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September 20, 2018
Ian Huen
Chief Executive Officer
Aptorum Group Ltd
17th Floor, Guangdong Investment Tower
148 Connaught Road Central
Hong Kong
Re: Aptorum Group Ltd.
Registration Statement on Form F-1
Filed September 5, 2018
File No. 333-227198
Dear Mr. Huen:
We have reviewed your 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 amending your registration statement
and providing the
requested information. 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 any amendment to your registration statement and the
information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form F-1 filed September 5, 2018
Cover page
1. We note your response to comment 1, which we reissue in part. You
continue to
reference a minimum and maximum dollar amount of offered securities.
Please amend
your prospectus cover page to state the volume of securities being
offered on a minimum
and maximum offering basis. Refer to Item 501(b)(2) of Regulation S-K.
2. Please expand your revisions in response to prior comment 3 to disclose
what the selling
shareholders' fixed price will be. If it will be the same as the primary
offering price,
please revise to so state.
Ian Huen
FirstName LastNameIan Huen
Aptorum Group Ltd
Comapany 20, 2018
September NameAptorum Group Ltd
September 20, 2018 Page 2
Page 2
FirstName LastName
Prospectus Summary
Aptorum's Lead Projects
ALS-1: Small molecule intended for the treatment of viral infections caused by
Influenza virus
A, page 3
3. We note your response to comment 10 and your revised disclosure
stating your belief that
"it is unlikely that ALS-1 will experience the resistance developed by
the viruses against
the existing anti-viral therapy." As you have not yet conducted any
clinical studies, it is
premature for you imply that ALS-1 will be effective. Please remove
this statement.
Similarly, please remove the disclosure on page 4 stating your belief
that ALS-4 is "less
likely to be susceptible to antibiotic resistance."
NLS-1: A Derivative pf Epigallocatechin-3-Gallate ("Pro-EGCH") for the
treatment of
Endometriosis, page 5
4. We note your response to comment 11, which we reissue in part. Please
remove your
conclusion that studies of EGCG for the treatment of endometriosis
have produced
"encouraging results." Additionally, please move the discussion of
p-values observed to
the Business section and expand your disclosure to explain how
p-values are used to
measure statistical significance and how they relate to the U.S. Food
and Drug
Administration's evidentiary standards of efficacy. Additionally,
please revise your
discussion of preclinical studies of NLS-1 stating that it "prevents
the progression of
fibrosis" and "reduced lesion size significantly better that EGCG and
other hormone-
based therapy" to remove these conclusions regarding the efficacy of
NLS-1. We will not
object to a discussion of objective data points in the Business
section.
Capitalization, page 54
5. We reissue our prior comment 18 since it does not appear that you have
revised your
capitalization table.
Business
Lead Projects
ALS-1: Small molecule intended for the treatment of viral infections caused by
Influenza virus
A, page 70
6. We note your response to comment 22. Please expand your disclosure to
briefly explain
EC50. Additionally, please remove your conclusion that the "animal
study results strongly
suggest that ALS-1 protected mice against hypervirulent influenza A
H5N1 virus in vivo."
Please also expand your disclosure on page 72 to briefly explain IC50.
Ian Huen
Aptorum Group Ltd
September 20, 2018
Page 3
Patent License, page 71
7. We note your response to comment 24, which we reissue in part as it does
not appear that
you have disclosed the aggregate regulatory development and aggregate
sales milestones
payable under the license agreement. Please revise here and make similar
revisions
concerning the license agreement related to each of ALS-4 discussed on
page 74
and NLS-1 discussed on page 79.
Notes to Consolidated Financial Statements (Successor Basis)
14. Summary of Significant Accounting Policies
Intangible Assets, page F-37
8. Refer to your response to comment 36. We believe that the aggregate
amount of the
milestone obligations and the description of the events that would
trigger these milestones
are significant terms of an agreement that should be disclosed. Please
revise your
disclosures accordingly.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
You may contact Keira Nakada at 202-551-3659 or Angela Connell at
202-551-3426 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Christine Westbrook at 202-551-5019 or Mary Beth Breslin at
202-551-3625 with any
other questions.
Sincerely,
FirstName LastNameIan Huen
Division of
Corporation Finance
Comapany NameAptorum Group Ltd
Office of Healthcare
& Insurance
September 20, 2018 Page 3
cc: Louis Taubman, Esq.
FirstName LastName