Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Investor Presentation (September 2017)
46 slides from Palatin Technologies's investor presentation, September 2017
Slide 1: Palatin Technologies Corporate Presentation Overview
Palatin Technologies, Inc. Corporate Presentation Overview September 2017 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 Overview
Palatin Technologies Overview Platform technology for the design of GPCR agonists MIDAS Technology Diverse Compound Libraries Rational Design Melanocortin Peptide Agonists Natriuretic Peptide Agonists Sexual Dysfunction Program Anti-Inflammatory Program Heart Failure Program Fibrotic Disease Program
Slide 5: Pipeline Overview
Pipeline Overview — Melanocortin Receptor Programs Pre-Clinical IDA Submiss' FDA Approval tgeatheiadSatalieed ee ee ee ee Hypoactive Sexual Desire Disorder PL-8177 MCir Agonist —— Inflammatory Bowel Disease PL-8331 MC1/5r Agonist ———9 Anti-inflammatory Ocular Indications aera ees (arcs ia te Heart F
Slide 6: Bremelanotide (BMT)
Bremelanotide (BMT) For Premenopausal Women with Hypoactive Sexual Desire Disorder 6
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 ◦ Hypoactive Sexual Desire Disorder (HSDD) is the most common FSD HSDD has a significant impact on patien
Slide 8: Bremelanotide Development Profile
Bremelanotide Development Profile Taken on-demand with a self-administered auto-injector pen in anticipation of sexual activity Novel mechanism of action: melanocortin receptor agonist (MC4r) ◦ Targets endogenous pathways involved in sexual desire and arousal Successful Phase 2B trial showed a
Slide 9: Phase 3 Top-line Results Overview
Phase 3 Top-line Results Overview Preliminary review of the overall safety population (1,247 patients) ◦ Generally well tolerated and the most frequent adverse events were nausea, headache and flushing (generally mild/moderate) ◦ Safety profile of bremelanotide was consistent with prior clinical e
Slide 10: Secondary Endpoints & Completers/Responders
Secondary Endpoints & Completers/Responders Secondary endpoints analysis ◦ Provides support of a robust effect across endpoints and questionnaires Completers Population ◦ Subjects who completed all 6 months of randomized treatment ◦ Population that could mimic a commercially viable group - 60% o
Slide 11: Results: FSFI
Results: FSFI Mean Change in FSFI Scores From Baseline to End of Core Phase FSFI Total Score BMT Was Associated With Significant Improvements in FSFI FSFI Satisfaction Domain Total, Arousal, Lubrication, Orgasm, FSFI Orgasm Domain and Satisfaction Domain Scores Compared With Placebo FSFI Lubrication
Slide 12: Results: FSDS-DAO
Results: FSDS-DAO BMT Significantly* Improved FSDS-DAO Distress from Arousal and Distress Total Scores Mean Change in FSDS-DAO Arousal and Total Scores: Baseline to End of Core Phase Study 301 Study 302 Study 301 Study 302 0.0 0 Mean Change in FSDS-DAO Bother With Arousal Score -1 Mean Change in FSD
Slide 13: Results: FSEP-R: Satisfaction with Desire and Arousal
Results: FSEP-R: Satisfaction with Desire and Arousal Mean Change in FSEP-R Satisfied Desire and Arousal Scores: Baseline to End of Core Phase Study 301 Study 302 * BMT Improved 0.3 0.3 FSEP-R Scores for Mean Change in FSEP-R Domain Score Satisfaction With * ** *** Desire and Arousal 0.2 0.2 0.2 0
Slide 14: Responder Analysis
Responder Analysis % Responders Based on Self-Assessment of Benefit Study 301 Study 302 GAQ question 3a score ≥5 (% responders BMT 1.75 mg SC) 59% 58% Responder Analysis Based on MCIDs Study 301 Study 302 FSFI-D (MCID=0.6) P=0.0002 P<0.0001 FSDS-DAO Item 13 (MCID=–1.0) P<0.0001 P=0.0419 a ”How often
Slide 15: Significant Market Opportunity
Significant Market Opportunity ~10M pre-menopausal women in U.S. with HSDD1 0.6M pre-menopausal women treated (Rx) 5.8M2 pre-menopausal 1.5M pre-menopausal women with women presented to HSDD HCP, but not treated (primary symptom) 3.7M pre-menopausal women not diagnosed 4.4M Potential initial pre-men
Slide 16: Highly Differentiated Target Product Profile
Highly Differentiated Target Product Profile 16
Slide 17: North American Bremelanotide Licensing Agreement
North American Bremelanotide Licensing Agreement AMAG Pharmaceuticals - specialty pharmaceutical company focused on developing and commercializing innovative healthcare solutions ◦ Annual sales > $600M Dedicated sales, marketing and commercial teams focused on female health Committed and capab
Slide 18: China Bremelanotide Licensing Agreement
China Bremelanotide Licensing Agreement Fosun Pharma – Chinese pharmaceutical company focused on developing and commercializing innovative healthcare solutions ◦ Annual sales >$2B Development, sales and marketing capabilities to commercialize bremelanotide in the Chinese market Exclusive licen
Slide 19: Bremelanotide Program Timelines
Bremelanotide Program Timelines NA Phase 3 top-line results / co-primary endpoints met 4Q2016 NA license agreement closed with AMAG 1Q2017 Completed OLE Study 2Q2017 Pre-NDA activities / Drug:Drug Interaction Studies 4Q2017 FDA NDA submission 1Q2018 FDA action / approval 1Q2019 EU c
Slide 20: Natriuretic Peptide Receptor Program
Natriuretic Peptide Receptor Program
Slide 21: Heart Failure Overview
Heart Failure Overview Heart failure (HF) is a common, progressive disorder in which impaired cardiac pump function leads to inadequate systemic perfusion required to meet the body's metabolic demands ◦ 5M US patients (Circulation. 2013;127(1):e6) ◦ > 1M annual US hospitalizations (Circulation. 20
Slide 22: Natural History of Heart Failure
Natural History of Heart Failure HF is progressive disease characterized by a downward spiral, punctuated by increasing episodes of acute decompensation Classification NYHA I NYHA II NYHA III NYHA IV % of HF Patients ~25% ~29% ~35% ~11% Annual Mortality 6.3% 10.5% 18.3% Rate Hypertension Remodelling
Slide 23: High Mortality & Morbidity Associated with HF
High Mortality & Morbidity Associated with HF Mortality rates in CHF remain high despite advances in therapy and increased use of beta blockers, ACEis and ARBs; no approved therapies for HFpEF exist today. HF remains a disease with a high unmet medical need 5yr Mortality in CHF Remains High1,2,3,4,5
Slide 24: Natriuretic Peptide System (NPS)
Natriuretic Peptide System (NPS) Neuropeptide hormone system plays an important role in the regulation of cardiovascular homeostasis Physiological Effects • Downregulate RAAS (renin- angiotensin-aldosterone system) • Suppression of cardiac hypertrophy, fibrosis & remodeling • Stimulation of diuresis
Slide 25: NPS — a Validated Target in HF
NPS — a Validated Target in HF Nesiritide (Natrecor®): short acting NPR-A agonist ◦ Acute vasodilator: symptomatic benefit in acutely decompensated HF (FDA approved) Entresto®: dual ARB+neutral endopeptidase (NEP) inhibitor ◦ NEP inhibitor component increases endogenous natriuretic peptides ◦ Ap
Slide 26: Natriuretic Peptide: Program Overview
Natriuretic Peptide: Program Overview The natriuretic peptide system represents an underexploited mechanism for treating HF and other CV diseases Proprietary natriuretic peptide library ◦ Compounds selective for NPR-A, NPR-B, NPR-A/B & NPR-C ◦ Comprehensive IP portfolio with composition of matter
Slide 27: Opportunities for Treating Heart Failure
Opportunities for Treating Heart Failure Heart Failure with Reduced Ejection Fraction (HF-rEF) ◦ Targeting patients with progressing disease Heart Failure with Preserved Ejection Fraction (HF-pEF) ◦ No approved treatment options, significant unmet medical need Patients with corin and/or reduce
Slide 28: PL-3994 Significantly Reduces Cardiac Remodeling
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 in 99 l
Slide 29: PL-3994 Cardiac cGMP and pKG
PL-3994 Cardiac cGMP and pKG cGMP response to PL3994 Mouse TAC model in cardiomyocyte conditional corin gene KO mice Collaboration with Dr. Daniel Dries, Temple Cardiovascular Research Center Samples are from LV apical region cGMP Dependent Kinase Response to PL3994 • 14 day continuous infusion of P
Slide 30: PL-3994 in Corin Cardiac-KO HF Model
PL-3994 in Corin “Cardiac-KO” HF Model Rescues cardiac hypertrophy Reduces cardiac fibrosis KO vs. PL-3994 p=0.03 KO vs. PL-3994 p=0.005 Reduces aldosterone expression Reduces TGF-β expression KO vs. PL-3994 p=0.03 KO vs. PL-3994 p=0.04 30
Slide 31: PL-3994 Preclinical Data Summary
PL-3994 Preclinical Data Summary Clear efficacy in multiple HF models ◦ Suppresses RAAS ◦ Reverses cardiac hypertrophy and fibrosis Systemic dosing activates NPR-A in cardiac tissue as well as associated down stream signaling pathways Rescues cardiomyocyte corin gene KO phenotype Effects are
Slide 32: NPS Development Program
NPS Development Program PL-3994 phase 2A (open label trial) in HF-pEF patients starts 2H2017 ◦ N=50, with ascending IV dosing ◦ Objectives – Characterization of systemic and pulmonary blood pressure effects – Cardiac biopsy to evaluate NPS pathway activation in HF-pEF patients – Characterization o
Slide 33: NPS Program Summary
NPS Program Summary Well positioned to take advantage of the growing interest in NPS based therapeutics in the treatment of HF Extensive compound library with receptor selective agonist and antagonists with strong IP positions PL-3994 is a novel NPR-A agonist with an extended half-life suitabl
Slide 34: Melanocortin Anti-Inflammation Program
Melanocortin Anti-Inflammation Program
Slide 35: Melanocortin Agonists Anti-Inflammatory Program
Melanocortin Agonists Anti-Inflammatory Program Goal: design and develop selective MC1r & MC1/5r agonists for treating a variety of inflammatory and autoimmune indications ◦ Inflammatory indications: inflammatory bowel disease, nephritis (inflammation of the kidneys) and rheumatoid arthritis ◦ Ocu
Slide 36: PL-8177 DSS IBD Model – Gross Pathology
PL-8177 DSS IBD Model – Gross Pathology Mean Gross Pathology (Groups 1-5) * p<0.05 vs. Vehicle (Group 2) using T-test PL-8177 0.5 µg/rat is 60X more potent than budesonide 0.125mg/kg 36
Slide 37: 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 38: PL-8177 Experimental Autoimmune Uveitis
PL-8177 Experimental Autoimmune Uveitis Cross section of the eye Healthy Diseased EA uveitis is an established disease model Inflammatory cell infiltration of the various layers of the eye Disruption of the eye morphology 38
Slide 39: PL-8177 Experimental Autoimmune Uveitis
PL-8177 Experimental Autoimmune Uveitis Cross section of the eye Healthy Untreated Diseased Untreated PL-8177 0.3 mg Treatment with PL-8177 results in reversal of the disease process with return to normal phenotype Reversal of immune cell infiltration and restoration of tissue morphology 39
Slide 40: Anti-Inflammatory Clinical Development Program
Anti-Inflammatory Clinical Development Program PL-8177 initial indication IBD ◦ IND & phase 1 clinical trial planned for the 2H2017 ◦ Phase 2 IBD patients trial anticipated 1H2018 – Establish clinical proof of concept PL-8331 initial indication ocular inflammation ◦ Preclinical IND enabling acti
Slide 41: Anti-Inflammatory Program Summary
Anti-Inflammatory Program Summary MC1r agonism resolves pro-inflammatory processes involved in autoimmune and inflammatory diseases Diverse compound library and extensive receptor SAR available to rapidly identify compounds with appropriate selectivity profile for numerous disease indications
Slide 42: Melanocortin Receptor-4 Agonist Obesity & Diabetes
Melanocortin Receptor-4 Agonist Obesity & Diabetes
Slide 43: Obesity & Diabetes Program Summary
Obesity & Diabetes Program Summary Developed MC4r selective agonists, peptide and small molecule No effect seen in MC4r knock-out model, establishing weight loss effect as MC4r based 2 phase 2a clinical trials established proof of concept Limited effects on blood pressure (excellent therapeu
Slide 44: Palatin Anticipated Development Milestones
Palatin Anticipated Development Milestones Bremelanotide for Female Sexual Dysfunction ◦ NA license agreement closed with AMAG 1Q2017 ◦ Complete OLE Study 2Q2017 ◦ FDA NDA submission 1Q2018 ◦ ROW development/commercial collaborations 2H2017-1H2018 ◦ China license agreement Fosun Pharma 3Q2017
Slide 45: Financial Snapshot
Financial Snapshot Financial Highlights as of June 30, 2017 Cash, Cash Equivalents, Accounts Receivable & Investments $55.6 million* Total Debt $14.1 million Summary of Capitalization as of June 30, 2017 Common Equivalent Common Stock 160.5 million shares Preferred 0.1 million shares Warrants 61.6 m
Slide 46: Thank You
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