MediWound (MDWD) investor relations material

Strategy and pipeline

• Bromelain-based enzymatic platform has 150+ publications, 14 successful clinical trials, and approvals from FDA, EMA and Japan; NexoBrid is the first revenue-generating product.

• EscharEx uses the same product at a different concentration for a larger market; near-term focus is the Phase III VALUE trial in venous leg ulcers (VLU).

• Diabetic foot ulcer and pressure ulcer indications are planned to advance alongside the VLU program; discussions with large companies cover indications related to eschar removal in burns and wounds.

EscharEx VALUE trial

• Global Phase III study compares EscharEx with placebo for the first 2 weeks, followed by standardized treatment; targets 216 patients across ~40 sites, with most sites actively recruiting.

• Independent interim review after ~65% enrollment, or ~140 patients, reassesses trial assumptions and sample size; management cited an 85%-90% modeled probability of success under the initial assumptions.

• Recruitment completion was expected in Q1 2027; sample size increases could extend timing, with ~3 months cited for an additional 50 patients and top-line results expected 3 months after the interim.

• Management said VALUE need not match Phase II effect sizes; a marginal advantage over placebo could be sufficient, while Phase II results were described as excellent.

• Management identified VALUE enrollment, safety and top-line results as the key near-term catalysts; the independent monitoring committee’s safety review did not require a change in trial handling.

NexoBrid commercialization and manufacturing

• Vericel reported ~80 U.S. burn centers had ordered NexoBrid; adoption requires gradual changes to burn-center protocols and utilization is expected to deepen over time.

• Current manufacturing capacity limits supply; the expanded facility is expected to support global demand, with management hoping for higher sales after it is running in mid-2027.

• Facility changes requested by European inspectors were described as operational and expected to be completed by year-end; production would then start, with inspections possible after 3 and 6 months and first European approval expected around mid-2027.

• The 10-year BARDA contract is valued at up to $197 million; procurement includes Vericel purchases from MediWound, and management cited Vericel’s statement that two-thirds of the agreement is Vericel revenue.

• A U.S. backup manufacturing facility under the government agreement was estimated to be ~4 years away and not expected to affect near-term revenue; the new facility has capacity for global demand.