The FDA alignment de-risks CLD-401's path to clinic, but the company will likely need to raise capital before Q1 2027 to fund the Phase 1 study. Monitor for financing announcements (dilutive offering or partnership) and any further regulatory updates. The stock's OTC listing and tiny market cap amplify volatility on news.
Price Chart
Executive Summary
Calidi Biotherapeutics reported Q2 2026 results with a narrowed net loss of $4.2M ($2.94/share) vs $5.7M ($31.75/share) a year ago, driven by a 48% reduction in G&A. The key catalyst is positive pre-IND FDA feedback for lead candidate CLD-401, aligning on development toward a first-in-human study targeting Q1 2027. However, cash burn continues ($4.1M on hand vs $5.6M at year-end 2025), highlighting near-term financing risk for this $4M market cap pre-revenue biotech.
Key Financial Metrics
Key Facts
- Positive pre-IND FDA feedback for CLD-401, agreeing on CMC, non-clinical, and first-in-human study design
- Net loss narrowed to $4.2M ($2.94/share) in Q2 2026 from $5.7M ($31.75/share) in Q2 2025
- G&A expenses reduced 48% YoY to $1.6M
- Cash and restricted cash $4.3M as of June 30, 2026, down from $5.8M at Dec 31, 2025
- Added Corsee Sanders, Ph.D. (former Genentech/Roche/Celgene executive) to Board of Directors
- First patient dosing for CLD-401 targeted for Q1 2027
Financial Impact
Net loss of $4.2M; cash burn rate implies limited runway beyond ~3 quarters at current spend; no revenue
Risk Factors
- Cash runway insufficient to reach first-in-human study without additional financing
- Dilution risk from potential equity offering given $4M market cap
- Clinical development risk — early FDA feedback does not guarantee eventual approval
- Low liquidity and OTC listing may exacerbate price swings
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3344982 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 25, 2026 4w ago | 8-K | $1.07 $0.6400 | ▲ +40.19% | ▲ +40.16% | $0.6400 (+40.19%) |
Sep 22, 2026 4w ago | 8-K | $1.09 $0.7680 | ▲ +29.54% | ▲ +30.23% | $0.6400 (+41.28%) |
Sep 17, 2026 5w ago | 424B5 | $1.10 $0.8370 | ▲ +23.91% | ▲ +24.11% | $0.6400 (+41.82%) |
Aug 13, 2026 10w ago | 8-K | $1.59 $1.22 | ▼ −23.27% | ▼ −21.28% | $0.6400 (−59.75%) |
Aug 13, 2026 10w ago | Press Release | $1.59 $1.22 | ▼ −23.27% | ▼ −21.28% | $0.6400 (−59.75%) |
Jun 29, 2026 17w ago | 3 | $0.1700 $0.0933 | ▼ −45.12% | ▼ −42.80% | $0.6400 (+276.47%) |
May 26, 2026 21w ago | Press Release | $2.83 $2.51 | ▼ −11.30% | ▼ −9.24% | $0.6400 (−77.40%) |
May 22, 2026 22w ago | Press Release | $2.83 $2.51 | ▲ +11.30% | ▲ +9.24% | $0.6400 (+77.40%) |
Apr 20, 2026 27w ago | Press Release | $0.2500 $0.1830 | ▼ −26.80% | ▼ −31.00% | $0.6400 (+156.00%) |
Mar 27, 2026 30w ago | Press Release | $0.2390 $0.2240 | ▼ −6.28% | ▼ −18.87% | $0.6400 (+167.78%) |
US Market Status
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