Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Investor Presentation (September 2010)
30 slides from Palatin Technologies's investor presentation, September 2010
Slide 1: Corporate Presentation September 2010
Corporate Presentation September 2010
Slide 2: Forward-Looking Statement
Forward-Looking Statement 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 21E of the Securities Exchange Act of 1934. Such forward-looking statements involve signif
Slide 3: Company Profile
Company Profile Palatin is a biopharmaceutical company using proprietary approaches to develop peptide mimetic and small molecule agonists for the treatment of medical indications with significant unmet need and commercial potential Palatin’s has built compound libraries specific for the melanocorti
Slide 4: Palatin Strategy
Palatin Strategy • Driving growth through developing our internal pipeline and collaborations – Acute or on-demand treatments with novel mechanisms for unmet needs – Establish safety and efficacy and extend development to chronic indications – On demand treatments: » sexual dysfunction FSD and ED –
Slide 5: Palatin Product Overview
Palatin Product Overview • Bremelanotide (BMT), a melanocortin receptor (MCR) agonist, in clinical development as a treatment for female sexual dysfunction (FSD) and erectile dysfunction (ED) • PL-3994, a natriuretic peptide receptor A (NPR-A) agonist, for treatment of acute severe asthma, heart fai
Slide 6: Pipeline
Pipeline Program Indication Preclinical Phase I Phase II Phase III BMT FSD BMT ED Melanocortin Receptor (MCR) MCR Compound Programs (partnered with Obesity & Diabetes AstraZeneca) PL-6983 FSD & ED Acute Severe PL-3994 Asthma Natriuretic Receptor PL-3994 Heart Failure Programs Refractory PL-3994 Hype
Slide 7: Melanocortin Sexual Dysfunction Program
Melanocortin Sexual Dysfunction Program FSD and ED PDE-5 non-responders
Slide 8: Sexual Dysfunction Program Overview
Sexual Dysfunction Program Overview • Extensive clinical experience with bremelanotide – Evaluated in over 2000 patients – Demonstrated efficacy as a treatment for both FSD and ED • BMT subcutaneous (PRN) is in development for – Treatment of women with FSD – Treatment of ED as a monotherapy or in co
Slide 9: Commercial Opportunity
Commercial Opportunity 100% • FSD is a large untapped commercial opportunity 90% – ~50m women in US have symptoms 80% • ~10% - 20% of patients are distressed and 70% may seek treatment – US market estimated at ~$4b 60% % o f m arket Female Sexual Dysfunction 50% Premature Ejaculation • Multiple diso
Slide 10: Bremelanotide FSD Market Opportunity
Bremelanotide FSD Market Opportunity Female Sexual Dysfunction (FSD) encompasses a collection of sexual disorders that affect ~43% of adult women • No FDA approved treatments available • Significant unmet clinical need • FDA, patients and clinicians want effective treatment options 50-59 year olds (
Slide 11: Bremelanotide ED Market Opportunity
Bremelanotide ED Market Opportunity 20% are “marginally satisfied” but 35% of patients are satisfied have no alternative treatment options PDE-5 inhibitor users 35% discontinue PDE-5 inhibitor therapy following initial prescription Initial Target Population BMT estimated global peak sales: $550 mill
Slide 12: Bremelanotide Clinical Experience
Bremelanotide Clinical Experience • Palatin has extensive clinical experience with BMT – Evaluated in 30 clinical studies intranasal (IN) or SC formulations – Demonstrated efficacy as a treatment for both FSD & ED • Commercializing SC formulation – Tight control of PK – Optimizes therapeutic opportu
Slide 13: Effects of Bremelanotide on SBP
Effects of Bremelanotide on SBP BMT Phase 1 data in premenopausal women Subcutaneous administration 15 Systolic Blood Pressure baseline (mm Hg) BMT Placebo 10 5 0 Change from predose -5 -10 -15 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 13 Day
Slide 14: BMT in the Treatment of FSD
BMT in the Treatment of FSD • Multiple phase 2 studies have established proof-of-concept in women with FSAD • Significant improvement in FDA accepted endpoints – Arousal, desire and satisfying sexual encounters – Decrease in distress caused by sexual dysfunction • Women reported an improvement in th
Slide 15: BMT Phase 2B FSAD Patients
BMT Phase 2B FSAD Patients P<0.001 6 P<0.001 P<0.003 % Change from Baseline 60 P<0.001 Arousal Success Rate 5 50 # of SSE’s 4 40 3 30 Placebo 2 20 BMT 1 10 0 0 BSL 1 mos. 2 mos. 1 mos. 2 mos. SSE: “Satisfying Sexual Events,” the Arousal success rate, the % of FDA required registration endpoint attem
Slide 16: Bremelanotide FSAD Clinical Program
Bremelanotide FSAD Clinical Program • Phase 2B in premenopausal women with FSAD – Dose ranging 12 week “at-home” placebo controlled study – FDA accepted endpoints • Improvement in arousal as measured by validated SEQ • Increase in SSE’s as measured by event log • Improvement in sexual distress as me
Slide 17: PDE-5 Inhibitor Non-Responsive Patients
PDE-5 Inhibitor Non-Responsive Patients • Multiple BMT ED studies have demonstrated efficacy in a broad range of patients, including those non-responsive to PDE-5 inhibitor treatment • Phase 2 clinical studies evaluating BMT co-administration with PDE-5 inhibitor demonstrate additive effect • Signif
Slide 18: Bremelanotide ED Clinical Program
Bremelanotide ED Clinical Program • Bremelanotide phase 2A study PDE-5 inhibitor non-responsive ED patients – Dose optimization of bremelanotide as an adjunct to PDE-5 inhibitors – Treatment effect size in target non-responder population – Continued evaluation of effects on blood pressure – Target s
Slide 19: Natriuretic Peptide Receptor Programs
Natriuretic Peptide Receptor Programs
Slide 20: Acute Severe Asthma: current therapy
Acute Severe Asthma: current therapy Drugs 2009; 69 (17): 2363-2391 asthma case fatality rates (asthma deaths per 100 000 asthmatic patients in the 5- to 34-year-old age group). Masoli et al. 20
Slide 21: Pulmonary Commercial Opportunity
Pulmonary Commercial Opportunity Subcutaneous Market Potential >$500M Nebulized Market Potential >$1B Dry Powder Market Potential >$3B *Crossover use of asthma therapeutics in COPD approx. 30% of asthma market 21
Slide 22: PL-3994 for Acute Severe Asthma
PL-3994 for Acute Severe Asthma • Acute ED use • Single or multiple subcutaneous or nebulized doses • Patients are refractory to LABA bronchodilators • Other bronchodilators ineffective • PL-3994 dilates airway smooth muscle via a different mechanism (cGMP vs cAMP) • Clinical precedent with short-ac
Slide 23: Natriuretic Peptides and Asthma
Natriuretic Peptides and Asthma • Published data demonstrate bronchodilator activity of IV and aerosol NPR-A agonists • NPR-A agonism relaxes smooth muscle in airways – effect is increased under conditions of β2 overload • NPR-A cGMP pathway is independent of β2-ADR/cAMP pathway • β2 refractory, acu
Slide 24: PL-3994 in Asthma Disease Models
PL-3994 in Asthma Disease Models 100 15 Δ in pulmonary inflation 80 % Inhibition of contraction PL3994 pressure (cmH 2O) PL5731 60 Vehicle 10 40 5 20 0 0 100 μg/kg -10 -9 -8 -7 -6 -5 10 μg/kg control 1 μg/kg Agonist (M) Pl-3994 Dose 160 140 Relaxation (%) 120 100 80 60 40 ISO 20 ISO + PL-3994 0 10-9
Slide 25: PL-3994 Clinical Results
PL-3994 Clinical Results • Phase 1 & 2A placebo-controlled dose escalation studies – Well tolerated - no adverse or severe adverse events – Clear dose response for key pharmacological effects – Prolonged duration of effect – Met key pharmacology endpoints SBP, ↑diuresis, ↑natriuresis, ↑cGMP plasma
Slide 26: PL-3994 Asthma Development
PL-3994 Asthma Development • Phase 2 proof-of-principle study in asthmatics – In clinic SC dosing in stable asthmatics – Objective is to determine bronchodilator effect of Pl-3994 – Target start 1Q11 • Nebulized formulation – Physical chemical studies – Animal toxicology program – Target phase 1 stu
Slide 27: PL-3994 Additional Indication
PL-3994 Additional Indication • Sub-chronic HF Indication – Frequent hospitalization for worsening symptoms • Hospitalization leads to decreased survival • Identified by NIH Institute of Medicine as a high priority medical issue • Significant driver of hospital costs – PL-3994 treatment for 3-6 mont
Slide 28: AstraZeneca Obesity Collaboration
AstraZeneca Obesity Collaboration • AstraZeneca is a global pharmaceutical company with a strong emphasis in metabolic disease • Exclusive global licensing and research collaboration – $10M up front and $12M milestones received – Royalties on commercialization – $85M in development and $60M in sales
Slide 29: 2010-2011 Milestones
2010-2011 Milestones • Bremelanotide phase 2B study in women with FSAD • Bremelanotide phase 2 study in ED patients non- responsive to PDE-5 inhibitor • PL-3994 phase 2 proof-of-principle study in asthmatic patients • AstraZeneca melanocortin obesity/diabetes program transition to clinical studies •
Slide 30: Financial Snapshot
Financial Snapshot Ticker Symbol NYSE AMEX: PTN 52-Week Price Range $0.15 - $0.48 Shares Outstanding – August 2010 ¾Common 117M ¾Fully Diluted 143M Market Capitalization – August 2010 $25M Cash and Investments Balance as of 3/31/10 $10.2M 30
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