# EDGAR Filing Document

**Accession Number:** 0001878313
**File Stem:** 0001493152-25-019014
**Filing Date:** 2025-10
**Character Count:** 14513
**Document Hash:** eadd1adf8ce03975c237b20762f28254
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-25-019014.hdr.sgml**: 20251023

**ACCESSION NUMBER**: 0001493152-25-019014

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 18

**CONFORMED PERIOD OF REPORT**: 20251019

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251023

**DATE AS OF CHANGE**: 20251023

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** MAIA Biotechnology, Inc.
- **CENTRAL INDEX KEY:** 0001878313
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41455
- **FILM NUMBER:** 251411614

**BUSINESS ADDRESS:**
- **STREET 1:** 444 WEST LAKE STREET, SUITE 1700
- **CITY:** CHICAGO
- **STATE:** IL
- **ZIP:** 60606
- **BUSINESS PHONE:** 312-416-8592

**MAIL ADDRESS:**
- **STREET 1:** 444 WEST LAKE STREET, SUITE 1700
- **CITY:** CHICAGO
- **STATE:** IL
- **ZIP:** 60606

?xml version='1.0' encoding='ASCII'?

**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): October 19. 2025**

**MAIA Biotechnology, Inc.**

**(Exact name of registrant as specified in its charter)**

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| | | |
|:---|:---|:---|
| **Delaware** | **001-41455** | **83-1495913** |
| **(State or other jurisdiction**<br> **of incorporation)** | **(Commission**<br> **File Number)** | **(IRS Employer**<br> **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:

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| | | |
|:---|:---|:---|
| **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.**

On October 23, MAIA Biotechnology, Inc. (the "Company") issued a press release entitled "MAIA Biotechnology Details 30-Month Patient Survival in Ongoing Phase 2 Clinical Trial in Non-Small Cell Lung Cancer." Pursuant to Regulation FD, the press release is furnished with this Current Report on Form 8-K (this "Report") as Exhibit 99.1.

The information set forth in Item 7.01 of this Report and in the attached Exhibit 99.1 is deemed to be "furnished" and shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section. The information set forth in Item 7.01 of this Report, including Exhibit 99.1, shall not be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing.

**Item 8.01** **Other Events**

1. The
 Company has prepared a poster (the "Poster") entitled "Presentation 1: A Phase 2 Study of Ateganosine (THIO; 6-thio-2'-deoxyguanosine)
 in Combination with Immune Checkpoint Inhibitor (ICI) in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Resistant to Prior
 ICI and Chemotherapy: THIO-101 Trial ("THIO-101 Trial Poster"). The THIO-101 Poster was presented at the European Society
 for Medical Oncology (ESMO) Congress 2025 held in Berlin, Germany starting on October 19, 2025 and posted to the Company's website
 on such date, a copy of which is filed as Exhibit 99.2 to this Report and is hereby incorporated by reference.

2. The
 Company has prepared a poster (the "Poster") entitled • Presentation 2: A Phase 3 Study of Ateganosine (THIO) Sequenced
 with Immune Checkpoint Inhibitor (ICI) versus Standard of Care Chemotherapy in ICI-Resistant Advanced NSCLC: THIO-104 Trial in Progress
 ("THIO-104Trial Poster"). The THIO-104 Poster was presented ESMO starting on October 19, 2025 and posted to the Company's
 website on such date, a copy of which is filed as Exhibit 99.3 to this Report and is hereby incorporated by reference.

Each of the THIO-101 Trial Poster and THIO-104 Trial Poster contain forward-looking statements, and as a result, investors should not place undue reliance on these forward-looking statements.

**Item 9.01 Financial Statements and Exhibits.**

(d) Exhibits.

---

| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [Press Release dated October 23, 2025](ex99-1.htm) |
| 99.2 | [THIO-101 Trial Poster](ex99-2.htm) |
| 99.3 | [THIO-104 Trial Poster](ex99-3.htm) |
| 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: October 23, 2025

---

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

---

## Exhibit 99.1

**Exhibit 99.1**

**MAIA Biotechnology Details 30-Month Patient Survival in Ongoing Phase 2 Clinical Trial in Non-Small Cell Lung Cancer**

● Outstanding measure of efficacy relative to high-risk cancers with limited treatment options

 ****

**CHICAGO – October 23, 2025 –** 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 recent presentation at the European Society for Medical Oncology (ESMO) Congress 2025 held in Berlin, Germany. Starting October 19, 2025, MAIA showcased two e-posters at ESMO detailing its ongoing Phase 2 and Phase 3 clinical trials of ateganosine in non-small cell lung cancer (NSCLC).

"The posters showcased at ESMO 2025 featured exceptional extended survival in third-line NSCLC patients. In addition, as of September 17, 2025, a patient that began therapy in March 2023 has shown survival of 30 months, or 912 days, an outstanding measure relative to many of the high-risk cancers," said MAIA CEO Vlad Vitoc, M.D. "Very few options exist for patients who are refractory or resistant to immune checkpoint inhibitors (ICI). We believe that a survival of over two years is a clear signal of ateganosine's role in effectively targeting and eliminating NSCLC tumor cells."

The THIO-101 patient with 30-month survival received therapy every three weeks, and concluded treatment upon reaching the maximum treatment duration of 2 years based on protocol requirements.

MAIA's newest posters featured at ESMO 205 are now available on MAIA's website at <u>maiabiotech.com/publications</u>.

● Presentation 1: A Phase 2 Study of Ateganosine (THIO; 6-thio-2'-deoxyguanosine) in Combination with Immune Checkpoint Inhibitor (ICI) in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Resistant to Prior ICI and Chemotherapy: THIO-101 Trial in Progress

● Presentation 2: A Phase 3 Study of Ateganosine (THIO) Sequenced with Immune Checkpoint Inhibitor (ICI) versus Standard of Care Chemotherapy in ICI-Resistant Advanced NSCLC: THIO-104 Trial in Progress

**About Ateganosine**

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<sup>®</sup>) 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 <u>www.maiabiotech.com</u>.

**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**

<u>+1 (872) 270-3518</u>

<u>ir@maiabiotech.com</u>

## Exhibit 99.2

**Exhibit 99.2**

![](ex99-2_0001.jpg)

## Exhibit 99.3

**Exhibit 99.3**

![](ex99-3_0001.jpg)