Funding Extends Company's Cash Runway into Second Quarter 2025, which is beyond the Anticipated Timing for SHIELD II Top-line Results if Warrants are Fully Exercised More than 300 Patients Enrolled in Ongoing SHIELD II Phase 3 Trial of D-PLEX100 for the Prevention of Abdominal Colorectal Surgical Site Infections Unblinded Interim Analysis to be Conducted Once Approximately 400 Patients Complete Their 30-Day Follow-up Expected in Fourth Quarter of 2024; Top-Line Results Anticipated in First Quarter of 2025 P ...

Funding Extends Company's Cash Runway into Second Quarter 2025, which is beyond the Anticipated Timing for SHIELD II Top-line Results if Warrants are Fully Exercised More than 300 Patients Enrolled in Ongoing SHIELD II Phase 3 Trial of D-PLEX100 for the Prevention of Abdominal Colorectal Surgical Site Infections Unblinded Interim Analysis to be Conducted Once Approximately 400 Patients Complete Their 30-Day Follow-up Expected in Fourth Quarter of 2024; Top-Line Results Anticipated in First Quarter of 2025 P ...

Known Procedure and Patient Risk-Factors Significantly Increase the Risk of SSIs and Impact Payer Costs PETACH TIKVA, Israel, June 18, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today hosted a virtual Key Opinion Leader event discussing the significant unmet medical need in the prevention of surgical site infections (SSIs). The Company also provided an update on its ongoing SHIELD II Phase 3 trial for ...

The event will feature Charles E. Edmiston, Ph.D. (Emeritus Professor of Surgery, Division of Vascular Surgery, Medical College of Wisconsin), who will discuss the significant clinical and economic burden, and current medical practice, for the prevention of surgical site infections (SSIs). It will also highlight PolyPid's lead product candidate, D-PLEX100, and its ongoing Phase 3 SHIELD II trial evaluating D-PLEX100 for the prevention of abdominal colorectal SSIs. PolyPid management intends to provide an up ...

PolyPid Ltd (NASDAQ:PYPD) Q1 2024 Earnings Conference Call May 8, 2024 8:30 AM ET Company Participants Brian Ritchie - IR Dikla Czaczkes Akselbrad - CEO & Director Jonny Missulawin - Chief Financial Officer Ori Warshavsky - Chief Operating Officer, US Conference Call Participants Roy Buchanan - JMP Operator Thank you all for participating in PolyPid's First Quarter 2024 Earnings Conference Call. Joining me on the call today will be Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid; Jonny Missulaw ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANTTO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission ...

PolyPid Ltd (NASDAQ:PYPD) Q4 2023 Earnings Call Transcript February 14, 2024 8:30 AM ET Company Participants Brian Ritchie - IR Dikla Czaczkes Akselbrad - CEO & Director Jonny Missulawin - Chief Financial Officer Conference Call Participants Roy Buchanan - JMP Boobalan Pachaiyappan - HC Wainwright Operator Greeting morning and welcome to the PolyPid Fourth Quarter and Full Year 2023 Conference Call. At this time, all participants are in a listen-only mode. As a reminder, this call is being recorded. And I ...

Financial Data and Key Metrics Changes - For the third quarter of 2023, the company reported a net loss of $5.6 million, a decrease from $9.3 million in the same period of 2022, indicating improved financial performance [64] - Research and development expenses for the three months ended September 30, 2023, were $3.8 million, down from $6.2 million in the same period of 2022, primarily due to the completion of the SHIELD I Phase 3 clinical trial [34] - General and administrative expenses decreased to $1.2 million in Q3 2023 from $1.7 million in Q3 2022 [64] - Net cash used in operating activities for the first nine months of 2023 decreased by $16.1 million, from $28.9 million to $12.8 million compared to the same period in 2022 [11] Business Line Data and Key Metrics Changes - The company has approximately 20 centers open for the SHIELD II trial, with plans to increase to about 40 centers by the end of 2023, which is expected to enhance patient recruitment [2][6] - The average recruitment rate is anticipated to be 1.5 patients per center per month, with a total of approximately 400 patients expected to complete their 30-day follow-up for an unblinded interim analysis [28] Market Data and Key Metrics Changes - The company regained compliance with NASDAQ's minimum closing bid price rule, indicating improved market standing [32] - D-PLEX100 was recognized as the winner of the 2023 Overall Biopharma Solution of the Year, highlighting its market potential [24] Company Strategy and Development Direction - The company is focused on the ongoing SHIELD II pivotal trial for D-PLEX100, aiming for potential NDA submission in the U.S. and EU marketing authorization [29] - The company has enhanced its clinical operations team to support the SHIELD II trial and is actively pursuing commercialization discussions for D-PLEX100 in various geographies [38][78] - The company emphasizes maintaining in-house manufacturing capabilities as a competitive advantage, having significantly scaled up production capacity [10][88] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term prospects of D-PLEX100, particularly in addressing surgical site infections [82] - The company anticipates that the interim analysis of the SHIELD II trial will provide critical data for future commercialization efforts [37] - Management noted that there has been no material impact on operations from recent geopolitical events, and the focus remains on trial progress [57] Other Important Information - The company completed a successful GMP audit by the Israeli Ministry of Health, validating its manufacturing facility for compliance with European regulators [60] - The company has cash and short-term deposits of $10.2 million as of September 30, 2023, which is expected to fund operations into late Q1 2024 [63] Q&A Session Summary Question: Key upcoming milestone events and catalysts - Management highlighted the completion of recruitment for the interim analysis of SHIELD II, expected by early Q2 2024, with feedback from the DMC Committee anticipated around July [37] Question: Update on the number of patients in SHIELD II who have completed their 30-day follow-up - Approximately 40 patients have completed their 30-day follow-up, with about 50 patients already enrolled in the trial [76] Question: Potential outcomes for the interim analysis and resizing the trial - The potential outcome could include an early stop for efficacy if the data is robust, similar to SHIELD I, and resizing the trial is also a possibility [70] Question: Partnering discussions and capital runway - The company is actively pursuing partnerships for D-PLEX and OncoPLEX, while also exploring financing options to support trial costs [45][73] Question: Non-core territories for potential partnerships - Management identified Canada, Australia, Japan, South Korea, South America, China, and India as potential markets for partnerships [80]

PolyPid Ltd (NASDAQ:PYPD) Q2 2023 Earnings Conference Call August 9, 2023 8:30 AM ET Brian Ritchie - LifeSci Advisors Dikla Akselbrad - CEO & Director Jonny Missulawin - CFO Ori Warshavsky - COO Douglas Buchanan - JMP Securities Greetings, and welcome to the PolyPid Second Quarter 2023 Conference Call. Brian Ritchie Earlier today, PolyPid released financial results for the 3 and 6 months ended June 30, 2023. A copy of the press release is available in the Investors section on the company's website, www.poly ...

Executive Vice President heading R&D, and Clinical & Regulatory Affairs Balance Sheet • An early stop to the trial can occur if the efficacy of DPLEX100 is better than expected • Opportunity to define the targeted patient enrollment range for the SHIELD I study 5 Total US addressable market (TAM) for D-PLEX100 is over 12.2M procedures Number of surgeries in DPLEX target indications (M) 4.42 12.15 2.44 0.47 4.82 Abdominal Gyn & Uro Sternum Orthopedic Total | --- | --- | |-------|----------------------------- ...