Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage biotechnology company developing oncolytic virus-based therapies designed to deliver genetic medicines to metastatic cancer sites. The company generates no product revenue; operations are funded through equity and debt financings, with grant income recorded as a non-operating item in FY2024. Calidi's proprietary RedTail platform features an engineered enveloped oncolytic virus intended for systemic delivery, shielding the virus from immune clearance to reach tumor sites and deliver genetic payloads such as IL-15 superagonist to the tumor microenvironment. Its lead compound, CLD-401, had an IND filing for a Phase I trial targeted by end of 2026 as of the 10-K filed March 27, 2026. Legacy platforms include SuperNova and NeuroNova, also built on oncolytic virus technology. As of December 31, 2025, Calidi held approximately $5.6 million in cash and carried an accumulated deficit of approximately $141.6 million, with management disclosing substantial doubt about the company's ability to continue as a going concern.

Revenue model

Pre-revenue stage. No product sales as of FY2025. Cash is sourced from equity offerings, including a March 2026 public offering that raised approximately $6.0 million in gross proceeds. Grant income appears as a non-operating line item. The company operates entirely on external financing.

Products and services

RedTail platform: engineered enveloped oncolytic virus for systemic delivery to metastatic tumor sites; lead candidate CLD-401 delivering IL-15 superagonist to the tumor microenvironment, IND filing targeted by end of 2026. Legacy SuperNova platform: oncolytic virus for oncology. Legacy NeuroNova platform: oncolytic virus technology. All candidates are pre-commercial as of the filing date.

Customers and end markets

No commercial customers as of FY2025. End market is oncology, specifically metastatic cancer. Clinical trial participants are the current subjects of the company's programs. Regulatory engagement involves the FDA (United States), EMA (European Union), and MHRA (United Kingdom).

Value-chain role

Drug developer and platform technology owner. Manufacturing is contracted to third-party contract manufacturers, with Calidi retaining ultimate regulatory responsibility. The company conducts preclinical research and sponsors clinical trials. It holds third-party licensing agreements for certain technologies.

Geographic exposure

Headquartered in the United States. Regulatory strategy references FDA (U.S.), EMA (EU), and MHRA (UK) pathways, including the UK's Innovative Licensing and Access Pathway. No commercial geographic revenue mix disclosed.

Source: SEC 10-K, filed 2026-03-27

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