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): November 3, 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.
As previously announced, on November 3, 2014, Oramed Pharmaceuticals Inc., or Oramed, will host a conference call to discuss the clinical results from its Phase IIa clinical trial of ORMD-0801, Oramed’s proprietary oral insulin capsules to treat type 1 diabetes. On the same day, Oramed posted to its website a presentation containing key top line results from the Phase IIa clinical trial. A copy of this 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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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 | ||
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Nadav Kidron
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| Title: |
President and CEO
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November 3, 2014
Exhibit 99.1
Oramed Clinical Conference Call
Monday, November 3, 2014 - 10:00 a.m.
Eastern Time
Eastern Time
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.
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Oramed ORA-D-010
A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (insulin
capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics
capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics
25 Subject (24 Planned, 25 Enrolled)
3 Day Placebo Run-in Period (Baseline) followed by 7 Days of Treatment
(Placebo or ORMD-0801)
(Placebo or ORMD-0801)
Treatment given 3 times / day (1 hour before each meal)
Primary Objective:
To evaluate the change from baseline in exogenous insulin requirements
(Basal, Bolus and Total) in Type 1 diabetes patients treated with ORMD-
0801, compared to the change from baseline for patients treated with
placebo.
(Basal, Bolus and Total) in Type 1 diabetes patients treated with ORMD-
0801, compared to the change from baseline for patients treated with
placebo.
Secondary Objectives:
To evaluate the change from baseline in mean nighttime, daytime and
fasting glucose levels (by continuous glucose monitoring) in Type 1 diabetes
patients treated with ORMD-0801, compared to the change from baseline
for patients treated with placebo.
fasting glucose levels (by continuous glucose monitoring) in Type 1 diabetes
patients treated with ORMD-0801, compared to the change from baseline
for patients treated with placebo.
To evaluate the safety and tolerability of ORMD-0801 in patients with Type
1 diabetes.
1 diabetes.
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All 25 subjects completed the study.
Demographics
The active treatment group had proportionally less females (20% vs. 50%)
The active treatment group had proportionally less Hispanics / Latinos (6.7% vs. 40%)
Ages are similar between treatment groups (37.6 (Placebo) vs. 38.9 (Active))
All subjects took all oral insulin doses.
Basal Exogenous Insulin - ITT - All Subjects
Placebo
Run-in Period Average- 50.15 IU
Day 6 and 7 Average - 49.05 IU
Change → -1.10 IU
Active Treatment
Run-in Period Average - 37.67 IU
Day 6 and 7 Average - 35.75 IU
Change → -1.92 IU
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Bolus Exogenous Insulin - ITT - All Subjects
Placebo
Run-in Period Average- 37.20 IU
Day 6 and 7 Average - 41.13 IU
Change → 3.93 IU
Active Treatment
Run-in Period Average -30.11 IU
Day 6 and 7 Average - 29.93 IU
Change → -0.18 IU
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Total Exogenous Insulin - ITT - All Subjects
Placebo
Run-in Period Average- 87.34 IU
Day 6 and 7 Average - 90.17 IU
Change → 2.83 IU
Active Treatment
Run-in Period Average - 67.78 IU
Day 6 and 7 Average - 65.68 IU
Change → -2.09 IU
7
Continuous Glucose Monitoring
Nighttime Glucose
Placebo
Run-in Period Combined - 161.73
Last 2 Days With At Least 80% of Readings - 133.17
Change → -28.56
Active Treatment
Run-in Period Combined - 158.77
Last 2 Days With At Least 80% of Readings - 137.65
Change → -21.12
Daytime Glucose
Placebo
Run-in Period Combined - 163.29
Last 2 Days With At Least 80% of Readings - 165.73
Change → 2.44
Active Treatment
Run-in Period Combined - 153.76
Last 2 Days With At Least 80% of Readings - 145.15
Change → -8.61
Oramed ORA-D-010 - Key Top Line Results
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Day 1 Change from Average Run-in Value
Placebo → -27.3
Active → -29.7
Day 2 Change from Average Run-in Value
Placebo → -31.8
Active → -43.5
Day 3 Change from Average Run-in Value
Placebo → -35.9
Active → -52.0
Day 4 Change from Average Run-in Value
Placebo → -37.6
Active → -59.5
Day 5 Change from Average Run-in Value
Placebo → -31.7
Active → -44.2
Day 6 Change from Average Run-in Value
Placebo → -28.0
Active → -58.9
Day 7 Change from Average Run-in Value
Placebo → -10.2
Active → -60.2
Oramed ORA-D-010 - Key Top Line Results
Finger Stick Fasting Blood Glucose Immediately Prior to
Breakfast
Breakfast
Delta → -2.4
Delta → -11.7
Delta → -16.1
Delta → -21.9
Delta → -12.5
Delta → -30.9
Delta → -50.0
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Day 6
Placebo
No events - 5 (50.0%)
1 event - 3 (30.0%)
2 events - 2 (20.0%)
Active
No events - 1 (6.7%)
1 event - 7 (46.7%)
2 events - 2 (13.3%)
3 events - 4 (26.7%)
5 events - 1 (6.7%)
Day 7
Placebo
No events - 4 (40.0%)
1 event - 4 (40.0%)
2 events - 1 (10.0%)
7 events - 1 (10.0%)
Active
No events - 3 (20.0%)
1 event - 5 (33.3%)
2 events - 4 (26.7%)
3 events - 1 (6.7%)
4 events - 2 (13.3%)
Oramed ORA-D-010 - Key Top Line Results
Hypoglycemic Events
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THANK YOU