Marker Therapeutics Reports Year-End 2024 Corporate and Financial Results
Marker Therapeutics (MRKR) reported its 2024 year-end results, highlighting significant progress in its lead program MT-601. The company's Phase 1 APOLLO study demonstrated promising results with a 78% objective response rate in lymphoma patients, including 44.4% complete responses. The therapy showed a favorable safety profile with minimal side effects.
MRKR secured $13 million in non-dilutive funding from CPRIT and NIH SBIR, and raised $16.1 million through a private placement. The company ended 2024 with $19.2 million in cash, expecting to fund operations into Q1 2026. Financial results showed R&D expenses of $13.5 million (up from $10.4M in 2023) and a net loss of $10.7 million (compared to $8.2M in 2023).
Marker Therapeutics (MRKR) ha riportato i risultati di fine anno 2024, evidenziando progressi significativi nel suo programma principale MT-601. Lo studio di Fase 1 APOLLO della compagnia ha dimostrato risultati promettenti con un 78% di tasso di risposta obiettiva nei pazienti affetti da linfoma, inclusi 44,4% di risposte complete. La terapia ha mostrato un profilo di sicurezza favorevole con effetti collaterali minimi.
MRKR ha ottenuto 13 milioni di dollari in finanziamenti non diluitivi da CPRIT e NIH SBIR, e ha raccolto 16,1 milioni di dollari tramite un collocamento privato. La compagnia ha chiuso il 2024 con 19,2 milioni di dollari in cassa, prevedendo di finanziare le operazioni fino al primo trimestre del 2026. I risultati finanziari hanno mostrato spese per R&S di 13,5 milioni di dollari (in aumento rispetto ai 10,4 milioni del 2023) e una perdita netta di 10,7 milioni di dollari (rispetto agli 8,2 milioni del 2023).
Marker Therapeutics (MRKR) inform贸 sus resultados de fin de a帽o 2024, destacando un progreso significativo en su programa principal MT-601. El estudio de Fase 1 APOLLO de la compa帽铆a demostr贸 resultados prometedores con un 78% de tasa de respuesta objetiva en pacientes con linfoma, incluyendo 44,4% de respuestas completas. La terapia mostr贸 un perfil de seguridad favorable con efectos secundarios m铆nimos.
MRKR asegur贸 13 millones de d贸lares en financiamiento no dilutivo de CPRIT y NIH SBIR, y recaud贸 16,1 millones de d贸lares a trav茅s de una colocaci贸n privada. La compa帽铆a termin贸 2024 con 19,2 millones de d贸lares en efectivo, esperando financiar operaciones hasta el primer trimestre de 2026. Los resultados financieros mostraron gastos en I+D de 13,5 millones de d贸lares (un aumento desde los 10,4 millones de 2023) y una p茅rdida neta de 10,7 millones de d贸lares (en comparaci贸n con los 8,2 millones de 2023).
Marker Therapeutics (MRKR)電� 2024雲� 鞐半 瓴瓣臣毳� 氚滍憸頃橂┌ 欤检殧 頂勲攴鸽灗 MT-601鞐愳劀 欷戩殧頃� 歆勳爠鞚� 臧曥“頄堨姷雼堧嫟. 須岇偓鞚� 1靸� APOLLO 鞐瓣惮電� 毽柬攧膦� 頇橃瀽鞐愳劀 78%鞚� 臧濌磤鞝� 氚橃潙毳�鞚� 氤挫榾鞙茧┌, 44.4%鞚� 鞕勳爠 氚橃潙鞚� 韽暔霅橃棃鞀惦媹雼�. 鞚� 旃橂氩曥潃 攵�鞛戩毄鞚� 斓滌唽頇旊悳 鞖办垬頃� 鞎堨爠靹� 頂勲頃勳潉 氤挫棳欤检棃鞀惦媹雼�.
MRKR鞚� CPRIT 氚� NIH SBIR搿滊秬韯� 1300毵� 雼煬鞚� 牍勴潿靹� 鞛愱笀鞚� 頇曤炒頄堨溂氅�, 1610毵� 雼煬毳� 靷 氚办爼鞙茧 氇笀頄堨姷雼堧嫟. 須岇偓電� 2024雲勳潉 1920毵� 雼煬鞚� 順勱笀鞙茧 毵堦皭頄堨溂氅�, 2026雲� 1攵勱赴旯岇 鞖挫榿 鞛愱笀鞚� 歆�鞗愴暊 瓴冹溂搿� 鞓堨儊頃橁碃 鞛堨姷雼堧嫟. 鞛 瓴瓣臣電� R&D 牍勳毄鞚� 1350毵� 雼煬(2023雲勳潣 1040毵� 雼煬鞐愳劀 歃濌皜)鞓�鞙茧┌, 靾滌啇鞁れ潃 1070毵� 雼煬(2023雲勳潣 820毵� 雼煬鞕� 牍勱祼)搿� 雮橅儉雮姷雼堧嫟.
Marker Therapeutics (MRKR) a annonc茅 ses r茅sultats de fin d'ann茅e 2024, mettant en avant des progr猫s significatifs dans son programme principal MT-601. L'茅tude de Phase 1 APOLLO de l'entreprise a montr茅 des r茅sultats prometteurs avec un taux de r茅ponse objective de 78% chez les patients atteints de lymphome, y compris 44,4% de r茅ponses compl猫tes. La th茅rapie a pr茅sent茅 un profil de s茅curit茅 favorable avec des effets secondaires minimaux.
MRKR a s茅curis茅 13 millions de dollars de financement non dilutif de la part de CPRIT et NIH SBIR, et a lev茅 16,1 millions de dollars par le biais d'un placement priv茅. L'entreprise a termin茅 2024 avec 19,2 millions de dollars en liquidit茅s, s'attendant 脿 financer ses op茅rations jusqu'au premier trimestre 2026. Les r茅sultats financiers ont montr茅 des d茅penses de R&D de 13,5 millions de dollars (en hausse par rapport 脿 10,4 millions de dollars en 2023) et une perte nette de 10,7 millions de dollars (compar茅 脿 8,2 millions de dollars en 2023).
Marker Therapeutics (MRKR) hat seine Jahresergebnisse 2024 ver枚ffentlicht und dabei erhebliche Fortschritte in seinem Hauptprogramm MT-601 hervorgehoben. Die Phase-1-Studie APOLLO des Unternehmens zeigte vielversprechende Ergebnisse mit einer 78% objektiven Ansprechrate bei Lymphom-Patienten, einschlie脽lich 44,4% vollst盲ndiger Antworten. Die Therapie zeigte ein g眉nstiges Sicherheitsprofil mit minimalen Nebenwirkungen.
MRKR sicherte sich 13 Millionen Dollar an nicht verw盲ssernder Finanzierung von CPRIT und NIH SBIR und sammelte 16,1 Millionen Dollar durch eine Privatplatzierung. Das Unternehmen schloss das Jahr 2024 mit 19,2 Millionen Dollar in bar ab und erwartet, die Betriebe bis ins erste Quartal 2026 zu finanzieren. Die finanziellen Ergebnisse zeigten F&E-Ausgaben von 13,5 Millionen Dollar (ein Anstieg von 10,4 Millionen Dollar im Jahr 2023) und einen Nettoverlust von 10,7 Millionen Dollar (im Vergleich zu 8,2 Millionen Dollar im Jahr 2023).
- Strong clinical efficacy with 78% objective response rate in lymphoma patients
- Secured $29.1M total funding ($13M non-dilutive + $16.1M private placement)
- Favorable safety profile in clinical trials with minimal side effects
- Reduced G&A expenses by 44% year-over-year
- Increased net loss to $10.7M from $8.2M year-over-year
- Higher R&D expenses at $13.5M, up 30% from 2023
- cash runway extending only to Q1 2026
Insights
Marker Therapeutics' year-end results spotlight their lead MAR-T cell therapy MT-601 (neldaleucel) which demonstrated
The safety profile appears remarkably favorable for a cell therapy - no immune effector cell-associated neurotoxicity syndrome and only one case of Grade 1 cytokine release syndrome. This differentiates MT-601 from conventional CAR-T therapies that often trigger significant toxicity management challenges. The multi-antigen targeting approach likely contributes to this improved safety-efficacy balance by preventing antigen escape while maintaining controlled immune activation.
Their pipeline expansion into pancreatic cancer represents a strategic entry into solid tumors, historically resistant to cell therapies. Similarly, the MT-401-OTS "off-the-shelf" approach could address manufacturing bottlenecks that limit current autologous cell therapies. The
Marker's financial position has been significantly strengthened through both dilutive and non-dilutive funding. The
The company's net loss widened to
Their cash position of
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
Secured over
Approval from United States Adopted Name (USAN) council and International Nonproprietary Names (INN) expert committee for 鈥渘eldaleucel鈥� 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) -- (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.
鈥淚n 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,鈥� said Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. 鈥淧reliminary 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
鈥淲e 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,鈥� concluded Dr. Vera.
2024 PROGRAM UPDATES & OPERATIONAL HIGHLIGHTS
MT-601 (Lymphoma)
- MT-601, Marker鈥檚 lead MAR-T cell therapy, is being evaluated in the nationwide multicenter Phase 1 APOLLO study ( 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 (). 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 鈥淥ff-the-Shelf鈥� (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鈥檚 MT-401-OTS program for patients with AML ().
- The United States Adopted Names (USAN) and International Nonproprietary Names (INN) committees approved 鈥�neldaleucel鈥� 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
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Marker reported a net loss 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鈥檚 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鈥檚 autologous and allogeneic MAR-T cell products were well tolerated and demonstrated durable clinical responses. Marker鈥檚 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鈥檚 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鈥檚 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 鈥渇orward-looking statements.鈥� 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鈥檚 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. Consolidated Balance Sheets (Audited) | |||||||
| 听 | |||||||
| 听 | December 31, | 听 | December 31, | ||||
| 听 | 听 | 2024 | 听 | 听 | 听 | 2023 | 听 |
| ASSETS | 听 | 听 | 听 | ||||
| Current assets: | 听 | 听 | 听 | ||||
| Cash and cash equivalents | $ | 19,192,440 | 听 | 听 | $ | 15,111,450 | 听 |
| Prepaid expenses and deposits | 听 | 483,717 | 听 | 听 | 听 | 988,126 | 听 |
| Other receivables | 听 | 2,346,703 | 听 | 听 | 听 | 1,027,815 | 听 |
| Total current assets | 听 | 22,022,860 | 听 | 听 | 听 | 17,127,391 | 听 |
| Total assets | $ | 22,022,860 | 听 | 听 | $ | 17,127,391 | 听 |
| 听 | 听 | 听 | 听 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | 听 | 听 | 听 | ||||
| Current liabilities: | 听 | 听 | 听 | ||||
| Accounts payable and accrued liabilities | $ | 1,753,954 | 听 | 听 | $ | 1,745,193 | 听 |
| Related party payable | 听 | 1,710,500 | 听 | 听 | 听 | 1,329,655 | 听 |
| Total current liabilities | 听 | 3,464,454 | 听 | 听 | 听 | 3,074,848 | 听 |
| Total liabilities | 听 | 3,464,454 | 听 | 听 | 听 | 3,074,848 | 听 |
| 听 | 听 | 听 | 听 | ||||
| Stockholders' equity: | 听 | 听 | 听 | ||||
| Preferred stock, | 听 | - | 听 | 听 | 听 | - | 听 |
| Common stock, | 听 | 10,708 | 听 | 听 | 听 | 8,891 | 听 |
| Additional paid-in capital | 听 | 465,564,876 | 听 | 听 | 听 | 450,329,515 | 听 |
| Accumulated deficit | 听 | (447,017,178 | ) | 听 | 听 | (436,285,863 | ) |
| Total stockholders' equity | 听 | 18,558,406 | 听 | 听 | 听 | 14,052,543 | 听 |
| Total liabilities and stockholders' equity | $ | 22,022,860 | 听 | 听 | $ | 17,127,391 | 听 |
| Marker Therapeutics, Inc. Consolidated Statements of Operations (Audited) | |||||||
| 听 | 听 | 听 | 听 | ||||
| 听 | For the Year Ended | ||||||
| 听 | December 31, | ||||||
| 听 | 听 | 2024 | 听 | 听 | 听 | 2023 | 听 |
| Revenues: | 听 | 听 | 听 | ||||
| Grant income | $ | 6,591,080 | 听 | 听 | $ | 3,311,133 | 听 |
| Total revenues | 听 | 6,591,080 | 听 | 听 | 听 | 3,311,133 | 听 |
| Operating expenses: | 听 | 听 | 听 | ||||
| Research and development | 听 | 13,467,845 | 听 | 听 | 听 | 10,416,789 | 听 |
| General and administrative | 听 | 4,241,607 | 听 | 听 | 听 | 7,475,722 | 听 |
| Total operating expenses | 听 | 17,709,452 | 听 | 听 | 听 | 17,892,511 | 听 |
| Loss from operations | 听 | (11,118,372 | ) | 听 | 听 | (14,581,378 | ) |
| Other income (expenses): | 听 | 听 | 听 | ||||
| Interest income | 听 | 437,010 | 听 | 听 | 听 | 539,158 | 听 |
| Loss from continuing operations before income taxes | 听 | (10,681,362 | ) | 听 | 听 | (14,042,220 | ) |
| Income tax expense | 听 | 49,953 | 听 | 听 | 听 | 3,675 | 听 |
| Net loss from continuing operations | 听 | (10,731,315 | ) | 听 | 听 | (14,045,895 | ) |
| 听 | 听 | 听 | 听 | ||||
| Discontinued operations: | 听 | 听 | 听 | ||||
| Loss from discontinued operations, net of tax | 听 | - | 听 | 听 | 听 | (2,922,406 | ) |
| Gain on disposal of discontinued operations | 听 | - | 听 | 听 | 听 | 8,731,487 | 听 |
| Income from discontinued operations | 听 | - | 听 | 听 | 听 | 5,809,081 | 听 |
| Net loss | $ | (10,731,315 | ) | 听 | $ | (8,236,814 | ) |
| 听 | 听 | 听 | 听 | ||||
| Net loss per share: | 听 | 听 | 听 | ||||
| Loss from continuing operations, basic and diluted | $ | (1.19 | ) | 听 | $ | (1.59 | ) |
| Income from discontinued operations, basic and diluted | $ | - | 听 | 听 | $ | 0.66 | 听 |
| Net loss per share, basic and diluted | $ | (1.19 | ) | 听 | $ | (0.94 | ) |
| 听 | 听 | 听 | 听 | ||||
| Weighted average number of common shares outstanding: | 听 | 听 | 听 | ||||
| Basic | 听 | 8,980,207 | 听 | 听 | 听 | 8,809,382 | 听 |
| Diluted | 听 | 8,980,207 | 听 | 听 | 听 | 8,809,382 | 听 |
| Marker Therapeutics, Inc. Consolidated Statements of Cash Flows (Audited) | |||||||
| 听 | |||||||
| 听 | For the Year Ended | ||||||
| 听 | December 31, | ||||||
| 听 | 听 | 2024 | 听 | 听 | 听 | 2023 | 听 |
| Cash Flows from Operating Activities: | 听 | 听 | 听 | ||||
| Net loss | $ | (10,731,315 | ) | 听 | $ | (8,236,814 | ) |
| Less: gain from discontinued operations, net of tax | 听 | - | 听 | 听 | 听 | 5,809,081 | 听 |
| Net loss from continuing operations | 听 | (10,731,315 | ) | 听 | 听 | (14,045,895 | ) |
| Reconciliation of net loss to net cash used in operating activities: | 听 | 听 | 听 | ||||
| Stock-based compensation | 听 | 245,864 | 听 | 听 | 听 | 858,269 | 听 |
| Changes in operating assets and liabilities: | 听 | 听 | 听 | ||||
| Prepaid expenses and deposits | 听 | 504,409 | 听 | 听 | 听 | 861,113 | 听 |
| Other receivables | 听 | (1,318,888 | ) | 听 | 听 | 1,374,189 | 听 |
| Related party payable | 听 | 380,845 | 听 | 听 | 听 | 1,329,655 | 听 |
| Accounts payable and accrued expenses | 听 | 8,761 | 听 | 听 | 听 | (718,393 | ) |
| Net cash used in operating activities - continuing operations | 听 | (10,910,324 | ) | 听 | 听 | (10,341,062 | ) |
| Net cash used in operating activities - discontinued operations | 听 | - | 听 | 听 | 听 | (6,098,899 | ) |
| Net cash used in operating activities | 听 | (10,910,324 | ) | 听 | 听 | (16,439,961 | ) |
| Cash Flows from Investing Activities: | 听 | 听 | 听 | ||||
| Net cash provided by investing activities - discontinued operations | 听 | - | 听 | 听 | 听 | 18,664,122 | 听 |
| Net cash provided by investing activities | 听 | - | 听 | 听 | 听 | 18,664,122 | 听 |
| Cash Flows from Financing Activities: | 听 | 听 | 听 | ||||
| Proceeds from issuance of common stock, net | 听 | 14,929,155 | 听 | 听 | 听 | 1,014,640 | 听 |
| Proceeds from stock options exercise | 听 | 62,159 | 听 | 听 | 听 | 90,477 | 听 |
| Net cash provided by financing activities | 听 | 14,991,314 | 听 | 听 | 听 | 1,105,117 | 听 |
| Net increase in cash and cash equivalents | 听 | 4,080,990 | 听 | 听 | 听 | 3,329,278 | 听 |
| Cash and cash equivalents at beginning of the period | 听 | 15,111,450 | 听 | 听 | 听 | 11,782,172 | 听 |
| Cash and cash equivalents at end of the period | $ | 19,192,440 | 听 | 听 | $ | 15,111,450 | 听 |
| 听 | 听 | 听 | 听 | ||||
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FAQ
What were the clinical results of MRKR's MT-601 therapy in lymphoma patients during 2024?
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