Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Investor Presentation (April 2023)
49 slides from Palatin Technologies's investor presentation, April 2023
Slide 1: Palatin Technologies Corporate Presentation April 2023
Palatin Technologies, Inc. NYSE American: PTN CORPORATE PRESENTATION April 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 Completed Phase 3 Melody1 Data 3Q2023 PL8177 Oral – Ulcerative Colitis Phase 2 Proof-of-Concept initiated and enrolling patients 4
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: Approximately 16MM People Diagnosed with DED in U.S.
Approximately 16MM People Diagnosed with DED in U.S. An estimated ~7MM 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 t
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 MELODY-1 Data TFLs & CSR Submission Complete Enrollment 2021 2022 2023 2024 2025 PL9643-301 MELODY-1 (Efficacy) PL9643-302 MELODY-2 (Efficacy) PL9643-303 MELODY-3 (Safety)0 19
Slide 20: 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 21: Melanocortin Agonists for Retinal Diseases
Melanocortin Agonists for Retinal Diseases
Slide 22: 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 23: 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 23 23
Slide 24: 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 25: 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 25
Slide 26: 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 27: PL8177 Oral for Ulcerative Colitis
PL8177 Oral for Ulcerative Colitis
Slide 28: 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 3Q23 final data 4Q23 MC1r on colon epithelial cells is accessi
Slide 29: 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 30: PL8177 Pre-Clinical Histological Findings (Total Colitis Index in Rats)
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 31: PL8177-Oral Pre-Clinical Cell Analysis in Rat Ulcerative Colitis 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 32: 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 PL8177-205 Oral LICENSING Product manufacturing PL8177-205 PL8177 Oral UC Study Part A Oral UC Study Patient Popula
Slide 33: 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 34: Melanocortin Agonist for Diabetic Nephropathy
Melanocortin Agonist for Diabetic Nephropathy
Slide 35: 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 36: 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 37: Vyleesi®
Vyleesi®
Slide 38: 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 38
Slide 39: 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 40: 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 41: Intellectual Property Position
Intellectual Property Position Composition of matter patent through June 28, 2025 • US 6,794,489; 35 USC §156, maximum 5-year extension 28 June 2025 5 November 2033 Multiple patents for Uses of Bremelanotide in Therapy for Female Sexual Dysfunction through November 5, 2033 • Limited to female sexual
Slide 42: 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 43: Recent Vyleesi® Quarterly Product Sales Results – 12/31/22
Recent Vyleesi® Quarterly Product Sales Results – 12/31/22 “We are excited with Vyleesi’s continued quarter over quarter increases across all value metrics, most notably regarding net product sales and prescriptions dispensed,” stated Carl Spana, Ph.D., President and CEO of Palatin. “We are especial
Slide 44: 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 • 2 FTE sales reps (primarily inside / limited office visits) • 1.5 FTE business analyst • 0.5 FTE sales/marketing head / 0.5 FTE market access hea
Slide 45: 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 46: Net Sales Analysis
Net Sales Analysis Gross to Net (GTN) / Net per Dispense $3,000,000 $400 $345 $321 $2,500,000 $300 $287 $2,000,000 $200 $1,500,000 $150 $100 $100 $74 $84 $1,000,000 $45 $0 $500,000 ($100) $- ($156) $(500,000) ($200) Q4 2020 Q1 2021 Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022 Q3 2022 Q4 2022 Gross Sales
Slide 47: Patient Distribution Metrics
Patient Distribution Metrics Dispenses / % Refills 3500 60% 3000 52% 50% 51% 51% 2500 40% 2000 36% 32% 30% 1500 27% 26% 20% 1000 20% 19% 10% 500 1264 1569 1483 1284 1275 1530 2282 2674 2982 0 0% Q4 2020 Q1 2021 Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022 Q3 2022 Q4 2022 Dispenses to Patients Refills as
Slide 48: Financial Snapshot
Financial Snapshot Financial Highlights as of September 30, 2022 Cash and Cash Equivalents $21.2 million Does not Include proceeds from the Registered Direct Offering which closed in November 2022 ($10.0 million Gross; ~$9.1 million net of expenses) Accounts Receivable $2.0 million Inventory $0.9 mi
Slide 49: Thank You.
Thank You. & PALATIN
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