NextCell Pharma (NXTCL) investor relations material

Clinical development and trial results

• ProTrans, a cell therapy using umbilical cord-derived mesenchymal stromal cells, targets autoimmune diseases, primarily type 1 diabetes, with over 90 patients treated in five clinical trials.

• Single infusions show long-term efficacy, preserving insulin production for up to five years, with repeated treatments halting disease progression for six years.

• No severe adverse events reported; higher doses maintain insulin levels, and treated patients avoid BMI increases seen in placebo groups.

• Pediatric phase II-B trial is ongoing, with full one-year data expected after summer and primary endpoint results in Q3 2026.

• Positive trends observed in subgroup analyses, with continued monitoring and expansion into new indications planned.

Commercial strategy and partnerships

• ProTrans is an off-the-shelf, cryopreserved product with a shelf life exceeding five years, requiring no donor-recipient matching.

• Collaboration with FUJIFILM Biosciences enables global sales of cells for research, leveraging their sales force and expanding into cell culturing products.

• Subsidiaries include CellaViva, the largest Nordic stem cell bank, and QVons, a QC analytics company for advanced therapies, both expanding services and product offerings.

• New revenue streams include sales of amniotic tissue for ophthalmology and the addition of placenta tissue to the biobank.

• GMP approval for QVons' QC analysis services is targeted for early next year.

Competitive positioning and future outlook

• Manufacturing process is patent-protected, with proprietary functional and potency assays to select optimal cells.

• Positioned as a second-generation MSC therapy, learning from industry leaders and focusing on product potency and safety.

• Plans to announce new autoimmune indications and expand business-to-business opportunities in the coming year.

• Exploring alternative regulatory pathways for earlier market access in specific regions.

• Confident in product differentiation based on manufacturing and clinical outcomes.