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Item 2. Management’s Discussion and Analysis

2024-11-14 compared with 2024-05-15 · 452 added, 369 removed, 129 unchanged (86% of the section changed)

14 unchanged sentences

“Risk Factors” in our Annual Report on Form 10-K as filed with the SEC on October 10, 2024.

The Company’s plans and objectives

are based, in part, on assumptions involving the continued expansion of the business.

Assumptions relating to the foregoing involve judgments

with respect to, among other things, future economic, competitive and market conditions and future business decisions, all of which are

difficult or impossible to predict accurately and many of which are beyond the control of the Company.

Although the Company believes its

assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate and, therefore, there

can be no assurance the forward-looking statements included in this Quarterly Report will prove to be accurate.

In light of the significant

uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as

a representation by the Company or any other person that the objectives and plans of the Company will be achieved.

operates in two subsidiaries, Renovaro Biosciences and RenovaroCube.

RenovaroCube was created upon our acquisition of GediCube Itnl.

and its wholly-owned subsidiary GediCube, BV, which closed on February 13, 2024.

Renovaro Biosciences

Biosciences is a biotechnology company committed to developing advanced allogeneic cell and gene therapies to promote stronger immune

system responses potentially for long-term or life-long cancer remission in some of the deadliest cancers, and potentially to treat or

cure serious infectious diseases such as Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) infections.

As a result of our

acquisition of GEDi Cube on February 13, 2024, we have also expanded our technology pipeline to include diagnostic related services with

an early emphasis on the detection of cancer.

Development strategy related to our allogeneic cell and gene therapies is anchored in the use of “non-self” or allogeneic

cells that enhance the immune response that we seek to elicit.

Over the past several years, Renovaro Biosciences has evolved from a company

with a single product candidate as a potential cure for HIV (RENB-HV12 and RENB-HV21), a pipeline for Hepatitis B Virus (HBV) (RENB-HB01),

and with a significant expansion into cancer immune therapies to address high unmet needs from difficult-to-treat solid tumors (RENB-DC11.)

The oncology platform is now at

the forefront of our development activities, beginning with pancreatic cancer and other solid tumors with poor life expectancy, such as

triple negative breast, second-line liver, head, neck, and oral among other possible targets.

Many operational aspects of our

platforms can be quickly adapted to multiple disease states from a single therapeutic approach, potentially streamlining and accelerating

development, and regulatory process, as well as manufacturing operations.

Moreover, because our product candidates do not require specialized

delivery devices and surgical procedures, our potentially groundbreaking interventions could have worldwide applicability.

Renovaro Biosciences responds

quickly to new data and perceived development opportunities and risk assessments.

Based on the maturation of our pipelines, the Company

makes business decisions to prioritize the programs that could move more rapidly through development and commercial processes.

Therapeutic Platforms

Renovaro Bioscience’s general

approach with gene- and/or cell-therapy is to train the immune system to allow a person to better fight diseases.

Our vision is for a

world free from toxic chemotherapy and healthy longevity for those with cancer and other diseases.

Renovaro Biosciences is leveraging

general principles and advances in the knowledge of the immune response to engineer cells with enhanced attributes to promote the recognition

and elimination of diseased cells.

Advanced Allogeneic Cell Therapy

The strategic benefit of cell

therapy platforms is to potentially allow for manufacture of large, “off-the-shelf” banks of therapeutic cells that could

be accessed on demand by health care professionals to potentially decrease the time between diagnosis and treatment.

In addition, because we focus

on cells from donors, the strategy could potentially enhance the ability of the therapeutic candidates to induce a more robust response

once injected into patients.

The human immune system is designed to recognize and distinguish “self” from “non-self”

and destroy “otherness” such as bacteria, viruses, and damaged or diseased cells such as cancer cells.

Alloreactivity (reacting

against another person’s cells) is the most powerful response the immune system generates.

Several of our technologies take advantage

of the alloreactivity to hyper stimulate a person’s immune response to better attack a chronic infection (e.g., HIV) or solid tumor.

The Company’s plans and

objectives are based, in part, on assumptions involving the continued expansion of the business.

Assumptions relating to the foregoing

involve judgments with respect to, among other things, future economic, competitive and market conditions and future business decisions,

all of which are difficult or impossible to predict accurately and many of which are beyond the control of the Company.

Although the Company

believes its assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate and,

therefore, there can be no assurance the forward-looking statements included in this Quarterly Report will prove to be accurate.

of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should

not be regarded as a representation by the Company or any other person that the objectives and plans of the Company will be achieved.

operates through two subsidiaries, Renovaro Biosciences and Renovaro Cube.

Renovaro Cube refers to Renovaro Cube Intl.

known as GediCube Intl.

Ltd.) and its wholly owned subsidiaries GediCube, B.V.

and Grace Systems B.V., which were acquired on February

Renovaro Biosciences Overview

Biosciences is a biotechnology company intending, if the necessary funding

is obtained, to develop advanced allogeneic cell and gene therapies to promote stronger immune system responses potentially for long-term

or life-long cancer remission in some of the deadliest cancers, and potentially to treat or cure serious infectious diseases such as Human

Immunodeficiency Virus (HIV) infections.

As a result of our acquisition of GEDi Cube Intl Ltd.

on February 13, 2024, we have shifted the

Company’s primary focus and resources to the development of the Renovaro Cube technologies.

Therapeutic Technologies

Renovaro Biosciences aims to train the immune system to allow a person to better

fight diseases through allogeneic cell and/or gene therapy.

Our vision is for a world with healthy longevity, and free from toxic chemotherapy,

for those with cancer and other serious diseases.

Renovaro Biosciences will seek to leverage general principles and advances in the knowledge

of the immune response to engineer cells with enhanced attributes to promote the recognition and elimination of disease cells.

Allogeneic Cell Therapy

The strategic benefit of the allogeneic

cell therapy technologies is to potentially allow for the manufacture of large, “off-the-shelf” banks of therapeutic cells

that are readily available on demand by healthcare professionals, to potentially decrease the time between diagnosis and treatment.

In certain treatments (e.g., HIV

and cancer), cells taken from healthy donors are sometimes genetically modified to introduce signaling molecules that are designed to

enhance the ability of specific immune cells to recognize diseased cells, and to help recruit other cells that will destroy cancer or

virus infected cells.

We believe that the combination

of off-the-shelf allogeneic cells, combined with genetic modifications designed to enhance immune signaling, could potentially generate

therapeutic candidates that have unique attributes that will increase the likelihood of clinical success.

HBV Gene Therapy

Renovaro Biosciences is exploring

various approaches for gene therapy design elements to potentially eliminate virus-infected cells with an innovative molecular mechanism

that co-opts the virus’ machinery to induce the death of infected cells rather than reproducing and causing more infection to exacerbate

and cancer), cells taken from healthy donors are engineered to introduce signaling molecules that are designed to enhance the ability

of specific immune cells to recognize diseased cells, and to help recruit other cells that will destroy cancer or virus infected cells.

Renovaro Biosciences may also seek

to explore various approaches for gene therapy design elements to potentially eliminate virus-infected or cancer cells by the modulation

of the patient’s immune system.

Upon injecting into the patients, these genetically engineered allogeneic cells have little to no

risk of passing those modifications to the patient since they are terminally differentiated with locked functionality to activate the

host immune system.

Gene modified allogeneic cells are expected to be rejected naturally once they activate the patient’s immune

system therefore will have a very short survival time.

Biosciences Focus Areas:

Genetically modified

Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Product for Long-term Remission of Solid Tumors – Starting with Pancreatic

Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Product for Long-term Remission of Solid Tumors;

specifically Pancreatic tumors

Allogeneic Cell Therapy Platform

– Advanced Pre-Clinical

on learnings from literature reviews of ongoing clinical development for solid tumors, and recent advances in immune modulation, we have

designed an innovative therapeutic vaccination platform that could potentially be used to induce life-long remission from some of the

deadliest solid tumors.

The survival rate in pancreatic cancer is currently only 5 to 10 percent at 5 years.

preclinical in vitro and proof of concept in vivo studies have been compelling.

The platform is designed to enable broad

immune enhancements that are combined with cancer specific antigens that could be applicable to a wide range of solid tumors.

plan to target pancreatic cancer.

Other potential targets for later development could include triple-negative breast cancer, liver or

mesothelioma amongst many.

Similar to our approach with HIV, RENB-DC11 would potentially allow for outpatient therapy without wiping out

or significantly impairing the patient’s immune system often associated with standard of care chemotherapies.

Renovaro Biosciences has initiated a collaboration

Anahid Jewett from UCLA to study further the in vitro and in vivo effectiveness of the approach in pancreatic cancer.

Jewett created an innovative pancreatic cancer mouse model that comprises the human immune system repertoire in combination with human

cancer cells implanted in the corresponding anatomical location found in human cancer.

Multiple experiments in different humanized mouse

models are consistently showing with only one regimen cycle of therapy (2 injections in mice, likely 5-6 in human) - what Dr.

“the Holy Grail of cancer research” with now seven independent animal studies:

Consistent superior therapeutic effect compared to mainstream cancer vaccine approach and other control

dendritic cell therapies

Significant infiltration of effector immune cells into the tumor

Significant peripheral T and NK cell immune activation

Primary tumor reduction and no metastases

Effective in early stage and late-stage cancer

The confirming

reproducibility and robustness of the therapeutic response in an aggressive form of human pancreatic cancer in several models is

We received FDA input from pre-IND interactions which helped solidify our IND-enabling plan as well as our

investigational plan.

We are now fully committed to process development/improvements and IND-enabling activities.

We believe that we

can complete IND-enabling activities in the second half of 2024 which if successful, would enable the start of clinical trials in

humans during the first half of 2025.

The investigational plan discussed with the FDA includes phase 1 safety testing broadly in all

solid tumor types, followed by a phase 2a focusing on a few solid tumor types that are difficult to treat and have poor life

expectancy, for example triple negative breast, second-line liver, and head and neck cancers.

Phase 2b would expand cohorts in

cancers with the strongest response in phase 2a.

RENB-DC-12--XX:

modified Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Product for Long-term Remission of Additional Indications

The technology is a platform that

could potentially be adapted to other solid tumors first line and/or salvage therapy, by itself or, potentially, in combination with other

cancer treatments.

Additional cancer vaccine designs are being evaluated strategically to balance risk and opportunity to advance therapeutic

development quickly in cancer indications with few treatment options.

– Completed pre-IND, IND-enabling phase.

on learnings from our internal research, literature reviews of ongoing clinical development for solid tumors, and recent advances in immune

modulation, we have designed an innovative therapeutic vaccination platform that could potentially be used to induce life-long remission

from some of the deadliest solid tumors such as pancreatic, liver, triple negative breast and head & neck cancers.

may one day enable broad immune enhancements that are combined with cancer specific antigens that could be applicable to a wide range

of solid tumors.

This approach allows us to quickly adapt our approach to any patient solid tumor using the same banked allogenic drug

Genetically modified Allogeneic Dendritic

Cell Therapeutic Vaccine as Potential Treatment Product for Long-term Remission of Triple Negative Breast Cancer

Triple Negative Breast Cancer (TNBC)

is a subtype of breast cancer that is negative for estrogens receptor (ER) negative, progesterone receptor (PR) negative and human epidermal

growth factor receptor 2 (HER2).

TNBC is characterized by its unique molecular profile, aggressive nature, and distinct metastatic patterns

that lack targeted therapies.

TNBC is well known for its aggressive behavior and is characterized by onset at a younger age, high mean

tumor size, and higher-grade tumors.

Based upon our internal research,

literature reviews of ongoing clinical development for solid tumors, and recent advances in immune modulation, we believe we may have

the ability to design an innovative therapeutic vaccination platform that could potentially be used to treat some of the deadliest and

hard-to-treat solid tumors that include triple negative breast cancer.

Infectious Diseases:

HIV Therapeutic Vaccines for Potential

Long-term Remission/Cure

Allogeneic Cell Therapy Platform

- Advanced Pre-Clinical Stage;

Non-Human Primate Studies Ongoing.

In persons living with HIV who

are controlling the spread of virus with anti-retroviral (ARV) treatment, boosting the immune system in a different way than the virus

already has through infection, could allow for control of HIV after stopping ARVs.

Biosciences is developing RENB-HV12 that utilizes a novel cellular and immunotherapy approach that could potentially provide

therapeutic vaccines for HIV.

A non-human study of the therapeutic vaccine in primates at the Fred Hutchinson Cancer Research Center

Animals began receiving the first injections of the potential therapeutic vaccine in August, 2023.

Preliminary results

assessment may potentially be available in the second half of 2024.

A Pre-IND request could be submitted in the first half of 2025,

with IND submission and the beginning of Phase I clinical trials by mid- to end-2025.

Immunotherapy with Allogeneic NK/GDT Cells

Allogeneic Cell Therapy Platform - Pre-IND conducted

- Advanced Pre-Clinical with Human Data through a Collaboration

We are also exploring RENB-HV21, an innovative treatment for HIV with allogeneic

Natural Killer (NK) and Gamma Delta T-Cells (GDT).

It is believed that the GDT cells, a small subset of immune cells that can be infected

with HIV, could both be infected by, and be a key factor in controlling the virus.

The initial scientific findings were presented during

the American Society of Gene & Cell Therapy (ASCGT) Annual Meeting in 2021.

We have an exclusive license to use the underlying patent

to develop RENB-HV21 for potential treatment or 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.

Potential Cure for

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

(“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

This platform applies a multi-omics approach to search for individual biomarkers that are present even in asymptomatic

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

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.

Genetically Modified

Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Treatment Product for Long-term Remission of HIV;

A Chronic Infectious Disease

The oncology therapeutic vaccine

technology could potentially be adapted to target infectious disease antigens and be a viable therapeutic approach in difficult to treat

chronic infectious diseases.

As described above, the engineered allogenic dendritic cell drug substance is thought to be able to be loaded

with various cancer antigens for specific solid tumors but could or may be loaded with infectious disease antigens to elicit a more robust

immune response to viruses and other difficult to treat infections.

Renovaro Cube Overview

Renovaro Cube is an AI-driven healthcare

technology company focusing on the earliest possible detection of cancer and its recurrence.

Renovaro Cube has developed a proprietary

AI platform that analyzes genetics using Explainable AI (as defined below) to provide earlier and more accurate cancer diagnosis.

platform uses a multi-omics approach to search for individual biomarkers that are present even in asymptomatic patients.

This approach

is combined with differential molecular capabilities that are designed to identify, differentiate and pinpoint the exact source.

Cube’s process also involves the mining of biomarker panels, which are integrated into a machine learning library referred to as

“RenovaroCube” to further enhance diagnosis.

Renovaro Cube also aims to utilize

its proprietary AI platform in the development of commercial products to support clinical, research and pharmaceutical organizations that

are trying to improve patient care through precision diagnosis, prediction of success of therapy, new drug discovery, treatment protocols

or clinical trials.

Specifically, Renovaro Cube is focused on developing products and services aimed at (i) early cancer characterization,

(ii) personalized treatment selection, (iii) prediction and tracking response to therapies, (iv) recurrence detection and efficacy monitoring,

and (v) ultimately, drug discovery.

Renovaro Cube was initially incorporated

as Grace Systems B.V.

(“Grace Systems”) in 2013 under the laws of the Netherlands to develop unique data mining algorithms

to enable banking, finance and government entities to extract business insights from data.

Grace Systems began applying its algorithms

to biological data in 2018 to uncover cancer-associated patterns.

Beginning in 2018, Grace Systems pivoted its platform to focus only

on healthcare.

Renovaro Cube has focused on developing its AI technology for early cancer detection.

Renovaro Cube has now focused on

commercialization of its AI technology.

Renovaro Cube believes that it has developed a unique approach to the early detection and diagnosis

of cancer and its recurrence and, in time, other rare diseases through the systematic analysis of data using AI technologies, data mining

procedures and algorithms for health technology.

Renovaro Cube’s technology

has been trained on complex heterogeneous cancer data and appears to find patterns associated with cancer in public and private data resources.

With the help of Renovaro Cube’s algorithms, discovered patterns may be translated into biomarkers that can be used in a clinical

setting to target various aspects of cancer diagnosis and treatment.

Renovaro Cube’s Strategy

RenCube’s prod uct

development focuses on four core areas:

Renovaro Cube’s product development

focuses on four core areas:

Early Detection.

Multi-cancer early detection

(“MCED”) blood tests are advanced diagnostic tools that analyze cell-derived molecules present in the bloodstream.

tests specifically look for genetic mutations, epigenetic alterations, cell-free DNA fragment patterns, gene expressions, proteomic

patterns or other genetic alterations of these tumor-derived molecules, which can indicate the presence of cancer cells.

the molecules shed from cancer cells, MCED tests aim to detect cancer at an early stage employing a non-invasive blood test.

Multi-cancer early detection (“MCED”) blood tests are advanced diagnostic

tools that analyze cell-derived molecules present in the bloodstream.

These tests specifically look for abnormal genetic, epigenetic or

proteomic patterns of these cell-derived molecules, which can indicate the presence of cancer cells.

By examining the molecules shed from

various cells, including cancer cells, MCED tests aim to detect cancer at an early stage.

This approach holds promise for improving cancer

detection and potentially saving lives.

Recurrence of cancer .

A recurrence refers to the return of cancer after a period of remission.

A cancer recurrence happens because, in spite of the efforts to eradicate the cancer, some cells may remain, which grow and eventually cause symptoms.

In rare instances, a patient may develop a new cancer that’s completely unrelated to the originally diagnosed cancer, which is referred to as a second primary cancer.

A cancer recurrence happens because, in spite of the efforts to kill the cancer, some cells may remain, which grow and eventually cause

In rare instances, a patient may develop a new cancer that’s completely unrelated to the originally diagnosed cancer,

which is referred to as a second primary cancer.

An early warning system could help to identify a recurrence as early as possible, thereby

helping to accelerate any treatment and diagnosis.

The different types of recurrence include:

Local recurrence, meaning that the cancer has returned in the same place it first started;

Regional recurrence , meaning that the cancer has returned to the lymph nodes near the place

it first started;

Distant recurrence , meaning the cancer has returned in another part of the body.

Response to treatment.

Most cancer treatments that are currently available are only effective in 30-40% of the cases.

In life threatening cases these patients only have one option and therefore reduce their chances of survival significantly.

Particularly, in patients with cancer, it is critical to be the ‘first time right’.

RenCube aims to develop a new array of diagnostic products that can accurately identify patients that are going to respond or fail to a certain drug thereby facilitating personalized treatment.

Treatment monitoring.

Current imaging modalities, while valuable, may not be sensitive enough to capture subtle changes in tumor size to guide treatment adjustments effectively.

Furthermore, the cost and availability of these imaging techniques can pose barriers to frequent monitoring, potentially delaying necessary interventions.

RenCube aims to develop non-invasive liquid biopsy tests that will provide real-time accurate feedback on tumor response thereby empowering clinicians to personalize treatment plans, optimize outcomes, and minimize unnecessary interventions, ultimately improving patient care and quality of life.

Renovaro Cube’s Technology and Techniques

RenCube’s AI technology aims

to address three critical facets of medical needs within the domain of cancer diagnosis:

At Renovaro Cube we aim to develop a new array of diagnostic products that

can accurately identify patients that are going to respond or fail to a certain drug.

In highly toxic therapies it will not only increase

survival but will also reduce unnecessary exposure to chemotherapy.

Furthermore, the costs for cancer drugs are usually very high.

the right therapy to the right patient will therefore significantly reduce the costs of medicine in cancer.

Clinical trials .

Clinical trials involve a type of research that studies new tests and treatments

and evaluates their effects on human health outcomes.

People volunteer to take part in clinical trials to test medical interventions including

drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioral treatments and preventive

Clinical trials are carefully designed, reviewed and completed, and need to be approved before they can start.

In response to these four core areas, the key components of Renovaro Cube’s

product development are to build a software and hardware platform that:

Uses data science to develop novel insights into the characterization of diseases

such as cancer.

Renovaro Cube intends to apply its proprietary technology to biological data from multiple sources to enable the typification

(or classification) of disease entities and sub-entities to provide insights about the nature and behavior of diseases to payers, providers,

pharmaceutical companies and patients.

Enables more accurate diagnosis and earlier detection of cancer and other diseases

with the goal of maximizing outcomes and minimizing the costs of treatment.

Renovaro Cube intends to develop a system to understand the

smallest fragments of cancer in the blood of the patient.

Presently, Renovaro Cube is developing a product to analyze results from liquid

biopsy run through an Oxford Nanopore Sequencer.

We expect the Renovaro Cube product will subsequently identify, train and validate explainable

biomarkers, panels and models on different molecular layers.

Multiple models will be individually trained for optimal stratification through

the entire health journey, ensuring the right accuracy for a therapeutic decision in every stage.

Renovaro Cube will integrate different

modalities and molecular data sources into a differential diagnostic report.

Diagnostics and prognosis will be explainable with quality

control reports and biomarker insights for different disciplines ensuring maximum trust and insight in medical decision making.

Assists in clinical trials with patient cohort selection and response tracking,

to be used by companies like Renovaro Biosciences in their patient cohort selection for their clinical trials, by looking at which patients

are reacting positively, negatively and have no reaction.

This data becomes more important through the progression of the different phases

of drug development, as more and more patients are added.

Renovaro Cube will provide multi-omic data analysis, looking for specific changes

in the patients that might indicate a change in their molecular make-up.

This can then be used for the next phase of a clinical trial

to look for the specific molecular data that has showed a positive reaction in the previous phase.

It also provides insights for more

effective response tracking, which Renovaro Cube believes is important to the providers of care as well as the development and evaluation

of new pharmaceuticals and immune therapies in clinical trials.

Patient response to treatment can be used to focus the target audience

for drugs in development and in subsequent clinical practice.

As Renovaro Cube collects more data, longitudinal about treatment and response,

it will have the ability to train prognostic models to give an insight in disease progression and treatment response, both critical for

enrolling in clinical trials and eventually every treatment.

Because Renovaro Cube consists of many independently trained and validated

models, it will have the ability to assist in virtually every therapeutic decision, for different subtypes and groups (stratifications).

The multi-omics and multi-modal pipelines could allow the use of multiple combinations of tissue samples and diagnostic platforms.

detailed diagnostic reports will allow and support insights for multiple disciplines such as cancer biology, genomics and pathology to

look at underpinning biomarkers, pathways and clinical annotations.

Provides insight into patients who have had cancer previously.

These insights will

provide for more effective recurrence monitoring, which Renovaro Cube believes is important to the providers of care and patients during

follow-up monitoring of remissions.

Renovaro Cube anticipates that payers want to detect and re-treat recurrences at the earliest possible

stage to maximize patients’ outcomes in terms of time and cost and that, similarly, patients with a recurrence are keen to re-engage

with effective treatment at the earliest opportunity.

A key aspect of this will be taking blood from the patients, sequencing this blood

and running it through the Renovaro Cube platform which will identify if the patient has any indication of the recurrence of the same

or a new cancer.

For recurrence monitoring, Renovaro Cube will focus on a highly sensitive combination of lab and information technology.

Lab protocols, sequence post processing and machine learning will all be designed, trained and validated to get the best signal with the

highest sensitivity to catch early signals of recurrence.

This will be done on a regular basis allowing surveillance analysis over time.

Includes biomarker panels that will be extended to include as many layers of genetic

information (multi-omics) as possible including mutation, gene expression, methylation status, fragmentomics, nucleosome mapping, collectively

named multi-omics, with the goal to reach the highest accuracy possible, both in terms of sensitivity and specificity of each individual

biomarker panel.

This provides a non-invasive alternative for the current complex, expensive and cumbersome procedures.

Create value through advancing more sophisticated typification of diseases in

an effort to address some of the pressing problems faced by modern healthcare, including healthcare costs, an aging population and developments

in medical technology that produce a stream of increasingly sophisticated treatments requiring more precise targeting.

One additional key focus of Renovaro

Cube is its multi-modal, data analysis.

Multi-modal data encompasses the whole aspect of data from a patient perspective, whether genomics,

imaging, phenotypic or even wearable data, which can be cross analyzed to produce data that could not be previously produced.

Cube intends to use multi-modal data to bring new insights to the clinical and research teams trying to understand what to do next with

Renovaro Cube’s Technology

and Techniques

Renovaro Cube is dedicated to

the development of early cancer detection blood tests and expects to develop partnerships with third-party laboratories across the United

Kingdom, the Netherlands and the rest of Europe and will also expand to the United States.

Renovaro Cube is focused on developing diagnostic

tests and test kits that would analyze samples derived from non-invasive liquid biopsy samples and intends to perform these tests from

Renovaro’s dedicated fully certified service laboratory and engage third-party laboratories to perform these tests for end-users.

For this purpose, Renovaro Cube

has developed an AI platform that aims to leverage expertise in both biological and computational sciences and to go beyond traditional

tumor signals by detecting the body’s early warning signs of cancer.

Renovaro Cube’s goal is to provide accurate and reliable

tests that can aid in the early diagnosis and treatment of cancer.

Renovaro Cube’s AI technology is created to detect a wide range

of biological signs to enhance the accuracy and sensitivity of early cancer detection and, thereby, enable earlier intervention and potentially

improved patient outcomes.

Renovaro Cube’s AI technology

aims to address three critical facets of medical needs within the domain of cancer diagnosis (as illustrated below):

type-specific cancer detection;

pan-cancer detection;

personalized treatment

patient stratification.

Moreover, the versatility of Renovaro

Cube’s AI technology extends to encompass the realm of rare cancers, including cases such as cancer of unknown primary.

Leveraging DNA methylation data,

Renovaro Cube has identified and validated biomarker panels tailored for the detection of a wide range of cancers, including bladder,

breast, colon, prostate, thyroid, head and neck, liver, kidney and lung cancer.

The foundational architecture of

RenCube’s AI technology will be engineered to facilitate comprehensive pan-cancer analysis through its extensive record of informative

Renovaro Cube’s AI technology is engineered to facilitate comprehensive pan-cancer analysis through its extensive record of informative

biomarkers discovered across a diverse array of cancer types.

This comprehensive repository empowers RenCube’s technology to swiftly

cross-reference biomarkers and explore molecular commonalities and distinctions that span multiple tumor categories.

Uses of RenCube’s AI Technology

RenCube’s AI platform will

be an enterprise software platform that is distinguished from its competitors’ technology by its core attributes encompassing AI-guided

This comprehensive repository empowers Renovaro Cube’s AI technology

to swiftly cross-reference biomarkers and explore molecular commonalities and distinctions that span multiple tumor categories.

For example, the capabilities of

Renovaro Cube’s AI technology have unearthed biomarkers capable of pinpointing a specific subgroup of thyroid cancer patients characterized

by a distinct genomic alteration, the neurotrophic tyrosine receptor kinase (“NTRK”) gene fusion.

Identification of these

NTRK-positive patients provides an actionable therapeutic target.

Uses of Renovaro Cube’s AI Technology

Renovaro Cube has developed its AI platform to support:

AI-assisted patient diagnostics;

multi-omic data analysis;

genome-wide or targeted analysis;

pan-cancer analysis;

different technology platforms (sequence or array);

tracking of each sample;

AI-guided biomarker discovery for single or multiple cancer types;

logs of analysis steps and outcomes (data preparation, discovery, validation).

Renovaro Cube’s AI platform

is an enterprise software platform that is distinguished from its competitors’ technology by its core attributes encompassing AI-guided

analysis and meticulous record-keeping of data handling procedures within audit trails, logs, and data discoveries.

RenCube is designing

Renovaro Cube designed

this technology to support and validate every phase of the process, from the initial handling of raw data to the creation of essential

biomarker panels.

RenCube’s AI platform may also facilitate the integration of data originating from diverse sources, including

Renovaro Cube’s AI platform also facilitates the integration of data originating from diverse sources, including

public databases and collaborative partnership data.

Illustrated below is the three-phase

workflow behind Renovaro Cube’s AI platform for biomarker discovery using DNA methylation data.

This workflow commences with the

identification of pertinent single- and multi-omic data best suited to address the specific inquiries of Renovaro Cube’s clients,

and the subsequent stages involve the meticulous pre-processing and loading of this data into the platform.

This process culminates in

the availability of a dashboard offering the client insights into the data’s characteristics, such as data quality, the technology

employed, and associated metadata.

Phase I of the workflow behind Renovaro Cube’s AI platform primarily centers on the pivotal process of biomarker discovery.

This intricate procedure unfolds through the application of data mining algorithms and statistical methodologies integrated into the AI platform.

The paramount objective of Phase I is to reduce the plethora of genomic features displaying variations across samples, which is accomplished by systematically eliminating extraneous or inconsequential features while preserving those features that exhibit the greatest potential for accurately detecting cancer.

Phase II of the workflow builds upon the foundation of selected biomarkers by focusing on understanding the dynamic interplay among these chosen biomarkers, culminating in the creation of composite panels.

The goal of Phase II is to pinpoint biomarker combinations that not only demonstrate robustness in detecting cancer but also maintain their efficacy across diverse contexts.

Renovaro Cube believes that its AI algorithms are adept at uncovering multiple combinations across a spectrum of panels, which is supported by Renovaro Cube’s AI-guided panel mining, a proprietary combinatorial optimization technique used by Renovaro Cube’s AI technology.

This approach, coupled with the capacity to explore numerous panels, significantly enhances the likelihood of discovering panels that align with specific metric criteria, such as sensitivity, specificity, precision, and recall and allows for tailoring criteria to align with clients’ unique needs, such as the number of biomarkers included per panel, or the inclusion of biomarkers associated with the expression of specific genes.

The performance of the top-tier panels is further fine-tuned through the application of machine learning models.

Subsequently, the efficacy of these biomarker panels in detecting cancer is validated through independent data sets.

Phase III of the workflow involves Renovaro Cube’s collaboration with its clinical partners to validate the performance of the biomarker panels.

Through this collaboration, Renovaro Cube can confirm the utility and accuracy of its biomarker panels in real-world clinical contexts.

AI-Assisted Diagnostics

The process of biomarker discovery

facilitated by RenCube’s AI technology has yielded a set of biomarkers that enables scrutiny of the genomic distinctions and commonalities

facilitated by Renovaro Cube’s AI technology has yielded a set of data that enables scrutiny of the genomic distinctions and commonalities

inherent in diverse cancer types.

This biomarker set may support the diagnosis of cancers when their type or origin remains unidentified.

This data set can support the diagnosis of cancers when their type or origin remains unidentified.

In addition to this role in biomarker

discovery and the development of diagnostic tests, RenCube’s AI technology will integrate AI-guided molecular profiling of patient

samples to generate diagnostic patient reports.

These diagnostic reports reflect the outcomes of molecular profiling, coupled with interpretations

provided by RenCube’s team, to facilitate the process of cancer diagnostics by a qualified healthcare provider, who can consider

these reports in the context of a patient’s medical history, clinical signs, and symptoms, among other factors.

discovery and the development of diagnostic tests, Renovaro Cube’s AI technology also integrates AI-guided molecular profiling of

patient samples and furnishes diagnostic patient reports.

These diagnostic reports reflect the outcomes of molecular profiling, coupled

with interpretations provided by Renovaro Cube’s team, to facilitate the process of cancer diagnostics by a qualified healthcare

provider, who can consider these reports in the context of a patient’s medical history, clinical signs, and symptoms, among other

Quality Control Process

Renovaro Cube undertakes post-processing

of data generated from sequence and arrays to ensure accurate and meaningful results.

These post-processing steps for omic data include:

Quality Control :

Quality control is performed to assess the overall data quality and to identify any technical issues or anomalies.

Normalization :

arrays can introduce various sources of technical variation, such as batch effects, intensity variations, and probe-specific biases.

Quality Filtering :

After genotype calling, additional quality filtering may be performed to remove low-quality SNPs based on criteria like call rates, minor allele frequency, Hardy-Weinberg equilibrium p-values, and linkage disequilibrium.

What changed 10-Q

Item 2. Management’s Discussion and Analysis