Marker Therapeutics Reports Fiscal Year 2021 Operating and Financial Results
Enrollment of first 20 patients of the Company’s Phase 2 acute myeloid leukemia (AML) trial completed in Q4 2021
Topline readout of Group 2 active disease anticipated in Q2 2022
Company plans to file INDs in lymphoma and pancreatic cancer by year end, with clinical trials to be initiated in 2023
“In 2021, we completed enrollment of the first 20 patients in our Phase 2 AML trial investigating our lead product candidate, MT-401,” said
PROGRAM UPDATES AND EXPECTED MILESTONES
Acute Myeloid Leukemia (AML)
February 2022, Marker announced the initial results of the safety lead-in stage of its Company-sponsored Phase 2 AML trial evaluating MT-401, Marker’s lead MultiTAA-specific T cell product candidate. Results from the safety lead-in demonstrate that MT-401 was well-tolerated, eliminated measurable residual disease (MRD) in one MRD positive patient and induced epitope spreading across multiple AML-associated antigens in that patient.
- The safety lead-in satisfied safety requirements with the FDA and the main Phase 2 stage of the AML trial began enrolling in
- Enrollment of the first 20 patients of the Phase 2 AML trial was completed in Q4 2021.
- Topline readout of Group 2 active disease is anticipated in Q2 2022.
- Marker announced in
February 2022that it intends to expand its AML program with the development of MT-401- OTS, a scalable, off-the-shelf product candidate with the potential to match patients to treatment in under three days. Marker’s open Investigational New Drug application (IND) for MT-401 for the treatment of AML includes approval of an off-the-shelf program. The Company is in the process of developing a patient cell bank inventory and expects to dose the first patient with MT-401- OTSin 2023.
Additional Clinical Programs (MT-601)
- Marker recently announced that the Company intends to file INDs for MT-601, Marker’s second MultiTAA-specific T cell product candidate, in lymphoma and pancreatic cancer in 2022. The Company expects to initiate these trials in 2023.
January 2022, Marker announced that the U.S. Food and Drug Administrationgranted Orphan Drug designation to MT-601 for the treatment of pancreatic cancer.
December 9, 2021, Marker announced the appointment of Katharine Knobil, M.D., to the Company's Board of Directors.
- Marker began manufacturing MT-401 for its Phase 2 AML trial at the Company’s cGMP manufacturing facility in the fourth quarter of 2021.
- The Company developed and is implementing a new nine-day MultiTAA-specific T cell manufacturing process for its current Company-sponsored Phase 2 AML trial as well as future clinical trials using a patient-specific manufacturing approach. The new T cell manufacturing process is designed to improve potency, increase antigen specificity and diversity and significantly reduce manufacturing time.
FISCAL YEAR 2021 FINANCIAL RESULTS
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
To receive future press releases via email, please visit: https://www.markertherapeutics.com/email-alerts.
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, including the Phase 2 trial of MT-401 and our planned trials of MT-401-
Consolidated Balance Sheets
|Cash and cash equivalents||$||42,351,145||$||21,352,382|
|Prepaid expenses and deposits||2,484,634||2,057,924|
|Total current assets||45,982,202||24,410,865|
|Property, plant and equipment, net||10,096,861||3,570,736|
|Construction in progress||2,225,610||6,789,098|
|Right-of-use assets, net||9,830,461||10,844,116|
|Total non-current assets||22,152,932||21,203,950|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable and accrued liabilities||$||11,134,913||$||6,013,010|
|Total current liabilities||12,901,589||6,401,802|
|Lease liability, net of current portion||11,247,950||11,868,440|
|Total non-current liabilities||11,247,950||11,868,440|
|Preferred stock -
|Additional paid-in capital||442,020,871||383,533,326|
|Total stockholders' equity||43,985,595||27,344,573|
|Total liabilities and stockholders' equity||$||68,135,134||$||45,614,815|
Consolidated Statements of Operations
|For the Years Ended|
|Research and development||27,794,879||18,880,751|
|General and administrative||12,924,826||10,471,846|
|Total operating expenses||40,719,705||29,352,597|
|Loss from operations||(39,477,995||)||(28,885,812||)|
|Change in fair value of warrant liabilities||-||31,000|
|Net loss per share, basic and diluted||$||(0.55||)||$||(0.61||)|
|Weighted average number of common shares outstanding, basic and diluted||76,505,675||47,039,862|
Condensed Consolidated Statements of Cash Flows
|For the Years Ended|
|Cash Flows from Operating Activities:|
|Reconciliation of net loss to net cash used in operating activities:|
|Depreciation and amortization||2,148,983||485,641|
|Changes in fair value of warrant liabilities||-||(31,000||)|
|Amortization on right-of-use assets||1,013,655||590,039|
|Changes in operating assets and liabilities:|
|Prepaid expenses and deposits||(426,710||)||(531,482||)|
|Accounts payable and accrued expenses||4,141,414||3,047,410|
|Net cash used in operating activities||(27,279,765||)||(20,034,691||)|
|Cash Flows from Investing Activities:|
|Purchase of property and equipment||(1,572,161||)||(3,422,754||)|
|Purchase of construction in progress||(1,558,970||)||(5,830,133||)|
|Net cash used in investing activities||(3,131,131||)||(9,252,887||)|
|Cash Flows from Financing Activities:|
|Proceeds from issuance of common stock, net||52,552,758||6,186,011|
|Proceeds from exercise of warrants||-||550,000|
|Proceeds from exercise of stock options||3,087||-|
|Net cash provided by financing activities||52,555,845||6,736,011|
|Net increase (decrease) in cash, cash equivlants and restricted cash||22,144,949||(22,551,567||)|
|Cash, cash equivalents and restricted cash at beginning of the year||21,352,382||43,903,949|
|Cash, cash equivalents and restricted cash at end of the year||$||43,497,331||$||21,352,382|
Investors and Media Contacts
Vice President/Head of Investor Relations, PR & Marketing
Source: Marker Therapeutics