Harrow, Inc. · NASDAQ:HROW
Harrow — Imprimis Pharmaceuticals — Investor Presentation (October 2018)
23 slides from Harrow's investor presentation, Oct 29, 2018
Slide 1: Corporate Presentation October 2018
MEL] = CORPORATE PRESENTATION OCTOBER 2018
Slide 2: Forward-looking statements
Bare HARBOR ee ‘Tis presentation contains express “forward Jooking statements” as defined in the Private Securities Litigation Reform Act of 1595. You are “cautioned not to rely on these forward-looking statements. Theze statements are based on current expectations of future events. i underlying ‘ze
Slide 3: Melt Pharmaceuticals overview and vision
foes | RAC T Our vision is to be the leading provider of non-opioid, non-intravenous pharmaceuticals used for conscious sedation and analgesia during medical procedures in a variety of healthcare settings Melt is fed by an experienced management and clinical advisory team Melt Pharmaceuticals is a s
Slide 4: Opportunity
OPPORTUNITY Our core IP is a patented series of combination non- opioid sedation drug formulations We intend to seek regulatory approval through the FDA's 505(b)(2) regulatory pathway for our proprietary drug candidates We believe there are in excess of 100M procedures in the US where our formulatio
Slide 5: Lead Drug Candidate: MELT-100 for Conscious Sedation
LEAD DRUG CANDIDATE MELT-100: FOR CONSCIOUS SEDATION sublingual midazolam + ketamine drug candidate Key competitive advantages: © Non-opioid © institutional use only; drug will never be prescribed to patients (lowering abuse deterrence need) © Patient preference for sublingual delivery over standard
Slide 6: Melt Opportunity
Mert ET OPPORTUNITY Near Term: Cataract Surgery Sedation ‘© Compounded drug experience is primarily during cataract surgery and “conscious sedation during cataract surgery” label may provide lowest development risk with immediate commercial upside © Attain Medicare Part B temporary pass-through code
Slide 7: Targeted Procedures: Annual Procedures (US)
TARGETED PROCEDURES Annual Procedures (US) _wonv cd gov/mmur volumes/65/s5/ss6512a1 him wwwweede gov/nchs/data/nhames/web tables/2015 ed web tables pdf “yum ncbinlm ih gow/pme/artcles/PNCI909546/
Slide 8: Melt Pipeline
Moe lel PLPELINE eo Gece eeee ination of ketamine + midazolam sublingual combination of ketamine + midszolam . eee ceo tion of ketamine + midazolam subtingual combination of ketamine + midsrolam
Slide 9: Competition
COMPETITION BACKGROUND Most widely used products in procedural sedation are IV propofol, fentanyl and midazolam. Common oral medications used for sedation in minor procedures include diazepam and lorazepam We believe IV midazolam alone and in many instances in combination with other medications, suc
Slide 10: Real World Experience
REAL WORLD EXPERIENCE MELT
Slide 11: Real World Experience with Melt Technologies
REAL WORLD PRPERIENCE WITH MELT TECHNOLOGIES @ Nearly 100,000 units of MELT-100 (with ondansetron) have been produced and dispensed by Imprimis as a compounded drug (the “MKO Melt”), primarily used during cataract surgery MKO Melt is currently dispensed from Imprimis’ FDA-registered outsourcing faci
Slide 12: Human Clinical Experience: The Jeffries Study - Cataract Surgery
HUMAN CLINICAL BOX PEAROPE.N CE The Jeffries Study - Cataract Surgery Aboard certified anesthesiologist conducted a 611 patient IRB approved prospective, controlled, randomized, 3 arm comparator study for conscious sedation during cataract surgery. ‘@ PRECIS: When used for cataract surgery, the MKO
Slide 13: Jeffries Study Outcomes with Melt Technologies
Slide 14: Clinical Program
CLINICAL PROGRAM MELT
Slide 15: Clinical Program: Expected Development Requirements
@eee® EEN 1. CAE PROG RAM* Expected Development Program Requirements: ® One pharmacological toxicity study before IND filing @ PK Study to establish bioavailability vs. reference drugs © Single factorial designed study (Phase III), with multiple study arms: @ Comparator against midazolam alone ©@ Co
Slide 16: Clinical Program: Key Points
ee OPIN 1. CAE PROG RAM * Key Points: © Establish endpoints via proceduralist and patient satisfaction, which we believe includes the need for additional/rescue medication (similar to Jeffries endpoints) @ Exclude ondansetron in MELT-100 drug candidate to lower trial risk, cost and complexity @ Util
Slide 17: Formulation Characteristics
FORMULATION CHARACTERISTICS MELT
Slide 18: Ketamine and Midazolam
BOBS Ts AaMsION| E Ketamine is an FDA approved anesthetic, and was first introduced in the U.S. market in 1970 Described as: “rapidly acting, nonbarbiturate general anesthetic” and a suggestion that ketamine, a unique intravenous anesthetic, would be useful for short procedures Ketamine is known to
Slide 19: Bioavailability Analysis
BIOAVAILABILITY ANALYSIS A 2016 pharmacokinetics and pharmacodynamics analysis of midazolam, ketamine and ondansetron in a conscious sedation troche reported: ® Significantly lower peak plasma concentrations of midazolam and ketamine for sublingual delivery as compared to IV @ Peak plasma concentrat
Slide 20: Summary
SUMMARY e Our vision is to be the leading provider of non-opioid, non-lV conscious sedation and analgesia pharmaceuticals used in hospital, outpatient, and in- office settings Our IP is based on a patented series of sedation drug formulations that have been dispensed - as a compounded drug — nearly
Slide 21: Appendix
APPENDIX MELT
Slide 22: IP Summary
IP SUMMARY eees @ US Patent 9,918,993 B2 entitled “Pharmaceutical compositions for anesthesiological applications” was issued on March 20, 2018 (filed date: June 16, 2016) @ 4 filed divisionals and CIPs for additional composition of matter and methods of use claims; additional routes of administrati
Slide 23: Thank You
THANK YOU
Imprimis Pharmaceuticals — Investor Presentation (October 2018) on 6ix