Monitor for upcoming IND filing for CLD-401 by year-end 2026 and any partnership announcements, which could provide validation and non-dilutive funding for clinical advancement.
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Executive Summary
Calidi Biotherapeutics presented preclinical data at AACR demonstrating its RedTail platform's ability to simultaneously activate T-cells and express T-cell engagers in the tumor microenvironment, with an IND for lead candidate CLD-401 expected by end of 2026. The data supports a novel approach to overcoming limitations of T-cell engagers in solid tumors.
Key Facts
- Presented new preclinical data at AACR 2026 on RedTail platform showing in situ expression of T-cell engagers and IL-15 superagonist in tumor microenvironment
- Lead candidate CLD-401 (IL-15 SA-expressing) in IND-enabling studies, with filing expected by end of 2026
- Developing CLD-501 targeting TROP2 using tumor-restricted expression to limit off-tumor toxicity
- Platform enables systemic delivery while confining therapeutic expression to tumors, addressing key challenge in solid tumor immunotherapy
- Company pursuing additional targets including EGFR, EpCAM, and Nectin-4
Financial Impact
No immediate financial impact; potential long-term value creation if clinical development succeeds
Risk Factors
- Preclinical data may not translate to clinical efficacy
- Risk of clinical trial delays or failure to secure sufficient capital for development
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3276929 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 25, 2026 4w ago | 8-K | $1.07 | awaiting T+20 | — | $0.6450 (+39.72%) |
Sep 22, 2026 4w ago | 8-K | $1.09 $0.7680 | ▲ +29.54% | ▲ +30.23% | $0.6450 (+40.83%) |
Sep 17, 2026 5w ago | 424B5 | $1.10 $0.8370 | ▲ +23.91% | ▲ +24.11% | $0.6450 (+41.36%) |
Aug 13, 2026 10w ago | 8-K | $1.59 $1.22 | ▼ −23.27% | ▼ −21.28% | $0.6450 (−59.43%) |
Aug 13, 2026 10w ago | Press Release | $1.59 $1.22 | ▼ −23.27% | ▼ −21.28% | $0.6450 (−59.43%) |
Jun 29, 2026 16w ago | 3 | $0.1700 $0.0933 | ▼ −45.12% | ▼ −42.80% | $0.6450 (+279.41%) |
May 26, 2026 21w ago | Press Release | $2.83 $2.51 | ▼ −11.30% | ▼ −9.24% | $0.6450 (−77.22%) |
May 22, 2026 22w ago | Press Release | $2.83 $2.51 | ▲ +11.30% | ▲ +9.24% | $0.6450 (+77.22%) |
Apr 20, 2026 27w ago | Press Release | $0.2500 $0.1830 | ▼ −26.80% | ▼ −31.00% | $0.6450 (+158.00%) |
Mar 27, 2026 30w ago | Press Release | $0.2390 $0.2240 | ▼ −6.28% | ▼ −18.87% | $0.6450 (+169.87%) |
US Market Status
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