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Letter Text
OnKure Therapeutics, Inc.
CIK: 0001637715  ·  File(s): 333-295304  ·  Started: 2026-04-30  ·  Last active: 2026-04-30
Response Received 1 company response(s) High - file number match
UL SEC wrote to company 2026-04-30
OnKure Therapeutics, Inc.
Regulatory Compliance Financial Reporting Offering / Registration Process
File Nos in letter: 333-295304
↓
CR Company responded 2026-04-30
OnKure Therapeutics, Inc.
Offering / Registration Process
File Nos in letter: 333-295304
OnKure Therapeutics, Inc.
CIK: 0001637715  ·  File(s): 333-282792  ·  Started: 2024-10-25  ·  Last active: 2024-10-28
Response Received 1 company response(s) High - file number match
UL SEC wrote to company 2024-10-25
OnKure Therapeutics, Inc.
Offering / Registration Process Regulatory Compliance Financial Reporting
File Nos in letter: 333-282792
↓
CR Company responded 2024-10-28
OnKure Therapeutics, Inc.
Offering / Registration Process Capital Structure Regulatory Compliance
File Nos in letter: 333-282792
OnKure Therapeutics, Inc.
CIK: 0001637715  ·  File(s): 333-280369  ·  Started: 2024-07-18  ·  Last active: 2024-08-23
Response Received 3 company response(s) High - file number match
UL SEC wrote to company 2024-07-18
OnKure Therapeutics, Inc.
File Nos in letter: 333-280369
↓
CR Company responded 2024-07-26
OnKure Therapeutics, Inc.
File Nos in letter: 333-280369
References: July 18, 2024
↓
CR Company responded 2024-08-19
OnKure Therapeutics, Inc.
File Nos in letter: 333-280369
References: August 12, 2024
↓
CR Company responded 2024-08-23
OnKure Therapeutics, Inc.
File Nos in letter: 333-280369
Filing - Correspondence from OnKure Therapeutics, Inc.
CORRESP · 2024-08-23
Generating summary...
OnKure Therapeutics, Inc.
CIK: 0001637715  ·  File(s): 333-280369  ·  Started: 2024-08-12  ·  Last active: 2024-08-12
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2024-08-12
OnKure Therapeutics, Inc.
File Nos in letter: 333-280369
OnKure Therapeutics, Inc.
CIK: 0001637715  ·  File(s): 333-275518  ·  Started: 2023-11-16  ·  Last active: 2023-11-17
Response Received 1 company response(s) High - file number match
UL SEC wrote to company 2023-11-16
OnKure Therapeutics, Inc.
File Nos in letter: 333-275518
Filing - SEC Comment Letter to OnKure Therapeutics, Inc.
UPLOAD · 2023-11-16
Generating summary...
↓
CR Company responded 2023-11-17
OnKure Therapeutics, Inc.
File Nos in letter: 333-275518
Filing - Correspondence from OnKure Therapeutics, Inc.
CORRESP · 2023-11-17
Generating summary...
OnKure Therapeutics, Inc.
CIK: 0001637715  ·  File(s): 333-272421  ·  Started: 2023-06-08  ·  Last active: 2023-06-09
Response Received 1 company response(s) High - file number match
UL SEC wrote to company 2023-06-08
OnKure Therapeutics, Inc.
File Nos in letter: 333-272421
Filing - SEC Comment Letter to OnKure Therapeutics, Inc.
UPLOAD · 2023-06-08
Generating summary...
↓
CR Company responded 2023-06-09
OnKure Therapeutics, Inc.
File Nos in letter: 333-272421
OnKure Therapeutics, Inc.
CIK: 0001637715  ·  File(s): 333-264616  ·  Started: 2022-05-04  ·  Last active: 2022-05-05
Response Received 1 company response(s) High - file number match
UL SEC wrote to company 2022-05-04
OnKure Therapeutics, Inc.
File Nos in letter: 333-264616
Filing - SEC Comment Letter to OnKure Therapeutics, Inc.
UPLOAD · 2022-05-04
Generating summary...
↓
CR Company responded 2022-05-05
OnKure Therapeutics, Inc.
File Nos in letter: 333-264616
Filing - Correspondence from OnKure Therapeutics, Inc.
CORRESP · 2022-05-05
Generating summary...
OnKure Therapeutics, Inc.
CIK: 0001637715  ·  File(s): N/A  ·  Started: 2021-03-12  ·  Last active: 2021-04-06
Response Received 3 company response(s) Medium - date proximity
UL SEC wrote to company 2021-03-12
OnKure Therapeutics, Inc.
Filing - SEC Comment Letter to OnKure Therapeutics, Inc.
UPLOAD · 2021-03-12
Generating summary...
↓
CR Company responded 2021-03-19
OnKure Therapeutics, Inc.
References: March 12, 2021
Filing - Correspondence from OnKure Therapeutics, Inc.
CORRESP · 2021-03-19
Generating summary...
↓
CR Company responded 2021-04-06
OnKure Therapeutics, Inc.
File Nos in letter: 333-254534
Filing - Correspondence from OnKure Therapeutics, Inc.
CORRESP · 2021-04-06
Generating summary...
↓
CR Company responded 2021-04-06
OnKure Therapeutics, Inc.
File Nos in letter: 333-254534
Filing - Correspondence from OnKure Therapeutics, Inc.
CORRESP · 2021-04-06
Generating summary...
DateTypeCompanyLocationFile NoLink
2026-04-30 Company Response OnKure Therapeutics, Inc. DE N/A
Offering / Registration Process
Read Filing View
2026-04-30 SEC Comment Letter OnKure Therapeutics, Inc. DE 333-295304
Regulatory Compliance Financial Reporting Offering / Registration Process
Read Filing View
2024-10-28 Company Response OnKure Therapeutics, Inc. DE N/A
Offering / Registration Process Capital Structure Regulatory Compliance
Read Filing View
2024-10-25 SEC Comment Letter OnKure Therapeutics, Inc. DE 333-282792
Offering / Registration Process Regulatory Compliance Financial Reporting
Read Filing View
2024-08-23 Company Response OnKure Therapeutics, Inc. DE N/A Read Filing View
2024-08-19 Company Response OnKure Therapeutics, Inc. DE N/A Read Filing View
2024-08-12 SEC Comment Letter OnKure Therapeutics, Inc. DE 333-280369 Read Filing View
2024-07-26 Company Response OnKure Therapeutics, Inc. DE N/A Read Filing View
2024-07-18 SEC Comment Letter OnKure Therapeutics, Inc. DE 333-280369 Read Filing View
2023-11-17 Company Response OnKure Therapeutics, Inc. DE N/A Read Filing View
2023-11-16 SEC Comment Letter OnKure Therapeutics, Inc. DE N/A Read Filing View
2023-06-09 Company Response OnKure Therapeutics, Inc. DE N/A Read Filing View
2023-06-08 SEC Comment Letter OnKure Therapeutics, Inc. DE N/A Read Filing View
2022-05-05 Company Response OnKure Therapeutics, Inc. DE N/A Read Filing View
2022-05-04 SEC Comment Letter OnKure Therapeutics, Inc. DE N/A Read Filing View
2021-04-06 Company Response OnKure Therapeutics, Inc. DE N/A Read Filing View
2021-04-06 Company Response OnKure Therapeutics, Inc. DE N/A Read Filing View
2021-03-19 Company Response OnKure Therapeutics, Inc. DE N/A Read Filing View
2021-03-12 SEC Comment Letter OnKure Therapeutics, Inc. DE N/A Read Filing View
DateTypeCompanyLocationFile NoLink
2026-04-30 SEC Comment Letter OnKure Therapeutics, Inc. DE 333-295304
Regulatory Compliance Financial Reporting Offering / Registration Process
Read Filing View
2024-10-25 SEC Comment Letter OnKure Therapeutics, Inc. DE 333-282792
Offering / Registration Process Regulatory Compliance Financial Reporting
Read Filing View
2024-08-12 SEC Comment Letter OnKure Therapeutics, Inc. DE 333-280369 Read Filing View
2024-07-18 SEC Comment Letter OnKure Therapeutics, Inc. DE 333-280369 Read Filing View
2023-11-16 SEC Comment Letter OnKure Therapeutics, Inc. DE N/A Read Filing View
2023-06-08 SEC Comment Letter OnKure Therapeutics, Inc. DE N/A Read Filing View
2022-05-04 SEC Comment Letter OnKure Therapeutics, Inc. DE N/A Read Filing View
2021-03-12 SEC Comment Letter OnKure Therapeutics, Inc. DE N/A Read Filing View
DateTypeCompanyLocationFile NoLink
2026-04-30 Company Response OnKure Therapeutics, Inc. DE N/A
Offering / Registration Process
Read Filing View
2024-10-28 Company Response OnKure Therapeutics, Inc. DE N/A
Offering / Registration Process Capital Structure Regulatory Compliance
Read Filing View
2024-08-23 Company Response OnKure Therapeutics, Inc. DE N/A Read Filing View
2024-08-19 Company Response OnKure Therapeutics, Inc. DE N/A Read Filing View
2024-07-26 Company Response OnKure Therapeutics, Inc. DE N/A Read Filing View
2023-11-17 Company Response OnKure Therapeutics, Inc. DE N/A Read Filing View
2023-06-09 Company Response OnKure Therapeutics, Inc. DE N/A Read Filing View
2022-05-05 Company Response OnKure Therapeutics, Inc. DE N/A Read Filing View
2021-04-06 Company Response OnKure Therapeutics, Inc. DE N/A Read Filing View
2021-04-06 Company Response OnKure Therapeutics, Inc. DE N/A Read Filing View
2021-03-19 Company Response OnKure Therapeutics, Inc. DE N/A Read Filing View
2026-04-30 - CORRESP - OnKure Therapeutics, Inc.
CORRESP
 1
 filename1.htm

 CORRESP

 OnKure Therapeutics, Inc.
 6707 Winchester Circle, Suite 400
 Boulder, Colorado 80301 April 30,
2026 VIA EDGAR U.S. Securities and Exchange
Commission Division of Corporation Finance
 100 F Street, N.E. Washington, D.C. 20549
 Attention: Chris Edwards

    

 Re:

 OnKure Therapeutics, Inc.

 Registration Statement on Form S-3

 File No. 333-295304

 Acceleration Request

    Requested Date:

 May 4, 2026

    Requested Time:

 4:00 p.m.
 Ladies and Gentlemen:
 Pursuant to Rule 461 under the Securities Act of 1933, as amended, OnKure Therapeutics, Inc.
(the “ Company ”) hereby requests that the above-referenced Registration Statement on Form S-3 (File No. 333-295304) (the
“ Registration Statement ”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon thereafter as practicable, or at such later time as the Company or its counsel may
orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with the Company’s
counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Phillip S. McGill at (858) 350-2249.
 [ Signature page follows ]

 Sincerely,

 OnKure Therapeutics, Inc.

 /s/ Nicholas A. Saccomano

 Nicholas A. Saccomano

 Chief Executive Officer

 cc:
 Phillip S. McGill, Wilson Sonsini Goodrich & Rosati, P.C.
2026-04-30 - UPLOAD - OnKure Therapeutics, Inc. File: 333-295304
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 April 30, 2026

Nicholas A. Saccomano
President and Chief Executive Officer
OnKure Therapeutics, Inc.
6707 Winchester Circle, Suite 400
Boulder, CO 80301

 Re: OnKure Therapeutics, Inc.
 Registration Statement on Form S-3
 Filed April 24, 2026
 File No. 333-295304
Dear Nicholas A. Saccomano:

 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 Chris Edwards at 202-551-6761 with any questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Life
Sciences
cc: Phillip McGill
</TEXT>
</DOCUMENT>
2024-10-28 - CORRESP - OnKure Therapeutics, Inc.
CORRESP
1
filename1.htm

CORRESP

 October 28, 2024

VIA EDGAR

 U.S. Securities and Exchange
Commission

 Division of Corporation Finance

 100 F Street,
N.E.

 Washington, D.C. 20549-3720

 Attention: Doris Stacey
Gama

Re:
 OnKure Therapeutics, Inc.

Registration Statement on Form S-1

File No. 333-282792

Acceleration Request

 Requested Date:
  October 30, 2024

 Requested Time:    4:30 p.m. Eastern Time, or as soon thereafter as
practicable

 Ladies and Gentlemen:

Pursuant to Rule 461 under the Securities Act of 1933, as amended, OnKure Therapeutics, Inc. (the “Company”) hereby requests
that its Registration Statement on Form S-1 (File No. 333-282792) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set
forth above or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared
effective, please orally confirm that event with our counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Jennifer Knapp at (650) 849-3041.

Sincerely,

ONKURE THERAPEUTICS, INC.

By:

 /s/ Nicholas A. Saccomano

Nicholas A. Saccomano

Chief Executive Officer

cc:
 Jennifer Knapp, Wilson Sonsini Goodrich & Rosati
2024-10-25 - UPLOAD - OnKure Therapeutics, Inc. File: 333-282792
October 25, 2024
Nicholas Saccomano
Chief Executive Officer
OnKure Therapeutics, Inc.
6707 Winchester Circle, #400
Boulder, CO 80301
Re:OnKure Therapeutics, Inc.
Registration Statement on Form S-1
Filed October 23, 2024
File No. 333-282792
Dear Nicholas Saccomano:
            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:Jennifer Knapp, Esq.
2024-08-23 - CORRESP - OnKure Therapeutics, Inc.
CORRESP
1
filename1.htm

CORRESP

 RENEO PHARMACEUTICALS, INC.

18575 Jamboree Road, Suite 275-S

Irvine, CA 92612

 August 23,
2024

 VIA EDGAR

 United States Securities and
Exchange Commission

 Division of Corporation Finance

 Office
of Life Sciences

 100 F Street, N.E.

 Washington, D.C. 20549

Attention:
 Gary Newberry

 
 Lynn Dicker

 
 Tyler Howes

 
 Tim Buchmiller

Re:
 Reneo Pharmaceuticals, Inc.

Registration Statement on Form S-4 (File No. 333-280369)

 Request for Acceleration of Effective Date

Ladies and Gentlemen:

 Pursuant to Rule 461 of
the General Rules and Regulations under the Securities Act of 1933, as amended, Reneo Pharmaceuticals, Inc. (the “Company”) hereby respectfully requests that the U.S. Securities and Exchange Commission accelerate the effective date
and time of the above referenced Registration Statement on Form S-4 (the “Registration Statement”) and declare the Registration Statement effective as of 4:30 p.m. Eastern Time on
August 26, 2024, or as soon thereafter as practicable.

 The Company requests that it be notified of such effectiveness by a telephone
call to either Bradley C. Brasser of Jones Day at (612) 217-8886 or Jonn R. Beeson of Jones Day at (949) 553-7528. Thank you for your attention to this matter.

cc:
 Bradley C. Brasser, Jones Day

Jonn R. Beeson, Jones Day

 Sincerely,

Reneo Pharmaceuticals, Inc.

 /s/ Gregory J. Flesher

 Gregory J. Flesher

President and Chief Executive Officer
2024-08-19 - CORRESP - OnKure Therapeutics, Inc.
Read Filing Source Filing Referenced dates: August 12, 2024
CORRESP
1
filename1.htm

CORRESP

 RENEO PHARMACEUTICALS, INC.

18575 Jamboree Road, Suite 275-S

Irvine, CA 92612

 August 19,
2024

 VIA EDGAR

 United States Securities and
Exchange Commission

 Division of Corporation Finance

 Office
of Life Sciences

 100 F Street, N.E.

 Washington, D.C. 20549

 Attention:  Gary Newberry

 Lynn
Dicker

 Tyler Howes

 Tim
Buchmiller

Re:
 Reneo Pharmaceuticals, Inc.

Amendment No. 1 to Registration Statement on Form S-4

Filed July 29, 2024

 File No. 333-280369

 Ladies and Gentlemen:

Reneo Pharmaceuticals, Inc., a Delaware corporation (“Reneo,” the “Company,” “we,” or
“our”), is in receipt of the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) set forth in the Commission’s letter dated August 12, 2024
(the “Comment Letter”) with respect to Amendment No. 1 to the Company’s Registration Statement on Form S-4 filed with the Commission on July 29, 2024.

An amended Form S-4 is being filed with the Commission on August 19, 2024 (the “Amended Form S-4”). Below are the Company’s responses to the Comment Letter. For your convenience, the italicized numbered responses set forth below correspond with the comments contained in the Comment Letter.

 Amendment No. 1 to Registration Statement on Form S-4 filed July 29, 2024

Opinion of Leerink Partners LLC

OnKure Forecasts, page 135

1.
 We note your revised disclosure in response to prior comment 11. Please further revise to discuss
why the projections utilized by Reneo assumed that commercialization for OKI-219 would be able to begin in 2032. Please also clarify here what milestones that will need to be satisfied in order for OKI-219 to achieve this timeline.

 Response:

In response to the Staff’s comment, the Company has revised the disclosure on page 135 of the Amended Form
S-4.

 OnKure Business

OKI-219, a Targeted Inhibitor of PI3Ka, page
222

2.
 We note your response to prior comment 19. Please further revise your discussion of the OnKure
generated preclinical data supporting the selectivity of OKI-219 to clarify if these studies were powered for statistical significance.

Response:

 In response to
the Staff’s comment, the Company has revised the disclosure on page 230 of the Amended Form S-4.

Phase 1 PIK-ture-01 Trial, page 230

3.
 We note your revised disclosure on page 232 stating the monotherapy portion of this trial will not
be powered to assess efficacy. However, disclosure on page 230 continues to state your Phase 1 trial of OKI-219 will be powered to assess the “efficacy of OKI-219
as monotherapy.” Please reconcile your disclosure or advise.

 Response:

In response to the Staff’s comment, the Company has revised the disclosure on page 235 of the Amended Form
S-4.

 Intellectual Property

PI3K Platform, page 235

4.
 We note your revised disclosure in response to prior comment 25. Please further revise to clarify
if the current patent applications relate to OKI-209, including whether such patent applications include composition of matter claims for OKI-209.

 Response:

In response to the Staff’s comment, the Company has revised the disclosure on page 240 of the Amended Form
S-4.

 2

 Unaudited Pro Forma Condensed Combined Financial Information, page 293

5.
 We note your response to prior comment 28 and the company’s claim that it intends to retain
Reneo’s intellectual property portfolio. We continue to consider your response to comment 28. However, in order to clarify the treatment of this business combination, please provide us with your accounting analysis of all relevant factors
supporting your conclusion that the merger should be accounted for as a reverse recapitalization. As part of your analysis, clearly identify the factors that are indicative that Reneo is a shell company versus the factors that
are indicative that it meets the definition of a business at the time of the merger, specifically addressing your ongoing operating activities.

Response:

 After further
consideration, including with respect to the accounting treatment of the Mergers, Reneo acknowledges that it will be deemed a shell company by the time of the closing of the Mergers. As stated on page 306 of the Amended Form S-4, for accounting purposes, the Mergers are expected to be accounted for as a reverse recapitalization of OnKure because on the closing date of the Mergers, the
pre-combination assets of Reneo are expected to be primarily cash, cash equivalents, short-term investments and other non-operating assets.

Accordingly, the Company respectfully advises the Staff that it has revised the disclosures on pages
95-96 and 319 of the Amended Form S-4.

 * * * * * * * * *

 3

 If you have any questions regarding these matters, please do not hesitate to contact Jonn R.
Beeson of Jones Day at (949) 553-7528 or at jbeeson@jonesday.com or Bradley C. Brasser of Jones Day at (612) 217-8886 or bcbrasser@jonesday.com.

Sincerely yours,

 /s/ Gregory J. Flesher

Gregory J. Flesher

President and Chief Executive Officer

Reneo Pharmaceuticals, Inc.

 Copies to:

 Jonn R.
Beeson, Jones Day

 Bradley C. Brasser, Jones Day

 4
2024-08-12 - UPLOAD - OnKure Therapeutics, Inc. File: 333-280369
August 12, 2024
Gregory J. Flesher
President and Chief Executive Officer
Reneo Pharmaceuticals, Inc.
18575 Jamboree Road, Suite 275-S
Irvine, CA 92612
Re:Reneo Pharmaceuticals, Inc.
Amendment No. 1 to Registration Statement on Form S-4
Filed July 29, 2024
File No. 333-280369
Dear Gregory J. Flesher:
            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. 1 to Registration Statement on Form S-4 filed July 29, 2024
Opinion of Leerink Partners LLC
OnKure Forecasts, page 135
1.We note your revised disclosure in response to prior comment 11. Please further revise to
discuss why the projections utilized by Reneo assumed that commercialization for OKI-
219 would be able to begin in 2032. Please also clarify here what milestones that will
need to be satisfied in order for OKI-219 to achieve this timeline.
OnKure Business
OKI-219, a Targeted Inhibitor of PI3K α;, page 222
2.We note your response to prior comment 19. Please further revise your discussion of
the OnKure generated preclinical data supporting the selectivity of OKI-219 to clarify if
these studies were powered for statistical significance.

August 12, 2024
Page 2
Phase 1 PIKture-01 Trial, page 230
3.We note your revised disclosure on page 232 stating the monotherapy portion of this trial
will not be powered to assess efficacy. However, disclosure on page 230 continues to state
your Phase 1 trial of OKI-219 will be powered to assess the "efficacy of OKI-219 as
monotherapy." Please reconcile your disclosure or advise.
Intellectual Property
PI3K Platform, page 235
4.We note your revised disclosure in response to prior comment 25. Please further revise to
clarify if the current patent applications relate to OKI-209, including whether such patent
applications include composition of matter claims for OKI-209.
Unaudited Pro Forma Condensed Combined Financial Information, page 293
5.We note your response to prior comment 28 and the company’s claim that it intends to
retain Reneo’s intellectual property portfolio. We continue to consider your response to
comment 28. However, in order to clarify the treatment of this business combination,
please provide us with your accounting analysis of all relevant factors supporting your
conclusion that the merger should be accounted for as a reverse recapitalization. As part
of your analysis, clearly identify the factors that are indicative that Reneo is a shell
company versus the factors that are indicative that it meets the definition of a business at
the time of the merger, specifically addressing your ongoing operating activities.
            Please contact Gary Newberry at 202-551-3761 or Lynn Dicker at 202-551-3616 if you
have questions regarding comments on the financial statements and related matters. Please
contact Tyler Howes at 202-551-3370 or Tim Buchmiller at 202-551-3635 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Jonn R. Beeson, Esq.
2024-07-26 - CORRESP - OnKure Therapeutics, Inc.
Read Filing Source Filing Referenced dates: July 18, 2024
CORRESP
1
filename1.htm

CORRESP

 RENEO PHARMACEUTICALS, INC.

18575 Jamboree Road, Suite 275-S

Irvine, CA 92612

 July 26,
2024

 VIA EDGAR

 United States Securities and
Exchange Commission

 Division of Corporation Finance

 Office
of Life Sciences

 100 F Street, N.E.

 Washington, D.C. 20549

Attention:
 Gary Newberry

 
 Lynn Dicker

 
 Tyler Howes

 
 Tim Buchmiller

Re:
 Reneo Pharmaceuticals, Inc.

Registration Statement on Form S-4

Filed June 21, 2024

 File No. 333-280369

 Ladies and Gentlemen:

Reneo Pharmaceuticals, Inc., a Delaware corporation (“Reneo,” the “Company,” “we,” or
“our”), is in receipt of the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) set forth in the Commission’s letter dated July 18, 2024 (the
“Comment Letter”) with respect to the Company’s Registration Statement on Form S-4 filed with the Commission on June 21, 2024 (the “Form S-4”).

 An amended Form S-4 is being filed with the Commission on
July 26, 2024 (the “Amended Form S-4”). Below are the Company’s responses to the Comment Letter. For your convenience, the italicized numbered responses set forth below correspond
with the comments contained in the Comment Letter. Unless otherwise indicated, page references in the responses correspond to the page numbers in the Amended Form S-4. Capitalized terms used in this letter but otherwise not defined herein shall have
the meanings set forth in the Amended Form S-4.

 Registration Statement on Form S-4

Following the Mergers, will Reneo’s securities be traded on a stock exchange?, page 12

1.
 We note your disclosure that it is expected that the NewCo
Class A Common Stock will trade on the Nasdaq Global Market after completion of the Proposed Transactions. Please revise to disclose if the terms of the merger agreement permit that the Nasdaq listing
closing condition could be waived without recirculation or resolicitation. If so, please revise your risk factors to reflect the risks associated with any such waiver and revise to indicate that shareholders may not have certainty at the time of the
vote that the shares of NewCo will be listed on Nasdaq following the merger or revise your disclosure in a preeffective amendment as appropriate if and when there is more certainty regarding the Nasdaq listing of the NewCo
Class A Common Stock.

 Response:

In response to the Staff’s comment, the Company has revised the disclosure on pages 12 and 156 of the Amended Form S-4.

 Prospectus Summary

OnKure, Inc., page 20

2.
 We note your disclosure here that OnKure is focused on developing
“best-in-class” precision medicines. Please revise this and similar statements throughout the proxy statement/prospectus that OnKure’s product candidates
may be “best-in-class” as these statements appear to be speculative given the current development status of those product candidates and the noted length and
uncertainty of the drug approval and commercialization processes.

 Response:

In response to the Staff’s comment, the Company has revised the disclosure throughout the Amended Form
S-4 to remove all references to “best-in-class” and similar statements.

3.
 Please tell us your basis for your statement asserting that OnKure’s design platform is
“proven” given that OnKure has no products approved for commercial sale.

 Response:

In response to the Staff’s comment, the Company has revised the disclosure throughout the Amended Form
S-4 to remove the reference to the OnKure drug design platform being “proven.”

 Risk Factors,
page 34

4.
 We note from Section 10.1 of the Merger Agreement
that, in general, the representations and warranties of the parties contained in the Merger Agreement do not survive the Closing and that there are no indemnification rights. Please include appropriate risk factor disclosure.

 Response:

In response to the Staff’s comment, the Company has revised the disclosure on pages 36–37 of the Amended Form S-4.

 2

 OnKure contracts with third parties for the manufacture of its product candidates for preclinical
studies..., page 80

5.
 Please revise this risk factor to name the single-source supplier OnKure currently relies upon and
clarify if OnKure has entered into any supply agreements with them.

 Response:

In response to the Staff’s comment, the Company has revised the disclosure on page 82 of the Amended Form
S-4 to name the two single-source suppliers that OnKure currently relies upon and disclosed that it has entered into a master services agreement with each of these suppliers.

The Amended Bylaws will provide that, unless NewCo consents in writing to the selection of an alternative forum..., page 91

6.
 We note that your forum selection provision identifies the Court of Chancery of the State of
Delaware as the exclusive forum for certain litigation, including any “derivative action.” Please disclose whether this provision applies to actions arising under the Exchange Act. In that regard, we note that
Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder. If this
provision does not apply to actions arising under the Exchange Act, please also ensure that the exclusive forum provision in the governing documents states this clearly, or tell us how you will inform investors in future filings that the provision
does not apply to any actions arising under the Exchange Act.

 Response:

In response to the Staff’s comment, the Company has revised the disclosure on page 93 of the Amended Form
S-4 and respectfully advises the Staff that the Amended Bylaws state the exception for exclusive federal jurisdiction over suits brought to enforce any duty or liability created by the Exchange Act.

The Mergers

 Background of the
Mergers, page 104

7.
 Please revise this section to provide a more fulsome description of the negotiations related to
the Concurrent PIPE Investments.

 Response:

In response to the Staff’s comment, the Company has revised the disclosure on pages 117–119 of the Amended Form S-4 to provide additional disclosure regarding the negotiations related to the Concurrent PIPE Investments.

 3

8.
 Please revise to explain why the board of Reneo found the proposal from OnKure “more
attractive” than the proposal from Party B. Please also clearly disclose when Reneo’s board decided to stop considering the proposal from Party B.

Response:

 In response to
the Staff’s comment, the Company has revised the disclosure on page 115 of the Amended Form S-4.

9.
 Please briefly explain why the Reneo board decided to also retain Cooley LLP in connection with
this transaction. In your revisions, provide a more fulsome discussion of the role Cooley played in negotiating the merger agreement with OnKure.

Response:

 In response to
the Staff’s comment, the Company has revised the disclosure on page 116 of the Amended Form S-4.

10.
 Please specify which terms remained under negotiation on
April 26, 2024.

 Response:

In response to the Staff’s comment, the Company has revised the disclosure on pages 118-119 of the
Amended Form S-4.

 Opinion of Leerink Partners LLC

Certain Unaudited Financial Projections of OnKure, page 130

11.
 Please revise to disclose the material assumptions underlying the Reneo-prepared OnKure financial
projections that were made available to Leerink Partners.

 Response:

In response to the Staff’s comment, the Company has revised the disclosure on pages 135-136 of the
Amended Form S-4 to add footnote disclosure describing the material assumptions underlying the OnKure Forecasts.

12.
 We note the disclaimers throughout this section that readers are cautioned not to rely on the
prospective financial projections. While it is acceptable to include qualifying language concerning subjective analyses, it is inappropriate to indicate that investors cannot rely on disclosure. Please revise accordingly.

 Response:

In response to the Staff’s comment, the Company has revised the disclosure on page 133 of the Amended Form
S-4.

 4

13.
 We see in the OnKure Forecasts on page 132 the significant variances among the amounts shown as
projected net sales, adjusted net sales and adjusted net revenue for the years presented. Briefly indicate how these terms were defined for purposes of the forecasts and the reasons for the material differences.

Response:

 In response to
the Staff’s comment, the Company has revised the disclosure on pages 135-136 of the Amended Form S-4 to add footnote disclosure describing how the financial
measures set forth in the OnKure Forecasts are defined and the reasons for the differences among those measures.

 OnKure Business, page 212

14.
 Please revise your disclosure to remove any implication that OnKure’s product candidates will
be safe or effective, as such conclusions are within the sole authority of the FDA and comparable foreign regulators. By way of example only, on page 216 you state that OKI-219 causes “tumor
regression” and has a “favorable safety profile.” We also note statements throughout OnKure’s business section claiming your product candidates are “more effective” than approved products or can “minimize known
side effects” observed in other PI3Kα inhibitors. Please remove these statements, and any others like them, or revise these statements to instead present the objective data resulting from your clinical
trials.

 Response:

In response to the Staff’s comment, the Company has revised the disclosure throughout the Amended Form
S-4 to remove any claim that OnKure’s product candidates will be safe or effective.

15.
 Please indicate if the data presented in figure 1 (page 216), figure 7 (page 223) and figure 8
(page 224) was statistically significant, and include p-values if appropriate.

Response:

 In response to
the Staff’s comment, the Company has revised figures 1, 7 and 8 on pages 223 and 229 of the Amended Form S-4, respectively.

OnKure’s Clinical Pipeline, page 214

16.
 Please revise your pipeline table to present all phases of clinical development.

 Response:

In response to the Staff’s comment, the Company has revised the pipeline table on page 221 of the Amended Form S-4 to present all phases of clinical development.

 5

 OnKure’s Preclinical Pipeline, page 214

17.
 We note the inclusion of OnKure’s preclinical pipeline in this section. Given the limited
disclosure related to the programs contained in this pipeline table throughout OnKure’s Business section, please explain why they are sufficiently material to OnKure’s business to warrant inclusion here. If they are material, please expand
the disclosure in the Business section related to these candidates to provide a more fulsome discussion of any development activities conducted. Alternatively, remove this pipeline table.

Response:

 In response to
the Staff’s comment, the Company has removed the pre-clinical pipeline table from page 221 of the Amended Form S-4.

OKI-219, a Targeted Inhibitor of PI3Kα, page 216

18.
 We note your disclosure in the last paragraph on page 215 that both alpelisib and capivasertib are
ATP-competitive kinase inhibitors. Please indicate if OKI-219 is also an ATP-competitive kinase inhibitor or works by some other
mechanism of action.

 Response:

In response to the Staff’s comment, the Company has revised the disclosure on page 222 of the Amended Form
S-4.

19.
 We note your disclosure that OnKure has shown preclinical data supporting the selectivity of OKI-219 and that OKI-219 targets the H1047R mutated PI3Kα with approximately 80-fold selectivity over
the wild-type PI3Kα. Please disclose the material data underlying this disclosure and indicate if such data was statistically significant, providing p-values, if
appropriate.

 Response:

In response to the Staff’s comment, the Company has revised the disclosure on page 225 of the Amended Form
S-4.

 Commercial Opportunity in Breast Cancer, page 217

20.
 Please revise this section to clearly state that you will need to receive FDA approval prior to
commercialization of any of your product candidates.

 Response:

In response to the Staff’s comment, the Company has revised the disclosure on page 223 of the Amended Form
S-4.

 6

 Limitations of Currently Approved PI3K Inhibitors, page 218

21.
 Please identify the parties that conducted the clinical studies referenced in this section that
targeted mutated PI3Kα. Please also clarify, if true, that OnKure did not conduct any of the studies referenced here.

Response:

 In response to
the Staff’s comment, the Company has revised the disclosure on page 225 of the Amended Form S-4 to identify the parties that conducted the clinical studies referenced and clarify that OnKure has not
independently conducted similar studies.

 Phase 1 PIKture-01 Trial, page 224

22.
 Please disclose the planned endpoints for all three parts of your Phase 1 PIKture- 01 trial.
Please also explain how this trial will be powered to assess efficacy.

 Response:

In response to the Staff’s comment, the Company has revised the disclosure on page 231 of the Amended Form
S-4.

 Figure 9. PIKture-01 trial design and timeline, page
225

23.
 Please revise this graphic to ensure that all text is legible without magnification.

 Response:

In response to the Staff’s comment, the Company has revised the graphic on page 232 of the Amended Form
S-4.

 Intellectual Property, page 228

24.
 We note your statement here that OnKure’s owned and licensed patent portfolio consists of 128
patents and patent applications, including two licensed issued patents. Please revise to clarify if any of the licensed patents are material to OnKure’s business. To the extent they are, please revise wherever appropriate to disclose the name
of the party or parties these patents are licensed from and discuss the material terms of the licensing agreements related to these patents. Please also file these agreements as exhibits to your registration statement. Refer to Item 601 of
Regulation S-K for guidance.

 Response:

OnKure respectfully advises the staff that the licensed patents are not material to OnKure’s business and the related license agreements
are not material agreements within the definition of Item 601 of Regulation S-K. The Company has revised the disclosure on page 235 of the Amended Form S-4.

 7

 PI3K Platform, page 228

25.
 Please revise this section to the disclose the type of patent protection and potential expiration
dates, if granted, for each of the eleven patent families relating to your PI3K platform. Please also discuss what a provisional patent application is and what rights flow from this type of application.

Response:

 In response to
the Staff’s comment, the Company has revised the disclosure beginning on page 235 of the Amended Form S-4.

Principal Stockholders of the Combined Company, page 326

26.
 Please revise the footnotes to the table on page 327 to identify the natural person(s) with voting
and/or dispositive control over the shares in the combined company that will be held by Acorn Bioventures, L.P., Cormorant Asset Management LP, Perceptive Life Sciences Master Fund, Ltd. and Samsara BioCapital, L.P.

 Response:

In response to the Staff’s comment, the Company has revised the footnotes on pages 335, 337 and 338 of the Amended Form S-4.

 Exhibits

27.
 We note you intend to file the form of preliminary proxy card as Exhibit 99.1. Please note that
the form of proxy card should be filed as an appendix rather than as an exhibit to the registration statement. Refer to the Note to paragraph (a)(3) of Exchange Act Rule 14a-4.

 Response:

In response to the Staff’s comment, the Company has revised the Amended Form S-4 to include a form
of the preliminary proxy card as Annex N.

 General

28.
 Please provide us your analysis as to whether Reneo Pharmaceuticals, Inc. is a shell company as
defined in Rule 12b-2 of the Exchange Act or whether it could beco
2024-07-18 - UPLOAD - OnKure Therapeutics, Inc. File: 333-280369
July 18, 2024
Gregory J. Flesher
President and Chief Executive Officer
Reneo Pharmaceuticals, Inc.
18575 Jamboree Road, Suite 275-S
Irvine, CA 92612
Re:Reneo Pharmaceuticals, Inc.
Registration Statement on Form S-4
Filed June 21, 2024
File No. 333-280369
Dear Gregory J. Flesher:
            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
Following the Mergers, will Reneo's securities be traded on a stock exchange?, page 12
1.We note your disclosure that it is expected that the NewCo Class A Common Stock will
trade on the Nasdaq Global Market after completion of the Proposed Transactions. Please
revise to disclose if the terms of the merger agreement permit that the Nasdaq listing
closing condition could be waived without recirculation or resolicitation. If so, please
revise your risk factors to reflect the risks associated with any such waiver and revise to
indicate that shareholders may not have certainty at the time of the vote that the shares of
NewCo will be listed on Nasdaq following the merger or revise your disclosure in a pre-
effective amendment as appropriate if and when there is more certainty regarding the
Nasdaq listing of the NewCo Class A Common Stock.

July 18, 2024
Page 2
Prospectus Summary
OnKure, Inc., page 20
2.We note your disclosure here that OnKure is focused on developing "best-in-
class" precision medicines. Please revise this and similar statements throughout the proxy
statement/prospectus that OnKure's product candidates may be "best-in-class" as these
statements appear to be speculative given the current development status of those product
candidates and the noted length and uncertainty of the drug approval and
commercialization processes.
3.Please tell us your basis for your statement asserting that OnKure's design platform is
"proven" given that OnKure has no products approved for commercial sale.
Risk Factors, page 34
4.We note from Section 10.1 of the Merger Agreement that, in general, the representations
and warranties of the parties contained in the Merger Agreement do not survive the
Closing and that there are no indemnification rights. Please include appropriate risk factor
disclosure.
OnKure contracts with third parties for the manufacture of its product candidates for preclinical
studies..., page 80
5.Please revise this risk factor to name the single-source supplier OnKure currently relies
upon and clarify if OnKure has entered into any supply agreements with them.
The Amended Bylaws will provide that, unless NewCo consents in writing to the selection of an
alternative forum..., page 91
6.We note that your forum selection provision identifies the Court of Chancery of the State
of Delaware as the exclusive forum for certain litigation, including any "derivative
action." Please disclose whether this provision applies to actions arising under
the Exchange Act. In that regard, we note that Section 27 of the Exchange Act creates
exclusive federal jurisdiction over all suits brought to enforce any duty or liability created
by the Exchange Act or the rules and regulations thereunder. If this provision does not
apply to actions arising under the Exchange Act, please also ensure that the exclusive
forum provision in the governing documents states this clearly, or tell us how you will
inform investors in future filings that the provision does not apply to any actions arising
under the Exchange Act.
The Mergers
Background of the Mergers, page 104
7.Please revise this section to provide a more fulsome description of the negotiations related
to the Concurrent PIPE Investments.
8.Please revise to explain why the board of Reneo found the proposal from OnKure "more
attractive" than the proposal from Party B. Please also clearly disclose when Reneo's
board decided to stop considering the proposal from Party B.
9.Please briefly explain why the Reneo board decided to also retain Cooley LLP in
connection with this transaction. In your revisions, provide a more fulsome discussion of
the role Cooley played in negotiating the merger agreement with OnKure.

July 18, 2024
Page 3
10.Please specify which terms remained under negotiation on April 26, 2024.
Opinion of Leerink Partners LLC
Certain Unaudited Financial Projections of OnKure, page 130
11.Please revise to disclose the material assumptions underlying the Reneo-prepared OnKure
financial projections that were made available to Leerink Partners.
12.We note the disclaimers throughout this section that readers are cautioned not to rely on
the prospective financial projections. While it is acceptable to include qualifying language
concerning subjective analyses, it is inappropriate to indicate that investors cannot rely on
disclosure. Please revise accordingly.
13.We see in the OnKure Forecasts on page 132 the significant variances among the amounts
shown as projected net sales, adjusted net sales and adjusted net revenue for the years
presented. Briefly indicate how these terms were defined for purposes of the forecasts and
the reasons for the material differences.
OnKure Business, page 212
14.Please revise your disclosure to remove any implication that OnKure's product candidates
will be safe or effective, as such conclusions are within the sole authority of the FDA
and comparable foreign regulators. By way of example only, on page 216 you state that
OKI-219 causes "tumor regression" and has a "favorable safety profile." We also note
statements throughout OnKure's business section claiming your product candidates are
"more effective" than approved products or can "minimize known side effects" observed
in other PI3K α inhibitors. Please remove these statements, and any others like them, or
revise these statements to instead present the objective data resulting from your
clinical trials.
15.Please indicate if the data presented in figure 1 (page 216), figure 7 (page 223) and
figure 8 (page 224) was statistically significant, and include p-values if appropriate.
OnKure's Clinical Pipeline, page 214
16.Please revise your pipeline table to present all phases of clinical development.
OnKure's Preclinical Pipeline, page 214
17.We note the inclusion of OnKure's preclinical pipeline in this section. Given the limited
disclosure related to the programs contained in this pipeline table throughout OnKure's
Business section, please explain why they are sufficiently material to OnKure's business
to warrant inclusion here. If they are material, please expand the disclosure in the
Business section related to these candidates to provide a more fulsome discussion of any
development activities conducted. Alternatively, remove this pipeline table.
OKI-219, a Targeted Inhibitor of PI3K α, page 216
18.We note your disclosure in the last paragraph on page 215 that both alpelisib and
capivasertib are ATP-competitive kinase inhibitors. Please indicate if OKI-219 is also an
ATP-competitive kinase inhibitor or works by some other mechanism of action.

July 18, 2024
Page 4
19.We note your disclosure that OnKure has shown preclinical data supporting the selectivity
of OKI-219 and that OKI-219 targets the H1047R mutated PI3K α with approximately 80-
fold selectivity over the wild-type PI3K α. Please disclose the material data underlying
this disclosure and indicate if such data was statistically significant, providing p-values, if
appropriate.
Commercial Opportunity in Breast Cancer, page 217
20.Please revise this section to clearly state that you will need to receive FDA approval prior
to commercialization of any of your product candidates.
Limitations of Currently Approved PI3K Inhibitors, page 218
21.Please identify the parties that conducted the clinical studies referenced in this section that
targeted mutated PI3K α. Please also clarify, if true, that OnKure did not conduct any of
the studies referenced here.
Phase 1 PIKture-01 Trial, page 224
22.Please disclose the planned endpoints for all three parts of your Phase 1 PIKture-
01 trial. Please also explain how this trial will be powered to assess efficacy.
Figure 9. PIKture-01 trial design and timeline, page 225
23.Please revise this graphic to ensure that all text is legible without magnification.
Intellectual Property, page 228
24.We note your statement here that OnKure's owned and licensed patent portfolio consists
of 128 patents and patent applications, including two licensed issued patents. Please revise
to clarify if any of the licensed patents are material to OnKure's business. To the extent
they are, please revise wherever appropriate to disclose the name of the party or parties
these patents are licensed from and discuss the material terms of the licensing agreements
related to these patents. Please also file these agreements as exhibits to your registration
statement. Refer to Item 601 of Regulation S-K for guidance.
PI3K Platform, page 228
25.Please revise this section to the disclose the type of patent protection and potential
expiration dates, if granted, for each of the eleven patent families relating to your PI3K
platform. Please also discuss what a provisional patent application is and what rights flow
from this type of application.
Principal Stockholders of the Combined Company, page 326
26.Please revise the footnotes to the table on page 327 to identify the natural person(s) with
voting and/or dispositive control over the shares in the combined company that will
be held by Acorn Bioventures, L.P., Cormorant Asset Management LP, Perceptive Life
Sciences Master Fund, Ltd. and Samsara BioCapital, L.P.
Exhibits
We note you intend to file the form of preliminary proxy card as Exhibit 99.1. Please note
that the form of proxy card should be filed as an appendix rather than as an exhibit to the 27.

July 18, 2024
Page 5
registration statement. Refer to the Note to paragraph (a)(3) of Exchange Act Rule 14a-4.
General
28.Please provide us your analysis as to whether Reneo Pharmaceuticals, Inc. is a shell
company as defined in Rule 12b-2 of the Exchange Act or whether it could become one
prior to the closing of the merger. For guidance, see Special Purpose Acquisition
Companies, Shell Companies, and Projections, Release No. 33-11265 (January 24, 2024)
at nt. 943.
            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 Gary Newberry at 202-551-3761 or Lynn Dicker at 202-551-3616 if you
have questions regarding comments on the financial statements and related matters. Please
contact Tyler Howes at 202-551-3370 or Tim Buchmiller at 202-551-3635 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Jonn R. Beeson, Esq.
2023-11-17 - CORRESP - OnKure Therapeutics, Inc.
CORRESP
1
filename1.htm

CORRESP

 Reneo Pharmaceuticals, Inc.

18575 Jamboree Road, Suite 275-S

Irvine, California 92612

 (858) 283-0280

 November 17, 2023

VIA EDGAR

 United States
Securities and Exchange Commission

 Division of Corporation Finance

100 F Street, N.E.

 Washington, D.C. 20549

Attn:
 Tyler Howes

Re:

Reneo Pharmaceuticals, Inc.

Registration Statement on Form S-3

File No. 333-275518

 Ladies and Gentlemen:

 Pursuant
to Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form S-3 to become effective at 4:30 p.m. Eastern Time on November 21, 2023, or as soon thereafter as is practicable.

Once the above-referenced Registration Statement has been declared effective, please orally confirm that event with Jason Kent of Cooley LLP, counsel to the
registrant, at (212) 479-6044.

 RENEO PHARMACEUTICALS, INC.

By:

/s/ Gregory J. Flesher

Gregory J. Flesher

 President and Chief Executive Officer
2023-11-16 - UPLOAD - OnKure Therapeutics, Inc.
United States securities and exchange commission logo
November 16, 2023
Gregory J. Flesher
Chief Executive Officer
Reneo Pharmaceuticals, Inc.
18575 Jamboree Road, Suite 275-S
Irvine, CA 92612
Re:Reneo Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed November 13, 2023
File No. 333-275518
Dear Gregory J. Flesher:
            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:       Wade Andrews, Esq.
2023-06-09 - CORRESP - OnKure Therapeutics, Inc.
CORRESP
1
filename1.htm

CORRESP

 Reneo Pharmaceuticals, Inc.

18575 Jamboree Road, Suite 275-S

Irvine, California 92612

 (858) 283-0280

 June 9, 2023

VIA EDGAR

 United States
Securities and Exchange Commission

 Division of Corporation Finance

100 F Street, N.E.

 Washington, D.C. 20549

Attn:  Dillon Hagius

Re:
 Reneo Pharmaceuticals, Inc.

Registration Statement on Form S-3

File No. 333-272421

 Ladies and
Gentlemen:

 Pursuant to Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant hereby requests that the Securities and Exchange
Commission take appropriate action to cause the above-referenced Registration Statement on Form S-3 to become effective at 4:30 p.m. Eastern Time on June 13, 2023, or as soon thereafter as is practicable.

 Once the above-referenced Registration Statement has been declared effective, please orally confirm that event with Jason Kent of Cooley LLP, counsel to
the registrant, at (212) 479-6044.

 RENEO PHARMACEUTICALS, INC.

By:

/s/ Gregory J. Flesher

Gregory J. Flesher

President and Chief Executive Officer
2023-06-08 - UPLOAD - OnKure Therapeutics, Inc.
United States securities and exchange commission logo
June 8, 2023
Gregory Flesher
President and Chief Executive Officer
Reneo Pharmaceuticals, Inc.
18575 Jamboree Road, Suite 275-S
Irvine, California 92612
Re:Reneo Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed June 5, 2023
File No. 333-272421
Dear Gregory Flesher:
            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 Dillon Hagius at 202-551-7967 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Jason Kent
2022-05-05 - CORRESP - OnKure Therapeutics, Inc.
CORRESP
1
filename1.htm

CORRESP

 RENEO PHARMACEUTICALS, INC.

18575 Jamboree Road, Suite 275-S

Irvine, California 92612

 May 5, 2022

VIA EDGAR

 U.S. Securities and Exchange Commission

 Division of Corporation Finance

 100 F Street, N.E.

Washington, D.C. 20549

 Attn: Michael Davis

Re:
 Reneo Pharmaceuticals, Inc.

Registration Statement on Form S-3 (File
No. 333-264616)

 Request for Acceleration of Effective Date

Dear Mr. Davis:

 Pursuant to Rule 461 under the
Securities Act of 1933, as amended, Reneo Pharmaceuticals, Inc. (the “Company”) hereby requests that the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the above-referenced
Registration Statement on Form S-3 (the “Registration Statement”) and declare the Registration Statement effective as of 4:00 p.m. Eastern time, on May 9, 2022, or as soon thereafter as
possible, or at such other time as the Company or its legal counsel, Cooley LLP, may request by telephone to the staff of the Commission. The Company hereby authorizes each of Jason Kent and Wade Andrews of Cooley LLP to make such a request on its
behalf.

 Once the Registration Statement has been declared effective, please orally confirm that event with Jason Kent of Cooley LLP at
(212) 479-6044, or in his absence, Wade Andrews of Cooley LLP at (858) 550-6042.

Very truly yours,

Reneo Pharmaceuticals, Inc.

 /s/ Gregory J. Flesher

By:

Gregory J. Flesher

Title:

President and Chief Executive Officer
2022-05-04 - UPLOAD - OnKure Therapeutics, Inc.
United States securities and exchange commission logo
May 4, 2022
Gregory Flesher
President and Chief Executive Officer
Reneo Pharmaceuticals, Inc.
18575 Jamboree Road, Suite 275-S
Irvine, California 92612
Re:Reneo Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed May 2, 2022
File No. 333-264616
Dear Mr. Flesher:
            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 Michael Davis at 202-551-4385 or Suzanne Hayes at 202-551-3675 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Jason Kent
2021-04-06 - CORRESP - OnKure Therapeutics, Inc.
CORRESP
1
filename1.htm

CORRESP

 RENEO PHARMACEUTICALS, INC.

12230 El Camino Real, Suite 230

San Diego, California 92130

 April 6, 2021

 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

Attn:
 Tracey Houser

Kevin Kuhar

Kasey Robinson

Suzanne Hayes

Re:
 Reneo Pharmaceuticals, Inc.

Registration Statement on Form S-1, as amended (File
No. 333-254534)

 Request for Acceleration of Effective Date

Ladies and Gentlemen:

Pursuant to Rule 461 under the Securities Act of 1933, as amended, Reneo Pharmaceuticals, Inc. (the “Company”)
hereby requests that the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the above-referenced Registration Statement on Form S-1 (as amended, the
“Registration Statement”) and declare the Registration Statement effective as of 4:00 p.m. Eastern time, on April 8, 2021, or as soon thereafter as possible, or at such other time as the Company or its counsel may request by
telephone to the staff of the Commission. The Company hereby authorizes each of Jason Kent and Kristin VanderPas of Cooley LLP, counsel to the Company, to make such a request on its behalf. This request for acceleration is subject, however, to your
receiving a telephone call prior to such time from Cooley LLP confirming this request.

 Once the Registration Statement
has been declared effective, please orally confirm that event with Jason Kent of Cooley LLP at (858) 550-6044, or in his absence, Kristin VanderPas of Cooley LLP at (415)
693-2097.

 Under separate cover, you will receive today a letter from the managing
underwriters of the proposed offering joining in the Company’s request for acceleration of the effectiveness of the Registration Statement.

[Signature page follows]

 Very truly yours,

 Reneo Pharmaceuticals, Inc.

 /s/ Gregory J. Flesher

 By:

 Gregory J. Flesher

 Title:

 President and Chief Executive Officer

 [Signature Page to Acceleration Request]
2021-04-06 - CORRESP - OnKure Therapeutics, Inc.
CORRESP
1
filename1.htm

CORRESP

 April 6, 2021

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

Attn:

Tracey Houser

Kevin Kuhar

Kasey Robinson

Suzanne Hayes

Re:

Reneo Pharmaceuticals, Inc.

Registration Statement on Form S-1, as amended

File No. 333-254534

Acceleration Request

Requested Date: Thursday, April 8, 2021

Requested Time: 4:00 P.M. Eastern Time

 Ladies and Gentlemen:

 In
accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as representatives of the several underwriters of Reneo Pharmaceuticals, Inc.’s (the “Company”) proposed offering of
common stock, hereby join in the request of the Company for acceleration of the effective time of the above-referenced Registration Statement, requesting effectiveness as of 4:00 P.M., Eastern Time, on April 8, 2021, or at such later time as
the Company or its outside counsel, Cooley LLP, may request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission.

Pursuant to Rule 460 under the Act, we, as representatives of the several underwriters, wish to advise you that approximately 1,050 copies of the preliminary
prospectus included in the above-named Registration Statement, as amended, were distributed during the period from April 5, 2021 through the date hereof, to prospective underwriters, institutions, dealers and others.

We, the undersigned, as representatives of the several underwriters, have complied and will comply, and we have been informed by the participating
underwriters that they have complied and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.

[Signature Page Follows]

Very truly yours,

JEFFERIES LLC

SVB LEERINK LLC

PIPER SANDLER & CO.

As representatives of the underwriters

Jefferies LLC

By:

 /s/ Michael Brinkman

Authorized Signatory

SVB Leerink LLC

By:

 /s/ Murphy Gallagher

Authorized Signatory

Piper Sandler & Co.

By:

 /s/ Neil Riley

Authorized Signatory

 [Signature Page to Underwriters’ Acceleration Request]
2021-03-19 - CORRESP - OnKure Therapeutics, Inc.
Read Filing Source Filing Referenced dates: March 12, 2021
CORRESP
1
filename1.htm

CORRESP

 Jason Kent

 +1 (858) 550-6044

 jkent@cooley.com

Via EDGAR and Courier

 March 19, 2021

 U.S. Securities
and Exchange Commission

 Division of Corporation Finance

Office of Life Sciences

 100 F Street, N.E.

Washington, D.C. 20549

 Attn: Tracey Houser

Kevin Kuhar

 Kasey Robinson

Suzanne Hayes

 Re: Reneo Pharmaceuticals,
Inc.

 Draft Registration Statement on Form S-1

Submitted February 12, 2021

CIK No. 0001637715

 Ladies and
Gentlemen:

 On behalf of Reneo Pharmaceuticals, Inc. (the “Company”), we submit this letter in response to comments received from
the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) by letter dated March 12, 2021 (the “Comment Letter”) with respect to the
Company’s draft Registration Statement on Form S-1 confidentially submitted to the Commission on February 12, 2021. Concurrently with the submission of this response letter, the Company is filing an
amended version of its Registration Statement on Form S-1 (the “Registration Statement”) with the Commission. In addition to addressing the comments raised by the Staff in the Comment
Letter, the Company has included other revisions and updates to its disclosure in the Registration Statement.

 For the convenience of the Staff, the
numbering of the paragraphs below corresponds to the numbering of the comment in the Comment Letter, the text of which we have incorporated into this response letter for convenience in italicized type and which is followed by the Company’s
response. Page references in the text of this response letter correspond to the page numbers of the Registration Statement.

 Prospectus Summary, page 1

1.
 We note references to early clinical data and preliminary results that treatment with REN001 produced
outcomes that are “substantially more than what would be expected in patients receiving a placebo,” “consistent with the potential of REN001 to provide what is considered meaningful clinical improvement” and similar statements
indicating findings of efficacy. Please revise to remove any statements that suggest the efficacy of your product candidate, as these determinations are the exclusive authority of the FDA or other regulators. Also, please limit the prospectus
summary discussion of trial results to an objective description of the endpoints of your trials and whether they were met. For example, rather than stating that treatment with REN001 “improved exercise performance and increased oxygen
consumption and stamina, as well as improved patient reported symptoms,” present your trial observations without concluding that REN001 caused the observations. To the extent your involved participants
received a placebo, you may contrast the objective results with the objective results of participants receiving a placebo. If your trial did not involve any participants receiving a placebo, it is not appropriate to compare the
results to your expectations of what the results you would expect from participants receiving a placebo. Similarly revise the disclosure throughout your filing.

Cooley LLP    101 California Street, 5th Floor    San Francisco, CA    94111-5800

 t: (415) 693-2000 f: (415) 693-2222 cooley.com

 U.S. Securities and Exchange Commission

March 19, 2021

 Page Two

 Response: In response to the Staff’s comment, the Company has revised the
disclosure on pages 1, 3, 85, 97 and 98 to remove statements that present a conclusion regarding the efficacy of its product candidates and to limit the discussion of clinical trial results to an objective description of the clinical trial
endpoints and whether they were met.

2.
 Please revise the last item in your pipeline table to identify the indication or tell us why you believe
this item is sufficiently material to warrant inclusion in the table despite not having identified an indication. The lack of information and the indication that you will select your next program in 2022 or later appears to
indicate that this is not currently material and does not warrant disclosure in the summary.

 Response: In
response to the Staff’s comment, the Company has revised the pipeline table on pages 2 and 97 of the Registration Statement to remove the previously included last item.

Our Strategy, page 3

3.
 Please revise to delete your intention to “rapidly” develop and “successfully”
commercialize REN001. Given the length of time it takes to conduct clinical trials and the frequency with which clinical trials fail to meet trial endpoints, any indications that you will be able to perform them rapidly appears
inappropriate.

 Response: In response to the Staff’s comment, the Company has revised the disclosure on
pages 3, 4, 99 and 100 of the Registration Statement.

 Use of Proceeds, page 75

4.
 Please revise your disclosure to separately disclose the amount of proceeds to be
allocated to fund the research and development of REN001 in LC-FAOD and McArdle disease, respectively.

Response: In response to the Staff’s comment, the Company has revised the disclosure on page 76 of the Registration Statement.

 Dilution, page 79

5.
 Please include a table comparing the public contribution under the proposed public offering and the
effective cash cost to officers, directors, promoters and affiliated persons of common equity acquired by them in transactions since inception. Include columns for the number and percent of shares purchased; amount and percent of
total consideration; and the average price per share for existing shareholders versus new investors. Refer to Item 506 of Regulation S-K.

 Cooley LLP 101 California
Street, 5th Floor San Francisco, CA 94111-5800

 t: (415) 693-2000 f: (415) 693-2222 cooley.com

 U.S. Securities and Exchange Commission

March 19, 2021

 Page Three

 Response: In response to the Staff’s comment, the Company has revised the
disclosure on page 81 of the Registration Statement to include the requested table which provides for comparison of the public contribution under the proposed public offering and the effective cash cost to officers, directors, promoters and
affiliated persons of common equity acquired by them in transactions since inception.

 Business

Phase 1b Clinical Results in PMM, page 101

6.
 Please revise your disclosure with respect to the Phase 1b clinical trial results discussed in this section
to disclose whether the studies were powered to show statistical significance.

 Response:
The Company respectfully advises the Staff that the REN001 Phase 1b clinical trials in PMM, LC-FAOD, and McArdle disease are open-label studies and do not include a comparator (placebo group). Open-label
studies have no comparator group to calculate statistical significance against, and therefore the concept of powering to show statistical significance is not applicable. The Company has revised the disclosure on page 105 of the Registration
Statement to clarify that the Phase 1 clinical trials are open-label.

 Preclinical Results and Plans, page 108

7.
 We note your disclosure that current FDA guidance requires sponsor companies developing
PPAR agonists to complete carcinogenicity studies prior to conducting clinical studies longer than 6-months in duration, and that you are currently conducting the required two-year carcinogenicity studies with REN001. Please expand your disclosure to explain what these studies entail and revise your development plan disclosure on pages 105-106 to discuss your plans as they relate to these studies.

Response: In response to the Staff’s comment, the Company has revised the disclosure on page 114 of the Registration Statement
to explain what the Company’s carcinogenicity studies with REN001 entail. The Company further advises the Staff the design of its clinical trials limits dosing to patients within the United States to
6-months in duration in conformity with the FDA’s guidance. In addition, the Company has revised the disclosure on page 114 of the Registration Statement to discuss the Company’s plans as they
relate to these carcinogenicity studies with REN001 and has included a cross reference to such disclosure in the section titled “Clinical development plans in PMM” on page 109 of the Registration Statement.

License Agreement with vTv Therapeutics LLC, page 111

8.
 We note your disclosure that your royalty obligations under the vTv License Agreement
will continue until the latest of (i) expiration of the licensed patents covering a licensed product in a country, (ii) expiration of regulatory exclusivity rights for a licensed product in a
country and (iii) a specified number of years after the first commercial sale of a licensed product in a country. Please revise to clarify when the patents and regulatory exclusivity rights underlying such
royalty terms are expected to expire and disclose the “specified number of years” after the first commercial sale of a licensed product. In addition, please revise to disclose the “certain development stage”
that triggers different termination provisions.

 Cooley LLP 101 California
Street, 5th Floor San Francisco, CA 94111-5800

 t: (415) 693-2000 f: (415) 693-2222 cooley.com

 U.S. Securities and Exchange Commission

March 19, 2021

 Page Four

 Response: In response to the Staff’s comment, the Company has revised the
disclosure on page 115 of the Registration Statement.

 Intellectual Property, page 112

9.
 We note your disclosure that, in addition to patent protection around REN001, you
also have licensed from vTv Therapeutics three issued patents in the United States and 20 issued patents in foreign countries related to other PPAR agonists. Please disclose the expected expiration dates of
these issued patents.

 Response: In response to the Staff’s comment, the Company has revised the
disclosure on pages 116 and 117 of the Registration Statement to provide the expected expiration dates for the issued patents related to other PPAR agonists.

Description of Capital Stock

 Choice of Forum, page
163

10.
 Please ensure that the exclusive forum provision in your amended and restated certificate
of incorporation and amended and restated bylaws to be in effect upon the closing of this offering clearly states that this provision does not apply to actions arising under the 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 Exchange Act.

Response: The Company respectfully advises the Staff that the exclusive forum provision in its amended and restated certificate of
incorporation and amended and restated bylaws to be in effect upon the closing of this offering and which are filed as exhibits to the Registration Statement clearly state that the exclusive forum provision does not apply to actions arising under
the Exchange Act.

 Subsequent Events, page F-21

11.
 Please expand your disclosure for the January 2021 stock options grant to include the total amount of
compensation expense associated with the grant and the period over which the expense will be recognized.

Response: In response to the Staff’s comment, the Company has revised the disclosure on page F-22 of the Registration Statement.

 General

12.
 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.

 Response: The Company is providing to the Staff, on a supplemental basis, copies of the written communications,
as defined in Rule 405 under the Securities Act of 1933, as amended (the “Securities Act”), that have been used in meetings with potential investors in reliance on Section 5(d) of the Securities Act. These materials were
only made available for viewing by potential investors during the Company’s presentations, and no copies were retained by any potential investor. Pursuant to Rule 418 under the Securities Act, the copies supplementally provided shall not be
deemed to be filed with, or a part of, or included in, the Registration Statement.

 Cooley LLP 101 California
Street, 5th Floor San Francisco, CA 94111-5800

 t: (415) 693-2000 f: (415) 693-2222 cooley.com

 U.S. Securities and Exchange Commission

March 19, 2021

 Page Five

 To the extent the Company conducts additional meetings, it expects to use the same or similar
materials, and the Company undertakes to provide the Staff with copies of any additional written communications that are presented to potential investors in the future by it or anyone authorized to do so on its behalf in reliance on
Section 5(d) of the Securities Act, whether or not such potential investors retain copies of such communications.

 Cooley LLP 101 California
Street, 5th Floor San Francisco, CA 94111-5800

 t: (415) 693-2000 f: (415) 693-2222 cooley.com

 U.S. Securities and Exchange Commission

March 19, 2021

 Page Six

 Please contact me at (858) 550-6044 or Kristin
VanderPas at (415) 693-2097 with any questions or further comments regarding the Company’s response to the Staff’s comments.

Sincerely,

 /s/ Jason Kent

Jason Kent

Cooley LLP

cc:
 Gregory Flesher, Reneo Pharmaceuticals, Inc.

Wendy Johnson, Reneo Pharmaceuticals, Inc.

Kristin VanderPas, Cooley LLP

Brian J. Cuneo, Latham & Watkins LLP

Matthew T. Bush, Latham & Watkins LLP

 Cooley LLP 101 California
Street, 5th Floor San Francisco, CA 94111-5800

 t: (415) 693-2000 f: (415) 693-2222 cooley.com
2021-03-12 - UPLOAD - OnKure Therapeutics, Inc.
United States securities and exchange commission logo
March 12, 2021
Gregory Flesher
President and Chief Executive Officer
Reneo Pharmaceuticals, Inc.
12230 El Camino Real, Suite 230
San Diego, California 92130
Re:Reneo Pharmaceuticals, Inc.
Draft Registration Statement on Form S-1
Submitted February 12, 2021
CIK No. 0001637715
Dear Mr. Flesher:
            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
Prospectus Summary, page 1
1.We note references to early clinical data and preliminary results that treatment with
REN001 produced outcomes that are "substantially more than what would be expected in
patients receiving a placebo," "consistent with the potential of REN001 to provide what is
considered meaningful clinical improvement" and similar statements indicating findings
of efficacy.  Please revise to remove any statements that suggest the efficacy of your
product candidate, as these determinations are the exclusive authority of the FDA or other
regulators.  Also, please limit the prospectus summary discussion of trial results to an
objective description of the endpoints of your trials and whether they were met.  For
example, rather than stating that treatment with REN001 "improved exercise performance

 FirstName LastNameGregory Flesher
 Comapany NameReneo Pharmaceuticals, Inc.
 March 12, 2021 Page 2
 FirstName LastNameGregory Flesher
Reneo Pharmaceuticals, Inc.
March 12, 2021
Page 2
and increased oxygen consumption and stamina, as well as improved patient reported
symptoms," present your trial observations without concluding that REN001 caused the
observations.  To the extent your involved participants received a placebo, you may
contrast the objective results with the objective results of participants receiving a placebo.
If your trial did not involve any participants receiving a placebo, it is not appropriate to
compare the results to your expectations of what the results you would expect from
participants receiving a placebo.  Similarly revise the disclosure throughout your filing.
2.Please revise the last item in your pipeline table to identify the indication or tell us why
you believe this item is sufficiently material to warrant inclusion in the table despite not
having identified an indication.  The lack of information and the indication that you will
select your next program in 2022 or later appears to indicate that this is not currently
material and does not warrant disclosure in the summary.
Our Strategy, page 3
3.Please revise to delete your intention to "rapidly" develop and "successfully"
commercialize REN001.  Given the length of time it takes to conduct clinical trials and
the frequency with which clinical trials fail to meet trial endpoints, any indications that
you will be able to perform them rapidly appears inappropriate.
Use of Proceeds, page 75
4.Please revise your disclosure to separately disclose the amount of proceeds to be
allocated to fund the research and development of REN001 in LC-FAOD and McArdle
disease, respectively.
Dilution, page 79
5.Please include a table comparing the public contribution under the proposed public
offering and the effective cash cost to officers, directors, promoters and affiliated persons
of common equity acquired by them in transactions since inception.  Include columns for
the number and percent of shares purchased; amount and percent of total consideration;
and the average price per share for existing shareholders versus new investors.  Refer to
Item 506 of Regulation S-K.
Business
Phase 1b Clinical Results in PMM, page 101
6.Please revise your disclosure with respect to the Phase 1b clinical trial results discussed in
this section to disclose whether the studies were powered to show statistical significance.
Preclinical Results and Plans, page 108
7.We note your disclosure that current FDA guidance requires sponsor companies
developing PPAR agonists to complete carcinogenicity studies prior to conducting clinical
studies longer than 6-months in duration, and that you are currently conducting the

 FirstName LastNameGregory Flesher
 Comapany NameReneo Pharmaceuticals, Inc.
 March 12, 2021 Page 3
 FirstName LastNameGregory Flesher
Reneo Pharmaceuticals, Inc.
March 12, 2021
Page 3
required two-year carcinogenicity studies with REN001.  Please expand your disclosure to
explain what these studies entail and revise your development plan disclosure on pages
105-106 to discuss your plans as they relate to these studies.
License Agreement with vTv Therapeutics LLC, page 111
8.We note your disclosure that your royalty obligations under the vTv License Agreement
will continue until the latest of (i) expiration of the licensed patents covering a licensed
product in a country, (ii) expiration of regulatory exclusivity rights for a licensed product
in a country and (iii) a specified number of years after the first commercial sale of a
licensed product in a country.  Please revise to clarify when the patents and regulatory
exclusivity rights underlying such royalty terms are expected to expire and disclose the
"specified number of years" after the first commercial sale of a licensed product.  In
addition, please revise to disclose the "certain development stage" that triggers different
termination provisions.
Intellectual Property, page 112
9.We note your disclosure that, in addition to patent protection around REN001, you
also have licensed from vTv Therapeutics three issued patents in the United States and 20
issued patents in foreign countries related to other PPAR agonists.  Please disclose the
expected expiration dates of these issued patents.
Description of Capital Stock
Choice of Forum, page 163
10.Please ensure that the exclusive forum provision in your amended and restated certificate
of incorporation and amended and restated bylaws to be in effect upon the closing of
this offering clearly states that this provision does not apply to actions arising under the
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 Exchange Act.
12. Subsequent Events, page F-21
11.Please expand your disclosure for the January 2021 stock options grant to include the total
amount of compensation expense associated with the grant and the period over which the
expense will be recognized.
General
12.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.

 FirstName LastNameGregory Flesher
 Comapany NameReneo Pharmaceuticals, Inc.
 March 12, 2021 Page 4
 FirstName LastName
Gregory Flesher
Reneo Pharmaceuticals, Inc.
March 12, 2021
Page 4
            You may contact Tracey Houser at 202-551-3736 or Kevin Kuhar at 202-551-3662 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:       Jason Kent

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