MAIA Biotechnology, Inc. is expanding its ongoing Phase 2 clinical trial, THIO-101, to further assess the efficacy of its lead drug candidate, THIO, in combination with Regeneron's Libtayo® (cemiplimab) for treating third-line non-small cell lung cancer (NSCLC) patients. This decision follows promising interim results from the trial, which targets patients resistant to prior checkpoint inhibitor therapies and chemotherapy.
THIO-101 Trial Expansion and Interim Results
The amended clinical supply agreement with Regeneron, initially established in 2021, will provide additional Libtayo® for the expanded trial. MAIA Biotechnology sponsors the THIO-101 trial and holds an exclusive worldwide patent license to develop and commercialize THIO. The company is also contemplating an accelerated approval pathway in the United States based on the trial's outcomes.
The Phase 2 trial of THIO has demonstrated encouraging interim results. The trial evaluates THIO in combination with cemiplimab for patients who have not responded to two or more standard-of-care therapy regimens. The interim median survival follow-up for these third-line patients was reported at 10.6 months, which compares favorably to the standard-of-care overall survival of 5.8 months. Full efficacy results from the trial are anticipated within the current year. Sixteen patients surpassed a 12-month survival follow-up, nine of whom were third-line treatment patients.
Insider Stock Purchases
In related news, MAIA Biotechnology director Ramiro Guerrero recently purchased 53,418 shares of common stock at approximately $1.872 per share, totaling $99,998. Following this transaction, Guerrero holds 514,970 shares of MAIA Biotechnology and warrants for an additional 53,418 shares, exercisable at $2.08 per share starting June 2025.
Additionally, director Stan Smith acquired 25,000 shares of common stock on December 13, 2024, at $1.872 per share, totaling $46,800, through The Stan V. Smith Trust Dated 1993. Smith also acquired 25,000 warrants at $2.08 per share, exercisable starting June 13, 2025, and expiring five years later. These transactions were executed under a Securities Purchase Agreement and are part of the Issuer's 2021 Equity Incentive Plan.
Financial Health and Analyst Outlook
MAIA Biotechnology maintains a healthy liquidity position with a current ratio of 2.56, indicating a strong ability to meet short-term obligations. Analysts' price targets range from $11.25 to $14.00, suggesting the company remains undervalued relative to its Fair Value, despite an impressive year-to-date gain.
