Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Investor Presentation (October 2024)
50 slides from Palatin Technologies's investor presentation, October 2024
Slide 1: Palatin Technologies Corporate Presentation
Palatin Technologies, Inc. NYSE American: PTN CORPORATE PRESENTATION October 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, Obesity, and Sexual Dysfunctions Demonstrated expertise moving programs from discovery to FDA approval Expertise in the biology and chemistry of melanocortin system (MCS) 1st company to
Slide 4: Palatin Leadership – Strong Team with Broad / Extensive Biopharma Experience
Palatin Leadership – Strong Team with Broad / 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, devel
Slide 5: 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 Hypoactive Sexual Desire Disorder Pipeline Development Programs Preclinical Phase 1 Phase 2 Phase 3 NDA Status/N
Slide 6: Ophthalmology MCR Programs
Ophthalmology MCR Programs • Dry Eye Disease – PL9643 • Glaucoma – PL9588 • Retinal Diseases – PL9654
Slide 7: 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 7 1
Slide 8: Melanocortin Agonists for Ophthalmic Disease
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 9: 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 10: 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 11: 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 12: 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 13: PL9643 for Dry Eye Disease
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 14: PL9643 for Dry Eye Disease
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 15: PL9643 for Dry Eye Disease
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 16: PL9643 for Dry Eye Disease
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 17: PL9643 for Dry Eye Disease
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 • MELODY-1 (completed) • NDA File Date (Est.): 2026 • MELODY-2 & -3 • FDA Approval/Launch (Est.): 2027 • FDA
Slide 18: PL9588 Treating Glaucoma
PL9588 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 have
Slide 19: PL9588 Treating Glaucoma
PL9588 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 • Most p
Slide 20: PL9588 for Glaucoma
PL9588 for 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.): 2028 • ~3 quarters & $5 million to Phase 1 safety/IOP data • FDA Approval
Slide 21: PL9654 For Retinal Diseases
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 22: PL9654 For Retinal Diseases
PL9654 For 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 inhibitors d
Slide 23: PL9654 for Retinal Disease
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 24: Palatin Melanocortin Agonists for Ophthalmic Disease
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 25: PL8177 Oral for Ulcerative Colitis
PL8177 Oral for Ulcerative Colitis
Slide 26: 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 analysis 4Q 2024; final data1H 2025 MC1R on colon epithelial cell
Slide 27: UC Patient Treatment Paradigm
UC Patient Treatment Paradigm Opportunity for PL8177 in UC Treatment 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 Steroids infusion Treatment flow Biologics & Immuno-moderators
Slide 28: PL8177-Oral Preclinical Data Rat DSS Model
PL8177-Oral Preclinical Data Rat DSS Model total colitis index 50 ✱✱✱✱ ✱✱✱ total colitis index 40 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 architecture • Preserves enterocyte cell p
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 Patient Population PL8177 Oral UC Study Licensing • Adult patients with active UCoral Drug PL8177 Product manufacturing • Modified M
Slide 30: 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 • Phase 1 clinical SAD/MAD study with the the oral formulation, confirmed c
Slide 31: Melanocortin-4 Receptor Obesity Management Program
Melanocortin-4 Receptor Obesity Management Program • Bremelanotide (BMT) MC4R Agonist • FDA Approved (Vyleesi® for Female HSDD) • Co-administration of BMT & Tirzepatide • Novel MC4R Selective Peptides • Oral MC4R Selective Small Molecules
Slide 32: Value of Palatin's MC4R Agonist Portfolio
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 Central mechanism of action FDA approved L
Slide 33: Emerging Obesity Treatment Landscape
Emerging Obesity Treatment Landscape U.S. market value – obesity (metabolic) over $5 billion today (2023) growing to $44 Billion (2030) Two treatment objectives will define the market • Safe, tolerable weight loss for all patients • Central Leptin-Melanocortin pathway • Long term maintenance healthy
Slide 34: Bremelanotide clinical weight loss studies
Melanocortin-4 Receptor Obesity Management Program Bremelanotide clinical weight loss studies 2-Week Study • Weight loss placebo -0.7kg; bremelanotide - 2.2kg p<0.001 • Bremelanotide reduction daily caloric intake ~400kcal p<0.01 • Steady weight loss for the duration of treatment • 2nd study with 1x
Slide 35: GLP-1 Agonist & MC4R Agonist: Co-Administration
GLP-1 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% in 34 weeks and 30% TBW at 52 weeks never mov
Slide 36: GLP-1 Agonist & MC4R Agonist: Co-Administration
GLP-1 Agonist & MC4R Agonist: Co-Administration Phase 2 co-administration of tirzepatide and bremelanotide (BMT-801) Study Design Primary Endpoint Randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of the Change in body weight: tirzepatide + addition of an MC4R ago
Slide 37: Review of Weight Loss Maintenance
Review of Weight Loss Maintenance Realizing the long-term benefits 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 “generat
Slide 38: Novel Next Generation Selective MC4R Agonists
Novel "Next Generation" Selective MC4R Agonists First series of ‘next generation’ MC4R agonists for obesity: • PL8905 is a selective MC4R agonist: ~350X binding selectivity for MC4R over MC1R • Efficacy in weight loss and food intake at doses that do not have blood pressure effects • To define SAR r
Slide 39: Melanocortin-4 Receptor Erectile Dysfunction (ED) Program
Melanocortin-4 Receptor Erectile Dysfunction (ED) Program • Bremelanotide (BMT) MC4R Agonist • FDA Approved – Vyleesi® for Female HSDD • Co-administration (co-formulation) of BMT & Tadalafil • PDE5i Non-Responders NON-CONFIDENTIAL
Slide 40: Value of MC4R Agonists for Sexual Dysfunction
Value of MC4R 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 45 clinical studies and 10,000 patients Novel co-formula
Slide 41: Bremelanotide Sexual Dysfunction Clinical Experience
Bremelanotide Sexual Dysfunction Clinical Experience The MC4R agonist bremelanotide has been evaluated in multiple sexual dysfunction trials Female sexual dysfunction Post-approval experience in men Male sexual dysfunction studies studies with sexual dysfunction • Clinical studies in pre and post •
Slide 42: 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 of IN ED patients BMT co-administered with sildenafil NO and cGMP signi
Slide 43: BMT/Tadalafil Co-Formulation Development Program
BMT/Tadalafil Co-Formulation Development Program Pre-IND FDA meeting 1Q 2025 IND filing 1H 2025 Phase 1 PK clinical study initiation/data 1H 2025 Phase 2/3 safety and efficacy studies initiation target 2H 2025 NDA potential target submission 2027 43
Slide 44: Vyleesi - FDA Approved for Female HSDD
Vyleesi® - FDA Approved for Female HSDD • Developed by Palatin • Acquired by Cosette (December 2023)
Slide 45: 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 45
Slide 46: Sale of Vyleesi to Cosette Pharmaceuticals – December 2023
Sale of Vyleesi to Cosette Pharmaceuticals – December 2023 Cosette acquired Vyleesi asset and rights for FSD (HSDD) $12 million upfront Potential sales-based milestones of up to $159 million Based on annual net sales ranging from $15 million to $200 million Palatin retained rights and use of bremela
Slide 47: Financial / Cap Table Snapshot, Milestones Recap
Financial / Cap Table Snapshot Milestones Recap
Slide 48: Financial Snapshot / Cap Table
Financial Snapshot / Cap Table Financial Highlights as of June 30, 2024 Cash and Cash Equivalents $9.5 million No debt Summary Capitalization as of September 30, 2024 Common Shares and Equivalent Common Stock 19.5 million shares Warrants* 8.0 million shares Options 2.3 million shares RSUs 1.1 millio
Slide 49: Milestones
Milestones Melanocortin System Development Programs Date PL9643 – Dry Eye Disease (DED) Phase 3 Melody-1 Topline Positive Results Completed FDA Confirmed Acceptability of Remaining Phase 3 Trial Protocols & Endpoints Completed Melody-2 and -3 Phase 3 Pivotal Clinical Trials Initiation Target 1Q 2025
Slide 50: Thank You.
Thank You. & PALATIN
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