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United States securities and exchange commission logo
March 28, 2021
Daniel J. Hicklin, Ph.D.
President and Chief Executive Officer
Werewolf Therapeutics, Inc.
1030 Massachusetts Avenue, Suite 210
Cambridge, MA 02138
Re: Werewolf
Therapeutics, Inc.
Draft Registration
Statement on Form S-1
Submitted February
26, 2021
CIK No. 0001785530
Dear Dr. Hicklin:
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. Please revise the
Company Overview section to clarify the status of the PREDATOR
platform and the nature
of the preclinical work performed on product candidates to date.
We note that this
context is necessary in order to assess the performance claims that are
included in the
Summary. With respect to the platform, we note that your disclosure at the
bottom of page 1
indicates that it is built whereas your risk factor disclosure on page 16
indicates that the
platform, as well as your product candidates, are under development.
With respect to your
product candidates, your Business discussion indicates that
preclinical testing has
been performed predominantly on mouse models and in certain
cases using surrogate
molecules; however, your disclosure makes claims which could be
Daniel J. Hicklin, Ph.D.
FirstName LastNameDaniel
Werewolf Therapeutics, Inc. J. Hicklin, Ph.D.
Comapany
March NameWerewolf Therapeutics, Inc.
28, 2021
March2 28, 2021 Page 2
Page
FirstName LastName
interpreted to indicate that the testing has been performed on humans
or on human cells.
In this regard, we refer to the disclosure on page 2 which addresses
how your platform
screens to identify protease-cleavable linkers that are efficiently
cleaved by a broad array
of human tumors with minimal cleavage in non-tumor tissues.
2. We note your statement on page 1 regarding your potentially first-
or best-in-class
therapies and several other references to first-in-class and
best-in-class on pages 3 and
4. These terms suggest that the product candidate is effective and
likely to be approved by
the FDA. Please delete these from the Summary. To the extent your use
of these terms is
intended to convey your belief that the product is based on a novel
technology or approach
and/or is further along in the development process, you may discuss
how your technology
differs from technology used by competitors and, as applicable, that
you are not aware of
competing products that are further along in the development process.
Statements such as
these should be accompanied by cautionary language that the statements
are not intended
to give any indication that the product candidate has been proven
effective or that it will
receive regulatory approval.
3. On page 2 you refer to your potent INDUKINE molecules and state
that your
INDUKINE molecules contain fully potent and functional cytokines
that mediate pro-
inflammatory, anti-cancer mechanisms within the [tumor
microenvironment]. As safety
and efficacy determinations are solely within FDA's authority and they
continue to be
evaluated throughout all phases of clinical trials, please remove
these references, or revise
the presentation to provide additional context so that it is clear
that these claims do not
connote a current or future regulatory finding of safety or efficacy.
Our Pipeline, page 3
4. Please revise to increase the width of the Pre-IND and
IND-Enabling columns so they
are no larger than the columns for Phases 1-3. Also, please remove the
unidentified
discovery programs from your pipeline table. In this regard, we note
that your Business
discussion of these early stage programs is limited to a few
sentences.
Leadership, page 4
5. Please revise here and/or elsewhere in the prospectus to explain the
basis for your claim of
leadership in protein engineering and developing optimized
conditionally activated
molecules.
Our Team, page 4
6. Please revise here, or elsewhere in the prospectus, to discuss the
founding of the company,
including the origins of your technology. In this regard, we note that
MPM Capital
identifies themselves on their website as your "founder" and it
appears that MPM also
controlled Harpoon Therapeutics at the time you and Harpoon first
entered into the license
agreement covering the technology used in your PREDATOR platform. With
a view to
disclosure, also tell us whether the platform, or any material work on
your three product
Daniel J. Hicklin, Ph.D.
FirstName LastNameDaniel
Werewolf Therapeutics, Inc. J. Hicklin, Ph.D.
Comapany
March NameWerewolf Therapeutics, Inc.
28, 2021
March3 28, 2021 Page 3
Page
FirstName LastName
candidates, derived from work conducted prior to the October 2017
incorporation of the
company and, if so, who conducted such work.
Risks Associated with Our Business, page 4
7. Please revise to highlight the risk on page 39 concerning uncertainty
as to whether you
will have patents that cover the composition of matter for your
product candidates.
Risks Related to this Offering, Ownership o Our Common Stock and Our Status as
a Public
Company, page 58
8. Please revise the exclusive forum risk factor to disclose that there
is also a risk that your
exclusive forum provision may result in increased costs for investors
to bring a claim.
Our Strategy, page 92
9. Here and in several places in your Business section you discuss the
possibility that your
product candidate could generate clinical benefit, with the
potential . . . to pursue an
expedited clinical and regulatory strategy. These references
improperly raise the
possibility of an expedited process without explaining the type and
magnitude of clinical
benefit that would be needed to garner an expedited process, and
without explaining the
nature of and hurdles to completing the expedited processes. Revise to
balance your
disclosure with these clarifications, and with the fact that, as your
candidates are
preclinical, there is no assurance the FDA would approve any form of
application. Also,
provide context to your statement on page 4 concerning your strategy
to "rapidly advance"
WTX-124 through clinical development. In this regard, we note that
your risk factor
disclosures explain that clinical development may take several years.
Linker Selection, page 94
10. We note your disclosure on page 95 indicating that your differentiated
approach begins
with a novel library of peptide sequences. Revise to discuss whether
this library is
internally developed and owned. Also, clarify whether your screening
of prioritized linker
sequences similarly relies on novel libraries or other proprietary
technology or knowledge.
Our Programs, page 96
11. Please revise to discuss briefly the planned IND-enabling work for
each of the three
product candidates. With reference to your disclosure on pages 18 and
117, please tell us
whether the referenced in vitro pre-clinical work using human cells
will need to be
performed on each product candidate prior to clinical testing or
whether this in vitro
testing occurred at the screening stage discussed on page 95.
Our Programs, page 96
12. We refer to your disclosures under the headings WTX-330 Preclinical
Results and
WTX-613 Preclinical Results. We note that your disclosure on
page 107 indicates that
Daniel J. Hicklin, Ph.D.
Werewolf Therapeutics, Inc.
March 28, 2021
Page 4
your testing used a surrogate molecule consisting of mouse IFN-a1 which
is otherwise
identical to WTX-613. By contrast, we do not see similar disclosure
concerning the
surrogate molecule that you used to assess WTX-330 in mice. Accordingly
please revise
your disclosure concerning your WTX-330 testing to discuss the
comparability of the
surrogate. In addition, please tell us whether prior to commencing
clinical trials you will
need to demonstrate that your product candidates are comparable to the
surrogates utilized
in your preclinical testing.
Intellectual Property, page 112
13. With reference to your disclosures on pages 94-95, please revise to
discuss briefly the
aspects of the PREDATOR platform that are covered by patent claims
directed to
"platform technology."
Principal Stockholders, page 154
14. Please identify the natural person or persons who directly or indirectly
exercise sole or
shared voting and/or dispositive power with respect to the common stock
held by
Longwood Fund III. Refer to Item 403 of Regulation S-K.
General
15. Please 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.
You may contact Gary Newberry at (202) 551-3761 or Brian Cascio at (202)
551-3676 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Abby Adams at (202) 551-6902 or Joe McCann at (202) 551-6262 with any
other
questions.
Sincerely,
FirstName LastNameDaniel J. Hicklin, Ph.D.
Division of
Corporation Finance
Comapany NameWerewolf Therapeutics, Inc.
Office of Life
Sciences
March 28, 2021 Page 4
cc: Rosemary G. Reilly, Esq.
FirstName LastName