United States securities and exchange commission logo
November 15, 2021
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.
Draft Registration
Statement on Form S-1
Submitted October
15, 2021
CIK No. 0001878313
Dear Dr. Vitoc:
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 October 15, 2021
Prospectus Summary, page 6
1. We note your statement
on page 6 that your lead product candidate is a "potential first-in-
class telomere
targeting agent and several other references to first-in-class on
pages 65,
71, 78, 80, and
elsewhere in the prospectus. This term suggest that the product candidate
is effective and likely
to be approved by the FDA. Please delete these references
throughout your
registration statement. To the extent your use of this term was intended to
convey your belief that
the product is based on a novel technology or approach and/or is
further along in the
development process, you may discuss how your technology differs
from technology used by
competitors and, as applicable, that you are not aware of
competing products that
are further along in the development process. Statements such as
Vlad Vitoc, M.D., M.B.A.
FirstName LastNameVlad
MAIA Biotechnology, Inc.Vitoc, M.D., M.B.A.
Comapany 15,
November NameMAIA
2021 Biotechnology, Inc.
November
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these should be accompanied by cautionary language that the statements
are not intended
to give any indication that the product candidate has been proven
effective or that it will
receive regulatory approval.
2. We note your statement that "The unique primary activity of THIO is
based on two
distinct Nobel Prize winning discoveries." Please revise to clarify
that THIO was not the
subject of Nobel Prizes and that the prizes relate to telomere
discoveries. The statement
currently implies that THIO was the subject of the Nobel Prizes.
Our Company, page 6
3. 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 86. Your
Summary should present a factual and balanced presentation of your
business. Please
revise to provide a discussion of the challenges you face in
implementing your business
strategy, including, but not limited to, that earlier clinical trials
of THIO were abandoned,
as referenced on page 80, and that you may face early generic
competition for THIO, as
referenced on page 29. To the extent that you intend to rely on
clinical data generated by
third parties, revise to make this clear and provide the basis for
your belief you will be
able do so. Where you discuss earlier preclinical and clinical
studies, revise to disclose
who conducted such studies, when the studies were conducted and
whether endpoints
were met.
Where you discuss your supply agreement with Regeneron, revise to make
clear the
nature of Regeneron s obligations and avoid characterizing this
agreement as a co-
development collaboration. As examples only, we note your reference on
page 8 to
strategic collaborations similar to and potentially more broadly
than [your] existing
agreement with Regeneron and on page 88 to using this technology
in collaboration
with Regeneron .
Our Lead Product Candidate , page 6
4. We note your disclosure in the second paragraph of this section.
Please revise to remove
your conclusions here and throughout your registration statement that
earlier data
establishes efficacy or proof-of-concept. You may describe the data
collected in
preclinical and clinical studies and any observations that support
continued development
efforts but may not imply that the data establishes efficacy or
proof-of-concept.
Our Development Pipeline, page 7
5. Given the lengthy timeline and uncertainty with regard to clinical
development, it appears
premature and inappropriate to present completion dates for your
planned Phase 2 studies.
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. We will not object to a narrative
discussion of your
clinical development plans. Be sure to include separate columns for
each phase of
Vlad Vitoc, M.D., M.B.A.
FirstName LastNameVlad
MAIA Biotechnology, Inc.Vitoc, M.D., M.B.A.
Comapany 15,
November NameMAIA
2021 Biotechnology, Inc.
November
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development. Please make similar revisions to the chart on page 88.
Additionally, please
tell is why you believe your 2nd Generation Telomeres Targeting
Agents program is
sufficiently material to warrant inclusion. In this regard, we note
that you have not
provided additional detail concerning your activities to date in the
Business section.
6. The graphic provided on page 7 contains text that is illegible. Please
revise this figure
accordingly. In addition, several graphics on pages 83-85 contain
abbreviations that are
not defined. Please define abbreviations in all graphics here and
elsewhere. Additionally,
all graphics throughout the prospectus, including those on pages
83-85, should be
accompanied by narrative disclosure that clearly explains the context
for the graphic.
Implications of Being an Emerging Growth Company, page 8
7. 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. Please contact the staff member
associated with the
review of this filing to discuss how to submit such copies.
Summary of Risk Factors, page 12
8. Please add a bullet point highlighting the risk that the FDA may
require the approval of a
companion diagnostic in order for your to market THIO, as referenced
on pages 25-26.
Risk Factors
We Risks Related to Development, Clinical Testing, Manufacturing and Regulatory
Approval
We may face future business disruption and related risks resulting from the
recent outbreak...,
page 17
9. Please revise to update your risk factor disclosure concerning the
impact COVID-19 has
had or is anticipated to have on your clinical development plans. In
this regard, we note
your disclosure on page 65 that you plan to enroll up to 164 patients
in your Planned
Phase 2 study in Australia. Similarly, please update your related
disclosure on page 66.
Risks Relating to Our Initial Public Offering and Ownership of our Common Stock
Our amended and restated bylaws will designate the Court of Chancery, page 55
10. We note your disclosure that your amended and restated bylaws will
designate the Court
of Chancery of the State of Delaware as the exclusive forum for
certain actions, including
any derivative action. However, you also state that the federal
district courts of the U.S.
will be the sole and exclusive forum for the resolution of any action
arising under the
Securities Act, the Exchange Act or the rules and regulations
thereunder. Further, you
state on page 126 that your bylaws will not apply to any suits brought
to enforce any duty
or liability created by the Securities Act or the Exchange Act or any
other claim for which
the federal courts have exclusive jurisdiction. Please reconcile your
disclosure for
consistency and disclose in your Risk Factors whether the exclusive
forum provision
Vlad Vitoc, M.D., M.B.A.
FirstName LastNameVlad
MAIA Biotechnology, Inc.Vitoc, M.D., M.B.A.
Comapany 15,
November NameMAIA
2021 Biotechnology, Inc.
November
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applies to actions arising under the Securities Act or Exchange Act.
In this regard, we note
that Section 27 of the Exchange Act creates exclusive federal
jurisdiction over all suits
brought to enforce any duty or liability created by the Exchange Act
or the rules and
regulations thereunder, and 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. If this
provision does not apply
to actions arising under the Securities Act or Exchange Act, please
also ensure that the
exclusive forum provision in the governing documents states this
clearly.
Industry and Other Data, page 59
11. Your statement that you have not independently verified statistical,
market and other
industry data may imply an inappropriate disclaimer of responsibility
with respect to this
information. Please either delete this statement or specifically state
that you are
responsible for such information.
Use of Proceeds, page 60
12. Please revise your disclosure to include the estimated amount of
proceeds you plan to
allocate for each of the uses identified. In addition, provide an
estimate of how far in the
clinical development process for THIO the allocated proceeds of the
offering will enable
you to reach. Please also disclose the sources of other funds needed
to reach regulatory
approval and commercialization for THIO. Refer to Instruction 3 to
Item 504 of
Regulation S-K.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Operating Expenses, page 66
13. We note in your discussion of General and administrative expenses, you
cite factors such
as increased compensation expense and payroll expense, but you do not
discuss the
underlying factors contributing to the increased expenses. Please
revise to expand your
disclosure to describe the underlying reasons in quantitative and
qualitative terms that
impacted your operating expenses.
Critical Accounting Policies and Significant Judgments and Estimates
Fair value of common stock and Stock-based compensation, page 69
14. 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
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
and beneficial conversion features. Please discuss with the staff how
to submit your
response.
15. Disclose the specific methodologies and the nature of assumptions used
to determine the
Vlad Vitoc, M.D., M.B.A.
FirstName LastNameVlad
MAIA Biotechnology, Inc.Vitoc, M.D., M.B.A.
Comapany 15,
November NameMAIA
2021 Biotechnology, Inc.
November
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fair value of your common stock for the periods presented. State that
the estimates are
highly subjective and once the company's initial public offering is
effective these
estimates will no longer be necessary since the fair value will be
based on the trading
value of the company's common stock.
Business, page 71
16. You make several assertions regarding the safety and efficacy of your
product candidate.
Safety and efficacy determinations are solely within the authority of
the FDA or
applicable foreign regulator. You may present clinical trial end
points and objective data
resulting from trials without concluding efficacy and you may state
that your product
candidate has been well tolerated, if accurate. Please revise or
remove
statements/inferences throughout your prospectus that your product
candidate is safe
and/or effective. As a non-exhaustive list of illustrative examples
only, we note the
following:
On page 6, "When THIO was administered to mice at low doses...
complete tumor
regression with no recurrence was achieved, representing a
curative or nearly curative
effect."
On page 65, "THIO...has demonstrated curative or near-curative
effect in preclinical
models of telomerase positive cancers when administered in
advance..."
On page 78, "THIO inhibited the cancer cell viability of colon
and lung cancers while
normal human cells were largely unaffected."
On page 79, "In 2019, further non-clinical research in synergic
and humanized mouse
models of telomerase-expressing cancers uncovered previously
unknown activity of
THIO, specifically resulting from its efficient killing of cancer
cells."
On page 80, "As a result of these prior human studies, THIO has
a well-established
safety profile," "In addition to a well-established safety
profile, THIO has shown a
promising efficacy profile in prior clinical and human
studies...", " We believe there
is reduced safety risk (compared to higher doses used in early
clinical studies) and
increased chance of efficacy based on the previously shown
clinical effects of THIO
combined with the current insights from the recently identified
evidence of its
immune-activating effects. "
In the graphic on page 81, "Newly discovered unprecedented
immunogenic activity."
On page 81, "although...results of unrelated clinical trials of
different drugs cannot be
relied upon as proof of comparative efficacy or safety, these
results are promising."
On page 82, "Extensive preclinical studies have been performed
to validate THIO's
primary mechanism of action: targeting telomeres directly,
killing cancer cells via
telomerase-mediated DNA damage."
On page 82, "in vivo, THIO....followed by an immune checkpoint
inhibitor ...resulted
in cures in NSCLC and CRC syngeneic tumor models."
On page 82 and 85, "we hypothesized that THIO...will
effectively 'prime' the tumor
environment and initiate an overall anti-tumor immune response,"
and "THIO alone
has shown high anti-cancer activity."
Vlad Vitoc, M.D., M.B.A.
FirstName LastNameVlad
MAIA Biotechnology, Inc.Vitoc, M.D., M.B.A.
Comapany 15,
November NameMAIA
2021 Biotechnology, Inc.
November
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On page 83, "THIO appears to be highly effective in vitro at
selectively killing cancer
cells with active enzyme telomerase versus normal cells," and
"THIO, as a single
agent, showed in vitro activity in cancer cells "
On page 86, "We believe there is reduced safety risk (compared
to higher doses used
in early clinical studies) and increased chance of efficacy based
on the previously
shown clinical effects of THIO combined with the current insights
from the recently
identified evidence of its immune-activating effects."
Our Strategy, page 72
17. We note your disclosure in this section that you intend to "rapidly
advance...THIO,
through clinical studies and toward accelerated approval". We also
note your disclosure
on page 7 that your focus is to leverage THIO's history to support
"rapid" development.
Please revise these statements to remove any implication that you will
be successful in
advancing your product candidates in a rapid or accelerated manner as
such statements are
speculative.
18. We note your intention to pursue an accelerated approval pathway.
Please revise to
include balancing disclosure that an accelerated approval pathway may
not lead to a faster
development or regulatory review or approval process and does not
increase the likelihood
that your product candidate will receive marketing approval.
Current Landscape of Checkpoint Inhibitor Franchises, page 74
19. We note that you have included in the table on page 74 sales of
checkpoint inhibitor
franchises marketed by third parties. Please tell us why the
information presented in the
table is material to an understanding of your business. Alternatively,
please remove this
graphic.
Intellectual Property, page 74
20. We note your disclosure of your license agreements with UTSW, as well
as your
disclosure on page 65 of your provisional patent application. Please
expand your
discussion of your intellectual property to disclose the types of
patents you hold (i.e.,
composition of matter, use or process), whether they are owned or
licensed, patent
expiration dates or expected expiration dates for your patent
applications, the applicable
jurisdictions where patents are granted or where patent applications
are pending.
Our Team, page 75
21. Please revise to briefly discuss the roles and responsibilities of
your Special Advisory
Board and any related compensation arrangements.
Our Programs, page 77
22. Please expand your disclosure on pages 85-86 to provide a textual
discussion of the
clinical trials listed in your chart, including a material description
of the studies, including
Vlad Vitoc, M.D., M.B.A.
FirstName LastNameVlad
MAIA Biotechnology, Inc.Vitoc, M.D., M.B.A.
Comapany 15,
November NameMAIA
2021 Biotechnology, Inc.
November
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when they were conducted, the endpoints of the trials, whether or not
the trials achieved
those endpoints, whether or not the data from the trial was found to
be statistically
significant, including the P-value, and drug related serious adverse
events and the number
of patients who experienced them. Address in your revisions how ORR,
PR and CR were
measured.
23. We note use of p-values on page 80. At first use, please explain how
"p-value" is used to
measure statistical significance and the relevance of statistical
significance to the FDA's
evidentiary standards for drug approval.
Targeting Telomeres via Telomerase to Kill Cancer, page 77
24. Please provide narrative disclosure explaining the graphic on page 78.
As currently
presented, it is not clear what the graphic is intended to represent.
Differentiated Activity of THIO, a Telomere-Targeting Agent, page 78
25. Your graphic representation of your theoretical method of action on
page 79 suggests that
you are farther along in the development process. Please remove it.
THIO: A Potential First-in-Class Telomere Targeting Agent, page 80
26. We note your statement on page 81 that "To [y]our knowledge, THIO s
cancer-specific
telomere targeting by using telomerase is different from all other
available cancer
therapies and those currently in clinical trials," as well as your use
of "novel" and
"unique" throughout the prospectus. Please expand your disclosure to
provide the basis for
these claims.
27. We note your comparison of THIO to approved drugs marketed by third
parties. To the
extent you did not conduct head-to-head comparisons in your trials,
please remove this
disclosure or tell us why you believe it is appropriate. Address in
your response whether
you expect to be able to rely on such comparisons for purposes of
securing marketing
approval for THIO.
Clinical Supply Agreement with Regeneron Pharmaceuticals, Inc. , page 88
28. To the extent not disclosed, please expand your disclosure to include
the material terms of
your agreement with Regeneron, including the parties' respective
rights and obligations,
financial terms, term and termination provisions.
Strategic Collaborations and Key Agreements, page 88
29. To the extent not disclosed, please expand your disclosure concerning
your license
agreements to include the material terms of such agreements,
including:
the technology or product candidates subject to the agreement;
each parties' rights and obligations;
Vlad Vitoc, M.D., M.B.A.
FirstName LastNameVlad
MAIA Biotechnology, Inc.Vitoc, M.D., M.B.A.
Comapany 15,
November NameMAIA
2021 Biotechnology, Inc.
November
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quantify any upfront payments;
quantify all payments made to date;
disclose separately the aggregate amount of all potential
development, regulatory and
commercial milestone payments;
disclose any milestones you are required to achieve;
quantify the royalty rate or range not to exceed ten percentage
points per tier;
disclose when the royalty provisions expire, if the expiration
is based on a number of
years, disclose the number of years;
the duration of the agreement; and
termination provisions.
30. We note your statement that you expect strong partnership interest
from other
pharmaceutical companies who have developed checkpoint inhibitor
franchises or those
with cancer immunotherapy interest. Please revise to provide the basis
for this claim or
state such claims are management s belief.
Competition, page 90
31. Revise to identify specific competitors for your target indications.
Refer to Item
101(h)(4)(iv) of Regulation S-K. Please also remove your statement
that competition is
expected given the magnitude of anticipated clinical effect and
revenue stream, as such
disclosure suggests that your product candidate is likely to be
approved.
Certain Relationships and Related Party Transactions, page 123
32. Please expand your disclosure to describe the consulting services
provided by Mr. Klohs
and Ms. Durant.
Financial Statements
THIO Asset Acquisition, page F-12
33. We also note that you acquired all outstanding stock of THIO through a
share exchange
agreement for 631,822 shares of your common stock with an estimated
fair value of
$1,137,342. Please tell us how you determined the fair value for this
transaction,
including your consideration of SAB Topic 5G.
Vlad Vitoc, M.D., M.B.A.
MAIA Biotechnology, Inc.
November 15, 2021
Page 9
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
November 15, 2021 Page 9
cc: Mitchell S. Nussbaum, Esq.
FirstName LastName