About Oramed Pharmaceuticals

Oramed Pharmaceuticals Inc., a pharmaceutical company, engages in the research and development of innovative pharmaceutical solutions with a technology platform that allows for the oral delivery of therapeutic proteins. Through the company’s research and development efforts, the company has developed an oral dosage form intended to withstand the harsh environment of the stomach and effectively deliver active biological insulin or other proteins. The excipients in the formulation are not intended to modify the proteins chemically or biologically, and the dosage form is designed to be safe to ingest. The company plans to continue to conduct clinical trials to show the effectiveness of the company’s technology. On January 11, 2023, the company announced that its Phase 3 trial, or the ORA-D-013-1 Phase 3 trial, did not meet its primary and secondary endpoints. As a result, the company terminated both ORA-D-013-1 and ORA-D-013-2 Phase 3 clinical trials. In parallel, the company has initiated a comprehensive analysis of the data to understand if there is a path forward for the company’s oral insulin candidate. The company is examining its existing pipeline and have commenced an evaluation process of potential strategic opportunities, with the goal of enhancing value for the company’s stockholders. Research and Development Oral insulin Type 2 Diabetes: The company conducted the ORA-D-013-1 Phase 3 trial on patients with type 2 diabetes, or T2D, with inadequate glycaemic control who were on two or three oral glucose-lowering agents. The primary endpoint of the trial was to evaluate the efficacy of the company’s oral insulin capsule, ORMD-0801, compared to placebo in improving glycaemic control as assessed by HbA1c, with a secondary efficacy endpoint of assessing the change from baseline in fasting plasma glucose at 26 weeks. On January 11, 2023, the company announced that the ORA-D-013-1 Phase 3 trial did not meet its primary and secondary endpoints. Following the results of the ORA-D-013-1 Phase 3 trial, the company also terminated the ORA-D-013-2 Phase 3 trial, a second Phase 3 trial that included T2D patients with inadequate glycaemic control who were attempting to manage their condition with either diet alone or with diet and metformin. NASH: In December 2020, the company initiated a double blind, placebo controlled clinical trial of ORMD-0801 for the treatment of non-alcoholic steatohepatitis, or NASH, in T2D. On September 13, 2022, the company reported positive top line results from this trial, demonstrating 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. All the measurements showed a consistent clinically meaningful trend in favor of ORMD-0801. The company is evaluating its path forward for ORMD-0801 for NASH. Oral Vaccine On March 18, 2021, the company entered into a license agreement, or the Oravax License Agreement, with Oravax, the company’s 63% owned joint venture, pursuant to which the company granted to Oravax an exclusive, worldwide license of the company’s rights in certain patents and related intellectual property relating to the company’s proprietary oral delivery technology to further develop, manufacture and commercialize oral vaccines for COVID-19 and other novel coronaviruses based on Premas Biotech Pvt. Ltd.’s, or Premas’s, proprietary vaccine technology involving a triple antigen virus like particle, or the Oravax product, which was previously owned by Cystron Biotech LLC, and later acquired by Akers Biosciences Inc., or Akers. Effective January 1, 2022, Oravax transferred its rights and obligations under the Oravax License Agreement to its wholly-owned subsidiary, Oravax Medical Ltd. In October 2021, Oravax’s oral virus-like particle, or VLP, COVID-19 vaccine received clearance from the South African Health Products Regulatory Authority (SAPHRA) to initiate a Phase 1 trial. On December 14, 2021, Oravax screened and enrolled the first participant in this Phase 1 clinical trial. The trial protocol was divided into two cohorts each consisted of 12 participants, with a 42-day safety waiting period between cohorts. On October 11, 2022, Oravax reported positive preliminary Phase 1 data for Cohort A of this trial, meeting primary and secondary endpoints of safety and immunogenicity. These results included significant antibody response (2-6 fold over baseline) as measured by multiple markers of immune response to VLP vaccine antigens observed in the majority of the patients dosed, and no safety issues were observed, including mild symptoms. Cohort B completed dosing on January 5, 2023 and data is expected in the first half of 2023. On December 29, 2021, Oravax signed a cooperation and purchase agreement for an initial pre-purchase of 10 million doses of oral COVID-19 vaccines with Tan Thanh Holdings to commercialize the vaccine in Southeast Asia. Raw Materials The company’s oral insulin capsule is manufactured by Fidelio Healthcare, a diversified European Contract Development and Manufacturing Organization (CDMO) in the pharmaceutical and healthcare industries. In July 2010, Oramed Ltd. entered into the Manufacturing and Supply Agreement with Sanofi-Aventis Deutschland GMBH, or Sanofi-Aventis. According to the agreement, Sanofi-Aventis supplies Oramed Ltd. with specified quantities of recombinant human insulin to be used for clinical trials. Intellectual Property and Patents The company holds 37 patent applications pending, with respect to various compositions, methods of production and oral administration of proteins and exenatide. Expiration dates for pending patents, if granted, will fall between 2026 and 2039. The company holds 112 patents, twenty of which were issued during the year ended December 31, 2022, including patents issued by the United States, Swiss, German, French, the U.K., Italian, the Netherlands, Swedish, Spanish, Australian, Israeli, Japanese, New Zealand, South African, Russian, Canadian, Hong Kong, Chinese, European and Indian patent offices that cover a part of the company’s technology, which allows for the oral delivery of proteins; patents issued by the Australian, Canadian, European, Austrian, Belgian, French, German, Irish, Italian, Luxembourg, Monaco, the Netherlands, Norwegian, Spanish, Swedish, Swiss, the U.K., Israeli, New Zealand, South African, Russian, Brazilian and Japanese patent offices that cover part of the company’s technology for the oral delivery of exenatide; and patents issued by the European, Austrian, Belgian, Denmark, French, German, Irish, Italian, Luxembourg, Monaco, the Netherlands, Norway, Spanish, Swedish, Swiss, the U.K. and Japanese patent offices for treating diabetes. Trademarks and Trade Secrets The company has trademark applications pending in Israel, with Corresponding international trademark applications in Australia, Brazil, Canada, China, Colombia, the European Union, India, Indonesia, Japan, Kazakhstan, Korea, Malaysia, Mexico, New Zealand, Norway, Oman, the Philippines, Russia, Singapore, Switzerland, Thailand, Turkey, Ukraine, the United Arab Emirates, the United Kingdom, the U.S.A., Uzbekistan and Vietnam. Out-Licensed Technology Entera Bio In June 2010, the company’s wholly-owned subsidiary, Oramed Ltd., entered into a joint venture agreement with DNA GROUP (T.R.) Ltd., or DNA, for the establishment of Entera Bio Ltd., or Entera. In March 2011, Oramed Ltd. sold shares of Entera to DNA, retaining 117,000 ordinary shares (after giving effect to a stock split by Entera in July 2018). In consideration for the shares sold to DNA, the company received, among other payments, ordinary shares of DNA. As of December 31, 2022, the company held approximately 1.4% of DNA’s outstanding ordinary shares and approximately 0.4% of Entera’s outstanding ordinary shares. HTIT On November 30, 2015, the company entered into a Technology License Agreement, or TLA, with Hefei Tianhui Incubator of Technologies Co., Ltd., or HTIT, and on December 21, 2015, these parties entered into an Amended and Restated Technology License Agreement that was further amended by the parties on June 3, 2016 and July 24, 2016, or the HTIT License Agreement. According to the HTIT License Agreement, the company granted HTIT an exclusive commercialization license in the territory of the People’s Republic of China, Macau and Hong Kong, related to the company’s oral insulin capsule, ORMD-0801, or the Product. On August 21, 2020, the company received a letter from HTIT, disputing certain pending payment obligations of HTIT under the TLA. The company wholly disputes said claims and the company is in discussions with HTIT in an attempt to reach a mutually agreeable solution. The company is evaluating with HTIT a path forward to continue the company’s collaboration, following the results of the company’s ORA-D-013-1 Phase 3 trial. Medicox License On November 13, 2022, the company entered into a distribution license agreement with Medicox Co., Ltd., or Medicox. an emerging biotech company with a consortium of proven partnerships in the Republic of Korea. The agreement grants Medicox the exclusive license to apply for regulatory approval and distribute ORMD-0801 for ten years in the Republic of Korea. Medicox will also be responsible for gaining regulatory approval in the Republic of Korea. The company is evaluating with Medicox a path forward to continue the company’s collaboration, following the results of the company’s ORA-D-013-1 Phase 3 trial. Government Regulation Various federal, state and local laws, regulations, and recommendations relating to safe working conditions, laboratory practices, the experimental use of animals, the environment and the purchase, storage, movement, import, export, use, and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with the company’s research are applicable to its activities. They include, among others, the U.S. Atomic Energy Act, the Clean Air Act, the Clean Water Act, the Occupational Safety and Health Act, the National Environmental Policy Act, the Toxic Substances Control Act, and Resources Conservation and Recovery Act, national restrictions on technology transfer, import, export, and customs regulations, and other present and possible future local, state, or federal regulation. Research and Development The company’s research and development expenses were $27,639,000 for the year ended December 31, 2022. History Oramed Pharmaceuticals Inc. was founded in 2002. The company was incorporated in 2002 under the laws of the state of Nevada.