Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage
immuno-oncology company focusing on developing next-generation T
cell-based immunotherapies for the treatment of hematological
malignancies and solid tumor indications, today announced it has
entered into a securities purchase agreement for a private
placement resulting in gross proceeds of $16.1 million, before
deducting placement agent fees and other expenses.
Proceeds from the financing will, among other
uses, support the clinical advancement of the Company’s Phase 1
APOLLO study investigating MT-601, a multi-antigen recognizing
(MAR) T cell product (formerly known as multiTAA-specific T cells),
in patients with lymphoma who have relapsed after anti-CD19
chimeric antigen receptor (CAR)-T cell therapy or where anti-CD19
CAR-T cells are not an option.
The financing included participation from new
and existing investors including Blue Owl Healthcare Opportunities,
New Enterprise Associates (NEA) and Aisling Capital, and will
support the collection of additional clinical data to advance
Marker’s lead clinical asset in lymphoma.
Marker is selling 5,031,250 shares of its common
stock (or pre-funded warrants in lieu thereof) and accompanying
warrants to purchase up to 5,031,250 shares of common stock, at a
purchase price of $3.20 per share (or $3.199 per pre-funded warrant
in lieu thereof) and accompanying warrant.
The pre-funded warrants and the accompanying
warrants will be exercisable upon shareholder approval and have a
term of five years commencing upon shareholder approval. The
pre-funded warrants will be exercisable at a price of $0.001 per
share and the accompanying warrants will have an exercise price of
$4.03 per share.
Canaccord Genuity is acting as lead placement
agent and Brookline Capital Markets, a division of Arcadia
Securities, LLC, is acting as co-placement agent.
The securities being sold in this private
placement have not been registered under the Securities Act of
1933, as amended (the “Securities Act”), or applicable state
securities laws, and may not be offered or sold in the United
States absent registration or an applicable exemption from the
registration requirements of the Securities Act. Marker has agreed
to file a registration statement with the Securities and Exchange
commission (SEC) registering the resale of the shares of common
stock and shares of common stock issuable upon exercise of the
pre-funded warrants and accompanying warrants.
This press release shall not constitute an offer
to sell or the solicitation of an offer to buy these securities,
nor shall there be any offer, solicitation or sale of these
securities in any jurisdiction in which such offer, solicitation or
sale would be unlawful.
About MT-601The 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
lymphoma cells (Survivin, PRAME, WT-1, NY-ESO-1, SSX-2, MAGEA-4).
Marker is currently investigating MT-601 in the Company-sponsored
Phase 1 APOLLO trial (clinicaltrials.gov identifier: NCT05798897)
for the treatment of patients with lymphoma who relapsed after or
are ineligible for anti-CD19 CAR-T cell therapies.
About APOLLO The APOLLO trial
(clinicaltrials.gov Identifier: NCT05798897) is a Phase 1,
multicenter, open-label study designed to evaluate the safety and
efficacy of MT-601 in participants with relapsed or refractory
lymphoma who either failed anti-CD19 chimeric antigen receptor
(CAR) T cell therapy or are ineligible for anti-CD19 CAR-T cell
therapy. The primary objective of this exploratory Phase 1 clinical
trial is to evaluate the optimum dose, safety, and preliminary
efficacy of MT-601 in participants with various lymphoma subtypes.
Under the APOLLO trial, it is anticipated that nine clinical sites
across the United States will cumulatively enroll up to
approximately 30 participants during the dose escalation phase.
About MAR-T cellsThe
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 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.
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Forward-Looking StatementsThis
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, interim results announcements and outcomes of our
clinical trials of our product candidates, including MT-601 for the
treatment of patients with 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.
ContactsInvestorsTIBEREND
STRATEGIC ADVISORS, INC.Jonathan
Nugent205-566-3026jnugent@tiberend.com
Marker Therapeutics (NASDAQ:MRKR)
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