MAIA Biotechnology, Inc. (MAIA) is a clinical-stage biopharmaceutical company leading the charge in the development of innovative, telomere-targeting immunotherapies for the treatment of various cancer indications. Established in 2018, the company has made remarkable strides in advancing its lead asset, THIO, through rigorous clinical trials, showcasing its potential to transform the landscape of cancer care.

Company History and Pipeline

MAIA Biotechnology, Inc. (MAIA) was incorporated in the state of Delaware on August 3, 2018, with the primary focus of developing oncology drug candidates to improve and extend the lives of people with cancer. In November 2018, the company achieved a significant milestone by in-licensing its lead asset, THIO, from the University of Texas Southwestern (UTSW) in Dallas. This global and exclusive patent license, valid for the duration of the patents' lives, set the foundation for MAIA's future developments.

The year 2019 marked a crucial breakthrough for MAIA, as the company generated the first data for THIO, demonstrating complete regression with no recurrence when administered in advance of atezolizumab (Tecentriq) in colorectal and lung cancer preclinical models. This promising result propelled MAIA to file a provisional patent application in the first quarter of 2020 for THIO in sequential combination with checkpoint inhibitors, covering all tumor types. The patent was allowed on March 12, 2021, with an expected expiration date in 2041, excluding any patent term adjustment or patent extension.

A significant partnership was formed in the first quarter of 2021 when MAIA entered into a Drug Supply Agreement with Regeneron Pharmaceuticals, Inc. Under this agreement, Regeneron committed to providing cemiplimab (Libtayo), its anti-PD-1 checkpoint inhibitor, at no charge for MAIA's THIO-101 trials. These trials are designed to test THIO administration for immune activation followed by cemiplimab in non-small cell lung cancer (NSCLC). Concurrent with this agreement, MAIA initiated its clinical supply manufacturing under Good Manufacturing Practices conditions to provide clinical supply for THIO-101 and other development needs.

MAIA's clinical development pipeline now includes several key programs:

• THIO-101: A Phase 2 clinical trial evaluating THIO in sequential combination with Regeneron's cemiplimab in patients with advanced NSCLC who have failed two or more standard-of-care therapy regimens.
• THIO-102: Planned Phase 2 trials to evaluate THIO in sequential combination with a checkpoint inhibitor in colorectal cancer, hepatocellular carcinoma (HCC), small-cell lung cancer (SCLC), and various solid tumors.
• THIO-103: Planned Phase 2 trials to evaluate THIO in first-line patients for both NSCLC and SCLC.

Regulatory Milestones

MAIA's commitment to advancing THIO's development has been recognized by various regulatory bodies. In March 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to THIO for the treatment of HCC and, in May 2022, for the treatment of SCLC. The ODD status provides financial incentives and the potential for up to seven years of market exclusivity for the designated indications if THIO is ultimately approved.

In July 2022, MAIA initiated its Phase 2 THIO-101 trial in Australia, with the first patient dosed. The company has also submitted a similar application to conduct the same Phase 2 study in Europe, and the FDA has cleared THIO's investigational new drug (IND) application for the U.S. expansion of the THIO-101 trial.

Clinical Development and Key Milestones

MAIA's clinical development efforts have yielded promising results, particularly in its flagship THIO-101 trial. In April 2023, the company announced positive topline data from the safety lead-in portion of the THIO-101 trial, which showed that the administration of THIO at the highest dose of 360 mg/cycle in sequential combination with Regeneron's Libtayo was well-tolerated with no dose-limiting toxicities or significant treatment-related adverse events reported.

In April 2023, MAIA also reported preliminary survival data from Part A of the THIO-101 trial, where the first two patients enrolled continued to be alive, approximately 10 and 9 months, respectively, from treatment initiation. Both patients had advanced Stage IV metastatic disease and were heavily pretreated, receiving third and fourth-line therapy, respectively, after previously failing treatment with an immune checkpoint inhibitor. Notably, the patients continued to be progression-free following their last dose of THIO, 7 and 6 months, respectively, with no new treatment.

In July 2023, MAIA announced that the first 11 patients with post-baseline scans in the THIO-101 trial had an 82% disease control rate at first response assessment, significantly outperforming the typical 25-35% disease control rates seen in similar heavily treated NSCLC patients.

On October 24, 2023, the company announced an unprecedented interim disease control rate (DCR) of 100% in second-line treatment, far surpassing the standard-of-care DCR of 53-64%. As DCR is a stronger predictor of overall survival benefit than overall response rate (ORR), this milestone further underscores THIO's potential to transform the treatment landscape for NSCLC patients.

Financials and Liquidity

As of September 30, 2024, MAIA had cash and cash equivalents of $8.69 million, which represented an increase of $1.54 million compared to December 31, 2023. The company's working capital as of September 30, 2024, was $5.63 million, an increase of $3.00 million compared to the end of 2023.

MAIA has not generated any revenue to date, as it remains in the clinical development stage. The company's net loss for the nine months ended September 30, 2024, was $19.68 million, compared to a net loss of $13.52 million for the same period in 2023. The increase in net loss was primarily driven by the ongoing development and clinical trials of THIO. However, the most recent quarter (Q3 2024) showed a year-over-year decrease in net loss of $2.14 million or 44%, with a quarterly net loss of $2.74 million.

For the fiscal year ended December 31, 2023, MAIA reported an annual net loss of $19.77 million and negative operating cash flow of $13.07 million. The company's annual free cash flow for 2023 was also negative at $13.07 million.

Research and development expenses for the first nine months of 2024 decreased slightly from $7.39 million to $7.04 million, while general and administrative expenses decreased from $6.41 million to $4.91 million compared to the same period in 2023.

To fund its operations and advance the development of THIO, MAIA has relied on the issuance of equity and debt financing. In July 2022, the company completed an initial public offering (IPO), raising approximately $10 million. MAIA has also executed several private placement offerings and implemented an at-the-market (ATM) equity offering program to raise additional capital.

As of September 30, 2024, MAIA's financial position showed a debt-to-equity ratio of 0, a current ratio of 2.56, and a quick ratio of 2.56. The company does not have any disclosed available credit lines.

Recent Developments and Outlook

In 2024, MAIA made significant strides in expanding the THIO-101 trial, securing regulatory clearances in Europe and the U.S. to further assess the efficacy of THIO in third-line NSCLC patients. The company also announced the selection of the 180 mg/cycle dose as the optimal dose for the trial, which demonstrated a better safety profile and outperformed the other doses in key measures of efficacy.

In February 2024, MAIA announced the completion of enrollment in the THIO-101 Phase 2 trial, reaching the target of 41 patients at the 180mg dose. The company also entered an ATM equity offering program to sell up to $11.28 million in common stock.

March 2024 brought interim efficacy data from THIO-101, showing a 38% ORR in third-line NSCLC patients. Additionally, MAIA completed private placements in March and April 2024, raising a total of $5.25 million to support ongoing operations and clinical development.

Looking ahead, MAIA plans to initiate a Phase 3 pivotal trial, THIO-104, in 2025 to evaluate the efficacy of THIO administered in sequence with a checkpoint inhibitor, compared to chemotherapy, in third-line NSCLC patients who are resistant to checkpoint inhibitors and chemotherapy. The company also intends to expand the THIO-101 trial to enroll patients in the U.S. and select countries in Europe and Asia, with multiple milestones expected in 2025.

Risks and Challenges

As a clinical-stage biopharmaceutical company, MAIA faces the inherent risks associated with drug development, including the potential for delays or failures in clinical trials, regulatory approval hurdles, and intense competition in the oncology space. The company's reliance on partnerships and licensing agreements also exposes it to the risks of these collaborations, such as the potential for disputes or the failure of partners to meet their obligations.

Additionally, MAIA's limited operating history and lack of revenue generation pose challenges to its long-term financial sustainability. The company will need to continue to raise additional capital through equity or debt financing to support its ongoing operations and clinical development efforts. As of the latest financial reports, MAIA continues to face substantial doubt about its ability to continue as a going concern due to its recurring losses and the need for additional funding to support its future operations and clinical trials.

Conclusion

MAIA Biotechnology, Inc. (MAIA) is a standout in the realm of cancer therapeutics, pioneering the development of innovative, telomere-targeting immunotherapies. The company's lead asset, THIO, has demonstrated promising results in clinical trials, showcasing its potential to transform the treatment landscape for NSCLC and other cancer indications. With a robust pipeline, strategic partnerships, and a dedicated team, MAIA is well-positioned to capitalize on the growing demand for more effective and targeted cancer therapies.

The company's focus on developing THIO as a potential treatment for various cancer indications, particularly in the NSCLC space, has shown promising preclinical and early clinical results. The collaboration with Regeneron and ongoing clinical trials will be critical in determining the future development and commercial potential of THIO.

As MAIA continues to push the boundaries of cancer research, investors and patients alike will be closely watching the company's progress and the transformative impact it may have on the lives of those affected by this devastating disease. The coming years will be crucial for MAIA as it advances its clinical programs and seeks to establish THIO as a groundbreaking treatment option in the field of oncology.