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Tesla Motors CEO Says Model 3 Could Generate Revenue of $20 Billion

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Gold Trading Remains Volatile

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Inching back up

Here's hoping for a strong finish

Oramed's President and CEO

Nadav Kidron, Esq, Chief Executive Officer, President & Director

Mr. Kidron serves as Chief Executive Officer & Director of Oramed Pharmaceuticals, which he co-founded in 2006.

Mr. Kidron is an entrepreneur whose experience includes senior executive roles in a wide range of industries.

He co-founded Entera Bio as a joint venture formed by Oramed and DNA Biomedical Solutions. He is a member of the IATI Board, and an international lecturer on Israel’s entrepreneurial culture and the country’s roots as an oasis of innovative ideas.

He holds a bachelors degree in law and an international masters in business administration, both from Bar-Ilan University in Israel. Mr. Kidron is a fellow of the Merage Business Executive Leadership Program and a member of the Israeli Bar Association.

Oramed Announces $6.5 Million Milestone Payment from HTIT

Payment comes in wake of positive topline phase IIB results

JERUSALEM, June 21, 2016 /PRNewswire/ — Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (www.oramed.com), a developer of oral drug delivery systems, today announced that Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT) is transferring a $6.5 million milestone payment from the previously-announced license and investment agreement between Oramed and HTIT. The payment follows Oramed’s positive top-line results from its Phase IIb U.S. Food and Drug Administration trial designed to evaluate the safety and efficacy of Oramed’s oral insulin capsule ORMD-0801 in patients with type 2 diabetes.

Per the terms of the agreement signed in December 2015, Oramed granted HTIT exclusive rights for commercialization of ORMD-0801 in Greater China. The up to $50 million license deal includes multiple milestone payments aggregating $38 million, with a $3 million upfront payment received by Oramed upon execution of the agreement, plus a $12 million investment made by HTIT in Oramed at $10.39 per share in December 2015. Oramed will receive a 10% royalty on net sales of ORMD-0801 and related commercialized products in Greater China.

“The completion of this milestone signifies our deepening partnership with HTIT as we move closer to bringing oral insulin to the vast and growing Chinese diabetes market,” said Nadav Kidron, CEO of Oramed.

“The positive Phase IIb data has further illustrated the huge potential this technology can have in China,” said HTIT CFO & Oramed Board Member Xiaopeng Li. “We are working diligently to lay the groundwork for the successful production and commercialization of ORMD-0801 focused on the Greater China market.”

The Top Four Diabetes Best Sellers and One Oral Insulin Pill That May Threaten Them All

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Price Target Update

The Phase IIb trial was initiated on June 30, 2015 and conducted at 33 clinical sites in the United States.

The primary objective is the effect of ORMD-0801 on weighted mean night time glucose levels based on 2 nights of Continuous Glucose Monitor (CGM) data by comparison of the mean % change between baseline and week 4 of ORMD-0801 treatment and placebo groups. Safety and tolerability will also be assessed.

This study showed a statistically significant decrease in the primary endpoint, pooled night-time glucose mean percentage change of 6.47% from run-in, between placebo and active cohorts (p=0.0268).

Further, the study demonstrated a good safety profile of ORMD-0801 with no drug related serious adverse events.

The positive top line results will also trigger some milestone payments from HTIT.

The Company plans to present and publish more comprehensive data in the future.

The positive data from the Phase IIb trial is a significant de-risk event for Oramed in our opinion. The top line data further confirm the efficacy and safety of ORMD-0801, an orally delivered intestinally absorbed insulin, from previously reported results including the Phase IIa study.

With the positive top line data from the Phase IIb trial, we believe the company will move forward with a pivotal Phase III trial when they get some feedback from the FDA. We estimate a Phase III trial could start as early as in late 2016 or early 2017.

We Raise Our Valuation

We raise our valuation to $30 per share from previous $25.00 per share based on the positive top line results from the Phase IIb study.

Oramed is a mid-stage development biotech company with a current focus on diabetes. Over the years, the company has developed a unique, proprietary protein oral delivery (POD) platform technology. This is the core value for the company and differentiates the company from other biotech companies in our view.

Base on its POD platform, Oramed has built a pipeline with focus on oral insulin (ORMD-0801) and oral GLP-1 analog (ORMD-0901).

Oral insulin mimics the role of natural insulin, therefore has many advantages over injectable insulins including better control of blood glucose and less side effects. The company has completed a Phase IIa study of ORMD-0801 for T2DM and reported positive data. A Phase IIb study has completed enrollment and the company just reported positive top line data. This is a significant de-risk event for the company. We estimate a pivotal Phase III trial could start in late 2016 or early 2017.

FDA could grant FAST TRACK designation - the stock would rocket

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Business Summary
Oramed Pharmaceuticals Inc. engages in the research and development of pharmaceutical solutions for the use of orally ingestible capsules or pills for delivery of polypeptides. Its product portfolio includes ORMD-0801, an oral insulin capsule that is in Phase IIb clinical trials for the treatment of diabetes; and ORMD-0901, an analog for GLP-1 gastrointestinal hormone, which is in Phase Ib clinical trials for the treatment of type 2 diabetes. The company was formerly known as Integrated Security Technologies, Inc. and changed its name to Oramed Pharmaceuticals Inc. in April 2006. Oramed Pharmaceuticals Inc. was founded in 2002 and is based in Jerusalem, Israel.

Oramed to present at the American Diabetes Association 76th Scientific Sessions

JERUSALEM, June 9, 2016 /PRNewswire/ —

Oramed Pharmaceuticals Inc. (NASDAQ: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that a scientific abstract summarizing a study performed in animals with its orally ingestible insulin capsule, ORMD-0801, will be presented in a poster at the ADA 76th Scientific Sessions on June 11-13, 2016 in New Orleans. The poster was also selected to be included in a moderated tour of select posters.

The American Diabetes Association 76th Scientific Sessions

Poster title: “Pharmacokinetic and Pharmacodynamic Profiles of Orally, Duodenally and Subcutaneously Delivered Insulin in Beagle Canines”

Date: June 11-13, 2016

Location: The Ernest N. Morial Convention Center in New Orleans

About the American Diabetes Association (ADA) Scientific Sessions

The American Diabetes Association’s Scientific Sessions offers researchers and health care professionals from around the world the unique opportunity to share ideas and learn about the significant advances in diabetes research, treatment, and care. Some 16,000 people are expected to attend.

Check out the website

Latest news posted there: http://www.oramed.com/

Nice start for the week

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