Marker Therapeutics, Inc. (MRKR) is a clinical-stage immuno-oncology company specializing in the development and commercialization of novel T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. The company's multi tumor associated antigen (multiTAA)-specific T cell technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens and kill tumor cells expressing those targets.

Business Overview

Marker Therapeutics' lead product candidates are derived from its multiTAA-specific T cell technology, which is designed to recognize multiple tumor targets and produce broad spectrum anti-tumor activity. The company's pipeline includes two product candidates for three clinical indications: an autologous multiTAA product for the treatment of lymphoma and pancreatic cancer (MT-601), and an off-the-shelf (OTS) product in various indications (e.g., MT-401-OTS).

The company's multiTAA-specific T cell therapies are non-genetically engineered, which Marker believes provides several advantages over T cells engineered with chimeric antigen receptors (CAR-T), including enhanced tumoricidal effect, improved safety profile, and reduced manufacturing complexity. Marker has licensed the underlying technology for multiTAA-specific T cell therapy from Baylor College of Medicine, where it has been utilized in seven exploratory clinical trials treating over 150 patients with various cancers.

Financials

For the full year 2023, Marker Therapeutics reported annual revenue of $3.3 million, primarily from grant income. The company's net loss for the year was $16.9 million, with an annual operating cash flow of -$16.4 million and annual free cash flow of -$16.4 million.

In the first quarter of 2024, the company generated $1.2 million in grant income, a 1% increase compared to the same period in 2023. Research and development expenses decreased 24% to $2.6 million, while general and administrative expenses decreased 44% to $1.2 million. The net loss from continuing operations for the quarter was $2.4 million.

Liquidity

As of March 31, 2024, Marker Therapeutics had $11.3 million in cash and cash equivalents, compared to $15.1 million as of December 31, 2023. The company's working capital stood at $11.8 million as of March 31, 2024, down from $14.1 million at the end of 2023.

The company has financed its operations primarily through public and private offerings of its stock, debt, and grants. In August 2021, Marker received a $13.1 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to support the clinical investigation of MT-401. The company has also received grants from the FDA ($2.0 million) and the National Institutes of Health Small Business Innovation Research (SBIR) program ($2.0 million) to support the development and investigation of MT-401.

Based on the company's clinical and research and development plans, Marker expects its current cash and cash equivalents, including drawdowns of available grant funds, will enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2025.

Organizational Changes

In 2023, Marker Therapeutics implemented changes to its organizational structure due to the transaction with Cell Ready and to reduce operational costs. The company reduced headcount, including the separation of its former Chief Executive Officer and Chief Accounting Officer. Effective May 1, 2023, the board of directors appointed Dr. Juan Vera as the company's President and Chief Executive Officer. Effective June 30, 2023, the board appointed Eliot M. Lurier as the company's Interim Chief Financial Officer, and on November 17, 2023, Dr. Vera was appointed as the company's Principal Financial and Accounting Officer.

Reverse Stock Split

On January 26, 2023, Marker Therapeutics effected a one-for-ten (1-for-10) reverse stock split of its common stock and a corresponding reduction in the total number of authorized shares of its common stock from 300,000,000 to 30,000,000.

Recent Developments

In February 2024, the company entered into a Master Services Agreement for Product Supply (MSA) with Cell Ready LLC, a contract development and manufacturing organization (CDMO) owned by one of Marker's directors and shareholders. Under the MSA, Cell Ready will perform a wide variety of services for Marker, including research and development and manufacturing in support of its clinical trials.

During the three months ended March 31, 2024, Marker incurred $1.2 million in expenses related to the services and manufacturing costs provided by Cell Ready and paid $2.2 million for invoices received. Additional work orders are expected to be generated for the remainder of 2024.

Pipeline and Clinical Progress

Marker Therapeutics' clinical-stage pipeline includes two product candidates for three clinical indications. The company's autologous multiTAA product, MT-601, is being investigated for the treatment of lymphoma and pancreatic cancer. The off-the-shelf (OTS) product, MT-401-OTS, is being developed for various indications.

In April 2024, the company announced that Geoffrey Shouse, D.O., Ph.D., the Principal Investigator at City of Hope National Medical Center, presented clinical experience from the APOLLO study at the 11th Global Summit on Hematologic Malignancies. Dr. Shouse reported that study participants tolerated the initial dose level well and demonstrated durable objective responses after MT-601 treatment.

Risks and Challenges

Marker Therapeutics faces several risks and challenges common to clinical-stage biotechnology companies, including the ability to successfully complete clinical trials, obtain regulatory approvals, and commercialize its product candidates. The company's reliance on grant funding and its limited operating history and revenue generation also pose risks to its long-term success.

Additionally, the current macroeconomic environment of high inflation and concerns about a potential recession in the United States or other major markets could negatively impact the company's ability to access capital, which could affect its liquidity and financial position.

Outlook

Marker Therapeutics is making progress in the development of its novel T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors. The company's non-genetically engineered multiTAA-specific T cell approach aims to provide enhanced tumoricidal effect, improved safety, and reduced manufacturing complexity compared to CAR-T therapies.

Conclusion

With a strengthened leadership team, a pipeline of promising product candidates, and a focus on cost optimization, Marker Therapeutics is well-positioned to navigate the complexities of the immuno-oncology landscape. However, the company will need to continue to execute on its clinical development plans, secure additional funding, and manage the risks inherent in the biotechnology industry to achieve long-term success.