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United States securities and exchange commission logo
June 25, 2021
Todd Harris, Ph.D.
President and Chief Executive Officer
Tyra Biosciences, Inc.
2333 State Street, Suite 201
Carlsbad, CA 92008
Re: Tyra Biosciences,
Inc.
Draft Registration
Statement on Form S-1
Submitted May 28,
2021
CIK No. 0001863127
Dear Dr. Harris:
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
Prospectus Summary
Our Programs, page 2
1. Please include
treatment indications in your pipeline table (e.g., MIBC or ICC).
Additionally, please
explain what is involved in "lead optimization" phase as opposed to a
more general discovery
phase. While we will consider your response, we do not currently
believe that the lead
optimization is a distinct discovery phase and should thus be depicted
under a column labeled
"discovery." A textual discussion of the program is likely a more
appropriate place to
make distinctions regarding different segments within a particular
phase.
Todd Harris, Ph.D.
FirstName LastNameTodd Harris, Ph.D.
Tyra Biosciences, Inc.
Comapany
June NameTyra Biosciences, Inc.
25, 2021
June 25,
Page 2 2021 Page 2
FirstName LastName
Our Leadership Team and Investors, page 4
2. We note that you identify certain entities as investors in your
company; however, some do
not appear to be among your principal stockholders as disclosed on
pages 166 and 167.
Specifically, BVF Partners, L.P., Cormorant Asset Management, Janus
Henderson
Investors, and Logos. If material, please expand your disclosure to
describe the nature of
each named entity's investment in you and explain to us why including
this information is
appropriate. Please also explain in your response your plans to update
investors about any
changes these entities make with respect to their investments in the
company.
Industry and Other Data, page 76
3. We note your statements regarding market data used in the prospectus,
including that the
sources of the information do not guarantee the accuracy or
completeness of the
information and that investors are cautioned "not to give undue
weight" to estimates.
Please revise these statements to eliminate any implication that
investors are not entitled
to rely on the information included in your registration statement.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies, Significant Judgments, and Use of Estimates
Determination of Fair Value of Common Stock, page 96
4. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the common stock underlying your equity
issuances and the
reasons for any differences between the recent valuations of your
common stock leading
up to the IPO and the estimated offering price. Please also discuss
how you considered
recent preferred share issuances. This information will help
facilitate our review of your
accounting for equity issuances, including stock compensation. Please
discuss with the
staff how to submit your response.
Our Strategy, page 102
5. We note disclosure here and elsewhere in the prospectus in which you
refer to accelerated
FDA approvals for therapies developed by other companies and that your
products
candidates may receive similar accelerated approvals. Please revise
your prospectus to
balance this disclosure with the fact that you have not submitted an
application for
accelerated approval and that the FDA's accelerated approval pathway
may not lead to a
faster development process or regulatory review and does not increase
the likelihood that
a product candidate will receive approval.
In vivo models, page 107
6. We note your disclosure that your use of in vivo models allows you to
"significantly" condense your "drug development timeline." This
statement implies that
your product candidates are likely to be approved. Please revise this
statement to remove
Todd Harris, Ph.D.
Tyra Biosciences, Inc.
June 25, 2021
Page 3
any implication that you will be successful in mitigating the risk of
uncertainty with
regard to clinical development or that you will be successful in
commercializing your
product candidates in a rapid or accelerated manner.
FGFR Inhibitors, page 108
7. We note your comparisons to erdafitinib and pemigatinib, drugs
approved by the FDA, as
well as infigratinib and futibatinib. Please tell us on what basis you
believe you are able to
make these comparisons given your early stage of development and the
lack of any head-
to-head clinical trials or, alternatively, delete these inappropriate
comparisons. Please
revise the prospectus throughout accordingly.
Clinical Development plans for TYRA-300, page 115
8. We note your statement that you plan to pursue accelerated approval if
data from the
Phase 2 trial is sufficient to support marketing authorization. Please
revise to disclose
whether you have received any indication from the FDA that your Phase
2 clinical trail
will be treated as a registrational clinical trial such that a Phase 3
trial will not be required.
Competition, page 122
9. Please disclose whether, to your knowledge, any of your competitors
are
developing cancer treatments for the same indications for which you
are developing your
treatments.
Management
Non-Employee Directors, page 142
10. Please revise the management biography for Jake Simson, Ph.D. to
clearly identify his
other employment in the last five years. See Item 401 of Regulation
S-K.
General
11. Please supplementally provide us with copies of all written
communications, as defined in
FirstName LastNameTodd Harris, Ph.D.
Rule 405 under the Securities Act, that you, or anyone authorized to do
so on your behalf,
Comapany NameTyra
present Biosciences,
to potential investors Inc.
in reliance on Section 5(d) of the
Securities Act, whether or
not
June 25, theyPage
2021 retain
3 copies of the communications
FirstName LastName
Todd Harris, Ph.D.
FirstName LastNameTodd Harris, Ph.D.
Tyra Biosciences, Inc.
Comapany
June NameTyra Biosciences, Inc.
25, 2021
June 25,
Page 4 2021 Page 4
FirstName LastName
You may contact Kristin Lochhead at 202-551-3664 or Terence O'Brien at
202-551-3355
if you have questions regarding comments on the financial statements and
related
matters. Please contact Dillon Hagius at 202-551-7967 or Chris Edwards at
202-551-6761 with
any other questions.
Sincerely,
Division of Corporation
Finance
Office of Life Sciences
cc: Matthew T. Bush