Polypid Ltd. · NASDAQ:PYPD
Polypid — IPO Roadshow (October 2014)
34 slides from Polypid's IPO roadshow presentation, Oct 31, 2014
Slide 1: Corporate Presentation
Corporate Presentation Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration No. 333 - 199297 October 31 , 2014
Slide 2: Forward-looking statements
Forward - looking statements This presentation includes statements that are, or may be deemed, “forward - looking statements.” In some cases these forward - look ing statements can be identified by the use of forward - looking terminology, including the terms “believes,” “estimates,” “anticipates,”
Slide 3: Free Writing Prospectus Statement
Free Writing Prospectus Statement This presentation highlights basic information about us and the offering. Because it is a summary, it does not contain all of the information that you should consider before investing. We have filed a registration statement (including a prospectus) with the SEC for
Slide 4: Initial Public Offering summary
Issuer PolyPid Ltd. Exchange / symbol NASDAQ Capital Market / PLPD Offering Size 1.8M shares (100% primary) Over - Allotment 15% or 273,000 shares (100% primary) Price Range $10 - $12 Indication of Interest from Insiders Up to $7 million Use of Proceeds • $7.5 million for clinical studies and regula
Slide 5: PolyPid snapshot
PolyPid snapshot Established: 2008 PLEX™ Technology: Local drug delivery matrix enabling highly effective and safe treatment for a period of up to several months Pipeline: Focused on the development and commercialization of a multiple solutions for the prevention and treatment of infection • F irst
Slide 6: PolyPid - unique investment opportunity
PolyPid - unique investment opportunity 6 PLEX™ Technology - based focused pipeline best - in - class products Impressive Clinical Data - Safety & performance Experienced Management Team Global Market & Strategic Partnership Opportunities Strong IP Scalable Business Model with Attractive Economics
Slide 7: Here with you today
Here with you today Amir Weisberg - Chief Executive Officer Leading PolyPid since 2010, Mr. Weisberg has 20 years of experience as an entrepreneur and CEO of start - up companies with two financial exits. Prior to PolyPid , Mr. Weisberg managed start - up companies in the Life Science sphere, from i
Slide 8: Optimized therapeutics for local delivery
Optimized therapeutics for local delivery 8 Location The right place Concentration Duration Overcome systemic limitations Optimized Therapeutics
Slide 9: PLEX technology setting new standards
PLEX™ technology setting new standards 9 Therapeutic window Toxic zone Hours up to days Weeks up to m onths Available Common Platforms • High & potentially toxic initial burst • Non - linear & limited controlled release • Often too short duration • Poor long term stability for many drugs PLEX™ Matri
Slide 10: PLEX: Polymer Lipid Encapsulation matriX
PLEX™: P olymer L ipid E ncapsulation matri X 10 • No covalent bonds between the compounds or with the drug ◦ Faster regulatory pathway ◦ Commercially available compounds ◦ Production under mild conditions
Slide 11: Core platform technology
Core platform technology 11 1 2 3 4 5 6 On a molecular level, polymers and lipid self - assembled into thousands of alternating layers that encapsulate the drug. Drug captured between the layers released over time by the gradual degradation of the layers
Slide 12: PLEX platform - breadth of drug applications
Any size or physical characteristics PLEX™ platform - breadth of drug applications 12 Small molecules Antibiotics 1 NSAID 3 , Anti - fungal 3 , Steroids 2 Peptides Several tested; including anti microbial 2 Proteins Antibodies 3 & Growth factors 2 Nucleic acids based drugs Plasmid DNA 3 & siRNA 3 •
Slide 13: PLEX platform - optimized therapeutics for local delivery
PLEX ™ platform - optimized therapeutics for local delivery 13 Location The right place Concentration Effective & safe concentration Duration The needed duration Overcome the limited penetration of systemic treatments into key organs Optimized Therapeutics
Slide 14: PLEX is best positioned to fight infection
PLEX ™ is best positioned to fight infection 14 Significant health economic burden: • Up to 15 % of patients incur infection while hospitalized in spite of all of the anti bacteria regimes • An on - going battle • . . . and it is getting worse – antibiotic resistance Pain Infection Inflammation Canc
Slide 15: Snapshot: Infection-focused portfolio
Snapshot: Infection - focused portfolio 15 * CE route was confirmed as Medical Device Class III ** PMA regulatory route pending FDA official confirmation Orthopedic & Trauma Indication Spine Peri - Implantitis Dental Surgical Site Infection (SSI) Others Preclinical Pilot Clinical Pivotal / Phase III
Slide 16: BonyPid-1000 Product Overview
BonyPid - 1000 ™ Product Overview
Slide 17: BonyPid-1000 answers an unmet need
BonyPid - 1000 ™ answers an unmet need 17 The Need Supports fast bone recovery But… Every open fracture is contaminated by bacteria Many of the open fractures are already infected at the time of initial treatment and the risk of infection continues after surgery Unmet Need Protect bone from bacteria
Slide 18: Open fracture: infection & amputation rates correlate with severity
Open fracture: infection & amputation rates correlate with severity of open fractures 18 Gustilo Grade I II IIIA IIIB IIIC Infection Rate 0 - 2% 2 - 7% 10 - 25% 10 - 50% 25 - 50% Amputation Rate 2.5% 5.6% 50% Type I Type II Type III Hans - Christoph Pape, Roy Sanders, Joseph Borrell , Jr. The Poly -
Slide 19: Current local treatment regimen in the USA
Current local treatment regiment in the USA • Gentamicin loaded PMMA beads • Short release of effective antibiotics – few days • Require a second operation for removal – interfere with bone growth • May contribute to bacterial Biofilm on top of the beads • Not yet approved as beads by the FDA 19
Slide 20: BonyPid-1000: combining PLEX, bone substitute and antibiotics
BonePid - 1000 ™: combining PLEX technology, bone substitute and antibiotics to enable local protection BonyPid - 1000 ™ coating components are well organized on a molecular level as a fine, sub - structure by self - assembly into PLEX™ 20 Granular bon e substitute Fine coated by PLEX™ + antibiotic
Slide 21: Local vs. systemic drug delivery
0 . 65 pill = 65 mg 60 pills = 6,000 mg Systemic Formulation of Doxycycline BonyPid - 1000 ™ - Local vs . systemic drug delivery BonyPid - 1000 ™ - Doxycycline x 92 21 x 1 A l ow, localized 30 - day dose is sufficient to achieve a significant therapeutic effect
Slide 22: BonyPid-1000 optimizes drug release (and beats competition)
8 , 450 155 81 54 27 30 41 41 27 27 41 41 27 24 27 14 14 41 0.229 0.104 0.094 0.049 0.013 0.006 0.001 0.01 0.1 1 10 100 1000 10000 0 5 10 15 20 25 30 MIC released antibiotics/hour Days BonyPid™ MIC S.aureus Calcium Sulphate + Tobramycin Calcium Sulphate and Hydroxyapatite + Gentamicin Calcium Sulpha
Slide 23: BonyPid-1000 - no change in the method of use
BonyPid - 1000 ™ - no change in the method of use 23 • Filling and reconstructing bone voids, defects or gaps • Implanted during the first surgery • Drug is released for 3 - 4 weeks Pour Hydrate & Use BonyPid - 1000 ™ • BonyPid - 1000 ™ is to be used in conjunction with standard of care in orthopedi
Slide 24: Example: open fracture IIIA patient
Example: patient no. 14 - primary closure 24 26 / Female Open fracture - IIIA 7 hrs. post - injury 7 days post - op 14 days post op 21 days post - op
Slide 25: Example: Gustilo IIIB soleus flap & skin graft
Example : patient no. 5 - Gustilo IIIB soleus flap & skin graft 25 Pt no 5 , 28 /M Open Fracture IIIB 132 hrs. post - injury 1 day post - debt. 19 days post - debt. 21 st hospital day 6 wks post - injury BonyPid - 1000 ™
Slide 26: BonyPid-1000 clinical trial results summary
BonyPid - 1000™ clinical trial results summary 19 patients / 6 - 12 months follow - up Validated in the most challenging bacteria - contaminated orthopedic indication 26 ( 1 ) “Infection complications of type III Tibial fractures among combat casualties” Clin . Infect. Dis. ( 2007 ) 45 ( 4 ): 409 -
Slide 27: Clinical trial results summary - cont.
Improved clinical and patient outcome suggesting significant health economics impact BonyPid - 1000™ clinical trial results summary - cont. 27 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 2 3 4 5 6 81 % 33 % 17 % 5 % 2 % % of patients Number of surgeries Number of repeated surgeries due to risk of infecti
Slide 28: Infection-focused portfolio: Next regulatory steps
Infection - focused portfolio: Next regulatory steps 1 28 Orthopedic BonyPId - 1000™ Indication Spine/Open Fracture BonyPid - 1000 ™ Dental BonyPid - 1000 ™ Dental BonyPid - 1000 ™ Peri - implantitis 2 BonyPid - 500 ™ Regulatory Pathway Clinical Trial 3 initiation Pivotal Trial initiation Clinical s
Slide 29: Next regulatory steps cont.
Infection - focused portfolio: Next regulatory steps cont. 29 Safety and performance of BonyPid - 1000 ™ in Gustilo IIIA and IIIB tibial open fractures Design : Prospective, Multinational, Multicenter, Randomized, Two arm, Open Label, Standard of Care Controlled, Blinded central reading center study
Slide 30: PLEX-doxycycline: Value proposition addresses significant market needs
PLEX™ - doxycycline antibacterial agents: Value proposition addresses significant market needs 30 Orthopedic Trauma, spine, joint replacement Fast route to EU market followed by spine indication for US ~ 2.7 million orthopedic surgical procedures annually in the US Dental Sinus lifts, ridge augmenta
Slide 31: Collaboration strategy
Collaboration strategy R&D and licensing License proprietary PLEX ™ technology to biopharmaceutical companies, enabling them to encapsulate their therapeutic agents under upfront, milestone and royalty - bearing agreements Marketing & distribution Market and distribute our products independently in
Slide 32: Capitalization table
10/31/2014 Shares Outstanding Preferred Shares* 6,461,962 Ordinary shares 967,742 Warrants on Preferred Shares* 114,530 Employees stock Options 1,505,376 Fully diluted total 9,049,610 Capitalization table * Preferred shares and warrants on preferred shares convert to Ordinary shares at the Offering
Slide 33: PolyPid - unique investment opportunity
PolyPid - unique investment opportunity 33 PLEX™ Technology - based focused pipeline best - in - class products Impressive Clinical Data - Safety & performance Experienced Management Team Global Market & Strategic Partnership Opportunities Strong IP Scalable Business Model with Attractive Economics
Slide 34: Thank you
POLYPID OPTIMIZED THERAPEUTICS Thank you www.PolyPid.com