PYPD PolyPid Ltd.
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.
Actionable Insight
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.
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
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3293895 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
|
Jun 1, 2026
8d ago
|
6-K
| $5.07 $4.50 | ▼ −11.24% | ▼ −8.49% | $4.62 (−8.88%) |
|
Jun 1, 2026
8d ago
|
Press Release
| $5.07 $4.50 | ▼ −11.24% | ▼ −8.49% | $4.62 (−8.88%) |
|
May 20, 2026
20d ago
|
Press Release
| $4.85 $4.77 | ▼ −1.65% | ▼ −2.89% | $4.62 (−4.74%) |
|
May 13, 2026
27d ago
|
6-K
| $4.22 $4.76 | ▲ +12.80% | ▲ +13.95% | $4.62 (+9.48%) |
|
May 13, 2026
27d ago
|
Press Release
| $4.22 $4.76 | ▲ +12.80% | ▲ +13.95% | $4.62 (+9.48%) |
|
Apr 13, 2026
8w ago
|
Press Release
| $4.40 $4.69 | ▲ +6.59% | ▲ +3.30% | $4.62 (+5.00%) |
|
Apr 6, 2026
9w ago
|
3
| $4.24 $4.40 | ▲ +3.77% | ▼ −0.36% | $4.62 (+8.96%) |
|
Mar 31, 2026
10w ago
|
6-K
| $4.38 $4.23 | ▼ −3.42% | ▼ −7.37% | $4.62 (+5.48%) |
|
Mar 31, 2026
10w ago
|
Press Release
| $4.38 $4.23 | ▼ −3.42% | ▼ −7.37% | $4.62 (+5.48%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Try SecBot Free Coming soon: SecBot Pro with alerts, watchlists, and API access