Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Investor Presentation (August 2024)
51 slides from Palatin Technologies's investor presentation, August 2024
Slide 1: Palatin Technologies Corporate Presentation August 2024
Palatin Technologies, Inc. NYSE American: PTN CORPORATE PRESENTATION August 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 - August 2024
Commercial Product and Development Programs - August 2024 Commercial Product Vyleesi® (bremelanotide) Asset Sale for FSD Rights to Cosette December 2023 Up to $159 million in potential sales milestones Hypoactive Sexual Desire Disorder Pipeline Development Programs Pre-clinical Phase 1 Phase 2 Phase
Slide 5: Ophthalmology MCR Programs
Ophthalmology MCR Programs • Dry Eye Disease – PL9643 • Glaucoma – PL9588 • Retinal Diseases – PL9654
Slide 6: Melanocortin Agonists for Ophthalmic Disease
Melanocortin Agonists for Ophthalmic Disease Back of the eye (BOTE) Front of the eye (FOTE) Choroid Retinal Pigment Epithelium Conjunctiva Dry Eye Disease Retinopathies Retina Ocular Surface Cornea Corneal Corneal Protection Epithelium Trabecular Meshwork Optic Nerve Ciliary Body Glaucoma 1 6 1
Slide 7: Melanocortin Agonists for Ophthalmic Disease: Target markets
Melanocortin Agonists for Ophthalmic Disease Target markets and opportunities Dry Eye Disease Glaucoma Global Market (2024 Est.) $7.0 Billion Global Market (2022 Act.) $8.03 Billion Global Market (2032 Est.) $12.3 Billion Global Market (2030 Est.) $11.52 Billion • Unsatisfied need for better tolerab
Slide 8: 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 9: PL9643 for Dry Eye Disease
PL9643 for Dry Eye Disease U.S. market value $1.65 billion1 Melanocortin agonism Resolves THE PROBLEM inflammation of corneal surface • No effective chronic treatment that can provide rapid relief of dry eye disease symptoms without tolerability issues Melanocortin Receptors present on THE OPPORTUNI
Slide 10: 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 11: 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 12: PL9643 for Dry Eye Disease: Melody-1 Phase 3 results
PL9643 for Dry Eye Disease Melody-1 Phase 3 clinical trial Solves 3 recognized problems with current treatments: Efficacy, Onset Time to Effect, and Tolerability Broad Efficacy Across Multiple Signs and Symptoms • Co-Primary symptom endpoint of pain met statistical significance (P<0.025) • 7 of 11 S
Slide 13: PL9643 for Dry Eye Disease: symptom relief
PL9643 for Dry Eye Disease Pain & Eye Dryness symptoms: best-in-class symptom relief • Multiple symptom endpoints statistically significant including co-primary Pain endpoint • Rapid onset of efficacy at 2-weeks (earliest time point measured) • Continuous improvement over the 12 weeks of treatment •
Slide 14: PL9643 for Dry Eye Disease: MELODY-1 sign endpoint
PL9643 for Dry Eye Disease MELODY-1 sign endpoint • PL9643 separates from Vehicle at 2-weeks (earliest time point measured) and continues to improve over 12 weeks • Primary sign endpoint did not reach statistical significance • Fluorescein staining endpoints statistically significant ITT population
Slide 15: PL9643 Safety and ocular tolerability
PL9643 for Dry Eye Disease Safety and ocular tolerability PL9643` Phase 2 Study Phase 3 Study Ocular Adverse Events PL9643 Vehicle PL9643 Vehicle Phase 3 Melody-1 Study (n=575) (N=80) (N=80) (N=287) (N=288) • PL9643 eye drop formulation was well-tolerated, Instillation Site Pain 0% 9% 3.1% 4.5% simi
Slide 16: PL9643 Program summary / next steps
PL9643 for Dry Eye Disease Program summary / next steps Solves 3 main problems with current treatments: Efficacy, Onset Time, and Tolerability ROBUST PHASE 3 PROGRAM NDA PACKAGE & TARGET FILING • Three Efficacy/Long Term Safety Studies: MELODY-1, 2 & 3 • NDA File: Efficacy, Safety and CMC data • Saf
Slide 17: PL9588 Treating Glaucoma: Executive summary
PL9588 Treating Glaucoma Executive summary • Progressive eye diseases characterized by elevated intraocular pressure (IOP) resulting in loss of retinal ganglion cells and progressive loss of vision (open angle glaucoma), 2nd leading cause of blindness • In U.S. ~3.4M people have open angle glaucoma*
Slide 18: PL9588 Treating Glaucoma
PL9588 Treating Glaucoma U.S. market $3.0 billion1 THE PROBLEM Reduced fluid • Increased IOP may damage the optic nerve and lead to vision loss outflow • Tolerability shortcomings with currently approved products • Current treatments don’t provide neuroprotection Increased IOP THE OPPORTUNITY Increa
Slide 19: PL9588 Mechanism of action lowering IOP
PL9588 Treating Glaucoma Mechanism of action lowering IOP 0.0375 0.8 0.0249 L/min/mm2/mmHg 0.6 Outflow Facility 0.4 • PL9588 tested in a fluid outflow model 0.2 • Human donor trabecular meshwork and Schlemm’s canal cells reconstituted 0.0 • PL9588 as effective as rho kinase inhibitor 2 88 8 Ki 88 Fβ
Slide 20: PL9654 For Retinal Diseases: Executive Summary
PL9654 For Retinal Diseases Executive Summary • Retinal disorders current drug market was USD $12.57B (2022) and is projected to be $25.6B by 2030 • DR/DME estimated was ~$10B (2023) • IVT anti-VEGF and steroids 1st line treatments • New treatments with novel MOA needed to expand treatment and addre
Slide 21: PL9654 For Retinal Diseases
PL9654 For Retinal Diseases U.S. diabetic retinopathy market value $2.4 billion MOA: Melanocortin Agonism Macular THE THEPROBLEM PROBLEM edema •• Retinal Retinal diseases diseases are are associated associated with with neurodegeneration neurodegeneration processes processes and and fibrosis fibrosi
Slide 22: PL9654 for Retinal Disease Summary
PL9654 for Retinal Disease Summary Novel mechanism to advance the treatment of retinal diseases: PL9654 lead compound ready to advance to clinical development • Efficacy established in 4 models of retinal disease • Genomic and proteomic data advances understanding of MoA • Sustained release IVT form
Slide 23: Palatin Melanocortin Agonists for Ophthalmic Disease: Summary
Palatin Melanocortin Agonists for Ophthalmic Disease Summary Novel differentiated products for ophthalmic indications Melanocortin MoA delivers efficacy with excellent safety & tolerability Proprietary compounds with long term IP estate Short, well defined, clinical pathways for regulatory approval
Slide 24: PL8177 Oral for Ulcerative Colitis
PL8177 Oral for Ulcerative Colitis
Slide 25: 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 MCR1 on colon epithelial c
Slide 26: 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 27: PL8177 Pre-Clinical Histological Findings
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 40 o Epithelial regeneration total colitis index 30 o Percentage involvement by the dis
Slide 28: PL8177-Oral Pre-Clinical Cell Analysis in Rat UC 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 29: 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 2022 2023 2024 2025 LICENSING PL8177 oral Drug PL8177-205 Oral Product manufacturing PL8177-205 Oral UC UC Study Part B PL8177 Oral Study Part A (n=16)
Slide 30: Ulcerative Colitis Target Product Profile
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 31: Melanocortin Receptor 4 Erectile Dysfunction 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-responders) NON-CONFIDENTIAL
Slide 32: 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 33: 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 34: 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 35: BMT-ISR-001 PDE5i Non-Responders Study Design
BMT-ISR-001 PDE5i Failures/Non-Responders – Study Design Co-administration of Tadalafil+Bremelanotide in PDE5i Non-Responders Study Week -4 0 4 8 12 Screening Treatment Period 1 Treatment Period 2 No Treatment 20mg Tadalafil (prn) 20mg Tadalafil+0.5mg Bremelanotide 0.5mg (prn) Tadalafil 20mg +Bremel
Slide 36: BMT/Tadalafil Co-Formulation Development Program
BMT/Tadalafil Co-Formulation Development Program Type C meeting with FDA – 2H 2024 Bridging tox study IND fling – 1H 2025 Phase 1 PK clinical study start 1H 2025; data 1H 2025 Phase 3 program start 2H 2025; data 2H 2026 36
Slide 37: 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 38: The Value of Palatin's MCR4 Agonists
The Value of Palatin’s MCR4 Agonists Differentiated product profile Clinically validated treatment Low clinical risk for obesity Defined development pathways Potential for high returns FDA approved product Has extensive efficacy and safety data Bremelanotide Evaluated in obesity clinical studies Can
Slide 39: Emerging Obesity Treatment Landscape
F o Emerging Obesity Treatment Landscape r I n U.S. market value – over $5 billion (2023) growing to $44 Billion (2030) v e s t o r U s e Two (2) treatment objectives will define the market O n - Safe, tolerable weight loss for all patients l • Central Leptin-Melanocortin pathway is a y - Long term
Slide 40: 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 41: GLP1 Agonist & MCR4 Agonist: Co-Administration
GLP1 Agonist & MCR4 Agonist: Co-Administration Clinical data* • No prospective studies have been done with combination pharmacotherapy • Previously published combination of setmelanotide plus 2.5mg of tirzepatide for obesity in BBS • 2 patients lost 26% in 34 weeks and 30% TBW at 52 weeks never movi
Slide 42: Phase 2 co-administration of tirzepatide and bremelanotide
GLP1 Agonist & MCR4 Agonist: Co-Administration Phase 2 co-administration of tirzepatide and bremelanotide (BMT-801) Study Design • Randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of the addition of an MCR4 agonist (BMT) to tirzepatide in obese subjects Study Wee
Slide 43: 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 44: Novel Next Generation Selective MCR4 Agonists
Novel "Next Generation" Selective MCR4 Agonists First series of ‘next generation’ MCR4 agonists for obesity: • PL8905 is a selective MCR4 agonist: ~350X binding selectivity for MCR4 over MCR1 • Efficacy in weight loss and food intake at doses that do not have blood pressure effects • To define SAR r
Slide 45: Vyleesi - FDA Approved for Female HSDD
Vyleesi® - FDA Approved for Female HSDD • Developed by Palatin • Acquired by Cosette (December 2023)
Slide 46: 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 46
Slide 47: 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 48: Milestones Recap; Financial / Cap Table Snapshot
Milestones Recap Financial / Cap Table Snapshot
Slide 49: Milestones
Milestones Melanocortin System Development Programs Date PL9643 – Dry Eye Disease (DED) Phase 3 Melody-1 Topline Positive Results Completed Commence Melody-2/3 Phase 3 clinical trials target 2H 2024 PL8177 Oral – Ulcerative Colitis Phase 2 Proof-of-Concept Interim Data 3Q 2024 Phase 2 Proof-of-Conce
Slide 50: Financial Snapshot / Cap Table
Financial Snapshot / Cap Table Financial Highlights as of March 31, 2024 Cash and Cash Equivalents $10.0 million* *Does not include ~6.1M equity raise June 2024 No debt Summary Capitalization as of June 30, 2024 Common Shares and Equivalent Common Stock 19.3 million shares Warrants* 8.0 million shar
Slide 51: Thank You!
Thank You! & PALATIN
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