UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
March 12, 2020
Date of Report (Date of earliest event reported)
MARKER THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-37939 | 45-4497941 |
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
|
3200 Southwest Freeway Suite 2240 Houston, Texas |
77027 | |
| (Address of principal executive offices) | (Zip Code) |
(713) 400-6400
Registrant’s telephone number, including area code
N/A
(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 Symbol(s) |
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 2.02 | Results of Operations and Financial Condition. |
On March 12, 2020, Marker Therapeutics, Inc. (the “Company”) reported financial results for the quarter and year ended December 31, 2019 and other recent corporate updates. A copy of the press release is furnished as Exhibit 99.1 to this report.
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 issued on March 12, 2020. |
SIGNATURES
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: March 12, 2020 | By: | /s/ Anthony Kim | ||||
| Anthony Kim | ||||||
| Chief Financial Officer | ||||||
Exhibit 99.1
Marker Therapeutics Reports Full Year 2019 Operating and Financial Results
Houston, TX—March 12, 2020—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 full year ended December 31, 2019.
“With a clear path forward for our Phase 2 trial in AML patients with our novel T cell therapy, and the cash resources needed to advance our studies, 2020 is shaping up to be a busy and productive year for our Company,” said Peter L. Hoang, President & CEO of Marker Therapeutics. “Based on promising results observed with our MultiTAA T cell therapy across various forms of cancer in investigator-sponsored trials, we are also evaluating opportunities for additional Marker-sponsored trials.”
PROGRAM UPDATES
Multi-Antigen Targeted (MultiTAA) T Cell Therapies
Marker Prepares to Initiate Phase 2 AML Trial
In February 2020, the Company announced an updated study protocol for its Phase 2 clinical trial of MultiTAA T cell therapy in post-allogeneic hematopoietic stem cell transplant patients with acute myeloid leukemia (AML) in both the adjuvant and active disease setting. Under an amended trial design, the U.S. Food and Drug Administration (FDA) has permitted the trial to move forward with the safety lead-in. During the second half of 2020, Marker expects to complete enrollment of the first three patients and to submit the information required by the FDA to lift a partial clinical hold during the second half of 2020. The Company does not currently expect the partial clinical hold to significantly impact site or patient enrollment.
Investigator-Sponsored Trials with MultiTAA T Cell Therapy Continue to Generate Positive Results
Marker previously reported interim data from an ongoing Phase 1/2 clinical trial of MultiTAA T cell therapy for the treatment of patients with pancreatic adenocarcinoma being conducted by its partners at the Baylor College of Medicine (BCM). In this trial, the modified T cells exhibited activity against both targeted tumor-associated antigens (TAA) and non-targeted TAAs, indicating induction of antigen spreading. To date, there has not been any cytokine release syndrome or neurotoxicity observed in this trial.
T Cell-Based Vaccines
Phase 2 Triple Negative Breast Cancer Trial Progressing
Marker’s T cell-based vaccine program in triple negative breast cancer has delivered the following results as of September 30, 2019:
| · | Based on a preliminary analysis of 34 patients enrolled in the triple negative breast cancer trial, 31 patients showed meaningful immune response to vaccine treatment; | |
| · | Of 80 patients treated at 11 clinical sites, 16 have shown disease progression following treatment with TPIV200. |
Phase 2 Platinum-Sensitive Advanced Ovarian Cancer Trial
| · | As previously announced, Marker has discontinued the development of TPIV200 in patients with platinum-sensitive advanced ovarian cancer based on an unblinded review of interim results from the trial conducted by the Data Safety Monitoring Board (DSMB). While the DSMB did not express safety concerns, Marker elected to discontinue the trial as it did not meet the threshold for probability of clinical benefit based upon the Company’s pre-specified criteria. |
FINANCING UPDATE
| · | On March 2, 2020, Marker announced that the Company entered into a Common Stock Purchase Agreement of up to $30 million with Aspire Capital Fund, LLC, a Chicago-based institutional investor and long-term Marker shareholder. |
FULL YEAR 2019 FINANCIAL RESULTS
Cash Position and Guidance: At December 31, 2019, Marker had cash and cash equivalents of $43.9 million. The Company believes that the financial flexibility provided by the Aspire transaction will enable the cash runway to extend beyond the second quarter of 2021.
R&D Expenses: Research and development expenses were $12.8 million for the year ended December 31, 2019 compared to $8.0 million for the year ended December 31, 2018. The increase was primarily attributable to increases in personnel-related expenses relating to the build-up of Marker’s internal infrastructure, an increase in clinical consulting and professional expenses relating to preparation of the AML trial, an increase in process development expenses, offset by a decrease in clinical trial expenses due to the stages of ongoing clinical trials and the decreased number of active patients in such trials.
G&A Expenses: General and administrative expenses were $10.0 million for the year ended December 31, 2019, compared to $24.4 million for the year ended December 31, 2018. The decrease was primarily attributable to a decrease of $12.8 million in stock-based compensation expenses due to executive stock option grants issued in fiscal year 2018, as well as a decrease in merger-related expenses during fiscal year 2019, offset by increased expenses in headcount-related and legal and other professional expenses.
Net Loss: Marker reported a net loss of $21.4 million for the year ended December 31, 2019, compared to a net loss of $148.0 million for the year ended December 31, 2018.
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
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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 use of proceeds from any sales
under the Common Stock Purchase Agreement with Aspire Capital; our research, development and regulatory activities and expectations
relating to our non-engineered multi-tumor antigen specific T cell therapies and 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, Inc.
Consolidated Balance Sheets
| December 31, | December 31, | |||||||
| 2019 | 2018 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 43,903,949 | $ | 61,746,748 | ||||
| Prepaid expenses and deposits | 1,526,442 | 141,717 | ||||||
| Interest receivable | 56,189 | 108,177 | ||||||
| Total current assets | 45,486,580 | 61,996,642 | ||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | 417,528 | 147,668 | ||||||
| Right-of-use assets, net | 455,174 | - | ||||||
| Total non-current assets | 872,702 | 147,668 | ||||||
| Total assets | $ | 46,359,282 | $ | 62,144,310 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 1,757,680 | $ | 2,754,572 | ||||
| Lease liability | 204,132 | - | ||||||
| Warrant liability | 31,000 | 49,000 | ||||||
| Total current liabilities | 1,992,812 | 2,803,572 | ||||||
| Non-current liabilities: | ||||||||
| Lease liability, net of current portion | 280,247 | - | ||||||
| Total non-current liabilities | 280,247 | - | ||||||
| Total liabilities | 2,273,059 | 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 December 31, 2019 and 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 December 31, 2019 and 2018, respectively | 45,728 | 45,440 | ||||||
| Additional paid-in capital | 371,573,909 | 365,400,748 | ||||||
| Accumulated deficit | (327,533,414 | ) | (306,105,450 | ) | ||||
| Total stockholders' equity | 44,086,223 | 59,340,738 | ||||||
| Total liabilities and stockholders' equity | $ | 46,359,282 | $ | 62,144,310 | ||||
Marker Therapeutics, Inc.
Consolidated Statements of Operations
| For the Years Ended | ||||||||
| December 31, | ||||||||
| 2019 | 2018 | |||||||
| Revenues: | ||||||||
| Grant income | $ | 213,194 | $ | 205,994 | ||||
| Total revenues | 213,194 | 205,994 | ||||||
| Operating expenses: | ||||||||
| Research and development - intellectual property acquired | - | 116,044,886 | ||||||
| Research and development | 12,764,804 | 7,952,870 | ||||||
| General and administrative | 9,977,196 | 24,379,871 | ||||||
| Total operating expenses | 22,742,000 | 148,377,627 | ||||||
| Loss from operations | (22,528,806 | ) | (148,171,633 | ) | ||||
| Other income (expense): | ||||||||
| Change in fair value of warrant liabilities | 18,000 | (40,000 | ) | |||||
| Interest income | 1,082,842 | 253,723 | ||||||
| Net loss | $ | (21,427,964 | ) | $ | (147,957,910 | ) | ||
| Net loss per share, basic and diluted | $ | (0.47 | ) | $ | (7.75 | ) | ||
| Weighted average number of common shares outstanding | 45,587,734 | 19,091,926 | ||||||
Marker Therapeutics, Inc.
Consolidated Statements of Cash Flows
| For the Years Ended | ||||||||
| December 31, | ||||||||
| 2019 | 2018 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (21,427,964 | ) | $ | (147,957,910 | ) | ||
| Reconciliation of net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 105,123 | - | ||||||
| Changes in fair value of warrant liabilities | (18,000 | ) | 40,000 | |||||
| Stock-based compensation | 5,356,972 | 16,350,592 | ||||||
| Amortization on right-of-use assets | 181,459 | - | ||||||
| Research and development - intellectual property acquired | - | 116,044,886 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and deposits | (1,384,725 | ) | (90,567 | ) | ||||
| Interest receivable | 51,988 | (108,177 | ) | |||||
| Accounts payable and accrued expenses | (963,967 | ) | 1,241,260 | |||||
| Lease liability | (185,179 | ) | - | |||||
| Net cash used in operating activities | (18,284,293 | ) | (14,479,916 | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Purchase of property and equipment | (374,983 | ) | (147,668 | ) | ||||
| Net cash used in investing activities | (374,983 | ) | (147,668 | ) | ||||
| Cash Flows from Financing Activities: | ||||||||
| Proceeds from issuance of common stock and warrants in private placement, net of offering costs | - | 66,945,000 | ||||||
| Proceeds from exercise of stock options | 57,744 | 18,125 | ||||||
| Proceeds from exercise of warrants, net of offering costs | 758,733 | 4,353,628 | ||||||
| Repurchase of common stock to pay for employee withholding taxes | - | (71,710 | ) | |||||
| Net cash provided by financing activities | 816,477 | 71,245,043 | ||||||
| Net (decrease) increase in cash | (17,842,799 | ) | 56,617,459 | |||||
| Cash and cash equivalents at beginning of year | 61,746,748 | 5,129,289 | ||||||
| Cash and cash equivalents at end of year | $ | 43,903,949 | $ | 61,746,748 | ||||
Contacts
Investor
Solebury Trout
Chiara Russo
(617) 221-9197
crusso@soleburytrout.com
Media
Solebury Trout
Amy Bonanno
(914) 450-0349
abonanno@soleburytrout.com