Palatin Technologies, Inc. · AMEX:PTN
Palatin Technologies — Investor Presentation (September 2018)
40 slides from Palatin Technologies's investor presentation, September 2018
Slide 1: Palatin Technologies Corporate Presentation
Palatin Technologies, Inc. Corporate Presentation September 2018 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
<> PALATIN Pipeline Overview a NDA Submission ons Vyleesi™ (bremelanotide) MC4r Agonist Hypoactive Sexual Desire Disorder PL-8177 MC1r Agonist |} | Inflammatory Bowel Diseases PL-8331 MC1/Sr Agonist > Anti-Inflammatory Ocular Indications MC4r Agonist Peptide & Small Molecules Rare Genetic Metabolic
Slide 6: Vyleesi (bremelanotide)
VyleesiTM (bremelanotide) 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: Vyleesi (bremelanotide) Overview
VyleesiTM (bremelanotide) Overview Self-administered auto-injector, taken on-demand ~30 min. before sexual activity Treatment effect up to 8-10 hours Activates endogenous pathways involved in sexual desire and arousal Does not interact with alcohol (alcohol interaction study completed) No
Slide 9: Phase 3 Top-Line Results
Phase 3 Top-Line Results 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 experience and no new safety issues were ide
Slide 10: 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 11: North American Vyleesi Licensing Agreement
North American VyleesiTM (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 Committ
Slide 12: ROW Vyleesi Licensing Agreements
ROW VyleesiTM (bremelanotide) Licensing Agreements Fosun Pharma – Chinese pharmaceutical company focused on developing and commercializing innovative healthcare solutions with >$2B in annual sales ◦ Exclusive licensing agreement covers China, Hong Kong, Taiwan and Macau markets – September 2017 ◦
Slide 13: Vyleesi Program Timelines
VyleesiTM (bremelanotide) Program Timelines NA Phase 3 top-line results / co-primary endpoints met 4Q2016 NA license agreement closed with AMAG 1Q2017 FDA NDA accepted for review 2Q2018 ADCOM Early 2019 PDUFA date 3/23/2019 cFDA approval for China anticipated 1H2020 S. Korean appro
Slide 14: Melanocortin Anti-Inflammation Program
Melanocortin Anti-Inflammation Program
Slide 15: 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 ◦ Rational design and synthesis of selective MC1r & MC1/5r agonists – PL-8177 cyclic peptide selective MC1r agonist – PL-8331 c
Slide 16: 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 delivered topically to the colon. Budesonide oral delivery. PL-8177 0.5 µg/rat is 60X more potent than budesonide 0.125mg/kg. 16
Slide 17: PL-8331 Pre-Clinical Scopolamine Dry Eye Model
PL-8331 Pre-Clinical Scopolamine Dry Eye Model Mouse model of Scopolamine induced dry eye, established disease, topical application PL-8331 as good or better (no level 4 disease) than Restasis Xiidra showed no improvement in fluorescein staining 17
Slide 18: 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 19: 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 19
Slide 20: Anti-Inflammatory Clinical Development Programs
Anti-Inflammatory Clinical Development Programs PL-8177 initial indication ulcerative colitis ◦ IND cleared 4Q2017 ◦ Phase 1 SAD/MAD study start in 1Q2018 SC delivery (data 3Q2018) ◦ Phase 1 pk & biodistribution study of oral formulation 4Q2018 ◦ Multiple phase 2A proof of mechanism studies 1H2019
Slide 21: Anti-Inflammatory Program Summary
Anti-Inflammatory Program Summary MC1r agonism resolves pro-inflammatory processes involved in autoimmune and inflammatory diseases ◦ PL-8177 and PL-8331 demonstrated reversal of pathology in multiple disease models Diverse compound library and extensive receptor SAR available to rapidly identif
Slide 22: Melanocortin Receptor-4 Agonist Obesity
Melanocortin Receptor-4 Agonist Obesity
Slide 23: PL-9610 Diet-Induced Obese vs MC4r Knockout Mice
PL-9610 Diet-Induced Obese vs MC4r Knockout Mice W e ig h t lo s s in D IO m ic e W e ig h t lo s s in M C 4 k n o c k o u t m ic e 5 V e h ic le P L -9 6 1 0 1 0 m g /k g P O V e h ic le P L -9 6 1 0 1 0 m g /k g P O 5 % c h a n g e in B W % c h a n g e in B W 0 0 -5 -5 0 1 2 3 4 0 1 2 3 4 Day Day
Slide 24: PL-9610 in Leptin-Deficient (ob/ob) Mice
PL-9610 in Leptin-Deficient (ob/ob) Mice W e ig h t lo s s in L e p tin -d e fic ie n t m ic e V e h ic le P O 3 0 m g /k g P L 9 6 1 0 P O 5 % c h a n g e in B W 0 -5 0 1 2 3 4 5 6 S tu d y D a y PL-9610 was dosed orally twice a day 24
Slide 25: MC4 Receptor Obesity Program Summary
MC4 Receptor Obesity Program Summary MC4r selective agonists, peptide and oral small molecules Efficacy established in DIO and leptin-deficient animal studies No effect seen in MC4r knock-out model, establishing weight loss effect as MC4r based Two phase 2a clinical trials established proof
Slide 26: Natriuretic Peptide Receptor Program
Natriuretic Peptide Receptor Program
Slide 27: 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 28: 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 29: 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 30: 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 31: 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 32: 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 33: 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 34: 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 34
Slide 35: 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 36: NPS Development Program
NPS Development Program PL-3994 - Two phase 1 trials completed ◦ Well tolerated and dosing range established ◦ Dose limiting effect hypotension (as anticipated) ◦ Ready for phase 2 PL-3994 phase 2A (open label trial) in HF-pEF patients starts 1H2018 ◦ N=50, with ascending IV dosing ◦ Objectives
Slide 37: 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 38: Palatin Anticipated Development Milestones
Palatin Anticipated Development Milestones VyleesiTM (bremelanotide) for Hypoactive Sexual Desire Disorder ◦ NA license agreement closed with AMAG 1Q2017 ◦ China license agreement Fosun Pharma 3Q2017 ◦ Republic of Korea license agreement Kwangdong Pharma 4Q2017 ◦ FDA NDA submission & acceptance
Slide 39: Financial Snapshot
Financial Snapshot Financial Highlights as of June 30, 2018 Cash and Cash Equivalents $38.0 million Total Debt $7.2 million Summary Capitalization as of June 30, 2018 Common Equivalent Common Stock 200.5 million shares Preferred 0.1 million shares Warrants 23.4 million shares Options 12.8 million sh
Slide 40: Thank You
<> Thank You
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