Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Investor Presentation (May 2022)
42 slides from Palatin Technologies's investor presentation, May 2022
Slide 1: Palatin Technologies Corporate Presentation May 2022
Palatin Technologies, Inc. NYSE American: PTN CORPORATE PRESENTATION May 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 Advancing a novel mechanism and approach to treating inflammatory & autoimmune diseases with a focus on ocular indications. Demonstrated expertise Expertise in the First company to Strategy leverages our MOAs with the moving programs from biology and chemistry procure FDA approval ch
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: Company Pipeline Valuation
Company Pipeline Valuation Total Market Size of Palatin’s Clinical Programs (2021) ~ $20 Billion Ulcerative • Need for safer, more tolerable UC Colitis products prior to use of steroids and biologics especially for pediatric patients • Market Size (2021) ~$5.5 Billion Addressing unmet and unsatisfie
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 2H2022 Phase 3 Melody-1 Data 2H2022 PL8177 Oral – Ulcerative Colitis Phase 2 Proof-of-Concept Initiation 1H2022 Phase 2 Pr
Slide 7: Inflammatory & Autoimmune Disease Programs
Inflammatory & Autoimmune Disease Programs Pioneering new ways to treat patients safely, effectively
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: Mechanism of Action of Melanocortin Systems
Mechanism of Action of Melanocortin Systems Mechanism of Melanocortin Signaling, Leading to Resolution of Inflammation • Melanocortin system is up-regulated and integral to the resolution of inflammation and autoimmune pathologies Immune Cell • Modulates the activity of cells of the immune system •
Slide 10: Melanocortin Therapeutics Have Broad Utility
Melanocortin Therapeutics Have Broad Utility Harnessing the melanocortin system in the body EYES (PL9643; PL9654) BRAIN (VYLEESI®) Palatin’s therapeutics work by activating endogenous LUNG (Lead ID) melanocortin pathways to resolve damaging inflammation and KIDNEY (Lead ID) promote tissue healing CO
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 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 13: 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 14: 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 15: 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 16: PL9643 DED Program Summary
PL9643 DED Program Summary PL9643 represents a novel approach to treating Dry Eye Disease (DED) by targeting the ability of the PL9643 Phase 2 DED study was the 1st evaluation melanocortin system to resolve pathological of melanocortin agonist in ocular inflammatory inflammation and promote tissue h
Slide 17: 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=61), PL9643 achieved registration studies population that included mi
Slide 18: Phase 2 Signs: Differences Between PL9643 and Vehicle
Phase 2 Study - Signs Differences Between PL9643 and Vehicle Least squares mean change from baseline fluorescein staining in the moderate/severe subgroup (n=53) Total Sum Total Corneal Total Conjunctival (corneal + (inferior + superior + (temporal + nasal) Temporal Nasal Inferior Superior Central co
Slide 19: Phase 2 Signs: Redness and Tear Film Break-up Time
Phase 2 Study - Signs Differences Between PL9643 and Vehicle Least squares mean change from baseline conjunctival redness & tear film break-up time moderate/severe subgroup (n=53) Conjunctival Redness Tear Film Break-up Time 0.00 0.45 * LS Mean Change from Baseline aLS Mean Change from Baseline 0.40
Slide 20: Phase 2 Symptoms: Differences Between PL9643 and Vehicle
Phase 2 Study – Symptoms Differences Between PL9643 and Vehicle Least squares mean change from baseline Ora Calibra® Ocular Discomfort and 4-Symptom Questionnaire† scores in the moderate/severe subgroup (n=53) Ocular Burning Dryness Grittiness Stinging discomfort 0.2 0.1 LS Mean Change from Baseline
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 favorable commercial Current FDA approved treatments have DED is estimated to affect over 34 million product profile / Differentiating factors to high disc
Slide 22: Phase 3 Study Design and Primary Endpoints
Phase 3 Study Design and Primary Endpoints 12-week, multicenter, 1:1 randomized, double-masked, vehicle-controlled adaptive design study Evaluate the efficacy and safety of PL9643 in up to 400 adults (initial target N=240) with moderate or severe dry eye disease defined as: Disease duration ≥ 5 year
Slide 23: PL9643 DED Program Timelines
PL9643 DED Program Timelines MELODY-1 Interim MELODY-1 TFLs & NDA Phase 2 Results Submission FPI Assessment CSR EOP2 meeting MELODY-2 & 3 TFLs & CSR 2021 2022 2023 2024 PL9643-301 MELODY-1 (Efficacy) initiated 4Q2021 PL9643-302 MELODY-2 (Efficacy) PL9643-303 MELODY-3 (Safety) 23
Slide 24: PL9654 for Retinal Diseases
PL9654 for Retinal Diseases & PALATIN
Slide 25: PL9654 for Retinal Disorders
PL9654 for Retinal Disorders Retinal disorders such as diabetic The total retinal disorders drug market is retinopathy (DR), diabetic macular edema valued at USD $20 billion in 2021, and is (DME), and AMD can significantly impair vision projected to be $27 billion by end of 2025; by damage to retina
Slide 26: Preclinical Proof-of-Concept
Preclinical Proof-of-Concept To validate melanocortin receptors as therapeutic targets for retinal vascular 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
Slide 28: 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 29: 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 second measure of visual acuity demonstrated similar efficacy to this measurement 29
Slide 30: 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 31: PL8177 for Ulcerative Colitis
PL8177 for Ulcerative Colitis
Slide 32: PL8177 Oral Formulation for Ulcerative Colitis
PL8177 Oral Formulation for Ulcerative Colitis Global ulcerative colitis (UC) market was MC1r is found on epithelial cells of the colon and valued at USD $5.5 billion in 2021, and is accessible from the lumen of the colon projected to be $8 billion by 2026 • Evidence from preclinical animal & human
Slide 33: 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 34: 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 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 Complete PL8177-205 Oral PL8177-205 Oral CMC/Regulatory UC Study Part A UC Study Pa
Slide 36: Ulcerative Colitis – Target Product Profile
Ulcerative Colitis – Target Product Profile Needed 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 (S
Slide 37: Vyleesi
Vyleesi®
Slide 38: FDA Approved Vyleesi
FDA Approved Vyleesi® Helping Premenopausal Women with Hypoactive Sexual Desire Disorder (HSDD) 38
Slide 39: Vyleesi Operations/Performance
Vyleesi Operations/ Performance OBJECTIVE Demonstrate the commercial value and upside of Vyleesi and re-license to a committed partner • Vyleesi is a valuable asset in the ‘right” hands o FDA approved product with limited competition • FSD market o Significant awareness needed / greater HCP and pati
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: Financial Snapshot
Financial Snapshot Financial Highlights as of March 31, 2022 Cash and Cash Equivalents $37.7 million Accounts Receivable $0.8 million Inventory $1.0 million Inventory Purchase Commitments (over the next 5 years) $9.0 million Summary Capitalization as of March 31, 2022 Common Shares and Equivalent Co
Slide 42: Thank You
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