United States securities and exchange commission logo
March 1, 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. 2 to
Draft Registration Statement on Form S-1
Submitted February
14, 2022
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. 2 to Draft Registration Statement on Form S-1 submitted
February 14, 2022
Cover Page
1. We reissue our prior
comment 1. Please revise to remove the pipeline table graphic from
appearing before the
prospectus summary as the prominence of this graphic is not
appropriate. Further,
please revise your statement on page 2 that you "take added
confidence in the
potential safety of THIO..." to remove the implication that THIO is safe,
as determinations of
safety are within the sole authority of the FDA and comparable
foreign regulators. We
will not object to statements indicating you have added confidence
in the "potential
tolerability" of THIO.
Vlad Vitoc, M.D., M.B.A.
FirstName LastNameVlad
MAIA Biotechnology, Inc.Vitoc, M.D., M.B.A.
Comapany
March NameMAIA Biotechnology, Inc.
1, 2022
March2 1, 2022 Page 2
Page
FirstName LastName
Prospectus Summary, page 2
2. We note your statements throughout the prospectus that "Even if [you]
are granted an
accelerated approval pathway, that may or may not lead to a faster
development or
regulatory review or approval process and may or may not increase the
likelihood that
THIO will receive marketing approval." Please revise to affirmatively
state that the FDA's
accelerated approval pathways do not guarantee an accelerated review
or marketing
approval by the FDA.
Our Pipeline, page 4
3. We note your revisions in response to our prior comment 3 and reissue.
Your disclosure
indicates that you have not yet started a Phase 2 trial for THIO-101,
THIO-102, or THIO-
103, but the arrows for each candidate extend into the Phase 2 column.
Progress arrows should clearly depict the progress of each candidate
to date and should
not encroach on phases not commenced. Please shorten the arrows in the
pipeline chart to
match the current status of each trial as described in the Business
section. Please remove
from the graphic the rows corresponding to your second generation
telomere targeting
agents as these programs does not appear currently material.
Alternatively, please provide
us your analysis as to why these programs are sufficiently material to
warrant inclusion in
your pipeline table.
Business
Current Landscape of the Checkpoint Inhibitor Franchises, page 78
4. We note your revisions in response to our prior comment 7 and reissue
in part. Please
clarify the significance of the years under the indication columns in
the table on page 78
so that investors have the appropriate context to evaluate your
disclosure.
THIO: A Telomere Targeting Agent, page 85
5. We note your response to our prior comment 2, which we reissue. You
continue to make
statements in your prospectus that imply THIO's efficacy, such as
"THIO has
demonstrated high activity..." and "The below graphic... demonstrates
in vivo anticancer
activity of THIO." You may present objective data from clinical trials
but may not state or
imply that the data establishes or demonstrates efficacy. Accordingly,
please revise your
disclosure to remove any implication that THIO's efficacy is
established. Additionally,
revise to explain what you mean by conditional approval on page 75.
THIO Program, page 94
6. We note your response to comment 11, which we reissue in part. You
state in your
response letter that you supplemented your disclosure to explain that
milestone payments
under the license agreement only exist with respect to commercial
sales milestones as well
as the maximum dollar amount of the milestone payments. However, you
refer on page 96
Vlad Vitoc, M.D., M.B.A.
MAIA Biotechnology, Inc.
March 1, 2022
Page 3
and 98 to aggregate milestone payments that do not exceed "low
nine-figure fees." Please
revise to disclose the dollar amount of total potential aggregate
milestone payments under
the license agreements.
You may contact Eric Attalah 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
March 1, 2022 Page 3
cc: Mitchell S. Nussbaum, Esq.
FirstName LastName