Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company at the forefront of developing cutting-edge T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. With a unique and differentiated approach, Marker aims to revolutionize the landscape of cancer treatment by harnessing the power of the human immune system.
Business Overview and History Marker Therapeutics was incorporated in Nevada in 1992 and reincorporated in Delaware in October 2018. The company's core technology platform is centered around the development of multi-tumor associated antigen (multiTAA)-specific T cell therapies. This innovative approach selectively expands natural tumor-specific T cells from a patient's or donor's blood, empowering them to recognize and eliminate a broad range of tumor targets without the need for genetic modifications.
In March 2018, Marker Therapeutics licensed the underlying technology for its multiTAA-specific T cell therapy from Baylor College of Medicine (BCM). BCM had previously utilized the therapy in seven exploratory clinical trials, treating over 150 patients suffering from a variety of cancers. These studies provided evidence of clinical benefit, expansion of infused cells, and decreased toxicity compared to other cellular therapies.
Unlike traditional chimeric antigen receptor (CAR) T cell therapies, Marker's multiTAA-specific T cells are designed to target multiple tumor antigens simultaneously, reducing the risk of tumor immune escape through antigen down-regulation. This strategy has the potential to provide more durable and comprehensive anti-tumor activity, while also maintaining a favorable safety profile.
Marker's lead product candidate, MT-601 (also known as Neldaleucel), is currently being evaluated in a Phase 1 clinical trial, the APOLLO study, for the treatment of patients with lymphoma who have relapsed following anti-CD19 CAR T cell therapy. Preliminary data from this study have demonstrated promising safety and efficacy, with 78% of patients achieving objective response rates and 44.4% demonstrating complete responses. Importantly, MT-601 was well-tolerated, with no observation of immune effector cell-associated neurotoxicity syndrome (ICANS).
In addition to the APOLLO study, Marker is also advancing MT-401, its multiTAA-specific T cell product candidate, for the treatment of acute myeloid leukemia (AML) and pancreatic cancer. The company has received Orphan Drug Designation from the European Medicines Agency for MT-401 in the treatment of AML, underscoring the unmet need and potential of this therapy.
Marker's clinical progress has been supported by a robust pipeline of non-dilutive funding. In 2021, the company received notice of a $13.1 million Product Development Research award from the Cancer Prevention and Research Institute of Texas (CPRIT) to support the clinical investigation of MT-401. Additionally, Marker received a $2 million grant from the FDA's Orphan Products Grant program that same year to support the clinical investigation of MT-401 for the treatment of post-transplant acute myeloid leukemia (AML).
In 2023, Marker Therapeutics implemented organizational changes in response to a transaction with Cell Ready, LLC and to reduce operational costs. This included the separation of its former Chief Executive Officer and Chief Accounting Officer, as well as the appointment of Dr. Juan Vera as the company's new President and Chief Executive Officer. Marker also entered into a Master Services Agreement with Cell Ready, a contract development and manufacturing organization (CDMO) owned by one of Marker's directors, to provide outsourced services previously performed by the company.
Financials and Liquidity As of September 30, 2024, Marker Therapeutics reported cash and cash equivalents of $9.0 million, compared to $15.1 million as of December 31, 2023. The company's net loss for the nine months ended September 30, 2024, was $6.9 million, a significant improvement from the $11.3 million net loss recorded in the same period of the prior year.
Marker's operating expenses for the nine months ended September 30, 2024, totaled $11.6 million, down from $13.9 million in the corresponding period of 2023. This reduction in expenses was primarily driven by lower general and administrative costs, which decreased by 47% to $3.2 million.
For the most recent fiscal year (2023), Marker reported an annual net loss of $14.1 million and an annual operating cash flow of -$16.4 million. The company did not generate any revenue from product sales during this period.
In the most recent quarter (Q3 2024), Marker reported revenue of $1.9 million, primarily consisting of grant income. The company saw a 647% year-over-year increase in grant income revenue during the quarter, which was primarily attributable to increased funding from the CPRIT, FDA, and SBIR grants. The net loss for Q3 2024 was $2.3 million.
The company's balance sheet remains healthy, with a current ratio of 3.15 as of September 30, 2024, indicating a strong liquidity position. Marker has no outstanding debt, resulting in a debt-to-equity ratio of 0. The quick ratio, which measures the company's ability to meet its short-term obligations with its most liquid assets, is also 3.15.
Marker's cash runway, including available grant funding, is expected to fund its operations into October 2025, according to management's guidance. The company primarily operates in the United States and does not have any significant international operations or revenue streams.
Recent Developments and Outlook In 2024, Marker Therapeutics made several significant strides in advancing its pipeline and strengthening its leadership team. The company appointed Dr. Juan Vera as President and Chief Executive Officer, and Dr. Monic Stuart as Chief Medical Officer, further bolstering its executive leadership.
Marker's clinical programs have continued to generate promising results. In the APOLLO study, the company reported that 78% of patients with lymphoma who had relapsed after anti-CD19 CAR T cell therapy achieved objective responses, with 44.4% demonstrating complete responses. Importantly, MT-601 was well-tolerated, with no observation of ICANS.
To support the further development of MT-601, Marker received a $2 million grant from the NIH SBIR program in 2024 to investigate the therapy in patients with non-Hodgkin's lymphoma who have relapsed following anti-CD19 CAR T cell therapy. Additionally, the company was awarded a $9.5 million grant from CPRIT to advance the clinical investigation of MT-601 in patients with metastatic pancreatic cancer.
On February 22, 2024, Marker entered into a Master Services Agreement with Cell Ready LLC, a related party, to provide outsourced services including research, development, and manufacturing. This strategic move is expected to streamline operations and potentially reduce costs.
Looking ahead, Marker Therapeutics remains focused on executing its clinical development strategy and advancing its multiTAA-specific T cell therapies for the benefit of patients with hematological malignancies and solid tumors. The company's innovative approach, coupled with its strong financial position and non-dilutive funding support, positions Marker as a promising player in the rapidly evolving immuno-oncology landscape.
Risks and Challenges As a clinical-stage biotechnology company, Marker Therapeutics faces several risks and challenges common to the industry. These include the inherent uncertainties of the drug development process, the potential for delays or failures in clinical trials, regulatory hurdles, and competition from other novel cancer therapies.
Additionally, Marker's reliance on non-dilutive funding sources, such as grants, poses a risk if these funding sources become unavailable or are reduced. The company's ability to secure additional financing through equity or debt offerings may also be impacted by market conditions and investor sentiment.
Lastly, Marker's success is heavily dependent on the continued development and commercialization of its lead product candidates, MT-601 and MT-401. Any setbacks or failures in these programs could have a significant impact on the company's overall prospects.
Conclusion Marker Therapeutics is a clinical-stage immuno-oncology company at the forefront of developing innovative T cell-based therapies for the treatment of hematological malignancies and solid tumors. With its unique multiTAA-specific T cell approach, the company aims to overcome the limitations of current cancer immunotherapies and provide more durable and comprehensive anti-tumor responses.
Marker's pipeline has shown promising results, particularly in the APOLLO study of MT-601 in patients with lymphoma who have relapsed after anti-CD19 CAR T cell therapy. The company's strong financial position, supported by non-dilutive funding, and its experienced leadership team position Marker for continued success as it advances its clinical programs and navigates the competitive immuno-oncology landscape.
As Marker Therapeutics continues to execute on its strategy and deliver on its clinical milestones, the company's innovative approach and strong pipeline could position it as a key player in the fight against cancer. The significant increase in grant income and the company's ability to maintain a healthy balance sheet despite ongoing clinical development expenses demonstrate Marker's potential for long-term success in the biotech industry.