Carisma Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights
PR Newswire
PHILADELPHIA, Nov. 7, 2024
Initial results from the Phase 1 study of CT-0525, lead product candidate, expected in the first quarter of 2025
Nomination of a development candidate for liver fibrosis program expected in the first quarter of 2025
New preclinical efficacy data from the anti-GPC3 in vivo CAR-M therapy to be presented on November 8 at SITC 2024 Annual Meeting
New preclinical efficacy data in liver fibrosis to be presented on November 17 at AASLD - The Liver Meeting $(R)$ 2024
Cash and cash equivalents of $26.9 million expected to fund the Company into the third quarter of 2025
PHILADELPHIA, Nov. 7, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today reported financial results for the quarter ended September 30, 2024, and highlighted recent business updates.
"Our recent progress across clinical and preclinical programs demonstrates our commitment to pioneering therapies that address significant unmet medical needs," said Steven Kelly, President and CEO of Carisma Therapeutics. "We are advancing on multiple fronts. We expect to report initial data from the Phase 1 study of CT-0525 in the first quarter of 2025. We also recently nominated our first development candidate in hepatocellular carcinoma with Moderna and are excited to bring additional in vivo CAR-M therapies forward, including autoimmune targets. Our liver fibrosis program is progressing as well, with the nomination of a development candidate anticipated in the first quarter of 2025. These key milestones move us closer to delivering transformative treatments for patients in need."
Third Quarter 2024 Highlights and Upcoming Milestones
Ex Vivo Oncology
-- CT-0525 (Anti-HER2 chimeric antigen receptor monocyte (CAR-Monocyte))
-- On November 5, 2024, Carisma announced the upcoming presentation
of a trial in progress $(TIP.AU)$ poster for its Phase 1 clinical trial
evaluating CT-0525, an autologous CAR-Monocyte therapy for the
treatment of HER2+ solid tumors. The poster will be presented at
the Society for Immunotherapy of Cancer $(SITC)$ Annual Meeting in
Houston, Texas, on November 8, 2024.
-- In September 2024, Carisma submitted a protocol amendment for its
Phase 1 study of CT-0525 to allow for the expansion of the study
to include repeat dosing (up to two billion CAR positive cells
administered every three weeks for up to five cycles) in
combination with pembrolizumab, bolus dosing (up to10 billion CAR
positive cells in a single dose) in combination with pembrolizumab,
or either of these two dosing schedules as monotherapy (without
checkpoint inhibitor). Repeat dosing in combination with
pembrolizumab will be prioritized and the other three study arms
may be activated as data indicates.
-- Carisma expects to report initial data for Cohorts 1 and 2 of its
Phase 1 study of CT-0525 in the first quarter of 2025.
In Vivo Program (Moderna Collaboration)
-- Autoimmune disease (CAR-M + mRNA/LNP)
-- On September 10, 2024, Carisma announced the expansion of its in
vivo chimeric antigen receptor macrophage and monocyte ("CAR-M")
collaboration with Moderna, Inc. ("Moderna") to include the
nomination of two research targets for the treatment of autoimmune
diseases. Carisma retains all rights in autoimmune disease beyond
the two nominated targets, which will be exclusively partnered
with Moderna.
-- GPC3+ solid tumors (CAR-M + mRNA/LNP)
-- On November 5, 2024, Carisma announced the upcoming presentation
of new pre-clinical data for its anti-GPC3 in vivo CAR-M therapy
for the treatment of hepatocellular carcinoma $(HCC)$, developed in
collaboration with Moderna. These data will be presented in a
poster session at the SITC Annual Meeting in Houston, Texas, on
November 8, 2024. These preclinical data demonstrate robust
anti-tumor activity and introduce a novel, off-the-shelf approach
for GPC3+ solid tumors.
Fibrosis
--
-- On August 6, 2024, Carisma announced that new preclinical data for
liver fibrosis will be highlighted in a poster presentation at the
American Association for the Study of Liver Diseases (AASLD) - The
Liver Meeting(R) 2024, to be held November 15 through 19, 2024, in
San Diego, California.
-- Carisma expects to nominate a development candidate for its liver
fibrosis program in the first quarter of 2025.
Corporate Update
-- On October 30, 2024, Carisma announced the appointment of Sohanya Cheng
to the Board of Directors of the Company, effective October 31, 2024. Ms.
Cheng brings over 20 years of experience in biopharmaceutical
commercialization and research, with a strong focus on oncology. The
Company concurrently announced the resignation of Michael Torok from
Carisma's Board of Directors, also effective October 31, 2024.
Third Quarter 2024 Financial Results
-- Cash and cash equivalents as of September 30, 2024, were $26.9 million,
compared to $40.4 million as of June 30, 2024.
-- Research and development expenses for the three months ended September
30, 2024 were $11.3 million, compared to $19.6 million for the three
months ended September 30, 2023. The decrease of $8.3 million was
primarily due to implementation of our revised operating plan in the
second quarter of 2024 in which we halted further development of CT-0508,
paused development of CT-1119 and implemented a workforce reduction. As
result of the revised operating plan, we experienced a decrease of $2.4
million related to halting development of CT-0508 and a $0.1 million
decrease from pausing the development of CT-1119. In addition, the
implementation of the revised operating plan resulted in a decrease in
facilities and other expenses of $3.1 million due to less laboratory
supplies and laboratory space needs and a $0.9 million decrease in direct
personnel costs due to a reduction in headcount. Further, we experienced
a $0.9 million decrease in direct costs associated with pre-clinical
development of CT-0525 due to the timing of the development program and a
decrease of $0.9 million in other clinical and pre-clinical development
expenses resulting from the timing of certain studies in our in vivo
collaboration with Moderna.
-- General and administrative expenses for the three months ended September
30, 2024 were $5.2 million, compared to $6.6 million for the three months
ended September 30, 2023. The decrease of $1.4 million was primarily due
to our revised operating plan in which we recognized a $1.3 million
decrease in professional fees as a result of our patent portfolio and
expanding infrastructure in 2023, a $0.3 million decrease in facilities
and supplies due to a decrease in office expenditures, a $0.2 million
decrease in insurance costs, and a $0.1 million decrease in other
expenses related to a decline in travel costs, partially offset by a $0.5
million increase in personnel costs driven by an increase in stock-based
compensation.
-- Net loss was $12.7 million for the third quarter of 2024, compared to a
$21.4 million net loss for the same period in 2023.
Outlook
Carisma anticipates that its cash and cash equivalents of $26.9 million as of September 30, 2024 are sufficient to sustain its planned operations into the third quarter of 2025. The Company's cash forecast contains estimates and assumptions, and management cannot predict the timing of all cash receipts and expenditures with certainty. Variances from management's estimates and assumptions could impact the Company's liquidity prior to the third quarter of 2025.
About CT-0525
CT-0525 is a first-in-class, ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2). It is being studied in a multi-center, open label, Phase 1 clinical trial for patients with advanced/metastatic HER2-overexpressing solid tumors that have progressed on available therapies. The CAR-Monocyte approach has the potential to address some of the challenges of treating solid tumors with cell therapies, including tumor infiltration, immunosuppression within the tumor microenvironment, and antigen heterogeneity. CT-0525 has the potential to enable significant dose escalation, enhance tumor infiltration, increase persistence, and reduce manufacturing time compared to macrophage therapy.
About Carisma Therapeutics
Carisma Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on utilizing our proprietary macrophage and monocyte cell engineering platform to develop transformative immunotherapies to treat cancer and other serious diseases. We have created a comprehensive, differentiated proprietary cell therapy platform focused on engineered macrophages and monocytes, cells that play a crucial role in both the innate and adaptive immune response. Carisma is headquartered in Philadelphia, PA. For more information, please visit www.carismatx.com.
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