Calidi Biotherapeutics, Inc. — Cyborg Score 2/10

Challenged
Oncology Drugs

Strategic Profile

The company's lead candidate CLD-401 is a systemically delivered oncolytic virus designed to express IL-15 superagonist only in the tumor microenvironment and is currently in IND-enabling studies, with clinical entry expected following IND filing by end of 2026. The RedTail platform has been expanded with a new approach of in situ T-cell engagers.

Cyborg Score Rationale

Calidi is pre-revenue, posting a Q1 2026 net loss of $4.1 million with operating expenses of $4.2 million, though this represented improvement from a $5.1 million loss a year earlier. Management discloses substantial doubt about continuing operations within 12 months, with future viability dependent on raising additional capital.

Top Insights

  • RedTail platform demonstrated in clinically relevant immunocompetent models and human immune assays that it prevents immune clearance after systemic administration with high tumor specificity and can express genetic medicines at the tumor site at levels comparable to localized dosing while avoiding systemic exposure (2025 data).
  • Cash and restricted cash totaled $6.9 million at Q1 2026 end with operating cash outflows of $4.1 million per quarter, implying short cash runway without new funding.
  • The company funded Q1 2026 operations mainly through equity offerings, including a March 2026 marketed public offering.
  • Calidi called a 2026 annual shareholder meeting on June 12, 2026 to approve a 1-for-2 to 1-for-16 reverse stock split at board discretion, signaling potential share restructuring.

Named Competitors

  • Oncolytic virus platform — Oncolytic immunotherapy for solid tumors
  • Oncolytic virus platform — Systemically delivered oncolytic viruses for cancer
  • Bispecific T-cell engagers — BiTE platform and antibody therapeutics
  • CAR-T cell therapy — Cell-based immunotherapy for oncology

Recent Developments

  • (June 2026) Appointed Corsee Sanders, Ph.D., former Genentech/Roche and Celgene executive, to Board of Directors as independent director
  • (April 2026) Presented new preclinical data on lead asset CLD-401 demonstrating IL-15 superagonist expression and tumor microenvironment remodeling at AACR Annual Meeting
  • (March 2026) Completed marketed public equity offering to fund operations
  • (May 2026) Reported Q1 2026 results with $6.9 million cash balance and management disclosure of substantial going-concern doubt within 12 months

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