Marker Therapeutics Reports Q2 2022 Operating and Financial Results
08/11/2022 - 04:22 PM
HOUSTON, Aug. 11, 2022 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today provided a corporate update and reported financial results for the second quarter ended June 30, 2022.
“We are proud of our progress this year in advancing our Company-sponsored clinical program in AML, and early results support the ability of MT-401, a multiTAA-specific T cell product, to drive results for patients with AML,” said Peter L. Hoang, Marker’s President and Chief Executive Officer. “This quarter, we continued to dose patients in the Phase 2 AML study, and we expect to provide a topline readout of active disease patients in Q3 2022. The recent $8 million upfront cash payment to Marker by Wilson Wolf has aided the efficient execution of Marker’s programs.”
Mr. Hoang continued: “In addition, we recently announced that FDA cleared our IND investigating the safety and efficacy of MT-601 in patients with relapsed/refractory lymphoma, and that we are on track to file another IND by year-end to investigate the safety and efficacy of MT-601 in patients with pancreatic cancer, which has already received FDA Orphan Drug Designation. We anticipate dosing the first patients in these trials, in addition to dosing patients in our off-the-shelf therapy for AML, next year.”
“We are very optimistic about the ability of MT-401 to drive results for patients with measurable residual disease given the results we have seen to date in the ARTEMIS study,” said Dr. Mythili Koneru, Marker’s Chief Medical Officer. “Of note, we were very pleased to note that the second patient we treated with MRD+ disease was found to be MRD- by that patient’s week 8 follow-up. The ability to administer MT-401 without the need for lymphodepletion, coupled with our improved accelerated manufacturing process, enable us to treat patients who have MRD+ disease. We believe that the results observed to date support the notion that patients with AML would have meaningful benefit from a multi-antigen targeted T cell therapy approach.”
PROGRAM UPDATES AND EXPECTED MILESTONES
Acute Myeloid Leukemia (MT-401)
Marker has enrolled 13 evaluable patients in total, including 6 in the Safety Lead-in cohorts. 5 patients have been treated with MT-401 manufactured by a revised process and have completed dose-limiting toxicity (DLT) periods with no DLTs reported. One additional MRD+ patient was treated and became MRD- at 8 weeks after the first infusion. 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. Lymphoma (MT-601)
On August 4, 2022, Marker announced that the U.S. Food and Drug Administration (FDA) cleared the Company's Investigational New Drug (IND) application for MT-601, a multi-tumor-associated antigen (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. Marker expects to initiate a Phase 1 trial in 2023. Pancreatic Cancer (MT-601)
Marker is on track to file an IND for MT-601 for the treatment of pancreatic cancer in 2022. 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. SECOND QUARTER 2022 FINANCIAL RESULTS
Cash Position and Guidance : At June 30, 2022, Marker had cash and cash equivalents of $25.8 million .R&D Expenses: Research and development expenses were $6.6 million for the quarter ended June 30, 2022, compared to $7.4 million for the quarter ended June 30, 2021.G&A Expenses: General and administrative expenses were $3.5 million for the quarter ended June 30, 2022, compared to $3.6 million for the quarter ended June 30, 2021.Net Loss: Marker reported a net loss of $9.2 million for the quarter ended June 30, 2022, compared to a net loss of $10.9 million for the quarter ended June 30, 2021. Organizational Restructuring
On August 10, 2022, the Company implemented changes to the Company’s organizational structure as part of an operational cost reduction plan to conserve the Company’s available capital. In connection with these changes, the Company reduced headcount in its general and administrative function by approximately 23.5% , including the separation of the Company’s Chief Financial Officer. The Company estimates that the severance and termination-related costs will total approximately $0.7 million and will be recorded in the third quarter of 2022. The Company expects that the payment of these costs will be substantially complete in September of 2023.
About Marker Therapeutics, Inc.
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Forward-Looking Statements
Marker Therapeutics, Inc. Condensed Consolidated Balance Sheets (Unaudited)
June 30, December 31, 2022 2021 ASSETS Current assets: Cash and cash equivalents $ 25,821,708 $ 42,351,145 Restricted cash - 1,146,186 Prepaid expenses and deposits 2,826,699 2,484,634 Other receivables 627,629 237 Total current assets 29,276,036 45,982,202 Non-current assets: Property, plant and equipment, net 13,740,158 10,096,861 Construction in progress - 2,225,610 Right-of-use assets, net 9,303,544 9,830,461 Total non-current assets 23,043,702 22,152,932 Total assets $ 52,319,738 $ 68,135,134 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and accrued liabilities $ 4,735,251 $ 11,134,913 Related party deferred revenue 8,000,000 - Lease liability 738,389 620,490 Deferred revenue - 1,146,186 Total current liabilities 13,473,640 12,901,589 Non-current liabilities: Lease liability, net of current portion 10,819,825 11,247,950 Total non-current liabilities 10,819,825 11,247,950 Total liabilities 24,293,465 24,149,539 Stockholders' equity: Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively - - Common stock, $0.001 par value, 300 million and 150 million shares authorized, 83.6 million and 83.1 million shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively 83,599 83,079 Additional paid-in capital 445,215,725 442,020,871 Accumulated deficit (417,273,051 ) (398,118,355 ) Total stockholders' equity 28,026,273 43,985,595 Total liabilities and stockholders' equity $ 52,319,738 $ 68,135,134
Marker Therapeutics, Inc. Condensed Consolidated Statements of Operations (Unaudited)
For the Three Months Ended For the Six Months Ended June 30, June 30, 2022 2021 2022 2021 Revenues: Grant income $ 790,508 $ - $ 1,754,830 $ - Total revenues 790,508 - 1,754,830 - Operating expenses: Research and development $ 6,555,299 $ 7,350,035 13,581,365 12,993,064 General and administrative 3,515,183 3,559,150 7,248,184 6,697,108 Total operating expenses 10,070,482 10,909,185 20,829,549 19,690,172 Loss from operations (9,279,974 ) (10,909,185 ) (19,074,719 ) (19,690,172 ) Other income (expenses): Arbitration settlement - - (118,880 ) - Interest income 35,786 2,403 38,903 3,940 Net loss per share, basic and diluted $ (0.11 ) $ (0.13 ) $ (0.23 ) $ (0.28 ) Weighted average number of common shares outstanding, basic and diluted 83,592,043 83,030,470 83,351,184 69,823,729
Marker Therapeutics, Inc. Condensed Consolidated Statements of Cash Flows (Unaudited)
For the Six Months Ended June 30, 2022 2021 Cash Flows from Operating Activities: Net loss $ (19,154,696 ) $ (19,686,232 ) Reconciliation of net loss to net cash used in operating activities: Depreciation and amortization 1,156,113 1,032,971 Stock-based compensation 3,131,801 3,029,125 Amortization on right-of-use assets 517,059 504,232 Changes in operating assets and liabilities: - Prepaid expenses and deposits (342,065 ) (743,876 ) Other receivables (627,392 ) 1,000,273 Accounts payable and accrued expenses (4,255,034 ) 108,230 Related party deferred revenue 8,000,000 - Deferred revenue (1,146,186 ) - Lease liability (300,368 ) (130,503 ) Net cash used in operating activities (13,020,768 ) (14,885,780 ) Cash Flows from Investing Activities: Purchase of property and equipment (1,229,298 ) (842,048 ) Purchase of construction in progress (3,489,130 ) (958,965 ) Net cash used in investing activities (4,718,428 ) (1,801,013 ) 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 equivlants and restricted cash (17,675,623 ) 35,869,052 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 $ 25,821,708 $ 57,221,434
Investors and Media Contacts
Marker Therapeutics:
Neda SafarzadehInvestor.Relations@markertherapeutics.com
Solebury Trout:
Media Abonanno@soleburytrout.com
