MAIA Biotechnology Inc. Stock Price, News & Analysis

MAIA Biotechnology (NYSE American: MAIA) announced the publication of preclinical data for its second-generation ateganosine prodrugs platform in Nucleic Acids Research journal. The study focuses on novel telomere-targeting dual-pharmacophore dinucleotide prodrugs for cancer treatment.

The company has developed over 80 ateganosine-like compounds and nominated two key candidates: MAIA-2021-20 (lead) and MAIA-2022-12 (backup). The research demonstrated that these compounds, when combined with immune checkpoint inhibitors, showed superior anticancer efficacy and stronger host immune-memory responses compared to monotherapies. MAIA plans to advance at least one candidate to human clinical trials following completion of required studies.

MAIA Biotechnology (NYSE American: MAIA) has announced the dosing of its first patient in Taiwan for the expansion phase of the THIO-101 Phase 2 trial, evaluating ateganosine in advanced non-small cell lung cancer (NSCLC). The trial focuses on heavily pre-treated third-line NSCLC patients who previously failed checkpoint inhibitors and chemotherapy treatments.

The study includes two treatment arms: ateganosine with cemiplimab (Libtayo®) and ateganosine monotherapy. Current data shows median overall survival of 17.8 months for third-line treatment patients, significantly exceeding the typical 5-6 months survival with chemotherapy. The NSCLC market, valued at $34.1B in 2024, is projected to reach $68.8B by 2033 with an 8.1% CAGR.

MAIA Biotechnology (NYSE American: MAIA) announced two upcoming poster presentations at the 49th Federation of European Biochemical Societies (FEBS) 2025 Congress in Istanbul, Turkey, scheduled for July 5-9, 2025. The presentations will focus on the company's telomere-targeting cancer therapeutics.

The first poster, presented by Dr. Z. Gunnur Dikmen, will discuss how RiboTHIO and THIO work synergistically with radiotherapy and immune checkpoint blockade in lung tumor treatment. The second poster, presented by Gamze Tuna, will explore the effects of novel telomerase-mediated compounds on DNA damage and repair in A549 cells.

The company also reported that its THIO-101 Phase 2 clinical trial for ateganosine in non-small cell lung cancer (NSCLC) demonstrated a median overall survival of 17.8 months in heavily pre-treated patients, based on May 15, 2025 data.

MAIA Biotechnology (NYSE American: MAIA) has strengthened its Scientific Advisory Board by appointing two leading HCC specialists, Dr. Claudia Fulgenzi and Dr. David J. Pinato. The appointments come as MAIA prepares for a Phase 2 clinical trial of its lead candidate ateganosine (THIO) in hepatocellular carcinoma (HCC).

The company expects to begin patient enrollment in the HCC trial by year-end, leveraging its 2022 FDA Orphan Drug Designation for ateganosine in HCC treatment, which could provide up to seven years of market exclusivity. Both appointees bring extensive expertise in liver cancer research and immunotherapy, with Dr. Pinato serving as Director of Developmental Cancer Therapeutics at Imperial College London and Dr. Fulgenzi specializing in immune-oncology at Imperial College London.

MAIA Biotechnology (NYSE: MAIA) has entered into a clinical master supply agreement with Roche to investigate combination therapies for hard-to-treat cancers. The partnership will focus on studying the combined effects of MAIA's telomere-targeting agent ateganosine (THIO) with Roche's checkpoint inhibitor atezolizumab (Tecentriq®). Preclinical studies have shown promising results, with ateganosine demonstrating high synergistic effectiveness when combined with Roche's anti-PD-L1 agent. This collaboration represents a significant step in MAIA's mission to develop safe and effective cancer treatments.

MAIA Biotechnology (NYSE: MAIA) announced its participation in the BIO International Convention 2025, scheduled for June 16-19 in Boston. CEO Vlad Vitoc will present the latest findings from the THIO-101 Phase 2 clinical trial, which evaluates ateganosine in combination with cemiplimab for advanced non-small cell lung cancer (NSCLC). Ateganosine is a telomere-targeting anticancer agent that causes telomeric DNA damage and triggers cancer-specific immune responses. The THIO-101 study is positioned to be the first completed clinical trial of a telomere-targeting agent in cancer treatment. The company has also announced plans to expand the trial to further evaluate treatment efficacy in third-line NSCLC patients. The presentation is scheduled for June 18 at 11:30 AM EDT.

MAIA Biotechnology reported a new partial response in its Phase 2 THIO-101 trial evaluating ateganosine with cemiplimab in advanced non-small cell lung cancer patients. The responding patient showed stable disease for over 20 months before achieving a partial response, defined as a 30% tumor size reduction. The trial's data cutoff from May 15, 2025, demonstrated a median overall survival of 17.8 months among 22 NSCLC patients, with the longest survival reaching 24.3 months after 32 treatment cycles. This significantly outperforms standard-of-care chemotherapy treatments, which typically show 5-6 months overall survival in similar settings. The company plans to expand its THIO-101 pivotal Phase 2 trial to further assess overall response rates in third-line NSCLC patients resistant to previous treatments.

MAIA Biotechnology reported promising updated data from its THIO-101 Phase 2 clinical trial for ateganosine (THIO) in combination with cemiplimab in advanced non-small cell lung cancer patients. The trial demonstrated a median overall survival of 17.8 months in third-line treatment for 22 NSCLC patients who received at least one dose of ateganosine. This represents nearly triple the standard-of-care survival rate of 5-6 months. The treatment showed a 95% confidence interval lower bound of 12.5 months and a 99% confidence interval lower bound of 10.8 months. The therapy has been well-tolerated in heavily pre-treated patients. MAIA is pursuing multiple regulatory pathways for potential accelerated FDA approval, with a possible decision expected next year.

MAIA Biotechnology (NYSE: MAIA) has secured a private placement offering of approximately $669,500 through the sale of 446,332 shares of common stock at $1.50 per share. The offering includes warrants to purchase an equal number of shares at $1.71 per share, exercisable after six months with a five-year term. The placement, expected to close around May 29, 2025, involves accredited investors and a Company director. MAIA will use the proceeds to fund Step 1 of Part C of the Phase II THIO-101 trial and for working capital. The securities are being offered under Section 4(a)(2) of the Securities Act and Regulation D, and have not been registered under the Securities Act.