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What changed in Marker Therapeutics, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Marker Therapeutics, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+304 added−403 removedSource: 10-K (2026-03-18) vs 10-K (2025-03-31)

Top changes in Marker Therapeutics, Inc.'s 2025 10-K

304 paragraphs added · 403 removed · 260 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

90 edited+16 added−40 removed214 unchanged
Biggest changeWe have agreed to indemnify BCM and certain persons affiliated with BCM against claims and liabilities directly or indirectly related to or arising out of the design, process, manufacture or use by any third party of the licensed products, even though such claims and liabilities result in whole or in part from the negligence of the BCM indemnified parties or are based upon doctrines of strict liability or product liability, but not claims or liabilities arising from the gross negligence or intentional misconduct of any such BCM indemnified parties. 15 Table of Contents Unless terminated sooner, the license will expire on a licensed product-by-product basis and country-by-country basis, on the later of (1) the date of expiration of the last valid claim of patent rights to expire that covers the sale of such licensed product in such country, or (2) the first date following the tenth anniversary of the first commercial sale of first licensed product by us in such country.
Biggest changeWe have agreed to indemnify BCM and certain persons affiliated with BCM against claims and liabilities directly or indirectly related to or arising out of the design, process, manufacture or use by any third party of the licensed products, even though such claims and liabilities result in whole or in part from the negligence of the BCM indemnified parties or are based upon doctrines of strict liability or product liability, but not claims or liabilities arising from the gross negligence or intentional misconduct of any such BCM indemnified parties.
Such laws include, without limitation: the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying remuneration, to induce, or in return for, either the referral of an individual, or the purchase or recommendation of an item or service for which payment may be made under any federal healthcare program; 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 24 Table of Contents requirements on HIPAA covered entities and their business associates and covered subcontractors relating to the privacy, security and transmission of individually identifiable health information; the U.S. 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; and U.S. state and foreign law equivalents of each of the above federal laws, which, in some cases, differ from each other in significant ways, and may not have the same effect, thus complicating compliance efforts.
Such laws include, without limitation: the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying remuneration, to induce, or in return for, either the referral of an individual, or the purchase or recommendation of an item or service for which payment may be made under any federal healthcare program; 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 22 Table of Contents requirements on HIPAA covered entities and their business associates and covered subcontractors relating to the privacy, security and transmission of individually identifiable health information; the U.S. 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; and U.S. state and foreign law equivalents of each of the above federal laws, which, in some cases, differ from each other in significant ways, and may not have the same effect, thus complicating compliance efforts.
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 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).
We are evaluating the safety and efficacy of MT-601 in a Phase 1, multicenter, open-label study (APOLLO) in participants with relapsed lymphoma who either failed or are ineligible for anti-CD19 CAR-T cell therapy. 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).
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. The Phase 1 APOLLO trial was initiated in January 2023. In June 2023, we reported first enrollment in the dose escalation stage of the Phase 1 study.
In August 2022, the FDA cleared our IND application for MT-601 for the treatment of patients with relapsed non-Hodgkin lymphoma who have failed or are ineligible to receive anti-CD19 CAR-T cell treatment. The Phase 1 APOLLO trial was initiated in January 2023. In June 2023, we reported first enrollment in the dose escalation stage of the Phase 1 study.
Fast track designation, breakthrough therapy designation, priority review, accelerated approval, and RMAT designation do not change the standards for approval but may expedite the development or approval process. 22 Table of Contents Orphan Drug Designation Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, which is a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States for which there is no reasonable expectation that the cost of developing and making available in the United States a drug or biologic for this type of disease or condition will be recovered from sales in the United States for that drug or biologic.
Fast track designation, breakthrough therapy designation, priority review, accelerated approval, and RMAT designation do not change the standards for approval but may expedite the development or approval process. 20 Table of Contents Orphan Drug Designation Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, which is a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States for which there is no reasonable expectation that the cost of developing and making available in the United States a drug or biologic for this type of disease or condition will be recovered from sales in the United States for that drug or biologic.
Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life. 20 Table of Contents BLA Submission and Review Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development, nonclinical studies and clinical trials are submitted to the FDA as part of a BLA requesting approval to market the product for one or more indications.
Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life. 18 Table of Contents BLA Submission and Review Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development, nonclinical studies and clinical trials are submitted to the FDA as part of a BLA requesting approval to market the product for one or more indications.
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.
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 hematologic malignancies or solid tumors.
TCRs recognize peptide fragments from proteins expressed either inside the cell or on the cell surface, which are presented to T cells via major histocompatibility complex molecules. CARs are programmed to recognize a specific cell surface protein.
TCRs recognize peptide fragments from proteins expressed either inside the cell or on the cell surface, which are presented to T cells via major histocompatibility complex (“MHC”) molecules. CARs are programmed to recognize a specific cell surface protein.
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).
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 healthy donors/commercially available leukapheresis material (in the case of the OTS program).
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.
For example, in BCM’s Phase 1 clinical trial in lymphoma (TACTAL), there were complete responses, or CRs, in six of the fifteen evaluable patients with both Hodgkin lymphoma and non-Hodgkin lymphoma with active disease.
Other potential consequences include, among other things: ● restrictions on the marketing or manufacturing of a product, complete withdrawal of the product from the market or product recalls; ● fines, warning letters or holds on post-approval clinical studies; ● refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of existing product approvals; ● product seizure or detention, or refusal of the FDA to permit the import or export of products; or 23 Table of Contents ● injunctions or the imposition of civil or criminal penalties.
Other potential consequences include, among other things: ● restrictions on the marketing or manufacturing of a product, complete withdrawal of the product from the market or product recalls; ● fines, warning letters or holds on post-approval clinical studies; ● refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of existing product approvals; ● product seizure or detention, or refusal of the FDA to permit the import or export of products; or 21 Table of Contents ● injunctions or the imposition of civil or criminal penalties.
As illustrated below, in the adjuvant lymphoma group, all 17 patients had entered CR, with 14 patients in continued complete remission, or CCR, without relapsing. The duration of response ranged from approximately nine months to over five years. ​ ​ In both treatment groups, the MAR-T cells were well tolerated, with no drug-related serious adverse events.
As illustrated below, in the adjuvant lymphoma group, all 17 patients had entered CR, with 14 patients in continued complete remission, or CCR, without relapsing. The duration of responses ranged from approximately nine months to over five years. In both treatment groups, the MAR-T cells were well tolerated, with no drug-related serious adverse events.
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. ​ ​ 11 Table of Contents BCM also treated 17 patients, including one patient who was treated a second time after a relapse, in remission (adjuvant lymphoma group).
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. ​ 8 Table of Contents BCM also treated 17 patients, including one patient who was treated a second time after a relapse, in remission (adjuvant lymphoma group).
Human Resources Employees As of December 31, 2024, we had 5 full-time employees: 1 clinical and 4 in administrative support. None of our employees is subject to a collective bargaining agreement. We consider our relationship with our employees to be good. Consultants We have consulting agreements with a number of leading academic scientists, clinicians and regulatory experts.
Human Resources Employees As of December 31, 2025, we had 5 full-time employees: 1 clinical and 4 in administrative support. None of our employees is subject to a collective bargaining agreement. We consider our relationship with our employees to be good. Consultants We have consulting agreements with a number of leading academic scientists, clinicians and regulatory experts.
The FDA may require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization and may limit further marketing of the product based on the results of these post-marketing studies. 21 Table of Contents Expedited Development and Review Programs The FDA offers a number of expedited development and review programs for qualifying product candidates.
The FDA may require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization and may limit further marketing of the product based on the results of these post-marketing studies. 19 Table of Contents Expedited Development and Review Programs The FDA offers a number of expedited development and review programs for qualifying product candidates.
These patients were heavily pre-treated and had failed a median of five prior lines of therapy (range four to eight) for the HL patients and a median of three prior lines of therapy (range three to four) for the NHL patients. As illustrated below, in the active lymphoma group, six patients entered CR and nine patients had experienced stable disease.
These patients were heavily pre-treated and had failed a median of five prior lines of therapy (range four to eight) for the HL patients and a median of three prior lines of therapy (range three to four) for the NHL patients. As illustrated below, in the active lymphoma group, six patients achieved CR and nine patients had experienced stable disease.
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.
We believe our MAR-T cell therapy represents 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.
We also plan to rely on regulatory protection afforded through orphan drug designations, data exclusivity, market exclusivity and patent term extensions when available, as well as contractual agreements with our academic and commercial partners. We require each of our employees, consultants and advisors to execute a confidentiality agreement upon the commencement of any employment, consulting or advisory relationship with us.
We also plan to rely on regulatory protection afforded through orphan drug designations, data exclusivity, market exclusivity and patent term extensions when available, as well as contractual agreements with our academic and commercial partners. 16 Table of Contents We require each of our employees, consultants and advisors to execute a confidentiality agreement upon the commencement of any employment, consulting or advisory relationship with us.
Our ability to compete successfully will depend, in part, on our ability to: ● develop proprietary products; ● develop and maintain products that reach the market first, are technologically superior to and/or are of lower cost than other products in the market; ● attract and retain scientific, product development and sales and marketing personnel; ● obtain patent or other proprietary protection for our products and technologies; ● obtain required regulatory approvals; and 14 Table of Contents ● manufacture, market, distribute and sell any products that we develop.
Our ability to compete successfully will depend, in part, on our ability to: ● develop proprietary products; ● develop and maintain products that reach the market first, are technologically superior to and/or are of lower cost than other products in the market; ● attract and retain scientific, product development and sales and marketing personnel; ● obtain patent or other proprietary protection for our products and technologies; ● obtain required regulatory approvals; and ● manufacture, market, distribute and sell any products that we develop.
The corresponding royalty percentages range from 0.65% to 5.0% - increasing in proportion to the aggregate net sales. The royalty fee may be reduced in the event that we must pay additional royalties with respect to third-party owned patent rights or technology necessary for the use, manufacture or sale of a licensed product.
The 13 Table of Contents corresponding royalty percentages range from 0.65% to 5.0% - increasing in proportion to the aggregate net sales. The royalty fee may be reduced in the event that we must pay additional royalties with respect to third-party owned patent rights or technology necessary for the use, manufacture or sale of a licensed product.
James Allison reported that monoclonal antibodies, or mAbs, blocking CTLA-4 could treat tumors in animal models. Subsequently, mAbs that targeted CTLA-4 and PD-1 became known as immune checkpoint inhibitors, or ICIs. Immune checkpoints are a means by which cancer cells inhibit or turn down the body’s immune response to cancer.
Matthew Krummel and Dr. James Allison reported that monoclonal antibodies, or mAbs, blocking CTLA-4 could treat tumors in animal models. Subsequently, mAbs that targeted CTLA-4 and PD-1 became known as immune checkpoint inhibitors, or ICIs. Immune checkpoints are a means by which cancer cells inhibit or turn down the body’s immune response to cancer.
No legislation or administrative actions have been finalized to implement these principles. However, it is 26 Table of Contents unclear whether these or similar policy initiatives will be implemented in the future.
No legislation or administrative actions have been finalized to implement these principles. However, it is 24 Table of Contents unclear whether these or similar policy initiatives will be implemented in the future.
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. 5 Table of Contents ● Invest in our platform to maximize the beneficial outcomes for cancer patients.
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.
Our website and the information contained therein or connected thereto are not intended to be incorporated into this Annual Report on Form 10-K. 27 Table of Contents
Our website and the information contained therein or connected thereto are not intended to be incorporated into this Annual Report on Form 10-K. 25 Table of Contents
The process required by the FDA before biologic product candidates may be marketed in the United States generally involves the following: ● completion of preclinical laboratory tests and animal studies performed in accordance with the FDA’s current Good Laboratory Practices, or GLP, regulation; ● submission to the FDA of an IND, which must become effective before clinical trials may begin and must be updated annually or when significant changes are made; ● approval by an independent Institutional Review Board, or IRB, or ethics committee at each clinical site before the trial is commenced; ● performance of adequate and well-controlled human clinical trials to establish the safety, purity and potency of the proposed biologic product candidate for its intended purpose; ● preparation of and submission to the FDA of a biologics license application, or BLA, after completion of all pivotal clinical trials; ● a determination by the FDA within 60 days of its receipt of a BLA to file the application for review; ● satisfactory completion of an FDA Advisory Committee review, if applicable; ● satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced to assess compliance with cGMP and to assure that the facilities, methods and controls are adequate to preserve the biological product’s continued safety, purity and potency, and of selected clinical investigation sites to assess compliance with Good Clinical Practices, or GCP; and ● FDA review and approval of the BLA to permit commercial marketing of the product for particular indications for use in the United States. 19 Table of Contents Preclinical and Clinical Development Prior to beginning the first clinical trial with a product candidate, we must submit an IND to the FDA.
The process required by the FDA before biologic product candidates may be marketed in the United States generally involves the following: ● completion of preclinical laboratory tests and animal studies performed in accordance with the FDA’s current Good Laboratory Practices, or GLP, regulation; ● submission to the FDA of an IND, which must become effective before clinical trials may begin and must be updated annually or when significant changes are made; ● approval by an independent Institutional Review Board, or IRB, or ethics committee at each clinical site before the trial may commence; ● performance of adequate and well-controlled human clinical trials to establish the safety, purity and potency of the proposed biologic product candidate for its intended purpose; ● preparation of and submission to the FDA of a biologics license application, or BLA, after completion of all pivotal clinical trials; ● a determination by the FDA within 60 days of its receipt of a BLA to file the application for review; ● satisfactory completion of an FDA Advisory Committee review, if applicable; ● satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced to assess compliance with cGMP and to assure that the facilities, methods and controls are adequate to preserve the biological product’s continued safety, purity and potency, and of selected clinical investigation sites to assess compliance with Good Clinical Practices, or GCP; and 17 Table of Contents ● FDA review and approval of the BLA to permit commercial marketing of the product for particular indications for use in the United States.
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.
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 MAR-T cells with the exception of one patient who died of an unrelated pneumonia while in a CR.
If existing or future patents held by third parties and containing broad claims over technology used by us were upheld 17 Table of Contents 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.
There is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, 25 Table of Contents improving quality or expanding access.
There is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, 23 Table of Contents improving quality or expanding access.
When a CAR-T cell product is applied to a 6 Table of Contents 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.
We also agreed to pay BCM up to an aggregate of $64.85 million in milestone payments upon the occurrence of nine particular milestones relating to completion of the first dosing in clinical trials for a first and second distinct product, receipt of approval from the FDA and the achievement of certain net sales goals.
We also agreed to pay BCM up to an aggregate of $64.85 million in milestone payments upon the occurrence of nine particular milestones relating to completion of the first dosing in the first Phase 3 clinical trial for a first and second distinct product, receipt of approval from the FDA and the achievement of certain net sales goals.
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.
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 10 Table of Contents with prednisone with complete resolution.
In addition, 16 Table of Contents 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.
In addition, 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.
We reassess the value of each patent at the time maintenance fees are due, and in cases where maintaining the patent is judged to be of no significant strategic value, we decline to pay the maintenance fee.
We reassess the 15 Table of Contents value of each patent at the time maintenance fees are due, and in cases where maintaining the patent is judged to be of no significant strategic value, we decline to pay the maintenance fee.
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.
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 11 Table of Contents demands, if at all.
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 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 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 ​ ​ 1 Table of Contents 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 anticipate to continue to advance 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 in AML or MDS) 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 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. 1 Table of Contents We believe that the simplicity of our manufacturing process allows additional modifications to expand MAR-T cell recognition of cancer targets.
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%].
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, 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.
Cancer immunotherapy began with treatments that nonspecifically activated the immune system and had limited efficacy and/or significant toxicity. In contrast, newer immunotherapy treatments activate specific, potent immune cells, leading to improved safety and efficacy. Within the immunotherapy category, treatments have included vaccines, cytokine therapies, antibody therapies, and adoptive cell therapies. In 1996, Dr. Dana Leach, Dr. Matthew Krummel and Dr.
Cancer immunotherapy began with treatments that nonspecifically activated the immune system and had limited efficacy and/or significant toxicity. In contrast, newer immunotherapy treatments activate specific, potent immune cells, leading to improved safety and efficacy. Within the immunotherapy category, treatments have included vaccines, cytokine therapies, antibody therapies, and adoptive cell therapies. 4 Table of Contents In 1996, Dr. Dana Leach, Dr.
Pancreatic Cancer 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.
Pancreatic Cancer In May 2020, we reported interim data from an ongoing Phase 1/2 clinical trial investigating MAR-T cells for the treatment of pancreatic adenocarcinoma being conducted by BCM.
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.
Compared to current gene-modified T cell therapies, the MAR-T cell product candidates are characterized by the following: 6 Table of Contents ● Clinical benefits observed in early-stage clinical trials in multiple cancer indications.
Our goal is to be the leader in the development and commercialization of transformative immunotherapies for the treatment of hematological malignancies and solid tumors.
Our goal is to become a leader in the development and commercialization of transformative immunotherapies for the treatment of hematological malignancies and solid tumors.
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 MAR-T cell therapy for the treatment of patients with post-transplant AML.
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 conducted a Phase 1 AML/MDS clinical trial investigating MAR-T cells for the treatment of patients with post-transplant AML.
T Cell Therapy Overview The field of adoptive cell transfer is currently comprised primarily of CAR and TCR engineered T cells and has emerged from principles of basic immunology to become a paradigm-shifting clinical immunotherapy. T cell therapy, we believe has evolved as one of the most promising branches of immunotherapy.
T Cell Therapy Overview The field of adoptive cell transfer is currently comprised primarily of chimeric antigen receptor (“CAR”) and T cell receptor (“TCR”) engineered T cells and has emerged from principles of basic immunology to become a paradigm-shifting clinical immunotherapy. T cell therapy, which we believe has evolved as one of the most promising branches of immunotherapy.
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 8 Table of Contents 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 (Vasileiou et al., J Clin Oncol, 2021). 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.
Company-Sponsored Clinical Development of MAR-T Cell Therapies MT-601 for the Treatment of Lymphoma 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.
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 MAR-T cell product capable of recognizing multiple target antigens expressed by the tumor, thereby limiting tumor adaptation by negative antigen selection or downregulation.
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 2450 Holcombe Blvd, Suite BCM-A, MS: BCM251, Houston, Texas, and our telephone number is (713) 400-6400.
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 2450 Holcombe Blvd, TMC Partners Office 1.311, Houston, Texas, and our telephone number is (713) 400-6400.
Tumors generally consist of individual cancer cells expressing different antigens, and each of those antigens can be present at a different level that can change over time.
Cancers are heterogeneous in their expression of antigens. Tumors generally consist of individual cancer cells expressing different antigens, and each of those antigens can be present at a different level that can change over time.
This highlights a significant unmet medical need for alternative and more effective treatments. 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.
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.
To date, there are four CD19-directed CAR-T cell therapies (Yescarta, Kymriah, Tecartus, and Bryanzi) 13 Table of Contents 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).
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.
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.
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 MAR-T cells are designed to kill cancer cells expressing the TAA.
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 MAR-T cell infusion.
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 MAR-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.
Upon release of the final patient product, the cells are frozen and transported to the site where the cells will be administered. The standard dose for patients with lymphoma ranges from 100 to 400 million cells per adult patient. Manufacturing Our manufacturing process was originally developed at Baylor College of Medicine, where we initially conducted our clinical trials.
Upon release of the final patient product, the cells are frozen and transported to the site where the cells will be administered. Manufacturing Our manufacturing process was originally developed at Baylor College of Medicine, where we initially conducted our clinical trials.
Overall, we have observed a clinical benefit correlated with the detection of tumor-reactive T cells in patient peripheral blood (Arms A, B and C) and within tumor biopsy samples (Arm C) post-infusion. No cytokine release syndrome or neurotoxicity has been observed in any arm of the trial to date.
Overall, we have observed a clinical benefit correlated with the detection of tumor-reactive T cells in patient peripheral blood (Arms A, B and C) and within tumor biopsy samples (Arm C) post-infusion.
Each agreement provides that all confidential information developed or made known to the individual during the course of the relationship will be kept confidential and not be disclosed to third parties except in specified circumstances.
Each agreement provides that all confidential information developed or made known to the individual during the course of the relationship will be kept confidential and not be disclosed to third parties except in specified circumstances. In the case of employees, the agreements provide that all inventions conceived by an employee shall be our exclusive property.
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.
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 (the “CPRIT AML Grant”).
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.
During the years ended December 31, 2025 and 2024, we paid approximately $3.0 million and $0.1 million related to BCM invoices received, respectively. During the years ended December 31, 2025 and 2024, we incurred $0.7 million and nil, respectively, in expenses related to Cellipont services and manufacturing costs.
This results in the selective expansion of T cells that specifically recognize the target antigens. At the end of the manufacturing process, the resulting product is a mix of helper (CD4+) and cytotoxic (CD8+) T cells that recognize the targeted antigens.
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. At the end of the manufacturing process, the resulting product is a mix of helper (CD4+) and cytotoxic (CD8+) T cells that recognize the targeted antigens.
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. ● Capable of addressing a broad repertoire of cancer cells.
This appears to compare favorably with published CD19 CAR-T studies that have been associated with substantial tolerability and safety concerns, and investigations by the FDA regarding the risk of CAR-T cell therapies to potentially induce secondary cancers. ● Capable of addressing a broad repertoire of cancer cells.
Lymphoma BCM evaluated the MAR-T cell therapy (5 TAA product) in a Phase 1 clinical trial for the treatment of patients with lymphoma.
In each trial, correlative studies showed significant expansion of MAR-T cells in vivo. Lymphoma BCM evaluated MAR-T cells (5 TAA product) in a Phase 1 clinical trial for the treatment of patients with lymphoma.
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”).
Per the CPRIT grant agreements, we will retain ownership over any intellectual property developed under the contracts (the “Project Results”).
Our intellectual property portfolio currently includes patent applications having: (1) claims directed to methods of generating multi-antigen specific T cell products; and (2) claims directed to therapeutic uses of such multi-antigen specific T cell products.
Our intellectual property portfolio currently includes patent applications having: (1) claims directed to methods of generating multi-antigen specific T cell products; and (2) claims directed to therapeutic uses of such multi-antigen specific T cell products. We believe our patent portfolio, together with our efforts to develop and patent next-generation technologies, provides us with a substantial intellectual property position.
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.
In 2024, the Company was awarded a $9.5 million grant from the Cancer Prevention & Research Institute of Texas (“CPRIT”) and a $2 million grant from the National Institutes of Health (“NIH”) Small Business Innovation Research (“SBIR”) program to support the clinical investigation of MT-601 in patients with metastatic pancreatic cancer.
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.
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.
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.
No cytokine release syndrome or neurotoxicity has been observed in any arm of the trial to date. 9 Table of Contents 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.
Competition 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.
During the years ended December 31, 2025 and 2024, we paid $0.6 million and nil related to Cellipont invoices received, respectively. Competition 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.
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.
In furtherance of the BCM License Agreement and as contemplated by the terms thereof, we entered into a Sponsored Research Agreement, or the SRA, with BCM, which provides for the conduct of research for us by credentialed personnel at BCM’s Center for Cell and Gene Therapy. 14 Table of Contents 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.
We protect our technology through various United States and foreign patent filings and maintain trade secrets that we own. Our policy is to seek appropriate patent protection both in the United States and abroad for our proprietary technologies and product candidates.
Our policy is to seek appropriate patent protection both in the United States and abroad for our proprietary technologies and product candidates.
Two of the eight patients achieved objective responses with one complete response and one partial response, with six patients continuing with stable disease. 9 Table of Contents 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.
In this trial, the infusion of MAR-T cells 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.
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.
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. Cell Ready, which is owned by one of our former directors, Mr. John Wilson, is a contract development and manufacturing organization (CDMO).
An IND is a request for authorization from the FDA to administer an investigational new drug product to humans. The central focus of an IND submission is on the general investigational plan and the protocol(s) for clinical studies.
The central focus of an IND submission is on the general investigational plan and the protocol(s) for clinical studies.
To date, we have not observed any cytokine release syndrome or neurotoxicity in this trial. In January 2022, the FDA granted orphan drug designation to MT-601 for the treatment of patients with pancreatic cancer.
To date, no cytokine release syndrome or neurotoxicity have been observed in this trial (Musher BL, Vasileiou S, Smaglo BG et al, Nat Med, 2026). 2 Table of Contents In January 2022, the FDA granted orphan drug designation to MT-601 for the treatment of patients with pancreatic cancer.
BCM had utilized the therapy in seven exploratory clinical trials. In these studies, BCM treated over 150 patients suffering from a variety of cancers including lymphoma, multiple myeloma, acute myeloid leukemia, or AML, acute lymphoblastic leukemia, or ALL, pancreatic cancer, breast cancer and various sarcomas.
In these studies, BCM treated over 150 patients suffering from a variety of cancers including lymphoma, multiple myeloma, acute myeloid leukemia, or AML, acute lymphoblastic leukemia, or ALL, pancreatic cancer, breast cancer and various sarcomas. In those studies, BCM saw evidence of clinical benefit, expansion of infused cells, and decreased toxicity compared to other cellular therapies.
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.
As of February 2026, the infusion of MAR-T cells was generally well tolerated by the patients across clinical trials in hematological and solid tumor indications, and no dose limiting toxicities or neurotoxicity were attributed to the use of MAR-T cells to date.
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.
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-OTS Program Since January 2024, Marker has been advancing MT-401 in an OTS program in patients with AML or MDS in the Phase 1 RAPID study.
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) MAR-T cell therapies – The MT-401-OTS product targets WT1, NY-ESO-1, PRAME, and Survivin antigens (MT-401-OTS).
FDA to investigate MT-601 in a Phase 1 trial in patients with pancreatic cancer in combination with frontline chemotherapy. 5 Table of Contents · Off-the-Shelf (“OTS”) MAR-T cell therapies – The OTS product targets WT1, NY-ESO-1, PRAME, and Surviving antigens (MT-401-OTS). Enrolled patients are matched to the pre-manufactured inventory of MT-401-OTS products based on their human leukocyte antigen (“HLA”).
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.
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. 7 Table of Contents As reported in a 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.
ITEM 1. BUSINESS Overview 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.
ITEM 1. BUSINESS Overview We are a clinical-stage immuno-oncology company specializing in the development of novel T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Harnessing millions of years of immunologic evolution, Marker’s Multi Antigen Recognizing (“MAR”)-T cell technology is designed to recognize and kill highly heterogeneous tumors without the need for genetic modifications.
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.
Based on the encouraging clinical data from the Phase 1 APOLLO study, we are prioritizing the advancement of MT-601 in patients with relapsed lymphoma and plan to advance the OTS program initially in patients with AML or MDS, with the potential to be expanded to other indications.
Further, it is possible that additional governmental action is taken in response to the COVID-19 pandemic. Product Liability and Insurance We face an inherent risk of product liability as a result of the clinical testing of our product candidates and will face an even greater risk if we commercialize any products.
Product Liability and Insurance We face an inherent risk of product liability as a result of the clinical testing of our product candidates and will face an even greater risk if we commercialize any products. We have not experienced any product liability claims to date. We currently carry products and clinical trial liability insurance policies.
We believe our patent portfolio, together with our efforts to develop and patent next-generation technologies, provides us with a substantial intellectual property position. However, the area of patent and other intellectual property rights in biotechnology is an evolving one with many risks and uncertainties. Patents Patents and other proprietary rights are vital to our business operations.
However, the area of patent and other intellectual property rights in biotechnology is an evolving one with many risks and uncertainties. Patents Patents and other proprietary rights are vital to our business operations. We protect our technology through various United States and foreign patent filings and maintain trade secrets that we own.
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. 12 Table of Contents Inside the cell culture device, PBMCs, including T cells and antigen-presenting cells, are exposed to the stimulating peptide pools.
Each library represents the entire protein sequence of a target antigen, with each peptide overlapping significantly with the peptides adjacent to it within the antigen’s protein sequence. 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.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIn 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.
Biggest changeWhile BCM continues to supply us with products, as we continue our clinical trials, in anticipation of the commencement of our larger pivotal trial for lymphoma in 2026, as well as the eventual need for commercial scale production, on June 16, 2025, the Company entered into a Statement of Work (the “SOW”) with Cellipont Bioservices (“Cellipont”), a leading cell therapy Contract Development and Manufacturing Organization (“CDMO”), for the manufacturing of MT-601, the Company’s lead MAR-T cell product. 33 Table of Contents Furthermore, we intend to evaluate additional potential third-party manufacturing capabilities to provide potential multiple sources of clinical and commercial supply.
Any such delay may lower our revenues and potential profitability. If any third-party breaches or terminates its agreement with us or fails to conduct its activities in a timely manner, the commercialization of our product candidates could be slowed down or blocked completely.
Any such delay may lower our revenues and potential profitability. If any third-party breaches or terminates its agreement with us or fails to conduct its activities in a timely manner, the commercialization of our product candidates could be slowed down or blocked completely.
Such laws include: ● the federal Anti-Kickback Statute which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid; ● the federal civil and criminal false claims laws, including the federal civil False Claims Act, and civil monetary penalties laws, which impose criminal and civil penalties against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; 56 Table of Contents ● the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, which also imposes obligations, including mandatory contractual terms, on covered entities, including certain healthcare providers, health plans, and healthcare clearinghouses, and their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity as well as their covered subcontractors, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; ● the 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 report annually to CMS, information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other health care professionals)(such as physician assistants and nurse practitioners) and teaching hospitals, as well as information regarding ownership and investment interests held by physicians and their immediate family members; and ● analogous state, local, and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third - party payors, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures or drug pricing; state and local laws that require the registration of pharmaceutical sales representatives; state and local “drug takeback” laws and regulations; and state and foreign laws governing the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
Such laws include: ● the federal Anti-Kickback Statute which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid; ● the federal civil and criminal false claims laws, including the federal civil False Claims Act, and civil monetary penalties laws, which impose criminal and civil penalties against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; ● the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, which also imposes obligations, including mandatory contractual terms, on covered entities, including certain healthcare providers, health plans, and healthcare clearinghouses, and their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity as well as their covered subcontractors, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; ● the 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 report annually to CMS, information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other health care professionals)(such as physician assistants and nurse practitioners) and teaching hospitals, as well as information regarding ownership and investment interests held by physicians and their immediate family members; and ● analogous state, local, and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third - party payors, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; state 53 Table of Contents laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures or drug pricing; state and local laws that require the registration of pharmaceutical sales representatives; state and local “drug takeback” laws and regulations; and state and foreign laws governing the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
The success of our MAR-T cell product candidates or any other product candidates that we develop or otherwise may acquire will depend on several factors, including: ● timely and successful completion of preclinical studies, including toxicology studies, biodistribution studies and minimally efficacious dose studies in animals, where applicable, and clinical trials; ● effective investigational new drug applications, or INDs, from the FDA or comparable foreign applications that allow commencement of our planned clinical trials or future clinical trials for our product candidates; ● sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials; ● successful enrollment and completion of clinical trials, including under the FDA’s current Good Clinical Practices, or GCPs, and current Good Laboratory Practices; ● successful development of, or making arrangements with third-party manufacturers for, our commercial manufacturing processes for any of our product candidates that receive regulatory approval; 30 Table of Contents ● receipt of timely marketing approvals from applicable regulatory authorities; ● launching commercial sales of products, if approved, whether alone or in collaboration with others; ● acceptance of the benefits and use of our products, including method of administration, if approved, by patients, the medical community and third-party payors, for their approved indications; ● the prevalence and severity of adverse events experienced by our product candidates; ● the availability, perceived advantages, cost, safety and efficacy of alternative therapies for any product candidate, and any indications for such product candidate, that we develop; ● our ability to produce and manufacture our product candidates, which is dependent on third-party vendors and their willingness to support our manufacturing and cell processing; ● obtaining and maintaining patent, trademark and trade secret protection and regulatory exclusivity for our product candidates and otherwise protecting our rights in our intellectual property portfolio; ● maintaining compliance with regulatory requirements, including the FDA’s current Good Manufacturing Practices, or cGMPs, and complying effectively with other procedures; ● obtaining and maintaining third-party coverage and adequate reimbursement and patients’ willingness to pay out-of-pocket in the absence of such coverage and adequate reimbursement; and ● maintaining a continued acceptable safety, tolerability and efficacy profile of the products following approval.
The success of our MAR-T cell product candidates or any other product candidates that we develop or otherwise may acquire will depend on several factors, including: ● timely and successful completion of preclinical studies, including toxicology studies, biodistribution studies and minimally efficacious dose studies in animals, where applicable, and clinical trials; ● effective investigational new drug applications, or INDs, from the FDA or comparable foreign applications that allow commencement of our planned clinical trials or future clinical trials for our product candidates; ● sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials; ● successful enrollment and completion of clinical trials, including under the FDA’s current Good Clinical Practices, or GCPs, and current Good Laboratory Practices; ● successful development of, or making arrangements with third-party manufacturers for, our commercial manufacturing processes for any of our product candidates that receive regulatory approval; ● receipt of timely marketing approvals from applicable regulatory authorities; ● launching commercial sales of products, if approved, whether alone or in collaboration with others; ● acceptance of the benefits and use of our products, including method of administration, if approved, by patients, the medical community and third-party payors, for their approved indications; ● the prevalence and severity of adverse events experienced by our product candidates; ● the availability, perceived advantages, cost, safety and efficacy of alternative therapies for any product candidate, and any indications for such product candidate, that we develop; ● our ability to produce and manufacture our product candidates, which is dependent on third-party vendors and their willingness to support our manufacturing and cell processing; ● obtaining and maintaining patent, trademark and trade secret protection and regulatory exclusivity for our product candidates and otherwise protecting our rights in our intellectual property portfolio; ● maintaining compliance with regulatory requirements, including the FDA’s current Good Manufacturing Practices, or cGMPs, and complying effectively with other procedures; ● obtaining and maintaining third-party coverage and adequate reimbursement and patients’ willingness to pay out-of-pocket in the absence of such coverage and adequate reimbursement; and ● maintaining a continued acceptable safety, tolerability and efficacy profile of the products following approval.
The loss of the services of any of our executive officer, other key employees, and other scientific and medical advisors, and our inability to find suitable replacements could result in delays in product development and harm to our business. We have a priority to quickly train additional qualified scientific and medical personnel to ensure the ability to maintain business continuity.
The loss of the services of our executive officer, other key employees, and other scientific and medical advisors, and our inability to find suitable replacements could result in delays in product development and harm to our business. We have a priority to quickly train additional qualified scientific and medical personnel to ensure the ability to maintain business continuity.
Those factors that could cause fluctuations include, but are not limited to, the following: ● price and volume of fluctuations in the overall stock market from time to time; ● fluctuations in stock market prices and trading volumes of similar companies; ● the thinly traded nature of our common stock; ● actual or anticipated changes in our net loss or fluctuations in our operating results or in the expectations of securities analysts; ● results of our preclinical studies and clinical trials or delays in anticipated timing; ● the issuance of new equity securities pursuant to a future offering, including issuances of preferred stock , or sales of large blocks of our stock and sales by insiders and our institutional investors; ● announcements of new collaboration agreements with strategic partners or developments by our existing collaboration partners; ● announcements of acquisitions, mergers or business combinations; ● competitive developments, including announcements by competitors of new products or services or significant contracts, acquisitions, strategic partnerships, joint ventures or capital commitments; ● general economic conditions and trends, including changes in interest rates, and other national and global conditions, including pandemics and related global economic uncertainty; ● major catastrophic events; ● departures of key personnel; ● events affecting BCM, Cell Ready or any future collaborators; 60 Table of Contents ● announcements of new product candidates or technologies, commercial relationships or other events , including the results of clinical trials, or variations in our quarterly operating results; ● regulatory developments in the United States and other countries , including changes in the structure of healthcare payment systems, or other positive and negative events relating to healthcare and the overall pharmaceutical and biotechnology sectors; ● failure of our common stock to maintain listing requirements on Nasdaq; ● the outcome of any litigation to which we are a party; ● changes in accounting principles; and ● discussion of our company or our stock price by the financial and scientific press and in online investor communities.
Those factors that could cause fluctuations include, but are not limited to, the following: ● price and volume of fluctuations in the overall stock market from time to time; ● fluctuations in stock market prices and trading volumes of similar companies; ● the thinly traded nature of our common stock; ● actual or anticipated changes in our net loss or fluctuations in our operating results or in the expectations of securities analysts; ● results of our preclinical studies and clinical trials or delays in anticipated timing; ● the issuance of new equity securities pursuant to a future offering, including issuances of preferred stock, or sales of large blocks of our stock and sales by insiders and our institutional investors; ● announcements of new collaboration agreements with strategic partners or developments by our existing collaboration partners; ● announcements of acquisitions, mergers or business combinations; ● competitive developments, including announcements by competitors of new products or services or significant contracts, acquisitions, strategic partnerships, joint ventures or capital commitments; ● general economic conditions and trends, including changes in interest rates, and other national and global conditions, including pandemics and related global economic uncertainty; ● major catastrophic events; ● departures of key personnel; ● events affecting BCM, our CDMO or any future collaborators; ● announcements of new product candidates or technologies, commercial relationships or other events, including the results of clinical trials, or variations in our quarterly operating results; ● regulatory developments in the United States and other countries, including changes in the structure of healthcare payment systems, or other positive and negative events relating to healthcare and the overall pharmaceutical and biotechnology sectors; ● failure of our common stock to maintain listing requirements on Nasdaq; ● the outcome of any litigation to which we are a party; ● changes in accounting principles; and 57 Table of Contents ● discussion of our company or our stock price by the financial and scientific press and in online investor communities.
Even if we receive regulatory approval of our product candidates, we will be subject to ongoing quality and regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates. ● The price of our stock may be volatile. 28 Table of Contents Risks Related to our Financial Position and Capital Needs We are a clinical stage company with a history of operating losses, and we expect losses to continue for the indefinite future.
Even if we receive regulatory approval of our product candidates, we will be subject to ongoing quality and regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates. ● The price of our stock may be volatile. 26 Table of Contents Risks Related to our Financial Position and Capital Needs We are a clinical stage company with a history of operating losses, and we expect losses to continue for the indefinite future.
Later discovery of previously unknown problems with our product candidates, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things: ● restrictions on the marketing or manufacturing of our product candidates, withdrawal of the product from the market, or voluntary or mandatory product recalls; ● fines, warning letters or holds on clinical trials; ● refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license approvals; ● product seizure or detention, or refusal to permit the import or export of our product candidates; and 55 Table of Contents ● injunctions or the imposition of civil or criminal penalties.
Later discovery of previously unknown problems with our product candidates, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things: ● restrictions on the marketing or manufacturing of our product candidates, withdrawal of the product from the market, or voluntary or mandatory product recalls; ● fines, warning letters or holds on clinical trials; ● refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license approvals; ● product seizure or detention, or refusal to permit the import or export of our product candidates; and ● injunctions or the imposition of civil or criminal penalties.
We currently plan to raise additional capital through the issuance of common shares and receipt of additional grant funds, which could enable us to fund our operating expenses and capital expenditure requirements beyond the first quarter of 2026, although no assurance can be given that such capital or existing awarded grants will be earned or future grants will be awarded.
We currently plan to raise additional capital through the issuance of common shares and receipt of additional grant funds, which could enable us to fund our operating expenses and capital expenditure requirements beyond the fourth quarter of 2026, although no assurance can be given that such capital or existing awarded grants will be earned or future grants will be awarded.
We and the third parties upon which we rely may be subject to a variety of threats, including, but not limited to, malicious code (such as viruses and worms), social engineering attacks (including through phishing attacks), malware (including as a result of advanced persistent threat intrusions), denial of service attacks (such as credential stuffing), credential harvesting, software bugs, server malfunctions, software or hardware failures, unauthorized access, natural disasters, 62 Table of Contents fire, terrorism, successful breaches, personnel misconduct or error, or human or technological error, war and telecommunication and electrical failures.
We and the third parties upon which we rely may be subject to a variety of threats, including, but not limited to, malicious code (such as viruses and worms), social engineering attacks (including through phishing attacks), malware (including as a result of advanced persistent threat intrusions), denial of service attacks (such as credential stuffing), credential harvesting, software bugs, server malfunctions, software or hardware failures, unauthorized access, natural disasters, fire, terrorism, successful breaches, personnel misconduct or error, or human or technological error, war and telecommunication and electrical failures.
In the event of a major hurricane or other serious weather event or catastrophic event such as fire, power loss, cyberattack, war, terrorist attack or epidemic or pandemic that impacts the facilities of any third parties on which we may rely, we may be unable to continue our 64 Table of Contents operations and may experience delays in our manufacturing process and shipment of clinical supply to trial sites or interruptions in our clinical trials and research activities, all of which could delay our development plans and materially harm our business, results of operations and prospects.
In the event of a major hurricane or other serious weather event or catastrophic event such as fire, power loss, cyberattack, war, terrorist attack or epidemic or pandemic that impacts the facilities of any third parties on which we may rely, we may be unable to continue our operations and may experience delays in our manufacturing process and shipment of clinical supply to trial sites or interruptions in our clinical trials and research activities, all of which could delay our development plans and materially harm our business, results of operations and prospects.
As previously disclosed, Mr. Wilson resigned as one of our directors on January 24, 2024. Some of our direct or indirect suppliers may not have the willingness or capacity to support commercial products manufactured under cGMP by biopharmaceutical firms or may otherwise be ill-equipped to support our needs.
As previously disclosed, Mr. Wilson resigned as one of our directors on January 24, 2025. Some of our direct or indirect suppliers may not have the willingness or capacity to support commercial products manufactured under cGMP by biopharmaceutical firms or may otherwise be ill-equipped to support our needs.
If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our products may be delayed. From time to time, we may estimate the timing of the accomplishment of various scientific, clinical, regulatory, manufacturing and other product development goals, which we sometimes refer to as milestones.
If we do not achieve our projected development goals in the timeframes we announce and expect, the commercialization of our products may be delayed. From time to time, we may estimate the timing of the accomplishment of various scientific, clinical, regulatory, manufacturing and other product development goals, which we sometimes refer to as milestones.
We may be unable to compete with more substantial enterprises. ● If we are unable to protect our proprietary rights, we may not be able to compete effectively or operate profitably. ● We are subject to extensive regulation, which can be costly, time consuming and can subject us to unanticipated delays.
We may be unable to compete with more substantial enterprises. ● If we are unable to protect our proprietary rights, we may not be able to compete effectively or operate profitably. ● We are subject to extensive regulations, which can be costly, time consuming and can subject us to unanticipated delays.
Generally, a product that has orphan drug designation and subsequently receives the first FDA approval for the disease for which it has such designation is entitled to orphan drug exclusive approval (or exclusivity), which means that the FDA may not approve any other applications to market the same drug or biologic for the same indication for seven years, except 35 Table of Contents in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity.
Generally, a product that has orphan drug designation and subsequently receives the first FDA approval for the disease for which it has such designation is entitled to orphan drug exclusive approval (or exclusivity), which means that the FDA may not approve any other applications to market the same drug or biologic for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity.
If we are unable to contract for a sufficient supply of needed materials on acceptable terms, or if we should encounter delays, difficulties or disputes with regard to in our relationships with manufacturers, our clinical trials may be delayed, 36 Table of Contents thereby delaying the submission of product candidates for regulatory approval or the market introduction and subsequent sales of any approved products.
If we are unable to contract for a sufficient supply of needed materials on acceptable terms, or if we should encounter delays, difficulties or disputes with regard to in our relationships with manufacturers, our clinical trials may be delayed, thereby delaying the submission of product candidates for regulatory approval or the market introduction and subsequent sales of any approved products.
The extent to which future pandemics impact our business and operations, including our clinical development and regulatory efforts, will depend on future developments that are highly uncertain and cannot be predicted with confidence, such as the continued geographic spread of the disease, the duration and effect of any future business disruptions in the United States and other countries to contain and treat patients with the disease.
The extent to which future pandemics impact our business and operations, including our clinical development and regulatory efforts, will depend on future developments that are highly uncertain and cannot be predicted with confidence, such as the continued geographic spread of the disease, the duration and effect of any future business disruptions in the United States and other countries to contain and 61 Table of Contents treat patients with the disease.
Under our license agreement with BCM for our MAR-T cell therapy technologies, we are currently required to pay both substantial milestone payments and royalties to BCM based on our revenues from sales of any approved products utilizing the licensed technologies, 51 Table of Contents and these payments could adversely affect the overall profitability for us of any products that we may seek to commercialize.
Under our license agreement with BCM for our MAR-T cell therapy technologies, we are currently required to pay both substantial milestone payments and royalties to BCM based on our revenues from sales of any approved products utilizing the licensed technologies, and these payments could adversely affect the overall profitability for us of any products that we may seek to commercialize.
Failure to remedy any material weakness in our internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict our future access to the capital markets. Our ability to use net operating losses and certain other tax attributes to offset future taxable income may be subject to limitation.
Failure to remedy any material weakness in our internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict our future access to the capital markets. 60 Table of Contents Our ability to use net operating losses and certain other tax attributes to offset future taxable income may be subject to limitation.
We face competition for these types of personnel from other biotechnology companies and more established organizations, many of which have significantly larger operations and greater financial, technical, human and other resources than us. We may not be successful in attracting and retaining qualified personnel on a timely basis, on competitive terms, or at all.
We face competition for these types of personnel from other biotechnology companies and more established organizations, many of which have significantly larger 40 Table of Contents operations and greater financial, technical, human and other resources than us. We may not be successful in attracting and retaining qualified personnel on a timely basis, on competitive terms, or at all.
Furthermore, different countries have different procedures for obtaining patents, and patents issued in different countries offer different degrees of protection against use of the patented invention by others. If we encounter such difficulties in protecting or are otherwise precluded from effectively protecting our intellectual property rights in foreign jurisdictions, our business prospects could be substantially harmed.
Furthermore, different countries have different procedures for obtaining patents, and patents issued in different countries offer different degrees of 49 Table of Contents protection against use of the patented invention by others. If we encounter such difficulties in protecting or are otherwise precluded from effectively protecting our intellectual property rights in foreign jurisdictions, our business prospects could be substantially harmed.
Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions. 59 Table of Contents Preparing for and complying with these obligations requires us to devote significant resources, which may necessitate changes to our services, information technologies, systems, and practices and to those of any third parties that process personal data on our behalf.
Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions. Preparing for and complying with these obligations requires us to devote significant resources, which may necessitate changes to our services, information technologies, systems, and practices and to those of any third parties that process personal data on our behalf.
We are aware of certain investigational new drugs under development or approved products by competitors that are used for the prevention, diagnosis, or treatment of certain diseases we have targeted for drug development. Various companies are developing biopharmaceutical products that have the potential to directly compete with our immunotherapies even though their approach may be different.
We are aware of certain investigational new drugs under development or approved products by competitors 41 Table of Contents that are used for the prevention, diagnosis, or treatment of certain diseases we have targeted for drug development. Various companies are developing biopharmaceutical products that have the potential to directly compete with our immunotherapies even though their approach may be different.
Weakness and volatility in the capital markets and the economy in general could also increase our costs of borrowing. Such additional financing may not be available on favorable terms, or at all.
Weaknesses and volatility in the capital markets and the economy in general could also increase our costs of borrowing. Such additional financing may not be available on favorable terms, or at all.
If government and other health care payors were not to provide adequate coverage and reimbursement levels for any of our products if approved, market acceptance and commercial success would be reduced. Our MAR-T cell therapy may be provided to patients in combination with other agents provided by third parties.
If government and other health care payors were not to provide adequate coverage and reimbursement levels for any of our products if approved, market acceptance and commercial success would be reduced. 39 Table of Contents Our MAR-T cell therapy may be provided to patients in combination with other agents provided by third parties.
The Medicare Access and CHIP Reauthorization Act of 2015 ended the use of the statutory formula, also referred to as the Sustainable Growth Rate, for clinician payment and also introduced a quality payment program, or the Quality Payment Program, under which certain individual Medicare providers will be subject to certain incentives or penalties based on new program quality standards.
The Medicare Access and CHIP Reauthorization Act of 2015 ended the use of the statutory formula, also referred to as the Sustainable Growth Rate, for clinician payment and also introduced a quality payment program, or the Quality Payment Program, under which certain individual Medicare providers 54 Table of Contents will be subject to certain incentives or penalties based on new program quality standards.
The combination of healthcare cost containment measures, increased health insurance costs, reduction of the number of people with health insurance coverage, as well as future legislation and regulations focused on reducing healthcare costs by reducing the cost of, or 58 Table of Contents reimbursement and access to, pharmaceutical products, may limit or delay our ability to commercialize our products, generate revenue or attain profitability.
The combination of healthcare cost containment measures, increased health insurance costs, reduction of the number of people with health insurance coverage, as well as future legislation and regulations focused on reducing healthcare costs by reducing the cost of, or reimbursement and access to, pharmaceutical products, may limit or delay our ability to commercialize our products, generate revenue or attain profitability.
Moreover, any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm our business, results of operations and prospects. We may not obtain or maintain the benefits associated with orphan drug designation, including market exclusivity.
Moreover, any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm our business, results of operations and prospects. 32 Table of Contents We may not obtain or maintain the benefits associated with orphan drug designation, including market exclusivity.
In addition, the loss of any current or future licenses or the exclusivity rights provided therein could materially harm our business financial condition and our operations. 54 Table of Contents Risks Related to Government Regulation We are subject to extensive regulation, which can be costly, time consuming and can subject us to unanticipated delays.
In addition, the loss of any current or future licenses or the exclusivity rights provided therein could materially harm our business financial condition and our operations. Risks Related to Government Regulation We are subject to extensive regulation, which can be costly, time consuming and can subject us to unanticipated delays.
Each of our programs and product candidates will require additional preclinical and/or clinical development, regulatory approval, obtaining manufacturing supply, capacity and expertise, building a commercial organization or successfully outsourcing commercialization, substantial investment and significant marketing efforts before we generate any revenue from product sales.
Each of our programs and product candidates will require additional preclinical and/or clinical development, regulatory approval, obtaining manufacturing supply, 27 Table of Contents capacity and expertise, building a commercial organization or successfully outsourcing commercialization, substantial investment and significant marketing efforts before we generate any revenue from product sales.
The BLA must also include significant information regarding the chemistry, manufacturing and controls for the product. We expect the novel nature of our product candidates to create further challenges in obtaining 31 Table of Contents regulatory approval. For example, the FDA has limited experience with commercial development of cell therapies for cancer.
The BLA must also include significant information regarding the chemistry, manufacturing and controls for the product. We expect the novel nature of our product candidates to create further challenges in obtaining regulatory approval. For example, the FDA has limited experience with commercial development of cell therapies for cancer.
For example, in November 2019 we elected to suspend our Phase 2 clinical trial of TPIV200 for the treatment of platinum-sensitive advanced ovarian cancer based on an unblinded review of interim results conducted by an independent Data and Safety Monitoring Board, or DSMB.
For example, in November 2019 we elected to suspend our Phase 2 clinical trial of TPIV200 30 Table of Contents for the treatment of platinum-sensitive advanced ovarian cancer based on an unblinded review of interim results conducted by an independent Data and Safety Monitoring Board, or DSMB.
There have been judicial, Congressional and executive branch challenges to certain aspects of the ACA. For example, Congress considered legislation that would 57 Table of Contents repeal or repeal and replace all or part of the ACA. While Congress has not passed repeal legislation, several bills affecting the implementation of certain taxes under the ACA have been signed into law.
There have been judicial, Congressional and executive branch challenges to certain aspects of the ACA. For example, Congress considered legislation that would repeal or repeal and replace all or part of the ACA. While Congress has not passed repeal legislation, several bills affecting the implementation of certain taxes under the ACA have been signed into law.
There can be no assurance that our patent applications or those of our licensor will result in additional patents being issued or that issued patents will afford sufficient protection against competitors with similar technology, nor can there be any assurance that the patents issued will not be infringed, designed around or invalidated by third parties.
There can be no assurance that our patent applications or those of our licensor will result in additional patents being issued or that issued patents will afford sufficient protection against competitors with similar technology, nor 43 Table of Contents can there be any assurance that the patents issued will not be infringed, designed around or invalidated by third parties.
Further, a clinical trial may be suspended or terminated by us, the IRB for the institutions in which such trials are being conducted, the Data and Safety Monitoring Board or Committee for such trial, or by the FDA or other regulatory authorities due to a number of factors.
Further, a clinical trial may be suspended or terminated by us, the IRB for the institutions in which such trials are being conducted, the Data and Safety Monitoring Board or Committee for such trial, or by the 29 Table of Contents FDA or other regulatory authorities due to a number of factors.
While these universities and public and private research institutions 44 Table of Contents primarily have educational objectives, they may develop proprietary technologies that lead to other FDA approved therapies or that secure patent protection that we may need for the development of our technologies and product candidates.
While these universities and public and private research institutions primarily have educational objectives, they may develop proprietary technologies that lead to other FDA approved therapies or that secure patent protection that we may need for the development of our technologies and product candidates.
However, damage and claims arising from such incidents may not be covered or may exceed the amount of any insurance available. Additionally, we cannot 63 Table of Contents be sure that such coverage will continue to be available on commercially reasonable terms or at all, or that such coverage will pay future claims.
However, damage and claims arising from such incidents may not be covered or may exceed the amount of any insurance available. Additionally, we cannot be sure that such coverage will continue to be available on commercially reasonable terms or at all, or that such coverage will pay future claims.
The patent application process is subject to numerous risks and uncertainties, and 47 Table of Contents there can be no assurance that we or any of our potential future collaborators will be successful in protecting our product candidates by obtaining and defending patents.
The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that we or any of our potential future collaborators will be successful in protecting our product candidates by obtaining and defending patents.
If any of our third-party suppliers encounter such difficulties, the supply of our product candidates for clinical 37 Table of Contents trials, or our product candidates for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.
If any of our third-party suppliers encounter such difficulties, the supply of our product candidates for clinical trials, or our product candidates for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.
Under the unitary patent system, European applications will have the option, upon grant of a patent, of 50 Table of Contents becoming a Unitary Patent which will be subject to the jurisdiction of the Unitary Patent Court, or UPC. As the UPC is a new court system, there is no precedent for the court, increasing the uncertainty of any litigation.
Under the unitary patent system, European applications will have the option, upon grant of a patent, of becoming a Unitary Patent which will be subject to the jurisdiction of the Unitary Patent Court, or UPC. As the UPC is a new court system, there is no precedent for the court, increasing the uncertainty of any litigation.
To the extent that any disruption or security breach results in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development of our product candidates could be delayed.
To the extent that any disruption or security breach results in a loss of or damage to our data or applications, or inappropriate 59 Table of Contents disclosure of confidential or proprietary information, we could incur liability and the further development of our product candidates could be delayed.
We will have 33 Table of Contents to conduct larger, well-controlled trials in our proposed indications at multiple sites to verify the results obtained to date and to support any regulatory submissions for further clinical development of our product candidates.
We will have to conduct larger, well-controlled trials in our proposed indications at multiple sites to verify the results obtained to date and to support any regulatory submissions for further clinical development of our product candidates.
It is possible that third parties relied upon by us will change their strategic focus, pursue alternative technologies, or develop alternative product candidates, either on their own or in collaboration 39 Table of Contents with others, as a means for developing treatments for the diseases targeted by our collaborative programs, or for other reasons.
It is possible that third parties relied upon by us will change their strategic focus, pursue alternative technologies, or develop alternative product candidates, either on their own or in collaboration with others, as a means for developing treatments for the diseases targeted by our collaborative programs, or for other reasons.
Clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. Because our product candidates are based on new technologies and manufactured on a patient-by-patient basis for our MAR-T cell 32 Table of Contents product candidates we expect that they will have substantial manufacturing costs.
Clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. Because our product candidates are based on new technologies and manufactured on a patient-by-patient basis for our MAR-T cell product candidates we expect that they will have substantial manufacturing costs.
In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval. We may also submit marketing applications in other countries.
In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval. 52 Table of Contents We may also submit marketing applications in other countries.
If we are unable to raise additional funds through equity or debt 61 Table of Contents financings when needed, we may be required to delay, limit, reduce or terminate our drug development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our drug development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our product candidates.
If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and 45 Table of Contents perhaps all, of the patent protection on our product candidates.
As of December 31, 2024, we had 10.7 million shares of our common stock issued and outstanding. Those outstanding shares represent a minority of our authorized shares, meaning that the ownership position of the current stockholders could be diluted significantly were we to issue a large number of additional shares.
As of December 31, 2025, we had 16.7 million shares of our common stock issued and outstanding. Those outstanding shares represent a minority of our authorized shares, meaning that the ownership position of the current stockholders could be diluted significantly were we to issue a large number of additional shares.
If we do not receive marketing approvals for any product candidate we develop, we may not be able to continue our operations. Because we have limited financial and management resources, we must focus on development programs and product candidates that we identify for specific indications.
If we do not receive marketing approvals for any product candidate we develop, we may not be able to continue our operations. 28 Table of Contents Because we have limited financial and management resources, we must focus on development programs and product candidates that we identify for specific indications.
It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection.
It is also possible that we will fail to identify patentable aspects of our research and development output before it is too 44 Table of Contents late to obtain patent protection.
Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial cost and be a distraction to our management and employees.
Even if we are successful in defending against these claims, litigation could result in substantial cost and be a distraction to our management and employees.
Based on our lack of recurring revenues, anticipated uses of cash and historical recurring cash losses from operating activity, and cash and cash equivalents as of December 31, 2024, we anticipate that we will be able to fund our operating expenses and capital expenditure requirements into the first quarter of 2026, assuming no additional grant funds are received.
Based on our lack of recurring revenues, anticipated uses of cash and historical recurring cash losses from operating activity, and cash and cash equivalents as of December 31, 2025, we anticipate that we will be able to fund our operating expenses and capital expenditure requirements through the fourth quarter of 2026, assuming no additional grant funds are received.
Our ongoing and future clinical trials may be also affected by future pandemics. Patient enrollment and clinical site initiation, while ongoing, may be delayed due to prioritization of hospital resources toward pandemics or other health emergencies, if they arise. Some patients may not be able to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services.
Patient enrollment and clinical site initiation, while ongoing, may be delayed due to prioritization of hospital resources toward pandemics or other health emergencies, if they arise. Some patients may not be able to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services.
Risks Related to the Development of our Product Candidates All of our product candidates are in clinical development. If we are unable to successfully develop, receive regulatory approval for and commercialize our product candidates, or successfully develop any other product candidates, or experience significant delays in doing so, our business will be harmed.
If we are unable to successfully develop, receive regulatory approval for and commercialize our product candidates, or successfully develop any other product candidates, or experience significant delays in doing so, our business will be harmed. We are early in our development efforts and all of our product candidates are still in clinical development.
While we do not believe that any of the patents owned or licensed by us will be found invalid based on these decisions, we cannot predict how future decisions by the courts, the U.S. Congress or the USPTO may impact the value of our patents.
While we do not believe that any of the patents owned or licensed by us will be found invalid based on these decisions, we cannot predict how future decisions by the courts, the U.S.
Risks Related to our Securities The price of our stock may be volatile. The listing of our common stock on Nasdaq does not assure that a meaningful, consistent and liquid trading market currently exists or will exist in the future. The trading price of our common stock may fluctuate substantially.
The listing of our common stock on Nasdaq does not assure that a meaningful, consistent and liquid trading market currently exists or will exist in the future. The trading price of our common stock may fluctuate substantially.
It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations.
Efforts to ensure that our business arrangements comply with applicable healthcare laws may involve substantial costs. It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations.
Furthermore, we intend to evaluate additional potential third-party manufacturing capabilities to provide potential multiple sources of clinical and commercial supply. However, even if we can secure multiple sources of clinical and commercial supply, third-party manufacturers may not be willing or able to meet our needs concerning timing, quantity, or quality and/or may cease or substantially reduce their business.
However, even if we can secure multiple sources of clinical and commercial supply, third-party manufacturers may not be willing or able to meet our needs concerning timing, quantity, or quality and/or may cease or substantially reduce their business.
Any of these events could have a material adverse effect on our reputation, business, or financial condition, including but not limited to: interruptions or stoppages in our business operations (including clinical trials); inability to process personal data or to operate in certain jurisdictions; limited ability to develop or commercialize our products; expenditure of time and resources to defend any claim or inquiry; adverse publicity; or substantial changes to our business model or operations.
Any of these events could have a material adverse effect on our reputation, business, or financial condition, including but not limited to: interruptions or stoppages in our business operations (including clinical trials); inability to process personal data or to operate in certain jurisdictions; limited ability to develop or commercialize our products; expenditure of time and resources to defend any claim or inquiry; adverse publicity; or substantial changes to our business model or operations. 56 Table of Contents Risks Related to our Securities The price of our stock may be volatile.
In addition, if there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding to us on commercially reasonable terms, or at all.
In addition, if there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding to us on commercially reasonable terms, or at all. Risks Related to the Development of our Product Candidates All of our product candidates are in clinical development.
Further, as of December 31, 2024, there were outstanding warrants for an aggregate of approximately 8.3 million shares of common stock at a weighted average exercise price of $2.43 per share.
Further, as of December 31, 2025, there were outstanding warrants for an aggregate of approximately 7.7 million shares of common stock at a weighted average exercise price of $2.62 per share.
We do not have any cGMP manufacturing facilities. Following the termination of our MSA with Cell Ready, we rely on BCM for the cGMP manufacture of our product candidates for clinical development.
Following the termination of our MSA with Cell Ready, we rely on BCM for the cGMP manufacture of our product candidates for clinical development.
Increased inflation rates can adversely affect us by increasing our costs, including labor and employee benefit costs. Any significant increases in inflation and related increase in interest rates could have a material adverse effect on our business, results of operations and financial condition. Changes in tax laws or regulations could materially adversely affect our company.
Any significant increases in inflation and related increase in interest rates could have a material adverse effect on our business, results of operations and financial condition. Changes in tax laws or regulations could materially adversely affect our company.
An inability to continue to source product from any of these suppliers, which could be due to regulatory actions or requirements affecting the supplier, adverse financial, or other strategic developments experienced by a supplier, labor disputes or shortages, unexpected demands, or quality issues, could adversely affect our ability to satisfy demand for our product candidates, which could adversely and materially affect our operating results or our ability to conduct clinical trials, either of which could significantly harm our business.
An inability to continue to source product from any of these suppliers, which could be due to regulatory actions or requirements affecting the supplier, adverse financial, or other strategic developments experienced by a supplier, labor disputes or shortages, unexpected demands, or quality issues, could adversely affect our ability to satisfy demand for our product candidates, which could adversely and materially affect our operating results or our ability to conduct clinical trials, either of which could significantly harm our business. 34 Table of Contents The manufacture of our product candidates is complex and we may encounter difficulties in production, particularly with respect to process development.
A number of jurisdictions outside of the United States have also established abbreviated pathways for regulatory approval of biological products that 45 Table of Contents are biosimilar to earlier versions of biological products. For example, the European Union has had an established regulatory pathway for biosimilars since 2005.
A number of jurisdictions outside of the United States have also established abbreviated pathways for regulatory approval of biological products that are biosimilar to earlier versions of biological products. For example, the European Union has had an established regulatory pathway for biosimilars since 2005. The increased likelihood of biosimilar competition has increased the risk of loss of innovators’ market exclusivity.
Sales of additional equity securities may adversely affect the market price of our common stock and your rights may be reduced. Our stockholders may experience dilution in the future and it may adversely affect the market price of our securities. We expect to continue to incur drug development and sale, general and administrative costs.
Our stockholders may experience dilution in the future and it may adversely affect the market price of our securities. We expect to continue to incur drug development and sale, general and administrative costs.
Due to the potential volatility of our stock price, we may therefore be the target of securities litigation in the future. Securities litigation could result in substantial costs and divert management’s attention and resources from our business.
Due to the potential volatility of our stock price, we may therefore be the target of securities litigation in the future. Securities litigation could result in substantial costs and divert management’s attention and resources from our business. Sales of additional equity securities may adversely affect the market price of our common stock and your rights may be reduced.
For instance, we expect our lead product candidate to initially target patients with lymphoma that relapsed after anti-CD19 CAR-T cell therapy.
For instance, we expect our lead product candidate to initially target patients with lymphoma who have relapsed after anti-CD19 CAR-T cell therapy or who are ineligible to receive anti-CD19 CAR-T cell treatment.
We are highly dependent on our management, scientific, and medical personnel and consultants, including Juan Vera, M.D., our President, Chief Executive Officer, and Principal Financial and 43 Table of Contents Accounting Officer, as well as others.
We are highly dependent on our management, scientific, and medical personnel and consultants, including in particular Juan Vera, M.D., who plays multiple roles as our President, Chief Executive Officer, and Principal Financial and Accounting Officer, as well as others.
Preclinical studies and clinical trials often fail to demonstrate safety or efficacy of the product candidate studied for the target indication. 34 Table of Contents In addition to side effects caused by the product candidate, the administration process or related procedures also can cause adverse side effects.
Preclinical studies and clinical trials often fail to demonstrate safety or efficacy of the product candidate studied for the target indication. In addition to side effects caused by the product candidate, the administration process or related procedures also can cause adverse side effects. If any such adverse events occur, our clinical trials could be suspended or terminated.
In addition, as of December 31, 2024, there were outstanding options for an aggregate of approximately 0.6 million shares of common stock at a weighted average exercise price of $22.85 per share.
In addition, as of December 31, 2025, there were outstanding options for an aggregate of approximately 1.8 million shares of common stock at a weighted average exercise price of $7.77 per share.
If we do not successfully develop and commercialize products based upon our approach or find suitable and economical sources for materials used in the production of our products, we will not become profitable. 42 Table of Contents Even if we are successful in getting market approval, commercial success of any of our product candidates will also depend in large part on the availability of coverage and adequate reimbursement from third-party payors, including government payors such as the Medicare and Medicaid programs and managed care organizations, which may be affected by existing and future health care reform measures designed to reduce the cost of health care.
Even if we are successful in getting market approval, commercial success of any of our product candidates will also depend in large part on the availability of coverage and adequate reimbursement from third-party payors, including government payors such as the Medicare and Medicaid programs and managed care organizations, which may be affected by existing and future health care reform measures designed to reduce the cost of health care.
If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or other regulatory authorities, we may be unable to obtain regulatory approval of our marketing applications. In addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel.
If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or other regulatory authorities, we may be unable to obtain regulatory approval of our marketing applications.
If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and distraction to management and other employees.
If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights. Such an outcome could have a material adverse effect on our business.
If we violate regulatory requirements at any stage, whether before or after marketing approval is obtained, we may be fined, forced to remove a product from the market and experience other adverse consequences including delay, which could materially harm our business development.
We will not be able to commercialize any of our potential product candidates until we obtain FDA approval, and so any delay in obtaining, or inability to obtain, FDA approval would harm our proposed business. 51 Table of Contents If we violate regulatory requirements at any stage, whether before or after marketing approval is obtained, we may be fined, forced to remove a product from the market and experience other adverse consequences including delay, which could materially harm our business development.
We also rely on trade secrets to protect our proprietary technologies, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our employees, consultants, outside scientific collaborators, sponsored researchers, and other advisors to protect our trade secrets and other proprietary information.
However, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our employees, consultants, outside scientific collaborators, sponsored researchers, and other advisors to protect our trade secrets and other proprietary information.
While it is not possible to predict whether and when any such changes will occur, changes in the laws, regulations, and policies governing the development and approval of our product candidates and the commercialization, importation, and reimbursement of our product candidates could adversely affect our business.
While it is not possible to predict whether and when any such changes will occur, changes in the laws, regulations, and policies governing the development and approval of our product candidates and the commercialization, importation, and reimbursement of our product candidates could adversely affect our business. 55 Table of Contents We are subject to stringent and changing laws, regulations, rules, contractual obligations, policies and other obligations related to data privacy and security.
Also, our collaborators may pursue existing or other development-stage products or alternative technologies in preference to those being developed in collaboration with us. Finally, if we fail to make required milestones or royalty payments to our collaborators or to observe other obligations in our agreements with them, our collaborators may have the right to terminate those agreements.
Finally, if we fail to make required milestones or royalty payments to our collaborators or to observe other obligations in our agreements with them, our collaborators may have the right to terminate those agreements.
In particular, under the Leahy-Smith Act, the United States transitioned in March 2013 to a “first inventor to file” system in which the first inventor to file a patent application will be entitled to the patent.
These include provisions that affect the way patent applications are prosecuted and may also affect patent litigation. In particular, under the Leahy-Smith Act, the United States transitioned in March 2013 to a “first inventor to file” system in which the first inventor to file a patent application will be entitled to the patent.
There is also the risk that, even if the validity of our patents was upheld, a court would refuse to stop the other party on the ground that its activities are not covered by, that is, do not infringe, our patents. 48 Table of Contents Should third parties file patent applications, or be issued patents claiming technology also used or claimed by our licensor(s) or by us in any future patent application, we may be required to participate in interference proceedings in the USPTO to determine priority of invention for those patents or patent applications that are subject to the first-to-invent law in the United States, or may be required to participate in derivation proceedings in the USPTO for those patents or patent applications that are subject to the “first-inventor-to-file” law in the United States.
Should third parties file patent applications, or be issued patents claiming technology also used or claimed by our licensor(s) or by us in any future patent application, we may be required to participate in interference proceedings in the USPTO to determine priority of invention for those patents or patent applications that are subject to the first-to-invent law in the United States, or may be required to participate in derivation proceedings in the USPTO for those patents or patent applications that are subject to the “first-inventor-to-file” law in the United States.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe expect to require third-party service providers with access to personal, confidential or proprietary information to implement and maintain cybersecurity practices consistent with applicable legal standards and industry best practices. Our business depends on the availability, reliability, and security of our information systems, networks, data, and intellectual property.
Biggest changeWe expect to require third-party service providers with access to personal, confidential or proprietary information to implement and maintain cybersecurity practices consistent with applicable legal standards and industry best practices. 62 Table of Contents Our business depends on the availability, reliability, and security of our information systems, networks, data, and intellectual property.
Our cybersecurity incident response processes are designed to escalate certain cybersecurity incidents to members of management depending on the circumstances, including in some cases to our executive team. Our cybersecurity incident management team, and other 66 Table of Contents individuals as needed, work to help us mitigate and remediate cybersecurity incidents of which we are notified.
Our cybersecurity incident response processes are designed to escalate certain cybersecurity incidents to members of management depending on the circumstances, including in some cases to our executive team. Our cybersecurity incident management team, and other individuals as needed, work to help us mitigate and remediate cybersecurity incidents of which we are notified.
In addition, our incident response processes include a procedure for reporting certain cybersecurity incidents to the board of directors. The board of directors receives regular reports from management concerning our cybersecurity risk management program. The board also receives various summaries and/or presentations related to cybersecurity threats, risks and mitigation. ​
In addition, our incident response processes include a procedure for reporting certain cybersecurity incidents to the board of directors. The board of directors receives regular reports from management concerning our cybersecurity risk management program. The board also receives various summaries and/or presentations related to cybersecurity threats, risks and mitigation. ​ 63 Table of Contents

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeMINE SAFETY DISCLOSURE Not Applicable ​ 67 Table of Contents PART II
Biggest changeMINE SAFETY DISCLOSURE Not Applicable ​ 64 Table of Contents PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThe price of our common stock on March 26, 2025 was $1.16 per share. Dividend Policy No dividends have been declared or paid on our common stock. We have incurred recurring losses and do not currently intend to pay any cash dividends in the foreseeable future.
Biggest changeThe price of our common stock on March 16, 2026 was $1.41 per share. Dividend Policy No dividends have been declared or paid on our common stock. We have incurred recurring losses and do not currently intend to pay any cash dividends in the foreseeable future. Recent Sales of Unregistered Securities None.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock is listed for trading on the Nasdaq Capital Market under the symbol “MRKR”. As of March 26, 2025, we had 38 stockholders of record, whom are holding shares.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock is listed for trading on the Nasdaq Capital Market under the symbol “MRKR”. As of March 16, 2026, we had 39 stockholders of record, whom are holding shares.
Removed
Recent Sales of Unregistered Securities As previously disclosed, on December 19, 2024, we entered into a securities purchase agreement (the “ Securities Purchase Agreement ”) with various investors for the issuance and sale in a private placement (the “ Private Placement ”) of (i) 1,783,805 shares of Common Stock par value $0.001 per share (the “ Common Stock ”), (ii) Series A Warrants to acquire 5,031,250 shares of Common Stock (the “ Private Placement Warrants ”) and (iii) partially prepaid warrants to acquire 3,247,445 additional shares of Common Stock (the “ Pre-Funded Warrants ”, and together with the Private Placement Warrants, the “ Warrants ”).
Removed
The Private Placement closed on December 23, 2024. The gross proceeds to the Company from the Private Placement were approximately $16.1 million, before deducting placement agent fees and offering expenses payable by the Company. The Company intends to use the net proceeds received from the Private Placement for general corporate purposes and working capital.
Removed
Pursuant to the Securities Purchase Agreement, the Company is obligated to call a meeting of its stockholders to obtain stockholder approval (the “ Stockholder Approval ”) for the issuance of the shares issuable upon exercise of the Warrants within 90 days of the closing date.
Removed
If the Stockholder Approval is not obtained at such meeting, the Company is required to cause an additional stockholder meeting to be held on or prior to the 180 th day after the closing date, and, if despite the Company’s reasonable best efforts the Stockholder Approval is not obtained after such subsequent stockholder meeting, the Company is required to cause an additional stockholder meeting to be held semi-annual thereafter until such Stockholder Approval is obtained.
Removed
In connection therewith, the Company entered into voting agreements with certain stockholders pursuant to which such stockholders, who collectively own approximately 27% of the shares of common stock outstanding immediately prior to the closing of the Private Placement, agreed to vote in favor of the Private Placement.
Removed
The Warrants are exercisable at any time on or after the date that the Stockholder Approval is obtained and have a term of five years commencing upon the date that the Stockholder Approval is obtained. The Pre-Funded warrants are exercisable at a price of $0.001 per share and the Private Placement Warrants have an exercise price of $4.00 per share.
Removed
None of the issuances of the shares of Common Stock, the Pre-Funded Warrants, the Private Placement Warrants, or the shares of Common Stock issuable upon exercise of the Warrants (the “ Warrant Shares ”) have been registered under the Securities Act of 1933, as amended (the “ Securities Act ”), or any state securities laws.
Removed
The shares of Common Stock, the Pre-Funded Warrants and the Private Placement Warrants, were issued, and Warrant Shares will be issued, in reliance on the exemptions from registration provided by Section 4(a)(2) under the Securities Act and/or Regulation D promulgated thereunder.
Removed
The investors who entered into to a Securities Purchase Agreement have represented that they are each an accredited investor, as defined in Rule 501 of Regulation D promulgated under the Securities Act.
Removed
In connection with the Private Placement, the Company entered into a registration rights agreement (the “ Registration Rights Agreement ”), dated as of December 19, 2024, with the investors in the Private Placement, pursuant to which the Company agreed to prepare and file a registration statement with the Securities and Exchange Commission (the “ SEC ”) registering the resale of the shares of Common Stock issued in the Private Placement along with the shares of Common Stock underlying the Warrants no later than January 14, 2025, and to use its best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any 68 Table of Contents event no later than the earlier of (A) February 14, 2024 and (B) the second business day after the date the Company is notified by the SEC that the Registration Statement will not be reviewed or will not be subject to further review Canaccord Genuity LLC acted as the Company’s lead placement agent and Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as co-placement agent (collectively, the “ Agents ”) in connection with the Private Placement, pursuant to that certain engagement letter, dated as of June 14, 2024, between the Company and Canaccord Genuity LLC (the “ Engagement Letter ”).
Removed
Pursuant to the Engagement Letter, the Company paid or agreed to pay the Agents a cash fee equal to (i) 6% of the aggregate gross proceeds of the Private Placement other than from certain identified investors (the “ Reduced Fee Investors ”), (ii) 3% of the first $5 million of aggregate gross proceeds of the Private Placement form the Reduced Fee Investors, and (iii) 6% of the aggregate gross proceeds of the Private Placement form the Reduced Fee Investors in excess of $5 million.
Removed
In addition, the Company agreed to pay Wainwright certain expenses. The Engagement Letter and the Securities Purchase Agreement contain customary representations and warranties, agreements and obligations, conditions to closing and termination provisions.
Removed
The foregoing descriptions of terms and conditions of the Securities Purchase Agreement, the Pre–Funded Warrants, the Private Placement Warrants, and the Registration Rights Agreement do not purport to be complete and are qualified in their entirety by the full text of the form of the Purchase Agreement, the form of the Pre–Funded Warrant, the form of Private Placement Warrant, and the form of the Registration Rights Agreement, which are attached hereto as Exhibits 10.7, 4.2, 4.3 and 10.8, respectively.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

51 edited+14 added−49 removed56 unchanged
Biggest changeResults of Operations for the Years Ended December 31, 2024 and 2023 The following table summarizes the results of our continuing operations (rounded to the thousands except for per share amounts) for the years ended December 31, 2024 and 2023, together with the changes to those items: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Years Ended ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ ​ ​ ​ ​ 2024 2023 Change Revenues: ​ ​ ​ ​ ​ Grant income ​ $ 6,591,000 ​ $ 3,311,000 ​ $ 3,280,000 99 % Total revenues ​ 6,591,000 ​ 3,311,000 ​ 3,280,000 99 % Operating expenses: ​ ​ ​ ​ ​ ​ ​ Research and development ​ 13,468,000 ​ 10,417,000 ​ 3,051,000 29 % General and administrative ​ 4,241,000 ​ 7,475,000 ​ (3,234,000) (43) % Total operating expenses ​ 17,709,000 ​ 17,892,000 ​ (183,000) (1) % Loss from operations ​ (11,118,000) ​ (14,581,000) ​ 3,463,000 (24) % Other income (expenses): ​ ​ ​ ​ ​ ​ ​ ​ Interest income ​ 437,000 ​ 539,000 ​ (102,000) (19) % Loss from continuing operations before income taxes ​ ​ (10,681,000) ​ ​ (14,042,000) ​ ​ 3,361,000 ​ (24) % ​ Revenue We did not generate any revenue during the years ended December 31, 2024 and 2023, respectively, from the sales or licensing of our product candidates.
Biggest changeResults of Operations for the Years Ended December 31, 2025 and 2024 The following table summarizes the results of our continuing operations (rounded to the thousands except for per share amounts) for the years ended December 31, 2025 and 2024, together with the changes to those items: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Years Ended ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ Change Revenues: ​ ​ ​ ​ ​ ​ ​ ​ ​ Grant income ​ $ 3,546,669 ​ $ 6,591,080 ​ $ (3,044,411) (46) % Total revenues ​ 3,546,669 ​ 6,591,080 ​ (3,044,411) (46) % Operating expenses: ​ ​ ​ ​ ​ ​ ​ ​ Research and development ​ 11,799,154 ​ 13,467,845 ​ (1,668,691) (12) % General and administrative ​ 4,184,806 ​ 4,241,607 ​ (56,801) (1) % Loss on early termination of vendor agreement ​ ​ 453,135 ​ ​ — ​ ​ 453,135 ​ NM ​ Total operating expenses ​ 16,437,095 ​ 17,709,452 ​ (1,272,357) (7) % Loss from operations ​ (12,890,426) ​ (11,118,372) ​ (1,772,054) 16 % Other income (expenses): ​ ​ ​ ​ ​ ​ ​ ​ Interest income ​ 594,206 ​ 437,010 ​ 157,196 36 % Other income ​ ​ 117,444 ​ ​ — ​ ​ 117,444 ​ NM ​ Loss from operations before income taxes ​ $ (12,178,776) ​ $ (10,681,362) ​ $ (1,497,414) ​ 14 % ​ Revenue We did not generate any revenue during the years ended December 31, 2025 and 2024, respectively, from the sales or licensing of our product candidates.
We currently plan to raise additional capital through the issuance of common shares and receive additional grant funds, which could enable us to fund our operating expenses and capital expenditure requirements beyond the first quarter of 2026, although no assurance can be given that such capital or existing awarded grants will be earned or future grants will be awarded.
We currently plan to raise additional capital through the issuance of common shares and receive additional grant funds, which could enable us to fund our operating expenses and capital expenditure requirements beyond the fourth quarter of 2026, although no assurance can be given that such capital or existing awarded grants will be earned or future grants will be awarded.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion of our financial condition, changes in financial condition, plan of operations and results of operations should be read in conjunction with (i) our audited consolidated financial statements as of December 31, 2024 and December 31, 2023 and (ii) the section entitled “Business”, included in this annual report.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion of our financial condition, changes in financial condition, plan of operations and results of operations should be read in conjunction with (i) our audited consolidated financial statements as of December 31, 2025 and December 31, 2024 and (ii) the section entitled “Business”, included in this annual report.
Under both accounting frameworks, revenue is recognized when the Company incurs expenses related to the grants for the amount the Company is entitled to under the provisions of the contract. During the two years ended December 31, 2024, the Company did not participate in any collaboration agreements.
Under both accounting frameworks, revenue is recognized when the Company incurs expenses related to the grants for the amount the Company is entitled to under the provisions of the contract. During the two years ended December 31, 2025, the Company did not participate in any collaboration agreements.
In those studies, BCM saw evidence of clinical benefit, expansion of infused cells, and decreased toxicity compared to other cellular therapies. 69 Table of Contents 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 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 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.
In those studies, BCM saw evidence of clinical benefit, expansion of infused cells, and decreased toxicity compared to other cellular therapies. 65 Table of Contents We anticipate to continue to advance 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 in AML or MDS) 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 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.
In May 2023, we received notice of a $2.0 million grant from the National Institutes of Health Small Business Innovation Research (“SBIR”) program to support the development and investigation of MT-401 for the treatment of AML patients following standard-of-care therapy with hypomethylating agents.
In May 2023, we received notice of a $2.0 million grant from the National Institutes of Health (“NIH”) Small Business Innovation Research (“SBIR”) program to support the development and investigation of MT-401 for the treatment of AML patients following standard-of-care therapy with hypomethylating agents (the “SBIR AML Grant”).
The incurrence of indebtedness would result in increased fixed payment obligations and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact 78 Table of Contents our ability to conduct our business.
The incurrence of indebtedness would result in increased fixed payment obligations and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.
We do not believe that inflation has had a material impact on our results of operations for the periods presented, except with respect to payroll-related costs and other costs arising from or related to government-imposed regulations. ITEM 7A.
We do not believe that inflation has had a material impact on our results of operations for the periods presented, except with respect to payroll-related costs and other costs arising from or related to government-imposed regulations. 76 Table of Contents ITEM 7A.
The federal net operating loss carryforwards of $99.9 million generated in 2018 and thereafter are subject to an 80% limitation on taxable income, do not expire and will carry forward indefinitely. The state net operating loss carryforwards of $21.9 million, if not utilized, will begin to expire in 2035.
The federal net operating loss carryforwards of $148.4 million generated in 2018 and thereafter are subject to an 80% limitation on taxable income, do not expire and will carry forward indefinitely. The state net operating loss carryforwards of $21.9 million, if not utilized, will begin to expire in 2035.
Our Phase 1 APOLLO study is investigating MT-601, a MAR-T cell product, in patients with lymphoma who have relapsed after anti-CD19 chimeric antigen receptor (CAR) T cell therapy or where anti-CD19 CAR-T cells are not an option.
Our Phase 1 APOLLO study is investigating MT-601, a MAR-T cell product, in patients with lymphoma who have relapsed after anti-CD19 chimeric antigen receptor (CAR) T cell therapy or for whom anti-CD19 CAR-T cells are not an option.
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.
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, Mr.
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”.
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.
Financing Activities Net cash provided by financing activities was $15.0 million and $1.1 million during the years ended December 31, 2024 and 2023, respectively, primarily due to the net proceeds received from sale of common stock through the Private Placement in 2024 and ATM Agreement in 2023, as well as the exercise of stock options.
Financing Activities Net cash provided by financing activities was $9.9 million and $15.0 million during the years ended December 31, 2025 and 2024, respectively, primarily due to the net proceeds received from sale of common stock through the ATM Agreement in 2025 and Private Placement in 2024, as well as the exercise of stock options.
Other Income (Expense) Interest Income Interest income was $0.4 million and $0.5 million for the years ended December 31, 2024 and 2023, respectively, and was attributable to interest income relating to funds that are held in U.S. Treasury notes and U.S. government agency-backed securities.
Other Income (Expense) Interest Income Interest income was $0.6 million and $0.4 million for the years ended December 31, 2025 and 2024, respectively, and was attributable to interest income relating to funds that are held in U.S. Treasury notes and U.S. government agency-backed securities.
Based on our lack of recurring revenues, anticipated uses of cash and historical recurring cash losses from operating activities, and cash and cash equivalents as of December 31, 2024, we anticipate that we will be able to fund our operating expenses and capital expenditure requirements into the first quarter of 2026, assuming no additional grant funds are received.
Based on our lack of recurring revenues, anticipated uses of cash and historical recurring cash losses from operating activities, and cash and cash equivalents as of December 31, 2025, we anticipate that we will be able to fund our operating expenses and capital expenditure requirements through the fourth quarter of 2026, assuming no additional grant funds are received.
The Company is not subject to any termination penalties related to the termination of the ATM Agreement. In November 2024, we entered into an At The Market Offering Agreement, or the Sales Agreement, with H.C. Wainwright & Co.
The Company is not subject to any termination penalties related to the termination of the ATM Agreement. In November 2024, we entered into an At The Market Offering Agreement (the “Sales Agreement”), with H.C. Wainwright & Co.
Tax Loss and Credit Carryforwards As of December 31, 2024, we have approximately $138.3 million of federal and $38.8 million of state net operating loss carryforwards that may be available to offset future taxable income, if any. The federal net operating loss carryforwards of $38.4 million, if not utilized, will expire between 2030 and 2037.
Tax Loss and Credit Carryforwards As of December 31, 2025, we have approximately $186.8 million of federal and $38.6 million of state net operating loss carryforwards that may be available to offset future taxable income, if any. The federal net operating loss carryforwards of $38.4 million, if not utilized, will expire between 2030 and 2037.
At December 31, 2024 and 2023, we recorded a 100% valuation allowance against our deferred tax assets of approximately $41.0 million and $39.7 million, respectively, as our management believes it is uncertain that they will be fully realized.
At December 31, 2025 and 2024, we recorded a 100% valuation allowance against our deferred tax assets of approximately $43.3 million and $41.0 million, respectively, as our management believes it is uncertain that they will be fully realized.
The use of cash primarily related to our net loss from continuing operations of $10.7 million and a $0.5 million decrease from changes in assets and liabilities, offset by $0.2 million of stock-based compensation. Net cash used in operating activities from continuing operations during the year ended December 31, 2023 was $10.3 million.
The use of cash primarily related to our net loss of $12.2 million and a $0.3 million decrease from changes in assets and liabilities, offset by $0.5 million of stock-based compensation. Net cash used in operating activities during the year ended December 31, 2024 was $10.9 million.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our stockholders will be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of our existing stockholders’ common stock.
We may also consider new collaborations or selectively partner our technology. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our stockholders will be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of our existing stockholders’ common stock.
In August 2024, the Company received notice of an additional $2.0 million grant from the SBIR program to support the clinical investigation of MT-601 in patients with non-Hodgkin’s lymphoma (NHL) who have relapsed following anti-CD19 chimeric antigen receptor (CAR) T cell therapy.
In August 2024, we received notice of an additional $2.0 million grant from the NIH SBIR program to support the clinical investigation of MT-601 in patients with non-Hodgkin’s lymphoma (“NHL”) who have relapsed following anti-CD19 chimeric antigen receptor (“CAR”) T cell therapy (the “SBIR NHL Grant”).
General and Administrative Expenses General and administrative expenses consist primarily of personnel costs, including share-based compensation, legal fees relating to patent and corporate matters, insurance costs, consulting and professional fees, audit and investor relations. Income Taxes We recognized $50,000 and $4,000 in state tax expense for the years ended December 31, 2024 and 2023, respectively.
General and Administrative Expenses General and administrative expenses consist primarily of personnel costs, including share-based compensation, legal fees relating to patent and corporate matters, insurance costs, consulting and professional fees, audit and investor relations. Income Taxes We recognized ($15,156) and $49,953 in state tax (benefit) expense for the years ended December 31, 2025 and 2024, respectively.
In June 2024, the Company received notice of a $2.0 million grant over a 2-year period from the National Institutes of Health - National Cancer Institute (“NIH”) to support control over tumor immune escape in pancreatic cancer using a dual T cell product strategy.
In June 2024, we received notice of a $2.0 million grant over a 2-year period from the National Institutes of Health SBIR program to support control over tumor immune escape in pancreatic cancer using a dual T cell product strategy (the “Decoy Grant”).
Costs and timing of clinical trials and development of our product candidates will depend on a variety of factors that include, but are not limited to, the following: ● per patient clinical trial costs; ● the number of patients that participate in the clinical trials; ● the number of sites included in the clinical trials; ● the length of time required to enroll eligible patients; ● the number of doses that patients receive; ● the drop-out or discontinuation rates of patients; ● potential additional safety monitoring or other studies requested by regulatory agencies; 72 Table of Contents ● the duration of patient follow-up; ● the efficacy and safety profile of the product candidates; and ● the ability to successfully manufacture patient doses.
Costs and timing of clinical trials and development of our product candidates will depend on a variety of factors that include, but are not limited to, the following: ● per patient clinical trial costs; ● the number of patients that participate in the clinical trials; ● the number of sites included in the clinical trials; ● the length of time required to enroll eligible patients; ● the number of doses that patients receive; ● the drop-out or discontinuation rates of patients; ● potential additional safety monitoring or other studies requested by regulatory agencies; ● the duration of patient follow-up; ● the efficacy and safety profile of the product candidates; and ● the ability to successfully manufacture patient doses. 68 Table of Contents In addition, the potential for success of each product candidate will depend on numerous factors, including clinical trial outcomes, acceptance by regulatory authorities, competition, manufacturing capability and commercial viability.
Operating Expenses Operating expenses incurred during the fiscal year ended December 31, 2024 were $17.7 million compared to $17.9 million in the prior year.
Operating Expenses Operating expenses incurred during the fiscal year ended December 31, 2025 were $16.4 million compared to $17.7 million in the prior year.
Operating expenses incurred during the fiscal year ended December 31, 2024 were $17.7 million compared to $17.9 million in the prior year.
Operating expenses incurred during the fiscal year ended December 31, 2025 were $16.5 million compared to $17.7 million in the prior year.
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 71 Table of Contents and commercial supply.
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.
Until such time, if ever, that we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity or debt financings and collaboration arrangements. We plan to continue to fund our operations and capital funding needs through equity and/or debt financing. We may also consider new collaborations or selectively partner our technology.
Until such time, if ever, that we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity or debt financings and collaboration arrangements. 73 Table of Contents We plan to continue to fund our operations and capital funding needs through equity and/or debt financing.
On December 19, 2024, we issued a press release providing an update on the progress and clinical observations from the Phase 1 APOLLO study, with a data cutoff date of September 10, 2024.
In August 2025, we issued a press release providing an update on the progress and clinical observations from the Phase 1 APOLLO study, with a data cutoff date of June 2025.
We currently plan to raise additional capital 75 Table of Contents through the issuance of common shares and receipt of additional grant funds, which could enable us to fund our operating expenses and capital expenditure requirements beyond the first quarter of 2026, although no assurance can be given that such capital or existing awarded grants will be earned or future grants will be awarded.
We are considering raising additional capital through the issuance of common shares or preferred shares and intend to apply for additional grant funds, which could enable us to fund our operating expenses and capital expenditure requirements beyond the fourth quarter of 2026, although no assurance can be given that such capital or existing awarded grants will be earned or future grants will be awarded.
Total gross proceeds from the sale of securities in the Private Placement, before deducting commissions to the placement agent and estimated offering expenses, was approximately $16.1 million, which does not include any proceeds that may be received upon exercise 79 Table of Contents of any warrants issued in the Private Placement.
The purchase price per share of common stock and accompanying Private Placement Warrant to purchase a share of common stock was $3.20, and the purchase price per Pre-Funded Warrant and accompanying Private Placement Warrant to purchase a share of common stock was $3.199. 74 Table of Contents Total gross proceeds from the sale of securities in the Private Placement, before deducting commissions to the placement agent and estimated offering expenses, was approximately $16.1 million, which does not include any proceeds that may be received upon exercise of any warrants issued in the Private Placement.
Our financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.
Our financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern. Critical Accounting Policies and Estimates The consolidated financial statements are prepared in conformity with U.S.
This estimate is subject to our ability to effectively manage our costs, raise additional capital, and receive additional grant funds.
This estimate is subject to our ability to effectively manage our costs, raise additional capital, and receive additional grant funds, of which there can be no assurance.
The increase of $3.1 million in 2024 was primarily attributable to the following: ● increase of $4.5 million in Cell Ready (outsourced) clinical manufacturing costs and process development expenses, ● increase of $1.8 million in clinical trial expenses, offset by ● decrease of $1.2 million in process development expenses, ● decrease of $1.5 million in headcount-related expenses, including stock-based compensation expense and ● decrease of $0.5 million in other expenses. 74 Table of Contents General and Administrative Expenses General and administrative expenses decreased by 43% to $4.2 million for the year ended December 31, 2024 from $7.5 million during the prior period.
The decrease of $1.7 million in 2025 was primarily attributable to the following: ● Net decrease of $3.2 million in clinical trial expenses, primarily related to the AML study, offset by ● increase of $1.4 million in clinical consulting expenses, process development costs, and other clinical expenses, and 70 Table of Contents ● increase of $0.1 million in headcount-related expenses, including stock-based compensation expense General and Administrative Expenses General and administrative expenses decreased by 1% to $4.2 million for the year ended December 31, 2025 from $4.2 million during the prior period, and therefore remained consistent overall year over year.
The use of cash primarily related to our net loss from continuing operations of $14.0 million, partially offset by a $2.8 million increase from changes in assets and liabilities and $0.9 million of stock-based compensation.
The use of cash primarily related to our net loss of $10.7 million and a $0.4 million decrease from changes in assets and liabilities, offset by $0.2 million of stock-based compensation.
The Company recognizes grant income when amounts eligible for reimbursement are determinable and have been incurred, the applicable conditions under the grant arrangements have been met, and collectability of amounts due is reasonably assured or already 80 Table of Contents received.
The Company recognizes grant income when amounts eligible for reimbursement are determinable and have been incurred, the applicable conditions under the grant arrangements have been met, and collectability of amounts due is reasonably assured or already received. The classification of costs incurred related to grants is based on the nature of the activities performed by the Company.
The classification of costs incurred related to grants is based on the nature of the activities performed by the Company. Grant Income is recognized when the related costs are incurred. Restricted cash received from grants in advance of incurring qualifying costs is recorded as deferred revenue and recognized as revenue when qualifying costs are incurred.
Grant Income is recognized when the related costs are incurred. Restricted cash received from grants in advance of incurring qualifying costs is recorded as deferred revenue and recognized as revenue when qualifying costs are incurred. Qualifying grant income earned in advance of cash received from grants is recognized as revenue and recorded as other receivable.
Liquidity and Capital Resources We have not generated any revenues from the sales or licensing of our product candidates since inception and only have limited revenue associated with grants to fund research.
Liquidity and Capital Resources We have not generated any revenues from the sales or licensing of our product candidates since inception and only have limited revenue associated with grants to fund research. We have financed our operations primarily through public and private offerings of our stock and debt including warrants and the exercise thereof, as well as grants.
During the year ended December 31, 2024, we recognized approximately $7,000 of revenue associated with this grant. In December 2024, the Company received notice an additional $9.5 million grant from CPRIT to support the clinical investigation of MT-601 in patients with metastatic pancreatic cancer.
In December 2024, we received notice an additional $9.5 million grant from CPRIT to support the clinical investigation of MT-601 in patients with metastatic pancreatic cancer (the “CPRIT Pancreatic Grant”).
Significant changes in operating expenses are outlined as follows: Research and Development Expense Research and development expenses or clinical trial costs increased by 29% to $13.5 million for the year ended December 31, 2024, compared to $10.4 million for the year ended December 31, 2023, mainly as a result of the Cell Ready transaction.
Significant changes in operating expenses are outlined as follows: Research and Development Expense Research and development expenses or clinical trial costs decreased by 12% to $11.8 million for the year ended December 31, 2025, compared to $13.5 million for the year ended December 31, 2024.
The Company recorded $0.7 million of grant income related to this grant as revenue for the year ended December 31, 2024. In August 2024, the Company received another $2.0 million grant from the National Institutes of Health SBIR Program to support the advancement of MT-601 in patients with pancreatic cancer.
In August 2024, we received another $2.0 million grant from the National Institutes of Health SBIR Program to support the advancement of MT-601 in patients with pancreatic cancer (the “PANACEA Grant”).
Unless otherwise discussed, the Company does not believe that the impact of recently issued standards that are not yet effective will have a material impact on its financial position or results of operations upon adoption.
Unless otherwise discussed, the Company does not believe that the impact of recently issued standards that are not yet effective will have a material impact on its financial position or results of operations upon adoption. 75 Table of Contents Government Grants (Topic 832): Accounting for Government Grants Received by Business Entities In December 2025, the FASB issued ASU 2025-10, Government Grants (Topic 832): Accounting for Government Grants Received by Business Entities.
Qualifying grant income earned in advance of cash received from grants is recognized as revenue and recorded as other receivable. New Accounting Standards From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date.
Recently Issued Accounting Standards Not Yet Adopted From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date.
The state net operating loss carryforwards of $16.9 million 81 Table of Contents generated in 2018 and thereafter are subject to an 80% limitation on taxable income, do not expire and will carry forward indefinitely.
The state net operating loss carryforwards of $16.7 million generated in 2018 and thereafter are subject to an 80% limitation on taxable income, do not expire and will carry forward indefinitely. Any change in ownership greater than 50% under Section 382 of the Internal Revenue Code places significant annual limitations on the use of such net operating loss carryforwards.
Cash and Working Capital The following table sets forth our cash and cash equivalents and working capital as of December 31, 2024 and 2023: ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2024 December 31, 2023 Cash and cash equivalents ​ $ 19,192,000 ​ $ 15,111,000 Working capital ​ $ 18,558,000 ​ $ 14,053,000 ​ Cash Flows The following table summarizes our cash flows for the years ended December 31, 2024 and 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Years Ended ​ ​ December 31, ​ 2024 2023 Continuing operations: ​ ​ ​ ​ ​ ​ Net cash used in operating activities $ (10,910,000) $ (10,341,000) Net cash provided by financing activities ​ ​ 14,991,000 ​ ​ 1,105,000 Discontinued operations ​ ​ ​ ​ ​ ​ Net cash used in operating activities ​ — ​ (6,099,000) Net cash provided by (used in) investing activities ​ $ — ​ $ 18,664,000 Net increase (decrease) in cash and cash equivalents ​ $ 4,081,000 ​ $ 3,329,000 ​ Continuing Operations Operating Activities Net cash used in operating activities from continuing operations during the year ended December 31, 2024 was $10.9 million.
Cash and Working Capital The following table sets forth our cash, cash equivalents, and restricted cash as well as working capital as of December 31, 2025 and 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2025 ​ ​ ​ December 31, 2024 Cash, cash equivalents, and restricted cash ​ $ 17,042,847 ​ $ 19,192,440 Working capital ​ $ 16,796,814 ​ $ 18,558,406 ​ 71 Table of Contents Cash Flows The following table summarizes our cash flows for the years ended December 31, 2025 and 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Years Ended ​ ​ December 31, ​ ​ ​ ​ 2025 ​ ​ ​ 2024 Net cash provided by (used in): ​ ​ ​ ​ ​ ​ Operating activities $ (12,014,081) $ (10,910,324) Investing activities ​ ​ — ​ ​ — Financing activities ​ ​ 9,864,488 ​ ​ 14,991,314 Net (decrease) increase in cash, cash equivalents, and restricted cash ​ $ (2,149,593) ​ $ 4,080,990 ​ Continuing Operations Operating Activities Net cash used in operating activities during the year ended December 31, 2025 was $12.0 million.
However, immunomonitoring data confirmed that lymphodepletion enhanced the expansion and persistence of MAR-T cell clones in vivo. 70 Table of Contents Pipeline Our clinical-stage pipeline is set forth below: Manufacturing Our manufacturing process was originally developed at Baylor College of Medicine, where we initially conducted our clinical trials.
Study participants showed objective responses and a favorable safety profile with and without lymphodepletion. 66 Table of Contents Pipeline Our clinical-stage pipeline is set forth below: Manufacturing Our manufacturing process was originally developed at Baylor College of Medicine, where we initially conducted our clinical trials.
Based on our lack of recurring revenues, anticipated uses of cash and historical recurring cash losses from operating activities, and cash and cash equivalents as of December 31, 2024, we anticipate that we will be able to fund our operating expenses and capital expenditure requirements into the first quarter of 2026, assuming no additional grant funds are received.
Wainwright & Co., LLC, we anticipate that we will be able to fund our operating expenses and capital expenditure requirements through the fourth quarter of 2026, assuming no additional grant funds are received, either from new grants or from existing awarded grants.
If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts. In August 2021, the Company received notice of a Product Development Research award totaling approximately $13.1 million from the CPRIT to support the Company’s clinical investigation of MT-401.
If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts. 72 Table of Contents Other receivable mainly consists of grant income receivable.
In August 2021, we received notice of a Product Development Research award totaling approximately $13.1 million from the Cancer Prevention and Research Institute of Texas, or CPRIT, to support our Phase 2 clinical trial of MT-401.
In August 2021, we received notice of a Product Development Research award totaling approximately $13.1 million from the Cancer Prevention and Research Institute of Texas (“CPRIT”), to support the clinical investigation of MT-401 as an Off-the-Shelf (“OTS”) product in patients with Acute Myeloid Leukemia (“AML”) (the “CPRIT AML Grant”). 69 Table of Contents In September 2022, we received notice from the FDA that we had been awarded a $2.0 million grant from the FDA’s Orphan Products Grant program to support the clinical investigation of MT-401 for the treatment of AML (the “FDA Grant”).
Net Loss from continuing operations The decrease in our net loss from continuing operations during the year ended December 31, 2024 compared to the year ended December 31, 2023 was due to cost reductions in our general and administrative expenses, as well as higher grant income.
Other Income Other income was $0.1 million and nil for the years ended December 31, 2025 and 2024, respectively, and was attributable to a state sales tax rebate from 2022. Net Loss The increase in our net loss during the year ended December 31, 2025 compared to the year ended December 31, 2024 was due to lower grant income.
A total of 10 patients have been treated in the study, for which clinical data is currently available for 9 patients from 5 clinical sites across the United States. Study participants showed early objective responses with and without lymphodepletion.
In this update, clinical data was available for a total of 24 B-cell lymphoma patients from 7 clinical sites across the United States, including 15 patients with Non-Hodgkin Lymphoma (“NHL”) and 9 patients with Hodgkin Lymphoma (“HL”). At the time of the data cutoff, 12 NHL and 9 HL patients have been assessed.
Removed
In July 2021, we opened an in-house cGMP manufacturing facility in Houston, Texas, where we manufactured the clinical supply of our product candidates.
Added
See “Risk Factors”. 67 Table of Contents Recent Developments On June 16, 2025, Company entered into a Statement of Work (the “SOW”) with Cellipont Bioservices, a leading cell therapy Contract Development and Manufacturing Organization (“CDMO”), for the manufacturing of MT-601, the Company’s lead MAR-T cell product candidate.
Removed
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”).
Added
Pursuant to the SOW, Cellipont will provide technology transfer and cGMP manufacturing services to support the scale-up and production of MT-601 for the Company’s APOLLO study. Between July 17 and 21, 2025, the Company sold 1,624,075 shares of common stock pursuant to our ATM Agreement, with H.C. Wainwright & Co.
Removed
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.
Added
LLC, for net proceeds of $4.5 million, after deducting agent commissions, at an average price per share of $2.87 per share. On August 26, 2025, the Company sold 3,734,217 shares of common stock pursuant to the ATM Agreement with H.C.
Removed
Additionally, BCM continues to supply us with products, as we continue our clinical trials.
Added
Wainwright & Co., LLC for net proceeds of $5.4 million, after deducting agent commissions, at an average price of $1.48 per share. On October 6, 2025, the Company announced that the first patient has been treated in the Off-the-Shelf (“OTS”) program, with encouraging preliminary safety data.
Removed
During the years ended December 31, 2024 and 2023, the Company incurred $5.8 million and $1.3 million in expenses related to the Cell Ready services and manufacturing costs, respectively. During the year ended December 31, 2024 the Company paid $5.5 million related to Cell Ready invoices received.
Added
The OTS program has the potential to provide a fast treatment option for patients with rapidly progressing diseases. The OTS product will be initially investigated in patients with acute myeloid leukemia (“AML”) or myelodysplastic syndromes (“MDS”), with the potential to be expanded to other indications. Effective November 1, 2025, Kathryn Penkus Corzo joined the Company’s Board of Directors.
Removed
Recent Developments On December 19, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”), pursuant to which the Company issued and sold in a private Placement the following securities: (i) 1,783,805 shares of common stock, (ii) Series B Warrants, or Pre-Funded Warrants, to purchase an aggregate of 3,247,445 shares of common stock in lieu of shares of common stock and (iii) Series A Warrants, or Private Placement Warrants, to purchase an aggregate of 5,031,250 shares of common stock.
Added
The following table summarizes grant income recorded for the years ended December 31, 2025 and 2024, by grant: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ For the Years Ended ​ ​ December 31, ​ ​ ​ ​ 2025 ​ ​ ​ 2024 Grant income: ​ ​ ​ ​ CPRIT AML Grant 1 ​ $ 900,014 ​ $ 4,411,149 FDA Grant ​ 118,478 ​ 519,750 SBIR AML Grant ​ 472,208 ​ 982,182 Decoy Grant ​ 391,305 ​ 5,822 SBIR NHL Grant ​ 665,000 ​ 665,000 PANACEA Grant ​ 425,670 ​ 7,177 CPRIT Pancreatic Grant 1 ​ 573,994 ​ — Total grant income ​ $ 3,546,669 ​ $ 6,591,080 (1) Both CPRIT grants are subject to certain revenue - sharing arrangements, as per the grant agreements (see Note 10).
Removed
The purchase price per share of common stock and accompanying Private Placement Warrant to purchase a share of common stock was $3.20, and the purchase price per Pre-Funded Warrant and accompanying Private Placement Warrant to purchase a share of common stock was $3.199.
Added
Based on our lack of recurring revenues, anticipated uses of cash and historical recurring cash losses from operating activities, and cash, cash equivalents, and restricted cash as of December 31, 2025, and taking into consideration the net proceeds received in July and August of 2025 through the sale of Common Stock pursuant to its ATM Agreement with H.C.
Removed
Total gross proceeds from the sale of securities in the Private Placement, before deducting commissions to the placement agent and estimated offering expenses, was approximately $16.1 million, which does not include any proceeds that may be received upon exercise of any warrants issued in the Private Placement.
Added
Qualifying grant income earned in advance of cash received from grants is recognized as revenue and recorded as other receivable.
Removed
On March 21, 2025, the Company held a Special Meeting of Stockholders (the “Special Meeting”) at which the stockholders approved, in accordance with Nasdaq Listing Rule 5635(d), of the issuance of the shares issuable upon exercise of (i) Series A Warrants to acquire 5,031,250 shares of Common Stock and (ii) Series B Warrants to acquire 3,247,445 shares of Common Stock.
Added
The following table summarizes the Company’s other receivable balance as of December 31, 2025 and 2024, respectively: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ ​ ​ ​ 2025 ​ ​ ​ 2024 Grant income receivable: ​ ​ ​ ​ ​ CPRIT AML Grant ​ $ 815,436 ​ $ 2,059,457 FDA Grant ​ 3,678 ​ — SBIR AML Grant ​ 162,897 ​ 244,810 Decoy Grant ​ 59,501 ​ 5,822 SBIR NHL Grant ​ 87,417 ​ — PANACEA Grant ​ 190,052 ​ 6,502 Total grant income receivable ​ 1,318,981 ​ 2,316,591 Interest receivable ​ 50,419 ​ 28,112 Other ​ — ​ 2,000 Total other receivable ​ $ 1,369,400 ​ $ 2,346,703 ​ As of December 31, 2025, we had working capital of $16.8 million, compared to working capital of $18.6 million as of December 31, 2024.
Removed
In addition, the potential for success of each product candidate will depend on numerous factors, including clinical trial outcomes, acceptance by regulatory authorities, competition, manufacturing capability and commercial viability.
Added
Between July 17 and 21, 2025, the Company sold 1,624,075 shares of common stock pursuant to our ATM Agreement with H.C. Wainwright & Co., LLC for net proceeds of $4.5 million, after deducting agent commissions, at an average price of $2.87 per share.
Removed
During the years ended December 31, 2024 and 2023, respectively, we recognized $4.4 million and $2.7 million of revenue associated with the CPRIT grant. 73 Table of Contents In September 2022, we received notice from the FDA that we had been awarded a $2.0 million grant from the FDA’s Orphan Products Grant program to support our Phase 2 clinical trial of MT-401 for the treatment of post-transplant AML.
Added
On August 26, 2025, the Company sold 3,734,217 shares of common stock pursuant to the ATM Agreement with H.C. Wainwright & Co., LLC for net proceeds of $5.4 million, after deducting agent commissions, at an average price of $1.48 per share.
Removed
During the years ended December 31, 2024 and 2023, we recognized $0.5 million and $0.4 million of revenue associated with the FDA grant, respectively.
Added
The new standard is intended to establish authoritative guidance on the accounting for government grants received by business entities and reduce diversity in practice. The amendments establish the timing and methods of recognition of both (1) a grant related to an asset and (2) a grant related to income.
Removed
During the years ended December 31, 2024 and 2023, we recognized $1.0 million and $0.2 million of revenue associated with the SBIR grant, respectively. The above funding agencies have agreed to continue their financial support and to shift funds to the MT-401-OTS program.
Added
The amendments also require certain disclosures including the nature of the grant received, the accounting policies used to account for the grant, and significant terms and conditions for the grant. The new guidance is effective for annual reporting periods beginning after December 15, 2028, and interim reporting periods within those annual reporting periods. Early adoption is permitted.
Removed
In June 2024, the Company received notice of a $2.0 million grant over a 2-year period from the National Institutes of Health – National Cancer Institute to support control over tumor immune escape in pancreatic cancer using a dual T cell product strategy. During the year ended December 31, 2024, we recognized approximately $6,000 of revenue associated with this grant.
Added
The new guidance may be applied on a modified prospective basis, modified retrospective basis, or full retrospective basis. The Company is currently evaluating the impact of ASU 2025-10 on its consolidated financial statements.
Removed
The Company did not record any grant income related to this grant for the year ended December 31, 2024. This CPRIT grant and the August 2021 CPRIT grant are subject to certain revenue-sharing arrangements, see Note 11 to the accompanying financial statements for further information.

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