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United States securities and exchange commission logo
May 7, 2021
Heather Turner
Chief General Counsel
Lyell Immunopharma, Inc.
400 East Jamie Court, Suite 301
South San Francisco, California 94080
Re: Lyell Immunopharma,
Inc.
Draft Registration
Statement on Form S-1
Submitted April 12,
2021
CIK No. 0001806952
Dear Ms. Turner:
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 April 12, 2021
Summary
Our Pipeline, page 2
1. We note that your
pipeline table does not include clinical phases 1, 2 and 3, which the
company's product
candidates will be required to complete prior to commercialization.
Please either revise
your table to include all phases of development both preclinical and
clinical, including
appropriate arrows for each indication to demonstrate progress, or
remove the graphic from
pages 2, 73, 93 and 122.
Dilution, page 69
2. It appears that the pro
forma net tangible book value was divided by 217,606,722 shares
Heather Turner
FirstName LastNameHeather
Lyell Immunopharma, Inc. Turner
Comapany
May 7, 2021NameLyell Immunopharma, Inc.
May 7,
Page 2 2021 Page 2
FirstName LastName
rather than 23,132,291 shares to arrive at pro forma net tangible book
value per share.
Please revise or advise as to the appropriateness of your disclosure.
Critical Accounting Policies and Significant Judgments and Estimates
Common Stock Valuations, page 89
3. 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 initial public offering and the estimated offering price.
This information will help
facilitate our review of your accounting for equity issuances
including stock compensation
and beneficial conversion features. Please discuss with the staff how
to submit your
response.
Business
Our Preclinical Data, page 129
4. We note certain disclosure in the Business section regarding your
preclinical data that may
be read to imply efficacy, such as your statement on page 130 that
your Epi-R T cell
populations have "demonstrated superior expansion". Please revise this
section to clarify,
as you have done on pages 6 and 31, that such observations may not be
repeated in
clinical trials and to remove any implication that your product
candidates are or will be
found to be safe or effective, as these determinations are solely
within the authority of the
FDA and comparable foreign regulators.
Collaboration, License and Success Payment Agreements
Fred Hutch, page 138
5. Please revise your disclosure regarding the company's agreements with
Fred Hutch to
address the following:
describe in greater detail the nature and scope of intellectual
property that the
company was granted access to under the license agreement;
disclose the duration and termination provisions of the license
agreement;
disclose the duration and termination provisions of the
collaboration agreement; and
file the license and collaboration agreements as exhibits or
explain why such filing is
not required.
6. We note that in the letter agreement with Fred Hutch, the company is
required to make
success payments up to $200 million based on the fair market value of
the series A
convertible preferred stock or any security into which it has been
converted. Please
explain in this section whether the preferred stock converts
automatically into common
stock upon the closing of the underwritten public offering and if it
would be on a one-for-
one basis. Also revise accordingly the similar provision and
disclosure under the letter
agreement with Stanford.
Heather Turner
FirstName LastNameHeather
Lyell Immunopharma, Inc. Turner
Comapany
May 7, 2021NameLyell Immunopharma, Inc.
May 7,
Page 3 2021 Page 3
FirstName LastName
GSK Collaboration and License Agreement, page 141
7. For applications of your Epi-R technology to the NY-ESO-1 TCR, and in
regards to the
company and GSK sharing responsibilities of development activities,
please disclose if
each is responsible for the costs associated with their
responsibilities.
National Cancer Institute (NCI) License Agreement, page 142
8. Please file the license agreement with NCI as an exhibit or advise us
why such agreement
is not required to be filed. See Item 601(b)(10) of Regulation S-K.
Intellectual Property, page 143
9. Please revise your intellectual property disclosure to clearly
describe on an individual or
patent family basis the type of patent protection granted for each
product, the expiration
year of each patent held, and the jurisdiction of each patent. Please
clearly distinguish
between owned patents and patents in-licensed or out-licensed to third
parties. In this
regard it may be useful to provide tabular disclosure.
Legal Proceedings, page 165
10. We note your statement on page 165 that the pending arbitration
proceedings between
Lyell and PACT Pharma are not material to your operations; however, we
also note the
disclosure provided on page F-21 which quantifies the impact of the
PACT Agreement.
Please provide an analysis supporting your conclusion that the pending
matter is not
material. Alternatively, revise your disclosure to describe the
factual basis alleged to
underlie the proceedings along with the relief sought, and provide any
updates to the
status of the arbitration. See Item 103 of Regulation S-K for
guidance.
Certain Relationships and Related Person Transactions, page 192
11. For each of the transactions, please disclose the name of the related
person and the basis
on which the person is a related person, the related person s
interest in the transaction, and
the approximate dollar value of the amount involved in the
transaction. See Item 404 of
Regulation S-K.
Report of Independent Registered Public Accounting Firm, page F-2
12. Please have your auditors amend their audit report to indicate that
their audit was
conducted in accordance with the standards of the PCAOB, rather than
only the auditing
standards. Refer to the guidance in paragraph .09 of AS 3101.
General
13. 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
Heather Turner
Lyell Immunopharma, Inc.
May 7, 2021
Page 4
not they retain copies of the communications.
You may contact Jenn Do at 202-551-3743 or Vanessa Robertson at
202-551-3649 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Samuel Kluck at 202-551-3233 or Laura Crotty at 202-551-7614 with any
other
questions.
Sincerely,
FirstName LastNameHeather Turner
Division of Corporation
Finance
Comapany NameLyell Immunopharma, Inc.
Office of Life Sciences
May 7, 2021 Page 4
cc: Dave Peinsipp
FirstName LastName