Marker Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Updates
Announced complete response in first patient with lymphoma treated with MT-601 in Phase 1 APOLLO trial following CAR T relapse
Received Orphan Drug Designation (ODD) from
Demonstrated enhanced anti-tumor activity in an aggressive, treatment-resistant AML cell line and provided an update on clinical readiness of the MT-401 Off-the-Shelf (OTS) program
“During the third quarter of 2023, we continued to diligently advance and execute our clinical objectives across our novel multiTAA-specific T cell pipeline,” commented
“In July, our MT-401 program was granted Orphan Drug Designation by the EMA for the treatment of patients with AML,” continued
“To maximize shareholder value and accelerate our patient-centric mission, we continue to engage in internal and external conversations with pertinent stakeholders to optimize our clinical development plan, which we expect to announce in the first quarter of 2024. With our healthy balance sheet and clinical progress shown to date, we believe we are well poised to achieve our near-and long-term growth objectives,” concluded
Program Updates and Expected Milestones:
MT-401 (Acute Myeloid Leukemia)
- Marker was granted ODD from the Committee for Orphan Medicinal Products of the EMA for the treatment of patients with AML. This follows the ODD from
U.S.FDA in 2020.
- Marker reported non-clinical proof-of-concept data of MT-401 in an
OTSsetting and provided updates on clinical readiness for the MT-401- OTSprogram, which will investigate the treatment of patients with relapsed/refractory AML. Marker has established an inventory for MT-401- OTSand anticipates initial patient treatment in 2024.
- Marker reported non-clinical data to bolster the clinical investigation of MT-401 after hypomethylating agent (HMA) administration and received a
$2 milliongrant from the NIH Small Business Innovation Research(SBIR) program in support of the clinical study.
- Complete response in the first patient with lymphoma treated with MT-601 in the Phase 1 multicenter APOLLO trial (clinicaltrials.gov identifier: NCT05798897) following participant’s failure to respond to four prior lines of therapy including anti-CD19 CAR T cell therapy. The study participant was treated with 2 doses of MT-601 at a 200 million cell dose level without prior lymphodepletion and showed no clinically significant treatment-related adverse events. At the first assessment, eight weeks after the second infusion of MT-601, the participant demonstrated a complete metabolic response based on PET-CT scans. MT-601 treatment was well tolerated with no treatment-related adverse events.
- This clinical observation is supported by in vitro data demonstrating the anti-tumor activity of MT-601 in anti-CD19 CAR T resistant lymphoma cells, highlighting the therapeutic potential of MT-601.
- Marker is treating and evaluating additional patients in the Phase 1 APOLLO trial and anticipates reporting additional data in the first half of 2024.
- Investigational New Drug (IND) application cleared by
U.S.FDA for multicenter Phase 1 trial of MT-601 in patients with metastatic pancreatic cancer in combination with first-line chemotherapy.
- Clinical advancement will be pending additional financial support from non-dilutive grant activities.
Third Quarter 2023 Financial Highlights:
- Cash Position: Cash and cash equivalents of
$17.5 millionat September 30, 2023.
- R&D Expenses: Research and development expenses were
$2.0 millionfor the quarter ended September 30, 2023, compared to $3.6 millionfor the quarter ended September 30, 2022. The decrease in R&D expenses was primarily attributable to lower expenses from the sale of Marker’s cell processing facility to Cell Ready, which was completed in June 2023.
- G&A Expenses: General and administrative expenses were
$1.4 millionfor the quarter ended September 30, 2023, compared to $3.2 millionfor the quarter ended September 30, 2022. The decrease in G&A expenses was also primarily attributable to the sale of Marker’s cell processing facility to Cell Ready.
- Net Loss: Marker reported a net loss of
($3.0) millionfor the quarter ended September 30, 2023, compared to a net loss of ($6.9) million, inclusive of the $(1.2) millionloss from discontinued operations, reflected in the quarter ended September 30, 2022.
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This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning Marker’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; the timing, conduct and success of our clinical trials of our product candidates, including MT-601 for the treatment of patients with lymphoma and MT-401 for the treatment of patients with AML; the potential benefits of orphan drug designation to MT401; and our future operating expenses and capital expenditure requirements, including our anticipated cash runway. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in Marker’s most recent Form 10-K, 10-Q and other
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||17,473,899||$||11,782,172|
|Prepaid expenses and deposits||1,929,355||1,849,239|
|Current assets of discontinued operations||-||585,840|
|Total current assets||19,486,567||16,619,255|
|Non-current assets of discontinued operations||-||17,802,929|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable and accrued liabilities||$||2,304,019||$||2,521,193|
|Related party payable||367,915||-|
|Current liabilities of discontinued operations||-||5,260,616|
|Total current liabilities||2,779,464||7,781,809|
|Non-current liabilities of discontinued operations||-||7,039,338|
|Additional paid-in capital||450,181,012||447,641,680|
|Total stockholders' equity||16,707,103||19,601,037|
|Total liabilities and stockholders' equity||$||19,486,567||$||34,422,184|
Condensed Consolidated Statements of Operations
|For the Three Months Ended||For the Nine Months Ended|
|Research and development||2,044,980||3,591,897||7,799,472||9,786,138|
|General and administrative||1,412,672||3,234,133||6,098,716||9,720,598|
|Total operating expenses||3,457,652||6,826,030||13,898,188||19,506,736|
|Loss from operations||(3,200,046||)||(5,826,459||)||(11,643,587||)||(16,752,335||)|
|Other income (expenses):|
|Loss from continuing operations||(2,981,961||)||(5,726,709||)||(11,305,768||)||(16,732,562||)|
|Loss from discontinued operations, net of tax||-||(1,192,874||)||(2,922,406||)||(9,341,717||)|
|Gain on disposal of discontinued operations||-||-||8,794,426||-|
|Income (loss) from discontinued operations||-||(1,192,874||)||5,872,020||(9,341,717||)|
|Net earnings (loss) per share:|
|Loss from continuing operations, basic and diluted||$||(0.34||)||$||(0.69||)||$||(1.29||)||$||(2.01||)|
|Income (loss) from discontinued operations, basic||$||-||$||(0.14||)||$||0.67||$||(1.12||)|
|Income (loss) from discontinued operations, diluted||$||-||$||(0.14||)||$||0.66||$||(1.12||)|
|Net loss per share||$||(0.34||)||$||(0.83||)||$||(0.62||)||$||(3.13||)|
|Weighted average number of common shares outstanding:|
Condensed Consolidated Statements of Cash Flows
|For the Nine Months Ended|
|Cash Flows from Operating Activities:|
|Less: gain (loss) from discontinued operations, net of tax||5,872,020||(9,341,717||)|
|Net loss from continuing operations||(11,305,768||)||(16,732,562||)|
|Reconciliation of net loss to net cash used in operating activities:|
|Gain on lease termination||-||(278,681||)|
|Changes in operating assets and liabilities:|
|Prepaid expenses and deposits||(80,116||)||(204,222||)|
|Accounts payable and accrued expenses||208,348||(289,148||)|
|Net cash used in operating activities - continuing operations||(8,036,416||)||(17,409,816||)|
|Net cash used in operating activities - discontinued operations||(6,035,961||)||(3,256,915||)|
|Net cash used in operating activities||(14,072,377||)||(20,666,731||)|
|Cash Flows from Investing Activities:|
|Net cash provided by (used in) investing activities - discontinued operations||18,664,122||(4,817,794||)|
|Net cash provided by (used in) investing activities||18,664,122||(4,817,794||)|
|Cash Flows from Financing Activities:|
|Proceeds from issuance of common stock, net||1,014,640||63,573|
|Proceeds from stock options exercise||85,342||-|
|Net cash provided by financing activities||1,099,982||63,573|
|Net increase (decrease) in cash, cash equivalents and restricted cash||5,691,727||(25,420,952||)|
|Cash, cash equivalents and restricted cash at beginning of the period||11,782,172||43,497,331|
|Cash, cash equivalents and restricted cash at end of the period||$||17,473,899||$||18,076,379|
Source: Marker Therapeutics