Positive THIO-101 Phase 2 lung cancer data reported by MAIA (MAIA)

Rhea-AI Filing Summary

MAIA Biotechnology filed an 8-K to share that it issued a press release announcing positive efficacy data from its THIO-101 Phase 2 clinical trial in non-small cell lung cancer. This suggests the company is seeing encouraging signals from THIO-101 in a difficult-to-treat cancer setting, although detailed results are contained in the attached press release rather than this summary document.

The company also includes standard cautionary language that these are forward-looking statements and that actual outcomes may differ due to clinical, regulatory, manufacturing, market acceptance, and intellectual property risks. No financial figures or commercial timelines are discussed in this filing.

Positive

• Positive Phase 2 efficacy signal: MAIA reports encouraging efficacy data from its THIO-101 Phase 2 trial in non-small cell lung cancer, a key milestone for this oncology candidate.

Negative

• None.

Insights

Biotech and clinical development analyst

MAIA reports encouraging Phase 2 lung cancer efficacy for THIO-101.

MAIA Biotechnology highlights positive efficacy data from its THIO-101 Phase 2 study in non-small cell lung cancer. Phase 2 is a key stage where a drug candidate’s ability to help patients starts to become clearer, so a positive update can be important for a pipeline focused on this asset.

The actual efficacy metrics, safety details, and study design are contained in the referenced press release, not in this summary, so the strength of the data cannot be assessed here. The company emphasizes that future progress depends on clinical results, regulatory decisions, manufacturing capabilities, market adoption, and patent protection.

Overall this is a positive clinical signal for THIO-101, but the real impact will depend on the full data set and how regulators and future trials, such as later-stage studies, respond to these results.

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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 11, 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 11, 2025, MAIA Biotechnology, Inc. (the “Company”) issued a press release announcing the positive efficacy data from THIO-101 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 September 11, 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 11, 2025

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

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FAQ

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

MAIA Biotechnology reported that it issued a press release announcing positive efficacy data from its THIO-101 Phase 2 clinical trial in non-small cell lung cancer.

Which MAIA Biotechnology drug is mentioned in the filing?

The filing focuses on THIO-101, a product candidate being evaluated in a Phase 2 clinical trial for non-small cell lung cancer.

What stage of development is THIO-101 in for MAIA Biotechnology (MAIA)?

THIO-101 is in a Phase 2 clinical trial, which is designed to evaluate its efficacy and safety in patients with non-small cell lung cancer.

Does the MAIA Biotechnology 8-K include detailed clinical results for THIO-101?

The 8-K states that the company issued a press release with positive efficacy data; the detailed results are contained in the attached Exhibit 99.1 press release, not in the body of this summary.

What risks does MAIA Biotechnology highlight regarding its forward-looking statements?

MAIA notes risks related to the initiation, timing, cost, progress and results of studies, the ability to advance and commercialize product candidates, regulatory filings and approvals, market acceptance, market size and growth, and maintaining intellectual property protection.

What exhibit is attached to the MAIA Biotechnology (MAIA) 8-K?

The filing attaches Exhibit 99.1, a press release dated September 11, 2025, containing the detailed information on the THIO-101 Phase 2 efficacy data.