Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Investor Presentation (June 2021)
31 slides from Palatin Technologies's investor presentation, June 2021
Slide 1: Palatin Technologies Corporate Presentation June 2021
PALATIN TECHNOLOGIES, INC. Corporate Presentation I June 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
Company Profile • Technology and expertise in developing drugs that modulate the melanocortin system with a primary focus on inflammatory and autoimmune diseases Demonstrated Expertise in the First company to Strategy leverages MOAs with the expertise moving biology and chemistry procure FDA approva
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 Initiated Data 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 Initiated
Slide 6: FDA Approved Vyleesi
FDA Approved Vyleesi® Helping Premenopausal Women with Hypoactive Sexual Desire Disorder (HSDD) 6
Slide 7: FDA Approved Vyleesi
FDA Approved Vyleesi® Vyleesi is a valuable asset (FDA approved product with limited competition) Goal • Demonstrate the commercial value of Vyleesi and re-license to a committed partner Highlights and recent operational results • Quarter ended March 31, 2021 over the prior quarter ended December 31
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 not on therapy3 1/10 1,2 • Focused on relevant digital channels Number of premenopausal • Creating an online community for HSDD patients
Slide 9: ROW Vyleesi Licensing Agreements
ROW Vyleesi Licensing Agreements FOSUN PHARMA KWANGDONG PHARMACEUTICAL CO. Chinese pharmaceutical company focused on developing Republic of Korea leading pharmaceutical company with and commercializing innovative healthcare solutions >$900M in annual sales with >$2B in annual sales • Exclusive licen
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: Mechanism of Action of Melanocortins
Mechanism of Action of Melanocortins 12
Slide 13: Melanocortin Anti-inflammatory Program
Melanocortin Anti-inflammatory Program Rational design and synthesis of selective MC1R Reversal of pathology in multiple inflammatory & MC1/5R agonists and autoimmune disease models PL8177: cyclic peptide selective MC1R agonist Including inflammatory bowel disease, dry eye, uveitis, PL9643: cyclic p
Slide 14: 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 15: DED Is One of the Most Common Eye Diseases in the United States
DED Is One of the Most Common Eye Diseases in the United States1 29 million = 1 out of every American 7 Adults2,3 AMERICAN ADULTS suffer from symptoms of DED2,3 15 1. Stern ME et al. Int Rev Immunol. 2013;32(1):19-41. 2. Lemp MA. Am J Ophthalmol. 2008;146(3):350-356. 3. Patel VD et al. Curr Med Res
Slide 16: 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 17: 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 18: PL9643 Dry Eye Phase 2 Results
PL9643 Dry Eye Phase 2 Results • Met primary objective of providing data required to advance into registration studies • Statistical significance for the primary endpoints was not achieved in the ITT population that included mild, moderate, and severe patients • In the sub-population of moderate to
Slide 19: Difference in LS Mean Change: Corneal Fluorescein Staining
Difference between PL9643 & Placebo for Corneal Fluorescein Staining Patients with Moderate or Severe Disease Total corneal Total Total Sum (inferior + conjunctival (corneal + superior + (temporal + conjunctival) central) nasal) Nasal Temporal Inferior Superior Central 0.2 0 Difference in LS Mean Ch
Slide 20: Conjunctival Redness and Tear Film Break-up Time
Differences between PL9643 & Placebo in Conjunctival Redness and Tear Film Break-up Time Patients with Moderate or Severe Disease Conjunctival Redness Tear Film Break-up Time 0 0.35 -0.02 * Difference in LS Mean Difference in LS Mean Square Change From Square Change From 0.3 -0.04 -0.06 0.25 Baselin
Slide 21: Ocular Discomfort and 4-Symptom Questionnaire
Differences between PL9643 & Placebo Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire† Score's patients with Moderate or Severe Disease Ocular Discomfort Burning Dryness Grittiness Stinging 0.3 LS Mean Change From Baseline 0.2 0.1 0 -0.1 -0.2 -0.3 -0.4 -0.5 * Week 2 Week 12 *P≤0.05 PL9643 de
Slide 22: PL9643 Dry Eye Commercial Opportunity
PL9643 Dry Eye Commercial Opportunity Existing therapies for dry eye disease generally regarded as DED is estimated to affect inadequate by many physicians PL9643 has a favorable over 20 million people in the and patients commercial product profile / United States • Limited clinical trial evidence D
Slide 23: PL9643 Dry Eye Disease Development – Next Steps
PL9643 Dry Eye Disease Development – Next Steps Submit Phase 2 EOP2 FDA Complete Non-clinical Study to FDA Meeting Activities 1H2021 1H2021 1H2021 Initiate Phase 2/3 Study Initiate 2nd Phase 3 NDA to FDA Submission Study 2H2021 1H2023 Data 1H2022 1H2022 23
Slide 24: 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 25: Streptozotocin Diabetic Mouse Model
Streptozotocin Diabetic Mouse Model NS NS 2000 5000 * * * * 4000 1500 IL-10 (pg/mL) TNFα (pg/ml) PL9643 is as efficacious as 3000 1000 NS Restasis® and several orders 2000 of magnitude more potent 500 1000 0 0 e ed l y 1 ro 33 ht on e ed l ty 31 ro on at nt lh al -8 3 at al nt tre co -8 al a He PL t
Slide 26: Melanocortin Agonists Preserve Contrast Vision and Acuity
Melanocortin Agonists Preserve Contrast Vision and Acuity Rat diabetic retinopathy model 26
Slide 27: 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 28: 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 29: 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 30: Financial Snapshot
Financial Snapshot Financial Highlights as of March 31, 2021 Cash and Cash Equivalents $68.6 million Working Capital $69.4 million No Debt Summary Capitalization as of March 31, 2021 Common Shares and Equivalents Common Stock 230.1 million shares Preferred 0.1 million shares Warrants 12.6 million sh
Slide 31: Thank You
NO Ca Io THANK YOU & PALATIN
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