The imminent completion of the NDA submission and late-stage partnership discussions are key catalysts. Monitor for NDA acceptance and PDUFA date confirmation, which would set a clear regulatory decision timeline for H1 2027. The cash runway into H2 2026 suggests potential financing needs before commercialization, but the PDUFA waiver and warrant exercises have extended the runway.
Price Chart
Executive Summary
PolyPid reported Q1 2026 financial results and provided a corporate update. The company initiated an NDA submission to the FDA for its lead product D-PLEX, with completion expected imminently, and is in late-stage discussions for a U.S. commercial partnership. Net loss narrowed to $7.7M ($0.35/share) from $8.3M ($0.70/share) in Q1 2025, while cash burn was modest at ~$2M, leaving $10.9M in cash expected to fund operations into H2 2026.
Key Facts
- Initiated NDA submission to FDA for D-PLEX under rolling review; completion expected imminently
- FDA granted small business waiver of ~$4.3M PDUFA fee for D-PLEX NDA
- U.S. commercial partnership discussions in late stages
- Net loss of $7.7M ($0.35/share) vs $8.3M ($0.70/share) in Q1 2025
- Cash, cash equivalents, and short-term deposits of $10.9M as of March 31, 2026
- Repaid remaining $0.8M venture loan in early May 2026; no remaining debt
- Warrant exercises generated ~$4.0M in Q1 2026
- New SHIELD II Phase 3 data showed 64% relative risk reduction in severe wound infections (p=0.0103)
- MAA submission to EMA planned for Q3 2026
- PDUFA target action date expected in Q1 2027
Financial Impact
Net loss improved by $0.6M YoY; cash burn of ~$2M in Q1; $4.0M from warrant exercises; $4.3M PDUFA fee waiver preserved capital
Risk Factors
- Cash runway only into H2 2026; may require additional financing before potential approval
- Regulatory risk: FDA could reject or require additional trials for D-PLEX
- Dilution risk: 19.2M shares outstanding, up from 18.2M at year-end 2025, with warrants still outstanding
- Commercialization risk: no revenue yet; partnership terms and launch execution uncertain
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001213900-26-055449 |
| Document: ea0290315-6k_polypid.htm | 0001213900-26-055449 |
| Document: 0001213900-26-055449-index-headers.html | 0001213900-26-055449 |
| Document: 0001213900-26-055449-index.html | 0001213900-26-055449 |
| Document: 0001213900-26-055449.txt | 0001213900-26-055449 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 15, 2026 12d ago | Press Release | $4.90 | awaiting T+60 | — | $5.74 (+17.24%) |
Oct 1, 2026 26d ago | 6-K | $5.37 | awaiting T+60 | — | $5.74 (+6.98%) |
Oct 1, 2026 26d ago | Press Release | $5.37 | awaiting T+60 | — | $5.74 (+6.98%) |
Oct 1, 2026 26d ago | 6-K | $5.37 | awaiting T+60 | — | $5.74 (+6.98%) |
Oct 1, 2026 26d ago | Press Release | $5.37 | awaiting T+60 | — | $5.74 (+6.98%) |
Aug 12, 2026 10w ago | 6-K | $4.78 | awaiting T+60 | — | $5.74 (+20.19%) |
Aug 12, 2026 10w ago | 6-K | $4.84 | awaiting T+60 | — | $5.74 (+18.70%) |
Aug 12, 2026 10w ago | Press Release | $4.84 | awaiting T+60 | — | $5.74 (+18.70%) |
Jul 29, 2026 12w ago | 6-K | $4.08 $5.13 | ▲ +25.74% | ▲ +21.01% | $5.74 (+40.81%) |
Jul 21, 2026 14w ago | 6-K | $3.74 $4.83 | ▲ +29.14% | ▲ +26.30% | $5.74 (+53.61%) |
US Market Status
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