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United States securities and exchange commission logo
February 21, 2021
Stephen Hurly
Chief Executive Officer
LAVA Therapeutics BV
Yalelaan 60
3584 CM Utrecht, the Netherlands
Re: LAVA Therapeutics
BV
Draft Registration
Statement on Form F-1
Submitted January
25, 2021
CIK No. 0001840748
Dear Mr. Hurly:
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
Cautionary statement regarding forward-looking statements, page ii
1. Please revise the last
sentence of this section to indicate that you will update or
revise forward-looking
statements to the extent required by applicable law.
Overview, page 1
2. Please remove any
references to the company being a clinical-stage biotechnology
company until you
initiate a Phase 1 clinical trial.
3. We note your statement
here that data collected in preclinical trials demonstrate your
gamma-delta bsTCEs
kills patient-derived tumor cells with "high potency and selectivity."
Stephen Hurly
FirstName LastNameStephen Hurly
LAVA Therapeutics BV
Comapany21,
February NameLAVA
2021 Therapeutics BV
February
Page 2 21, 2021 Page 2
FirstName LastName
We also note the disclosure that LAVA-051 is designed to be an
"effective" anti-tumor
agent against CD1d-expressing tumor cells. As your product candidate
has not received
FDA approval, it is premature to suggest or imply that it is
effective. Please revise your
disclosure here and any similar statements throughout the prospectus
accordingly.
4. We note your disclosure here and elsewhere in your prospectus that
gamma-delta bsTCE
could materially improve clinical responses while maintaining a
"favorable safety profile."
Since this disclosure may imply that your product candidate is safe,
and safety
determinations are solely within the authority of the FDA and
comparable regulatory
bodies, please revise your disclosure to remove this implication. We
also note the
disclosure that you demonstrated that the CD1d-binding moiety of the
bsTCE led to
effective iNKT cell activation and anti-tumor activity. Please provide
the basis for this
statement. Please revise throughout including where you indicate your
gamma-delta
bsTCE platform has the potential to generate potent and safe
therapeutics.
Our pipeline, page 3
5. Please revise your product pipeline table as follows:
For purposes of consistency with the discussion of the
regulatory drug approval
process, replace the term "Pivotal" with Phase 3. If "Pivotal" is
intended to mean
something other than Phase 3, please provide further explanation.
We note you have created a distinction between "preclinical"
and "IND-enabling." As
"IND-enabling" studies are preclinical, please revise your table
to show all your
product candidates in the preclinical phase.
Your table indicates that the Phase 1/2a clinical trial for
LAVA-051 has begun but
elsewhere you state that LAVA-051 has not yet entered the clinic.
Please revise the
arrows in the pipeline table to accurately reflect where each
product candidate is in
development.
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. In this regard, we note your disclosure page 104 that
patients from the
U.S. would be included in the Phase 1 part of your clinical trial
for LAVA-051, if
approved.
We note the last two rows in your pipeline table with unnamed
product candidates
and "undisclosed targets" that are not discussed elsewhere in the
prospectus. To the
extent these are material programs, disclose the targets and
provide descriptions of
these programs. If you have not yet identified product candidates
or target
indications, please remove them from the table or explain the
basis for your belief
that they are material and should be included in your pipeline
table.
Please also state whether larger Phase 2b clinical trials will be
required prior to
commencing Phase 3 clinical trials and if so, please revise your table
to clarify that there
will be multiple Phase 2 trials.
Stephen Hurly
LAVA Therapeutics BV
February 21, 2021
Page 3
Use of proceeds, page 83
6. Please revise your disclosure in this section to specify which
candidates will be advanced
with the proceeds of the offering and which clinical trials will be
funded. Please indicate
how far you expect the proceeds from the offering will allow you to
proceed in the clinical
development of your product candidates. If the anticipated proceeds
from your offering
will not be sufficient to complete those trials, please disclose the
amount and sources of
other funds needed.
Series C preferred financing, page 92
7. Please revise to disclose the milestones that would have to be
satisfied in order to close
the remaining two trances of your Series C preferred financing. Please
also clarify if
those tranches could be closed after your public offering and if
preferred stock would be
issued please include risk factor disclosure if appropriate.
VUmc agreement, page 140
8. We note you are obligated to pay VUmc a tiered percentage of your
value upon the listing
of majority of your shares on a stock exchange. Please clarify if the
current offering will
trigger this payment obligation and quantify the amount that would be
due.
Janssen collaboration and license agreement, page 141
9. Please specify the research stages that must be completed before
milestone payments
become payable pursuant to the agreement and disclose the aggregate
amount of of those
payments. Please also quantify the royalties payable under the the
agreement upon
commercialization and the fixed period for which royalties are
payable.
Government regulation, page 146
10. Please include a description of the material foreign regulations that
apply to the
development of your product candidates or include disclosure, if true,
indicating the
process is substantially similar to the process in the United States.
Principal shareholders, page 168
11. Please include footnotes to your table that disclose the natural
persons who
have beneficial ownership of the shares held by each of the entities
listed in your table.
Exhibits
FirstName LastNameStephen Hurly
12. Please revise to mark exhibits 10.1 and 10.2 to indicate, if true, that
certain portions of
Comapany
theseNameLAVA
exhibits haveTherapeutics BVbecause they are both not material and
would likely
been redacted
cause
February 21, competitive
2021 Page 3harm if publicly disclosed.
FirstName LastName
Stephen Hurly
FirstName LastNameStephen Hurly
LAVA Therapeutics BV
Comapany21,
February NameLAVA
2021 Therapeutics BV
February
Page 4 21, 2021 Page 4
FirstName LastName
General
13. Please provide us with supplemental 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,
have presented or expect to present to potential investors in reliance
on Section 5(d) of the
Securities Act, whether or not you retained, or intend to retain,
copies of those
communications. Please contact the staff member associated with the
review of this filing
to discuss how to submit the materials, if any, to us for our review.
You may contact Christie Wong at 202-551-3684 or Al Pavot at
202-551-3738 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Chris Edwards at 202-551-6761 or Tim Buchmiller at 202-551-3635 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Joshua A. Kaufman, Esq.