Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Investor Presentation (September 2023)
52 slides from Palatin Technologies's investor presentation, September 2023
Slide 1: Palatin Technologies Corporate Presentation
Palatin Technologies, Inc. NYSE American: PTN CORPORATE PRESENTATION September 2023 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 3
Slide 4: Commercial Product and Development Programs
Commercial Product and Development Programs Commercial Product Vyleesi® (bremelanotide) FDA Approval 2Q2019 Seeking U.S. and ROW Licenses Hypoactive Sexual Desire Disorder Pipeline Development Programs FDA Melanocortin Receptor Programs Pre-clinical Phase 1 Phase 2 Phase 3 NDA Status/Next Steps Appr
Slide 5: Milestones
Milestones Melanocortin System Inflammatory & Autoimmune Disease Programs Date PL9643 – Dry Eye Disease Phase 3 Melody1 Initiated 4Q2021 Phase 3 Melody1 Interim Analysis / Lead-In Population Analysis Completed Phase 3 Melody1 Data 2H2023 PL8177 Oral – Ulcerative Colitis Phase 2 Proof-of-Concept init
Slide 6: Melanocortin Inflammatory & Autoimmune Disease Programs
Melanocortin Inflammatory & Autoimmune Disease Programs Pioneering a new way to treat patients Meeting the need for safe effective treatments
Slide 7: 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 7
Slide 8: Multiple Pathways From MCR Agonism to Resolution of Inflammation
Multiple Pathways From MCR Agonism to Resolution of Inflammation MCR Agonism d d Fibroblast Glial Endothelial Epithelial Dendritic Podocytes Melanocytes Melanocortin Receptor agonism reduces tissue stress signaling from Macrophages T-cells Natural Killer Eosinophils B-cells Neutrophils Basophils res
Slide 9: Melanocortin Therapeutics Have Broad Utility
Melanocortin Therapeutics Have Broad Utility Melanocortin System: A Platform for Drugs to Treat Inflammatory Diseases EYES: PL9643 Phase 3 BRAIN: VYLEESI® Palatin’s therapeutics work by Sexual Dysfunction activating endogenous LUNG: PL9680 melanocortin pathways to resolve S damaging inflammation and
Slide 10: Melanocortin System Palatin's Approach
Melanocortin System Palatin’s Approach • Potential for a new class of drugs treating inflammatory diseases without immune suppression Value • Better efficacy, tolerability, and safety to address significant unmet medical needs in large markets • Advance our understanding of the melanocortin system a
Slide 11: Ocular
& PALATIN
Slide 12: Ophthalmic Diseases with Unmet Medical Need: Front to Back
Ophthalmic Diseases with Unmet Medical Need: Front to Back √ Conjunctiva/Cornea/Ocular surface • Dry eye • Ocular surface protection Cornea endothelium • Protect donor corneas for transplantation • Improve corneal transplant survival • Protection of cornea with cataract surgery • Fuchs Dystrophy Iri
Slide 13: PL9643 DED Program Summary
PL9643 DED Program Summary PL9643 (melanocortin agonist) represents a novel topical approach to treating the signs The positive PL9643 Ph. 2 DED study was the and symptoms of Dry Eye Disease (DED) 1st evaluation of MCr agonist in ocular inflammatory indication PL9643 resolves inflammation underlying
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: Patient Satisfaction is an Issue with Current Therapies
Patient Satisfaction is an Issue with Current 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 Burning 72% Burning 64% Slow onset of effect
Slide 16: PL9643 Safety & Ocular Tolerability Comparability
PL9643 Safety & Ocular Tolerability Comparability Approved Products PL9643 Phase 2 Study Phase 3 Lead-In Cases (N=160) (N=120) Restasis PL9643 Vehicle PL9643 Vehicle (N=80) (N=80) (N=60) (N=60) • Phase 2 n=160 Ocular Burning 17% 0% 0% 0% 3% Xiidra • No treatment-related serious AEs or ocular AEs Ins
Slide 17: PL9643 Phase 2 DED Results
PL9643 Phase 2 DED Results Difference between active and vehicle least squares change from baseline moderate/severe subgroup (n=53) *P<0.05; †P<0.1 17
Slide 18: PL9643 Phase 3 Study Design
PL9643 Phase 3 Study Design* 12-week, Multicenter, 1:1 Randomized, Double-Masked, Vehicle-Controlled Adaptive Design Study Evaluate the efficacy and safety of PL9643 in up to 600 adults with moderate or severe dry eye disease defined as: Disease duration ≥ 5 years; Inferior Corneal Staining score >1
Slide 19: PL9643 MELODY Phase 3 Program Timeline
PL9643 MELODY Phase 3 Program Timeline MELODY-2 & 3 NDA MELODY-1 FPI Interim Analysis Complete Enrollment MELODY-1 Data TFLs & CSR Submission 2021 2022 2023 2024 2025 PL9643-302 MELODY-2 (Efficacy) PL9643-301 MELODY-1 (Efficacy) PL9643-303 MELODY-3 (Safety)0 19
Slide 20: PL9643 Lead-In Population Analysis Process
PL9643 Lead-In Population (LIP) Analysis Process Systematic analysis approach to increase the probability for clinical trial success Lead-In Population: Initial 120 patients completing 12 weeks of treatment Un-Blinded LIP analysis by the Detailed analysis LIP Independent Confirmation of Blinded Stud
Slide 21: Analyses Lead-In Population: Clinical Signs & Symptoms
Analyses Lead-In Population: Clinical Signs & Symptoms • PL9643 was superior to Vehicle for all 13 Clinical Signs Nasal Lissamine Green Staining * Inferior Fluorescein Staining * Corneal Sum Lissamine Green Staining Temporal Fluorescein Staining Conjunctival Sum Lissamine Green Staining * Nasal Fluo
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 superior commercial product Current FDA approved treatments have DED is estimated to affect over 34 million profile compared to approved therapies poor ocu
Slide 23: PL9643 Dry Eye Summary Statements
PL9643 Dry Eye Summary Statements PL9643 MELODY-1 Phase 3 clinical trial is on track to • Demonstrate efficacy for multiple sign and symptom endpoints of DED • With excellent ocular tolerability and safety Analysis of Lead-In population has identified • Symptom sub-population and informed primary si
Slide 24: Melanocortin Agonists for Retinal Diseases
Melanocortin Agonists for Retinal Diseases
Slide 25: Melanocortin Agonism for Retinal Disorders
Melanocortin Agonism 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 Melanocortin
Slide 26: 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 26 26
Slide 27: 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 t
Slide 28: PL9654 Diabetic Retinopathy Model
PL9654 Diabetic Retinopathy Model PL9654 Subcutaneous Delivery PL9654 Improved Key Components of Retinal Health • Preserves contrast vision and visual acuity • Preserved retinal anatomy • Suppressed pro-inflammatory cytokines • Increased IL-10 a marker of inflammation resolution 28
Slide 29: Retinopathy – Desired Target Product Profile
Retinopathy – Desired Target Product Profile to Determine Commercial Success Preclinical Profile: Ongoing Activities: Next Steps: • High receptor potency • IND enabling studies • Expanding preclinical models • Efficacy in preclinical animal models • Genomic and proteomic studies to define MOA • Phas
Slide 30: PL8177 Oral for Ulcerative Colitis
PL8177 Oral for Ulcerative Colitis
Slide 31: PL8177 Oral Formulation for Ulcerative Colitis
PL8177 Oral Formulation for Ulcerative Colitis Global ulcerative colitis (UC) market USD Phase 2 study evaluating safety and efficacy $5.5 billion 2021, projected to be $8 billion of PL8177-Oral in UC patients, interim by 2026 assessment 2H23 final data1H24 MC1r on colon epithelial cells is accessib
Slide 32: UC Patient Treatment Paradigm
UC Patient Treatment Paradigm Opportunity for PL8177 in UC Treatment Moderate Mild UC Moderate UC Severe UC 5-ASA (LialdaTM) Low 5-ASA PL8177 failure Drug Steroids enema/ suppository Price Steroids oral Steroids infusion Treatment flow Biologics & Immuno-moderators (Adalimumab BS) Surgical Operation
Slide 33: PL8177 Pre-Clinical Histological Findings
PL8177 Pre-Clinical Histological Findings (Total Colitis Index in Rats) Total Colitis Index o Abnormalities of mucosal architecture total colitis index o Extent of inflammation 50 ✱✱✱✱ ✱✱✱ o Erosion or ulceration total colitis index 40 o Epithelial regeneration 30 o Percentage involvement by the dis
Slide 34: PL8177-Oral Pre-Clinical Cell Analysis in Rat Model
PL8177-Oral Pre-Clinical Cell Analysis in Rat Ulcerative Colitis Model In a rat DSS colitis model: PL8177 preserves relative enterocyte cell population PL8177 prevents increase in relative T cell population PL8177 prevents increase in multiple inflammatory pathways Single nuclei RNAseq of rat colon
Slide 35: 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 UC PL8177-205 PL8177 Oral Study Part A (n=16) Oral UC Study Patient
Slide 36: Ulcerative Colitis – Target Product Profile for Commercial Success
Ulcerative Colitis – Target Product Profile for Commercial Success PL8177 Preclinical Profile PL8177 Oral Formulation PK PL8177 Clinical • High potency at melanocortin receptors 1 • Phase 1 radiolabeled micro-dose study with the • Phase 1 clinical SAD/MAD study with the • Efficacy in multiple animal
Slide 37: Melanocortin Agonist for Diabetic Nephropathy
Melanocortin Agonist for Diabetic Nephropathy
Slide 38: Melanocortin Agonists Increase Key Kidney Cell Types in Diabetic Rats
Melanocortin Agonists Increase Key Kidney Cell Types in Diabetic Rats Cell Populations by snRNAseq* Podocyte Podocyte Density Density by Histopathology 45 ✱ ✱✱ Healthy WT1+ cells/glomerular area 60 40 Percent of Nuclei Diabetic 35 Diabetic + 40 30 4 MC1R agonist 3 2 20 1 0 0 Podocytes Proximal Tubul
Slide 39: BREAKOUT Phase 2 Study Design & Timelines
BREAKOUT Phase 2 Study Design & Timelines Multicenter, Open-Label, Prospective Study (n=45) 2022 2023 2024 First Patients’ 6 Months Data PL8177 oral Drug Product manufacturing Total Enrollment (n=45) and Patient Completion Full 6 Month Data n=45 (6 Months Treatment) Follow Up Period/Patient Completi
Slide 40: Vyleesi®
Vyleesi®
Slide 41: FDA Approved Vyleesi® For HSDD
FDA Approved Vyleesi® For HSDD Helping Premenopausal Women with Hypoactive Sexual Desire Disorder (HSDD) Visit: www.vyleesi.com / www.vyleesipro.com 41
Slide 42: 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 43: 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 44: Intellectual Property Position
Intellectual Property Position Composition of Matter Patent through June 28, 2025 Use of bremelanotide in Patients with Controlled • US 6,794,489; 35 USC §156, maximum 5-year extension Hypertension 5 November 2033 28 June 2025 29 April 2041 Multiple patents for Uses of Bremelanotide in Therapy for F
Slide 45: Vyleesi® / Addyi® Comparison / Differentiating Factors
Vyleesi® / Addyi® Comparison / Differentiating Factors Prescription / Use • Addyi® • Oral / chronic use - must be taken once daily • Month supply of pills / WAC $400 • Requires 4-6 weeks before initial onset of efficacy • Vyleesi® • SC / on-demand treatment taken as-needed • Pack of 4 single-use aut
Slide 46: Vyleesi Product Revenue Results Fourth Quarter FY 2023
Vyleesi Product Revenue Results Fourth Quarter FY 2023 (6/30/23) • $4.1 million in Gross Product Revenue o 20% growth over prior quarter o 78% growth over FY 4Q22 • $1.7 million in Net Product Revenue o 42% growth over prior quarter o 122% growth over FY 4Q22 • Prescriptions dispensed o 14% growth o
Slide 47: Current Go-To-Market Approach
Current Go-To-Market Approach Objective: Re-license U.S. rights • Plan: Enhance brand value / improve net ASP, reimbursement, demand oIt’s working - 6 consecutive quarters of double-digit growth Commercial Infrastructure • 2 FTE sales reps (primarily inside / limited office visits) • 1.5 FTE busines
Slide 48: Financial / Operational Fundamentals
Financial / Operational Fundamentals WAC $899 Package size is a 4-pack (4 single-use autoinjectors) Increased execution of Prior Authorizations driving greater Net ASP >$300 reimbursement/insurance covered prescriptions COGS ~$38 (4-pack) GM ~87% of target net ASP Distribution Closed-network through
Slide 49: Net Sales Analysis (GTN)
Net Sales Analysis (GTN) Gross to Net (GTN) / Net per Dispense $4,500,000 $400 $345 $371 $4,000,000 $321 $313 $300 $3,500,000 $287 $3,000,000 $200 $2,500,000 $150 $2,000,000 $100 $100 $74 $84 $1,500,000 $45 $0 $1,000,000 $500,000 ($100) $- ($156) $(500,000) ($200) Q4 '20 Q1 '21 Q2 '21 Q3 '21 Q4 '21
Slide 50: Patient Distribution Metrics
Patient Distribution Metrics Dispenses / % Refills 5000 60% 4500 52% 50% 4000 51% 51% 48% 3500 40% 41% 3000 36% 2500 32% 30% 2000 27% 26% 20% 1500 20% 19% 1000 10% 500 1264 1569 1483 1284 1275 1530 2282 2674 2982 3780 4371 0 0% Q4 '20 Q1 '21 Q2 '21 Q3 '21 Q4 '21 Q1 '22 Q2 '22 Q3 '22 Q4 '22 Q1 '23 Q2
Slide 51: Financial Snapshot
Financial Snapshot Financial Highlights as of March 31, 2023 Cash and Cash Equivalents $19.6 million Accounts Receivable $1.7 million Inventory $0.6 million No debt Inventory Purchase Commitments (over the next 5 years) $6.9 million Summary Capitalization as of March 31, 2023 Common Shares and Equiv
Slide 52: Thank You.
Thank You. & PALATIN
Palatin Technologies — Investor Presentation (September 2023) on 6ix