In This Article:
Release Date: May 14, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
-
PolyPid Ltd (NASDAQ:PYPD) successfully concluded enrollment of the Shield 2 phase 3 trial, which is a significant milestone for the company.
-
The company anticipates submitting a new drug application (NDA) for Dplex 100 in early 2026, leveraging fast track and breakthrough therapy designations.
-
PolyPid Ltd (NASDAQ:PYPD) has secured $15 million in financing, extending its cash runway into the third quarter of 2025.
-
There is growing interest from potential US partners for Dplex 100, indicating strong commercial potential.
-
The total addressable market for Dplex 100 in the US is substantial, with over 12 million surgeries annually, providing a significant commercial opportunity.
Negative Points
-
PolyPid Ltd (NASDAQ:PYPD) reported a net loss of $8.3 million for the first quarter of 2025, an increase from the $6.4 million loss in the same period of 2024.
-
Research and development expenses increased to $6.1 million, up from $5.1 million in the previous year, driven by the Shield 2 trial.
-
The company has not finalized its pricing strategy for Dplex 100, which could impact future revenue projections.
-
There are uncertainties regarding the FDA inspection readiness and capacity to meet demand post-launch.
-
The company's cash and cash equivalents stand at $8 million, which may not be sufficient if additional funding is not secured.
Q & A Highlights
Q: Can you discuss the pricing strategy for Dplex 100, including the price per vial and the number of vials per procedure? A: We have not finalized the pricing strategy yet. Preliminary research suggests a price of $600 per vial, with an average of 2.5 vials used per procedure, depending on the incision length. This is subject to change based on further studies and discussions with potential partners. - CEO
Q: For the SHIELD 2 trial, was there a strict requirement for the number of vials used per procedure? A: Yes, the primary endpoint analysis includes patients with long incisions using three vials. A separate group of about 170 patients was recruited for other purposes, but they are not part of the primary endpoint analysis. - CEO
Q: What is the timeline and process for the NDA filing following the SHIELD 2 trial data? A: The NDA submission involves three modules: CMC, pre-clinical, and clinical data. We are finalizing the CMC and pre-clinical modules and will start on the clinical module once we have the top-line data. We plan to meet with the FDA for a pre-NDA meeting and aim to submit in early 2026. - CEO