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Marker Therapeutics, Inc. (MRKR): Business Model Canvas [Dec-2025 Updated] |
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Marker Therapeutics, Inc. (MRKR) Bundle
You're looking at a clinical-stage biotech, Marker Therapeutics, Inc. (MRKR), where the business model isn't about sales yet-it's about hitting milestones and managing cash. Honestly, the real story here is the MultiTAA platform, which showed a defintely compelling 66% objective response rate for MT-601, a huge value proposition against tumor escape. Still, with cash at $17.6 million as of September 30, 2025, and Q3 burn covering R&D of $2.3 million, understanding their key partnerships, like the one with Baylor College of Medicine, and how they are funding the next steps via grants ($1.23 million in Q3 2025) and equity is crucial. Dive into the full canvas below to see exactly how Marker Therapeutics, Inc. (MRKR) is structuring its path from R&D to potential commercialization.
Marker Therapeutics, Inc. (MRKR) - Canvas Business Model: Key Partnerships
You're looking at the core external relationships that let Marker Therapeutics, Inc. (MRKR) move its science from the lab bench to the clinic, so let's break down the key players supporting their MAR-T cell platform as of late 2025.
Baylor College of Medicine (BCM) for technology development and clinical trials
The foundation of Marker Therapeutics, Inc.'s technology is deeply rooted in academic research. The proprietary Multi-Antigen Recognizing (MAR) T cell platform was founded at Baylor College of Medicine. This institutional connection is critical because it's where the initial science was developed and where early clinical validation occurred. For instance, the TACTOPS trial, which provided early data on MT-601's safety and durable control in pancreatic cancer patients, was conducted at Baylor College of Medicine. This partnership provides the necessary scientific pedigree and historical clinical infrastructure for their autologous MAR-T cell therapies, like MT-601, which targets six tumor-specific antigens.
Cellipont Bioservices for cGMP manufacturing scale-up of MT-601
Moving a cell therapy into later-stage trials and toward commercial readiness requires robust manufacturing, and that's where Cellipont Bioservices comes in. Marker Therapeutics, Inc. entered a current good manufacturing practice (cGMP) manufacturing agreement with Cellipont in June 2025. This collaboration specifically focuses on the scale-up and production of MT-601, which is currently being investigated in the Phase 1 APOLLO study for patients with lymphoma who have relapsed after anti-CD19 CAR-T cell therapy. The goal here is clear: accelerate clinical supply and lay the foundation for a potential pivotal trial and commercial readiness. This de-risks a major operational hurdle, as Marker's platform is designed to be manufactured at a fraction of the cost and complexity of gene-modified T cell products.
Cancer Prevention and Research Institute of Texas (CPRIT) for grant funding
Non-dilutive funding from CPRIT has been essential for advancing MT-601 into new indications. You should note the specific awards tied to the pancreatic cancer program. Marker Therapeutics, Inc. was awarded a $9.5 million grant from CPRIT to support the clinical investigation of MT-601 in patients with metastatic pancreatic cancer. This is part of a larger non-dilutive funding effort. For the three months ended June 30, 2025, the Company recognized $0.2 million of grant income related to this specific CPRIT Pancreatic Grant. The total non-dilutive funding from governmental institutions, including CPRIT, the NIH, and the FDA, has exceeded $30 million cumulatively.
National Institutes of Health (NIH) for non-dilutive grant income
The NIH has also provided crucial, non-dilutive support, which helps fund research and development without immediately diluting ownership. Marker Therapeutics, Inc. previously secured a $2.0 million grant from the NIH Small Business Innovation Research (SBIR) program to support the development of MT-601 in metastatic pancreatic cancer. Furthermore, an additional $2.0 million NIH SBIR grant was awarded in August 2024 to support the clinical investigation of MT-601 in patients with non-Hodgkin's lymphoma (NHL). For the three months ended June 30, 2025, approximately $0.1 million of revenue was recognized associated with the NIH PANACEA Grant for pancreatic cancer. The company's total grant income for the year ended December 31, 2024, was $6.6 million. As of September 30, 2025, the grant income for Q3 2025 was reported as $1.23 million.
Here's a quick look at the specific, identified non-dilutive funding amounts supporting the MT-601 program:
| Funding Source | Program Focus | Award Amount (USD) | Recent Recognized Income (3M Ended 6/30/2025) |
|---|---|---|---|
| CPRIT | MT-601 (Pancreatic Cancer) | $9,500,000 | $0.2 million |
| NIH (SBIR) | MT-601 (Pancreatic Cancer) | $2,000,000 | $0.1 million (PANACEA Grant) |
| NIH (SBIR) | MT-601 (NHL) | $2,000,000 | $0 (No revenue recorded in 3M ended 6/30/2025) |
| FDA (Orphan Products) | MT-401 (Previous Program) | $2,000,000 | Not specified |
The reliance on these grants is a key part of their financial strategy, helping to fund R&D and extend the cash runway, which, as of September 30, 2025, was projected through the third quarter of 2026 without additional grant funds. Still, year-to-date non-dilutive grant income fell 44%, putting pressure on the operating budget, which saw a year-to-date operating loss widen by 52% to $11 million.
These partnerships are the engine for Marker Therapeutics, Inc.'s clinical progress.
Marker Therapeutics, Inc. (MRKR) - Canvas Business Model: Key Activities
You're looking at the core operational engine of Marker Therapeutics, Inc. (MRKR) as of late 2025. For a clinical-stage biotech, Key Activities are all about advancing the science while managing the burn rate, and Marker Therapeutics is definitely executing on that tightrope walk.
Advancing lead candidate MT-601 in Phase 1 APOLLO study for lymphoma
The primary focus remains the lead candidate, MT-601, a Multi-Antigen Recognizing (MAR)-T cell product, in the Phase 1 APOLLO study for relapsed B-cell lymphoma. Data reported from the dose escalation portion, with a cutoff date of June 2025, showed compelling early signals. The study has treated a total of 24 B-cell lymphoma patients across 7 U.S. clinical sites, comprising 15 patients with Non-Hodgkin Lymphoma (NHL) and 9 patients with Hodgkin Lymphoma (HL). For the NHL cohort assessed (12 patients), the objective response rate (ORR) hit 66%, which translates to 8 out of 12 patients responding. Even more critically, the complete response (CR) rate was 50%, meaning 6 out of 12 NHL patients achieved a complete response. The safety profile supported progression, as no dose-limiting toxicities (DLTs) or immune effector cell-associated neurotoxicity (ICANS) were observed across the dose range evaluated, which spanned from 100x106 to 400x106 cells. This favorable profile allowed the Safety Review Committee (SRC) to clear the pre-specified maximum dose of 400x106 cells on June 17, advancing the trial into the dose expansion phase, specifically targeting Diffuse Large B Cell Lymphoma (DLBCL) patients who have relapsed after or are ineligible for CAR-T cell therapy. It's a clear path forward for the lead asset.
Research and development (R&D) of the Multi-Antigen Recognizing (MAR)-T cell platform
The R&D activity centers on validating and expanding the proprietary MAR-T cell platform. This is the non-genetically modified approach that differentiates Marker Therapeutics from some competitors. While the clinical execution is costly, management has shown some cost discipline in the R&D spend. Research and development expenses for the third quarter ended September 30, 2025, were reported at $2.3 million. This is a reduction from the $3.5 million reported for the same quarter in 2024. The platform supports both the lead MT-601 program and the emerging Off-the-Shelf (OTS) pipeline.
Executing clinical trials for MT-601 and the MT-401-OTS program
Clinical execution is happening on two major fronts. For MT-601, the APOLLO trial has advanced to the dose expansion cohort. Furthermore, the company is launching the next major program, MT-401-OTS, which is being evaluated in the Phase 1 RAPID study (clinicaltrials.gov Identifier: NCT06552416) for relapsed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS). The first patient in the RAPID trial was treated in October 2025. The initial dose level tested was 100x106 cells, and the first participant was monitored for 28 days, showing well-tolerated treatment. The MT-401-OTS product targets four tumor-associated antigens: Survivin, PRAME, NY-ESO-1, and WT-1. The company anticipates the clinical program for MT-601 in metastatic pancreatic cancer will launch in the first half of 2026.
Here's a snapshot of the key operational and financial metrics as of late 2025:
| Metric Category | Program/Period | Value/Amount |
| Clinical Efficacy (MT-601 NHL) | Objective Response Rate (ORR) | 66% |
| Clinical Efficacy (MT-601 NHL) | Complete Response (CR) Rate | 50% |
| Clinical Trial Status (MT-601) | Patients Treated (Total Lymphoma) | 24 |
| Clinical Trial Status (MT-401-OTS) | First Patient Treated Date | October 2025 |
| Financial Performance (Q3 2025) | Research & Development Expenses | $2.3 million |
| Financial Performance (Q3 2025) | Total Revenue (Grant Income) | $1.23 million |
| Financial Performance (Q3 2025) | Net Loss from Continuing Operations | $2.0 million |
Securing capital through equity financing and non-dilutive grants
Funding operations is a constant Key Activity. In the third quarter of 2025, Marker Therapeutics successfully raised approximately $10 million through its At-The-Market (ATM) equity facility. This capital infusion is projected to extend the cash runway well into the third quarter of 2026, which is a critical window to hit upcoming milestones. The company also continues to secure non-dilutive funding. Specifically for the pancreatic cancer program, Marker was awarded $2.0 million from the NIH and $9.5 million from the Cancer Prevention and Research Institute of Texas (CPRIT). The MT-401-OTS program is also supported by non-dilutive funds from the National Cancer Institute (Award Number 1R44CA285177), the FDA (Award Number R01FD007272), and CPRIT (Award Number DP210042).
Manufacturing T-cell product candidates under cGMP guidelines
To support clinical progression, Marker Therapeutics established a current good manufacturing practice (cGMP) manufacturing agreement with Cellipont Bioservices. This collaboration is specifically designed to scale up the production of MT-601 for the ongoing APOLLO study, which also lays the groundwork for a potential pivotal trial and commercial readiness. The OTS program, using commercially available leukapheresis material, is also designed to facilitate large-scale manufacturing with a potential time-to-treatment as fast as 72 hours.
You need to keep an eye on the cash position, too. As of September 30, 2025, Marker had cash and cash equivalents of $17.6 million, with total cash and restricted cash at $19.0 million. Finance: draft 13-week cash view by Friday.
Marker Therapeutics, Inc. (MRKR) - Canvas Business Model: Key Resources
You're looking at the core assets Marker Therapeutics, Inc. (MRKR) relies on to execute its strategy as of late 2025. These aren't just line items; they are the foundation for their entire value proposition, especially given the competitive nature of cell therapy.
Proprietary Technology and Data Assets
The most significant resource is the science itself. Marker Therapeutics' platform is built around its Proprietary Multi-Antigen Recognizing (MAR)-T cell technology. This is a key differentiator because it uses a non-genetically modified cell therapy approach. Instead of engineering T cells to target one specific part of one antigen, MAR-T cells selectively expand a patient's natural T cells to recognize hundreds of different portions, called epitopes, across up to six tumor-specific antigens. This breadth is intended to reduce the chance of tumor escape.
This technology has generated concrete clinical proof points that serve as a critical resource:
- Clinical data showing a 66% objective response rate for MT-601 in Non-Hodgkin Lymphoma (NHL) patients from the Phase 1 APOLLO study.
- A 50% complete response rate within that same NHL cohort for MT-601.
- The technology was developed at Baylor College of Medicine.
Intellectual Property and Manufacturing Infrastructure
Protecting the unique process is paramount. The Intellectual property protects the non-genetically modified T-cell process, which the company believes offers advantages in manufacturing cost and toxicity compared to gene-modified CAR-T and TCR-based therapies. This non-engineered nature is central to their competitive positioning.
Physical infrastructure is also a hard asset. Marker Therapeutics maintains a dedicated, leased cGMP manufacturing facility in Houston, Texas. This facility, located near the George Bush Intercontinental Airport, is fully operational and spans approximately 48,500 square feet.
Here's a quick look at the facility's status and intended use:
| Facility Detail | Metric/Status |
| Location | Houston, Texas |
| Status (as of late 2025) | Fully Operational (since July 2021) |
| Size | Approximately 48,500 square feet |
| Design Feature | Scalable using modular processes |
Financial Capital
Cash on hand directly funds the advancement of clinical programs and operations. As of September 30, 2025, Marker Therapeutics reported its liquidity position:
Cash and equivalents totaled $17.6 million, with an additional $1.4 million in restricted cash. The company also raised approximately $10 million through its At-The-Market (ATM) facility, which was intended to extend the cash runway well into 2026.
The financial strength can be summarized:
- Cash and cash equivalents: $17.6 million as of September 30, 2025.
- Restricted cash: $1.4 million as of September 30, 2025.
- Recent Financing: Raised approximately $10 million via ATM facility.
This cash position is what keeps the lights on while they push MT-601 into the dose expansion cohort. Finance: draft 13-week cash view by Friday.
Marker Therapeutics, Inc. (MRKR) - Canvas Business Model: Value Propositions
You're looking at a platform that aims to sidestep the major hurdles of current gene-modified cell therapies. The core value here is the non-genetically modified T-cell approach, which is designed to offer a better safety profile right out of the gate.
For the lead program, MT-601, clinical observations as of January 2025 showed no treatment-related adverse events, including neurotoxicity, attributed to the MAR-T cell therapies in trials. More recently, in the dose expansion cohort for MT-601, no dose-limiting toxicities (DLTs) or immune effector cell-associated neurotoxicity (ICANS) were observed at any dose level. This is a key differentiator when you look at published CAR-T data, such as a Phase 1 trial where 95% of patients experienced Grade 3 or higher adverse events during treatment.
The MultiTAA (Multi-Antigen Recognizing) aspect is designed to keep the tumor from finding an easy way out. While many competing therapies target a single epitope, Marker Therapeutics, Inc.'s MAR-T cell platform is built to recognize a broad range of tumor antigens. This is supported by observations of consistent epitope spreading in clinical trials, a feature not typically seen with other T cell therapies.
The manufacturing proposition is about cost and speed. Marker Therapeutics, Inc. believes its process allows for manufacturing at a fraction of the cost of a gene-modified T cell product, with substantially reduced complexity. To support this, a cGMP manufacturing collaboration was established with Cellipont Bioservices.
The clinical data strongly positions MT-601 as a necessary option for patients who have exhausted other lines of therapy. The FDA cleared the Investigational New Drug (IND) application for MT-601 specifically for patients with relapsed/refractory non-Hodgkin lymphoma who have failed or are ineligible to receive anti-CD19 CAR-T cell treatment. The latest update from the Phase 1 APOLLO study showed an 66% objective response rate, including a 50% complete response rate, in these heavily pre-treated NHL patients, including those previously treated with CAR-T cell therapies.
The Off-the-Shelf (OTS) program, starting with MT-401 for AML/MDS, speaks directly to the administration value. The use of commercially sourced leukapheresis in this program could potentially enable treatment as fast as 72 hours.
Here's a quick comparison mapping the clinical value points:
| Value Proposition Attribute | MAR-T Cell Therapy (MT-601/MT-401) | Gene-Modified CAR-T Therapy (Comparative Benchmark) |
| Genetic Modification | Non-genetically modified T cells | Gene-modified T cell product |
| Safety Signal (Neurotoxicity) | No treatment-related ICANS observed as of January 2025 | Associated with substantial tolerability concerns, including neurotoxicity |
| Antigen Targeting | Targets multiple tumor antigens (MultiTAA) | Generally targets a single epitope |
| Response in CAR-T Failed Patients (NHL) | 66% Objective Response Rate; 50% Complete Response Rate | Target population includes those who have failed prior CAR-T therapy |
| Manufacturing Potential | Potential for fraction of the cost and reduced complexity | Higher cost and complexity benchmark |
The operational advantages are further supported by the clinical progress, which includes:
- Clinical data from over 200 patients showed MAR-T cell products were well tolerated.
- Durability: Five NHL patients in the APOLLO study maintained response for $\ge 6$ months, with three at $\ge 12$ months (range 3-24 months).
- The OTS program is designed for rapid treatment, potentially as fast as 72 hours.
Financially, the company is funding this development through non-dilutive means, reporting Q3 2025 revenue of just $1.23 million, entirely from grant income. This funding model supports the high R&D focus, which saw Research and development expenses at $2.3 million for the quarter ended September 30, 2025.
Marker Therapeutics, Inc. (MRKR) - Canvas Business Model: Customer Relationships
You're managing a clinical-stage biotech, so your relationships aren't about selling widgets; they're about trust, data integrity, and keeping the lights on until the next milestone. For Marker Therapeutics, Inc. (MRKR), the customer relationships are intensely focused on the scientific and financial communities that fuel its development engine.
High-touch, collaborative relationships with clinical investigators and sites
The progression of MT-601 in the Phase 1 APOLLO study requires deep collaboration with the medical institutions running the trials. This isn't a transactional relationship; it's about ensuring every data point is accurate and every patient is cared for according to stringent protocols. You need to keep those sites engaged, especially as you move into new cohorts.
For instance, the Phase 1 APOLLO trial for MT-601 in lymphoma was previously reported to involve data from 5 clinical sites across the United States as of a December 2024 cutoff. Now, the focus is on enrolling the dose expansion cohort for Diffuse Large B Cell Lymphoma (DLBCL). Furthermore, the initiation of the Off-the-Shelf (OTS) program, the Phase 1 RAPID study, which treated its first patient in October 2025, also relies on establishing new, high-trust relationships with sites equipped for that novel approach.
Investor relations focused on communicating clinical milestones and cash runway
For a company like Marker Therapeutics, Inc. (MRKR), the investor base is a critical 'customer' whose confidence directly impacts operational flexibility. Communication must be precise regarding both scientific progress and financial sustainability. You need to clearly map out when the money runs out and what value you'll deliver before then.
The Q3 2025 financial update provided concrete figures to manage expectations. At September 30, 2025, the company held $17.6 million in cash and cash equivalents, plus $1.4 million in restricted cash. Crucially, after raising approximately $10 million via its ATM facility, the management communicated a clear cash runway extending well into 2026. This transparency helps investors contextualize the quarterly net loss, which was reported around $2.0 million for Q3 2025.
Here's a quick look at the financial context driving investor communications:
| Metric | Value as of Q3 2025 End Date (Sept 30, 2025) | Context/Event |
| Cash & Equivalents | $17.6 million | Balance sheet strength |
| Restricted Cash | $1.4 million | Total cash position |
| ATM Raise (Q3 2025) | Approx. $10 million | Extended runway into 2026 |
| Net Loss (Q3 2025) | $2.0 million | Compared to $2.3 million in Q3 2024 |
| R&D Expenses (Q3 2025) | $2.3 million | Primary driver of operating costs |
The focus isn't just on the balance sheet, though. Clinical achievements are the primary value drivers communicated to this group.
Direct engagement with regulatory bodies (e.g., FDA) for clinical trial progression
Direct, formal engagement with the U.S. Food and Drug Administration (FDA) is essential for clearing regulatory hurdles and advancing programs. Marker Therapeutics, Inc. (MRKR) has had specific interactions that define its near-term path.
- The FDA lifted a partial clinical hold on the Phase 2 trial for MT-401 in Acute Myeloid Leukemia (AML).
- The Investigational New Drug (IND) application for MT-601 in pancreatic cancer was cleared by the FDA in November 2022 to start the PANACEA study.
- As of late 2025, the company has not received any FDA approvals for its therapy in the last two years.
These interactions directly govern the timeline for moving from Phase 1 data to potential pivotal trials, which is what investors are watching.
Scientific communication via presentations at major oncology conferences
Presenting data at peer-reviewed scientific forums is how Marker Therapeutics, Inc. (MRKR) validates its science to the broader medical community, which in turn influences investigator recruitment and future prescribing patterns. The 67th American Society of Hematology (ASH) Annual Meeting in December 2025 was a key venue.
The company announced it would present data from the Phase 1 APOLLO study in two posters at ASH. The data shared highlighted significant efficacy in heavily pre-treated patients:
- For Non-Hodgkin lymphoma (NHL) patients: 66% Objective Response Rate (ORR), with 50% achieving Complete Response (CR).
- For Hodgkin lymphoma (HL) patients: 78% ORR.
Beyond ASH, management actively engages with the investment community at industry events to translate this science into investment rationale. For example, the CEO participated in a fireside chat at the H.C. Wainwright 27th Annual Global Investment Conference in September 2025.
Finance: draft 13-week cash view by Friday.
Marker Therapeutics, Inc. (MRKR) - Canvas Business Model: Channels
You're mapping out how Marker Therapeutics, Inc. (MRKR) gets its science and its stock in front of the right people. It's a mix of clinical execution, public market presence, and mandatory disclosure. Honestly, for a clinical-stage biotech, these channels are everything.
Academic Medical Centers and Specialized Cancer Treatment Centers for Trials
The core channel for validating the science is the clinical trial network. Marker Therapeutics, Inc. leverages established institutions to run its studies. For instance, the Phase 1 APOLLO study for MT-601 in relapsed/refractory B-cell lymphoma was being run across 5 clinical sites as of the data cutoff in late 2024. The company's foundational work originated at Baylor College of Medicine. Furthermore, the newer Off-the-Shelf (OTS) program, the RAPID study for Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS), treated its first patient in October 2025. To support specific indications, they've secured non-dilutive funding, like the $2.0 million from the NIH and $9.5 million from CPRIT for MT-601 development in pancreatic cancer.
Here's a look at the recent financial and operational support flowing through these clinical channels:
| Metric | Value/Count | Context/Date |
|---|---|---|
| Cash & Equivalents (Sep 30, 2025) | $17.6 million | Balance sheet position as of Q3 2025 |
| Restricted Cash (Sep 30, 2025) | $1.4 million | Balance sheet position as of Q3 2025 |
| ATM Funding Raised (2025) | Approx. $10 million | Extended runway well into 2026 |
| APOLLO Study Sites (as of Dec 2024) | 5 | Sites across the United States for MT-601 trial |
| NIH Grant Funding | $2.0 million | Awarded to support MT-601 in pancreatic cancer |
NASDAQ Stock Exchange for Raising Public Equity Capital
The NASDAQ is the primary public venue for capital formation. Marker Therapeutics, Inc. uses this listing to attract investment, which is critical for funding those expensive trials. You saw them raise approximately $10 million via their ATM Agreement in 2025, which helps keep the lights on until 2026. To gauge market sentiment, look at the trading data. For example, on November 28, 2025, the closing price was $1.24. The 52-week trading range shows the volatility you'd expect, with a low of $0.81 and a high of $5.95. Analysts are still projecting upside, with the average twelve-month price target set at $10.25 based on 5 Wall Street analysts.
Scientific Publications and Conference Presentations (e.g., ASH)
Validating the science publicly happens through peer-reviewed output and major medical meetings. This is where the data gets scrutinized by the scientific community. Marker Therapeutics, Inc. announced that data from the ongoing Phase 1 APOLLO study would be presented in two posters at the 67th ASH Annual Meeting and Exposition in Orlando, Florida, spanning December 6-9, 2025. The MT-601 program targets six tumor-specific antigens, including Survivin, PRAME, and NY-ESO-1. The Q3 2025 results showed a 66% objective response rate, including 50% complete responses, in relapsed Non-Hodgkin lymphoma (NHL) patients within that study.
Direct Communication via Press Releases and SEC Filings to Investors
This is the formal, required communication channel to keep the market informed. Marker Therapeutics, Inc. is diligent here. For instance, they issued a press release on November 14, 2025, detailing their Third Quarter 2025 Financial Results. This was followed closely by an 8-K filing on November 5, 2025, reporting an unscheduled material event, and a 10-Q on November 13, 2025. These filings provide the hard numbers you need to see. For Q3 ending September 30, 2025, total revenues were reported at $1.23 million, largely from grant income, against a net loss of $1.99 million. Also, large investors use filings to signal their position; a Schedule 13D/A from August 18, 2025, showed NEA reporting 1,625,678 shares, representing 12.6% ownership as of August 4, 2025.
You can track the short seller interest too; the short sale ratio as of December 2, 2025, stood at 38.16%.
Finance: draft 13-week cash view by Friday.
Marker Therapeutics, Inc. (MRKR) - Canvas Business Model: Customer Segments
You're hiring before product-market fit, so focusing on the specific patient populations that your clinical data directly address is key to defining your initial customer segments.
Marker Therapeutics, Inc. (MRKR) is targeting specific, high-need patient populations within hematological malignancies, with plans to expand into solid tumors based on secured non-dilutive funding.
The primary customer segments as of late 2025 are:
- Patients with relapsed/refractory B-cell lymphoma ineligible for or failed CAR-T.
- Patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS).
- Oncology key opinion leaders (KOLs) and clinical trial principal investigators.
- Future: Patients with solid tumors, such as pancreatic cancer.
The current focus on relapsed/refractory B-cell lymphoma is supported by strong efficacy data from the Phase 1 APOLLO study for MT-601. The dose expansion cohort is currently evaluating MT-601 at a dose of 400x106 cells in Diffuse Large B Cell Lymphoma (DLBCL) patients who have relapsed after or are ineligible for CAR-T cell therapy.
Here's a quick look at the performance metrics for the lead program targeting these initial segments:
| Indication/Program | Clinical Trial | Patient Group Size | Objective Response Rate (ORR) | Complete Response (CR) Rate |
| Relapsed NHL (Post-CAR-T) | Phase 1 APOLLO | 12 patients | 66% | 50% |
| Relapsed HL | Phase 1 APOLLO | 9 patients | 78% | 11% |
| AML/MDS (OTS) | Phase 1 RAPID | First patient treated on October 6, 2025 | Data pending | Data pending |
The patient population for the MT-401 Off-the-Shelf (OTS) program, which began treating its first patient in the Phase 1 RAPID study in October 2025, includes patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). This OTS approach is designed to potentially provide treatment in as little as 72 hours.
Engagement with KOLs and principal investigators is evidenced by the ongoing, multi-center nature of the APOLLO trial and the initiation of the RAPID study. The company reported a net loss from continuing operations of $2.0 million for the quarter ended September 30, 2025, with Research and Development Expenses at $2.3 million for that same quarter, reflecting the investment in these customer-facing clinical programs.
For the future solid tumor segment, Marker Therapeutics, Inc. has secured non-dilutive funding to support the development of MT-601 in metastatic pancreatic cancer. This funding includes $2 million from NIH SBIR and $9.5 million from CPRIT, with a clinical program launch anticipated in the second half of 2025.
The current financial health dictates the pace of segment expansion. As of September 30, 2025, Marker Therapeutics, Inc. held cash and cash equivalents of $17.6 million, which, along with approximately $10 million raised in Q3 2025 via an ATM facility, is projected to fund operations through the third quarter of 2026.
The durability of responses observed in the NHL segment further defines the potential customer base:
- Five NHL patients maintained response for $\ge$6 months.
- Three NHL patients maintained response for $\ge$12 months (range 3-24 months).
- No dose-limiting toxicities (DLTs) or immune effector cell-associated neurotoxicity (ICANS) were observed in the MT-601 dose escalation cohort.
Finance: draft 13-week cash view by Friday.
Marker Therapeutics, Inc. (MRKR) - Canvas Business Model: Cost Structure
You're looking at the core expenses that fuel Marker Therapeutics, Inc.'s pipeline development as of late 2025. For a clinical-stage biotech, the cost structure is heavily weighted toward science and trials, not sales. Honestly, these numbers show where the cash is going to get MT-601 and the Off-the-Shelf program to the next inflection point.
The third quarter of 2025 gives us a clear snapshot of the burn rate. Research and Development (R&D) expenses were reported at $2.3 million for the quarter ended September 30, 2025. General and Administrative (G&A) expenses came in at $1.0 million for the same period. These two categories form the bulk of the operating outlay. To be fair, the net loss from continuing operations for Q3 2025 was only $2.0 million, which is an improvement year-over-year, partly due to that controlled R&D spend.
Here's a quick breakdown of the operating expenses for the third quarter of 2025:
| Cost Category | Q3 2025 Amount | Context/Driver |
| Research and Development (R&D) Expenses | $2.3 million | Advancement of MT-601 (Lymphoma/Pancreatic Cancer) and OTS program. |
| General and Administrative (G&A) Expenses | $1.0 million | Corporate overhead, management salaries, and general operations. |
| Total Operating Expenses (Calculated from R&D + G&A) | $3.3 million | Total operating expenses reported were $3.37 million. |
Clinical trial execution, monitoring, and patient enrollment costs are embedded within that R&D figure. Marker Therapeutics, Inc. is actively advancing MT-601 in the Phase 1 APOLLO study for relapsed/refractory B-cell lymphoma. The company also treated the first patient in the RAPID study for its Off-the-Shelf program in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) during Q3 2025, which adds to these costs.
Manufacturing costs for clinical supply are a critical, variable expense. Marker Therapeutics, Inc. established a current good manufacturing practice (cGMP) manufacturing agreement with Cellipont Bioservices in June 2025 to scale up production of MT-601. The company believes its Multi-Antigen Recognizing T cell (MAR-T) platform can be manufactured at a fraction of the cost of gene-modified T cell products, aiming to reduce complexity and associated overhead over time. The prior year saw a significant increase in outsourced clinical manufacturing costs related to the Cell Ready transaction.
Intellectual property protection and related legal fees are structured around key agreements. The cost structure includes potential future obligations tied to the Baylor College of Medicine (BCM) License Agreement. These obligations are contingent, but they represent a significant potential future cost:
- Royalty payments upon commercial sales.
- Milestone payments up to an aggregate of $64.85 million.
- A one-time liquidity incentive payment of 0.5% of liquidity event proceeds to BCM.
The company is currently sustaining operations through its existing cash, which stood at $17.6 million in cash and cash equivalents as of September 30, 2025, bolstered by a recent $10 million raise via its ATM facility. This funding is projected to last through the third quarter of 2026, so managing these costs is defintely paramount.
Finance: draft 13-week cash view by Friday.
Marker Therapeutics, Inc. (MRKR) - Canvas Business Model: Revenue Streams
You're looking at the current financial reality for Marker Therapeutics, Inc. (MRKR) as of late 2025, and the revenue streams tell a very clear story for a company deep in clinical development. Honestly, the current revenue profile is entirely non-commercial, which is the expected trade-off for advancing novel cell therapies like MT-601.
The primary, and currently sole, source of recognized revenue is non-dilutive funding. For the third quarter of 2025, Marker Therapeutics, Inc. (MRKR) reported $1.23 million in grant income from non-dilutive sources, which you know helps offset the significant research and development costs. This grant income is typically sourced from entities like the Cancer Prevention and Research Institute of Texas (CPRIT) and the National Institutes of Health (NIH), supporting specific programs like the MT-601 development for pancreatic cancer.
To manage the operational burn rate, Marker Therapeutics also relies on capital raises. In Q3 2025, the company executed an equity financing event, securing proceeds of $10 million via an At-The-Market (ATM) facility. While this is a crucial cash infusion, extending the cash runway through the third quarter of 2026, it does come with the dilution cost that you're tracking.
Here's a quick look at the key financial figures defining the current revenue picture:
| Revenue Component | Amount/Detail | Period/Context |
| Grant Income (Non-Dilutive) | $1.23 million | Q3 2025 |
| Equity Financing Proceeds | $10 million | Q3 2025 (ATM Raise) |
| Estimated Annual Revenue (FY 2025) | Approximately $2.71 million | Entirely from grants |
| Cash Runway Extension | Through Q3 2026 | Post-ATM Raise |
The estimated annual revenue for the full fiscal year 2025 is approximately $2.71 million, and it's important to note that this entire amount is derived from grants, underscoring the pre-commercial status of Marker Therapeutics, Inc. (MRKR).
Looking ahead, the entire financial model pivots on transitioning these non-revenue streams into true commercial income. This future revenue is entirely dependent on the clinical success of their pipeline assets:
- Product sales of MT-601 for relapsed/refractory B-cell lymphoma, which showed a 66% objective response rate in the Phase 1 APOLLO study.
- Product sales of MT-601 for the pancreatic cancer indication, with a clinical program launch anticipated in the first half of 2026.
- Potential revenue from the Off-the-Shelf Program targeting Acute Myeloid Leukemia or Myelodysplastic Syndrome.
Also critical to the future revenue structure are potential non-product-sale milestones. Marker Therapeutics, Inc. (MRKR) will look to secure value through:
- Potential licensing agreements for its MAR-T platform technology.
- Collaboration milestone payments tied to the progression of its pipeline candidates through later-stage trials.
The current structure is a classic R&D investment phase, where non-dilutive grants cover some costs, and dilutive equity covers the rest until a major partnership or regulatory approval unlocks product sales.
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