UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 2.02 | Results of Operations and Financial Condition. |
On November 10, 2022, Marker Therapeutics, Inc. (the “Company”) reported financial results for the quarter ended September 30, 2022 and other recent corporate updates. A copy of the press release is furnished as Exhibit 99.1 to this report and incorporated by reference.
The information in this Item 2.02 of this Current Report on 8-K (including Exhibit 99.1) is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information shall not be deemed incorporated by reference into any other filing with the Securities and Exchange Commission made by the Company, whether made before or after today’s date, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific references in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. | Description |
| 99.1 | Press release, dated November 10, 2022 |
| 104 | Inline XBRL for the cover page of this Current Report on Form 8-K |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Marker Therapeutics, Inc. | ||
| Dated: November 10, 2022 | By: | /s/ Peter Hoang |
| Peter Hoang | ||
| President and Chief Executive Officer | ||
Exhibit 99.1
Marker Therapeutics Reports Q3 2022 Operating and Financial Results
Company awarded $2 million U.S. FDA Orphan Products Grant to support Phase 2 ARTEMIS trial of its lead T cell therapy candidate MT-401 in patients with post-transplant AML
Houston, TX— November 10, 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 third quarter ended September 30, 2022.
“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 L. Hoang, Marker’s President and Chief Executive Officer. “We are also pleased to receive a grant from the FDA Orphan Products program to support the Phase 2 treatment arm evaluating MT-401 in patients with minimal residual disease. We believe the MRD-positive patient population represents a significant opportunity for MT-401 as we continue to dose more patients in the trial and measure long-term response.”
PROGRAM UPDATES AND EXPECTED MILESTONES
Acute Myeloid Leukemia (MT-401)
| • | In September 2022, Marker announced that it had been awarded a $2 million grant 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. |
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Lymphoma (MT-601)
| • | In 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 million of grant income and $2.95 million of related party service revenue. |
| • | R&D Expenses: Research and development expenses were $7.3 million for the quarter ended September 30, 2022, compared to $6.8 million for the quarter ended September 30, 2021. |
| • | G&A Expenses: General and administrative expenses were $3.7 million for the quarter ended September 30, 2022, compared to $3.2 million for the quarter ended September 30, 2021. |
| • | Net Loss: Marker reported a net loss of $6.9 million for the quarter ended September 30, 2022, compared to a net loss of $12.4 million for the quarter ended September 30, 2021. |
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: https://www.markertherapeutics.com/email-alerts.
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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 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.
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Marker Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 18,076,379 | $ | 42,351,145 | ||||
| Restricted cash | — | 1,146,186 | ||||||
| Prepaid expenses and deposits | 2,665,668 | 2,484,634 | ||||||
| Other receivables | 1,681,019 | 237 | ||||||
| Total current assets | 22,423,066 | 45,982,202 | ||||||
| Non-current assets: | ||||||||
| 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 | ||||||
| Total assets | $ | 41,114,565 | $ | 68,135,134 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 5,746,404 | $ | 11,134,913 | ||||
| Related party deferred revenue | 5,050,000 | — | ||||||
| Lease liability | 490,449 | 620,490 | ||||||
| Deferred revenue | — | 1,146,186 | ||||||
| Total current liabilities | 11,286,853 | 12,901,589 | ||||||
| Non-current liabilities: | ||||||||
| Lease liability, net of current portion | 7,225,990 | 11,247,950 | ||||||
| Total non-current liabilities | 7,225,990 | 11,247,950 | ||||||
| Total liabilities | 18,512,843 | 24,149,539 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at September 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 September 30, 2022 and December 31, 2021, respectively | 83,599 | 83,079 | ||||||
| Additional paid-in capital | 446,710,757 | 442,020,871 | ||||||
| Accumulated deficit | (424,192,634 | ) | (398,118,355 | ) | ||||
| Total stockholders' equity | 22,601,722 | 43,985,595 | ||||||
| Total liabilities and stockholders' equity | $ | 41,114,565 | $ | 68,135,134 | ||||
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Marker Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
| For the Three Months Ended | For the Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenues: | ||||||||||||||||
| Grant income | $ | 999,571 | $ | — | $ | 2,754,401 | $ | — | ||||||||
| Related partry service revenue | 2,950,000 | — | 2,950,000 | — | ||||||||||||
| Total revenues | 3,949,571 | — | 5,704,401 | — | ||||||||||||
| Operating expenses: | ||||||||||||||||
| 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): | ||||||||||||||||
| Arbitration settlement | — | (2,406,576 | ) | (118,880 | ) | (2,406,576 | ) | |||||||||
| Interest income | 99,750 | 791 | 138,653 | 4,731 | ||||||||||||
| Net loss | $ | (6,919,583 | ) | $ | (12,429,323 | ) | $ | (26,074,279 | ) | $ | (32,115,555 | ) | ||||
| 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 | ||||||||||||
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Marker Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
| For the Nine Months Ended | ||||||||
| September 30, | ||||||||
| 2022 | 2021 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (26,074,279 | ) | $ | (32,115,555 | ) | ||
| Reconciliation of net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 1,975,996 | 1,584,495 | ||||||
| Stock-based compensation | 4,626,833 | 4,497,145 | ||||||
| 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 | ) | ||||
| Other receivables | (1,680,782 | ) | 1,000,316 | |||||
| Accounts payable and accrued expenses | (3,310,051 | ) | 2,742,154 | |||||
| Related party deferred revenue | 5,050,000 | — | ||||||
| Deferred revenue | (1,146,186 | ) | — | |||||
| Lease liability | (413,988 | ) | (244,752 | ) | ||||
| 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 | ||||
Contacts
Investors
Xuan Yang
xyang@soleburystrat.com
Media
Amy Bonanno
abonanno@soleburystrat.com
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