MAIA Biotechnology, Inc. - MAIA STOCK NEWS

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.

MAIA Biotechnology (NYSE American: MAIA) has announced a private placement of 507,364 shares of common stock at $1.872 per share to accredited investors and company directors. Each share comes with a warrant to purchase one additional share at $2.08, exercisable after six months with a five-year term.

The placement is expected to raise approximately $950,000 in gross proceeds, closing around December 11, 2024. The funds will be used to manufacture THIO for Phase II clinical trials and 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 has expanded its 2021 clinical supply agreement with Regeneron for the Phase 2 THIO-101 trial. The expansion will evaluate THIO's efficacy when administered sequentially with Libtayo® (cemiplimab) in third-line non-small cell lung cancer (NSCLC) patients who were resistant to previous checkpoint inhibitor treatments and chemotherapy. Under the amended agreement, MAIA remains the trial sponsor while Regeneron will supply Libtayo® for all patients. The trial has shown promising results in disease control, progression-free survival, and overall response rates. MAIA plans to begin new patient enrollment soon and is exploring potential accelerated approval opportunities in the United States.

MAIA Biotechnology announced that independent director Stan V. Smith, Ph.D. purchased 100,000 shares of common stock and warrants to purchase an additional 100,000 shares for a total of $225,900 in the company's recent private placement. The transaction, announced on October 28, 2024, closed on November 1, 2024. Smith, one of MAIA's original investors, has participated in nearly every private placement financing round since the company's inception. As president of Smith Economics Group, , he expressed confidence in MAIA's THIO franchise's potential in treating multiple difficult-to-treat cancer types through telomere targeting and immunogenicity.

MAIA Biotechnology announced that its late-breaking abstract from the THIO-101 Phase 2 clinical trial has been selected for presentation at the 2024 SITC Annual Meeting. The presentation will showcase new efficacy and safety data for THIO combined with cemiplimab in advanced non-small cell lung cancer (NSCLC) patients who failed multiple standard treatments. As of August 1, 2024, 16 patients had survival follow-up exceeding 12 months, with 9 in third-line treatment showing interim median survival of 10.6 months, significantly surpassing the standard-of-care survival of 5.8 months.

MAIA Biotechnology (NYSE American: MAIA) has secured a $2.44 million private placement through the sale of 1,079,784 common stock shares at $2.259 per share to accredited investors and company directors. Each share comes with a warrant to purchase one additional share at $2.51, exercisable after six months with a five-year term. The proceeds will fund the manufacturing of THIO for the Phase 2 THIO-101 trial in non-small cell lung cancer (NSCLC) and working capital. The private placement is expected to close around October 30, 2024.

MAIA Biotechnology (NYSE American: MAIA) announced that an abstract on its second-generation telomere-targeting THIO prodrugs has been accepted for poster presentation at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain (October 23-25, 2024). The presentation will showcase preclinical studies of MAIA-2021-20 and MAIA-2022-12, lipid-conjugated compounds derived from THIO, belonging to a new class called telomere targeting divalent dinucleotides.

The studies evaluated these compounds' efficacy alone and in combination with immune checkpoint-blocking antibodies. Results demonstrated high efficacy, ability to overcome immunotherapy resistance, and marked activity in advanced tumors, showing tumor growth inhibition in preclinical models of lung cancer, colorectal carcinoma, melanoma, and hepatocellular carcinoma. MAIA is actively working to advance these candidates toward clinical development.