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August 24, 2019
Jielun Zhu
Chief Financial Officer
I-Mab
Suite 802, West Tower, OmniVision
88 Shangke Road, Pudong District
Shanghai, 201210
People's Republic of China
Re: I-Mab
Draft Registration Statement on Form F-1
Submitted July 29, 2019
CIK No. 0001778016
Dear Mr. Zhu:
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 29, 2019
Prospectus Summary
Overview, page 1
1. We note your references throughout your registration statement to your
product candidates
as potentially "first-in-class" or ``best-in-class biologics. These
terms suggest that the
product candidates are effective and likely to be approved. Further, it
is inappropriate for
you to state or imply that you will achieve a given market share given
the length of time
and uncertainty with respect to securing marketing approval for your
product candidates.
Please delete these references throughout your registration statement.
If your use of these
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FirstName LastNameJielun Zhu
I-Mab
Comapany NameI-Mab
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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, if
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
candidates have been proven effective or that they will receive
regulatory approval.
Commercial Opportunities in China and Our Unique Position, page 1
2. The prospectus summary should include a balanced presentation of your
business,
including your competitive position in the industry. In the
presentation of your business,
you state you are "one of the top clinical stage innovative biotech
companies in China."
We also note your statement on page 4 that you are regarded as an
ideal China partner
based on your strong development capabilities and proven track record.
Please tell us the
basis for these claims and balance your summary presentation by
providing equally
prominent disclosure about the competitive and regulatory challenges
you face.
Fast-to-Market China Approach, page 2
3. Statements indicating safety and efficacy are not appropriate for
product candidates in
clinical trials. Safety and efficacy determinations are solely within
the authority of the
applicable regulators and are continually assessed through all phases
of clinical trials.
Please revise your document to remove all statements that indicate or
imply that your
product candidates are safe or effective, including preliminary
indications of safety or
efficacy. We specifically note the following examples:
On page 2, "All of these investigational drugs have passed Phase 1
or Phase 2 clinical
trials with favorable safety and preliminary efficacy data in
Europe, the United States
or elsewhere"
On page 5, "TJ202 is a differentiated CD38 antibody originally
developed by
MorphoSys with good clinical safety and efficacy data..."
On page 6, "The clinical safety and effect of TJ107 on T cells have
been demonstrated
in multiple previous and ongoing clinical trials in South Korea
and the United States"
On page 136, "TJ202 was safe..."
On page 139, "TJ107 provides additional treatment efficacy when
combined with PD-
1/PD-L1 therapies..."
On page 142, "TJ101 demonstrated a good safety profile..."
On page 144, "Overall, TJ101 was shown to be safe..."
On page 145, "There results indicated that weekly or twice monthly
treatment with
TJ101 produced clinical efficacy..."
On page 146, "TJ301 demonstrated efficacy in pre-clinical
studies..."
On page 148 and 149, "TJ301 was safe...[t]he safety profile of TJ301
was favorable..."
On page 154, "The combination of enoblituzumab and pembrolizumab
demonstrated
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acceptable safety..."
These examples are provided for illustrative purposes and this is not
a complete list of
statements indicating that the product candidates are safe or
effective. Note that you may
present the summary results from the clinical trials without
presenting your conclusion
relating to safety or efficacy, e.g., you may present data and
disclose whether trial
endpoints were met. Please revise similar statements on pages 157-158
stating your
conclusions that third parties have demonstrated efficacy in clinical
trials of otilimab and
mavrilimumab. Additionally, we note your disclosure on page 3 that
"TJC4 has been
validated...." Please clarify what you mean by "validated" in your
disclosure.
Our Unique Business Model, page 2
4. We note your use of "fast-to-market" and "fast-to-PoC" here and
throughout the
prospectus. Please revise your disclosure and similar statements
throughout your
prospectus to remove any implication that you will be successful in
commercializing your
product candidates in a rapid or accelerated manner as these
statements are speculative for
you to make.
Our Drug Pipeline, page 5
5. We note your disclosure on pages 176-177 that you have agreed to share
in the
development costs of TJ202 with Everest Medicines Limited and that you
will share in the
product's profit and loss in proportion to the development costs
incurred. Please add
explanatory disclosure to your pipeline table presentation to reflect
these terms.
6. It appears from your disclosure that you have not yet commenced Phase
2 clinical
development of enoblituzumab. Accordingly, please shorten the arrow in
your pipeline
table to reflect the current stage of development.
Use of Proceeds, page 81
7. Please revise to identify the stage of development you expect to
achieve for each listed
product candidate with the proceeds of the offering. To the extent
material amounts of
other funds are necessary to accomplish the specified purposes, state
the amounts and
sources of such other funds needed for each specified purpose. Refer
to Item 3.C.1 of
Form 20-F.
Management's Discussion and Analysis and Financial Conditions and Results of
Operations
Results of Operations
Research and Development Expenses, page 98
8. You provide a breakdown of the major components of your research and
development
expenses on page 98. For each of your key research and development
projects, please
also revise to quantify the research and development costs incurred
during each period
presented.
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Critical Accounting Policies and Significant Judgments and Estimates
Fair Value of Ordinary Shares, page 109
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 initial public offering and the estimated offering price.
This information will help
facilitate our review of your accounting for equity issuances
including stock
compensation, beneficial conversion features, and changes in the fair
value of the
warrants.
Industry, page 111
10. We note your use of the Frost & Sullivan report throughout your
prospectus. Please
provide us with a complete copy of the report marked to show the
relevant sections you
cite in your disclosure.
Business, page 126
11. We note that your disclosures throughout this section reference to
"progressive
disease," "stable disease," "minimal response," "partial response,"
"very good partial
response," "complete response," and "stringent complete response."
Please revise your
document to define these terms and disclose how responses were
measured.
Phase 1 Study of Enoblituzumab Monotherapy, page 153
12. We note your reference on page 153 to treatment-related Grade 3 or
higher adverse events
(AEs). Please revise to disclose the definitions for Grade 3 or
higher. To the extent a
drug-related serious adverse event has occurred, or an event the
investigator could not
determine was unrelated to treatment, please clearly disclose the
event and the number of
affected patients.
Global Portfolio, page 157
13. Please expand your disclosure on page 161 with respect to the Phase 1
clinical trial
for TJM2 and on page 165 with respect to the Phase 1 clinical trial
for TJC4 to provide the
number of patients enrolled in each referenced cohort. Please also
revise page 168 to
disclose the number of patients enrolled in your TJD5 program.
Licensing Agreement with MorphoSys (MOR202/TJ202), page 170
14. We note your disclosure that you are required to pay tiered
double-digit royalties. This
disclosure is overly broad and may imply that your royalty rate is up
to 49%. Please revise
your disclosure here and throughout the prospectus to give investors a
reasonable idea of
the amount of the royalty rate that does not exceed 10 percentage
points. Please also
disclose the number of years relevant to the royalty term.
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Licensing and Collaboration Arrangements, page 170
15. For each of your license and collaboration agreements, please expand
your disclosure to
include the termination provisions. For each of your in-license
agreements and your
agreements discussed under the heading "Collaboration Arrangements" on
page 176,
please disclose amounts paid to date.
Collaboration Agreement with Macrogenics (enoblituzumab) , page 173
16. With respect to ownership of the clinical data generated pursuant to
your collaboration
agreement with Macrogenics, Inc., please clarify what you mean by your
reference "where
co-ownership is possible." Additionally, your disclosure that you will
co-own the clinical
data to the extent not required for Macrogenics to maintain marketing
approvals in China
appears inconsistent with your disclosure that you own an exclusive
license to
Macrogenics' patents to commercialize enoblituzumab in Greater China.
Please revise or
advise. Please also disclose the expiry date for the latest data
exclusivity period referenced
on page 174.
Out-Licensing Arrangements
Licensing Agreement with CSPC Entity, page 175
17. Please disclose when the latest to expire patent is scheduled to
expire.
Description of American Depositary Shares
Limitations on Obligations and Liability to ADS Holders, page 253
18. We note your disclosure that the deposit agreement contains a waiver
of jury trial
provision. Please revise your disclosure to clarify that by agreeing
to the provision,
investors will not be deemed to have waived the Company's or the
depositary's
compliance with the federal securities laws or the rules and
regulations promulgated
thereunder. Please also ensure that the deposit agreement includes a
statement to that
effect.
Taxation
PRC Taxation, page 257
19. We note your statement of belief that I-Mab is not a PRC resident for
PRC tax purposes.
Please revise to clearly state that the disclosure in this section is
the opinion of named
counsel, and revise to express a firm opinion for each material tax
consequence. If such
opinion is subject to uncertainty, counsel may provide a "should' or
"more likely than not"
opinion and explain why a "will" opinion cannot be given and describe
the degree of
uncertainty. For guidance, please refer to Section III.C.4 of Staff
Legal Bulletin No. 19.
Jielun Zhu
I-Mab
August 24, 2019
Page 6
Financial Statements
Notes to the Consolidated Financial Statements
18. Licensing and Collaboration Arrangements
Out-Licensing Collaboration Arrangements, page F-45
20. With regards to your revenue recognition conclusions for your
collaboration agreement
with CSPS Pharmaceutical Group Limited, please explain what consideration
was given
to the ongoing performance obligation of assisting CSPC in the continued
optimization of
the manufacturing technology.
General
21. 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.
22. Please ensure that all graphics are legible and provide us proofs of all
graphics, visual, or
photographic information you will provide in the printed prospectus prior
to its use, for
example in a preliminary prospectus. Please note that we may have
comments regarding
this material.
You may contact Christine Torney at 202-551-3652 or Kevin Vaughn at
202-551-3494 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Jeffrey Gabor at 202-551-2544 or Christine Westbrook at 202-551-5019
with any other
questions.
Sincerely,
FirstName LastNameJielun Zhu
Division of
Corporation Finance
Comapany NameI-Mab
Office of
Healthcare & Insurance
August 24, 2019 Page 6
cc: Z. Julie Gao, Esq.
FirstName LastName