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CHICAGO - MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical company with a market capitalization of $53 million, has announced updated results from its Phase 2 clinical trial for ateganosine (THIO), a treatment for advanced non-small cell lung cancer (NSCLC). According to InvestingPro data, analysts maintain a Strong Buy consensus on the stock, with price targets ranging from $10.27 to $14. The trial, which includes a combination therapy with Regeneron’s cemiplimab, showed a median overall survival (OS) of 17.8 months for patients who are resistant to standard therapies.
The latest data, as of May 15, 2025, from the THIO-101 pivotal trial, indicates that the 22 NSCLC patients treated with ateganosine experienced a median OS of 17.8 months. This figure surpasses the standard-of-care chemotherapy treatments for NSCLC, which typically show an OS of 5 to 6 months in similar patient populations. The treatment has been generally well-tolerated among the participants.
MAIA’s Chairman and CEO, Vlad Vitoc, M.D., expressed optimism about the results, stating that the new benchmark of 17.8 months median OS is nearly triple that of current third-line NSCLC treatments. The company believes that these findings could significantly alter the treatment landscape for NSCLC. InvestingPro analysis shows MAIA maintains a healthy balance sheet with more cash than debt and a current ratio of 2.35, indicating strong liquidity to support its clinical programs.
Ateganosine is a telomere-targeting agent that induces selective cancer cell death by causing telomerase-dependent telomeric DNA damage. When used sequentially with PD-(L)1 inhibitors, the treatment has shown potential in inducing profound and persistent tumor regression in advanced cancer models.
MAIA is exploring multiple regulatory pathways for ateganosine, which could lead to accelerated FDA approval and robust market exclusivity for the treatment of NSCLC. A decision by the FDA could come as early as next year.
This news is based on a press release statement and should be considered in the context of MAIA’s caution regarding forward-looking statements, which are subject to various risks and uncertainties. The company’s statements about the potential for regulatory approval and the treatment’s efficacy are projections and not guarantees of future performance. While currently trading below its Fair Value according to InvestingPro analysis, investors should note that the company is not yet profitable, with analysts forecasting continued losses in 2025. Get access to 6 additional ProTips and comprehensive financial metrics with an InvestingPro subscription.
In other recent news, MAIA Biotechnology has announced several financial and strategic developments. The company secured approximately $1.08 million and $669,500 in two separate private placements, allocating funds towards their Phase II THIO-101 trial and working capital. This trial is a significant part of MAIA’s efforts in developing cancer treatments. Additionally, MAIA has revised its maximum aggregate offering price from $30 million to $11.2 million, as disclosed in a recent SEC filing. This adjustment reflects the company’s strategic financial planning. MAIA also doubled its authorized common stock from 70 million to 150 million shares, a move approved by stockholders to provide flexibility for future business opportunities. The company is targeting 2026 for potential FDA approval of its anticancer agent, THIO, focusing on non-small cell lung cancer. This timeline is part of MAIA’s broader strategy to address unmet medical needs in cancer treatment. These developments underscore MAIA’s ongoing efforts to advance its clinical programs and financial strategies.
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