United States securities and exchange commission logo
October 26, 2021
Chee Kong CHOO
Director and Chairman
CytoMed Therapeutics Pte. Ltd.
21 Bukit Batok Crescent
#17-80 WCEGA Tower
Singapore 658065
Re: CytoMed
Therapeutics Pte. Ltd.
Draft Registration
Statement on Form F-1
Submitted September
28, 2021
CIK No. 0001873093
Dear Mr. CHOO:
We have reviewed your draft offering 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 offering statement or publicly filing your offering
statement on
EDGAR. Please refer to Rule 252(d) regarding the public filing
requirements for non-public
submissions, amendments and correspondence. 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 your amended draft offering statement
or filed offering
statement and the information you provide in response to these comments,
we may have
additional comments.
Draft Registration Statement on Form F-1 Submitted September 28, 2021
Summary
Our Business, page 19
1. Revise to clarify the
current status of your three product candidates. You state on page 19
that you are in the
midst of developing them, and that you are a preclinical
biopharmaceutical
company. Revise to further clarify at what stage you are with each
product and where you
intend to submit them for approval. With respect to CTM-N2D,
we note from page 89
you are close to starting a Phase I trial, and from page 107 that
you submitted a Phase I
study to the HSA. Revise to clarify and disclose the correct stage
in the summary. Provide
similarly specific information about the status of your other two
Chee Kong CHOO
CytoMed Therapeutics Pte. Ltd.
October 26, 2021
Page 2
main product candidates. For example, if the HSA requires an IND
application as a first
step, like the FDA, disclose the date you anticipate filing the IND
for each of your other
two product candidates.
Use of Procceds, page 74
2. Please revise to disclose the amount of proceeds that you intend to
allocate toward the
development of each product candidate and also how far along in the
preclinical or
clinical trials you intend to fund with the proceeds.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Overview, page 80
3. Revise the disclosure on pages 81 and 86 to disclose for how long you
believe the net
proceeds from this offering, together with existing cash, will be
sufficient to fund your
operations.
Business
Overview, page 89
4. Revise your pipeline table to include all three Phases of clinical
development, and to
remove proof of concept and manufacturing process validation
as separate phases of
development. Clarify what you mean by trial application. Revise
the indication for
each product candidate to clarify the specific indication for which
you will seek regulatory
approval. Revise the table to clearly disclose the jurisdiction in
which you are seeking
regulatory approval, as you are a Singapore company operating
primarily in Malaysia
seeking to raise capital in the United States.
5. To the extent you are seeking regulatory approval in Singapore, revise
your Business
section to briefly explain that process and in what category your
product candidates fall,
that is, whether they require a CTA, CTN or Clinical Trial
Certificate, and what
procedures you must undertake to conduct human clinical trials.
Essentially, explain how
the regulations described beginning on page 123 apply to your product
candidates.
Strategy, page 90
6. Revise to avoid statements such as having the competitive edge, in
the disclosure and
the table on page 90, where your products are pre-clinical. Where the
comparison
products are commercialized and yours are yet to be proven, it is
premature to address the
FirstName LastNameChee Kong CHOO
technology evolution as presented in the graphic, which should be
deleted. Similarly,
Comapany NameCytoMed
rephrase Therapeutics
the Advantages of yourPte. Ltd. in the heading on page
102 to clarify they are
therapy
Octoberpotential
26, 2021advantages.
Page 2
FirstName LastName
Chee Kong CHOO
FirstName LastNameChee
CytoMed Therapeutics Pte.Kong
Ltd. CHOO
Comapany
October 26,NameCytoMed
2021 Therapeutics Pte. Ltd.
October
Page 3 26, 2021 Page 3
FirstName LastName
CTM-N2D, page 95
7. Revise to clarify the nature of the deep discussion with a
potential clinical trial partner to
formally submit a Phase I trial application for CTM-N2D. Also
clarify what it means
that HSA reviewed [your] submission and concluded that it has no
major issues with
[your] documents. It is unclear where this places you in the
regulatory pathway.
Product Design and Manufacturing of CTM-N2D, page 101
8. As safety and efficacy determinations are solely within the authority
of regulators such as
the HSA and FDA, and they continue to be evaluated throughout all
phases of clinical
trials, please remove the reference to your products as safer
from Figure 10, the
reference to safer drug-like product features, and
characterizing the product-candidate
as safe on page 103, and other statements of safety throughout
the prospectus. Also
avoid statements of the potency of CTM-N2D, as referenced at the
bottom of page 103, on
page 105, and elsewhere in the prospectus, as this has yet to be
proven. avoid any
statements of efficacy in the prospectus. You may present the results
of pre-clinical tests
without drawing conclusions regarding efficacy or potency.
Gamma delta NKT Cells Recognize and Kill a Broad-spectrum of Cancer Cells, page
111
9. Revise Figure 22 on page 112 so the font is large enough to be legible
in each of the
tables.
Property, page 113
10. Clarify the importance of the lease beginning March 1, 2008 on the
property you recently
purchased.
Intellectual Property, page 115
11. Please update your description of the Patent License, Know-How License
and K562 Cell
License with ATPL to disclose, as applicable:
the aggregate amounts paid to date;
aggregate milestone payments; and
For the Patent and Know-How Licenses, please quantify the royalty rate
or provide a
reasonable range not exceeding 10 percentage points, and disclose when
the royalty
provisions expire.
Foreign Private Issuer Exemptions, page 147
12. You disclose here that you intend to follow the practices of your home
country,
Singapore, with respect to the practices listed here, rather than the
Nasdaq Listing Rules
standards, however, for several of these matters, it appears you may
meet the Nasdaq
Listing standards. For example, you state on page 146 that you will
adopt a Code of
Business Conduct and Ethics. Also, it appears from page 146 that your
compensation
Chee Kong CHOO
CytoMed Therapeutics Pte. Ltd.
October 26, 2021
Page 4
committee will be independent and will have a charter. Please revise the
appropriate
sections to clarify.
Financial Statements
Audit Report, page F-2
13. Please obtain an audit report which addresses the following issues:
Revise the language of the opinion paragraph to make clear that the
opinion covers
the consolidated statements of comprehensive income, changes in
equity, and cash
flows for both fiscal years ended December 31, 2019 and December 31,
2020;
Refer to the International Financial Reporting Standards as issued
by the International
Accounting Standards Board, as per the guidance in Item 17(c) of Form
20-F;
Include representations, if true, that the audit was conducted in
accordance with the
standards of the Public Company Accounting Oversight Board (United
States), and
conform the audit report accordingly; and
Include the date of the audit opinion in accordance with Rule
2-02(a) of Regulation
S-X.
You may contact Tracie Mariner at (202) 551-3744 or Daniel Gordon at
(202) 551-3486
if you have questions regarding comments on the financial statements and
related
matters. Please contact Abby Adams at (202) 551-6902 or Celeste Murphy at (202)
551-
3257 with any other questions.
Sincerely,
FirstName LastNameChee Kong CHOO
Division of
Corporation Finance
Comapany NameCytoMed Therapeutics Pte. Ltd.
Office of Life
Sciences
October 26, 2021 Page 4
cc: Richard I. Anslow, Esq.
FirstName LastName