Marker Therapeutics Reports Second Quarter 2020 Operating and Financial Results
HOUSTON, Aug. 10, 2020 /PRNewswire/ -- 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, 2020.
"We continue to make progress toward advancing our planned Phase 2 trial with our novel MultiTAA-specific T cell therapy in patients with acute myeloid leukemia, or AML," said Peter L. Hoang, President & CEO of Marker Therapeutics. "While the COVID-19 pandemic has impacted hospital systems globally, we have augmented our process development for our MT-401 product, continued the buildout of our manufacturing facility and added further clinical sites for our Phase 2 AML trial. With a novel cell therapy product candidate that has demonstrated the ability to induce broad and durable immune responses in earlier clinical studies, Marker remains well-positioned to provide a potential treatment option for patients suffering from this devastating disease."
PROGRAM UPDATES
Multi-Antigen Targeted (MultiTAA) T Cell Therapies
Phase 2 AML Trial Update
The Company continues to identify and add clinical trial sites in preparation for the Phase 2 AML trial initiation. The study is currently subject to a partial clinical hold on the use of a new reagent in the manufacturing process until the FDA reviews and accepts the final data and certificates of analysis for the new reagent. The alternate supplier has been delayed in providing the reagent but expects to ship the reagent to Marker in Q3. Once Marker receives the reagent and completes the required analyses for FDA, the Company will provide additional clarification around the timing of the AML trial enrollment.
USAN Council Approval of "Zelenoleucel" for MT-401
Marker recently announced that the United States Adopted Names (USAN) Council approved "zelenoleucel" as the nonproprietary (generic) name for MT-401, a MultiTAA-specific T cell product candidate for the treatment of patients with AML following allogeneic stem cell transplant in both adjuvant and active disease settings.
Pancreatic Cancer Data Presented During ASCO
Updated clinical results from an ongoing investigator-sponsored Phase 1 trial led by the Baylor College of Medicine, evaluating the Company's MultiTAA-specific T cell therapy in patients with advanced or metastatic pancreatic adenocarcinoma, were presented during the 2020 American Society of Clinical Oncology (ASCO) Virtual Annual Meeting. Data from a cohort of patients receiving MultiTAA-specific T cell therapy in combination with standard-of-care chemotherapy in the first-line setting (Arm A) were presented.
-- Out of the 13 evaluable patients (best overall response): four patients
experienced objective responses, including one complete response; six
patients experienced stable disease; one patient experienced a mixed
response (some lesions increased in size and others decreased for a net
zero change in size of tumor lesions).
-- Patients had durable cancer control with 9 of the 13 patients exceeding
historical control of overall survival.
-- Evidence of epitope-spreading was observed in all responders, suggesting
that the MultiTAA T cell therapy triggered the recruitment of a broader
endogenous immune system response for improved anti-tumor activity.
-- No infusion-related reactions, cytokine release syndrome or
neurotoxicity was observed.
BUSINESS UPDATES
On June 30, 2020, Marker announced that the Company executed a lease agreement to establish an in-house cGMP manufacturing facility in Houston, TX. The facility is expected to be completed by year-end and operational in 2021. Marker will continue to manufacture its MultiTAA-specific T cell therapy at the Baylor College of Medicine to support the Company-sponsored AML trial until the in-house cGMP manufacturing facility is operational.
SECOND QUARTER 2020 FINANCIAL RESULTS
Cash Position and Guidance: At June 30, 2020, Marker had cash and cash equivalents of $32.1 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses and capital expenditure requirements into Q2 2021.
R&D Expenses: Research and development expenses were $4.3 million for the quarter ended June 30, 2020, compared to $3.2 million for the quarter ended June 30, 2019.
G&A Expenses: General and administrative expenses were $2.5 million for the quarter ended June 30, 2020, compared to $2.7 million for the quarter ended June 30, 2019.
Net Loss: Marker reported a net loss of $6.3 million for the quarter ended June 30, 2020, compared to a net loss of $5.6 million for the quarter ended June 30, 2019.
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.
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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; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; the impact of the COVID-19 pandemic; 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. 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,
2020 2019
(Unaudited)
(Audited)
---
ASSETS
Current assets:
Cash and cash equivalents $32,124,187 $43,903,949
Prepaid expenses and deposits 2,632,514 1,526,442
Interest receivable 3,440 56,189
Total current assets 34,760,141 45,486,580
Non-current assets:
Property, plant and equipment,
net 1,592,094 417,528
Construction in progress 2,629,141
Right-of-use assets, net 9,542,228 455,174
Total non-current assets 13,763,463 872,702
Total assets $48,523,604 $46,359,282
LIABILITIES AND STOCKHOLDERS'
EQUITY
Current liabilities:
Accounts payable and accrued
liabilities $4,528,021 $1,757,680
Lease liability 456,065 204,132
Warrant liability 31,000
Total current liabilities 4,984,086 1,992,812
Non-current liabilities:
Lease liability, net of
current portion 9,025,273 280,247
Total non-current liabilities 9,025,273 280,247
Total liabilities 14,009,359 2,273,059
Commitments and contingencies
Stockholders' equity:
Preferred stock -$0.001 par
value, 5 million shares
authorized and 0 shares
issued and outstanding at
June 30, 2020 and December
31, 2019, respectively
Common stock, $0.001 par
value, 150 million shares
authorized, 46.6 million and
45.7 million shares issued
and outstanding as of June
30, 2020 and December 31,
2019, respectively 46,617 45,728
Additional paid-in capital 374,828,385 371,573,909
Accumulated deficit (340,360,757) (327,533,414)
Total stockholders' equity 34,514,245 44,086,223
Total liabilities and
stockholders' equity $48,523,604 $46,359,282
Marker Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
For the Three Months Ended For the Six Months Ended
June 30,
June 30,
---
2020 2019 2020 2019
---
Revenues:
Grant income $466,785
$ - $466,785
$ -
Total revenues 466,785 466,785 -
Operating expenses:
Research and development 4,277,052 3,152,445 8,093,670 5,985,140
General and administrative 2,547,289 2,721,120 5,374,284 5,526,895
---
Total operating expenses 6,824,341 5,873,565 13,467,954 11,512,035
---
Loss from operations (6,357,556) (5,873,565) (13,001,169) (11,512,035)
Other income (expense):
Change in fair value of
warrant liabilities (7,000) 31,000 (16,000)
Interest income 15,857 310,174 142,826 638,719
Net loss $(6,341,699) $(5,570,391) $(12,827,343) $(10,889,316)
Net loss per share, basic
and diluted $(0.14) $(0.12) $(0.28) $(0.24)
Weighted average number of
common shares outstanding 46,572,739 45,501,078 46,328,561 45,483,513
===
Marker Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
For the Six Months Ended
June 30,
2020 2019
---
Cash Flows from Operating Activities:
Net loss $(12,827,343) $(10,889,316)
Reconciliation of net loss to net cash used in operating activities:
Depreciation and amortization 124,627 39,811
Changes in fair value of warrant
liabilities (31,000) 16,000
Stock-based compensation 2,705,365 2,889,243
Amortization on right-of-use
assets 96,973 89,178
Changes in operating assets and liabilities:
Prepaid expenses and deposits (1,106,072) (349,750)
Interest receivable 52,749 10,023
Accounts payable and accrued
expenses 2,770,341 225,135
Lease liability (187,068) (89,907)
Net cash used in operating
activities (8,401,428) (8,059,583)
---
Cash Flows from Investing Activities:
Purchase of property and
equipment (1,299,193) (305,382)
Purchase of construction in
progress (2,629,141)
Net cash used in investing
activities (3,928,334) (305,382)
---
Cash Flows from Financing Activities:
Proceeds from exercise of stock
options 57,744
Proceeds from exercise of
warrants 550,000 5,379
Net cash provided by financing
activities 550,000 63,123
---
Net decrease in cash (11,779,762) (8,301,842)
Cash and cash equivalents at
beginning of the period 43,903,949 61,746,748
---
Cash and cash equivalents at end
of the period $32,124,187 $53,444,906
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SOURCE Marker Therapeutics, Inc.
