Scancell Holdings (SCLP) H.C. Wainwright 28th Annual Global Investment Conference summary

Strategic overview and investment pillars

• Lead program iSCIB1+ is a phase III-ready, off-the-shelf cancer vaccine showing strong efficacy in advanced melanoma.

• Pipeline includes additional Immunobody platform products targeting hard-to-treat cancers and a peptide vaccine, Moditope, in phase II.

• Antibody portfolio includes partnered ADCs and in-house T-cell engagers, expanding collaboration and funding opportunities.

• Merger with Neuphoria Therapeutics provides $95 million in funding and a Nasdaq listing, ensuring runway through early 2029.

• Multiple near-term catalysts include phase III initiation, data readouts, and new studies in perioperative settings.

Clinical data and regulatory progress

• Phase II data for iSCIB1+ shows 77% progression-free survival at 22 months, outperforming historical controls.

• Safety profile is favorable, with no increase in checkpoint blockade-related toxicity and only low-grade, transient adverse events.

• FDA has granted Accelerated Approval opportunity and Fast Track designation; phase III is double-blind, placebo-controlled, and global.

• Adaptive trial design allows for patient population adjustments to maximize statistical significance.

• Regulatory clearances obtained in the US and UK, with European submission underway; first patient expected by end of 2026.

Mechanism, delivery, and market opportunity

• iSCIB1+ delivers six epitopes from antigens GP100 and TRP2 via a modified antibody plasmid, inducing robust CD8 and CD4 T-cell responses.

• Delivered with a needle-free device in partnership with PharmaJet, enabling easy administration and scalability.

• Market opportunity in the US includes approximately 14,000 advanced melanoma patients annually, with additional global potential.

• Product is positioned as a best-in-class, off-the-shelf therapy with potential expansion into other melanoma subtypes and glioblastoma.

• Commercial strategy leverages strong clinical data, scalable delivery, and a robust regulatory path.