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Washington, D.C. 20549





Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934


August 10, 2021

Date of Report (Date of earliest event reported)



(Exact name of registrant as specified in its charter)


Delaware 001-37939 45-4497941
(State or other jurisdiction of
(Commission File Number) (IRS Employer Identification No.)


3200 Southwest Freeway

Suite 2500

Houston, Texas

(Address of principal executive offices)   (Zip Code)


(713) 400-6400

Registrant’s telephone number, including area code



(Former name or former address, if changed since last report)


Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:


¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Securities registered pursuant to Section 12(b) of the Act:


Title of each class   Trading
  Name of each exchange on which registered
Common Stock, par value $0.001 per share   MRKR   The Nasdaq Stock Market LLC


Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨


If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨





Item 2.02Results of Operations and Financial Condition.


On August 10, 2021, Marker Therapeutics, Inc. (the “Company”) reported financial results for the quarter ended June 30, 2021 and other recent corporate updates. A copy of the press release is furnished as Exhibit 99.1 to this report and incorporated by reference.


The information in this Item 2.02 of this Current Report on 8-K (including Exhibit 99.1) is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information shall not be deemed incorporated by reference into any other filing with the Securities and Exchange Commission made by the Company, whether made before or after today’s date, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific references in such filing.


Item 9.01.Financial Statements and Exhibits.


(d) Exhibits.


Exhibit No. Description
99.1 Press release, dated August 10, 2021
104 Inline XBRL for the cover page of this Current Report on Form 8-K







Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


  Marker Therapeutics, Inc.
Dated: August 10, 2021 By:   /s/ Anthony Kim
      Anthony Kim
      Chief Financial Officer




Exhibit 99.1




Marker Therapeutics Reports Second Quarter 2021 Operating and Financial Results


Marker continues to enroll patients and activate clinical sites in Phase 2 AML trial following
completion of safety lead-in


Company’s new in-house cGMP manufacturing facility in Houston is fully operational


Houston, TX—August 10, 2021—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, 2021.


“Marker accomplished a number of strategic goals and clinical milestones this quarter, including completing the safety lead-in portion of our company-sponsored Phase 2 trial investigating Marker’s MultiTAA-specific T cell therapy in post-transplant acute myeloid leukemia, or AML,” said Peter L. Hoang, President & CEO of Marker Therapeutics. “We are now enrolling patients as well as activating additional clinical sites in the main portion of the trial. In parallel, we opened a new in-house cGMP manufacturing facility in Houston and recently announced that the facility is fully operational. We look forward to manufacturing study drug at the new facility next quarter, which we expect will yield quality product, reduce manufacturing costs and expand patient access to Marker’s MultiTAA-specific cell therapies.”




·In June 2021, Marker completed the six-patient safety lead-in portion of the Company's Phase 2 trial of MT-401, its lead MultiTAA-specific T cell product candidate, for the treatment of post-transplant AML.

·The Company continues to enroll patients in the main portion of the trial and activate clinical sites across the U.S. The trial is expected to enroll approximately 120 patients in the adjuvant setting and 40 patients with active disease at approximately 20 clinical sites.




·Marker recently announced that the Company’s new cGMP manufacturing facility in Houston, TX, located near the George Bush Intercontinental Airport, is fully operational. The facility will manufacture Marker’s MultiTAA-specific T cell products for the Company’s Phase 2 AML trial as well as future hematological and solid tumor trials, in addition to producing the potential commercial supply of any approved products.







AML Trial Milestones


Complete enrollment of 20 patients in main portion of Phase 2 trial in Q4 2021

Topline readout of Group 2 (active disease) in Q1 2022


Manufacturing Milestones


Manufacture MT-401 at Marker’s new cGMP facility for Phase 2 AML trial in Q3 2021




·Cash Position and Guidance: At June 30, 2021, Marker had cash and cash equivalents of $57.2 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses and capital expenditure requirements into the first quarter of 2023.


·R&D Expenses: Research and development expenses were $7.4 million for the quarter ended June 30, 2021 compared to $4.3 million for the quarter ended June 30, 2020. The increase was primarily attributable to increases in clinical trial and sponsored research expenses and headcount-related expenses due to growth of research and development operations.


·G&A Expenses: General and administrative expenses were $3.6 million for the quarter ended June 30, 2021 compared to $2.5 million for the quarter ended June 30, 2020.


·Net Loss: Marker reported a net loss of $10.9 million for the quarter ended June 30, 2021, compared to a net loss of $6.3 million for the quarter ended June 30, 2020.


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 Statements


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 timing, conduct and success of our clinical trials, including the Phase 2 trial of MT-401, as well as clinical trials conducted by our collaborators; our manufacturing processes and our ability to use our current and planned manufacturing facilities to support clinical and commercial demand; and our future operating expenses and capital expenditure requirements. 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, 
   2021   2020 
Current assets:          
Cash and cash equivalents  $57,221,434   $21,352,382 
Prepaid expenses and deposits   2,801,800    2,057,924 
Other receivables   286    1,000,559 
Total current assets   60,023,520    24,410,865 
Non-current assets:          
Property, plant and equipment, net   10,107,579    3,570,736 
Construction in progress   -    6,789,098 
Right-of-use assets, net   10,339,884    10,844,116 
Total non-current assets   20,447,463    21,203,950 
Total assets  $80,470,983   $45,614,815 
Current liabilities:          
Accounts payable and accrued liabilities  $5,100,943   $6,013,010 
Lease liability   558,657    388,792 
Total current liabilities   5,659,600    6,401,802 
Non-current liabilities:          
Lease liability, net of current portion   11,568,072    11,868,440 
Total non-current liabilities   11,568,072    11,868,440 
Total liabilities   17,227,672    18,270,242 
Commitments and contingencies   -    - 
Stockholders' equity:          
Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively   -    - 
Common stock, $0.001 par value, 150 million shares authorized, 83.1 million and 50.7 million shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively   83,079    50,731 
Additional paid-in capital   439,085,948    383,533,326 
Accumulated deficit   (375,925,716)   (356,239,484)
Total stockholders' equity   63,243,311    27,344,573 
Total liabilities and stockholders' equity  $80,470,983   $45,614,815 





Marker Therapeutics, Inc.

Condensed Consolidated Statements of Operations



   For the Three Months Ended   For the Six Months Ended 
   June 30,   June 30, 
   2021   2020   2021   2020 
Grant income  $-   $466,785   $-   $466,785 
Total revenues   -    466,785    -    466,785 
Operating expenses:                    
Research and development   7,350,035    4,277,052    12,993,064    8,093,670 
General and administrative   3,559,150    2,547,289    6,697,108    5,374,284 
Total operating expenses   10,909,185    6,824,341    19,690,172    13,467,954 
Loss from operations   (10,909,185)   (6,357,556)   (19,690,172)   (13,001,169)
Other income:                    
Change in fair value of warrant liabilities   -    -    -    31,000 
Interest income   2,403    15,857    3,940    142,826 
Net loss  $(10,906,782)  $(6,341,699)  $(19,686,232)  $(12,827,343)
Net loss per share, basic and diluted  $(0.13)  $(0.14)  $(0.28)  $(0.28)
Weighted average number of common shares outstanding, basic and diluted   83,030,470    46,572,739    69,823,729    46,328,561 



Marker Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows



   For the Six Months Ended 
   June 30, 
   2021   2020 
Cash Flows from Operating Activities:          
Net loss  $(19,686,232)  $(12,827,343)
Reconciliation of net loss to net cash used in operating activities:          
Depreciation and amortization   1,032,971    124,627 
Changes in fair value of warrant liabilities   -    (31,000)
Stock-based compensation   3,029,125    2,705,365 
Amortization on right-of-use assets   504,232    96,973 
Changes in operating assets and liabilities:          
Prepaid expenses and deposits   (743,876)   (1,106,072)
Other receivables   1,000,273    52,749 
Accounts payable and accrued expenses   (912,067)   2,770,341 
Lease liability   (130,503)   (187,068)
Net cash used in operating activities   (15,906,077)   (8,401,428)
Cash Flows from Investing Activities:          
Purchase of property and equipment   (780,716)   (1,299,193)
Purchase of construction in progress   -    (2,629,141)
Net cash used in investing activities   (780,716)   (3,928,334)
Cash Flows from Financing Activities:          
Proceeds from issuance of common stock, net   52,552,758    - 
Proceeds from exercise of warrants   -    550,000 
Proceeds from exercise of stock options   3,087      
Net cash provided by financing activities   52,555,845    550,000 
Net increase (decrease) in cash   35,869,052    (11,779,762)
Cash and cash equivalents at beginning of the period   21,352,382    43,903,949 
Cash and cash equivalents at end of the period  $57,221,434   $32,124,187 








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