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United States securities and exchange commission logo
May 17, 2021
Markus Warmuth
President and Chief Executive Officer
Monte Rosa Therapeutics, Inc.
645 Summer Street, Suite 102
Boston, MA 02210
Re: Monte Rosa
Therapeutics, Inc.
Draft Registration
Statement on Form S-1
Submitted April 19,
2021
CIK No. 0001826457
Dear Dr. Warmuth:
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 submitted April 19, 2021
Prospectus Summary
Overview, page 1
1. We note your disclosure
here and throughout your prospectus regarding your goal
of discovering and
developing "first-in-class" precision medicines. Please remove
references to
"first-in-class" as this statement implies an expectation of regulatory
approval and is
inappropriate given the length of time and uncertainty with respect to
securing marketing
approval. If your intention is to convey your belief that your platform
or your programs
utilize a novel technology or approach, you may discuss how your
technology differs from
technology used by competitors or that you are not aware of
competing products that
are further along in the development process. Statements such as
Markus Warmuth
FirstName
Monte RosaLastNameMarkus
Therapeutics, Inc.Warmuth
Comapany
May NameMonte Rosa Therapeutics, Inc.
17, 2021
May 17,
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FirstName LastName
these should be accompanied by cautionary language that the statements
are not
intended to give any indication that your technology or any potential
product candidates
have been proven effective or will receive regulatory approval.
2. We note your statement that you are focused on delivering therapies to
targets in "well-
validated biological pathways" and similar statements throughout the
registration
statement. As currently drafted, this statement could imply that the
FDA has approved, or
will more easily approve, your products. Although your drugs may
target
certain pathways that have been used by other drugs, we note that your
drug is still distinct
from prior drugs that have been approved by the FDA. While it is
appropriate to say that
you are using a similar pathway to help guide your development
program, please revise
your disclosure to remove any implication that your product candidates
are more likely to
receive FDA approval than others.
3. We note your statements that certain of your programs comprise a
series of potent,
selective and orally bioavailable MGD molecules that can
effectively address certain
targets "while possessing attractive pharmaceutical properties. We
note similar
statements on page 121 that oral administration of MRT-1577 "led to
potent antitumor
activity." As findings of safety or efficacy are solely within the
authority of the FDA or
similar foreign regulators, please revise your disclosure here and
throughout the
prospectus to remove any statements that suggest the efficacy or
safety of your potential
product candidates. Where you deem appropriate, you may present
objective data without
including your conclusions related to safety or efficacy.
Our Approach, page 2
4. Please define the term "non-heterobifunctional" when first used so
that an investor not
familiar with this term may understand its meaning.
Our Pipeline, page 3
5. Please revise your pipeline table as follows:
Include separate columns for each material stage you will need to
complete before
marketing your products. For instance, include separate columns
for each of Phase 1,
Phase 2 and Phase 3.
We note that your pipeline table includes three separate
pre-clinical phases, which
gives the impression that your product candidates are farther
along in the clinical
process. Please revise the table to eliminate the separate column
for lead
optimization, as this stage is not sufficiently distinct. In
addition, revise the length of
the arrows for each candidate to accurately show its progression
in relation to each
stage of development once the table has been revised.
It appears that you have included every in-house program in your
pipeline table.
Please explain to us why each program is sufficiently material to
your business to
warrant inclusion in your pipeline table or revise your table to
remove any program
that is not currently material.
Markus Warmuth
Monte Rosa Therapeutics, Inc.
May 17, 2021
Page 3
Risks Associated with Our Business, page 4
6. Please add a bullet highlighting that your patent portfolio is pending
and that you do not
own any issued patents or in-license any patents related to your QuEEN
platform and
GSPT1 program. We note your disclosure on page 47.
7. Please add a bullet highlighting the risks related to the
concentration of ownership of your
common stock, as discussed on page 71. Please include in this bullet
and in the
corresponding risk factor beginning on page 71 a discussion of the
number of your
executive officers and directors who are affiliated with your
principal stockholders.
Use of Proceeds, page 79
8. Refer to the first and third bullet points. Please revise to provide
an estimate of how far in
the clinical development process for your GSPT1 program and your
discovery programs
the allocated proceeds of the offering will enable you to reach. If
any material amounts of
other funds are necessary to complete your clinical trials for these
candidates, please
revise your disclosure to state the amounts and the sources of such
other funds. Refer to
Instruction 3 of Item 504 of Regulation S-K.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical accounting policies and significant judgments and estimates
Stock-based compensation, page 95
9. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the common stock underlying your equity
issuances and the
reasons for any differences between the recent valuations of your
common stock leading
up to the IPO and the estimated offering price. This information will
help facilitate our
review of your accounting for equity issuances, including stock
compensation. Please
discuss with the staff how to submit your response.
Business
Our Approach, page 112
10. Where you first provide measures of statistical significance, please
explain for the benefit
of the lay reader the significance of p-values and the "Z-score" and
clarify the threshold p-
value or "Z-score" that corresponds to statistical significance.
Our services, collaboration and licenses agreements
Services
FirstNameagreement with Ridgeline,
LastNameMarkus Warmuthpage 128
Comapany
11. NameMonte
Please Rosa Therapeutics,
revise to disclose the aggregateInc.
amounts paid to date under the
Ridgeline Services
Agreement.
May 17, 2021 Page 3
FirstName LastName
Markus Warmuth
FirstName
Monte RosaLastNameMarkus
Therapeutics, Inc.Warmuth
Comapany
May NameMonte Rosa Therapeutics, Inc.
17, 2021
May 17,
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Agreements with Cancer Research Technology Limited and the Institute of Cancer
Research,
page 129
12. Please revise to clarify the product candidates or technologies to
which the agreements
with Cancer Research Technology Limited and the Institute of Cancer
Research relate.
To the extent that your product candidates or technologies rely on
intellectual property
licensed from a third-party, please revise your Intellectual Property
disclosure on page 131
accordingly.
Collaboration and option agreement, page 129
13. We note your disclosure that your royalty obligations will terminate
on a product-by-
product and country-by-country basis upon the later of the expiration
of the last patent
which covers such product in such country or certain other terms.
Please disclose when
the last-to-expire patent is expected to expire. Please also disclose
the royalty rate or a
royalty range that does not exceed 10 percentage points, the aggregate
amounts paid to
date under the agreement, the aggregate future potential milestone
payments to be paid,
and the termination provisions under the agreement.
License agreement, page 130
14. Please disclose the amount of the technology access fee paid to CRT
and revise to
quantify the value of the 4,000,000 common shares issued to CRT, the
ICR and affiliated
founding scientists at the time of issuance.
Intellectual Property, page 131
15. Please revise your intellectual property disclosure to disclose for
each material patent and
patent application the specific products or technologies to which such
patents or patent
applications relate. Also clearly describe on an individual basis the
type of patent
protection granted or sought for each product or technology
(composition of matter, use,
or process) and the expiration of each such patent. In this regard, it
may be useful to
provide this disclosure in tabular form to support the narrative
already included.
Principal Stockholders, page 176
16. Please revise the footnotes to your table to disclose the natural
persons who have or share
beneficial ownership of the securities held by each of the entities
listed in your table.
General
17. 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.
Markus Warmuth
FirstName
Monte RosaLastNameMarkus
Therapeutics, Inc.Warmuth
Comapany
May NameMonte Rosa Therapeutics, Inc.
17, 2021
May 17,
Page 5 2021 Page 5
FirstName LastName
You may contact Tara Harkins at 202-551-3639 or Lynn Dicker at
202-551-3616 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Kasey Robinson at 202-551-5880 or Jeffrey Gabor at 202-551-2544 with
any other
questions.
Sincerely,
Division of Corporation
Finance
Office of Life Sciences
cc: Robert E. Puopolo, Esq.