United States securities and exchange commission logo
December 14, 2020
Bahija Jallal, Ph.D.
Chief Executive Officer and Director
Immunocore Ltd
92 Park Drive
Milton Park
Abingdon, Oxfordshire OX14 4RY
United Kingdom
Re: Immunocore Ltd
Amendment No. 1 to
Draft Registration Statement on Form F-1
Submitted November
19, 2020
CIK No. 0001671927
Dear Dr. Jallal:
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.
Amendment No. 1 to Draft Registration Statement on Form F-1
PROSPECTUS SUMMARY
Our Pipeline, page 2
1. Please revise your
product pipeline table here and in the Business section as follows:
Please replace the
term "Pivotal" with "Phase 3". If "Pivotal" is intended to mean
something other
than Phase 3, please provide further explanation.
Include separate
columns for Phase 1 and Phase 2 trials or tell us the basis for your
belief that you
will be able to conduct Phase 1/2 trials for all your product candidates.
Bahija Jallal, Ph.D.
Immunocore Ltd
December 14, 2020
Page 2
We note that your Phase 3 clinical trial for Tebentafusp is
ongoing. Please revise the
"Upcoming Milestone" column for Tebentafusp to reflect the fact
that you must either
(i) complete the Phase 3 clinical trial or (ii) complete
event-driven interim analyses,
prior to submitting a BLA.
2. We note the inclusion of Autoimmune Program in your pipeline table on
pages 2. Given
the status of development and the limited disclosure on pages 145
regarding this program,
it seems premature to highlight this program prominently in your
Summary pipeline table.
Accordingly, please revise to remove this program from the Summary
table or advise.
Implications of Being an Emerging Growth Company, page 5
3. 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, page 11
Risks Related to Our Financial Position, page 11
4. We note in the first risk factor your disclosure that "Our net losses
were 93.5 million,
118.3 million, 61.7 million and 42.6 million for the years ended
December 31, 2019
and 2018 and the six months ended June 30, 2019 and 2020,
respectively." Please revise
accordingly, as these amounts refer to your operating losses instead
of net losses. Also,
please ensure the amounts agree to the Statements of Operations for
the respective
periods.
ADSs holders may not be entitled to a jury trial..., page 74
5. Please update your disclosure to clarify whether the jury trial waiver
provision in the
deposit agreement would apply if the ADS holder were to withdraw the
ordinary shares
and whether the provision applies to purchasers in secondary
transactions. Please also
update your disclosure on page 221 to address both of these questions.
Use of Proceeds, page 91
6. We note your disclosure that you intend to use portions of the proceeds
of this offering to
(i) advance clinical development of IMC-C103C, (ii) advance the clinical
development of
IMC-F106C and (iii) advance the clinical development of IMC-I109V.
Please specify
what amounts will be allocated to each of your programs and specify how
far in the
development of each of your projects you expect to reach with the
proceeds of the
FirstName LastNameBahija Jallal, Ph.D.
offering. If any material amounts of other funds are necessary to
accomplish the specified
Comapany NameImmunocore
purposes, Ltd and sources of other funds needed for each
specified purpose
state the amounts
and 14,
December the 2020
sources.
PageRefer
2 to Item 3.C.1 of Form 20-F.
FirstName LastName
Bahija Jallal, Ph.D.
FirstName LastNameBahija Jallal, Ph.D.
Immunocore Ltd
Comapany14,
December NameImmunocore
2020 Ltd
December
Page 3 14, 2020 Page 3
FirstName LastName
7. We note your statement that you expect that you will require
additional funding to
complete the clinical development of any of your current or future
product candidates.
Earlier in Use of Proceeds, you indicate that you anticipate that the
proceeds will be
sufficient for you to complete your Phase 3 clinical trial of
tenbentafusp as well as
preparations for a commercial launch. Please revise your disclosure to
reconcile these two
statements or explain to us how they are consistent.
Management's Discussion and Analysis
Results of Operations
Research and Development Expenses, page 105
8. For each of your significant key product candidates, please provide a
breakdown of
research and development expenses for each period presented. To the
extent the
information is not known, please consider providing an alternative
breakdown that would
assist a user in evaluating your research and development expense.
Business
Our Next-Generation ImmTAX Immunotherapy Platform, page 123
9. We note your statement that you believe your "clinically validated"
ImmTAX platform
will allow you to create "first-in-class" therapies. We further note
that your lead product
candidate is still in a Phase 3 trial. Please remove the assertion
that your ImmTAX
platform has been "clinically validated". Please also remove the term
"first-in-class" and
any other disclosure that states or implies that your product
candidates will be the first or
most effective approved treatments for the indications discussed in
the prospectus.
Our Proprietary ImmTAX Development Engine, page 127
10. Please provide us with the basis for your statement that you have
developed a "field
leading in vitro toxicity platform". Alternatively, please revise this
statement to be more
specific concerning the nature of the platform.
Advantages of our ImmTAC Platform vs. Other Cancer Immunotherapies, page 129
11. Please revise your disclosure in this section to clarify that none of
your product candidates
has been approved as of yet and that there is no guarantee that your
product candidates
will prove to be safe and efficacious for the treatment of your target
indications.
Please also update your graphic on page 130 to clarify if the data
presented in the graphic
were observed in a comparison assay or study or whether they are
theoretical.
Tebentafusp: Our Most Advanced Oncology Therapeutic Candidate, page 133
12. We note your statement that your clinical development of tebentafusp
has demonstrated a
number of "promising" results. Please revise to avoid characterizing
the results of your
clinical trials and development as "promising" as this may create an
inference that your
Bahija Jallal, Ph.D.
Immunocore Ltd
December 14, 2020
Page 4
product is more likely to be found safe and effective, which is a
determination solely in
the authority of regulatory agencies such as the FDA.
13. Please revise your disclosure to provide a brief summary of the RECIST
rules and criteria.
Phase 1/2 Clinical Trial, page 135
14. We note your comparison of the Phase 1/2 clinical trial results to the
meta-analysis by
Rantala et al., including your statement on page 133 that the patients
in your trial had a
62% survival rate as compared to a historical rate of 37%. As you have
not conducted
head-to-head clinical trials, please tell us why you believe it is
appropriate to include these
comparisons. Include in your response whether you expect to be able to
rely on this data
to support an application for marketing approval from the FDA or
comparable regulatory
body for commercialization of tebentafusp.
Please also update your discussion of the Phase 2 portion of your
clinical trial of
tebentafusp to clarify whether the trial achieved its primary
endpoint.
15. We note your reference on page 137 to adverse events Grade 3. Please
revise to disclose
the definition of an adverse event Grade 3 or greater. To the extent a
serious adverse event
has occurred, please clearly disclose the event and the number of
affected patients.
Additional ImmTAC Clinical Programs, page 138
16. With respect to your clinical programs described on pages 138 - 143,
please disclose, as
applicable, the number of patients (e.g., number of patients enrolled
and treated and the
criteria for participation in the study); duration of treatment,
dosage information; and the
specific endpoints established by the trial protocol.
Intellectual Property, page 148
17. Please revise to disclose for each material patent and patent
application the specific
product(s) to which such patents or patent applications relate, the
type of patent
protection, the expiration dates, and applicable jurisdictions.
Genentech Collaboration, page 151
18. Please revise to clarify when the royalty term is expected to expire.
GSK Collaboration, page 153
19. We note that you are entitled to royalties from GSK based on net sale
from mid-single-
digit percentage and a low double-digit. Please revise your description
of the royalty rates
FirstName LastNameBahija Jallal, Ph.D.
to provide a range that does not exceed ten percent (e.g., between
twenty and thirty
Comapany NameImmunocore
percent). Ltd when the patent underlying the royalty term
is expected to
Please also clarify
expire.
December 14, 2020 Page 4
FirstName LastName
Bahija Jallal, Ph.D.
FirstName LastNameBahija Jallal, Ph.D.
Immunocore Ltd
Comapany14,
December NameImmunocore
2020 Ltd
December
Page 5 14, 2020 Page 5
FirstName LastName
Lilly Collaboration, page 154
20. Please clarify when the patent underlying the royalty term is expected
to expire.
Consolidated Notes to the Financial Statements
1. Accounting policies
Revenue recognition, page F-9
21. With respect to each collaboration agreement, please clarify your
statement on pages 114
and F-9 that performance obligations are deemed satisfied when the
collaborator is
contractually entitled to exercise an option to obtain either
exclusive rights or benefit from
co-exclusive rights to the intellectual property license and whether
recognition is over
time or at a point in time consistent with IFRS paragraphs 31-38.
22. You state on page F-11 that reimbursements are recognized net of costs
where the Group
does not control the goods or services prior to transferring the goods
or services to the
collaboration partner. Please clarify your accounting policy for
reimbursements when the
Group controls the goods or services and tell us the basis for your
policy for
reimbursements.
3. Revenue & segmental reporting, page F-17
23. We note the collaboration agreements as described on pages 151-155.
For each of the
agreements with Genentech, GSK and Eli Lilly, please revise herein and
in the
corresponding June 30, 2020 footnote as applicable to clearly disclose
sufficient
information to enable users of financial statements to understand the
nature, amount,
timing and uncertainty of revenue and cash flows pursuant to IFRS 15
paragraphs 110-
128. For example, disclose the transaction price allocated to the
remaining performance
obligations that are unsatisfied as of December 31, 2019 and June 30,
2020, the
performance period or term of agreement and if revenue is recognized
over time or at a
point in time. Quantify both current and non-current deferred income
by collaboration
agreement for each period presented.
Exhibits
24. Please file the loan and security agreement with Oxford Finance
Luxembourg S.A.R.L.
and the assignment and exclusive license agreement with Adaptimmune
Limited as
exhibits to your registration statement or explain to us why they are
not required to be
filed.
Bahija Jallal, Ph.D.
FirstName LastNameBahija Jallal, Ph.D.
Immunocore Ltd
Comapany14,
December NameImmunocore
2020 Ltd
December
Page 6 14, 2020 Page 6
FirstName LastName
You may contact Jenn Do at 202-551-3743 or Mary Mast at 202-551-3613 if
you have
questions regarding comments on the financial statements and related matters.
Please contact
Alan Campbell at 202-551-4224 or Jeffrey Gabor at 202-551-2544 with any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Courtney T. Thorne, Esq.