The NDA submission completion and PDUFA target action date (expected Q1 2027) are the next major catalysts. Late-stage partnership discussions suggest potential near-term deal announcement. Monitor cash runway — $10.9M covers operations into H2 2026, but a partnership or financing may be needed to fund through potential approval.
Price Chart
Executive Summary
PolyPid reported Q1 2026 net loss of $7.7M ($0.35/share), beating consensus EPS of -$0.43 by 18.6%. The company initiated rolling NDA submission for D-PLEX100 to the FDA, with completion expected imminently, and is in late-stage U.S. commercial partnership discussions. Cash of $10.9M is expected to fund operations into H2 2026.
Key Financial Metrics
Key Facts
- Q1 2026 net loss $7.7M ($0.35/share) vs consensus -$0.43 — 18.6% beat
- Rolling NDA submission for D-PLEX100 initiated March 30, 2026; completion imminent
- FDA granted small business waiver of ~$4.3M PDUFA fee
- U.S. commercial partnership discussions in late stages
- EMA meetings scheduled Q2 2026; MAA submission planned Q3 2026
- Cash, cash equivalents, and short-term deposits $10.9M as of March 31, 2026
- Warrant exercises generated ~$4.0M in Q1 2026
- Remaining $0.8M venture loan fully repaid in May 2026 — no debt outstanding
- New SHIELD II data showed 64% relative risk reduction in ASEPSIS score >20 (p=0.0103)
Financial Impact
EPS beat of $0.08 vs consensus; cash burn ~$2M in Q1; $4.3M PDUFA fee waived
Risk Factors
- Cash runway only into H2 2026 — may require dilutive financing if partnership delays
- FDA approval not guaranteed; D-PLEX100 has no approved precedent
- Commercial partnership may not materialize on favorable terms
- Stock is micro-cap with low liquidity — high volatility expected on binary events
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3293895 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 15, 2026 11d ago | Press Release | $4.90 | awaiting T+60 | — | $5.29 (+7.96%) |
Oct 1, 2026 25d ago | 6-K | $5.37 | awaiting T+60 | — | $5.29 (−1.49%) |
Oct 1, 2026 25d ago | Press Release | $5.37 | awaiting T+60 | — | $5.29 (−1.49%) |
Oct 1, 2026 25d ago | 6-K | $5.37 | awaiting T+60 | — | $5.29 (−1.49%) |
Oct 1, 2026 25d ago | Press Release | $5.37 | awaiting T+60 | — | $5.29 (−1.49%) |
Aug 12, 2026 10w ago | 6-K | $4.78 | awaiting T+60 | — | $5.29 (+10.67%) |
Aug 12, 2026 10w ago | 6-K | $4.84 | awaiting T+60 | — | $5.29 (+9.30%) |
Aug 12, 2026 10w ago | Press Release | $4.84 | awaiting T+60 | — | $5.29 (+9.30%) |
Jul 29, 2026 12w ago | 6-K | $4.08 $5.13 | ▲ +25.74% | ▲ +21.01% | $5.29 (+29.66%) |
Jul 21, 2026 13w ago | 6-K | $3.74 $4.83 | ▲ +29.14% | ▲ +26.30% | $5.29 (+41.44%) |
US Market Status
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