UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of: July 2021
Commission File Number: 001-38428
PolyPid Ltd.
(Translation of registrant’s name into English)
18 Hasivim Street
Petach Tikva 495376, Israel
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
☒ Form 20-F ☐ Form 40-F
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
CONTENTS
Corporate Presentation
On July 2, 2021, the Registrant made available a corporate presentation on its website. A copy of the corporate presentation is attached hereto as Exhibit 99.1.
EXHIBIT INDEX
| Exhibit No. | ||
| 99.1 | Corporate Presentation |
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| POLYPID LTD. | |||
| Date: July 2, 2021 | By: | /s/ Dikla Czaczkes Akselbrad | |
| Name | Dikla Czaczkes Akselbrad | ||
| Title: | Executive Vice President and Chief Financial Officer | ||
2
Exhibit 99.1
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 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 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 product candidates, 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 . Forward - looking statements are not historical facts, and are based upon management’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 that management’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 the Company’s Annual Report on Form 20 - F, filed with the SEC on March 5 , 2021 . 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 . Disclaimer
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 unmet medical needs Polymer - Lipid Encapsulation matriX (PLEX) Platform Our proprietary matrix of several thousand layers of polymers and lipids that physically embed an active drug and enable a customizable, predetermined release rate of up to several months Lead Product D - PLEX 100 is currently in Phase 3 development for the prevention of surgical site infections (SSIs) following abdominal (soft tissue) or post - cardiac sternal (bone) surgeries 1 As of June 2021.
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
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 >10cm, 10cm < 2vials > 20cm, 3 vials >20cm x Release Duration: Prolonged effect up to 4 weeks x Release profile: No Burst > Constant & linear release x Effective release rate : T o o v e r c o me r esi s t a n t bacteria & biofilm
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 follow - up in SHIELD I, the study design provides for a blinded sample size re - estimation based on the primary endpoint of the study in order to determine final patient sample size within the 616 to 900 patients range. We expect to report topline results from SHIELD I at the end of 2021 assuming the study will be completed at the lower range of the sample size. 2 In December 2019, we initiated a potentially pivotal Phase 3 clinical trial of D - PLEX 100 for the prevention of sternal SSIs after cardiac surgery and, subject to feedback from the FDA, we plan to continue development of D - PLEX 100 for the prevention of SSIs in patients undergoing abdominal surgery. We intend to pursue a broad label for D - PLEX 100 for the prevention of SSIs, the scope of which will depend on the clinical data generated from our potentially pivotal Phase 3 clinical trials and discussions with the FDA and the EMA. D - PLEX 100 Prevention of SSI in soft tissue (abdominal) SHEILD 1 pivotal study for approval in colorectal surgery SHEILD 2 supplemental study for expanded indication • SHIELD 1 approval sufficient for FDA approval • First Patient Enrolled in Jul. 2020 • Top - Line Results from First Phase 3 Trial Expected by End of 2021 (1) D - PLEX 100 Prevention of SSI in bone tissue (sternum) • First Patient Enrolled in Feb. 2020 (2)
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 discharged. 3 Financial Impact of Surgical Site Infections on Hospitals. John Shepard and al. JAMA Surg. 2013;148(10):907 - 914. https://www.cagesideseats.com/wwe/2018/2/6/16980406/big - show - reveals - hip - surgery - complication s ; 4 Surgical site infection - a European perspective of incidence and economic burden. Leaper DJ et al. Int Wound J. 2004 Dec;1(4):247 - 73. 5 ~€11bn represents the midpoint of the range discussed in WHO Global guidelines on the prevention of surgical site infection. Nov 2016: 29 ; 6 New WHO recommendations on intraoperative and postoperative measures for surgical site infection prevention: an evidence - based global perspective. Benedetta Allegranzi et al. Lancet Infect Dis. 2016 Dec;16(12):e288 - e303. 7 Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, JAMA Surgery , Special Communication, 2017 7 A Globally Recognized Problem Up to 30% Estimated SSI rate of patients undergoing colorectal surgery 1,2 $11k - 26k Cost of treatment per infection directly attributable to SSIs 20% SSI rate of all health care - associated infections in US hospitals 3 7 - 11 days Additional post - operative hospital days for patients with SSIs 3 2 - 11x Increased risk of death for SSI patient (up to 40% mortality after deep sternal infection) 1 Estimated SSI - related incremental annual hospital costs in the US and EU 4, 5 US EU $10bn ~ € 11bn “ The human and financial costs of treating surgical site infections (SSIs) are increasing . The number of surgical procedures performed in the United States continues to rise , and surgical patients are initially seen with increasingly complex comorbidities .” 7 “The prevention of SSIs is complex and requires the integration of a range of preventive measures before, during, and after surgery . No international guidelines are available…the prevention of SSIs is a priority for patient safety .“ 6
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 measures for surgical site infection prevention: an evidence - based global perspective - Benedetta Allegranzi et al. The Lancet Infectious Diseases, Vol. 16, No. 12*In CABG, left internal mammary artery (LIMA) harvesting further decrease antibiotic penetration ; Furthermore, Tissue perfusion is impaired in patients with diabetes or atherosclerosis, who are common in CABG / cardiac Surgery. 1 Cefazolin and linezolid penetration into sternal cancellous bone during coronary artery bypass grafting . Martin Andreas et al. European Journal of Cardio - Thoracic Surgery 48 (2015) 758 – 764 ; 2 Direct sternal administration of Vancomycin and Gentamicin during closure prevents wound infection. Andreas M. et al. Interactive CardioVascular and Thoracic Surgery (2017) 1 – 5. Systemic antibiotic p r oph y l ax i s Maintain i nt r a - o p e r at iv e normothermia “Topical” anti s eptics/ antibiotics Maintain intra - operati v e gl ucose control Skin prepa r ation A nti s eptic sutures The Goal: effective and safe antibiotic concentrations over prolonged period within the surgical site In SSIs, the surgical incision becomes contaminated by bacteria Our solution: Direct local antibiotic administration at the site Systemic Antibiotics Are Not Enough Systemic antibiotic prophylaxis (IV, Oral) ½ - 1 - hour before the surgery is generally used to prevent SSIs But because of the surgical incision, the antibiotic penetration into the surgical wound is significantly limited (due to blood flow interruption) 1,2 * The Current Paradigm Supplemental oxygen delivery Wound care TYRX Absorbable Antibacterial Envelope PICO ѕ 7 Selected Key Players
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 - heart surgery D - PLEX 100 is a potential game changer in the prevention of SSIs D - PLEX 100 : locally - administered doxycycline • Administered directly in the surgical site • Local constant, effective concentration of antibiotic over prolonged duration (4 weeks) • Simple administration that requires no additional training
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 and subsequent high local concentrations and has the potential to supersede existing antibiotic delivery systems, and may offer advantages over systemic treatments in the prevention of SSIs, including against many antibiotic - resistant bacterial strains
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 a s s e ss m e n t s c or e during 30 days post - surgery • Number of surgical interventions due to SSI * SSI include Superficial and Deep SSIs ; Combined primary endpoint as confirmed by a Blinded and independent adjudication committee. 0 D - PLEX 100 + SOC (N=101) SOC (N=100) C o l o r e c tal S ur g ery 1 : 1 Randomization N= 201 Assess efficacy and safety of D - PLEX 100 for prevention of deep and incisional SSI after elective abdominal colon surgery (prospective, multicenter, randomized, controlled, two arm study) Safety Assessment at 60 days post Index Surgery
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%
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 standard of care for preventing SSIs involves the implementation of a range of treatment and prevention measures before, during and after surgery, including prophylactic antibiotic administration, antiseptic measures and wound care. 10% 24% Primary Endpoint* ITT Analysis Primary Endpoint - Per Protocol Analysis 59% reduction (p=0.0086) 8% 25% 69% reduction (p=0.0024) SOC+D - PLEX 100 n=10 n=100 n=101 SOC n=24 n=91 n=88 • 5 deaths observed in the SoC treatment arm, as compared to zero observed in the D - PLEX 100 +SOC treatment arm within the first 60 days post - surgery (p=0.0290) • Generally well tolerated, with no confirmed drug - related SAEs and no increase in wound healing impairment at the incision site as compared to control SOC+D - PLEX 100 n=7 SOC n=23
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) 6 - 10 0% SOC (n = 2 3 ) SOC + D - PLEX - 100 Ρ (n=58) % of Sternum Wound infection Sternum Wound Infection Rate (%) 4.3% No treatment related SAEs 1 Modified ITT results, based on 3 months follow - up Clinical Study Report; 2 One event ; 3 Two events where another surgery and implantation of bone graft was needed ; 4 Prodromidis et al. The 6 - Hour Rule for Surgical Debridement of Open Tibial Fractures: A Systematic Review and Meta - Analysis of Infection and Nonunion Rates. 2016 ; 5 Poletti FL et al. Current Concepts and Principles in Open Tibial Fractures - Part II Management and Controversies. 2017. 6 Adding vancomycin to perioperative prophylaxis decreases deep sternal wound infections in high - risk cardiac surgery patients. Reneike S. et al. European Journal of Cardio - Thoracic Surgery (2017) 1 – 7 7 Direct sternal administration of Vancomycin and Gentamicin during closure prevents wound infection. Andreas M. et al. Interactive CardioVascular and Thoracic Surgery (2017) 1 – 5 8 Prevention of surgical site sternal infections in cardiac surgery: a two - centre prospective randomized controlled study. Schimmer C et al. European Journal of Cardio - Thoracic Surgery (2016) 1 – 6. 9 Based on 3 months follow - up interim report. 10 Surgical Site Infections Volume - Outcome Relationship and Year - to - Year Stability of Performance Rankings. Calderwood MS. et al. Med Care 2017;55: 79 – 85; 11 Predecessor product candidate to D - PLEX100. D - PLEX 1000 : Open - Tibia Fractures 11 D - PLEX 1000 + SoC SoC D eep bone i nfect i ons 2 / non - union 3 rate (%) 0% (0/24) 11.1 % ( 3/27) No deep bone infections after 6 months across 24 treated patients, in comparison with reported incidences in the literature ranging between 7% to 19% 4 - 5
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 Study 900 - 1400 pts 60 centers in US, EU and IL Bone Tissue (Sternal wound infections in open - heart surgery) Phase 3 Study 1,284 - 1,600 pts 45 centers in US, EU and IL Pivotal Study Recruiting Supplement to NDA Recruiting Supplement to NDA
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 exclusivity ▪ Improved CMS add - on payment , increase of the NTAP from 50% to 75% ▪ All the benefits of Fast Track ▪ Intensive guidance from FDA on an efficient drug development program ▪ Organizational commitment from FDA involving senior managers 2 Fast Track Des i gn a ti o n s 2 Qualified Infectious Disease Product (QIDP) Designations B r ea k t h r ough Therapy Designation
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 major surgeries 1,2 Soft Tissues Bone Tissues General Surgeries • Open Abdominal/GI/Colorectal Surgeries • Stomach & Intestinal • Herniorrhaphies • Colorectal • Cholecystectomies • Appendectomies Cardiac • Open - Heart Surgeries (CABG, valve repair / replacement, heart / lung transplant, congenital defect repair) Selected Gynecological / Urological Surgeries Hysterectomies ; Salpingo - Oophorectomies & Oophorectomies ; Breast Reconstruction ; Prostatectomies ; Nephrectomies Orthopedic • Fractures • Hip Arthroplasties (primary + Revision) • Knee Arthroplasties (primary + Revision) • Spine Fusions (Cervical, Thoracic and Lumbar)
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 readmission rates (frequently are caused by HAIs) • Payment reductions are applied (up to 3% of all Medicare base operating DRG payments ) VBP Value - Based Purchasing • CMS rewards acute - care hospitals with incentive or penalties for the quality of care they provide (up to 2 % of DRG payment) • Episodes of care for 90 days Key CMS Programs are Strong Drivers for D - PLEX 100 In fiscal 2020, CMS will withhold an estimated $563 million in Medicare payments to hospitals under the Hospital Readmissions Reduction Program 4 Source: 1) Preeminent Hospitals Penalized Over Rates Of Patients’ Injuries, Kaiser Health News, https://tinyurl.com/y5863xt l 2) Hospital Inpatient Pay - for - Performance Programs 2013 - 2021: Final Impact Summary . T 1 he 8 Advisory Board analysis 3) https://www.cms.gov/Medicare/Medicare - Fee - for - Service - Payment/AcuteInpatientPPS/Readmissions - Reduction - Program 4 ) https:// www.beckershospitalreview.com/finance/cms - penalizes - 2 - 583 - hospitals - for - high - readmissions - 5 - things - to - know.html
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 Non - Surgeons n=34* (IDs n=7; Admins n=27) Anticipated Use of D - Plex 100 By Surgery and Respondent Type Source: Polypid market research , March 2021
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 wound that is trying to heal with open incision . This keeps the fires burning in terms of antibiotic presence . ” – Infectious Disease Specialist "Any infection needs to be reported. If there's a readmission for infection and that procedure was performed at the hospital, that case is reviewed by Head of Orthopedics and the Infectious Disease Specialist." – Orthopedic Surgeon “I think if Product X caused a 69% reduction in surgical site infection, I think anybody who wouldn't use it would be doing a detriment to the patient , if the contrast is so stark.“ – Colorectal/Abdominal Surgeon Source: Polypid market research , March 2021
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 – machinery, qualifications and validations • Supply capacity – meets commercial demand for at least 30 months from launch 21
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