Release Date: August 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- PolyPid Ltd (PYPD, Financial) has made significant clinical and operational progress, particularly in the SHIELD II pivotal trial for D-PLEX100.
- The recent successful financing extends the company's cash runway through the expected interim analysis results in Q4 2024 and the completion of full planned patient enrollment in early 2025.
- Approximately 320 subjects have been enrolled in the SHIELD II trial, with around 50 centers open in multiple countries, indicating robust and consistent enrollment.
- The Data Safety Monitoring Committee has recommended continuing the SHIELD II study without modifications three times, indicating no safety issues related to D-PLEX100.
- PolyPid Ltd (PYPD) has a clear regulatory pathway for the potential NDA submission for D-PLEX100 in the US, with the FDA acknowledging the supportive evidence from SHIELD I results.
Negative Points
- Research and development expenses increased to $4.8 million for Q2 2024, up from $4 million in the same period of 2023, driven by the ramp-up of the SHIELD II trial.
- The company reported a net loss of $6.3 million for Q2 2024, compared to $5.8 million in Q2 2023.
- General and administrative expenses, although reduced, still amounted to $1.1 million for Q2 2024.
- The company remains dependent on the successful exercise of warrants and additional financing to extend its cash runway beyond Q2 2025.
- There is still uncertainty regarding the final outcomes of the SHIELD II trial, with potential risks if the interim analysis does not yield positive results.
Q & A Highlights
Q: Just the interim analysis coming up in the next quarter. What are the options of what you can announce? Will you disclose the infection rate?
A: We will not be aware of the infection rate. The DSMB will provide one of three options: stop the study due to futility, stop the study due to efficacy, or continue to the end of the study with up to 630 patients. There is also a fourth option to upscale the study. We will not know the infection rate before unblinding the data. - Dikla Akselbrad, CFO & EVP
Q: Are the warrants eligible for exercise if the trial size goes above 630? Any potential advanced milestones on the interim?
A: The warrants are exercisable at any time within the next two years. If the study stops early due to efficacy or reaches the minimal sample size, the warrants will be exercised within 10 days. ADVANZ has several development milestones, with the first being positive top-line results. - Dikla Akselbrad, CFO & EVP
Q: Any progress with partnering D-PLEX in additional geographies or with the broader platform?
A: We are progressing on commercialization discussions and expect to see a deal this year, focusing on different geographies in Europe. We are also in discussions for platform deals and expect to sign before the end of the year. - Dikla Akselbrad, CFO & EVP
Q: Can you provide more granularity around the timing of the completion of the interim analysis?
A: Once we reach 400 patients, it will take about two months for the DSMB recommendation. The interim data is expected in the fourth quarter of this year. For top-line results, it will take a bit longer due to data cleaning and unblinding, expected in the first quarter of next year. - Dikla Akselbrad, CFO & EVP
Q: What are the underlying market dynamics for the SHIELD II target indication post-COVID?
A: We assume that the market will resemble the pre-COVID environment when we publish the data. We see comparability between SHIELD I and SHIELD II in demographics, which is encouraging and derisks the study. - Dikla Akselbrad, CFO & EVP
Q: How will G&A spending evolve if the interim analysis is positive?
A: We do not foresee a substantial increase in G&A expenditure. Most marketing and medical affairs responsibilities are on our partners, so any increase will not significantly change our P&L. - Dikla Akselbrad, CFO & EVP
Q: Can you elaborate on the recent KOL event with Professor Charles Edmiston?
A: Key takeaways included the increase in surgical site infections back to pre-COVID rates, underreporting of infections, and the high cost of infections. The 30-day high concentration release of antibiotics with D-PLEX100 has potential clinical and economic benefits. - Ori Warshavsky, Chief Operating Officer - US
Q: What is the current financial status of PolyPid?
A: As of June 30, 2024, we had $9.3 million in cash, not including the $8.1 million from the recent PIPE financing. Our pro forma cash balance is expected to fund operations into the first quarter of 2025. - Jonny Missulawin, CFO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
