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Marker Therapeutics Reports First Quarter 2019 Operating and Financial Results -Company on track to submit IND for Phase 2 AML clinical trial in the third quarter, with first patient enrolled by year end- -MultiTAA T cel

Key Takeaway: Therapeutics Reports First Quarter 2019 Operating and Financial Results on track to submit IND for Phase 2 AML clinical trial in the third quarter, with first patient enrolled by year end- T cell therapies continue to generate positive clinical results across various indication

Full Press Release Details

Therapeutics Reports First Quarter 2019 Operating and Financial Results
on track to submit IND for Phase 2 AML clinical trial in the third quarter, with first patient enrolled by year end-
T cell therapies continue to generate positive clinical results across various indications in investigator-sponsored trials-
to report update from Phase 1/2 clinical trial in pancreatic cancer in Q3 2019-
TX -May 9th, 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 first quarter ended March 31, 2019.
to make significant progress this quarter. Based on our early interactions with the U.S. FDA, we are confident in our submission
package for our IND for post-transplant acute myeloid leukemia (AML). In light of the feedback from the FDA, we plan to submit
an IND for a Phase 2 clinical trial in the third quarter, which should enable us to enroll the first
patient by the end of the year," said Peter L. Hoang, President & CEO of
Marker Therapeutics. "Depending on the results and upon further discussions with the FDA, we believe that if results
are positive, this has the potential to serve as a pivotal trial-particularly if results are consistent with data generated
to date from our MultiTAA therapies in investigator-sponsored trials. We look forward to initiating our first company-sponsored
trial in such an important disease area, for which there are limited treatment options. Additionally,
we anticipate reporting an update from our solid tumor program in pancreatic cancer in the third quarter."
Targeted (MultiTAA) T Cell Therapies
on interactions with the U.S. Food and Drug Administration (FDA) on the clinical trial design of the planned Marker-sponsored Phase
2 clinical trial in post-transplant AML, the Company remains on track to submit an Investigational New Drug (IND) application in
the third quarter, and anticipates first patient enrolled by the end of 2019. The multicenter trial will evaluate clinical efficacy
of Marker's MultiTAA-specific T cells in patients with AML in both the adjuvant and active disease setting, following an
allogeneic hematopoietic stem cell transplant (HSCT). The dose to be administered in the trial is expected to be the maximum tolerated
dose currently determined in the Baylor College of Medicine-sponsored Phase 1 trial. In the adjuvant setting, patients will be
randomized to either MultiTAA therapy at approximately 90 days post-transplant or standard of care observation, while the active
disease patients will receive MultiTAA T cells as part of a single-arm group at approximately 90 days post-transplant.
In several ongoing investigator-sponsored
Phase 1 clinical trials led by Baylor College of Medicine (BCM), Marker's MultiTAA therapies have demonstrated the potential
to mediate a meaningful anti-tumor effect, as well as significant in vivo expansion of T cells. Across all hematological
indications studied in these trials-including AML, lymphoma, acute lymphoblastic leukemia (ALL), and multiple myeloma-MultiTAA
therapy has appeared to be well-tolerated, with no incidence of cytokine release syndrome, neurotoxicity or any other serious adverse
events related to the therapy.
Marker plans to report additional
interim data from BCM's ongoing Phase 1/2 clinical trial in pancreatic cancer in the third quarter of 2019. The
Phase 1/2 trial is a three-arm trial which includes chemo-responsive patients (Arm A), chemo-refractory patients (Arm B)
and an exploratory arm for patients who have surgically-resectable disease (Arm C). Patients in the chemo-responsive arm have completed
at least three months of standard-of-care chemotherapy, and are receiving up to six administrations of MultiTAA T cells in alternation
with chemotherapy. Patients in the chemo-refractory arm are either ineligible for chemotherapy or have progressed on chemotherapy,
and are receiving up to six doses of MultiTAA T cells as a monotherapy. The surgically-resectable patients are receiving a dose
of T cells prior to surgical resection which allows Marker to assess the tumor samples for T-cell infiltration, epitope spreading
and other important characteristics. These patients are eligible to receive five additional doses of T cells after surgical resection.
T Cell Based Vaccines
January 2019, the Company has completed enrollment in its Phase 2 clinical trial in ovarian cancer using TPIV200 as a maintenance
therapy for patients in their first remission after surgery and platinum-based chemotherapy, with a total of 120 patients enrolled,
randomized, and treated at 17 clinical sites. The trial completed enrollment six months faster than anticipated and the Company
expects to reach its planned interim analysis trigger of 55 patients who have progressed before the end of 2019 and to report the
results of this interim analysis in the fourth quarter of 2019.
Company reported initial findings from its dose-finding, four-arm Phase 2 clinical trial in triple negative breast cancer, including
low- and high-dose TPIV200 with or without cyclophosphamide. Of 27 patients evaluated for immunogenicity, 26 showed significant
immune response to the vaccine treatment. Of 80 patients treated at 11 clinical sites, 14 have shown disease progression, as of
April 30, 2019, following treatment with TPIV200.
loss for the quarter ended March 31,
2019 was $5.3 million compared to a net loss of $3.2 million for the quarter ended March 31, 2018.
and development expenses were $2.8 million for the quarter ended March 31, 2019, an increase of $1.2 million, compared to $1.6
million for the quarter ended March 31, 2018. The increase was primarily attributable to increased headcount-related expenses,
stock-based compensation expenses and consulting expenses resulting from the expansion of our internal infrastructure as we advance
the clinical development of our MultiTAA T cell product candidates.
and administrative expenses were $2.8 million for the quarter ended March 31, 2019, an increase of $1.2 million, compared to $1.6
million for the quarter ended March 31, 2018. The increase was primarily attributable to an increase in general and administrative
headcount and stock-based compensation expenses.
March 31, 2019, Marker had cash and cash equivalents of $57.7 million. The Company believes that its existing cash and cash equivalents
will fund the Company's current operations into late 2020.
UPCOMING NEAR-TERM POTENTIAL MILESTONES
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 cells 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 therapeutic
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 and ovarian cancers and the HER2/neu program (TPIV100/110) for breast cancer, currently in Phase 2 clinical
For additional information, please call
toll free at (904) 862-6490 or visit: markertherapeutics.com
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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 and development activities 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
Marker Therapeutics, Inc.
Consolidated Balance Sheets
March 31, December 31,
2019 2018
ASSETS
Current assets:
Cash and cash equivalents $ 57,706,579 $ 61,746,748
Prepaid expenses and deposits 216,433 141,717
Interest receivable 112,200 108,177
Total current assets 58,035,212 61,996,642
Non-current assets:
Property, plant and equipment, net 360,280 147,668
Right-of-use assets, net 592,422 -
Total non-current assets 952,702 147,668
TOTAL ASSETS $ 58,987,914 $ 62,144,310
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities $ 2,694,019 $ 2,754,572
Lease liability 189,791 -
Warrant liability 58,000 49,000
Total current liabilities 2,941,810 2,803,572
Non-current liabilities:
Lease liability, net of current portion 435,192 -
Total non-current liabilities 435,192 -
Total liabilities 3,377,002 2,803,572
COMMITMENTS AND CONTINGENCIES
Stockholders' equity:
Preferred stock - $0.001 par value, 5 million shares authorized at March 31, 2019 and December 31, 2018, respectively
Series A, $0.001 par value, 1.25 million shares designated, 0 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively - -
Series B, $0.001 par value, 1.5 million shares designated, 0 shares issued and outstanding as of March 31, 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 March 31, 2019 and December 31, 2018, respectively 45,484 45,440
Additional paid-in capital 366,989,803 365,400,748
Accumulated deficit (311,424,375 ) (306,105,450 )
Total stockholders' equity 55,610,912 59,340,738
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 58,987,914 $ 62,144,310
Marker Therapeutics, Inc.
Consolidated Statements of Operations
For the Three Months Ended
March 31,
2019 2018
Operating expenses:
Research and development $ 2,832,695 $ 1,599,550
General and administrative 2,805,775 1,597,936
Total operating expenses 5,638,470 3,197,486
Loss from operations (5,638,470 ) (3,197,486 )
Other income (expense):
Change in fair value of warrant liabilities (9,000 ) 1,000
Interest income 328,545 -
Net loss $ (5,318,925 ) $ (3,196,486 )
Net loss per share, Basic and Diluted $ (0.12 ) $ (0.30 )
Weighted average number of common shares outstanding 45,465,754 10,622,420
Last updated: May 9, 2019