Marker Therapeutics Reports Third Quarter 2021 Operating and Financial Results

Rhea-AI Summary

Marker Therapeutics, Inc. (Nasdaq:MRKR) provided a corporate update and reported Q3 2021 financial results. They continue to advance the Phase 2 trial of MT-401 for post-transplant AML, with first patients dosed and plans to enroll 20 patients by Q4 2021. The company’s cGMP manufacturing facility is operational, supporting ongoing operations and potential future trials. Financially, Marker had cash reserves of $48.7 million, enough to fund operations into Q1 2023. However, the net loss for Q3 2021 was $12.4 million, up from $7.4 million in Q3 2020.

Positive

• First patients dosed in Phase 2 AML trial.
• cGMP manufacturing facility fully operational.
• Received $13.1 million from CPRIT for Phase 2 AML trial.
• Cash on hand expected to fund operations into Q1 2023.

Negative

• Net loss increased to $12.4 million in Q3 2021 from $7.4 million in Q3 2020.
• R&D expenses rose to $6.8 million, up from $4.8 million YoY.

HOUSTON, Nov. 10, 2021 /PRNewswire/ -- 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 third quarter ended September 30, 2021.  

"This quarter, we continued our momentum in advancing Marker's Phase 2 trial of MT-401, Marker's lead MultiTAA-specific T cell therapy, for the treatment of post-transplant acute myeloid leukemia, or AML," said Peter L. Hoang, President & CEO of Marker Therapeutics. "We are pleased to announce that the first patients in Marker's Phase 2 AML trial have been dosed with study drug. Further, we are on track to enroll the first 20 patients of the trial in the fourth quarter, with the first data readout expected in the first quarter of 2022. We look forward to providing year-end updates in a conference call and webcast early next year."

PROGRAM UPDATES

• The Company continues to enroll patients and activate clinical sites across the U.S. in Marker's Phase 2 trial of MT-401, its lead MultiTAA-specific T cell product candidate, for the treatment of post-transplant AML. The trial is expected to enroll approximately 120 patients in the adjuvant setting and 40 patients with active disease at approximately 20 clinical sites.

BUSINESS UPDATES

• The Company's new cGMP manufacturing facility in Houston, Texas is fully operational and is supporting ongoing operations. The facility will also manufacture Marker's MultiTAA-specific T cell products for future hematological and solid tumor trials, in addition to producing the potential commercial supply of any products, if approved.
• In August, the Company announced that it received notice of a Product Development Research award totaling approximately $13.1 million from the Cancer Prevention and Research Institute of Texas (CPRIT) to support the Company's Phase 2 AML trial.

ANTICIPATED PROGRAM MILESTONES

AML Trial Milestones

• Enrollment of first 20 patients of the Phase 2 AML trial expected in Q4 2021
• Topline readout of Group 2 active disease anticipated in Q1 2022

THIRD QUARTER 2021 FINANCIAL RESULTS

• Cash Position and Guidance: At September 30, 2021, Marker had cash and cash equivalents of $48.7 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses and capital expenditure requirements into the first quarter of 2023.
• R&D Expenses: Research and development expenses were $6.8 million for the quarter ended September 30, 2021 compared to $4.8 million for the quarter ended September 30, 2020. The increase was primarily attributable to increases in clinical trial and sponsored research expenses and headcount-related expenses due to growth of research and development operations.
• G&A Expenses: General and administrative expenses were $3.2 million for the quarter ended September 30, 2021 compared to $2.6 million for the quarter ended September 30, 2020.
• Net Loss: Marker reported a net loss of $12.4 million for the quarter ended September 30, 2021, compared to a net loss of $7.4 million for the quarter ended September 30, 2020.

About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is 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. Marker's cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. This population of T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient's immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cell therapies, we believe that our 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 benefit. As a result, Marker believes 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; the timing, conduct and success of our clinical trials, including the Phase 2 trial of MT-401; our ability to use our manufacturing facilities to support clinical and commercial demand; the timing and use of the CPRIT award; 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 SEC filings which are available through EDGAR at www.sec.gov. Such risks and uncertainties may be amplified by the COVID-19 pandemic and its impact on our business and the global economy. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

 

Marker Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
	September 30,		December 31,
	2021		2020
ASSETS
Current assets:
Cash and cash equivalents	$          48,705,297		$         21,352,382
Prepaid expenses and deposits	2,701,327		2,057,924
Other receivables	243		1,000,559
Total current assets	51,406,867		24,410,865
Non-current assets:
Property, plant and equipment, net	9,846,745		3,570,736
Construction in progress	600,005		6,789,098
Right-of-use assets, net	10,086,158		10,844,116
Total non-current assets	20,532,908		21,203,950
Total assets	$       71,939,775		$      45,614,815
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities	$            7,645,287		$           6,013,010
Lease liability	581,588		388,792
Total current liabilities	8,226,875		6,401,802
Non-current liabilities:
Lease liability, net of current portion	11,430,892		11,868,440
Total non-current liabilities	11,430,892		11,868,440
Total liabilities	19,657,767		18,270,242
Commitments and contingencies	-		-
Stockholders' equity:
Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively	-		-
Common stock, $0.001 par value, 150 million shares authorized, 83.1 million and 50.7 million shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively	83,079		50,731
Additional paid-in capital	440,553,968		383,533,326
Accumulated deficit	(388,355,039)		(356,239,484)
Total stockholders' equity	52,282,008		27,344,573
Total liabilities and stockholders' equity	$       71,939,775		$      45,614,815

 

Marker Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
	For the Three Months Ended				For the Nine Months Ended
	September 30,				September 30,
	2021		2020		2021		2020
Revenues:
Grant income	$                        -		$                     -		$                        -		$              466,785
Total revenues	-		-		-		466,785
Operating expenses:
Research and development	6,784,390		4,803,605		19,777,454		12,897,275
General and administrative	3,239,148		2,572,562		9,936,256		7,946,846
Total operating expenses	10,023,538		7,376,167		29,713,710		20,844,121
Loss from operations	(10,023,538)		(7,376,167)		(29,713,710)		(20,377,336)
Other income:
Change in fair value of warrant liabilities	-		-		-		31,000
Arbitration settlement	(2,406,576)		-		(2,406,576)		-
Interest income	791		4,667		4,731		147,493
Net loss	$     (12,429,323)		$    (7,371,500)		$     (32,115,555)		$     (20,198,843)
Net loss per share, basic and diluted	$                   (0.15)		$                (0.16)		$                   (0.43)		$                   (0.43)
Weighted average number of common shares outstanding, basic and diluted	83,078,675		46,867,119		74,290,598		46,509,391

 

Marker Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
	For the Nine Months Ended
	September 30,
	2021		2020
Cash Flows from Operating Activities:
Net loss	$        (32,115,555)		$        (20,198,843)
Reconciliation of net loss to net cash used in operating activities:
Depreciation and amortization	1,584,495		272,725
Changes in fair value of warrant liabilities	-		(31,000)
Stock-based compensation	4,497,145		3,974,536
Amortization on right-of-use assets	757,958		337,530
Changes in operating assets and liabilities:
Prepaid expenses and deposits	(643,403)		(840,703)
Other receivables	1,000,316		56,054
Accounts payable and accrued expenses	2,742,154		2,065,929
Lease liability	(244,752)		(166,723)
Net cash used in operating activities	(22,421,642)		(14,530,495)
Cash Flows from Investing Activities:
Purchase of property and equipment	(1,262,092)		(2,005,160)
Purchase of construction in progress	(1,519,196)		(3,147,566)
Net cash used in investing activities	(2,781,288)		(5,152,726)
Cash Flows from Financing Activities:
Proceeds from issuance of common stock, net	52,552,758		2,186,009
Proceeds from exercise of warrants	-		550,000
Proceeds from exercise of stock options	3,087		-
Net cash provided by financing activities	52,555,845		2,736,009
Net increase (decrease) in cash	27,352,915		(16,947,212)
Cash and cash equivalents at beginning of the period	21,352,382		43,903,949
Cash and cash equivalents at end of the period	$         48,705,297		$         26,956,737

 

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SOURCE Marker Therapeutics, Inc.

FAQ

What were the financial results for Marker Therapeutics in Q3 2021?

Marker Therapeutics reported a net loss of $12.4 million for Q3 2021, up from $7.4 million in Q3 2020.

What is the status of the Phase 2 AML trial for MRKR?

The Phase 2 trial of MT-401 for AML has dosed its first patients, with enrollment of the first 20 patients expected in Q4 2021.

How much cash does Marker Therapeutics have as of September 30, 2021?

Marker Therapeutics reported cash and cash equivalents of $48.7 million as of September 30, 2021.

What support did Marker Therapeutics receive for its Phase 2 AML trial?

The company received approximately $13.1 million from the Cancer Prevention and Research Institute of Texas (CPRIT) for the Phase 2 AML trial.