Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Investor Presentation (October 2022)
45 slides from Palatin Technologies's investor presentation, October 2022
Slide 1: Palatin Technologies Corporate Presentation October 2022
Palatin Technologies, Inc. NYSE American: PTN CORPORATE PRESENTATION October 2022 Carl Spana, Ph.D. President & CEO Stephen T. Wills, CPA/MST CFO / COO
Slide 2: Forward Looking Statements
Forward Looking Statements The statements in this presentation that relate to future plans, events or performance are forward-looking statements, which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended. Such forward-looking statements involve si
Slide 3: Company Profile
Company Profile Targeting the Melanocortin System: A Platform for the Development of Drugs to Treat Inflammatory & Autoimmune Diseases Demonstrated expertise Expertise in the biology First company to Strong scientific Mechanism of action moving programs from and chemistry of procure FDA approval fou
Slide 4: Commercial Product and Development Programs
Commercial Product and Development Programs 4 Source: Company Filings
Slide 5: Developing Drugs to Address Unmet Clinical Needs
Developing Drugs to Address Unmet Clinical Needs Total Market Size of Palatin’s Top Priority Clinical Programs (2021) ~ $20 Billion Addressing unmet and unsatisfied medical needs, through safer better • Need for safer, more tolerable UC Ulcerative Colitis products prior to steroids & biologics toler
Slide 6: Target Milestones
Target Milestones Melanocortin System Inflammatory & Autoimmune Disease Programs Date Data PL9643 – Dry Eye Phase 3 Melody 1 Initiated 4Q2021 Phase 3 Melody-1 Interim Assessment Completed Phase 3 Melody-1 Data 1H2023 PL8177-Oral – Ulcerative Colitis Phase 2 Proof-of-Concept initiated and enrolling p
Slide 7: Melanocortin Inflammatory & Autoimmune Disease Programs
Melanocortin Inflammatory & Autoimmune Disease Programs Pioneering a new way to treat patients, and meeting the need for safe effective treatments.
Slide 8: The Inflammatory Process in Health and Disease
The Inflammatory Process in Health and Disease Non-Resolving/Chronic Excessive Response Inflammation Tissue Damage Balanced Response Pharmacological Resolution: Tissue Melanocortin System Protection Onset Phase Resolution Phase Melanocortin System LTB4 PGD2 PGE2 Resolvins Protectins TNF-⍺ IL - 1β 8
Slide 9: Multiple Pathways From MCR Agonism to Resolution of Inflammation
Multiple Pathways From MCR Agonism to Resolution of Inflammation MCR Agonism MCR agonism changes Immune cell phenotypes to non-inflammatory d d Glial Endothelial Epithelial Dendritic Podocytes Melanocytes MCR agonism reduces Stress signaling Macrophages T-cells Natural Killer Eosinophils B-cells Neu
Slide 10: Melanocortin Therapeutics Have Broad Utility
Melanocortin Therapeutics Have Broad Utility Targeting the Melanocortin System a platform for drugs to treat inflammatory diseases EYES (PL9643; PL9654) BRAIN (VYLEESI®) Palatin’s therapeutics work by activating endogenous LUNG (Lead ID) melanocortin pathways to resolve damaging inflammation and KID
Slide 11: Validating the Melanocortin System
Validating the Melanocortin System Goal: Validate the Melanocortin system as a new target for the development of drugs to treat multiple inflammatory and autoimmune diseases Why: Potential for a new class of drugs not based on immune suppression with better efficacy, tolerability and safety to addre
Slide 12: Ocular
& PALATIN
Slide 13: Ophthalmic Diseases with Unmet Medical Need: Front to Back
Ophthalmic Diseases with Unmet Medical Need: Front to Back Conjunctiva/Cornea/Ocular surface • Dry eye EYE ANATOMY Cornea endothelium • Protect donor corneas for transplantation • Improve corneal transplant survival • Protection of cornea with cataract surgery • Fuchs Dystrophy Iris/Ciliary Body/Cho
Slide 14: Dry Eye Overview
Dry Eye Overview Dry eye disease (DED) or keratoconjunctivitis is a multifactorial disorder of the tears and ocular surface Symptoms include dryness, irritation, redness, discharge and blurred vision Inflammation plays a prominent role in the development and amplification of the signs and symptoms o
Slide 15: Compliance Remains an Issue with Current SoC Therapies
Compliance Remains an Issue with Current SoC Therapies Poor tolerability leads to high discontinuation rates Patients Receiving Rx for Dry Eye (48%)7 Response Rate Discontinuation Rate Response Rate Discontinuation Rate 68-80%1-4 Unknown 70.8% 6** 64.4% 6** Due to 8* Due to 8* Burning 72%* Burning 6
Slide 16: Approximately 16M People Diagnosed with DED in U.S.
Approximately 16M People Diagnosed with DED in U.S. An estimated ~7M may be open to new treatment DED EPIDEMIOLOGY DED Population Potential Addressable DED Population ~16M ~50% of the estimated 34M 16 people in the U.S. with dry eye 80% of patients ever treated are have been diagnosed willing to try
Slide 17: PL9643 DED Program Summary
PL9643 DED Program Summary PL9643 a novel approach to treat Dry Eye Disease MELODY-1 phase 3 study innovative adaptive design (DED) targeting the melanocortin system to resolve Interim analysis completed August 2022 pathological inflammation and promote tissue healing Data 1H2023 PL9643 peptide agon
Slide 18: PL9643 Dry Eye Phase 2 Results
PL9643 Dry Eye Phase 2 Results Met primary objective of providing Statistical significance for the primary In the sub-population of moderate to data required to advance into endpoints was not achieved in the ITT severe patients (N=53), PL9643 achieved registration studies population that included mi
Slide 19: Phase 2 Study - Signs Differences Between PL9643 and Vehicle
Phase 2 Study - Signs Differences Between PL9643 and Vehicle Least squares change from baseline moderate/severe subgroup (N=53) *P<0.05; †P<0.1 19
Slide 20: Phase 3 Study Design & Endpoints Based on DMC Recommendations
Phase 3 Study Design & Endpoints Based on DMC Recommendations 12-week, multicenter, 1:1 randomized, double-masked, vehicle-controlled adaptive design study Evaluate the efficacy and safety of PL9643 in up to 350 adults (initial target N=240) with moderate or severe dry eye disease Disease duration ≥
Slide 21: PL9643 DED Program Timelines Adjusted for DMC Recommendations
PL9643 DED Program Timelines Adjusted for DMC Recommendations Original Plan Additional 230 Patients NDA MELODY-1 Interim Phase 2 Results MELODY-1 TFLs & CSR MELODY-1 TFLs & CSR Submission FPI Assessment EOP2 meeting MELODY-2 & 3 TFLs & CSR 2021 2022 2023 2024 PL9643-301 MELODY-1 (Efficacy) initiated
Slide 22: PL9643 Dry Eye Commercial Opportunity
PL9643 Dry Eye Commercial Opportunity DIFFERENTIATED PRODUCT UNMET MEDICAL NEEDS SPEED/SAFETY/TOLERABILITY LARGE MARKET OPPORTUNITY PL9643 has a very favorable commercial Current FDA approved treatments have DED is estimated to affect over 34 million product profile compared to approved high discont
Slide 23: PL9654 for Retinal Diseases
PL9654 for Retinal Diseases & PALATIN
Slide 24: PL9654 for Retinal Disorders
PL9654 for Retinal Disorders The total retinal disorders drug market, USD Retinal disorders can significantly impair vision $20 billion in 2021, projected to be $27 billion preservation of vision is the key outcome for by 2026; DR/DME estimated ~$10 billion. drug treatment. PL9654 is a highly potent
Slide 25: Preclinical Proof-of-Concept
Preclinical Proof-of-Concept To validate melanocortin receptors as therapeutic targets for retinal diseases, Palatin’s melanocortin agonist compounds were tested in two relevant animal models Laser-Induced Choroid Diabetic Retinopathy Neovascularization (CNV) Model Model 25 25
Slide 26: PL9654 Laser Induced Choroid Neovascularization Model
PL9654 Laser Induced Choroid Neovascularization Model Model recapitulates main features of human age-related macular degeneration (AMD) MEAN LEAKAGE AREA MEAN AREA OF ANGIOGENESIS MEAN AREA OF FIBROSIS Treatment Groups Treatment Groups Treatment Groups • PL9654 showed therapeutic activity comparable
Slide 27: Diabetic Retinopathy Model
Diabetic Retinopathy Model Melanocortin agonist demonstrated key indicators of improve retinal health, including: Preserved retinal anatomy Suppressed pro-inflammatory Increased levels of IL-10, a marker of cytokine to healthy control levels inflammation resolution Healthy Control Diabetic; Untreate
Slide 28: PL9654 in a Rat Diabetic In-Life Retinopathy Model
PL9654 in a Rat Diabetic In-Life Retinopathy Model CONTRAST VISION Vehicle 0.05 mg/kg 0.1 mg/kg 0.5 mg/kg PL9654 preserves contrast vision as compared to controls. A 2nd measure of visual acuity demonstrated similar efficacy. 28
Slide 29: Retinopathy – Desired Target Product Profile
Retinopathy – Desired Target Product Profile to Determine Commercial Success Efficacy Pharmacokinetics (ROA) Safety PL9654 was chosen based on: PL9654 Ongoing Activities: PL9654 • High potency at melanocortin receptors 1 & 5 • IVT sustained release formulation development • IND enabling studies and
Slide 30: PL8177 for Ulcerative Colitis
PL8177 for Ulcerative Colitis
Slide 31: PL8177 Oral Formulation for Ulcerative Colitis
PL8177 Oral Formulation for Ulcerative Colitis Global ulcerative colitis (UC) market USD MC1r is found on epithelial cells of the colon and $5.5 billion 2021, projected to be is accessible from the lumen of the colon. $8 billion by 2026. • Evidence from preclinical animal & human studies Most treatm
Slide 32: Opportunity for PL8177 in UC Treatment Landscape
Opportunity for PL8177 in UC Treatment Landscape Severity: Mild Moderate Severe Patient number: Large Small 5-ASA (Lialda) Low 5-ASA PL8177 failure Steroids enema/ suppository Drug Price Steroids oral Steroids infusion Treatment flow Biologics & Immuno-moderators (Adalimumab BS) Surgical Operation H
Slide 33: PL8177 Pre-Clinical Histological Findings
PL8177 Pre-Clinical Histological Findings (Total Colitis Index in Rats) • The scoring was based on examining three total colitis index sections from each colon per animal: 50 ✱✱✱✱ ✱✱✱ • Sections were taken at the distance of 2.5cm, 5cm and 7.5cm from the anus total colitis index 40 30 • Total coliti
Slide 34: PL8177-205 Phase 2 Study Design & Timelines
PL8177-205 Phase 2 Study Design & Timelines Phase 2 RCT parallel group study using an adaptive design to evaluate safety, tolerability and efficacy 2021 2022 2023 2024 PL8177 oral Drug LICENSING Product manufacturing PL8177-205 Oral PL8177-205 Oral Patient Population: PL8177 Oral UC Study Part A UC
Slide 35: Ulcerative Colitis – Target Product Profile for Commercial Success
Ulcerative Colitis – Target Product Profile for Commercial Success Efficacy Pharmacokinetics (ROA) Safety PL8177 in animal models and Phase 2 PL8177 oral formulation PK: • Phase 1 clinical SAD/MAD study with the planned: • Phase 1 radiolabeled micro-dose study with the systemic formulation (SC) comp
Slide 36: Vyleesi®
Vyleesi®
Slide 37: FDA Approved Vyleesi® For HSDD
FDA Approved Vyleesi® For HSDD Helping Premenopausal Women with Hypoactive Sexual Desire Disorder (HSDD) 37
Slide 38: Vyleesi – Melanocortin Receptor Agonist
Vyleesi – Melanocortin Receptor Agonist Women with HSDD may have an imbalance of neurotransmitter activity in the brain that impacts sexual desire: too few excitatory signals, too many inhibitory signals, or both.2 Excitatory Signals Inhibitory Signals + Dopamine + Serotonin (5-HT) + Norepinephrine
Slide 39: HSDD is a Significant Market Opportunity
HSDD is a Significant Market Opportunity 1/101,2 Affects 5.8 million U.S. premenopausal women3 (1 in 10 premenopausal women)1,2 98% (5.7M) of affected premenopausal women not on therapy3 Focused on relevant Creating an online community for Ensure HCP readiness, provide digital channels HSDD patients
Slide 40: Current Go-To-Market Approach
Current Go-To-Market Approach Objective: Re-license U.S. rights • Enhance brand value / improve net ASP, reimbursement, demand Commercial Infrastructure • 3 FTE sales reps (primarily inside / limited office visits) • 1 FTE business analyst • 1/2 FTE sales/marketing head / 1/2 FTE market access head
Slide 41: Financial / Operational Fundamentals
Financial / Operational Fundamentals WAC $899 Package size is a 4-pack (4 single-use autoinjectors) Increased execution of Prior Authorizations will drive Net ASP $275-$300 greater reimbursement/insurance covered prescriptions COGS ~$38 (4-pack) GM ~87% of target net ASP Distribution Closed-network
Slide 42: Net Sales Analysis
Net Sales Analysis Gross to Net (GTN) / Net per Dispense $2,500,000 $350 $300 $287 $2,000,000 $250 $200 $1,500,000 $150 $150 $100 $100 $1,000,000 $84 $74 $45 $50 $0 $500,000 ($50) $- ($100) ($156) ($150) $(500,000) ($200) Q4 2020 Q1 2021 Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022 Gross Sales Net Sales
Slide 43: Dispenses / % Refills
Dispenses / % Refills 43 *Data source: TrialCard 2021 Corporate Presentation I 43
Slide 44: Financial Snapshot
Financial Snapshot Financial Highlights as of June 30, 2022 Cash and Cash Equivalents $29.9 million Accounts Receivable $1.8 million Inventory $0.9 million Inventory Purchase Commitments (over the next 5 years) $8.6 million Summary Capitalization as of September 20, 2022 Common Shares and Equivalent
Slide 45: Thank You.
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