Phase III Success and Clinical Validation
Completed SHIELD II Phase III trial; D-PLEX100 met its primary endpoint and all key secondary endpoints, demonstrating a meaningful reduction in surgical site infections. External clinical engagement (KOL webinar with Dr. Steven D. Wexner) reinforced trial design and real-world relevance.
Regulatory Progress — FDA Pre‑NDA Feedback and Rolling NDA Plan
Received positive written feedback from the FDA after the pre‑NDA meeting: agency agreed the existing clinical data package is adequate to support an NDA and supported a rolling NDA submission. Company expects to begin rolling submission by end of Q1 2026 and anticipates an accelerated review (priority/6‑month review due to Fast Track / Breakthrough designations).
Advanced U.S. Partnership Discussions
Moved into advanced, operationally detailed U.S. partnership discussions with potential hospital-focused commercial partners; due diligence progressing and discussions driven by partners with hospital and surgical suite capabilities.
Technology & Pipeline Expansion — Kynatrix and GLP‑1 Program
Formally introduced Kynatrix as next‑generation controlled-release/delivery platform (collects expanded IP and capabilities beyond PLEX). Launched an ultra‑long‑acting GLP‑1 receptor agonist preclinical program targeting ~60+ day exposure, representing a systemic/metabolic expansion of the platform and a potential early partnering opportunity.
Corporate & Commercial Readiness
Refreshed corporate brand and website to support commercialization orientation. Appointed Brooke Story as Chair of the Board (experience at Becton Dickinson and Medtronic) to guide strategic commercialization and partner engagement.
Financial Actions and Expense Tailoring
Q4 2025 R&D expense decreased to $6.2M from $7.0M year‑ago (≈11.4% decrease) reflecting completion of Phase III and shift to regulatory activities. Subsequent warrant exercises generated $3.7M gross proceeds post‑quarter, and company reports $12.9M cash and short‑term deposits as of Dec 31, 2025; management believes cash resources sufficient to fund operations into H2 2026.