A clear, capital-efficient path through IND-enabling studies, Phase Ib, Phase IIb and strategic partnership — built around the value inflections that matter to patients and to capital.
In-vitro efficacy across 3 cell lines; murine excisional model showed 42% accelerated closure; diabetic rat model demonstrated ~90% closure by Day 10. Non-GLP toxicology established NOAEL with no adverse events.
Shelf-stable topical formulation finalized. ICH Q1A long-term and accelerated stability demonstrated >95% purity at 25°C/60% RH for 24 months and 40°C/75% RH for 6 months.
FDA pre-IND interaction requested. GLP toxicology studies in pig models underway. CMC scale-up initiated for clinical supply.
Regulatory documentation finalized for FDA IND submission. Quality systems implementation. Clinical trial site activation begins.
Safety, tolerability and preliminary efficacy in diabetic-foot-ulcer patients. Read-out provides first-in-human signal for partners and regulators.
Randomized, controlled study vs. standard of care. Primary endpoint: complete wound closure at 12 weeks. Major value inflection.
Seek pharma partnership or out-licensing for Phase III. Concurrent NDA preparation activities for accelerated regulatory pathway exploration.
A disciplined, milestone-driven capital plan to complete GLP toxicology and execute Phase I — the two events that re-rate biotech assets like ours.
Pig-model GLP tox, ADME, and IND-enabling safety package.
cGMP scale-up, quality systems, clinical supply manufacture.
60-patient open-label DFU study including site activation and clinical operations.
Pig-model GLP tox, ADME, and IND-enabling safety package.
| IP Asset | Type | Status |
|---|---|---|
| Core Composition of Matter | Full US Patent | Compound & analogs · projected exclusivity to 2044+ |
| Formulation | US Provisional | Shelf-stable topical-gel formulation |
| Method of Treatment | US Provisional | Wound healing indications across DFU, VLU, pressure, surgical |
| Manufacturing Know-How | Trade Secret | Process know-how & analytical methods |
Zegen-X5 is the lead. Several additional preclinical programs are in development — extending the platform across adjacent regenerative-medicine indications.
Diabetic foot ulcers · IND-enabling · Phase Ib 2026
Venous leg ulcers · preclinical · candidate-selection stage
Burns & trauma · early discovery · adjacent indication
Detailed clinical-development protocol, milestone-based budget, and projected value inflections are available to qualified partners under NDA.
A preclinical-stage biopharmaceutical company developing first-in-class, shelf-stable wound healing therapeutics — making advanced care accessible everywhere.
