PolyPid Ltd. (PYPD)
NASDAQ:PYPD
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Earnings Data
Report Date
Aug 12, 2026Before Open (Confirmed)
Period Ending
2026 (Q2)Consensus EPS Forecast
-0.37Last Year’s EPS
-0.78Same Quarter Last Year
Strong Buy
Based on 3 Analysts Ratings
Earnings Call Summary
Earnings Call Sentiment|Positive
The call conveyed substantial forward momentum: a rolling NDA is underway with Fast Track/Breakthrough designations, strong SHIELD II efficacy and ~30-day PK data, manufacturing and inspection preparedness, late-stage U.S. partnership discussions, progress on a planned EU MAA, and elimination of outstanding loan liabilities. Major risks highlighted include a limited cash runway into H2 2026, the NDA not yet fully complete or accepted, dependence on a not-yet-finalized commercial partner, and uncertainty around FDA inspection timing (partly due to geopolitical factors). Overall, the company presented multiple near-term value-driving milestones balanced by execution and funding risks.Company Guidance
Rolling NDA Submission Initiated
PolyPid initiated a rolling NDA submission to the FDA on March 30, 2026; CMC and nonclinical modules plus administrative modules were submitted and the clinical module is expected imminently, completing the full NDA filing.
Regulatory Designations and Potential Priority Review
D-PLEX100 holds Fast Track and Breakthrough Therapy designations, making it eligible for FDA priority review which would shorten the review period from 10 months to approximately 6 months if granted.
PDUFA Fee Waiver
The FDA granted a small business waiver for the PDUFA fee, approximately $4.3 million, reducing near-term cash burden and allowing more resources to be allocated to commercialization preparation.
Positive Clinical and PK Data
SHIELD II asepsis score analysis showed a 64% relative risk reduction in patients with an asepsis score >20 (p = 0.0103), indicating reduced severity of wound events; additional PK data demonstrated sustained controlled release of doxycycline for ~30 days in the largest human data set to date.
Manufacturing and Inspection Readiness
Company manufactures in its own facility (not a CMO), has passed four consecutive GMP inspections including the Israeli Ministry of Health, conducted multiple mock inspections with industry quality veterans, and reports no major unresolved findings ahead of anticipated FDA inspection.
U.S. Commercial Partnership Progress
Strategic partnership discussions for U.S. commercialization are described as in late stages with active negotiation of definitive agreement terms and a target commercial launch in Q1 2027 (partner expected to handle commercialization/hospital sales presence).
European Regulatory Pathway Advancing
Meetings with EMA Rapporteur and Co-Rapporteur are scheduled this quarter to align on MAA content/structure, with a planned MAA submission under centralized procedure in Q3 2026, subject to meeting outcomes.
Improved Loss and Debt Position
Net loss improved to $7.7 million ($0.35/sh) in Q1 2026 from $8.3 million ($0.70/sh) in Q1 2025 (≈7.2% reduction). Subsequent to quarter end, the company completed full repayment of its remaining loan facility and reports no remaining loan-related liabilities.
PYPD Earnings History
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed
PYPD Earnings-Related Price Changes
Report Date | Price 1 Day Before | Price 1 Day After | Percentage Change |
|---|---|---|---|
May 13, 2026 | $4.56 | $4.22 | -7.46% |
Feb 11, 2026 | $4.68 | $4.62 | -1.28% |
Nov 12, 2025 | $3.76 | $3.75 | -0.27% |
Aug 13, 2025 | $3.42 | $3.49 | +2.05% |
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.
FAQ
When does PolyPid Ltd. (PYPD) report earnings?
PolyPid Ltd. (PYPD) is schdueled to report earning on Aug 12, 2026, Before Open (Confirmed).
What is PolyPid Ltd. (PYPD) earnings time?
PolyPid Ltd. (PYPD) earnings time is at Aug 12, 2026, Before Open (Confirmed).
Where can I see when companies are reporting earnings?
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What companies are reporting earnings today?
You can see a list of the companies which are reporting today on TipRanks earnings calendar.
What is PYPD EPS forecast?
PYPD EPS forecast for the fiscal quarter 2026 (Q2) is -0.37.