SEC Comment Letter 0000000000-23-007786 to BioLingus (Cayman) Ltd (CIK 0001966522)
BioLingus (Cayman) Ltd (CIK 0001966522)
Date: July 21, 2023 · CIK: 0001966522 · Accession: 0000000000-23-007786
AI Filing Summary & Sentiment
File numbers found in text: 333-273093
Letter
United States securities and exchange commission logo July 21, 2023 Yves Decadt Chief Executive Officer BioLingus (Cayman) Limited Grossmatt 6 CH-6052 Hergiswil NW Switzerland Re:BioLingus (Cayman) Limited Amendment No. 1 to Registration Statement on Form F-1 Filed July 13, 2023 File No. 333-273093 Dear Yves Decadt: We have reviewed your amended 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 amending your registration statement and providing the requested information. 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 any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Amendment No. 1 to Registration Statement on Form F-1 Risk Factors, page 23 1.We note that you are currently conducting a Phase Ib trial for your Liraglutide Sublingual candidate in Hong Kong and are planning to pursue regulatory approval for this candidate in the United States. Please include a risk factor discussing the potential risks related to conducting trials in a foreign jurisdiction. Your risk factor should highlight the risk that the FDA may not accept data from your trials conducted in a foreign jurisdiction or may require you to conduct additional trials.
FirstName LastNameYves Decadt Comapany NameBioLingus (Cayman) Limited July 21, 2023 Page 2 FirstName LastName Yves Decadt BioLingus (Cayman) Limited July 21, 2023 Page 2 Regulations, page 103 2.Please revise to discuss the regulatory environment for your ongoing Phase Ib clinical trial for Liraglutide Sublingual in Hong Kong. Please also include corresponding disclosure for any other foreign jurisdictions you are currently conducting, or planning to conduct, clinical trials within. 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.
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United States securities and exchange commission logo
July 21, 2023
Yves Decadt
Chief Executive Officer
BioLingus (Cayman) Limited
Grossmatt 6
CH-6052 Hergiswil NW
Switzerland
Re:BioLingus (Cayman) Limited
Amendment No. 1 to Registration Statement on Form F-1
Filed July 13, 2023
File No. 333-273093
Dear Yves Decadt:
We have reviewed your amended 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Amendment No. 1 to Registration Statement on Form F-1
Risk Factors, page 23
1.We note that you are currently conducting a Phase Ib trial for your Liraglutide Sublingual
candidate in Hong Kong and are planning to pursue regulatory approval for this candidate
in the United States. Please include a risk factor discussing the potential risks related to
conducting trials in a foreign jurisdiction. Your risk factor should highlight the risk that
the FDA may not accept data from your trials conducted in a foreign jurisdiction or may
require you to conduct additional trials.
FirstName LastNameYves Decadt
Comapany NameBioLingus (Cayman) Limited
July 21, 2023 Page 2
FirstName LastName
Yves Decadt
BioLingus (Cayman) Limited
July 21, 2023
Page 2
Regulations, page 103
2.Please revise to discuss the regulatory environment for your ongoing Phase Ib clinical trial
for Liraglutide Sublingual in Hong Kong. Please also include corresponding disclosure
for any other foreign jurisdictions you are currently conducting, or planning to conduct,
clinical trials within.
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.