Palatin Technologies, Inc.

Transcription

1 Palatin Technologies, Inc. Corporate Presentation November 2016 Carl Spana, Ph.D. President & CEO Stephen T. Wills, CPA/MST CFO / COO

2 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 significant risks and uncertainties, and actual results, events and performance may differ materially from those expressed or implied in this presentation. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements include, but are not limited to, statements concerning the following: (i) estimates of our expenses, future revenue, capital requirements; (ii) our ability to obtain additional financing on terms acceptable to us, or at all; (iii) our ability to advance product candidates into, and successfully complete, clinical trials; (iv) the initiation, timing, progress and results of future preclinical studies and clinical trials, and our research and development programs; (v) the timing or likelihood of regulatory filings and approvals; (vi) our expectations regarding the results and the timing of results in our Phase 3 clinical trials of bremelanotide for female sexual dysfunction (FSD); (vii) our expectation regarding the timing of our regulatory submissions for approval of bremelanotide for FSD in the United States and Europe; (viii) the potential for commercialization of bremelanotide for FSD and other product candidates, if approved, by us; (ix) our expectations regarding the potential market size and market acceptance for bremelanotide for FSD and our other product candidates, if approved for commercial use; (x) our ability to compete with other products and technologies similar to our product candidates; (xi) the ability of our third party collaborators to timely carry out their duties under their agreements with us in; (xii) the ability of our contract manufactures to perform their manufacturing activities for us in compliance with applicable regulations; (xiii) our ability to recognize the potential value of our licensing arrangements with third parties; (xiv) the potential to achieve revenues from the sale of our product candidates; (xv) our ability to maintain product liability insurance at a reasonable cost or in sufficient amounts, if at all; (xvi) the retention of key management, employees and third-party contractors; (xvii) the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; (xviii) our compliance with federal and state laws and regulations; (xix) the timing and costs associated with obtaining regulatory approval for our product candidates; (xx) the impact of legislative or regulatory healthcare reforms in the United States; and (xxi) other risks disclosed in our SEC filings. The forward-looking statements in this presentation do not constitute guarantees of future performance. We undertake no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date of this presentation. 2

3 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

4 Palatin Technologies Key Products Palatin Technologies, Inc. is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential Lead product: Bremelanotide for the treatment of Hypoactive Sexual Desire Disorder (HSDD) Unmet medical need with significant commercial opportunity North American (NA) Phase 3 pivotal trials completed 3Q2016 Top-line Phase 3 results released 4Q2016 Co-primary efficacy endpoints met NDA submission target 2H2017 PL-3994 targeting Natriuretic Receptor A for cardiovascular indications Upregulation of the natriuretic peptide (NP) system is a validated target for improving treatment outcomes in heart failure 2 Phase 1 studies complete; Phase 2 ready Melanocortin receptor-1 (MC1r) agonist peptide program for inflammatory disorders Efficacy demonstrated in multiple preclinical animal models IND enabling studies complete first in humans study targeted for 1H2017 Melanocortin receptor-4 (MC4r) obesity/diabetes Clinical proof of principle established Lead compound identified 4

5 Pipeline Overview Preclinical Phase 1 Phase 2 Phase 3 Melanocortin Receptor Programs Bremelanotide MC4r Agonist for Hypoactive Sexual Desire Disorder PL-8905 MC4r Agonist MC4r Agonist Next Generation Peptide PL-8177 MC1r Agonist Obesity, Metabolic Syndrome & Diabetes Female Sexual Dysfunction & Erectile Dysfunction Inflammatory & Dermatologic Diseases Natriuretic Peptide Receptor Programs PL-3994 for Cardiovascular Indications PL-3994 for Pulmonary Indications 5

6 Female Sexual Dysfunction Program

7 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 HSSD has a significant impact on patient self-image, relationships and general well-being >60 million premenopausal women in US 1 22% reported a sexual problem 2 11% were distressed by their sexual problems 2 Market size One-third sought formal care 2 Presenting premenopausal women ~8.0 million 2 Annual U.S. sales anticipated to be ~$1.3 billion by Assumes 2 FDA approved treatments on the market Market analysts estimate global market > $2 billion annually Forecasted U.S. annual sales of bremelanotide (BMT) at peak ~$500 million References: 1) US Census ) PRESIDE Study - Shifren JL et al. Sexual Problems and Distress in United States Women: Prevalence and Correlates. Obstet Gynecol 2008; 112: ) Estimates from EvaluatePharma 7

8 Target Indication Indication: Premenopausal women with HSDD The treatment of premenopausal women with acquired generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulties and is NOT due to: A co-existing medical or psychiatric condition Problems with the relationship, or The effect of a medication or other drug substance 8

9 Bremelanotide Profile Novel mechanism of action activating endogenous melanocortin pathways involved in sexual arousal response Evaluated in 31 clinical studies (n = 2300) showing efficacy in both FSD and erectile dysfunction Phase 2B trial showed a statistically significant and clinically meaningful effect Met both primary and secondary endpoints Phase 3 NA pivotal trials - follow FDA design guidance Enrollment completed 4Q2015 All patient visits completed 3Q2016 Top-line Phase 3 results released 4Q Co-primary efficacy endpoints met Safety profile consistent with prior clinical experience Most frequent adverse event was nausea generally mild in nature On-demand treatment taken as-needed Well tolerated by patients Rapid onset of activity ~30 minutes Treatment effect for 8-10 hours No food or alcohol interaction 9

10 Bremelanotide Non-Clinical Summary 10 NDA-ready non-clinical toxicology package including: Full toxicology package Complete Reproductive Tox program Including Seg I, II, and III Submitted to FDA and acknowledged as sufficient Long term carcinogenecity studies completed Two species Submitted to FDA and acknowledged as sufficient No issues 10

11 Bremelanotide Drug Product Development 11 Manufacturing process for the drug substance has been developed and validated with pharmaceutical manufacturer Drug product is defined, with the formulated product packaged in prefilled syringes and secondarily fitted into an autoinjector Full manufacturing process and process controls have been established Drug product stability testing has established that the dosage form will be stable for at least 2 years at room temperature Proven manufacturing capabilities Drug API manufactured by Lonza at commercial scale Ypsomed Group autoinjector Catalent fill, finish and packaging 11

12 Bremelanotide Intellectual Property Status 12 Issued patents on bremelanotide in the U.S., major countries in Europe, Japan, Australia, Canada and Mexico Compositions of matter patents expire late 2020 Extensions of up to five years under Hatch-Waxman (35 USC 156) through 2025 Extension possible through counterpart provisions in other countries Notice of allowance patent for specific subcutaneous doses for FSD Specific to subcutaneous injection of 1.0 to 1.75 mg dose (and resulting peak plasma concentrations) Patent issued 3Q2016 Patent terms through late

13 Phase 2B FSD Clinical Trial Dose ranging 16 week at-home placebo-controlled study Subcutaneous dosing: placebo and 0.75 mg, 1.25 mg and 1.75 mg bremelanotide Enrollment: 395 patients Validated patient reported outcome (PRO) endpoints Increase in Satisfying Sexual Events (SSEs) As measured by event log Female Sexual Function Index (FSFI) 19-item questionnaire measuring improvement in arousal, desire and overall sexual function Female Sexual Distress Scale-DAO (FSDS-DAO) 15-item questionnaire that measures personal distress associated with FSD Objectives Evaluate safety and efficacy in premenopausal patients with HSDD, female sexual arousal disorder (FSAD) and FSAD/HSDD Multiple presentations and publications of Phase 2B data 13

14 Phase 2B FSD Clinical Data Analysis of the primary and key secondary endpoints of 327 pre-menopausal patients shows clinically meaningful and statistically significant effects for bremelanotide vs. placebo. Pre-specified analysis was of pooled 1.25 mg & 1.75 mg doses vs. placebo. Primary endpoint improvement in the number of satisfying sexual events (SSE) Bremelanotide mean change from baseline 1.6 to 2.4 (50% increase) (p=0.018) Placebo mean change from baseline 1.7 to 1.9 (12% increase) Key secondary endpoints FSFI-total score mean change 3.55 vs (p=0.0017) FSDS-DAO-total score mean change vs (p=0.036) 1.75 mg dose analysis also demonstrated clinically meaningful and statistical significance SSE improvement from baseline FSFI-total score mean change FSDS-DAO-total score mean change 1.8 to 2.6 (p=0.021) 4.4 vs (p=0.0021) vs (p=0.0005) 0.75 mg dose analysis demonstrated a response that was not significantly different from placebo 14

15 Phase 2B FSD Clinical Data SSE * FSFI Total Score ** 0.0 Placebo 0.75 mg 1.25 mg 1.75 mg Mean Change From Baseline Mean Change From Baseline * Mean Change From Baseline * Placebo 0.75 mg 1.25 mg 1.75 mg Placebo 0.75 mg 1.25 mg 1.75 mg FSDS-DAO Total Score *** * P<0.05 ** P<0.01 *** P<

16 Phase 2B FSD Clinical Data 395 premenopausal FSD patients were randomized to receive drug or placebo 26 patients met the predefined blood pressure withdrawal criteria and were evenly distributed among placebo and active arms of the study Drug treated subjects had ~2 mm Hg change in blood pressure, predominately during the first 4 hours of dosing No significant adverse events attributed to bremelanotide occurred during the study Most common adverse events on drug were nausea, flushing, headache <3% discontinued due to adverse events 16

17 Key Points FDA Activity on FSD October 27 & 28, 2014 the FDA held a Patient-Focused Drug Development Public Meeting and Scientific Workshop on Female Sexual Dysfunction FSD is an underserved, unmet medical need that distresses patients and is in need of multiple treatment options FSFI (28 day recall period) is a well validated PRO instrument and is the appropriate end point for Phase 3 registration trials Flibanserin June 2015 FDA ADCOM & Approval August to 6 vote in favor of approval with the inclusion of a comprehensive REMS program Co-primary endpoints of SSE s & FSFI-D (28 day recall) accepted as measure of benefit Approved (Addyi ) to treat premenopausal women with acquired HSDD REMS because of increased risk of hypotension and syncope due to alcohol interaction Physician and pharmacist certification / Patient-Provider Agreement form Pharmacist counseling of patients not to use alcohol Boxed Warning highlighting against use with alcohol and CYP3A4 inhibitors Flibanserin June 2015 FDA ADCOM & Approval August 2015 FDA Draft Guidance document October 2016 Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment 17

18 Phase 3 NA Pivotal Program Key Points Patient population - Premenopausal women with a primary diagnosis of acquired hypoactive sexual desire disorder (HSDD) with or without decreased arousal 1.75 mg versus placebo / 24 week treatment evaluation period Co-primary endpoints Female sexual function index (FSFI) Desire subdomain (28 day recall) Female sexual distress scale (FSDS-R) (revised) question #13 Cardio-Renal Division Intra-nasal Definitive QTc study is acceptable for NDA submission Proposed blood pressure monitoring is acceptable (standard blood pressure cuff) Carcinogenicity and reproductive toxicity studies acceptable for NDA submission No outstanding CMC issues Phase 3 NA clinical program 2 pivotal trials randomized 1267 women Patient enrollment completed 3Q2016 Top-line data released 4Q2016 / Co-primary endpoints met 18

19 Phase 3 Studies Overview Consisted of two randomized, double-blinded, placebo-controlled Phase 3 studies Compared the efficacy and safety of bremelanotide versus placebo in premenopausal women diagnosed with HSDD Randomized 1,267 women with HSDD The primary efficacy analysis population was the modified intent-to-treat (MITT) patient population Consisting of 1,202 women with HSDD Patients self-administered either 1.75 mg of bremelanotide or placebo as needed in anticipation of sexual activity The double blind or efficacy portion of each study consisted of a 24-week treatment evaluation period The open-label safety extension portion of the Phase 3 studies is ongoing 19

20 Phase 3 Top-line Results Overview Both Phase 3 Studies met the pre-specified co-primary efficacy endpoints Improvement in desire and decrease in distress associated with low sexual desire as measured using validated patient-reported outcome instruments Preliminary review of the overall safety population (1,247 patients) Bremelanotide appeared to be well tolerated Most frequent adverse events were nausea (generally mild in nature), flushing, and headache Safety profile of bremelanotide was consistent with prior clinical experience, and no new or unusual safety issues were identified Full results data and secondary endpoint analyses is ongoing Palatin expects to present additional results from the Phase 3 studies at future sexual medicine and women s health conferences and in peer reviewed journal publications 20

21 Phase 3 Top-line Results / Co-Primary Endpoints The Female Sexual Function Index: Desire Domain (FSFI-D) Showed a statistically significant increase for bremelanotide compared to placebo in both trials Study 301: Mean change of 0.54 vs. 0.24, median change of 0.60 vs. 0.00, p=0.0002; and, Study 302: Mean change of 0.63 vs. 0.21, median change of 0.60 vs. 0.00, p< The Female Sexual Distress Scale - Desires/Arousal/Orgasm (FSDS-DAO) Item 13 Showed a statistically significant reduction in distress related to low sexual desire for bremelanotide compared to placebo in both trials Study 301: Mean change of vs , median change of -1.0 vs. 0.0, p<0.0001; and, Study 302: Mean change of vs , median change of -1.0 vs. 0.0, p=

22 Phase 3 Top-line Results / Clinical Significance Clinical significance of co-primary endpoint study results Evaluated by an independent committee using multiple anchors of patient assessment of benefit, consistent with discussions with the FDA and guidance documents Clinical Significance for the FSFI-D Subscale - Based on application of three selected anchors, a median value of 0.6 was set for defining clinical significance in baseline to endpoints changes in FSFI-D subscale scores Clinical Significance for the FSDS-DAO Item 13 Score - Based on application of three selected anchors, a median value of 1.0 point improvement in FSDS-DAO Item 13 scores was set for defining clinical significance 22

23 Differentiating Factors to Addyi Based on the Phase 2B clinical results, bremelanotide is anticipated to have several distinct differences to Addyi (flibanserin) - most significant are: Administration/Use Addyi - Must be taken once daily - Requires 4-6 weeks before initial onset of efficacy Bremelanotide - On-demand treatment taken as needed - Onset of efficacy in ~30 minutes - Treatment effect for 8-10 hours 23

24 Differentiating Factors to Addyi Label Addyi (actual) - Boxed Warning for hypotension and syncope in certain settings - Use of Addyi and alcohol increases the risk of severe hypotension and syncope - Patients using Addyi are advised to abstain from the use of alcohol - Addyi contraindications include alcohol, moderate or strong CYP3A4 inhibitors, hepatic impairment - Due to significant safety concerns by the FDA, Addyi is only available through a restricted REMS program Bremelanotide (draft subject to full Phase 3 results and NDA) - Not anticipated to have a Boxed Warning - Does not interact with alcohol and is not anticipated to have any contraindications - Alcohol interaction study completed - Not anticipated to have a restrictive REMS program 24

25 Bremelanotide NA & EU Program Timelines NA (primarily U.S.) Phase 3 pivotal trials enrolling patients Completed Phase 3 enrollment All phase 3 patient visits completed Phase 3 top-line results / Co-primary endpoints met FDA NDA submission FDA action EU (subject to funding) EMA/CHMP guidance - completed Commence Phase 3 trial EU submission EU action 4Q2014 2H2015 3Q2016 4Q2016 2H2017 2H2018 1H2014 2H2017 2H2018 2H

26 Natriuretic Peptide Receptor Program

27 Natriuretic Peptide System Neuropeptide hormone system plays an important role in the regulation of cardiovascular homeostasis Physiological Effects Downregulate RAAS Suppression of cardiac hypertrophy, fibrosis & remodeling Stimulation of diuresis & natriuresis Increased myocardial perfusion Vasodilation & decreased blood pressure Bronchodilation Prohormone Corin processing 27

28 NPS Clinical Validation 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 Approved July 2015 to treat HF patients with reduced ejection fraction NPS augmentation will become part of standard of care for HF Corin: serine protease Converts inactive pro-anp and pro-bnp into active hormone Human loss-of-function corin mutations characterized by decreased active natriuretic peptides and increased refractory hypertension, cardiac hypertrophy, mortality 28

29 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 Good in vivo stability Composition of matter patents issued worldwide; methods of use patents pending PL-3994 Lead Product candidate Selective for NPR-A Increased metabolic stability due to NEP resistance Once daily SC patient self-administration Phase 2 drug development candidate Clinical studies confirm that PL-3994 is potent NPR-A agonist 2 clinical studies completed Multiple preclinical studies to define potential clinical indications 29

30 PL-3994 Profile Novel NPR-A Agonist Raises cgmp in target tissues Increases diuresis and natriuresis Decreases activity of RAAS (Renin-Angiotensin-Aldosterone System) Inhibits cardiac remodeling and fibrosis Decreases systolic and diastolic BP Improved kidney function Excellent subcutaneous pharmacokinetics Half-life in human 3 hours with duration of action 6-8 hours 30

31 Daily PL-3994 Significantly Reduces Cardiac Remodeling HW/BW Sham (saline) Heart Weight /Body Weight following 6 weeks of treatment * p < 0.05 * * Sham (PL3994) 2K1C (saline) 2K1C (PL3994) Plasma aldosterone (pg/ml) Attenuation of RAAS Activation * -7 Time (days) * 7 2K1C (saline) 2K1C (PL3994) * p < The 2 Kidney, 1 Clip rat model causes renovascular hypertension and cardiac hypertrophy. Treatment with PL-3994 reduces both excess production of aldosterone and cardiac hypertrophy. 31

32 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 PL day continuous infusion of PL-3994 PL-3994 had no effect on systemic blood pressure Systemic PL-3994 activated NPR-A & pkg in cardiomyocytes PL-3994 rescued cardiac hypertrophy and reduced cardiac fibrosis 32

33 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 TGF-β expression Reduces aldosterone expression KO vs. PL-3994 p=0.03 KO vs. PL-3994 p=

34 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 seen at doses that do not cause significant decreases in systemic blood pressure 34

35 Opportunities for Treating Heart Failure Heart Failure with Preserved Ejection Fraction (HF-PEF) Phase 2A multiple dose study in HF patients High unmet need; no approved treatment options Heart Failure with Reduced Ejection Fraction (HF-REF) HF-PEF, HF-REF & corin deficient patients Evaluate safety, symptom relief and cardiac imaging, LVEF Targeted start 1H2017; data anticipated 2H2017 Patients with corin and/or reduced active NP expression High unmet medical need; poor response to current therapies Potential orphan designation Restore normal NP function Phase 2 proof-of-principle study 3-6 month treatment Evaluate safety, cardiac function, effects on remodeling, symptom improvement and hospital admission Targeted start 1H2018; data anticipated 1H

36 Melanocortin Receptor-1 Agonists Inflammation and Dermatologic Indications

37 MC1r Agonist Anti-Inflammatory Program Goal: design and develop selective MC1r agonists for treating a variety of inflammatory and autoimmune indications Inflammatory indications: inflammatory bowel disease, nephritis (inflammation of the kidneys) and rheumatoid arthritis Ocular indications: uveitis and dry eye Dermatologic indications: vitiligo and erythropoietic protoporphyria Rational design and synthesis of selective MC1r agonists Excellent metabolic stability (> 2 hour in vivo half life) MC1r agonism functions to resolve pro-inflammatory responses Lead pre-clinical candidate PL-8177 selective MC1r agonist Demonstrated efficacy in multiple preclinical models: EAU, IBD and nephritis Preclinical toxicology and CMC activities to support IND filing completed First-in-human clinical trial targeted start 1H2016 Actively exploring collaboration or licensing transactions for specific market areas 37

38 TNF-α Inhibition via MC1r Agonists pmole/ml TNFa Results Dose mg/kg SC 0 Vehicle Preclinical mouse model TNF-α stimulated by LPS administration with dexamethasone as positive control 38

39 PL-8177 Experimental Autoimmune Uveitis 4 Untreated EAU mice PL-8177 Low Dose Treated EAU mice PL-8177 High Dose Treated EAU mice α-msh Treated EAU mice EAU Clinical Score * Day Days of injections * P = by Anova MC1r agonism has significant effects in reversing uveitis Conducted in collaboration with Dr. A. Taylor at Boston University School of Medicine 39

40 Melanocortin Receptor-4 Agonist Obesity & Diabetes

41 Melanocortins and Obesity Overview arcuate nucleus Hypothalamus Peripheral Signals Leptin Grelin GLP-1 Insulin CCK POMC Stimulates MC4r decrease in food intake & weight loss MC4r Brainstem & Cortex signals Down stream effects on food intake, weight and energy expenditure AGRP Inhibits MC4r increase in food intake & weight gain MC4r mutations most prevalent form of monogenetic obesity in humans MC4r loss of function hyperphagic, obese increased growth & hyperinsulinemia MC4r agonist BMT reduces food intake and weight loss in obesity clinical studies Currently approved obesity treatments require functional MC4r pathway 41

42 MC4r Obesity & Diabetes Program Goal: design and develop selective for MC4r agonists for treating obesity, diabetes and related metabolic syndrome High selectivity for MC4r with limited off-target effect None of the toxicities associated with small molecules Clinical proof-of-concept studies for MC4r mechanism have been completed Primary objectives met: significant decrease in food intake and weight loss Lead compound PL-8905 High selectivity of MC4r over MC1r (>100x functional) Minimal effect on blood pressure, limited CNS penetration Chemical/metabolic stability (>2 hour in vivo half life) Preclinical studies in animal models: Body weight change from Day 0 Body Weight Change (g) Day Vehicle PL mg/kg PL mg/kg PL mg/kg 42

43 MC4r Obesity/Diabetes Program Overview Peptide-based program focused on design and development of MC4rtargeted treatment for obesity and diabetes Rapid development of highly selective MC4r compounds Limited potential for off-target effects Limited potential for toxicities associated with small molecules Easy to define structure/function relations to guide future chemistry efforts Lead compounds have been identified Defined synergistic interactions between MC4r agonist and GLP-1 agonist Positive affects on weight loss and glucose regulation Orally active MC4r selective compounds in preclinical evaluation 43

44 Summary of PL-8905 PL-8905 is a highly selective MC4r agonist No effect seen in MC4r knock-out model, establishing weight loss effect as MC4r based Synergistic effect with GLP-1 in weight loss and glucose regulation in rodent models PL-8905 demonstrated anorexic activity in normal and DIO mouse and rat models PL-8905 has limited effects on blood pressure Internal chemistry effort generating several new chemotypes with similar pharmacological profiles 44

45 Palatin Potential Near-Term Development Milestones* Bremelanotide for Female Sexual Dysfunction Commenced Phase 3 pivotal trials in NA Completed Phase 3 enrollment in NA All Phase 3 patient visits completed Phase 3 pivotal top-line trial results (met co-primary endpoints) Commence Phase 3 pivotal trial in EU* Corporate collaborations (ongoing discussions) 4Q2014 2H2015 3Q2016 4Q2016 2H2017 PL-3994 for Cardiovascular/Pulmonary Indications * Commence Phase 2A clinical trial in HF patients Corporate collaboration MC1r Inflammation/Dermatologic Indications * Phase 1/ First-in-human clinical trial Corporate collaboration (ongoing discussions) MC4r development obesity/diabetes program * Phase 1/ First-in-human clinical trial Corporate collaboration (ongoing discussions) 1H2017 1H2017 1H2017 *Certain activities and milestones are subject to funding 45

46 Financial Snapshot Financial Highlights as of June 30, 2016 Cash, Cash Equivalents & Investments Total Debt $9.4 million* $20 million Summary of Capitalization as of October 2016 Common Equivalent Common Stock Preferred million shares 0.1 million shares Warrants million shares 1 Options RSU s Fully Diluted Shares 6.4 million shares 3.5 million shares million shares * August 2016 equity raise of ~$9.2 million (net proceeds of ~$8.5 million) 1) Includes pre-funded warrants to purchase ~69 million shares of common stock at a $0.01 per share exercise 46

47 Thank You