PolyPid(US:PYPD)2022-08-11 01:51Financial Data and Key Metrics Changes - As of June 30, 2022, the company had cash, cash equivalents, and short-term deposits of $23.8 million, excluding the second tranche of $2.5 million from the loan drawn in July 2022 [32] - Research and development expenses for Q2 2022 were $8.4 million, up from $7.4 million in the same period in 2021, primarily due to increased costs in the SHIELD I Phase 3 clinical trials [34] - The company reported a loss of $11.1 million for Q2 2022, compared to a loss of $10.5 million in the prior year period [35] Business Line Data and Key Metrics Changes - The exclusive license agreement with ADVANZ PHARMA for D-PLEX100 includes potential development-related milestones totaling up to $23.5 million and sales-related milestones of up to $89 million [9] - D-PLEX100 targets a significant market opportunity in Europe, with approximately 3 million annual surgeries in selected abdominal surgeries and an additional estimated 450,000 open heart surgeries in the big 5 EU countries [11] Market Data and Key Metrics Changes - Surgical site infections (SSIs) occur in up to 15% to 20% of major surgical procedures in Europe, representing a major unmet medical need [11] - The World Health Organization estimates that SSIs result in up to EUR 11 billion of traditional hospital costs per year in Europe [12] Company Strategy and Development Direction - The company aims to maximize the value of D-PLEX100 through additional collaborations in the U.S. and globally, with ongoing dialogues with several large and mid-sized pharmaceutical companies [14] - The SHIELD I study is the largest infection prevention trial in colorectal surgery conducted in over a decade, with full top-line results anticipated by the end of the current quarter [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the potential for D-PLEX100, highlighting the strong interest from additional potential partners and the strategic importance of the ADVANZ PHARMA agreement [14][12] - The company is preparing for a targeted NDA submission and potential commercialization of D-PLEX100, while also making progress with OncoPLEX, its lead intratumoral product candidate in oncology [28] Other Important Information - The company obtained a nondilutive secured term loan facility of up to $15 million, which broadens financing options and supports investment in commercial capabilities for D-PLEX100 [30] - Changes to the Board include the promotion of Jonny Missulawin to Senior Vice President of Finance [29] Q&A Session Summary Question: Can you elaborate on ADVANZ PHARMA's capabilities in the hospital space in Europe? - ADVANZ PHARMA has a strong focus on the hospital space and has significantly increased its sales force, targeting major EU countries [38] Question: What is the expected timing for filing in Europe? - The filing in Europe is expected to be around the same time as the U.S., with a potential slight delay [39] Question: What are the expectations for the rolling submission in the U.S.? - The rolling submission is expected to start early next year, with completion anticipated within six months [40] Question: How is the company preparing for the U.S. launch? - The strategy is to find a partner for co-promotion rather than licensing, maintaining some level of control in the U.S. market [42] Question: How do infection rates differ between countries in Europe? - Infection rates in Europe for major surgeries are generally around 15% to 20%, which may be slightly higher than in the U.S. [47] Question: What is the expectation for the D-PLEX label initially? - The company aims for a broad abdominal indication with the FDA, preparing for potential backup options based on ongoing studies [49] Question: Are there any new developments with competitors? - Current competitors do not have the level of evidence or trial size that D-PLEX100 is expected to provide [61]