MAIA details Phase 2 THIO-101 lung cancer poster

MAIA Biotechnology, Inc. filed a current report describing new clinical data communication activities.

(Moderate)

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

MAIA Biotechnology, Inc. filed a current report describing new clinical data communication activities. The company prepared a scientific poster showing efficacy data from its Phase 2 THIO-101 trial, which evaluates THIO given in sequence with the immune checkpoint inhibitor cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer who had already failed two or more standard-of-care treatments.

The poster was selected as an abstract titled “Study of THIO Sequenced with Cemiplimab in 3rd Line Immune Checkpoint Inhibitor-resistant aNSCLC: Improvement in PFS” and was presented at the 2025 IASLC World Conference on Lung Cancer on September 7, 2025. MAIA plans to post the same poster on its website on September 8, 2025 and has filed it as Exhibit 99.1 to this report. The company notes that the poster includes forward-looking statements and cautions investors not to place undue reliance on them.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

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, or exhibit attachments filed with this report.

FAQ

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

MAIA Biotechnology disclosed that it prepared and presented a poster with efficacy data from its Phase 2 THIO-101 trial, evaluating THIO sequenced with cemiplimab (Libtayo®) in advanced non-small cell lung cancer, and filed this poster as Exhibit 99.1.

What is the focus of MAIA Biotechnology’s THIO-101 Phase 2 trial mentioned in the filing?

The THIO-101 Phase 2 trial evaluates THIO given in sequence with the immune checkpoint inhibitor cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer who have failed two or more standard-of-care therapy regimens.

Where and when was MAIA’s THIO-101 poster presented?

The poster, titled “Study of THIO Sequenced with Cemiplimab in 3rd Line Immune Checkpoint Inhibitor-resistant aNSCLC: Improvement in PFS,” was originally presented and displayed at the 2025 IASLC World Conference on Lung Cancer on September 7, 2025.

Will investors be able to view the MAIA (MAIA) THIO-101 poster online?

Yes. The company states that the poster will be posted to MAIA Biotechnology’s website on September 8, 2025, and it is also filed as Exhibit 99.1 to the report and incorporated by reference.

Does the MAIA Biotechnology poster contain forward-looking statements?

Yes. The company notes that the poster contains forward-looking statements and cautions that investors should not place undue reliance on these forward-looking statements.

Which exhibit in the MAIA (MAIA) 8-K corresponds to the THIO-101 clinical poster?

Exhibit 99.1 in the 8-K is identified as the poster relating to the THIO-101 Phase 2 trial. Exhibit 104 is the cover page interactive data file embedded within the Inline XBRL document.

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Accepted by SEC EDGAR 09/08/2025 - 06:11 AM

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 7, 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 7.01 Regulation FD Disclosure.

MAIA Biotechnology, Inc. (the “Company”) has prepared a poster (the “Poster”) showing the efficacy data from its Phase 2 THIO-101 clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who failed 2 or more standard-of-care therapy regimens. The Poster was selected as an abstract titled Study of THIO Sequenced with Cemiplimab in 3rd Line Immune Checkpoint Inhibitor-resistant aNSCLC: Improvement in PFS” and originally presented and displayed at the 2025 IASLC World Conference on Lung Cancer (WCLC) on September 7, 2025. The Poster will also be posted to the Company’s website on September 8, 2025, a copy of which is filed as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”) and is hereby incorporated by reference.

The Poster contains forward-looking statements, and as a result, investors should not place undue reliance on these forward-looking statements.

Item 8.01 Other Events

Reference is made to the disclosure under Item 7.01 above which is hereby incorporated in this Item 8.01 by reference.

-2-

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
99.1		Poster
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

-3-

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 8, 2025

	MAIA BIOTECHNOLOGY, INC.

	By:	/s/ Vlad Vitoc
	Name:	Vlad Vitoc
	Title:	Chief Executive Officer

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Source: View Original Filing on SEC EDGAR

MAIA details Phase 2 THIO-101 lung cancer poster

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