New York, May 18, 2026 (GLOBE NEWSWIRE) -- Diamond Equity Research, a leading equity research firm with a focus on small capitalization public companies has released an update note on MAIA Biotechnology, Inc. (NYSE:MAIA). The research summary below is from a report commissioned by MAIA Biotechnology, Inc. and produced by Diamond Equity Research. The update note includes detailed information on the MAIA Biotechnology's business, recent updates, management commentary, financial results, valuation, and risks.

The full update note is available below.

Highlights from the note include:

Activates First U.S. Site in THIO-101 Phase 2 Expansion Trial, Expanding Access to Advanced NSCLC Patients and Strengthening Global Clinical Execution: MAIA Biotechnology announced the activation of its first U.S. clinical site for the ongoing THIO-101 Phase 2 expansion trial evaluating ateganosine (THIO) as a third-line treatment for advanced non-small cell lung cancer (NSCLC). The expansion into the United States represents a significant operational and regulatory milestone, potentially opening access to a substantially larger patient population, with the company estimating approximately 50,000 third-line NSCLC patients annually in the U.S. who have failed checkpoint inhibitors and chemotherapy. The trial is currently active across 44 sites in six countries spanning Europe and Asia, with MAIA planning to open four additional U.S. sites during 2026. The expansion study evaluates two treatment arms: ateganosine sequenced with cemiplimab (Libtayo®) and ateganosine monotherapy, supported in part by a $2.3 million NIH grant funding U.S. enrollment. The company also highlighted continued encouraging efficacy data from THIO-101, including overall survival beyond two years in eight patients, with one patient reaching 33 months of survival and four patients exceeding 30 months, metrics that management believes surpass known benchmarks in refractory third-line NSCLC. Ateganosine continues to benefit from the FDA Fast Track designation, which may facilitate accelerated regulatory interactions and review pathways. In our view, U.S. site activation further strengthens MAIA's clinical execution capabilities and enhances the potential relevance of the THIO-101 dataset as the company advances toward broader regulatory and commercialization objectives in NSCLC.
Expects Recent $33 Million Financing to Fully Fund Pivotal Phase 3 THIO-104 Trial, Enhancing Visibility into Late-Stage Clinical Execution: MAIA Biotechnology announced that net proceeds from its recently completed $33 million public equity financing are expected to fully fund the ongoing pivotal Phase 3 THIO-104 trial evaluating ateganosine as a third-line treatment for advanced non-small cell lung cancer (NSCLC). The financing, which saw participation from healthcare-focused investors and existing shareholders, materially strengthens the company's funding position as it advances through late-stage clinical development. THIO-104 is a global multicenter, open-label Phase 3 study enrolling up to 300 third-line NSCLC patients resistant to checkpoint inhibitors and chemotherapy, directly comparing ateganosine sequenced with a checkpoint inhibitor against chemotherapy in a 1:1 randomized design. Ateganosine continues to benefit from the FDA Fast Track designation in NSCLC, supporting an accelerated regulatory pathway. MAIA also indicated that statistical assessments suggest a high probability of technical success if Phase 3 outcomes remain consistent with prior Phase 2 data, and noted that interim data expected next year could potentially support discussions with the FDA regarding early full commercial approval. We note that a strengthened capital position meaningfully improves execution visibility for the THIO-104 program while reducing near-term financing uncertainty as MAIA progresses toward potentially value-defining clinical and regulatory milestones.
Reports Overall Survival Beyond Two Years in Eight NSCLC Patients from Ongoing THIO-101 Phase 2 Trial, Further Supporting Durability of Ateganosine-Based Therapy: MAIA Biotechnology presented updated clinical data from its ongoing Phase 2 THIO-101 trial at the European Lung Cancer Congress (ELCC) 2026, highlighting overall survival beyond two years in eight non-small cell lung cancer (NSCLC) patients treated with ateganosine sequenced with cemiplimab. Notably, the patients had not received subsequent lines of therapy following treatment in the study. The dataset included one third-line patient with survival of 33 months compared to an expected survival benchmark of approximately 5.8 months in heavily pre-treated populations, alongside four second-line patients with survival exceeding 30 months versus approximately 10.5 months reported for standard-of-care chemotherapy or checkpoint inhibitor monotherapy. All patients had previously failed checkpoint inhibitor treatment prior to enrollment in THIO-101. Most patients completed 29–34 cycles of therapy, while one patient achieved 725 days of survival follow-up after receiving only two cycles of therapy. Additionally, survival follow-up remains ongoing in five of the eight patients. The company also noted that THIO-101 Parts A and B enrolled 79 patients, while the ongoing Part C expansion is enrolling up to 48 participants across Asia and Europe. Treatment with ateganosine followed by cemiplimab has continued to demonstrate an acceptable safety profile in this heavily pre-treated setting. In our view, the extended survival outcomes observed in these refractory NSCLC patients further strengthen the durability profile of the ateganosine regimen (although additional data will be required for further validation), and may provide additional support for the ongoing Phase 3 THIO-104 registrational program.
Valuation: Building on the strengthened balance sheet and improved funding visibility, our valuation framework for THIO in NSCLC continues to reflect a 35% probability of success (PoS), supported by THIO-104's advancement into a pivotal Phase 3 trial, encouraging efficacy signals observed in earlier studies, and regulatory momentum, including Fast Track designation. We continue to assume an expected commercialization timeline of 2028, aligning with the anticipated duration of the Phase 3 trial and the regulatory review process. While dilution from the recent capital raise weighs on per-share value, this is partially offset by improved funding visibility, reduced near-term financing risk, and an increased probability of clinical success. Our discount rate remains unchanged at 13.60%. Based on these assumptions, alongside our comparable company analysis, we derive an illustrative valuation of $10.27 per share, contingent on successful execution by the company.

About MAIA Biotechnology, Inc

Founded in 2018 and headquartered in Chicago, Illinois, MAIA is a biotechnology company engaged in discovering, developing, and commercializing novel cancer therapies with high unmet medical needs.

For more information, visit https://maiabiotech.com/

About Diamond Equity Research

Diamond Equity Research is a leading equity research and corporate access firm focused on small capitalization companies. Diamond Equity Research is an approved sell-side provider on major institutional investor platforms.

For more information, visit https://www.diamondequityresearch.com.

Disclosures:

Diamond Equity Research LLC is being compensated by MAIA Biotechnology, Inc. for producing research materials regarding MAIA Biotechnology, Inc. and its securities, which is meant to subsidize the high cost of creating the report and monitoring the security, however the views in the report reflect that of Diamond Equity Research. All payments are made in advance of each service provided and are billed for the research services under an annual engagement agreement. As of 05/18/26, the issuer paid us $129,500 in cash compensation for research services that continue only if mutually agreed in writing by both parties. Payments were made as follows: $20,000 for an initiation report and $15,000 for update notes in the first year; $20,000 for one update note and $11,500 for three follow-on notes in the second year; $20,000 for one update note and $11,500 for three follow-on notes in the third year; and $20,000 for one update note and $11,500 for three follow-on notes in the fourth year. Research services commenced and initiation payment was made on 11/10/22. Additional compensation may be received in future years if the engagement is renewed. Diamond Equity Research LLC may be compensated for non-research related services, including presenting at Diamond Equity Research investment conferences, press releases and other additional services. The non-research related service cost is dependent on the company, but usually do not exceed $5,000. The issuer has not paid us for non-research-related services as of 05/18/26. Issuers are not required to engage us for these additional services. Additional fees may have accrued since then. Although Diamond Equity Research company sponsored reports are based on publicly available information and although no investment recommendations are made within our company sponsored research reports, given the small capitalization nature of the companies we cover we have adopted an internal trading procedure around the public companies by whom we are engaged, with investors able to find such policy on our website public disclosures page. This report and press release do not consider individual circumstances and does not take into consideration individual investor preferences.This report is based on information we consider reliable, including the subject of the report. This report does not explicitly or implicitly affirm that the information contained in this document is accurate and/or comprehensive, and as such should not be relied on in such capacity. All information contained within this report is subject to change without any formal or other notice provided. Statements within this report may constitute forward-looking statements, these statements involve many risk factors and general uncertainties around the business, industry, and macroeconomic environment. Investors need to be aware of the high degree of risk in small capitalization equities including the complete potential loss of their investment. Investors can find various risk factors in the initiation report and in the respective financial filings for MAIA Biotechnology, Inc. Please review update report attached for full disclosures.

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MAIA Biotechnology May 2026 Update Note

Diamond Equity Research
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Diamond Equity Research Releases Update Note on MAIA Biotechnology, Inc. (NYSE: MAIA)