The positive FDA pre-IND alignment for CLD-401 is a meaningful derisking event for the lead program, but the company's cash runway of ~$4.3M is likely insufficient to reach the Q1 2027 first-patient-dosing milestone without additional financing. Monitor for capital raise announcements (dilutive offering or partnership) which are highly probable given the $4M market cap and ongoing burn rate.
Price Chart
Executive Summary
Calidi Biotherapeutics reported Q2 2026 results with a net loss of $4.2M ($2.94/share), narrowing from $5.7M ($31.75/share) in Q2 2025, driven by a 48% reduction in G&A expenses. The key catalyst is positive pre-IND feedback from the FDA for lead candidate CLD-401, aligning on development strategy toward a first-in-human study targeting Q1 2027. Cash burn continues with $4.1M cash on hand vs $5.6M at year-end 2025, highlighting near-term financing risk for a $4M market cap pre-revenue biotech.
Key Financial Metrics
Key Facts
- Net loss attributable to common stockholders was $4.2M ($2.94/share) for Q2 2026 vs $5.7M ($31.75/share) in Q2 2025.
- Cash and restricted cash totaled $4.3M as of June 30, 2026, down from $5.8M at December 31, 2025.
- Received positive pre-IND feedback from FDA for CLD-401, with agreement on CMC, non-clinical programs, and first-in-human study design.
- G&A expenses reduced by $1.5M (48%) year-over-year to $1.6M in Q2 2026.
- Board strengthened with addition of Corsee Sanders, Ph.D., former Genentech/Roche and Celgene executive.
- Completed a 1-for-16 reverse stock split in July 2026.
- Weighted average shares outstanding were 1.4M in Q2 2026 vs 180K in Q2 2025, reflecting significant dilution.
Financial Impact
Net loss of $4.2M on zero revenue; cash burn of ~$1.5M/quarter; $4.3M cash runway likely <3 quarters
Risk Factors
- Cash runway of ~$4.3M likely insufficient to fund operations through Q1 2027 first-patient dosing without additional capital
- Pre-revenue clinical-stage biotech with no approved products or revenue stream
- Significant dilution risk given low market cap ($4M) and need for financing
- Preclinical data may not translate to clinical success; CLD-401 has not yet entered human trials
- Reverse stock split (1-for-16) completed July 2026 may indicate listing compliance pressure
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001493152-26-037840 |
| Document: form8-k.htm | 0001493152-26-037840 |
| Document: 0001493152-26-037840-index-headers.html | 0001493152-26-037840 |
| Document: 0001493152-26-037840-index.html | 0001493152-26-037840 |
| Document: 0001493152-26-037840.txt | 0001493152-26-037840 |
| 8-K Data (Synthetic) | 0001493152-26-037840 |
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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