PolyPid Ltd.
PYPD · Surgical & Medical Instruments & Apparatus · EDGAR filings ↗
Grade
D47Clinical-stage name with a positive pivotal SHIELD II Phase 3 readout but dire sub-quarter cash runway.
Strengths
- SHIELD II Phase 3 met primary endpoint (40% SSI reduction, p<0.005) plus all key secondaries; positive Phase 2 confirmatory
- Positive FDA pre-NDA meeting with Fast Track/Breakthrough; NDA submission starting Q1 2026
Risks
- Cash runway ~0.9 quarters (11th pct), only $6.4M cash — acute near-cash-out funding risk
- Prior D-PLEX 311 Phase 3 missed (p=0.152), and ROE -3.1/ROA -1.5 reflect deep losses
Notable findings
- Cash burnNegative free cash flow (-28.1M)
Key metrics
Return on equity
-311.4%
Return on assets
-153.2%
Current ratio
2.0×
Free cash flow
-$28M
Tangible book value
$11M
Cash & investments
$6M
Cash runway
1q
Clinical trials
| Trial | Title | Phase | Status | Primary completion |
|---|---|---|---|---|
| NCT04411199 ↗ | D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II) Surgical Site Infection, Colon Surgery | PHASE3 | Completed | 2025-04-14 |
| NCT03558984 ↗ | D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery Surgical Site Infection, Sternal Infection | PHASE3 | Terminated | 2022-10-24 |
| NCT04233424 ↗ | D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection Surgical Site Infection, Colon Surgery | PHASE3 | Completed | 2022-09-02 |
| NCT03633123 ↗ | D-PLEX 310: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection Abdominal Surgery, Colon Surgery | PHASE2 | Completed | 2019-09-06 |
| NCT02491047 ↗ | Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures Tibial Fractures, Open Fractures | NA | Completed | 2018-09-01 |
| NCT02531100 ↗ | BonyPid-500TM Bone Graft Substitute Study Peri Implantitis | NA | Completed | 2018-05-01 |
| NCT02731573 ↗ | Safety and Efficacy of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery. Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site | PHASE1/PHASE2 | Completed | 2018-02-01 |
Source: ClinicalTrials.gov (U.S. NIH) · active studies first.
Recent filings
| Form | Filed | Period | Accession |
|---|---|---|---|
| 20-F | 2026-02-25 | 2025-12-31 | 0001213900-26-020370 ↗ |
| 20-F | 2025-02-26 | 2024-12-31 | 0001213900-25-017412 ↗ |
| 20-F | 2024-03-06 | 2023-12-31 | 0001213900-24-020424 ↗ |
| 20-F | 2023-03-31 | 2022-12-31 | 0001213900-23-025399 ↗ |
| 20-F | 2022-02-28 | 2021-12-31 | 0001213900-22-009722 ↗ |
| 20-F | 2021-03-05 | 2020-12-31 | 0001213900-21-013722 ↗ |