Carisma to undergo staff and clinical candidate restructuring to stretch cash reserves

Carisma, a Philadelphia-based biotech company, is undergoing significant restructuring to extend its cash reserves into the third quarter of next year. As part of this effort, the company is reducing its workforce by 34% and discontinuing its only clinical candidate, CT-0525.
CT-0525, a gene-modified autologous chimeric antigen receptor-monocyte (CAR-M) cell therapy, was developed to treat solid tumors overexpressing human epidermal growth factor receptor 2 (HER2). Earlier this year, the therapy received fast-track designation from the FDA, and a phase 1 clinical trial was launched with an anticipated enrollment of six patients with advanced solid tumors. Initial data from the trial was expected by the end of this year.

However, Carisma recently announced that trial recruitment has been halted, and no new patient cohorts will be enrolled. In a filing with the Securities and Exchange Commission (SEC), the company revealed it does not plan to complete ongoing trial activities. This decision was not due to safety concerns, as Carisma confirmed the therapy was safe and well-tolerated. Instead, the move was driven by challenges in the competitive landscape, including HER2 antigen loss and the availability of recently approved anti-HER2 therapies.
Carisma is now focusing its efforts on macrophage-focused therapeutics, particularly its in vivo macrophage engineering platform. This approach aims to simplify cell therapy by eliminating the need for ex vivo cell culture, leveraging an mRNA/lipid nanoparticle (LNP) strategy. The platform targets oncology, autoimmune diseases, and fibrosis therapies.
In 2022, Carisma received a $45 million investment from Moderna to develop ten oncology research targets based on this platform. Earlier this year, the partnership was expanded to include two undisclosed autoimmune disease targets.
To optimize its financial position, Carisma reported $27 million in cash reserves as of September 2023, which it expects to last into late 2025. Alongside the clinical pivot, Carisma is executing a second round of layoffs this year, affecting 23 full-time employees across manufacturing, finance, corporate activities, and R&D. Departing senior executives include General Counsel Eric Siegel, Senior Vice President of Human Resources Terry Shields, and Chief Financial Officer Richard Morris, all of whom are expected to leave by year’s end.
This workforce reduction follows an earlier restructuring in the spring, which saw a 37% cut in staff and the termination of another CAR-M candidate, CT-0508. Carisma anticipates completing the current layoffs by the end of the first quarter of 2024.

Carisma CEO Steven Kelly emphasized that the restructuring is intended to streamline operations and prioritize the company’s most promising areas of research. By pivoting to macrophage engineering and reducing costs, the company aims to sustain its operations and continue developing innovative therapies for oncology and autoimmune diseases.

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