– Oral insulin program continues to advance with topline efficacy data expected in H2 2022
– Significant value creation opportunities through oral COVID-19 vaccine program and partnerships
– Well positioned to capitalize on opportunities with strong cash balance of ~$174 million as of December 3, 2021
NEW YORK, Jan. 12, 2022 /PRNewswire/ — Oramed Pharmaceuticals Inc. (NASDAQ:ORMP) (TASE: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today issued a Letter to Shareholders from its Chief Executive Officer, Nadav Kidron. To see a video message from the CEO please click here: https://www.youtube.com/watch?v=vgq1I7ylKsk
Dear Shareholders,
2021 was a defining year for Oramed as we advanced existing programs, added a new significant opportunity to address a major unmet medical need, and strategically positioned our organization to execute on anticipated 2022 milestones and beyond.
Our proprietary platform oral delivery technology has positioned the company with two potential world firsts: an oral insulin capsule and an oral triple antigen COVID-19 vaccine. Throughout 2021, the lion’s share of our clinical efforts focused on the successful enrollment of subjects in the world’s first pivotal Phase 3 trials for oral insulin under an FDA protocol. We anticipate topline, 6-month efficacy results, in H2, 2022. At the height of the pandemic, we along with our partner, Premas Biotech, developed a novel, proprietary oral COVID-19 vaccine via our majority-owned subsidiary, Oravax Medical. Forging ahead into 2022 with ~$174 million (unaudited) on our balance sheet as of December 3, 2021, and an expanded management team, we believe we are well positioned to complete our Phase 3 oral insulin trials and to advance Oravax’s oral COVID-19 vaccine through late-stage clinical trials for potential emergency use authorization in select countries where it is most needed.
Phase 3 Oral Insulin (ORMD-0801) Trials for the Treatment of Type 2 Diabetes: Over 75% Enrollment Completed
ORA-D-013-1, the larger of two concurrent Phase 3 oral insulin trials, has enrolled over 75% of the 675 subjects planned for the U.S.-based trial. Additionally, more than a quarter of the planned 450 patients in our second Phase 3 trial, ORA-D-013-2, have been enrolled.
Upcoming Milestones:
- 6-month topline efficacy results from larger ORA-D-013-1 trial expected in 2022
- ORA-D-013-2 trial expected to complete enrollment in 2022
