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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
Current
Report
Pursuant
to Section 13 or 15(d)
of
The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): February 27, 2024
MAIA
Biotechnology, Inc.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-41455 |
|
83-1495913 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
| 444
West Lake Street, Suite 1700 |
|
|
| Chicago,
IL |
|
60606 |
| (Address
of principal executive offices) |
|
(Zip
Code) |
(312)
416-8592
(Registrant’s
telephone number, including area code)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
| ☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
| Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange
on
which registered |
| Common
Stock |
|
MAIA |
|
NYSE
American |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405)
or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
On
February 27, 2024, MAIA Biotechnology, Inc. (the “Company”) issued a press release announcing the appointment of Remus Vezan,
M.D., Ph.D., to its Scientific Advisory Board.
A
copy of the press release is filed herewith as Exhibit 99.1 and is incorporated herein by reference.
Forward-looking
Statements
The
Company cautions that all statements, other than statements of historical facts, contained in this Current Report on Form 8-K, or furnished
herewith, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other
factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different
from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,”
“could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,”
“project,” “intend,” “future,” “potential,” or “continue,” and other similar
expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are
not forward-looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that,
although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as
to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However,
these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control
that may cause actual results to differ materially from those expressed in any forward-looking statement, including, but not limited
to: (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs,
(ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory
filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing
process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for
our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain
intellectual property protection for our product candidates. Any forward-looking statement speaks only as of the date on which it was
made. The Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information,
future events or otherwise, except as required by law.
| Item
9.01. |
Financial
Statements and Exhibits. |
(d)
Exhibits.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
Dated:
February 27, 2024
| |
MAIA
BIOTECHNOLOGY, INC. |
| |
|
|
| |
By: |
/s/
Vlad Vitoc |
| |
Name: |
Vlad
Vitoc |
| |
Title: |
Chief
Executive Officer |
Exhibit
99.1
MAIA
Biotechnology Appoints Leading Immuno-Oncology Scientist Dr. Remus Vezan as Scientific Advisor
| |
● |
New
Scientific Advisory Board member played instrumental role in FDA approval and commercialization of multiple blockbuster products |
CHICAGO,
IL – February 27, 2024 - MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage
biopharmaceutical company developing targeted immunotherapies for cancer, today announced the appointment of immuno-oncology leader Remus
Vezan, M.D., Ph.D., to its Scientific Advisory Board (SAB).
With
over 20 years of academic and biopharmaceutical industry experience, Dr. Vezan is a highly regarded leader in drug development of novel
therapeutic modalities, including cell and gene therapies, and played a pivotal role in the development and approval of CAR-T cell products
TECARTUS® and YESCARTA® (Gilead), and kinase inhibitor IMBRUVICA® (AbbVie). Dr. Vezan currently serves as Vice President,
Global Clinical Development at BeiGene.
“Dr.
Vezan holds vast experience in guiding oncology assets through all stages of development, from research to clinical strategies and registration.
His extensive engagement with the regulatory agencies to maximize clinical and commercial opportunities has been instrumental in garnering
multiple FDA and global approvals for novel therapies including biologics and CAR-T cell products,” said Vlad Vitoc, M.D., MAIA’s
Chairman and Chief Executive Officer. “It is a pleasure to welcome Remus to the MAIA franchise, where he will provide valued guidance
along our pathway to approval and commercialization of our lead candidate THIO.”
Previously,
as executive director of clinical development at Kite Pharma (Gilead Sciences), Dr. Vezan was primarily responsible for managing and
overseeing the clinical development of CART-cell products, including axi-cell/YESCARTA®, the first CART-cell therapy approved for
relapsed/refractory B-cell lymphoma, and brexu-cell/TECARTUS®, the first CART-cell therapy approved for mantle cell lymphoma and
adult acute lymphoblastic leukemia. Earlier, Remus served as Medical Director at Pharmacyclics, an AbbVie Company, where he was the clinical
lead for IMBRUVICA® in lymphoplasmacytic lymphomas.
Dr.
Vezan’s therapeutic expertise includes both hematology and oncology, with various treatment modalities including next generation
small molecules and adaptive cellular therapies (CAR-T, NK, autologous, allogeneic).
Dr.
Remus Vezan commented, “It is my pleasure and privilege to join MAIA as scientific advisor and support the efforts of the MAIA
team in advancing the clinical development of its first-in-class telomere targeting agent. THIO is a next generation asset with the potential
to provide meaningful clinical benefit to many patients with malignancies.”
Dr.
Vezan completed his medical training (M.D. and Ph.D.) at the University of Medicine and Pharmacy Cluj, Romania, and University of Bern,
Switzerland. He holds multiple medical and scientific affiliations including the American Society of Hematology (ASH), the European Hematology
Association (EHA), and the American Society of Clinical Oncology (ASCO). His work has appeared in numerous scientific papers and publications.
Remus Vezan, M.D., Ph.D.
Scientific
Advisor to MAIA Biotechnology
About
THIO
THIO
(6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development
to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role
in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO)
induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric
fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential
treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models
by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC
for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About
MAIA Biotechnology, Inc.
MAIA
is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with
novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is
THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive
cancer cells. For more information, please visit www.maiabiotech.com.
Forward
Looking Statements
MAIA
cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements.
Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s
actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements.
The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,”
“plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,”
“future,” “potential,” or “continue,” and other similar expressions are intended to identify forward
looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements
we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and
development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing
or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates
and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth
potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our
ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking
statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable,
are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good
faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees
of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ
materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it
was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information,
future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,”
“we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
Investor
Relations Contact
+1
(872) 270-3518
ir@maiabiotech.com
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