MAIA Biotechnology Inc. Stock Price, News & Analysis

MAIA Biotechnology (NYSE: MAIA) has published preclinical data in Naunyn-Schmiedeberg's Archives of Pharmacology regarding their novel THIO dimer compound. The study, published on February 15, 2025, demonstrates that THIO and its dimer form effectively inhibit Glutathione S-transferase Pi (GSTP1), an enzyme important in cancer progression and chemoresistance.

The research reveals the compound's potential dual mechanism of action for enhancing standard cancer treatments and addressing drug resistance. As part of MAIA's second-generation research platform, which has developed over 80 THIO-like compounds, this breakthrough aims to identify telomere-targeting compounds with improved cancer cell specificity and increased anticancer activity.

The findings suggest that the dimerized form of THIO could enhance chemotherapeutic efficacy through GSTP1 targeting, potentially offering new strategies for combating drug-resistant cancers.

MAIA Biotechnology (NYSE: MAIA) announced that the United States Adopted Names (USAN) Council has approved 'ateganosine' as the nonproprietary name for its lead molecule THIO, a telomere-targeting anticancer agent in development for advanced non-small cell lung cancer (NSCLC).

The USAN Council, comprising experts from the American Medical Association, U.S. Pharmacopeial Convention, and FDA, is responsible for selecting standardized generic drug names. The name ateganosine was chosen to reflect the drug's mechanism of action in altering telomeric guanosine of cancer cells.

This approval represents a significant milestone in MAIA's regulatory pathway as the company progresses with Phase 2 and 3 clinical trials. The company will continue using the name THIO in its clinical trial designations (THIO-101, THIO-102, THIO-103, THIO-104).

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.