Lead program in sufferers with lymphoma demonstrated preliminary security and efficacy outcomes with sustained full response in first research 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 medical program for therapy of sufferers with Acute Myeloid Leukemia (AML)
Acquired Orphan Drug Designation (ODD) from European Medicines Company (EMA) for multiTAA-specific T cell product candidate MT-401 (Zedenoleucel) for the therapy 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 major discount in overhead bills and lengthening Marker’s runway into the fourth quarter of 2025
Strategic prioritization of medical pipeline with give attention to 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 growing next-generation T cell-based immunotherapies for the therapy of hematological malignancies and strong tumors, at present reported latest company developments and monetary outcomes for the yr ended December 31, 2023.
“The progress achieved in 2023 we consider establishes a sturdy basis for Marker and units the stage for continued development in our medical applications 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 research milestone, the place we noticed a sustained full response in our first research 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 therapy, indicating that MT-601 has superior sturdiness on this research participant. The promising medical and non-clinical observations from our lymphoma research bolstered our strategic resolution, 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 concentrating on a number of antigens, our strategy differs considerably from rivals, and we consider that MT-601 may handle 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 predicted to allow us to proceed with the OTS program with out affecting our ongoing research for sufferers with lymphoma. Lowering time to therapy is vital 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 therapy delay that’s related to patient-specific manufacture and will shorten the time till the product is made out there to sufferers, whereas lowering 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 about $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 important 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 expertise for sufferers in want, and our emphasis on money preservation and operational excellence. As we have now pivoted into 2024, we stay poised to advance our medical endeavors with the purpose 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 Information on MT-601
- Marker developed a long-term in vitro killing assay 1) to analyze resistance mechanisms after CAR T cell therapy, and a pair of) to investigate if MT-601 (concentrating on 6 TAAs) can remove CAR-resistant lymphoma cells.
- Anti-CD19 CAR T cell therapy killed 98% of lymphoma cells in vitro. Nonetheless, after three weeks, CD19-negative tumor cells began to develop. Additional anti-CD19 CAR T cell therapies had been ineffective as these tumor cells lack goal antigen (CD19) expression (Pre-Clinical Data in Lymphoma, May 31, 2023).
- Remedy with MT-601 demonstrated long-term progress 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 Release, May 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 based mostly on promising preliminary medical outcomes and non-clinical proof-of-concept knowledge.
- The primary research participant, a 57-year-old feminine with diffuse giant 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 research participant tolerated preliminary dose degree nicely and had maintained an entire response to remedy six months after preliminary therapy with MT-601 (Press Release, December 11, 2023).
- The Firm is enrolling further sufferers within the Section 1 APOLLO trial and expects to report additional knowledge 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) software 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 increase.
- Marker introduced non-clinical proof-of-concept knowledge supporting the medical 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 medical investigation of MT-401-OTS in sufferers with AML with out affecting the continued Section 1 APOLLO research in sufferers with lymphoma.
- Granted ODD from the Committee for Orphan Medicinal Merchandise of the EMA for the therapy 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 medical pipeline prioritization in January 2024 to strategically give attention to 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, below which Cell Prepared bought sure cell manufacturing belongings from Marker for about $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 medical trials.
- Terminated frequent 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 had 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 had been $7.5 million for the yr ended December 31, 2023, in comparison with $11.3 million for the yr ended December 31, 2022.
Web Loss: Marker reported a web lack of $8.2 million for the yr ended December 31, 2023, in comparison with a web 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 strategy 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 aren’t genetically engineered, Marker believes that its product candidates can be simpler and cheaper to fabricate, with lowered toxicities, in comparison with present engineered CAR-T and TCR-based approaches, and will present sufferers with significant medical advantages. Consequently, 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 therapy of hematological malignancies and strong tumors. Medical trials that enrolled greater than 200 sufferers throughout numerous hematological and strong tumor indications confirmed that the Firm’s autologous and allogeneic multiTAA-specific T cell merchandise had been nicely tolerated and demonstrated sturdy medical responses. Marker’s purpose is to introduce novel T cell therapies to the market and enhance affected person outcomes. To attain these targets, 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 through e mail, please go to: https://www.markertherapeutics.com/email-alerts.
Ahead-Wanting Statements
This launch comprises 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 some other statements regarding assumptions made or expectations as to any future occasions, circumstances, efficiency or different issues, are “forward-looking statements.” Ahead-looking statements embrace statements relating to our intentions, beliefs, projections, outlook, analyses or present expectations regarding, amongst different issues: our analysis, improvement and regulatory actions and expectations referring to our non-engineered multi-tumor antigen particular T cell therapies; the effectiveness of those applications or the attainable vary of software and potential healing results and security within the therapy of ailments; and the timing, conduct and success of our medical 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 acknowledged in such statements. Such dangers, uncertainties and components embrace, however aren’t 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 info, future occasions or in any other case, after the date of this press launch.
Marker Therapeutics, Inc. Consolidated Stability 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 | ||||||
Whole present belongings | 17,127,391 | 16,619,255 | ||||||
Non-current belongings of discontinued operations | – | 17,802,929 | ||||||
Whole 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 social gathering payable | 1,329,655 | – | ||||||
Present liabilities of discontinued operations | – | 5,260,616 | ||||||
Whole present liabilities | 3,074,848 | 7,781,809 | ||||||
Non-current liabilities of discontinued operations | – | 7,039,338 | ||||||
Whole 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 | – | – | ||||||
Widespread 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 Notice 10) | 8,891 | 8,406 | ||||||
Further paid-in capital | 450,329,515 | 447,641,680 | ||||||
Gathered deficit | (436,285,863 | ) | (428,049,049 | ) | ||||
Whole stockholders’ fairness | 14,052,543 | 19,601,037 | ||||||
Whole 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 | ||||
Whole 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 | ||||||
Whole 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 | ) | ||||
Earnings tax expense | 3,675 | – | ||||||
Web 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, web of $63,000 in tax | 8,731,487 | – | ||||||
Earnings (loss) from discontinued operations | 5,809,081 | (10,154,779 | ) | |||||
Web loss | $ | (8,236,814 | ) | $ | (29,930,694 | ) | ||
Web earnings (loss) per share: | ||||||||
Loss from persevering with operations, primary and diluted | $ | (1.59 | ) | $ | (2.37 | ) | ||
Earnings (loss) from discontinued operations, primary and diluted | $ | 0.66 | $ | (1.22 | ) | |||
Web loss per share, primary and diluted | $ | (0.94 | ) | $ | (3.58 | ) | ||
Weighted common variety of frequent 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: | ||||||||
Web loss | $ | (8,236,814 | ) | $ | (29,930,694 | ) | ||
Much less: acquire (loss) from discontinued operations, web of $63,000 in tax | 5,809,081 | (10,154,779 | ) | |||||
Web loss from persevering with operations | (14,045,895 | ) | (19,775,915 | ) | ||||
Reconciliation of web loss to web money utilized in working actions: | ||||||||
Inventory-based compensation | 858,269 | 3,304,634 | ||||||
Acquire on lease termination | – | (278,681 | ) | |||||
Adjustments 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 | ) | |||||
Web money utilized in working actions – persevering with operations | (10,341,062 | ) | (21,513,478 | ) | ||||
Web money utilized in working actions – discontinued operations | (6,098,899 | ) | (5,458,675 | ) | ||||
Web money utilized in working actions | (16,439,961 | ) | (26,972,153 | ) | ||||
Money Flows from Investing Actions: | ||||||||
Web money offered by (utilized in) investing actions – discontinued operations | 18,664,122 | (4,945,136 | ) | |||||
Web money offered by (utilized in) investing actions | 18,664,122 | (4,945,136 | ) | |||||
Money Flows from Financing Actions: | ||||||||
Proceeds from issuance of frequent inventory, web | 1,014,640 | 202,130 | ||||||
Proceeds from inventory choices train | 90,477 | – | ||||||
Web money offered by financing actions | 1,105,117 | 202,130 | ||||||
Web 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
dboateng@tiberend.com
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