Full Press Release Details
Marker Therapeutics Reports Q2 2022 Operating and Financial Results
Houston, TX- August 11, 2022-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
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
PROGRAM UPDATES AND EXPECTED MILESTONES
Acute Myeloid Leukemia (MT-401)
Pancreatic Cancer (MT-601)
SECOND QUARTER 2022 FINANCIAL RESULTS
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.
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.
To receive future press releases via email, please visit:
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 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 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
| 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
| 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 | $ | (9,244,188 | ) | $ | (10,906,782 | ) | $ | (19,154,696 | ) | $ | (19,686,232 | ) | ||||
| 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
| 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:
Vice President/Head of Investor Relations, PR