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United States securities and exchange commission logo
February 6, 2021
Mark Manfredi, Ph.D.
President and Chief Executive Officer
Ikena Oncology, Inc.
50 Northern Avenue
Boston, MA 02210
Re: Ikena Oncology,
Inc.
Draft Registration
Statement on Form S-1
Submitted January
8, 2021
CIK No. 0001835579
Dear Dr. Manfredi:
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 January 8, 2021
IK-930, a TEAD inhibitor, page 3
1. Please explain the
basis for your belief that IK-930 is one of the most advanced TEAD
inhibitors in
development. Additionally, balance this statement with disclosure that you
have not performed any
clinical trials to date and developing this candidate will require
Phase I, II and III
clinical trials which will take years to complete. Provide similar
disclosure about IK-175
nd IK-007.
Our Targeted Oncology Programs, page 3
2. We note references to
initial data, early clinical data, and preliminary data that your
product candidates have
demonstrated potent antitumor activity, and similar statements
Mark Manfredi, Ph.D.
FirstName LastNameMark Manfredi, Ph.D.
Ikena Oncology, Inc.
Comapany6,NameIkena
February 2021 Oncology, Inc.
February
Page 2 6, 2021 Page 2
FirstName LastName
indicating findings of efficacy. Please revise to remove any
statements that suggest the
efficacy of your candidates, as these determinations are the exclusive
authority of the
FDA or other regulators. Also, please limit the prospectus summary
discussion of
preclinical studies and trial results to an objective description of
the endpoints of your
studies and trials and whether they were met. For example, rather than
stating that ERK5
prevented tumor formation, present your trials observations without
concluding that ERK5
caused the observations. Similarly revise the disclosure throughout
your filing.
Our Strategy, page 5
3. Please delete your intention to "rapidly" advance IK-930 through
clinical trials. Given the
length of time it takes to conduct clinical trials and the frequency
with clinical trials fail to
meet trial endpoints, any indications that you will be able to perform
them rapidly appears
inappropriate.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Use of Estimates
Stock-Based Compensation, page 103
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. 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, page 107
5. Please revise your graphics throughout this section as applicable to
ensure that the text is
legible. For example, the footnotes to your pipeline table and the
table on page 113 are
unclear and difficult to read.
IK-930, a TEAD inhibitor, page 111
6. We note you intend to evaluate IK-930 in Hippo-mutated cancers. Please
clarify that the
primary purpose of Phase 1 trials are to evaluate safety and
evaluating efficacy is a
primary purpose of later phase trials.
Master Collaboration Agreement with Bristol-Myers Squibb, page 138
7. We note your disclosure on page 138 that you may be eligible to
receive tiered royalties at
rates ranging from the high single to low double digit percentages.
The upper bound of
the range is very broad and therefore does not provide investors with
a meaningful
understanding of the potential royalty payments. Accordingly, please
revise so that the
range of the royalty rate does not exceed 10 percentage points.
Mark Manfredi, Ph.D.
FirstName LastNameMark Manfredi, Ph.D.
Ikena Oncology, Inc.
Comapany6,NameIkena
February 2021 Oncology, Inc.
February
Page 3 6, 2021 Page 3
FirstName LastName
Patent License Agreement with the University of Texas at Austin, page 139
8. We note your disclosure with respect to the License Agreement that
your royalty
obligations will continue as long as there is an existing valid claim
under the licensed
patents in such country, and your disclosure with respect to the AskAt
Agreement that
your royalty obligations will continue until the later of 10 years
from the first commercial
sale in such country or the expiration of valid claims in such
country. Please revise to
clarify when the patents underlying such royalty terms are expected to
expire.
Intellectual Property
Patent Protection, page 140
9. Please revise your intellectual property disclosure to clearly
describe on an individual
basis the type of patent protection granted for each technology, the
expiration of each
patent held, and the jurisdiction, including any foreign jurisdiction,
of each pending or
issued patent. In addition, with respect to your disclosure on page
142 of patents related
to your IK-412 program, please clarify whether each such patent is
owned or licensed. In
this regard, it may be useful to provide this disclosure in tabular
form to support the
narrative already included.
Certain Relationships and Related Party Transactions
Merger Agreements, page 186
10. Please file the Arrys Merger Agreement and the AMI Merger Agreement as
exhibits or
provide your analysis identifying how you determined that the
agreements did not need to
be filed as exhibits. Please refer to Items 601(b)(2) and 601(b)(10)
of Regulation S-K.
Description of Capital Stock
Choice of Forum, page 195
11. Please ensure that the exclusive forum provision in your bylaws that
will become effective
upon the completion of this offering clearly states that this
provision does not apply to
actions arising under the Securities Act or Exchange Act, or tell us
how you will inform
investors in future filings that the provision does not apply to any
actions arising under the
Securities Act or Exchange Act.
Exhibits
12. We note your disclosure in footnote 2 to your product pipeline table
on pages 2 and 108
that pembrolizumab for your Phase 1b clinical trial of IK-007 is
provided through a
clinical trial collaboration and supply agreement with Merck. Please
provide your
analysis supporting your determination that you are not required to
file it in accordance
with Item 601(b)(10) of Regulation S-K.
General
Mark Manfredi, Ph.D.
Ikena Oncology, Inc.
February 6, 2021
Page 4
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
not they retain copies of the communications.
You may contact Tracie Mariner at 202-551-3744 or Mary Mast at
202-551-3613 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Kasey Robinson at 202-551-5880 or Suzanne Hayes at 202-551-3675 with
any other
questions.
FirstName LastNameMark Manfredi, Ph.D. Sincerely,
Comapany NameIkena Oncology, Inc.
Division of
Corporation Finance
February 6, 2021 Page 4 Office of Life
Sciences
FirstName LastName