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United States securities and exchange commission logo
June 30, 2023
Iain Brown
Chief Financial Officer
Mural Oncology Ltd
10 Earlsfort Terrace
Dublin 2, D02 T380, Ireland
Re: Mural Oncology Ltd
Amendment No. 1 to
Draft Registration
Statement on Form 10
Submitted June 16,
2023
CIK No. 0001971543
Dear Iain Brown:
We have reviewed your amended draft registration statement and
have the following
comments. In some of our comments, we may ask you to provide us with
information so we
may better understand your disclosure.
Please respond to this letter by providing the requested
information and either submitting
an amended draft registration statement or publicly filing your
registration statement on
EDGAR. If you do not believe our comments apply to your facts and
circumstances or do not
believe an amendment is appropriate, please tell us why in your
response.
After reviewing the information you provide in response to these
comments and your
amended draft registration statement or filed registration statement, we
may have additional
comments.
Amendment No. 1 to Registration Statement on Form 10 as Confidentially
Submitted on June
16, 2023
Information Statement Summary, page 11
1. We note your response
to prior comment 3, which we reissue in part. Please revise the
Summary to provide to
disclose your reliance on the initial cash contribution from
Alkermes.
Nemvaleukin Alfa, page 12
2. We note your response
to prior comment 6, which we reissue in part. Please revise to
eliminate the use of
terms implying efficacy to describe your trial results. Determinations
Iain Brown
FirstName LastNameIain Brown
Mural Oncology Ltd
Comapany
June NameMural Oncology Ltd
30, 2023
June 30,
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FirstName LastName
of efficacy are within the sole authority of the FDA or equivalent
foreign regulator. Define
terms such as "complete response," "partial response rate" and "stable
disease" the first
time they are used, so it is clear that the terms are based on
objective criteria and are not
determinations of efficacy. Explain how the overall response rate and
disease control rate
are calculated.
3. We note your response to comment 7.
With respect to your statements of "anti-tumor activity" revise
your statements to
describe the observations in objective terms without indicating a
cause and effect. It
is in the sole authority of the FDA to determine if your product
candidate is solely
responsible for the trial observations.
Explain the terms overall response rate, partial responses, and
disease control rate the
first time they are used.
Describe the Response Evaluation Criteria in Solid Tumors
guidelines version 1.1 the
first time it is referenced.
Irish law differs from the laws in effect in the U.S. and might afford less
protection..., page 80
4. We note your response to prior comment 13, which we reissue in part.
You state on page
80 that your Constitution will provide that the federal district
courts of the United States
shall be the sole and exclusive forum for resolving any disputes
arising under the
Securities Act and the Exchange Act. As such, please revise your
disclosure as follows:
On both page 80 and in the Description of Mural's Share Capital
section, describe
your exclusive forum provision and the carve out for actions
arising under the
Exchange Act and Securities Act. State that there is uncertainty
as to whether a court
would enforce such provision, and state that shareholders will
not be deemed to have
waived the company s compliance with federal securities laws
and the rules and
regulations thereunder. In this regard, we note that Section 22
of the Securities Act
creates concurrent jurisdiction for federal and state courts over
all suits brought to
enforce any duty or liability created by the Securities Act or
the rules and regulations
thereunder.
Further revise your risk factor on page 80 to explain that your
exclusive forum
provision may result in increased costs to bring a claim and/or
limit investors ability
to bring a claim in a judicial forum that they find favorable.
Dividend Policy
Creation of Distributable Reserves, page 86
5. We acknowledge the information provided in your response to prior
comment 14 but
continue to have difficulty in understanding how distributable
reserves will be created,
given Mural's negative net parent investment of $21.6 million at
December 31, 2022.
Please describe and quantify the expected capital structure of Mural,
following the
Separation and Distribution and then following subsequent approval of
the resolution
by the High Court of Ireland. Also, describe in greater detail the
sequence of events that
will be necessary to establish a distributable reserve and the
expected sources for funding
Iain Brown
FirstName LastNameIain Brown
Mural Oncology Ltd
Comapany
June NameMural Oncology Ltd
30, 2023
June 30,
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FirstName LastName
this reserve. In addition, provide the following information to
facilitate our understanding
of your discussion on page 86.
Explain the difference between the merger reserve and the
distributable reserves.
Describe the nature and expected timing for planned "internal
restructuring
transactions" to create sufficient capital to fund the
distributable reserves.
Quantify the expected "share premium" in the unconsolidated
balance sheet
immediately following the separation and distribution that you
state will equal the
"aggregate historical book value of the oncology business at the
time of its transfer to
Mural less the share capital."
Describe and quantify capital and other transactions that are
expected to create a
positive book value for the oncology business prior to the
separation and distribution
compared to the apparent negative book value for the oncology
business reported at
December 31, 2022.
Explain your statement that "the pre-distribution shareholder of
Mural is expected to
pass a resolution that would create distributable reserves
following the distribution by
converting to distributable reserves up to all of our share
premium." In this regard,
quantify the expected amount of "our share premium" to be
converted to distributable
reserves.
Business, page 105
6. We note your response to prior comment 16. However, many of your
graphics continue to
include text printed in type that is too small to read. For example:
Notes to the Artistry Development Program on page 115;
Part C and notes to Artistry-1 Trial Design and Dosing Regimen on
page 115;
Line items on the x and y axes in many of your tables; and
Notes to the Artistry-7 Trial Design Table and sections labeled
"Pembrolizumab
dosing" and "Nemvaleukin dosing" on page 124.
Please further review and revise the formatting in your graphics
throughout to use font
size that is clearly readable without the need for magnification.
Nemvaleukin Alfa, page 106
7. We note your response to comment 7, which indicates "Artistry-1 was
not designed to
generate comparisons, and as such, there are no p-values to disclose."
While we
understand that the trials are currently ongoing, and therefore you
have not been able to
perform any statistical analyses, please confirm that you will
disclose the results of any
statistical analyses, including the p-values. If your trials are not
designed to generate data
that is statistically significant, please provide further explanation.
Our Strategy, page 108
8. We note your response to prior comment 18, which we reissue. We
continue to object to
the reference to your belief that nemvaleukin, if approved by the FDA,
has the potential to
Iain Brown
FirstName LastNameIain Brown
Mural Oncology Ltd
Comapany
June NameMural Oncology Ltd
30, 2023
June 30,
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FirstName LastName
be a "first-in-class" IL-2 variant. This statement is speculative in
light of the current
regulatory status of your product candidates and the uncertainty
involved in clinical
development. Further, the use of such term may be read to imply that
your lead product
candidate is effective or likely to be approved, and such
determinations are solely within
the authority of the FDA and comparable regulatory bodies. Please
revise your disclousre
accordingly.
Establish an integrated development and commercial capability, page 109
9. We note your response to prior comment 19. You state on page 40 that
the "first step"
under the UK's ILAP is receipt of an "Innovation Passport" allowing
for enhanced
engagement with the MHRA and its partner agencies, and that you were
granted this
designation for nemvaleukin for the treatment of mucosal melanoma in
January 2023.
Please further revise this section to briefly explain any additional
material steps that you
will need to complete as you continue the application process of
designating nemvaleukin
under the ILAP.
Safety Observations, page 121
10. Please revise your disclosure to define the acronym "AESIs" on page
122.
11. Your letter states in response to prior comment 23 that Grade 4
treatment related adverse
events are not always considered serious adverse events. Please
identify for us any
classification system used by the Company with respect to grading of
adverse events and
explain the differences in severity grades.
ARTISTRY-7, page 123
12. Please revise your description of the Artisty-7 Phase 3 trial to
describe GOG 's and
ENGOG's roles in the trial. Additionally, clarify that MSD will
jointly own any clinical
data, inventions and patents resulting from the combined use of
nemvaleukin and
pembrolizaumab in the ARTISTRY-7 clinical trial.
Material U.S. Federal Income Tax Consequences of the Distribution, page 170
13. We note that the tax consequences described in this section continue
to assume that the
Distribution, together with certain related transactions, will qualify
as tax-free for U.S.
federal income tax purposes. If there is uncertainly regarding the tax
consequences,
please revise the disclosure in this section, and elsewhere as
appropriate, to clarify the
reason(s) for the uncertainty.
Voting, page 186
14. We note the revisions made in response to prior comments 9 and 28,
which we reissue in
part. Please further revise your disclsoure here, and as appropriate
in your risk factors, to
clarify the allowable methods for which votes may be taken at
corporate meetings and the
Iain Brown
Mural Oncology Ltd
June 30, 2023
Page 5
manner in which the votes may be counted, including any material
distinctions between
such methods.
Please revise your disclosure to briefly explain what a "poll" or
"poll voting" means.
Please reconcile your disclosures regarding poll voting. In this
regard, we note your
disclosure that your Constitution provides that "at any general
meeting all resolutions
put to the vote of the meeting shall be decided on a poll" is
seemingly at odds with
disclosure appearing to indicate that a poll vote must be "demanded."
Indicate who
may demand a poll under Irish law and/or your Constitution.
Disclose what manner of voting and vote counting may be used in the
absence of a
demand for a poll. If appropriate, include an explanation of any
impact on
shareholders procedural or substantive rights associated with a
demand, or lack
thereof, for poll voting.
General
15. We note your disclosure on page 156 that on June 1, 2023, you entered
into an
employment agreement with Dr. Caroline Loew. Please file the Loew
Employment
Agreement as an exhibit to the Information Statement.
You may contact Franklin Wyman at 202-551-3660 or Vanessa Robertson at
202-551-
3660 if you have questions regarding comments on the financial statements and
related
matters. Please contact Lauren Hamill at 303-844-1008 or Suzanne Hayes at
202-551-3675 with
any other questions.
Sincerely,
FirstName LastNameIain Brown
Division of
Corporation Finance
Comapany NameMural Oncology Ltd
Office of Life
Sciences
June 30, 2023 Page 5
cc: Robert E. Puopolo
FirstName LastName