Marker Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Updates
Marker Therapeutics (NASDAQ: MRKR) reported Q3 2025 results and program updates on Nov 14, 2025. Key clinical highlights include a 66% objective response rate and 50% complete response rate for MT-601 in relapsed NHL from the Phase 1 APOLLO study (8/12 ORR; 6/12 CR), with five responses ≥6 months and three ≥12 months. No DLTs or ICANS observed. The company treated the first patient in its Off-the-Shelf RAPID study and signed a cGMP manufacturing collaboration with Cellipont. Marker raised approximately $10.0 million via ATM; cash and restricted cash totaled $19.0 million at 9/30/25, funding operations into Q3 2026 under current assumptions.
Marker Therapeutics (NASDAQ: MRKR) ha riportato i risultati del Q3 2025 e aggiornamenti sui programmi il 14 novembre 2025. I principali highlight clinici includono un 66% tasso di risposta obiettivo e un 50% tasso di risposta completa per MT-601 nella LNH ricorrente dall'studio di fase 1 APOLLO (8/12 ORR; 6/12 CR), con cinque risposte ≥6 mesi e tre ≥12 mesi. Nessuna DLT o ICANS osservata. L'azienda ha trattato il primo paziente nel suo studio Off-the-Shelf RAPID e ha firmato una collaborazione di produzione cGMP con Cellipont. Marker ha raccolto circa $10.0 milioni tramite ATM; la cassa e la cassa vincolata ammontavano a $19.0 milioni al 30/09/25, finanziando le operazioni fino al Q3 2026 secondo le ipotesi correnti.
Marker Therapeutics (NASDAQ: MRKR) informó sobre los resultados del tercer trimestre de 2025 y actualizaciones de programa el 14 de noviembre de 2025. Los aspectos clínicos clave incluyen una tasa de respuesta objetiva del 66% y una tasa de respuesta completa del 50% para MT-601 en LNH recidivante a partir del estudio de fase 1 APOLLO (8/12 ORR; 6/12 CR), con cinco respuestas ≥6 meses y tres ≥12 meses. No se observaron DLTs ni ICANS. La compañía trató al primer paciente en su estudio Off-the-Shelf RAPID y firmó una colaboración de fabricación cGMP con Cellipont. Marker recaudó aproximadamente $10.0 millones mediante ATM; el efectivo y el efectivo restringido totalizaron $19.0 millones al 30/09/25, financiando las operaciones hasta el Q3 2026 bajo las hipótesis actuales.
Marker Therapeutics (NASDAQ: MRKR)는 2025년 11월 14일에 2025년 3분기 실적 및 프로그램 업데이트를 발표했습니다. 주요 임상 하이라이트로는 MT-601이 재발성 NHL에서 1상 APOLLO 연구의 객관적 반응률 66% 및 완전 반응률 50%를 기록했으며(8/12 ORR; 6/12 CR), 반응이 ≥6개월인 케이스 5건, ≥12개월인 케이스 3건이 보고되었습니다. DLT나 ICANS는 관찰되지 않았습니다. 회사는 Off-the-Shelf RAPID 연구의 첫 환자를 치료했고 Cellipont와 cGMP 제조 협력 계약을 체결했습니다. Marker는 ATM을 통해 약 $10.0 백만을 조달했고, 9/30/25 기준 현금 및 제한 현금은 $19.0 백만으로 집계되어 현 가정 하에 2026년 3분기까지 운영 자금을 확보했습니다.
Marker Therapeutics (NASDAQ: MRKR) a publié les résultats du T3 2025 et des mises à jour de programme le 14 novembre 2025. Les points forts cliniques clés incluent un taux de réponse objective de 66% et un taux de réponse complète de 50% pour MT-601 dans le LNM récidivant à partir de l'essai de phase 1 APOLLO (8/12 ORR; 6/12 CR), avec cinq réponses ≥6 mois et trois ≥12 mois. Aucune DLT ni ICANS observée. L'entreprise a traité le premier patient dans son étude Off-the-Shelf RAPID et a signé une collaboration de fabrication cGMP avec Cellipont. Marker a levé environ $10.0 millions via ATM; la trésorerie et les montants en espèces restreints totalisaient $19.0 millions au 30/09/25, finançant les opérations jusqu’au T3 2026 selon les hypothèses actuelles.
Marker Therapeutics (NASDAQ: MRKR) meldete am 14. November 2025 die Ergebnisse des Q3 2025 und Programmupdates. Zu den wichtigsten klinischen Highlights gehören eine 66%-ige objektive Ansprechrate und eine 50%-ige komplette Ansprechrate für MT-601 bei rezidiviertem NHL aus der Phase-1-APOLLO-Studie (8/12 ORR; 6/12 CR), mit fünf Antworten ≥6 Monate und drei ≥12 Monate. Es wurden keine DLTs oder ICANS beobachtet. Das Unternehmen behandelte den ersten Patienten in seiner Off-the-Shelf RAPID-Studie und unterzeichnete eine cGMP-Fertigungskooperation mit Cellipont. Marker hat ca. $10.0 Millionen über ATM aufgenommen; Barbestand und eingeschränkter Barbestand betrugen zum 30.09.2025 insgesamt $19.0 Millionen, wodurch die Operationen bis ins Q3 2026 unter den aktuellen Annahmen finanziert werden.
Marker Therapeutics (NASDAQ: MRKR) أبلغت عن نتائج الربع الثالث من 2025 وتحديثات البرنامج في 14 نوفمبر 2025. تشمل أبرز النقاط السريرية معدل الاستجابة الموضوعية 66% و معدل الاستجابة الكلية 50% لـ MT-601 في LNH المعاود من دراسة المرحلة 1 APOLLO (8/12 ORR؛ 6/12 CR)، مع وجود خمس استجابات ≥6 أشهر و ثلاث استجابات ≥12 شهراً. لم تُلاحظ DLTs أو ICANS. قامت الشركة بعلاج المريض الأول في دراستها Off-the-Shelf RAPID ووقَّعت تعاون تصنيع cGMP مع Cellipont. جمعت Marker ما يقرب من $10.0 مليون عبر ATM؛ وبلغ النقد والسوائل النقدية المقيدة $19.0 مليون في 30/09/2025، ممَّا يموّل العمليات حتى الربع الثالث من 2026 وفق الافتراضات الحالية.
- MT-601 ORR of 66% (8/12)
- MT-601 complete response rate 50% (6/12)
- Five NHL responses maintained ≥6 months
- No DLTs or ICANS observed
- Raised approximately $10.0 million via ATM
- Cash and restricted cash of $19.0 million at 9/30/25
- Clinical ORR/CR based on only 12 patients
- Company expects cash to fund operations only through Q3 2026
- General and administrative expenses rose by ~11% year-over-year
Insights
Phase 1 results show promising activity and safety; operational steps support scaling and near-term readouts.
MT-601 showed a 66% objective response rate and 50% complete response rate in 12 relapsed NHL patients, with responses lasting ≥6 months in five patients and ≥12 months in three. The dose expansion at the highest dose (400x10^6 cells) is underway and no DLTs or ICANS were observed, which supports continued clinical development and short-term data generation.
The company advanced manufacturing and program milestones: first patient dosed in the Off-the-Shelf RAPID study, a cGMP collaboration with Cellipont, and approximately
Watch for the additional APOLLO update in the first half of
APOLLO study showed encouraging overall responses and favorable safety profile in relapsed/refractory B-cell lymphoma
MT-601 demonstrated
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
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
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 and50% (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
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Marker reported a net loss from continuing operations of
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.
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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.
| Marker Therapeutics, Inc. Condensed Consolidated Balance Sheets (Unaudited) | ||||||||
| September 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 17,589,978 | $ | 19,192,440 | ||||
| Restricted cash | 1,352,975 | — | ||||||
| Prepaid expenses and deposits | 1,126,724 | 483,717 | ||||||
| Other receivables | 1,665,153 | 2,346,703 | ||||||
| Total current assets | 21,734,830 | 22,022,860 | ||||||
| Total assets | $ | 21,734,830 | $ | 22,022,860 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 1,664,647 | $ | 1,753,954 | ||||
| Related party payable | 328,315 | 1,710,500 | ||||||
| Deferred revenue | 1,352,975 | — | ||||||
| Total current liabilities | 3,345,937 | 3,464,454 | ||||||
| Total liabilities | 3,345,937 | 3,464,454 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 16,672 | 10,708 | ||||||
| Additional paid-in capital | 475,849,809 | 465,564,876 | ||||||
| Accumulated deficit | (457,477,588 | ) | (447,017,178 | ) | ||||
| Total stockholders’ equity | 18,388,893 | 18,558,406 | ||||||
| Total liabilities and stockholders’ equity | $ | 21,734,830 | $ | 22,022,860 | ||||
| Marker Therapeutics, Inc. Condensed Consolidated Statements of Operations (Unaudited) | ||||||||||||||||
| For the Three Months Ended | For the Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenues: | ||||||||||||||||
| Grant income | $ | 1,232,938 | $ | 1,926,020 | $ | 2,443,255 | $ | 4,339,317 | ||||||||
| Total revenues | 1,232,938 | 1,926,020 | 2,443,255 | 4,339,317 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,345,843 | 3,471,216 | 9,658,322 | 8,381,661 | ||||||||||||
| General and administrative | 1,023,821 | 854,677 | 3,338,200 | 3,214,611 | ||||||||||||
| Loss on early termination of vendor agreement | — | — | 453,135 | — | ||||||||||||
| Total operating expenses | 3,369,664 | 4,325,893 | 13,449,657 | 11,596,272 | ||||||||||||
| Loss from operations | (2,136,726 | ) | (2,399,873 | ) | (11,006,432 | ) | (7,256,955 | ) | ||||||||
| Other income: | ||||||||||||||||
| Interest income | 138,064 | 91,681 | 428,578 | 363,264 | ||||||||||||
| Other income | — | — | 117,444 | — | ||||||||||||
| Net loss | $ | (1,998,662 | ) | $ | (2,308,192 | ) | $ | (10,460,410 | ) | $ | (6,893,691 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Net loss per share | $ | (0.12 | ) | $ | (0.26 | ) | $ | (0.75 | ) | $ | (0.77 | ) | ||||
| Weighted average number of common shares outstanding: | ||||||||||||||||
| Basic | 16,757,678 | 8,923,170 | 13,960,791 | 8,914,487 | ||||||||||||
| Diluted | 16,757,678 | 8,923,170 | 13,960,791 | 8,914,487 | ||||||||||||
| Marker Therapeutics, Inc. Condensed Consolidated Statements of Cash Flows (Unaudited) | ||||||||
| For the Nine Months Ended | ||||||||
| September 30, | ||||||||
| 2025 | 2024 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (10,460,410 | ) | $ | (6,893,691 | ) | ||
| Reconciliation of net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 426,409 | 195,320 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and deposits | (643,007 | ) | (178,148 | ) | ||||
| Other receivables | 681,550 | 283,405 | ||||||
| Related party payable | (1,382,185 | ) | (426,217 | ) | ||||
| Accounts payable and accrued expenses | (89,307 | ) | 812,142 | |||||
| Deferred revenue | 1,352,975 | — | ||||||
| Net cash used in operating activities | (10,113,975 | ) | (6,207,189 | ) | ||||
| Cash Flows from Financing Activities: | ||||||||
| Proceeds from issuance of common stock, net | 9,863,883 | 36,902 | ||||||
| Proceeds from exercise of warrants and stock options | 605 | 58,501 | ||||||
| Net cash provided by financing activities | 9,864,488 | 95,403 | ||||||
| Net decrease in cash, cash equivalents, and restricted cash | (249,487 | ) | (6,111,786 | ) | ||||
| Cash, cash equivalents, and restricted cash at beginning of the period | 19,192,440 | 15,111,450 | ||||||
| Cash, cash equivalents, and restricted cash at end of the period | $ | 18,942,953 | $ | 8,999,664 | ||||
Media and Investor Contact
Marker Therapeutics, Inc.
+1 (713) 400-6400
investor.relations@markertherapeutics.com
FAQ
What were Marker Therapeutics (MRKR) APOLLO study results announced Nov 14, 2025?
How durable were MT-601 responses reported by MRKR on Nov 14, 2025?
What is Marker Therapeutics' (MRKR) cash position and runway as of Q3 2025?
What corporate actions did MRKR take to support MT-601 manufacturing in 2025?
What regulatory or investor events will feature MRKR clinical data in December 2025?
What progress did MRKR report for its Off-the-Shelf (OTS) RAPID study on Nov 14, 2025?
