Lead program in sufferers with lymphoma demonstrated preliminary security and efficacy outcomes with sustained full response in first examine participant handled with MT-601 (Neldaleucel) following CAR T relapse
Secured non-dilutive funding of $2 million from Nationwide Institute of Well being (NIH) to help scientific program for remedy of sufferers with Acute Myeloid Leukemia (AML)
Obtained Orphan Drug Designation (ODD) from European Medicines Company (EMA) for multiTAA-specific T cell product candidate MT-401 (Zedenoleucel) for the remedy of sufferers with AML
Carried out management transition leading to appointments of Juan Vera, M.D. as President and Chief Govt Officer and Monic Stuart, M.D., MPH as Chief Medical Officer
Executed complete non-dilutive settlement with Cell Prepared effecting a big discount in overhead bills and lengthening Marker’s runway into the fourth quarter of 2025
Strategic prioritization of scientific pipeline with concentrate on MT-601 (Neldaleucel) in sufferers with lymphoma
HOUSTON, March 25, 2024 (GLOBE NEWSWIRE) — Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology firm specializing in creating next-generation T cell-based immunotherapies for the remedy of hematological malignancies and stable tumors, immediately reported current company developments and monetary outcomes for the yr ended December 31, 2023.
“The progress achieved in 2023 we consider establishes a strong basis for Marker and units the stage for continued development in our scientific packages and enterprise operations within the upcoming yr,” commented Juan Vera, M.D. President and Chief Govt Officer of Marker Therapeutics. “A pinnacle of final yr’s success was the Section 1 lymphoma examine milestone, the place we noticed a sustained full response in our first examine participant handled with MT-601 following CAR T relapse. This affected person relapsed inside 90 days of CAR T remedy however has remained in an entire remission for at the very least six months after MT-601 remedy, indicating that MT-601 has superior sturdiness on this examine participant. The promising scientific and non-clinical observations from our lymphoma examine bolstered our strategic choice, made public this January, to prioritize the event of MT-601 in sufferers with lymphoma who’ve failed or are ineligible for CAR T remedy. Specializing in this distinctive area of interest of sufferers and by focusing on a number of antigens, our method differs considerably from rivals, and we consider that MT-601 may tackle an unmet medical want on this affected person inhabitants with a greater security profile and at decrease prices when in comparison with gene-modified cell remedy approaches.”
Additional bolstering Marker’s place is the award of $2 million in non-dilutive funding from the NIH final yr, which is instrumental in supporting the development of the Firm’s MT-401 “Off-the-Shelf” (MT-401-OTS) program in sufferers with Acute Myeloid Leukemia (AML).
Dr. Vera added, “This award is anticipated to allow us to proceed with the OTS program with out affecting our ongoing examine for sufferers with lymphoma. Lowering time to remedy is crucial for quickly progressing cancers, akin to sufferers with minimal residual illness (MRD) in AML.”
Using an OTS product manufactured from wholesome donors will assist to bypass the remedy delay that’s related to patient-specific manufacture and will shorten the time till the product is made out there to sufferers, whereas decreasing manufacturing prices. Moreover, receiving Orphan Drug Designation (ODD) by the European Medicines Company (EMA) substantiates the potential influence of MT-401 in sufferers with AML and presents a possibility to develop the remedy on an expedited foundation.
Marker additionally executed a complete non-dilutive settlement with Cell Prepared which included a sale of choose cell manufacturing belongings from Marker for roughly $19 million in money. This main transaction, which we count on will allow a discount of overhead bills of about $11 million yearly, not solely improves our monetary well being however, we consider, additionally positions us uniquely within the cell remedy trade — a sector the place such vital non-dilutive funding and operational financial savings are remarkably uncommon. This strategic foresight, along with the drawdowns out there from our grant funds, ought to prolong the money runway into the fourth quarter of 2025.
“These accomplishments underline our dedication to driving scientific innovation, our imaginative and prescient in making main influence with our novel multiTAA know-how for sufferers in want, and our emphasis on money preservation and operational excellence. As now we have pivoted into 2024, we stay poised to advance our scientific endeavors with the objective of introducing transformative therapies to the market and bettering affected person outcomes,” concluded Dr. Vera.
2023 PROGRAM UPDATES & OPERATIONAL HIGHLIGHTS
MT-601 (Lymphoma)
Non-Medical Knowledge on MT-601
- Marker developed a long-term in vitro killing assay 1) to analyze resistance mechanisms after CAR T cell remedy, and a couple of) to investigate if MT-601 (focusing on 6 TAAs) can eradicate CAR-resistant lymphoma cells.
- Anti-CD19 CAR T cell remedy killed 98% of lymphoma cells in vitro. Nonetheless, after three weeks, CD19-negative tumor cells began to develop. Additional anti-CD19 CAR T cell remedies have been ineffective as these tumor cells lack goal antigen (CD19) expression (Pre-Medical Knowledge in Lymphoma, Might 31, 2023).
- Therapy with MT-601 demonstrated long-term development inhibition (over three weeks) of CAR-resistant lymphoma cells, highlighting that MT-601 has the potential to successfully deal with CD19 CAR-resistant tumors (Press Launch, Might 31, 2023).
Medical Highlights
- Section 1 multicenter APOLLO trial (clinicaltrials.gov identifier: NCT05798897), investigating MT-601 in sufferers with lymphoma who relapsed or are ineligible for anti-CD19 CAR T cell therapies, was chosen as lead program primarily based on promising preliminary scientific outcomes and non-clinical proof-of-concept information.
- The primary examine participant, a 57-year-old feminine with diffuse massive B cell lymphoma (DLBCL), was enrolled within the Section 1 dose escalation stage of the trial after failing 4 prior traces of remedy, together with relapsing inside 90 days of anti-CD19 CAR T cell remedy. With out prior lymphodepletion, the participant was handled with MT-601. In December 2023, the Firm introduced that the examine participant tolerated preliminary dose degree properly and had maintained an entire response to remedy six months after preliminary remedy with MT-601 (Press Launch, December 11, 2023).
- The Firm is enrolling further sufferers within the Section 1 APOLLO trial and expects to report additional information within the first half of 2024.
- MT-601 designated non-proprietary title “Neldaleucel” by United States Adopted Title (USAN) Counsel and Worldwide Nonproprietary Names (INN) Knowledgeable Committee.
MT-601 (Pancreatic)
- Investigational New Drug (IND) utility cleared by U.S. Meals and Drug Administration (FDA) for multicenter Section 1 trial of MT-601 in sufferers with metastatic pancreatic most cancers together with front-line chemotherapy.
- Medical development can be pending further monetary help from non-dilutive grant actions.
MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic Syndrome)
- U.S. FDA has granted an Investigational New Drug (IND) to analyze MT-401 as an “Off-the-Shelf” (MT-401-OTS) product in sufferers with AML or Myelodysplastic Syndrome (MDS). MT-401-OTS is manufactured from wholesome donors and a mobile stock has been established with ongoing efforts to develop.
- Marker introduced non-clinical proof-of-concept information supporting the scientific advantages of MT-401-OTS in AML.
- The Firm has secured $2M in non-dilutive funding from the NIH Small Enterprise Innovation Analysis (SBIR) program. These funds will help the scientific investigation of MT-401-OTS in sufferers with AML with out affecting the continued Section 1 APOLLO examine in sufferers with lymphoma.
- Granted ODD from the Committee for Orphan Medicinal Merchandise of the EMA for the remedy of sufferers with AML in 2023. ODD was acquired from the U.S. FDA in 2020.
- Medical program initiation of MT-401-OTS anticipated for the second half of 2024.
2023 CORPORATE HIGHLIGHTS
- Introduced scientific pipeline prioritization in January 2024 to strategically concentrate on MT-601 in sufferers with lymphoma. This announcement additionally included program updates that highlighted the potential of the Firm’s MT-401-OTS program for AML.
- Appointed Juan Vera, M.D., as President and Chief Govt Officer and Monic Stuart, M.D., MPH, as Chief Medical Officer. Dr. Vera was additionally appointed the Firm’s Principal Monetary and Accounting Officer.
- On June 26, 2023, Marker accomplished a non-dilutive transaction with Cell Prepared, underneath which Cell Prepared bought sure cell manufacturing belongings from Marker for roughly $19 million in money. On February 22, 2024, Marker entered right into a Grasp Companies Settlement for Product Provide with Cell Prepared. Underneath this settlement, Cell Prepared will carry out all kinds of providers for Marker, together with analysis and improvement, and manufacturing in help of Marker’s scientific trials.
- Terminated widespread inventory buy settlement with Lincoln Park Capital.
- Prolonged monetary runway into the fourth quarter of 2025.
FISCAL YEAR 2023 FINANCIAL HIGHLIGHTS
Money Place and Steerage: At December 31, 2023, Marker had money and money equivalents of $15.1 million. The Firm believes that its present money and money equivalents will fund its working bills into the fourth quarter of 2025, inclusive of obtainable drawdowns from grant funds.
R&D Bills: Analysis and improvement bills have been $10.4 million for the yr ended December 31, 2023, in comparison with $12.0 million for the yr ended December 31, 2022.
G&A Bills: Normal and administrative bills have been $7.5 million for the yr ended December 31, 2023, in comparison with $11.3 million for the yr ended December 31, 2022.
Internet Loss: Marker reported a internet lack of $8.2 million for the yr ended December 31, 2023, in comparison with a internet lack of $29.9 million for the yr ended December 31, 2022.
About multiTAA-specific T cells
The multi-tumor related antigen (multiTAA)-specific T cell platform is a novel, non-genetically modified cell remedy method that selectively expands tumor-specific T cells from a affected person’s/donor’s blood able to recognizing a broad vary of tumor antigens. Since multiTAA-specific T cells are usually not genetically engineered, Marker believes that its product candidates can be simpler and cheaper to fabricate, with diminished toxicities, in comparison with present engineered CAR-T and TCR-based approaches, and will present sufferers with significant scientific advantages. In consequence, Marker believes that its portfolio of T cell therapies has a compelling product profile, as in comparison with present gene-modified CAR-T and TCR-based therapies.
About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a Houston, TX-based clinical-stage immuno-oncology firm specializing within the improvement of next-generation T cell-based immunotherapies for the remedy of hematological malignancies and stable tumors. Medical trials that enrolled greater than 200 sufferers throughout varied hematological and stable tumor indications confirmed that the Firm’s autologous and allogeneic multiTAA-specific T cell merchandise have been properly tolerated and demonstrated sturdy scientific responses. Marker’s objective is to introduce novel T cell therapies to the market and enhance affected person outcomes. To realize these goals, the Firm prioritizes the preservation of economic assets and focuses on operational excellence. Marker’s distinctive T cell platform is strengthened by non-dilutive funding from U.S. state and federal businesses supporting most cancers analysis.
To obtain future press releases by way of e mail, please go to: https://www.markertherapeutics.com/email-alerts.
Ahead-Wanting Statements
This launch incorporates forward-looking statements for functions of the protected harbor provisions of the Personal Securities Litigation Reform Act of 1995. Statements on this information launch regarding the Firm’s expectations, plans, enterprise outlook or future efficiency, and every other statements regarding assumptions made or expectations as to any future occasions, situations, efficiency or different issues, are “forward-looking statements.” Ahead-looking statements embody statements relating to our intentions, beliefs, projections, outlook, analyses or present expectations regarding, amongst different issues: our analysis, improvement and regulatory actions and expectations regarding our non-engineered multi-tumor antigen particular T cell therapies; the effectiveness of those packages or the attainable vary of utility and potential healing results and security within the remedy of ailments; and the timing, conduct and success of our scientific trials of our product candidates, together with MT-601 and MT-401-OTS. Ahead-looking statements are by their nature topic to dangers, uncertainties and different components which may trigger precise outcomes to vary materially from these said in such statements. Such dangers, uncertainties and components embody, however are usually not restricted to the dangers set forth within the Firm’s most up-to-date Kind 10-Ok, 10-Q and different SEC filings which can be found via EDGAR at www.sec.gov. The Firm assumes no obligation to replace our forward-looking statements whether or not on account of new data, future occasions or in any other case, after the date of this press launch.
Marker Therapeutics, Inc. Consolidated Steadiness Sheets (Audited) |
||||||||
December 31, | December 31, | |||||||
2023 | 2022 | |||||||
ASSETS | ||||||||
Present belongings: | ||||||||
Money and money equivalents | $ | 15,111,450 | $ | 11,782,172 | ||||
Pay as you go bills and deposits | 988,126 | 1,849,239 | ||||||
Different receivables | 1,027,815 | 2,402,004 | ||||||
Present belongings of discontinued operations | – | 585,840 | ||||||
Complete present belongings | 17,127,391 | 16,619,255 | ||||||
Non-current belongings of discontinued operations | – | 17,802,929 | ||||||
Complete belongings | $ | 17,127,391 | $ | 34,422,184 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Present liabilities: | ||||||||
Accounts payable and accrued liabilities | $ | 1,745,193 | $ | 2,521,193 | ||||
Associated celebration payable | 1,329,655 | – | ||||||
Present liabilities of discontinued operations | – | 5,260,616 | ||||||
Complete present liabilities | 3,074,848 | 7,781,809 | ||||||
Non-current liabilities of discontinued operations | – | 7,039,338 | ||||||
Complete liabilities | 3,074,848 | 14,821,147 | ||||||
Stockholders’ fairness: | ||||||||
Most popular inventory, $0.001 par worth, 5 million shares approved, 0 shares issued and excellent at December 31, 2023 and 2022, respectively | – | – | ||||||
Frequent inventory, $0.001 par worth, 30 million shares approved, 8.9 million and eight.4 million shares issued and excellent as of December 31, 2023 and 2022, respectively (see Be aware 10) | 8,891 | 8,406 | ||||||
Further paid-in capital | 450,329,515 | 447,641,680 | ||||||
Amassed deficit | (436,285,863 | ) | (428,049,049 | ) | ||||
Complete stockholders’ fairness | 14,052,543 | 19,601,037 | ||||||
Complete liabilities and stockholders’ fairness | $ | 17,127,391 | $ | 34,422,184 |
Marker Therapeutics, Inc. Consolidated Statements of Operations (Audited) |
||||||||
For the Years Ended | ||||||||
December 31, | ||||||||
2023 | 2022 | |||||||
Revenues: | ||||||||
Grant revenue | $ | 3,311,133 | $ | 3,513,544 | ||||
Complete revenues | 3,311,133 | 3,513,544 | ||||||
Working bills: | ||||||||
Analysis and improvement | 10,416,789 | 11,968,428 | ||||||
Normal and administrative | 7,475,722 | 11,336,120 | ||||||
Complete working bills | 17,892,511 | 23,304,548 | ||||||
Loss from operations | (14,581,378 | ) | (19,791,004 | ) | ||||
Different revenue (bills): | ||||||||
Arbitration settlement | – | (232,974 | ) | |||||
Curiosity revenue | 539,158 | 248,063 | ||||||
Loss from persevering with operations earlier than revenue taxes | (14,042,220 | ) | (19,775,915 | ) | ||||
Revenue tax expense | 3,675 | – | ||||||
Internet loss from persevering with operations | (14,045,895 | ) | (19,775,915 | ) | ||||
Discontinued operations: | ||||||||
Loss from discontinued operations | (2,922,406 | ) | (10,154,779 | ) | ||||
Acquire on disposal of discontinued operations, internet of $63,000 in tax | 8,731,487 | – | ||||||
Revenue (loss) from discontinued operations | 5,809,081 | (10,154,779 | ) | |||||
Internet loss | $ | (8,236,814 | ) | $ | (29,930,694 | ) | ||
Internet earnings (loss) per share: | ||||||||
Loss from persevering with operations, primary and diluted | $ | (1.59 | ) | $ | (2.37 | ) | ||
Revenue (loss) from discontinued operations, primary and diluted | $ | 0.66 | $ | (1.22 | ) | |||
Internet loss per share, primary and diluted | $ | (0.94 | ) | $ | (3.58 | ) | ||
Weighted common variety of widespread shares excellent: | ||||||||
Fundamental | 8,809,382 | 8,351,003 | ||||||
Diluted | 8,809,382 | 8,351,003 |
Marker Therapeutics, Inc. Consolidated Statements of Money Flows (Audited) |
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For the Years Ended | ||||||||
December 31, | ||||||||
2023 | 2022 | |||||||
Money Flows from Working Actions: | ||||||||
Internet loss | $ | (8,236,814 | ) | $ | (29,930,694 | ) | ||
Much less: acquire (loss) from discontinued operations, internet of $63,000 in tax | 5,809,081 | (10,154,779 | ) | |||||
Internet loss from persevering with operations | (14,045,895 | ) | (19,775,915 | ) | ||||
Reconciliation of internet loss to internet money utilized in working actions: | ||||||||
Inventory-based compensation | 858,269 | 3,304,634 | ||||||
Acquire on lease termination | – | (278,681 | ) | |||||
Modifications in working belongings and liabilities: | ||||||||
Pay as you go bills and deposits | 861,113 | 104,147 | ||||||
Different receivables | 1,374,189 | (2,401,767 | ) | |||||
Accounts payable and accrued bills | 611,262 | (1,319,710 | ) | |||||
Deferred income | – | (1,146,186 | ) | |||||
Internet money utilized in working actions – persevering with operations | (10,341,062 | ) | (21,513,478 | ) | ||||
Internet money utilized in working actions – discontinued operations | (6,098,899 | ) | (5,458,675 | ) | ||||
Internet money utilized in working actions | (16,439,961 | ) | (26,972,153 | ) | ||||
Money Flows from Investing Actions: | ||||||||
Internet money offered by (utilized in) investing actions – discontinued operations | 18,664,122 | (4,945,136 | ) | |||||
Internet money offered by (utilized in) investing actions | 18,664,122 | (4,945,136 | ) | |||||
Money Flows from Financing Actions: | ||||||||
Proceeds from issuance of widespread inventory, internet | 1,014,640 | 202,130 | ||||||
Proceeds from inventory choices train | 90,477 | – | ||||||
Internet money offered by financing actions | 1,105,117 | 202,130 | ||||||
Internet improve (lower) in money and money equivalents | 3,329,278 | (31,715,159 | ) | |||||
Money and money equivalents at starting of the yr | 11,782,172 | 43,497,331 | ||||||
Money and money equivalents at finish of the yr | $ | 15,111,450 | $ | 11,782,172 | ||||
Contacts
TIBEREND STRATEGIC ADVISORS, INC.
Buyers
Daniel Kontoh-Boateng
(862) 213-1398
[email protected]
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