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United States securities and exchange commission logo
September 2, 2021
Mei Mei Hu
Chief Executive Officer
Vaxxinity, Inc.
1717 Main St, Ste 3388
Dallas, TX 75201
Re: Vaxxinity, Inc.
Draft Registration
Statement on Form S-1
Submitted August 6,
2021
CIK No. 0001851657
Dear Ms. Hu:
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 S-1
Market, Industry and Other Data, page iii
1. Your statements that
(i) neither you nor the underwriters have independently verified any
third-party
information, (ii) data from your internal research has not been verified by any
independent source and
(iii) investors are cautioned not to place undue reliance on such
market and industry
data or any other such estimates may imply an inappropriate
disclaimer of
responsibility with respect to the third party information and internal
research. Please either
delete these statements or specifically state that you are liable for
such information.
Mei Mei Hu
FirstName
Vaxxinity, LastNameMei Mei Hu
Inc.
Comapany 2,
September NameVaxxinity,
2021 Inc.
September
Page 2 2, 2021 Page 2
FirstName LastName
Prospectus Summary, page 1
2. Please balance the disclosure in the Summary by addressing your
dependence on
intellectual property rights licensed from UBIA, your intent to enter
into a license
agreement with UBIA pursuant to which UBIA would commercialize UB-612
in Taiwan
should the EUA be approved while you would receive royalty payments,
and the
difficulties in manufacturing peptide-based medicines.
3. Please revise your disclosure here and in the Business section to
provide appropriate
context for various conclusions and predictions as to the performance
of your product
candidates and revise and/or remove any statements that imply safety
or efficacy as safety
and efficacy determinations are solely within the authority of the FDA
or similar foreign
regulators. For example, we note statements that one or more of your
product candidates
can "safely break immune tolerance and target self-antigens," have
safety profiles "at least
comparable to the competing mAb or small molecule alternative for the
relevant disease,"
penetrate the BBB at a higher rate than mAb, generate antibodies that
bind to the S1-
RBD protein and neutralize SARS-CoV-2, "have broken immune tolerance
against self-
antigens consistently, safely and at therapeutically meaningful
levels," "have stimulated
the development of antibodies against the desired target in clinical
trial subjects (including
the elderly) to develop antibodies against the desired target at
relevant doses," "help
achieve a relatively long duration of action, as B-cells continue to
produce antibodies
following a dose," "could offer similar efficacy as mAbs at a
meaningfully lower cost and
improved administrative convenience to patients, thereby potentially
allowing for access
to broader patient populations versus mAbs, and greater efficacy than
small molecules,"
"may have the potential to help ease the global COVID-19 pandemic,"
"have the potential
to be as or more effective than comparable mAb and small molecule
treatments," and that
you "believe the concentrations of antibodies elicited by [y]our
neurodegenerative disease
product candidates may potentially prove relevant for clinical
success." Please revise this
disclosure and similar statements throughout your prospectus to remove
any suggestion
that there is an expectation that your product candidates will be safe
or effective or will
have improved performance over approved therapies. You may provide a
summary of the
data that you used to draw these conclusions but not the conclusions
or predictions, and
such discussion is more appropriate in the Business section where full
and proper context
can be provided.
4. We note several comparisons to certain approved therapies in the
Summary and in the
Business section, including the chart on pages 3 and 109 comparing the
attributes of your
product candidates to mAbs and small molecule therapeutics. If you
have not conducted
head-to-head trials, please revise your disclosure to clearly state
this fact and disclose why
you believe these comparisons are appropriate. If you provide
disclosure regarding results
from other trials, expand your disclosure to provide the other
information regarding these
trials that would help an investor make a meaningful comparison and
understand the
supporting trials and any limitations and qualifications associated
with such trials (e.g.,
number of patients and whether any patients dropped out of the trial
or were otherwise
Mei Mei Hu
FirstName
Vaxxinity, LastNameMei Mei Hu
Inc.
Comapany 2,
September NameVaxxinity,
2021 Inc.
September
Page 3 2, 2021 Page 3
FirstName LastName
excluded and the reasons, patient population, dosage, how the baseline
was measured in
each study, the phase of the trial, serious adverse events, etc.).
Our Solution, page 2
5. Please revise to eliminate your conclusions as to the effectiveness
and safety of your
product candidates in the chart on pages 3 and 109 as findings of
safety and efficacy are
solely within the authority of the FDA and are assessed throughout all
clinical trial phases.
Our Pipeline, page 3
6. Please clarify what you mean by "IND" in the column header. It is not
clear what this
column is meant to reflect since you have UB-313, which has initiated
IND-enabling
studies, and PCSK9, which has yet to initiate IND-enabling studies
according to your
disclosure, with activity in this column.
Our Strategy, page 5
7. We note your disclosure here and in the Business section that your
strategy is to "rapidly
advance" your chronic disease pipeline. Please revise this disclosure
to remove any
implication that you will be successful in commercializing your
product candidates in a
rapid or accelerated manner as such statements are speculative.
Risks Related to Our Class A Common Stock and This Offering, page 65
8. Please expand your risk factor discussion to discuss that future
issuances of your Class B
common stock as well as mandatory and optional conversions of your
Class B common
stock may be dilutive to holders of your Class A common stock.
Use of Proceeds, page 77
9. Please revise your disclosure to indicate how far the proceeds from
the offering will allow
you to proceed with continued development of each program referenced.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Research and Development Expenses, page 92
10. We note the statement on page 89 that you track direct research and
development
expenses on a program-by-program basis. Please revise the filing to
provide more
quantified detail for your research and development expenses for each
period presented,
including but not limited to by product candidate as well as by the
type or nature of
expense.
Determination of the Fair Value of Common Stock, page 100
11. 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
Mei Mei Hu
FirstName
Vaxxinity, LastNameMei Mei Hu
Inc.
Comapany 2,
September NameVaxxinity,
2021 Inc.
September
Page 4 2, 2021 Page 4
FirstName LastName
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. Please discuss with the staff how to submit your
response.
Business, page 103
12. With respect to the discussion of the clinical trials for each of your
product candidates in
this section, please disclose whether any serious adverse events were
experienced, what
they were and how many subjects experienced them.
Our Strategy, page 106
13. We note that several steps of your strategy depend on approval of the
EUA for UB-612 in
Taiwan. Please make it clear in this section that there is no
guarantee that the EUA for
UB-612 will be approved and your intent to enter into a license
agreement with UBIA
pursuant to which UBIA would commercialize UB-612 in Taiwan should the
EUA be
approved while you would receive royalty payments.
Development Plans for UB-311, page 123
14. We note your disclosure that you expect that together, the Phase 2b
trial and the Phase 3
program, if successful, will provide sufficient data to enable filing
a BLA with the FDA.
Please revise to state that there is no guarantee that you will not
have to do additional
trials or studies prior to a BLA submission.
Our Product Candidate: UB-312, page 124
15. We note your statement here regarding your belief that the
concentrations of antibodies
elicited by your neurodegenerative disease product candidates may
potentially prove
relevant for clinical success, your statement on page 128 that a
capsaicin-induced dermal
blood flow model in mice has demonstrated strong translational value
into clinical
efficacy, and your statement on page 134 that the ratio of titers seen
in trials of UB-612 is
similar to that of other approved and clinical-stage vaccines that
have shown efficacy in
large placebo-controlled studies. These statements appear to imply an
expectation that
your product candidates will demonstrate clinical efficacy. Please
revise these statements
accordingly.
UBIA License Agreement, page 140
16. Please revise the reference to "mid-double-digit" royalties to a
royalty range within ten
percentage points (for example, between twenty and thirty percent).
Aurobindo License Agreement, page 141
17. Please revise to disclose a range for the tiered royalties no greater
than ten percent.
Mei Mei Hu
FirstName
Vaxxinity, LastNameMei Mei Hu
Inc.
Comapany 2,
September NameVaxxinity,
2021 Inc.
September
Page 5 2, 2021 Page 5
FirstName LastName
Principal Stockholders, page 171
18. Please revise your disclosure to identify the natural person or
persons who have voting
and investment control of the shares held by United Biomedical, Inc.
and the entities
affiliated with Prime Movers Lab Fund I LP.
Common Stock, page 173
19. Please disclose the percentage of outstanding shares that Class B
shareholders must
maintain to continue to control the outcome of matters submitted to
shareholders for
approval.
20. We note your disclosure that each share of Class B common stock will
automatically
convert into one share of Class A common stock upon any transfer,
whether or not for
value and whether voluntary or involuntary or by operation of law,
except for certain
transfers described in your charter, including, without limitation,
certain transfers for tax
and estate planning purposes. Please clarify the scope of this
exception. Explain the
circumstances under which these transfers may occur without automatic
conversion of the
shares and the parties to whom the shares may be transferred,
including whether shares
may be transferred upon death or total disability of a Class B holder
without conversion.
Description of Capital Stock, page 173
21. We note that you refer shareholders to, in part, the relevant
provisions of the Delaware
General Corporation Law. It is not appropriate to qualify your
disclosure by reference to
information that is not included in the filing or filed as an exhibit.
Please revise
accordingly.
Note 13 - Common stock, page F-26
22. We note from your combined consolidated statements of convertible
preferred stock and
stockholders' deficit on page F-5 that you issued 51,350,191 shares of
common stock
during the year ended December 31, 2020. Please disclose the
significant terms of the
transaction(s) of the common stock issuance.
General
23. 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.
Mei Mei Hu
Vaxxinity, Inc.
September 2, 2021
Page 6
You may contact Eric Atallah at 202-551-3663 or Kevin Kuhar at
202-551-3662 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Ada D. Sarmento at 202-551-3798 or Jeffrey Gabor at 202-551-2544 with
any other
questions.
Sincerely,
FirstName LastNameMei Mei Hu
Division of Corporation
Finance
Comapany NameVaxxinity, Inc.
Office of Life Sciences
September 2, 2021 Page 6
cc: Joseph D. Zavaglia, Esq.
FirstName LastName