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
August 15, 2019
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 7.01 | Regulation FD Disclosure. |
On August 15, 2019, Marker Therapeutics, Inc. (the “Company”) issued a press release announcing the appointment of Nadia Agopyan, Ph.D., RAC as Vice President of Regulatory Affairs of the Company.
The information in this Item 7.01 of this Current Report on 8-K 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 August 15, 2019. |
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: August 15, 2019 | By: | /s/ Anthony Kim | ||||
| Anthony Kim | ||||||
| Chief Financial Officer | ||||||
Exhibit 99.1
Marker Therapeutics Appoints Nadia Agopyan, Ph.D., RAC as
Vice President of Regulatory Affairs
Houston, TX – August 15, 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 announced the appointment of Nadia Agopyan, Ph.D., RAC as Vice President of Regulatory Affairs, effective August 15.
“We are pleased to welcome a professional of Nadia’s caliber and senior leadership experience to Marker,” said Peter L. Hoang, President & CEO of Marker. “With more than 15 years of industry knowledge in regulatory affairs and clinical development, Nadia will be instrumental in helping shape our regulatory strategy as we prepare to initiate the first Marker-sponsored trial with MultiTAA therapy in patients with post-transplant acute myeloid leukemia.”
Dr. Agopyan joins Marker from Kite Pharma, a subsidiary of Gilead Sciences, where she served as Director of Regulatory Affairs, Global Regulatory Lead. In this role, she was responsible for overseeing the global marketing authorization and lifecycle management of the YESCARTA® franchise, defining the global regulatory strategies for CAR T cell products in lymphoma/leukemia, and overseeing clinical programs from Phase 1-4 development, as well as all operational aspects of global regulatory submissions. Previously, she served as Global Regulatory Lead at Baxter Biosciences leading Vonvendi (recombinant von Willebrand Factor) approval/launch, Senior Director Regulatory Affairs at Ambit Biosciences, and Director Regulatory Affairs at Cougar Biotechnology, a unit of Johnson and Johnson Ortho Biotech Oncology, where she led the approval of Zytiga, abiraterone acetate, for the treatment of patients with metastatic castrate-resistant prostate cancer.
Earlier in her career, Dr. Agopyan served in various roles at biotechnology companies such as Amgen, CATO Research and Allelix Biopharmaceuticals and as Assistant Professor in academia including Duke University and University of Toronto.
Dr. Agopyan earned her Ph.D. and B.Sc. in Neurophysiology from McGill University (Montreal Canada).
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 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 trials.
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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; 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.
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Contacts
Investor
Solebury Trout
Chiara Russo
(617) 221-9197
crusso@soleburytrout.com
Media
Solebury Trout
Amy Bonanno
(914) 450-0349
abonanno@soleburytrout.com
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