Marker Therapeutics Inc.
11/13/2025 | Press release | Distributed by Public on 11/13/2025 16:30
Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)
Management's Discussion and Analysis of Financial Condition and Results of Operations
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, that involve risks and uncertainties. All statements other than statements relating to historical matters including statements to the effect that we "believe", "expect", "anticipate", "plan", "target", "intend" and similar expressions should be considered forward-looking statements. Our actual results could differ materially from those discussed in the forward-looking statements as a result of a number of important factors, including factors discussed in this section and elsewhere in this Quarterly Report on Form 10-Q, and the risks discussed in our other filings with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management's analysis, judgment, belief, or expectation only as the date hereof. We assume no obligation to update these forward-looking statements to reflect events or circumstance that arise after the date hereof.
As used in this quarterly report: (i) the terms "we", "us", "our", "Marker" and the "Company" mean Marker Therapeutics, Inc. and its wholly owned subsidiaries, Marker Cell Therapy, Inc. and GeneMax Pharmaceuticals Inc. which wholly owns GeneMax Pharmaceuticals Canada Inc., unless the context otherwise requires; (ii) "SEC" refers to the Securities and Exchange Commission; (iii) "Securities Act" refers to the Securities Act of 1933, as amended; (iv) "Exchange Act" refers to the Securities Exchange Act of 1934, as amended; and (v) all dollar amounts refer to United States dollars unless otherwise indicated.
The following should be read in conjunction with our unaudited condensed consolidated interim financial statements and related notes included in this Quarterly Report on Form 10-Q.
Company 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. This approach selectively expands natural tumor-specific T cells from a patient's/donor's blood that are capable of recognizing a broad range of tumor associated antigens, or TAAs. Unlike other T cell therapies, MAR-T cells are able to recognize hundreds of different epitopes within up to six tumor-specific antigens to produce broad spectrum anti-tumor activity. Targeting multiple antigens simultaneously exploits the natural capacity of T cells to recognize and kill tumor targets via native T cell receptors ("TCR"), while limiting tumor adaptation/escape by antigen-negative selection or antigen down-regulation. When infused into a patient with cancer, MAR-T cells are designed to recognize and kill cancer cells expressing the TAA.
We licensed the underlying technology for MAR-T cell therapy from Baylor College of Medicine, or BCM, in March 2018. BCM had utilized the therapy in seven exploratory clinical trials. 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.
We are advancing two product candidates for 3 clinical indications as part of our MAR-T cell program for:
| ● | Autologous MAR-T cell product candidate for the treatment of lymphoma and pancreatic cancer (MT-601) |
| ● | Off-the-Shelf (OTS) product candidate in various indications (e.g., MT-401-OTS) |
We do not genetically engineer our MAR-T cells 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 cells to date |
| ● | Non-genetically engineered T cell → 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 product candidates may provide meaningful clinical benefit and safety to patients with both hematological and solid tumors.
We believe that the simplicity of our manufacturing process allows additional modifications to expand MAR-T cell recognition of cancer targets. For example, we are assessing the potential of combining MAR-T cell product candidates with other products.
On August 26, 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. The Phase 1 APOLLO study is investigating MT-601, a MAR-T cell product candidate, in patients with lymphoma who have relapsed after anti-CD19 CAR-T cell therapy or for whom anti-CD19 CAR-T cells are not an option. 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. Study participants showed objective responses and a favorable safety profile with and without lymphodepletion.
Key findings from the APOLLO study include:
| ● | Safety- The dose escalation portion of the study tested doses ranging from 100x106-400x106cells. Infusion of MT-601 was well tolerated in all study participants, with no observation of immune-effector cell associated neurotoxicity syndrome ("ICANS") and two reported Grade 1 cytokine release syndrome ("CRS") events (fever; no treatment was required). No dose limiting toxicities ("DLTs") have been reported to date. No change in DLTs or ICANS was observed between patients treated with and without lymphodepletion. |
| ● | Efficacy and Duration of Response- Eight out of 12 NHL patients achieved objective responses (66%), with 6 patients demonstrating complete response ("CR") as best response (50%). Durable responses were observed (range 3-24 months) with 5 NHL patients showing continued response over 6 months, including 3 patients with over 12 months durability. Seven out of 9 HL patients had objective responses (78%), with 1 patient demonstrating CR (11%) highlighting the versatility of MT-601 across multiple histologies. |
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. We continue to contract and collaborate with BCM and others to perform a wide variety of services to ensure the continuation of our research and development efforts, with the goal of optimizing our manufacturing process, product quality and commercial scalability.
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"). On March 27, 2025, we mutually agreed with Cell Ready to terminate the MSA. In connection therewith, we and Cell Ready entered into a settlement and release agreement pursuant to which we paid Cell Ready approximately $453,000 and we and Cell Ready provided one another mutual releases of all claims associated with any and all agreements between Marker and Cell Ready.
While 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, 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 Multi-Antigen Recognizing (MAR)-T cell therapy. 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.
However, there is no guarantee that we will or have properly estimated our required manufacturing capacities or that the third parties on which we rely to manufacture our products will be able or willing to perform on our proposed timelines or to meet our manufacturing demands, if at all. If any of our third-party vendors experience disruptions, or otherwise cease or substantially reduce the amount of products they are willing to supply us, our business and operations could be adversely affected.
During the three and nine months ended September 30, 2025, we incurred $0.1 million and $1.1 million in expenses related to Cell Ready services and manufacturing costs, respectively (three and nine months ended September 30, 2024 - $1.2 million and $3.1 million, respectively). During the nine months ended September 30, 2025, we paid $2.6 million related to Cell Ready invoices received (three and nine months ended September 30, 2024 - $0.5 million and $3.4 million, respectively). During the three and nine months ended September 30, 2025, we incurred $0.4 million and $3.0 million, respectively, in expenses related to BCM services and manufacturing costs. BCM expenses were $6,000 during the three and nine months ended September 30, 2024. During the three and nine months ended
September 30, 2025, we paid approximately $4,000 and $2.7 million related to BCM invoices received, respectively. During the three and nine months ended September 30, 2025, we incurred $0.1 million and $0.3 million, respectively, in expenses related to Cellipont services and manufacturing costs. No Cellipont expenses were incurred during the three or nine months ended September 30, 2024. During the three and nine months ended September 30, 2025, we paid nil and $0.4 million related to Cellipont invoices received, respectively.
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. 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. 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. 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. 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.
Results of Operations
In this discussion of our results of operations and financial condition, amounts in financial tables, other than per-share amounts, have been rounded to the nearest thousand.
Comparison of the Three months Ended September 30, 2025 and 2024
The following table summarizes the results of our continuing operations for the three months ended September 30, 2025 and 2024:
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|
|
|
|
|
|
|
|
|
|
|
|
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For the Three Months Ended |
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||||
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|
|
September 30, |
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|
|
|
||||||
|
|
2025 |
2024 |
Change |
|||||||||
|
Revenues: |
|
|
|
|
|
|||||||
|
Grant income |
|
$ |
1,233,000 |
|
$ |
1,926,000 |
|
$ |
(693,000) |
|
(36) |
% |
|
Total revenues |
|
1,233,000 |
|
1,926,000 |
|
(693,000) |
(36) |
% |
||||
|
Operating expenses: |
|
|
|
|
|
|
|
|
||||
|
Research and development |
|
2,346,000 |
|
|
3,471,000 |
|
|
(1,125,000) |
|
(32) |
% |
|
|
General and administrative |
|
1,024,000 |
|
|
855,000 |
|
|
169,000 |
|
20 |
% |
|
|
Total operating expenses |
|
3,370,000 |
|
|
4,326,000 |
|
|
(956,000) |
|
(22) |
% |
|
|
Loss from operations |
|
(2,137,000) |
|
|
(2,400,000) |
|
|
263,000 |
|
(11) |
% |
|
|
Other income (expenses): |
|
|
|
|
|
|
|
|
||||
|
Interest income |
|
138,000 |
|
|
92,000 |
|
|
46,000 |
|
50 |
% |
|
|
Loss from continuing operations |
|
$ |
(1,999,000) |
|
|
(2,308,000) |
|
$ |
309,000 |
|
(13) |
% |
Revenue
We did not generate any revenue during the three months ended September 30, 2025 and 2024, respectively, from the sales or licensing of our product candidates.
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"). During the three months ended September 30, 2025 and 2024, we recognized $0.2 million and $0.9 million of revenue, respectively, associated with the CPRIT AML Grant.
In September 2022, we received notice from the FDA that it had awarded us 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 post-transplant AML (the "FDA Grant"). During the three months ended September 30, 2025 and 2024, we recognized approximately $0.01 million and $0.02 million of revenue, respectively associated with the FDA Grant.
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"). During the three months ended September 30, 2025 and 2024, we recognized $0.2 million and $0.3 million of revenue associated with the SBIR AML Grant.
The above funding agencies have agreed to continue their financial support and to shift funds to the MT-401-OTS program.
In June 2024, we received notice of a $2.0 million grant over a 2-year period from the NIH SBIR program to support control over tumor immune escape in pancreatic cancer using a dual T cell product strategy (the "Decoy Grant"). During the three months ended September 30, 2025 and 2024, we recognized approximately $0.1 million and nil of revenue associated with the Decoy Grant, respectively.
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"). During the three months ended September 30, 2025 and 2024, we recognized $0.6 million and $0.7 million of revenue associated with the SBIR NHL Grant, respectively.
In August 2024, we received another $2.0 million grant from the NIH SBIR program to support the advancement of MT-601 in patients with pancreatic cancer (the "PANACEA Grant"). During the three months ended September 30, 2025 and 2024, we recognized approximately $0.2 million and nil of revenue associated with the PANACEA Grant, respectively.
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 metastatic pancreatic cancer (the "CPRIT Pancreatic Grant"). The Company recorded no grant income related to this grant for the three months ended September 30, 2025. As of September 30, 2025, $1.4 million was recorded as restricted cash and deferred revenue on the Company's condensed consolidated balance sheet. The CPRIT Pancreatic Grant and the CPRIT AML Grant are subject to certain revenue-sharing arrangements, see Note 11 to the accompanying condensed consolidated financial statements for further information.
Operating Expenses
Operating expenses incurred during the three months ended September 30, 2025 were $3.4 million compared to $4.3 million during the same period ended September 30, 2024.
Significant changes and expenditures in operating expenses are outlined as follows:
Research and Development Expenses
Research and development expenses decreased by 32% to $2.3 million for the three months ended September 30, 2025, compared to $3.5 million for the three months ended September 30, 2024.
The decrease of $1.2 million in 2025 was primarily attributable to the following:
| ● | decrease of $1.5 million in clinical trial expenses, offset by |
| ● | increase of $0.3 million in clinical consulting and other expenses. |
General and Administrative Expenses
General and administrative expenses increased by 20% to $1.0 million for the three months ended September 30, 2025, compared to $0.9 million during the same period ended September 30, 2024.
The increase of $0.1 million in 2025 was primarily attributable to headcount-related expenses.
Other Income (Expense)
Interest Income
Interest income was $0.1 million for the three months ended September 30, 2025 and 2024, and was attributable to interest income relating to funds that are held in U.S. Treasury notes and U.S. government agency-backed securities.
Net Loss
The decrease in our net loss during the three months ended September 30, 2025 compared to the three months ended September 30, 2024 was primarily due to cost decreases in our research and development activities. We anticipate that we will continue to incur net losses in the future as we continue to invest in research and development activities, including clinical development of our MAR-T cell product candidates.
Comparison of the Nine months Ended September 30, 2025 and 2024
The following table summarizes the results of our continuing operations for the nine months ended September 30, 2025 and 2024:
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For the Nine Months Ended |
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|
September 30, |
|
|
|
|
||||||
|
|
2025 |
2024 |
Change |
|||||||||
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant income |
|
$ |
2,443,000 |
|
$ |
4,339,000 |
|
$ |
(1,896,000) |
|
(44) |
% |
|
Total revenues |
|
2,443,000 |
|
|
4,339,000 |
|
|
(1,896,000) |
|
(44) |
% |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|||||
|
Research and development |
|
9,658,000 |
|
|
8,382,000 |
|
|
1,276,000 |
|
15 |
% |
|
|
General and administrative |
|
3,338,000 |
|
|
3,215,000 |
|
|
123,000 |
|
4 |
% |
|
|
Loss on early termination of vendor agreement |
|
|
453,000 |
|
|
- |
|
|
453,000 |
|
- |
% |
|
Total operating expenses |
|
13,449,000 |
|
|
11,597,000 |
|
|
1,852,000 |
|
16 |
% |
|
|
Loss from operations |
|
(11,006,000) |
|
|
(7,258,000) |
|
|
(3,748,000) |
|
52 |
% |
|
|
Other income (expenses): |
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|
|
|
|
|
|
|
||||
|
Interest income |
|
429,000 |
|
|
363,000 |
|
|
66,000 |
|
18 |
% |
|
|
Other income |
|
|
117,000 |
|
|
- |
|
|
117,000 |
|
- |
% |
|
Loss from continuing operations |
|
$ |
(10,460,000) |
|
|
(6,895,000) |
|
$ |
(3,565,000) |
|
52 |
% |
Revenue
We did not generate any revenue during the nine months ended September 30, 2025 and 2024, respectively, from the sales or licensing of our product candidates.
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"). During the nine months ended September 30, 2025 and 2024, we recognized $0.7 million and $2.4 million of revenue, respectively, associated with the CPRIT AML Grant.
In September 2022, we received notice from the FDA that it had awarded us 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 post-transplant AML (the "FDA Grant"). During the nine
months ended September 30, 2025 and 2024, we recognized $0.1 million and $0.5 million of revenue, respectively associated with the FDA Grant.
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"). During the nine months ended September 30, 2025 and 2024, we recognized $0.3 million and $0.7 million of revenue associated with the SBIR AML Grant.
The above funding agencies have agreed to continue their financial support and to shift funds to the MT-401-OTS program.
In June 2024, the Company received notice of a $2.0 million grant over a 2-year period from the NIH SBIR program to support control over tumor immune escape in pancreatic cancer using a dual T cell product strategy (the "Decoy Grant"). During the nine months ended September 30, 2025 and 2024, we recognized approximately $0.3 million and nil of revenue associated with the Decoy Grant, respectively.
In August 2024, the Company 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"). During the nine months ended September 30, 2025 and 2024, we recognized $0.6 million and $0.7 million of revenue associated with the SBIR NHL Grant, respectively.
In August 2024, the Company received another $2.0 million grant from the NIH SBIR Program to support the advancement of MT-601 in patients with pancreatic cancer (the "PANACEA Grant"). During the nine months ended September 30, 2025 and 2024, we recognized approximately $0.2 million and nil of revenue associated with the PANACEA Grant, respectively.
In December 2024, the Company received notice of 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"). The Company recorded $0.2 million of grant income related to this grant for the nine months ended September 30, 2025. As of September 30, 2025, $1.4 million was recorded as restricted cash and deferred revenue on the Company's condensed consolidated balance sheet. The CPRIT Pancreatic Grant and the CPRIT AML Grant are subject to certain revenue-sharing arrangements, see Note 11 to the accompanying financial statements for further information.
Operating Expenses
Operating expenses incurred during the nine months ended September 30, 2025 were $13.4 million compared to $11.6 million during the same period ended September 30, 2024.
Significant changes and expenditures in operating expenses are outlined as follows:
Research and Development Expenses
Research and development expenses increased by 15% to $9.7 million for the nine months ended September 30, 2025, compared to $8.4 million for the nine months ended September 30, 2024.
The increase of $1.3 million in 2025 was primarily attributable to the following:
| ● | increase of $0.6 million in clinical consulting expenses and other expenses, |
| ● | increase of $0.4 million in clinical trial expenses, |
| ● | increase of $0.2 million process development costs, and |
| ● | increase of $0.1 million in headcount-related expenses. |
General and Administrative Expenses
General and administrative expenses increased by 4% to $3.3 million for the nine months ended September 30, 2025, compared to $3.2 million during the same period ended September 30, 2024.
The increase of $0.1 million in 2025 was primarily attributable to higher headcount-related expenses and higher legal and professional fees.
Other Income (Expense)
Interest Income
Interest income was $0.4 million for the nine months ended September 30, 2025 and 2024, 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
Other income was $0.1 million and nil for the nine months ended September 30, 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 nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 was primarily due to cost increases in our research and development activities and the loss on termination of the Cell Ready MSA, as well as lower grant income. We anticipate that we will continue to incur net losses in the future as we continue to invest in research and development activities, including clinical development of our MAR-T cell product candidates.
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.
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 September 30, 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. Wainwright & Co., LLC, we anticipate that we will be able to fund our operating expenses and capital expenditure requirements through the third quarter of 2026, assuming no additional grant funds are received, either from new grants or from existing awarded grants. We are considering raising additional capital through the issuance of common shares and intend to apply for additional grant funds, which could enable us to fund our operating expenses and capital expenditure requirements beyond the third 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. 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.
Cash and Working Capital
The following table sets forth our cash, cash equivalents, restricted cash, and working capital as of September 30, 2025 and December 31, 2024:
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September 30, |
December 31, |
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|
|
2025 |
|
2024 |
||
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Cash, cash equivalents, and restricted cash |
|
$ |
18,943,000 |
|
$ |
19,192,000 |
|
Working capital |
|
$ |
18,389,000 |
|
$ |
18,558,000 |
Cash Flows
The following table summarizes our cash flows for the nine months ended September 30, 2025 and 2024:
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For the Nine Months Ended |
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|
September 30, |
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2025 |
2024 |
||||
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Net cash provided by (used in): |
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|
||
|
Operating activities |
|
$ |
(10,113,000) |
|
$ |
(6,207,000) |
|
Investing activities |
|
|
- |
|
|
- |
|
Financing activities |
|
|
9,864,000 |
|
|
95,000 |
|
Net decrease in cash, cash equivalents, and restricted cash |
|
$ |
(249,000) |
|
$ |
(6,112,000) |
Operating Activities
Net cash used in operating activities during the nine months ended September 30, 2025 was $10.1 million. The use of cash primarily related to our net loss of $10.5 million, offset by $0.4 million of non-cash stock-based compensation.
Net cash used in operating activities from continuing operations during the nine months ended September 30, 2024 was $6.2 million. The use of cash primarily related to our net loss from continuing operations of $6.9 million offset by a $0.5 million increase from changes in assets and liabilities and a $0.2 million increase from stock-based compensation.
Financing Activities
Net cash provided by financing activities was $9.9 million during the nine months ended September 30, 2025 due to net proceeds from the sale of common stock and the net proceeds from the exercise of warrants. Net cash provided by financing activities was $0.1 million during the nine months ended September 30, 2024 due to the net proceeds from the sale of common stock and the exercise of stock options.
Future Capital Requirements
To date, we have not generated any revenues from the commercial sale of approved drug products, and we do not expect to generate substantial revenue for at least the next several years. If we fail to complete the development of our product candidates in a timely manner or fail to obtain their regulatory approval, our ability to generate future revenue will be compromised. We do not know when, or if, we will generate any revenue from our product candidates, and we do not expect to generate significant revenue unless and until we obtain regulatory approval of, and commercialize, our product candidates. Assuming the Company can continue to raise additional capital and obtain ongoing grant funding, of which there can be no assurances, we expect our expenses to increase in connection with our ongoing activities, particularly if we are able to expand patient enrollment as we continue the research and development of our product candidates and if we are able to successfully commence our pivotal trial for lymphoma, of which there can be no assurances. In addition, if we obtain approval for any of our product candidates, of which there can be no assurances, we expect to incur significant commercialization expenses related to sales, marketing, manufacturing and distribution. We anticipate that we will need substantial additional funding in connection with our continuing operations, of which there can be no assurances. 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 in patients with AML. Through the date of this filing, the Company has received $11.8 million of funds from the CPRIT AML Grant. The Company recorded $0.2 million and $0.7 million of grant income related to the CPRIT grant as revenue during the three and nine months ended September 30, 2025, respectively, and as of September 30, 2025, the Company had a grant income receivable balance of $0.6 million for this grant.
On September 13, 2022, the Company received notice from the FDA that it had awarded the Company 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 post-transplant AML. Through the date of this filing, the Company has received $1.2 million from the FDA Grant. The Company recorded approximately
$0.01 million and $0.1 million of grant income related to the FDA Grant as revenue during the three and nine months ended September 30, 2025, and as of September 30, 2025, the Company had approximately $0.01 million of grant income receivable balance for this grant.
In May 2023, the Company announced that it had received 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. Through the date of this filing, the Company has received $1.5 million from the SBIR AML Grant. The Company recorded $0.2 million and $0.3 million of grant income from the SBIR AML Grant as revenue during the three and nine months ended September 30, 2025, respectively, and as of September 30, 2025, the Company had a grant income receivable balance of $0.2 million for this grant.
The above funding agencies have agreed to continue their financial support and to shift funds to the MT-401-OTS program.
In June 2024, the Company received notice of a $2.0 million grant over a 2-year period from the NIH SBIR program to support control over tumor immune escape in pancreatic cancer using a dual T cell product strategy. Through the date of this filing, the Company has received approximately $0.3 million from the NIH for the Decoy Grant. The Company recorded $0.1 million and $0.3 million of grant income related to the Decoy Grant as revenue during the three and nine months ended September 30, 2025, respectively, and as of September 30, 2025, the Company had a grant income receivable balance of approximately $0.02 million for this grant.
In August 2024, the Company received notice of a $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. Through the date of this filing, the Company has received $1.2 million of funds from the SBIR NHL Grant. The Company recorded $0.6 million grant income related to the SBIR NHL Grant as revenue for the three and nine months ended September 30, 2025, and as of September 30, 2025, the Company had a grant income receivable balance of $0.6 million for this grant.
In August 2024, the Company received another $2.0 million grant from the NIH SBIR Program to support the advancement of MT-601 in patients with pancreatic cancer. Through the date of this filing, the Company has received approximately $0.2 million of funds from the PANACEA Grant. The Company recorded approximately $0.2 million of grant income related to this grant as revenue for the three and nine months ended September 30, 2025, and as of September 30, 2025, the Company had a grant income receivable balance of $0.2 million for this grant.
In December 2024, the Company received notice of an additional $9.5 million grant from CPRIT to support the clinical investigation of MT-601 in patients with metastatic pancreatic cancer. As of the date of this filing, the Company has received $1.5 million of funds related to this grant. The Company recorded nil and $0.2 million of grant income related to this grant as revenue for the three and nine months ended September 30, 2025, respectively. As of September 30, 2025, $1.4 million was recorded as restricted cash and deferred revenue on the Company's condensed consolidated balance sheet. The CPRIT Pancreatic Grant and the CPRIT AML Grant are subject to certain revenue-sharing arrangements, see Note 11 to the accompanying financial statements for further information.
As discussed further below, 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. On August 26, 2025, the Company sold an additional 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.
As of September 30, 2025, we had working capital of $18.4 million, compared to working capital of $18.6 million as of December 31, 2024. Operating expenses incurred during the three and nine months ended September 30, 2025 were $3.4 million and $13.4 million, respectively, compared to $4.3 million and $11.6 million during the equivalent prior year periods, respectively. 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 September 30, 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. Wainwright & Co., LLC, we anticipate that we will be able to fund our operating expenses and capital expenditure requirements through the third quarter of 2026, assuming no additional grant funds are received, either from new grants or from existing awarded grants. We are considering raising additional capital through the issuance of securities and intend to apply for additional grant funds, which could enable us to fund our operating expenses and capital expenditure requirements beyond the third 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. This estimate is subject to our ability to effectively manage our costs, raise additional capital, and receive additional grant funds. Our assumptions may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Furthermore, our operating plan may change, and we may need additional funds sooner than planned in order to meet operational needs and capital requirements for product development and commercialization. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates and the extent to which we may enter into additional collaborations with third parties to participate in their development and commercialization, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical trials. Our future funding requirements will depend on many factors, as we:
| ● | initiate or continue clinical trials of our product candidates; |
| ● | continue the research and development of our product candidates and seek to discover additional product candidates; seek regulatory approvals for our product candidates if they successfully complete clinical trials; |
| ● | continue development of our manufacturing capabilities; |
| ● | establish sales, marketing and distribution infrastructure and scale-up manufacturing capabilities to commercialize any product candidates that may receive regulatory approval; |
| ● | evaluate strategic transactions we may undertake; and |
| ● | enhance operational, financial and information management systems and hire additional personnel, including personnel to support development of our product candidates and, if a product candidate is approved, our commercialization efforts. |
Because all of our product candidates are in the early stages of clinical and preclinical development and the outcome of these efforts is uncertain, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of product candidates or whether, or when, we may achieve profitability. 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. 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. 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. If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or product candidates or grant licenses on terms unfavorable to us. We may also be required to pay damages or have liabilities associated with litigation or other legal proceedings involving our company.
In addition to the foregoing, high inflation and concerns about an economic recession in the United States or other major markets have resulted in, among other things, volatility in the capital markets that may have the effect of reducing our ability to access capital, which
could in the future negatively affect our liquidity. In addition, a recession or market correction due to these factors could materially affect our business and the value of our common stock.
ATM Agreement
In August 2021, we entered into a Controlled Equity OfferingSM Sales Agreement, or the ATM Agreement, with Cantor Fitzgerald & Co. and RBC Capital Markets, LLC, or the Sales Agents, pursuant to which we could offer and sell, from time to time at our sole discretion through the Sales Agents, shares of our common stock having an aggregate offering price of up to $75.0 million. Any shares of our common stock sold were issued pursuant to our shelf registration statement on Form S-3 (File No. 333-258687), which the SEC declared effective on August 19, 2021. However, our use of the shelf registration statement on Form S-3 was limited for so long as we are subject to General Instruction I.B.6 of Form S-3, which limits the amounts that we could sell under the registration statement and in accordance with the ATM agreement. The Sales Agents were entitled to compensation under the Sales Agreement at a commission rate equal to 3.0% of the gross sales price per share sold under the ATM Agreement, and we provided each of the Sales Agents with indemnification and contribution rights. There was no common stock issued under the ATM Agreement during the three months ended March 31, 2024. On June 10, 2024, the Company provided notice of its termination of the ATM Agreement with Cantor Fitzgerald & Co. and RBC Capital Markets, LLC. 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. LLC, relating to the sale of shares of our common stock having an agreement offering price of up to $11,431,713 from time to time through H.C. Wainwright & Co. LLC. Any shares of our common stock sold will be issued pursuant to our shelf registration statement on Form S-3 (File No. 333-283512), which the SEC declared effective on December 6, 2024. However, our use of the shelf registration statement on Form S-3 will be limited for so long as we are subject to General Instruction I.B.6 of Form S-3, which limits the amounts that we may sell under the registration statement and in accordance with the ATM agreement. H.C. Wainwright & Co. LLC will be entitled to compensation under the Sales Agreement at a commission rate equal to 3.0% of the gross sales price per share sold under the ATM Agreement, and we have provided H.C. Wainwright & Co. LLC with indemnification and contribution rights.
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.
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.
Private Placement
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. The transaction closed on December 23, 2024. 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. 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. Both the Pre-Funded Warrants and the Private Placement Warrants were not exercisable until the Company obtained shareholder approval, which approval was received on March 21, 2025.
Going Concern
We have no sources of revenue, other than grant income, to provide incoming cash flows to sustain our future operations. As outlined above, our ability to pursue our long-term planned business activities is dependent upon our successful efforts to raise additional capital.
These factors raise substantial doubt regarding our ability to continue as a going concern. Our condensed consolidated financial statements have been prepared on a going concern basis, which implies that we will continue to realize our assets and discharge our liabilities in the normal course of business. 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 Estimates
The condensed consolidated financial statements are prepared in conformity with U.S. GAAP, which require the use of estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements, and the reported amounts of expenses in the periods presented.
The Company's critical accounting policies include grant income. The Company does not have any critical accounting estimates.
With respect to grant income, the Company recognizes revenue when qualifying costs are incurred for the amount the Company is entitled to under the provisions of the contract.
Marker Therapeutics Inc. published this content on November 13, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on November 13, 2025 at 22:30 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]