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United States securities and exchange commission logo
June 3, 2021
Faraz Ali
Chief Executive Officer
Tenaya Therapeutics, Inc.
171 Oyster Point Boulevard, 5th Floor
South San Francisco, CA 94080
Re: Tenaya
Therapeutics, Inc.
Draft Registration
Statement on Form S-1
Submitted May 7,
2021
CIK No. 0001858848
Dear Mr. Ali:
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
Our Pipeline, page 4
1. Please revise your
pipeline table to condense the preclinical phases to no more than two
columns and to
separately depict clinical phases 1, 2 and 3.
Overview of heart disease, page 5
2. We note your statements
that you have the opportunity to advance multiple product
candidates into the
clinic by ____ and that TN-201 is a potentially curative therapy.
Given that you have not
completed any IND enabling studies, these statement appears to
be an inappropriate
predictions that the FDA will approve multiple INDs and that the
product will be
effective. Please remove these statements. Additionally, in other
Faraz Ali
FirstName LastNameFaraz
Tenaya Therapeutics, Inc. Ali
Comapany
June 3, 2021NameTenaya Therapeutics, Inc.
June 3,
Page 2 2021 Page 2
FirstName LastName
instances where you reference advancing candidates to the clinic,
please revise to more
specifically reference clinical trials, as opposed to the clinic.
"Our amended and restated bylaws ...", page 91
3. Please revise the narrative in the risk factor to disclose that there
is also a risk that your
exclusive forum provisions may result in increased costs for investors
to bring a claim.
Use of Proceeds, page 96
4. Please revise your disclosure to separately quantify the amount of
proceeds you expect to
allocate to TN-201 and TYA-11631. Additionally, indicate how far in
the development
process you expect to get for each of your product candidates with the
proceeds from this
offering.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Estimates
Stock-Based Compensation, page 114
5. Please expand your disclosure to include the valuation methodologies
used by the
independent third party valuation firm to estimate your total equity
value along with the
nature of material assumptions used within those methodologies. If
more than
one methodology is used, provide a discussion of the weighting of
those methodologies.
Our Management Team and Investors, page 122
6. We note that you identify certain entities as investors in your
company that do not appear
to be among your principal stockholders as disclosed on page 215. If
material, please
expand your disclosure to describe the nature of each named entity's
investment
and explain to us why including this information is appropriate.
Please also explain in
your response letter your plans to update investors about any changes
these entities make
with respect to their investments in the company.
Business
Third Party Agreements, page 170
7. Please indicate which product candidate(s) rely on intellectual
property licensed from
UTSW.
9. Stock-Based Compensation
Restricted Stock, page F-22
8. We note that when you repurchase shares of common stock related to
early exercise of
options, you reduce the number of shares of common stock outstanding.
Please disclose
your accounting policy for the issuance of shares of common stock from
the early exercise
of stock options prior to vesting. Refer to ASC 718-10-55-31.a. for
guidance.
Faraz Ali
Tenaya Therapeutics, Inc.
June 3, 2021
Page 3
13. Subsequent Events, page F-25
9. Please expand your disclosures for the stock options grants to include
the total amount of
compensation expense to be recognized over the 4 year vesting period.
General
10. 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 Brian Cascio at 202-551-3676 or Tracey Houser at
202-551-3736 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Tom Kluck at 202-551-3233 or Suzanne Hayes at 202-551-3675 with any
other
questions.
Sincerely,
FirstName LastNameFaraz Ali
Division of
Corporation Finance
Comapany NameTenaya Therapeutics, Inc.
Office of Life
Sciences
June 3, 2021 Page 3
cc: Jennifer Knapp
FirstName LastName