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United States securities and exchange commission logo
November 15, 2021
Robert Hershberg, M.D., Ph.D.
Chief Executive Officer
HilleVax, Inc.
75 State Street
Suite 100 - #9995
Boston, MA 02109
Re: HilleVax, Inc.
Draft Registration
Statement on Form S-1
Submitted October
19, 2021
CIK No. 0001888012
Dear Dr. Hershberg:
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.
Robert Hershberg, M.D., Ph.D.
FirstName LastNameRobert Hershberg, M.D., Ph.D.
HilleVax, Inc.
Comapany 15,
November NameHilleVax,
2021 Inc.
November
Page 2 15, 2021 Page 2
FirstName LastName
Draft Registration Statement submitted on October 19, 2021
Overview, page 1
1. We note your disclosure that you plan to initiate a Phase 2b clinical
trial for HIL-214.
Please revise to disclose whether you will need to submit an
investigational new drug
application to the FDA before you can begin that trial and clarify
when you intend to
make such submission, if required. We also note your disclosure on
page 117 that you
have designed your planned Phase 2b clinical trial based on learnings
from the NOR-211
Phase 2b study as well as preliminary feedback Takeda received from
the FDA and
European Medicines Agency. Given this disclosure, please also
indicate, if true, that the
FDA may not accept or view the clinical trial results from Takeda,
other third parties, or
non-U.S. regulators as sufficient to allow you to advance to a Phase
2b study and may
require you to conduct additional trials before proceeding to a Phase
2b trial.
Summary, page 1
2. Please revise your disclosure to include a pipeline table illustrating
your clinical
development program for HIL-214.
3. Please balance your disclosure in the Summary to clarify that the nine
clinical trials of
HIL-214 to date have been conducted by Takeda and its predecessor,
LigoCyte
Pharmaceuticals, Inc., and that you have not yet completed any
clinical trials or submitted
an IND or its equivalent to the applicable regulatory agencies.
HIL-214 clinical data and development plan, page 4
4. We refer to your disclosure on page 4 that HIL-214 s adverse event
profile was observed
to be similar to that of approved alum-adjuvanted vaccines. Please
revise to expand your
disclosure of any adverse events that were observed in the clinical
trials in both infants
and adults.
Commercial opportunity, page 5
5. We note your disclosure here and elsewhere in the registration
statement that you believe
that Shingrix, a vaccine developed to prevent shingles, is a market
analogue for HIL-214
for purposes of estimating your market opportunity. In an appropriate
location in your
prospectus, please expand your discussion to support this statement.
Robert Hershberg, M.D., Ph.D.
FirstName LastNameRobert Hershberg, M.D., Ph.D.
HilleVax, Inc.
Comapany 15,
November NameHilleVax,
2021 Inc.
November
Page 3 15, 2021 Page 3
FirstName LastName
Our team and investors, page 6
6. We note that you identify a group of "leading investors" in your
company in this section,
however, some of these investors do not appear to be among the
principal stockholders
that are identified on page 168. Please relocate this disclosure from
your prospectus
summary to your "Principal Stockholder" section. We note in this
regard that the
identification of the pre-IPO investors in your prospectus summary may
appear to suggest
that potential investors in your public offering consider investments
made by the pre-IPO
investors as a factor in making an investment decision without
knowing, among other
things, the amount of each pre-IPO investor s investment in total or
on a per share basis,
their investment strategies or whether those investors will continue
to hold their shares in
the future, as some of the pre-IPO investors may not be subject to the
reporting
requirements of Section 16 of the Exchange Act, and investors in your
public offering will
not necessarily know when some of the pre-IPO investors decide to sell
any of their
shares. In addition to relocating this disclosure, please limit any
textual description of your
pre-IPO investors in your "Principal Stockholders" section to the
investors identified in
that table.
Summary of risks related to our business, page 7
7. We refer to your disclosure on pages 37 and 119 that a key element of
your commercial
strategy is to receive advisory body recommendations for the use of
HIL-214, particularly
from the Advisory Committee on Immunization Practices (ACIP) of the
CDC. Please
include as a principal risk factor the risk to your business in the
event your vaccine
candidate is not recommended by ACIP.
Risk factors, page 14
8. We note your disclosure on page 156 that the administrator of the 2022
Plan may, without
the approval of stockholders, amend any outstanding stock option or
SAR to reduce its
price per share, other than in the context of corporate transactions
or equity
restructurings. Please include appropriate risk factor disclosure,
including whether proxy
advisory firms could find such repricing without stockholder approval
contrary to a
performance-based pay philosophy.
We face significant competition..., page 39
9. We refer to your disclosure relating to your competitors who are also
developing a
vaccine for norovirus. Please disclose whether any of your competitors
are also focused
on developing a vaccine consisting of VLPs representing the GI and GII
genogroups of
norovirus. Please also disclose whether any of your competitors are
also developing
pediatric vaccines for the prevention of norovirus-related illness.
Robert Hershberg, M.D., Ph.D.
FirstName LastNameRobert Hershberg, M.D., Ph.D.
HilleVax, Inc.
Comapany 15,
November NameHilleVax,
2021 Inc.
November
Page 4 15, 2021 Page 4
FirstName LastName
Our amended and restated certificate of incorporation and amended and restated
bylaws..., page
74
10. We note your disclosure on page 74 that the forum selection in your
amended and restated
certificate of incorporation and bylaws may limit a shareholder's
ability to bring a claim in
a judicial forum that it finds favorable for disputes with you and may
discourage such
lawsuits. Please revise this risk factor to disclose that there is
also a risk that your forum
selection provision may result in increased costs for investors to
bring a claim.
Special note regarding forward-looking statements, page 80
11. We note your statement cautioning investors not to rely on
forward-looking statements
and projections in your prospectus. These statements may imply an
inappropriate
disclaimer of responsibility; therefore, please either remove the
potential disclaiming
language or clearly state in this section that you are liable for such
information.
Use of proceeds, page 82
12. Please revise to disclose how far the proceeds you plan to allocate
from the offering
toward the clinical development of HIL-214 will allow you to proceed
with such
program. Refer to Instruction 3 to Item 504 of Regulation S-K.
Management's discussion and analysis of financial condition and results of
operations
Critical accounting policies and significant judgments and estimates, page 98
13. 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 IPO and the estimated offering price. This information will
help facilitate our
review of your accounting for equity issuances including stock
compensation and
beneficial conversion features. Please discuss with the staff how to
submit your response.
Business, page 100
14. Please clarify the meaning of scientific or technical terms the first
time they are used in
order to ensure that all investors will understand the disclosure. For
example, please
briefly explain what you mean by bivalent, immunogenicity and
seroresponse rates.
Dose finding and formulation trials in adults, page 112
15. We refer to your disclosure of the dose finding and formulation trials
and efficacy trials
conducted in adults starting on page 112. Please expand your
disclosure of the scope and
design of the trials, including the size of each trial and the type of
placebo used, whether
the dose finding trials were powered for statistical significance,
whether any adverse side
effects were observed and to discuss the data from the results to
support the conclusions
drawn concerning immunogenicity, as applicable.
Robert Hershberg, M.D., Ph.D.
HilleVax, Inc.
November 15, 2021
Page 5
Safety results in infants and children, page 115
16. We note your disclosure on pages 115 and 116 of the adverse events and
reactions
observed in infants, children and older adults in the NOR-202 and
other clinical trials for
HIL-214. Please revise to clarify the number of participants who
experienced the adverse
effects referenced.
Phase 2b infant efficacy trial, page 117
17. We note your disclosure that subjects in your planned Phase 2b infant
efficacy trial will
receive HIL-214 (50/150 g GI.1/GII.4 VLP combination with 500 g
alum) in a two-
dose regimen delivered 28 to 56 days apart and that you have designed
your planned
Phase 2b clinical trial based on learnings from the NOR-211 Phase 2b
study as well as
preliminary feedback Takeda received from the FDA and European
Medicines
Agency. We also note your disclosure on page 112 regarding the dosage
and scheduling
for infants in the NOR-202 trial. If your dosage and scheduling in
your Phase 2b infant
efficacy trial also will be based on data from NOR-202, please revise
to make that clear
and indicate the dosing schedule for infants in NOR-202.
Intellectual property, page 120
18. We note your disclosure relating to the nine patent families of your
patent
portfolio. Please clarify your disclosure to identify for each patent
family the scope and
technology of each such patent family or patent application, the type
of patent protection
(such as composition of matter, use or process), the applicable
jurisdiction of the issued
foreign patents and foreign pending patent applications and expiration
years.
License agreement and clinical manufacturing and supply agreement, page 164
19. We note your disclosure that in connection with the Takeda License,
you provided Takeda
with various investor rights, including pre-emptive rights, drag along
rights, voting rights
and certain registration rights. Please clarify whether these rights
will terminate upon the
closing of your public offering.
Principal stockholders, page 168
20. In your revised prospectus, please identify in the footnote to your
table the natural persons
who are the beneficial owners of the shares held by Takeda Vaccines,
Inc., as applicable.
Financial
FirstNameStatements, page F-1
LastNameRobert Hershberg, M.D., Ph.D.
Comapany
21. NameHilleVax,
Please Inc.a description of your capital stock and
disclose the terms of all
revise to provide
common
November and Page
15, 2021 preferred
5 shares, warrants, etc. in the footnotes to your
financial statements.
FirstName LastName
Robert Hershberg, M.D., Ph.D.
FirstName LastNameRobert Hershberg, M.D., Ph.D.
HilleVax, Inc.
Comapany 15,
November NameHilleVax,
2021 Inc.
November
Page 6 15, 2021 Page 6
FirstName LastName
General
22. 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.
You may contact Julie Sherman at 202-551-3640 or Terence O'Brien at
202-551-3355 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Jane Park at 202-551-7439 or Tim Buchmiller at 202-551-3635 with any
other questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Cheston J. Larson, Esq.