Slides
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NASDAQ: PYPD SHIELD II Topline Results June 9, 2025
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2 This presentation of PolyPid Ltd. (the“Company”) contains“forward-lookingstatements” 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 the safety, efficacy and benefits of D-PLEX100, the expected submissions of an New Drug Application, or NDA, to the U.S. Food and Drug Administration, or FDA, and a Marketing Authorization Application, or MAA, and the timing thereof. Forward-looking statements are not historical facts, and are based uponmanagement’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance thatmanagement’s expectations, beliefs and projections will be achieved and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission(“SEC”), including, but not limited to, the risks detailed in theCompany’s Annual Report on Form 20-F, filed with the SEC on February 26, 2025. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. Cautionary Note Regarding Forward Looking Statements
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3 30 600 D-PLEX100 + SOC (N=405) SOC (N=393) Scope • Assess the efficacy and safety of D-PLEX100 in the prevention of post abdominal surgery incisional infection • Prospective, multinational, randomized, controlled, two- arm, double-blind study • Global trial, ~60 sites in US, Europe, and Israel Patient Population • Patients undergoing elective abdominal colorectal surgery with incision length > 20 cm • ITT cohort: 798 patients • Randomization 1:1 Primary efficacy endpoint assessment within 30 days post index surgery Safety assessment at 60 days post index surgery
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4 Standard of Care (SoC) • IV antibiotic only / IV antibiotic with mechanical bowel prep / IV antibiotic with oral antibiotics combined with mechanical bowel • 1st , 2nd or 3rd generation cephalosporin family plus metronidazole given within 60 minutes prior to surgery and discontinued at a maximum of 24- hour post index surgery • Each site used the same pre-defined SoC for all its subjects during the study Change picture
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5 SHIELD II Demographics & Surgery Characteristics (ITT Cohort) Parameter D-PLEX100 (N=405) SoC (N=393) Age (yrs) 67.0 68.0 Female (%) 44.0% 37.9% BMI (Kg/m2) 26.2 26.4 Charlson co-morbidity index 4.0 5.0 Surgery duration (hrs) 2.4 2.3 Indication for index surgery (%) Cancer 86.2% 91.1% Inflammatory Bowel Disease (IBD) 2.0% 0.3% Other 11.9% 8.7% Preoperative IV antibiotics given prior to index surgery (%) 100% 99.5%
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6 Primary Efficacy Endpoint The Primary Efficacy Endpoint is the combination of the following events measured for 30 days from index surgery: 1. Surgical Site Infections (SSI), deep & superficial, as approved by adjudication committee 2. All-cause mortality 3. Reintervention Re-opening through the same target surgical incision, used for the original index surgery, in the operation room
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7 D-PLEX100 Showed Statistically Significant Reduction in the Primary Efficacy Endpoint * SoC - Standard of Care 71 44 SoC * D-PLEX100 + SOC n=393 n=405 (10.9%) (18.1%) 38% reduction (p<0.005) D-PLEX100 + SoC Primary Efficacy Endpoint (ITT cohort)
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8 36 15 SoC * D-PLEX100 + SOC Surgical Site Infection (SSI) (ITT Cohort) Key Secondary Efficacy Endpoint #1 * SoC - Standard of Care n=377 n=391 (3.8%) (9.5%) 58% reduction (p<0.005) D-PLEX100 + SoC Surgical Site Infection rate – intention to treat population: At least one abdominal incisional surgical site infection event, occurring within 30 days post abdominal (index) surgery in the population of subjects with incision length >20 cm (n=798 patients)
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9 Key Secondary Efficacy Endpoint #2 * SoC - Standard of Care Combined Efficacy Endpoint - overall study population: A combination of at least one SSI event in the overall study population of subjects with incision length >7 cm (n=975 patients), all-cause mortality and re-interventions through the abdominal incision within 30 days post index surgery 85 54 SoC * D-PLEX100 + SOC n=488 n=487 (11.1%) (17.4%) 36% reduction (p<0.005) D-PLEX100 + SoC Combined Efficacy Endpoint (Overall Study Population)
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10 Key Secondary Efficacy Endpoint #3 * SoC - Standard of Care ASEPSIS Score – ITT Cohort: Number of subjects with ASEPSIS score >20 within 30 days post abdominal (index) surgery. The ASEPSIS score is a clinical tool used to objectively assess surgical wound infections. 21 8 SoC * D-PLEX100 + SOC n=377 n=391 (2.0%) (5.6%) 62% reduction (p<0.05) D-PLEX100 + SoC ASEPSIS Score >20 (ITT Cohort)
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11 Next Steps NDA submission planned for early 2026 Pre-NDA meeting with the FDA planned by end of 2025
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Q & A