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Marker TherapeuticsD
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-06
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Earnings documents stored for MRKR.

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Investor releaseQuarter not tagged2026-08-06

Aurinia Pharmaceuticals (AUPH) Surpasses Q2 Earnings Estimates

Zacks
Aurinia Pharmaceuticals (AUPH) came out with quarterly earnings of $0.28 per share, beating the Zacks Consensus Estimate of $0.19 per share. This compares to earnings of $0.16 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +47.37%. A quarter ago, it was expected that this biotechnology company would post earnings of $0.18 per share when it actually produced earnings of $0.25, delivering a surprise of +38.89%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Aurinia, which belongs to the Zacks Medical - Drugs industry, posted revenues of $83.22 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 0.1%. This compares to year-ago revenues of $70.01 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Aurinia shares have lost about 4.8% since the beginning of the year versus the S&P 500's gain of 12.8%. While Aurinia has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Aurinia was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) s…Read full document

Aurinia Pharmaceuticals (AUPH) came out with quarterly earnings of $0.28 per share, beating the Zacks Consensus Estimate of $0.19 per share. This compares to earnings of $0.16 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +47.37%. A quarter ago, it was expected that this biotechnology company would post earnings of $0.18 per share when it actually produced earnings of $0.25, delivering a surprise of +38.89%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Aurinia, which belongs to the Zacks Medical - Drugs industry, posted revenues of $83.22 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 0.1%. This compares to year-ago revenues of $70.01 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Aurinia shares have lost about 4.8% since the beginning of the year versus the S&P 500's gain of 12.8%. While Aurinia has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Aurinia was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.20 on $84.85 million in revenues for the coming quarter and $0.85 on $332.6 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the bottom 39% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, MARKER THERAPEUTICS, INC. (MRKR), is yet to report results for the quarter ended June 2026. This company is expected to post quarterly loss of $0.25 per share in its upcoming report, which represents a year-over-year change of +13.8%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. MARKER THERAPEUTICS, INC.'s revenues are expected to be $0.6 million, down 30.2% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Aurinia Pharmaceuticals Inc (AUPH) : Free Stock Analysis Report MARKER THERAPEUTICS, INC. (MRKR) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-03-19

Marker Therapeutics Reports Year-End 2025 Corporate and Financial Results

GlobeNewswire
Phase 1 APOLLO data update demonstrated encouraging clinical activity with a 66% objective response rate in relapsed non-Hodgkin lymphoma, including 50% complete responses Research published in Nature Medicine highlighted promising results of multi-antigen targeted T cells in pancreatic cancer Strengthened manufacturing capabilities through collaboration with Cellipont Bioservices and expanded Board of Directors with appointment of Kathryn Penkus Corzo HOUSTON, March 18, 2026 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company developing next-generation T cell-based immunotherapies for hematological malignancies and solid tumors, today announced corporate updates and financial results for the year ended December 31, 2025. “In 2025, we continued to advance MT-601, our lead Multi-Antigen Recognizing (MAR)-T cell therapy, and generated highly encouraging clinical data from our ongoing Phase 1 APOLLO study,” said Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. “Updated results reported last August demonstrated a 66% objective response rate in relapsed non-Hodgkin lymphoma, including durable complete responses, with a favorable safety profile across evaluated doses. During the year we also reported immunomonitoring data indicating that lymphodepletion enhances the expansion and persistence of MT-601, and we advanced the APOLLO study into dose expansion in patients with relapsed Diffuse Large B Cell Lymphoma (DLBCL). We anticipate providing a data update from the APOLLO study in the second quarter of 2026.” Dr. Vera continued, “Beyond lymphoma, we made important progress expanding our MAR-T platform across hematologic and solid tumors. Recent research from Baylor College of Medicine published in Nature Medicine in early 2026 showed promising results in pancreatic cancer using MAR-T cells and received national coverage on Good Morning America.” “Looking ahead, we expect continued clinical execution across our programs, including additional APOLLO data updates and initiation of our company-sponsored pancreatic cancer clinical program, which we believe positions the next 12 to 18 months as an important value-creating period for Marker,” concluded Dr. Vera. 2025 PROGRAM UPDATES & OPERATIONAL HIGHLIGHTS MT-601 (Lymphoma) MT-601, Marker’s lead MAR-T cell therapy, is being evaluated in the…Read full document

Phase 1 APOLLO data update demonstrated encouraging clinical activity with a 66% objective response rate in relapsed non-Hodgkin lymphoma, including 50% complete responses Research published in Nature Medicine highlighted promising results of multi-antigen targeted T cells in pancreatic cancer Strengthened manufacturing capabilities through collaboration with Cellipont Bioservices and expanded Board of Directors with appointment of Kathryn Penkus Corzo HOUSTON, March 18, 2026 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company developing next-generation T cell-based immunotherapies for hematological malignancies and solid tumors, today announced corporate updates and financial results for the year ended December 31, 2025. “In 2025, we continued to advance MT-601, our lead Multi-Antigen Recognizing (MAR)-T cell therapy, and generated highly encouraging clinical data from our ongoing Phase 1 APOLLO study,” said Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. “Updated results reported last August demonstrated a 66% objective response rate in relapsed non-Hodgkin lymphoma, including durable complete responses, with a favorable safety profile across evaluated doses. During the year we also reported immunomonitoring data indicating that lymphodepletion enhances the expansion and persistence of MT-601, and we advanced the APOLLO study into dose expansion in patients with relapsed Diffuse Large B Cell Lymphoma (DLBCL). We anticipate providing a data update from the APOLLO study in the second quarter of 2026.” Dr. Vera continued, “Beyond lymphoma, we made important progress expanding our MAR-T platform across hematologic and solid tumors. Recent research from Baylor College of Medicine published in Nature Medicine in early 2026 showed promising results in pancreatic cancer using MAR-T cells and received national coverage on Good Morning America.” “Looking ahead, we expect continued clinical execution across our programs, including additional APOLLO data updates and initiation of our company-sponsored pancreatic cancer clinical program, which we believe positions the next 12 to 18 months as an important value-creating period for Marker,” concluded Dr. Vera. 2025 PROGRAM UPDATES & OPERATIONAL HIGHLIGHTS MT-601 (Lymphoma) MT-601, Marker’s lead MAR-T cell therapy, is being evaluated in the nationwide multicenter APOLLO study (clinicaltrials.gov identifier: NCT05798897) in patients with lymphoma who have relapsed after anti-CD19 CAR-T cell therapy or for whom CAR-T therapy is not an option. The Company provided an update on the Phase 1 study in August 2025 (Press Release, Aug 26, 2025) highlighting encouraging overall response rates. These data were also presented at the 67th American Society of Hematology (ASH) Annual Meeting in December 2025. Key findings from the update included: 66% objective response rate (8/12) in patients with relapsed non-Hodgkin lymphoma, including 50% complete responses. Durable responses were observed (range 3-24 months). 78% objective response rate (7/9) observed in patients with Hodgkin lymphoma. Favorable safety profile across all dose levels (100×10⁶–400×10⁶ cells), with no dose-limiting toxicities (DLTs) and no ICANS reported. The dose expansion phase of the study is enrolling patients with anti-CD19 CAR-relapsed Diffuse Large B Cell Lymphoma (DLBCL) at the maximum dose level (400×10⁶ cells). Additional patient data and FDA feedback on study design are expected in the second quarter of 2026. MT-601 (Pancreatic Cancer) Marker continues to advance MT-601 in pancreatic cancer, supported by non-dilutive funding from the National Institutes of Health (NIH), Small Business Innovation Research (SBIR) program and the Cancer Prevention and Research Institute of Texas (CPRIT). Nature Medicine publication (January 2026): Researchers at Baylor College of Medicine reported encouraging results evaluating multi-antigen targeted T cells in pancreatic cancer, demonstrating a favorable safety profile and up to 84.6% disease control rate when combined with frontline chemotherapy (Press Release, Jan 5, 2026). Marker expects to initiate its company-sponsored pancreatic cancer program in the second quarter of 2026, incorporating learnings from prior studies. MT-401 Off-the-Shelf Program (AML/MDS) Marker is evaluating MT-401, a MAR-T cell therapy targeting four antigens, as an Off-the-Shelf (OTS) product in the Phase 1 RAPID study in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The study is supported by non-dilutive grant funds from National Cancer Institute (NCI), the Food and Drug Administration (FDA) and the Cancer Prevention and Research Institute of Texas (CPRIT). ADDITIONAL 2025 CORPORATE HIGHLIGHTS Manufacturing collaboration with Cellipont Bioservices to advance cGMP production of MT-601. Technical transfer expected to be completed in Q2 2026. Kathryn Penkus Corzo, R.Ph., MBA joined the Board of Directors (November 1, 2025). FISCAL YEAR 2025 FINANCIAL HIGHLIGHTS Cash Position and Guidance: At December 31, 2025, Marker had cash, cash equivalents and restricted cash of $17 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses through the fourth quarter of 2026, assuming no additional grant funds are received, either from new grants or from existing awarded grants. R&D Expenses: Research and development expenses were $11.8 million for the year ended December 31, 2025, compared to $13.5 million for the year ended December 31, 2024. G&A Expenses: General and administrative expenses were $4.2 million for the year ended December 31, 2025, compared to $4.2 million for the year ended December 31, 2024. Net Loss: Marker reported a net loss of $12.2 million for the year ended December 31, 2025, compared to a net loss of $10.7 million for the year ended December 31, 2024. About MAR-T cells The multi-antigen recognizing (MAR) T cell platform (formerly known as multiTAA-specific T cells) 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, MAR-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 MAR-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. The Company was founded at Baylor College of Medicine, and clinical trials that enrolled more than 200 patients across various hematological and solid tumor indications showed that the Company’s autologous and allogeneic MAR-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 APOLLO study is supported by the National Cancer Institute of the National Institutes of Health under Award Number R44CA291521. The Company’s pancreatic cancer program is supported by the National Cancer Institute of the National Institutes of Health (Award Number R44CA295168), and the Cancer Prevention and Research Institute of Texas (CPRIT, Award Number DP250150). Marker’s OTS program is supported by the National Cancer Institute of the National Institutes of Health (Award Number 1R44CA285177), the Food and Drug Administration Department of Health and Human Services (R01FD007272), and the Cancer Prevention and Research Institute of Texas (CPRIT, Award Number DP210042). 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, interim results announcements and outcomes of our clinical trials of our product candidates, including MT-601 for the treatment of patients with lymphoma or pancreatic cancer, and MT-401-OTS for the treatment of patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). 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. Media and Investor Contact Marker Therapeutics, Inc. +1 (713) 400-6400 [email protected]

Investor releaseQuarter not tagged2026-01-05

Baylor College of Medicine Publishes Promising Safety and Efficacy Results of Multi-Antigen Targeted T Cells in Patients with Pancreatic Cancer

GlobeNewswire
Clinical study from Baylor College of Medicine demonstrates a favorable safety profile and up to 84.6% disease control rate in patients with pancreatic cancer in Arm A of the clinical study Study highlights correlation between the clinical benefit and the expansion and persistence of Multi-Antigen Targeted T cells HOUSTON, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR) is a clinical-stage immuno-oncology Company with the worldwide exclusive license of Multi-Antigen Targeted T cells (also referred to as Multi-Antigen Recognizing T cells, or MAR-T cells, by Marker), a technology developed at Baylor College of Medicine for the treatment of hematologic and solid tumors. A research team from Baylor College of Medicine has now published groundbreaking work in Nature Medicine investigating Multi-Antigen Targeted T cells in patients with pancreatic cancer. The Phase 1/2 clinical study conducted at Baylor College of Medicine demonstrated encouraging objective clinical responses and a disease control rate of 84.6% when combining Multi-Antigen Targeted T cells with frontline chemotherapy (Arm A). In this arm of the study, median duration of response for patients achieving a partial or complete response was 7.5 months (range 3.5 – 16.6) with a median overall survival rate of 14.1 months suggesting a clinical benefit of combining Multi-Antigen Targeted T cells with standard chemotherapy. Clinical results from this Phase 1 study demonstrated a favorable safety profile and potential synergistic effect when combining Multi-Antigen Targeted T cells with chemotherapy without affecting the toxicity profile. Chemotherapy was previously shown to break down the tumor’s supporting stromal cells, which act as a protective barrier, to facilitate T cell infiltration into the tumor and to boost anti-tumor response (Gao Z et al, Frontiers in Oncology, 2023). The research group from Baylor also highlighted a correlation between the clinical effect and the expansion and persistence of infused Multi-Antigen Targeted T cells. The data showed that infused T cells were still present in patients 12 months post-treatment and found at higher frequencies in patients that responded to the investigational product. “We congratulate the research team at Baylor College of Medicine on this outstanding work and encouraging results in patients with pancreatic cancer,” said Ju…Read full document

Clinical study from Baylor College of Medicine demonstrates a favorable safety profile and up to 84.6% disease control rate in patients with pancreatic cancer in Arm A of the clinical study Study highlights correlation between the clinical benefit and the expansion and persistence of Multi-Antigen Targeted T cells HOUSTON, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR) is a clinical-stage immuno-oncology Company with the worldwide exclusive license of Multi-Antigen Targeted T cells (also referred to as Multi-Antigen Recognizing T cells, or MAR-T cells, by Marker), a technology developed at Baylor College of Medicine for the treatment of hematologic and solid tumors. A research team from Baylor College of Medicine has now published groundbreaking work in Nature Medicine investigating Multi-Antigen Targeted T cells in patients with pancreatic cancer. The Phase 1/2 clinical study conducted at Baylor College of Medicine demonstrated encouraging objective clinical responses and a disease control rate of 84.6% when combining Multi-Antigen Targeted T cells with frontline chemotherapy (Arm A). In this arm of the study, median duration of response for patients achieving a partial or complete response was 7.5 months (range 3.5 – 16.6) with a median overall survival rate of 14.1 months suggesting a clinical benefit of combining Multi-Antigen Targeted T cells with standard chemotherapy. Clinical results from this Phase 1 study demonstrated a favorable safety profile and potential synergistic effect when combining Multi-Antigen Targeted T cells with chemotherapy without affecting the toxicity profile. Chemotherapy was previously shown to break down the tumor’s supporting stromal cells, which act as a protective barrier, to facilitate T cell infiltration into the tumor and to boost anti-tumor response (Gao Z et al, Frontiers in Oncology, 2023). The research group from Baylor also highlighted a correlation between the clinical effect and the expansion and persistence of infused Multi-Antigen Targeted T cells. The data showed that infused T cells were still present in patients 12 months post-treatment and found at higher frequencies in patients that responded to the investigational product. “We congratulate the research team at Baylor College of Medicine on this outstanding work and encouraging results in patients with pancreatic cancer,” said Juan Vera, MD, President and CEO of Marker Therapeutics. “The data highlights the excellent safety profile of Multi-Antigen Targeted T cells and demonstrates that they can be used in combination with frontline chemotherapy. We believe that this clinical proof-of-concept study emphasizes the potential of Multi-Antigen Targeted T cells in pancreatic cancer and sets the stage for continued development toward addressing a critical unmet need.” Dr. Vera continued, “At Marker, we have further advanced the technology, referring to it as MAR-T cells, and hope to build on the strong results observed in the Baylor study by increasing the number of target antigens, using higher cell doses, and by adding lymphodepletion to the study to further support the expansion of infused MAR-T cells. We are excited about our progress and anticipate clinical initiation of our pancreatic cancer program in the first half of 2026.” The Company recently reported promising safety and efficacy results from its Phase 1 study investigating a MAR-T cell product (MT-601) in lymphoma (APOLLO study, Press Release, August 26, 2025). This study included several improvements compared to earlier trials resulting in a 66% objective response rate in patients with non-Hodgkin lymphoma, with 50% achieving complete response. Improvements from this clinical study will also be incorporated in the pancreatic cancer program. The Company has secured non-dilutive funding from the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program and the Cancer Prevention and Research Institute of Texas (CPRIT) to support the pancreatic cancer program. We anticipate that using these allocated non-dilutive funds should allow the Company to proceed with the pancreatic program without affecting the Company’s runway and its efforts to advance MT-601 in patients with lymphoma in the ongoing Phase 1 APOLLO study (clinicaltrials.gov identifier: NCT05798897). Reference Benjamin L. Musher, Spyridoula Vasileiou, Brandon G. Smaglo, Catherine S. Robertson, Mengfen Wu, Tao Wang, Ayumi Watanabe, Manik Kuvalekar, Yovana Velazquez, Shamika Ketkar, Tamadar Al Doheyan, Penelope G. Papayanni, Aakash Shah, Natalia Lapteva, Bambi J. Grilley, George Van Buren, Premal D. Lulla, Helen E. Heslop, Cliona M. Rooney, Malcolm K. Brenner, and Ann M. Leen. Autologous multiantigen-targeted T cell therapy for pancreatic ductal adenocarcinoma (PDAC): results of a Phase I, three-arm, nonrandomized clinical trial (TACTOPS). Nature Medicine. doi:10.1038/s41591-025-04043-5 About MAR-T cells The multi-antigen recognizing (MAR) T cell platform (formerly known as multiTAA-specific T cells) 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, MAR-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 MAR-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 MT-601 The Company’s lead product, MT-601, is a multi-antigen recognizing (MAR) T cell product that utilizes a non-genetically modified approach that specifically targets six different tumor antigens upregulated in tumor cells (Survivin, PRAME, WT-1, NY-ESO-1, SSX-2, MAGEA-4). Marker is currently investigating MT-601 in the Phase 1 APOLLO trial (clinicaltrials.gov identifier: NCT05798897) for the treatment of patients with lymphoma who have relapsed after or are ineligible to receive anti-CD19 CAR-T cell therapies. Due to the broad target recognition profile of MT-601, the Company is exploring its potential application beyond lymphoma in patients with pancreatic cancer. The Company’s pancreatic cancer program is supported by the National Cancer Institute of the National Institutes of Health (Award Number R44CA295168), and the Cancer Prevention and Research Institute of Texas (CPRIT, Award Number DP250150). 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. The Company was founded at Baylor College of Medicine, and clinical trials that enrolled more than 200 patients across various hematological and solid tumor indications showed that the Company’s autologous and allogeneic MAR-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; the timing, conduct, interim results announcements and outcomes of our clinical trials of our product candidates, including MT-601 for the treatment of patients with lymphoma or pancreatic cancer. 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. Media and Investor Contact Marker Therapeutics, Inc. +1 (713) 400-6400 [email protected]

Investor releaseQuarter not tagged2025-11-14

Marker Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Updates

GlobeNewswire
APOLLO study showed encouraging overall responses and favorable safety profile in relapsed/refractory B-cell lymphoma MT-601 demonstrated 66% objective response rate with 50% complete response in relapsed Non-Hodgkin lymphoma (NHL) patients in the ongoing APOLLO study First patient treated in Off-the-Shelf program (RAPID study) investigating MAR-T cells in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) cGMP manufacturing collaboration established with Cellipont Bioservices HOUSTON, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company developing next-generation T cell-based therapies, today reported corporate updates and financial results for the third quarter ended September 30, 2025. “Marker entered the second half of 2025 with strong clinical momentum as we continue to advance our lead program, MT-601, in patients with relapsed or refractory B-cell lymphoma,” said Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. “The most recent update from our Phase 1 APOLLO study showed a 66% objective response rate including 50% complete responses, in heavily pre-treated NHL patients. These data, together with a favorable safety profile, reinforce the potential of MT-601 to meet the critical needs of patients who have exhausted multiple lines of therapy, including CAR-T cell therapies and bispecific antibodies. We’re encouraged by the durability of responses and plan to share an additional update in the first half of 2026.” Dr. Vera continued, “We also achieved a number of key milestones in this quarter, including treating the first patient in our Off-the-Shelf (OTS) program and entering a strategic manufacturing collaboration with Cellipont to scale up production of MT-601. In parallel, we have strengthened our balance sheet by raising approximately $10 million through our ATM facility, extending our cash runway well into 2026. Looking ahead, we are focused on enrolling patients in the MT-601 dose expansion cohort to build on our promising observations from our APOLLO study. Having executed on the priorities we set at the beginning of the year we are entering the final stretch of 2025 with strong operational footing and a clear clinical focus.” PROGRAM UPDATES & OPERATIONAL HIGHLIGHTS MT-601 (Lymphoma) Positive clinical data from the Phase 1 APOLL…Read full document

APOLLO study showed encouraging overall responses and favorable safety profile in relapsed/refractory B-cell lymphoma MT-601 demonstrated 66% objective response rate with 50% complete response in relapsed Non-Hodgkin lymphoma (NHL) patients in the ongoing APOLLO study First patient treated in Off-the-Shelf program (RAPID study) investigating MAR-T cells in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) cGMP manufacturing collaboration established with Cellipont Bioservices HOUSTON, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company developing next-generation T cell-based therapies, today reported corporate updates and financial results for the third quarter ended September 30, 2025. “Marker entered the second half of 2025 with strong clinical momentum as we continue to advance our lead program, MT-601, in patients with relapsed or refractory B-cell lymphoma,” said Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. “The most recent update from our Phase 1 APOLLO study showed a 66% objective response rate including 50% complete responses, in heavily pre-treated NHL patients. These data, together with a favorable safety profile, reinforce the potential of MT-601 to meet the critical needs of patients who have exhausted multiple lines of therapy, including CAR-T cell therapies and bispecific antibodies. We’re encouraged by the durability of responses and plan to share an additional update in the first half of 2026.” Dr. Vera continued, “We also achieved a number of key milestones in this quarter, including treating the first patient in our Off-the-Shelf (OTS) program and entering a strategic manufacturing collaboration with Cellipont to scale up production of MT-601. In parallel, we have strengthened our balance sheet by raising approximately $10 million through our ATM facility, extending our cash runway well into 2026. Looking ahead, we are focused on enrolling patients in the MT-601 dose expansion cohort to build on our promising observations from our APOLLO study. Having executed on the priorities we set at the beginning of the year we are entering the final stretch of 2025 with strong operational footing and a clear clinical focus.” PROGRAM UPDATES & OPERATIONAL HIGHLIGHTS MT-601 (Lymphoma) Positive clinical data from the Phase 1 APOLLO study (clinicaltrials.gov identifier: NCT05798897) showed a 66% (8 out of 12) objective response rate and 50% (6 out of 12) complete response rate in relapsed NHL patients, including those previously treated with CAR-T cell therapies and bispecific antibodies (Press Release, August 26, 2025). Responses were durable with five NHL patients maintaining response for ≥6 months, including three with ≥12 months (range 3-24 months). Favorable safety profile with no dose-limiting toxicities (DLTs) or immune effector cell–associated neurotoxicity (ICANS) observed at any dose level in the dose escalation cohort. Dose expansion cohort underway, evaluating MT-601 at highest dose level (400x106 cells) in patients with Diffuse Large B Cell Lymphoma (DLBCL) who have relapsed after or are ineligible for CAR-T cell therapy. Additional clinical data are expected in the first half of 2026. MT-601 (Pancreatic Cancer) Marker was previously awarded $2.0 million from the NIH and $9.5 million from the Cancer Prevention and Research Institute of Texas (CPRIT) to support the development of MT-601 in metastatic pancreatic cancer. Clinical program launch is anticipated in the first half of 2026. Off-the-Shelf Program (Acute Myeloid Leukemia or Myelodysplastic Syndrome) Marker announced first patient treated in Phase 1 RAPID study (clinicaltrials.gov Identifier: NCT06552416) evaluating MT-401 as an Off-the-Shelf (OTS) product (Press Release, October 6, 2025). Treatment with MT-401-OTS was well tolerated, consistent with the favorable safety profile previously reported for MAR-T cells. The OTS program is investigating MAR-T cells in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) with the potential for future expansion to other indications. The Company previously secured non-dilutive funding from NIH, FDA and CPRIT to support the OTS program. Corporate Updates Marker entered a current good manufacturing practice (cGMP) manufacturing agreement with Cellipont Bioservices to scale up the production of MT-601 for the APOLLO study. This partnership supports clinical supply and lays the ground for a potential pivotal trial and commercial readiness (Press Release, June 17, 2025). Data from the Phase 1 APOLLO study will be presented in two posters at the 67th ASH Annual Meeting and Exposition, held from December 6-9, 2025, in Orlando, Florida (Press Release, November 3, 2025). Appointed Kathryn Penkus Corzo, R.Ph., MBA to the Company’s Board of Directors, effective November 1, 2025 (Press Release, November 5, 2025). Marker raised approximately $10 million through its ATM Agreement, extending the Company’s runway well into 2026. THIRD QUARTER 2025 FINANCIAL HIGHLIGHTS Cash Position and Guidance: At September 30, 2025, Marker had cash and cash equivalents of $17.6 million and restricted cash of $1.4 million. The Company believes that its existing cash, cash equivalents and restricted cash will fund its operating expenses through the third quarter of 2026, assuming no additional grant funds are received, either from new grants or from existing awarded grants. R&D Expenses: Research and development expenses were $2.3 million for the quarter ended September 30, 2025, compared to $3.5 million for the quarter ended September 30, 2024. G&A Expenses: General and administrative expenses were $1 million for the quarter ended September 30, 2025, compared to $0.9 million for the quarter ended September 30, 2024. Net Loss: Marker reported a net loss from continuing operations of $2.0 million for the quarter ended September 30, 2025, compared to $2.3 million for the quarter ended September 30, 2024. About MAR-T cells The multi-antigen recognizing (MAR) T cell platform (formerly known as multiTAA-specific T cells) 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, MAR-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 MAR-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. The Company was founded at Baylor College of Medicine, and clinical trials that enrolled more than 200 patients across various hematological and solid tumor indications showed that the Company’s autologous and allogeneic MAR-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, interim results announcements and outcomes 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. Media and Investor Contact Marker Therapeutics, Inc. +1 (713) 400-6400 [email protected]

Investor releaseQuarter not tagged2025-04-02

Marker Therapeutics Full Year 2024 Earnings: Misses Expectations

Simply Wall St.

Revenue: US$6.59m (up 99% from FY 2023). Net loss: US$10.7m (loss narrowed by 24% from FY 2023). US$1.20 loss per share (improved from US$1.59 loss in FY 2023). AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 21%. Earnings per share (EPS) also missed analyst estimates by 63%. Looking ahead, revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 4.2% from a week ago. You should always think about risks. Case in point, we've spotted 4 warning signs for Marker Therapeutics you should be aware of, and 1 of them is a bit concerning. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Investor releaseQuarter not tagged2025-03-31

Marker Therapeutics Reports Year-End 2024 Corporate and Financial Results

GlobeNewswire
Lead program investigating MT-601 in patients with refractory lymphomas, including anti-CD19 CAR-T cell therapy, demonstrated safety and efficacy in 9 patients with 78% having objective responses, including durable complete responses Secured over $13 million in non-dilutive funding from the Cancer Prevention & Research Institute of Texas (CPRIT) and the National Institute of Health (NIH) Small Business Innovation Research (SBIR) to support pancreatic and lymphoma clinical programs Approval from United States Adopted Name (USAN) council and International Nonproprietary Names (INN) expert committee for “neldaleucel” as nonproprietary name for MT-601 Strategic financing to support clinical advancements to investigate MT-601 in patients with lymphoma HOUSTON, March 31, 2025 (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 announced corporate updates and financial results for the year ended December 31, 2024. “In 2024, we made substantial progress advancing MT-601, our lead multi antigen recognizing (MAR)-T cell therapy, and laid the groundwork for continued momentum in 2025,” said Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. “Preliminary data from our Phase 1 APOLLO study showed encouraging safety and efficacy results in lymphoma patients who relapsed after anti-CD19 CAR-T cell therapy. With a 78% objective response rate and favorable safety profile, we believe MT-601 has the potential to provide a transformative treatment option for this patient population. We look forward to sharing additional insights during a webinar in the second quarter of 2025.” “We also strengthened our financial position through a strategic private placement and additional non-dilutive funding from the NIH and CPRIT. As we move further into 2025, our focus remains on cash preservation and disciplined execution to maximize the impact of our clinical programs,” concluded Dr. Vera. 2024 PROGRAM UPDATES & OPERATIONAL HIGHLIGHTS MT-601 (Lymphoma) MT-601, Marker’s lead MAR-T cell therapy, is being evaluated in the nationwide multicenter Phase 1 APOLLO study (clinicaltrials.gov identifier: NCT05798897) in patients with anti-CD19 CAR-T relapsed lymphoma or where CAR-T ce…Read full document

Lead program investigating MT-601 in patients with refractory lymphomas, including anti-CD19 CAR-T cell therapy, demonstrated safety and efficacy in 9 patients with 78% having objective responses, including durable complete responses Secured over $13 million in non-dilutive funding from the Cancer Prevention & Research Institute of Texas (CPRIT) and the National Institute of Health (NIH) Small Business Innovation Research (SBIR) to support pancreatic and lymphoma clinical programs Approval from United States Adopted Name (USAN) council and International Nonproprietary Names (INN) expert committee for “neldaleucel” as nonproprietary name for MT-601 Strategic financing to support clinical advancements to investigate MT-601 in patients with lymphoma HOUSTON, March 31, 2025 (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 announced corporate updates and financial results for the year ended December 31, 2024. “In 2024, we made substantial progress advancing MT-601, our lead multi antigen recognizing (MAR)-T cell therapy, and laid the groundwork for continued momentum in 2025,” said Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. “Preliminary data from our Phase 1 APOLLO study showed encouraging safety and efficacy results in lymphoma patients who relapsed after anti-CD19 CAR-T cell therapy. With a 78% objective response rate and favorable safety profile, we believe MT-601 has the potential to provide a transformative treatment option for this patient population. We look forward to sharing additional insights during a webinar in the second quarter of 2025.” “We also strengthened our financial position through a strategic private placement and additional non-dilutive funding from the NIH and CPRIT. As we move further into 2025, our focus remains on cash preservation and disciplined execution to maximize the impact of our clinical programs,” concluded Dr. Vera. 2024 PROGRAM UPDATES & OPERATIONAL HIGHLIGHTS MT-601 (Lymphoma) MT-601, Marker’s lead MAR-T cell therapy, is being evaluated in the nationwide multicenter Phase 1 APOLLO study (clinicaltrials.gov identifier: NCT05798897) in patients with anti-CD19 CAR-T relapsed lymphoma or where CAR-T cells are not an option. The Company provided an update on the APOLLO study (Press Release, December 19, 2024). Key findings from the study include: Safety: MT-601 was well tolerated across all study participants. No immune-effector cell associated neurotoxicity syndrome (ICANS) and one case of Grade 1 cytokine release syndrome (CRS) were observed. No dose limiting toxicities (DLTs) have been reported to date. Efficacy: In the first dose cohort, 7 out of 9 patients achieved objective responses (78%) at first response assessment, with 4 patients demonstrating complete response (CR; 44.4%). Time in Follow-Up: Three patients have been followed for 6 to 12 months, with ongoing follow-up underway. All study participants are monitored closely to ensure comprehensive data collection and patient safety. The Company is enrolling additional study participants in the Phase 1 APOLLO trial and expects to report further data in the second half of 2025. MT-601 (Pancreatic) Marker received $2 million from NIH SBIR and $9.5 million from CPRIT to support the development of MT-601 in metastatic pancreatic cancer. Clinical program launch is anticipated in the second half of 2025. MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic Syndrome) The Company previously secured non-dilutive funding to support the clinical investigation of 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 a cellular inventory has been established with ongoing efforts to expand. The Company anticipates clinical program initiation during the second half of 2025. 2024 CORPORATE HIGHLIGHTS Announced clinical pipeline prioritization in January 2024 to strategically focus on MT-601 in patients with lymphoma. This announcement also included program updates that highlighted the potential of the Company’s MT-401-OTS program for patients with AML (Press Release, January 8, 2024). The United States Adopted Names (USAN) and International Nonproprietary Names (INN) committees approved “neldaleucel” as the nonproprietary (generic) name for MT-601. On December 23, 2024, the Company announced a $16.1 million private placement to support the clinical advancements of the Phase 1 APOLLO study. The financing involved participation from new and existing investors, including esteemed firms such as Blue Owl, New Enterprise Associates (NEA) and Aisling Capital. FISCAL YEAR 2024 FINANCIAL HIGHLIGHTS Cash Position and Guidance: At December 31, 2024, Marker had cash and cash equivalents of $19.2 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses into the first quarter of 2026, assuming no additional grant funds are received. We anticipate receiving additional grant funding, which we expect could extend our runway beyond Q1 2026. R&D Expenses: Research and development expenses were $13.5 million for the year ended December 31, 2024, compared to $10.4 million for the year ended December 31, 2023. G&A Expenses: General and administrative expenses were $4.2 million for the year ended December 31, 2024, compared to $7.5 million for the year ended December 31, 2023. Net Loss: Marker reported a net loss of $10.7 million for the year ended December 31, 2024, compared to a net loss of $8.2 million for the year ended December 31, 2023. About MAR-T cells The multi-antigen recognizing (MAR) T cell platform (formerly known as multiTAA-specific T cells) 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, MAR-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 MAR-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. The Company was founded at Baylor College of Medicine, and clinical trials that enrolled more than 200 patients across various hematological and solid tumor indications showed that the Company’s autologous and allogeneic MAR-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; the timing, conduct, interim results announcements and outcomes 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. Media and Investor Contact Marker Therapeutics, Inc. +1 (713) 400-6400 [email protected]

As of 2026-08-08 • Updated weeklySource: Earnings sourceIngestion runbook