Oramed Pharmaceuticals Inc. · NASDAQ:ORMP
Oramed Pharmaceuticals — Investor Presentation (November 2019)
37 slides from Oramed Pharmaceuticals's investor presentation, Nov 18, 2019
Slide 1: Investor & Analyst Breakfast
INVESTOR & ANALYST BREAKFAST November 18, 2019 1
Slide 2: Safe Harbor
Safe Harbor Certain statements contained in this material are forward-looking statements. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materi
Slide 3: Oramed Snapshot
Oramed Snapshot ▪ Proprietary oral protein delivery platform ▪ Diabetes first - initially targeting the lucrative insulin market. Additional huge markets in the pipeline ▪ Strong financial position over $37M in cash and investments, no debt1 ▪ Strong management team backed by world-class scientific
Slide 4: Agenda
Agenda 8:30-9:15 ▪ Opening Remarks - Nadav Kidron, Chief Executive Officer, Oramed Pharmaceuticals ▪ Review of the P2b Data - Joel Neutel, Director of Research Orange County Research Center & Kenneth Homer, Director of Biometrics, Integrium ▪ A Clinical Perspective - Ramachandra Naik, Professor of M
Slide 5: Third Party Review of Phase IIb Data
Third Party Review of Phase IIb Data: A Placebo-controlled, Multi-center Randomized, Phase 2b Study to Evaluate the Efficacy and Safety of ORMD-0801 in Type 2 Diabetes Mellitus Patients with Inadequate Glycemic Control on Oral Therapy Joel Neutel, Director of Research Orange County Research Center &
Slide 6: Oramed Protocol ORA-D-015 Presentation of Results
Oramed Protocol ORA-D-015 Presentation of Results ▪ Primary Endpoint – mean change in HbA1c from baseline to Week 12 ▪ 39 sites screened subjects; 36 sites randomized subjects ▪ The Primary Treatment are the subjects who received QD, BID or TID Placebo and ORMD- 0801 32mg ▪ 273 subjects received pri
Slide 7: HbA1c – Observed Means – Primary Analysis
HbA1c – Observed Means – Primary Analysis 7
Slide 8: HbA1c – Least Square Means – Primary Analysis
HbA1c – Least Square Means – Primary Analysis 8
Slide 9: HbA1c – Week 12 – Primary Analysis
HbA1c – Week 12 – Primary Analysis 9
Slide 10: Secondary Endpoints
Secondary Endpoints ▪ Safety assessed by adverse event reporting including adverse events of special significance such as hypoglycemia ▪ Change from baseline in glycemic parameters measured using outpatient CGM ▪ Change in weight from baseline to week 12 of the treatment period 10
Slide 11: Adverse Events Overall Summary
Adverse Events Overall Summary Safety Population Combined Placebo 32 mg QD 32 mg BID 32 mg TID (N=66) (N=69) (N=68) (N=69) Number of Reported Adverse Events: 111 108 56 79 Number (%) of Subjects With at Least One: Treatment Emergent Adverse Event (TEAE) 46 (69.7) 38 (55.1) 27 (39.7) 35 (50.7) Severe
Slide 12: Treatment Emergent Adverse Events Leading to Discontinuation
Treatment Emergent Adverse Events Leading to Discontinuation Safety Population Combined Placebo 32 mg QD 32 mg BID 32 mg TID (N=66) (N=69) (N=68) (N=69) Number of Subjects with At Least One Adverse Event 1 ( 1.5) 0 ( 0.0) 1 ( 1.5) 1 ( 1.4) Cardiac Disorders 1 (1.5) 0 (0.0) 0 (0.0) 0 (0.0) Myocardial
Slide 13: Hypoglycemic Events
Hypoglycemic Events Safety Population Hypoglycemic Events as reported on the Hypoglycemic / Hyperglycemic Log: Number of Hypoglycemic Events: ▪ Placebo – 21 ▪ ORMD-0801 QD – 16 ▪ ORMD-0801 BID – 4 ▪ ORMD-0801 TID – 32 Number of Subjects with at least 1 Hypoglycemic Event: ▪ Placebo – 4 / 66 (6.1%) ▪
Slide 14: Continuous Glucose Monitoring – Area Under the Curve
Continuous Glucose Monitoring – Area Under the Curve 14
Slide 15: Serum Glucose (mg/dL) – Change from Baseline
Serum Glucose (mg/dL) – Change from Baseline 15
Slide 16: Summary of Weight Change (kg) at Week 12
Summary of Weight Change (kg) at Week 12 16
Slide 17: Summary of Diabetes Medication Usage During Study
Summary of Diabetes Medication Usage During Study There were a total of 68 subjects on Metformin Alone: ▪ Placebo – 16 (of which 14 have a Week 12 HbA1c) ▪ ORMD-0801 QHS – 20 (of which 16 have a Week 12 HbA1c) ▪ ORMD-0801 BID – 20 (of which 16 have a Week 12 HbA1c) ▪ ORMD-0801 TID – 12 (of which 8 h
Slide 18: HbA1c Levels – Change from Baseline by Baseline HbA1c
HbA1c Levels – Change from Baseline (Subjects with Baseline HbA1c > or <= 9%) Baseline HbA1c Values > 9 (92 Subjects): ▪ ORMD-0801 QHS Placebo Adjusted = -0.72 ▪ ORMD-0801 BID Placebo Adjusted = -0.65 ▪ ORMD-0801 TID Placebo Adjusted = -0.54 Baseline HbA1c Values <= 9 (117 Subjects): ▪ ORMD-0801 QHS
Slide 19: Discussion of Treatment by Site Interaction
Discussion of Treatment by Site Interaction When we analyze the data for one group of sites and get one answer which differs from the analysis of the second group of sites, in statistics this is called a treatment by site interaction. This is where we find ourselves. Least Squares Mean Change in HbA
Slide 20: Handling Data not in Total Agreement
Handling Data not in Total Agreement We are constantly bombarded by information that is not in total agreement. When asking 36 sites: Does ORMD-0801 Lower When asking 269 sites: Does ORMD-0801 Lower HbA1c at Week 12? HbA1c at Week 12? 36 34 270 233 32 216 Number of Subjects 28 Number of Sites 24 162
Slide 21: Discussion of Results for Sites 13 and 20 – HbA1c Results
Discussion of Results for Sites 13 and 20 – HbA1c Results 21
Slide 22: Discussion of Results for Sites 13 and 20 – Serum Glucose
Discussion of Results for Sites 13 and 20 – Serum Glucose 22
Slide 23: Summary of Results
Summary of Results Primary endpoint of reduction in HbA1c at Week 12 was achieved ▪ ORMD-0801 32mg QD showed a reduction of 0.54 after adjusting for placebo (p-value=0.036) ▪ ORMD-0801 32mg BID showed a reduction of 0.53 after adjusting for placebo (p-value=0.042) Significant observed outcomes ▪ No
Slide 24: Oral Insulin in the Therapeutic Armamentarium of Type 2 Diabetes
Oral Insulin in the Therapeutic Armamentarium of Type 2 Diabetes: An Endocrinologist’s Perspective Ramachandra G. Naik, MD Professor of Medicine Division of Endocrinology, Diabetes, and Metabolism Assistant Dean for Translational and Clinical Research Programs SUNY Upstate Medical University Syracus
Slide 25: Learnings from the Oramed Phase IIb Study: Efficacy
Learnings from the Oramed Phase IIb Study: Efficacy ▪ Study met the primary efficacy endpoint ▪ Clinically meaningful reduction in A1C from baseline to Week 12 ▪ Comparable A1C-lowering when administered once daily at bedtime (QHS) or twice daily (BID) - Possible mechanism of QHS dosing could be sup
Slide 26: Learnings from the Oramed Phase IIb Study: Safety
Learnings from the Oramed Phase IIb Study: Safety ▪ Reassuring safety profile ▪ No drug related severe or serious Treatment Emergent Adverse Events (TRAE) ▪ No increased frequency of hypoglycemic episodes ▪ Weight neutrality 26
Slide 27: ORMD-0801: Therapeutic Potential
ORMD-0801: Therapeutic Potential ▪ An oral formulation of insulin (ORMD-0801) may have significant benefits in fostering treatment acceptance and adherence ▪ The data support a unique mechanism of action of ORMD-0801: The oral route of administration replicates the normal physiology of insulin secre
Slide 28: Standards of Medical Care in Diabetes – 2019
Standards of Medical Care in Diabetes – 2019 28
Slide 29: Pharmacologic Approaches to Glycemic Treatment
29 Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S90-S102
Slide 30: Pharmacologic Approaches to Glycemic Treatment
GLPARA SGLT2# ; GLP-ARA SGLT2# soLT2? ‘OR oR oR DPP-4i 1Z0 1zD oR zp Continue with addition of other agents as outlined above Consider the addition of SU* OR basal insuli = Choose later generation SU with lower risk of hypoglycemia = Consider basal insulin with lower risk of hypoglycemia” 6. Choose
Slide 31: Pharmacologic Approaches to Glycemic Treatment
} { Continue with addition of other agents as outlined above ] GLPARA SGLT2# SGLT2* OR 1Z. GLPlRA Wi with good efficacy for weight loss* Consider the addition of SU* OR basal insulin: = Choose later generation SU with lower risk of hypoglycemia = Consider basal insulin with lower risk of hypoglycemi
Slide 32: If A1C is above target despite first-line treatment
▪ If A1C is above target despite recommended first- line treatment and the patient has ASCVD or CKD: ▪ ASCVD Predominates: ▪ Add GLP-1 RA with proven CVD benefit, OR ▪ Add SGLT-2 inhibitor with proven CVD benefit (if eGFR adequate) ▪ If HF or CKD Predominates: ▪ Add SGLT-2 inhibitor with evidence of
Slide 33: If A1C is above target despite first-line treatment
▪ If A1C is above target despite recommended first- line treatment and the patient has ASCVD or CKD: ▪ ASCVD Predominates: ▪ Add GLP-1 RA with proven CVD benefit, OR ▪ Add SGLT-2 inhibitor with proven CVD benefit (if eGFR adequate) ▪ If HF or CKD Predominates: ▪ Add SGLT-2 inhibitor with evidence of
Slide 34: ORMD-0801: Forward Looking Regulatory Pathway
ORMD-0801: Forward Looking Regulatory Pathway Alexander Fleming CEO Kinexum, Former Head of Clinical Review of Endocrine and Metabolic Drugs at FDA 34
Slide 35: China License Deal: 500M patient potential
China License Deal: 500M patient potential ▪ License: Exclusive right to ORMD-0801 in Greater China Chinese diabetes market* ▪ Licensee: Hefei Tianhui ("HTIT") Owns with Sinopharm a state-of-the-art GMP API insulin diabetic manufacturing facility 114M (10.9% of adult population) - IND approved for o
Slide 36: Q&A Panel
Q&A Panel ▪ Joel Neutel, Director of Research Orange County Research Center ▪ Kenneth Homer, Director of Biometrics, Integrium ▪ Ramachandra Naik, Professor of Medicine, Division of Endocrinology, Diabetes and Metabolism, SUNY Medical University, Syracuse ▪ Alexander Fleming, CEO Kinexum, Former Hea
Slide 37: Thank you
Thank you 37
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