UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): September 8, 2014
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ORAMED PHARMACEUTICALS INC.
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(Exact name of registrant as specified in its charter)
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DELAWARE
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001-35813
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98-0376008
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(State or Other Jurisdiction
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(Commission
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(IRS Employer
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of Incorporation)
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File Number)
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Identification No.)
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Hi-Tech Park 2/4 Givat Ram, PO Box 39098, Jerusalem, Israel
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91390
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(Address of Principal Executive Offices)
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(Zip Code)
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+972-2-566-0001
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
ITEM 7.01. REGULATION FD DISCLOSURE.
Oramed Pharmaceuticals Inc. has posted an updated corporate presentation to its website. A copy of the presentation is furnished with this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.
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ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.
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(d)
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Exhibits.
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99.1
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Corporate Presentation
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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ORAMED PHARMACEUTICALS INC.
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By:
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/s/ Nadav Kidron | |
| Name: Nadav Kidron | |||
| Title: President and CEO | |||
September 8, 2014
Exhibit 99.1
March 2014
Nasdaq: ORMP
September 2014
Corporate Presentation
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 materially from those described
in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost,
and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory
approval or patent protection for our product candidates; competition from other pharmaceutical or
biotechnology companies; and our ability to obtain additional funding required to conduct our research,
development and commercialization activities, and others, all of which could cause the actual results or
performance of Oramed to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to
these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the
occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting
Oramed, reference is made to Oramed's reports filed from time to time with the Securities and Exchange
Commission. which involve known and unknown risks, uncertainties and other factors which may cause the
actual results, performance or achievements of the company, or industry results, to be materially different
from any future results, performance or achievements expressed or implied by such forward-looking
statements. Please refer to the company's filings with the Securities and Exchange Commission for a
comprehensive list of risk factors that could cause actual results, performance or achievements of the
company to differ materially from those expressed or implied in such forward-looking statements. Oramed
undertakes no obligation to update or revise any forward-looking statements.
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 materially from those described
in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost,
and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory
approval or patent protection for our product candidates; competition from other pharmaceutical or
biotechnology companies; and our ability to obtain additional funding required to conduct our research,
development and commercialization activities, and others, all of which could cause the actual results or
performance of Oramed to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to
these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the
occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting
Oramed, reference is made to Oramed's reports filed from time to time with the Securities and Exchange
Commission. which involve known and unknown risks, uncertainties and other factors which may cause the
actual results, performance or achievements of the company, or industry results, to be materially different
from any future results, performance or achievements expressed or implied by such forward-looking
statements. Please refer to the company's filings with the Securities and Exchange Commission for a
comprehensive list of risk factors that could cause actual results, performance or achievements of the
company to differ materially from those expressed or implied in such forward-looking statements. Oramed
undertakes no obligation to update or revise any forward-looking statements.
2
Investment Highlights
Proprietary technology platform (POD™) for oral delivery of peptides
Significant market opportunity: focus on significant medical needs
Clinical proof of concept achieved
Orally ingestible insulin: US FDA Phase II clinical development
Strong product pipeline: potential to expand to other indications
Strong management team backed
by world-leading scientific experts
Multiple value-creating milestones in 2H14 and 2015
3
Oramed
An Oral Solution
An Oral Solution
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Harsh pH
Protease
threat
Mechanical
challenges
Absorption
barrier
Fate of proteins/peptides in GIT
Leads to protein breakdown and lack of absorption
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Oramed POD™ Technology:
Oral Protein and Peptide Delivery and Absorption
Absorption Enhancers
Assists with translocation of
active ingredient (protein/
peptides) across intestinal
membrane into bloodstream
active ingredient (protein/
peptides) across intestinal
membrane into bloodstream
Oramed’s delivery platform protects proteins and enhances
their absorption, allowing them to reach the bloodstream via
the portal vein, thereby establishing a more physiologic protein
gradient when compared to other delivery systems.
their absorption, allowing them to reach the bloodstream via
the portal vein, thereby establishing a more physiologic protein
gradient when compared to other delivery systems.
Protease Inhibitors
Protects protein from
degradation by proteases
once capsule degrades in
the small intestine
degradation by proteases
once capsule degrades in
the small intestine
Enteric Coating
pH sensitive - only degrades in the small
intestine, thus protecting capsule
constituents during travel through the
upper gastrointestinal tract
intestine, thus protecting capsule
constituents during travel through the
upper gastrointestinal tract
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Physiologic Insulin Delivery
l Portal insulin delivery is
physiologic, while systemic insulin
delivery (injected, inhaled, etc.) is
not
physiologic, while systemic insulin
delivery (injected, inhaled, etc.) is
not
l Blood glucose - insulin secretion
system forms a 'closed-loop'
system forms a 'closed-loop'
l Peripheral insulin promotes
glucose uptake in fat and muscle
glucose uptake in fat and muscle
l First-pass hepatic metabolism
extracts 80% of secreted insulin
extracts 80% of secreted insulin
l Systemic exposure is minimized
portal vein
liver
small intestine
stomach
To systemic
circulation
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Insulin
GLP-1
Analog
Analog
Other
Targeting Diabetes Treatment:
Oramed has Opportunities in many Large Markets
$20 billion 2013 global insulin market1
$47 billion projected market for 20201
$2+ billion 2012 global GLP-1 market2
$6.6 billion projected for 20183
Many patients stop treatment as a result of
injection-related side effects
injection-related side effects
Vaccines: $24 billion in 2013 - grew from
$5 billion in 20004
$5 billion in 20004
Flu vaccine estimated at $2.9 billion in
2011 to $3.8 billion in 20184
2011 to $3.8 billion in 20184
Interferon: $10+ billion, projected for 20155
1 Grand View Research, Inc., 2014
2 Novo Nordisk Annual Report, 2013
3 Goldman Sachs Global Investment Research, 2013
4 World Health Organization,
5 Research and Markets, 2012
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9
As of Nov 12, 2013
Total number of
study subjects:
181
Total number of
human doses:
human doses:
1748
ORMD-0801
Type 2 Diabetes
(T2DM)
Type 2 Diabetes
(T2DM)
10
Initial Treatment:
• Lifestyle Modification
• Diet & Exercise
Single & Combination Oral
Therapies:
Therapies:
• Reduce insulin resistance
• Stimulate insulin secretion
Final Treatment:
• Insulin Replacement
(injections)
ORMD-0801 is not a substitute
for insulin injections, but rather
a new earlier treatment option
for insulin injections, but rather
a new earlier treatment option
Criteria for advancing to next stage:
AIC not at target < 7.0%
ORMD-0801 Treats Diabetes Sooner:
Type 2 Diabetes Stages & Treatment Options
0
25
50
75
100
IGT
Post-
prandial
hyper-
glycemia
T2DM
phase I
T2DM
phase II
T2DM
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Fasting Blood Glucose (FBG):
• Measurement of blood glucose levels after a fast (e.g. first thing in the morning)
Elevated FBG
• Elevated FBG levels are a major issue in T2DM
• Main cause: excessive nocturnal glucose production from liver
FBG: Stats
• Approximately 70% of individuals with impaired FBG develop T2DM
ORMD-0801: Unique Indication
• Nighttime dose
• Focused on reducing the excessive nocturnal glucose production from the liver
T2DM
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• Healthy, non-diabetic, cannulated beagle dogs
showed a 60-75% drop in blood glucose levels
within 30-100 minutes of treatment
• No hypoglycemia or adverse events were
observed over the three years of testing (in dogs)
• Randomized, double-blind, multi-center study
on 29 patients - 21 dosed, 8 placebo,
6 weeks of monitoring
• Showed relevant clinical impact
• Good safety profile
• Safe and well tolerated by all patients
• No SAEs
T2DM Patients
Pre-clinical
T2DM
ORA-D-004
Insulin
CRP
ORMD-0801
placebo
-4
-2
0
2
4
6
8
13
ORMD-0801
Phase IIa Results
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ORMD-0801: Phase IIa FDA Study
T2DM - ORA-D-009
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• 30 T2DM patients
• US site
• In-patient setting
• Double blind
• Randomized
• 1 week of treatment
• Primary objective:
• Safety and tolerability
• Secondary objectives:
• Pharmacodynamic effects on mean nighttime glucose
• Pharmacokinetics on AUC, Cmax, Tmax, T½
• Changes from baseline in FBG morning fasting insulin, C-peptide
Objectives
Overview
Phase 2a: Primary Objective Safety
Hypoglycemic Events
0
Serious Adverse Events
0
Severe Adverse Events
0
ORMD 0801 Related Adverse Events
0
Adverse Events (non treatment related):
Placebo
5 patients
7 reported adverse events
8 mg + 8 mg
3 patients
5 reported adverse events
8 mg + 16 mg
4 patients
5 reported adverse events
-No Serious Adverse Events-
The study showed that ORMD-0801 is safe and well tolerated
T2DM - ORA-D-009
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Fasting CGM
Glucose - mg/DL (1)
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Placebo (n = 10)
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ORMD-0801
8 mg + 8mg (n=10)
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Difference
(ORMD 0801 - placebo)
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ORMD-0801
8 mg + 16mg (n=8)
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Difference
(ORMD 0801-placebo)
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Last 2 days of data
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156.26 (58.62)
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126.02 (27.26)
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-30.24
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136.12 (43.17)
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-20.14
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All 7 days
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154.37 (57.99)
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129.27 (27.43)
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-25.10
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144.83 (39.28)
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-9.54
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(1) Per Protocol (PP) population, consisting of all study completers with an endpoint of adequate weighted mean nighttime glucose and no
major protocol violations
major protocol violations
T2DM - ORA-D-009
Mean fasting blood glucose concentrations (CGM)
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Mean night time glucose concentrations (CGM)
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Night time mean (SD)
CGM Glucose - mg/DL(1)
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Placebo (n = 10)
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ORMD 0801
8 mg + 8 mg (n = 10)
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Difference
(ORMD 0801-placebo)
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ORMD 0801
8 mg + 16 mg (n = 8)
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Difference (ORMD
0801 - placebo) |
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Last 2 days of data
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167.95 (64.17)
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135.64 (39.40)
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-32.31
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150.24 (49.26)
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-17.71
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All 7 days
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165.85 (60.76)
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139.73 (38.86)
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-26.12
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149.38 (38.25)
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-16.47
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Mean daytime glucose concentrations (CGM)
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Daytime mean (SD)
CGM Glucose - mg/DL (1)
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Placebo (n = 10)
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ORMD 0801
8 mg + 8 mg (n = 10)
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Difference
(ORMD 0801 - placebo)
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ORMD 0801
8 mg + 16 mg (n = 8)
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Difference (ORMD
0801-placebo) |
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Last 2 days of data
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176.06 (63.70)
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153.23 (40.16)
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-22.83
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158.58 (40.67)
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-17.48
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All 7 days
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175.99 (61.12)
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152.55 (36.99)
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-23.44
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163.05 (30.28)
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-12.94
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Phase IIa
• ORMD-0801 oral insulin gel caps were observed to be safe and well-tolerated
for the dosing regimen considered in this study
for the dosing regimen considered in this study
• No hypoglycemic events occurred at any point during the study in any
treatment group
treatment group
• No ORMD-0801 related adverse events observed
• Both ORMD-0801 dose groups showed trends towards sustained reduction in
nighttime, daytime and mean fasting glucose concentrations compared to
placebo
nighttime, daytime and mean fasting glucose concentrations compared to
placebo
• 8mg + 8mg dose group showed a more pronounced effect over placebo, versus
the intended 8mg + 16mg dose
the intended 8mg + 16mg dose
T2DM - ORA-D-009
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Safety Conclusions
Efficacy
ORMD-0801:
Proposed Phase IIb FDA Study
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• ~180 T2DM patients
• >30 US sites
• Double blind
• Randomized
• 28 days of treatment
• Primary objective:
• Safety: Evaluate the safety of ORMD-0801
• Efficacy: evaluate the PF effects of ORMD-0801 on mean nighttime
glucose (determined using continuous glucose monitoring)
glucose (determined using continuous glucose monitoring)
• Secondary objectives:
• Evaluate changes from baseline in fasting blood glucose (FBG),
morning fasting serum insulin, C-peptide, and triglycerides
morning fasting serum insulin, C-peptide, and triglycerides
Objectives
Overview
T2DM
ORMD-0801
Type 1 Diabetes
(T1DM)
Type 1 Diabetes
(T1DM)
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T1DM
21
50.75
38
49.7
DAY
NIGHT
pretreatment
treatment
Frequency glucose >200mg/dL
20
30
40
50
60
06:00
-
08:59
09:00
-
11:59
12:00
-
13:59
14:00
-
18:59
19:00
-
20:59
21:00
-
23:59
00:00
-
05:59
Time
Design: 8 T1DM, monitor glycemic stability of orally administered ORMD-0801
(1 capsule (8 mg insulin) before meals, three times daily). Glucose monitored
with continuous, blinded glucose monitor
(1 capsule (8 mg insulin) before meals, three times daily). Glucose monitored
with continuous, blinded glucose monitor
ORMD-0801: T1DM
DAY
NIGHT
180
200
220
240
260
280
300
pretreatment
treatment
Mean glucose n=8
ê 11.5%
Results: Safe, well tolerated,
reduced glycemia.
reduced glycemia.
T1DM
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ORMD-0801: Phase IIa FDA Study
T1DM
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Last Patient Out: August 2014
• 24 T1DM patients
• US site
• In-patient setting
• Double blind
• Randomized
• Placebo-controlled
• 7 days of treatment
• Primary objective:
• To evaluate the change in exogenous insulin requirements in T1DM
patients
patients
• Secondary objectives:
• To evaluate the changes in glucose in T1DM patients
• To evaluate safety and tolerability
Objectives
Overview
ORMD-0901
Oral GLP-1
Analog (T2DM)
Oral GLP-1
Analog (T2DM)
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Oral GLP-1 Analog (Exenatide)
GLP-1: Hormone Facts
• Secreted by the intestine
• Has effect on the satiety center in the brain
• Has effect on pancreatic β-cells
GLP-1 Analog: Drug Facts
• Good safety profile
• Mimics the natural hormone in the body
• Decreases blood glucose levels - aids in
blood sugar balance
blood sugar balance
• Does not cause hypoglycemia
• Effectively reduces HbA1c
• Preserves beta cell function
• Promotes weight loss
• Current therapy is via injection only
• Pre-IND package submitted to
the US FDA Q3 2013
the US FDA Q3 2013
• IND-enabling tox studies Q3,
2014
2014
• PIb ex-US study Q4, 2014
ORMD-0901
Oral GLP-1
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Oral GLP-1 - ORMD-0901
Blunting of glucose excursions in dogs
Blunting of glucose excursions in dogs
0
20
40
60
80
100
120
S.C.
AG
4
AG
3
-
+
+
+
+
Exenatide
*
*
*
Glucose
Results: Subcutaneous exenatide delivery amounted to a 51% reduction in mean glucose
AUC0-150, while formulations AG4 and AG3 prompted 43% and 29% reductions, respectively
(* p = 0.068, demonstrating a treatment-related trend for the sample size).
ORMD-0901 formulations preserved the biological activity of orally
delivered exenatide. ORMD-0901 successfully curbed blood sugar
excursions following glucose challenge.
delivered exenatide. ORMD-0901 successfully curbed blood sugar
excursions following glucose challenge.
Methods:
Ø Healthy, fasting, cannulated
dogs
Ø Single dose ORMD-0901
formulation
Ø Administered 30 minutes
pre-glucose challenge
Ø Blood samples collected
every 15 minutes
every 15 minutes
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Mean AUC
Placebo:
148.5±30.5
No Nausea
Insulin:
180.3±106.3
21%
150 mg
exenatide
0
40
60
80
100
120
140
Time (min)
-50
0
100
150
n=4
ORMD-0901
placebo
ORMD-0901 - T2DM
Study
• First in Human
• 4 healthy volunteers
• Placebo controlled
• Pre-prandial
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Pipeline Overview
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Phase I
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Phase II
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Phase III
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Timeline
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ORMD-0801
oral insulin
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Type 2 diabetes
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Q4, ‘13: Phase IIa completed
Q4, ’14: Phase IIb multi-center study
projected initiation |
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Type 1 diabetes
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Q1, ’14: Phase IIa initiated (LPO 8/2014)
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ORMD-0901
oral GLP-1
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Type 2 diabetes
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Q3, ’14: Preclinical/IND studies projected
initiation Q4, ’14: Phase Ib ex-US study projected
initiation Q3, ’15: Phase II multi-center study projected
initiation |
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Corporate
Overview
Overview
29
Management
Josh Hexter - COO, VP Bus. Dev.
More than 15 years of prominent leadership
roles in biotech and pharma
roles in biotech and pharma
Yifat Zommer, CPA, MBA - CFO
Extensive experience in corporate financial
management
management
Michael Berelowitz, MD
• Chairman of Oramed SAB
• SVP Clinical Development &
Medical Affairs, Pfizer (former)
Medical Affairs, Pfizer (former)
Harold Jacob, MD
• Chief Medical Officer, Given
Imaging (former)
Imaging (former)
Gerald Ostrov
• CEO, Bausch&Lomb (former)
• Senior level Executive J&J
(former)
(former)
Leonard Sank
• Entrepreneur and businessman
Board of Directors
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Scientific Advisory Board
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Corporate Overview*
Ticker: NASDAQ: ORMP
• $43M raised to date **
• No Debt
• Cash and investments: $21.3M
• Shares issued: 10.1M
• Fully diluted: 12M ***
• Strong intellectual property estate
• Methods & Compositions for Oral
Administration of Proteins
Administration of Proteins
• Methods & Compositions for Oral
Administration of Exenatide
Administration of Exenatide
• Methods & Compositions (insulin +
exenatide)
exenatide)
• Improved Protease Inhibitors
* As of August 31, 2014
** Including the shares of D.N.A Biomedical Solutions Ltd.
*** Including outstanding 1M options and 1M warrants
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ORMD-0801
Oral Insulin
ORMD-0901
Oral GLP-1Analog
Anticipated Milestones 2014-2015
• Initiation & Completion of IND-enabling studies
• Initiation & Completion of Phase Ib ex-US study
• Initiation of Phase II multi-site study under US IND
T2DM
üCompletion of Phase IIa FDA study
• Initiation & Completion of Phase IIb multi-site
study under US IND
study under US IND
T1DM
• Completion of Phase IIa FDA study
33
Summary
Proprietary technology platform (POD™) for oral delivery of peptides
Significant market opportunity: focus on significant medical needs
Clinical proof of concept achieved
Orally ingestible insulin: US FDA Phase II clinical development
Strong product pipeline: potential to expand to other indications
Strong management team backed
by world-leading scientific experts
Multiple value-creating milestones in 2H14 and 2015
34
Breakthrough Technology
for a Brighter Future
Contact :
Nadav Kidron
CEO
nadav@oramed.com
Josh Hexter
COO
josh@oramed.com
35