MAIA Biotechnology Inc. Stock Price, News & Analysis

MAIA Biotechnology (NYSE:MAIA) announced that its CEO presented at Smart Diaspora 2025 and that Romania has begun screening patients for the Phase 2 THIO-101 Part C expansion evaluating ateganosine sequenced with an immune checkpoint inhibitor as a third-line treatment for non-small cell lung cancer (NSCLC).

The company highlighted an observed 38% response rate from its treatment in third-line NSCLC versus current third-line responses of up to 6%, and noted it is pursuing accelerated approval in the U.S. following an FDA Fast Track designation received in July. Romanian investigators and a key local investigator, Tudor Ciuleanu MD PhD, will support the expansion.

MAIA (NYSE American: MAIA) presented a Trial in Progress poster at the 2025 AACR-NCI-EORTC conference and reported that the first five patients in Part C (expansion) of the THIO-101 Phase 2 trial were enrolled in Taiwan and Turkey as of Oct 27, 2025. The company said screening is ongoing across Europe and Asia and that the safety profile observed so far is well aligned with Parts A and B. The presentation focused on ateganosine (THIO) combined with immune checkpoint inhibitors for advanced NSCLC resistant to prior ICI and chemotherapy. The poster is available at maiabiotech.com/publications.

MAIA Biotechnology (NYSE: MAIA) reported clinical highlights from ESMO Congress 2025 describing extended survival in non-small cell lung cancer (NSCLC) patients treated with ateganosine (THIO).

Key point: as of Sept 17, 2025 one THIO-101 patient who began therapy in March 2023 showed 30 months (912 days) survival; that patient completed treatment after the protocol maximum of two years. MAIA presented two e-posters on Oct 19, 2025 covering the ongoing Phase 2 (THIO-101) and Phase 3 (THIO-104) trials in ICI-resistant advanced NSCLC; posters are available at maiabiotech.com/publications.

MAIA Biotechnology (NYSE American: MAIA) announced a private placement to accredited investors for 603,769 shares of common stock at $1.22 per share, each accompanied by a warrant to buy one share at an exercise price of $1.52. The warrants become exercisable six months after issuance and expire three years from issuance.

The offering is expected to close on or about October 15, 2025, with gross proceeds of approximately $736,600 before offering expenses. The company intends to use net proceeds to fund Step 1 of Part C of the Phase II THIO-101 trial and for working capital. The securities are being offered in a private placement and are unregistered.

MAIA (NYSE American: MAIA) announced on October 7, 2025 a new digital asset treasury strategy permitting corporate officers to buy and sell Bitcoin (BTC), Ethereum (ETH) and USD Coin (USDC).

The Board authorized holdings of up to 90% of the company’s liquid assets in cryptocurrencies and will review transactions, cybersecurity, accounting policies, risks, and material developments. Management said it will keep adequate working capital for operations and seek Board approval to form a Digital Assets Advisory Board to support execution.

MAIA Biotechnology (NYSE American: MAIA) has secured a $2.25 million private placement through the sale of 1,733,766 shares of common stock at $1.30 per share to accredited investors and a Company director.

The offering includes warrants to purchase one share of common stock at $1.57 per share, exercisable after six months with a three-year term. The private placement is expected to close around October 1, 2025. The proceeds will fund Step 1 of Part C of the Phase II THIO-101 trial and working capital needs.

MAIA Biotechnology (NYSE American: MAIA) has secured a $2.3 million NIH grant to expand its THIO-101 Phase 2 clinical trial of ateganosine for advanced non-small cell lung cancer (NSCLC) treatment. The grant will support U.S. patient enrollment over 2025-2027 for third-line treatment of patients resistant to chemo and immunotherapy.

The trial has shown promising results, with median overall survival of 17.8 months in 22 third-line treatment patients, significantly higher than the 5-6 months typical with standard chemotherapy. The trial's expansion phase began in July 2025 in Taiwan, following FDA IND clearance in 2023.

MAIA Biotechnology (NYSE American: MAIA) reported positive Phase 2 clinical trial results for ateganosine (THIO) in combination with cemiplimab for advanced non-small cell lung cancer (NSCLC) patients. The trial showed remarkable efficacy with 5.6 months median progression-free survival in third-line treatment (180 mg dose), more than double the standard of care of 2.5 months.

The study demonstrated an estimated median overall survival of 17.8 months, with confidence intervals showing a lower bound of 12.5 months (95% CI) and 10.8 months (99% CI). Two patients completed 33 treatment cycles, indicating ateganosine's potential for extended dosing. The company has initiated a Phase 2 expansion trial in July 2025 to further validate these promising results.

MAIA Biotechnology (NYSE American: MAIA) announced that its abstract on ateganosine (THIO) treatment for non-small cell lung cancer (NSCLC) has been selected for poster presentation at the 2025 IASLC World Conference on Lung Cancer in Barcelona.

The presentation will highlight promising data from the THIO-101 trial, showing a median overall survival of 17.8 months with a 95% confidence interval lower bound of 12.5 months. Notably, the FDA has recently granted Fast Track designation for ateganosine in NSCLC treatment, potentially expediting its regulatory process towards Accelerated Approval and Priority Review.