Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Investor Presentation (January 2015)
35 slides from Palatin Technologies's investor presentation, January 2015
Slide 1: Palatin Technologies
Palatin Technologies January 2015 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 Palatin Technologies, Inc. (NYSE MKT: PTN) is a biopharmaceutical company developing targeted, receptor- specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. 3
Slide 4: Palatin Technologies Value Proposition
Palatin Technologies Value Proposition Palatin Technologies, Inc. is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential Lead product: Bremelanotide (BMT) for the treatm
Slide 5: Pipeline Overview
Pipeline Overview Preclinical Phase 1 Phase 2 Phase 3 Melanocortin Receptor Programs Bremelanotide for Female Sexual Dysfunction MC4r Agonist AstraZeneca Collaboration Obesity, Metabolic Syndrome & Diabetes MC4r Agonist Female Sexual Dysfunction & Erectile Dysfunction Next Generation Peptide PL-8177
Slide 6: Female Sexual Dysfunction Program
Female Sexual Dysfunction Program
Slide 7: Female Sexual Dysfunction Overview
Female Sexual Dysfunction Overview Female Sexual Dysfunction (FSD) is defined as persistent or recurring problems during one or more of the stages of sexual response with associated distress FSD has a significant impact on patient self-image, relationships and general well-being >60 million pr
Slide 8: Approaches to Treating FSD
Approaches to Treating FSD Low dose transdermal testosterone in surgically menopausal Hypoactive Sexual Desire Disorder (HSDD) patients. ◦ Intrinsa testosterone patch successful Phase 3 program – Failure to approve based on long term use safety risks of cancer and cardiovascular adverse events ◦ L
Slide 9: Bremelanotide Profile
Bremelanotide Profile Novel mechanism of action activating endogenous melanocortin hormone pathways involved in sexual arousal response Evaluated in 31 clinical studies (n = 2300) showing efficacy in both FSD and erectile dysfunction Phase 2B trial showed a statistically significant and clinic
Slide 10: Phase 2B FSD Clinical Trial
Phase 2B FSD Clinical Trial Dose ranging 16 week at-home placebo-controlled study ◦ Subcutaneous dosing: placebo and 0.75 mg, 1.25 mg and 1.75 mg bremelanotide ◦ Enrollment: 395 patients Validated patient reported outcome (PRO) endpoints ◦ Increase in Satisfying Sexual Events (SSEs) – As measure
Slide 11: Phase 2B FSD Clinical Data
Phase 2B FSD Clinical Data Analysis of the primary and key secondary endpoints of 327 pre-menopausal patients shows clinically meaningful and statistically significant effects for bremelanotide vs. placebo. Pre-specified analysis was of pooled 1.25 mg & 1.75 mg doses vs. placebo. Primary endpoin
Slide 12: Phase 2B FSD Clinical Data
Phase 2B FSD Clinical Data 0.9 SSE 5.0 FSFI Total Score 0.0 Placebo 0.75 mg 1.25 mg 1.75 mg 0.8 * 4.5 ** -2.0 4.0 0.7 Mean Change From Baseline Mean Change From Baseline Mean Change From Baseline 3.5 -4.0 0.6 3.0 0.5 * -6.0 2.5 0.4 2.0 -8.0 0.3 1.5 * -10.0 0.2 1.0 0.1 0.5 -12.0 FSDS-DAO Total Score
Slide 13: Phase 2B FSD Clinical Data
Phase 2B FSD Clinical Data 395 premenopausal FSD patients were randomized to receive drug or placebo 26 patients met the predefined blood pressure withdrawal criteria and were evenly distributed among placebo and active arms of the study Drug treated subjects had ~2 mm Hg change in blood press
Slide 14: Phase 3 NA Pivotal Program
Phase 3 NA Pivotal Program Key Points ◦ Patient population – HSDD & HSDD with decreased arousal ◦ 24 week treatment evaluation period ◦ Co-primary endpoints – SSE and FSFI Desire subdomain (28 day recall) ◦ Key secondary endpoint – FSDS-R (revised) question #13 ◦ 1.75 mg versus placebo ◦ Cardio-Re
Slide 15: Phase 2B Analyzed for Phase 3 Patient Population & Endpoints
Phase 2B Analyzed for Phase 3 Patient Population & Endpoints SSE FSFI-Desire FSDS-Q13 0.8 1.2 0 P=0.03 0.7 1 P=0.001 -0.25 0.6 0.8 0.5 -0.5 0.4 0.6 -0.75 0.3 0.4 0.2 -1 0.2 P=0.008 0.1 0 0 -1.25 Placebo 1.25mg 1.75mg Placebo 1.25mg 1.75mg Placebo 1.25mg 1.75mg Phase 2B data from patients diagnosed w
Slide 16: Corporate Partnering
Corporate Partnering European rights licensed to Gedeon Richter (August 2014) ◦ European pharmaceutical company with a focus on female healthcare - $1.6B in 2013 sales - $500M in female healthcare ◦ EMA/ CHMP guidance on the EU Phase 3 program received ◦ Jointly working on EU Phase 3 clinical deve
Slide 17: Key Points FDA Public Meeting on FSD
Key Points FDA Public Meeting on FSD On October 27 & 28, 2014 the FDA held a Patient-Focused Drug Development Public Meeting and Scientific Workshop on Female Sexual Dysfunction ◦ FSD is an underserved, unmet medical need that distresses patients and is in need of multiple treatment options ◦ FDA
Slide 18: Bremelanotide NA & EU Program Timelines
Bremelanotide NA & EU Program Timelines NA (primarily U.S.) ◦ Phase 3 pivotal trials enrolling patients 4Q2014 ◦ Complete Phase 3 enrollment 2H2015 ◦ Phase 3 trials topline results Mid-2016 ◦ FDA NDA submission 4Q2016 ◦ FDA action 4Q2017 EU ◦ EMA/CHMP guidance - completed 1H2014 ◦ Commence Pha
Slide 19: Natriuretic Peptide Receptor Program
Natriuretic Peptide Receptor Program
Slide 20: Natriuretic Peptide System
Natriuretic Peptide System Neuropeptide hormone system Prohormone plays an important role in the regulation of cardiovascular homeostasis CNP BNP ANP Corin processing Neutral endopeptidase (neprilysin) And the NP-C receptor downregulate GTP PKG the NP system through removal of active ANP, BNP and CN
Slide 21: Paradigm Shift in HF: Upregulation of NP System
Paradigm Shift in HF: Upregulation of NP System LCZ696 (Novartis compound) – combined ARB & neprilysin inhibitor ◦ Inhibits angiotensin function and upregulates endogenous natriuretic peptides Phase 3 trial in heart failure (HF) patients with reduced ejection fraction compared LCZ696 to ACEi (en
Slide 22: Overview Palatin Natriuretic Peptide Program
Overview Palatin Natriuretic Peptide Program Design and develop commercial candidates selective for NPR-A, NPR-B, NPR-C & NPR-A/B PL-3994 lead product candidate ◦ Selective NPR-A agonist ◦ Increased metabolic stability ◦ Once daily subcutaneous (SC) patient administration ◦ Phase 2 ready drug de
Slide 23: Daily PL-3994 Significantly Reduces Cardiac Remodeling
Daily PL-3994 Significantly Reduces Cardiac Remodeling Heart Weight /Body Weight Attenuation of RAAS Activation following 6 weeks of treatment 0.6 80000 * * * Plasma aldosterone 60000 * p < 0.05 0.4 HW/BW 40000 2K1C (saline) (pg/ml) 2K1C (PL3994) 0.2 20000 * p < 0.05 2000 * 0.0 1000 0 ) e) 4) e) 4 i
Slide 24: Opportunities for Treating Heart Failure
Opportunities for Treating Heart Failure Heart Failure with Preserved Phase 2A multiple dose study in HF Ejection Fraction (HF-PEF) patients ◦ High unmet need; no approved ◦ HF-PEF, HF-REF & corin deficient patients treatment options ◦ Evaluate safety, symptom relief and cardiac imaging, LVEF
Slide 25: Melanocortin Receptor-1 Agonists Inflammation and Dermatologic Indications
Melanocortin Receptor-1 Agonists Inflammation and Dermatologic Indications
Slide 26: MC1r Agonist Anti-Inflammatory Program
MC1r Agonist Anti-Inflammatory Program Goal: design and develop selective MC1r agonists for treating a variety of inflammatory and autoimmune indications ◦ Inflammatory indications: inflammatory bowel disease, nephritis (inflammation of the kidneys) and rheumatoid arthritis ◦ Ocular indications: u
Slide 27: TNF-α Inhibition via MC1r Agonists
TNF-α Inhibition via MC1r Agonists Results 3000 Dose – mg/kg SC pmole/mL TNFa 2000 1000 0 1 1 le 10 10 5 @ @ @ ic @ @ eh 76 77 a 76 77 ex V 1 1 1 1 L8 L8 D L8 L8 P P P P Preclinical mouse model TNF-α stimulated by LPS administration with dexamethasone as positive control 27
Slide 28: PL-8177 Experimental Autoimmune Uveitis
PL-8177 Experimental Autoimmune Uveitis Untreated EAU mice PL-8177 Low Dose Treated EAU mice PL-8177 High Dose Treated EAU mice 4 α-MSH Treated EAU mice EAU Clinical Score 3 2 * 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 agonism ha
Slide 29: Melanocortin Receptor-4 Agonist Obesity & Diabetes
Melanocortin Receptor-4 Agonist Obesity & Diabetes
Slide 30: Melanocortins and Obesity Overview
Melanocortins and Obesity Overview Hypothalamus arcuate nucleus Stimulates MC4r – decrease in food intake & weight loss POMC Brainstem & Cortex Peripheral Signals MC4r signals Leptin Grelin GLP-1 Down stream effects on Insulin food intake, weight CCK and energy expenditure AGRP Inhibits MC4r – incre
Slide 31: MC4r Obesity & Diabetes Program
MC4r Obesity & Diabetes Program Goal: design and develop selective for MC4r agonists for treating obesity, diabetes and related metabolic syndrome ◦ High selectivity for MC4r with limited off-target effect ◦ None of the toxicities associated with small molecules Lead compound PL-8905 ◦ High sele
Slide 32: AstraZeneca Obesity Collaboration
AstraZeneca Obesity Collaboration Exclusive global licensing and research collaboration ◦ $10M upfront and $10M milestones received ◦ $145M in additional potential milestones ◦ Royalties on sales of approved products Clinical proof-of-concept studies for MC4r mechanism have been completed ◦ Prim
Slide 33: Palatin Potential Near-Term Development Milestones
Palatin Potential Near-Term Development Milestones Bremelanotide for Female Sexual Dysfunction ◦ Commence Phase 3 pivotal trials in NA 4Q2014 ◦ Complete Phase 3 enrollment in NA 2H2015 ◦ Commence Phase 3 pivotal trial in EU 2H2015 ◦ NA Phase 3 pivotal trial results Mid-2016 ◦ Corporate collabora
Slide 34: Financial Snapshot
Financial Snapshot Financial Highlights as of September 30, 2014 Cash & Equivalents $17.8 million1 Total Debt $0.01 Summary of Capitalization as of January 2015 Common Equivalent2 Common Stock 41.5 million shares Preferred 0.1 million shares Warrants 116.7 million shares3 Options 4.2 million shares
Slide 35: Thank You
<> Thank You
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