Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Investor Presentation (June 2025)
64 slides from Palatin Technologies's investor presentation, June 2025
Slide 1: Palatin Technologies Corporate Presentation
Palatin Technologies, Inc. OTCQB: PTNT CORPORATE PRESENTATION June 2025 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 Technology platform – validated drug development based on the melanocortin system Therapeutics for Obesity, Inflammatory & Autoimmune Diseases Demonstrated expertise moving programs from discovery to FDA approval Expertise in the biology and chemistry of melanocortin system (MCS) 1st
Slide 4: Palatin Leadership
Palatin Leadership Strong team, with broad and extensive biopharma experience Stephen T. Wills, CPA/MST Carl Spana, PhD Chief Financial Officer and President and Chief Executive Officer Chief Operating Officer Co-founder with 25-plus years in drug 25-plus years in finance, operations, research, deve
Slide 5: Development Programs
Development Programs Pipeline Development Programs Preclinical Phase 1 Phase 2 Phase 3 NDA Status/Next Steps Obesity Bremelanotide Phase 2 MC4R agonist + GLP-1 in obese patients initiated Obesity - GLP-1 adjunct therapy Positive topline data reported 1Q25 IND enabling – CMC activities 1Q25 – 4Q25 No
Slide 6: Melanocortin-4 Receptor Obesity Management
Melanocortin-4 Receptor Obesity Management • Co-administration of Bremelanotide & Tirzepatide (GLP-1/GIP) o Bremelanotide (BMT) MC4R Agonist ✓ FDA Approved (Vyleesi® for Female HSDD) • Novel “Next Generation” MC4R Selective Agonists o MC4R Selective Peptides Once Weekly Dosing o Oral MC4R Selective
Slide 7: Emerging obesity treatment landscape
Melanocortin-4 Receptor Obesity Management Emerging obesity treatment landscape U.S. market value – metabolic/obesity over $5 billion (2023) growing to $44 Billion (2030) Two treatment objectives will define the market • Safe, tolerable weight loss for all patients • Central Leptin-Melanocortin path
Slide 8: Review of weight loss maintenance
Melanocortin-4 Receptor Obesity Management Review of weight loss maintenance Realizing the long-term benefits of obesity treatment Excess body weight and fat is associated with Including cardiovascular disease, diabetes, fatty liver disease, negative health conditions musculoskeletal disorders and s
Slide 9: The melanocortin receptor system: obesity and energy management
C o n Melanocortin-4 Receptor Obesity Management f The melanocortin receptor system: obesity and energy management i d e n t i a l Central leptin-melanocortin pathway is a critical pathway that regulates feeding and body weight to maintain energy homoeostasis 9 Sweeney, P et.al. Nature Reviews Endoc
Slide 10: Value of Palatin's MC4R agonist portfolio
Melanocortin-4 Receptor Obesity Management Value of Palatin’s MC4R agonist portfolio New mechanisms will be Clinically validated Novel improved “Next Gen” required for obesity therapy Bremelanotide treatment for obesity Selective MC4R agonists and weight loss maintenance Obesity therapy will require
Slide 11: Bremelanotide Phase 1b weight loss study
C o n Melanocortin-4 Receptor Obesity Management f i Bremelanotide MC4R agonist obesity Phase 1b clinical weight loss study in general obese subjects d e n 2-Week Study t i • General obese subjects: BMI ~35 a • Bremelanotide: n=27 l • Vehicle: n=26 • Weight loss: • Placebo -0.7kg; Bremelanotide: -2.
Slide 12: GLP-1/GIP agonist + MC4R agonist co-administration clinical data
Melanocortin-4 Receptor Obesity Management GLP-1/GIP agonist + MC4R 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
Slide 13: BMT-801 signal detection study objectives
Melanocortin-4 Receptor Obesity Management BMT-801 Phase 2 signal detection study objectives Co-Administration GLP1/GIP Agonist Tirzepatide (2.5mg Weekly) + MC4R Agonist Bremelanotide (1.25mg Daily) Main Research Questions • Does co-administration result in increased weight loss? • Does MC4R agonism
Slide 14: BMT-801 study design
Melanocortin-4 Receptor Obesity Management BMT-801 Phase 2 signal detection study Co-Administration GLP1/GIP Agonist Tirzepatide & MC4R Agonist Bremelanotide Study Design: Randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of the addition of an MC4R agonist (BMT) t
Slide 15: BMT-801 patient weight loss from baseline to end of study
Melanocortin-4 Receptor Obesity Management BMT-801 patient weight loss from baseline to end of study Primary Endpoint – Co-Administration Group Greatest Weight Loss Patient Weight Change (%) from Baseline to End of Study Compared to PBO Patient Weight Change (%) from Baseline to End of Study Compare
Slide 16: Co-administration additive effect – primary analysis
Melanocortin-4 Receptor Obesity Management Co-administration additive effect – primary analysis Analysis for Additive Effect Percent of Subjects with ≥5% Reduction in Percent Weight Loss at End of Study 60 Group 1 Group 2 Group 3 Group 4 Group 1: Tirzepatide (2.5 mg SC) weekly/BMT (1.25 mg SC) daily
Slide 17: Effect of co-administration on increased weight loss
Melanocortin-4 Receptor Obesity Management Effect of co-administration on increased weight loss Weekly Change in Percent Body Weight (%) by Group 0 -0.5 • Comparison of Group 4 to Group 3 -1 during Treatment Period 2 demonstrates a weight loss Percent Change in % Weight -1.5 maintenance effect -2 -2
Slide 18: BMT-801 questions and outcomes
Melanocortin-4 Receptor Obesity Management BMT-801 Phase 2 signal detection study questions / outcomes Co-Administration GLP1/GIP Agonist Tirzepatide (2.5mg Weekly) + MC4R Agonist Bremelanotide (1.25mg Daily) Main Research Questions Main Study Outcomes 1. Does co-administration result in increased 1
Slide 19: Appetite suppression patient-reported outcomes
Melanocortin-4 Receptor Obesity Management BMT-801 MC4R/GLP-1-GIP co-administration detection study Appetite Suppression (Patient-Reported Outcomes) • Patients receiving co-administered bremelanotide + tirzepatide, tirzepatide alone, and bremelanotide alone, experienced significant improvements in a
Slide 20: Value of the study results and next steps
Melanocortin-4 Receptor Obesity Management BMT-801 MC4R/GLP-1-GIP co-administration detection study Value of the study results and next steps Confirmation that MC4R treatment with GLP-1/GIP can be additive without increasing safety and BMT-801 Study tolerability issues Support to perform co-administ
Slide 21: Novel Next Generation MC4R Selective Agonists
Novel “Next Generation” MC4R Selective Agonists • MC4R selective peptides once weekly dosing • Oral MC4R selective small molecules
Slide 22: Legacy challenges of MC4R agonism have been solved
C o n Novel "Next Generation" Selective MC4R Agonists f The melanocortin receptor system i d e Legacy Challenges of MC4R Agonism Have Been Solved! n t Current Therapy Challenges Palatin Achieved Solutions i a l Palatin’s compounds with high potency coupled with structural Injection Frequency element
Slide 23: Next generation MC4R peptide agonists for obesity
C o n Novel "Next Generation" Selective MC4R Agonists f i d e First series of ‘next generation’ MC4R peptide agonists for obesity: n t • Palatin studies in MC4R knock-out model confirm weight loss is dependent on a functional MC4R i • PL8905 lead development candidate a l o Selective MC4R agonist: S
Slide 24: MC4R selective oral small molecule program
C o n Novel "Next Generation" Selective MC4R Agonists f MC4R selective oral small molecule program i d e Understanding What is Required for Success n t Historically, MC4R small molecule programs have failed due to a lack of understanding the receptor biology and i the structure/function relationship
Slide 25: Obesity focused development programs
Novel "Next Generation" Selective MC4R Agonists Obesity focused development programs Multiple clinical trials targeted in 1H26 with novel, long-acting MC4R peptide and PL7737 small molecule compound for treating general obesity, weight loss management, and rare MC4R pathway diseases such as hypothal
Slide 26: Summary – Palatin's MC4R obesity program
C o n Novel "Next Generation" Selective MC4R Agonists f Summary – Palatin’s MC4R obesity program i d e Experts in the Design and Development of MC4R Agonists n t • Clinically validated mechanism for safe, effective treatment of obesity i a • Mechanism addresses the negative physiology that drives we
Slide 27: Spin-Out / Out-License Programs
Spin-Out / Out-License Programs
Slide 28: Spin-Out / Out-License Programs pipeline
Spin-Out / Out-License Programs Product/Indication R&D Phase 1 Phase 2 Phase 3 NDA Status/Next Steps Ocular Phase 3 MELODY-1 completed - positive data FDA confirmation on protocols and endpoints PL9643 MCR Agonist Phase 3 Melody-2 & -3 target start 1H26 Dry eye disease (DED) Phase 3 Melody-2 & -3 ta
Slide 29: Ophthalmology MCR Programs
Ophthalmology MCR Programs • Dry Eye Disease – PL9643 • Glaucoma – PL9588 • Retinal Diseases – PL9654
Slide 30: 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 Retinopathies Dry Eye Disease Retina Ocular Surface Cornea Corneal Protection Corneal Epithelium Trabecular Meshwork Optic Nerve Ciliary Body Glaucoma 1 30 1
Slide 31: Target markets and opportunities
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 32: 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 33: PL9643 for Dry Eye Disease
PL9643 for Dry Eye Disease U.S. market value $1.65 billion1 Melanocortin agonism Resolves The Problem inflammation of • No effective chronic treatment that can provide rapid relief of dry eye corneal surface disease symptoms without tolerability issues Melanocortin Receptors present on The Opportuni
Slide 34: 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 64.4% 5,6,8 68-80%1-4 70.8% 5,6,8 Unknown Burning 72% Burning 64% Slow onset of
Slide 35: 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 36: Melody-1 Phase 3 clinical trial
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 37: Pain & Eye Dryness symptoms
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 38: 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 39: MELODY-1 symptom responder analysis
PL9643 for Dry Eye Disease MELODY-1 symptom responder analysis The First DED Therapy to Demonstrate Significant Clearing of Multiple Symptoms! ➢ For ALL symptoms PL9643 had a higher percentage of patients clearing symptoms ➢ 6 of 13 symptom endpoints were significant (p<0.05) in favor of PL9643 ➢ 2
Slide 40: 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 (N=80) (N=80) (N=287) (N=288) Phase 3 Melody-1 Study (n=575) Instillation Site Pain 0% 9% 3.1% 4.5% • PL9643 eye drop formulation was well-tolerated, Blur
Slide 41: Program summary / next steps
PL9643 for Dry Eye Disease Program summary / next steps Robust Phase 3 Program NDA Package & Target Filing • Three Efficacy/Long Term Safety Studies: • NDA File: Efficacy, Safety and CMC data o MELODY-1 (completed) • NDA File Date (Est.): 2H 2027 o MELODY-2 & -3 • FDA Approval/Launch (Est.): 2H 2028
Slide 42: PL9588 for Treating Glaucoma
PL9588 for Treating Glaucoma Lowers IOP and direct neuroprotection • 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 h
Slide 43: Mechanism of action lowering IOP
PL9588 for Treating Glaucoma Mechanism of action lowering IOP Humonix’ Model 0.0375 0.8 0.0249 L/min/mm2/mmHg 0.6 Outflow Facility PL9588 tested in a fluid outflow model 0.4 • Human donor trabecular meshwork and Schlemm’s canal cells reconstituted 0.2 PL9588 as effective as rho kinase inhibitor • Mo
Slide 44: PL9588 program summary / next steps
PL9588 for Treating Glaucoma Program summary / next steps PL9588-Lead Development Compound NDA Package & Target Filing • Topical eyedrops • NDA File: Efficacy, Safety and CMC data • Ocular tox programs are short • NDA File Date (Est.): 2029 • ~3 quarters /~$5 million to Phase 1 safety-IOP data • FDA
Slide 45: PL9654 for Treating Retinal Diseases
PL9654 for Treating Retinal Diseases Executive Summary • Retinal disorders current drug market was USD $12.57B (2022) and is projected to be $25.6B by 2030 o DR/DME estimated was ~$10B (2023) • IVT anti-VEGF and steroids 1st line treatments • New treatments with novel MOA needed to expand treatment
Slide 46: PL9654 melanocortin agonism mechanism
PL9654 for Treating Retinal Diseases U.S. diabetic retinopathy market value $2.4 billion MOA: Melanocortin Agonism The Problem • Retinal diseases are associated with neurodegeneration Macular processes and fibrosis that have a long-term impact on vision edema Current Treatment • IVT angiogenesis inh
Slide 47: PL9654 Summary
PL9654 for Treating Retinal Diseases 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 releas
Slide 48: Melanocortin Agonists for Ophthalmic Diseases Summary
Palatin Melanocortin Agonists for Ophthalmic Diseases 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 49: PL8177 Oral Formulation for Ulcerative Colitis
PL8177 Oral Formulation for Ulcerative Colitis
Slide 50: 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; by 2026 enrollment completed; topline data1Q 2025 MC1R on colon epithelial cells
Slide 51: UC patient treatment paradigm
PL8177 Oral Formulation for Ulcerative Colitis UC patient treatment paradigm Opportunity for PL8177 in Treating UC Indication Throughout the Treatment Paradigm Moderate Mild UC Moderate UC Severe UC 5-ASA (LialdaTM) Low 5-ASA PL8177 failure Drug Steroids enema/ suppository Price Steroids oral Steroi
Slide 52: Preclinical data rat DSS model
PL8177 Oral Formulation for Ulcerative Colitis Preclinical data rat DSS model total colitis index 50 ✱✱✱✱ ✱✱✱ 40 total colitis index 30 20 10 0 m bo 0u g kg a e g/ Sh ac 10 Pl 7 0m 17 30 8 e PL in am al es M Total colitis index Single nuclei RNAseq of DSS rat colon • Abnormalities of mucosal archite
Slide 53: PL8177-205 Phase 2 study design & timelines
PL8177 Oral Formulation for Ulcerative Colitis 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 Patient Population PL8177 Oral UC Study Licensing • Adult patients with active UCoral
Slide 54: Topline data PL8177-205 Phase 2 UC study
C o n PL8177 Oral Formulation for Ulcerative Colitis f i Topline data PL8177-205 Phase 2 UC study d e n • Clinical Remission t i o Achieved in 33% of PL8177 treated subjects versus 0% on placebo after 8-weeks of treatment a • Clinical Response l o Achieved in 78% of PL8177 treated subjects versus 33
Slide 55: Target product profile for commercial success
PL8177 Oral Formulation for 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 • Phase 1 clinical SAD/MAD study with the the ora
Slide 56: Melanocortin Agonist for Diabetic Nephropathy
Melanocortin Agonist for Diabetic Nephropathy
Slide 57: Diabetic nephropathy
Melanocortin Agonist for Diabetic Nephropathy Diabetic nephropathy Diabetic nephropathy (DN) is a severe microvascular Diabetes and DN prevalence complication of diabetes mellitus (DM) It is the most common form of chronic kidney ~ 30 million US patients have CKD secondary to the disease (CKD) combi
Slide 58: Melanocortin agonists increase key kidney cell types in diabetic rats
Melanocortin Agonist for Diabetic Nephropathy Melanocortin agonists increase key kidney cell types in diabetic rats Cell Populations by snRNAseq* Podocyte Podocyte Density Density by Histopathology 45 ✱ ✱✱ Healthy 60 WT1+ cells/glomerular area 40 Diabetic Percent of Nuclei 35 Diabetic + 40 30 4 MC1R
Slide 59: BREAKOUT study in diabetic nephropathy
Melanocortin Agonist for Diabetic Nephropathy BREAKOUT study in diabetic nephropathy BREAKOUT Study Schema Primary Research Question • Proportion of subjects with a ≥50% reduction in UP/Cr Secondary Research Questions • Proportion of subjects that achieve a reduction in UP/Cr ratios of ≥ 30% from ba
Slide 60: Topline results – BREAKOUT Study
Melanocortin Agonist for Diabetic Nephropathy Topline results – BREAKOUT Study in Diabetic Nephropathy • Addition of Bremelanotide to maximum tolerated RAAS inhibition therapy Results o Resulted in positive and clinically • 57% of patients achieved a clinical response >30% beneficial improvements in
Slide 61: Financial / Cap Table Snapshot, Milestones Recap
Financial / Cap Table Snapshot Milestones Recap
Slide 62: Financial Snapshot / Cap Table
Financial Snapshot / Cap Table Financial Highlights as of March 31, 2025 Cash and Cash Equivalents $2.5 million* No debt *Cash above does not include net proceeds from the ATM facility & equity offering of $3.5 million in April and May Summary Capitalization as of May 31, 2025 Common Shares and Equi
Slide 63: Milestones Recap
Milestones Recap Melanocortin System Development Programs Date Obesity - MC4R Agonists – Weight Loss (Maintenance) Phase 2 BMT-801 Clinical Study Bremelanotide + GLP-1 – Positive Topline Data Reported Completed Novel MC4R Selective Long-Lasting Agonist – IND Filing / SAD/MAD Data (to include HO pati
Slide 64: Thank You.
Thank You. & PALATIN
Palatin Technologies — Investor Presentation (June 2025) on 6ix