Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Investor Presentation (November 2022)
46 slides from Palatin Technologies's investor presentation, November 2022
Slide 1: Palatin Technologies Corporate Presentation November 2022
Palatin Technologies, Inc. NYSE American: PTN CORPORATE PRESENTATION November 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 Commercial Product Vyleesi® (bremelanotide) FDA Approval 2Q2019 Seeking U.S. and ROW Licenses Hypoactive Sexual Desire Disorder Pipeline Development Programs Melanocortin Receptor Programs Pre-clinical Phase 1 Phase 2 Phase 3 NDA FDA Approval Status/Next S
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 2Q2023 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 Melanocortin receptors present on a wide range of resident cells and immune cells d d Fibroblast Glial Endothelial Epithelial Dendritic Podocytes Melanocytes Melanocortin receptor agonism reduces tissue stress signaling to
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 KI
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: 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 19: 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 20: PL9643 DED Program Timelines Adjusted for DMC Recommendations
PL9643 DED Program Timelines Adjusted for DMC Recommendations Interim Original Plan Additional 230 Patients NDA MELODY-1 Phase 2 Results EOP2 meeting Assessment MELODY-1 TFLs & CSR MELODY-1 TFLs & CSR Submission FPI MELODY-2 & 3 TFLs & CSR 2021 2022 2023 2024 2025 PL9643-301 MELODY-1 (Efficacy) init
Slide 21: 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 22: PL9654 for Retinal Diseases
PL9654 for Retinal Diseases & PALATIN
Slide 23: 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 24: 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 25: 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 26: 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 27: 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 28: 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 29: PL8177 for Ulcerative Colitis
PL8177 for Ulcerative Colitis
Slide 30: 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 31: 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 32: PL8177 Pre-Clinical Histological Findings (Total Colitis Index in Rats)
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 33: PL8177 Pre-Clinical Cell Analysis in Rat Ulcerative Colitis Model
PL8177 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 34
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 PL8177 Oral UC Study Part A UC Study Part B Patient
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) 38
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: Recent Vyleesi Quarterly Product Sales Results
Recent Vyleesi Quarterly Product Sales Results “We are pleased with Vyleesi’s continued quarter over quarter growth on net product revenue and prescriptions dispensed for the quarter ended September 30, 2022,” stated Carl Spana, Ph.D., President and CEO of Palatin. “We are especially pleased with ou
Slide 41: 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 42: 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 $300 greater reimbursement/insurance covered prescriptions COGS ~$38 (4-pack) GM ~87% of target net ASP Distribution Closed-network throu
Slide 43: Net Sales Analysis
Net Sales Analysis Gross to Net (GTN) / Net per Dispense $2,500,000 $400 $319 $2,000,000 $299 $300 $1,500,000 $200 $150 $1,000,000 $100 $100 $84 $74 $45 $500,000 $0 $- ($100) ($156) $(500,000) ($200) Q4 2020 Q1 2021 Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022 Q3 2022 Gross Sales Net Sales Net per Dispen
Slide 44: Quarterly Dispenses / Refill Rate %
Quarterly Dispenses / Refill Rate % Dispenses / % Refills 3000 60% 2500 50% 51% 52% 2000 40% 36% 1500 30% 32% 26% 27% 1000 20% 19% 20% 500 10% 1264 1569 1483 1284 1275 1530 2282 2674 0 0% Q4 2020 Q1 2021 Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022 Q3 2022 Dispenses to Patients Refills as % of Total RX 4
Slide 45: 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 46: Thank You.
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