PolyPid (PYPD) Q2 2025 Earnings Call August 13, 2025 08:30 AM ET Speaker0Greetings, and welcome to Polypeed's Second Quarter twenty twenty five Conference Call. At this time, participants are in a listen only mode. As a reminder, this call is recorded. And I would now like to introduce your host for today's conference, Juda Liebla from ARTS Capital Markets. Mr.Liebla, you may begin.Speaker1Thank you all for participating in Polypid's second quarter twenty twenty five earnings conference call. Joining me on ...

Summary of PolyPid's SHIELD II Phase III Trial Conference Call Company Overview - **Company**: PolyPid - **Product**: DPLEX100 - **Trial**: SHIELD II Phase III trial Key Industry Insights - **Industry**: Pharmaceutical/Biotechnology - **Focus**: Prevention of surgical site infections (SSIs) in patients undergoing abdominal colorectal surgery Core Findings and Arguments 1. **Successful Trial Results**: The SHIELD II trial met its primary and key secondary endpoints, demonstrating the efficacy of DPLEX100 in reducing SSIs [2][9][10] 2. **Primary Efficacy Endpoint**: DPLEX100 plus standard of care resulted in a 38% reduction in the primary efficacy endpoint (deep and superficial SSIs, all-cause mortality, and surgical reinterventions) compared to standard care alone, with a statistically significant p-value of less than 0.005 [9][10] 3. **Secondary Efficacy Endpoint**: There was a 58% reduction in SSI rates (from 9.5% to 3.8%) in the DPLEX100 group compared to the control group, also statistically significant with a p-value of less than 0.005 [10] 4. **Additional Secondary Endpoints**: The DPLEX100 arm showed a 36% reduction in combined SSI mortality and reintervention events, and a 62% reduction in patients with a sepsis score greater than 20 [12][13] 5. **Unmet Medical Need**: SSIs are a significant burden, costing the U.S. healthcare system approximately $10 billion annually and increasing hospital stays by an average of 9.7 days [13][14] 6. **Regulatory Pathway**: Plans for a pre-NDA meeting with the FDA by the end of 2025, followed by NDA submission in early 2026 and MAA submission in Europe shortly thereafter [15][16] 7. **Breakthrough Designation**: DPLEX100 has received Breakthrough Therapy, Fast Track, and QIDP designations from the FDA, enhancing its regulatory pathway and market exclusivity [16] Additional Important Insights 1. **Patient Demographics**: The trial included 798 patients, primarily cancer patients, with balanced demographics across treatment groups [6][8] 2. **Partnership Discussions**: Ongoing global partnership discussions are expected to accelerate following the positive trial results, with potential partners already engaged [30][32] 3. **Warrant Information**: There are 6.7 million warrants with a $4 exercise price, expiring soon, which could provide additional funding [27][28] 4. **Future Development**: The company is prioritizing its pipeline and exploring additional partnerships for new molecules, leveraging the validation of its platform technology [45][46] 5. **Market Launch Timeline**: Anticipated timeline for product launch in the U.S. is approximately 6 to 9 months post-approval, contingent on finding a suitable partner [56] Conclusion - The SHIELD II trial results position PolyPid favorably for regulatory approval and market entry, with significant implications for addressing SSIs in surgical settings. The company is poised for strategic partnerships and further development of its product pipeline.

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had cash and cash equivalents of $8 million, which is expected to fund operations into the third quarter of 2025 [16] - Research and development expenses for Q1 2025 were $6.1 million, up from $5.1 million in the same period of 2024, driven by the ongoing SHIELD II Phase III trial [17] - The net loss for Q1 2025 was $8.3 million, compared to a net loss of $6.4 million in Q1 2024 [17] Business Line Data and Key Metrics Changes - The SHIELD II Phase III trial for DPLEX100 has successfully concluded enrollment with 800 patients, following a recommendation from the Data Safety Monitoring Board [7][8] - The company anticipates top line data availability by the end of next month, with plans for NDA submission in early 2026 [8][9] Market Data and Key Metrics Changes - The total addressable market for DPLEX100 in the U.S. is estimated at over 12 million surgeries annually, with approximately 4.4 million being abdominal soft tissue surgeries [12] - Recent market research identified four groups of surgeons as potential users for DPLEX100, indicating a significant unmet need in high-risk surgical procedures [13] Company Strategy and Development Direction - The company is focused on identifying a U.S. partner with an existing dedicated hospital product sales force to maximize DPLEX100's sales potential [10] - An exclusive licensing agreement is already in place with Advanced Pharma for commercialization in Europe, with pre-launch activities being planned [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term prospects of DPLEX100 and is preparing for regulatory submissions while awaiting SHIELD II trial results [51] - The company is actively engaging in partnership discussions in the U.S. as interest in DPLEX100 is gaining momentum [15] Other Important Information - The company is in the finalization stages of CMC and nonclinical NDA modules, with plans for a pre-NDA meeting with the FDA [30][32] - The company plans to conduct several mock inspections to prepare for FDA review [43] Q&A Session Summary Question: Pricing strategy for DPLEX100 - Management has not finalized the pricing strategy but is considering a preliminary price of $600 per vial, with an average usage of 2.5 vials per procedure [21] Question: NDA filing requirements - The NDA will consist of three modules, with the company preparing the CMC and preclinical data while working on the clinical module post top line data [29][30] Question: Expectations for top line data - The company expects to report both primary and key secondary endpoints upon unblinding the data, with plans for an investor call shortly after [41][36] Question: Inspection readiness and capacity - The company is prioritizing inspection readiness and believes its facility will be sufficient for the first four to five years post-launch [44]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had cash and cash equivalents of $8 million, which is expected to fund operations into the third quarter of 2025 [15] - Research and development expenses for Q1 2025 were $6.1 million, up from $5.1 million in Q1 2024, driven by the ongoing SHIELD II Phase III trial [16] - The net loss for Q1 2025 was $8.3 million, compared to a net loss of $6.4 million in Q1 2024 [16] Business Line Data and Key Metrics Changes - The company is focused on the SHIELD II Phase III trial for DPLEX100, which has recently concluded enrollment with 800 patients, following a recommendation from the Data Safety Monitoring Board [5][6] - The anticipated top line data from the SHIELD II trial is expected by the end of the current quarter [15] Market Data and Key Metrics Changes - The total addressable market for DPLEX100 in the U.S. is estimated to be over 12 million surgeries annually, with approximately 4.4 million being abdominal soft tissue surgeries [11] - The company identified four groups of surgeons as potential users for DPLEX100, indicating a significant market opportunity [12] Company Strategy and Development Direction - The company aims to submit a New Drug Application (NDA) in early 2026, with preparations for regulatory submissions already underway [7][8] - The strategy includes finding a U.S. partner with an existing dedicated hospital product sales force to maximize sales potential [9][13] - An exclusive licensing agreement is already in place with Advanced Pharma for commercialization in Europe [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term prospects of DPLEX100 and the potential to transform the surgical landscape [47] - The company is actively preparing for regulatory submissions and engaging in partnership discussions as they await SHIELD II trial results [8][13] Other Important Information - The company has received Fast Track and Breakthrough Therapy designations for DPLEX100, which may expedite the regulatory process [7] - The company is in advanced discussions with multiple potential partners in the U.S. as they approach pivotal data readout [13] Q&A Session Summary Question: Pricing strategy for DPLEX100 - Management has not finalized the pricing strategy but anticipates an average of 2.5 vials per procedure at a preliminary price of $600 per vial [20] Question: NDA filing requirements - The NDA will consist of three modules, with the company currently finalizing the CMC and preclinical modules [27] Question: Expectations for top line data - The company expects to report both primary and key secondary endpoints upon unblinding the data [32] Question: Inspection readiness for commercial manufacturing - The company is preparing for FDA inspections and plans to conduct several mock inspections prior to the review [40] Question: Comparison of SSI data pre-COVID and post-COVID - The CDC reported a 3% increase in SSIs in 2023 compared to 2022, marking the first uptick since the COVID pandemic [42]