Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Investor Presentation (September 2011)
33 slides from Palatin Technologies's investor presentation, September 2011
Slide 1: Corporate Presentation September 2011
Corporate Presentation September 2011
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 Technologies, Inc. (NYSE Amex: PTN) is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. Our programs are based on molecules that modulate the act
Slide 4: The Palatin Opportunity
The Palatin Opportunity Well positioned to drive growth through our internal pipeline and external collaborations • Our lead product: bremelanotide (BMT) for treatment of female sexual dysfunction (FSD) • PL-3994: targeting natriuretic receptors for pulmonary indications • Collaborations: melanocort
Slide 5: Bremelanotide (BMT)
Bremelanotide (BMT) Lead product: bremelanotide for the treatment of female sexual dysfunction (FSD) • Unmet medical need with multi-billion dollar market opportunity • Active Phase 2B clinical trial – enrolling patients • Extensive clinical and manufacturing data; proof-of-principle established 5
Slide 6: PL-3994 targets natriuretic receptors for pulmonary indications
PL-3994 PL-3994 targets natriuretic receptors for pulmonary indications • Novel mechanism of action – initial indication acute treatment of severe asthma • Phase 1 subcutaneous clinical studies are complete, phase 2 program is ready • Developing inhalation formulation of PL-3994 6
Slide 7: Obesity/Diabetes – AstraZeneca
Obesity/Diabetes – AstraZeneca Collaboration with AstraZeneca on melanocortin specific compounds for obesity and metabolic syndrome • AZD2820 currently in phase 1 clinical trials • AstraZeneca responsible for clinical development and costs • Potential of up to $145 million in milestones plus royalti
Slide 8: Pipeline
Pipeline Program Indication Preclinical Phase I Phase II Phase III Bremelanotide Female Sexual Dysfunction Melanocortin AZD2820 Receptor (partnered with Obesity and Diabetes (MCR) AstraZeneca) Programs Female Sexual Dysfunction PL-6983 and Erectile Dysfunction PL-3994: Acute Severe Asthma Inhalation
Slide 9: Female Sexual Dysfunction Program
Female Sexual Dysfunction Program 9
Slide 10: Female Sexual Dysfunction Overview
Female Sexual Dysfunction Overview • Female sexual dysfunction (FSD) is a persistent or recurrent problem in sexual activity that is associated with distress • FSD is prevalent in adult women ~43% experience some form of FSD ~22% have FSD associated distress • FSD has a significant impact on patient
Slide 11: FSD: Untapped Market Opportunity
FSD: Untapped Market Opportunity US market estimated ~$4B annual sales No FDA approved treatments available >90% of FSD patients desire treatment 11
Slide 12: Bremelanotide Profile
Bremelanotide Profile • First in class melanocortin receptor 4 agonist for female sexual dysfunction • Novel mechanism of action activating endogenous pathways involved in sexual arousal response • On demand use with rapid onset of activity • Evaluated in 30 clinical studies with intranasal (IN) and
Slide 13: Bremelanotide Subcutaneous Development
Bremelanotide Subcutaneous Development • Demonstrated desired pharmacokinetics – Subcutaneous “on-demand” formulation: less variation in patient exposure – Good therapeutic window avoids known adverse events associated with high exposure • Completed and submitted preclinical toxicology to FDA – Repr
Slide 14: Female Sexual Response Cycle
Female Sexual Response Cycle M O T Sexual Sexual Stimuli I Receptivity V A T Multiple I reasons for O N engaging in sex Desire Subjective Arousal Sexual satisfaction Non-Sexual rewards Responsive sexual arousal and desire Key points for drug intervention are the sites of bremelanotide action 14
Slide 15: Bremelanotide FSD Clinical Data
Bremelanotide FSD Clinical Data • Studies in rodent and primate models of female sexual function demonstrated pronounced effects on perceptive and appetitive sexual behaviors • Phase 2A Efficacy Studies – Double-blind, placebo controlled – SC or IN dosing in pre- and postmenopausal FSD patients – Si
Slide 16: Phase 2 “At-Home” Intranasal Study
Phase 2 “At-Home” Intranasal Study • “At-home” study of IN bremelanotide 10 mg – Pre- & Postmenopausal women with FSD – Double-blind placebo controlled study • Objectives – Evaluated efficacy and safety of bremelanotide under “at-home” use conditions – Evaluated efficacy endpoints for larger studies
Slide 17: Phase 2 IN “At-Home” FSD Efficacy Data
Phase 2 IN “At-Home” FSD Efficacy Data “When using the drug, did you feel that your level of sexual excitement (arousal) changed?” 60 7 p<0.05 Satisfying Sexual Events Placebo Placebo 6 50 BMT 10 mg % in Category 5 per 4 weeks 40 4 3 30 2 20 1 10 0 Baseline Month One Month Two 0 Premenopausal Women
Slide 18: FSD Clinical Program: Next Step
FSD Clinical Program: Next Step Phase 2B subcutaneous bremelanotide trial design – 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 premenopausal FSD patients – FDA accepted endpoints • Increase in
Slide 19: Summary FSD Program
Summary FSD Program • Multiple phase 2 studies have established proof-of- concept in FSD patients • SC on-demand formulation is well-tolerated • Positive patient experience; notable improvement in the quality of sexual experience – Quality of orgasm improved – Increased desire, arousal and focus on
Slide 20: Natriuretic Peptide Receptor Pulmonary Program
Natriuretic Peptide Receptor Pulmonary Program 20
Slide 21: The Need for New Treatments
The Need for New Treatments • Current therapies can lead to a refractory state requiring emergency room (ER) treatment • ER Standard of care requires several hours and patients remain at risk • Recent FDA guidance has questioned the safety of beta-agonist monotherapy Significant need for fast onset
Slide 22: Pulmonary Market Opportunity
Pulmonary Market Opportunity Administration Indication Stage Market Potential Phase 2 Subcutaneous Acute Severe Asthma ER >$500M* Ready Acute Severe Asthma ER Nebulized Preclinical >$1B rescue medication PRN Broader and Chronic Inhalation/DPI Planned >$3B COPD/Asthma** *Individual treatment cost $1,
Slide 23: PL-3994 Profile
PL-3994 Profile • Novel direct acting guanylate cyclase A (GC-A) activator • Raises cGMP, and is a potent bronchodilator in guinea pig and human lung • Half-life of 3 hours in man • Desirable properties for development as a subcutaneous or inhaled therapy • Enhances human airway smooth muscle respon
Slide 24: PL-3994 in Asthma Disease Models
PL-3994 in Asthma Disease Models PL-3994 relaxed human lung slices at a lower concentration than the endogenous peptide, human BNP. Other studies showed that PL-3994 in combination with a beta-agonist resulted in increased relaxation. 50 Relaxation (%) 40 human BNP 30 PL-3994 20 10 0 10-10 10-8 10-6
Slide 25: PL-3994 Asthma Development Program
PL-3994 Asthma Development Program • Nebulized formulation under development – Physical chemical studies – Designed animal toxicology program • Subcutaneous phase 2A study design is completed – In-clinic SC dosing in stable asthmatics – Objective is to determine if patients can have a clinically mea
Slide 26: Melanocortin Receptor 4 Agonist Obesity & Diabetes
Melanocortin Receptor 4 Agonist Obesity & Diabetes 26
Slide 27: AstraZeneca Obesity Collaboration
AstraZeneca Obesity Collaboration • Exclusive global licensing and research collaboration with AstraZeneca – $10 million up-front and $12 million milestones received – Royalties on commercialization – $85 million in development and $60 million in sales milestones remaining • Clinical proof-of-concep
Slide 28: Development Programs and Technology Available to Partner
Development Programs and Technology Available to Partner 28
Slide 29: Development Programs to Partner
Development Programs to Partner • Novel and highly selective and specific melanocortin receptor 1 peptides, with potential for treatment of inflammatory diseases and dermatology indications • Novel melanocortin receptor 4 peptides, with potential for treatment of melanocortin receptor mediated disea
Slide 30: Milestones
Milestones Bremelanotide FSD Program – Started patient enrollment 2Q11 – Patient enrollment completed 1Q12 – Top-line data 2H12 AstraZeneca MCR4 obesity/diabetes program – Phase 1 data 4Q11 – Initiation phase 2 program 1H12 PL-3994 Acute Asthma – Corporate collaboration target 1Q12 • Inhaled formula
Slide 31: Financial Snapshot
Financial Snapshot Ticker Symbol NYSE AMEX: PTN 52-Week Price Range $0.50 -$1.90 Shares Outstanding – 6/30/11 Common 34.9M Fully Diluted 60.5M Market Capitalization – 6/30/11 $45M Cash and Investments Balance as of 6/30/11 $18.9M 31
Slide 32: Palatin Executive Management
Palatin Executive Management • Carl Spana, Ph.D. President & Chief Executive Officer • Stephen T. Wills, CPA / MST Chief Financial Officer & Chief Operating Officer • Jeffrey Edelson, M.D. Chief Medical Officer 32
Slide 33: Palatin Board of Directors
Palatin Board of Directors Chairman of the Board • John K.A. Prendergast, Ph.D. Directors • Carl Spana, Ph.D. • Robert K. deVeer, Jr. • Zola P. Horovitz, Ph.D. • J. Stanley Hull • Perry Molinoff, M.D. • Robert I. Taber, Ph.D. • Alan W. Dunton, M.D. 33
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