MAIA Biotechnology Inc. Stock Price, News & Analysis

MAIA (NYSE:MAIA) announced the first patient dosing in the THIO-104 Phase 3 pivotal trial of ateganosine given in sequence with a checkpoint inhibitor (CPI) as a third-line treatment for advanced non-small cell lung cancer (NSCLC).

The multicenter, open-label trial will randomize up to 300 patients 1:1 to ateganosine+CPI versus investigator’s choice chemotherapy, with overall survival as the primary endpoint. MAIA has regulatory approval to screen in Taiwan, Turkey, select EMA countries, and Georgia; screening and enrollment are underway.

Supporting data cited: prior THIO-101 observed PFS 5.6 months versus ~2.5 months standard of care, one patient reached 30 months survival, and the FDA has granted Fast Track designation for ateganosine in NSCLC.

MAIA (NYSE American: MAIA) reported additional insider open-market purchases and highlighted clinical progress for its small-molecule telomere-targeting therapy ateganosine.

Directors and officers acquired approximately 182,445 shares between Nov 21–28, 2025, and continue to hold 4,480,120 shares (12.95%) of the company. The company said ateganosine is advancing through mid‑ to late‑stage development with encouraging clinical signals in advanced non‑small cell lung cancer (NSCLC).

MAIA (NYSE:MAIA) announced progress for its telomere-targeting candidate ateganosine as a potential new class for advanced non-small cell lung cancer (NSCLC) on Dec 10, 2025. MAIA said ateganosine has received FDA Fast Track designation for NSCLC patients resistant to immunotherapy and chemotherapy and that it is initiating a Phase 3 THIO-104 trial.

The release highlights market context and figures: the CPI category generated about $50B in 2024, NSCLC market value cited at $34.1B now and projected to $68.8B by 2033, ~180,000 U.S. NSCLC patients entering treatment annually, and Keytruda revenue of $29.5B in 2024. Ateganosine also holds FDA orphan drug designations for glioblastoma, HCC, and SCLC, each conferring seven years of U.S. exclusivity if approved.

MAIA Biotechnology (NYSE American: MAIA) announced that the CEO and certain directors purchased approximately 182,445 shares of MAIA common stock in open-market trades between November 21 and 28, 2025 at an average price of $1.06 per share. Vlad Vitoc, chairman and CEO, purchased 94,300 shares at an average of $1.08, while directors Cristian Luput and Stan V. Smith purchased a combined 88,145 shares at an average of $1.04.

The company highlighted clinical progress for ateganosine in its Phase 2 THIO-101 trial, reporting a 38% response rate and 17.8 months overall survival to date.

MAIA (NYSE American: MAIA) reported clinical updates for its telomere‑targeting agent ateganosine at SITC 2025. The company confirmed 12 patients enrolled in the Phase 2 THIO-101 expansion (Part C) with enrollment active in EMA countries including Hungary and Poland, plus screening in Turkey and Taiwan. MAIA has begun screening patients in the Phase 3 THIO-104 trial. The FDA has granted Fast Track designation for ateganosine in NSCLC. MAIA reported an observed overall survival (OS) of 17.8 months in THIO-101 to date and a single patient with 912 days (30 months) survival as of September 17, 2025. Posters for THIO-101 and THIO-104 were filed on Form 8-K and posted on the company website on November 7, 2025.

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.