Marker Therapeutics Reports Q3 2022 Operating and Financial Results
“This quarter we reached a major milestone in treating the first six patients in our Phase 2 AML trial with T cells derived from our new manufacturing process, which are designed for increased potency against tumor antigens,” said Peter
PROGRAM UPDATES AND EXPECTED MILESTONES
Acute Myeloid Leukemia (MT-401)
September 2022, Marker announced that it had been awarded a $2 milliongrant from the U.S. Food and Drug Administration(FDA) Orphan Products Grants program to support the Phase 2 ARTEMIS trial of the company’s lead multi-tumor-associated antigen (MultiTAA) T cell product candidate, MT-401, in patients with post-transplant AML. The FDA grant will support the Company’s treatment arm evaluating MT-401 in patients with post-transplant AML with minimal residual disease. MT-401 was granted Orphan Drug Designation for the treatment of patients with AML following allogeneic stem cell transplant in 2020.
- The Company has treated all six patients in Cohorts 4 and 5 using MT-401 manufactured with Marker’s new T cell manufacturing process. The new manufacturing process is designed to produce a more potent product with increased antigen specificity and diversity and a reduction in manufacturing time. To date, all six patients have completed dose-limiting toxicity (DLT) periods with no DLTs reported. The Company expects to announce an efficacy analysis from the six patients in Cohorts 4 and 5 by year-end.
- Marker remains on track to dose the first patient in 2023 with MT-401-
OTS, a scalable, off-the-shelf product candidate with the potential to match patients to treatment in under three days. The Company is in the process of developing a patient cell bank inventory.
August 2022, Marker announced that the U.S.FDA cleared the Company’s Investigational New Drug Application (IND) for a Phase 1 study of MT-601, a multiTAA-specific T cell product targeting six antigens, for the treatment of patients with relapsed/refractory non-Hodgkin lymphoma who have failed or are ineligible to receive anti-CD19 CAR T cell treatment.
- The Company expects some sites to open before the end of the year and to enroll the first patient in the Phase 1 trial in Q1 of 2023.
Pancreatic Cancer (MT-601)
- The Company intends to initiate a Phase 1 multicenter study of MT-601 administered in combination with front-line chemotherapy to patients with locally advanced unresectable or metastatic pancreatic cancer in 2023.
THIRD QUARTER 2022 FINANCIAL RESULTS
- Cash Position and Guidance: At
September 30, 2022, Marker had cash and cash equivalents of $18.1 million.
- Revenues: For the quarter ended
September 30, 2022, Marker recorded $1.0 millionof grant income and $2.95 millionof related party service revenue.
- R&D Expenses: Research and development expenses were
$7.3 millionfor the quarter ended September 30, 2022, compared to $6.8 millionfor the quarter ended September 30, 2021.
- G&A Expenses: General and administrative expenses were
$3.7 millionfor the quarter ended September 30, 2022, compared to $3.2 millionfor the quarter ended September 30, 2021.
- Net Loss: Marker reported a net loss of
$6.9 millionfor the quarter ended September 30, 2022, compared to a net loss of $12.4 millionfor the quarter ended September 30, 2021.
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This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; the timing, conduct and success of our clinical trials of our product candidates; our ability to use our manufacturing facilities to support clinical and commercial demand; and our future operating expenses and capital expenditure requirements. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||18,076,379||$||42,351,145|
|Prepaid expenses and deposits||2,665,668||2,484,634|
|Total current assets||22,423,066||45,982,202|
|Property, plant and equipment, net||13,059,816||10,096,861|
|Construction in progress||-||2,225,610|
|Right-of-use assets, net||5,631,683||9,830,461|
|Total non-current assets||18,691,499||22,152,932|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable and accrued liabilities||$||5,746,404||$||11,134,913|
|Related party deferred revenue||5,050,000||-|
|Total current liabilities||11,286,853||12,901,589|
|Lease liability, net of current portion||7,225,990||11,247,950|
|Total non-current liabilities||7,225,990||11,247,950|
|Preferred stock -
|Additional paid-in capital||446,710,757||442,020,871|
|Total stockholders' equity||22,601,722||43,985,595|
|Total liabilities and stockholders' equity||$||41,114,565||$||68,135,134|
Condensed Consolidated Statements of Operations
|For the Three Months Ended||For the Nine Months Ended|
|Related partry service revenue||2,950,000||-||2,950,000||-|
|Research and development||7,290,899||6,784,390||20,872,264||19,777,454|
|General and administrative||3,678,005||3,239,148||10,926,189||9,936,256|
|Total operating expenses||10,968,904||10,023,538||31,798,453||29,713,710|
|Loss from operations||(7,019,333||)||(10,023,538||)||(26,094,052||)||(29,713,710||)|
|Other income (expenses):|
|Net loss per share, basic and diluted||$||(0.08||)||$||(0.15||)||$||(0.31||)||$||(0.43||)|
|Weighted average number of common shares outstanding, basic and diluted||83,599,187||83,078,675||83,434,760||74,290,598|
Condensed Consolidated Statements of Cash Flows
|For the Nine Months Ended|
|Cash Flows from Operating Activities:|
|Reconciliation of net loss to net cash used in operating activities:|
|Depreciation and amortization||1,975,996||1,584,495|
|Amortization on right-of-use assets||739,446||757,958|
|Loss on disposal of assets||25,995||-|
|Gain on lease termination||(278,681||)||-|
|Changes in operating assets and liabilities:|
|Prepaid expenses and deposits||(181,034||)||(643,403||)|
|Accounts payable and accrued expenses||(3,310,051||)||2,742,154|
|Related party deferred revenue||5,050,000||-|
|Net cash used in operating activities||(20,666,731||)||(22,421,642||)|
|Cash Flows from Investing Activities:|
|Purchase of property and equipment||(1,328,664||)||(1,262,092||)|
|Purchase of construction in progress||(3,489,130||)||(1,519,196||)|
|Net cash used in investing activities||(4,817,794||)||(2,781,288||)|
|Cash Flows from Financing Activities:|
|Proceeds from issuance of common stock, net||63,573||52,552,758|
|Proceeds from exercise of stock options||-||3,087|
|Net cash provided by financing activities||63,573||52,555,845|
|Net (decrease) increase in cash, cash equivalents and restricted cash||(25,420,952||)||27,352,915|
|Cash, cash equivalents and restricted cash at beginning of the period||43,497,331||21,352,382|
|Cash, cash equivalents and restricted cash at end of the period||$||18,076,379||$||48,705,297|
Source: Marker Therapeutics