Full Press Release Details
Marker Therapeutics Reports Third Quarter
2019 Operating and Financial Results
Conference Call and Webcast Today
Houston, TX - November 12, 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 third quarter ended September 30, 2019.
"We continue to make progress in advancing our next-generation
T-cell based immunotherapies for the treatment of hematological malignancies and solid tumors," said Peter L. Hoang, President
and CEO of Marker Therapeutics. "Our partner-sponsored MultiTAA T-cell therapy trials at the Baylor College of Medicine continue
to show promising results. In addition, we continue to expand our team and build out our infrastructure to support future Marker-sponsored
clinical trials. We expect the next 12 to 18 months to be an exciting and productive time for our Company."
Continued Mr. Hoang: "We recently filed an Investigational
New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for our MultiTAA T-cell therapy as part of a planned
Marker Phase 2 study in post-allogeneic hematopoietic stem cell transplant patients with acute myeloid leukemia in both the adjuvant
and active disease setting. The FDA reviewed our submission and requested additional information regarding certain quality and
technical specifications for two reagents supplied by third party vendors that are used in our manufacturing process. Because the
FDA requires these data in order to clear the IND, the Marker AML trial has been placed on clinical hold until our complete response
to the technical questions is satisfactory to the FDA. While these reagents are not present in the final product, we worked with
respective manufacturers of these reagents to satisfy the FDA's questions and subsequently submitted a complete response
to the FDA in late October. We currently project to initiate our Phase 2 trial in 2020 and look forward to providing an update
on our clinical path forward upon receiving the FDA's feedback."
Multi-Antigen Targeted (MultiTAA) T-Cell Therapies
Marker Submits Response to FDA Clinical
The Company worked with regulatory and quality groups at the
respective manufacturers to address the FDA's request and submitted a complete response to the issues raised by the FDA on
October 28, 2019. The FDA will respond within 30 days after receiving Marker's complete response, indicating whether
the hold is lifted and, if not, specifying the reasons the clinical trial remains on hold. Marker expects to initiate its
Phase 2 clinical trial of MultiTAA therapy for the treatment of post-transplant AML in 2020.
T Cell-Based Vaccines
Negative Breast Cancer Trial Progressing
continues to advance its T cell-based vaccine program in triple negative breast cancer. To date, results have shown:
Phase 2 Platinum-Sensitive
Advanced Ovarian Cancer Trial Update
Marker will be discontinuing the development of TPIV200 in patients
with platinum-sensitive advanced ovarian cancer based on an unblinded review of interim results from its Phase 2 study conducted
by an independent Data and Safety Monitoring Board (DSMB). Although the DSMB did not express any safety concerns with respect to
TPIV200, Marker has elected to suspend the trial because it did not meet the threshold for probability of success based upon the
Company's pre-specified criteria. Pending full review of the data, Marker anticipates closing the trial in the first quarter
THIRD QUARTER 2019 FINANCIAL RESULTS
Net loss for the quarter ended September 30, 2019 was $5.5 million,
compared to a net loss of $4.4 million for the quarter ended September 30, 2018.
Research and development expenses during the three months ended
September 30, 2019 were $3.1 million, compared to $1.9 million during the three months ended September 30, 2018. The increase of
$1.2 million was primarily attributable to increases in personnel-related expenses, relating to the build-up of Marker's
internal infrastructure.
General and administrative expenses were $2.5 million during
the three months ended September 30, 2019 as compared to $2.6 million during the three months ended September 30, 2018. The decrease
was primarily attributable to $0.6 million of merger-related expenses incurred during the three months ended September 30, 2018,
offset by increased expenses in headcount-related and legal and other professional expenses.
CASH POSITION AND GUIDANCE
At September 30, 2019, Marker had cash and cash equivalents
of $48.5 million. The Company believes that its existing cash and cash equivalents will fund its current operations through at
least the fourth quarter of 2020.
Conference Call and Webcast
The Company will host a webcast and
conference call to discuss its third quarter 2019 financial results and provide an update on recent corporate activities today
The webcast will be accessible in
the Investors section of the Company's website at www.markertherapeutics.com. Individuals can participate
in the conference call by dialing 877-407-8913 (domestic) or 201-689-8201 (international) and referring to the "Marker Therapeutics
Third Quarter 2019 Earnings Call."
The archived webcast will be available for replay on the Marker
website following the event.
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.
Marker 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 cancer and the HER2/neu program (TPIV100/110) for breast cancer, currently in Phase 2 clinical trials.
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Forward-Looking Statement Disclaimer
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; 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,
Condensed Consolidated Balance Sheets
| September 30, | December 31, | |||||||
| 2019 | 2018 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 48,477,670 | $ | 61,746,748 | ||||
| Prepaid expenses and deposits | 1,906,062 | 141,717 | ||||||
| Interest receivable | 78,145 | 108,177 | ||||||
| Total current assets | 50,461,877 | 61,996,642 | ||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | 438,881 | 147,668 | ||||||
| Right-of-use assets, net | 501,714 | - | ||||||
| Total non-current assets | 940,595 | 147,668 | ||||||
| Total assets | $ | 51,402,472 | $ | 62,144,310 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 2,858,808 | $ | 2,754,572 | ||||
| Lease liability | 199,266 | - | ||||||
| Warrant liability | 129,000 | 49,000 | ||||||
| Total current liabilities | 3,187,074 | 2,803,572 | ||||||
| Non-current liabilities: | ||||||||
| Lease liability, net of current portion | 333,480 | - | ||||||
| Total non-current liabilities | 333,480 | - | ||||||
| Total liabilities | 3,520,554 | 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 September 30, 2019 and December 31, 2018, respectively | - | - | ||||||
| Common stock, $0.001 par value, 150 million shares authorized, 45.7 million and 45.4 million shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively | 45,723 | 45,440 | ||||||
| Additional paid-in capital | 370,290,447 | 365,400,748 | ||||||
| Accumulated deficit | (322,454,252 | ) | (306,105,450 | ) | ||||
| Total stockholders' equity | 47,881,918 | 59,340,738 | ||||||
| Total liabilities and stockholders' equity | $ | 51,402,472 | $ | 62,144,310 |
Marker Therapeutics,
Condensed Consolidated Statements of Operations
| For the Three Months Ended | For the Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Revenues: | ||||||||||||||||
| Grant income | $ | - | $ | - | $ | - | $ | 205,994 | ||||||||
| Total revenues | - | - | - | 205,994 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 3,118,530 | 1,877,260 | 9,103,670 | 5,303,647 | ||||||||||||
| General and administrative | 2,536,204 | 2,551,146 | 8,063,099 | 7,202,036 | ||||||||||||
| Total operating expenses | 5,654,734 | 4,428,406 | 17,166,769 | 12,505,683 | ||||||||||||
| Loss from operations | (5,654,734 | ) | (4,428,406 | ) | (17,166,769 | ) | (12,299,689 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Change in fair value of warrant liabilities | (64,000 | ) | 40,000 | (80,000 | ) | (98,000 | ) | |||||||||
| Interest income | 259,248 | - | 897,967 | - | ||||||||||||
| Net loss | $ | (5,459,486 | ) | $ | (4,388,406 | ) | $ | (16,348,802 | ) | $ | (12,397,689 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.12 | ) | $ | (0.32 | ) | $ | (0.36 | ) | $ | (1.03 | ) | ||||
| Weighted average number of common shares outstanding | 45,655,387 | 13,733,406 | 45,541,434 | 12,082,176 |
Marker Therapeutics,
Condensed Consolidated Statements of Cash Flows