MAIA Biotechnology (MAIA) Stock News

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.

MAIA Biotechnology (NYSE: MAIA) has announced a private placement offering of 463,332 shares of common stock at $1.50 per share to accredited investors and a Company director. The offering includes warrants to purchase an equal number of shares at $1.71 per exercise price, exercisable after six months with a five-year term. The private placement is expected to close around May 29, 2025, with anticipated gross proceeds of approximately $695,000.

The company plans to 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.

MAIA Biotechnology (NYSE: MAIA) announced the acceptance of their abstract for poster presentation at the 2025 ASCO Annual Meeting in Chicago. The presentation will showcase efficacy data from their Phase 2 THIO-101 clinical trial of ateganosine (THIO), a telomere targeting agent, in combination with cemiplimab for third-line immune checkpoint inhibitor-resistant advanced NSCLC.

The poster, titled "Phase 2 Study of Telomere-Targeting Agent THIO Sequenced With Cemiplimab in Third-Line Immune Checkpoint Inhibitor–Resistant Advanced NSCLC: Evaluation of Overall Survival," will be presented by Dr. Tomasz Jankowski on May 31, 2025, from 1:30 PM to 4:30 PM CDT in the Lung Cancer track. CEO Vlad Vitoc expressed confidence in ateganosine's potential to become a best-in-class anticancer treatment.

MAIA Biotechnology (NYSE: MAIA) announced that two independent directors participated in its recent private placement offering. Dr. Stan V. Smith invested $100,000 for 66,666 shares and warrants, while Ramiro Guerrero invested $30,000 for 20,000 shares and warrants. The total gross proceeds from the offering were $1.08 million. CEO Vlad Vitoc highlighted this insider participation as a signal of board confidence in the company's direction. The directors expressed strong conviction in MAIA's clinical and regulatory strategies, particularly regarding ateganosine, their potential first-in-class cancer telomere targeting treatment.