Carisma Therapeutics Q1 2024 Financial Results and Business Highlights

Carisma Therapeutics Inc. (Nasdaq: CARM), a clinical-stage biopharmaceutical company, unveiled its financial results for the quarter ending March 31, 2024, and highlighted strategic business updates. Carisma is dedicated to pioneering immunotherapies aimed at treating cancer and other severe diseases.

Steven Kelly, the company's President and CEO, emphasized the company's focused approach moving into the second quarter. He highlighted the promising progression of their anti-HER2 CAR-M program, particularly the shift towards developing CT-0525, a product believed to significantly boost anti-tumor activity. Additionally, recent preclinical data in liver fibrosis supports the potential of engineered macrophages beyond oncology.

Key updates from the first quarter of 2024 include the prioritization of the CT-0525 program. Carisma shifted its resources to CT-0525 because of its potential to offer a 2,000-fold increase in total exposure compared to their previous candidate, CT-0508. They plan to initiate the CT-0525 Phase 1 clinical study by the second quarter of 2024 and expect initial data by the end of the year.

For CT-0508, Carisma reported data from a Phase 1 study combining CT-0508 with pembrolizumab, a PD-1 checkpoint inhibitor. Preliminary results from three patients indicated that the combination therapy was generally well-tolerated, with no dose-limiting toxicities. One patient achieved stable disease, showing significant T cell clonality and a notable reduction in target lesions. Carisma plans to present further data from this study in the second quarter of 2024.

Carisma has halted the development of CT-1119, an anti-mesothelin CAR-Monocyte, pending additional funding.

At the American Society of Gene and Cell Therapy (ASGCT) 2024 Annual Meeting, Carisma showcased preclinical proof of concept data for engineered macrophages in treating liver fibrosis. The data demonstrated that engineered macrophages expressing anti-fibrotic and anti-inflammatory factors significantly reduced fibrosis in liver models. They also showed promising results in pulmonary fibrosis models. Carisma plans to nominate a development candidate for the liver fibrosis program by early 2025.

Recent corporate restructuring includes the appointment of Dr. Eugene P. Kennedy as the Chief Medical Officer and Dr. John Hohneker to the Board of Directors. Alongside these appointments, Carisma announced a pipeline reprioritization, focusing on CT-0525 and pausing other developments. This strategic shift led to a 37% reduction in workforce in the second quarter of 2024.

Financially, Carisma reported cash and cash equivalents totaling $56.5 million as of March 31, 2024, expected to sustain operations into the third quarter of 2025. Research and development expenses increased slightly to $17.5 million, while general and administrative expenses decreased significantly to $5.4 million due to reduced personnel costs and professional fees. The net loss for the first quarter of 2024 was $19.0 million, down from $24.6 million in the same period the previous year.

Carisma remains committed to advancing its product candidates, particularly CT-0525, an ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) therapy aimed at treating HER2-overexpressing solid tumors. This approach promises to overcome challenges associated with treating solid tumors, such as tumor infiltration and immunosuppression. CT-0525 is expected to enable dose escalation and improve tumor infiltration and persistence compared to CT-0508.

Overall, Carisma Therapeutics continues to make strides in its immunotherapy programs, focusing on innovative treatments for cancer and other severe diseases, with significant milestones expected in the near future.