unimold, please disclose the material terms of these
agreements and file these agreements as exhibits to the Registration Statement.
Competitive Strengths, page 11
7.We note your revisions in response to our prior comment 16. Please revise to provide a
basis for your statement that you are able to "complete the detection and analysis in a
short period of time while ensuring the accuracy of the results and reducing the death
number of targeted cells throughout the process."
8.We note your revisions in response to our prior comment 10. Please revise the "Ready for
Commercialization" label under your "Competitive Strengths" section to remove the
implication that your products are ready to be commercialized, as none of your products
have received the regulatory approvals necessary to commercialize them.
Risks Factors
Risks Related to Doing Business in Taiwan
Advanced Biomed Taiwan does not currently own any trademark or patent, page 34
9.We note your revisions in response to our prior comment 20 and reissue in part. Please
disclose the material terms of your agreement with National Applied Research
Laboratories in an appropriate section of your Business section. Please be sure to disclose
the payment obligations of the agreement, the aggregate amounts paid or received to date
under the agreement, the duration of the agreement, and any termination provisions.
Use of Proceeds, page 54
10.We note your revisions in response to our prior comment 22 and reissue. Please
disclose how far in the development process you estimate that the allocated proceeds from
the offering will enable you to reach. For example, please indicate if you expect to be able
to fully fund your clinical trial starting June 2023, complete the design and development
of specific chips or finish building your laboratory without raising additional capital.
Critical Accounting Policies and Estimates, page 61
11.We note your response to comment 25. Your disclosures continue to indicate that your
significant accounting estimates include the useful lives for property, plant and equipment
and intangible assets, fair value of financial instruments, assumptions used in assessing
right of use assets and goodwill, impairment of long-lived assets, property, plant and
equipment, intangible assets and goodwill and uncertain tax position. However you only
disclose a critical accounting policy related to goodwill. Please revise as necessary. As
FirstName LastNameHung To Pau, Ph.D.
Comapany NameAdvanced Biomed Inc.
March 17, 2023 Page 5
FirstName LastName
Hung To Pau, Ph.D.
Advanced Biomed Inc.
March 17, 2023
Page 5
previously requested, please also revise your disclosures to address the material
implications of the uncertainties that are associated with the methods, assumptions and
estimates underlying your critical accounting estimates. Your expanded disclosures should
address the risk related to using different assumptions and analyze their sensitivity to
change based on outcomes that are deemed reasonably likely to occur. It does not appear
that your additional disclosures related to goodwill address this. Refer to Item
303(b)(3) of Regulation S-K
Business
Quality Control System, page 75
12.We note your revisions in response to our prior comment 19. Please expand your Quality
Control Section to disclose how you assess whether your products and processes adhere
to the regulations subject to your Quality Control System.
Intellectual Property, page 77
13.We note your revisions in response to our prior comment 29 and reissue in part. Please
revise your table to disclose the expiration dates of all your granted and pending patents
and provide a product candidate that each patent relates to or clarify any patents that are
not associated with any of your product candidates. Please also revise to explain what a
utility model is and specify the type of invention patent to the extent subtypes exist for
such jurisdictions.
Regulations in the PRC
Registration and Filings of Medical Devices, page 84
14.We note your response to our prior comment 31 and your statement on page 84: “As of
the date of this prospectus, we have completed the filing for the Class I medical device.
Our products are Class III medical devices and are required to conduct clinical trials
before completing the registration process.” Please clarify for which device you
completed the filing for as a Class I medical device and revise your summary to state that
your products are Class III medical devices required to conduct clinical trials before
completing the registration process.
FirstName LastNameHung To Pau, Ph.D.
Comapany NameAdvanced Biomed Inc.
March 17, 2023 Page 6
FirstName LastName
Hung To Pau, Ph.D.
Advanced Biomed Inc.
March 17, 2023
Page 6
National Medical Insurance Program, page 87
15.We note your revisions in response to our prior comment 32 and reissue in part. We note
your intention to "make [y]our products covered by medical insurance programs in the
future." Please discuss how you anticipate reimbursement coverage and rates will be
determined for your products, the applicable agency or agencies that will make
such determinations in the PRC and the anticipated timeline for any such decisions. Please
also include risk factor disclosure regarding risks and uncertainties around reimbursement
coverage and rates, particularly with respect to the need to negotiate such terms with
government entities in the PRC, and the impact that an inability to receive third-party
payor coverage will have on your business. We note, for example, your statement on page
29 that "In the absence of guarantee and reimbursement from third-party payers and
government departments, end users pay for their own expenses will use our products."
Compensation of Directors and Executive Officers, page 103
16.We note your response to our prior comment 33. Please disclose all of the information
required by Item 402(m) of Regulation S-K with regard to your CFO. We also note your
intention to supplementally file the employment agreements with the current management
team. Please revise your exhibit index to include these employment agreements.
Enforceability of Civil Liabilities, page 119
17.We note your response to our prior comment 34. Please revise to state the
jurisdiction where your Chairman of the Board is located and where the remaining
directors are located, when available.
Note 1. Organization and Principal Activities, page F-7
18.We note your response to comment 36. Please help us understand how you determined
that the reorganization should be accounted for as a transaction under common control per
the guidance of ASC 805. Specifically, please tell us how you determined that Dr. Yi Lu
controlled both Advanced Biomed Inc. (Taiwan) as well as Advanced Biomed Inc. at the
time of the transaction in July 2022. In this regard, we note that your disclosures on pages
48 and 105 indicate that Dr. Yi Lu only owned 33.54% of your outstanding shares of
common stock. Please refer to the definition of control and guidance in ASC 805-50-15-6
, ASC 805 20-20, and ASC 810-10-15-8. As previously requested, please also disclose
the terms of the reorganization, including how many shares of common stock were
exchanged as part of this transaction.
FirstName LastNameHung To Pau, Ph.D.
Comapany NameAdvanced Biomed Inc.
March 17, 2023 Page 7
FirstName LastName
Hung To Pau, Ph.D.
Advanced Biomed Inc.
March 17, 2023
Page 7
Note 5. Goodwill, page F-13
19.We note your response to comment 37. Please address the following:
•Please provide us with a comprehensive analysis as to how you determined that you
acquired a business pursuant to ASC 805. Refer to the ASC 805-10-55-3A through
55-9. As previously requested, please also specifically address the guidance in ASC
805-10-55-5A which states if substantially all of the fair value of the gross assets
acquired is concentrated in a single identifiable asset or group of similar identifiable
assets, the set is not considered a business;
•As previously requested, please address what considera