$2.3M NIH grant backs MAIA Biotechnology (NYSE American: MAIA) Phase 2 lung cancer trial

Rhea-AI Filing Summary

MAIA Biotechnology announced that it has been awarded a $2.3 million grant from the National Institutes of Health. The funding is designated to expand its THIO-101 Phase 2 clinical trial, which is evaluating ateganosine as a third-line treatment for patients with advanced non-small cell lung cancer. This grant supports further clinical development of the program without relying on equity financing. The company provided more details in a press release attached as an exhibit.

Insights

Biotech & Clinical Development Analyst

$2.3M NIH grant supports MAIA’s Phase 2 lung cancer trial.

The award of a $2.3 million grant from the National Institutes of Health gives MAIA Biotechnology non-dilutive funding to expand its THIO-101 Phase 2 trial. The study evaluates ateganosine as a third-line option for advanced non-small cell lung cancer, a setting where patients typically have limited treatment choices.

Grant funding from a major public institution often reflects scientific and clinical interest in the underlying program, although it does not guarantee success or regulatory approval. The additional resources are specifically tied to the Phase 2 trial, so the impact depends on how effectively MAIA converts this funding into patient enrollment, data quality, and study completion.

Investors will likely focus on future disclosures about the progress and results of the THIO-101 Phase 2 trial, as these outcomes will determine whether ateganosine can advance toward later-stage development in non-small cell lung cancer.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

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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): September 24, 2025

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 September 24, 2025, MAIA Biotechnology, Inc. (the “Company”) issued a press release announcing the award of a $2.3 Million grant by National Institutes of Health to the Company for the expansion of its THIO-101 Phase 2 clinical trial evaluating ateganosine as a third-line treatment for patients with advanced 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 September 24, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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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: September 24, 2025

	MAIA BIOTECHNOLOGY, INC.
	By:	/s/ Vlad Vitoc
	Name:	Vlad Vitoc
	Title:	Chief Executive Officer

3

FAQ

What did MAIA (MAIA) announce in this 8-K filing?

MAIA Biotechnology reported that it received a $2.3 million grant from the National Institutes of Health to support expansion of its THIO-101 Phase 2 clinical trial.

How much NIH funding did MAIA (MAIA) receive and for what purpose?

The company was awarded $2.3 million by the National Institutes of Health to expand its THIO-101 Phase 2 trial, which studies ateganosine in advanced non-small cell lung cancer.

What is the THIO-101 Phase 2 trial mentioned by MAIA Biotechnology?

THIO-101 is a Phase 2 clinical trial evaluating ateganosine as a third-line treatment for patients with advanced non-small cell lung cancer.

Does the NIH grant relate to a specific type of cancer in MAIA’s pipeline?

Yes. The grant supports the THIO-101 Phase 2 trial of ateganosine for advanced non-small cell lung cancer in the third-line treatment setting.

Where can investors find more details about MAIA’s NIH grant?

Additional details are provided in a press release dated September 24, 2025, which is attached to the filing as Exhibit 99.1.

What type of SEC filing did MAIA Biotechnology submit for this NIH grant news?

The company used an Item 8.01 Other Events disclosure in a Form 8-K to report the NIH grant and reference the related press release.