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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): November 5, 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.
Item 8.01 Other Events.
On
November 5, 2024, MAIA Biotechnology, Inc. (the “Company”) issued a press release announcing the late-breaking abstract of
THIO-101 updates was selected. for oral and poster presentation at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting
A
copy of the press release is attached hereto 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:
November 5, 2024
| |
MAIA
BIOTECHNOLOGY, INC. |
| |
|
|
| |
By: |
/s/
Vlad Vitoc |
| |
Name: |
Vlad
Vitoc |
| |
Title: |
Chief
Executive Officer |
Exhibit
99.1
MAIA
Biotechnology Announces Late-Breaking Abstract of THIO-101 Updates Selected for Oral and Poster Presentation at the Society for Immunotherapy
of Cancer (SITC) 39th Annual Meeting
| ● | Late
breaking abstract to provide new updates from THIO-101 Phase 2 clinical trial in non-small
cell lung cancer (NSCLC) |
| ● | Poster
to highlight long-term therapeutic benefits of THIO sequenced with cemiplimab beyond treatment
cessation |
CHICAGO
– November 05, 2024 - MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage
biopharmaceutical company developing targeted immunotherapies for cancer, today announced that a late-breaking abstract (LBA) detailing
new updates from its Phase 2 THIO-101 clinical trial was selected for oral and poster presentation at the 2024 Annual Meeting of the
Society for Immunotherapy of Cancer (SITC), being held November 6-10, 2024, in Houston, Texas. The updates will include new data on efficacy
and safety from its clinical trial evaluating THIO sequenced with Regeneron’s immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®)
in patients with advanced non-small cell lung cancer (NSCLC) who have failed two or more standard-of-care therapy regimens.
“We
are honored to have our THIO-101 data recognized by SITC in a late-breaking abstract, a category reserved for research that has the
potential to change medical practices. We believe that our latest data is compelling and further supports the ability of THIO to
produce cancer cell specific immune memory and to remain active against cancer cells after extended periods of time,” said Vlad
Vitoc, M.D., Chairman and CEO of MAIA. “Our findings to date are particularly significant for advanced-stage patients resistant
to CPI and chemotherapy treatments who are in desperate need of new treatment options. In our opinion, the combination of THIO with a
CPI is showing promise as a durable and effective NSCLC treatment.”
Presentation
details:
| Title: |
Telomere-Targeting
Agent THIO in Sequential Combination with Cemiplimab Demonstrates Long Term Therapeutic Benefits Beyond Treatment Cessation —
A Phase 2 Trial in Advanced Immune Checkpoint Inhibitor Resistant Non-Small Cell Lung Cancer Patients |
| Abstract
number: |
1492 |
| Session: |
Late
Breaking Abstract Session 1 |
| Date: |
Friday,
November 8, 2024 |
| Time: |
11:45
a.m.-12:15 p.m. CDT |
| MAIA
Presenter: |
Victor
Zaporojan, M.D., Sr. Medical Director |
| Poster
access: |
MAIA’s
poster will be available at maiabiotech.com/publications on November
8, 2024 |
According
to SITC, a late-breaking abstract (LBA) submission is solely for abstracts with late-breaking data from interventional clinical trials
in humans. The reference does not refer to abstracts that are submitted “late,” as in after submission deadlines.
As
of August 1, 2024, 16 patients in the THIO-101 trial had survival follow-up surpassing 12 months, including 9 in third line treatment
(3L). Interim median survival follow-up in 3L was 10.6 months. THIO’s substantial survival benefit in third line NSCLC surpasses
current standard-of-care overall survival of 5.8 months.1
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
THIO-101, a Phase 2 Clinical Trial
THIO-101
is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor
activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to Regeneron’s
PD-1 inhibitor cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did
not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial
design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming
immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment
with THIO followed by cemiplimab (Libtayo®) has been generally well-tolerated to date in a heavily pre-treated population. For more
information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.
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.
1 Girard N, et al. J Thorac Onc 2009;12:1544-1549.
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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