MAIA Biotechnology, Inc. (NYSE:MAIA) is a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer. The company's lead asset, THIO, is a first-in-class investigational telomere-targeting agent currently in clinical development for the treatment of Non-Small Cell Lung Cancer (NSCLC).
Business Overview
MAIA is focused on the discovery, development, and commercialization of therapies targeting cancer. The company's initial disease target is lung cancer, a serious medical condition with an incidence of over 236,000 new cases in the US in 2022, representing 12.3% of all cancers, and over 130,000 deaths, or 21.4% of all cancers. Worldwide, lung cancer incidence is over 2,200,000 per year (ranking second only after breast cancer), and mortality over 1,800,000 (ranking first). Specifically, the company is targeting Non-Small Cell Lung Cancer (NSCLC), which represents 85% of all lung cancers.
THIO (6-thio-dG or 6-thio-2'-deoxyguanosine), MAIA's lead asset, is an investigational dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. In November 2018, the company in-licensed THIO from the University of Texas Southwestern. The patent license is global and exclusive for the duration of the patients' lives.
In 2019, MAIA generated the first data for THIO demonstrating complete regression with no recurrence when administered in advance of atezolizumab (TecentriQ®; Genentech), in colorectal and lung cancer preclinical models. In the first quarter of 2020, the company filed a provisional patent application for THIO in sequential combination with checkpoint inhibitors, covering all tumor types.
In the first quarter of 2021, MAIA entered into a Drug Supply Agreement with Regeneron Pharmaceuticals, Inc. Under this agreement, Regeneron will provide cemiplimab (Libtayo®; anti-PD-1 checkpoint inhibitor) at no charge for the THIO-101 trials, testing THIO administration for immune activation followed by cemiplimab in NSCLC. This drug supply agreement replaces direct drug purchase expense that the company would be otherwise required to incur. In exchange, Regeneron received development exclusivity in NSCLC for the duration of the trial, meaning MAIA cannot conduct trials in NSCLC with another checkpoint inhibitor during the time of the trial. All other areas of study and development in any other tumor types remain open.
Also in the first quarter of 2021, MAIA initiated its clinical supply manufacturing under Good Manufacturing Practices conditions to provide clinical supply for THIO-101 and other development needs.
In the first half of 2022, the company completed a crossover round consisting of sales of 274,840 shares of its common stock at a price of $9.00 per share for gross proceeds of approximately $2.5 million.
In the first quarter of 2022, THIO received approval by the Bellberry Human Research Ethics Committee ("HREC") in Australia to initiate the THIO-101 Phase 2 clinical study. In March 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to THIO for the treatment of hepatocellular carcinoma, and in May 2022, the FDA granted ODD to THIO for the treatment of small-cell lung cancer.
In May 2022, MAIA entered into a research and collaboration agreement with the Nationwide Children's Hospital to evaluate the potential of THIO in combination with current standard-of-care therapies for brain cancer. The organizations are conducting preclinical studies to assess the efficacy and safety of THIO in combination with radiotherapy and immune checkpoint inhibitors in vitro and in vivo models.
In July 2022, the company completed its selection process for the clinical sites for its Phase 2 study in Australia and Europe, and its application to start the Phase 2 study in Australia has been approved. In July 2022, the first patient was administered with THIO in MAIA's Phase 2 human trial (THIO-101) in Australia. The company has also submitted a similar application to conduct the same Phase 2 study in Europe.
On July 28, 2022, MAIA's shares of common stock began trading on the NYSE American under the symbol MAIA. On August 1, 2022, the company sold 2,000,000 shares of common stock at $5.00 per share for gross proceeds of $10,000,000 in an initial public offering prior to deducting underwriting discounts, commissions, and other offering expenses. On August 3, 2022, the company sold an additional 300,000 shares of common stock at $5.00 per share when the underwriter exercised the overallotment for net proceeds of $1,500,000 prior to deducting underwriting discounts, commissions, and other offering expenses.
Financials
For the fiscal year ended December 31, 2023, MAIA reported an annual net loss of $19,772,905, with no revenue generated. The company's annual operating cash flow was -$13,071,016, and its annual free cash flow was also -$13,071,016.
In the first quarter of 2024, MAIA reported a net loss of $8,067,455. The company did not generate any revenue during this period. MAIA's operating cash flow for the first quarter of 2024 was -$3,586,800, and its free cash flow was also -$3,586,800.
Liquidity
As of March 31, 2024, MAIA had cash totaling approximately $8,271,000, which represented an increase of approximately $1,121,000 compared to December 31, 2023. As of March 31, 2024, the company had working capital of approximately $3,792,000, which represents an increase of approximately $1,165,000 compared to December 31, 2023.
MAIA has generated no revenues as of March 31, 2024. The company's current operating plan indicates that it will continue to incur losses from operations and generate negative cash flows from operating activities given ongoing expenditures related to the completion of its ongoing clinical trials and its lack of revenue generating activities.
Based on the company's cash reserves as of March 31, 2024 of $8,271,000 and current financial condition, there is substantial doubt about MAIA's ability to continue as a going concern within one year after the financial statements are issued. To meet the company's future working capital needs, MAIA will need to raise additional equity or enter into debt financing. While the company has historically been able to raise additional capital through issuance of equity and/or debt financing, and MAIA has implemented a plan to control its expenses, it cannot guarantee that it will be able to raise additional equity, raise debt, or contain expenses.
Recent Developments
Operational Highlights
In April 2023, MAIA announced positive topline data related to the completion of Part A, the safety lead-in portion of the THIO-101 trial, which showed that administration of THIO, at the highest dose of 360 mg/cycle in sequential combination with Regeneron's anti-PD-1 therapy, Libtayo®, was well tolerated with no dose-limiting toxicities or significant treatment-related adverse events reported.
In April 2023, the company published data in Hepatocellular Carcinoma ("HCC") (liver cancer) models: as monotherapy, THIO achieved complete and durable responses in HCC, the dominant histology in primary liver cancer (90%), in in vivo models. When combined with Libtayo®, duration of response was further potentiated. Upon rechallenge with two times more cancer cells and no additional treatment, tumor growth was completely prevented. Administration of THIO alone and in combination with Libtayo® generated anti-cancer immune memory.
In April 2023, MAIA announced preliminary survival data from Part A of THIO-101. The first two patients enrolled in Part A of the study continue to be alive, approximately 10 and 9 months respectively, from treatment initiation. Both patients have advanced Stage IV metastatic disease and are heavily pretreated, receiving third and fourth line of therapy respectively after previously failing treatment with an immune checkpoint inhibitor. They continue to be progression free following their last dose of THIO, 7 and 6 months respectively, with no new treatment.
In June 2023, the company announced updates in enrollment in THIO-101 in Europe. To that date, 29 patients had been dosed in THIO-101. 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. Thirteen sites were activated with another two new additional sites ready to open shortly afterward.
In July 2023, MAIA announced that 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. The company also highlighted that out of the first 11 patients with post-baseline scans, 82% (9 patients) met the disease control primary endpoint at first response assessment. For contrast, in similar heavily treated NSCLC patients, typical disease control rates are in the 25-35% range.
In October 2023, MAIA announced that 49 patients have been dosed in its Phase 2 clinical trial, THIO-101, evaluating THIO in sequential combination with an immune checkpoint inhibitor in patients with advanced NSCLC.
In October 2023, the company announced the unprecedented interim disease control rate (DCR) of 100% in second-line treatment that far surpasses standard of care (SoC) DCR of 53-64%, presented at ESMO 2023. DCR is far stronger than overall response rate (ORR) in predicting overall survival benefit, as shown in a recent meta-analysis of 74 clinical trials worldwide in NSCLC.
In December 2023, MAIA announced dose selection for THIO-101, a Phase 2 clinical trial evaluating its lead asset, THIO, in sequential combination with Regeneron's anti-PD-1 cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC). The selected dose, 180mg/cycle, presented better safety profile and outperformed the other doses in the key measures of efficacy for NSCLC trials.
In January 2024, the company announced new interim data for its ongoing THIO-101 Phase 2 trial in non-small cell lung cancer (NSCLC). In the latest available data from THIO-101 (November 13, 2023), 60 patients had been dosed with THIO in sequential combination with Libtayo®. The observed disease control was well sustained compared to previous scans.
In March 2024, MAIA announced interim efficacy data for THIO-101 Phase 2 trial in NSCLC. In the latest data available (January 8, 2024), the overall response rate (ORR), characterized as partial or complete response to therapy, was 38% (3 out of 8 patients) in the efficacy evaluable population for combination THIO 180mg + cemiplimab in third-line treatment for NSCLC patients who failed treatment with immune checkpoint inhibitors in prior lines of therapy, with or without chemotherapy.
Outlook
MAIA has not provided any formal financial guidance or outlook for the future. However, the company's ongoing clinical trials and development activities suggest that it is making progress in advancing its lead asset, THIO, as a potential treatment for NSCLC and other cancer indications. The positive data and updates from the THIO-101 Phase 2 trial, as well as the company's efforts to expand the trial globally, indicate that MAIA is committed to developing THIO as a viable treatment option for patients with limited alternatives.
Risks and Challenges
As a clinical-stage biopharmaceutical company, MAIA faces several risks and challenges, including the inherent risks associated with the development and commercialization of novel drug candidates, the ability to secure additional funding to support its operations, and the competitive landscape in the oncology space. The company's reliance on the successful development and approval of THIO, as well as its ability to navigate the regulatory environment, are also key risks that investors should consider.
Conclusion
MAIA Biotechnology is a promising clinical-stage biopharmaceutical company focused on developing innovative cancer therapies. Its lead asset, THIO, has shown encouraging results in early-stage trials for the treatment of NSCLC, a significant unmet medical need. The company's ongoing efforts to advance THIO through clinical development, as well as its collaborations and strategic partnerships, suggest that MAIA is well-positioned to potentially bring a new treatment option to patients with limited alternatives. However, the company's financial performance and liquidity position remain areas of concern, and MAIA will need to continue to execute on its development strategy and secure additional funding to support its operations and future growth.