View:
United States securities and exchange commission logo
May 14, 2020
Eric Ostertag, M.D., Ph.D.
Chief Executive Officer
Poseida Therapeutics, Inc.
9390 Towne Centre Drive, Suite 200
San Diego, CA 92121
Re: Poseida
Therapeutics, Inc.
Draft Registration
Statement on Form S-1
Submitted April 17,
2020
CIK No. 0001661460
Dear Dr. Ostertag:
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 submitted on April 17, 2020
Prospectus Summary, page 1
1. We note your disclosure
on page 1 that you are currently evaluating P-BCMA-101 in a
potentially
registrational Phase 2 clinical trial. Please revise to clarify what you mean
by
the term
"registrational clinical trial." 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.
Eric Ostertag, M.D., Ph.D.
FirstName LastNameEric Ostertag, M.D., Ph.D.
Poseida Therapeutics, Inc.
Comapany NamePoseida Therapeutics, Inc.
May 14, 2020
Page 2
May 14, 2020 Page 2
FirstName LastName
CAR-T for Oncology
P-BCMA-101, page 5
2. Please revise to limit the discussion of pre-clinical and clinical
trial results in your
prospectus summary to the endpoints of the trial and whether they were
met. For
example, we note you characterize the interim results of the Phase 1
trial for your
candidate P-BCMA-101 as "encouraging, with strong response rates and
duration of
responses."
3. To the extent that you have not conducted head-to-head clinical
trials, please revise your
disclosure to remove comparisons of your product candidates to other
treatments, products
and product candidates. As but one example, we note your statement on
page 5 that you
have seen "a highly differentiated tolerability profile compared to
other CAR-T
approaches."
Our Pipeline, page 5
4. Please revise your pipeline chart here and on page 115 to identify the
product
candidate listed as "undisclosed" or remove this candidate from the
chart.
Use of Proceeds, page 81
5. Please ensure that your disclosure regarding the proceeds to be used
for your product
candidates in clinical development describes how far in the
development process you
estimate the allocated proceeds from this offering will enable you to
reach. Also
include an estimate of the amount and sources of other funds necessary
for the
development of your product candidates as we note your disclosure that
the proceeds from
this offering will be insufficient to fund any of your product
candidates through regulatory
approval.
Capitalization, page 83
6. Please revise the table to include debt as part of your
capitalization.
Management's Discussion and Analysis, page 91
Components of Our Results of Operations, page 95
7. On page 96 you state "[w]e track external costs by the stage of
program, clinical or
preclinical" but that internal costs are not tracked on a specific
program basis. Please
revise to disclose external costs by product candidate for all periods
presented or direct us
to that disclosure.
Critical Accounting Policies and Significant Judgments and Estimates, page 104
8. We note the options awarded during 2019 to certain of your executives
(page 193) and
directors (page 205). Please revise to disclose the extent to which
any stock-based
Eric Ostertag, M.D., Ph.D.
FirstName LastNameEric Ostertag, M.D., Ph.D.
Poseida Therapeutics, Inc.
Comapany NamePoseida Therapeutics, Inc.
May 14, 2020
Page 3
May 14, 2020 Page 3
FirstName LastName
compensation has been awarded during 2020. 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
valuations of your common stock leading up to the initial public
offering and the
estimated offering price for any grants subsequent to September 2019.
This information
will help facilitate our review of your accounting for equity
issuances including stock
compensation.
Safety, page 127
9. Please indicate the clinical symptoms of neurotoxicity seen in
early-generation CAR-T
treatments and that your product candidates are trying to reduce.
Interim Safety Results, page 139
10. Please expand to disclose, or revise to clarify that you have
disclosed, all treatment-
emergent serious adverse events reported rather than those that were
commonly reported.
In addition, where you note that some SAEs were "not generally
believed to be related to
CAR-T therapies," please clarify if this is your belief or the
conclusion of the trial
investigator.
Potential Additional Programs and Partnership Opportunities, page 160
11. We note your disclosure that CAR-T may be used as a safe and non-
myeloablative preconditioning regimen for stem cell transplants. If
the FDA has not
approved your products for such use, please remove any disclosure that
your products are
safe or effective as these determinations are within the authority of
the FDA and
comparable regulatory bodies. Please make similar revisions throughout
your prospectus.
For instance, we note the statements on page 5 describing the piggyBac
platform as a
"safer delivery vehicle" than AAV and its ability to permanently
integrate into DNA.
Company-Owned Intellectual Property, page 165
12. For the patent described in second to last sentence of the last
paragraph of this section,
please disclose the duration of the patent. Please also disclose the
jurisdictions and
expected duration of the patents described in the last sentence of the
last paragraph of this
section. Also disclose the type of patent protection (e.g.,
composition of matter, use or
process) for these patents.
License Agreement with Genus Oncology, page 168
13. Please briefly describe any of the material terms of the rights
retained by the upstream
licensor and the rights of the U.S. government referred to in the
first paragraph of this
section. If there are any material march-in-rights, address the
portion of your business
that would be impacted by exercise of such rights, and describe the
conditions which
might prompt the U.S. government to exercise any such rights. Include
risk factor
Eric Ostertag, M.D., Ph.D.
Poseida Therapeutics, Inc.
May 14, 2020
Page 4
disclosure if appropriate.
License Agreements with Transposagen and Hera, page 169
14. Please refer to Item 601(b)(10) of Regulation S-K and provide us with
your analysis of
why the agreements referenced in this section should not be filed as
exhibits to your
registration statement.
Policies and Procedures for Related Party Transactions, page 212
15. Please disclose the standards that will be applied in determining whether
to approve any
of the transactions described in this section. Refer to Item
404(b)(1)(ii) of Regulation S-
K.
Choice of Forum, page 219
16. We note your exclusive forum provision is intended to designate the Court
of Chancery of
the State of Delaware as the exclusive forum for resolving any complaint
asserting a cause
of action arising under the Securities Act, unless you consent in writing
to the selection of
an alternative forum. Please revise your disclosure to state that
investors will not be
deemed to have waived the company's compliance with the federal
securities laws and the
rules and regulations thereunder.
General
17. Please 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 Jenn Do at (202) 551-3743 or Kevin Kuhar at (202)
551-3662 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Tim Buchmiller at (202) 551-3635 or Mary Beth Breslin at (202) 551-3625
with any
other questions.
Sincerely,
FirstName LastNameEric Ostertag, M.D., Ph.D.
Division of
Corporation Finance
Comapany NamePoseida Therapeutics, Inc.
Office of Life
Sciences
May 14, 2020 Page 4
cc: Sean M. Clayton, Esq.
FirstName LastName