Research analysts who have asked questions during PolyPid earnings calls.
Chase Knickerbocker
Craig-Hallum Capital Group
4 questions for PYPD
Also covers: AVDL, BFLY, BVS +17 more
BP
Boobalan Pachaiyappan
ROTH Capital Partners
1 question for PYPD
Also covers: ADXN, CAPR, LGVN +3 more
BF
Brandon Folkes
Rodman & Renshaw
1 question for PYPD
Also covers: ACHV, ANIP, AVDL +10 more
RS
Raghuram Selvaraju
H.C. Wainwright & Co.
1 question for PYPD
Also covers: ABEO, ACOG, AQST +20 more
RS
Ram Selvaraju
H.C. Wainwright
1 question for PYPD
Also covers: ABEO, ADXN, BCPC +8 more
RB
Roy Buchanan
Citizens JMP
1 question for PYPD
Also covers: ABUS, CDTX, CVAC +5 more
Recent press releases and 8-K filings for PYPD.
PolyPid Provides Update on D-PLEX 100 NDA Submission and Commercialization Plans
PYPD
Product Launch
New Projects/Investments
Guidance Update
- PolyPid's lead asset, D-PLEX 100, for surgical site infection prevention, is expected to have its NDA submitted early 2026 following a successful pre-NDA meeting with the FDA. The company anticipates a 6-month priority review, with potential approval by late 2026 or early 2027.
- The Phase 3 study for D-PLEX 100 demonstrated a 40% reduction in mortality, surgical site infection, and re-operation (from 18% to 9.9%) and a 60% reduction in sepsis score, with statistically significant results (P-value < 0.005).
- PolyPid is actively engaged in discussions to secure a U.S. commercialization partner for D-PLEX 100, with an announcement expected around the time of the NDA submission.
- The company reported a cash position of close to $20 million (last reported), which is projected to fund operations well into 2026 and through the approval process, contingent on successful partnership discussions.
- Future pipeline objectives for 2026 include expanding D-PLEX 100 to other abdominal surgeries and advancing the GLP-1 program, with additional preclinical, PK, and efficacy data expected later in the year.
Jan 15, 2026, 3:30 PM
PolyPid Prepares for D-PLEX 100 NDA Submission and Commercial Partnership
PYPD
Product Launch
New Projects/Investments
Guidance Update
- PolyPid's lead asset, D-PLEX 100, is slated for NDA submission early this year (2026) after a successful pre-NDA meeting with the FDA, with expected approval by late 2026 or early 2027 due to Breakthrough Therapy Designation and priority review.
- The Phase 3 study for D-PLEX 100 demonstrated a 40% reduction in the combined endpoint of mortality, surgical site infection, and re-operation, decreasing the incident rate from 18% to 9.9%.
- PolyPid is in discussions to secure a U.S. commercial partner for D-PLEX 100, with an announcement anticipated around the NDA submission period.
- The company's cash position of nearly $20 million is projected to fund operations well into 2026 and through the approval process, contingent on the maturation of partnership discussions.
Jan 15, 2026, 3:30 PM
PolyPid Discusses D-PLEX 100 Phase 3 Results and Upcoming NDA Submission
PYPD
Product Launch
New Projects/Investments
- PolyPid's lead asset, D-PLEX 100, is slated for an NDA submission early this year (2026), with FDA approval anticipated towards the end of 2026 or early 2027 due to priority review.
- Phase 3 results for D-PLEX 100 demonstrated a 40% reduction in mortality, surgical site infection, and re-operation, specifically reducing surgical site infection from 10% to 3.8%.
- The company is actively pursuing a U.S. commercial partner for D-PLEX 100, with an announcement expected around the NDA submission timeframe.
- PolyPid's cash position of nearly $20 million is projected to fund operations well into 2026 and through the approval process, assuming successful partnership discussions.
Jan 15, 2026, 3:30 PM
PolyPid Provides Update on D-PLEX100 Clinical Data and Regulatory Pathway
PYPD
Product Launch
New Projects/Investments
- PolyPid's D-PLEX100, a treatment for surgical site infections (SSIs), demonstrated a 60% reduction in infection rates in the SHIELD II study, lowering the rate from 9.5% in the standard of care arm to 3.9% in the D-PLEX100 arm.
- The FDA has confirmed that the SHIELD II data is sufficient for a New Drug Application (NDA) submission.
- PolyPid intends to submit the NDA for D-PLEX100 in early 2026, with an anticipated PDUFA date (approval) between the end of 2026 and early 2027.
- D-PLEX100 has been granted Breakthrough Therapy, Fast-Track, and three QIDP designations, enabling eligibility for priority review.
- Market research suggests high adoption potential, with 80% of surgeons and 90% of pharmacy directors indicating extreme likelihood to use or add D-PLEX100 to formulary, at an expected price point of around $600 per vial.
Dec 10, 2025, 4:30 PM
PolyPid Provides D-PLEX100 Clinical and Regulatory Update
PYPD
Product Launch
New Projects/Investments
- PolyPid's D-PLEX100 demonstrated a 60% reduction in surgical site infection (SSI) rates in the SHIELD II study, decreasing from almost 10% in the standard of care arm to less than 4% in the D-PLEX100 arm, with a p-value less than 0.005.
- The FDA has determined that the SHIELD II data is sufficient for an NDA submission. PolyPid plans to submit the NDA for D-PLEX100 early 2026 and anticipates a PDUFA date by end of 2026 or early 2027, supported by Breakthrough Therapy and Fast-Track designations.
- Surgical site infections represent a significant healthcare burden, costing the U.S. system over $3 billion annually. Market research indicates strong potential for D-PLEX100 adoption, with 80% of surgeons and 90% of pharmacy directors reporting they would be extremely likely to use the product if it is on formulary.
Dec 10, 2025, 4:30 PM
PolyPid Provides Update on D-PLEX100 Phase III Results and Regulatory Pathway
PYPD
Product Launch
New Projects/Investments
Guidance Update
- PolyPid's D-PLEX100 demonstrated significant efficacy in its SHIELD II Phase III trial for preventing surgical site infections (SSI), showing a 60% reduction in SSI rates (from nearly 10% to less than 4%) and a 40% reduction in the combined primary endpoint of mortality and reoperation. The product also maintained a robust safety profile.
- Following a positive pre-NDA meeting where the FDA found the SHIELD II data sufficient, PolyPid plans to submit the New Drug Application (NDA) for D-PLEX100 in early 2026.
- With Breakthrough Therapy and Fast-Track designations, the company anticipates a PDUFA date towards the end of 2026 or early 2027.
- Market research indicates strong potential for adoption, with 80% of surgeons and 90% of pharmacy directors expressing extreme likelihood to use or place D-PLEX100 on formulary, respectively.
Dec 10, 2025, 4:30 PM
PolyPid receives positive FDA Pre-NDA meeting minutes for D-PLEX100
PYPD
Product Launch
New Projects/Investments
- PolyPid Ltd. announced on December 3, 2025, that it received positive FDA Pre-NDA meeting minutes for D-PLEX100, its lead product candidate for preventing surgical site infections.
- The FDA agreed that the existing clinical data package, including Phase 3 SHIELD II trial results, is adequate to support the New Drug Application (NDA) submission and review.
- The FDA also approved a rolling NDA review, with PolyPid planning to submit the first completed sections in early 2026.
Dec 3, 2025, 1:35 PM
PolyPid Reports Q3 2025 Financial Results and Advances D-PLEX100 Regulatory and Commercial Milestones
PYPD
Earnings
Guidance Update
New Projects/Investments
- PolyPid reported a net loss of $7.5 million or $0.37 per share for Q3 2025, an improvement from the prior year, and held $18.8 million in cash, cash equivalents, and short-term deposits as of September 30, 2025, with an expected cash runway well into 2026.
- The company is on track for a pre-NDA meeting with the FDA for D-PLEX100 in early December and plans to submit the New Drug Application (NDA) in early 2026, leveraging its Fast Track and Breakthrough Therapy Designations.
- PolyPid successfully completed its fourth consecutive Israeli Ministry of Health Good Manufacturing Practice (GMP) inspection, an important step towards commercial manufacturing readiness for D-PLEX100.
- A recent US market access study for D-PLEX100 showed strong commercial potential, with 80% of surgeons indicating they are extremely likely to use the product and 70% of hospital pharmacy directors reporting a high likelihood to add and stock it; strategic partnership discussions are progressing.
Nov 12, 2025, 1:30 PM
PolyPid Reports Q3 2025 Financial Results and Provides Corporate Update
PYPD
Earnings
Guidance Update
Product Launch
- PolyPid reported a net loss of $7.5 million, or ($0.37) per share, for the three months ended September 30, 2025.
- Research and development expenses decreased to $5.3 million for the three months ended September 30, 2025, compared to $6.0 million in the same period of 2024, primarily due to the successful completion of the SHIELD II Phase 3 trial.
- As of September 30, 2025, the company had $18.8 million in cash, cash equivalents, and short-term deposits, which is expected to fund operations well into 2026.
- A face-to-face pre-New Drug Application (NDA) meeting with the FDA is scheduled for early December, with the NDA submission for D-PLEX₁₀₀ on track for early 2026.
- The company is advancing strategic partnership discussions with potential U.S. partners for D-PLEX₁₀₀ following positive Phase 3 trial results and successfully completed an IMOH GMP inspection as part of commercial manufacturing readiness.
Nov 12, 2025, 12:38 PM
PolyPid Reports Q3 2025 Financial Results and Corporate Update
PYPD
Earnings
Guidance Update
New Projects/Investments
- PolyPid is on track to submit a New Drug Application (NDA) for D-PLEX100 in early 2026, with a face-to-face pre-NDA meeting with the FDA scheduled for early December 2025.
- The company is advancing strategic partnership discussions in the U.S. for D-PLEX100 following positive Phase 3 trial results.
- For the three months ended September 30, 2025, PolyPid reported a net loss of $7.5 million, or ($0.37) per share.
- As of September 30, 2025, PolyPid held $18.8 million in cash, cash equivalents, and short-term deposits, which is expected to fund operations well into 2026.
Nov 12, 2025, 12:30 PM
Quarterly earnings call transcripts for PolyPid.
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