Slide 1: Palatin Technologies November 2012
Palatin Technologies November 2012 Carl Spana, Ph.D. President & CEO Stephen T. Wills, CPA/MST CFO / COO
Slide 2: 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 21 E of the Securities Exchange Act of 1934 . Such forward - looking statements involve significant risks and unce
Slide 3: Company Profile
3 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. Company Profile
Slide 4: Palatin Investment Opportunity
Palatin Investment Opportunity 4 Well positioned to drive growth through internal pipeline/collaborations Lead product: bremelanotide (BMT) for the treatment of female sexual dysfunction (FSD) ◦ Unmet medical need with multi - billion dollar market opportunity ◦ Phase 2B clinical trial positive -
Slide 5: Pipeline
Pipeline 5 Program Indication Preclinical Phase I Phase II Phase III Melanocortin Receptor (MCR) Programs Bremelanotide Female Sexual Dysfunction MCR-4 Agonist (partnered with AstraZeneca) Obesity and Diabetes Next generation peptide Female Sexual Dysfunction and Erectile Dysfunction Natriuretic Rec
Slide 6: Female Sexual Dysfunction Program
Female Sexual Dysfunction Program —_—a
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 is prevalent in U.S. adult women ◦ ~43% experiencing some symptoms of FSD ◦ ~23% experiencing associa
Slide 8: FSD: Significant Untapped Market Opportunity
FSD: Significant Untapped Market Opportunity No FDA approved treatments available 50 million pre - menopausal women in US o 22% reported a sexual problem o 9% were distressed by their sexual problems • One - third sought formal care Market size – U.S. o Potential presenting pre - menopausal wo
Slide 9: Bremelanotide Profile
First - in - class melanocortin receptor 4 agonist for FSD On - demand use with rapid onset of activity and well - tolerated Novel mechanism of action activating endogenous pathways involved in sexual arousal response Evaluated in 30 clinical studies showing efficacy in both FSD and ED Breme
Slide 10: BMT Subcutaneous Development
BMT Subcutaneous Development 10 Demonstrated optimal pharmacokinetics ◦ Subcutaneous on - demand formulation: less variation in patient exposure ◦ Good therapeutic dosing window to avoid potential AE’s (GI and BP effects) associated with over - exposure Completed and submitted preclinical toxico
Slide 11: Female Sexual Response Cycle
Female Sexual Response Cycle 11 Key points for drug intervention are the sites of bremelanotide action Sexual satisfaction Non-Sexual rewards Multiple reasons for engaging in sex M O T I V A T I O N Subjective Arousal Sexual Receptivity Desire Sexual Stimuli Responsive sexual arousal and desire
Slide 12: Bremelanotide FSD Clinical Data
Bremelanotide FSD Clinical Data Studies of sexual function in female rodent and primate models demonstrated pronounced effects on perceptive and appetitive sexual behaviors Multiple Phase 2 efficacy studies ◦ Double - blind, placebo - controlled ◦ In - clinic dosing and “at - home” use ◦ SC or I
Slide 13: BMT Phase 2B FSD Clinical Trial
BMT Phase 2B FSD Clinical Trial 13 Dose ranging 16 week at - home placebo - controlled study ◦ Subcutaneous dosing: placebo; 0.75 mg BMT; 1.25 mg BMT and 1.75 mg BMT ◦ Target enrollment: 400 patients Used FDA accepted and validated endpoints ◦ Increase in Satisfying Sexual Events (SSE’s) ◦ A s m
Slide 14: Phase 2B Clinical Data
Phase 2B Clinical Data 14 Analysis of the primary and key secondary endpoints of 327 pre - menopausal patients shows clinically meaningful and statistically significant effects for BMT vs. placebo Primary endpoint ◦ Improvement in the number of satisfying sexual events BMT vs. Placebo (p=0.018)
Slide 15: Phase 2B Clinical Data: Safety
Phase 2B Clinical Data 15 395 premenopausal FSD patients were randomized to receive drug or placebo 26 patients met the predefined BP withdrawal criteria and were evenly distributed among placebo and active arms of the study 12 patients withdrew for AE’s (2 on placebo), predominately emesis, n
Slide 16: BMT FSD Next Steps
BMT FSD Next Steps 16 Complete data analysis by 4Q12 End - of - Phase 2 meeting with FDA 1Q13 Full data presentation at scientific conferences 1Q13 Corporate partnership Start of Phase 3 program targeted for 4Q13
Slide 17: Summary of BMT FSD Program
Summary of BMT FSD Program Patient Testimony “ I was focused on sex, I wasn’t thinking of anything else.” “Quality of orgasms was better - more intense, lasted longer.” 17 Multiple Phase 2 studies establish proof - of - concept in FSD Phase 2B study met all key objectives and supports transition
Slide 18: Melanocortin Receptor Agonist Obesity & Diabetes
Melanocortin Receptor 4 Agonist Obesity & Diabetes
Slide 19: AstraZeneca Obesity Collaboration
AstraZeneca Obesity Collaboration Exclusive global licensing and research collaboration ◦ $10M upfront and $12M milestones received ◦ $145M in additional milestones ◦ Royalties upon commercialization Clinical proof - of - concept studies for MCR - 4 mechanism have been completed ◦ Primary object
Slide 20: Melanocortins and Obesity Overview
Melanocortins and Obesity Overview MCR - 4 neurons located in the hypothalamus play a key role in coordinating central, peripheral and behavioral signals of energy balance MCR - 4 neurons are activated by a variety of appetite suppressing signals resulting in decreased hunger and increased energ
Slide 21: Natriuretic Peptide Receptor Program
Natriuretic Peptide Receptor Program _
Slide 22: Medical need for new therapy in acute severe asthma
Medical need for new therapy with faster onset acting independently of the beta - agonist mechanism Acute Severe Asthma Asthma episode in which symptoms do not adequately respond to current therapies Patients often require emergency room (ER) treatment ER Standard of Care requires several hour
Slide 23: PL-3994 Market Opportunity
PL - 3994 Market Opportunity 23 *Individual treatment cost $ 1 , 000 **Crossover use of asthma therapeutics in COPD approx . 30 % of asthma market Administration Indication Stage Market Potential Subcutaneous Acute Severe Asthma ER Phase 2 >$ 500M* Nebulized Acute Severe Asthma ER Rescue M edication
Slide 24: PL-3994 Overview
PL - 3994 Overview 24 Guanylate Cyclase - A (GC - A) activators have clinical precedent as effective bronchodilators in asthmatics ◦ PL - 3994: novel direct acting GC - A activator NPR - A agonism relaxes smooth muscle in airways ◦ Effect maintained under conditions of 2 overload Half - life
Slide 25: PL-3994 in Asthma Disease Models
-10 -9 -8 -7 -6 -5 0 20 40 60 80 100 PL3994 PL5731 Vehicle Agonist (M) % Inhibition of contraction 0 20 40 60 80 100 120 140 160 ISO ISO + PL-3994 10 -6 10 -5 10 -4 10 -7 10 -8 10 -9 [ISO] M Relaxation (%) 0 10 20 30 40 50 10 -6 10 -4 10 -8 10 -10 [hBNP] M [PL-3994] M [compound] M Relaxation (%) PL
Slide 26: PL-3994 Program
PL - 3994 Program Subcutaneous formulation ◦ Phase 2 proof - of - principle study in stable asthmatics ◦ Placebo - controlled dose escalation crossover study design ◦ Objective is to determine if patients can have a clinically meaningful increase in pulmonary function (FEV 1 ) Nebulized formulat
Slide 27: Milestones
Milestones Bremelanotide Phase 2B study in FSD patients ◦ Complete patient enrollment 1Q12 x ◦ Positive Top - line data released 4Q12 x ◦ EOP2 meeting targeted 1Q13 ◦ Corporate collaboration 2013 AstraZeneca MCR development obesity/diabetes program ◦ Clinical candidate selection 4Q12 ◦ Phase 1 c
Slide 28: Financial Snapshot
Financial Snapshot Ticker Symbol NYSE MKT: PTN Shares Outstanding – September 30, 2012 ◦ Common 38.9M ◦ Fully Diluted 133.6M Market Capitalization – September 30, 2012 $27.0M Cash and Cash Equivalents Balance – September 30, 2012 $33.5M 28
Slide 29: Thank You
<> Thank You