Carisma Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights
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 ® 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) 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® 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
