Oramed Pharmaceuticals Inc. Issues Letter to Shareholders

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Dear Friends, Shareholders and Associates, As we recently entered into the New Year, I thought this would be a good opportunity to reflect on the achievements of this past year while also looking forward to the coming one. I am very proud to highlight the following milestones which we accomplished: Positive Data from Phase IIa Studies of ORMD-0801 in Type 1 and Type 2 Diabetes In early 2014, we reported positive data from our Phase IIa study of ORMD-0801 to treat type 2 diabetes. The data showed ORMD-0801 to be safe and well-tolerated. Importantly, the decreases in blood glucose observed were not associated with any hypoglycemic events and no treatment related adverse events were observed. We are very encouraged by the positive trends showing a pattern of well-defined and short-term increases in plasma insulin and decreases in blood glucose. In addition, in October 2014, we reported positive top-line data from our Phase IIa clinical study of ORMD-0801 in type 1 diabetes patients. The data showed that ORMD-0801 appeared to be safe and well-tolerated for the dosing regimen in this study and no treatment related adverse events were observed. There were internally consistent trends observed showing a decrease in rapid acting insulin, a decrease in post-prandial glucose and a decrease in daytime glucose. The successful conclusion of these two trials allow us to move forward with our planned U.S. Phase IIb trial in individuals with type 2 diabetes, which will investigate ORMD-0801 over a longer treatment period and which will have statistical power to give us greater insight into the drug's efficacy. We have received Institutional Review Board (IRB) approval and anticipate initiating this trial within the next 90 days. Financing In November 2014, we successfully closed a $5 million investment from Guangxi Wuzhou Pharmaceutical Co., Ltd., a subsidiary of Guangxi Wuzhou Zhongheng Group Company Ltd. Wuzhou is a publically traded company on the Shanghai Stock Exchange, with a market capitalization of over $3 billion. Wuzhou's main businesses consists of the manufacturing of pharmaceuticals, including cardiovascular drugs, medicine for bruises, gynecology medication and other general drugs. The shares were sold in a private placement at the market price, without discount or warrant coverage, minimizing the dilutive effect to existing shareholders. This investment enhances Oramed's cash position, which will allow us to continue to execute on our clinical development activities. To date, our interactions with Wuzhou as a shareholder have been very fruitful and have opened new avenues for us and provided us with new options to explore possibilities in the Asian market. Intellectual Property Throughout the past year we have made inroads in strengthening our intellectual property portfolio. We were granted patents in multiple jurisdictions including the European Union, Russia, Australia and Israel amongst other areas. We will continue to build our patent portfolio with the intention of fortifying our patent position in oral insulin delivery, while creating additional barriers to entry for any would-be competitors. Looking ahead to 2015, we have a number of exciting and potentially value-creating developments including: ORMD-0801 Phase IIb Initiation We are happy to report that we intend to initiate our U.S. Phase IIb trial for oral insulin in the next 90 days. The trial's protocol includes approximately 30 U.S. sites covering approximately 180 patients and has both efficacy and safety as its primary end-points. The Phase IIb trial initiation has been made possible following the successful conclusion of the two Phase IIa trials mandated by the U.S. Food and Drug Administration (FDA) in both type 1 and type 2 diabetes patients, which we believe convincingly demonstrated that the oral administered insulin (ORMD-0801) was absorbed and successfully decreased blood glucose levels. ORMD-0901 Development Our oral GLP-1 project is also on track, and we anticipate an exciting 2015. We recently initiated IND-enabling studies, as per the guidance we received from the FDA. We then intend to file an IND and move immediately and directly into a large Phase II multi-center trial in the U.S. We completed the revamping of our website and launched it this past week. Please visit us at http://www.oramed.com. We are on the threshold of what we expect to be a very exciting year ahead - and we look forward to sharing news of our progress throughout the coming year. Sincerely, Nadav Kidron, CEO
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