Marker Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Updates
Preliminary safety and efficacy with sustained objective responses observed in patients with lymphoma treated with MT-601 in Phase 1 APOLLO study
Study participant with Non-Hodgkin’s Lymphoma who relapsed within 90 days of anti-CD19 CAR T cell therapy remains in complete response nine months after MT-601 treatment
Company received approval from United States Adopted Name (USAN) council and International Nonproprietary Names (INN) expert committee for “neldaleucel” as nonproprietary name for MT-601
“We are pleased to report a strong start to the first quarter of 2024, marked by continued advances in our clinical programs,” said
“Another significant milestone this quarter was to receive approval from the United States Adopted Name (USAN) council and International Nonproprietary Names (INN) expert committee for “neldaleucel” as nonproprietary drug name for MT-601. Having made these steady advances, we are confident that we are well positioned to achieve our near- and long-term goals related to MT-601 in patients with lymphoma,” concluded
PROGRAM UPDATES & EXPECTED MILESTONES
MT-601 (Lymphoma)
- Phase 1 multicenter APOLLO trial (clinicaltrials.gov identifier: NCT05798897), investigating MT-601 in patients with lymphoma who relapsed or are ineligible for anti-CD19 CAR T cell therapies, was selected as lead program based on promising preliminary clinical results and non-clinical proof-of-concept data (Press Release,
January 8, 2024 ). - Three patients were treated at
City of Hope National Medical Center as part of the APOLLO study:- First study participant treated with MT-601 had diffuse large B cell lymphoma (DLBCL) and failed four prior lines of therapy, including a relapse within 90 days of anti-CD19 CAR T cell therapy (Breyanzi) (Press Release,
June 12, 2023 ). Without prior lymphodepletion, this participant achieved a complete response eight weeks after the second infusion of MT-601 and remains in complete response nine months after initial treatment with MT-601 (Press Release,April 8, 2024 ). - Another study participant had transformed follicular Non-Hodgkin’s Lymphoma (NHL) and failed 12 lines of therapy, including bispecific T cell engager therapy (mosunetuzumab) for follicular NHL, and anti-CD19 CAR T cells (Yescarta) after transformation into DLBCL. At the time of MT-601 infusion, only follicular NHL persisted in this patient. Eight weeks after initial infusion with MT-601 without prior lymphodepletion, the study participant achieved a complete response, which remains three months following treatment with MT-601(Press Release,
April 8, 2024 ). - The third study participant treated had DLBCL with cutaneous involvement and was not eligible for CAR T cell therapy. This participant achieved a partial response eight weeks after MT-601 treatment without prior lymphodepletion with all lesions decreasing in size including one that has completely resolved (Press Release,
April 8, 2024 ). - Treatment was well tolerated among all patients with no significant treatment-related adverse events including cytokine release syndrome or neurotoxicity.
- All patients continue to be observed for durability of response.
- First study participant treated with MT-601 had diffuse large B cell lymphoma (DLBCL) and failed four prior lines of therapy, including a relapse within 90 days of anti-CD19 CAR T cell therapy (Breyanzi) (Press Release,
- The Company is enrolling additional patients in the Phase 1 APOLLO trial and expects to report further data in the second half of 2024.
- MT-601 designated non-proprietary name “neldaleucel” by United States Adopted Name (USAN) Counsel and International Nonproprietary Names (INN) Expert Committee.
MT-601 (Pancreatic)
- Investigational New Drug (IND) application cleared by U.S. Food and Drug Administration (FDA) for multicenter Phase 1 trial of MT-601 in patients with metastatic pancreatic cancer in combination with front-line chemotherapy.
- Clinical advancement will be pending additional financial support from non-dilutive grant activities.
MT-401-
- To streamline resources and to reduce time to treatment, Marker decided to discontinue the patient-specific part of the Acute Myeloid Leukemia (AML) program and to focus on a ready for use “Off-the-Shelf” product (Press Release,
January 8, 2024 ). U.S. FDA has granted an Investigational New Drug (IND) to investigate MT-401 as an “Off-the-Shelf” (MT-401-OTS ) product in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). MT-401-OTS is manufactured from healthy donors, and Marker has established a cellular inventory with ongoing efforts of expanding it further.- Granted Orphan Drug Designation from the
European Medicines Agency (EMA) andU.S. FDA. - Marker has non-clinical proof-of-concept data supporting the clinical benefits of MT-401-
OTS in AML and secured$2M in non-dilutive funding from theNIH Small Business Innovation Research (SBIR) program to support the clinical investigation of MT-401-OTS in patients with AML. - Clinical program initiation of MT-401-
OTS anticipated for the second half of 2024.
FIRST QUARTER 2024 FINANCIAL HIGHLIGHTS
Cash Position and Guidance: At
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 multiTAA-specific T cells
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. Since multiTAA-specific T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefits. As a result, Marker believes that its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies.
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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 and success of our clinical trials of our product candidates, including MT-601 and MT-401-
Condensed Consolidated Balance Sheets (Unaudited) |
||||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 11,323,428 | $ | 15,111,450 | ||||
| Prepaid expenses and deposits | 917,009 | 988,126 | ||||||
| Other receivables | 1,851,462 | 1,027,815 | ||||||
| Total current assets | 14,091,899 | 17,127,391 | ||||||
| Total assets | $ | 14,091,899 | $ | 17,127,391 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 1,949,700 | $ | 1,745,193 | ||||
| Related party payable | 353,965 | 1,329,655 | ||||||
| Total current liabilities | 2,303,665 | 3,074,848 | ||||||
| Total liabilities | 2,303,665 | 3,074,848 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, |
— | — | ||||||
| Common stock, |
8,910 | 8,891 | ||||||
| Additional paid-in capital | 450,458,009 | 450,329,515 | ||||||
| Accumulated deficit | (438,678,685 | ) | (436,285,863 | ) | ||||
| Total stockholders' equity | 11,788,234 | 14,052,543 | ||||||
| Total liabilities and stockholders' equity | $ | 14,091,899 | $ | 17,127,391 | ||||
Condensed Consolidated Statements of Operations (Unaudited) |
||||||||
| For the Three Months Ended | ||||||||
| 2024 | 2023 | |||||||
| Revenues: | ||||||||
| Grant income | $ | 1,244,061 | $ | 1,234,336 | ||||
| Total revenues | 1,244,061 | 1,234,336 | ||||||
| Operating expenses: | ||||||||
| Research and development | 2,575,015 | 3,376,497 | ||||||
| General and administrative | 1,218,063 | 2,167,318 | ||||||
| Total operating expenses | 3,793,078 | 5,543,815 | ||||||
| Loss from operations | (2,549,017 | ) | (4,309,479 | ) | ||||
| Other income (expenses): | ||||||||
| Interest income | 156,195 | 84,654 | ||||||
| Loss from continuing operations | (2,392,822 | ) | (4,224,825 | ) | ||||
| Discontinued operations: | ||||||||
| Loss from discontinued operations, net of tax | — | (742,751 | ) | |||||
| Income (loss) from discontinued operations | — | (742,751 | ) | |||||
| Net loss | $ | (2,392,822 | ) | $ | (4,967,576 | ) | ||
| Net earnings (loss) per share: | ||||||||
| Loss from continuing operations, basic and diluted | $ | (0.27 | ) | $ | (0.48 | ) | ||
| Income (loss) from discontinued operations, basic and diluted | $ | — | $ | (0.09 | ) | |||
| Net loss per share, basic and diluted | $ | (0.27 | ) | $ | (0.57 | ) | ||
| Weighted average number of common shares outstanding: | ||||||||
| Basic | 8,901,962 | 8,721,031 | ||||||
| Diluted | 8,901,962 | 8,721,031 | ||||||
Condensed Consolidated Statements of Cash Flows (Unaudited) |
||||||||
| For the Three Months Ended | ||||||||
| 2024 | 2023 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (2,392,822 | ) | $ | (4,967,576 | ) | ||
| Less: loss from discontinued operations, net of tax | - | (742,751 | ) | |||||
| Net loss from continuing operations | (2,392,822 | ) | (4,224,825 | ) | ||||
| Reconciliation of net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 79,417 | 659,913 | ||||||
| Changes in operating assets and liabilities: | — | — | ||||||
| Prepaid expenses and deposits | 71,117 | 36,452 | ||||||
| Other receivables | (823,647 | ) | 1,319,118 | |||||
| Related party receivable | — | (1,000,000 | ) | |||||
| Related party payable | (975,690 | ) | ||||||
| Accounts payable and accrued expenses | 204,507 | 111,171 | ||||||
| Net cash used in operating activities - continuing operations | (3,837,118 | ) | (3,098,171 | ) | ||||
| Net cash used in operating activities - discontinued operations | — | (2,790,124 | ) | |||||
| Net cash used in operating activities | (3,837,118 | ) | (5,888,295 | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Net cash provided by (used in) investing activities - discontinued operations | — | (112,608 | ) | |||||
| Net cash provided by (used in) investing activities | — | (112,608 | ) | |||||
| Cash Flows from Financing Activities: | ||||||||
| Proceeds from issuance of common stock, net | — | 619,974 | ||||||
| Proceeds from stock options exercise | 49,096 | — | ||||||
| Net cash provided by financing activities | 49,096 | 619,974 | ||||||
| Net increase (decrease) in cash and cash equivalents | (3,788,022 | ) | (5,380,929 | ) | ||||
| Cash and cash equivalents at beginning of the period | 15,111,450 | 11,782,172 | ||||||
| Cash and cash equivalents at end of the period | $ | 11,323,428 | $ | 6,401,243 | ||||
Contacts
TIBEREND STRATEGIC ADVISORS, INC.
Investors
(862) 213-1398
DBOATENG@TIBEREND.COM
Source: Marker Therapeutics