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United States securities and exchange commission logo
September 30, 2021
Mei Mei Hu
Chief Executive Officer
Vaxxinity, Inc.
1717 Main St, Ste 3388
Dallas, TX 75201
Re: Vaxxinity, Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted September
16, 2021
CIK No. 0001851657
Dear Ms. Hu:
We have reviewed your amended 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 S-1
Prospectus Summary
Our Solution, page 2
1. Please revise your
disclosure to explain what you mean by your product candidates have
yielded "comparatively
high" response rates, "high" target-specific antibodies against self-
antigens and
"relatively long" durations of action in clinical trials conducted to date.
Please also revise your
disclosure to provide the data from the preclinical and clinical
studies that support
this statement.
2. Please revise to remove
the statement in the chart on pages 3 and 110 that your product
candidates penetrate
the BBB at a higher rate than mABs. It appears that this statement is
Mei Mei Hu
Vaxxinity, Inc.
September 30, 2021
Page 2
based on a preclinical trial and the first part of a Phase 1 clinical
trial of UB-312. It also
appears that these trials were not head-to-head trials with mABs.
Use of Proceeds, page 78
3. We note your revisions in response to prior comment 9. Please revise to
disclose whether
you will be able to complete your Phase 2 clinical trial for UB-311 with
the proceeds from
this offering and how far you expect to reach in the development of each
of your other
existing chronic disease product candidates and UB-612A with the
proceeds from this
offering.
Gross Profit, page 92
4. We note your discussion for the six months ended June 30, 2021 of gross
profit
percentage excluding the impairment of ELISA test inventory represents a
non-GAAP
measure. Please revise to include all of the disclosures required by
Item 10(e) of
Regulation S-K or modify the discussion to remove the non-GAAP measure.
Business
COVID-19 Program
Development Strategy, page 142
5. We note your disclosure that your preliminary data gives you reason to
believe that UB-
612A could be meaningfully more effective than UB-612. Please revise to
remove any
implication that UB-612 is effective since it has yet to be approved.
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 30, 2021 Page 2
cc: Joseph D. Zavaglia, Esq.
FirstName LastName