Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Investor Presentation (July 2020)
30 slides from Palatin Technologies's investor presentation, July 2020
Slide 1: Palatin Technologies Corporate Presentation July 2020
PALATIN TECHNOLOGIES, INC. Corporate Presentation I July 2020 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
Demonstrated expertise moving programs from discovery to FDA approval Deep expertise in the biology and chemistry of the melanocortin system First company to procure FDA approval for a melanocortin agent (Vyleesi®) Company Profile Strategy leverages our chemistry and biology across Technology and ex
Slide 4: Development Programs
Development Programs Clinical Pipeline Melanocortin Receptor Programs Pre-clinical Phase 1 Phase 2 Phase 3 NDA Submission FDA Approval Status/Next Steps FDA Approval 6/21/2019. Licensees: Vyleesi® (bremelanotide) MC4r Agonist Fosun (China, Taiwan, HK, Macau) and Kwangdong (S. Korea) Seeking Hypoacti
Slide 5: Targeted Milestones
Targeted Milestones Vyleesi (bremelanotide) for Hypoactive Sexual Desire Disorder North American rights regained 3Q2020 China licensee PK study 2H2020 South Korea licensee PK study 2H2020 Additional ROW partnerships 2020/2021 Melanocortin System Inflammatory & Autoimmune Disease Programs Initiate Da
Slide 6: Vyleesi: North American & Global Rights Reunited
Vyleesi: North American (NA) & Global Rights Reunited NA license with AMAG Pharmaceuticals mutually terminated -- rights returned to Palatin from AMAG ◦ All rights and related assets returned to Palatin – including inventory with a cost value of >$15M ◦ AMAG remitted $12M to Palatin at closing with
Slide 7: FDA Approved Vyleesi
FDA Approved Vyleesi® Helping Premenopausal Women with Hypoactive Sexual Desire Disorder (HSDD) 2020 Corporate Presentation I 7
Slide 8: HSDD is a Significant Market Opportunity
HSDD is a Significant Market Opportunity Affects 5.8 million U.S. premenopausal women3 (1 in 10 premenopausal women)1,2 98% (5.7M) of affected premenopausal women 1,2 not on therapy3 1/10 Focused on relevant digital channels Number of Creating an online community for HSDD patients premenopausal
Slide 9: ROW Vyleesi Licensing Agreements
ROW Vyleesi Licensing Agreements Fosun Pharma Kwangdong Pharmaceutical Co. Chinese pharmaceutical company focused on Republic of Korea leading pharmaceutical developing and commercializing innovative company with >$900M in annual sales healthcare solutions with >$2B in annual sales Exclusive licensi
Slide 10: Melanocortin Inflammatory & Autoimmune Disease Programs
Melanocortin Inflammatory & Autoimmune Disease Programs
Slide 11: Immunological Effects of Melanocortin System
Immunological Effects of Melanocortin System Melanocortin system is up-regulated by and integral to the resolution of autoimmune pathologies Modulates the activity of cells of the immune system Activated during disease state Activates resolution of proinflammatory processes ◦ Reduces NF-κB a
Slide 12: Melanocortin Inflammatory & Autoimmune Disease Portfolio
Melanocortin Inflammatory & Autoimmune Disease Portfolio PL8177, PL8331 and PL9643 demonstrated reversal of Rational design and synthesis of selective MC1r & pathology in multiple inflammatory and autoimmune MC1/5r agonists disease models ◦ PL8177: cyclic peptide selective MC1r agonist ◦ Including i
Slide 13: Dry Eye Overview
Dry Eye Overview Dry eye syndrome or keratoconjunctivitis symptoms include irritation, redness, discharge and blurred vision. Aqueous-Deficient ◦ Autoimmune disease (e.g. Sjögren’s Syndrome) Lipid-Deficient ◦ Meibomian gland dysfunction, hormonal changes Mucin-Deficient ◦ Goblet cell loss Ne
Slide 14: PL9643 Pre-Clinical Scopolamine Dry Eye Model
CFS (s CFS (s CFS ( CFS ( 1 1 1 1 PL9643 Pre-Clinical 0 Scopolamine Dry Eye Model 0 0 0 Day eye, 12 Day Day 12 24 Day 24 Day 12 Day 12 Day 24 Day 24 Mouse model of scopolamine-induced dry established disease, topical application Vehicle PL9643, 1 × 10-3 mg ml-1, three timesRestasis daily â â 1 × 10-
Slide 15: PL9643 Dry Eye Program
PL9643 Dry Eye Program Single use aqueous eye drop formulation developed Ora, Inc., world-leading ophthalmic CRO, managing dry eye development program ◦ Preclinical IND enabling activities completed 2H2019 ◦ Pre-IND meeting – agreement on Phase 2 study design and overall development program thro
Slide 16: PL8177 COVID-19 Infection
PL8177 COVID-19 Infection PL8177 in preclinical models has demonstrated anti-inflammatory activity and protection against lung damage and fibrosis Many COVID-19 patients have lung damage due to fibrosis that compromises lung function after recovery and reduces their quality of life Treating CO
Slide 17: Bleomycin Lung Fibrosis Model
Bleomycin Lung Fibrosis Model P=0.4963 ***P=0.0006 **P=0.0033 4 Disease is established before initiation of treatment 3 PL8177 is very potent (1.25 micrograms/mouse/day) Fibrosis (%) 2 Fibrosis level of PL8177 treated animals is similar to unchallenged 1 Improvements in right ventricular hyp
Slide 18: PL8177 COVID-19 Phase 2 Clinical Trial
PL8177 COVID-19 Phase 2 Clinical Trial Study Title: A Randomized, Adaptive study design, independent Placebo-Controlled Phase 2 Study Sample Size: Data Monitoring Committee of PL8177 in Hospitalized COVID-19 N=176 patients (88 per arm) examining the results when 25%, Patients 50%, 75%, and 100% enro
Slide 19: PL8177 COVID-19 Phase 2 Clinical Trial
PL8177 COVID-19 Phase 2 Clinical Trial Palatin submitted a Comprehensive Potential submission Potential Clinical Advancement preliminary proposal advice on pre-IND of IND: 4Q2020 Trial Initiation: subject to funding - to the Biomedical package from the 1Q2021 Pursuing multiple Advanced Research Divi
Slide 20: Diabetic Retinopathy & Macular Edema
Diabetic Retinopathy & Macular Edema By 2050, the number of Americans with diabetic retinopathy is expected to nearly double, from 7.7 million to 14.6 million DME affects ~10% of people with diabetic retinopathy ◦ ~750,000 in the USA & 2.2 million people in the EU IVT VEGF antagonists and ster
Slide 21: Streptozotocin Diabetic Mouse Model
Streptozotocin Diabetic Mouse Model NS NS 80 2000 * NS * * 5000 * 60 * 1500 VEGF (pg/ml) * IL-10 (pg/mL) 4000 TNFα (pg/ml) 40 1000 3000 NS 20 2000 500 1000 0 0 a d 1 0 tin te 33 e ed l y 1 a ro e 8 33 ht on r re L- at nt e ed l ty 31 al nt ro -8 y al on P tre co lh th He 3 at PL nt U + lls al -8 al
Slide 22: PL8177 Non-Infectious Uveitis
PL8177 Non-Infectious Uveitis Non-Infectious Uveitis (NIU) is a potentially blinding intraocular inflammatory disease that arises without a known infectious trigger and is often associated with immunological responses to unique retinal proteins Prevalence of NIU in N. America ◦ Adults: ~72,000 ◦
Slide 23: PL8177 Experimental Autoimmune Uveitis
PL8177 Experimental Autoimmune Uveitis Untreated EAU mice PL-8177 Low Dose Treated EAU mice PL-8177 High Dose Treated EAU mice 4 -MSH Treated EAU mice MC1r agonism has significant EAU Clinical Score 3 effects in reversing uveitis 2 * Conducted in collaboration with Dr. A. Taylor at Boston Unive
Slide 24: PL8177 Experimental Autoimmune Uveitis Cross section of the eye
PL8177 Experimental Autoimmune Uveitis Cross section of the eye Untreated Diseased PL8177 0.3 mg Treatment with PL8177 results in reversal of the disease process with return to normal phenotype Reversal of immune cell infiltration and restoration of tissue morphology 2020 Corporate Presentation
Slide 25: Back of the Eye Development Programs
“Back of the Eye” Development Programs Demonstrated efficacy in experimental autoimmune uveitis model Orphan Drug Designation received for non-infectious uveitis Demonstrated efficacy in DR/DME animal model DR/DME Phase 2 proof-of-mechanism clinical study ◦ File IND mid-2021, data anticipate
Slide 26: PL8177 Ulcerative Colitis Program
PL8177 Ulcerative Colitis Program MC1r agonism is an endogenous mechanism that downregulates and resolves inflammatory/immune responses ◦ MC1r are expressed on the cell surface of intestinal epithelia in UC patients and normal subjects ◦ Numerous animal IBD models have demonstrated that the endoge
Slide 27: Crucial Role of MC1r in Experimental Colitis
Crucial Role of MC1r in Experimental Colitis c57BL/6 MC1re/e No DSS DSS C Maaser, K Kannengiesser, C Specht, A Lϋgering, T Brzoska, T A Luger, W Domschke, T Kucharzik, 1st OnLine Gut 2006;55:1415-1422. doi: 10.1136/gut.2005.083634 2020 Corporate Presentation I 27
Slide 28: PL8177 DSS IBD Model – Gross Pathology
PL8177 DSS IBD Model – Gross Pathology PL8177 delivered topically to the colon. Budesonide oral delivery. Naïve Vehicle Budesonide PL-8177 PL-8177 PL8177 (Group 1) 0.125 mg/kg 0.5ug 0.5ug (Group 2) (Group 3) (Group 4) (Group 5) 0.5 µg/rat is 60X more potent than budesonide 0.125mg/kg. Mean Gross Pat
Slide 29: Financial Snapshot
Financial Snapshot Financial Highlights as of June 30, 2020 Cash and Cash Equivalents $82.6 million No debt Summary Capitalization as of June 30, 2020 Common Shares and Equivalent Common Stock 229.2 million shares Preferred 0.1 million shares Warrants 15.1 million shares Options 19.9 million shares
Slide 30: Thank You
Thank You PALATIN TECHNOLOGIES, INC.
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