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Biotech On Track for Trio of Drugs in Clinical Trials in 2021
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The next steps for advancing Oramed Pharmaceuticals' oral therapy candidates are provided in an H.C. Wainwright & Co. report.

In a Dec. 28 research note, H.C. Wainwright & Co. analyst Ram Selvaraju provided an update, including new initial clinical data, on Oramed Pharmaceuticals Inc.'s (ORMP:NASDAQ) top three drug candidates: ORMD-0801 (oral insulin), ORMD-0901 (oral exenatide) and oral leptin.

The biopharma's proprietary platform technology allows for the oral delivery of drugs that now are only administered by injection.

Selvaraju noted that Israel-based Oramed just released initial results from the proof-of-concept study of its oral leptin drug, the third candidate in the pipeline, in patients with type 1 diabetes. Of the 10 patients enrolled for the trial, seven were randomized to receive leptin whereas the other three were to get a placebo.

The data showed that on average, glucose dropped in the patients who received leptin in 30 to 180 minutes after dosing, but it did not decrease in the placebo patients. Further, at various times, the glucagon levels in the leptin-treated patients were either lower than or about the same as those of patients in the placebo cohort.

Oramed intends to move its oral leptin candidate into a Phase 2 study, involving about 30 patients, in 2021.

"Its future successful clinical development could transform Oramed into a true triple threat," wrote Selvaraju.

The analyst then addressed ORMD-0801, Oramed's lead drug candidate, noting that its worldwide pivotal program continues. Next are two Phase 3 studies of this oral insulin, ORA-D-013-1 and ORA-D-013-2, in type 2 diabetes patients with six to 12 months of inadequate glycemic control. For the trials, a total of 1,125 patients will be enrolled at multiple centers.

As far as a possible timeline for ORMD-0801, Selvaraju outlined completion of enrollment in early 2022 with data readout later in the year. Submission of a biologics license application would follow, likely in 2023, with approval by the U.S. Food and Drug Administration in 2024.

Finally, the analyst covered Oramed's second candidate, ORMD-0901, oral exenatide. Based on positive results to date, the company is expected to advance the drug next year, by conducting a bioavailability study in type 2 diabetes patients.

Excluding any valuation for the oral leptin candidate, Dawson James' 12-month price target on Oramed Pharmaceuticals is $17 per share. The stock's current share price is about $4.47. Oramed is rated Buy.

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Disclosures from H.C. Wainwright & Co., Oramed Pharmaceuticals Inc., Company Update, December 28, 2020

Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.

I, Raghuram Selvaraju, Ph.D., certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst's household has a financial interest in the securities of Oramed Pharmaceuticals, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of November 30, 2020 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Oramed Pharmaceuticals, Inc.

Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The firm or its affiliates received compensation from Oramed Pharmaceuticals, Inc. for non-investment banking services in the previous 12 months.

The Firm or its affiliates did not receive compensation from Oramed Pharmaceuticals, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

The Firm does not make a market in Oramed Pharmaceuticals, Inc. as of the date of this research report.

H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.





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