Oramed Pharmaceuticals Inc. announced additional positive data from its Phase 2 double-blind, fully randomized, placebo-controlled, multicenter clinical trial (ORA-D-N02) to assess the safety and efficacy of its oral insulin candidate (ORMD-0801), to reduce liver fat content in Type 2 Diabetes patients with non-alcoholic steatohepatitis ("NASH"). The presentation of this new data, including a discussion by key opinion leaders, was featured in a webinar with a replay available on Oramed's website under Events and Presentations. As previously announced, the Phase 2 trial enrolled 32 patients (with 30 patients completing) over a treatment period of 12-weeks.

The trial demonstrated that ORMD-0801 was safe and well tolerated at 8 mg twice daily dosing, meeting the primary endpoint of no difference in adverse events for ORMD-0801 compared to placebo. The trial also evaluated the effectiveness of ORMD-0801 in reducing liver fat content over the 12-week treatment period by observing several independent measures. These measurements included MR PDFF (%) as measured by MRI, Steatosis and Fibrosis as measured by Fibroscan, Lipids and HbA1c.

All the measurements showed a consistent clinically meaningful trend in favor of ORMD-0801. Safety Data Summary: Primary objective of safety met with no serious adverse events and no difference in the incidence rate of adverse events between ORMD-0801 and placebo. Efficacy Data Summary Overall, the Phase 2 trial achieved the proof of concept that ORMD-0801 may be a potential candidate for the reduction in liver fat and stiffness and lipids in patients with T2D and NASH.

condaryry objective of reducing liver fat content in patients with NASH anT2D (Percent Change from Baseleline to Week 12 in MR PDFF (%): Whole Liver showed a placebo adjusted mean decrease of 0.96 with a placebo adjusted median decrease of 6.0 for ORMD-0801. Exploratory objective of median change from baseline in Fibroscan fibrosis levels:- Median Change from Baseline to Week 12 in Fibrosis Median (kPa) showed a placebo adjusted median decrease of 1.1 for ORMD-0801. - Median change from Baseline to Week 12 in Steatosis Median (dB/m) showed a placebo adjusted median decrease of 29 for ORMD-0801.

Exploratory objective of change from baseline in Lipid levels:- Mean Change from Baseline to Week 12 in Total Cholesterol (mmol/L) showed a placebo adjusted mean decrease of 0.40 for ORMD-0801.- Results were similar for LDL, HDL and Triglycerides.