Company Summary - Calidi Biotherapeutics, Inc.

Overview

• Company Type: Clinical stage immuno-oncology company
• Focus: Developing proprietary allogeneic stem cell-based platforms and enveloped virus platforms for cancer therapy

Product Platforms

• Stem Cell Platforms:
  • Allogeneic culture-expanded mesenchymal stem cells (derived from healthy donors)
  • Neural stem cells loaded with oncolytic viruses (engineered adenoviruses such as CRAd-S-pk7)
  • Adipose-derived mesenchymal stem cells loaded with vaccinia virus (CAL1)
• Virotherapies:
  • Enveloped vaccinia virus designed to avoid immune neutralization
  • Allogeneic stem cell carriers to protect oncolytic viruses, enhance viral amplification, and modify the tumor microenvironment (TME)

Key Product Candidates

• CLD-101: Targeting high-grade gliomas (HGG), loaded into neural stem cells
• CLD-201: Internal product candidate targeting solid tumors (breast cancer, head & neck squamous cell carcinoma, soft tissue sarcomas), using stem cell delivery of vaccinia virus
• CLD-400: Enveloped vaccinia virus program for lung cancer and metastatic tumors (preclinical stage)

Technology Platforms

• NeuroNova™ Platform: Uses neural stem cells loaded with engineered adenovirus for brain gliomas
• SuperNova™ Platform: Uses adipose-derived MSCs loaded with vaccinia virus for systemic delivery against metastatic cancers
• RTNova Platform: Enveloped vaccinia virus designed to target disseminated tumors through the bloodstream

Company Operations

• Employees: 28 (as of December 31, 2024)
• Employees in R&D: 17
• Customers: Not specified
• Revenue: None reported (has not generated product sales or revenue to date)
• Net Losses: Approximately $22.2 million in 2024 and $29.2 million in 2023
• Assets: Not specified
• Market Cap: Approximately $14 million as of June 28, 2024

Regulatory & Development Status

• Regulatory Approvals: None received yet
• Clinical Trials: CLD-101 in Phase 1 for high-grade glioma; City of Hope conducting additional studies; IND applications filed for CLD-201
• Partnerships & Licenses:
  • Northwestern University (licensing for oncolytic adenovirus and trial data)
  • University of Chicago (patents for oncolytic adenoviruses with neural stem cells)
  • City of Hope (neural stem cell bank and IND transfers)

Financials

• Total Shares Outstanding: 28,467,580 (as of March 24, 2025)
• Market Capitalization (as of June 28, 2024): Approx. $14 million
• Revenue: None from product sales
• Net Income: Operating losses; approximately $22.2 million in 2024

Additional Notes

• Business Model: Focused on developing "off-the-shelf" allogeneic therapies with plans for future commercialization
• Intellectual Property: Multiple patent families covering platforms, delivery methods, and specific viral constructs, with patent protections extending into the 2030s
• Recent Transactions: Completed Business Combination in September 2023; several financings including public offerings and private placements in 2024 and 2025