Release Date: November 13, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- PolyPid Ltd (PYPD, Financial) has achieved significant acceleration in patient enrollment for the Shield 2 pivotal trial, with approximately 550 subjects enrolled and 60 centers open globally.
- The company is operating from a position of financial strength, with funding secured beyond the upcoming interim analysis and into 2026 if all warrants are exercised.
- The Shield 1 trial results, which showed highly positive and statistically significant data, were published in the prestigious International Journal of Surgery.
- PolyPid Ltd (PYPD) has the potential to secure an additional $24.6 million through warrant exercises from recent private placement financings, extending their cash runway.
- The company has ongoing discussions with strategic partners for the commercialization of DPLEX 100 in the US and other regions, indicating strong interest in the product's market potential.
Negative Points
- PolyPid Ltd (PYPD) reported a net loss of $7.8 million for the third quarter of 2024, an increase from $5.6 million in the same period of 2023.
- Research and development expenses increased significantly to $6 million, up from $3.8 million in the previous year, driven by the ramp-up in patient enrollment.
- The company’s current cash balance is expected to fund operations only into the first quarter of 2025, highlighting a need for additional funding.
- There is uncertainty regarding the outcome of the Shield 2 trial's interim analysis, which could impact the trial's continuation or early conclusion.
- PolyPid Ltd (PYPD) faces risks associated with the potential for futility in the Shield 2 trial, although management expresses confidence in the trial's success.
Q & A Highlights
Q: Can you provide an update on the blinded infection rate for the Shield 2 trial and the criteria needed to stop for efficacy during the interim analysis?
A: We are blinded to the specific infection rates between the two arms, but the overall rate is in line with our expectations. The CDC recently reported a 3% increase in SSI rates post-COVID, which aligns with our expectations. For the interim analysis, a P-value of 0.01 or lower is required to stop for efficacy. In Shield 1, a similar patient population showed a P-value of 0.0032 with a 54% effect size, which provides a reference point for Shield 2. - Dikla Chaus Axelrad, CEO
Q: What is the current breakdown of patients in the Shield 2 trial between the US and other countries?
A: Most patients are from outside the US. The interim analysis requires a P-value of 0.01 or lower, similar to the high-risk patient population in Shield 1, which had a P-value of 0.0032. - Dikla Chaus Axelrad, CEO
Q: What should investors expect from the interim analysis of the Shield 2 trial?
A: The Data Safety Monitoring Board will provide a recommendation on whether to stop for efficacy, continue to the planned study size, or increase the sample size. We will issue a press release with their recommendation this quarter. - Dikla Chaus Axelrad, CEO
Q: Are there any concerns about maintaining the current pace of patient enrollment in the Shield 2 trial?
A: We do not foresee any issues. Enrollment has stabilized at about 80 patients per month since the end of summer, and we expect to recruit the last patient in December. - Dikla Chaus Axelrad, CEO
Q: What are the plans for commercializing DPLEX 100, assuming approval?
A: We plan to partner with a strategic partner for commercialization in the US. Discussions are ongoing, and we expect them to accelerate after topline results. We are also in discussions for other geographies, which may mature by the end of the year. - Dikla Chaus Axelrad, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
