MAIA Biotechnology Reports Increased Net Loss and Clinical Trial Developments for 2024

MAIA Biotechnology, Inc., a clinical-stage biopharmaceutical company, reported a net loss of $23.25 million for the year ended December 31, 2024, compared to a net loss of $19.77 million in 2023. This increase in net loss is primarily attributable to a decrease in other income, which shifted from a net income of $409,476 in 2023 to a net expense of $6,297,446 in 2024, largely due to a change in the fair value of warrant liability. Operating expenses decreased by 16% year-over-year, with research and development expenses falling by 10% to $10.01 million and general and administrative expenses decreasing by 23% to $6.95 million.

Significant developments during the fiscal year included the completion of enrollment in the Phase 2 THIO-101 clinical trial in February 2024, ahead of schedule. The trial evaluated THIO in combination with Regeneron's cemiplimab in advanced non-small cell lung cancer (NSCLC) patients. The company also announced positive topline data from Part A of the THIO-101 trial, showing that THIO was well-tolerated at the highest dose tested. Further, the company announced the publication of a PCT application for new telomere-targeting dinucleotides and secured continued insider investment through private placement equity financings totaling over $12 million.

Operational highlights included the dosing of 79 patients in the THIO-101 trial by February 2024, with the selection of 180mg/cycle as the optimal dose. Interim efficacy data from the trial showed an overall response rate (ORR) of 38% in the efficacy evaluable population for combination THIO 180mg + cemiplimab in third-line NSCLC patients. The company also announced updates on survival data, with some patients surpassing 12 months of treatment and showing progression-free survival exceeding expectations. As of December 31, 2024, the company employed 13 full-time employees, including one in its Romanian subsidiary.

In the first quarter of 2025, MAIA entered into a clinical supply agreement with BeiGene to evaluate THIO in combination with tislelizumab across three cancer indications (HCC, SCLC, and CRC). Updated data from the THIO-101 trial showed a median overall survival of 16.9 months for third-line NSCLC patients. The company also announced plans to initiate a Phase 3 pivotal trial (THIO-104) in 2025 and received FDA designation of THIO as a drug for a rare pediatric disease, making it eligible for a priority review voucher. The USAN Council approved "ateganosine" as the nonproprietary name for THIO.

The company's 10-K filing notes substantial doubt about its ability to continue as a going concern without additional funding. As of December 31, 2024, the company had $9.6 million in cash and an accumulated deficit of $87.23 million. The company plans to seek additional capital through equity offerings, debt financings, and collaborations to fund its operations and the development and commercialization of THIO and other potential drug candidates. The filing also details numerous risks related to clinical trials, regulatory approvals, commercialization, intellectual property, and competition within the biopharmaceutical industry.