Oramed Pharmaceuticals Inc (ORMP)

[Billy987]

New Canaccord Genuity Report. Posted on another forum.

Negative, unauthored piece creates ideal buying opportunity on sell-off
Shares of ORMP closed down yesterday 28.5% and were down ~8% this morning. We attribute the sell-off to the online posting of a negatively-biased piece with no
attribution to authorship. We spoke with management first thing this morning regarding
the sell-off.
The CEO stated that the company has hired an outside firm to investigate the online posting in depth and to try to identify the author(s) of the report. The company will
likely turn this over to the SEC for further investigation.
We do not believe the report has any merit. The factual points that were addressed in the report have been well known and were reviewed in our own due diligence efforts before initiating coverage on Oramed (see our initiation of coverage). The management team is compensated very much in line with the prevailing standards of most publicly traded biotech companies. Additionally, the clinical studies conducted by Oramed todate for type 2 diabetes were, in our view, sufficiently designed with adequate dosing duration to deliver the signal and results needed to move into Phase III testing. The studies that were conducted were of the size expected from a biotech company and of course not of the size and magnitude in early studies that a large pharmaceutical company would conduct over multiple years. Importantly, both ongoing Phase III trials for type 2 diabetes have been designed with input from the FDA and are similar in design and powering to most approved drugs for type 2 diabetes.

ORMD-0801 Phase III enrollment remains strong
Additionally, this morning the company announced that the Phase III ORA-D-013-1 study of the oral insulin ORMD-0801 for type 2 diabetes (T2D) treatment has reached a patient enrollment of 75%. This trial is one of the two ongoing Phase III trials being conducted by Oramed in patients with type 2 diabetes.
ORA-D-013-1 is the larger study being conducted in the U.S. with T2D patients who are currently on two to three oral blood glucose-lowering medications and have inadequate glycemic control over a period of six to 12 months. The trial intends to enroll 675 patients. Top-line data is expected in 1H23.
The second Phase III study, ORA-D-013-2, is recruiting 450 T2D patients in the U.S., Western Europe, and Israel. Patients participating in this study are managing
their diabetes with either diet alone or with diet and metformin. In August 2021, the company stated that this study had enrolled and randomized over 25% of the planned 450 patients.
We are pleased to see the fast enrollment of both Phase III trials. Oramed is also at the final stages of submitting data from the statistically significant second Phase IIb trial examining ORMD-0801's effect on HbAc1 to a peer-reviewed journal.
We stand by our analyses and continue to maintain our BUY rating of the share and the $30 price target.