Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Investor Presentation (November 2023)
40 slides from Palatin Technologies's investor presentation, November 2023
Slide 1: Palatin Technologies Corporate Presentation November 2023
Palatin Technologies, Inc. NYSE American: PTN CORPORATE PRESENTATION November 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 Melanocortin System Drug Development Platform Therapeutics for inflammatory & Autoimmune Diseases, Sexual Dysfunctions & Obesity Demonstrated Expertise in the biology 1st company to gain Strategy leverages MOA with potential to expertise moving and chemistry of FDA approval for a our
Slide 4: Commercial Product and Development Programs
Commercial Product and Development Programs Commercial Product Vyleesi® (bremelanotide) FDA Approval 2Q2019 / Currently Marketed by Palatin Seeking U.S. and ROW Licenses Hypoactive Sexual Desire Disorder Pipeline Development Programs FDA Melanocortin Receptor Programs Pre-clinical Phase 1 Phase 2 Ph
Slide 5: Melanocortin Programs - Ocular
Melanocortin Programs - Ocular Dry Eye Disease Glaucoma Retinal Diseases
Slide 6: 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 Iris/
Slide 7: 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 8: 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 9: 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 10: 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 11: Interim Analyses Lead-In Population: Clinical Signs & Symptoms
Interim Analyses Lead-In Population: Clinical Signs & Symptoms • PL9643 was superior to Vehicle for all 13 Clinical Signs Nasal Lissamine Green Staining * Inferior Corneal Fluorescein Staining * Corneal Sum Lissamine Green Staining Temporal Fluorescein Staining Conjunctival Sum Lissamine Green Stain
Slide 12: Analyses Lead-In Population: Clinical Signs
Analyses Lead-In Population: Clinical Signs LIP analysis of clinical signs following 12 weeks of treatment • PL9643 was superior to vehicle for all 13 clinical * signs evaluated * • Multiple clinical signs were statistically significant ** • PL9643 has a “global effect” ** * on improving the clinica
Slide 13: Analyses Lead-In Population: Clinical Symptom
Analyses Lead-In Population: Clinical Symptom Identified clinical symptom responder population and primary endpoint: Ocular Pain Ocular Pain (VAS) Symptom Endpoint Surveillance *p<0.05 • Ocular pain visual analogue scale (VAS) - at 12 weeks PL9643 had a statistically significant and clinically meani
Slide 14: PL9643 Topical Treatment for Dry Eye Disease
PL9643 Topical Treatment for Dry Eye Disease Emerging profile indicates PL9643 will be the best approved DED treatment Category Attribute Indication Dry Eye Disease Product Overview PL9643 is a melanocortin agonist which resolves inflammation and promotes tissue healing Safety/Ocular PL9643 Based on
Slide 15: PL9643 Dry Eye Summary Statements
PL9643 Dry Eye Summary Statements PL9643 MELODY-1 Analysis of Lead-In Emerging and Adaptive design Phase 3 clinical trial is population has differentiated product approach on track to identified profile • Demonstrate efficacy • Symptom sub- • Has significantly • Positioning PL9643 as for multiple si
Slide 16: 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 17: Broad Potential for Retinal Diseases
Broad Potential for Retinal Diseases Retinal disorders current drug market USD $20B, projected to be $27B by 2026 DR/DME estimated ~$10B • Palatin melanocortin agonists active in 4 pre-clinical retinal disease models* • Unprecedented versatility • Predictive of potential efficacy across human retina
Slide 18: Retinopathy – Desired Target Product Profile for Commercial Success
Retinopathy – Desired Target Product Profile for Commercial Success PL9654 Preclinical Data: Ongoing Activities: Next Steps: • Efficacy in 4 diverse preclinical animal • Expanding preclinical models • IND enabling studies models • Genomic and proteomic studies to define • Phase 1 SAD/MAD • Broad eff
Slide 19: PL9588 Treating Glaucoma - Optic Neuropathy
PL9588 Treating Glaucoma - Optic Neuropathy • Group of progressive eye diseases characterized by elevated intraocular pressure (IOP) resulting in or from ocular nerve damage • Elevated IOP results in loss of retinal ganglion cells and progressive loss of vision (open angle glaucoma), 2nd leading cau
Slide 20: Vyleesi® - FDA Approved for HSDD
Vyleesi® - FDA Approved for HSDD
Slide 21: 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 21
Slide 22: 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 23: 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 24: 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 25: 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 26: Vyleesi Product Revenue Results Fourth Quarter FY 2023
Vyleesi Product Revenue Results Fourth Quarter FY 2023 (6/30/23) 20% growth over prior quarter $4.1 million in Gross Product Revenue 78% growth over FY 4Q22 41% growth over prior quarter $1.7 million in Net Product Revenue 117% growth over FY 4Q22 15% growth over prior quarter Prescriptions dispense
Slide 27: Net Sales Analysis (GTN)
Net Sales Analysis (GTN) Gross to Net (GTN) / Net per Dispense $4,500,000 $500 $4,000,000 $400 $378 $3,500,000 $345 $321 $313 $3,000,000 $300 $287 $2,500,000 $200 $2,000,000 $150 $100 $100 $1,500,000 $74 $84 $45 $1,000,000 $0 $500,000 ($100) $- ($156) $(500,000) ($200) Q4 '20 Q1 '21 Q2 '21 Q3 '21 Q4
Slide 28: Patient Distribution Metrics
Patient Distribution Metrics Dispenses / % Refills 5000 60% 4500 50% 4000 51% 52% 51% 48% 3500 40% 41% 3000 36% 2500 30% 32% 2000 27% 26% 20% 1500 19% 20% 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 29: Significant Growth Within Insured, Drug Covered Segment
Vyleesi Performance Significant Growth Within Insured, Drug Covered Segment Vyleesi Coverage Vyleesi Coverage Vyleesi Coverage Q1 2021 Q2 2022 Q3 2022 15% 26% 26% 16% 12% 27% 59% 58% 61% Cash Cash Cash Insured, Drug Covered Insured, Drug Covered Insured, Drug Covered Insured, Drug Not Covered Insure
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 (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 34: 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 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: Milestones Recap; Financial Snapshot / Cap Table
Milestones Recap Financial Snapshot / Cap Table
Slide 38: 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 4Q2023 PL8177 Oral – Ulcerative Colitis Phase 2 Proof-of-Concept init
Slide 39: Financial Snapshot / Cap Table
Financial Snapshot / Cap Table Financial Highlights as of June 30, 2023 Cash, Cash Equivalents and Marketable Securities $11.0 million Accounts Receivable $2.9 million Inventory $0.5 million No debt Summary Capitalization as of June 30, 2023 Common Shares and Equivalents Common Stock 11.6 million sh
Slide 40: Thank You
Thank You & PALATIN
Palatin Technologies — Investor Presentation (November 2023) on 6ix