PIPELINE

Pipeline & Development

Development Pipeline

The following outlines the development stages and next milestones for Panectin^®.

CLINICAL EXPERIENCE — Investigator-Initiated Phase 1 (University of Tokyo & Teikyo University) — Ongoing

Nectin-4-Positive Solid Tumors

Intratumoral — Investigator-initiated Ph.1

✓ Preclin. Ongoing

NEXT PoC TARGET Priority Indication for Early Clinical PoC

BCG-Unresponsive NMIBC CIS

Intravesical — Ph.1b & Ph.2 Planned

Ongoing※ Preclinical 2028– Ph.1b 2030– Ph.2

※ Safety studies for the intravesical route are planned.

FUTURE EXPANSION Expansion Candidates After NMIBC PoC

Nectin-4-Positive Solid Tumors (Expanded Indications)

TNBC (Breast Cancer) Lung Cancer Pancreatic Cancer Other Nectin-4-Positive Cancers

Following clinical PoC in NMIBC, we plan to expand the Nectin-4 platform stepwise across multiple solid tumor indications in combination with ICIs (immune checkpoint inhibitors).

Platform Technologies

Nectin-4 IHC Patient Selection

SLAM-blind Design

Direct Tumor Killing via Syncytium Formation

Immune Induction

Future ICI Combination (Patent Pending)

Nectin-4 IHC Patient Selection(In Development)

Development Timeline

Through 2019

GMP investigational drug manufactured by Prof. Kai's laboratory at the University of Tokyo Institute of Medical Science

April 2021

Development of Nectin-4 IHC patient selection platform initiated

2026

Phase 1 trial results presented at IOVC 2026 (Reykjavik, Iceland) by Panectin® inventor Prof. Kai

2026

Building manufacturing and clinical development infrastructure for Ph.1b/Ph.2

2028

Australia CTA submission / Phase 1b initiation target (BCG-unresponsive NMIBC)

2029

Ph.1b Topline — Recommended Phase 2 Dose (RP2D) established

2030

Phase 2 Topline — PoC achievement target

2031

US Phase 2 completion