#United States #Philadelphia #oncology #Carisma Therapeutics #liver fibrosis

Carisma Therapeutics Announces Corporate Updates

Carisma Therapeutics Inc. (NASDAQ: CARM) has recently made crucial announcements regarding its strategic direction and operational adjustments. The company's Board of Directors has authorized a revised operating plan focused on both reducing operational cash burn and evaluating potential strategic alternatives. This change comes after recognizing the necessity to optimize cash conservation in a challenging funding environment.

Operational Adjustments

Carisma is now aiming to enhance the value of its existing assets, particularly in the fields of liver fibrosis and oncology development. In this pursuit, the company plans to leverage its macrophage and monocyte engineering platform, which is key to their CAR-M therapies. To support this strategic shift, Carisma has made the difficult decision to reduce its workforce, maintaining only those staff members essential for pursuing these alternatives. As of this adjustment, the company estimates it has sufficient cash and cash equivalents to sustain operations through the latter part of 2025.

Strategic Alternatives Exploration

The company is committed to exploring a comprehensive range of strategic alternatives. This could include the sale, licensing, or monetization of certain assets, as well as forming partnerships or possibly a merger with other entities. Although the exploration may not lead to a successful transaction or guaranteed value for stakeholders, the move is seen as a necessary step to ensure the company's future.

CEO Steven Kelly's Comments
Steven Kelly, the President and CEO of Carisma, emphasized the importance of these changes:

"While difficult, we believe pursuing strategic alternatives coupled with a reduction in operating costs has the potential to maximize the value of our science and assets in light of the funding challenges we currently face."

He expressed pride in the company's pioneering work on liver fibrosis and oncology programs, which have displayed significant preclinical potential. Kelly conveyed optimism about finding a strategic transaction to continue valuable scientific efforts.

Insights Into the Pipeline

Fibrosis Program

Carisma’s liver fibrosis initiative centers on a notable efferocytosis defect found in macrophages within patients with fibrosis. Their candidate product, CT-2401, is designed utilizing a novel mRNA/LNP technology, aiming to reverse fibrotic conditions and enhance patient outcomes significantly. Encouragingly, preclinical proof-of-concept was achieved in early 2024, showing the anti-fibrotic effectiveness of engineered macrophages across two liver fibrosis models.

Oncology Initiatives

The company’s oncology program includes CT-1119, engineered to target advanced mesothelin-positive solid tumors, including notable cancers such as pancreatic and ovarian cancers. Although research activities have been paused, the initial plans for a Phase 1 clinical trial in collaboration with tislelizumab indicated the company's strong focus on this area.
Additionally, a collaboration with Moderna regarding in vivo candidate therapies targeted against Glypican-3 also poses potential advancements, although further research funding has been suspended. Recent data indicated promising anti-tumor effects, suggesting long-term potential despite current uncertainties.

Corporate Review Process

Following a recent decision from the Board of Directors to refine focus towards core functions, the company has suspended all research and development activities pending the strategic review outcome. Carisma is also considering seeking external advisory assistance to facilitate proper evaluation and, if necessary, prepare for potential operational wind-downs. This comprehensive reassessment underscores the management's commitment to finding a sustainable path forward.

About Carisma Therapeutics

Carisma Therapeutics is at the forefront of biotechnology, specializing in macrophage engineering to innovate treatments for fibrosis and cancer. Headquartered in Philadelphia, PA, the company emphasizes a patient-centric approach to create scalable solutions that can pioneer new treatment standards. For additional details, visit Carisma's website.

Cautionary Statement

It’s important to note that forward-looking statements contained in this update represent management’s current expectations and may be influenced by various risks and uncertainties, which could lead to actual results differing materially. Stakeholders are encouraged to consider these factors when evaluating the company's future prospects.