MediWound Advances EscharEx Phase III VALU Trial as Updated U.S. Market Assessment Tops $1 Billion
核心洞察
MediWound reported second-quarter 2026 revenue of $3.1 million, down 45.6% year over year, primarily reflecting the timing of BARDA-funded development revenue.
The EscharEx Phase III VALU trial in venous leg ulcers (搜索) remains on track, with interim sample-size reassessment and enrollment completion expected by the end of Q1 2027.
An updated independent U.S. market assessment, expanded to include pressure ulcers (搜索), now projects $1.05 billion in annual peak sales for EscharEx.
MediWound reported second-quarter 2026 revenue of $3.1 million, a 45.6% decline from $5.7 million in the prior-year period, a decrease management attributed primarily to the timing of BARDA-funded development revenue. The company's core strategic narrative centered on pipeline execution for its enzymatic debridement candidate EscharEx and the continued expansion of NexoBrid's government-backed franchise.
EscharEx Phase III VALU Trial Advances Toward Key Milestones
The global Phase III VALU trial in venous leg ulcers (搜索) (VLU) remains MediWound's top development priority and key long-term value driver. The study targets 216 patients across approximately 40 sites in the United States, Europe, and Israel. Management confirmed that both the pre-specified interim sample-size reassessment and completion of enrollment are expected by the end of the first quarter of 2027.
"We do not need any improvement or changes in trends. We are on track," said Chief Executive Officer Ofer Gonen, while declining to disclose specific enrollment numbers to protect study integrity. The company reported it is within less than 10% of having all targeted sites actively recruiting. If the trial proceeds as planned, top-line data is expected roughly one quarter after the interim assessment, with final results following several months later.
Updated Market Assessment Expands to Pressure Ulcers
During the quarter, an independent global consulting firm completed an updated U.S. market assessment. Following expansion of the analysis to include pressure ulcers (搜索), the assessment now estimates U.S. annual peak sales for EscharEx at $1.05 billion, up from a prior estimate in the $800 million range that excluded pressure ulcers.
"This analysis further strengthened our view that EscharEx across multiple chronic wound indications has the potential to address a substantial market opportunity," Gonen said. The company's collaboration network now spans essentially all major advanced wound care companies, including Coloplast, ConvaTec, Mölnlycke, Solventum, B. Braun, and MIMEDX.
MediWound also outlined plans to broaden EscharEx's clinical footprint. A randomized Phase II study in diabetic foot ulcers (搜索) (DFU) is expected to enroll 50 patients in a 1:1 design comparing EscharEx versus placebo, with time to complete debridement as the primary endpoint, starting in the fourth quarter of 2026. An investigator-initiated, open-label study in pressure ulcers (搜索), enrolling approximately 10 to 15 patients, is also expected to begin in the fourth quarter of 2026. Following the VALU readout, the company plans to approach the FDA to determine requirements for pursuing DFU and pressure ulcer approvals.
Competitive Positioning Against Second-Generation SANTYL
Addressing analyst questions about Smith & Nephew's interest in a second-generation SANTYL, Executive Vice President of Strategy and Corporate Development Barry Wolfenson noted that the molecule, SN-514, is being developed by Certa Therapeutics (搜索), a company in which Smith & Nephew has invested. "Based on all the publicly available information we've been able to see, we're not aware of this drug having entered into any clinical development in chronic wound patients," Wolfenson said. "EscharEx, as you know, is already in Phase III in chronic wounds, and that gives us what we believe to be a substantial clinical lead."
NexoBrid Commercial Momentum and Government-Backed Expansion
Vericel reported NexoBrid's strongest quarter since launch, with record quarterly revenue, hospital unit sales, and ordering centers. Approximately 80 U.S. burn centers have ordered the product since launch. Following Vericel's 10-year BARDA contract valued at up to $197 million, MediWound signed a master service agreement (MSA) covering NexoBrid and next-generation product development activities, with revenue recognition expected to begin in the second half of 2026.
The first development program under the MSA supports a potential expansion into blast and friction-related injuries, leveraging real-world evidence. Vericel expects approximately $6 million of BARDA procurement revenue in the second half of 2026. MediWound also continues to advance a room-temperature stable formulation of NexoBrid for battlefield burn care, supported by non-dilutive funding from the Department of War with a total program budget of $18.3 million.
Manufacturing Facility and Regulatory Timeline
MediWound is implementing modifications requested by the European Medicines Agency (EMA) following a pre-audit of its expanded NexoBrid manufacturing facility. Gonen clarified that the EMA feedback was "operational in nature, not related to product quality, safety or comparability concerns," and that the modifications will be completed in the fourth quarter of 2026, not 2027. Commercial supply from the expanded facility remains subject to regulatory approval and is expected in the second half of 2027, with manufacturing expected to begin in early 2027.
Management emphasized that current NexoBrid sales are constrained by manufacturing capacity rather than demand, with inventory described as essentially zero in most territories. "The demand is there. Second half of 2027, we can sell significantly more than we are selling now," Gonen said.
Financial Results and Guidance
Research and development expenses rose 68.6% to $5.9 million in the quarter, funding the VALU study. Operating loss was $9.5 million, compared with $5.7 million in the prior-year period. Net loss narrowed to $7.4 million, or $0.57 per share, from $13.3 million, or $1.23 per share, helped by non-cash financial income. Adjusted EBITDA loss widened to $8.3 million from $4.5 million.
The company ended June 2026 with approximately $36 million in cash, cash equivalents, and deposits, down from $54 million at year-end 2025, reflecting $20 million of first-half cash burn. Management reaffirmed full-year 2026 revenue guidance of $24 million to $26 million, with a pronounced second-half weighting tied to the Vericel MSA, product supply contracts, and other government-funded programs.