Press release
Oramed Pharmaceuticals Issues CEO Shareholder Letter Providing Business Update Amid COVID-19
- Oral insulin FDA End-of-Phase 2 meeting expected this quarter - Strong balance sheet with roughly $50M in cash - NASH intermediate study data expected this
About this update from Oramed Pharmaceuticals Inc.
[{"type":"text","content":"- Oral insulin FDA End-of-Phase 2 meeting expected this quarter\n - Strong balance sheet with roughly $50M in cash\n - NASH intermediate study data expected this quarter\n\n\nNEW YORK, April 1, 2020 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, is pleased to provide the following Letter to Shareholders from Chief Executive Officer Nadav Kidron.\n\n \n \n \n \n \n \n\n \nDear Shareholders,\nAs the world faces an unprecedented challenge with much uncertainty, we at Oramed wanted to provide our shareholders and other constituents with an update on our business. Over the past weeks, we have closely followed the guidance of governments and leading public health institutes to ensure the safety of our employees. Additionally, we have conducted a business review to assess the potential impact of COVID-19. At this time, we continue to move ahead with all strategic initiatives and anticipate limited long-term impact from COVID-19. As our platform technology could be effective for protein-based vaccines, we are closely monitoring developments on the efforts to find a vaccine for COVID-19 and any potential partnerships on this front.\nOral Insulin (ORMD-0801) We are moving ahead with the planning for our oral insulin (ORMD-0801) Phase 3 clinical studies and have accomplished several key milestones to this end. In February, Oramed conducted its initial End-of-Phase 2 (EoP2) meeting with the U.S. Food and Drug Administration (FDA) to discuss Chemistry Manufacturing and Control (CMC) of ORMD-0801 (Press Release dated March 19, 2020). The meeting followed the successful completion of Oramed's Phase 2b study of ORMD-0801 for the treatment of type 2 diabetes (Press Release dated November 12, 2019), which achieved its primary endpoint. During the meeting, the FDA provided feedback on key issues relating to Drug Product manufacturing. We are also looking forward to the second of the EoP2 meetings with FDA. This meeting will include a discussion of the results from the Phase 2 study and the design of the Phase 3 clinical studies proposed to support a license application for a Type 2 diabetes indication if the Phase 3 studies are successfully completed. During this meeting, we anticipate receiving the FDA's gui...