Resources realigned to focus primarily
on in vivo macrophage engineering platform for
fibrosis, oncology and autoimmune disease therapies
Development of CT-0525 to be discontinued;
workforce reduced by 34%
PHILADELPHIA, Dec. 9, 2024
/PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq:
CARM) ("Carisma" or the "Company"), a leader in
macrophage-focused therapeutics, today announced a strategic
reprioritization of its pipeline, cessation of development of
CT-0525, and a reduction in the workforce by 34%. These measures
will enable Carisma to focus its resources on advancing its in
vivo macrophage engineering platform for the development of
fibrosis, oncology and autoimmune disease therapies. This decision
aligns Carisma's efforts with next-generation, high-potential
programs addressing significant unmet patient needs while enhancing
operational efficiency.
"Following a comprehensive review of our portfolio, we have made
the strategic decision to prioritize advancing our in vivo
macrophage engineering platform," said Steven Kelly, President and Chief Executive
Officer of Carisma. "The compelling data generated by both the
Moderna-partnered in vivo CAR-M oncology programs as well as
our internal liver fibrosis program underscore the potential to
revolutionize treatment paradigms with an innovative and
patient-centric approach."
"These strategic initiatives, re-directing
our investments to the in vivo macrophage engineering
platform, discontinuing development of our anti-HER2 program and
reducing our workforce, aim to streamline our operations and reduce
operating expenses over time," Kelly continued. "While these
decisions are very challenging, they are made in the best interest
of our shareholders. We remain deeply grateful for the significant
contributions of the employees departing Carisma."
Reprioritization Plan, Pipeline Updates, and Upcoming
Milestones:
As part of this reprioritization of our pipeline, Carisma will
discontinue development of the anti-human epidermal growth factor
receptor 2 ("anti-HER2") program, and redirect the Company's
focus to developing off-the-shelf products using its in vivo
macrophage engineering platform:
Fibrosis
- Carisma's initial fibrosis program is focused on addressing
liver fibrosis, a significant global health challenge. Preclinical
data presented at the American Association for the Study of Liver
Diseases (AASLD) Liver Meeting® 2024 demonstrated the potential of
Carisma's engineered macrophages to reduce inflammation, resolve
fibrosis, and promote liver regeneration.
- The Company plans to nominate a development candidate for its
liver fibrosis program in the first quarter of 2025, reflecting its
expertise in macrophage biology and fibrotic diseases.
Oncology
- In collaboration with Moderna, Inc. (Nasdaq: MRNA), Carisma is
advancing multiple programs utilizing an in vivo
chimeric antigen receptor macrophage and monocyte ("CAR-M") plus
mRNA/LNP approach. The lead program is an anti-glypican 3 (GPC3)
in vivo CAR-M therapy that has demonstrated the potential
for this scalable, patient-friendly approach to transform solid
tumor therapy. In addition to this program, Moderna has nominated
four undisclosed oncology research targets under the collaboration
and has the right to designate up to ten oncology targets as
development targets.
Autoimmune
- In collaboration with Moderna, Carisma has two in vivo
CAR-M research programs for the treatment of autoimmune diseases
associated with two distinct targets where there is significant
unmet medical need.
- Carisma retains all rights in autoimmune disease beyond these
two nominated targets.
Discontinuation of anti-HER2 Development
- The Company's decision was based on an assessment of the
competitive landscape in anti-HER2 treatments, including the impact
of recently approved anti-HER2 therapies on HER2 antigen
loss/downregulation, and the effects on the future development
strategy of any anti-HER2 treatment.
- The Company has completed patient enrollment of the Phase 1
clinical trial of CT-0525 and will not enroll patients in the
previously planned Cohort 3 of the study.
- Based on the data available to date from the anti-HER2 program,
CAR-M cell therapy has been shown to be safe, well-tolerated, and
feasible to manufacture, and it holds the potential to become a
meaningful treatment option for patients.
Corporate Updates
- As part of the strategic restructuring, Carisma will reduce its
workforce by 34%. The Company expects the reduction in workforce to
be substantially complete and to pay the majority of related
reduction in workforce amounts by the end of the first quarter of
2025. The Company is committed to supporting affected employees
through this transition.
- As part of the workforce reductions, our Chief Financial
Officer, Richard Morris, our General
Counsel, Eric Siegel, and our Senior
Vice President, Human Resources, Terry
Shields, will leave the Company effective December 31, 2024. Carisma expresses gratitude
for their contributions.
- The Company expects to incur approximately $2.7 million in connection with the reduction in
the workforce, which primarily represents one-time employee
termination benefits directly associated with the workforce
reduction.
About Carisma
Carisma Therapeutics is a biopharmaceutical Company pioneering
macrophage engineering to develop groundbreaking therapies for
fibrosis, cancer, and other diseases. With a strong commitment to
patient-centric innovation, Carisma aims to deliver scalable,
next-generation solutions that transform treatment paradigms.
Carisma is headquartered in Philadelphia,
PA. For more information, please visit
www.Carismatx.com.
Cautionary Note on Forward-Looking Statements
Statements in this press release about future expectations,
plans and prospects, as well as any other statements regarding
matters that are not historical facts, may constitute
"forward-looking statements" within the meaning of The Private
Securities Litigation Reform Act of 1995. These statements include,
but are not limited to, statements relating to the Company's
intentions, beliefs, projections, outlook, analyses or current
expectations concerning, among other things, the expected timing
for the completion of the reduction in workforce; the expected
charges to be incurred and the related cash payments and the timing
thereof; future employment relationships; the future development
focus of the Company and related timelines; and other statements
that are not historical fact. The words "continue," "estimate,"
"expect," "may," "plan," "will," and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Any
forward-looking statements are based on management's current
expectations of future events and are subject to a number of risks
and uncertainties that could cause actual results to differ
materially and adversely from those set forth in, or implied by,
such forward-looking statements. These risks and uncertainties
include, but are not limited to, changes to the assumptions on
which the estimated charges associated with the reduction in
workforce are based; the "at-will" nature of employment
relationships; changes in the macroeconomic environment or
competitive landscape that impact the Company's business; and risks
related to the Company's business and the Company's ongoing
evaluation of strategic alternatives. For a discussion of these
risks and uncertainties, and other important factors, any of which
could cause the Company's actual results to differ from those
contained in the forward-looking statements, see the "Risk Factors"
set forth in the Company's Annual Report on Form 10-K for the year
ended December 31, 2023, its
Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as well as discussions of
potential risks, uncertainties, and other important factors in the
Company's other recent filings with the Securities and Exchange
Commission. Any forward-looking statements that are made in this
press release speak as of the date of this press release. The
Company undertakes no obligation to revise the forward-looking
statements or to update them to reflect events or circumstances
occurring after the date of this press release, whether as a result
of new information, future developments or otherwise, except as
required by the federal securities laws.
Investors:
Shveta
Dighe
Head of Investor Relations
investors@Carismatx.com
Media:
Julia Stern
(763) 350-5223
jstern@realchemistry.com
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SOURCE Carisma Therapeutics Inc.
