Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Investor Presentation (April 2024)
44 slides from Palatin Technologies's investor presentation, April 2024
Slide 1: Corporate Presentation
Palatin Technologies, Inc. NYSE American: PTN CORPORATE PRESENTATION April 2024 Carl Spana, Ph.D. Stephen T. Wills, CPA/MST President & CEO 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) Asset Sale for FSD Rights to Cosette December 2023 Up to $159 million in potential sales milestones and Hypoactive Sexual Desire Disorder $10.5 million in potential regulatory milestones Pipeline Development Prog
Slide 5: Ophthalmology MCr Programs
Ophthalmology MCr Programs • Dry Eye Disease – PL9643 • Glaucoma – PL9588 • Retinal Diseases – PL9654
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% 5,6,8 64.4% 5,6,8 Burning 72% Burning 64% Slow onset of
Slide 9: PL9643 Melody-1 Phase 3 Study Design
PL9643 Melody-1 Phase 3 Study Design 12-week, Multicenter, 1:1 Randomized, Double-Masked, Vehicle-Controlled Adaptive Design Study Evaluate the efficacy and safety of PL9643 (575 patients enrolled) with moderate or severe dry eye disease defined as: Disease duration ≥ 5 years; Inferior Corneal Stain
Slide 10: Analyses Lead-In Population: Clinical Signs & Symptoms at 12 Weeks
Analyses Lead-In Population: Clinical Signs & Symptoms at 12 Weeks Clinical Signs Ocular Pain (VAS) 40.0 Conjunctival Sum 35.0 Lissamine Green… 33.1 30.0 Nasal Lissamine Green 25.0 23.4 Staining (Ora Calibra… 20.0 15.0 15.0 13.8 Total Staining Score 10.0 8.7 Lissamine Green… 5.0 2.4 P=0.0079 Inferio
Slide 11: PL9643 Phase 3 Melody-1 Study Topline Results
PL9643 Phase 3 Melody-1 Study Topline Results • Positive Phase 3 Study Topline Results • Co-primary symptom endpoint of pain met statistical significance (P<0.025) • 7 of 11 secondary symptom endpoints met statistical significance (P<0.05), 12-week treatment period • Rapid onset of Efficacy at the 2
Slide 12: PL9643 Safety & Ocular Tolerability Comparability
PL9643 Safety & Ocular Tolerability Comparability Approved Products PL9643 Phase 2 Study Phase 3 All Patients (N=160) (N=575) Restasis PL9643 Vehicle PL9643 Vehicle (N=80) (N=80) (N=287) (N=288) Ocular Burning 17% 0% 0% 0% 0% • Phase 3 Melody-1 Study Xiidra Instillation Site Irritation 18% 0% 0% 0%
Slide 13: Dry Eye Market Landscape
Dry Eye Market Landscape • PL9643 represents an opportunity to bring relief to dry eye sufferers • DED is one of the most common ocular disorders • Affecting an estimated 38 million people in the U.S.¹ • About 18 million are diagnosed and less than 10% of those diagnosed are treated with an Rx produ
Slide 14: PL9643 Topical Treatment for Dry Eye Disease Summary
PL9643 Topical Treatment for Dry Eye Disease Summary Emerging profile indicates PL9643 could address significant unmet need in DED treatment Category Attribute Indication Dry Eye Disease Product Overview PL9643 is a melanocortin agonist which resolves inflammation and promotes tissue healing PL9643
Slide 15: 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 16: 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 & proteomic studies to define • Phase 1 SAD/MAD • Broad effic
Slide 17: 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 18: PL8177 Oral for Ulcerative Colitis
PL8177 Oral for Ulcerative Colitis
Slide 19: 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 ongoing; interim by 2026 assessment 2Q 2024; final data 2H 2024 MC1r on colon epithelial c
Slide 20: UC Patient Treatment Paradigm
UC Patient Treatment Paradigm Opportunity for PL8177 in UC Treatment throughout Moderate the treatment paradigm 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
Slide 21: 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 22: 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 23: 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 LICENSING PL8177 oral Drug PL8177-205 Product manufacturing PL8177-205 Oral UC Oral UC Study PL8177 Oral Study Part A (n=16) Part B
Slide 24: 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 25: Melanocortin Receptor 4 Erectile Dysfunction (ED) Program
Melanocortin Receptor 4 Erectile Dysfunction (ED) Program • Bremelanotide (BMT) MCR4 Agonist • FDA Approved – Vyleesi® for Female HSDD • Co-administration (co-formulation) of BMT & Tadalafil • PDE5i Failures NON-CONFIDENTIAL
Slide 26: Value of MCR4 Agonists for Sexual Dysfunction
Value of MCR4 Agonists for Sexual Dysfunction Low clinical risk, defined development pathways with potential for high returns Bremelanotide has extensive efficacy and safety data and can be rapidly expanded to ED indication • Evaluated in over 70 clinical studies and 10,000 patients Novel co-formula
Slide 27: Bremelanotide Sexual Dysfunction Clinical Experience
Bremelanotide Sexual Dysfunction Clinical Experience The MCR4 agonist bremelanotide has been evaluated in multiple sexual dysfunction trials Female sexual dysfunction Male sexual dysfunction Post-approval experience in studies studies men with sexual dysfunction • Clinical studies in pre and • Multi
Slide 28: Bremelanotide for Treating ED
Bremelanotide for Treating ED 30%-40% of ED patients have an inadequate response to PDE5i therapy, there remains an unmet need for drugs to treat men in whom PDE5i treatment fails* BMT drives erectile activity through production IN ED patients BMT co-administered with sildenafil of NO and cGMP signi
Slide 29: BMT-ISR-001 in ED – Study Design
BMT-ISR-001 in ED – Study Design Investigator Sponsored Research Study Screening subjects will be included in a 4-week roll-in period with tadalafil only to confirm non-response to PDE5-I (Day 28 to 0) - Non-responsiveness will be defined as having an IIEF-EF score of less than 30 Eligible subjects
Slide 30: BMT/Tadalafil Co-Formulation
BMT/Tadalafil Co-Formulation PTN IND program in parallel to clinical PoC ISR study (BMT-ISR-001) Adequacy of bridging tox study Type C meeting with FDA – 2Q 2024 Confirmation of clinical program for approval •PK study / Phase 2/3 study CMC activities – 2Q 2024 – 3Q 2024 Characterization tasks/stabil
Slide 31: Melanocortin Receptor 4 Obesity Management Program
Melanocortin Receptor 4 Obesity Management Program • Bremelanotide (BMT) MCR4 Agonist • FDA Approved (Vyleesi® for Female HSDD) • Co-administration of BMT & Tirzepatide • Novel MCR4 Selective Peptides • Oral MCR4 Selective Small Molecules
Slide 32: Melanocortin Receptor 4 Obesity Management Program Overview
Melanocortin Receptor 4 Obesity Management Program Overview Clinical development and commercial experience with a Research, IP, and Our proprietary MCR4 agonist for know-how in the structure function data sexual dysfunction design and MCR4 is a well- supports the (FDA-approved) and development of MC
Slide 33: Melanocortin Agonist in Obesity Management
Melanocortin Agonist in Obesity Management Dose titration Gap days Dose sparing Binge eating Bremelanotide PRN Enhance or restore GLP1 activity Weight loss maintenance GLP1 Agonist Novel MCR4 Agonist Sexual AEs GLP1/MCR4 Synergy Tolerability Non-responsive 33
Slide 34: Bremelanotide Clinical Weight Loss Studies
Melanocortin Receptor 4 Obesity Management Program Bremelanotide Clinical Weight Loss Studies 2-Week Study 3-Way Crossover Study • Weight loss placebo -0.7kg; bremelanotide -2.2kg p<0.001 • Weight loss placebo -0.9kg, bremelanotide -1.7kg p<0.001 after 4 days of dosing • Bremelanotide reduction dail
Slide 35: BMT-801 Phase 2 Co-administration of BMT & Tirzepatide
BMT-801 Phase 2 Co-administration of BMT & Tirzepatide Study Objective • Evaluate the safety and efficacy data for the addition of an MCR4 agonist (BMT) to tirzepatide in treating obese subjects Study Design • Randomized, double-blind, placebo-controlled trial Primary Efficacy Endpoint • Change in b
Slide 36: Review of Weight Loss Maintenance
Review of Weight Loss Maintenance The other side of obesity treatment • Excess body weight and fat is associated with negative health conditions • Including cardiovascular disease, diabetes, fatty liver disease, musculoskeletal disorders and some cancers • Current and next “generation” incretin base
Slide 37: Pathway to an Oral Small Molecule MCR4 for Obesity Management
Pathway to an Oral Small Molecule MCR4 for Obesity Management Current Issues Palatin Solutions • Oral bioavailability • Small molecules with excellent preclinical oral bioavailability have been identified. • Skin pigmentation • Palatin small molecules lack the structural motif necessary for activati
Slide 38: Vyleesi - FDA Approved for Female HSDD
Vyleesi® - FDA Approved for Female HSDD • Developed by Palatin • Acquired by Cosette (December 2023)
Slide 39: FDA Approved Vyleesi For Female HSDD
FDA Approved Vyleesi® For Female HSDD Helping Premenopausal Women with Hypoactive Sexual Desire Disorder (HSDD) Visit: www.vyleesi.com / www.vyleesipro.com 39
Slide 40: Sale of Vyleesi to Cosette Pharmaceuticals – December 2023
Sale of Vyleesi to Cosette Pharmaceuticals – December 2023 Palatin retained rights and use of Cosette acquired Vyleesi asset and rights bremelanotide (Vyleesi) for obesity and for FSD (HSDD) male ED treatments $12 million upfront Plus, potential sales-based milestones of Based on annual net sales ra
Slide 41: Milestones Recap; Financial / Cap Table Snapshot
Milestones Recap Financial / Cap Table Snapshot
Slide 42: Milestones
Milestones Melanocortin System Development Programs Date PL9643 – Dry Eye Disease (DED) Phase 3 Melody-1 Topline Results Completed Meet with FDA to Discuss Next Steps Towards Regulatory Approval 2Q 2024 PL8177 Oral – Ulcerative Colitis Phase 2 Proof-of-Concept Interim Data 2Q 2024 Phase 2 Proof-of-C
Slide 43: Financial Snapshot / Cap Table
Financial Snapshot / Cap Table Financial Highlights as of December 31, 2023 Cash, Cash Equivalents and Marketable Securities * $9.5 million Accounts Receivable $2.3 million No debt * Does not include $9.2 million of net proceeds from the January 2024 Registered Direct Offering. Summary Capitalizatio
Slide 44: Thank You.
Thank You. & PALATIN
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