View:
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
Gregory Flesher
FirstName LastNameGregory
Reneo Pharmaceuticals, Inc. Flesher
Comapany
March NameReneo Pharmaceuticals, Inc.
12, 2021
March2 12, 2021 Page 2
Page
FirstName LastName
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
Gregory Flesher
FirstName LastNameGregory
Reneo Pharmaceuticals, Inc. Flesher
Comapany
March NameReneo Pharmaceuticals, Inc.
12, 2021
March3 12, 2021 Page 3
Page
FirstName LastName
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.
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,
FirstName LastNameGregory Flesher
Division of Corporation
Finance
Comapany NameReneo Pharmaceuticals, Inc.
Office of Life Sciences
March 12, 2021 Page 4
cc: Jason Kent
FirstName LastName