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United States securities and exchange commission logo
September 1, 2020
Ra Session, II
President and Chief Executive Officer
Taysha Gene Therapies, Inc.
2280 Inwood Road
Dallas, TX 75235
Re: Taysha Gene
Therapies, Inc.
Draft Registration
Statement on Form S-1
Submitted on August
3, 2020
CIK No. 0001806310
Dear Mr. Session:
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 August 3, 2020
Prospectus Summary, page 1
1. Please revise your
summary to include a balanced discussion of your company and
product candidates. For
example:
clarify that no
therapies utilizing the intrathecal method of administration and only
two candidates
utilizing gene transduction have ever been approved by the FDA;
remove indications
that you will develop these candidates quickly;
clarify that Rhett
syndrome is extremely rare;
disclose when you
were founded and that you have no experience developing or
commercializing
pharmaceutical or biologic products; and
disclose UT
Southwestern has collaborative arrangements with third parties,
Ra Session, II
FirstName LastNameRa Session, II
Taysha Gene Therapies, Inc.
Comapany 1,
September NameTaysha
2020 Gene Therapies, Inc.
September
Page 2 1, 2020 Page 2
FirstName LastName
including some competitors, which may present competing interests
with respect to
their priorities and resources.
2. Please explain the term "patient-centric gene therapy company" and
"patient-centric
business."
Our Pipeline, page 2
3. Please revise your product pipeline table as follows:
For purposes of consistency with the discussion of the regulatory
drug approval
process, replace the term "Pivotal" with Phase 3. If "Pivotal" is
intended to mean
something other than Phase 3, please provide further explanation.
We note you have created a distinction between "preclincal" and
"IND-enabling." As
"IND-enabling" studies are preclinical, please revise your table
to show all your
product candidates in the preclincial phase.
Additionally, your table indicates that all product candidates
have completed
preclincal trials. Your disclosure appears to indicate that you
are close to being ready
to submit INDs for TSHA-101, TSHA-102, TSHA-103 and TSHA-104. If
all
preclincial testing for these candidates has been completed,
depicting the program
with a bar through the preclincial column in the table is
appropriate. It is not
appropriate to depict the bar through the preclincal column for
any program that has
not completed all preclincial work, including "IND enabling"
studies.
Please clarify what the "Rights" column is intended to convey. For
example if it is
intended to indicate that you have licensed the rights to
commercialize the product
candidates, please make that clear.
Include separate columns for Phase 1 and Phase 2 trials or tell us
the basis for your
belief that you will be able to conduct Phase 1/2 trials for all
your product candidates.
We note that TSHA-107, TSHA-108 and TSHA 109 appear in your
pipeline table
with "undisclosed targets", and are not discussed elsewhere in the
prospectus. To the
extent these are material programs, disclose the targets and
provide descriptions of
these programs. If you have not yet identified target indications,
please remove them
from the table or explain the basis for your belief that they are
material and should be
included in your pipeline table.
Our Strategic Partnership with the University of Texas Southwestern Medical
Center, page 3
4. Please confirm that the credentials identified are held by individuals
involved in the
development of your product candidates. If they are not, please revise
your disclosure to
only present credentials held by faculty involved in the development
of your product
candidates.
Our History and Team, page 6
5. Please limit the disclosure identifying your investors to investors
identified in your
Ra Session, II
Taysha Gene Therapies, Inc.
September 1, 2020
Page 3
Principal Stockholder table.
Implications of Being an Emerging Growth Company and a Smaller Reporting
Company, page 8
6. 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.
License Agreement with Queen's University at Kingston, page 90
7. Please expand your description of the license agreement with Queen's
University at
Kingston to describe the technology licensed; identify your product
candidates that are
dependent on the license; and disclose when the latest to expire
patents is scheduled to
expire.
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.
FirstName LastNameRa Session, II Sincerely,
Comapany NameTaysha Gene Therapies, Inc.
Division of
Corporation Finance
September 1, 2020 Page 3 Office of Life
Sciences
FirstName LastName