View:
United States securities and exchange commission logo
January 14, 2021
R. Michael Dudley
Chief Executive Officer
TransCode Therapeutics, Inc.
6 Liberty Square, #2382
Boston, MA 02109
Re: TransCode
Therapeutics, Inc.
Draft Registration
Statement on Form S-1
Submitted December
18, 2020
CIK No. 0001829635
Dear Mr. Dudley:
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 S-1 submitted December 18, 2020
Prospectus Summary
Overview, page 1
1. We note your statement
here and similar statements elsewhere throughout your draft
registration statement
that "[i]n preclinical studies, [y]our drug candidate was successfully
delivered to existing
metastatic lesions, and eliminated metastasis and elicited complete
regression without
recurrence in 100% of subjects treated in a Stage II/III cancer model."
Given the stage of
development of your product candidate, please
balance this statement
by also disclosing material description of the study, including: (i)
identifying the drug
candidate, (ii) disclosing the number and type of subjects, (iii)
whether the study
results were statistically significant, including the p-value if applicable
R. Michael Dudley
TransCode Therapeutics, Inc.
January 14, 2021
Page 2
and (iv) other material details of your trial design and results. In
addition, we note your
statement on page 102 that your lead product candidate was used in
combination with low
dose doxorubicin in preclinical trials. Please advise us on whether or
not doxorubicin was
also administered in the preclinical study you reference in the
summary section. To the
extent it was used, please include relevant disclosure here.
2. Given the current state of development of your product candidates from
your TTX
platform, please substantiate or provide the basis for your beliefs
regarding the potential
effectiveness of the TTX platform or otherwise add balancing
disclosure. By way of
example, we note statements on page 1 that your platform enables you
to design product
candidates that "are highly efficient at reaching and engaging their
targets and " [yo]ur
nanocarrier is poised for immediate clinical translation" and on page
3 where you state
your science is "revolutionary."
3. Please amend your disclosure to clarify what makes your platform
different from other
research platforms, and whether any other research currently employs a
similar approach.
In particular, explain what you mean when you say your "discovery
platform consists of a
modular toolbox ," and whether that is unique to your company. If
it is not unique,
contrast your approach to those of other companies.
Implications of Being an Emerging Growth Company and a Smaller Reporting
Company, page 3
4. 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.
Risk Factors, page 9
5. Please update your risk factor disclosure by relocating risks that
could apply generally to
any company or offering of securities to the end of the risk factor
section under the
caption General Risk Factors. Refer to Item 105 of Regulation
S-K and SEC Release
No. 33-10825.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical accounting policies and significant judgments and estimates
Stock-based compensation, page 86
6. Once you have an estimated offering price range, please explain to us
the reasons for any
differences between recent valuations of your common shares leading up
to the planned
FirstName LastNameR. Michael Dudley
offering and the midpoint of your estimated offering price range. This
information will
Comapany NameTransCode
facilitate our review ofTherapeutics, Inc. for stock compensation.
Please discuss with the
your accounting
Januarystaff
14, how
2021toPage
submit
2 your response.
FirstName LastName
R. Michael Dudley
FirstName
TransCode LastNameR.
Therapeutics,Michael
Inc. Dudley
Comapany
January 14,NameTransCode
2021 Therapeutics, Inc.
January
Page 3 14, 2021 Page 3
FirstName LastName
Our Pipeline, page 93
7. Please revise your pipeline tables here and in the graphic immediately
proceeding the
table of contents to include columns depicting each of Phase 1, Phase
2, and Phase 3 to
ensure that all stages in the clinical trial process prior to seeking
FDA approval are shown.
In addition, we note your references to a certain undisclosed programs
in
your pipeline table. The pipeline table should be limited to current
material product
candidates. Please remove from your pipeline tables items that have
not yet been
identified and are not currently material. To the extent they are
material, you should revise
the prospectus to identify and describe them.
8. We note your disclosure that you are currently planning to initiate a
Phase 0 trial in 2021
for TTX-MC138. However, your pipeline table suggests that you have
already initiated
the clinical trial. Please shorten the arrow for TTX-MC138 as
appropriate to illustrate the
product candidate's current status. In addition, please revise your
disclosure in the "Key
Anticipated Milestone" column to clarify the milestones and
anticipated timing to the
extent available. For example, we note that "Tox study; First in Human
Study" is unclear.
9. We note references describing your product candidates as well as
potential candidates that
you have the right to license as "a promising therapeutic," "miRNAs
represent promising
candidates," "promising target" and other similar statements. Please
revise to remove any
statements that suggest the safety and efficacy of your candidates, as
these determinations
are the exclusive authority of the FDA or other regulators. In
addition, we note your
disclosure in figure 5 that you believe that "TTX-MC138 is a
first-in-class therapeutic to
address metastatic disease." Please remove the term "first-in-class"
and any other
disclosure that states or implies that your product candidates will be
the first approved
treatments for an indication.
Our approach Mechanism of action of TTX-MC138, page 102
10. We note your statement that "[i]n a different study, a group from Tel
Aviv University the
study concluded that it likely had a robust effect on c-JUN, as
illustrated in Fig. 9." Please
revise your disclosure to include all material information related to
the study, including
for example only, the study design, the number of participants, and
primary and secondary
endpoints. In addition, please include additional narrative disclosure
that clearly explains
the context for the illustration shown in Fig. 9.
11. We note your statement that "[n]o recurrence of metastatic disease was
observed by the
end of the study." Please revise your disclosure to clarify how the
subjects were observed
and the length of time the subjects were observed.
Detailed Objectives of the Phase 0 Trial:, page 106
12. We note your disclosure that you plan to validate your proprietary
companion diagnostic
CDx-miR10b against the gold-standard PCR method during the Phase 0
trial. Please
expand your disclosure to discuss the specific process you plan to use
to compare your
R. Michael Dudley
FirstName
TransCode LastNameR.
Therapeutics,Michael
Inc. Dudley
Comapany
January 14,NameTransCode
2021 Therapeutics, Inc.
January
Page 4 14, 2021 Page 4
FirstName LastName
CDx diagnostic with the PCR method.
TTX-siPDL1, page 107
13. We note your statements at the bottom of page 107 where you compare
checkpoint
inhibitors to your product candidate. Please revise your disclosure to
include a discussion
of the objective data observed to support your statement that your
product candidate
"prevent[s] the synthesis of PD-L1 all together rather than blocking
its function."
Alternatively, please remove the statement. In addition, given the
stage of your product
candidate please remove your analogy that equates checkpoint
inhibitors to "mopping the
floor" during a flood whereas your product candidate to "turning off
the faucet." We will
not object to objective descriptions of the mechanism of action for
your product
candidates, including objective descriptions of how you believe the
potential mechanism
of action for your product candidate is different from checkpoint
inhibitors.
Results, page 108
14. Please disclose the overall size of the study as well as the number of
mice that
received TTX-siPDL1 versus the control group.
Competition, page 112
15. Please expand your disclosure here to describe the competition you
face in the diagnostic
space.
Regulation of companion diagnostics, page 123
16. We note your statement on page 133 that the "success of certain of our
product candidates
may depend, in part, on the development and commercialization of a
companion
diagnostic." In your business section, please revise your disclosure
to explain how the
potential approval of your CDx-miR10b diagnostic tool impacts the
timing of potential
approval and/or commercialization of TTX-MC138. Please also disclose
the impact to
potential approval and or/marketing of TTX-MC138 if the diagnostic
tool is not approved.
Employees, page 133
17. Please revise to provide a description of your human capital resources
as required by Item
101(c)(2)(ii) of Regulation S-K. Refer to SEC Release No. 33-10825.
General
18. Please revise your graphics throughout as applicable so that the text
is legible. For
example only, Figure 3 on page 98, Figure 8 on page 102 and Figure 11
on page
103, contain text that is unclear and difficult to read.
19. We note that you have not yet disclosed the exchange on which you will
list your common
stock. In your next amendment please identify the exchange you plan to
list your common
R. Michael Dudley
TransCode Therapeutics, Inc.
January 14, 2021
Page 5
stock.
You may contact Frank Wyman at 202-551-3660 or Angela Connell at
202-551-3426 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Jason L. Drory at 202-551-8342 or Mary Beth Breslin at 202-551-3625
with any other
questions.
Sincerely,
FirstName LastNameR. Michael Dudley
Division of
Corporation Finance
Comapany NameTransCode Therapeutics, Inc.
Office of Life
Sciences
January 14, 2021 Page 5
cc: Michael Rosenberg
FirstName LastName