PolyPid(US:PYPD)2021-11-10 17:28Financial Data and Key Metrics Changes - As of September 30, 2021, the company had cash and cash equivalents of $42 million, down from $67 million as of December 31, 2020, indicating a decrease in liquidity [25] - The net loss attributable to ordinary shares for Q3 2021 was $9.9 million, compared to $6.5 million in the same period of 2020, reflecting increased operational costs [27] Business Line Data and Key Metrics Changes - Research and development expenses for Q3 2021 were $7.3 million, up from $4.2 million in Q3 2020, driven by costs associated with the ongoing SHIELD I and SHIELD II Phase 3 clinical trials [26] - Marketing and business development expenses increased to $400,000 in Q3 2021 from $300,000 in Q3 2020, indicating a rise in promotional activities [27] Market Data and Key Metrics Changes - Approximately 70% of patients currently enrolled in the SHIELD I trial have a colorectal cancer diagnosis, consistent with previous trials [17] - The SHIELD I trial has enrolled about 480 patients, with expectations to reach 500 by the end of the month and to continue increasing enrollment to 200-250 patients per quarter [11][12] Company Strategy and Development Direction - The company is focused on advancing its D-PLEX100 program for the prevention of surgical site infections (SSI) and has developed a comprehensive launch plan for its commercial preparations [6][9] - The company is also pursuing the OncoPLEX development platform, targeting brain tumors, and is preparing for a pre-IND meeting with the FDA to discuss clinical development plans [10][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the financial position, stating that the current balance sheet is sufficient to complete the SHIELD I study and prepare for NDA submission [10] - The company anticipates an extension of its cash runway into the end of 2022, an improvement from previous expectations [16] Other Important Information - The Data Safety Monitoring Committee has recommended continuing the SHIELD I study without modification, indicating no major safety issues observed to date [18] - The company is in discussions with potential partners for the commercialization of D-PLEX100, indicating a high level of interest from large and midsized pharmaceutical companies [20] Q&A Session Summary Question: What is the potential change in target enrollment for SHIELD I? - Management clarified that the target number for SHIELD I is expected to remain at 900 patients, as the FDA agreed that one pivotal trial is sufficient for NDA submission [30][31] Question: What are the partnership discussions regarding commercialization? - The company plans to have a strategic collaboration in the U.S. while also exploring licensing agreements in Europe and Asia [34][35] Question: What is the expected timeline for SHIELD II? - Management indicated that SHIELD II will be pursued with a broader eligibility criteria but will not require the same robust size as initially planned [46] Question: What is the status of OncoPLEX and its clinical trial? - The company is preparing for a pre-IND meeting with the FDA to discuss the clinical development plan for OncoPLEX, with a focus on initiating a Phase 1/2 trial in 2022 [24][81] Question: How is the cash runway being managed? - Management confirmed that there is no immediate need to utilize the ATM facility, as the cash runway has been extended into the end of next year [67] Question: What insights have been gained from market research on D-PLEX100? - Recent market research indicated a high level of interest and understanding of the costs associated with surgical site infections among stakeholders, which is encouraging for future commercialization efforts [78]