Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Investor Presentation (November 2021)
43 slides from Palatin Technologies's investor presentation, November 2021
Slide 1: Corporate Presentation
Palatin Technologies, Inc. NYSE American: PTN CORPORATE PRESENTATION November 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 Pioneering a novel mechanism and approach to treating inflammatory & autoimmune diseases with a focus on ocular indications Demonstrated Expertise in the First company to Strategy leverages MOAs with the expertise moving biology and chemistry procure FDA approval our chemistry and po
Slide 4: Commercial Product and Development Programs
Commercial Product and Development Programs Commercial Product Vyleesi® (bremelanotide) FDA Approval 2Q2019 Seeking U.S. and ROW Licenses Hypoactive Sexual Desire Disorder Pipeline Development Programs Melanocortin Receptor Programs Pre-clinical Phase 1 Phase 2 Phase 3 NDA Submission FDA Approval St
Slide 5: Milestones
Milestones Vyleesi (bremelanotide) for Hypoactive Sexual Desire Disorder Initiation Status/Completion North American Rights Regained 3Q2020 China Licensee PK Study / S. Korea Licensee PK Study 2H2021 Seeking U.S. and ROW Partnerships 2H2021-2022 Melanocortin System Inflammatory & Autoimmune Disease
Slide 6: Melanocortin Inflammatory & Autoimmune Disease Programs
Melanocortin Inflammatory & Autoimmune Disease Programs Pioneering a new way to patients
Slide 7: 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 8: Mechanism of Action of Melanocortins
Mechanism of Action of Melanocortins 8
Slide 9: 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, diabetic retinop
Slide 10: Ocular
& PALATIN
Slide 11: Ophthalmic Diseases: Front to Back
Ophthalmic Diseases: Front to Back Conjunctiva Seasonal allergic Vernal (Orphan) Atopic (Orphan) Conjunctiva/Cornea/Ocular surface Dry eye Corneal Epithelium Toxicity from chemotherapy (Orphan) Cornea endothelium Protect donor corneas for transplantation Improve corneal transplant survival Protectio
Slide 12: Ophthalmic Diseases: Unmet Medical Needs
Ophthalmic Diseases: Unmet Medical Needs REGION OF THE EYE INDICATION UNMET NEED Seasonal Allergic Minimal unmet need Conjunctiva Vernal (orphan) One product approved Atopic (orphan) Need for steroid-sparing agent Conjunctiva/Cornea/Ocular surface Dry eye Huge market, tolerability is lacking Toxicit
Slide 13: Ophthalmic Diseases: Unmet Medical Needs
Ophthalmic Diseases: Unmet Medical Needs REGION OF THE EYE INDICATION UNMET NEED Iris/Ciliary Body/Choroid Non-Infectious Uveitis Need steroid-sparing therapy Diabetic retinopathy Largest market Retina Age-related macular degeneration Largest market Optic nerve Neuro-protection in glaucoma Unique 13
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 - One of the Most Common Eye Diseases in the United States
DED - 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 O
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 & 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 DED is estimated to affect Existing therapies for dry eye PL9643 has a favorable over 20 million people in the disease generally regarded as commercial product profile / United States inadequate by many physicians Differentiating factors to and patients current
Slide 23: PL9643 Dry Eye Disease Development – Status/Next Steps
PL9643 Dry Eye Disease Development – Status/Next Steps Submitted Phase 2 EOP2 FDA Completed Non-clinical Study to FDA Meeting Held Activities 1H2021 1H2021 1H2021 Initiate Phase 3 Study Initiate 2nd Phase 3 NDA to FDA Submission Study 2H2021 2H2023 Data 1H/2H2022 1H/2H2022 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: PL8177 for Ulcerative Colitis
PL8177 for Ulcerative Colitis
Slide 31: Why a Melanocortin Peptide for Ulcerative Colitis?
Why a Melanocortin Peptide for Ulcerative Colitis? • MC1r is found on epithelial cells of the colon and appear to be accessible from the lumen of the colon ◦ Evidence from preclinical animal studies • PL8177 is a highly potent peptide of 7 aa that is a selective agonist at MCr1 • PL8177 main metabol
Slide 32: Opportunity for PL8177 in UC Treatment Landscape
Opportunity for PL8177 in UC Treatment Landscape 32
Slide 33: Study Design
Study Design • PL8177 (20ug, 50ug and 100ug) and PL9680 (50ug) are given as a polymer formulation placed into #9 capsules • Placebo capsules and test article capsules are administered twice daily • Mesalamine is administered orally once daily 33
Slide 34: Histological Findings: Total Colitis Index
Histological Findings: Total Colitis Index • The scoring was based on examining three total colitis index sections from each colon per animal: 50 ✱✱✱✱ ✱✱✱ • Sections were taken at the distance of 2.5cm, 5cm and 7.5cm from the anus total colitis index 40 30 • Total colitis index includes observations
Slide 35: PL8177 Oral Formulation Clinical Study Summary
PL8177 Oral Formulation Clinical Study 102 Summary Confirmation of local colonic delivery based on presence of PL8177 and metabolite • This was a phase 0, open-label clinical study conducted at a single center in The Netherlands designed to examine an oral formulation of PL8177 ◦ A microdose study w
Slide 36: PL8177 Oral Formulation – Human PK (microdose study)
PL8177 Oral Formulation – Human PK (microdose study) Confirmation of GI tract release & no systemic exposure Mean Percent Excretion vs Time in Feces of [14C]-PL8177 and [14C]-PL8435 Cohort 1 = [14C]-PL8177 + laxative 5 h postdose Cohort 2 = [14C]-PL8177 + laxative 8 h postdose Cohort 3 = [14C] PL817
Slide 37: PL8177 Oral Formulation for UC – Summary Status
PL8177 Oral Formulation for UC – Summary Status • Multiple positive animal model proof of efficacy data in gold standard disease model • Efficacy as good/better than 5-ASA and glucocorticoids in animal model data • Phase 1 SAD/MAD study with the systemic formulation (SC) up to 3mg for 7 days, up to
Slide 38: Vyleesi
& PALATIN
Slide 39: Vyleesi Operations/Performance
Vyleesi Operations/ Performance • Objective ◦ Demonstrate the commercial value and upside of Vyleesi and re-license to a committed partner • Vyleesi is a valuable asset in the ‘right” hands ◦ FDA approved product with limited competition • FSD market ◦ Significant awareness needed / greater HCP and
Slide 40: FDA Approved Vyleesi
FDA Approved Vyleesi® Helping Premenopausal Women with Hypoactive Sexual Desire Disorder (HSDD) 40
Slide 41: 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 42: Financial Snapshot
Financial Snapshot Financial Highlights as of September 30, 2021 Cash and Cash Equivalents $53.4 million Accounts Receivable $0.9 million Inventory $1.1 million Inventory Purchase Commitments (over the next 5 years) $9.8 million Summary Capitalization as of October 31, 2021 Common Shares and Equival
Slide 43: Thank You
NO Ca Io THANK YOU & PALATIN
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