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United States securities and exchange commission logo
May 16, 2023
Iain Brown
Chief Financial Officer
Mural Oncology Ltd
10 Earlsfort Terrace
Dublin 2, D02 T380, Ireland
Re: Mural Oncology Ltd
Draft Registration
Statement on Form 10
Submitted April 14,
2023
CIK No. 0001971543
Dear Iain Brown:
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 10 as Confidentially Submitted on
April 14, 2023
Cover Page
1. We note that you intend
to apply for listing of Mural's ordinary shares on the Nasdaq
Global Market in
connection with the distribution. Please revise the cover page and the
Q&A as follows, and
make conforming revisions throughout the Information Statement
where appropriate:
State, if true,
that no assurance can be given that your listing application will be
approved.
State whether the
distribution is contingent upon final approval of your NASDAQ
listing.
Revise to clarify,
if true, that the condition to obtain Nasdaq listing approval prior to
Iain Brown
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the distribution may be waived by Alkermes in its sole discretion
as you have on page
165.
Questions and Answers About the Separation and Distribution, page 3
2. Please tell us when you expect to determine the distribution ratio.
Please explain why you
indicate that the distribution will be pro rata despite your plan to
aggregate fractional
shares into whole shares, sell the whole shares into the open market
and distribute the
aggregate proceeds.
Information Statement Summary, page 11
3. We note that your auditors have issued a going concern opinion
regarding your
operations. Please revise your disclosure throughout the Information
Statement as
follows:
Expand and balance your Summary disclosure by including discussion
regarding
Mural's recurring operating losses, the expectation of continuing
operating losses for
the foreseeable future, the need to raise additional capital to
finance your future
operations, your agreements and obligations under the Tax Matters
Agreement with
Alkermes which may limit your ability to issue ordinary shares to
raise capital during
the four-year period beginning two years before and ending two
years after the
distribution, your reliance on an initial cash contribution from
Alkermes for funding
following the separation until you are able to access capital
markets and other sources
of capital, and the auditor's going concern opinion.
Disclose in both the Summary Risk Factors and Risk Factors that
your ability to
continue as a going concern is contingent upon the receipt of
funding from Alkermes
through the date of separation that will be contributed to Mural
immediately prior to
or in connection with the separation to cover Mural s capital
needs following the
separation until it is able to access capital markets and other
sources of capital, as you
have on page 97. Additionally, explain how this reliance on an
initial contribution
from Alkeremes relates to the Tax Matters Agreement, which you
state may limit
Mural's ability to access capital on page 72. Disclose that if
you cannot continue as a
viable entity, your stockholders may lose some or all of their
investment in your
company.
4. Please revise the description of your ongoing trials to identify the
trial phase in the text
and define the term "registrational studies" and explain why your
studies are "potentially"
registrational. Your discussion should clarify the factors that will
determine whether they
are registrational and who will make such determination.
Nemvaleukin Alfa, page 12
5. Please revise pages 13 and 104 to briefly describe the significance of
having obtained
Orphan Drug Designation for nemvaleukin for the treatment of muscosal
melanoma and
Fast Track Designation for nemvaleukin for treatment of muscosal
melanoma and to
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nemvaleukin in combination with pembrolizumab for the treatment of
PROC.
Additionally, explicitly state that fast track designation does not
guarantee an accelerated
review by the FDA. Provide similar disclosure on page 121 with respect
to the
accelerated approval pathway.
6. We note that your disclosures throughout this section, and a similar
section on page 104,
reference terms such as "durable and deepening responses," "complete
responses," "partial
responses," "confirmed" responses, "disease control rate," "overall
response rate," and
"stable disease." Please revise your discussion to describe the
results of your clinical trials
using objective terminology based on the clinical trial end points.
7. With reference to the following non-exhaustive list of illustrative
examples, please
remove these and all other statements throughout the Information
Statement that state or
imply that your product candidates are safe or effective, as these
determinations are solely
within the authority of the U.S. Food and Drug Administration and
comparable regulatory
bodies:
"Our data has shown anti-tumor activity with nemvaleukin as a
monotherapy in
cancers for which high dose rhIL had proven efficacy, such as
melanoma and renal
cell carcinoma." (page 12);
Your statement of belief that features of nemvaleukin "may widen
its potential
therapeutic window compared to that of high-dose rhIL02, in terms
of both safety and
efficacy" (page 111);
References to your belief that nemvaleukin's molecular design may
provide benefits
over other IL-2 treatment options that may confer "enhanced
efficacy" (table on page
112);
Reference to the "initial efficacy signals" observed with
nemvaleukin in combination
with pembrolizumab in patients with PROC in the ARTISTRY-1
study (page 121).
You should include a discussion of your clinical trials that includes
a description of the
trials, the number of participants, the trial endpoints, serious
advers events, and whether
the results were statistically significant, including p values.
Risk Factors , page 21
8. We note your discussion of the conditions to the distribution on page
165. Given that the
Nasdaq listing condition pertaining to Mural's ordinary shares appears
to be waivable,
please include a risk factor reflecting that that this condition may
be waived. Describe the
consequences of not securing Nasdaq listing approval prior to the
distribution.
9. With reference to your disclsoure on page 184, please describe in an
appropriate risk
factor the risks related to:
Your quorum requirements; and
The allowable methods for which polls are to be taken at corporate
meetings and the
manner in which the votes are to be counted, including any
material distinctions
between such methods.
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We are conducting, and intend in the future to conduct, clinical trials for
certain of our product
candidates..., page 29
10. We note your disclosure that you are conducting, and may continue to
conduct, clinical
trials outside the U.S. Please expand this risk factor disclosure to
state the location(s) of
current and planned trial sites located outside the U.S.
Side effects, serious adverse events, or other undesirable properties could
arise from the use of
our product candidates..., page 30
11. Please revise to describe all serious adverse events that occurred in
your clinical trials and
quantify the number of occurrences.
If we are a passive foreign investment company, there could be material adverse
U.S federal
income tax consequences..., page 72
12. Please clarify whether the financial statements for the year ended
December 31, 2022
would result in you being considered a PFIC.
Irish law differs from the laws in effect in the U.S. and might afford less
protection..., page 79
13. We note that your Articles of Association will provide that the Irish
courts have exclusive
jurisdiction to determine the outcome of certain litigation, including
derivative actions
Please disclose in your Risk Factors and Description of Share
Capital section whether
this provision applies to actions arising under the Exchange Act
and the Securities
Act. If so, please address the 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. If the provision does not apply to actions arising
under the Exchange Act
and the Securities Act, please also ensure that the disclosure in
your Risk Factors and
Description of Share Capital sections and the exclusive forum
provision in your
Articles of Association state this clearly, or confirm that you
will inform investors in
future filings that the provision does not apply to any actions
arising under the
Securities Act or Exchange Act.
Additionally, please expand this risk factor to highlight the
material impact and risks
to shareholders related to this exclusive forum provision. Such
risks may include,
but are not limited to, increased costs to bring a claim and that
these provisions can
discourage claims or limit investors ability to bring a claim
in a judicial forum that
they find favorable.
Unaudited Pro Forma Combined Financial Statements, page 87
14. On page 85, you state that immediately following the separation and
distribution, Mural's
unconsolidated balance sheet will show shareholders' equity comprised
of share capital
and share premium equal to the "aggregate value of the oncology
business at the time of
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transfer to Mural less the share capital." Please explain how this
aggregate value of the
oncology business will be determined. In addition, explain how you
plan to present
Mural's shareholders' equity following the distribution and related
internal restructuring
transactions in your pro forma presentation. Refer us to the technical
guidance upon which
you intend to rely and revise your pro forma presentation accordingly.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations
Research and Development Expenses, page 93
15. We note your disclosure on page 109 that nemvaleukin is being
developed across multiple
indications and on page 113 that you have several ongoing clinical
studies of nemvaleukin
including ARTISTRY-1, ARTISTRY-2, ARTISTRY-3, ARTISTRY-6, ARTISTRY-7.
Please break out the external research and development expense line
item for nemvaleukin
by indication or by study. If you do not track this information,
please disclose this fact. In
addition, you disclose that other external R&D expense increased
primarily due to
increased spend on the IL-12 and IL-18 early-stage oncology
development programs.
Please break out external R&D expense separately for these programs or
disclose that you
do not track this information.
Business, page 103
16. Many of your graphics throughout the Business section include text
within the graphic and
in footnotes that are too small to be legible. Please revise your
graphics to ensure that all
text is legible.
17. With respect to all completed clinical trials discussed in this
section, please revise your
disclosure to provide results within proper context. Please disclose
the primary and any
secondary endpoints, the number of trial participants, the results
observed relative to the
endpoints, any serious adverse events and whether statistical
significance was
demonstrated, including supporting p-values. If no statistical
analysis was performed,
please state as such. Remove all statements indicating that the trial
demonstrated anti-
tumor activity or proven efficacy.
Our Strategy, page 105
18. Please remove your statement that nemvaleukin is "a potentially
first-in-class" IL-2
variant. Such term suggests that your lead product candidate is
effective and likely to be
an approved therapeutic for oncology. You may discuss how your
candidate differs from
that used by competitors.
Our Strategy, page 105
19. Based on your disclsoure on pages 39 and 116, it appears that you may
be pursing
accelerated development pathways from foreign regulatory agencies,
such as the United
Kingdom's Innovative Licensing and Access Pathway ( ILAP ), which
you state
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has granted an Innovation Passport designation for nemvaleukin for the
treatment of
mucosal melanoma. If material, please expand this section to provide
context for these
references and briefly explain your development strategy for
nemvaleukin in the UK.
Nemvaleukin Program , page 110
20. With respect to your description of cell expansion analyses from your
ARTISTRY-1
clinical trial, you indicate in the narrative and graphic on page 112
that nemvaleukin
showed similar or greater levels of cancer fighting cell expansion
than observed
historically with high-dose rhIL-2, with lower levels of Treg
expansion. Please remove all
statements indicating that treatment candidates that are not FDA
approved are as effective
or superior to approved immunotherapies. You may present objective
result of clinical
trials but such results should not be compared to alternative
treatment products unless
head-to-head studies were conducted.
ARTISTRY-1, page 113
21. Please explain the term clinically meaningful as used to
describe responses observed
with nemvaleukin monotherapy in patients with RCC and melanoma in the
ARTISTRY-1
trial. Similarly, explain the reference on page 118 to "clinically
meaningful disease
control" observed when nemvaleukin was used as both monotherapy and in
combination
with pembrolizumab.
IV Nemvaleukin Monotherapy Response Summary in Melanoma (Part B), page 116
22. Please revise to ensure that each acronym used in the first column of
this table is defined.
In this regard, we note that it is not evident from your preceding
disclsoure what "PD"
or "ORR" refers to.
Safety Observations, page 119
23. Please revise to clarify that Grade 4 TRAE are serious adverse events
and confirm that
you have disclosed all serious adverse events and quantified the
number of incidents, as
opposed to the majority or most frequent categories.
ARTISTRY-7, page 121
24. We note your disclosure that your ongoing Phase 3 clinical trial of IV
nemvaleukin in
combination with pembrolizumab is being conducted in collaboration
with various
partners, including Gynecologic Oncology Group, European Network of
Gynecological
Trial groups and MSD. Please describe the material terms of the
collaboration
agreements. File the agreements as exhibits or tell us why you believe
you are not
required to file it in accordance with Item 601(b)(10) of Regulation
S-K.
Intellectual Property , page 131
25. We note your disclosure that Mural and Alkermes may enter into an
intellectual property
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Mural Oncology Ltd
May 16, 2023
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license agreement prior to or concurrently with the completion of the
separation. In
relation to the intellectual property described, please clarify whether
the patents and patent
applications will be owned by Mural or licensed to mural by Alkermes or a
third party.
Certain Relationships and Related Person Transactions, page 156
26. Please file the "Form of" Separation Agreement, Tax Matters Agreement,
Employee
Matters Agreement, and Intellectual Property License Agreement with your
next
amendment. We may have additional comments once we have had an
opportunity to
review these agreements.
Material U.S. Federal Income Tax Consequences of the Distribution, page 168
27. We note your disclosure that the distribution is intended to be generally
tax-free for U.S.
federal income tax and Irish tax purposes to Alkermes shareholders. We
also note that
the disclosed tax consequences in this section assume that the
Distribution, together with
certain related transactions, so qualifies. Please revise the disclosure
in this section, and
elsewhere as appropriate, to remove language stating that "generally"
certain tax
consequences will apply and express a firm opinion for each material tax
consequence. If
there is uncertainty regarding the tax treatment of the transaction,
counsel may issue a
should or more likely than not opinion to make clear that the
opinion is subject to a
degree of uncertainty and explain why it cannot give a firm opinion.
Voting, page 184
28. We note your disclosure that your Constitution provides that the board of
directors or the
chairman "may determine the manner in which the poll is to be taken at
each meeting and
the manner in which the votes are to be counted." Please expand this
disclosure to
describe the allowable methods for taking a poll and for counting votes,
and describe any
material distinctions between such methods. File your Constitution as an
exhibit.
You may contact Franklin Wyman at 202-551-3660 or Vanessa Robertson at
202-551-
3649 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
May 16, 2023 Page 7
cc: Robert E. Puopolo
FirstName LastName