United States securities and exchange commission logo
January 10, 2022
Vlad Vitoc, M.D., M.B.A.
Chief Executive Officer
MAIA Biotechnology, Inc.
4444 West Lake Street, Suite 1700
Chicago, IL 60606
Re: MAIA Biotechnology,
Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted December
22, 2021
CIK No. 0001878313
Dear Dr. Vitoc:
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 submitted
December 22, 2021
Cover page
1. Please revise to remove
the graphics that appear before the Summary as these graphics are
presented without
appropriate context for an investor to be able to evaluate your
disclosure. We refer to
our prior comment 3, which we reissue in part. Please revise to
disclose in the Summary
that you are working with experts to evaluate the extent and
quality of the existing
data supporting THIO, as referenced on page 89. Make clear in the
Summary the extent to
which you intend to rely on clinical data generated by third parties
and the basis for your
belief that you will be permitted to do so.
Vlad Vitoc, M.D., M.B.A.
FirstName LastNameVlad
MAIA Biotechnology, Inc.Vitoc, M.D., M.B.A.
Comapany
January 10,NameMAIA
2022 Biotechnology, Inc.
January
Page 2 10, 2022 Page 2
FirstName LastName
Our Lead Product Candidate, page 2
2. We note your response to our prior comment 4, which we reissue in
part. We note your
statement that "Similar high and durable anti-cancer activities of
THIO have been
consistently demonstrated in multiple preclinical models..." It is
inappropriate to present
conclusions that data establishes safety and/or efficacy. Please
revise your disclosure
accordingly. As additional examples, we note the following:
We believe we will generate favorable clinical safety data...
We believe this drug discovery program will lead to the
development of additional
proprietary drug candidates, more specifically with increased
efficacy and a better
safety profile across multiple cancer types.
Additionally, please revise to explain what you mean by "conditional
approval," as
referenced at the top of page 3.
Our Science--Driven Telomere Targeting Approach, page 3
3. We note your response to our prior comment 5, which we reissue. Please
revise your
presentation to present all of the necessary phases of clinical
development and an accurate
representation of how far along you are in the development process or
remove this graphic
in its entirety. Your revised presentation should make clear, if true,
that you have not yet
initiated your Phase 2 study of THIO-101 and that you plan to conduct
this study in
Australia and Europe. Please also delete from your pipeline table the
projected FDA
approval for THIO in NSCLC as such projection is premature and
speculative. Additionally, we note your revised disclosure stating
that you have initiated
an early-stage research and discovery program aimed at identifying new
compounds
capable of acting through similar mechanisms of activity as THIO.
However, you have not
provided any additional detail regarding these efforts or discussion
of your platform
elsewhere. Please revise to remove from the graphic the row
corresponding to your next
generation telomere targeting agents as this program does not appear
currently material.
We will not object to a narrative discussion of your early-stage
programs.
Risk Factors
Risks Related to Our Initial Public Offering and Ownership of Our Common Stock
Our amended and restated bylaws will designate the Court of Chancery of the
State of Delaware
as the sole and exclusive forum..., page 52
4. We note your response to our prior comment 10 and your disclosure that
the exclusive
forum provisions shall not apply to suits brought to enforce a duty or
liability created by
the Securities Act, the Exchange Act or any other claim for which the
federal courts have
exclusive jurisdiction, for which the federal district courts of the
District of Delaware shall
be the sole and exclusive forum unless the Company consents in writing
to the selection of
an alternative forum. Please revise to make clear that Section 22
of the Securities Act
creates concurrent jurisdiction for federal and state courts over all
suits brought to enforce
any duty or liability created by the Securities Act or the rules and
regulations thereunder.
Vlad Vitoc, M.D., M.B.A.
FirstName LastNameVlad
MAIA Biotechnology, Inc.Vitoc, M.D., M.B.A.
Comapany
January 10,NameMAIA
2022 Biotechnology, Inc.
January
Page 3 10, 2022 Page 3
FirstName LastName
Critical Accounting Policies and Significant Judgments and Estimates
Fair value of common stock, page 70
5. We acknowledge the changes made in response to comment number 15.
Please revise
throughout the filing to clarify what methodology was used to
determine the fair value of
your common stock (e.g. market or income approach) for each valuation
date. Reference
to the third-party valuation firm is not sufficient and the
straight-line interpolation for your
common stock is not an acceptable methodology.
Our Strategy, page 75
6. We note your response to our prior comment 17 and reissue. You still
make statements
implying that you will advancing your product candidates in a "rapid"
manner. For
example, we note your statements on pages 4 and 75 that "[Y]our
initial focus is to
leverage the existing preclinical and clinical data available for THIO
to support rapid and
cost-efficient development." Clinical development is a lengthy process
and statements that
imply you will be successful in developing your product candidates in
a rapid or
accelerated manner are inappropriate and speculative. Please revise
your disclosure
accordingly.
Current Landscape of the Checkpoint Inhibitor Franchises, page 76
7. We note your revisions and response to our prior comment 19. Please
revise to make
clear that THIO has not been tested in combination with any other
check-point inhibitor
and your current development plans are to initiate a Phase 2 study in
combination with
cemiplimab only. Please also clarify the significance of the years
under the indication
columns. If the dates are meant to indicate when the product was
either approved or
commercialized for the respective indication, please remove from the
table references to
checkpoint inhibitors that are in clinical development. Given the
inherent uncertainty of
drug development, it is speculative to imply that THIO could be used
in combination with
check-point inhibitors that have not been approved by the FDA.
Intellectual Property, page 77
8. We note your revisions and response to our prior comment 20 and
reissue in part. Please
expand your discussion of your intellectual property to disclose the
types of patents you
hold (i.e., composition of matter, use or process) for each patent.
Our Programs, page 80
9. We note your response to our prior comment 23. Please explain whether
earlier clinical
trials were powered for statistical significance. Where applicable,
disclose the relevant p-
values and explain how statistical significance relates to FDA
standards of efficacy.
Vlad Vitoc, M.D., M.B.A.
MAIA Biotechnology, Inc.
January 10, 2022
Page 4
Differentiated Activity of THIO, a Telomere-Targeting Agent, page 81
10. We your revisions in response to our prior comment 26 and reissue in
part. Please explain
the basis for your claim that "To our knowledge, THIO s cancer-specific
and direct
telomere targeting mechanism of action using telomerase is different from
all other
available cancer therapies and those currently in clinical trials."
THIO Program, page 92
11. We note your revisions in response to our prior comment 29. Please revise
to disclose the
dollar amount of the aggregate potential milestones segregated by
development,
regulatory and commercial sales milestones.
You may contact Eric Atallah at 202-551-3663 or Mary Mast at
202-551-3613 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jordan Nimitz at 202-551-6001 or Christine Westbrook at 202-551-5019
with any other
questions.
Sincerely,
FirstName LastNameVlad Vitoc, M.D., M.B.A.
Division of
Corporation Finance
Comapany NameMAIA Biotechnology, Inc.
Office of Life
Sciences
January 10, 2022 Page 4
cc: Mitchell S. Nussbaum, Esq.
FirstName LastName