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United States securities and exchange commission logo
September 16, 2020
RA Session, II
President and Chief Executive Officer
Taysha Gene Therapies, Inc.
2280 Inwood Road
Dallas, TX 75235
Re: Taysha Gene
Therapies, Inc.
Amendment No. 1 to
Registration Statement on Form S-1
Filed September 8,
2020
File No. 333-248559
Dear Mr. Session:
We have reviewed your 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 S-1 filed September 8,
2020
Our Pipeline, page 2
1. We note your response
to prior comment 3 and reissue our comment. Please revise your
table to depict the
current status of your product candidates in a manner that is consistent
with the regulatory
process for drug development. Including the following changes:
We will not
object to separate columns for discovery and preclinical, but object to the
a separate column
for "construct selection" as that should be considered part of the
discovery and/or
preclinical work.
The Term
"IND-enabling" assumes the outcome of the preclinical work, as the FDA
will determine
whether the results of the preclinical activities support an IND. Please
revise your table
to clarify that the second column refers to preclinical work.
With respect to
the column heading "Pivotal Trial," our concern is that the table
depicts the status
of the product candidate in a manner that is not consistent with the
RA Session, II
Taysha Gene Therapies, Inc.
September 16, 2020
Page 2
regulatory process for drug development with separate column for
phases 1, 2 and 3.
We will not object to columns for phase 1/2 and/or 2/3 trials if the
trials are designed
to meet the requirements of both phases represented.
With respect to "Clinical expected..." text for TSHA-101,
TSHA-102, TSHA-103 and
TSHA-104, please revise to indicate when you expect to file an IND.
To the extent
you have already submitted an IND, we have no further concerns with
respect to the
current disclosure.
History and Team, page 7
2. We note your response to comment 7. As noted in your response, the
identification
appears to suggest that potential investors may consider investments made
by these
institutional investors as a factor in making their investment decisions
without knowing
the amount of their investment in total or on a per share basis, their
investment strategies
or whether these institutional investors continue to hold their shares.
Additionally, as
these shareholders are not subject to the reporting requirements of
Section 16, investors
will not know when they decide to sell their shares. Therefore, we
continue to believe the
disclosure is inappropriate for the registration statement.
Exhibits
3. Please file the employment agreement or offer letter, as applicable, with
each of Kamran
Alam and Suyash Prasad as exhibits to your registration statement.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
You may contact Li Xiao at 202-551-4391 or Angela Connell at
202-551-3426 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Alan Campbell at 202-551-4224 or Suzanne Hayes at 202-551-3675 with any
other
questions.
Sincerely,
FirstName LastNameRA Session, II
Division of
Corporation Finance
Comapany NameTaysha Gene Therapies, Inc.
Office of Life
Sciences
September 16, 2020 Page 2
cc: Madison Jones
FirstName LastName