MAIA Biotechnology Files 8-K, Confirms Emerging Growth Status

TL;DR

**MAIA filed a routine 8-K, confirming its emerging growth company status and NYSE American listing.**

AI Summary

MAIA Biotechnology, Inc. filed an 8-K on January 17, 2024, to report an 'Other Event' and 'Financial Statements and Exhibits.' This filing indicates that MAIA is an emerging growth company and its Common Stock trades on the NYSE American under the symbol MAIA. For investors, this filing primarily serves as a routine disclosure, confirming the company's status and listing details, which is important for transparency but doesn't reveal new operational or financial developments that would immediately impact stock valuation.

Why It Matters

This filing is a standard disclosure, confirming MAIA Biotechnology's status as an emerging growth company and its NYSE American listing, which is important for regulatory transparency but doesn't contain new material financial or operational news.

Risk Assessment

Risk Level: low — This 8-K filing is purely administrative and does not introduce any new financial or operational risks to the company.

Analyst Insight

A smart investor would recognize this as a routine administrative filing that provides no new material information to alter investment decisions. It's a 'no news is good news' type of filing, confirming existing public information.

Key Players & Entities

• MAIA Biotechnology, Inc. (company) — the registrant filing the 8-K
• NYSE American (company) — the exchange where MAIA's Common Stock is registered
• MAIA (company) — the trading symbol for MAIA Biotechnology, Inc.
• January 17, 2024 (date) — date of earliest event reported

FAQ

Filing Documents

• d712719d8k.htm (8-K) — 27KB
• d712719dex991.htm (EX-99.1) — 17KB
• 0001193125-24-009509.txt ( ) — 175KB
• maia-20240117.xsd (EX-101.SCH) — 3KB
• maia-20240117_lab.xml (EX-101.LAB) — 18KB
• maia-20240117_pre.xml (EX-101.PRE) — 11KB
• d712719d8k_htm.xml (XML) — 3KB

01

Item 8.01 Other Events. On January 17, 2024, MAIA Biotechnology, Inc. (the "Company") issued a press release announcing new interim data for THIO-101, a Phase 2 clinical trial evaluating THIO in patients with non-small cell lung cancer, and outlining key clinical milestones achieved for 2024. In the latest available data from THIO-101 as of November 13, 2023, 60 patients had been dosed with THIO in sequential combination with Libtayo . The patients received either 60mg, 180mg, or 360mg of THIO per dose, and 42 had at least one post baseline assessment completed. The Company's key findings from THIO-101 included an observed 100% preliminary disease control rate ("DCR") in second-line and 88% in third-line, in highly difficult-to-treat patients who already progressed through previous lines of treatment. Additionally, the Company determined that DCR across all dose levels met pre-determined statistical requirements earlier than expected to proceed to next stage of the trial. The Company's key clinical milestones for 2024 include its second-generation telomere-targeting program focused on the research and development of new prodrugs derived from lipid-modified THIO molecules, which compounds the Company believes are capable of acting through similar mechanisms of activity as THIO with higher potency at lower dose levels. A copy of the press release is filed herewith as Exhibit 99.1 and is incorporated herein by reference.

Forward-looking Statements

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)

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibits: Exhibit No. Description 99.1 Press release, dated January 17, 2024 104 Cover Page Interactive Data File (embedded within the Inline XBRL Document)

SIGNATURES

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: January 18, 2024 MAIA BIOTECHNOLOGY, INC. By: /s/ Vlad Vitoc Name: Vlad Vitoc Title: Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR