Full Press Release Details
THERAPEUTICS announces comprehensive
non-dilutive AGREEMENT WITH CELLREADY
TO EXTEND MARKER'S FINANCIAL RUNWAY
THROUGH YEAR-END 2025
Announces LeADERSHIP TRANSITION &
ProVIdes UPDATE ON OPERATIONAL STRATEGY
2023 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage company specializing in the development
of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced
that it has entered into a comprehensive agreement with CellReady , a newly formed Contract Development and Manufacturing Organization
(CDMO) founded by John Wilson, founder and CEO of Wilson Wolf Corporation and Marker Co-Founder and Board Member.
the terms of the non-dilutive agreement, CellReady will purchase certain cell manufacturing assets from Marker for approximately $19
million in cash and reduce Marker's overhead by about $11 million annually by employing Marker's manufacturing, development,
quality, and regulatory affairs personnel, and assuming the leases for Marker's Houston-based manufacturing and research and development
facilities. The parties anticipate the transaction will close on June 26, 2023.
also agreed to enter into a long-term contract with Marker wherein CellReady will perform a wide variety of services for Marker including
research and development, manufacturing, and regulatory activity in support of Marker's clinical trials.
agreement allows Marker to concentrate solely on the clinical advancement of its unique form of T cell therapy, which has demonstrated
the ability to recognize and kill cancer cells even as the cancer cells evolve to escape detection. Currently approved genetically engineered
CAR T and TCR therapies cannot recognize evolving cancer cells, and this limitation can lead to relapse.
Vera, M.D., formerly Marker's COO and Chief Scientific Officer, has assumed the role of Chief Executive Officer of Marker Therapeutics
effective May 1, 2023. Dr. Vera commented, "Marker's management and impartial members of the board worked with
John Wilson and CellReady to develop a very creative and non-dilutive plan that provides Marker with the financial runway to pursue its
clinical priorities through the end of 2025. At the same time, through CellReady, Marker will maintain full access to its industry-leading
operational, quality, development, and regulatory team and facilities whenever it needs them. I look forward to working with the Marker
clinical team to advance the development of MT-601 in our ongoing non-Hodgkin's lymphoma trial and eventual pancreatic cancer trial,
in addition to MT-401 for our post-transplant AML trail. Additionally, I am spearheading a strategic review process of our clinical
programs with the Marker management team as part of our restructuring efforts."
Wilson, founder and CEO of Wilson Wolf Corporation and Marker Co-Founder and Board Member, stated, "I continue to believe that
Marker's unique therapies can make a positive impact in the cancer field. This is why I co-founded Marker, made investments along
the way, and have remained a longtime shareholder. Advancing these therapies would not be possible without the institutional and retail
investors who have joined our mission. The reality is that Marker has not yet met our investors' expectations. Therefore, extending
Marker's clinical runway without investor dilution is the right thing to do. Paying Marker approximately $19 million in cash and
simultaneously eliminating about $11 million of Marker's annual costs related to its personnel and facilities, greatly reduces
Marker's cash needs as it pursues clinical development of its lead programs. Meanwhile, CellReady will provide Marker with all
resources required to advance its clinical program, including people, facilities, and cell manufacturing capabilities. I estimate the
net benefit to Marker to be approximately $42 million through the end of 2025."
Clinical Strategy Update
MT-601, a multi-tumor-associated antigen (multi-TAA) specific T cell product targeting six cancer
antigens, is in an ongoing clinical trial for the treatment of patients with relapsed/refractory non-Hodgkin's lymphoma who have
failed, or are ineligible to receive, an anti-CD19 CAR T cell treatment.
MT-601 study is based on the results that were observed in the Phase I/II TACTAL study that enrolled patients with Hodgkin's and
non-Hodgkin's lymphoma. The TACTAL study, which used a multi-TAA specific T cell product targeting five lymphoma antigens, reported
long-term complete response (CR) rates that were comparable to recently approved anti-CD19 CAR-T cell therapies, even at very low cell
is also continuing the clinical development of MT-401, its multi-TAA specific T cell product for the treatment of pediatric and
adult patients with acute myeloid leukemia (AML) after receiving allogeneic transplant. AML is a very challenging form of cancer and,
in September 2022, Marker indicated that it had observed promising early clinical results which suggested that MT-401 can potentially
rescue post-transplant AML patients with measurable residual disease. Should data continue to demonstrate the potential to stop AML from
progressing into the dire condition of Frank Relapse, Marker believes this will be a significant advance in AML treatment.
extensive scientific review, Marker believes the magnitude of a patient's tumor burden may correlate with MT-401 and MT-601 clinical
outcomes. Marker is now updating clinical protocols to potentially improve patient outcomes by assessing tumor burden. Data availability
is expected toward the latter half of 2024.
pancreatic trial is awaiting news on grant funding and Marker is analyzing the relationship between starting cellular material and manufactured
cell quantity to ensure optimal conditions for its pancreatic trial outcomes. Marker will be following up to keep investors informed
about the status of its pancreatic trial as information becomes available.
connection with this transaction, Marker's board of directors established a special transactions committee of impartial directors
to review the terms of the transaction, as well as other strategic alternatives, and to issue a recommendation to the board of directors.
The impartial members of the board of directors unanimously approved entry into the transaction based on the special transactions committee's
to the agreement, Marker has made certain representations and warranties on the transferred assets and has agreed to certain customary
covenants and restrictions with respect to assets and liabilities comprising the transaction consistent with a transaction of this nature.
parties will also enter into a long-term supply agreement for the manufacture and supply of Marker's clinical product candidates.
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.
receive future press releases via email, please visit: HTTPS://WWW.MARKERTHERAPEUTICS.COM/EMAIL-ALERTS.
mission is to radically improve the business model of cell and gene therapy (CGT) by providing CGT companies with a standard G-Rex centric
cell manufacturing platform, manufacturing protocols, quality management system, CMC section that is sanctioned by the FDA, and regulatory
guidance. This can save CGT companies at least two years of time and millions of dollars.
will provide these services at minimal profit and with full transparency to ensure that its customer's precious investor money
can be directed at what truly matters - clinical data and patient outcomes.
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 occurrence of any event, change or other circumstances
that could give rise to the termination of the equipment purchase agreement or failure to close the transaction; the institution or outcome
of any legal proceedings that may be instituted against Marker following the announcement of the proposed transaction, including due
to the failure to satisfy the conditions to closing the transaction; the inability of the parties to complete the transaction, including
due to the failure to satisfy the conditions to closing the transaction; the risk that the proposed transaction disrupts current plans
and operations as a result of the announcement and consummation of the proposed transaction; the ability to recognize the benefits of
the proposed transaction; costs related to the proposed transaction; anticipated cost savings as a result of the proposed transaction;
and our future operating expenses and capital expenditure requirements, including our anticipated cash runway. 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.
STRATEGIC ADVISORS, INC.
Rando/Casey McDonald
930-6346/ (646) 577-8520