PRF Technologies Ltd. · NASDAQ:PRFX
PRF Technologies — PainReform — Investor Presentation (January 2021)
16 slides from PRF Technologies's investor presentation, January 2021
Slide 1: Investor Presentation
Investor Presentation January 2021
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements about our expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”,
Slide 3: PRF-110 Executive Summary
PRF-110 Executive Summary ▪ Post-operative pain treatment is a growing market (~$12B) with a need for better therapeutics1 o Local anesthetics provide pain relief for up to 6 hours and require augmentation with non-steroidal anti-inflammatory drugs (NSAIDs) o NSAIDs or opioids for moderate to severe
Slide 4: Management Team
Management Team Ehud Geller, PhD, MBA. Executive Chairman ▪ Former President & CEO of Interpharm Laboratories and EVP of Teva Group ▪ Former head of the Israeli Pharmaceutical Manufacturers Association and board member of the Tel Aviv Stock Exchange ▪ National Industry award for contribution to biot
Slide 5: Post-Operative Pain Management Market Overview
Post-Operative Pain Management Market Overview ▪ The 2017 world-wide overall post-operative pain treatment market was estimated at US$~12B and is expected to reach in excess of US$45B by the end of 20261 4 ▪ Significant unmet need for long-acting local anesthetic agents in order to spare opioids use
Slide 6: Problem: State of Opioid Crisis in America
Problem: State of Opioid Crisis in America ▪ 99% of surgical patients receive opioids to manage post-surgical pain1 ▪ Opioids dependency can start within 3 days of initial use 11.4 Million 2.1 Million People misused opioids in 2019. 886K People have an opioid use disorder. 1.7 ▪ 6% to 10% of surgica
Slide 7: Current Approaches in Post-Operative Analgesia Are Lacking
Current Approaches in Post-Operative Analgesia Are Lacking Short-Acting Opioids Long-Acting Opioids ▪ Repeated dosing required ▪ Poor efficacy in acute pain control ▪ Inconsistent pain control between doses ▪ Not intended for the treatment of post-operative pain ▪ Dependence risk increases with trea
Slide 8: PainReform Solution: PRF-110 Post Operative Pain Management
PainReform Solution: PRF-110 Post Operative Pain Management ▪ PainReform has developed a platform formulation for extended release of drugs ▪ Low COGS compared to current drug landscape Pain Reduction Time Scalable and Cost Effective Studies have shown 48 hours of pain Low variable costs allows for
Slide 9: PRF-110: Timeline to NDA
PRF-110: Timeline to NDA Historical Future Initiate double blind, 3-arm FDA determined (PRF-110: active comparator: the CMC data Positive Phase 2, proof- placebo), placebo controlled adequate to of-concept study in Phase 3 studies in NDA submission ~22 proceed to Phase I hernia repair: pain bunionec
Slide 10: Product differentiation PRF-110 vs. Competition
Product differentiation PRF-110 vs. Competition Pacira1 – Exparel™ Heron2-HTX 011 PRF-110 PRF-110 Advantages Watery, complex liposomal Biochronomer technology(4): Non-dilutable Waterless, viscous, oil-based solution Formulation Uniformity, viscosity, & retention suspension (Limited market) (GRAS) Po
Slide 11: PRF-110 Safety
PRF-110 Safety ▪ PainReform carried out extensive FDA requested wound healing and related animal studies that showed: ✓ PRF-110 allows for normal wound healing of surgical incisions equal to both Naropin® and saline without any untoward histological or radiologic (microCT) effects observed in soft o
Slide 12: PRF-110 Phase 2 Results in Hernia
PRF-110 Phase 2 Results in Hernia PRF-110 Pain Reduction Up to 72-Hours After a Single Application 8 ▪ Efficacy PBO ➢ PRF-110 provided post- 7 Historical placebo data operative pain control for up Mean Pain Score 6 to 72 hours after a single PRF-110 Scale 1-10 application 5 4 ▪ Safety ➢ PRF-110 was
Slide 13: PRF-110: Phase III Clinical Trial Protocol
PRF-110: Phase III Clinical Trial Protocol ▪ Two, double blind, placebo control 72-hour treatment period, studies planned (bunionectomy and hernia surgery). For each study: ▪ Three cohorts (n= ~400): PRF-110; Naropin® (ropivacaine); placebo; in a 2:2:1 ratio Primary endpoint (Efficacy) • Compare the
Slide 14: PRF-110: Potential Best-In-Class
PRF-110: Potential Best-In-Class Efficacy Safety Cross study comparison of Phase II Met FDA required extensive pre-clinical studies data, 72 hours pain AUC to demonstrate no wound healing issues Administration COGS Low cost of good sold allows a highly PRF-110 viscosity and uniformity are highly str
Slide 15: Summary
Summary 1 2 3 4 5 Innovative Opioid Epidemic Seasoned Robust US and Core platform Formulation / Presents Management International can be utilized Delivery System Significant Team with IP Portfolio for wide-range Commercial Decades of of APIs to Opportunity Experience generate sustainable pipeline La
Slide 16: Thank You
Thank You