UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
Current Report
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| Item 8.01 | Other Events. |
On October 24, 2023, MAIA Biotechnology, Inc. (the “Company”) issued a press release announcing that it reported positive preliminary efficacy data from its ongoing Phase 2 clinical human trial, THIO-101, which evaluates THIO (our drug candidate that provides for an investigational dual mechanism of action that incorporates telomere targeting and immunogenicity) in patients with advanced Non-Small Cell Lung Cancer (“NSCLC”) in sequential combination with Regeneron’s anti-PD-1 cemiplimab (Libtayo®), which is administered a few days after patients with advanced NSCLC are treated with THIO. The Company intends to continue providing updates on our THIO-101 clinical trial as they become available.
On October 30, 2023, the Company issued a press release announcing that an investigational new drug-enabling study of the Company’s second-generation telomere-targeting agents derived from lipid-modified THIO molecules generated positive results. The Company intends to continue to further study THIO conjugates as second generation cancer therapies. THIO’s telomere-centric action is currently being evaluated in Phase 2 of the THIO-101 clinical human trial, as described above.
A copy of the press release, dated October 24, 2023, and the press release, dated October 30, 2023, are filed herewith as Exhibits 99.1 and 99.2, respectively, and are 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 October 24, 2023 | |
| 99.2 | Press Release, dated October 30, 2023. | |
| 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: October 30, 2023
| MAIA BIOTECHNOLOGY, INC. | ||
| By: | /s/ Vlad Vitoc | |
| Name: | Vlad Vitoc | |
| Title: | Chief Executive Officer | |
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