Form 8-K

8-K — MAIA Biotechnology, Inc.

Accession: 0001493152-26-013879

Filed: 2026-03-31

Period: 2026-03-31

CIK: 0001878313

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

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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)

The Securities Exchange Act of 1934

Date

of Report (Date of earliest event reported): March 31, 2026

MAIA

Biotechnology, Inc.

(Exact

name of registrant as specified in its charter)

Delaware

001-41455

83-1495913

(State

or other jurisdiction

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

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 ☒

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.

March 31, 2026, MAIA Biotechnology, Inc. (the “Company”) issued a press release entitled “MAIA Biotechnology Reports

Overall Survival Exceeding Two Years for Eight Patients in Ongoing Phase 2 Clinical Trial in Non-Small Cell Lung Cancer” 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.

Exhibit No.

Description

99.1

Press Release dated March 31 2026

104

Cover

Page Interactive Data File (embedded within the Inline XBRL document)

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:

March 31, 2026

MAIA

BIOTECHNOLOGY, INC.

By:

/s/

Vlad Vitoc

Name:

Vlad

Vitoc

Title:

Chief

Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

MAIA

Biotechnology Reports Overall Survival Exceeding Two Years for Eight Patients in Ongoing Phase 2 Clinical Trial in Non-Small Cell Lung

Cancer

Potential

breakthrough therapeutic targets $50B+ global immunotherapy market1

CHICAGO

– March 31, 2026 – MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a

clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced highlights from a

poster presented on March 27, 2026, at the European Lung Cancer Congress 2026 (ELCC), a premier thoracic oncology forum held March 25-28,

2026, in Copenhagen, Denmark.

MAIA

reports overall survival (OS) beyond two years for eight patients treated with ateganosine sequenced with cemiplimab in Parts A and B

of its ongoing Phase 2 THIO-101 clinical trial in non-small cell lung cancer (NSCLC). The patients did not receive subsequent lines of

therapy.

The

eight patients featured in the poster include:

●

patient in third-line (3L) therapy with survival of 33 months. Expected survival in this heavily pre-treated population is 5.8 months.2

●

patients in 2L therapy with survival over 30 months. Documented OS for standard of care treatment (chemotherapy or checkpoint inhibitors

alone) in second-line (2L) therapy is 10.5 months.3

●

All

patients have failed previous treatment (prior to THIO-101) with a checkpoint inhibitor (CPI) alone.

●

All

patients completed 29-34 cycles of therapy, except for 1 patient who completed 2 cycles of therapy with survival follow-up of 725

off therapy.

●

of the 8 patients have survival follow-up ongoing.

“It’s

very encouraging to see such outstanding survival from these patients extending beyond our 24-month trial protocol and without any subsequent

treatment. OS surpassing two-years bodes well as we continue to monitor patients in our ongoing Phase 3 pivotal trial and in THIO-101

Part C,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “These results illuminate ateganosine’s

valuable role in targeting telomeres to eliminate NSCLC tumor cells and support this treatment—ateganosine sequenced by a CPI—as

a potential breakthrough therapeutic option for NSCLC.”

1 Immune

Checkpoint Inhibitors Market Analysis by Mordor Intelligence, July 2025

Girard N, et al. J Thorac Onc 2009;12:1544-1549

https://clinicaltrials.gov/study/NCT01168973?tab=results

THIO-101

treated 79 patients in Parts A and B of the trial. The Part C expansion is currently enrolling up to 48 participants in Asia and Europe.

Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily

pre-treated population.

MAIA’s

ELCC poster is available on MAIA’s website at maiabiotech.com/publications.

About

Ateganosine

(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

induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric

fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential

treatment of ateganosine 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. Ateganosine 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 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 ateganosine’s anti-tumor

activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to

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 ateganosine administered as an anticancer compound

and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical

endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy

who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab

(Libtayo®) has shown an acceptable safety profile 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

ateganosine (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

(872) 270-3518

ir@maiabiotech.com

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