Tillkännagivande • Jan 09

Marker Therapeutics Announces Clinical Program Updates and Pipeline Prioritization

Marker Therapeutics, Inc. announced a restructuring of its clinical programs and a strategic prioritization of its multi-tumor associated antigen (multiTAA)-specific T cell product pipeline. In addition, the Company reported a clinical update on the Phase 2 ARTEMIS study investigating MT-401, a multiTAA-specific T cell product, for the treatment of patients with acute myeloid leukemia (AML).Following the non-dilutive transaction with Cell Ready (Press Release, May 1, 2023), Marker has made significant progress on clinical and corporate restructuring with the objective of accelerating the commercial development of their unique multiTAA technology. The Company announced the prioritization of MT-601 in chimeric antigen receptor (CAR) relapse patients with lymphoma (APOLLO; clinicaltrials.gov identifier: NCT05798897). This strategic decision was made based on 1) the Company’s promising non-clinical and clinical data using the multiTAA technology in lymphoma, and 2) the lack of an approved treatment for patients who experience relapse after treatment with CD19 CAR T (up to 60% within a year; Chong EA et al, N Engl J Med, 2021), which is a clear unmet medical need and provides an opportunity for accelerated product development. Highlights from the Lymphoma Study: Clinical Efficacy in Patients with Lymphoma in Previous Clinical Trial: The multiTAA-specific T cell product targeting 5 TAAs was investigated in the TACTAL study, a Phase 1 trial conducted at Baylor College of Medicine. The TACTAL study enrolled patients with Hodgkin’s and non-Hodgkin’s lymphoma and demonstrated clinical safety and efficacy with durable clinical responses for 6 years.Non-Clinical Proof-of-Concept Data: Marker developed a long-term in vitro killing assay 1) to better understand resistance mechanisms following CAR T cell treatment and 2) to determine if a product that is capable of targeting 6 TAAs (MT-601) will be able to kill CAR-resistant lymphoma cells. After CD19-targeting CAR T cell treatment, 98% of lymphoma cells were eliminated in vitro. Long-term follow-up (three weeks) demonstrated outgrowth of CD19-negative tumor cells. Additional anti-CD19 CAR T cell treatment failed to inhibit tumor growth due to the lack of target antigen (CD19) expression on the tumor. Treating CAR-resistant lymphoma cells with MT-601 resulted in complete long-term growth inhibition (over three weeks) highlighting that MT-601 has the potential to effectively treat CD19 CAR-resistant tumors. Durable Response in CAR Relapsed Patient with Lymphoma: The Company-sponsored Phase 1 APOLLO study investigates the safety and efficacy of MT-601 in patients with lymphoma who have failed or are ineligible to receive anti-CD19 CAR T cell therapy. The first study participant, a 57-year-old female with diffuse large B cell lymphoma (DLBCL), was enrolled in the Phase 1 dose escalation stage of the trial after failing 4 prior lines of therapy, including anti-CD19 CAR T cell therapy. The participant relapsed within 90 days of CAR T cell therapy, and was treated with MT-601 without prior lymphodepletion. The patient tolerated MT-601 well without treatment-related adverse events and achieved a complete response eight weeks after the second infusion of MT-601. Six months following treatment with MT-601 the study participant has maintained a complete response to treatment suggesting that MT-601 is more durable compared to CAR T cells in this study participant . CD19-targeting CAR T cell therapies are associated with severe side effects and toxicities, and up to 60% of patients with DLBCL relapse within a year (Chong EA et al, N Engl J Med, 2021). Additionally, the FDA is investigating CAR T therapies for the potential risk of inducing secondary cancers (U.S. Food and Drug Administration, Nov. 28, 2023). To date, multiTAA-specific T cell therapies have been well-tolerated in over 200 patients in clinical trials, and Marker believes that, unlike CAR T cells, multiTAA-specific T cells could represent a safer therapeutic option due to their non-genetically engineered approach that selectively expands tumor-specific T cells from a patient’s/donor’s blood without the risk of mutagenesis. Promising Clinical Observations and New Directions with MT-401 in Patients with MRD in AML: Marker is providing a clinical update on the Phase 2 ARTEMIS clinical study (clinicaltrials.gov identifier: NCT04511130), and the direction it will pursue. This multicenter study is evaluating the safety and efficacy of MT-401 in patients with AML after allogeneic hematopoietic stem cell transplantation (HSCT). A total of 8 patients with MRD+ AML after HSCT were enrolled and treated with MT-401. None of the 8 treated patients experienced a drug related adverse event. Of the 8 treated patients, 4 experienced a clinical benefit, with 3 showing a conversion to MRD-negative, and one patient showing a partial response with a logarithmic reduction of MRD levels by PCR. One patient has not yet had the first assessment post treatment. Of the 8 treated patients in the study, only 1 patient had documented disease progression and was taken to a second transplant. The other 3 patients were taken off the study for reasons unrelated to the clinical outcome. Obtaining timely consent and re-accessing HSCT donors for apheresis for the manufacture of MT-401 caused delayed patient accrual and patient eligibility issues. Consequently, the rapid progression of disease contributed to some patients to withdraw from the study prior to administration of study product. Therefore, to streamline resources and to reduce time to treatment, Marker intends to focus on a ready for use product from commercially available leukapheresis material and will discontinue the patient-specific part (ARTEMIS) of the AML program. The Company previously announced that the FDA has cleared the clinical protocol to investigate a ready for use MT-401 product manufactured from healthy donors in patients with AML, and a cellular inventory has been established with continuous efforts to expand this inventory. Marker has secured non-dilutive funding to support the clinical investigation of a ready for use MT-401 product in patients with AML. Using these allocated funds will allow the Company to proceed with the ready for use program without affecting the ongoing Phase 1 APOLLO study and the capital runway of the Company into the fourth quarter of 2025. In addition, the Company has an Investigational New Drug (IND) application cleared by the U.S. FDA for a Phase 1 trial to investigate MT-601 in patients with pancreatic cancer in combination with first-line chemotherapy. The clinical advancement of this multicenter study will be pending additional funding from non-dilutive sources, including grant activities.

Tillkännagivande • Dec 12

Marker Therapeutics, Inc. Reports Clinical Update on the Apollo Study

Marker Therapeutics, Inc. reported a clinical update on the APOLLO study. The Phase 1 APOLLO study is investigating MT-601, a multi-tumor associated antigen (multiTAA)-specific T cell product, for the treatment of patients with lymphoma who have failed or are ineligible to receive anti-CD19 CAR T cell therapy. The Company previously reported first enrollment in the dose escalation stage of the Phase 1 trial. The patient had diffuse large B cell lymphoma and failed four prior lines of therapy, including anti-CD19 CAR T cell therapy. Marker reported in September that the study participant tolerated the treatment well without treatment-related adverse events and achieved a complete metabolic response eight weeks after the second infusion of MT-601. Marker reports that six months following the initial treatment with MT-601 the study participant has maintained complete response to treatment. These clinical results are reinforced by non-clinical proof-of-concept data demonstrating that MT-601 has the potential to eradicate lymphoma cells resistant to anti-CD19 CAR T cells, highlighting the therapeutic potential of MT-601 in vitro. Although CD19-targeting CAR T cell therapies have gained acceptance as treatment for patients with lymphoma, up to 60% of patients treated with CAR T therapies relapse within one year (Chong EA et al, N Engl J Med, 2021). This APOLLO study participant relapsed within 90 days after CAR T cell therapy, yet maintained a complete response for at least six months after treatment with MT-601, suggesting that MT-601 is more durable compared to CAR T cells in this study participant. CAR T cell therapies, which have known severe side effects such as neurotoxicity, are also currently being investigated by the FDA for the risk of potential induction of secondary cancers, adding another layer of concern for patients and clinicians. Notably, multiTAA-specific T cell therapies have been well-tolerated in clinical trials, and Marker believes that multiTAA-specific T cells are a safe alternative to CAR T cells due to their non-genetically engineered approach that selectively expands tumor-specific T cells from a patient’s/donor’s blood without the risk of mutagenesis. MT-601 utilizes a novel non-genetically modified approach that specifically targets six different tumor antigens upregulated in lymphoma cells (Survivin, PRAME, WT-1, NY-ESO-1, SSX-2, MAGEA-4). 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/refractory after or ineligible to anti-CD19 CAR T cell therapies. The APOLLO trial is a Phase 1, multicenter, open-label study designed to evaluate the safety and efficacy of MT-601 in participants with relapsed or refractory lymphoma who either failed anti-CD19 chimeric antigen receptor (CAR) T cell therapy or are ineligible for anti-CD19 CAR T cell therapy. The primary objective of this exploratory Phase 1 clinical trial is to evaluate the optimum dose, safety, and preliminary efficacy of MT-601 in participants with various lymphoma subtypes. Under the APOLLO trial, 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. Clinical trials that enrolled more than 200 patients with various hematological malignancies and solid tumors showed that autologous and allogeneic multiTAA-specific T cell products were well tolerated and demonstrated durable clinical responses, and consistent epitope spreading. The latter is typically not observed with other T cell therapies and enables the potential contribution to a lasting anti-tumor effect.

Total avkastning till aktieägarna	-41.4%
Framtida utdelningsavkastning	n/a
Utdelningstillväxt	n/a
Nästa utbetalningsdag för utdelning	n/a
Ex utdelningsdag	n/a
Utdelning per aktie	n/a
Utdelningsandel	n/a

Segment	Utdelningsavkastning
Företag (MRKR)	n/a
Marknadens lägsta 25% (US)	1.4%
Marknad Topp 25% (US)	4.3%
Genomsnitt för branschen (Biotechs)	2.4%
Prognosanalytiker (MRKR) (upp till 3 år)	n/a

Uppgifter	Senast uppdaterad (UTC-tid)
Analys av företag	2026/05/22 01:37
Aktiekurs vid dagens slut	2026/05/22 00:00
Intäkter	2026/03/31
Årlig intjäning	2025/12/31

Paket	Uppgifter	Tidsram	Exempel US-källa
Företagets finansiella ställning	10 år	Resultaträkning Kassaflödesanalys Balansräkning	SEC Form 10-K SEC Form 10-Q
Analytikernas konsensusuppskattningar	+3 år	Prognos för finansiella poster Analytikernas prismål	Rapporter från analytiker Blue Matrix
Marknadspriser	30 år	Aktiekurser Utdelningar, splittar och åtgärder	ICE Marknadsdata SEC Form S-1
Ägarskap	10 år	Största aktieägare Insiderhandel	SEC Formulär 4 SEC Formulär 13D
Förvaltning	10 år	Ledningsgrupp Styrelse och verkställande direktörer	SEC Form 10-K SEC Form DEF 14A
Viktiga utvecklingstendenser	10 år	Företagsmeddelanden	SEC Formulär 8-K

Analytiker	Institution
Yun Zhong	Brean Capital Historical (Janney Montgomery)
Leah Rush Cann	Brookline Capital Markets
John Newman	Canaccord Genuity

Marker Therapeutics Utdelningar och återköp

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Senaste utdelnings- och återköpsuppdateringar

Recent updates

No longer forecast to breakeven

First quarter 2026 earnings: EPS and revenues exceed analyst expectations

Consensus EPS estimates upgraded to US$0.99 loss

Full year 2025 earnings: EPS and revenues exceed analyst expectations

Marker Therapeutics, Inc., Annual General Meeting, May 01, 2026

Here's Why We're Watching Marker Therapeutics' (NASDAQ:MRKR) Cash Burn Situation

Forecast to breakeven in 2028

Third quarter 2025 earnings: EPS and revenues exceed analyst expectations

New minor risk - Profitability

Marker Therapeutics, Inc. Appoints Kathryn Penkus Corzo to Board of Directors, Effective November 1, 2025

Marker Therapeutics, Inc. Announces Data from Phase 1 APOLLO Study to Present in Two Posters at 67Th American Society of Hematology Annual Meeting and Exposition

Marker Therapeutics, Inc. Announces First Patient Treated in Off-The-Shelf Program

Marker Therapeutics, Inc. Provides Update on Phase 1 APOLLO Study Highlighting Encouraging Overall Response Rates in Relapsed Lymphoma

Insider recently sold US$148k worth of stock

Second quarter 2025 earnings: EPS and revenues exceed analyst expectations

Marker Therapeutics Reports That Lymphodepletion Improves the Expansion and Persistence of Multi-Antigen Recognizing T Cells in Patients with Lymphoma

First quarter 2025 earnings released: US$0.40 loss per share (vs US$0.27 loss in 1Q 2024)

Price target decreased by 45% to US$6.00

Marker Therapeutics, Inc., Annual General Meeting, Jun 06, 2025

Full year 2024 earnings: EPS and revenues miss analyst expectations

New major risk - Share price stability

Marker Therapeutics, Inc. Announces Resignation of John Wilson from the Board of Directors

New minor risk - Shareholder dilution

Insufficient new directors

Marker Therapeutics, Inc. announced that it has received $16.1 million in funding

Marker Therapeutics, Inc. announced that it expects to receive $16.1 million in funding

Marker Therapeutics, Inc. Provides Clinical Update on MT-601 in Patients with Lymphoma

Marker Therapeutics Receives $9.5 Million Grant from the Cancer Prevention & Research Institute of Texas to Support the Investigation of Mt-601 in Patients with Pancreatic Cancer

Marker Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $11.431731 million.

Third quarter 2024 earnings: EPS and revenues exceed analyst expectations

Second quarter 2024 earnings released: US$0.25 loss per share (vs US$0.47 loss in 2Q 2023)

New minor risk - Share price stability

First quarter 2024 earnings released: US$0.27 loss per share (vs US$0.48 loss in 1Q 2023)

New major risk - Revenue and earnings growth

Marker Therapeutics, Inc., Annual General Meeting, Jun 06, 2024

Full year 2023 earnings released: US$1.59 loss per share (vs US$3.58 loss in FY 2022)

Marker Therapeutics, Inc. Receives Approval from United States Adopted Name, Council and International Nonproprietary Names Expert Committee for “Neldaleucel” as Nonproprietary Name for MT-601

Marker Therapeutics Announces Clinical Program Updates and Pipeline Prioritization

New major risk - Share price stability

Marker Therapeutics, Inc. Reports Clinical Update on the Apollo Study

Marker Therapeutics, Inc. Announces Complete Response in First Lymphoma Patient Treated with MT-601 After Car T Relapse

Second quarter 2023 earnings released: US$0.47 loss per share (vs US$1.11 loss in 2Q 2022)

Marker Therapeutics, Inc. Announces Zedenoleucel, Its Multi-Tumor-Associated Antigen (Multitaa)-Specific T Cell Product Candidate, Mt-401

Marker Therapeutics, Inc. Appoints Eliot M. Lurier as Interim Chief Financial Officer

Marker Therapeutics Reports MT-401 Non-Clinical Data in AML Cells After Hypomethylating Agent Administration

Marker Therapeutics, Inc. Reports Pre-Clinical Data of Its MT-601 multiTAA-Specific T Cell Product Candidate in Lymphoma Cells

Marker Therapeutics, Inc. Appoints Monic Stuart, M.D., as Chief Medical Officer

Consensus revenue estimates increase by 277%

Price target decreased to US$2.17

Marker Therapeutics (NASDAQ:MRKR) Will Have To Spend Its Cash Wisely

Marker Therapeutics, Inc. Announces Resignation of Anthony Kim as Chief Financial Officer, Effective September 30, 2022

Marker Therapeutics Wins $2 Million Grant from U.S. FDA to Support Marker’s Phase 2 Artemis Trial of Mt-401 in Post-Transplant AML

Marker Therapeutics awarded $2M FDA grant for leukemia candidate

Nasdaq Grants an Additional 180-Calendar Day Compliance Period to Marker Therapeutics to Regain Compliance with the Minimum Bid Price Requirement

Consensus revenue estimates fall by 41%

Marker Therapeutics GAAP EPS of -$0.11 misses by $0.01, revenue of $0.79M misses by $1.71M

Marker Therapeutics, Inc. Announces FDA Clearance of IND for Mt-601, the Six-Antigen Targeted T Cell Therapy for the Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma

Companies Like Marker Therapeutics (NASDAQ:MRKR) Could Be Quite Risky

Price target decreased to US$3.63

Marker Therapeutics, Inc., Annual General Meeting, May 24, 2022

Marker Therapeutics, Inc. Announces Frederick Wasserman Will Not Stand for Reelection as Director

Full year 2021 earnings: EPS misses analyst expectations

Marker Therapeutics (NASDAQ:MRKR) Will Have To Spend Its Cash Wisely

Marker Therapeutics, Inc. Announces Clinical Program Updates and Pipeline Expansion

Price target decreased to US$5.63

Here's Why We're Watching Marker Therapeutics' (NASDAQ:MRKR) Cash Burn Situation

Marker Therapeutics: Passing Through A Catalyst Desert

Here's Why We're Watching Marker Therapeutics' (NASDAQ:MRKR) Cash Burn Situation

Marker Therapeutics, Inc.(NasdaqGM:MRKR) dropped from Russell 3000E Value Index

Here's Why We're Watching Marker Therapeutics' (NASDAQ:MRKR) Cash Burn Situation

Marker Therapeutics to Present Multi-Tumor-Associated Antigen (mTAA)-Specific T Cell Manufacturing Robotics Data at the 2021 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting

Earnings beat expectations, revenue disappoints

Marker Therapeutics, Inc. Announces Dosing of First Patient in Phase 2 Trial of Mt-401 in Acute Myeloid Leukemia Following Stem Cell Transplant

Do Insiders Own Lots Of Shares In Marker Therapeutics, Inc. (NASDAQ:MRKR)?

New 90-day high: US$3.19