Calidi Biotherapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Reported a net loss of $3.6 million for the three months ended September 30, 2026, compared to a net loss of $10.8 million for the same period in 2025, which included a $5.7 million non-cash charge for a deemed dividend on warrants.
• Research and development expenses increased to $2.7 million in Q3 2026 from $2.4 million in Q3 2025.
• General and administrative expenses decreased to $1.6 million in Q3 2026 from $2.7 million in Q3 2025, representing a 39% reduction year-over-year.
• Total operating expenses were $4.3 million for Q3 2026 versus $5.0 million for Q3 2025.
• Cash and cash equivalents stood at $3.9 million as of September 30, 2026, down from $5.6 million as of December 31, 2025.
• Restricted cash was $0.2 million as of September 30, 2026, compared to $0.2 million as of December 31, 2025.
• Total assets decreased to $5.5 million as of September 30, 2026, from $8.9 million as of December 31, 2025.
• Total liabilities decreased to $3.9 million as of September 30, 2026, from $5.1 million as of December 31, 2025.
• Net loss per share (basic and diluted) was $(1.47) for Q3 2026, compared to $(35.25) for Q3 2025.

Guidance and Future Outlook:

• The company plans to dose the first patient in the second half of 2027.
• A restructuring plan executed on November 6, 2026, is expected to save $3 million on an annualized basis to extend the company's cash runway.
• The company aims to reduce costs and preserve capital while pursuing additional financing.

Business Segments and Product Lines:

• Advanced the development of CLD-401, the lead candidate from the RedTail platform, towards the clinic.
• Presented preclinical data at the ESMO Congress 2026 showing CLD-401 achieved complete tumor eradication in 80% of EMT6 breast cancer tumor-bearing mice versus 0% in the control arm.
• CLD-401 demonstrated antitumor activity in an MB49 bladder cancer model with both systemic intravenous and localized intratumoral administration.
• Presented data on the in situ T-cell engager (TCE) platform, including candidates CLD-501 (TROP-2-targeted) and CLD-502 (EpCAM-targeted).
• The in situ TCE platform generated approximately 10 ng/mL of EpCAM-targeted TCE directly within tumors following intravenous delivery.
• CLD-501 and CLD-502 demonstrated antigen-dependent, dose-responsive T-cell mediated cytotoxicity.
• CLD-401 is currently in IND-enabling studies targeting metastatic non-small cell lung cancer, head and neck cancer, and other tumor types.

Market and Competitive Landscape:

• No specific market share, competitor names, or market size data were provided in the press release.

Risks and Challenges:

• Risks include the inability to raise sufficient capital to support current and anticipated clinical trials.
• Early clinical trial results may not predict final results, and clinical outcomes may change with more patient data.
• There is a risk of not receiving FDA approval for therapeutic candidates.
• Potential delays or cost overruns in research and development activities and preclinical studies.
• Uncertainty regarding regulatory feedback and interactions with the FDA.
• Risks related to manufacturing, supply chain matters, and changes in business or economic conditions.

Management Commentary and Tone:

• CEO Eric Poma, Ph.D., stated the company continued to advance the RedTail platform for systemic and local delivery and redefine the potential of oncolytic viruses and genetic medicine.
• Management highlighted that CLD-401 demonstrated "remarkable anti-tumor activity with systemic administration in syngeneic tumor models."

Other Key Points:

• Received $1.2 million in gross proceeds from an at-the-market registered direct offering that closed on September 18, 2026.
• Executed a restructuring plan on November 6, 2026, predominantly through a reduction in headcount.
• General and administrative expenses were reduced by $3.6 million (42%) for the nine months ended September 30, 2026, versus the same period in the prior year.
• The company operates the RedTail platform, an engineered enveloped oncolytic virus designed for systemic delivery to metastatic sites.
• The company is headquartered in San Diego, California.