Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-Q/A
Source: 0001731122-25-000250
Chunk: 72

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-Q/A
Chunk 72
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 cure of HIV. A successful investigator-initiated
Pre-IND was completed in October 2021. However, due to a shift in priorities to the Oncology pipeline, Renovaro Biosciences does not plan
to pursue the IND and potential clinical trial in the medium- to long-term.

HBV:

RENB-HB01: Potential Cure for HBV

HBV Gene Therapy - Pre-Clinical

RENB-HB01 is in an early pre-clinical
phase as we explore various approaches for gene therapy design elements. If those explorations are successful, it is possible we could
begin the regulatory process at the earliest in the second half of 2024. However, our highest priority is currently the oncology platform,
beginning with pancreatic cancer and other solid tumors with poor life expectancy.

Renovaro Cube

Renovaro Cube (“RenCube”)
is an artificial intelligence driven healthcare technology company focused on developing diagnostic tests and test kits that would analyze
samples derived from non-invasive liquid biopsy procedures for the early detection of cancer, disease recurrence, treatment selection
and monitoring of treatment in cancer. RenCube is developing a proprietary platform that will analyze genetic information using “Explainable
AI” (as defined below) to provide earlier and more accurate cancer diagnosis. This platform applies a multi-omics approach to search
for individual biomarkers that are present even in asymptomatic patients. RenCube’s process also generates biomarker panels, which
are used for training models per cancer type and per clinical application, and are integrated into a machine learning library referred
to as a “Cube” to facilitate accurate diagnosis. The “Cube” will become more effective and accurate over time
due to retraining of its models on the enriched database of molecular data.

RenCube also aims to utilize and
commercialize its proprietary platform RenCube for use in developing products and services by third parties aimed at (i) early cancer
characterization, (ii) personalized treatment selection, (iii) tracking response to therapies, (iv) recurrence detection, and (v) ultimately,
drug discovery.

As part of RenCube’s dedication to the development
of early cancer detection blood tests it expects to develop partnerships with third-party laboratories across the United Kingdom, the
Netherlands, Europe and the United States. In particular, RenCube is focused on developing diagnostic tests and test kits that make use
of non-invasive liquid biopsy samples.

Renovaro Cube’s Strategy

RenCube’s product development
focuses on