Q2 2024 PolyPid Ltd Earnings Call Transcript
Key Points
- PolyPid Ltd (PYPD) 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.
- 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.
Thank you all for participating in PolyPid second-quarter 2024 earnings conference call. Joining me on the call today will be Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid; Jonny Missulawin, PolyPid's Chief Financial Officer; and Ori Warshavsky, Chief Operating Officer, United States of PolyPid.
Earlier today, PolyPid released its financial results for the three and six months ended June 30, 2024. A copy of the press release is available in the Investors section on the company's website, www.polypid.com.
I'd like to remind you that on this call, management will make forward-looking statements within the meaning of the federal securities laws. For example, management is making forward-looking statements when it discusses the expected timing for recruitment, number of centers, top-line results from the SHIELD II trial and of the unblinded interim analysis, the planned new drug application submission for D-PLEX100, and the company's expected cash runway and the potential
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