MAIA Biotechnology CEO Details Anticipated Clinical Milestones for Novel Cancer Immunotherapy in 2025 Letter to Shareholders

Rhea-AI Summary

MAIA Biotechnology (NYSE: MAIA) has outlined key clinical milestones for 2025 in a shareholder letter from CEO Vlad Vitoc. The company's lead compound THIO (ateganosine) is highlighted as the only clinical-stage telomere-targeting anticancer agent in cancer discovery.

Key developments include:

• Phase 2 trial THIO-101 expansion is ongoing with potential FDA filing for accelerated approval in 2026
• Phase 3 THIO-104 trial scheduled to begin mid-2025, with potential filing for early full approval in 2026
• THIO demonstrates exceptional efficacy in advanced non-small cell lung cancer (NSCLC)
• Multiple additional THIO trials planned for various cancer indications

The company is pursuing multiple regulatory pathways for THIO in NSCLC treatment, targeting significant market opportunities in hard-to-treat cancers with unmet medical needs.

Positive

• Only clinical-stage telomere-targeting anticancer agent in development
• Potential for dual FDA filings in 2026 (accelerated and full approval)
• Demonstrated exceptional efficacy in advanced NSCLC
• Multiple cancer indication opportunities in development

Negative

• No immediate FDA approvals expected before 2026
• Phase 3 trial not yet initiated

Insights

Oncology Researcher

MAIA Biotechnology's announcement represents a significant scientific development in cancer therapeutics. THIO (ateganosine) employs a highly novel mechanism of action as a telomere-targeting agent - the only clinical-stage compound with this approach in cancer research. This distinguishes it from conventional immunotherapies and cytotoxic agents currently dominating the NSCLC treatment landscape.

The progression of the Phase 2 THIO-101 trial into an expansion phase suggests preliminary efficacy signals were sufficient to warrant broader testing. Simultaneously advancing preparation for a Phase 3 study (THIO-104) indicates confidence in their technology platform. While the release mentions "exceptional efficacy" in advanced NSCLC, the absence of specific response rates or survival data requires cautious interpretation.

The dual regulatory strategy pursuing both accelerated and full approval pathways demonstrates strategic flexibility. For context, accelerated approval would likely require compelling objective response rates in a single-arm study, while full approval typically demands progression-free or overall survival benefits in a randomized controlled trial. The aggressive timeline targeting potential FDA filings in 2026 suggests management believes their data package will be robust enough to support regulatory review relatively quickly.

Biotech Investment Analyst

MAIA's clinical development plan establishes concrete milestones that provide much-needed visibility for a micro-cap biotech ($48.5M market cap). The detailed regulatory strategy with planned FDA submissions in 2026 offers a clear value-creation roadmap that spans multiple potential approval pathways.

The company's focus on non-small cell lung cancer is strategically sound, targeting a large market opportunity with established reimbursement pathways. However, this space is highly competitive with entrenched players offering PD-1/PD-L1 inhibitors, targeted therapies, and various combination approaches.

What differentiates MAIA is their novel telomere-targeting approach, potentially creating a new treatment class if efficacy is confirmed in larger trials. The parallel pursuit of both accelerated and full approval paths helps mitigate regulatory risk, though executing simultaneously on Phase 2 expansion and Phase 3 initiation will require disciplined resource allocation.

Investors should monitor several critical factors: 1) actual clinical data supporting the "exceptional efficacy" claim, 2) cash runway adequacy to reach these 2026 filing targets, and 3) potential partnership opportunities to support late-stage development. The ambitious timeline for both trials suggests confidence in their preliminary data, though typical development hurdles could still affect these projections.

• Lead compound THIO (ateganosine) is the only clinical-stage telomere-targeting anticancer agent throughout the field of cancer discovery
• Potential FDA filings in 2026 for accelerated approval from THIO-101 and early full approval from THIO-104
• Full Shareholder Letter available in Investors section of MAIA’s corporate website

CHICAGO--(BUSINESS WIRE)-- MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today published a 2025 Shareholder Letter by CEO Vlad Vitoc, M.D. detailing the Company’s key milestones for 2025 including several clinical trials and regulatory pathways.

“MAIA continues to bring innovation to the biotech industry as one of the earliest pioneers of telomere targeting as a strategy for cancer treatment. Our lead candidate is THIO (ateganosine), the only clinical-stage telomere-targeting anticancer agent throughout the field of cancer discovery,” states Dr. Vitoc at the opening of his shareholder letter. “We are working on multiple potential regulatory pathways that could provide accelerated approval and robust exclusivity for THIO in non-small cell lung cancer (NSCLC). Multiple milestones this year are expected to pave the path toward a potential FDA decision as early as next year.”

Letter Highlights

• Phase 2 trial THIO-101 expansion underway; potential filing in 2026 for accelerated approval.
• Phase 3 THIO-104 set to begin in mid-2025; potential filing in 2026 for early full approval.
• Lead asset THIO shows exceptional efficacy in advanced NSCLC.
• Multiple THIO trials planned in additional cancer indications.
• Significant market opportunity in hard-to-treat cancers with unmet medical needs.

MAIA’s letter to shareholders is available at ir.maiabiotech.com.

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 www.maiabiotech.com.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250401656979/en/

Investor Relations Contact

+1 (872) 270-3518

ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

FAQ

What are the key FDA filing timelines for MAIA Biotechnology's THIO treatment?

MAIA plans two FDA filings in 2026: one for accelerated approval from the THIO-101 trial and another for early full approval from the THIO-104 trial.

When will MAIA Biotechnology begin its Phase 3 THIO-104 trial?

MAIA Biotechnology plans to begin its Phase 3 THIO-104 trial in mid-2025.

What types of cancer is MAIA's THIO treatment targeting?

THIO is primarily targeting non-small cell lung cancer (NSCLC), with plans for trials in additional cancer indications.

What makes MAIA Biotechnology's THIO unique in cancer treatment?

THIO (ateganosine) is the only clinical-stage telomere-targeting anticancer agent in the field of cancer discovery.