SecProbe.io

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