UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
Current Report
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| 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
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 January 17, 2024 | |
| 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: January 18, 2024
| MAIA BIOTECHNOLOGY, INC. | ||
| By: | /s/ Vlad Vitoc | |
| Name: | Vlad Vitoc | |
| Title: | Chief Executive Officer | |