SEC Comment Letter 0000000000-25-003953 to ImageneBio, Inc. (IMA)
ImageneBio, Inc.
Date: April 14, 2025 · CIK: 0001835579 · Accession: 0000000000-25-003953
AI Filing Summary & Sentiment
File numbers found in text: 333-285881
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April 14, 2025
Jotin Marango, M.D., Ph.D.
Chief Financial Officer and Chief Operating Officer
Ikena Oncology, Inc.
645 Summer Street, Suite 101
Boston, MA 02210
Re: Ikena Oncology, Inc.
Registration Statement on Form S-4
Filed March 18, 2025
File No. 333-285881
Dear Jotin Marango M.D., Ph.D.:
We have reviewed your registration statement and have the following
comments.
Please respond to this letter by amending your registration statement
and providing
the requested information. If you do not believe a comment applies to your
facts and
circumstances or do not believe an amendment is appropriate, please tell us why
in your
response.
After reviewing any amendment to your registration statement and the
information
you provide in response to this letter, we may have additional comments.
Registration Statement on Form S-4
Cover Page
1. Please revise your Cover Page to disclose your valuation of Inmagene.
Questions and Answers
Q: What is the Merger?, page 1
2. Please revise this Q&A, or elsewhere in the Q&A as appropriate, to
disclose the
ownership breakdown of the combined company on a fully-diluted basis.
Alternatively, please tell us why this information would not be
required.
Q: What is the Ikena concurrent financing?, page 2
3. Please revise under this heading and elsewhere, as appropriate, to
disclose the per
share price of the common stock to be sold pursuant to the subscription
agreements.
April 14, 2025
Page 2
To the extent it is currently unknown, revise to disclose how the price
per share will
be determined.
Q: What are Ikena contingent value rights ("Ikena CVRs")? , page 5
4. We note that your responses to this question and the following question
("Q: What are
Inmagene contingent value rights ( Inmagene CVRs )?") state that
Ikena CVR
holders will receive 90% of the net proceeds, if any, received by Ikena
as a result of
the Ikena CVR payments for agreements entered into after the closing
date of the
Merger and prior to the first anniversary of the Merger and that
Inmagene CVR
holders will be treated similarly with respect to the Inmagene CVR
payments. Please
revise the responses to both of these questions to clarify whether the
combined
company will be obligated to continue to attempt to sell or dispose of
the Ikena CVR
Assets and the Inmagene CVR Assets following the first anniversary of
the Merger, if
these assets remain unsold. Please also clarify how any proceeds related
to CVR
assets received pursuant to agreements entered into after the first
anniversary of the
Merger will be treated. Alternatively, please advise.
Please also revise to clarify whether payments, if any, received by
Ikena pursuant to
its existing out-license agreements will be subject to the Ikena CVR
agreement.
Q: Who will be the executive officers of the combined company immediately
following the
Merger?, page 8
5. To the extent that the combined company will not have a chief financial
officer please
revise to identify who the principal accounting officer of the combined
company will
be, or otherwise advise.
Prospectus Summary
Inmagene, page 13
6. Please revise to remove the statement that Inmagene s topline results
were positive
and to instead briefly summarize the data from the Phase 2a trial
reported in January
2025. Revise to summarize the data supporting Inmagene s conclusion
that it
achieved proof-of-concept ( POC ) for IMG-007 in AD and to
clarify, if true, that
proof-of-concept does not provide a guarantee of clinical effectiveness.
7. Please revise under this heading to disclose that Inmagene licenses the
technology
underlying IMG-007 pursuant to the Hutchmed Agreement and that it relies
on WuXi
Biologics, pursuant to the Cell Line License Agreement, to supply the
active
pharmaceutical ingredients and drug product for IMG-007.
8. Please revise under this heading to disclose that IMG-007 is Inmagene
s only product
candidate in clinical development and the only product candidate the
combined
company initially plans to develop. Please similarly revise the Q&A to
include this
disclosure and describe whether the combined company will be able to use
any of
Inmagene's assets or technology other than IMG-007.
April 14, 2025
Page 3
Ikena's Reasons for the Merger, page 14
9. Please revise this section to briefly summarize the risks and
countervailing factors
related to entering into the Merger that were considered by the Ikena
board.
Opinion of Leerink Partners LLC, page 17
10. We note your disclosure that Ikena retained Leerink Partners as its
exclusive financial
advisor in connection with the Merger. Please revise to disclose why
Ikena did not
retain a third-party financial firm to provide a fairness opinion.
Subscription Agreements and Registration Rights Agreement, page 20
11. To the extent any of the investors in the Ikena concurrent financing are
affiliated with
Ikena or Inmagene, please identify these investors and disclose the
amount of their
investment. If applicable, please similarly revise your disclosure on
page 214.
Loan and Security Agreement, page 22
12. Please revise here and in the Q&A where the Exchange Ratio is discussed
to disclose
how the Term Loan Advances will be treated for the purposes of Ikena's
net cash and
the Ikena Valuation. To the extent that the Term Loan Advances will not
be included
in Ikena's net cash, please revise to explain why.
Risks Related to Ikena
We have incurred significant net losses since our inception..., page 39
13. Please revise to disclose the net losses and accumulated deficit for
Ikena that reconcile
to the Ikena financial statements beginning on page F-1.
Risks Related to Manufacturing and Our Reliance on Third Parties, page 100
14. We note the disclosure on pages 100, 103 and 313 that WuXi Biologics is
the supplier
for IMG-007 s active pharmaceutical ingredients and drug product and
that you have
licensed certain rights from WuXi. Please revise your Risk Factors
section where
appropriate to disclose the risks associated with WuXi Biologics and the
BIOSECURE Act.
Background of the Merger, page 154
15. Please revise this section to describe negotiations related to the PIPE
financing and to
identify the lead investor.
16. We note your disclosure that the Ikena board identified criteria that
were important in
reviewing potential counterparties in a reverse merger transaction and
that Ikena
management believed that Inmagene had the most potential to meet the
criteria
because of the strength of its technologies and pipeline products and
the absence of
meaningful competitors. We further note your disclosure elsewhere in the
prospectus
which appears to indicate that the only product candidate or technology
to be owned
by the combined company will be IMG-007 and that there are two
competitor
products targeting OX-40 or OX40L that are further along in development.
Please
revise your disclosure to describe how these factors impacted the Ikena
board and
management determination that Inmagene met the criteria. Please also
describe the
April 14, 2025
Page 4
reasons why Ikena did not pursue Inmagene's other product candidates and
technologies.
Certain Unaudited Prospective Financial Information, page 176
17. We note your statement that Ikena management assumed a "cumulative
probability of
success at 22%" for IMG-007. Please revise to explain if this relates to
the probability
of obtaining marketing approval, achieving market acceptance or another
factor.
Please also explain how this probability impacted IMG-007's projected
net revenues.
Inmagene's Business
Inmagene Overview, page 288
18. Please revise to remove the disclosure on page 288 that Inmagene s
topline results for
its Phase 2a trial were positive and instead summarize the data
supporting
Inmagene s conclusion.
19. Please revise your statement that "inhibiting OX40-OX40L signaling using
antagonistic monoclonal antibodies ( mAbs ) targeting OX40 or OX40L
have shown
sustained clinical activity results, lasting for months even after the
treatment
cessation" to clarify that the demonstration of "clinical activity" does
not mean that
this approach is effective or will be found to be effective.
IMG-007's potential competitive advantages, page 289
20. Please revise to clarify whether any product candidates targeting either
the OX40
receptor or OX40L to block OX40-OX40L signaling have received marketing
approval for the treatment of moderate-to-severe AD. To the extent that
no such
product candidates have been approved, please revise under this heading
to remove
the statement that Inmagene s approach is validated to treat
moderate-to-severe AD.
Current treatments for AD and their limitations, page 291
21. Please revise to define the term "PBO-adjusted" in your table on page
293. Similarly,
please revise where appropriate to explain what is meant by the term
"non-depleting"
and to define the term "ADCC."
IMG-007 - Inmagene's differentiated solution, page 294
22. Please revise your disclosure on page 294 to describe the function of
telazorlimab
similar to how you describe that rocatinlimab is an anti-OX40 mAb on
page 293.
Pharmacokinetics in Humans
IMG-007 has an extended half-life, page 300
23. We note Inmagene s disclosure in Table 5 on page 301 of half-life
comparisons and
the disclosure on page 307 comparing IMG-007 s mean percent change
of EASI and
the EASI-75 response at Week 16 data to rocatinlimab and amlitelimab
are not the
results of head-to-head clinical trials. Please revise to remove the
comparisons.
Similarly, revise to remove the comparisons between IMG-007 and
Rocatinlimab on
pages 308 and 309 and the comparisons between IMG-007 and Amlitelimab on
page
309.
April 14, 2025
Page 5
Clinical Activity in Atopic Dermatitis, page 301
24. Please revise the figures in this section to ensure that the information
presented is
legible.
Dose-related clinical activity signal was observed in IMG-007's Phase 2a AA
study, page 303
25. Please revise to disclose the number of patients for which you have
obtained
preliminary data supporting your statements that dose-related signal
of clinical
activity has been observed and that [a] short 4-week treatment
with IMG-007
resulted in a dose-related and sustained improvement in the SALT score.
IP Overview, page 310
26. Please revise to describe the patent family Inmagene licenses from
Hutchmed.
Summary of License and Collaboration Agreements
Hutchmed Collaboration, Option and License Agreement, page 313
27. We note your statements that you "are obligated to pay high single-digit
to low
double-digit royalties to Hutchmed" and that the Hutchmed agreement will
remain in
effect until the expiration of all royalty payment obligations. Please
revise to disclose
the Hutchmed Agreement royalty term and revise the royalty range to a
range within
10 percentage points.
Unaudited Pro Forma Condensed Combined Financial Information
Notes to the Unaudited Pro Forma Condensed Combined Financial Information
5. Adjustments to Unaudited Pro Forma Condensed Combined Balance Sheet as of
December
31, 2024, page 364
28. Please explain how the adjustment for the one-time derecognition of
property and
equipment that will be fully depreciated prior to the closing and
estimated to have no
value upon consummation of the Merger, is an event directly attributable
to the
Merger consistent with Article 11 of Regulation S-X.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence
of action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
Please contact Christine Torney at 202-551-3652 or Lynn Dicker at
202-551-3616 if
you have questions regarding comments on the financial statements and related
matters. Please contact Daniel Crawford at 202-551-7767 or Alan Campbell at
202-551-4224
with any other questions.
April 14, 2025
Page 6
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Amanda Gill, Esq.
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