EscharEx Phase III Progress and Expanded Clinical Program
Enrollment ongoing in global Phase III VALUE study with >30 active sites across the U.S., Europe and Israel and ~40 sites expected to be active within weeks; interim sample size reassessment and enrollment completion targeted by end of Q1 2027. Additional EscharEx development: DFU Phase II and investigator-initiated pressure ulcer study planned H2 2026, head-to-head Phase II vs collagenase planned, and required PK/human factors studies slated to start H2 2026.
Broad Industry Collaborations for EscharEx
Expanded collaboration network includes Medline (joining this quarter), Coloplast/Kerecis, Convatec, Essity, Mölnlycke, Solventum, B. Braun and MIMEDX — effectively covering major advanced wound care players; Medline to supply Marathon skin protectant for upcoming DFU trial.
Strong Strategic and Government Support for NexoBrid
Vericel awarded a 10-year BARDA contract valued up to $197M (to begin procurement and development H2 2026), building on ~$138M previously received from BARDA/Department of War over past decade; continued commercial adoption and guideline recognition (new national recommendations in Japan and U.K. added to WHO and several countries).
Manufacturing Progress and Regulatory Work Underway
Completed EMA pre-audit for expanded NexoBrid manufacturing facility; identified operational modifications being implemented with expected completion in H2 2026. U.S. inspection by FDA planned early 2027 following EMA/other agency activities.
Gross Margin Improvement Despite Revenue Drop
Q1 2026 gross profit $0.3M with gross margin 21.9% vs Q1 2025 gross margin 18.7% — margin improved by ~3.2 percentage points despite lower revenue, indicating cost or mix improvements.
Reaffirmed Full-Year 2026 Revenue Guidance
Company reaffirmed 2026 revenue guidance of $24M to $26M, expecting revenue to be weighted to the second half of the year driven primarily by government-related procurement and development services.