Polypid Ltd. · NASDAQ:PYPD
Polypid — Investor Presentation (July 2021)
22 slides from Polypid's investor presentation, Jul 2, 2021
Slide 1: Slide 1
Slide 2: Forward-looking statements
2 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 express
Slide 3: PolyPid Overview
3 PolyPid Overview 101 issued p a t e n t s ( 1) HQs Global: Petach Tikva, Israel US: Summit, NJ >80 employees (1) PolyPid is a Phase 3 clinical - stage biopharmaceutical company focused on developing targeted, locally administered and prolonged release therapeutics to address diseases with high unm
Slide 4: Localized Drug Delivery System Optimized for Management of SSIs
4 Toxic zone Therapeutic window PL E X Other local platforms Hours up to days Weeks up to months C on ce n t r a t i on D - PLEX 100 – Localized Drug Delivery System that is Optimized for the Management of Surgical Site Infections (SSIs) 1 2 3
Slide 5: D-PLEX100 product profile
5 x Active Ingredient: Doxycycline (broad spectrum antibiotic) D - PLEX 100 - Localized Drug Delivery System Optimized for Prevention of SSIs x Indication: prevention of post cardiac surgery sternal infection and post abdominal surgery incisional infection x Dosing: Varies by incision size. 1 vial >
Slide 6: Pipeline Summary
Pipeline Summary 6 Product candidate and indication Preclinical Phase 1 Phase 2 Phase 3 Key milestones • Preclinical Stage OncoPLEX Intratumoral therapy Unencumbered, late - stage pipeline with near - term value inflection 1 Following the enrolment of 500 patients that will complete their 30 days fo
Slide 7: The Burden of Surgical Site Infections
7 The Burden of Surgical Site Infections 1 DeverickJ et al, Strategies to Prevent Surgical Site Infections in Acute Care Hospitals: 2014 Update, Infection Control and Hospital Epidemiology, 2014. 2 Estimated figures likely underestimated as ~50% of SSIs become evident only after a patient has been d
Slide 8: Our Initial Focus: Enhancing Post-Operative SSI Prevention
8 Our Initial Focus: Enhancing Post - Operative SSI Prevention Source: American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. Ban et al. J Am CollSurg Vol. 224, No. 1, January 2017 ; New WHO recommendations on intraoperative and postoperative me
Slide 9: A potential game changer in the prevention of SSIs
9 Source: BCC research report Antibiotic drug reservoir PLEX TM matrix + antibiotic • PLEX technology to physically encapsulate a broad spectrum antibiotic • Designed to provide localized and prolonged infection management after surgery Example of surgeon spreading the D - PLEX 100 paste in an open
Slide 10: A Small Single Dose Sufficient for High Local Concentrations
10 A Small Single Dose of D - PLEX 100 is Sufficient for High Local Concentrations for Several Weeks 55 - 164 mg Local delivery of doxycycline 60 pills = 6,000 mg Systemic formulation of doxycycline x1 x 4 0 - 115 D - PLEX 100 is designed to provide prolonged delivery following single administration
Slide 11: Phase 2: Prevention of Post Abdominal Surgery SSIs
11 30 60 Primary Endpoint : Combined SSI and mortality rate at 30 days post Index Surgery* Phase 2: D - PLEX 100 for the Prevention of Post Abdominal Surgery (Soft Tissue) SSIs Key secondary efficacy endpoints • Number of hospitalization days post colorectal surgery due to SSI • A v er age ASEP S IS
Slide 12: Demographics and Baseline Data Summary
12 Demographics and Baseline Data Summary Statistics Surgery P r oc e du r e La p a r os c o p y 66% Baseline demographic (Age, BMI etc) and surgical characteristics were balanced between the two treatment groups Laparotomy 34% Cancer 74% C r o hn ’ s disease 13% R ea son f or surgery O ther 13%
Slide 13: Positive Phase 2 Results in Abdominal Surgery
13 Positive Phase 2 Results in Abdominal Surgery * PEP is the Combined SSI and mortality rate which is measured by the number and proportion of subjects with either an SSI event (as determined by the abdominal surgery) or mortality or any reason within 30 days post index surgery. Note: The current s
Slide 14: D-PLEX in Sternal/Bone Surgeries: P1b Open Heart Surgery Results
14 D - PLEX 100 : P1b / 2 Open Heart Surgery Results 1 D - PLEX in Sternal / Bone Surgeries No Sternal Wound Infection in 58 Treated patients (Based on recent literature, we would have expected ~3 - 5 patients with SWIs in the D - PLEX 100 treatment group and 1 - 2 patients in the SoC control group)
Slide 15: Trials Completed and Two Potentially Pivotal Phase 3 Trials Underway
15 5 Trials Completed and Two Potentially Pivotal Phase 3 Trial Underway D - PLEX has already completed 5 clinical trials with c. 400 patient data set 1 st Soft Tissue (open abdominal surgery) Phase 3 Study 616 - 900 pts 60 centers in US, EU and IL 2 nd Soft Tissue (open abdominal and MIS) Phase 3 S
Slide 16: FDA Recognizes the Potential Value of D-PLEX in SSI
16 Recognizes the Potential Value of DPLEX 100 in SSI ▪ More frequent meetings with the FDA to discuss the development plan ▪ Eligible for accelerated approval and priority review, if relevant criteria are met ▪ Rolling Review ▪ All the benefits of Fast Track ▪ Additional 5 - years of market exclusi
Slide 17: Could Provide Clinical Benefit in Broad Surgical Population
17 D - PLEX 100 Could Provide Clinical Benefit in Broad Surgical Population 1 Source: IQVIA PM&I Global FlexView. Internal analysis; based on Current Clinical Development program and regulatory strategy ; 2 Mainly major Open - surgeries (except for Colorectal Surgeries). US market represents c.14M m
Slide 18: Key CMS Programs are Strong Drivers for D-PLEX
HAC reduction Hospital - Acquired Condition Reduction • CMS’s non - payment for HACs - SSIs • Total Medicare payments to facilities reduced by 1% • Payment adjusted on all CMS claims • Public reporting of quality measures HRRP Hospital Readmissions Reduction • Incentivize hospitals to decrease readm
Slide 19: Surgeons and non-surgeons anticipate high adoption rate
19 Surgeons and non - surgeons anticipate high adoption rate of D - PLEX 100 51% 30% 57% Abdominal Surgeries Cardiac Surgeries Orthopedic Surgeries % of All Surgical Cases Surgeons Abdominal n=17; Cardiac n=10; Orthopedic n=10 58% 51% 34% Abdominal Surgeries Cardiac Surgeries Orthopedic Surgeries No
Slide 20: Feedback from the market research study
20 Feedback from the market research study "The fact that you leave it in there for 28 days, that's interesting ... because a lot of our wounds get infected way down the road . ” – Cardiac Surgeon “If there's a sustained release over a period of weeks, that would continue antibiotic presence in a wo
Slide 21: State-of-the-Art Manufacturing Facility
PolyPid was granted Manufacturer Authorization and Good Manufacturing Practice (GMP) certification by Israel’s Ministry of Health (IMOH) and EU qualified person for its state - of - the - art ~10,500 square feet GMP manufacturing facility State - of - the - Art Manufacturing Facility • Investment –
Slide 22: Summary
22 Summa r y POLYPID is poised for potential near - term value creation • Pursuing expedited development pathway • Large and growing target market • Broad applicability of PLEX technology • Near - term value inflection points • Strong management team