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Cue Biopharma, Inc.
Response Received
1 company response(s)
High - file number match
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Cue Biopharma, Inc.
Awaiting Response
0 company response(s)
High
Cue Biopharma, Inc.
Response Received
2 company response(s)
High - file number match
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Company responded
2019-07-09
Cue Biopharma, Inc.
Summary
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Company responded
2024-12-11
Cue Biopharma, Inc.
References: December 5, 2024
Cue Biopharma, Inc.
Awaiting Response
0 company response(s)
High
Cue Biopharma, Inc.
Response Received
1 company response(s)
High - file number match
↓
Cue Biopharma, Inc.
Response Received
1 company response(s)
High - file number match
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Company responded
2022-12-12
Cue Biopharma, Inc.
Summary
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Cue Biopharma, Inc.
Awaiting Response
0 company response(s)
High
Cue Biopharma, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2018-07-03
Cue Biopharma, Inc.
Summary
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Company responded
2018-07-13
Cue Biopharma, Inc.
Summary
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Company responded
2018-07-17
Cue Biopharma, Inc.
Summary
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Cue Biopharma, Inc.
Response Received
5 company response(s)
High - file number match
Company responded
2017-11-01
Cue Biopharma, Inc.
Summary
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SEC wrote to company
2017-11-14
Cue Biopharma, Inc.
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Company responded
2017-11-17
Cue Biopharma, Inc.
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Company responded
2017-12-04
Cue Biopharma, Inc.
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Company responded
2017-12-11
Cue Biopharma, Inc.
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Company responded
2017-12-13
Cue Biopharma, Inc.
Summary
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Cue Biopharma, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2017-12-06
Cue Biopharma, Inc.
Summary
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Cue Biopharma, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2017-11-30
Cue Biopharma, Inc.
Summary
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Cue Biopharma, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-10-23
Cue Biopharma, Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-27 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2026-03-23 | SEC Comment Letter | Cue Biopharma, Inc. | DE | 333-294366 | Read Filing View |
| 2024-12-16 | SEC Comment Letter | Cue Biopharma, Inc. | DE | 001-38327 | Read Filing View |
| 2024-12-11 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2024-12-05 | SEC Comment Letter | Cue Biopharma, Inc. | DE | 001-38327 | Read Filing View |
| 2023-05-24 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2023-05-16 | SEC Comment Letter | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2022-12-12 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2022-12-09 | SEC Comment Letter | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2019-07-31 | SEC Comment Letter | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2019-07-09 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2019-07-03 | SEC Comment Letter | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2018-07-17 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2018-07-13 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2018-07-03 | SEC Comment Letter | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2017-12-13 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2017-12-11 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2017-12-06 | SEC Comment Letter | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2017-12-04 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2017-11-30 | SEC Comment Letter | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2017-11-17 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2017-11-14 | SEC Comment Letter | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2017-11-01 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2017-10-23 | SEC Comment Letter | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-23 | SEC Comment Letter | Cue Biopharma, Inc. | DE | 333-294366 | Read Filing View |
| 2024-12-16 | SEC Comment Letter | Cue Biopharma, Inc. | DE | 001-38327 | Read Filing View |
| 2024-12-05 | SEC Comment Letter | Cue Biopharma, Inc. | DE | 001-38327 | Read Filing View |
| 2023-05-16 | SEC Comment Letter | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2022-12-09 | SEC Comment Letter | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2019-07-31 | SEC Comment Letter | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2019-07-03 | SEC Comment Letter | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2018-07-03 | SEC Comment Letter | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2017-12-06 | SEC Comment Letter | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2017-11-30 | SEC Comment Letter | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2017-11-14 | SEC Comment Letter | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2017-10-23 | SEC Comment Letter | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-27 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2024-12-11 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2023-05-24 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2022-12-12 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2019-07-09 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2018-07-17 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2018-07-13 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2017-12-13 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2017-12-11 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2017-12-04 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2017-11-17 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
| 2017-11-01 | Company Response | Cue Biopharma, Inc. | DE | N/A | Read Filing View |
2026-03-27 - CORRESP - Cue Biopharma, Inc.
CORRESP 1 filename1.htm CORRESP CUE BIOPHARMA, INC. 40 Guest Street Boston, Massachusetts 02135 March 27, 2026 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance, Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Tim Buchmiller Re: Cue Biopharma, Inc. Registration Statement on Form S-3 Filed March 16, 2026 File No. 333-294366 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Cue Biopharma, Inc. (the “ Registrant ”) hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-294366), so that it may become effective at 4:00 p.m. Eastern time on March 31, 2026, or as soon thereafter as practicable, or at such later time as the Registrant or its counsel may orally request via telephone call to the Staff. Very truly yours, CUE BIOPHARMA, INC. By: /s/ Lucinda Warren Name: Lucinda Warren Title: Interim President and Chief Executive Officer
2026-03-23 - UPLOAD - Cue Biopharma, Inc. File: 333-294366
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 23, 2026 Lucinda Warren Chief Financial and Business Officer Cue Biopharma, Inc. 40 Guest Street Boston, Massachusetts 02135 Re: Cue Biopharma, Inc. Registration Statement on Form S-3 Filed March 16, 2026 File No. 333-294366 Dear Lucinda Warren: 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 Tim Buchmiller at 202-551-3635 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Caroline Dotolo, Esq. </TEXT> </DOCUMENT>
2024-12-16 - UPLOAD - Cue Biopharma, Inc. File: 001-38327
December 16, 2024
Kerri-Ann Millar
Chief Financial Officer
Cue Biopharma, Inc.
40 Guest Street
Boston, MA 02135
Re:Cue Biopharma, Inc.
Form 10-K for Fiscal Year Ended December 31, 2023
File No. 001-38327
Dear Kerri-Ann Millar:
We have completed our review of your filings. 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.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2024-12-11 - CORRESP - Cue Biopharma, Inc.
CORRESP 1 filename1.htm CORRESP December 11, 2024 By Electronic Submission Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, DC 20549 Attention: Lynn Dicker and Eric Atallah Re: Cue Biopharma, Inc. Form 10-K for Fiscal Year Ended December 31, 2023 File No. 001-38327 Ladies and Gentlemen: Cue Biopharma, Inc. (the “Company” or “we”) is responding to the comments of the staff (the “Staff”) of the Securities and Exchange Commission contained in the Staff’s letter dated December 5, 2024 (the “Comment Letter”), relating to the above referenced Form 10-K for the fiscal year ended December 31, 2023. For convenience, the heading and text of the Staff’s numbered comment from the Comment Letter is set forth below, followed by the Company’s response. Form 10-K for Fiscal Year Ended December 31, 2023 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations Research and Development, page 99 1. We note from the disclosures on page 5 that you have two oncology drug product candidates, CUE-101 and CUE-102. Please revise future filings to disclose the costs incurred during each period presented for each of your key research and development product candidates. If you do not track your research and development costs by project, disclose that fact and explain why you do not maintain and evaluate research and development costs by project. Also, revise to provide other quantitative and qualitative disclosures that give more transparency as to the type of research and development expenses incurred (i.e., by nature or type of expense) which should reconcile to total research and development expenses on your Statements of Operations. Response: We respectfully acknowledge the Staff’s comments. We will include such information in our future filings. Page 2 If you have any further questions or comments, or if you require any additional information, please contact the undersigned by telephone at (617) 949-2680. Thank you for your assistance. Very truly yours, /s/ Daniel R. Passeri Daniel R. Passeri Chief Executive Officer ___________________ cc: Kerri-Ann Millar, Chief Financial Officer, Cue Biopharma, Inc. Cynthia Mazareas, Wilmer Cutler Pickering Hale and Dorr LLP
2024-12-05 - UPLOAD - Cue Biopharma, Inc. File: 001-38327
December 5, 2024
Kerri-Ann Millar
Chief Financial Officer
Cue Biopharma, Inc.
40 Guest Street
Boston, MA 02135
Re:Cue Biopharma, Inc.
Form 10-K for Fiscal Year Ended December 31, 2023
File No. 001-38327
Dear Kerri-Ann Millar:
We have limited our review of your filings to the financial statements and related
disclosures and have the following comment.
Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments.
Form 10-K for Fiscal Year Ended December 31, 2023
Item 7. Management's Discussion and Analysis of Financial Condition and Results of
Operations
Research and Development, page 99
1.We note from the disclosures on page 5 that you have two oncology drug product
candidates, CUE-101 and CUE-102. Please revise future filings to disclose the costs
incurred during each period presented for each of your key research and development
product candidates. If you do not track your research and development costs by
project, disclose that fact and explain why you do not maintain and evaluate research
and development costs by project. Also, revise to provide other quantitative and
qualitative disclosures that give more transparency as to the type of research and
development expenses incurred (i.e., by nature or type of expense) which should
reconcile to total research and development expenses on your Statements of
Operations.
December 5, 2024
Page 2
In closing, 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 Lynn Dicker at 202-551-3616 or Eric Atallah at 202-551-3663 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2023-05-24 - CORRESP - Cue Biopharma, Inc.
CORRESP 1 filename1.htm CORRESP CUE BIOPHARMA, INC. 40 Guest Street Boston, Massachusetts 02135 May 24, 2023 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance, Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Tyler Howes Re: Cue Biopharma, Inc. Registration Statement on Form S-3 Filed May 9, 2023 File No. 333-271786 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Cue Biopharma, Inc. (the “Registrant”) hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-271786), so that it may become effective at 4:30 p.m. Eastern time on May 26, 2023, or as soon thereafter as practicable, or at such later time as the Registrant or its counsel may orally request via telephone call to the Staff. Very truly yours, CUE BIOPHARMA, INC. By: /s/ Kerri-Ann Millar Name: Kerri-Ann Millar Title: Chief Financial Officer
2023-05-16 - UPLOAD - Cue Biopharma, Inc.
United States securities and exchange commission logo
May 16, 2023
Daniel R. Passeri
Chief Executive Officer
Cue Biopharma, Inc.
40 Guest Street
Boston, MA 02135
Re:Cue Biopharma, Inc.
Registration Statement on Form S-3
Filed May 9, 2023
File No. 333-271786
Dear Daniel R. Passeri:
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: Caroline Dotolo, Esq.
2022-12-12 - CORRESP - Cue Biopharma, Inc.
CORRESP 1 filename1.htm CORRESP December 12, 2022 VIA EDGAR SUBMISSION Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Attention: Doris Stacey Gama Re: Cue Biopharma, Inc. Registration Statement on Form S-3 File No. 333-268687 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Cue Biopharma, Inc. hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-268687), so that it may become effective at 4:00 p.m., Eastern Time, on December 14, 2022, or as soon as practicable thereafter. Very truly yours, CUE BIOPHARMA, INC. By: /s/ Kerri-Ann Millar Name: Kerri-Ann Millar Title: Chief Financial Officer
2022-12-09 - UPLOAD - Cue Biopharma, Inc.
United States securities and exchange commission logo
December 9, 2022
Kerri-Ann Millar
Chief Financial Officer
Cue Biopharma, Inc.
40 Guest Street
Boston, MA 02135
Re:Cue Biopharma, Inc.
Registration Statement on Form S-3
Filed December 6, 2022
File No. 333-268687
Dear Kerri-Ann Millar:
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 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Cynthia Mazareas, Esq.
2019-07-31 - UPLOAD - Cue Biopharma, Inc.
July 31, 2019
Kerri-Ann Millar
Vice President, Finance
Cue Biopharma, Inc.
21 Erie St.
Cambridge, MA 02139
Re:Cue Biopharma, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2018
Filed March 14, 2019
File No. 001-38327
Dear Ms. Millar:
We have completed our review of your filing. 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.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2019-07-09 - CORRESP - Cue Biopharma, Inc.
CORRESP 1 filename1.htm Response Letter K&L GATES LLP HEARST TOWER, 47TH FLOOR 214 NORTH TRYON STREET CHARLOTTE, NC 28202 T +1 704 331 7400 F +1 704 331 7598 klgates.com July 9, 2019 VIA EDGAR CORRESPONDENCE U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Attn: Office of Healthcare & Insurance Re: Cue Biopharma, Inc. Form 10-K for the Fiscal Year Ended December 31, 2018 Filed March 14, 2019 File No. 001-38327 Ladies and Gentleman: On behalf of Cue Biopharma, Inc. (the “Company”), we submit this letter providing a response to the comment raised by the Staff of the Securities and Exchange Commission (the “Staff”) on June 26, 2019 with respect to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018 (the “Form 10-K”). Simultaneously with the filing of this letter, the Company is filing by EDGAR Amendment No. 2 to the Form 10-K (the “Form 10-K Amendment”) and Amendment No. 1 (the “Form 10-Q Amendment”) to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2019 (the “Form 10-Q”) responding to the Staff’s comment as noted below. The bold type below is the Staff’s comment and the regular type constitutes the Company’s response thereto. Form 10-K for the Fiscal Year Ended December 31, 2018 Item 15. Exhibits, Financial Statements and Schedules, page 62 1. Please amend your filing to provide new certifications filed as Exhibits 31.1 and 31.2 to conform exactly to that provided in Item 601(b)(31) of Regulation S-K as it relates to internal controls over financial reporting (ICFR). In this regard, the introductory sentence in paragraph 4 should refer to ICFR as defined in the Exchange Act and certification 4(b) should discuss your obligations related to ICFR. Similarly, please amend the 10-Q for the quarterly period ended March 31, 2019. New certifications have been filed as Exhibits 31.1 and 31.2 to each of the Form 10-K Amendment and the Form 10-Q Amendment in response to the Staff’s comment. U.S. Securities and Exchange Commission July 9, 2019 Page 2 We appreciate your time and attention to the Company’s response to the Staff’s comment. Should you have any questions, please call me at (704) 331-7440. Very truly yours, /s/ Mark Busch Mark Busch cc: Daniel Passeri, Chief Executive Officer Kerri-Ann Millar, Vice President, Finance
2019-07-03 - UPLOAD - Cue Biopharma, Inc.
June 26, 2019
Kerri-Ann Millar
Vice President, Finance
Cue Biopharma, Inc.
21 Erie St.
Cambridge, MA 02139
Re:Cue Biopharma, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2018
Filed March 14, 2019
File No. 001-38327
Dear Ms. Millar:
We have reviewed your filing and have the following comment. In our comment, we
may ask you to provide us with information so we may better understand your disclosure.
Please respond to this comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this comment, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2018
Item 15. Exhibits, Financial Statements and Schedules, page 62
1.Please amend your filing to provide new certifications filed as Exhibits 31.1 and 31.2 to
conform exactly to that provided in Item 601(b)(31) of Regulation S-K as it relates to
internal controls over financial reporting (ICFR). In this regard, the introductory
sentence in paragraph 4 should refer to ICFR as defined in the Exchange Act and
certification 4(b) should discuss your obligations related to ICFR. Similarly, please amend
the 10-Q for the quarterly period ended March 31, 2019.
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.
FirstName LastNameKerri-Ann Millar
Comapany NameCue Biopharma, Inc.
June 26, 2019 Page 2
FirstName LastName
Kerri-Ann Millar
Cue Biopharma, Inc.
June 26, 2019
Page 2
You may contact Vanessa Robertson at 202-551-3649 or Rolf Sundwall at 202-551-3105
if you have questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2018-07-17 - CORRESP - Cue Biopharma, Inc.
CORRESP 1 filename1.htm Acceleration Request Cue Biopharma, Inc. 675 W. Kendall Street Cambridge, MA 02142 July 17, 2018 VIA EDGAR Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Abigail Jacobs Re: Cue Biopharma, Inc. Registration Statement on Form S-1 File No. 333-225800 Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, registrant Cue Biopharma, Inc. (the “Company”) hereby respectfully requests that the above-referenced Registration Statement on Form S-1 (the “Registration Statement”) be declared effective at 4:00 p.m., Eastern Time, on Thursday, July 19, 2018, or as soon thereafter as is practicable. Please direct any questions regarding this request to Mark R. Busch ((704) 331-7440; mark.busch@klgates.com) of K&L Gates LLP. In addition, please notify Mr. Busch when this request for acceleration has been granted. Sincerely, /s/ Daniel R. Passeri Daniel R. Passeri Chief Executive Officer
2018-07-13 - CORRESP - Cue Biopharma, Inc.
CORRESP 1 filename1.htm Response Letter K&L GATES LLP HEARST TOWER, 47TH FLOOR 214 NORTH TRYON STREET CHARLOTTE, NC 28202 T +1 704 331 7400 F +1 704 331 7598 klgates.com July 13, 2018 VIA EDGAR CORRESPONDENCE U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Attn: Abigail Jacobs Re: Cue Biopharma, Inc. Registration Statement on Form S-1 Filed June 21, 2018 File No. 333-225800 Dear Ms. Jacobs: On behalf of Cue Biopharma, Inc. (the “Company”), we submit this letter providing a response to the comment raised by the Staff of the Securities and Exchange Commission (the “Staff”) on July 2, 2018 with respect to the Company’s registration statement on Form S-1 (File No. 333-225800) (the “Registration Statement”). Simultaneously with the filing of this letter, the Company is filing by EDGAR Amendment No. 1 to the Registration Statement (the “Registration Statement Amendment”) responding to the Staff’s comment as noted below. The bold type below is the Staff’s comment and the regular type constitutes the Company’s response thereto. Incorporation of Certain Information By Reference, page 16 1. We note that you incorporate by reference future reports to be filed pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act in your registration statement. However, to be eligible to forward incorporate, you must be a smaller reporting company. Refer to Item 12(b) of Form S-1. Please tell us how you determined you are eligible to forward incorporate or revise your registration statement accordingly. Page 16 of the Registration Statement Amendment includes revised disclosure in response to this comment. We appreciate your time and attention to the Company’s response to the Staff’s comment. Should you have any questions, please call me at (704) 331-7440. Very truly yours, /s/ Mark Busch Mark Busch cc: Daniel Passeri, Chief Executive Officer Kerri-Ann Millar, Vice President, Finance
2018-07-03 - UPLOAD - Cue Biopharma, Inc.
July 2, 2018
Daniel R. Passeri
Chief Executive Officer
Cue Biopharma, Inc.
21 Erie Street
Cambridge, MA 02139
Re:Cue Biopharma, Inc.
Registration Statement on Form S-1
File No. 333-225800
Filed June 21, 2018
Dear Mr. Passeri:
We have limited our review of your registration statement to those issues we have
addressed in our comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our 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 comment, we may have additional comments.
Registration Statement on Form S-1, filed on June 21, 2018
Incorporation of Certain Information By Reference, page 16
1.We note that you incorporate by reference future reports to be filed pursuant to Sections
13(a), 13(c), 14 or 15(d) of the Exchange Act in your registration statement. However, to
be eligible to forward incorporate, you must be a smaller reporting company. Refer to
Item 12(b) of Form S-1. Please tell us how you determined you are eligible to forward
incorporate or revise your registration statement accordingly.
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.
FirstName LastNameDaniel R. Passeri
Comapany NameCue Biopharma, Inc.
July 2, 2018 Page 2
FirstName LastName
Daniel R. Passeri
Cue Biopharma, Inc.
July 2, 2018
Page 2
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 Abigail Jacobs at 202-551-2909 or Mary Beth Breslin at 202-551-3625
with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Mark R. Busch
2017-12-13 - CORRESP - Cue Biopharma, Inc.
CORRESP 1 filename1.htm Cue Biopharma, Inc. 675 W. Kendall Street Cambridge, MA 02142 December 13, 2017 Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Irene Paik Re: Cue Biopharma, Inc. Registration Statement on Form S-1 File No. 333-220550 Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, registrant Cue Biopharma, Inc. (the “Company”) hereby respectfully requests that the above-referenced Registration Statement on Form S-1 (the “Registration Statement”) be declared effective at 4:00 p.m., Eastern Time, on Thursday, December 14, 2017, or as soon thereafter as is practicable. In connection with the foregoing request, the Company acknowledges that (i) should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; (ii) the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and (iii) the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Sincerely, /s/ Gary Schuman Gary Schuman Chief Financial Officer
2017-12-11 - CORRESP - Cue Biopharma, Inc.
CORRESP
1
filename1.htm
K&L
Gates LLP
Hearst
Tower, 47th Floor
214
North Tryon Street
Charlotte,
NC 28202
T +1 704 331 7400 F +1
704 331 7598
klgates.com
December 11,
2017
VIA EDGAR CORRESPONDENCE
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street N.E.
Washington, D.C. 20549
Attn: Irene Paik
Re: Cue Biopharma, Inc.
Registration Statement on Form S-1
Filed September 21, 2017
File No. 333-220550
Dear Ms. Paik:
On behalf of Cue Biopharma, Inc. (the “Company”),
we submit this letter providing a response to the comments raised by the Staff of the Securities and Exchange Commission (the “Staff”)
on December 6, 2017 with respect to the Company’s registration statement on Form S-1 (File No. 333-220550) (the “Registration
Statement”). Simultaneously with the filing of this letter, the Company is filing by EDGAR Amendment No. 4 to the Registration
Statement (the “Registration Statement Amendment”) responding to the Staff’s comments as noted below. The bold
type below is the Staff’s comments and the regular type constitutes the Company’s responses thereto.
Cover
page
1. We note that you may extend the termination date beyond the initial offering period. Please expand
your disclosure to indicate that if there are funds in escrow when you extend the offering period that these funds will be returned
to subscribers who do not affirmatively reconfirm their subscription.
Revised disclosure responding
to this comment has been added on the cover page and on page 12 of the Registration Statement Amendment.
Risk
Factors
Concentration
of ownership among our existing executive officers..., page 35
2. It appears you only have seven members on your board of directors, yet you state that three of
the eight members of your board of directors are also employees of MDB. Please revise as appropriate to reconcile this discrepancy.
Revised disclosure responding
to this comment is included on page 35.
U.S. Securities and Exchange Commission
December
11, 2017
Page 2
Business
Our Collaboration
Agreement with Merck, page 55
3. We note your revisions to page 55 in response to our prior comment three. Please revise your disclosure
to quantify the potential research and development, regulatory and commercial milestones separately.
Revised disclosure responding
to this comment has been added on pages 56-57, 74 and F-49 of the Registration Statement Amendment.
Exhibits
4. Please file a complete copy of Exhibit 10.21, including all schedules and exhibits thereto. See
Item 601(b)(10) of Regulation S-K.
Exhibit 10.21 has been
refiled including the schedules and exhibits (of which there are none).
We appreciate your time
and attention to the Company’s responses to the Staff’s comments. Should you have any questions, please call me at
(704) 331-7440.
Very truly yours,
/s/ Mark Busch
Mark Busch
cc: Daniel Passeri, Chief Executive Officer
Gary Schuman, Chief Financial
Officer
2017-12-06 - UPLOAD - Cue Biopharma, Inc.
December 6, 2017
Daniel Passeri
Chief Executive Officer
Cue Biopharma, Inc.
675 W. Kendall Street
Cambridge, MA 02142
Re:Cue Biopharma, Inc
Amendment No. 3 to Registration Statement on Form S-1
Filed December 5, 2017
File No. 333-220550
Dear Mr. Passeri:
We have reviewed your amended 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our [Month day, year] letter.
Amendment No. 3 to Registration Statement on Form S-1 filed December 5, 2017
Cover page
1.We note that you may extend the termination date beyond the initial offering period.
Please expand your disclosure to indicate that if there are funds in escrow when you
extend the offering period that these funds will be returned to subscribers who do not
affirmatively reconfirm their subscription.
FirstName LastNameDaniel Passeri
Comapany NameCue Biopharma, Inc.
June 16, 2017 Page 2
FirstName LastName
Daniel Passeri
Cue Biopharma, Inc.
December 6, 2017
Page 2
Risk Factors
Concentration of ownership among our existing executive officers..., page 35
2.It appears you only have seven members on your board of directors, yet you state that
three of the eight members of your board of directors are also employees of MDB.
Please revise as appropriate to reconcile this discrepancy.
Business
Our Collaboration Agreement with Merck, page 55
3.We note your revisions to page 55 in response to our prior comment three. Please revise
your disclosure to quantify the potential research and development, regulatory and
commercial milestones separately.
Exhibits
4.Please file a complete copy of Exhibit 10.21, including all schedules and exhibits
thereto. See Item 601(b)(10) of Regulation S-K.
You may contact Rolf Sundwall at 202-551-3105 or Mark Brunhofer at 202-551-3638 if
you have questions regarding comments on the financial statements and related matters. Please
contact Irene Paik at 202-551-6553 or me at 202-551-3675 with any other questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Mark R. Busch - K&LGates LLP
2017-12-04 - CORRESP - Cue Biopharma, Inc.
CORRESP
1
filename1.htm
K&L Gates LLP
Hearst
Tower, 47th Floor
214
North Tryon Street
Charlotte,
NC 28202
T
+1 704 331 7400 F +1 704 331 7598
klgates.com
December 4, 2017
VIA EDGAR CORRESPONDENCE
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street N.E.
Washington, D.C. 20549
Attn: Irene Paik
Re: Cue Biopharma, Inc.
Registration Statement on Form S-1
Filed September 21, 2017
File No. 333-220550
Dear Ms. Paik:
On behalf of Cue Biopharma, Inc. (the “Company”),
we submit this letter providing a response to the comments raised by the Staff of the Securities and Exchange Commission (the “Staff”)
on November 30, 2017 with respect to the Company’s registration statement on Form S-1 (File No. 333-220550) (the “Registration
Statement”). Simultaneously with the filing of this letter, the Company is filing by EDGAR Amendment No. 3 to the Registration
Statement (the “Registration Statement Amendment”) responding to the Staff’s comments as noted below. The bold
type below is the Staff’s comments and the regular type constitutes the Company’s responses thereto.
The Offering,
page 12
1. Please expand the discussion of the escrow account to clarify that the funds will not be released
from escrow until you secure the listing on the Nasdaq Capital Market and that all funds will be returned to investors if you are
unable to secure the listing.
Revised disclosure responding
to this comment has been added on the cover page and pages 11, 12 and 32 of the Registration Statement Amendment.
Business
Our Collaboration
Agreement with Merck, page 58
2. We note your agreement with Merck required you to "forebear from researching, developing or
licensing to a third party rights related to any Cue Biologics drug candidate for the treatment of autoimmune disease." Please
revise the disclosure throughout your filing to clarify how this provision impacts your current operations and your strategic plans.
For example:
U.S. Securities and Exchange Commission
December 4, 2017
Page 2
• On page 1 you indicate you are "developing a novel and proprietary class of biologic drugs
...to treat a broad range of cancers and autoimmune disorders."
• On page 2 in the discussion of your approach for next generation immunotherapies, you discuss Type
1 diabetes, celiac disease, arthritis and other autoimmune diseases.
• On page 3, you state that you are expanding your technology to "generate highly promising
and novel immunotherapeutics for the treatment of debilitating autoimmune disorders."
• On page 41, you indicate that you intend to use proceeds from the offering to "optimize drug
scaffold for the treatment of autoimmune indications...".
Revised disclosure responding
to this comment has been added on pages 6, 8, 19, 50, 53 and 55 of the Registration
Statement Amendment.
3. Please revise your description of the Collaboration Agreement with Merck to provide the following
information:
• the duration of the agreement and royalty term;
• your rights and performance obligations under the agreement;
• termination provisions;
• up-front payment to be received;
• whether the up-front payment is refundable or not;
• aggregate future potential milestone payment to be received for each of the research, development,
regulatory and/or commercial milestone categories, if applicable; and
• royalty rates or a royalty range within a ten-percent range if confidential treatment is requested.
Please also file the Collaboration
Agreement as an exhibit to your registration statement. Alternatively, please provide us with an analysis supporting your determination
that the agreement is not a required exhibit. See Item 601(b)(10) of Regulation S-K.
Revised disclosure responding
to this comment has been added on pages 55 and 56 of the Registration Statement Amendment. In addition, the Collaboration
has been filed with the Registration Statement Amendment as Exhibit No. 10.21.
We appreciate your time
and attention to the Company’s responses to the Staff’s comments. Should you have any questions, please call me at
(704) 331-7440.
U.S. Securities and Exchange Commission
December 4, 2017
Page 3
Very truly yours,
/s/ Mark Busch
Mark Busch
cc: Daniel Passeri, Chief Executive Officer
Gary Schuman, Chief Financial
Officer
2017-11-30 - UPLOAD - Cue Biopharma, Inc.
November 30, 2017
Daniel Passeri
Chief Executive Officer
Cue Biopharma, Inc.
675 W. Kendall Street
Cambridge, MA 02142
Re:Cue Biopharma, Inc.
Amendment No. 2 to Registration Statement on Form S-1
Filed November 17, 2017
File No. 333-220550
Dear Mr. Passeri:
We have reviewed your amended 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our November 14, 2017 letter.
Amendment No. 2 to Registration Statement on Form S-1 filed November 17, 2017
The Offering, page 12
1.Please expand the discussion of the escrow account to clarify that the funds will not be
released from escrow until you secure the listing on the Nasdaq Capital Market and that
all funds will be returned to investors if you are unable to secure the listing.
FirstName LastNameDaniel Passeri
Comapany NameCue Biopharma, Inc.
June 16, 2017 Page 2
FirstName LastNameDaniel Passeri
Cue Biopharma, Inc.
November 30, 2017
Page 2
Business
Our Collaboration Agreement with Merck, page 58
2.We note your agreement with Merck required you to "forebear from researching,
developing or licensing to a third party rights related to any Cue Biologics drug candidate
for the treatment of autoimmune disease." Please revise the disclosure throughout your
filing to clarify how this provision impacts your current operations and your strategic
plans. For example:
•On page 1 you indicate you are "developing a novel and proprietary class of biologic
drugs ...to treat a broad range of cancers and autoimmune disorders."
•On page 2 in the discussion of your approach for next generation immunotherapies,
you discuss Type 1 diabetes, celiac disease, arthritis and other autoimmune diseases.
•On page 3, you state that you are expanding your technology to "generate highly
promising and novel immunotherapeutics for the treatment of debilitating
autoimmune disorders."
•On page 41, you indicate that you intend to use proceeds from the offering to
"optimize drug scaffold for the treatment of autoimmune indications..."
3.Please revise your description of the Collaboration Agreement with Merck to provide the
following information:
•the duration of the agreement and royalty term;
•your rights and performance obligations under the agreement;
•termination provisions;
•up-front payment to be received;
•whether the up-front payment is refundable or not;
•aggregate future potential milestone payment to be received for each of the research,
development, regulatory and/or commercial milestone categories, if applicable; and
•royalty rates or a royalty range within a ten-percent range if confidential treatment is
requested.
Please also file the Collaboration Agreement as an exhibit to your registration statement.
Alternatively, please provide us with an analysis supporting your determination that the
agreement is not a required exhibit. See Item 601(b)(10) of Regulation S-K.
FirstName LastNameDaniel Passeri
Comapany NameCue Biopharma, Inc.
June 16, 2017 Page 3
FirstName LastName
Daniel Passeri
Cue Biopharma, Inc.
November 30, 2017
Page 3
You may contact Rolf Sundwall at 202-551-3105 or Mark Brunhofer at 202-551-3638
if you have questions regarding comments on the financial statements and related matters.
Please contact Irene Paik at 202-551-6553 or Suzanne Hayes at 202-551-3675 with any
other questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Mark R. Busch - K&LGates LLP
2017-11-17 - CORRESP - Cue Biopharma, Inc.
CORRESP
1
filename1.htm
K&L Gates LLP
Hearst Tower, 47th Floor
214 North Tryon Street
Charlotte, NC 28202
T +1 704 331 7400 F +1 704 331 7598
klgates.com
November 17, 2017
VIA EDGAR CORRESPONDENCE
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street N.E.
Washington, D.C. 20549
Attn: Irene Paik
Re: Cue Biopharma, Inc.
Registration
Statement on Form S-1
Filed September
21, 2017
File No. 333-220550
Dear Ms. Paik:
On behalf of Cue Biopharma, Inc. (the “Company”),
we submit this letter providing a response to the comments raised by the Staff of the Securities and Exchange Commission (the “Staff”)
on November 14, 2017 with respect to the Company’s registration statement on Form S-1 (File No. 333-220550) (the “Registration
Statement”). Simultaneously with the filing of this letter, the Company is filing by EDGAR Amendment No. 2 to the Registration
Statement (the “Registration Statement Amendment”) responding to the Staff’s comments as noted below. The bold
type below is the Staff’s comments and the regular type constitutes the Company’s responses thereto.
1. We note your response to our prior comment two and
your risk factor disclosure stating that you do not expect to complete the offering if you do not receive approval for the listing
of your common stock on Nasdaq. Please revise your cover page and other disclosures related to Nasdaq listing to clarify that
you will not complete the sale of any shares if you do not receive Nasdaq listing approval. Alternatively, discuss the factors
that you will consider in deciding whether to continue with your offering.
In response to this
comment, revised disclosure has been added on the cover page and page 13 of the Registration Statement Amendment
and certain disclosure has been deleted on page 101 of the Registration Statement Amendment.
2. We note your revised disclosure in response to to
our prior comment five. However, the referenced studies do not appear to compare the CUE Biologics platform to other existing
immunotherapies on a head to head basis. Additionally, it is inappropriate at this stage to conclude that a product in preclinical
development is superior to existing immunotherapies. Please remove the tables on pages 4 and 50. Alternatively, provide additional
analysis explaining why this table is appropriate.
U.S. Securities and Exchange Commission
November 17, 2017
Page 2
The tables on pages 4
and 50 of the Registration Statement have been removed from the Registration Statement Amendment in response to this comment.
3. Please revise your disclosure to clearly indicate
that the adjustments you recorded in 2016 and 2015 were to correct the classification of patent legal costs and intellectual property
management fees from research and development expenses to general and administrative expenses. Also, revise your disclosure to
present the 2016 amounts you recorded. This comment also applies to your 2017 and 2016 interim financial information included
in your similar footnote on page F-31 of your interim financial statements.
In response to this
comment, revised disclosure has been added on pages 70, F-7 and F-8
of the Registration Statement Amendment and certain disclosure has been deleted on page F-31 of the Registration Statement
Amendment.
4. Please amend your filing to provide a signed consent
from your auditor.
A signed consent from
the Company’s auditor is filed as Exhibit 23.1 to the Registration Statement Amendment.
We appreciate your time
and attention to the Company’s responses to the Staff’s comments. Should you have any questions, please call me at
(704) 331-7440.
Very truly yours,
/s/ Mark Busch
Mark Busch
cc: Daniel Passeri, Chief Executive Officer
Gary Schuman, Chief Financial
Officer
2017-11-14 - UPLOAD - Cue Biopharma, Inc.
November 14, 2017
Daniel Passeri
Chief Executive Officer
Cue Biopharma, Inc.
675 W. Kendall Street
Cambridge, MA 02142
Re:Cue Biopharma, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed November 2, 2017
File No. 333-220550
Dear Mr. Passeri:
We have reviewed your amended 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our October 20, 2017 letter.
Amendment No. 1 to Form S-1 filed November 2, 2017
Cover Page
1.We note your response to our prior comment two and your risk factor disclosure stating
that you do not expect to complete the offering if you do not receive approval for the
listing of your common stock on Nasdaq. Please revise your cover page and other
disclosures related to Nasdaq listing to clarify that you will not complete the sale of any
shares if you do not receive Nasdaq listing approval. Alternatively, discuss the
factors that you will consider in deciding whether to continue with your offering.
Prospectus Summary
FirstName LastNameDaniel Passeri
Comapany NameCue Biopharma, Inc.
June 16, 2017 Page 2
FirstName LastName
Daniel Passeri
Cue Biopharma, Inc.
November 14, 2017
Page 2
Our Approach for Next Generation Immunotherapies, page 4
2.We note your revised disclosure in response to to our prior comment five. However, the
referenced studies do not appear to compare the CUE Biologics platform to other existing
immunotherapies on a head to head basis. Additionally, it is inappropriate at this stage to
conclude that a product in preclinical development is superior to existing
immunotherapies. Please remove the tables on pages 4 and 50. Alternatively, provide
additional analysis explaining why this table is appropriate.
Notes to the Financial Statements
Note 1: Organization and Basis of Presentation
Reclassifications, page F-8
3.Please revise your disclosure to clearly indicate that the adjustments you recorded in
2016 and 2015 were to correct the classification of patent legal costs and intellectual
property management fees from research and development expenses to general and
administrative expenses. Also, revise your disclosure to present the 2016 amounts you
recorded. This comment also applies to your 2017 and 2016 interim financial
information included in your similar footnote on page F-31 of your interim financial
statements.
Exhibits
4.Please amend your filing to provide a signed consent from your auditor.
You may contact Rolf Sundwall at 202-551-3105 or Mark Brunhofer at 202-551-3638 if
you have questions regarding comments on the financial statements and related matters. Please
contact Irene Paik at 202-551-6553 or Suzanne Hayes at 202-551-3675 with any other
questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Mark R. Busch - K&LGates LLP
2017-11-01 - CORRESP - Cue Biopharma, Inc.
CORRESP
1
filename1.htm
K&L Gates LLP
Hearst Tower, 47th Floor
214 North Tryon Street
Charlotte, NC 28202
T +1 704 331 7400 F +1 704 331 7598
klgates.com
November 2, 2017
VIA EDGAR CORRESPONDENCE
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street N.E.
Washington, D.C. 20549
Attn: Irene Paik
Re:
Cue Biopharma, Inc.
Registration Statement on Form S-1
Filed September 21, 2017
File No. 333-220550
Dear Ms. Paik:
On behalf of Cue Biopharma, Inc. (the “Company”),
we submit this letter providing a response to the comments raised by the Staff of the Securities and Exchange Commission (the “Staff”)
on October 20, 2017 with respect to the Company’s registration statement on Form S-1 (File No. 333-220550) (the “Registration
Statement”). Simultaneously with the filing of this letter, the Company is filing by EDGAR an amendment to the Registration
Statement (the “Registration Statement Amendment”) responding to certain the Staff’s comments as noted below.
The bold type below is the Staff’s comments and the regular type constitutes the Company’s responses thereto.
1. We note that you have structured your offering to include a minimum and maximum dollar amount of
common stock that you plan to sell. Please note you are required to register the number of securities you plan to offer. Revise
the cover page to quantify the number of securities constituting the minimum and maximum. Please also make corresponding changes
throughout the prospectus as appropriate. For guidance, please refer to Regulation S-K Item 501(b)(2) and Securities Act Rules
Compliance & Disclosure Interpretations Question 227.02.
Revised disclosure responding
to this comment has been added on the cover page and page 11 of the Registration Statement Amendment.
2. We note your disclosure on the prospectus cover page that you intend to apply to list your common
stock on the Nasdaq Capital Market and that you expect the listing to occur upon consummation of the offering. However, we note
your risk factor on page 35 that there is no assurance that your listing application will be approved. Please tell us whether you
have applied for listing and whether you will continue your offering if your listing is not approved. If you intend to proceed
with your offering before receiving Nasdaq approval of your listing application, that, please clarify the listing of the common
stock on the Nasdaq Capital Market is not a condition to the offering.
Revised disclosure responding
to this comment has been added on the cover page and pages 12, 32 and 94 of the Registration Statement Amendment.
U.S. Securities and Exchange Commission
November 2, 2017
Page 2
3. You indicate on the cover page and on page 41 that you are a smaller reporting company. However,
based on your security ownership table on page 96, your minimum offering price and the minimum offering amount, it appears your
public float will be above the $75 million following the offering. Please tell us how you determined that you are a smaller reporting
company. Refer to the definition of “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Revised disclosure responding
to this comment has been added on the cover page and page 39 of the Registration Statement Amendment.
4. Please expand your disclosure in the last paragraph of the cover page to provide a brief statement
regarding the role and responsibilities of the qualified independent underwriter. Expand your reference to MDB and "its associated
persons," to clarify that this includes officers and directors of the company. Additionally, tell us whether Schiff Hardin
LLP represents MDB, Feltl or both. If Schiff Hardin represents both, please tell us how you have determined that this does not
present a conflict of interest or impacted Feltl's ability to qualify as a qualified independent underwriter.
Revised disclosure responding
to the portion of this comment relating to the role and responsibilities of the qualified independent underwriter has been added
on the cover page of the Registration Statement Amendment. With respect to the remainder of this comment, the Company understands
from the Staff that the references to Schiff Hardin LLP in this comment were inadvertent and that the Staff intended to
reference LKP Global Law, LLP instead. In this connection, the Company advises the Staff that LKP Global Law represents only MDB
in connection with the offering.
5. Please provide your basis for the table on page 4 depicting a comparison of Cue Biologics with
other immunotherapy technologies and explain how you are able to conclude that your technologies are superior given the early stage
of development.
Revised disclosure responding
to this comment has been added on page 3 of the Registration Statement Amendment.
6. Please disclose the significance of "rIL-2" in the first row of the first chart on page
5.
Additional disclosure responding
to this comment has been added on page 5 of the Registration Statement Amendment.
U.S. Securities and Exchange Commission
November 2, 2017
Page 3
7. We refer to your statement on page 5 that you intend to move the lead candidate into the clinic
by the end of 2018. If you are currently conducting additional preclinical studies or if additional preclinical studies will be
required in order to submit an Investigational Drug Application, please provide a description of the studies being conducted and/or
any planned preclinical studies.
Additional disclosure responding
to this comment has been added on page 5 of the Registration Statement Amendment.
8. Given the early stage of development, your belief that CUE-101 offers significant advantages over
current therapies and has the potential to provide a more effective and safer alternative in treating HPV-driven cancers seems
premature. Please provide the basis for your belief or delete the statement from your registration statement.
The language mentioning “significant
advantages” has been deleted from pages 4 and 50 of the Registration Statement Amendment.
9. Please revise your statement that you plan to leverage your platform's modular capabilities to
"rapidly and efficiently" develop drug candidates to more clearly explain how the drug development process will differ
using your platform and how rapidly you expect to be able to develop a drug. Your response should clarify the basis for the statement
that you will be able to develop drugs rapidly. Additionally, explain how your development process differs from that of other immunotherapy
drug development companies and why you believe these differences present a competitive advantage. Your responses should clarify
the basis for your beliefs given the early stage of your development and that you have not yet conducted any clinical trials.
Revised disclosure responding
to this comment has been added on pages 8 and 54 of the Registration Statement Amendment.
10. Please revise the first bullet point of this section to include disclosure that your independent
registered public accounting firm has raised substantial doubt about your ability to continue as a going concern, as discussed
on page 17.
Revised disclosure responding
to this comment has been added on page 9 of the Registration Statement Amendment.
11. We refer to the eighth bullet point in this section regarding your intellectual property rights.
Please expand this risk factor to disclose that your technology is not covered by any issued patents.
Additional disclosure responding
to this comment has been added on page 10 of the Registration Statement Amendment.
12. Please revise the tenth bullet point to specify, if accurate, that the net proceeds for the offering
will only be sufficient to allow you to initiate a Phase I trial for your lead product candidate.
Revised disclosure responding
to this comment has been added on page 10 of the Registration Statement Amendment.
U.S. Securities and Exchange Commission
November 2, 2017
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.
The Company advises the Staff
that no written communications, as defined in Rule 405 under the Securities Act, have been provided to potential investors in reliance
on Section 5(d) of the Securities Act. If any such materials are used in the future in connection with the offering, the Company
will provide copies of such materials to the Staff supplementally.
14. Please expand this risk factor to disclose that MDB will be issued warrants to purchase shares
of common stock in an amount up to 10% of the shares of common stock sold in the public offering and the increase in concentration
of ownership that may result from the exercise of such warrants. In addition, please disclose that four of the seven members of
the board of directors are also employees of MDB and how this may impact new investors' ability to influence significant corporate
decisions.
Additional disclosure responding
to this comment has been added on pages 35 and 36 of the Registration Statement Amendment.
15. We refer to the last bullet of this risk factor. Please present risks related to the exclusive
forum provision in your charter in a separately captioned risk factor, including a discussion that such a provision may limit a
shareholder’s ability to bring a claim in a judicial forum that it finds favorable for such disputes and may discourage lawsuits
with respect to such claims.
Additional disclosure responding
to this comment has been added on page 38 of the Registration Statement Amendment.
16. Your statement that there is no assurance you will sell any shares or receive any proceeds is inconsistent
with the stated minimum offering amount. Please remove the statement or revise it to clarify that the statement refers to a situation
in which any offering proceeds would be returned to subscribers.
Revised disclosure responding
to this comment has been added on page 40 of the Registration Statement Amendment.
17. Please expand your discussion of the license agreement with Einstein to disclose the following
information:
· the amounts paid to date;
· aggregate potential milestone payments; and
· the “number of years” in the royalty term.
Revised disclosure responding
to this comment has been added on pages 55 and 56 of the Registration Statement Amendment.
U.S. Securities and Exchange Commission
November 2, 2017
Page 5
18. We refer to your disclosure regarding the March 2017 and July 2017 agreements with Catalent. Please
file such agreements as exhibits to the registration statement or tell us why you believe that you are not required to file such
agreements pursuant to Item 601(b)(10) of Regulation S-K.
The Company respectfully submits
that the March 2017 and July 2017 agreements with Catalent (together, the “Services Agreements”) are not required to
be filed as exhibits to the Registration Statement pursuant to Item 601(b)(10) of Regulation S-K. Item 601(b)(10) states in relevant
part that “if the contract is such as ordinarily accompanies the kind of business conducted by the registrant . . . it will
be deemed to have been made in the ordinary course of business and need not be filed unless it [is] a contract upon which the registrant’s
business is substantially dependent, as in the case of continuing contracts to sell the major part of registrant’s products
or services or … license or other agreement to use a patent, formula, trade secret, process or trade name upon which registrant’s
business depends to a material extent.”
The Company’s primary
business consists of the development of immunotherapeutic drugs to treat cancers and autoimmune disorders. As is typical among
small research-based companies in the biopharmaceutical industry, the Company is focused on the development of novel drug candidates
and does not have the capability to produce such drugs in quantities necessary to submit applications to regulatory agencies and
conduct clinical studies. Thus, to conduct certain pre-clinical and clinical testing activities, the Company, and similarly situated
biopharmaceutical drug developers, must contract with a third party contract research organization that provides clinical development
services (a “CRO”). Therefore, the Services Agreements are contracts that ordinarily accompany the kind of business
conducted by the Company and are only required to be filed as exhibits to the Registration Statement if the Company’s business
substantially depends on the Services Agreements to a material extent. There exist many other CROs with which the Company can partner
in lieu of its current arrangement with Catalent and the Company may terminate the Services Agreements upon 90 days’ notice
without penalty. Furthermore, the Company does not expect to move its lead candidate into the clinic until 2018, and any anticipated
revenues associated with the activities to be performed under the Services Agreements are even further distant. Accordingly, the
Company is in no way “substantially dependent” upon the Service Agreements.
The Company acknowledges that,
in accordance with Section 102 of the Staff’s Compliance & Disclosure Interpretations regarding Form 8-K, if either or
both of the Services Agreements becomes material in a future period it will file such Services Agreement(s) as an exhibit(s) to
the periodic report relating to the relevant reporting period.
19. Please provide executive compensation disclosure for Cameron Gray, who appears to have served as
the principal executive officer prior to Daniel R. Passeri in the last completed fiscal year. Refer to Item 402(m)(2)(ii) of Regulation
S-K.
The Company respectfully
submits that no compensation was awarded to Cameron Gray in his capacity as principal executive officer in 2015 or 2016. Therefore,
pursuant to Item 402(a)(5) of Regulation S-K, he is omitted from the table on page 83 of the Registration Statement Amendment.
U.S. Securities and Exchange Commission
November 2, 2017
Page 6
20. We note your disclosure on page 103 that you have "agreed to issue to the underwriters and
designees a warrant to purchase shares" of your common stock. Please revise your disclosure here and elsewhere in the prospectus
as appropriate to clarify, if true, that only MDB will be receiving warrants to purchase up to 10% of the shares of common stock
sold in the offering.
Revised disclosure responding
to this comment has been added on page 100 of the Registration Statement Amendment.
21. We note your statement that the underwriters are under no obligation to purchase shares in the
offering for their own account. Please revise the disclosure to clarify that they cannot purchase shares in order to guarantee
that the minimum of the offering is met.
Revised disclosure responding
to this comment has been added on page 98 of the Registration Statement Amendment.
22. We note your disclosure on page 105 that MDB may consent to an early release from the lock-up periods
if in its opinion the market would not be adversely impacted by sales and in cases of a financial emergency of an officer, director
or other stockholder. Please disclose whether MDB needs the consent of any other party in order to obtain a release from the lock-up
agreement.
Revised disclosure responding
to this comment has been added on page 100 of the Registration Statement Amendment.
23. You disclose that you charge patent expenses to research and development expenses. Please revise
your financial statements to charge these expenses to general and administrative expenses consistent with the guidance in ASC 730-10-55-2i.
Otherwise tell us how these expenses meet the definit
2017-10-23 - UPLOAD - Cue Biopharma, Inc.
October 20, 2017
Mark Busch
Chief Executive Officer
Cue Biopharma, Inc.
675 W. Kendall Street
Cambridge, MA 02142
Re:Cue Biopharma, Inc
Draft Registration Statement on Form S-1
Submitted on September 21, 2017
CIK No. 0001645460
Dear Mr. Busch:
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.
Form S-1 filed September 21, 2017
Cover Page
1.We note that you have structured your offering to include a minimum and maximum
dollar amount of common stock that you plan to sell. Please note you are required to
register the number of securities you plan to offer. Revise the cover page to quantify the
number of securities constituting the minimum and maximum. Please also make
corresponding changes throughout the prospectus as appropriate. For guidance, please
refer to Regulation S-K Item 501(b)(2) and Securities Act Rules Compliance &
Disclosure Interpretations Question 227.02.
FirstName LastNameMark Busch
Comapany NameCue Biopharma, Inc.
June 16, 2017 Page 2
FirstName LastNameMark Busch
Cue Biopharma, Inc.
October 20, 2017
Page 2
2.We note your disclosure on the prospectus cover page that you intend to apply to list your
common stock on the Nasdaq Capital Market and that you expect the listing to occur
upon consummation of the offering. However, we note your risk factor on page 35 that
there is no assurance that your listing application will be approved. Please tell us
whether you have applied for listing and whether you will continue your offering if your
listing is not approved. If you intend to proceed with your offering before receiving
Nasdaq approval of your listing application, that, please clarify the listing of the common
stock on the Nasdaq Capital Market is not a condition to the offering.
3.You indicate on the cover page and on page 41 that you are a smaller reporting company.
However, based on your security ownership table on page 96, your minimum offering
price and the minimum offering amount, it appears your public float will be above the
$75 million following the offering. Please tell us how you determined that you are a
smaller reporting company. Refer to the definition of “smaller reporting company” in
Rule 12b-2 of the Exchange Act.
4.Please expand your disclosure in the last paragraph of the cover page to provide a brief
statement regarding the role and responsibilities of the qualified independent
underwriter. Expand your reference to MDB and "its associated persons," to to clarify
that this includes officers and directors of the company. Additionally, tell us whether
Schiff Hardin LLP represents MDB, Feltl or both. If Schiff Hardin represents both,
please tell us how you have determined that this does not present a conflict of interest or
impacted Feltl's ability to qualify as a qualified independent underwriter.
Our Approach for Next Generation Immunotherapies, page 2
5.Please provide your basis for the table on page 4 depicting a comparison of Cue
Biologics with other immunotherapy technologies and explain how you are able to
conclude that your technologies are superior given the early stage of development.
CUE-101, page 5
6.Please disclose the significance of "rIL-2" in the first row of the first chart on page 5.
7.We refer to your statement on page 5 that you intend to move the lead candidate into the
clinic by the end of 2018. If you are currently conducting additional preclinical studies
or if additional preclinical studies will be required in order to submit an Investigational
Drug Application, please provide a description of the studies being conducted and/or any
planned preclinical studies.
8.Given the early stage of development, your belief that CUE-101 offers significant
advantages over current therapies and has the potential to provide a more effective
and safer alternative in treating HPV-driven cancers seems premature. Please provide the
basis for your belief or delete the statement from your registration statement.
FirstName LastNameMark Busch
Comapany NameCue Biopharma, Inc.
June 16, 2017 Page 3
FirstName LastNameMark Busch
Cue Biopharma, Inc.
October 20, 2017
Page 3
Business Strategy, page 8
9.Please revise your statement that you plan to leverage your platform's modular
capabilities to "rapidly and efficiently" develop drug candidates to more clearly explain
how the drug development process will differ using your platform and how rapidly you
expect to be able to develop a drug. Your response should clarify the basis for the
statement that you will be able to develop drugs rapidly. Additionally, explain how your
development process differs from that of other immunotherapy drug development
companies and why you believe these differences present a competitive advantage. Your
responses should clarify the basis for your beliefs given the early stage of your
development and that you have not yet conducted any clinical trials.
Risks Related to Our Business, page 9
10.Please revise the first bullet point of this section to include disclosure that your
independent registered public accounting firm has raised substantial doubt about your
ability to continue as a going concern, as discussed on page 17.
11.We refer to the eighth bullet point in this section regarding your intellectual property
rights. Please expand this risk factor to disclose that your technology is not covered by
any issued patents.
12.Please revise the tenth bullet point to specify, if accurate, that the net proceeds for the
offering will only be sufficient to allow you to initiate a Phase I trial for your lead
product candidate.
Status as an Emerging Growth Company, page 10
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.
Concentration of ownership among our existing executive officers, directors and significant
stockholders..., page 39
14.Please expand this risk factor to disclose that MDB will be issued warrants to purchase
shares of common stock in an amount up to 10% of the shares of common stock sold in
the public offering and the increase in concentration of ownership that may result from
the exercise of such warrants. In addition, please disclose that four of the seven members
of the board of directors are also employees of MDB and how this may impact new
investors' ability to influence significant corporate decisions.
Our charter documents and Delaware law may inhibit a takeover that stockholders consider
favorable., page 40
FirstName LastNameMark Busch
Comapany NameCue Biopharma, Inc.
June 16, 2017 Page 4
FirstName LastNameMark Busch
Cue Biopharma, Inc.
October 20, 2017
Page 4
15.We refer to the last bullet of this risk factor. Please present risks related to the exclusive
forum provision in your charter in a separately captioned risk factor, including a
discussion that such a provision may limit a shareholder’s ability to bring a claim in a
judicial forum that it finds favorable for such disputes and may discourage lawsuits with
respect to such claims.
Use of Proceeds, page 42
16.Your statement that there is no assurance you will sell any shares or receive any proceeds
is inconsistent with the stated minimum offering amount. Please remove the statement or
revise it to clarify that the statement refers to a situation in which any offering
proceeds would be returned to subscribers.
Business
Our License Agreement with Einstein, page 57
17.Please expand your discussion of the license agreement with Einstein to disclose the
following information:
•the amounts paid to date;
•aggregate potential milestone payments; and
•the "number of years" in the royalty term.
Agreements with Catalent Pharma Solutions, LLC, page 75
18.We refer to your disclosure regarding the March 2017 and July 2017 agreements with
Catalent. Please file such agreements as exhibits to the registration statement or tell us
why you believe that you are not required to file such agreements pursuant to Item
601(b)(10) of Regulation S-K.
Executive Compensation, page 86
19.Please provide executive compensation disclosure for Cameron Gray, who appears to
have served as the principal executive officer prior to Daniel R. Passeri in the last
completed fiscal year. Refer to Item 402(m)(2)(ii) of Regulation S-K.
Underwriting (Conflicts of Interest), page 102
20.We note your disclosure on page 103 that you have "agreed to issue to the underwriters
and designees a warrant to purchase shares" of your common stock. Please revise your
disclosure here and elsewhere in the prospectus as appropriate to clarify, if true, that only
MDB will be receiving warrants to purchase up to 10% of the shares of common stock
sold in the offering.
21.We note your statement that the underwriters are under no obligation to purchase shares
FirstName LastNameMark Busch
Comapany NameCue Biopharma, Inc.
June 16, 2017 Page 5
FirstName LastName
Mark Busch
Cue Biopharma, Inc.
October 20, 2017
Page 5
in the offering for their own account. Please revise the disclosure to clarify that they
cannot purchase shares in order to guarantee that the minimum of the offering is met.
Lock-Up Agreements, page 104
22.We note your disclosure on page 105 that MDB may consent to an early release from the
lock-up periods if in its opinion the market would not be adversely impacted by sales and
in cases of a financial emergency of an officer, director or other stockholder. Please
disclose whether MDB needs the consent of any other party in order to obtain a release
from the lock-up agreement.
Notes to Financial Statements
Note 2: Summary of Significant Accounting Policies
Patent Expenses, page F-9
23.You disclose that you charge patent expenses to research and development expenses.
Please revise your financial statements to charge these expenses to general and
administrative expenses consistent with the guidance in ASC 730-10-55-2i. Otherwise
tell us how these expenses meet the definition of either research or development in ASC
730-10-20.
You may contact Rolf Sundwall at 202-551-3105 or Mark Brunhofer at 202-551-3638 if
you have questions regarding comments on the financial statements and related matters. Please
contact Irene Paik at 202-551-6553 or Suzanne Hayes at 202-551-3675 with any other
questions.
Division of Corporation Finance
Office of Healthcare & Insurance