Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Investor Presentation (January 2021)
26 slides from Palatin Technologies's investor presentation, January 2021
Slide 1: Palatin Technologies Corporate Presentation January 2021
PALATIN TECHNOLOGIES, INC. Corporate Presentation I January 2021 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 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 experti
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) Fosun (China, Taiwan, HK, Macau) and Kwangdong (S. Korea) Seeking Hypoactive Sexual Des
Slide 5: Milestones
Milestones Vyleesi (bremelanotide) for Hypoactive Sexual Desire Disorder North American rights regained 3Q2020 China licensee PK study 1H2021 South Korea licensee PK study 1H2021 Additional ROW partnerships 2021 Melanocortin System Inflammatory & Autoimmune Disease Programs Initiate Data PL9643 – Dr
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) 2021 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 2021 Corporate Presentation I
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 Anti-inflammatory Program
Melanocortin Anti-inflammatory Program Rational design and synthesis of selective MC1R & Reversal of pathology in multiple inflammatory and MC1/5R agonists autoimmune disease models ◦ PL8177: cyclic peptide selective MC1R agonist ◦ Including inflammatory bowel disease, dry eye, ◦ PL9643: cyclic pept
Slide 13: 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 symp
Slide 14: PL9643 Dry Eye Program
PL9643 Dry Eye Program PL9643 represents a novel approach to treating Dry Eye Disease (DED) by targeting the ability of the MS to resolve pathological inflammation ◦ PL9643 treats inflammation underlying the development and maintenance of DED, addressing both signs and symptoms of DED PL9643 is
Slide 15: 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 16: PL9643 Dry Eye Phase 2 Strategy
PL9643 Dry Eye Phase 2 Strategy Multi-center phase 2 RCT comparing PL9643 to placebo in DED patients with a 12-week treatment period Co-primary end points, a sign and symptom of DED ◦ Sign: improvement in inferior fluorescein staining at week 12 ◦ Symptom: ocular discomfort measured at week 12
Slide 17: PL9643 Dry Eye Phase 2 Results
PL9643 Dry Eye Phase 2 Results Met primary objective of providing data required to advance into registration studies In the sub-population of moderate to severe patients (N=61), PL9643 achieved statistical significance (P value <0.05 vs. vehicle) at week 2 and week 12 ◦ Inferior (primary sign en
Slide 18: PL9643 Dry Eye Commercial Opportunity
PL9643 Dry Eye Commercial Opportunity DED is estimated to affect over 20 million people in the United States ◦ Majority of people suffering from DED are in the moderate to severe category (>75%) ◦ Most patients have persistent disease (>5yrs) Existing therapies for dry eye disease generally rega
Slide 19: PL9643 Dry Eye Disease Development – Next Steps
PL9643 Dry Eye Disease Development – Next Steps 19 Submit Phase 2 Complete Non- EOP2 FDA Meeting Study to FDA clinical Activities 1H2021 1H2021 1H2021 Initiate Phase 2/3 Initiate Phase 3 NDA to FDA Study Study Submission Mid 2021 Data 1H2022 1H2022 1H2023 2021 Corporate Presentation I 19
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 EAU Clinical Score 3 2 * Untreated 1 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 Day Days of injections * P = 0.0001 by Anova MC1R ago
Slide 24: Ocular Development Programs
Ocular Development Programs Demonstrated efficacy, safety and tolerability in phase 2 DED study ◦ 1st evaluation of melanocortin system therapeutic in ocular inflammatory indication ◦ Establishes translation of preclinical data into humans ◦ Moving forward into registrational studies PL9643 phas
Slide 25: Financial Snapshot
Financial Snapshot Financial Highlights as of September 30, 2020 Cash and Cash Equivalents $86.6 million Accounts Receivable $5.0 million Inventory $6.0 million Inventory Purchase Commitments (over the next 5 years) $18.2 million Summary Capitalization as of September 30, 2020 Common Shares and Equi
Slide 26: Thank You
Thank You 2021 Corporate Presentation I
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