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ImageneBio, Inc.
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ImageneBio, Inc.
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ImageneBio, Inc.
Response Received
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SEC wrote to company
2021-02-25
ImageneBio, Inc.
References: February 6,
2021
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2021-03-05
ImageneBio, Inc.
References: February 25, 2021 | February 6, 2021
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2021-03-12
ImageneBio, Inc.
References: February 6, 2021
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2021-03-23
ImageneBio, Inc.
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| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-11 | SEC Comment Letter | ImageneBio, Inc. | DE | 333-290108 | Read Filing View |
| 2025-09-11 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2025-06-10 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2025-06-09 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2025-06-03 | SEC Comment Letter | ImageneBio, Inc. | DE | 333-285881 | Read Filing View |
| 2025-05-07 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2025-05-02 | SEC Comment Letter | ImageneBio, Inc. | DE | 333-285881 | Read Filing View |
| 2025-04-21 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2025-04-14 | SEC Comment Letter | ImageneBio, Inc. | DE | 333-285881 | Read Filing View |
| 2023-09-06 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2022-05-03 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2022-05-02 | SEC Comment Letter | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2021-03-23 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2021-03-23 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2021-03-12 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2021-03-05 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2021-02-25 | SEC Comment Letter | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2021-02-08 | SEC Comment Letter | ImageneBio, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-11 | SEC Comment Letter | ImageneBio, Inc. | DE | 333-290108 | Read Filing View |
| 2025-06-03 | SEC Comment Letter | ImageneBio, Inc. | DE | 333-285881 | Read Filing View |
| 2025-05-02 | SEC Comment Letter | ImageneBio, Inc. | DE | 333-285881 | Read Filing View |
| 2025-04-14 | SEC Comment Letter | ImageneBio, Inc. | DE | 333-285881 | Read Filing View |
| 2022-05-02 | SEC Comment Letter | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2021-02-25 | SEC Comment Letter | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2021-02-08 | SEC Comment Letter | ImageneBio, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-11 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2025-06-10 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2025-06-09 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2025-05-07 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2025-04-21 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2023-09-06 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2022-05-03 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2021-03-23 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2021-03-23 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2021-03-12 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
| 2021-03-05 | Company Response | ImageneBio, Inc. | DE | N/A | Read Filing View |
2025-09-11 - UPLOAD - ImageneBio, Inc. File: 333-290108
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 11, 2025 Kristin Yarema Chief Executive Officer ImageneBio, Inc. 12526 High Bluff Drive, Suite 345 San Diego, CA 92130 Re: ImageneBio, Inc. Registration Statement on Form S-1 Filed September 8, 2025 File No. 333-290108 Dear Kristin Yarema: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. 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. Please contact Tyler Howes at 202-551-3370 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Asa Henin, Esq. </TEXT> </DOCUMENT>
2025-09-11 - CORRESP - ImageneBio, Inc.
CORRESP 1 filename1.htm CORRESP ImageneBio, Inc. 12526 High Bluff Drive, Suite 345 San Diego, CA 92130 (858) 345-6265 September 11, 2025 V IA E DGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3010 Attn: Tyler Howes Re: ImageneBio, Inc. Registration Statement on Form S-1 File No. 333-290108 Acceleration Request Requested Date: Monday, September 15, 2025 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “ Registrant ”) hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form S-1 (the “ Registration Statement ”) to become effective at 4:00 p.m. Eastern Time on Monday, September 15, 2025, or as soon thereafter as is practicable. Once the Registration Statement has been declared effective, please orally confirm that event with Patrick Loofbourrow of Cooley LLP at (858) 550-6090 or Asa Henin of Cooley LLP at (858) 550-6104. Sincerely, ImageneBio, Inc. By: /s/ Jotin Marango Jotin Marango, M.D., Ph.D. Chief Financial Officer and Corporate Secretary
2025-06-10 - CORRESP - ImageneBio, Inc.
CORRESP 1 filename1.htm Ikena Oncology, Inc. 645 Summer Street, Suite 101 Boston, MA 02210 June 10, 2025 VIA EDGAR Office of Life Sciences Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street NE Washington, D.C. 20549-3628 Attention: Ms. Christine Torney Ms. Lynn Dicker Mr. Daniel Crawford Mr. Alan Campbell Re: Ikena Oncology, Inc. Acceleration Request for Registration Statement on Form S-4 File No. 333-285881 Requested Date: June 11, 2025 Requested Time: 4:15 p.m. Eastern Time Dear Ms. Torney, Ms. Dicker, Mr. Crawford and Mr. Campbell: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “ Act ”), Ikena Oncology, Inc. (the “ Company ”) hereby requests that the effective date of the above-referenced registration statement (the “ Registration Statement ”) be accelerated to June 11, 2025, at 4:15 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP by calling Stephanie Richards at (617) 570-1927. We also respectfully request that a copy of the written order from the Securities and Exchange Commission verifying the effective time and date of the Registration Statement be sent to our counsel, Goodwin Procter LLP, Attention: Stephanie Richards, by email to srichards@goodwinlaw.com . If you have any questions regarding this request, please contact Stephanie Richards of Goodwin Procter LLP at (617) 570-1927. Sincerely, Ikena Oncology, Inc. /s/ Mark Manfredi Mark Manfredi, Ph.D. President and Chief Executive Officer cc: Stephanie Richards, Goodwin Procter LLP John T. Haggerty, Goodwin Procter LLP Richard A. Hoffman, Goodwin Procter LLP Amanda Gill, Goodwin Procter LLP Lauren Visek, Goodwin Procter LLP
2025-06-09 - CORRESP - ImageneBio, Inc.
CORRESP 1 filename1.htm Goodwin Procter 100 Northern Ave. Boston, MA 02210 VIA EDGAR June 9, 2025 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3628 Attention: Christine Torney, Lynn Dicker, Daniel Crawford and Alan Campbell Re: Ikena Oncology, Inc. Amendment No. 4 to Registration Statement on Form S-4 Filed May 30, 2025 File No. 333-285881 Ladies and Gentlemen: On behalf of Ikena Oncology, Inc. (the “ Company ”), we are submitting this letter in response to the comment letter from the staff of the Division of Corporation Finance (the “ Staff ”) of the Securities and Exchange Commission (the “ SEC ”), dated June 3, 2025 (the “ Comment Letter ”), pertaining to the Company’s above-referenced Amendment No. 4 to Registration Statement on Form S-4 (the “ Registration Statement ”). In connection with such responses, the Company is concurrently filing Amendment No. 5 to the Registration Statement (the “ Amended Registration Statement ”). For your convenience, the text of the Comment Letter has been reproduced herein, and each comment is followed by the applicable responses on behalf of the Company. Unless otherwise indicated, page references in the responses correspond to the page numbers in the Amended Registration Statement, and page references otherwise correspond to the page numbers in the Registration Statement. Capitalized terms used in this letter but otherwise not defined herein shall have the meanings set forth in the Amended Registration Statement. Amendment No. 4 to Registration Statement on Form S-4 Questions and Answers Q: Who will be the executive officers of the combined company immediately following the Merger?, page 9 1. We note your revised disclosure indicating that the chief executive officer and chief financial officer of the combined company have not been identified. Please revise the response to this question to disclose why they have not been identified, the criteria that will be used to appoint a new CEO and CFO, the person(s) who will act as your principal executive officer and principal financial officer following the Merger and the risks of operating as a public company without a permanent CEO and/or CFO. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 9, 24, 148, 356, 357, 400 and 401 of the Amended Registration Statement. U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences June 9, 2025 Page 2 Management Following the Merger, page 353 2. Prior to effectiveness, please revise this section, as well as the Q&A on page 8, to identify each of the directors of the combined company following the Merger, including the director to be jointly agreed between Ikena and Inmagene and the director to be designated by Deep Track Master Fund. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 8, 9, and 356 of the Amended Registration Statement. ***** Please contact the undersigned at (617) 570-1927 or via email at srichards@goodwinlaw.com if you have any questions with respect to the foregoing. Very truly yours, /s/ Stephanie Richards Stephanie Richards Goodwin Procter LLP cc: Mark Manfredi, Ikena Oncology, Inc. Jotin Marango, Ikena Oncology, Inc. John T. Haggerty, Esq., Goodwin Procter LLP Richard A. Hoffman, Esq., Goodwin Procter LLP Amanda Gill, Esq., Goodwin Procter LLP Lauren Visek, Esq., Goodwin Procter LLP Patrick Loofbourrow, Esq., Cooley LLP Rama Padmanabhan, Esq., Cooley LLP Asa M. Henin, Esq., Cooley LLP
2025-06-03 - UPLOAD - ImageneBio, Inc. File: 333-285881
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> June 3, 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. Amendment No. 4 to Registration Statement on Form S-4 Filed May 30, 2025 File No. 333-285881 Dear Jotin Marango M.D., Ph.D.: We have reviewed your amended 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. Amendment No. 4 to Registration Statement on Form S-4 Questions and Answers Q: Who will be the executive officers of the combined company immediately following the Merger?, page 9 1. We note your revised disclosure indicating that the chief executive officer and chief financial officer of the combined company have not been identified. Please revise the response to this question to disclose why they have not been identified, the criteria that will be used to appoint a new CEO and CFO, the person(s) who will act as your principal executive officer and principal financial officer following the Merger and the risks of operating as a public company without a permanent CEO and/or CFO. Management Following the Merger, page 353 2. Prior to effectiveness, please revise this section, as well as the Q&A on page 8, to June 3, 2025 Page 2 identify each of the directors of the combined company following the Merger, including the director to be jointly agreed between Ikena and Inmagene and the director to be designated by Deep Track Master Fund. 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. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Amanda Gill, Esq. </TEXT> </DOCUMENT>
2025-05-07 - CORRESP - ImageneBio, Inc.
CORRESP 1 filename1.htm Goodwin Procter 100 Northern Ave. Boston, MA 02210 VIA EDGAR May 7, 2025 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3628 Attention: Christine Torney, Lynn Dicker, Daniel Crawford and Alan Campbell Re: Ikena Oncology, Inc. Amendment No. 1 to Registration Statement on Form S-4 Filed April 21, 2025 File No. 333-285881 Ladies and Gentlemen: On behalf of Ikena Oncology, Inc. (the “ Company ”), we are submitting this letter in response to the comment letter from the staff of the Division of Corporation Finance (the “ Staff ”) of the Securities and Exchange Commission (the “ SEC ”), dated May 2, 2025 (the “ Comment Letter ”), pertaining to the Company’s above-referenced Amendment No. 1 to Registration Statement on Form S-4 (the “ Registration Statement ”). In connection with such responses, the Company is concurrently filing Amendment No. 2 to the Registration Statement (the “ Amended Registration Statement ”). For your convenience, the text of the Comment Letter has been reproduced herein, and each comment is followed by the applicable responses on behalf of the Company. Unless otherwise indicated, page references in the responses correspond to the page numbers in the Amended Registration Statement, and page references otherwise correspond to the page numbers in the Registration Statement. Capitalized terms used in this letter but otherwise not defined herein shall have the meanings set forth in the Amended Registration Statement. Amendment No. 1 to Registration Statement on Form S-4 Questions and Answers, Page 1 1. We note your response to prior comment 8 and reissue the comment in part. Please revise your Questions and Answers section, where appropriate, 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. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 2 and 7 of the Amended Registration Statement. U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences May 7, 2025 Page 2 Q: What are Ikena contingent value rights (“Ikena CVRs”)?, page 5 2. We note your response to prior comment 4 and reissue in part. Please also revise your disclosure to clarify how any proceeds related to CVR assets received pursuant to agreements entered into after the first anniversary of the Merger will be treated. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 6 and 22 of the Amended Registration Statement. The Merger Background of the Merger, page 156 3. We note your response to prior comment 16 and reissue the comment in part. Please revise your disclosure on page 161 where you disclose you believed Inmagene “had the most potential to meet the Criteria, in particular because of the strength of its fundamental technologies and pipeline products” to disclose whether Ikena's management had also determined at that time “that the IMG-004 product candidate was further behind in development compared to competitors and IMG-017 was preclinical and it was in too early a stage to make an assessment as to its marketability.” If so, disclose how these factors impacted management's determination that Inmagene met the Criteria. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 161 of the Amended Registration Statement. Certain Unaudited Prospective Financial Information Financial Projections, page 180 4. We note your response to prior comment 17 including your statement that the 22% “probability of success did not impact IMG-007's projected net revenues, but was instead accounted for in the discounted cash flow analysis.” However, we further note your revised disclosure on page 180 indicates that in calculating net revenue and gross profit for IMG-007, Ikena management assumed “a cumulative probability of success at 22%, representing the likelihood of regulatory approval of IMG-007.” Please reconcile your disclosure or advise. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 177 and 180 of the Amended Registration Statement. ***** Please contact the undersigned at (617) 570-1927 or via email at srichards@goodwinlaw.com if you have any questions with respect to the foregoing. U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences May 7, 2025 Page 3 Very truly yours, /s/ Stephanie Richards Stephanie Richards Goodwin Procter LLP cc: Mark Manfredi, Ikena Oncology, Inc. Jotin Marango, Ikena Oncology, Inc. John T. Haggerty, Esq., Goodwin Procter LLP Richard A. Hoffman, Esq., Goodwin Procter LLP Amanda Gill, Esq., Goodwin Procter LLP Lauren Visek, Esq., Goodwin Procter LLP Patrick Loofbourrow, Esq., Cooley LLP Rama Padmanabhan, Esq., Cooley LLP Asa M. Henin, Esq., Cooley LLP
2025-05-02 - UPLOAD - ImageneBio, Inc. File: 333-285881
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
May 2, 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.
Amendment No. 1 to Registration Statement on Form S-4
Filed April 21, 2025
File No. 333-285881
Dear Jotin Marango M.D., Ph.D.:
We have reviewed your amended 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. Unless
we note
otherwise, any references to prior comments are to comments in our April 14,
2025 letter.
Amendment No. 1 to Registration Statement on Form S-4
Questions and Answers, page 1
1. We note your response to prior comment 8 and reissue the comment in
part. Please
revise your Questions and Answers section, where appropriate, 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.
Q: What are Ikena contingent value rights ("Ikena CVRs") ?, page 5
2. We note your response to prior comment 4 and reissue in part. Please
also revise your
disclosure to clarify how any proceeds related to CVR assets received
pursuant to
agreements entered into after the first anniversary of the Merger will
be treated.
May 2, 2025
Page 2
The Merger
Background of the Merger, page 156
3. We note your response to prior comment 16 and reissue the comment in
part. Please
revise your disclosure on page 161 where you disclose you believed
Inmagene "had
the most potential to meet the Criteria, in particular because of the
strength of its
fundamental technologies and pipeline products" to disclose whether
Ikena's
management had also determined at that time "that the IMG-004 product
candidate
was further behind in development compared to competitors and IMG-017
was
preclinical and it was in too early a stage to make an assessment as to
its
marketability." If so, disclose how these factors impacted management's
determination
that Inmagene met the Criteria.
Certain Unaudited Prospective Financial Information
Financial Projections, page 180
4. We note your response to prior comment 17 including your statement that
the 22%
"probability of success did not impact IMG-007's projected net revenues,
but was
instead accounted for in the discounted cash flow analysis." However, we
further note
your revised disclosure on page 180 indicates that in calculating net
revenue and gross
profit for IMG-007, Ikena management assumed "a cumulative probability
of success
at 22%, representing the likelihood of regulatory approval of IMG-007."
Please
reconcile your disclosure or advise.
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.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Amanda Gill, Esq.
</TEXT>
</DOCUMENT>
2025-04-21 - CORRESP - ImageneBio, Inc.
CORRESP 1 filename1.htm Goodwin Procter 100 Northern Ave. Boston, MA 02210 VIA EDGAR April 21, 2025 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3628 Attention: Christine Torney, Lynn Dicker, Daniel Crawford and Alan Campbell Re: Ikena Oncology, Inc. Registration Statement on Form S-4 Filed March 18, 2025 File No. 333-285881 Ladies and Gentlemen: On behalf of Ikena Oncology, Inc. (the “ Company ”), we are submitting this letter in response to the comment letter from the staff of the Division of Corporation Finance (the “ Staff ”) of the Securities and Exchange Commission (the “ SEC ”), dated April 14, 2025 (the “ Comment Letter ”), pertaining to the Company’s above-referenced Registration Statement on Form S-4 (the “ Registration Statement ”). In connection with such responses, the Company is concurrently filing Amendment No. 1 to the Registration Statement (the “ Amended Registration Statement ”). For your convenience, the text of the Comment Letter has been reproduced herein, and each comment is followed by the applicable responses on behalf of the Company. Unless otherwise indicated, page references in the responses correspond to the page numbers in the Amended Registration Statement, and page references otherwise correspond to the page numbers in the Registration Statement. Capitalized terms used in this letter but otherwise not defined herein shall have the meanings set forth in the Amended Registration Statement. Registration Statement on Form S-4 Cover Page 1. Please revise your Cover Page to disclose your valuation of Inmagene. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure appearing on the cover page of the Amended Registration Statement. U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences April 21, 2025 Page 2 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. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure throughout the Amended Registration Statement, including on pages 2, 7, 8, 14, 19, 29, 31, 195, 240 and 389, to indicate that the ownership breakdown of the combined company is presented on a fully diluted basis. 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. To the extent it is currently unknown, revise to disclose how the price per share will be determined. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure throughout the Amended Registration Statement, including on pages 2, 21, 216, 354 and 365, to describe how the price per share of the common stock to be sold pursuant to the subscription agreements 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. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 6, 21, 22, 218, 328, 358 and 359 of the Amended Registration Statement. U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences April 21, 2025 Page 3 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. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 23 and 349 of the Amended Registration Statement to identify the person who we expect will be the principal accounting officer of the combined company. Additionally, prior to the effectiveness of the Registration Statement, the Company will revise the Registration Statement to identify who the chief financial officer of the combined company will be. 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. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 1, 13, 14, 290 and 339 of the Amended Registration Statement. 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. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 14 and 290 of the Amended Registration Statement. 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. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 14 and 341 of the Amended Registration Statement. 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. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 15 of the Amended Registration Statement. U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences April 21, 2025 Page 4 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. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 18 and 174 of the Amended Registration Statement. 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. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 21 and 216 of the Amended Registration Statement to identify investors that are affiliated with Ikena, and disclose the amount of shares that each such investor has agreed to purchase pursuant to the subscription agreements. The Company further respectfully advises the Staff that none of the investors in the Ikena concurrent financing are affiliated with Inmagene. 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. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 23, 219 and F-32 of the Amended Registration Statement. 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. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 40 of the Amended Registration Statement. U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences April 21, 2025 Page 5 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. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 105 of the Amended Registration Statement. 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. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 166 and 167 of the Amended Registration Statement. 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 reasons why Ikena did not pursue Inmagene’s other product candidates and technologies. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 161 and 164 of the Amended Registration Statement. 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. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 180 of the Amended Registration Statement to explain that the cumulative probability of success represents the likelihood of regulatory approval of IMG-007. The Company further advises the Staff that this probability of success did not impact IMG-007’s projected net revenues, but was instead accounted for in the discounted cash flow analysis. Specifically, the discounted cash flow analysis applied this probability of success to the unlevered free cash flow for each forecast year to calculate the estimated present value. U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences April 21, 2025 Page 6 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. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 290 and 339 of the Amended Registration Statement. 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. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 291 of the Amended Registration Statement. 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. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 291 of the Amended Registration Statement. 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.” Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 110, 290, 291, 295 and 339 of the Amended Registration Statement. 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. Response : The Company respectfully acknowledges the Staff’s comment
2025-04-14 - UPLOAD - ImageneBio, Inc. File: 333-285881
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
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.
</TEXT>
</DOCUMENT>
2023-09-06 - CORRESP - ImageneBio, Inc.
CORRESP 1 filename1.htm CORRESP September 6, 2023 Via EDGAR Transmission United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Ikena Oncology, Inc. Acceleration Request for Registration Statement on Form S-3 File No. 333-274072 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Ikena Oncology, Inc. (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to September 8, 2023, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. If you have any questions regarding this request, please contact Stephanie Richards of Goodwin Procter LLP at (617) 570-1927. Sincerely, IKENA ONCOLOGY, INC. /s/ Mark Manfredi, Ph.D. Mark Manfredi, Ph.D. Chief Executive Officer cc: Mark Manfredi, Ph.D., Chief Executive Officer, Ikena Oncology, Inc. Stephanie Richards., Esq., Goodwin Procter LLP
2022-05-03 - CORRESP - ImageneBio, Inc.
CORRESP 1 filename1.htm CORRESP May 3, 2022 Via EDGAR Transmission United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Ikena Oncology, Inc. Acceleration Request for Registration Statement on Form S-3 File No. 333-264517 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Ikena Oncology, Inc. (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to May 5, 2022, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. If you have any questions regarding this request, please contact Stephanie Richards of Goodwin Procter LLP at (617) 570-1927. Sincerely, IKENA ONCOLOGY, INC. /s/ Mark Manfredi, Ph.D. Mark Manfredi, Ph.D. Chief Executive Officer cc: Mark Manfredi, Ph.D., Chief Executive Officer, Ikena Oncology, Inc. Stephanie Richards, Esq., Goodwin Procter LLP
2022-05-02 - UPLOAD - ImageneBio, Inc.
United States securities and exchange commission logo
May 2, 2022
Mark Manfredi
Chief Executive Officer
Ikena Oncology, Inc.
645 Summer Street, Suite 101
Boston, MA 02210
Re:Ikena Oncology, Inc.
Registration Statement on Form S-3
Filed April 27, 2022
File No. 333-264517
Dear Dr. Manfredi:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
Please contact Doris Stacey Gama at 202-551-3188 or Laura Crotty at 202-551-7614 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Stephanie Richards, Esq.
2021-03-23 - CORRESP - ImageneBio, Inc.
CORRESP 1 filename1.htm CORRESP VIA EDGAR March 23, 2021 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Kasey Robinson Suzanne Hayes Re: Ikena Oncology, Inc. Acceleration Request for Registration Statement on Form S-1 File No. 333-253919 Dear Ms. Robinson, Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Ikena Oncology, Inc. (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to March 25, 2021, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP by calling Stephanie Richards at (617) 570-1927. We also respectfully request that a copy of the written order from the Securities and Exchange Commission (the “Commission”) verifying the effective time and date of the Registration Statement be sent to our counsel, Goodwin Procter LLP, Attention: Stephanie Richards, by facsimile to (617) 321-4374. If you have any questions regarding this request, please contact Stephanie Richards of Goodwin Procter LLP at (617) 570-1927. Sincerely, IKENA ONCOLOGY, INC. /s/ Mark Manfredi Mark Manfredi, Ph.D. President and Chief Executive Officer cc: Douglas R. Carlson, Ikena Oncology, Inc. Richard Hoffman, Esq., Goodwin Procter LLP William D. Collins, Esq., Goodwin Procter LLP Stephanie Richards, Esq., Goodwin Procter LLP
2021-03-23 - CORRESP - ImageneBio, Inc.
CORRESP 1 filename1.htm CORRESP Jefferies LLC 520 Madison Avenue New York, New York 10022 Cowen and Company, LLC 599 Lexington Avenue New York, New York 10022 Credit Suisse Securities (USA) LLC Eleven Madison Avenue New York, New York 10010 William Blair & Company, L.L.C. 150 North Riverside Plaza Chicago, Illinois 60606 VIA EDGAR March 23, 2021 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Kasey Robinson Suzanne Hayes Re: Ikena Oncology, Inc. Acceleration Request for Registration Statement on Form S-1 File No. 333-253919 Dear Ms. Robinson, Pursuant to Rule 460 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), we, as representatives of the several underwriters, wish to advise you that approximately 1,725 copies of the preliminary prospectus included in the above referenced registration statement (the “Registration Statement”) were distributed during the period March 22, 2021 through the date hereof, to prospective underwriters, institutions, dealers and others. We have been informed by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. In accordance with Rule 461 of the Act, we hereby join in the request of Ikena Oncology, Inc. for acceleration of the effective date of the Registration Statement so that it becomes effective at 4:00 p.m. Eastern Time on March 25, 2021, or as soon thereafter as practicable. [Remainder of page intentionally left blank] Very truly yours, By: JEFFERIES LLC By: /s/ Charlie Glazer Name: Charlie Glazer Title: Managing Director By: COWEN AND COMPANY, LLC By: /s/ Mariel A. Healy Name: Mariel A. Healy Title: Managing Director By: CREDIT SUISSE SECURITIES (USA) LLC By: /s/ Rebecca Kotkin Name: Rebecca Kotkin Title: Director By: WILLIAM BLAIR & COMPANY, L.L.C. By: /s/ Steve Maletzky Name: Steve Maletzky Title: Partner, Head of Equity Capital Markets [Signature page to Acceleration Request Letter]
2021-03-12 - CORRESP - ImageneBio, Inc.
CORRESP 1 filename1.htm CORRESP March 12, 2021 FOIA CONFIDENTIAL TREATMENT REQUEST The entity requesting confidential treatment is Ikena Oncology, Inc. 645 Summer Street, Suite 101 Boston, MA 02210 Telephone: (857) 273-8343 CERTAIN PORTIONS OF THIS LETTER HAVE BEEN OMITTED FROM THE VERSION FILED VIA EDGAR. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. INFORMATION THAT WAS OMITTED IN THE EDGAR VERSION HAS BEEN NOTED IN THIS LETTER WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***].” VIA EDGAR, FACSIMILE AND FEDERAL EXPRESS United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences Mail Stop 4561 100 F Street, N.E. Washington, D.C. 20549 Attention: Kasey Robinson Suzanne Hayes RE: Ikena Oncology, Inc. Registration Statement on Form S-1 (the “Registration Statement”) File No. 333-253919 CIK No. 0001835579 Rule 83 Confidential Treatment Request by Ikena Oncology, Inc. Dear Ms. Robinson and Ms. Hayes: On behalf of Ikena Oncology, Inc. (the “Company”), in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by letter dated February 6, 2021 (the “Original Comment Letter”) relating to the Company’s Registration Statement on Form S-1, originally confidentially submitted to the Commission on January 8, 2021, resubmitted confidentially to the Commission on February 11, 2021 and subsequently publicly filed by the Company with the Commission on March 5, 2021 (File No. 333-253919) (the “Registration Statement”), we submit this supplemental letter to further address comment 4 of the Original Comment Letter. Because of the commercially sensitive nature of information contained herein, this submission is accompanied by the Company’s request for confidential treatment for selected portions of this letter. The Company has concurrently filed a separate letter with the Office of Freedom of Information and Privacy Act Operations in connection with the confidential treatment request, pursuant to Rule 83 of the Commission’s Rules on Information and Requests, 17 C.F.R. § 200.83. For the Staff’s reference, we have enclosed a copy of the Company’s letter to the Office of Freedom of Information and Privacy Act Operations. We confirm on behalf of the Company that, prior to circulating copies of the preliminary prospectus in connection with the offering, the Company will file a pre-effective amendment to the Registration Statement that will include all information other than information that may be excluded in reliance upon Rule 430A of Regulation C, and the actual price range to be included in such amendment which will comply with the Staff’s interpretation regarding the parameters of a bona fide price range. CONFIDENTIAL TREATMENT REQUESTED BY IKENA ONCOLOGY, INC. The Company expects to reflect the Stock Split (as defined below) in a pre-effective amendment to the Registration Statement that includes the actual price range; however, all dollar amounts and per share amounts in this letter are pre-Stock Split, and therefore, consistent with the Registration Statement. The Company respectfully requests that the bracketed information contained in this letter be treated as confidential information pursuant to Rule 83 promulgated by the Commission, 17 C.F.R. §200.8, and that the Commission provide timely notice to Mark Manfredi, Ph.D., President and Chief Executive Officer, Ikena Oncology, Inc., 645 Summer Street, Suite 101, Boston, MA 02210 before it permits any disclosure of the bracketed information in this letter. For the convenience of the Staff, we have recited the prior comment from the Staff in the Original Comment Letter in italicized type and have followed the comment with the Company’s response. 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. Preliminary IPO Price Range The Company advises the Staff that it estimates a preliminary price range of approximately $[***] to $[***] per share (the “Preliminary Price Range”) for its IPO, before giving effect to a reverse stock split that the Company plans to implement prior to effectiveness of the Registration Statement (the “Stock Split”) resulting in a midpoint of the Preliminary Price Range of $[***] per share (the “Midpoint Price”). The actual price range to be included in a subsequent amendment to the Registration Statement (which will comply with the Staff’s interpretation regarding the parameters of a bona fide price range) has not yet been determined and remains subject to adjustment based on factors outside of the Company’s control. However, the Company believes that the foregoing Preliminary Price Range will not be subject to significant change. Determining the Fair Value of Common Stock Prior to the IPO As there has been no public market for the Company’s common stock to date, the estimated fair value of its common stock has been determined by the Company’s board of directors (the “Board”) as of the date of each option grant, with input from management, considering the Company’s most recent third-party valuations of its common stock and the Board’s assessment of additional objective and subjective factors that it believed were relevant and which may have changed from the date of the most recent third-party valuation through the date of the grant. As presented in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Use of Estimates – Stock-Based Compensation” in the Company’s Registration Statement, the following table summarizes by grant date the number of shares subject to options granted between January 1, 2019 and March 2, 2021, the per share exercise price of the options and the fair value of common stock underlying the options on each grant date: Grant Date Type of Award Number of Common Shares Exercise Price of Award per Share Fair Value of Common Stock per Share on Grant Date Per Share Estimated Fair Value of Award Date of third-party valuation March 20, 2019 Option 6,633,540 $ 0.58 $ 0.58 $ 0.36 January 14, 2019 May 16, 2019 Option 1,898,181 $ 0.58 $ 0.58 $ 0.37 January 14, 2019 July 11, 2019 Option 875,584 $ 0.58 $ 0.58 $ 0.35 January 14, 2019 October 18, 2019 Option 1,338,858 $ 0.58 $ 0.58 $ 0.35 January 14, 2019 December 6, 2019 Option 654,633 $ 0.63 $ 0.63 $ 0.38 November 15, 2019 May 6, 2020 Option 440,024 $ 0.63 $ 0.63 $ 0.41 November 15, 2019 July 23, 2020 Option 1,388,269 $ 0.63 $ 0.77 (1) $ 0.52 July 1, 2020 February 12, 2021 Option 15,167,545 $ 1.10 $ 1.10 $ 0.70 December 18, 2020 March 2, 2021 Option 1,815,973 $ 1.10 $ 1.10 $ 0.71 December 18, 2020 CONFIDENTIAL TREATMENT REQUESTED BY IKENA ONCOLOGY, INC. (1) At the time of the option grants on July 23, 2020, our board of directors determined that the fair value of our common stock of $0.63 per share calculated in the contemporaneous valuation as of November 15, 2019 reasonably reflected the per share fair value of our common stock as of the grant date. However, in connection with a retrospective fair value assessment, the fair value of our common stock at the date of these grants was adjusted to $0.77 per share for accounting purposes. The third-party valuations were performed in accordance with the guidance outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation (“Practice Aid”), and were prepared using either the option-pricing method (“OPM”) or the hybrid method, both of which used market approaches to estimate the Company’s enterprise value. The hybrid method is a hybrid between the probability-weighted expected return method (“PWERM”) and the OPM, estimating the probability-weighted value across multiple scenarios but using the OPM to estimate the allocation of value in at least one scenario. The PWERM involves a forward-looking analysis of the potential future outcomes available to the enterprise, the estimation of future value and present value under each outcome, and the application of a probability factor to each outcome as of the valuation date. Unlike the PWERM, the OPM begins with the current equity value and estimates the future distribution of outcomes using a lognormal distribution around that current value. The OPM treats common and preferred stock as call options on the enterprise’s equity value, with exercise prices based on the liquidation preference of the preferred stock. In the PWERM and the OPM, a discount for lack of marketability (“DLOM”) is applied to the value indicated for the common stock. January 14, 2019 Valuation The third-party valuation as of January 14, 2019 was based on the OPM utilizing the Market Approach, specifically a weighted average of the asset accumulation method, the guideline transaction method and the guideline public company (“GPC”) method. The equity value of the Company was determined taking into account (i) the December 18, 2018 merger transaction between the Company and Arrys, pursuant to which each share of Arrys Series A preferred stock was exchanged for the right to receive 1.5801 shares of Company Series A-1 preferred stock, and common option shares were exchanged using the same ratio and (ii) the terms of the January 14, 2019 master collaboration agreement with Celgene, pursuant to which Celgene made an up-front payment of $80.5 million and acquired 14,545,450 shares of Company Series A-1 preferred stock at a purchase price of $1.00 per share. A DLOM of 28.0% was applied, which was derived from a put option calculation. The Board relied, in part, on the results of the January 14, 2019 valuation in its determination of the fair value of common stock of $0.58 per share for the 10,746,163 options granted from March 20, 2019 through October 18, 2019. Between January 14, 2019 and October 18, 2020, the Company continued to operate its business in the ordinary course and there were no significant developments that would impact the per share value of the Company’s common stock. November 15, 2019 Valuation The third-party valuation as of November 15, 2019 was based on the OPM utilizing the GPC method under Market Approach. The increase in valuation was in part due to the Company’s ongoing research and development activities, including its progress in the trials for IK-007 and an IND filing for IK-175; however, it did not achieve any significant scientific, financing or other milestones during this period necessary for a successful exit. A DLOM of 26.0% was applied, which was implied by a put option calculation. The Board relied, in part, on the results of the November 15, 2019 valuation in its determination of the fair value of common stock of $0.63 per share for the 1,094,657 options granted from December 6, 2019 through May 6, 2020. CONFIDENTIAL TREATMENT REQUESTED BY IKENA ONCOLOGY, INC. Between November 15, 2019 and May 6, 2020, the Company continued to operate its business in the ordinary course and there were no significant developments that would impact the per share value of the Company’s common stock The options to purchase 440,024 shares of common stock issued in May occurred in the onset of the COVID-19 pandemic. In response to the pandemic, the Company adjusted its operational and financing plans due to work from home orders and other risks and uncertainties applicable to clinical stage biotechnology companies during this time period. In addition, the Company observed broad U.S. and worldwide market volatility, uncertainty around investor interest in public offerings, concerns regarding unemployment rates, and unsettled debt financing markets. July 1, 2020 Valuation A retrospective third-party appraisal used a hybrid PWERM to estimate the value of the Company’s common stock as of July 1, 2020. The Company used this valuation for the 1,388,269 options granted on July 23, 2020. Two scenarios were considered, an IPO scenario and a remain-private scenario. In the IPO scenario, the GPC method was used to estimate our future value in an IPO. The GPCs consisted of a group of clinical-stage companies with recent IPOs. The IPO market for biotechnology IPOs improved since the Company’s prior valuation, including 13 biotechnology IPOs that were completed in May and June 2020, of which a majority priced at or above the mid-point of the price range included in the respective registration statements. The Company’s estimated future IPO value was adjusted for dilution associated with a prospective Series B financing and converted to present value. A DLOM of 20% was applied, which was implied by a put option calculation and a weight of 5% was assigned to the IPO scenario. In the remain private scenario, the value of the Company’s equity in a successful exit was adjusted for dilution associated with a prospective Series B financing, present value, the risk associated with clinical milestones, and the probability of achieving a successful exit. The OPM was used to allocate the weighted-average equity value to the Company’s preferred and common shares. A DLOM of 28% was applied and a weight of 95% was assigned to the remain-private scenario. October 1, 2020 Valuation In order to estimate the fair value of the Company’s common stock in connection with the Company’s acquisition of Amplify Medicines, Inc. (“AMI”) in October 2020, a contemporaneous third-party appraisal was done using a hybrid PWERM to estimate the value of the Company’s common stock as of October 1, 2020, which was determined to be $0.92. Two scenarios were considered, an IPO scenario and a remain-private scenario. In the IPO scenario, the GPC method was used to estimate our future value in an IPO. The GPCs consisted of a group of clinical-stage companies with recent IPOs. The Company’s estimated future IPO value was adjusted for dilution associated with a prospective Series B financing and converted to present value. A DLOM of 17% was applied, which was implied by a put option calculation, and a weight of 30% was assigned to the IPO scenario. In the remain private scenario, the value of the Company’s equity in a successful exit was adjusted for dilution associated with a prospective Series B financing, present value, the risk associated with clinical milestones, and the probability of achieving a successful exit. The OPM to allocate the equity value to the Company’s preferred and common shares. A DLOM of 29% was applied to the Company’s common stock and a weight of 70% was assigned to the remain-private scenario. December 18, 2020 Valuation As market conditions began to improve, the Company reassessed the possibility of an IPO with its Board. On December 2, 2020, the Company initiated efforts with investment bankers and advisors to complete a confidential draft registration statement filing. In addition, the Company considered the issuance and sale of 85,806,214 shares of Series B preferred stock at a price per share of $1.3985 for gross proceeds of $120 million to existing and crossover investors, which occurred on December 21, 2020. Consequently, the Company obtained a third-party valuation of its common stock as of December 18, 2020, which included the Series B closing. CONFIDENTIAL TREATMENT REQUESTED BY IKENA ONCOLOGY, INC. The hybrid PWERM used in the December 18, 2020 valuation included the following two scena
2021-03-05 - CORRESP - ImageneBio, Inc.
CORRESP 1 filename1.htm CORRESP March 5, 2021 VIA EDGAR AND FEDERAL EXPRESS United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences Mail Stop 4561 100 F Street, N.E. Washington, D.C. 20549 Attention: Kasey Robinson and Suzanne Hayes Re: Ikena Oncology, Inc. Amendment No. 1 to Draft Registration Statement on Form S-1 Submitted February 11, 2021 CIK No. 0001835579 Dear Ms. Robinson and Ms. Hayes: This letter is submitted on behalf of Ikena Oncology, Inc. (the “Company”) in response to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the Company’s Amendment No. 1 to Draft Registration Statement on Form S-1, confidentially submitted on February 11, 2021 (the “Draft Registration Statement”) as set forth in the Staff’s letter, dated February 25, 2021, addressed to Mark Manfredi (the “Comment Letter”). In response to the comment set forth in the Comment Letter, the Company has revised the Draft Registration Statement and is publicly filing its Registration Statement on Form S-1 (the “Registration Statement”) together with this response letter. The Registration Statement also contains certain additional updates and revisions. For reference purposes, the text of the Comment Letter has been reproduced herein with a response below the numbered comment. For your convenience, we have italicized the reproduced Staff comment from the Comment Letter. Unless otherwise indicated, page references in the descriptions of the Staff’s comment refer to the Draft Registration Statement, and page references in the responses refer to the Registration Statement. All capitalized terms used and not otherwise defined herein shall have the meanings set forth in the Registration Statement. The responses provided herein are based upon information provided to Goodwin Procter LLP by the Company. In addition to submitting this letter via EDGAR, we are sending via Federal Express four (4) copies of each of this letter and the Registration Statement (marked to show changes from the Draft Registration Statement). Amendment No. 1 to the Draft Registration Statement on Form S-1 Prospectus Summary Overview, page 1 1. We note your revised disclosure in response to comment 1 in our letter dated February 6, 2021. To provide context for your product pipeline table and the corresponding discussion of your programs, please revise your prospectus summary to disclose that developing your product candidates will require Phase 1, 2 and 3 clinical trials that will take years to complete. RESPONSE: The Company respectfully advises the Staff that it has included such disclosure on pages 2 and 105 of the Registration Statement in response to the Staff’s comment. United States Securities and Exchange Commission March 5, 2021 Page 2 If you should have any questions regarding the enclosed matters, please contact the undersigned at (617) 570-1927. Sincerely, /s/ Stephanie Richards Stephanie Richards, Esq. cc: Mark Manfredi, Ph.D., President and Chief Executive Officer, Ikena Oncology, Inc. Douglas Carlson, Chief Operating Officer and Executive Vice President of Finance, Ikena Oncology, Inc. Richard Hoffman, Goodwin Procter LLP William D. Collins, Goodwin Procter LLP
2021-02-25 - UPLOAD - ImageneBio, Inc.
United States securities and exchange commission logo
February 25, 2021
Mark Manfredi, Ph.D.
President and Chief Executive Officer
Ikena Oncology, Inc.
50 Northern Avenue
Boston, MA 02210
Re:Ikena Oncology, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted February 11, 2021
CIK No. 0001835579
Dear Dr. Manfredi:
We have reviewed your amended 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.
Amendment No. 1 to the Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1.We note your revised disclosure in response to comment 1 in our letter dated February 6,
2021. To provide context for your product pipeline table and the corresponding
discussion of your programs, please revise your prospectus summary to disclose that
developing your product candidates will require Phase 1, 2 and 3 clinical trials that will
take years to complete.
FirstName LastNameMark Manfredi, Ph.D.
Comapany NameIkena Oncology, Inc.
February 25, 2021 Page 2
FirstName LastName
Mark Manfredi, Ph.D.
Ikena Oncology, Inc.
February 25, 2021
Page 2
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.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: William D. Collins
2021-02-08 - UPLOAD - ImageneBio, Inc.
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
FirstName LastNameMark Manfredi, Ph.D.
Comapany NameIkena Oncology, Inc.
February 6, 2021 Page 2
FirstName LastNameMark Manfredi, Ph.D.
Ikena Oncology, Inc.
February 6, 2021
Page 2
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.
FirstName LastNameMark Manfredi, Ph.D.
Comapany NameIkena Oncology, Inc.
February 6, 2021 Page 3
FirstName LastNameMark Manfredi, Ph.D.
Ikena Oncology, Inc.
February 6, 2021
Page 3
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
FirstName LastNameMark Manfredi, Ph.D.
Comapany NameIkena Oncology, Inc.
February 6, 2021 Page 4
FirstName LastName
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.
Sincerely,
Division of Corporation Finance
Office of Life Sciences