- Key points from this morning's call hosted by Oramed Pharmaceuticals (NASDAQ:ORMP -7.5%) regarding its announcement of successful results in a Phase 2b clinical trial assessing lead product candidate ORMD-0801, its oral insulin capsule, in type 2 diabetics:
- ORMD-0801 will advance to Phase 3. Strategic partners sought.
- Pooled data combined 16 mg and 24 mg dose cohorts. Awaiting results from various additional glucose measures, including continuous monitoring. Will be shared as soon as feasible. Primary endpoint is what's important. Secondary endpoints only exploratory? Hemoglobin A1c levels: need three-month data, only have one-month at present. No specific timelines given. Meeting with FDA will be scheduled as soon as possible.
- Results from individual doses may be shared at a later time, but study was based on pooled data so not a priority at this point.
- Co. believes oral insulin may enable treatment earlier in T2D.
- One case of hypoglycemia in placebo group, one in the pooled group.
- Current cash position: ~$36M. $10M - 15M in new capital expected in near term. More $ needed for Phase 3.
- Investors are getting less enthused about the data. Shares have reversed and are now down 5%.