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MAIA Biotechnology Inc. (MAIA+4.00%) has submitted its 10-K filing for the fiscal year ended December 31, 2024.
The filing details the company's progress in developing THIO, an investigational drug targeting telomeres in cancer cells. THIO is currently in a Phase 2 clinical trial for non-small cell lung cancer (NSCLC) in combination with the immune checkpoint inhibitor Libtayo®.
The company reported a net loss of $23,254,656 for the year ended December 31, 2024, compared to a net loss of $19,772,905 in the previous year. This increase is attributed to expanded clinical trial activities and associated costs.
MAIA Biotechnology has been granted Orphan Drug Designation by the FDA for THIO in the treatment of hepatocellular carcinoma and small cell lung cancer, providing potential market exclusivity benefits.
The company has entered into a clinical supply agreement with BeiGene to assess THIO in combination with the immune checkpoint inhibitor tislelizumab in three cancer indications: hepatocellular carcinoma, small cell lung cancer, and colorectal cancer.
MAIA Biotechnology announced updates on its Phase 2 clinical trial, THIO-101, showing promising interim results, including a median overall survival of 16.9 months for patients receiving THIO in combination with Libtayo®.
MAIA's financial condition as of December 31, 2024, includes cash reserves of $9.60 million, with substantial doubt expressed by its auditors about the company's ability to continue as a going concern without additional capital.
The company plans to initiate a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of THIO in third-line NSCLC patients resistant to checkpoint inhibitors and chemotherapy.
MAIA Biotechnology's strategy includes expanding its clinical development program to additional cancer indications and pursuing strategic collaborations to enhance its drug development pipeline.
The filing also highlights the company's intellectual property strategy, with several patent applications filed to protect its telomere-targeting technology and next-generation compounds.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the MAIA Biotechnology Inc. annual 10-K report dated March 21, 2025. To report an error, please email earnings@qz.com.