MAIA Biotechnology Inc. Stock Price, News & Analysis

MAIA Biotechnology (NYSE: MAIA) has announced plans to initiate THIO-104, a Phase 3 pivotal trial in 2025, evaluating THIO in sequence with checkpoint inhibitor (CPI) for third-line non-small cell lung cancer (NSCLC) patients resistant to checkpoint inhibitors and chemotherapy.

The multicenter, open-label trial will compare THIO's efficacy directly against chemotherapy, involving up to 300 patients in a 1:1 randomization. The study's primary endpoint is overall survival, with secondary endpoints including disease control rate, overall response rate, duration of response, progression-free survival, and safety.

Patient enrollment is expected to begin in the second half of 2025 across select countries in Asia, Europe, and the U.S. The company reports that THIO has shown superior performance compared to standard treatments in their ongoing THIO-101 Phase 2 trial.

MAIA Biotechnology (NYSE: MAIA) has announced the expansion design of its THIO-101 Phase 2 trial for advanced non-small cell lung cancer (NSCLC). The expanded study will evaluate overall response rates in third-line (3L) patients resistant to previous checkpoint inhibitor treatments and chemotherapy.

The trial will include two arms with up to 48 patients: Arm 1 evaluating THIO sequenced with Libtayo® (cemiplimab), and Arm 2 assessing THIO as monotherapy. An additional 100 patients will be enrolled for the registration phase across the U.S., Europe, and Asia.

Current data as of January 15, 2025, shows a Median Overall Survival (OS) of 16.9 months in third-line treatment, with a 95% confidence interval lower bound of 12.5 months. The treatment has been well-tolerated in heavily pre-treated patients. MAIA has amended its clinical supply agreement with Regeneron for Libtayo provision and plans to seek accelerated FDA approval.

MAIA Biotechnology (NYSE: MAIA) has announced a non-brokered private placement of 952,300 shares of common stock at $1.50 per share, along with warrants to purchase additional shares at $1.85 per share. The warrants will be exercisable one year after issuance and have a six-year term.

This placement is expected to raise approximately $1.43 million in gross proceeds. Combined with a previous private placement of $2.7 million closed on February 24, 2025, the total gross proceeds will reach $4.1 million. The funds will be used to finance the starting costs for Part C of the Phase 2 THIO-101 clinical trial and working capital needs.

The securities are being offered under Section 4(a)(2) of the Securities Act and Regulation D, and will be restricted securities without registration rights. The placement is expected to close around February 26, 2025, subject to customary closing conditions.

MAIA Biotechnology (NYSE: MAIA) has announced a private placement agreement to sell 1,810,000 shares of common stock at $1.50 per share, expected to raise gross proceeds of $2.715 million. Each share comes with a warrant to purchase one additional share at $1.87, exercisable one year after issuance with a six-year term.

The private placement, which includes participation from company directors, is expected to close around February 20, 2025. The proceeds will fund the initiation of Part C of the Phase II THIO-101 trial and provide working capital. The securities are being offered under Section 4(a)(2) of the Securities Act and Regulation D, and have not been registered under the Securities Act.

MAIA Biotechnology (NYSE: MAIA) reported positive updates from its THIO-101 Phase 2 clinical trial, evaluating THIO in combination with cemiplimab for advanced non-small cell lung cancer (NSCLC) patients who failed multiple standard treatments.

Key findings as of January 15, 2025, showed a median overall survival (OS) of 16.9 months for 22 NSCLC patients who received at least one THIO dose in parts A and B of the trial. The analysis demonstrated a 95% confidence interval lower bound of 12.5 months and a 99% confidence interval lower bound of 10.8 months. This significantly outperforms standard-of-care chemotherapy treatments, which typically show OS of 5-6 months in similar settings.

The treatment has been well-tolerated in this heavily pre-treated population. Based on these results, MAIA is pursuing potential accelerated FDA approval through the ongoing expansion of the THIO-101 trial.

MAIA Biotechnology (NYSE: MAIA) has announced its participation in the Biotech Showcase™ 2025 investor conference, scheduled for January 13-15, 2025, in San Francisco, with a follow-up virtual event on January 21-22, 2025.

CEO Vlad Vitoc, M.D. will present on January 13, 2025, at 3:00 PM PST, discussing key developments including:

• Expansion of the THIO-101 pivotal Phase 2 clinical trial for advanced non-small cell lung cancer (NSCLC) patients receiving third-line therapy
• Plans for multiple THIO trials across additional cancer indications
• Market potential for THIO in major tumor types globally

The presentation will be available via webcast with on-demand playback accessible for 6 months following the event. Dr. Vitoc will also conduct one-on-one meetings with investors throughout the conference.

MAIA Biotechnology has entered into a clinical supply agreement with BeiGene to evaluate THIO in combination with tislelizumab in three Phase 2 pivotal trials. The trials will study the drug combination in hepatocellular carcinoma (HCC), small cell lung cancer (SCLC), and colorectal cancer (CRC).

Preclinical results showed promising outcomes: complete anti-tumor immune response in HCC, activation of anti-tumor responses in SCLC, and 100% complete response in CRC with no recurrence. THIO has received orphan drug designation for HCC, SCLC, and glioblastoma. Under the agreement, MAIA will sponsor and fund the trials while BeiGene provides tislelizumab. MAIA retains global development and commercial rights to THIO.

The target markets show significant potential: HCC market valued at $780M (2023), SCLC therapeutics at $6.5B (2024), and CRC therapeutics projected to reach $26.49B by 2032.

MAIA Biotechnology (NYSE: MAIA) announced that two independent directors participated in recent private placement closings, demonstrating insider confidence. The closings, which occurred on November 1 and December 13, 2024, raised total gross proceeds of $3.4 million.

Director Ramiro Guerrero invested approximately $300,000 to purchase 141,952 shares and warrants, while Dr. Stan V. Smith invested about $273,000 for 125,000 shares and warrants. Both directors expressed confidence in MAIA's clinical strategy and THIO's potential for treating multiple cancer indications.

MAIA Biotechnology (NYSE: MAIA) announced that the FDA has granted Rare Pediatric Disease Designation for THIO in treating pediatric-type diffuse high-grade gliomas (PDHGG). This designation makes MAIA eligible for a priority review voucher upon future FDA approval, which can be sold as an asset with an average value of $100 million since 2015.

Previous research demonstrated THIO's effectiveness when combined with ionizing radiation in treating diffuse intrinsic pontine glioma (DIPG), a PDHGG subtype, showing significant decrease in cell proliferation. THIO, believed to be the only direct telomere-targeting agent in clinical development, also holds orphan drug designations for hepatocellular carcinoma, small cell lung cancer, and glioblastoma.