SEC Comment Letter 0000000000-23-005753 to BioLingus (Cayman) Ltd (CIK 0001966522)
BioLingus (Cayman) Ltd (CIK 0001966522)
Date: June 1, 2023 · CIK: 0001966522 · Accession: 0000000000-23-005753
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United States securities and exchange commission logo
May 31, 2023
Yves Decadt
Chief Executive Officer
BioLingus (Cayman) Limited
Grossmatt 6
CH-6052 Hergiswil NW
Switzerland
Re:BioLingus (Cayman) Limited
Amendment No. 1 to
Draft Registration Statement on Form F-1
Submitted May 16, 2023
CIK No. 0001966522
Dear Yves Decadt:
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.
Amendment No. 1 to Draft Registration Statement on Form F-1
Cover Page
1.We note your response to prior comment 2 and reissue in part. Please further revise your
cover page to quantify the amounts transferred between the holding company and its
subsidiaries, as you have done in your revisions to page 14.
FirstName LastNameYves Decadt
Comapany NameBioLingus (Cayman) Limited
May 31, 2023 Page 2
FirstName LastName
Yves Decadt
BioLingus (Cayman) Limited
May 31, 2023
Page 2
Prospectus Summary
Overview, page 5
2.We note your response to prior comment 5, including your revised disclosure that
"[a] perpetual and irrevocable license has been granted to all non-metabolic applications
from BioLingus IP GmbH to BioLingus IP II GmbH. BioLingus IP GmbH only holds the
rights to the metabolic applications." Please revise your disclosure to clarify that
BioLingus IP GmbH was spun-out in 2019 and you no longer own BioLingus IP GmbH or
otherwise advise. In addition, please include the legend referenced in your response when
immunology is first referenced on page 84.
Our Products, page 7
3.We note your response to prior comment 7 and revised pipeline table and reissue in
part. Your pipeline table should depict when an entire phase of development has been
completed. Please tell us why you believe it is appropriate to indicate that you have
completed Phase I testing when you are currently conducting a Phase Ib/II trial.
Significant Risk Factors, page 9
4.Please revise your summary risk factors to restore the specific references to 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.
Business, page 84
5.We note your response to prior comment 15, including your revised disclosure and reissue
in part. We continue to note claims or conclusions related to the ability of your
"platform" or product candidates that do not appear to be supported with disclosure
relating to specific trials or objective data. For example only, please provide your basis for
your statement that you "can stabilize specific peptides and proteins for over 2 years at
room temperature." In addition, we note you reference outside publications, such as,
"(Kleinert et al., 2018)" and "(Smeekins et al, 2021)" but your disclosure does not appear
to describe the material details of the studies referenced. Please revise your disclosure to
include additional disclosure on the material details of the studies, including, for example
only, the sponsor, type of study, trial design and objective results.
Our Products, page 87
6.We note your response to prior comment 21 and reissue in part. Please further revise your
discussion of the 505(b)(2) regulatory pathway to provide a more fulsome description of
the specific, material studies and results you intend to rely on in pursuing this pathway.
Your revised disclosure should also identify the parties that performed these studies and
discuss how the studies were performed.
FirstName LastNameYves Decadt
Comapany NameBioLingus (Cayman) Limited
May 31, 2023 Page 3
FirstName LastNameYves Decadt
BioLingus (Cayman) Limited
May 31, 2023
Page 3
7.We note your disclosure that your "Liraglutide Sublingual product is currently being
evaluated in phase 1b/2a clinical studies." Please update your disclosure to discuss the
material details on the trial, including, for example:
•when the trial began;
•the number of expected participants and participants enrolled as of a recent date;
•the location;
•the trial design; and
•the endpoints and any protocols.
8.We note your revised disclosure on page 88, including a table setting forth a discussion of
development activities conducted since inception as well as current status of your
development. We note your disclosure here, that you are "finalizing pre-clinical data
package in preparation for phase 1b/2a clinical trial" for “Insulin+ Sublingual.” However,
your arrow on your pipeline table on page 7 and 87 for “Insulin+ Sublingual” depicts that
you have not begun preclinical activities. Please correct for this inconsistency or otherwise
advise.
9.We note your revised disclosure on page 88, including a table setting forth a discussion of
development activities conducted since inception. Please revise your disclosure to
describe the specific pharmacodynamic studies that were conducted for each of your
material product candidates in development or otherwise advise.
A. License Core Products, page 88
10.We note your reference to certain market research with the product profile of Exenatide
Sublingual. Please provide us with context and additional detail about the parameters of
this survey, including a discussion of the number of doctors you surveyed, the number that
responded, when the interviews were conducted, the types of questions that were asked,
and how your survey results support your statement that "80% of the patients who
currently take the injectable forms would switch to an oral form of these products.”
Our Commercialization Strategy, page 88
11.We note your disclosure that "[w]hen Semaglutide oral dosage form is out of patent, it is
expected that our Semaglutide Sublingual will take over the market share from Liraglutide
Sublingual in the established/high price markets." Please update your disclosure to clarify
when Semaglutide oral dosage form is "out of patent." In addition, please revise your
disclosure to remove any implications that your product candidates will be approved.
Competition, page 90
12.We note your disclosure on page 88 that you may "[r]ely on studies from reference listed
drug: Astra Zeneca (exenatide)." Please revise your disclosure here to discuss the
competition you may face from Astra Zeneca or otherwise advise.
FirstName LastNameYves Decadt
Comapany NameBioLingus (Cayman) Limited
May 31, 2023 Page 4
FirstName LastName
Yves Decadt
BioLingus (Cayman) Limited
May 31, 2023
Page 4
Consolidated Financial Statements
Index to Audited Consolidated Financial Statements , page F-1
13.We note the audited financial statements included in the filing are older than 12 months as
of May 1, 2023. Since it appears this Form F-1 represents your initial public offering,
please update your financial statements pursuant to Item 8.A.4 of Form 20-F or provide
the appropriate representations in an exhibit. Refer to Instruction 2 to Item 8.A.4.
Report of Independent Registered Public Accounting Firm, page F-2
14.Please have your auditor explain to us their rationale for labelling the restatement
paragraph as an "Emphasis of Matter.” We note PCAOB AS 3101.18(e) requires the
auditor to include explanatory language (or an explanatory paragraph) in the auditor's
report in circumstances when a material misstatement in previously issued financial
statements has been corrected. An Emphasis of a Matter paragraph is provided to comply
with PCAOB AS 3101.19. Please revise or advise.
You may contact Li Xiao at 202-551-4391 or Kevin Kuhar at 202-551-3662 if you have
questions regarding comments on the financial statements and related matters. Please
contact Tyler Howes at 202-551-3370 or Jason Drory at 202-551-8342 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Benjamin Tan, Esq.