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United States securities and exchange commission logo
June 16, 2021
Tillman U. Gerngross, Ph.D.
Chief Executive Officer
Adagio Therapeutics, Inc.
303 Wyman Street, Suite 300
Waltham, MA 02451
Re: Adagio
Therapeutics, Inc.
Draft Registration
Statement on Form S-1
Submitted May 21,
2021
CIK No. 0001832038
Dear Dr. Gerngross:
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 submitted May 21, 2021
Prospectus Summary
Overview, page 1
1. We note your disclosure
on page 1 that "ADG20 has demonstrated an ability to potently
neutralize SARS-CoV-2,"
that "[p]otent neutralization has translated into the ability to
conveniently deliver
ADG20 as a single . . . injection," that "[i]nterim data has
demonstrated safety
[and] tolerability." As safety and efficacy determinations are solely
within the FDA's
authority and they continue to be evaluated throughout all phases of
clinical trials, please
remove these and any such references in your prospectus. In your
Business section, you
may present clinical trial endpoints and objective data resulting
from trials without
concluding efficacy and you may state that your product candidates
Tillman U. Gerngross, Ph.D.
FirstName LastNameTillman U. Gerngross, Ph.D.
Adagio Therapeutics, Inc.
Comapany
June NameAdagio Therapeutics, Inc.
16, 2021
June 16,
Page 2 2021 Page 2
FirstName LastName
have been well tolerated, if accurate. Please revise these and similar
statements here and
throughout the document that profess or imply safety or efficacy.
ADG20: Our Solution for the Treatment and Prevention of COVID-19, page 3
2. We note your disclosure on page 4 that your STAMP trial is "a combined
Phase 2/3
clinical trial designed to provide a rapid path to authorization,
marketing approval and
commercial launch" and on page 5 that your strategy is to "rapidly
complete development
and obtain global approval for...ADG20." Please replace your use of
the terms "rapid"
and "rapidly" with specific disclosure regarding the development or
regulatory approval
process that you believe will abbreviate your path towards
commercialization. In this
regard, we note your disclosure on pages 19 and 20 that clinical
testing is expensive and
can take many years to complete, and its outcome is inherently
uncertain and depends on
numerous factors.
Risk Factors
Risks Related to the Manufacturing of our Product Candidates, page 32
3. In the risk factor on page 34, you discuss your relationship with
WuXi, a CDMO in
China. In the next risk factor on page 36, you disclose your reliance
on a sole supplier of
the purification resins and cell culture media and a Chinese CDMO,
without identifying
those companies. Revise to clarify if you are referring to WuXi, and
if not, name the
other entity or entities. We note the discussion of WuXi on page 136
and elsewhere in the
prospectus. Refer to Item 101(h)(4)(v) of Regulation S-K.
Risks Related to This Offering, Ownership of Our Common Stock and Our Status as
a Public
Company, page 72
4. Please revise the exclusive forum risk factor beginning on page 78 to
disclose that there is
also a risk that your forum selection provisions may result in
increased costs for investors
to bring a claim.
Market and Industry Data, page 84
5. You state here regarding third party research relied upon or cited in
your document that
"the sources of such data cannot guarantee the accuracy or
completeness of such
information" and "while we are not aware of any misstatements
regarding the third-party
information and we believe that each of these studies and publications
is reliable," the
risks cited in the prospectus and "other factors could cause results
to differ materially from
those expressed in the estimates made by third parties." These
statements may imply an
inappropriate disclaimer of responsibility with respect to the third
party information and
your own research. Please either delete these statements or
specifically state that you are
liable for the disclosure in your document.
Tillman U. Gerngross, Ph.D.
FirstName LastNameTillman U. Gerngross, Ph.D.
Adagio Therapeutics, Inc.
Comapany
June NameAdagio Therapeutics, Inc.
16, 2021
June 16,
Page 3 2021 Page 3
FirstName LastName
Business, page 112
6. Revise the graphics throughout this section so the fonts are large
enough to be legible.
We note in particular the graphics on pages 124 and 129.
Preclinical Data, page 125
7. We note the table on page 126 that depicts the potency and
neutralizing activity of
ADG20 and what appear to be other products in development. Please
confirm whether the
rows below ADG20 depict other products in development and disclose how
these specific
products were chosen to compare against ADG20.
Manufacturing Strategy, page 136
8. Please expand your discussion of the WuXi cell license agreement to
disclose the royalty
rate or a reasonable range not exceeding 10 percentage points, the
royalty term, and the
amount required to buy out your royalty obligations.
Licenses, Collaborations and Partnerships, page 137
9. Revise your disclosure of the agreements with Adimab to more
specifically disclose the
fees payable to them, which are currently described as in the "low
six-digit' and "low
seven-digit" dollar amounts. Please also disclose the total payments
made to date.
Principal Stockholders, page 181
10. Please identify the natural person or persons who directly or
indirectly exercise sole or
shared voting and/or dispositive power with respect to the common
stock held by entities
affiliated with GV. Refer to Item 403 of Regulation S-K.
Exhibits
11. Please file as exhibits to the registration statement the employment
or consulting
agreements with each of your named executive officers. Refer to Item
601(b)(10)(iii) of
Regulation S-K.
General
12. Please 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.
Tillman U. Gerngross, Ph.D.
Adagio Therapeutics, Inc.
June 16, 2021
Page 4
You may contact Tara Harkins at 202-551-3639 or Al Pavot at 202-551-3738
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Abby Adams at 202-551-6902 or Irene Paik at 202-551-6553 with any other
questions.
Sincerely,
FirstName LastNameTillman U. Gerngross, Ph.D.
Division of
Corporation Finance
Comapany NameAdagio Therapeutics, Inc.
Office of Life
Sciences
June 16, 2021 Page 4
cc: Divakar Gupta
FirstName LastName