Neldaleucel

Marker Therapeutics to receive non-dilutive funding from NIH Small Business Innovation Research Program based on preliminary clinical results and non-clinical data in lymphoma Aug. 12, 2024-- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that the Company has been awarded 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 non-Hodgkin’s lymphoma (NHL) who have relapsed following anti-CD19 chimeric antigen receptor (CAR) T cell therapy. The SBIR grant has been awarded based in part on Marker’s preliminary clinical data in patients with lymphoma (Press Release, September 11, 2023) as well as non-clinical data demonstrating the anti-tumor activity of MT-601 on anti-CD19 CAR resistant lymphoma cells (Press Release, May 31, 2023). The proceeds of the grant will support the nationwide multi-center Phase 1 APOLLO study (ClinicalTrials.gov identifier: NCT05798897), evaluating the safety and efficacy of MT-601, a multi-tumor associated antigen (multiTAA)-specific T cell product, in patients with relapsed NHL including those previously treated with anti-CD19 CAR-T cell therapy. Including this SBIR grant, the Company has been awarded over $19 million in non-dilutive funding proceeds. “We are pleased to receive the SBIR grant from the NIH to support our clinical Phase 1 study in CAR-relapsed patients with non-Hodgkin’s lymphoma,” said Juan Vera, M.D., President and CEO of Marker Therapeutics. “Although anti-CD19 CAR-T cells are rapidly expanding as a treatment option in patients with hematological malignancies, approximately 40-60% of patients will relapse within the first year of therapy with currently no standard of care for patients post CD19-targeting CAR-T cells. The NIH award process is highly competitive, and we believe that the decision the NIH made suggests the potential scientific merit and the capacity of Marker’s APOLLO study to address an unmet medical need.” Dr. Vera continued: “While our results of the APOLLO study are preliminary, as we move through the dose escalation part of the study, we are encouraged by the objective responses observed in all three study participants treated at City of Hope (Press Release, April 8, 2024) and the lack of cytokine release syndrome (CRS) or immune effector cell associated neurotoxicity syndrome (ICANS) observed. We will continue to closely monitor all patients for long-term treatment effects and durability of response, and with the non-dilutive funding support from NIH we look forward to treating additional participants in this Phase 1 study.” “This grant award is a testimony of our continued commitment to apply for non-dilutive funding and allows us to leverage our data to drive innovation and growth while maximizing shareholder value. Obtaining non-dilutive funding is an ongoing effort, and we are actively applying for additional opportunities as they become available,” concluded Dr. Vera. The NIH Small Business Innovation Research (SBIR) Program sets aside more than $1.2 billion from its Research & Development Funding to specifically support early-stage small businesses throughout the United States. Many companies leverage the NIH SBIR funding to attract the partners and investors needed to take an innovation to market. The Small Business program focuses on a variety of high-impact technologies including research tools, diagnostics, digital health, drugs, and medical devices, and can provide the seed funding needed to bring scientific innovations from bench to bedside. The Company’s lead product, MT-601, is a multi-tumor associated antigen (multiTAA)-specific T cell product that utilizes a non-genetically modified approach that specifically targets six different tumor antigens upregulated in lymphoma cells (Survivin, PRAME, WT-1, NY-ESO-1, SSX-2, MAGE-A4). Marker is currently investigating MT-601 in the Company-sponsored Phase 1 APOLLO trial (clinicaltrials.gov identifier: NCT05798897) for the treatment of lymphoma patients who are relapsed after or where CD19 CAR-T cell therapy is not an option.About APOLLO The APOLLO trial (clinicaltrials.gov Identifier: NCT05798897) is a Phase 1, multicenter, open-label study designed to evaluate the safety and efficacy of MT-601 in participants with lymphoma who relapsed after anti-CD19 CAR-T cell therapy or where anti-CD19 CAR-T cell therapy is not an option. The primary objective of this exploratory Phase 1 clinical trial is to evaluate the safety and preliminary efficacy of MT-601 in participants with various lymphoma subtypes. Under the APOLLO trial, it is anticipated that nine clinical sites across the United States will cumulatively enroll up to approximately 30 participants during the dose escalation phase. The multi-tumor associated antigen (multiTAA)-specific T cell platform is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient's/donor’s blood capable of recognizing a broad range of tumor antigens. Unlike other T cell therapies, multiTAA-specific T cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since multiTAA-specific T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with an improved safety profile, compared to current engineered T cell approaches, and may provide patients with meaningful clinical benefits. Marker Therapeutics, Inc. is a Houston, TX-based clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors. Clinical trials that enrolled more than 200 patients across various hematological and solid tumor indications showed that the Company’s autologous and allogeneic multiTAA-specific T cell products were well tolerated and demonstrated durable clinical responses. Marker’s goal is to introduce novel T cell therapies to the market and improve patient outcomes. To achieve these objectives, the Company prioritizes the preservation of financial resources and focuses on operational excellence. Marker’s unique T cell platform is strengthened by non-dilutive funding from U.S. state and federal agencies supporting cancer research. The content above comes from the network. if any infringement, please contact us to modify.

Preliminary safety and efficacy with sustained objective responses observed in patients with lymphoma treated with MT-601 in Phase 1 APOLLO study MT-601 was well tolerated with no observation of cytokine release syndrome (CRS) or immune effector cell associated neurotoxicity syndrome (ICANS) Marker Therapeutics to receive $2 million funding from NIH Small Business Innovation Research (SBIR) program to support clinical investigation of MT-601 in patients with lymphoma HOUSTON, Aug. 14, 2024 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors, today reported corporate updates and financial results for the second quarter ended June 30, 2024. “The second quarter of 2024 was characterized by ongoing momentum in our clinical programs,” said Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. “Following the positive outcomes reported in the first quarter, we continued to advance our Phase 1 APOLLO study investigating MT-601 in patients with lymphoma who have relapsed after anti-CD19 CAR-T cell therapy or where CAR-T therapy is not an option. In April, Geoffrey Shouse, D.O., Ph.D., the Principal Investigator at City of Hope National Medical Center, presented encouraging data from the APOLLO study, at the 11th Global Summit on Hematologic Malignancies. The data showed that three out of three participants had objective responses, and that treatment was well tolerated among all patients with no significant treatment-related adverse events, further signifying the potential benefit of MT-601 in patients with lymphoma. We are gratified by these preliminary results and expect to provide a more comprehensive clinical update on the APOLLO study in the upcoming quarter.” “Additionally, after the close of the quarter, we announced that Marker has been awarded a $2 million Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support our Phase 1 APOLLO study evaluating the safety and efficacy of MT-601 in patients with non-Hodgkin’s lymphoma (NHL) who have relapsed following anti-CD19 CAR-T cell therapy. We were pleased to receive this highly competitive grant, which reinforces the potential scientific merit and the capacity of the APOLLO study to address an unmet medical need,” added Dr. Vera. PROGRAM UPDATES & EXPECTED MILESTONES MT-601 (Lymphoma) Marker’s lead program is investigating MT-601 in the nationwide multicenter Phase 1 APOLLO study (clinicaltrials.gov identifier: NCT05798897) in patients with lymphoma who relapsed after anti-CD19 CAR-T cell therapy or where CAR-T cells are not an option.The Company previously reported preliminary safety and efficacy with sustained objective responses observed in three study participants treated at City of Hope National Medical Center (Press Release, April 8, 2024). Treatment was well tolerated among all study participants with no observation of cytokine release syndrome (CRS) or immune effector cell associated neurotoxicity syndrome (ICANS).All study participants continue to be observed for long-term treatment effects and durability of response. The Company is enrolling additional study participants in the Phase 1 APOLLO trial and expect to provide an update on safety and durability during the third quarter.The Company was awarded a $2 million grant from NIH Small Business Innovation Research Program (SBIR) to support the clinical investigation of MT-601 in patients with lymphoma who have relapsed following anti-CD CAR-T cell therapy (Press Release, August 12, 2024). MT-601 (Pancreatic) Investigational New Drug (IND) application cleared by U.S. Food and Drug Administration (FDA) for multicenter Phase 1 trial to investigate MT-601 in combination with front-line chemotherapy in patients with metastatic pancreatic cancer.Clinical advancement will be pending additional financial support from non-dilutive funding activities. MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic Syndrome) U.S. FDA has granted an IND to investigate MT-401 as an “Off-the-Shelf” (MT-401-OTS) product in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).MT-401-OTS is manufactured from healthy donors, and Marker has established a cellular inventory for MT-401-OTS with ongoing efforts to further expansion.Marker has non-clinical proof-of-concept data supporting the potential clinical benefits of MT-401-OTS in patients with AML or MDS (Press Release, August 7, 2023).The Company secured non-dilutive funding to support the clinical investigation of MT-401-OTS and anticipates the clinical program initiation of MT-401-OTS during the fourth quarter of 2024. SECOND QUARTER 2024 FINANCIAL HIGHLIGHTS Cash Position and Guidance: At June 30, 2024, Marker had cash and cash equivalents of $7.8 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses into the fourth quarter of 2025, inclusive of available drawdowns from grant funds. R&D Expenses: Research and development expenses were $2.3 million for the quarter ended June 30, 2024, compared to $2.4 million for the quarter ended June 30, 2023. G&A Expenses: General and administrative expenses were $1.1 million for the quarter ended June 30, 2024, compared to $2.5 million for the quarter ended June 30, 2023. Net Loss: Marker reported a net loss from continuing operations of $2.2 million for the quarter ended June 30, 2024, compared to $4.1 million for the quarter ended June 30, 2023. “The financial performance in the past quarter demonstrates the benefits that we are seeing from our restructuring efforts that we initiated in the second quarter of 2023, including our agreement with Cell Ready, and the favorable impact that they are having on our business, especially our Operating Expenses. Unlike most small, pre-revenue companies in the Cell Therapy space, our extremely efficient structure, combined with our successful grant funding initiatives, are allowing us to maximize our cash runway and to focus the majority of our available funds on our clinical programs,” concluded Dr. Vera. About multiTAA-specific T cells The multi-tumor associated antigen (multiTAA)-specific T cell platform is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient's/donor’s blood capable of recognizing a broad range of tumor antigens. Unlike other T cell therapies, multiTAA-specific T cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since multiTAA-specific T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with an improved safety profile, compared to current engineered T cell approaches, and may provide patients with meaningful clinical benefits. About Marker Therapeutics, Inc. Marker Therapeutics, Inc. is a Houston, TX-based clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors. Clinical trials that enrolled more than 200 patients across various hematological and solid tumor indications showed that the Company’s autologous and allogeneic multiTAA-specific T cell products were well tolerated and demonstrated durable clinical responses. Marker’s goal is to introduce novel T cell therapies to the market and improve patient outcomes. To achieve these objectives, the Company prioritizes the preservation of financial resources and focuses on operational excellence. Marker’s unique T cell platform is strengthened by non-dilutive funding from U.S. state and federal agencies supporting cancer research. To receive future press releases via email, please visit: https://www.markertherapeutics.com/email-alerts. Forward-Looking Statements This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and the timing, conduct and success of our clinical trials of our product candidates, including MT-601 for the treatment of patients with lymphoma. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at WWW.SEC.GOV. The Company assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release except as may be required by law. Marker Therapeutics, Inc.Condensed Consolidated Balance Sheets(Unaudited) June 30,2024 December 31,2023 ASSETS Current assets: Cash and cash equivalents$7,800,464 $15,111,450 Prepaid expenses and deposits 1,384,394 988,126 Other receivables 2,490,147 1,027,815 Total current assets 11,675,005 17,127,391 Total assets$ 11,675,005 $ 17,127,391 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and accrued liabilities$1,679,672 $1,745,193 Related party payable 292,569 1,329,655 Total current liabilities 1,972,241 3,074,848 Total liabilities 1,972,241 3,074,848 Stockholders' equity: Preferred stock, $0.001 par value, 5 million shares authorized, 0 shares issued andoutstanding at June 30, 2024 and December 31, 2023, respectively - - Common stock, $0.001 par value, 30 million shares authorized, 8.9 million sharesissued and outstanding as of June 30, 2024 and December 31, 2023, respectively(see Note 8) 8,922 8,891 Additional paid-in capital 450,565,204 450,329,515 Accumulated deficit (440,871,362) (436,285,863) Total stockholders' equity 9,702,764 14,052,543 Total liabilities and stockholders' equity$ 11,675,005 $ 17,127,391 Marker Therapeutics, Inc.Condensed Consolidated Statements of Operations(Unaudited) For the Three Months EndedJune 30, For the Six Months EndedJune 30, 2024 2023 2024 2023 Revenues: Grant income$1,169,236 $762,658 $2,413,297 $1,996,995 Total revenues 1,169,236 762,658 2,413,297 1,996,995 Operating expenses: Research and development 2,335,430 2,377,993 4,910,446 5,754,492 General and administrative 1,141,871 2,518,725 2,359,934 4,686,044 Total operating expenses 3,477,301 4,896,718 7,270,380 10,440,536 Loss from operations (2,308,065) (4,134,060) (4,857,083) (8,443,541) Other income (expenses): Interest income 115,388 35,080 271,584 119,734 Loss from continuing operations (2,192,677) (4,098,980) (4,585,499) (8,323,807) Discontinued operations: Loss from discontinued operations, net of tax - (2,179,657) - (2,922,406) Gain on disposal of discontinued operations - 8,794,426 - 8,794,426 Income from discontinued operations - 6,614,769 - 5,872,020 Net income/(loss)$ (2,192,677) $ 2,515,789 $ (4,585,499) $ (2,451,787) Net loss per share: Loss from continuing operations, basic and diluted$(0.25) $(0.47) $(0.51) $(0.95) Income from discontinued operations, basic and diluted$- $0.75 $- $0.67 Net income/(loss) per share, basic and diluted$(0.25) $0.29 $(0.51) $(0.28) Weighted average number of common shares outstanding: Basic 8,918,233 8,798,956 8,910,097 8,760,209 Diluted 8,918,233 8,798,956 8,910,097 8,760,209 Marker Therapeutics, Inc.Condensed Consolidated Statements of Cash Flows(Unaudited) For the Six Months EndedJune 30, 2024 2023 Cash Flows from Operating Activities: Net loss$(4,585,499) $(2,451,787) Less: income from discontinued operations, net of tax - 5,872,020 Net loss from continuing operations (4,585,499) (8,323,807) Reconciliation of net loss to net cash used in operating activities: Stock-based compensation 142,018 539,858 Changes in operating assets and liabilities: Prepaid expenses and deposits (396,268) (238,223) Other receivables (1,462,332) 655,904 Related party payable (1,037,086) - Accounts payable and accrued expenses (65,521) 197,030 Net cash used in operating activities - continuing operations (7,404,688) (7,169,238) Net cash used in operating activities - discontinued operations - (5,775,680) Net cash used in operating activities (7,404,688) (12,944,918) Cash Flows from Investing Activities: Net cash provided by (used in) investing activities - discontinued operations - 18,664,122 Net cash provided by (used in) investing activities - 18,664,122 Cash Flows from Financing Activities: Proceeds from issuance of common stock, net 36,902 619,974 Proceeds from stock options exercise 56,800 736 Net cash provided by financing activities 93,702 620,710 Net (decrease)/increase in cash and cash equivalents (7,310,986) 6,339,914 Cash and cash equivalents at beginning of the period 15,111,450 11,782,172 Cash and cash equivalents at end of the period$7,800,464 $18,122,086 ContactsInvestorsTIBEREND STRATEGIC ADVISORS, INC.Jonathan Nugent205-566-3026jnugent@tiberend.com