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NASDAQ: PYPDCorporate PresentationJune 2025
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2 This presentation of PolyPid Ltd. (the “Company”) contains “forward-lookingstatements” within the meaning of the Private Securities Litigation ReformAct and other securities laws. Words such as “expects,” “anticipates,”“intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions orvariations of such words are intended to identify forward-lookingstatements. For example, the Company is using forward-lookingstatements when it discusses statements relating to our objectives, plans,and strategies, the expected timing of trials, the research, development,and use of our platform technologies, technologies, products and productcandidates, potential benefits and advantages of our products and productcandidates, and all statements (other than statements of historical facts)that address activities, events, or developments that the Company intends,expects, projects, believes, or anticipates will or may occur in the future, thesafety, efficacy and benefits of D-PLEX100and US addressable market.Forward-looking statements are not historical facts, and are based uponmanagement’s current expectations, beliefs and projections, many ofwhich, by their nature, are inherently uncertain. Such expectations, beliefsand projections are expressed in good faith. However, there can be noassurance that management’s expectations, beliefs and projections will be achieved and actual results may differ materially from what is expressed inor indicated by the forward-looking statements. Forward-lookingstatements are subject to risks and uncertainties that could cause actualperformance or results to differ materially from those expressed in theforward-looking statements. For a more detailed description of the risksand uncertainties affecting the Company, reference is made to theCompany’s reports filed from time to time with the Securities andExchange Commission (“SEC”), including, but not limited to, the risksdetailed in the Company’s Annual Report on Form 20-F, filed with the SECon February 26, 2025. Forward-looking statements speak only as of the datethe statements are made. The Company assumes no obligation to updateforward-looking statements to reflect actual results, subsequent events orcircumstances, changes in assumptions or changes in other factorsaffecting forward-looking information except to the extent required byapplicable securities laws. If the Company does update one or moreforward-looking statements, no inference should be drawn that theCompany will make additional updates with respect thereto or with respectto other forward-looking statements. Cautionary Note RegardingForward Looking Statements
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3 PolyPid Overview Global:Petach Tikva, IsraelUS:New Jersey granted and pending patents(1) employees(1) Polymer-Lipid Encapsulation matriX(PLEX) PlatformLate clinical stage biopharma company Unique LOCAL Prolonged Delivery of APIsLead Product D-PLEX100in Phase 3 trialOncoPLEX Next Big Opportunity for Solid Tumors1 As of June ‘25NASDAQ: PYPD
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5 Robust Pipeline with Multiple Near- and Longer-Term Inflection Points Key milestonesPreclinical Phase 1 Phase 2 Phase 3Product candidate and indicationD-PLEX100 Prevention of Surgical ComplicationsPrevention of SSI inColorectal AbdominalPrevention of SSI inAbdominal SurgeryPrevention of SSI inOrthopedic SurgeryOncoPLEXPost Surgical Tumor Resection (Adjuvant)Intratumoral Solid Tumors (Neoadjuvant) SHIELD I pivotal study in abdominal colorectal surgery SHIELD II abdominal colorectal surgeries with large incisionsSHIELD I study completedSHIELD IIStudy Completed PK + Safety Study Post-ApprovalEfficacy Study20262027/2028Pre-IND meeting completed (FDA) for GBMPre-clinical stage
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6 D-PLEX100is a Potential First-in-class for the prevention of SSIsIndication:Prevention of abdominal incisional SSIDoxycycline (broad spectrum antibiotic) FDA 505(b)(2) regulatory pathwayAdministered directly into the surgical site for prolonged 30 days release~12M Surgeries addressable market in US Abdominal 4.5MGyn & Uro 2.5MSternum 0.5MOrthopedic 5.0M~12Mprocedures Breakthrough Therapy, Fast Track, and QIDP designations
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8 30 60 0 D-PLEX100+ SOC (N=405)SOC (N=393) Scope•Assess the efficacy and safety of D-PLEX100in 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 IsraelPatient 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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9 SHIELD II Demographics & Surgery Characteristics (ITT Cohort) SoC(N=393)D-PLEX100(N=405)Parameter68.067.0Age (yrs)37.9%44.0%Female (%)26.426.2BMI (Kg/m2) 5.04.0Charlson co-morbidity index 2.32.4Surgery duration (hrs)Indication for index surgery (%)91.1%86.2%Cancer0.3%2.0%Inflammatory Bowel Disease (IBD)8.7%11.9%Other 99.5%100%Preoperative IV antibiotics given prior to index surgery (%)
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10 D-PLEX100Showed Statistically Significant Reduction in the Primary Efficacy Endpoint * SoC - Standard of Care 7144 SoC * D-PLEX100 + SOCn=393n=405 (10.9%)(18.1%)38%reduction (p<0.005) D-PLEX100+ SoC Primary Efficacy Endpoint(ITT cohort)
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11 3615SoC * D-PLEX100 + SOC Surgical Site Infection (SSI) (ITT Cohort) Key Secondary Efficacy Endpoint #1 * SoC - Standard of Caren=377n=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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12 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 surgery8554SoC * D-PLEX100 + SOCn=488n=487(11.1%)(17.4%)36%reduction (p<0.005) D-PLEX100+ SoC Combined Efficacy Endpoint(Overall Study Population)
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13 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. 218SoC * D-PLEX100 + SOCn=377n=391(2.0%)(5.6%)62%reduction (p<0.05) D-PLEX100+ SoC ASEPSIS Score >20(ITT Cohort)
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14 Target Market at Launch is>7M Surgeriesin US & Europe* * Assuming additional safety and PK Study for US ; Expected Abdominal Indication in Europe based on SHIELD 2 phase 3 trial**Source IQVIA PM&I Global FlexView. Internal analysis 8MEurope total addressable market in-patient surgical procedure 12MUS total addressable market in-patient surgical procedures 3MAbdominal Surgeries4.4MAbdominal Surgeries7,400K**Core Target Surg. Procedures
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Demonstrated Economic Benefits will be Essential for Market Access and Sales UptakeD-PLEX100is eligiblefor NTAP programup to 75% reimbursementof cost of drug 15 Direct costSSI costs ~$25K/patient1on average•Prolonged length of stay and higher readmission rates•Re-operation in some cases (to debride and remove infected / necrotic tissues)Reputational costHospital SSI rates are public information and have direct influence on hospital ranking by CMS and U.S. News best hospitals ranking Indirect costCMS 1-3% penalty on all the yearly Hospital Medicare reimbursement 1. Stone PW. Economic burden of healthcare-associated infections: an American perspective. Expert Rev Pharmacoecon Outcomes Res. 2009 Oct;9(5):417-22.
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16 Global Go-to-market Strategy *Announced August 3rd, 2022Next-in-lineUS, Canada, China and South America Agreement highlightsPartnerships with leading pharma companies with established hospital-focused commercial capabilities and resourcesIncludes European Economic Area and UKPotentially receive over $115 million in upfront and milestone payments as well as royalties on net sales$2.7 million upfront payment paid upon signature of licensing agreement Focused on abdominal and cardiac indications Development-related milestones for a total of up to $25 millionSigned licensing agreement includes transfer price, development and sales-related milestone payments and royaltiesNext-in-linePartnered territories w/ Advanz Pharma
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17 State-of-the-Art Manufacturing Facility PolyPid was granted Manufacturer Authorization and Good Manufacturing Practice –GMP - certification by Israel’s MoH and EU qualified person for its state-of-the-art ~18,000 square feet (~1,700 m2) manufacturing facility.Investmentmachinery, qualifications and validationsSupply capacityexpected to meet commercial demand for the first 4-5 years from launch
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18 R&D Collaboration Agreement with Immunogenesisfor Controlled and Prolonged Intratumoral Delivery •Houston-based company founded by Dr. Michael Curran, Associate Professor of Immunology at the MD Anderson Cancer Center•Combined Immunogenesis potent anti-tumor STING agonist with PolyPid’s technology to enhance treatment for solid tumors•Aim to overcome shortcoming of STING agonists molecules, which are susceptible to rapid clearance
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19 OncoPLEX - The Next BigOpportunity @ PolyPidNew approach for solid tumors - every year, 1.6 million new cases of solid tumors in the U.S. alone Prolonged 3wks release of docetaxel: intratumoral (neoadjuvant) and post surgical resection of the tumor (adjuvant)Evaluated successfully in various animal modelsPre-IND meeting (FDA) completed for GBM Post-Tumor resectionapplication of OncoPLEX (adjuvant)Intratumoral injection of OncoPLEX (neoadjuvant)
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20 Single Intratumoral Injection of OncoPLEX reduced tumor growth 050010001500200025003000 0 2 4 6 8 10 12 14 16 18 20Tumor volume (mm3)Days post treatment Average tumor volume post treatment UntreatedDose 1Dose 2Dose 3 B16 murine melanoma: Dose response Key Takeaways•OncoPLEX spheres remain anchored to the injection site over the entire period•The prolonged and constant release mechanism allows the released drug to generate an effective microenvironment far from the injection site
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21 60% Survival at Day 19 for the Most Effective Dose B16 murine melanoma: Dose response OncoPLEX Focal Deposits are mostly Surrounded by Necrotic Tumor Tissues and Inflammation 020406080100120 0 5 10 15 20% SurvivalDays post treatment Mice survival following treatment OncoPLEX
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22 Post-Surgical Resection in GBM & Other Solid Tumors •Prolonged 3wks. local release of Docetaxel directly in the tumor resection pocket•Evaluated successfully in various animal models•98% tumor growth inhibition (day 41) in resected GBM tumor mouse model compared to the untreated control (p<0.001) •60% survival (day 41) in resected GBM tumor mouse model vs 20% for the systemic treated mice (p=0.0165)•75% overall tumor free survival in resected colon carcinoma tumor mouse model compared to 25% for the systemic docetaxel arm •Pre-IND meeting in GBM completed (FDA) GBM Surgical Resection Tumor Recurrence Intra-operative application of OncoPLEXResidual Infiltrate Tumor Cells 1. Delveinsight, Brain Cancer, Market Insight, Epidemiology, and Market Forecast—2030
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23 FinancialsTop Holders Analyst coverage Roy BuchananBrandon Folkes1. As of June 11, 2025 Stock InformationNASDAQListingPYPDTicker$2.30-$4.4952-week range1 $34 MMarket cap1Share Structure10.2 MShares outstanding1.6 M @ $0.0001 exercise pricePre-funded warrants 1.7 M @ $3.61 exercise priceWarrants 6.7 M @ $4.00 exercise priceWarrants 3.4 M @ $5.50 exercise priceWarrants 1.8 M @ $6.73 WAEPOptions Chase KnickerbockerBoobalan Pachaiyappan
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Key AccomplishmentsReached primary and all key secondary endpoints in D-PLEX100Phase 3 trial Completed process validation for D-PLEX100and passed cGMP inspection – manufacturing facility ready for EU launchCompleted the largest Phase 3 trial in prevention of SSI in colorectal resection in over a decade Signed a commercialization agreement for Europe - deal worth >$110 million in milestone payments plus royalties and transfer price Advanced the development of OncoPLEXincluding pre-IND studiesRaised over $65 million from existing and new life science-focused investors
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THANK YOUPolypid.com
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26 SHIELD I: Deep Dive into the Large-Incision Subgroup EffectControl(N=211)D-PLEX(N=212)Parameter54%(p=0.0032)37 (17.5%)17 (8%)Primary endpointKey Secondary Efficacy Endpoints55%19 (9.7%)9 (4.4%)Infection rate during 30 days post abdominal surgery62%5 (2.6%)2 (1.0%)Number of subjects with at least 1 score of ASEPSIS >20 Additional Efficacy Endpoints49%17 (8.7%)9 (4.4%)Incidence of SSSI rate during 30 days post surgery100%2 (1.0%)0Incidence of DSSI rate during 30 days post surgery40%10 (4.7%)6 (2.8%)Mortality rate within 30 days post abdominal surgeryNA5.0 (1, 13)8.0 (4, 28)Time to adjudicated SSI during 30 days post index surgery (days)77%9 (47.4%)1 (11.1%)Number of subjects treated with IV Antibiotic as treatment for adjudicated SSI 55%19 (9.7%)9 (4.4%)Number of subject with any surgical re-interventions
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D-PLEX100Effect on in Patients w/ SSI Risk Factors* LargeIncision(>20cm)N=423 High risk*PatientsN=670N=816816 Patientshad a large incision and/or high-risk factors (comorbidities)37% Reductionof the primary endpoint (p=0.0162) 27
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28 PLEX based product typical presentationSolid spheresMicron range in diameterDry format (powder) and sterileReady to useEach particle containsthe PLEX formulation & the Pre-Encapsulated API/APIsThe PLEX formulationis predesigned to achieve the needed release characteristicsThe dry powder can beprepared for administration by either: Hydration into a paste, to be applied locally into the wound/tumor bed during the surgeryInjected (≥21G) as a paste, or as a dry powder – Once or multiple applications