SEC Comment Letter 0000000000-23-004205 to BioLingus (Cayman) Ltd (CIK 0001966522)
BioLingus (Cayman) Ltd (CIK 0001966522)
Date: April 25, 2023 · CIK: 0001966522 · Accession: 0000000000-23-004205
AI Filing Summary & Sentiment
Show Raw Text
United States securities and exchange commission logo
April 25, 2023
Yves Decadt
Chief Executive Officer
BioLingus (Cayman) Limited
Grossmatt 6
CH-6052 Hergiswil NW
Switzerland
Re:BioLingus (Cayman) Limited
Draft Registration Statement on Form F-1
Submitted March 29, 2023
CIK No. 0001966522
Dear Yves Decadt:
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 F-1 submitted March 29, 2023
Cover Page
1.We note your disclosure about Holding Foreign Companies Accountable Act. Please
update your disclosure here, and wherever else appropriate, to reflect that the Holding
Foreign Companies Accountable Act’s timeline for a potential trading prohibition was
shortened from three years to two years as part of the Consolidated Appropriations Act,
2023 which was signed into law on December 29, 2022.
FirstName LastNameYves Decadt
Comapany NameBioLingus (Cayman) Limited
April 25, 2023 Page 2
FirstName LastName
Yves Decadt
BioLingus (Cayman) Limited
April 25, 2023
Page 2
2.Please provide a description of how cash is transferred through your organization. State
whether any transfers, dividends, or distributions have been made to date to investors, and
quantify the amounts if applicable.
3.We note that you checked the Rule 415 box on the cover page, yet disclosures elsewhere
indicate that this is a firm commitment, underwritten offering. Please advise or revise
accordingly.
Prospectus Summary, page 5
4.Please balance your prospectus summary by including disclosure regarding your history of
net losses and the auditor's explanatory paragraph regarding your ability to continue as a
going concern.
5.We note your disclosure here and at the top of page 89 that it has become clear to you that
there are two areas for your technology with significant commercial potential, including
"Immunology." However, we note your disclosure on page 87 that you spun-out and
licensed all the rights to all non-metabolic applications from BioLingus I to BioLingus II,
which you do not appear to own. When discussing the application of your technology to
immunology, please clarify that you only hold the rights to metabolic applications or
otherwise advise.
Advantages of the BioLingus Platform, page 6
6.Please provide support for your statement that your products produce "no or little gastro-
intestinal side effects".
Our Products, page 7
7.We note your pipeline table on page 7 includes a combined Phase Ib/IIa column for all of
your product candidates. Please revise your pipeline table to include separate columns for
Phase I and Phase II since you do not appear to have received authorization to proceed
with a Phase I/II combined trial for each of your product candidates shown in the table.
8.We note your footnotes under your pipeline table indicate that certain of your product
candidates are “trailing” your other product candidates by a certain number of months.
Given the stage of your product candidates and the length of time and uncertainty
involved in product candidate development, it appears premature and inappropriate to
quantify how many months one candidate is “trailing” from another one of your product
candidates.
9.Please revise your pipeline table to clarify what “SL” means.
10.We note your disclosure here that “[u]ntil now, both drugs [(Liraglutide and Exenatide)]
are generally only available by injection” and that “Semaglutide is a GLP-1 product
available as an oral dosage form.” Please clarify whether Liraglutide and Exenatide are
currently available in an oral version or otherwise advise.
FirstName LastNameYves Decadt
Comapany NameBioLingus (Cayman) Limited
April 25, 2023 Page 3
FirstName LastName
Yves Decadt
BioLingus (Cayman) Limited
April 25, 2023
Page 3
Significant Risk Factors, page 9
11.Your risk factor summary currently exceeds two pages. Please revise your risk factor
summary to be no more than two pages and to discuss the principal factors that make an
investment in you or the offering speculative or risky, rather than listing each heading that
appears in the Risk Factors section. For guidance, please refer to Item 105(b) of
Regulation S-K.
Transfers of Cash to and from Our Subsidiaries, page 14
12.Provide a clear description of how cash is transferred through your organization. Please
also 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.
Use of Proceeds, page 60
13.We note that you intend to use 10% of the proceeds from this offering to repay external
borrowings due in 2023. Please revise to set forth the interest rate and maturity of any
indebtedness to be discharged with the proceeds from this offering. If any of the
indebtedness to be discharged was incurred within one year, describe the use of the
proceeds of such indebtedness. Refer to Item 3.C.4 of Form 20-F for guidance.
Capitalization, page 68
14.Please revise to address the following comments for your capitalization table:
•Include long-term debt as part of your capitalization as presented on the page F-24
balance sheet as of October 31, 2022.
•Include share information, both historical and pro forma, in the caption for ordinary
shares, no par value.
•Double underline cash and cash equivalent so it is obvious that cash and cash
equivalents are not part of your capitalization.
Industry
Our Competitive Strengths, page 84
15.We note references to conclusions related your scientific data here and throughout your
registration statement. For example only, we note your statement that sublingual drug
delivery "substantially enhances the efficacy of immuno-active and other drugs." Please
replace all claims or conclusions related to efficacy with a description of the objective
data resulting from the trials and explain how the trials were conducted.
FirstName LastNameYves Decadt
Comapany NameBioLingus (Cayman) Limited
April 25, 2023 Page 4
FirstName LastName
Yves Decadt
BioLingus (Cayman) Limited
April 25, 2023
Page 4
16.We note your statements here that your BioLingus platform is a "[b]reakthrough
formulation technology" and a "breakthrough platform." Please tell us your basis for
asserting that your platform is a "breakthrough" technology or platform given the current
stage of your clinical development or otherwise advise.
17.You cite to reports for statistical information regarding your industry in this section and
elsewhere in the prospectus. Please note that when you include an active hyperlink or an
inactive URL for a website that could be converted into an active hyperlink within a
document required to be filed or delivered under the federal securities laws, you assume
responsibility for the information that is accessible through the hyperlinked website as if it
were part of the filing. Refer to Release No. 34-42728 for further guidance regarding the
use of hyperlinks in your document.
Business
Overview, page 86
18.Please define the meaning of the Latin phrase "primus inter pares."
19.We note your disclosure that as part of your spin-out of BioLingus IP II GmbH
you "granted the rights to all non-metabolic applications from BioLingus I to BioLingus
II." Please update your disclosure to discuss the material terms of the agreement,
including the aggregate amounts paid to date under the agreement, the aggregate future
potential payments and the termination provisions.
Our Products, page 89
20.Please revise this section to provide a more fulsome discussion of your product
candidates, including a discussion of any development activities conducted since
inception, the current development status of your product candidates and the indications
you are targeting.
21.We refer to your statements here that you intend to pursue a section 505(b)(2) approval
pathway. Please also update your Prospectus Summary section to disclose the potential
approval pathway you plan to rely on. In addition, please expand your discussion of this
approval pathway so that investors understand the necessary steps to receive FDA
approval using this process. Please identify and describe the specific studies and results
you intend to rely on, including identifying the parties that performed these studies.
Please also disclose if the FDA has given any indication that you may use such pathway
for your candidates and consider updating your risk factor section to discuss any specific
risks to this potential product approval pathway.
22.We note your disclosure that benefits of the 505(b)(2) pathway include: "faster
development" and "lower development risk." Please revise your disclosure to remove any
implications that your product candidates will be approved, are more likely to receive
FDA approval or will be approved quickly.
FirstName LastNameYves Decadt
Comapany NameBioLingus (Cayman) Limited
April 25, 2023 Page 5
FirstName LastName
Yves Decadt
BioLingus (Cayman) Limited
April 25, 2023
Page 5
Our Commercialization Strategy, page 90
23.Please remove the statement implying that you will be able to commercially sell your
product candidates two to three years after signing licensing agreements with
potential partners, as this statement is speculative in light of the current regulatory status
of your product candidates.
24.Please provide a brief summary of the market research conducted to support your
statement that “80% of the patients who currently take the injectable forms, would switch
to an oral form of these products.”
Intellectual Property, page 93
25.Please revise your intellectual property disclosure to clearly identify: (i) the
product candidate(s) dependent on each patent, (ii) whether the patent is owned
or licensed, (iii) the type of patent protection (e.g., composition of matter, use, or
process) and (iv) the expiration dates for each patent discussed in this section.
Principal Shareholders, page 108
26.Please revise your table to identify the natural person(s) that has voting and/or dispositive
control over the shares held by Glorious Quintessence Limited.
Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm, page F-2
27.Your auditor refers to a going concern as an emphasis of matter in its auditor's report
which also references Note 1 that the Company had a working capital deficit, incurred a
net loss, an accumulated deficit and its net cash outflows from operating activities which
raised substantial doubt about the Company's ability to continue as a going
concern. Please note that PCAOB AS 2415.03c requires the auditor to include an
explanatory paragraph, including an appropriate title (immediately following the opinion
paragraph), in its audit report to reflect its conclusion if substantial doubt exists. Please
have your auditor revise their opinion, if necessary, or explain in detail why no revision is
necessary.
Note 1. Organization and Principal Activities, page F-8
28.The organization chart presented here appears different from the version presented
on page 18 in regard to Glorious Quintessence Limited and the share percentages for the
three founders. Please revise to be consistent, or explain otherwise.
FirstName LastNameYves Decadt
Comapany NameBioLingus (Cayman) Limited
April 25, 2023 Page 6
FirstName LastName
Yves Decadt
BioLingus (Cayman) Limited
April 25, 2023
Page 6
Note 2. Summary of Significant Accounting Policies
Revenue recognition, page F-12
29.Here you disclose that you recognize license income on the straight-line basis over the
license terms because the customer simultaneously receives and consumes the benefits
provided by the company. Tell us whether this policy applies to your license agreement
with BioLingus IP II GmbH as disclosed at page 87. And if so, please provide us an
analysis for your revenue recognition under this license agreement. In your response,
specify your determination of the nature of the company's promises under ASC 606-10-
55-59 through 63. Please also expand your disclosures here, or elsewhere in the filing, to
include material rights and obligations for each party under the license agreement.
Note 10. Provision for Income Taxes, page F-18
30.Please revise to provide all the required disclosures under ASC 740-10-50, including those
disclosures required for public entities.
Exhibits
31.Please refile your exhibits in the proper text-searchable format. Please refer to Item 301 of
Regulation S-T.
General
32.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
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.