CARISMA THERAPEUTICS INC (NASDAQ: CARM)

Introduction

CARISMA Therapeutics Inc. is a clinical-stage biopharmaceutical company headquartered in Philadelphia, Pennsylvania. Founded in 2016, the company specializes in developing engineered macrophage and monocyte therapies—known as CAR-Macrophages (CAR-M)—for indications in oncology, fibrosis, and autoimmune diseases.

Corporate Structure

• Headquarters: Philadelphia, PA
• Employees: 51–200 (LinkedIn)
• Leadership:
  • Steven Kelly, President & Chief Executive Officer (joined February 2018; approximately 30 years in the pharmaceutical and biotechnology sectors)
  • Michael Klichinsky, PharmD, PhD, Co-Founder & Chief Scientific Officer (co-inventor of CAR-M technology during doctoral work at the University of Pennsylvania)

Recent Developments and News

Strategic Restructuring (December 9, 2024)

• Development of CT-0525 (anti-HER2 program) has been discontinued.
• Workforce has been reduced by 34%.
• Resources have been realigned to concentrate on in vivo macrophage engineering for treatments targeting fibrosis, oncology, and autoimmune indications.

Clinical and Scientific Milestones

• CT-0508 Phase 1 results published in Nature Medicine, providing first-in-human data for metastatic HER2-positive solid tumors, indicating safety, tumor microenvironment remodeling, and potentially inducing anti-tumor immunity.
• CT-1119 (anti-mesothelin CAR-Monocyte) is set to enter Phase 1 trials for ovarian and pancreatic cancers, with data anticipated in Q4 2025.

Partnerships and Presentations

• Collaboration with Moderna Therapeutics:
  • The lead program focuses on the anti-glypican-3 (GPC3) in vivo CAR-M therapy for hepatocellular carcinoma.
  • Four additional oncology targets have been nominated, with an option for up to seven additional targets.
  • Two in vivo programs for autoimmune diseases are also part of this collaboration.
• Upcoming Conference Appearances:
  • Oppenheimer 35th Annual Healthcare Life Sciences Conference (Steven Kelly; February 11, 2025)
  • SITC Spring Scientific Meeting, San Diego & Virtual (March 12–14, 2025)
  • Keystone Symposia, Plenary on Immune Cell Therapies (Michael Klichinsky; March 19, 2025)
  • H.C. Wainwright 3rd Annual Cell Therapy Virtual Conference (fireside chat by Michael Klichinsky)

Financial and Strategic Analysis

Metric	Value
Stock Price (2025-06-11)	$0.6547
YTD Price Change	–41.02%
Volume (2025-06-11)	12,165,535
Market Cap (intraday)	$27.38 M
52-Week Range	$0.1420 – $1.9000
TTM Revenue	$19.96 M
Net Income (TTM)	–$50.77 M
EPS (TTM)	–5.97
Cash (MRQ)	$8.59 M
Beta (5Y Monthly)	2.79

• Liquidity and runway: The company has $8.59 million in cash and no reported debt.
• Profitability: Reports a net loss of $50.77 million for the trailing twelve months, resulting in an EPS of –5.97.
• Operational focus: A strategic shift to the in vivo CAR-M platform aims to streamline research and development expenditures while targeting indications with significant unmet needs.
• Volatility: A beta of 2.79 indicates a higher sensitivity to market fluctuations.

Market Position and Industry Context

• Cell Therapy Sector: CAR-Macrophages represent an emerging approach alongside established CAR-T therapies in the biotechnology field.
• Unmet Needs: There is a lack of curative options for solid tumors, liver fibrosis, and various autoimmune disorders, which delineates the potential role of CAR-M as a distinct therapeutic strategy.
• Competitive Landscape: Collaborations with Moderna and academic institutions bolster Carisma’s approach to utilizing in vivo mRNA/LNP methods as opposed to ex vivo processes.
• Regulatory Path: Early-stage clinical data are required to establish efficacy and safety; FDA designations could facilitate expedited processes for development.

TL;DR

• Stock price decreased by 41.02% as of June 11, 2025, trading at $0.6547 with a volume of 12.2 million.
• A restructuring on December 9, 2024, halted the CT-0525 program, led to a 34% reduction in workforce, and refocused on the in vivo CAR-M platform.
• CT-0508 Phase 1 results published in Nature Medicine confirmed safety and anti-tumor activity; CT-1119 Phase 1 data is expected in Q4 2025.
• Collaborations with Moderna cover both oncology and autoimmune targets, with four disclosed oncology research programs and two additional programs targeting autoimmune diseases.
• Cash reserves of $8.59 million support key upcoming milestones; total market capitalization approximately $27 million; a high beta indicates potential share price volatility.