The positive FDA meeting for CLN-049 and advancement of autoimmune programs toward Phase 2 are significant pipeline catalysts. Monitor upcoming data readouts: CLN-978 multi-dose RA data in Q3 2026, SLE data in Q4 2026, and CLN-049 Phase 1 update in Q4 2026. The zipalertinib PDUFA date in February 2027 is a key milestone for potential first product revenue.
Price Chart
Executive Summary
Cullinan Therapeutics reported Q2 2026 EPS of -$0.81, beating consensus of -$0.85 by 4.9%, while net loss narrowed to $53.7M from $70.1M YoY. The key catalyst is the positive End-of-Phase 1 FDA meeting for CLN-049, enabling a potentially registrational Phase 2 study in R/R AML starting Q3 2026, alongside advancing CLN-978 and velinotamig autoimmune programs toward Phase 2 expansion in early 2027. Cash of $356M provides runway into 2029, but the company remains pre-revenue with no approved products.
Key Financial Metrics
Key Facts
- EPS of -$0.81 beat consensus of -$0.85 (4.9% beat)
- Net loss narrowed to $53.7M from $70.1M YoY, a 23.4% improvement
- Cash and investments of $356.0M as of June 30, 2026, providing runway into 2029
- Positive End-of-Phase 1 FDA meeting for CLN-049; potentially registrational Phase 2 study in R/R AML to begin Q3 2026
- CLN-978 and velinotamig autoimmune programs advancing toward Phase 2 expansion in early 2027
- R&D expenses decreased to $44.4M from $61.0M YoY, reflecting disciplined spending
- Zipalertinib NDA accepted by FDA with PDUFA date of February 27, 2027; Cullinan eligible for $30M-$100M milestones plus 50/50 U.S. profit share
Financial Impact
Net loss improved 23.4% YoY to $53.7M; cash burn of ~$83M in H1 2026; $356M cash runway into 2029
Risk Factors
- Pre-revenue clinical-stage company with no approved products
- Clinical trial risks across multiple pipeline programs
- Dependence on partner Taiho for zipalertinib development and commercialization
- Cash burn rate may accelerate with Phase 2 studies
- Competitive T cell engager landscape in autoimmune diseases
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-336700 |
| Document: cgem-20260806.htm | 0001193125-26-336700 |
| Document: 0001193125-26-336700-index-headers.html | 0001193125-26-336700 |
| Document: 0001193125-26-336700-index.html | 0001193125-26-336700 |
| Document: 0001193125-26-336700.txt | 0001193125-26-336700 |
| 8-K Data (Synthetic) | 0001193125-26-336700 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 1, 2026 24d ago | Press Release | $15.51 | awaiting T+60 | — | $14.54 (−6.25%) |
Sep 24, 2026 4w ago | 8-K | $15.44 | awaiting T+60 | — | $14.54 (−5.83%) |
Sep 24, 2026 4w ago | Press Release | $15.44 | awaiting T+60 | — | $14.54 (−5.83%) |
Sep 22, 2026 4w ago | Institutional Cluster | $21.67 | awaiting T+60 | — | $14.54 (−32.90%) |
Sep 14, 2026 6w ago | 8-K | $20.40 | awaiting T+60 | — | $14.54 (−28.73%) |
Aug 6, 2026 11w ago | 8-K | $17.95 | awaiting T+60 | — | $14.54 (−19.00%) |
Jun 11, 2026 19w ago | Institutional Cluster | $12.98 $21.69 | ▲ +67.10% | ▲ +63.28% | $14.54 (+12.02%) |
Jun 10, 2026 19w ago | Press Release | $12.05 $22.09 | ▲ +83.32% | ▲ +77.15% | $14.54 (+20.66%) |
Jun 8, 2026 20w ago | 8-K | $13.28 $22.33 | ▲ +68.15% | ▲ +64.64% | $14.54 (+9.49%) |
May 19, 2026 22w ago | Press Release | $14.18 $19.64 | ▲ +38.55% | ▲ +32.26% | $14.54 (+2.57%) |
US Market Status
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