On August 8, 2023 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported financial results for the second quarter ended June 30, 2023, and provided a corporate update (Press release, MAIA Biotechnology, AUG 8, 2023, View Source [SID1234634017]).

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"We recently reached an important milestone in the THIO-101 phase 2 trial, with our first patients dosed in the trial crossing the 1 year mark since starting therapy with THIO followed by an immune checkpoint inhibitor, without any additional cancer treatment. These positive preliminary results align well with our preclinical data and supported a faster pace of enrollment in the last quarter in Europe as we continue to activate more sites," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "In addition to THIO, we have 3 proprietary home-grown telomere-targeting molecules patented which further expands our options to treat several cancer indications. For the second half of the year, we look forward to continue evolving in the Part B randomized efficacy/dose selection of THIO-101."

Corporate Highlights

Reported second broad provisional patent application, nominating MAIA-2021-029 as the third new molecular candidate in MAIA’s Telomere-Targeting Molecule Program: MAIA is creating and evaluating multiple telomere-targeting compounds designed to modify the telomeric structure through the cancer cell intrinsic telomerase activity and cause the death of these cells. The studies, conducted in vitro in multiple cancer cell lines and in vivo in several pre-clinical cancer models, demonstrated the intended mechanism of action and high-level anti-cancer activity for these new molecules.

Announced updates in enrollment in THIO-101 Phase 2 clinical trial: As of July 2023, announced that 35 patients have been dosed in MAIA’s Phase 2 clinical trial, THIO-101, evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC). With the addition of sites in Hungary, Poland, and Bulgaria in March 2023, THIO-101 has rapidly increased the number of patients enrolled and dosed with THIO.

Reported positive updates on preliminary survival data for THIO-101: As of July 2023, the first 2 patients dosed with THIO continue to be alive for approximately 12.2 and 11.5 months respectively, from treatment initiation. They have remained free of disease progression for 10.2 and 8.5 months, respectively, without requiring any additional therapy.

Reported updates on disease control rates for THIO-101 Phase 2 trial for advanced Non-Small Cell Lung Cancer: As of July 2023, out of the first 11 patients with post-baseline scans, 82% (9 patients) met the disease control primary endpoint (defined as a complete response, partial response, or stable disease per RECIST 1.1) at first response assessment. In similar heavily treated NSCLC patients, typical disease control rates (DCR) are in the 25-35% range. All patients enrolled had previously failed 2 or more prior lines of treatment including an immune checkpoint inhibitor (CPI) and platinum-based chemotherapy for advanced NSCLC. No new safety analysis was conducted at the time.

Second Quarter 2023 Financial Results

Cash Position: The Company had cash totaling approximately $9.1 million as of June 30, 2023, compared to $8.2 million in cash as of June 30, 2022.

Research and Development (R&D) Expenses: R&D expenses were approximately $2.6 million for the quarter ended June 30, 2023, compared to approximately $2.1 million for quarter ended June 30, 2022. The increase was primarily related to an increase in scientific research expenses of approximately $0.44 million, an increase in payroll and bonus expenses of approximately $0.20 million related to the increased headcount of additional research and development employees, an increase in stock-based compensation costs of approximately $0.06 million and an increase of approximately $0.03 million in other expenses offset by a decrease in Clinical and Scientific research expenses of approximately $0.21 million due to less THIO-101 trial start-up fees, and a decrease in consulting of approximately $0.04 million.

General and Administrative (G&A) Expenses: G&A expenses were approximately $2.0 million for the quarter ended June 30, 2023, compared to approximately $1.3 million for the quarter ended June 30, 2022. The increase for the quarter was primarily due to an increase in other expenses of approximately $0.73 million related to the costs of operating as a public company, and an increase in payroll expense of approximately $0.13 million, offset by a decrease in stock-based compensation of approximately $0.02 million and professional fees of approximately $0.09 million.

Other Income (Expense): Other income was approximately $0.14 million for the quarter ended June 30, 2023, and other income for the quarter ended June 30, 2022 was approximately $0.14 million. The quarterly activity included a gain from the change in the fair value of the warrant liability of approximately $0.10 million offset by a reduction in the Australia research and development incentives of approximately $0.10 million and an increase in interest expense of approximately $0.002 million.

Net Income (Loss): Net loss was approximately $4.5 million for the quarter ended June 30, 2023, as compared to net loss of approximately $3.3 million for the quarter ended June 30, 2022.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is an investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s potential immune system activation effects in NSCLC patients by administering THIO in sequential combination an anti-PD1 therapy, allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to a checkpoint inhibitor will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer agent and a priming immune system agent (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.