PolyPid(PYPD)
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PolyPid(PYPD) - 2022 Q2 - Earnings Call Transcript
2022-08-11 01:51
Financial 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]
PolyPid (PYPD) Investor Presentation - Slideshow
2022-06-16 20:55
| --- | --- | --- | |------------------------|-------|-------| | | | | | | | | | P&LYPID | | | | | | 电 | | CORPORATE PRESENTATION | | | | | | | OPTIMIZED THERAPEUTICS JUNE 2022 Disclaimer This presentation of PolyPid Ltd. (the "Company") contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such wor ...
PolyPid(PYPD) - 2022 Q1 - Earnings Call Transcript
2022-05-11 17:41
PolyPid Ltd. (NASDAQ:PYPD) Q1 2022 Earnings Conference Call May 11, 2022 8:30 AM ET Company Participants Bob Yedid - Investor Relations, LifeSci Advisors Amir Weisberg - Chief Executive Officer Dikla Czaczkes Akselbrad - Executive Vice President and Chief Financial Officer Ori Warshavsky - Chief Operating Officer, US Operations Conference Call Participants Balaji Prasad - Barclays Michael Parolari - Raymond James Gary Nachman - BMO Capital Markets Brandon Folkes - Cantor Fitzgerald Roy Buchanan - JMP Securi ...
PolyPid(PYPD) - 2021 Q4 - Annual Report
2022-02-28 21:07
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, 2021 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(PYPD) - 2021 Q4 - Earnings Call Transcript
2022-02-09 15:46
PolyPid Ltd. (NASDAQ:PYPD) Q4 2021 Earnings Conference Call February 9, 2022 8:30 AM ET Company Participants Bob Yedid - Investor Relations Amir Weisberg - Chief Executive Officer Dikla Czaczkes Akselbrad – Executive Vice President and Chief Financial Officer Conference Call Participants Hannah Smith - Raymond James Brandon Folkes - Cantor Fitzgerald Roy Buchanan - JMP Securities Disclaimer*: This transcript is designed to be used alongside the freely available audio recording on this page. Timestamps withi ...
PolyPid(PYPD) - 2021 Q3 - Earnings Call Transcript
2021-11-10 17:28
Financial 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]
PolyPid(PYPD) - 2021 Q2 - Earnings Call Transcript
2021-08-11 17:01
PolyPid Ltd. (NASDAQ:PYPD) Q2 2021 Earnings Conference Call August 11, 2021 8:30 AM ET Company Participants Bob Yedid – Investor Relations Amir Weisberg – Chief Executive Officer Dikla Czaczkes Akselbrad – Executive Vice President and Chief Financial Officer Conference Call Participants Brandon Folkes – Cantor Fitzgerald Gary Mattan – BMO Capital Balaji Prasad – Barclays Michael Parolari – Raymond James Jim Molloy – Alliance Global Partners Bob Yedid Thank you all for participating in PolyPid's Second Quart ...
PolyPid(PYPD) - 2021 Q2 - Earnings Call Presentation
2021-08-11 16:00
pm @ P OLY PID OPTIMIZED THERAPEUTICS Disclaimer This presentation of PolyPid Ltd. (the "Company") contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses stat ...
PolyPid(PYPD) - 2021 Q1 - Earnings Call Transcript
2021-05-12 19:38
PolyPid's (NASDAQ:PYPD) Q1 2021 Earnings Conference Call May 12, 2021 8:30 AM ET Company Participants Bob Yedid - LifeSci Advisors Amir Weisberg - Chief Executive Officer Dikla Czaczkes Akselbrad - Executive Vice President and Chief Financial Officer Noam Emanuel - Founder and Chief Scientific Officer Conference Call Participants Gary Mattan - BMO capital markets Kelly - Raymond James Operator Greetings and welcome to the PolyPid's First Quarter 2021 Conference Call. At this time, participants are in listen ...
PolyPid (PYPD) Investor Presentation - Slideshow
2021-03-07 14:12
| --- | --- | --- | |------------------------|-------|-------| | | | | | | | | | P & LY PID | | @ | | OPTIMIZED THERAPEUTICS | | | | | | | FEBRUARY 2021 Disclaimer This presentation of PolyPid Ltd. (the "Company") contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to ident ...