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United States securities and exchange commission logo
April 11, 2021
Julien Gander, LL.M.
General Counsel
Molecular Partners AG
Wagistrasse 14
8952 Z rich-Schlieren
Switzerland
Re: Molecular Partners
AG
Draft Registration
Statement on Form F-1
Submitted March 15,
2021
CIK No. 0001745114
Dear Mr. Gander:
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 F-1
Prospectus Summary, page 1
1. We note certain
statements in this section and in the Business section discussing
"positive" progress on
your first COVID-19 antiviral therapeutic product
candidates, "positive"
preclinical data from your existing COVID-19 antiviral therapeutic
product candidates, the
"encouraging" activity and tolerability of certain of your product
candidates, the success
of abicipar in two positive Phase 3 trials in nAMD, that you are
encouraged by anecdotal
signs of clinical efficacy in AMG506, that DARPin based TCEs
showed equivalent
efficacy and that conditionally activated CD3-PDD shows similar
efficacy but none of
the toxicity of the active TCE. Efficacy and safety are determinations
Julien Gander, LL.M.
FirstName LastNameJulien Gander, LL.M.
Molecular Partners AG
Comapany
April NameMolecular Partners AG
11, 2021
April 211, 2021 Page 2
Page
FirstName LastName
that are solely within the authority of the FDA or similar foreign
regulators. You may
present clinical trial end points and objective data resulting from
trials without concluding
efficacy, and you may state that your product candidates are well
tolerated if true. Please
revise these statements, and any other statements regarding safety or
efficacy, as
appropriate.
Our Pipeline, page 2
2. Please revise the pipeline to indicate the current status of
development of each of your
product candidates. For example, we note your disclosure on page 5
that following the
submission of a BLA for abicipar, your partner Abbvie is considering
next steps because
the FDA determined that the ocular inflammation profile seen in the
two Phase 2 clinical
trials did not provide an adequate risk reward benefit as submitted,
and additional work
would be required to show the ocular inflammation profile of abicipar
would be similar to
those products already approved for the treatment of nAMD. We also
note your disclosure
on page 17 that your Phase 1 trial of ensovibep has been delayed due
to an inability to
dose healthy volunteers due to government restrictions in the UK since
the end of 2020 in
response to the pandemic.
3. We note that you have included two programs in the discovery phase in
your pipeline
table. Given the early-stage development of these programs, please
explain why each
program is sufficiently material to your business to warrant inclusion
in your pipeline
table.
Our Strategy, page 6
4. Please provide the basis for your statement that you are the world
leaders in DARPin
engineering and research.
5. We note that part of your strategy is to rapidly advance the clinical
development of your
COVID-19 antiviral therapeutic product candidates in your infectious
disease program in
collaboration with Novartis and you discuss that it took you less than
eight weeks to go
from concept to candidate identification on page 119. Please balance
this disclosure and
similar disclosure throughout the prospectus to clarify that the
process of clinical
development is inherently uncertain and that there can be no guarantee
that you will
achieve similar development timelines with your future product
candidates.
Risk Factors, page 14
6. Given the length of your risk factor section, please revise to comply
with Regulation S-K
Item 105 by relocating risks that could generically apply to any
registrant or offering to
the end of the section under the caption "General Risk Factors."
Use of Proceeds, page 83
7. Please revise to disclose if you intend to complete your planned Phase
1 clinical trial for
Julien Gander, LL.M.
FirstName LastNameJulien Gander, LL.M.
Molecular Partners AG
Comapany
April NameMolecular Partners AG
11, 2021
April 311, 2021 Page 3
Page
FirstName LastName
MP0317 and your ongoing Phase 1 clinical trial for MP0420 with the
proceeds of the
offering. Please also revise to disclose whether you intend to
initiate or complete a Phase
1 trial for MP0423 using the proceeds of the offering and how far you
expect the proceeds
from the offering to allow you to proceed in the development of your
AML CD3 product
candidate.
Business
COVID-19 Product Candidates: Ensovibep (MP0420) and MP0423, page 118
8. We note your disclosure on page 120 that Part A of the EMPATHY trial
is "ongoing" yet
your disclosure on page 119 indicates that the EMPATHY trial has not
yet
commenced. Please revise or advise.
B. Our Oncology Program, page 124
9. Please balance the disclosure in this section by noting that AMG 506
(MP0310) and
MP0317 both utilize novel mechanisms of action which may result in
greater research and
development expenses, regulatory issues that could delay or prevent
approval, or the
discovery of unknown or unanticipated adverse effects.
Beyond Bi-specifics: Our Next Generation DARPin-based TCE Platform, page 131
10. Please explain what you mean by "IND-ready" in this section.
Intellectual Property, page 138
11. Please revise to disclose the material foreign jurisdictions where you
own or license
patents or pending patent applications.
12. We note your disclosure that certain patents that you licensed from
the University of
Zurich pertaining to your DARPin platform to generate your DARPin
product
candidates will expire in 2021 and one patent will expire in 2023.
Please revise to disclose
what effect you expect the expiration of these patent to have on your
patent portfolio and
your business and if you intend to take any action to mitigate such
effect. Please also
disclose whether the inability to enter into a non-exclusive license
with the University of
Zurich for the remaining U.S. patent that will expire in 2023 would
have a material impact
on your business and, if so, if you intend to take any action to
mitigate such impact.
License and Collaboration Agreements, page 141
13. If you would be unable to enforce royalty obligations under any of
your license and
collaboration agreements after the licensed patent rights have
expired, please revise to
clarify this in this section as appropriate.
Option and Equity Rights Agreement with Novartis, page 141
14. Please revise to disclose when the royalty term will end under this
agreement or how it is
Julien Gander, LL.M.
Molecular Partners AG
April 11, 2021
Page 4
determined.
Discovery Alliance Agreement with Allergan, an AbbVie Company, page 143
15. Please revise to clarify whether the royalty term is the same as the term
of the agreement.
License Agreement with the University of Zurich, page 144
16. Please revise to disclose the term of the agreement, the termination
provisions, the royalty
term, and any other payment terms such as aggregate future potential
milestone payments,
upfront or execution payments made or aggregate amounts paid under the
agreement to
date.
Principal Shareholders, page 174
17. Please revise your disclosure to identify the natural person or persons
who have voting
and investment control of the shares held by each entity in the table.
Certain Important Provisions of our Articles of Association, Organizational
Rules and Swiss
Law, page 179
18. We note that you refer shareholders to, in part, Swiss law. It is not
appropriate to qualify
your disclosure by reference to information that is not included in the
filing or filed as an
exhibit. Please revise accordingly.
General
19. 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.
You may contact Christie Wong at (202) 551-3648 or Terence O Brien at
(202) 551-3355
if you have questions regarding comments on the financial statements and
related matters.
Please contact Ada Sarmento at (202) 551-3798 or Tim Buchmiller at (202)
551-3635 with any
other questions.
Sincerely,
FirstName LastNameJulien Gander, LL.M.
Division of
Corporation Finance
Comapany NameMolecular Partners AG
Office of Life
Sciences
April 11, 2021 Page 4
cc: Ryan Sansom, Esq.
FirstName LastName