Full Press Release Details
Marker Therapeutics Reports Second Quarter
2019 Operating and Financial Results
TX-August 8, 2019-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, 2019.
are encouraged by the data generated to date with our MultiTAA T cell therapies-particularly in pancreatic cancer-a
disease that has not seen meaningful improvements in treatment outcomes in more than 40 years," said Peter L. Hoang, President
& CEO of Marker Therapeutics. "These data suggest that our therapy-which targets multiple antigens-continues
to demonstrate epitope spreading, potentially contributing to the T cells' ability to expand and produce a lasting
anti-tumor effect, with no added toxicities. We will continue to follow these patients and
enroll new patients to further evaluate durability."
Mr. Hoang: "Encouraged by results from our investigator-sponsored trials, we are now looking forward to initiating our first
Marker-sponsored trial with MultiTAA T cell therapies in patients with post-transplant acute myeloid leukemia, and look forward
to continuing our discussions with the FDA regarding our Phase 2 trial."
HIGHLIGHTS AND CURRENT UPDATES
Targeted (MultiTAA) T Cell Therapies
Interim Pancreatic Cancer Data Reported at AACR Meeting in July
recently reported interim data from an ongoing investigator-sponsored Phase 1/2 clinical trial led by Baylor College of Medicine
(BCM), evaluating the Company's MultiTAA T cell therapy in patients with pancreatic adenocarcinoma. Investigators plan to
enroll a total of 45 patients with advanced or borderline resectable pancreatic cancer in the three-arm trial and a total of 19
patients had received infusions of MultiTAA T cell therapy as of July 5, 2019. The results from these patients-which were
reviewed in an oral presentation during a plenary session at AACR's Cell Therapy meeting in July-suggested that MultiTAA
T cell therapy may contribute to more durable responses without added toxicity when used in combination with standard-of-care chemotherapy,
or as a second-line therapy for patients who are chemo-refractory. Additionally, in patients with borderline surgically resectable
disease-a challenging setting due to the associated dense fibrotic tissue-interim data suggest that MultiTAA T cells
are capable of meaningfully infiltrating the tumor. Marker plans to follow these patients and enroll new patients to further evaluate
Preparing for Company-Sponsored Phase 2 Clinical Trial in AML
multicenter trial will evaluate clinical efficacy of Marker's MultiTAA T cell therapy in patients with AML in both the adjuvant
and active disease setting following an allogeneic hematopoietic stem cell transplant (HSCT). The dose in the Phase 2 trial is
expected to be the maximum tolerated dose currently determined in the BCM-sponsored Phase 1 trial. In the adjuvant setting, patients
will be randomized to either MultiTAA T cell therapy at approximately 90 days post-transplant or standard of care observation,
while the active disease patients will receive MultiTAA T cells upon relapse as part of a single-arm group.
Company continues to advance its T cell-based vaccine programs in ovarian cancer and triple negative breast cancer.
2 Ovarian Cancer Clinical Trial Highlights
2 Triple Negative Breast Cancer Trial Highlights
QUARTER 2019 FINANCIAL RESULTS
loss for the quarter ended June 30, 2019 was $5.6 million, compared to a net loss of $4.8 million for the quarter ended June 30,
and development expenses were $3.2 million for the quarter ended June 30, 2019, an increase of $1.4 million, compared to $1.8 million
for the quarter ended June 30, 2018. The increase was primarily attributable to increases in personnel-related expenses, including
stock-based compensation expenses and consulting expenses, relating to the build-up of Marker's internal infrastructure as
the Company advances the clinical development of its MultiTAA T cell product candidates.
and administrative expenses were $2.7 million for the quarter ended June 30, 2019, a decrease of $0.4 million, compared to $3.1
million for the quarter ended June 30, 2018. The decrease was primarily attributable to $1.2 million of merger-related expenses
incurred during the three months ended June 30, 2018, offset by increased expenses relating to $0.3 million of headcount-related
expenses, $0.4 million of non-merger-related legal and other professional expenses and $0.1 million of office-related and insurance
POSITION AND GUIDANCE
June 30, 2019, Marker had cash and cash equivalents of $53.4 million. The Company believes that its existing cash and cash equivalents
will fund the Company's current operations into late 2020.
Marker Therapeutics, Inc.
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.
is also advancing a number of innovative peptide and gene-based immuno-therapeutics for the treatment of metastatic solid tumors,
including the Folate Receptor Alpha program (TPIV200) for breast and ovarian cancers and the HER2/neu program (TPIV100/110) for
breast cancer, currently in Phase 2 clinical trials.
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Statement Disclaimer
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 and our TPIV200 and TPIV100/110
programs; the effectiveness of these programs or the possible range of application and potential curative effects and safety in
the treatment of diseases; and, the timing and success of our clinical trials, as well as clinical trials conducted by our collaborators.
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. 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, | |||||||
| 2019 | 2018 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 53,444,906 | $ | 61,746,748 | ||||
| Prepaid expenses and deposits | 491,467 | 141,717 | ||||||
| Interest receivable | 98,154 | 108,177 | ||||||
| Total current assets | 54,034,527 | 61,996,642 | ||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | 413,239 | 147,668 | ||||||
| Right-of-use assets, net | 547,455 | - | ||||||
| Total non-current assets | 960,694 | 147,668 | ||||||
| Total assets | $ | 54,995,221 | $ | 62,144,310 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 2,946,782 | $ | 2,754,572 | ||||
| Lease liability | 194,482 | - | ||||||
| Warrant liability | 65,000 | 49,000 | ||||||
| Total current liabilities | 3,206,264 | 2,803,572 | ||||||
| Non-current liabilities: | ||||||||
| Lease liability, net of current portion | 385,169 | - | ||||||
| Total non-current liabilities | 385,169 | - | ||||||
| Total liabilities | 3,591,433 | 2,803,572 | ||||||
| Commitments and contingencies | - | - | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively | - | - | ||||||
| Common stock, $0.001 par value, 150 million shares authorized, 45.5 million and 45.4 million shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively | 45,513 | 45,440 | ||||||
| Additional paid-in capital | 368,353,041 | 365,400,748 | ||||||
| Accumulated deficit | (316,994,766 | ) | (306,105,450 | ) | ||||
| Total stockholders' equity | 51,403,788 | 59,340,738 | ||||||
| Total liabilities and stockholders' equity | $ | 54,995,221 | $ | 62,144,310 |
Marker Therapeutics, Inc.
Condensed Consolidated Statements of
| For the Three Months Ended | For the Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Revenues: | ||||||||||||||||
| Grant income | $ | - | $ | 205,994 | $ | - | $ | 205,994 | ||||||||
| Total revenues | - | 205,994 | - | 205,994 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 3,152,445 | 1,826,837 | 5,985,140 | 3,426,387 | ||||||||||||
| General and administrative | 2,721,120 | 3,052,954 | 5,526,895 | 4,650,890 | ||||||||||||
| Total operating expenses | 5,873,565 | 4,879,791 | 11,512,035 | 8,077,277 | ||||||||||||
| Loss from operations | (5,873,565 | ) | (4,673,797 | ) | (11,512,035 | ) | (7,871,283 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Change in fair value of warrant liabilities | (7,000 | ) | (139,000 | ) | (16,000 | ) | (138,000 | ) | ||||||||
| Interest income | 310,174 | - | 638,719 | - | ||||||||||||
| Net loss | $ | (5,570,391 | ) | $ | (4,812,797 | ) | $ | (10,889,316 | ) | $ | (8,009,283 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.12 | ) | $ | (0.41 | ) | $ | (0.24 | ) | $ | (0.71 | ) | ||||
| Weighted average number of common shares outstanding | 45,501,078 | 11,838,371 | 45,483,513 | 11,233,755 |
Marker Therapeutics, Inc.
Condensed Consolidated Statements of
| For the Six Months Ended | ||||||||
| June 30, | ||||||||
| 2019 | 2018 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (10,889,316 | ) | $ | (8,009,283 | ) | ||
| Reconciliation of net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 39,811 | - | ||||||
| Changes in fair value of warrant liabilities | 16,000 | 138,000 | ||||||
| Stock-based compensation | 2,889,243 | 1,096,472 | ||||||
| Amortization on right-of-use assets | 89,178 | - | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and deposits | (349,750 | ) | (57,566 | ) | ||||
| Interest receivable | 10,023 | - | ||||||
| Accounts payable and accrued expenses | 225,135 | 2,086,840 | ||||||
| Lease liability | (89,907 | ) | - | |||||
| Net cash used in operating activities | (8,059,583 | ) | (4,745,537 | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Purchase of property and equipment | (305,382 | ) | - | |||||
| Net cash used in investing activities | (305,382 | ) | - | |||||
| Cash Flows from Financing Activities: | ||||||||
| Proceeds from issuance of common stock and warrants in private placement, net of offering costs | - | 3,120,000 | ||||||
| Proceeds from exercise of stock options | 57,744 | 18,125 | ||||||
| Proceeds from exercise of warrants | 5,379 | 4,261,085 | ||||||
| Net cash provided by financing activities | 63,123 | 7,399,210 | ||||||
| Net (decrease) increase in cash | (8,301,842 | ) | 2,653,673 | |||||
| Cash and cash equivalents at beginning of period | 61,746,748 | 5,129,289 | ||||||
| Cash and cash equivalents at end of period | $ | 53,444,906 | $ | 7,782,962 |