INVESTORS

INTRODUCTION

Nonagen Bioscience Corporation is a privately held cancer diagnostics company developing and commercializing a new generation of noninvasive, computationally enabled diagnostic tests.

Our lead platform, Oncuria®, combines urine-based liquid biopsy, multiplex proteomics, clinical data, and proprietary computational algorithms to address three critical needs in bladder cancer care: cancer detection, recurrence monitoring, and prediction of treatment response.

Oncuria® is currently available as a suite of three commercial laboratory-developed tests (LDTs) through Nonagen's CAP/CLIA laboratory. The platform has been evaluated in more than 5,500 patients across 40+ peer-reviewed publications and is being advanced toward FDA-regulated in vitro diagnostic (IVD) applications.

OPPORTUNITY

Bladder cancer presents a significant diagnostic and economic burden driven by invasive testing, frequent recurrence, and the need for lifelong surveillance. Current diagnostic pathways rely heavily on cystoscopy and cytology, creating an opportunity for accurate, noninvasive molecular diagnostics that can improve clinical decision-making while potentially reducing unnecessary procedures and healthcare costs.

Nonagen is initially addressing three large clinical opportunities:

Detection — Patients being evaluated for urothelial cancer
Monitoring — Patients undergoing surveillance for bladder cancer recurrence
Treatment Selection — Patients being considered for BCG therapy

Together, these indications represent a substantial U.S. commercial opportunity and provide the foundation for broader applications of Nonagen's multiplex proteomic and computational diagnostics platform.

Commercial Today. Built to Scale

Today

Oncuria® is commercially available through Nonagen's CAP/CLIA laboratory with established coding, pricing, and reimbursement.

Next

Nonagen is advancing Oncuria® toward FDA-regulated IVD applications designed to enable broader decentralized testing through qualified laboratories.

Clinical Evidence

Built on an extensive body of clinical evidence

Oncuria® has been evaluated across multiple clinical settings, including bladder cancer detection, recurrence surveillance, upper tract urothelial cancer, and prediction of BCG treatment response. The platform has been studied in more than 5,500 patients and reported across 40+ peer-reviewed publications, including large prospective and multicenter studies.INTELLECTUAL PROPERTY

Intellectual Property & Technology

Nonagen has built a proprietary intellectual property portfolio encompassing its cancer biomarker signatures, diagnostic applications, and computational approaches. The Oncuria® platform combines a proprietary 10-protein biomarker signature with clinical variables and indication-specific computational algorithms to generate actionable diagnostic and predictive information.

The platform is designed for multiplex analysis using established laboratory instrumentation, supporting both Nonagen's centralized LDT model and its future distributed IVD strategy.

Investor Relations:
Dave Mori
mori@nonagen.com