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 and commercialization 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, (“TAAs”). Unlike other T cell therapies, MAR-T cells are able to recognize hundreds of different epitopes within up to six tumor-specific antigens to produce broad spectrum anti-tumor activity. Targeting multiple antigens simultaneously exploits the natural capacity of T cells to recognize and kill tumor targets via native T cell receptors (“TCR”), while limiting tumor adaptation/escape by antigen-negative selection or antigen down-regulation. When infused into a patient with cancer, the MAR-T cells are designed to kill cancer cells expressing the TAA and potentially recruit the patient’s immune system to participate in the cancer killing process.
We licensed the underlying technology for MAR-T cell therapy from Baylor College of Medicine (“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 anticipate continuing to advance 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 in AML or MDS)
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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 therapies may provide meaningful clinical benefit and safety to patients with both hematological and solid tumors.
We believe that the simplicity of our manufacturing process allows additional modifications to expand MAR-T cell recognition of cancer targets. For example, we are assessing the potential of combining MAR-T cell products with other products.
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. 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. 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.
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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 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. John Wilson, is a contract development and manufacturing organization (CDMO). The MSA contains customary representations, warranties and indemnification provision. The initial term of the MSA is three years and may be extended upon the mutual written agreement of the parties. On March 27, 2025, we mutually agreed with Cell Ready to terminate the MSA. In connection therewith, we 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 with 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, 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. 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 have or have properly estimated our required manufacturing capacities or that the third parties on which we rely to manufacture our products will be able or willing to perform on our proposed timelines or to meet our manufacturing demands, if at all. If any of our third-party vendors experience disruptions, or otherwise cease or substantially reduce the amount of products they are willing to supply us, our business and operations could be adversely affected. See “Risk Factors”.
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Recent Developments
On May 4, 2026, the Company filed a Certificate of Amendment to its Certificate of Incorporation, increasing its authorized shares of Common Stock from 30,000,000 to 130,000,000.
In July 2026, the Company received notice of a $4.2 million grant from the U.S. Department of War (previously Department of Defense) to support the clinical investigation of MT-601 in relapsed/refractory large B-cell lymphoma (“LBCL”) (the “DoW Grant”).
Results of Operations
Comparison of the Three months Ended June 30, 2026 and 2025
The following table summarizes the results of our continuing operations for the three months ended June 30, 2026 and 2025:
For the Three Months Ended
June 30,
2026 2025 Change
Operating expenses:
Research and development 1,476,161 4,177,054 (2,700,893) (65) %
General and administrative 1,144,205 945,163 199,042 21 %
Total operating expenses 2,620,366 5,122,217 (2,501,851) (49) %
Loss from operations (2,620,366) (5,122,217) 2,501,851 (49) %
Other income:
Grant income 681,579 861,184 (179,605) (21) %
Interest income 112,558 128,025 (15,467) (12) %
Other income — 117,444 (117,444) (100) %
Net loss $ (1,826,229) (4,015,564) $ 2,189,335 (55) %
Operating Expenses
Operating expenses incurred during the three months ended June 30, 2026 were $2.6 million compared to $5.1 million during the same period ended June 30, 2025. Significant changes and expenditures in operating expenses are outlined as follows:
Research and Development Expenses
Research and development expenses decreased by 65% to $1.5 million for the three months ended June 30, 2026, compared to $4.2 million for the three months ended June 30, 2025.
The decrease of $2.7 million in 2026 was primarily attributable to the following:
●decrease of $2.3 million in clinical trial expenses,
●decrease of $0.3 million in clinical consulting expenses, and
●decrease of $0.1 million in other clinical expenses.
General and Administrative Expenses
General and administrative expenses increased by 21% to $1.1 million for the three months ended June 30, 2026, compared to $0.9 million during the same period ended June 30, 2025.
The increase of $0.2 million in 2026 was primarily attributable to headcount-related expenses, including stock-based compensation expense.
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Other Income
Grant Income
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”).
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”).
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 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 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”).
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”).
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”).
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”).
In July 2026, the Company received notice of a $4.2 million grant from the U.S. Department of War (previously Department of Defense) to support the clinical investigation of MT-601 in relapsed/refractory large B-cell lymphoma (“LBCL”) (the “DoW Grant”).
The following table summarizes grant income recorded for the three months ended June 30, 2026 and 2025, by grant:
For the Three Months Ended
June 30,
2026 2025
Grant income:
CPRIT AML Grant1 $ 256,890 $ 319,610
FDA Grant 20,055 104,461
SBIR AML Grant — 11,594
Decoy Grant 167,206 189,076
PANACEA Grant 105,601 53,168
CPRIT Pancreatic Grant1 131,827 183,275
Total grant income $ 681,579 $ 861,184
(1) Both CPRIT grants are subject to certain revenue - sharing arrangements, as per the grant agreements (see Note 11).
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Interest Income
Interest income was $0.1 million and $0.1 million for the three months ended June 30, 2026 and 2025, 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
Other income was nil and $0.1 million for the three months ended June 30, 2026 and 2025, respectively, and was attributable to a state sales tax rebate from 2022.
Net Loss
The decrease in our net loss during the three months ended June 30, 2026 compared to the three months ended June 30, 2025 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 Six months Ended June 30, 2026 and 2025
The following table summarizes the results of our continuing operations for the six months ended June 30, 2026 and 2025:
For the Six Months Ended
June 30,
2026 2025 Change
Operating expenses:
Research and development 4,318,888 7,312,481 (2,993,593) (41) %
General and administrative 2,374,012 2,314,378 59,634 3 %
Loss on early termination of vendor agreement — 453,135 (453,135) (100) %
Total operating expenses 6,692,900 10,079,994 (3,387,094) (34) %
Loss from operations (6,692,900) (10,079,994) 3,387,094 (34) %
Other income (expenses):
Grant income 1,433,270 1,210,288 222,982 18 %
Interest income 245,446 290,514 (45,068) (16) %
Other income 8,677 117,444 (108,767) (93) %
Net loss $ (5,005,507) (8,461,748) $ 3,456,241 (41) %
Operating Expenses
Operating expenses incurred during the six months ended June 30, 2026 were $6.7 million compared to $10.1 million during the same period ended June 30, 2025.
Significant changes and expenditures in operating expenses are outlined as follows:
Research and Development Expenses
Research and development expenses decreased by 41% to $4.3 million for the six months ended June 30, 2026, compared to $7.3 million for the six months ended June 30, 2025.
The decrease of $3.0 million in 2026 was primarily attributable to the following:
● decrease of $2.8 million in clinical trial expenses,
● decrease of $0.3 million in headcount-related expenses, and
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● decrease of $0.1 million process development costs, offset by
● increase of $0.2 million in other clinical expenses.
General and Administrative Expenses
General and administrative expenses increased by 3% to $2.4 million for the six months ended June 30, 2026, compared to $2.3 million during the same period ended June 30, 2025.
The increase of $0.1 million in 2026 was primarily attributable to increases in headcount-related expenses.
Other Income
Grant Income
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”).
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”).
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 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 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”).
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”).
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”).
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”).
In July 2026, the Company received notice of a $4.2 million grant from the U.S. Department of War (previously Department of Defense) to support the clinical investigation of MT-601 in relapsed/refractory large B-cell lymphoma (“LBCL”) (the “DoW Grant”).
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The following table summarizes grant income recorded for the six months ended June 30, 2026 and 2025, by grant:
For the Six Months Ended
June 30,
2026 2025
Grant income:
CPRIT AML Grant1 $ 465,399 $ 537,254
FDA Grant 22,958 104,461
SBIR AML Grant 116,504 108,317
Decoy Grant 265,840 203,291
PANACEA Grant 179,079 61,147
CPRIT Pancreatic Grant1 383,490 195,818
Total grant income $ 1,433,270 $ 1,210,288
(1) Both CPRIT grants are subject to certain revenue - sharing arrangements, as per the grant agreements (see Note 11).
Interest Income
Interest income was $0.2 million and $0.3 million for the six months ended June 30, 2026 and 2025, 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
Other income was immaterial and $0.1 million for the six months ended June 30, 2026 and 2025, respectively, and was attributable to a state sales tax rebate from 2022.
Net Loss
The decrease in our net loss during the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was primarily due to cost decreases in our research and development activities and the loss on termination of the Cell Ready MSA. 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 grant income 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 June 30, 2026, 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 into the second quarter of 2027, 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 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 second quarter of 2027, 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.
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Cash and Working Capital
The following table sets forth our cash, cash equivalents, restricted cash, and working capital as of June 30, 2026 and December 31, 2025:
June 30, December 31,
2026 2025
Cash, cash equivalents, and restricted cash $ 11,922,332 $ 17,042,847
Working capital $ 12,165,464 $ 16,796,814
Cash Flows
The following table summarizes our cash flows for the six months ended June 30, 2026 and 2025:
For the Six Months Ended
June 30,
2026 2025
Net cash provided by (used in):
Operating activities $ (5,120,515) $ (7,378,099)
Investing activities — —
Financing activities — 605
Net decrease in cash, cash equivalents, and restricted cash $ (5,120,515) $ (7,377,494)
Operating Activities
Net cash used in operating activities during the six months ended June 30, 2026 was $5.1 million. The use of cash primarily related to our net loss of $5.0 million and a $0.5 million decrease from changes in assets and liabilities, offset by $0.4 million of non-cash stock-based compensation.
Net cash used in operating activities during the six months ended June 30, 2025 was $7.4 million. The use of cash primarily related to our net loss of $8.5 million offset by $0.4 million of non-cash stock-based compensation and a $0.7 million increase from changes in assets and liabilities.
Financing Activities
There was no cash provided by financing activities during the six months ended June 30, 2026.
Net cash provided by financing activities was $605 during the six months ended June 30, 2025 due to the net proceeds from the exercise of warrants.
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. We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, continue or initiate clinical trials of and seek marketing approval for our product candidates. In addition, if we obtain approval for any of our product candidates, 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. 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.
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Other receivable mainly consists of grant income receivable. Qualifying grant income earned in advance of cash received from grants is recognized as other income and recorded as other receivable. The following table summarizes the Company’s other receivable balance as of June 30, 2026 and December 31, 2025, respectively:
June 30, December 31,
2026 2025
Grant income receivable:
CPRIT AML Grant $ 1,311,557 $ 815,436
FDA Grant 20,055 3,678
SBIR AML Grant — 162,897
Decoy Grant 141,900 59,501
SBIR NHL Grant — 87,417
PANACEA Grant 105,601 190,052
Total grant income receivable 1,579,113 1,318,981
Interest receivable 33,161 50,419
Other 7,203 —
Total other receivable $ 1,619,477 $ 1,369,400
As of June 30, 2026, we had working capital of $12.2 million, compared to working capital of $16.8 million as of December 31, 2025. Operating expenses incurred during the three and six months ended June 30, 2026 were $2.6 million and $6.7 million, respectively, compared to $5.1 million and $10.1 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 June 30, 2026, we anticipate that we will be able to fund our operating expenses and capital expenditure requirements into the second quarter of 2027, assuming no additional grant funds are received. 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 second quarter of 2027 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
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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 November 2024, we entered into an At The Market Offering Agreement (the “ATM 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 ATM 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. There was no activity under the ATM Agreement during any of the periods presented.
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 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 did 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. On March 21, 2025, the Company obtained shareholder approval for the exercise of such warrants. The transaction closed on December 23, 2024.
Going Concern
We have no sources of income, 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.
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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 grant income when qualifying costs are incurred for the amount the Company is entitled to under the provisions of the contract.