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Item 1. Business

2025-03-31 compared with 2024-03-26 · 158 added, 107 removed, 526 unchanged (34% of the section changed)

We are 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.

We developed our lead product candidates from our multi tumor associated antigen (“multiTAA”)-specific T cell technology, which is based on the manufacture of non-engineered, tumor-specific T cells that recognize multiple tumor-associated antigens, or TAAs.

This approach selectively expands tumor-specific T cells from a patient’s/donor’s blood and is able to recognize multiple tumor targets to produce broad spectrum anti-tumor activity.

Harnessing millions of years of immunologic evolution, Marker’s multi antigen recognizing (“MAR”)-T cell technology (formerly known as multi-tumor associated antigen-specific T cells, or multiTAA) is designed to recognize and kill highly heterogeneous tumors without the need for genetic modifications.

This approach selectively expands natural tumor-specific T cells from a patient’s/donor’s blood that are capable of recognizing a broad range of tumor associated antigens, or TAAs.

Unlike other T cell therapies, MAR-T cells are able to recognize hundreds of different epitopes within up to six tumor-specific antigens to produce broad spectrum anti-tumor activity.

Targeting multiple antigens simultaneously exploits the natural capacity of T cells to recognize and kill tumor targets via native T cell receptors (“TCR”), while limiting tumor adaptation/escape by antigen-negative selection or antigen down-regulation.

When infused into a patient with cancer, the multiTAA-specific T cells are designed to kill cancer cells expressing the TAA and potentially recruit the patient’s immune system to participate in the cancer killing process.

We licensed the underlying technology for multiTAA-specific T cell therapy from Baylor College of Medicine, or BCM, in March 2018.

When infused into a patient with cancer, the MAR-T cells are designed to kill cancer cells expressing the TAA and potentially recruit the patient’s immune system to participate in the cancer killing process.

We licensed the underlying technology for MAR-T cell therapy from Baylor College of Medicine, or BCM, in March 2018.

BCM had utilized the therapy in seven exploratory clinical trials.

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In those studies, BCM saw evidence of clinical benefit, expansion of infused cells, and decreased toxicity compared to other cellular therapies.

We are advancing two product candidates for 3 clinical indications as part of our multiTAA-specific T cell program for:

● Autologous multiTAA product for the treatment of lymphoma and pancreatic cancer (MT-601)

We are advancing two product candidates for 3 clinical indications as part of our MAR-T cell program for:

● Autologous MAR-T cell product for the treatment of lymphoma and pancreatic cancer (MT-601)

● Off-the-Shelf (OTS) product in various indications (e.g., MT-401-OTS)

We do not genetically engineer our multiTAA-specific T cell therapies and we believe that our product candidates are superior to T cells engineered with chimeric antigen receptors, or CAR-T, for several reasons including:

We do not genetically engineer our MAR-T cell therapies and we believe that our product candidates are superior to T cells engineered with chimeric antigen receptors, or CAR-T, for several reasons including:

● Multiple targets → enhanced tumoricidal effect→ minimized tumor immune escape

● Clinical safety → no treatment-related side effects, including cytokine release syndrome (CRS) or other severe adverse effects (SAEs), were attributed to the use of multiTAA-specific T cell therapies to date

● Clinical safety → no treatment-related side effects, including immune effector cell-associated neurotoxicity syndrome (ICANS) or other severe adverse effects (SAEs), were attributed to the use of MAR-T cell therapies to date

● Non-genetically engineered T cell products → selective expansion of tumor-specific T cells from a patient’s or donor’s blood capable of recognizing a broad range of tumor antigens → no risk of mutagenesis and reduced manufacturing complexity → lower cost

For these reasons, we believe our endogenous T cell receptor-based therapies may provide meaningful clinical benefit and safety to patients with both hematological and solid tumors.

We believe that the simplicity of our manufacturing process allows additional modifications to expand multiTAA-specific T cell recognition of cancer targets.

For example, we are assessing the potential of combining multiTAA-specific T cell products with other products.

Company-Sponsored Clinical Development of MultiTAA Specific T Cell Therapies

We believe that our manufacturing process allows additional modifications to expand MAR-T cell recognition of cancer targets.

For example, we are assessing the potential of combining MAR-T cell products with other products.

Company-Sponsored Clinical Development of MAR-T Cell Therapies

MT-601 for the Treatment of Lymphoma

We developed MT-601, a multiTAA-specific autologous T cell product capable of recognizing multiple target antigens expressed by the tumor, thereby limiting tumor adaptation by negative antigen selection or downregulation.

We developed MT-601, a MAR-T cell product capable of recognizing multiple target antigens expressed by the tumor, thereby limiting tumor adaptation by negative antigen selection or downregulation.

We are evaluating the safety and efficacy of MT-601 in a Phase 1, multicenter, open-label study (APOLLO) in participants with relapsed or refractory lymphoma who either failed or are ineligible for anti-CD19 CAR-T cell therapy.

MT - 601 is a multiTAA-specific T cell product that specifically targets six different tumor antigens upregulated in lymphoma cells (Survivin, PRAME, WT1, NY-ESO-1, SSX-2, MAGEA-4).

MT-601 is a MAR-T cell product that specifically targets six different tumor antigens upregulated in lymphoma cells (Survivin, PRAME, WT1, NY-ESO-1, SSX-2, MAGEA-4).

Although CD19-targeting CAR-T cell therapies have gained acceptance as treatment for patients with lymphoma, 40-60% of patients relapse within the first year of treatment ( Chong et al, N Engl J Med, 2021;

Neelapu et al, Blood, 2023 .).

These post-CD19 CAR-T relapsed patients currently have no approved standard of care, illustrating a high unmet medical need and urgency for new therapies.

In addition, CAR-T cells are associated with severe side effects such as CRS or ICANS and may increase the risk for secondary malignancies ( U.S.

Food and Drug Administration, November 28, 2023 ).

Data from clinical trials to date have demonstrated that MAR-T cells are well tolerated with no evidence of ICANS.

In addition, Marker’s non-engineered MAR-T cell approach selectively expands natural tumor-specific T cells from a patient’s blood that can recognize a broad range of tumor antigens, minimizing the risk of mutagenesis.

In August 2022, the FDA cleared our IND application for MT-601 for the treatment of patients with relapsed/refractory non-Hodgkin lymphoma who have failed or are ineligible to receive anti-CD19 CAR-T cell treatment.

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In June 2023, we reported first enrollment in the dose escalation stage of the Phase 1 study.

The study participant tolerated the treatment well without treatment-related adverse events and achieved a complete metabolic response eight weeks after the second infusion of MT - 601.

Six months following the initial treatment with MT-601 the study participant has maintained a complete response to treatment and will continue to be monitored for long-term treatment effects and durability of response.

In December 2024, the Company provided an update on the progress and clinical observations from the Phase 1 study, with a data cutoff date of September 10, 2024.

In this update, clinical data was available for 9 patients from 5 clinical sites across the United States.

Study participants showed early objective responses with and without lymphodepletion.

However, immunomonitoring data confirmed that lymphodepletion enhanced the expansion and persistence of MAR-T cell clones in vivo.

Key findings from the APOLLO study include:

● Safety – Infusion of MT-601 was well tolerated in all study participants, with no observation of immune-effector cell associated neurotoxicity syndrome (ICANS) and one reported Grade 1 cytokine release syndrome (CRS).

No dose limiting toxicities (DLTs) have been reported to date.

● Efficacy – In the first dose cohort, 7 out of 9 patients achieved objective responses (78%) at first response assessment, with 4 patients demonstrating complete response (CR;

44.4%) (Table 1).

● Time in Follow-Up – Long-term follow-up of 6 to 12 months is currently available for three patients (Table 2).

Ongoing follow-up visits are being conducted to assess the durability of responses.

All study participants are monitored closely to ensure comprehensive data collection and patient safety.

MT-601 shows objective responses at first disease assessment.

Prior Lines of

Response Rate at First

of Patients Treated

CR at First Assessment

CR, Complete Response.

Data as of September 10, 2024.

Duration of patient follow-up in Phase 1 APOLLO study;

Longest Follow-Up

Clinical Response

CR, Complete Response;

PR, Partial Response.

Data as of September 10, 2024.

To further validate these observations, additional patients are currently being enrolled in the Phase 1 study.

MT-601 for the Treatment of Pancreatic Cancer

We reported interim data for an ongoing Phase 1/2 clinical trial (TACTOPS) of the multiTAA-specific T cell therapy targeting five TAAs for the treatment of pancreatic adenocarcinoma being conducted by BCM.

We reported interim data for an ongoing Phase 1/2 clinical trial (TACTOPS) of the MAR-T cell therapy targeting five TAAs for the treatment of pancreatic adenocarcinoma being conducted by BCM.

In this trial, we have observed a clinical benefit with 4 of 13 patients (31%) showing objective responses in front-line unresectable or metastatic pancreatic cancer, which correlated with the post-infusion detection of tumor-reactive T cells in patient peripheral blood and within tumor biopsy samples in patients in the tumor-resection arm of the trial.

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The PANACEA trial will include a dose escalation portion followed by a dose expansion portion.

Clinical advancement will be pending additional financial support from non-dilutive grant activities.

We recently announced that the Company has been awarded a $9.5 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT) and a $2 million grant from the NIH Small Business Innovation Research (SBIR) program to support the clinical investigation of MT-601 in patients with metastatic pancreatic cancer.

With the support of these grants, we will be able to advance MT-601 in pancreatic cancer without affecting our operations in the ongoing study of MT-601 in patients with lymphoma.

MT-401 for the Treatment of Patients with AML and MT-401-OTS Program

MT-401 ARTEMIS Study:

We previously announced discontinuation of the Phase 2 ARTEMIS study to prioritize the MT-401-OTS program in patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS).

In January 2024, we announced discontinuation of the Phase 2 ARTEMIS study to prioritize the MT-401-OTS program in patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS).

The previous ARTEMIS study was investigating MT-401 (zedenoleucel), in post-allogeneic hematopoietic stem cell transplant (HSCT) patients with AML.

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The dose administered in this multicenter trial was up to 200 million cells every two weeks for up to three doses.

● In April 2020, the Orphan Product Development Office of the United States Food and Drug Administration, or the FDA, granted orphan drug designation to MT-401 (zedenoleucel), a multiTAA-specific T cell therapy that targets four TAAs, for the treatment of AML.

● The same multiTAA-specific T cell therapy has been well tolerated in an ongoing Phase 1 clinical trial in AML and myelodysplastic syndrome, or MDS, conducted by our strategic partner Baylor College of Medicine, or BCM.

● As reported in a 2021 publication by Lulla et al., 11 of the 17 patients in the adjuvant disease setting dosed with the multiTAA-specific T cell therapy after receiving an allogeneic HSCT were relapse free [median leukemia-free survival, or LFS, not reached at a median follow-up of 1.9 years], with 11 of 15 patients (two patients were each treated during two different remissions) remaining alive (estimated two-year overall survival of 77%) at a median follow-up of 1.9 years post-infusion, which compares favorably with HSCT outcomes for risk-matched AML/MDS patients post-HSCT [median LFS of nine to 15 months and two-year survival probability of 42%].

● In April 2020, the Orphan Product Development Office of the United States Food and Drug Administration, or the FDA, granted orphan drug designation to MT-401 (zedenoleucel), a MAR-T cell therapy that targets four TAAs, for the treatment of AML.

● The same MAR-T cell therapy has been well tolerated in an ongoing Phase 1 clinical trial in AML and myelodysplastic syndrome, or MDS, conducted by our strategic partner Baylor College of Medicine, or BCM.

● As reported in a 2021 publication by Lulla et al., 11 of the 17 patients in the adjuvant disease setting dosed with the MAR-T cell therapy after receiving an allogeneic HSCT were relapse free [median leukemia-free survival, or LFS, not reached at a median follow-up of 1.9 years], with 11 of 15 patients (two patients were each treated during two different remissions) remaining alive (estimated two-year overall survival of 77%) at a median follow-up of 1.9 years post-infusion, which compares favorably with HSCT outcomes for risk-matched AML/MDS patients post-HSCT [median LFS of nine to 15 months and two-year survival probability of 42%].

● Additionally, eight patients were treated for active disease that was resistant to salvage therapy post-HSCT with a median of five prior lines of therapy (range:

o One of the eight patients crossed over from the adjuvant group, while two patients enrolled twice, but all three patients had active AML that failed another line of salvage therapy after their first multiTAA-specific T cell infusion.

o Two of the eight patients achieved objective responses, with one complete response and one partial response, with six patients continuing with stable disease.

o We have observed evidence of a patient’s natural immune system participating in cancer killing (epitope spreading) after infusion of our multiTAA-specific T cell therapy.

In 2021, the ARTEMIS trial conducted by Marker has completed the safety lead-in portion, which tested the comparability of MT-401 or zedenoleucel, the multiTAA-specific T cell product manufactured using peptides from two different vendors and enrolled six patients with active disease:

o We have observed evidence of a patient’s natural immune system participating in cancer killing (epitope spreading) after infusion of our MAR-T cell therapy.

In 2021, the ARTEMIS trial conducted by Marker has completed the safety lead-in portion, which tested the comparability of MT-401 or zedenoleucel, the MAR-T cell product manufactured using peptides from two different vendors and enrolled six patients with active disease:

one measurable residual disease (MRD) positive patient and five frank relapse patients.

● Consistent with the results of the BCM Phase 1 trial, there were no dose-limiting toxicities, cytokine release syndrome or neurotoxicity observed in this stage of the trial.

Correlative studies showed that the patient saw significant expansion of infused multiTAA-specific T cells.

Correlative studies showed that the patient saw significant expansion of infused MAR-T cells.

There were no objective responses from the frank relapse patients.

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Specifically, the new process involves an improved T cell manufacturing process for MT-401 that reduces production time to 9 days (compared to the original process of >30 days).

This allows a 90% decrease in the number of interventions during production and an improved final T cell product compared to the original product used in previous clinical trials on multiTAA-specific T cells.

This allows a 90% decrease in the number of interventions during production and an improved final T cell product compared to the original product used in previous clinical trials on MAR-T cells.

● After completing the safety lead-in portion, we initiated the remainder of the Phase 2 trial in July 2021.

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All funding agencies have agreed to continue their financial support and to shift funds to the MT-401-OTS program.

Off-the-Shelf MT-401 (MT-401-OTS) for the Treatment of AML:

Marker previously announced that it intends to focus on the advancement of the MT-401-OTS program in patients with AML.

Off- the-Shelf MT-401 (MT-401-OTS) for the Treatment of AML and MDS:

Marker previously announced that it intends to focus on the advancement of the MT-401-OTS program in patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS).

MT-401-OTS has the potential to provide treatment to patients in as little as 72 hours.

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FDA has cleared our clinical protocol to investigate MT-401-OTS as a treatment in patients with AML.

already established a cellular inventory manufactured from healthy donors, with ongoing efforts to further expand the inventory.

At full scale production, we estimate a single donor could provide treatment for approximately 40 patients, and the current stability program indicates that OTS multiTAA-specific T cell products are stable for more than a year in liquid nitrogen, which we expect will permit future on-demand availability for broad-scale implementation.

We already established a cellular inventory manufactured from healthy donors, with ongoing efforts to further expand the inventory.

At full scale production, we estimate a single donor could provide treatment for approximately 40 patients, and the current stability program indicates that OTS MAR-T cell products are stable for more than a year in liquid nitrogen, which we expect will permit future on-demand availability for broad-scale implementation.

We expect to dose the first patient in the second half of 2025, and, if our OTS program shows promising results in the clinic, we intend to expand the OTS platform to other hematological malignancies and solid tumors.

With the grant support from the FDA Orphan Products Grant program, NIH Small Business Innovation Research (SBIR) program and the Cancer Prevention and Research Institute of Texas (CPRIT), the Company will be able to advance MT-401-OTS without affecting the investigation of its lead asset, MT-601, in patients with lymphoma.

Our clinical-stage pipeline is set forth below:

Our multiTAA-specific T cells are designed to enhance the capacity of non-engineered T cells to find and kill cancer by increasing the diversity and quantity of naturally occurring cancer killing T cells within the patient.

Our MAR-T cells are designed to enhance the capacity of non-engineered T cells to find and kill cancer by increasing the diversity and quantity of naturally occurring cancer killing T cells within the patient.

Our goal is to be the leader in the development and commercialization of transformative immunotherapies for the treatment of hematological malignancies and solid tumors.

We are developing a portfolio of highly differentiated T cell therapies utilizing the multiTAA-specific T cell platform that we believe has the potential to significantly disrupt the current cell therapy landscape, while substantially improving survival and quality of life for patients with cancers.

We are developing a portfolio of highly differentiated T cell therapies utilizing the MAR-T cell platform that we believe has the potential to significantly disrupt the current cell therapy landscape, while substantially improving survival and quality of life for patients with cancers.

The key elements of our strategy include:

● Expedite clinical development, regulatory approval, and commercialization of our lead product candidates.

Based on the results of the Phase 1 clinical trials of the multiTAA-specific T cell therapies conducted at BCM and the positive clinical data from the Phase 1 APOLLO study, we plan to prioritize the advancement of MT-601 in patients with lymphoma and to advance the MT-401-OTS program in patients with AML.

Based on the results of the Phase 1 clinical trials of the MAR-T cell therapies conducted at BCM and the positive clinical data from the Phase 1 APOLLO study, we plan to prioritize the advancement of MT-601 in patients with lymphoma and to advance the MT-401-OTS program in patients with AML and MDS.

We intend to initiate future additional clinical trials in other tumor types based on emerging data.

On June 26, 2023, we completed the previously announced transaction with Cell Ready, LLC, or Cell Ready, pursuant to a Purchase Agreement, or the Cell Ready Purchase Agreement, dated May 1, 2023, by and between us and Cell Ready.

Following the Closing Date, on February 22, 2024, we and Cell Ready entered into a long-term contract, pursuant to which Cell Ready will perform a wide variety of services for us, including research and development, and manufacturing in support of our clinical trials.

● Continue to collaborate with our partners and increase our clinical activities to improve and develop adoptive cell therapy technologies.

We are contracting with Cell Ready to perform a wide variety of services to ensure the continuation of our research and development efforts and process development to optimize our manufacturing process, product quality and commercial scalability.

We previously optimized the multiTAA-specific T cell manufacturing process by closing the system and reducing the total manufacturing time from the original 36 days (BCM) to nine days.

The improved manufacturing process has been implemented to supply all of the clinical products used in our current company-sponsored clinical trials.

We intend to continue to contract and collaborate with third-parties to perform a wide variety of services to ensure the continuation of our research and development efforts, with the goal of optimizing our manufacturing process, product quality and commercial scalability.

Marker previously optimized the MAR-T cell manufacturing process by decreasing the number of manipulations, semi-closing the system and reducing the total manufacturing time from the original 36 days (BCM studies) to nine days.

We believe the improved manufacturing process enables products with increased antigen specificity and diversity, both of which have a strong linear correlation to anti-tumor activity and has resulted in a four-fold increase in potency in vitro.

● Invest in our platform to maximize the beneficial outcomes for cancer patients.

We plan to explore new product opportunities by increasing and/or customizing the antigens we target to expand the indications in which the multiTAA-specific T cell products will be efficacious, including solid tumors or other hematologic malignancies.

We plan to explore new product opportunities by increasing and/or customizing the antigens we target to expand the indications in which the MAR-T cell products will be efficacious, including solid tumors or other hematologic malignancies.

Additionally, our research and development efforts may include the exploration of different doses and/or frequency of dosing and the relationship of these factors with potential therapeutic benefit.

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Because CARs are specific for a single antigen, or more precisely a single epitope within the single antigen, they are very narrowly focused and have limitations.

When a CAR-T cell product is applied to a specific antigen of a heterogeneous disease, CAR-T cells may leave behind tumor cells that do not express the target antigen, which can lead to tumor relapse due to immune escape.

When a CAR-T cell product is applied to a

specific antigen of a heterogeneous disease, CAR-T cells may leave behind tumor cells that do not express the target antigen, which can lead to tumor relapse due to immune escape.

Our approach is to avoid genetic engineering by relying upon the native T cell receptor, which has evolved over millions of years to provide T cells with an exquisite capacity to recognize and kill cancer cells.

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Once infused, the natural characteristics of T cells take over and the T cells multiply in quantity, forming an army of T cells that kill the targeted cancer cells.

The MultiTAA-Specific T Cell Therapies

We are advancing two multiTAA-specific T cell therapies through clinical development:

Autologous multiTAA-specific T cell therapies – The autologous product targets the NY-ESO-1, PRAME, MAGE - A4, Survivin, WT1 and SSX2 antigens (MT-601).

MAR-T Cell Therapies

We are advancing two MAR-T cell therapies through clinical development:

Autologous MAR-T cell therapies – The autologous product targets the NY-ESO-1, PRAME, MAGE - A4, Survivin, WT1 and SSX2 antigens (MT-601).

We recently reported updated clinical data from our Phase 1 clinical trial investigating MT-601 for the treatment of patients with lymphoma who have relapsed after CAR-T therapy.

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FDA to investigate MT-601 in a Phase 1 trial in patients with pancreatic cancer in combination with first-line chemotherapy.

Off-the-Shelf (OTS) multiTAA-specific T cell therapies – The OTS product targets WT1, NY-ESO-1, PRAME, and Survivin antigens (MT-401-OTS).

Off- the-Shelf (OTS) MAR-T cell therapies – The MT-401-OTS product targets WT1, NY-ESO-1, PRAME, and Survivin antigens (MT-401-OTS).

We plan to enroll patients that will be matched to the pre-manufactured inventory of MT-401-OTS products based on their human leukocyte antigen, or HLA.

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Our solution to the problem of tumor heterogeneity is the development of T cell products that are intended to simultaneously attack multiple tumor-expressed antigens and thereby enable more complete initial tumor targeting, thus minimizing the subsequent opportunity for the cancer to engage escape mechanisms.

We believe our proprietary multiTAA-specific T cell platform may have meaningful advantages over current CAR and TCR-engineered cell therapy approaches.

Compared to current gene-modified T cell therapies, the multiTAA-specific T cell product candidates are characterized by the following:

We believe that by targeting up to six tumor-specific antigens, our MAR-T cell approach facilitates robust killing of targeted cancer cells and minimizes tumor escape.

We believe our proprietary MAR-T cell platform may have meaningful advantages over current CAR and TCR-engineered cell therapy approaches.

Compared to current gene-modified T cell therapies, the MAR-T cell product candidates are characterized by the following:

● Clinical benefits observed in early-stage clinical trials in multiple cancer indications.

Based on our observations in clinical trials in AML, pancreatic cancer, lymphoma, ALL and MM, we believe that the multiTAA-specific T cell therapies have the potential to mediate a meaningful anti-tumor effect, as well as significant in vivo expansion of T cells.

Based on our observations in clinical trials in AML, pancreatic cancer, lymphoma, ALL and MM, we believe that the MAR-T cell therapies have the potential to mediate a meaningful anti-tumor effect, as well as significant in vivo expansion of T cells.

For example, in BCM’s Phase 1 clinical trial in lymphoma, there were complete responses, or CRs, in six of the fifteen evaluable patients with both Hodgkin lymphoma and non-Hodgkin lymphoma with active disease.

Significantly, no patient with a CR has subsequently

relapsed with disease, whereas typically 30% or more of patients with CR in reported CAR-T studies relapse within one year.

In patient results to date in this trial, observed therapeutic responses appear to be highly durable, with some patients being relapse-free beyond five years.

Significantly, no patient with a CR has subsequently relapsed with disease, whereas typically 30% or more of patients with CR in reported CAR-T studies relapse within one year.

In patient results

to date in this trial, observed therapeutic responses appear to be highly durable, with some patients being relapse-free beyond five years.

In 2023, Marker treated the first patient in the Phase 1 APOLLO trial investigating the safety and efficacy of MT-601 in patients with lymphoma.

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● Non-genetically modified T cells.

Unlike CAR and TCR-based approaches, the multiTAA-specific T cell therapy does not require genetic modification of T cells, a costly and complex process that significantly complicates the manufacturing of a patient product.

We believe our multiTAA-specific T cell therapy represent a safe alternative to CAR-T cells and can be manufactured at a fraction of the cost of a gene-modified T cell product, with substantially reduced complexity of manufacturing.

Unlike CAR and TCR-based approaches, the MAR-T cell therapy does not require genetic modification of T cells, a costly and complex process that significantly complicates the manufacturing of a patient product.

We believe our MAR-T cell therapy represent a safe alternative to CAR-T cells and can be manufactured at a fraction of the cost of a gene-modified T cell product, with substantially reduced complexity of manufacturing.

● Low incidence rate of adverse events.

As of January 2024, the multiTAA-specific T cell therapy was generally well tolerated by the patients across clinical trials in hematological and solid tumor indications, and no treatment-related adverse events, including CRS or neurotoxicity, were attributed to the use of multiTAA-specific T cell therapies to date.

As of January 2025, the MAR-T cell therapy was generally well tolerated by the patients across clinical trials in hematological and solid tumor indications, and no treatment-related adverse events, including neurotoxicity, were attributed to the use of MAR-T cell therapies to date.

This appears to compare favorably with published CD19 CAR-T studies that have been associated with substantial tolerability concerns, including a Phase 1 trial in which 95% of patients had Grade 3 or higher adverse events during treatment and current investigations by the FDA regarding the risk of CAR-T cell therapies to potentially induce secondary cancers.

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Deep gene sequencing of our products shows that a typical patient dose usually consists of approximately 4,000 unique T cell clonotypes, some of which target up to six different tumor-associated antigens.

The six antigen targets can be recognized by a very wide range of T cells, which we believe facilitates robust killing of targeted cancer cells.

Clinical Development of Our multiTAA-Specific T Cell Therapies by BCM

The six antigen targets can be recognized by a very wide range of T cells, and we believe that this multi antigen approach facilitates robust killing of targeted cancer cells and minimizes tumor escape.

Clinical Development of Our MAR-T Cell Therapies by BCM

The following clinical trials were conducted by BCM pursuant to our strategic alliance.

In each trial, correlative studies showed significant expansion of multiTAA-specific T cells, as well as evidence of epitope spreading against tumor-associated antigens that were not targeted by the multiTAA-specific T cell therapy.

In each trial, correlative studies showed significant expansion of MAR-T cells, as well as evidence of epitope spreading against tumor-associated antigens that were not targeted by the MAR-T cell therapy.

Acute Myeloid Leukemia

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The five-year mortality rate for patients who receive an allogeneic HSCT exceeds 50%, and patients who relapse after a transplant have a survival expectation of approximately 4.5 months.

BCM recently completed a Phase 1 AML/MDS clinical trial of the multiTAA-specific T cell therapy for the treatment of patients with post-transplant AML.

BCM recently completed a Phase 1 AML/MDS clinical trial of the MAR-T cell therapy for the treatment of patients with post-transplant AML.

In this trial, patients in remission with high risk for relapse, as well as patients with active disease post-transplant were treated.

As reported in a 2021 publication by Lulla et al., 11 of the 17 patients in the adjuvant disease setting dosed with the multiTAA-specific T cell therapy after receiving an allogeneic HSCT did not relapse during the follow-up period of the study [median LFS not reached at a median follow-up of 1.9 years], with 11 of 15 patients (two patients were each treated during two different remissions) remaining alive (estimated two-year overall survival of 77%) at a median follow-up of 1.9 years post-infusion which compares favorably with HSCT outcomes for risk-matched AML/MDS patients post-HSCT [median LFS of nine to 15 months and two-year survival probability of 42%].

As reported in a 2021 publication by Lulla et al., 11 of the 17 patients in the adjuvant disease setting dosed with the MAR-T cell therapy after receiving an allogeneic HSCT did not relapse during the follow-up period of the study [median LFS not reached at a median follow-up of 1.9 years], with 11 of 15 patients (two patients were each treated during two different remissions) remaining alive (estimated two-year overall survival of 77%) at a median follow-up of 1.9 years post-infusion which compares favorably with HSCT outcomes for risk-matched AML/MDS patients post-HSCT [median LFS of nine to 15 months and two-year survival probability of 42%].

Additionally, eight patients were treated for active disease that was resistant to salvage therapy post-HSCT with a median of five prior lines of therapy (range:

four to ten).

One of the eight patients crossed over from the adjuvant group while two patients enrolled twice, but all three patients had active AML that failed another line of salvage therapy after their first multiTAA-specific T cell infusion.

Two of the eight patients achieved objective responses with one complete response and one partial response, with six patients continuing with stable disease.

In this trial, the multiTAA-specific T cell therapy was well tolerated, with no drug-related serious adverse events and no instances of greater than Grade 2 acute graft-versus-host disease or moderate-severe chronic GVHD.

In this trial, the MAR-T cell therapy was well tolerated, with no drug-related serious adverse events and no instances of greater than Grade 2 acute graft-versus-host disease or moderate-severe chronic GVHD.

The maximum grade treatment-related adverse event was seen in one patient in the adjuvant disease group who had a possibly drug-related Grade 3 elevation of liver enzymes but was treated with prednisone with complete resolution.

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Pancreatic Cancer

In May 2020, we reported interim data from an ongoing Phase 1/2 clinical trial of the multiTAA-specific T cell therapy for the treatment of pancreatic adenocarcinoma being conducted by BCM.

In 2020, we reported that in this trial, BCM administered multiTAA-specific T cells to a total of 31 patients with advanced or borderline resectable pancreatic adenocarcinoma in three arms:

In May 2020, we reported interim data from an ongoing Phase 1/2 clinical trial of the MAR-T cell therapy for the treatment of pancreatic adenocarcinoma being conducted by BCM.

In 2020, we reported that in this trial, BCM administered MAR-T cells to a total of 31 patients with advanced or borderline resectable pancreatic adenocarcinoma in three arms:

13 patients in Arm A, which included patients with unresectable/metastatic disease who were responding to standard first-line chemotherapy;

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No cytokine release syndrome or neurotoxicity has been observed in any arm of the trial to date.

Arm A was designed to evaluate the safety and potential efficacy of using multiTAA-specific T cell therapy as part of first-line treatment for patients with pancreatic cancer.

These patients in the chemo-responsive arm have completed at least three months of standard-of-care chemotherapy (gemcitabine/nab-paclitaxel or FOLFIRINOX), which is the period during which a response to chemotherapy would typically occur, before receiving up to six administrations of multiTAA-specific T cell therapy in conjunction with chemotherapy.

Arm A was designed to evaluate the safety and potential efficacy of using MAR-T cell therapy as part of first-line treatment for patients with pancreatic cancer.

These patients in the chemo-responsive arm have completed at least three months of standard-of-care chemotherapy (gemcitabine/nab-paclitaxel or FOLFIRINOX), which is the period during which a response to chemotherapy would typically occur, before receiving up to six administrations of MAR-T cell therapy in conjunction with chemotherapy.

● Out of the 13 evaluable patients (best overall response):

o four patients experienced objective responses after administration of multiTAA-specific T cells;

o four patients experienced objective responses after administration of MAR-T cells;

o one patient experienced a radiographic complete response occurring at month nine after starting chemotherapy;

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● Patients had durable cancer control with nine of the 13 patients exceeding historical control of overall survival;

● Five patients enrolled in the study were not administered multiTAA-specific T cells, either because of disease progression (four patients) which made them ineligible for treatment, or because insufficient starting material from the patient was available for manufacturing (one patient);

● Evidence of epitope-spreading was observed in all responders, suggesting that the multiTAA-specific T cell therapy triggered the recruitment of a broader endogenous immune system response for improved anti-tumor activity;

● Five patients enrolled in the study were not administered MAR-T cells, either because of disease progression (four patients) which made them ineligible for treatment, or because insufficient starting material from the patient was available for manufacturing (one patient);

● Evidence of epitope-spreading was observed in all responders, suggesting that the MAR-T cell therapy triggered the recruitment of a broader endogenous immune system response for improved anti-tumor activity;

● No infusion-related reactions, cytokine release syndrome or neurotoxicity was observed;

In patients responding to therapy, significant expansion of the infused multiTAA-specific T cell therapy was observed.

BCM evaluated the multiTAA-specific T cell therapy (5 TAA product) in a Phase 1 clinical trial for the treatment of patients with lymphoma.

A total of 32 patients received two protocol-specified infusions of multiTAA-specific T cells, 14 with Hodgkin lymphoma, or HL, and 18 with aggressive non-Hodgkin lymphoma, or NHL, [diffuse large B-cell lymphoma, or DLBCL, (n=12), mantle cell lymphoma, or MCL, (n=2), T-cell lymphoma (n=3) and composite lymphoma (HL and DLBCL, n=1)].

In patients responding to therapy, significant expansion of the infused MAR-T cell therapy was observed.

BCM evaluated the MAR-T cell therapy (5 TAA product) in a Phase 1 clinical trial for the treatment of patients with lymphoma.

A total of 32 patients received two protocol-specified infusions of MAR-T cells, 14 with Hodgkin lymphoma, or HL, and 18 with aggressive

non-Hodgkin lymphoma, or NHL, [diffuse large B-cell lymphoma, or DLBCL, (n=12), mantle cell lymphoma, or MCL, (n=2), T-cell lymphoma (n=3) and composite lymphoma (HL and DLBCL, n=1)].

As reported in a recent publication by Vasileiou et al., BCM had treated 15 patients with active disease (active lymphoma group), all of whom had completed a follow-up period beyond three months post-infusion.

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As illustrated below, in the active lymphoma group, six patients entered CR and nine patients had experienced stable disease.

None of the patients in CR had relapsed, and the range for the duration of CR in these patients was between two and over five years after being infused with the multiTAA-specific T cell therapy with the exception of one patient who died of an unrelated pneumonia while in a CR.

None of the patients in CR had relapsed, and the range for the duration of CR in these patients was between two and over five years after being infused with the MAR-T cell therapy with the exception of one patient who died of an unrelated pneumonia while in a CR.

Responses in all six patients who entered CR were associated with an expansion of infused T cells, as well as induction of broad-based antigen spreading across many tumor-associated antigens.

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The duration of response ranged from approximately nine months to over five years.

In both treatment groups, the multiTAA-specific T cell therapy was well tolerated, with no drug-related serious adverse events.

Process Development and Manufacturing of the MultiTAA-Specific T Cell Therapies

In both treatment groups, the MAR-T cells were well tolerated, with no drug-related serious adverse events.

Process Development and Manufacturing of the MAR-T Cell Therapies

In the manufacturing process, blood is drawn from either the individual patient (in the case of the autologous T cells) or from a healthy donors/commercially available leukapheresis material (in the case of the OTS program).

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After blood is drawn, PBMCs are isolated and used to manufacture a patient-specific product.

These cells are placed inside a G-Rex manufacturing device and combined with an experimentally optimized mix of GMP-grade cytokines that is used to restore and enhance the functional capability of the cultured T cells.

These cells are placed inside a cell culture device and combined with an experimentally optimized mix of GMP-grade cytokines that is used to restore and enhance the functional capability of the cultured T cells.

In addition, libraries of overlapping peptides, which we refer to as peptide pools, are added to the cell culture.

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This overlapping structure allows us to isolate, activate and expand any T cell that is specific for any segment of the antigens that we target in the unique genetic background of every patient.

The G-Rex is a cell culture device manufactured by Wilson Wolf Manufacturing Corporation, or Wilson Wolf, used by many cell therapy developers, both in commercial and academic settings.

The device allows a user to introduce cells, medium and other reagents into a cell culture chamber, which has a gas-permeable membrane at its bottom.

The cells settle on this gas-permeable membrane through which oxygen and carbon dioxide are exchanged (i.e.

the cells can breathe at the base of the device), while nutrients required for cell expansion are obtained from the medium above the cells.

This system allows for the highly robust growth of cells in culture, by providing them with superior access to oxygen and nutrients.

Cells manufactured in the device grow efficiently without need for agitation by a technician, scientist or automated system.

Inside the G-Rex, PBMCs, including T cells and antigen-presenting cells, are exposed to the stimulating peptide pools.

Inside the cell culture device, PBMCs, including T cells and antigen-presenting cells, are exposed to the stimulating peptide pools.

This results in the selective expansion of T cells that specifically recognize the target antigens.

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Manufacturing

The manufacturing process was originally developed at Baylor College of Medicine, where we also conducted our clinical trials.

In 2021, we validated an additional manufacturing site (now Cell Ready) for our multiTAA-specific T cell products.

On June 26, 2023, we completed the transaction with Cell Ready, LLC, or Cell Ready, pursuant to a Purchase Agreement, or the Cell Ready Purchase Agreement, dated May 1, 2023, by and between us and Cell Ready.

Pursuant to the Cell Ready Purchase Agreement, effective as of the Closing Date, we (i) assigned to Cell Ready the leases for our two manufacturing facilities in Houston, Texas, or the Manufacturing Facilities, (ii) sold to Cell Ready all of the equipment and leasehold improvements at the Manufacturing Facilities and (iii) assigned to Cell Ready our rights, title and interest in any contracts related to the equipment and Manufacturing Facilities (collectively referred to as the “Purchased Assets”).

Cell Ready acquired the Purchased Assets for total consideration of $19.0 million.

On February 22, 2024, we entered into a Master Services Agreement for Product Supply, or MSA, with Cell Ready.

Cell Ready, which is owned by one of our directors and shareholders, Mr.

Our manufacturing process was originally developed at Baylor College of Medicine, where we initially conducted our clinical trials.

We continue to contract and collaborate with BCM and others to perform a wide variety of services to ensure the continuation of our research and development efforts, with the goal of optimizing our manufacturing process, product quality and commercial scalability.

In July 2021, we opened an in-house cGMP manufacturing facility in Houston, Texas, where we manufactured the clinical supply of our product candidates.

Subsequently, on June 26, 2023, we completed a transaction with Cell Ready, LLC, or Cell Ready, pursuant to a Purchase Agreement, or the Cell Ready Purchase Agreement, dated May 1, 2023, by and between us and Cell Ready, pursuant to which we (i) assigned to Cell Ready the leases for our two manufacturing facilities in Houston, Texas, or the Manufacturing Facilities, (ii) sold to Cell Ready all of the equipment and leasehold improvements at the Manufacturing Facilities and (iii) assigned to Cell Ready our rights, title and interest in any contracts related to the equipment and Manufacturing Facilities (collectively referred to as the “Purchased Assets”).

Following the closing of the Cell Ready Purchase Agreement, we no longer operate our own cGMP manufacturing facility and instead rely on third parties for the clinical and, once approved, commercial manufacture of our product candidates.

As such, on February 22, 2024, we entered into a Master Services Agreement for Product Supply (the “MSA”) with Cell Ready for the provision of various products and services by Cell Ready pursuant to work orders that may be entered into from time to time.

Cell Ready, which is owned by one of our former directors and current shareholders, Mr.

John Wilson, is a contract development and manufacturing organization (CDMO).

Under the MSA, it is anticipated Cell Ready will perform a wide variety of services for us, including research and development, and manufacturing in support of our clinical trials.

Pursuant to the MSA, the Company may contract with Cell Ready for the provision of various products and services from time to time by entering into work orders with Cell Ready.

If the services involve the supply of product, Cell Ready is required to supply such product in conformance with the product requirements set forth in the applicable work order(s).

Under the MSA, Cell Ready is to use only personnel with sufficient qualifications and experience to supply the services contemplated by the MSA, provide its personnel with adequate training and assume full responsibility for its personnel’s compliance with the MSA.

Further, Cell Ready is required to provide the Company with assistance and cooperation in order for the Company to obtain and maintain all necessary regulatory approvals, at the Company’s expense.

The MSA contains customary representations, warranties and indemnification provisions.

The initial term of the MSA is three years and may be extended upon the mutual written agreement of the parties.

On March 27, 2025, we mutually agreed with Cell Ready to terminate the MSA.

In connection therewith, we entered into a settlement and release agreement with Cell Ready pursuant to which we paid Cell Ready approximately $453,000 and we provided one another with mutual releases of all claims associated with any and all agreements between Marker and Cell Ready.

Additionally, BCM continues to supply us with products as we continue our clinical trials.

Furthermore, in anticipation of the commencement of our larger pivotal trial for Lymphoma in 2026, as well as the eventual need for commercial scale production, we intend to evaluate and qualify additional potential third-party manufacturing partners to provide potential multiple sources of clinical and commercial supply.

We currently are in discussions with a number of CDMO candidates and anticipate that we will select a partner organization and commence the qualification and technology transfer process later this year.

However, there is no guarantee that we will or have properly estimated our required manufacturing capacities or that the third parties on which we rely to manufacture our products will be able or willing to perform on our proposed timelines or to meet our manufacturing demands, if at all.

If any of our third-party vendors experience disruptions or otherwise cease or substantially reduce the amount of products they are willing to supply us, our business and operations could be adversely affected.

See “Risk Factors”.

During the years ended December 31, 2024 and 2023, the Company incurred $5.8 million and $1.3 million in expenses related to the services and manufacturing costs, and paid $5.5 million and nil related to invoices received, respectively.

We face competition from numerous pharmaceutical and biotechnology companies, as well as from academic institutions, private and public research institutions, and government agencies.

Treatment of relapsed patients with lymphoma remains a challenge with relatively low overall survival rates.

To date, there are four CD19-directed CAR T cell therapies (Yescarta, Kymriah, Tecartus, and Bryanzi) approved for patients with relapsed lymphoma.

To date, there are four CD19-directed CAR-T cell therapies (Yescarta, Kymriah, Tecartus, and Bryanzi)

approved for patients with relapsed lymphoma.

However, up to 60% of CD19 CAR-T cell treated patients will relapse, particularly in the third line setting (Chong EA et al, N Engl J Med, 2021).

This highlights a significant unmet medical need for alternative and more effective treatments.

Our multiTAA-specific T cell drug candidates may compete with product candidates from a number of companies, which are developing various types of immunotherapies to treat cancer, including non-CD19 targeting CAR T cells that target different antigens beyond CD19, multi-targeted CAR T cells as well as NK-CAR therapies.

Our MAR-T cell drug candidates may compete with product candidates from a number of companies, which are developing various types of immunotherapies to treat cancer, including non-CD19 targeting CAR-T cells that target different antigens beyond CD19, multi-targeted CAR-T cells as well as NK-CAR therapies.

In addition, bispecific antibodies represent promising therapies for patients with lymphoma and provide competition in the oncology space.

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BCM Exclusive License Agreement

On March 16, 2018, we entered into an exclusive license agreement, or the BCM License Agreement, with BCM, under which we received a worldwide, exclusive license to BCM’s rights in and to certain intellectual property rights, including European patent EP 2470644 (estimated expiration date August 24, 2030), to develop and commercialize multiTAA-specific T cell product candidates.

Exclusive License to BCM’s Subject Technology:

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We have entered into additional agreements with BCM with respect to a strategic alliance to advance pre-clinical research, early-stage clinical trials, and Phase 2 clinical trials with respect to our product candidates, as well as continued access to our clinical data, and product manufacturing and support, including personnel and space at the institution for the foreseeable future.

Cancer Prevention and Research Institute of Texas

In August 2021, we received notice of a Product Development Research award totaling approximately $13.1 million from CPRIT to support our clinical investigation of MT-401.

In December 2024, we received notice of an additional $9.5 million grant from CPRIT to support the clinical investigation of MT-601 in patients with pancreatic cancer.

Both CPRIT grants contain identical terms surrounding intellectual property and revenue sharing.

Per the CPRIT grant agreements, we will retain ownership over any intellectual property developed under the contracts (the “Project Results”).

With respect to non-commercial use of any Project Results, we agreed to grant to CPRIT a nonexclusive, irrevocable, royalty-free, perpetual, worldwide license with the right to sublicense any necessary additional intellectual property rights to exploit all Project Results by CPRIT, other governmental entities and agencies of the State of Texas, and private or independent institutions of higher education located in Texas, solely for academic, research, and other non-commercial purposes.

If our products become commercially saleable, we are obligated to make payments to CPRIT, with respect to net sales of any product covered in the contract, equal to a percentage of revenue ranging from the low-to-mid single digits.

These payments will continue up to and until CPRIT receives an aggregate amount of 400% of the sum of all monies paid to us by CPRIT under the grant agreements.

If we are required to obtain a license from a third party to sell any such product, the revenue sharing percentages may be reduced.

once we have paid CPRIT 400% of the monies received under the grant agreements, we will continue to pay CPRIT a revenue-sharing percentage of 0.5% for the remainder of the Revenue Term as specified in the grant agreement.

Intellectual Property

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Our ability to stop third parties from making, using, selling, offering to sell, or importing our products may depend on the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities — for example, the rights obtained under exclusive license arrangements such as those pursuant to our BCM License Agreement.

patents or any patents that may be granted in the future will be commercially useful in protecting our commercial products and methods of manufacturing the same.

With respect to both licensed and company-owned intellectual property, we cannot be sure that patents will be granted with respect to any of our pending patent applications or with respect to any patent applications filed in the future, nor can we be sure that any of our existing patents or any patents that may be granted in the future will be commercially useful in protecting our commercial products and methods of manufacturing the same.

To achieve this objective, a strategic focus for us has been identifying and licensing key patents and patent applications that serve to enhance our intellectual property and technology position.

Currently, all of our multiTAA-specific T cell intellectual property rights are licensed from BCM.

Currently, all of our MAR-T cell intellectual property rights are licensed from BCM.

Our intellectual property portfolio currently includes patent applications having:

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and (2) claims directed to therapeutic uses of such multi-antigen specific T cell products.

With regard to Cell Ready, the MSA provides that each party will solely and exclusively own all right, title and interest in and to their Background IP and all inventions derived from such Background IP (such invention being referred to as Foreground IP).

Background IP means all intellectual property either (a) owned or controlled by a party prior to the effective date of the MSA or (b) developed or acquired by a party independently from performance under the MSA without the use of, reliance on, or access to the other party’s confidential information.

Furthermore, pursuant to the MSA, Cell Ready grants to the Company a non-exclusive, perpetual, irrevocable, transferable, assignable, fully-paid up, royalty-free, worldwide license to and under any of Cell Ready’s Background IP and Foreground IP to the extent they are incorporated or embedded in any deliverables provided to the Company or in the process of generating or manufacturing such deliverables and reasonably necessary or useful for the Company to make, have made, manufacture, have manufactured, use, have used, offer for sale, sell, import, and otherwise exploit such deliverables.

The Company grants to Cell Ready until the termination or expiry of any applicable Work Order and for a period not exceeding the term of the MSA, a non-exclusive, fully paid-up, non-transferable, non-sublicensable limited license under and to the Company’s Background IP made available to Cell Ready pursuant to a Work Order solely to the extent required for Cell Ready to provide the services under such Work Order.

We believe our patent portfolio, together with our efforts to develop and patent next-generation technologies, provides us with a substantial intellectual property position.

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In addition, no assurances can be given that any patents issued, assigned, or licensed to us will not be infringed upon or designed around by others or that others will not obtain patents that we would need to license or design around.

If existing or future patents held by third parties and containing broad claims over technology used by us were upheld by a court or other authority of competent jurisdiction, the holders of such patents could require us to obtain licenses to use such technology.

If existing or future patents held by third parties and containing broad claims over technology used by us were upheld

by a court or other authority of competent jurisdiction, the holders of such patents could require us to obtain licenses to use such technology.

Patent coverage may also vary from country to country based on the scope of available patent protection.

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federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment to the federal government, including federal healthcare programs, that are false or fraudulent;

the Health Insurance Portability and Accountability Act, or HIPAA, which created additional federal criminal statutes which prohibit, among other things, executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters, and which, as amended by Health Information Technology for Economic and Clinical Health Act, or HITECH, also imposes certain requirements on HIPAA covered entities and their business associates and covered subcontractors relating to the privacy, security and transmission of individually identifiable health information;

requirements on HIPAA covered entities and their business associates and covered subcontractors relating to the privacy, security and transmission of individually identifiable health information;

federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually report to the federal government, information related to payments or other transfers of value made to physicians (as defined by the Physician Payments Sunshine Act), other covered physicians and teaching hospitals, as well as ownership and investment interests held by health care professionals and their immediate family members;

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The United States and some foreign jurisdictions are considering or have enacted a number of reform proposals to change the healthcare system.

There is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality or expanding access.

There is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs,

improving quality or expanding access.

In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by federal and state legislative initiatives, including those designed to limit the pricing, coverage, and reimbursement of pharmaceutical and biopharmaceutical products, especially under government-funded health care programs, and increased governmental control of drug pricing.

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For example, on July 24, 2020 and September 13, 2020, the Trump Administration announced several executive orders related to prescription drug pricing that seek to implement several of the administration’s proposals.

As a result, the FDA concurrently released a final rule and guidance in September 2020 providing pathways for states to build and submit importation

plans for drugs from Canada.

As a result, the FDA concurrently released a final rule and guidance in September 2020 providing pathways for states to build and submit importation plans for drugs from Canada.

Further, on November 20, 2020, HHS finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law.

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No legislation or administrative actions have been finalized to implement these principles.

However, it is unclear whether these or similar policy initiatives will be implemented in the future.

However, it is

unclear whether these or similar policy initiatives will be implemented in the future.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

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As of December 31, 2024, we had 5 full-time employees:

There were 6 in clinical and 2 were in administrative support.

1 clinical and 4 in administrative support.

None of our employees is subject to a collective bargaining agreement.

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Corporate Information

We were incorporated under the laws of the State of Nevada in 1991 under the name “TapImmune, Inc.” and reincorporated in Delaware in October 2018 under the name “Marker Therapeutics, Inc.” Our principal executive offices are located at 9350 Kirby Drive, Suite 300, Houston, Texas 77054, and our telephone number is (713) 400-6400.

BCM251, Houston, Texas, and our telephone number is (713) 400-6400.

Our common stock is listed for trading on the Nasdaq Capital Market under the symbol “MRKR”.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business