SEC Comment Letter for Aptorum Group Ltd (APM) (CIK 0001734005) (NIKI) — Dec 12, 2018
Aptorum Group Ltd (APM) (CIK 0001734005)
Date: Dec. 12, 2018 · CIK: 0001734005 · Accession: 0000000000-18-037813
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August 10, 2018
Ian Huen
Chief Executive Officer
Aptorum Group Ltd
17th Floor, Guangdong Investment Tower
148 Connaught Road Central
Hong Kong
Re:Aptorum Group Ltd.
Draft Registration Statement on Form F-1
Submitted July 13, 2018
CIK No. 0001734005
Dear Mr. Huen:
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 Submitted July 13, 2018
Cover page
1.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.
Additionally, please expand your disclosure to include the date the offering will end, any
plans to place funds in escrow, or alternatively, that you have no such plans. Refer to Item
501(b)(8)(iii) of Regulation S-K.
FirstName LastNameIan Huen
Comapany NameAptorum Group Ltd
August 10, 2018 Page 2
FirstName LastNameIan Huen
Aptorum Group Ltd
August 10, 2018
Page 2
2.We note your disclosure on page 6 and elsewhere that your Class B ordinary shares are
entitled to ten votes per share for any matter submitted for shareholder approval. Please
expand your cover page disclosure to briefly discuss your dual-class structure and the
relative voting rights of your Class A and Class B ordinary shares.
3.We note that there is currently no public market for your Class A ordinary shares, that you
"plan to apply" to have this class listed on the Nasdaq Global Market, and that the offering
is conditioned on the "reasonable expectation" that the shares would qualify for listing.
We further note your disclosure that the selling shareholders may not sell "on any trading
market" until the shares are approved for listing, but that they may sell in negotiated
transactions. Please amend the cover page to indicate that the selling stockholders will sell
the shares at a fixed price until the shares are listed on the Nasdaq and thereafter at
prevailing market prices or privately negotiated prices.
Propsectus Summary
Overview, page 1
4.We note from your disclosure that you have not yet conducted any clinical trials. Terms
such as “award-winning” and "first-in-class" suggest that the product candidates are
effective and likely to be approved. Please delete these references throughout your
registration statement. If your use of these terms was intended to convey your belief that
the products are 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 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
candidates have been proven effective or that they will receive regulatory approval.
Similarly, please remove the reference to “First-in-Class/Best-in-Class innovations” on
page 62 and the statements concerning the poster award and live demonstration prize on
page 73.
5.We note your disclosure that you may develop formulations of your therapeutic molecules
which may qualify as nutraceuticals or some other product category which may be subject
to less regulation and provide a faster path to revenue generation. Please expand your
disclosure to identify the relevant product candidate(s) and the contingencies to
commercializing such product candidate(s) as nutraceuticals. Alternatively, please delete
this disclosure.
6.We note your disclosure that you determined to pursue projects in your non-therapeutics
segment, such as the AML clinic, to provide some interim revenue. Please balance your
disclosure by quantifying your estimated operating expenses and/or identifying the
relevant factors to achieving profitability at the clinic.
FirstName LastNameIan Huen
Comapany NameAptorum Group Ltd
August 10, 2018 Page 3
FirstName LastNameIan Huen
Aptorum Group Ltd
August 10, 2018
Page 3
Aptorum’s Lead Projects, page 2
7.Please expand the number of columns in the development chart so that it includes all
phases of development that must be completed in order to market your products (i.e.,
Phase 2 and 3). Please make similar revisions to the chart on page 65.
8.Please clarify the distinctions between "Target ID & Selection," "Lead Discovery," "Lead
Optimization" and "IND Enabling" and describe the activities conducted at each of these
stages.
9.As you are in the preclinical stage of development, have not completed your preclinical
studies and do not intend to submit an IND application until 2020 or 2021, please revise
your disclosure to avoid characterizing your chart as a "pipeline" chart.
10.We note your disclosure that “preclinical studies of ALS-1 indicate that it inhibits the
replication of influenza virus in vitro with a nanomolar EC50 and protects mice challenged
with lethal doses of avian influenza A H5N1.” Please delete this language or place this
selected information in its full and proper context by providing the specific details and
parameters of the study from which the data was drawn.
11.We note your disclosure on page 3 that “The target site on NP where ALS-1 is acting has
been identified and mechanism established. Animal model efficacy has been
demonstrated, while chemical structures are being optimized” as well as numerous other
statements throughout your registration statement that present your conclusions regarding
the safety and efficacy of your product candidates, which are premature and inappropriate
for you to make as these determinations are within the sole authority of the U.S. Food and
Drug Administration and comparable regulatory bodies. Please revise your disclosure to
remove these statements here and throughout your registration statement.
As a non-exhaustive list of examples only, we note the following statements:
•“NLS-1 is a drug molecule derived from natural products (green tea) which appears to
be effective for the treatment of endometriosis…” on page 4;
•“In an animal study…oral administration of Pro-EGCG exhibits superior efficacy over
other conventional therapeutic agents…” on page 4;
•“Assuming our research continues to generate positive results…” on page 63;
•“According to data in our preclinical studies…ALS-1 outperforms oseltamivir (sold
under the brand name Tamiflu) in cell-based assays and stops virus replication during
the early to late stages of viral infection…” on page 66;
•“EGCG, a naturally occurring molecule occurring extracted from green tea, appears to
be efficacious for the treatment of endometriosis…” on page 68;
•“The target site has been identified and animal efficacy and safety have been
demonstrated…” on page 72; and
FirstName LastNameIan Huen
Comapany NameAptorum Group Ltd
August 10, 2018 Page 4
FirstName LastNameIan Huen
Aptorum Group Ltd
August 10, 2018
Page 4
•“We intend to develop SPLS-1 as an alternative treatment for liver cancer, which we
believe will offer improved safety and efficacy…” on page 73.
12.Please remove the graphics from the Summary section and discuss them in the Business
section where appropriate context may be provided.
Our Structure, page 5
13.We note your disclosure that prior to the completion of the offering, and as long as
officers and directors own at least 50% of the voting power of the Company’s outstanding
stock, you will qualify as a “controlled company” under Nasdaq listing rules. Please revise
your disclosure to clarify whether you expect to qualify as a controlled company after the
offering (on a minimum and maximum basis) and if so, please add a related risk factor
discussing the scope of the controlled company exemption from corporate governance
standards.
Our Securities, page 6
14.Please expand your disclosure to discuss the concentration of voting power due to the
ownership of your Class B ordinary shares. Please add related risk factor disclosure
discussing the following risks as they relate to the concentration of ownership of your
Class B common shares:
•Your Class A ordinary shares may be undervalued;
•Your capital structure may have the effect of delaying or preventing a change of
control that shareholders may view as beneficial or result in your Class A shares being
undervalued; and
•Future issuances of your Class B ordinary shares may be dilutive to holders of your
Class A ordinary shares.
Implications of Being an Emerging Growth Company, page 7
15.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.
Risk Factors
Risks related to our IP
“A significant portion of our IP portfolio currently comprises pending patent applications and
provisional patents…”, page 23
16.We note your discussion that a significant portion of your IP portfolio includes pending
patent applications and provisional patents that have not yet been issued. Please revise
FirstName LastNameIan Huen
Comapany NameAptorum Group Ltd
August 10, 2018 Page 5
FirstName LastNameIan Huen
Aptorum Group Ltd
August 10, 2018
Page 5
your disclosure to identify the product candidates for which you have obtained patents
versus pending or provisional patents.
Use of Proceeds, page 49
17.Please revise this section so that it provides your intended use of proceeds of the offering
on a minimum and maximum offering basis. Additionally, it appears from your disclosure
that the proceeds from the offering will not be sufficient to complete all of your specified
uses. Please disclose how far in the development you expect to achieve with the proceeds
of this offering and identify the sources of other funds needed to complete development of
your product and device candidates through commercialization, development of your
AML clinic and establishment of your self-owned laboratory. Refer to Instruction 3 to
Item 504 of Regulation S-K.
Capitalization, page 50
18.You indicate that you present capitalization information on an actual, pro forma, and pro
forma as adjusted basis. However, your table shows columns for actual, as adjusted
(minimum offering amount), and as adjusted (maximum offering amount), which do not
match this description. Please revise, as necessary.
Dilution, page 51
19.Please disclose the percentage of immediate dilution resulting from the offering. Refer to
Item 9.E of the instruction to Form 20-F.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations (Successor Basis)
Research and Development Expenses, page 60
20.Please disclose your research and development expense incurred by project. If you do not
keep track of such costs by project, disclose that fact and the costs incurred by the types of
costs classified as research and development.
Business
Lead Projects and Significant Projects, page 64
21.We note your disclosure that your Project Companies have entered into standard license
agreements with various university and licensing entities customized to the nature of each
project. Given the current stage of development of your product candidates, these
agreements appear to be material. Please expand your disclosure to include the material
terms of these agreements. Additionally, please file these license agreements as exhibits to
the registration statement or tell us why you believe you are not substantially dependent
upon these agreements. Refer to Item 601(b)(10) of Regulation S-K.
FirstName LastNameIan Huen
Comapany NameAptorum Group Ltd
August 10, 2018 Page 6
FirstName LastNameIan Huen
Aptorum Group Ltd
August 10, 2018
Page 6
Lead Projects, page 66
22.Please revise your disclosure of your preclinical studies for ALS-1, ALS-4, and NLS-1 to
remove conclusory statements regarding efficacy and to discuss the results in terms of
objective data points. Additionally, please tell us whether the results shown represent
results that were achieved consistently in the preclinical studies, and also explain whether
such studies were powered for statistical significance.
23.Please ensure that the graphics presented are legible and include legends defining
abbreviated terms and that include relevant disclosure so that lay readers will understand
the graphic.
Patent License, page 66
24.Please expand your disclosure concerning the license agreement related to product
candidate ALS-1 to include all material terms, including the following:
•each parties’ rights and obligations;
•financial terms, including potential milestone payments and royalty rate or range not
to exceed ten percent;
•duration of the agreement and royalty term; and
•termination provisions.
Please make similar revisions to the disclosure concerning the license agreements related
to ALS-4 on page 68 and NLS-1 on page 71. Please also explain what you mean by “ITF
matching scheme” on page 71.
SLS-1: Robotic Catheter Platform..., page 73
25.Please expand to describe the current development stage and regulatory status of this
device.
Intellectual Property, page 74
26.We note your disclosure on page 68 that a U.S. provisional patent has been filed related to
ALS-4. We note also your disclosure on page 74 that a U.S. provisional patent
application was filed related to VLS-3. Please expand your disclosure to explain what a
provisional patent application is and whether you or another party is actively preparing a
patent application and, if so, when you anticipate filing this application. Please also
include the dates that the provisional patent applications were filed, how the cost of a
patent application, if any, will be funded, and the date that you will lose the filing date
established by the provisional patent application if a patent application is not filed.
27.Please expand your disclosure in the chart on page 75 to include all patents, patent
applications and provisional patents that are material to your business. Refer to Item 4.B.6
of Form 20-F.
FirstName LastNameIan Huen
Comapany NameAptorum Group Ltd
August 10, 2018 Page 7
FirstName LastNameIan Huen
Aptorum Group Ltd
August 10, 2018
Page 7
Important Advisors and Consultants to the Company, page 77
28.Please expand your disclosure to identify the services provided by each individual that are
material to your business. To the extent these individuals do not actively provide services
that are material to your business, please remove these biographies or tell us why you
believe it is appropriate to include them.
Government Regulation, page 80
29.We note the only disclosure regarding government regulations specific to medical device
testing and approval is a statement on page 81 that "devices are subject to different forms
of testing and approval" and must satisfy "various FDA requirements in order to be
brought to market." Please expand to describe the regulations specific to the SLS-1
robotic catheter device.
Appointment Letters, page 101
30.Please revise to describe the material terms of each letter separately as it appears the terms
of the letters were not the same for each officer. For instance, we note that Dr. Cheng
received a stock bonus of 5% of Aptorum Medica