PolyPid Ltd.
PYPD evidence brief
What we can confirm
- Market Cap:
- $107.9M
What it means
What to watch
Prepared research question
What matters most for PYPD—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · PYPD
PolyPid Ltd. (PYPD) is a late-stage biopharmaceutical company developing D-PLEX100, a product candidate for preventing surgical site infections, with an FDA PDUFA date of November 28, 2026, and a commercialization partnership with Azurity Pharmaceuticals.
Key risk: Cash runway risk
Market Cap
$107.9M
Cash Runway
—
Lead Asset
—
Next Catalyst
—
Financial data as of Dec 31, 2025.
Tracking 5 clinical trials for PolyPid Ltd..
PolyPid Ltd. (PYPD) is a late-stage biopharmaceutical company developing D-PLEX100, a product candidate for preventing surgical site infections, with an FDA PDUFA date of November 28, 2026, and a commercialization partnership with Azurity Pharmaceuticals.
- D-PLEX100 met its primary efficacy endpoint in the Phase 3 SHIELD II trial, demonstrating a 58% reduction in surgical site infections [news · 2025-08-13].
- FDA accepted the NDA for D-PLEX100 with Priority Review; PDUFA goal date is November 28, 2026 [news · 2026-08-12].
- PolyPid entered an exclusive U.S. and Canada commercialization partnership with Azurity Pharmaceuticals, with $30 million in upfront and near-term milestones achieved and over $290 million in additional milestones plus tiered royalties [news · 2026-08-12].
- Cash & equivalents were $6.4M as of 2025-12-31 [sec].
- The company also unveiled a Long-Acting GLP-1 Receptor Agonists Delivery Platform targeting the obesity and diabetes market [news · 2025-08-13].
What works
- D-PLEX100 achieved a statistically significant 58% reduction in surgical site infections in the Phase 3 SHIELD II trial, supporting its efficacy [news · 2025-08-13].
- The FDA granted Priority Review for the D-PLEX100 NDA, with a PDUFA date approximately one quarter ahead of prior guidance, indicating regulatory interest [news · 2026-08-12].
- The Azurity partnership provides $30 million in upfront and near-term milestones, plus a pathway to over $290 million in additional milestones and tiered royalties, strengthening commercialization prospects [news · 2026-08-12].
What to weigh
- Cash & equivalents were only $6.4M as of 2025-12-31, which may limit operational runway without additional milestones or financing [sec].
- The company has no approved products and is entirely dependent on the successful regulatory approval and commercial launch of D-PLEX100 [news · 2026-08-12].
- The GLP-1 delivery platform is early-stage and has not yet generated clinical data, adding pipeline risk [news · 2025-08-13].
From the filings
Quoted directly from source documents.
D-PLEX100 met its primary endpoint with a 58% reduction in SSI
“Positive Phase 3 SHIELD II Trial Results - D-PLEX₁₀₀ successfully met its primary efficacy endpoint and demonstrated 58% reduction in SSI”
News · August 13, 2025
FDA accepted NDA with Priority Review and set PDUFA date
“FDA Accepted D-PLEX₁₀₀ NDA with Priority Review; PDUFA Goal Date of November 28, 2026”
News · August 12, 2026
Azurity partnership includes $30M upfront and near-term milestones
“Exclusive U.S. and Canada Commercialization Partnership with Azurity Pharmaceuticals; $30 Million in Upfront and Near-Term Milestones Achieved Following NDA Acceptance”
News · August 12, 2026
Catalyst timeline
- 2016-10-12 · Phase 2 start for D-PLEX in sternal infection prevention — Initiated a Phase Ib/II study for D-PLEX in cardiac surgery patients.
- 2018-10-04 · Phase 2 start for D-PLEX in abdominal surgery infection prevention — Began a Phase II study for D-PLEX in post-abdominal surgery incisional infection.
- 2019-12-17 · Phase 3 start for D-PLEX — Launched the pivotal Phase 3 SHIELD II trial for D-PLEX.
Risks & what to watch (3)›
Key risks
- Cash runway risk — With only $6.4M cash as of 2025-12-31, the company may need additional funding before potential D-PLEX100 revenue [sec].
- Single-product dependency — PolyPid has no approved products; all value hinges on D-PLEX100 regulatory and commercial success [news · 2026-08-12].
- GLP-1 platform early stage — The long-acting GLP-1 delivery platform is preclinical and unvalidated, adding pipeline uncertainty [news · 2025-08-13].
What to watch
- FDA decision on D-PLEX100 NDA by PDUFA date November 28, 2026 [news · 2026-08-12].
- Commercial launch execution by Azurity Pharmaceuticals in early 2027, if approved [news · 2026-08-12].
- Progress of the GLP-1 receptor agonists delivery platform toward clinical development [news · 2025-08-13].
- Financial updates in upcoming quarterly reports, particularly cash position and milestone payments from Azurity [news · 2026-08-12].
Sources: Catalysts · News · Generated October 12, 2026 · How we verify sources →
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Evidence & data
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
19
Total value held
$13.7M
| Holder | Shares | Value |
|---|---|---|
| aigh capital management llc | 1,593,587 | $7.0M |
| rosalind advisors, inc. | 597,926 | $2.6M |
| dafna capital management llc | 207,900 | $911K |
| morgan stanley | 176,892 | $775K |
| j. goldman & co lp | 149,499 | $655K |
| adar1 capital management, llc | 103,950 | $455K |
| symmetry peak management llc | 87,193 | $382K |
| citadel advisors llc | 57,769 | $253K |
| lumbard & kellner, llc | 38,200 | $167K |
| xtx topco ltd | 29,463 | $129K |
Showing top 10 of 19 institutional holders of PolyPid Ltd.. Open the full 13F history after sign-in.
Short Interest
as of May 22, 2026- % of float
- 0.2%
- Days to cover
- 0.5
- Shares short
- 30,140
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
PYPD short interestFrequently asked questions
What is the AI investment thesis for PolyPid Ltd.?
PolyPid Ltd. (PYPD) is a late-stage biopharmaceutical company developing D-PLEX100, a product candidate for preventing surgical site infections, with an FDA PDUFA date of November 28, 2026, and a commercialization partnership with Azurity Pharmaceuticals.
Who is the CEO of PolyPid Ltd.?
Ms. Dikla Czaczkes Akselbrad is the chief executive officer of PolyPid Ltd. (PYPD).
Where is PolyPid Ltd. headquartered?
PolyPid Ltd. (PYPD) is headquartered in Petah Tikva, Israel.
What therapeutic areas does PolyPid Ltd. focus on?
PolyPid Ltd. develops therapies across Oncology, Cardiovascular, Infectious Disease.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.