Form 8-K

8-K — MAIA Biotechnology, Inc.

Accession: 0001493152-26-015662

Filed: 2026-04-08

Period: 2026-04-08

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): April 8, 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,

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.

April 8, 2026, MAIA Biotechnology, Inc. (the “Company”) issued a press release entitled “MAIA Biotechnology Expects

Recent $33 Million Capital Raise to Fully Fund Ongoing Pivotal Phase 3 Trial of Novel Telomere-Targeting Anticancer Therapy” 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, (vii) our expectations regarding our ability to obtain and maintain intellectual

property protection for our product candidates and (viii) the funding status for our Phase 3 trial for ateganosine. 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 April 8, 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:

April 8, 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 Expects Recent $33 Million Capital Raise to Fully Fund Ongoing Pivotal Phase 3 Trial of Novel Telomere-Targeting Anticancer

Therapy

Strong

participation in recent $33 million common stock offering highlights investor confidence in late-stage clinical momentum and commercial

potential

Statistical

assessments point to high probability of technical success in Phase 3 full approval trial

FDA

granted Fast Track designation for dual mechanism therapy as a treatment for non-small cell lung cancer (NSCLC)

CHICAGO

– April 08, 2026 – MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a

clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that net proceeds

from its $33 million public offering of common stock in March 2026 are expected to fully fund the Company’s ongoing pivotal Phase

3 clinical trial of its lead investigational therapy, ateganosine, as a treatment for non-small cell lung cancer (NSCLC). Ateganosine

is a dual mechanism therapy designed to break down telomere structure and function in cancer cells while inducing immune activation.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the drug in third line (3L) NSCLC treatment.

“We

are grateful for the support and confidence shown by the healthcare-dedicated investors and existing shareholders who participated in

our recent offering. The $33 million raise is expected to complete the necessary funding for our pivotal Phase 3 trial through completion,”

said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA

“Statistical

assessments point to a high probability of technical success in the third-line setting if Phase 3 data is consistent with our

Phase 2 trial results,” Dr. Vitoc continued. “Interim data from the Phase 3 trial, expected next year, may support a discussion

with the FDA to present our case for early full commercial approval in third-line NSCLC.”

MAIA’s

pivotal Phase 3 trial, THIO-104, evaluates the efficacy of ateganosine administered in sequence with a checkpoint inhibitor (CPI) in

third-line NSCLC patients who are resistant to checkpoint inhibitors alone and chemotherapy. The global multicenter, open-label, pivotal

Phase 3 trial is designed to provide a direct comparison to chemotherapy in a 1:1 randomization of up to 300 patients. Chemotherapy is

the standard utilized treatment for third-line NSCLC patients.

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-104 Phase 3 Clinical Trial

THIO-104

is a multicenter, open-label, randomized Phase 3 clinical trial, designed to evaluate ateganosine’s telomere-targeting anti-tumor

activity when followed by PD-(L)1 inhibition in patients with advanced third-line NSCLC who previously did not respond or developed resistance

to treatment regimens containing checkpoint inhibitor and/or chemotherapy and have progressed. The trial has two primary objectives:

(1) to assess the clinical efficacy of ateganosine compared to investigator’s choice of chemotherapy, using median Overall Survival

(OS) as the primary clinical endpoint (2) to evaluate the safety and tolerability of ateganosine in sequential combination with a checkpoint

inhibitor. For more information on this Phase 3 trial, please visit ClinicalTrials.gov using the identifier NCT06908304.

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, (vii) our expectations regarding our ability

to obtain and maintain intellectual property protection for our product candidates and (viii) the funding status for our Phase 3 trial

for ateganosine, 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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