PHILADELPHIA, PA — Carisma Therapeutics Inc. (Nasdaq: CARM) released its financial results for the second quarter ended June 30, 2024. The company also provided updates on its ongoing clinical and research developments.
Key Developments
Carisma highlighted significant strides in its lead product candidates and collaboration programs. Initial data for CT-0525, the company’s flagship anti-HER2 program, is expected by the end of 2024. Carisma also plans to nominate a development candidate for its liver fibrosis program in the first quarter of 2025. Additionally, the company announced the nomination of its first in vivo CAR-M development candidate targeting Glypican-3 to treat hepatocellular carcinoma in collaboration with Moderna.
Financial Highlights
For the second quarter of 2024, Carisma reported:
- Cash and cash equivalents stood at $40.4 million as of June 30, 2024.
- Research and development expenses were $15.3 million, down from $18.5 million in the same period last year.
- General and administrative expenses were $5.6 million, compared to $6.0 million in the previous year.
- Net loss was $11.2 million, a significant improvement from the $19.9 million net loss reported for the same period in 2023.
Clinical and Research Updates
CT-0525
On May 16, 2024, Carisma dosed the first patient in its Phase 1 clinical trial for CT-0525, an ex vivo gene-modified autologous CAR-Monocyte therapy for solid tumors overexpressing HER2. The U.S. Food and Drug Administration granted Fast Track designation for CT-0525 on June 25, 2024. Initial data from this trial are expected by year-end.
CT-0508
Carisma completed all clinical activities related to CT-0508 and its combination study with pembrolizumab by July 2024. Preliminary data showed a decrease in circulating tumor DNA in 75% of evaluable HER2 3+ patients, suggesting anti-tumor activity. The combination therapy was well-tolerated, with no dose-limiting toxicities, and showed potential for synergy.
GPC3+ Solid Tumors
In June 2024, Carisma nominated its first in vivo CAR-M development candidate under its collaboration with Moderna. This candidate targets Glypican-3 for treating solid tumors, including hepatocellular carcinoma. Carisma received a $2.0 million milestone payment from Moderna in July 2024 and plans to present preclinical data at an upcoming medical meeting.
Liver Fibrosis
Carisma announced that additional preclinical data for liver fibrosis will be presented at the American Association for the Study of Liver Diseases conference in November 2024. The company aims to nominate a development candidate for its liver fibrosis program by Q1 2025.
Corporate Updates
In July 2024, Carisma appointed David Scadden, M.D., and Marella Thorell to its Board of Directors. Additionally, Scott Friedman, M.D., and Ira Tabas, M.D., Ph.D. joined the Scientific Advisory Board, bringing extensive expertise in liver fibrosis.
Carisma Therapeutics: Driving Innovation and Growth in CAR-M Therapies
Carisma’s strategic focus on advancing its clinical pipeline and expanding its development programs is evident. The company’s collaboration with Moderna and the FDA’s Fast Track designation for CT-0525 highlight its innovative approach and potential for future growth. Despite a decrease in research and development expenses, Carisma has maintained momentum in its key programs.
The financial results indicate a prudent approach to managing resources, with a significant reduction in net loss compared to the previous year. The anticipated cash runway into the third quarter of 2025 provides a stable financial outlook, though management acknowledges variability in cash flow projections.
Carisma Therapeutics continues to position itself as a leader in the development of CAR-M therapies, with multiple value drivers expected in both the short and long term. Investors will be keen to monitor upcoming clinical data releases and the progress of the company’s development candidates.
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