Form 8-K

8-K — Marker Therapeutics, Inc.

Accession: 0001104659-26-116720

Filed: 2026-10-19

Period: 2026-10-19

CIK: 0001094038

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm2627740d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2627740d1_ex99-1.htm)

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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

October 19, 2026

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.)

2450 Holcombe Blvd, TMC Partners Office 1.311

Houston,

Texas

77021

(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

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 8.01. Other Information

On October19, 2026, Marker Therapeutics, Inc. (“Marker”

or the “Company”) issued a press release announcing that it was awarded a $2.6 Million Grant by the Food & Drug

Administration (“FDA”) under the FDA’s Orphan Products development program to advance the Company’s lead

investigational MAR-T cell therapy, MT-601, in patients with locally advanced unresectable pancreatic cancer.

A copy of the Press Release is attached hereto

as Exhibit 99.1 and is incorporated by reference herein.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.

Description

99.1

Press release, dated October 19, 2026.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

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: October 19, 2026

By:

/s/ Juan Vera

Juan Vera

President and Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2627740d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Marker Therapeutics Awarded $2.6 Million FDA

Orphan Products Development Grant to Advance MT-601 in Pancreatic Cancer

Competitive selection reinforces independent

recognition of the scientific rationale and development potential of Marker’s multi-antigen recognizing T cell platform

Houston, TX – October 19, 2026 –

Marker Therapeutics, Inc. (Nasdaq: MRKR), is a clinical-stage immuno-oncology company developing multi-antigen recognizing (MAR)-T cell

therapies under an exclusive worldwide license from Baylor College of Medicine for patients with cancer. Today, Marker announced that

the Company has been awarded $2.6 million from the U.S. Food and Drug Administration (FDA) through its Orphan Products Clinical Trials

grants program. The funding will support a Phase 1 clinical study evaluating the Company’s lead investigational MAR-T cell therapy,

MT-601, in patients with locally advanced unresectable pancreatic cancer.

The FDA’s Orphan Products Clinical Trials

grants program is a highly competitive federal funding initiative designed to support clinical research that may advance the development

of treatments for rare diseases. Applications undergo independent scientific peer review, including evaluation of scientific rationale,

clinical trial design, feasibility, and potential contribution to product development. In fiscal year 2026, the FDA received 66 applications

and selected six projects for funding.

“We are honored to be among the six recipients

selected for funding through the FDA’s highly competitive Orphan Products Clinical Trials grants program,” said Juan Vera,

MD, President and Chief Executive Officer of Marker Therapeutics. “This award represents meaningful independent recognition and

external validation of the scientific rationale underlying our MAR-T platform and its potential application in pancreatic cancer. Our

technology is designed to recognize multiple tumor-associated antigens, offering a differentiated approach to addressing tumor heterogeneity

and antigen escape, while maintaining the favorable safety profile observed in more than 200 patients treated across our clinical programs

in hematologic malignancies and solid tumors. The additional non-dilutive funding from the FDA will further support our efforts to advance

MT-601 in an area of significant unmet medical need.”

The FDA grant award further expands Marker’s

track record of securing competitive federal and state research funding to support the development of the Company’s innovative MAR-T

cell therapies. In addition to the FDA Orphan Products Clinical Trials grant, Marker has secured non-dilutive funding from the National

Institutes of Health (NIH) Small Business Innovation Research (SBIR) program and the Cancer Prevention and Research Institute of Texas

(CPRIT) to support the pancreatic cancer program.

The clinical development of MT-601 in pancreatic

cancer builds on encouraging results from a Phase 1/2 study conducted at Baylor College of Medicine and published in Nature Medicine

earlier this year (Musher BL, Vasileiou S, Smaglo BG et al. Nat Med. 2026). The findings also received national coverage on Good Morning

America (January 22, 2026). The study demonstrated a favorable safety profile and disease control rate of 84.6% in patients receiving

multi-antigen targeted T cells in combination with frontline chemotherapy, with a median duration of response of 7.5 months and a median

overall survival of 14.1 months.

“These encouraging clinical findings provide

a strong foundation for the development of MT-601 in pancreatic cancer, particularly given the limited outcomes with current treatment

options,” commented Dr. Vera. “For context, a recent clinical trial evaluating standard frontline chemotherapy regimens in

metastatic pancreatic cancer reported median overall survival of 9.2-11.1 months and median duration of response of 5-7.3 months. Through

our company-sponsored study, we aim to build on our previous observations from the Baylor study by incorporating an expanded antigen-targeting

profile, higher T cell doses, and lymphodepletion to potentially enhance T cell expansion, persistence, and clinical outcomes. The FDA

grant provides important non-dilutive funding and further recognition of the scientific rationale and development potential of our program.

We anticipate clinical initiation of our study in pancreatic cancer in the first quarter of 2027 and look forward to advancing MT-601

as a potential treatment option for patients with a significant unmet medical need.”

About the FDA Orphan Products Clinical Trials

Grants Program

The U.S. Food and Drug Administration's (FDA)

Orphan Products Clinical Trials grants program supports clinical research evaluating the safety and efficacy of investigational products

for rare diseases and conditions. The program provides competitive, non-dilutive funding to advance promising therapies through clinical

development. Applications undergo a rigorous scientific peer-review process assessing scientific merit, clinical study design, feasibility,

and potential impact on patients with unmet medical needs. Since its inception in 1983, the program has supported clinical research contributing

to the approval of more than 85 medical products for rare diseases.

About MAR-T cells

The multi-antigen recognizing (MAR) T cell platform

(formerly known as multiTAA-specific T cells) is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific

T cells from a patient's/donor’s blood capable of recognizing a broad range of tumor antigens. Unlike other T cell therapies, MAR-T

cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility

of tumor escape. Since MAR-T cells are not genetically engineered, Marker believes that its product candidates will be easier and less

expensive to manufacture, with an improved safety profile compared to current engineered T cell approaches and may provide patients with

meaningful clinical benefits.

About MT-601

The Company’s lead product, MT-601, is a

multi-antigen recognizing (MAR) T cell product that utilizes a non-genetically modified approach that specifically targets six different

tumor antigens upregulated in tumor cells (Survivin, PRAME, WT-1, NY-ESO-1, SSX-2, MAGEA-4). Marker is currently investigating MT-601

in the Phase 1 APOLLO trial (clinicaltrials.gov identifier: NCT05798897) for the treatment of patients with lymphoma who have relapsed

after or are ineligible to receive anti-CD19 CAR-T cell therapies. Due to the broad target recognition profile of MT-601, the Company

is exploring its potential application beyond lymphoma in patients with pancreatic cancer. The Company’s pancreatic cancer program

is supported by the National Cancer Institute of the National Institutes of Health (Award Number R44CA295168), the Cancer Prevention and

Research Institute of Texas (CPRIT, Award Number DP250150), and the Food and Drug Administration Orphan Products Clinical Trials Grants

program (Award Number 1R01FD008756-01).

About Marker Therapeutics, Inc.

Marker Therapeutics, Inc. is a Houston, TX-based

clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment

of hematological malignancies and solid tumors. The Company was founded at Baylor College of Medicine, and clinical trials that enrolled

more than 200 patients across various hematological and solid tumor indications showed that the Company’s autologous and allogeneic

MAR-T cell products were well tolerated and demonstrated durable clinical responses. Marker’s goal is to introduce novel T cell

therapies to the market and improve patient outcomes. To achieve these objectives, the Company prioritizes the preservation of financial

resources and focuses on operational excellence. Marker’s unique T cell platform is strengthened by non-dilutive funding from U.S.

state and federal agencies supporting cancer research, including the National Cancer Institute of National Institutes of Health, U.S.

Department of War, the FDA Orphan Drug program and the Cancer Prevention Research Institute of Texas (CPRIT).

To receive future press releases via email, please

visit: https://www.markertherapeutics.com/email-alerts.

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; and the timing, conduct, interim results announcements and outcomes

of our clinical trials of our product candidates, including neldaleucel (MT-601) for the treatment of patients with pancreatic

cancer or lymphoma. 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 its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press

release except as may be required by law.

Media and Investor Contact

Marker Therapeutics, Inc.

+1 (713) 400-6400

investor.relations@markertherapeutics.com

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