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."


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.


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.


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 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




     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


     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


                                                                For the Three Months Ended                                       For the Six Months Ended

          June 30,                                 
                June 30,


                                                           2020                                     2019               2020                                           2019



     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


                                                                                                        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.