What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-05-15 compared with 2024-02-14 · 318 added, 230 removed, 180 unchanged (75% of the section changed)

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

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) infection.

Development strategy is anchored in the use of “non-self” or allogeneic cells that enhance the immune response that we seek

Over the past several years, Renovaro

has evolved from a company with a single product candidate as a potential cure for HIV (RENB-HV01), adding two additional

pipeline candidates 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.)

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, for example

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.

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

The Company 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.

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

The Company’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.

The Company 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.

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

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virus infected cells.

The Company believes 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 success.

Cell Therapy enabling technology

In addition to the platform described

above, Renovaro has an innovative gene therapy approach to enhance the selection and engraftment (uptake) of cells carrying

therapeutic attributes.

Enhanced uptake or engraftment could play a critical role in some cases to increase the likelihood of therapeutic

This technology was initially developed for autologous cell therapy from a person living with HIV, and genetically modifying

those cells so they cannot be infected with most variants of HIV, plus a gene modification to enhance uptake.

We have sublicensed under

a profit-sharing agreement our technology to potentially increase engraftment for use in CAR-T therapy as a potential cure for HIV.

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 Inc.

Renovaro Biosciences is exploring

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

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– Advanced Pre-Clinical

on learning from peer-reviewed publications of Phase I/IIa trials, 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.

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 might also allow for non-specific

immune enhancement that could have impact against a broad array of solid tumors.

We initially plan to target pancreatic cancer.

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

As with HIV, our approach

would potentially allow for outpatient therapy without wiping out or significantly impairing the patient’s immune system, as many

current approaches require.

Renovaro Inc.

has initiated

a collaboration with Dr.

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 implanted human cancer cells.

Multiple experiments in different humanized mouse models are consistently showing with

only one cycle of therapy – in humans five to ten are likely - what Dr.

Jewett calls “the Holy Grail of cancer research”:

80-90% substantial tumor size reduction (volume and weight)

Remnant of tumor sack significantly infiltrated with effector immune cells indicating ongoing killing of cancer.

Significant correlation with expected immune response important to fight cancer detected in blood, and

No metastases

The confirming reproducibility

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

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 second half of 2024.

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, head

and neck cancers.

Phase 2b would expand cohorts in cancers with the strongest response in phase 2a.

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:

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

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 is ongoing.

began receiving the first injections of the potential therapeutic vaccine in August, 2022.

Preliminary results assessment may potentially

be available in the second half of 2023.

A Pre-IND request could be submitted in the second half of 2024, with IND submission and the

beginning of Phase I clinical trials by mid- to end-2025.

Autologous Transplant with Genetically

Modified Cells :

FDA INTERACT Meeting Held February 2020 - Advanced

Pre-Clinical Stage

We have pioneered a novel enabling

technology (ALDH gene modification) that we believe will allow sufficient engraftment of the CCR5 gene-modified Hematopoietic Stem Cell

(HSC) to eliminate the need for Antiretroviral Treatment (ART.)

Management conducted a successful

FDA INTERACT Meeting in alignment with the Company’s experimental plan.

Although in vitro and in vivo studies have

demonstrated promising results, further development of RENB-HV01 at this time was deemed costly and a long-term undertaking.

Company plans to return to full development of the approach when resources are available, it has become less attractive and been deprioritized

for business reasons, while pipelines that could move more quickly have been prioritized (e.g., RENB-DC11).

Therefore, a business decision

was made to sub-license the ALDH gene modification.

RENB-HV01 was sub-licensed to

Caring Cross with a profit share arrangement.

Caring Cross is developing a CAR-T approach that they believe, when combined with Renovaro

ALDH gene modification, could enhance engraftment of their CAR-T cell therapy and enhance their likelihood of success.

Immunotherapy with Allogeneic NK/GDT

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

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

Renovaro Inc.

has an exclusive license to use the underlying

patent to develop RENB-HV21 for potential treatment or cure of HIV.

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 does not plan to pursue the IND and potential clinical

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.

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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.

Renovaro Cube’s Strategy

RenCube’s prod uct

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.

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.

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:

type-specific cancer detection;

pan-cancer detection;

personalized treatment

The foundational architecture of

RenCube’s AI technology will be 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

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

RenCube is designing

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

public databases and collaborative partnership data.

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

inherent in diverse cancer types.

This biomarker set may 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.

The unique panel mining technique

in RenCube’s technology repeatedly investigates genes to identify relevant biomarkers.

The proprietary technique in RenCube’s

technology not only searches for individual biomarkers, but also integrates validated panels for different cancer types into the “Cube”

machine learning library.

This process enables precision diagnosis, by including one cancer and excluding others on the basis of statistically,

scientifically and clinically validated machine-learning panels.

Explainable AI

The term “Explainable AI”

refers to the ability of an artificial intelligence system or model to provide human-understandable explanations for its decision-making

process or predictions.

This feature aims to bridge the gap between the “black box” nature of many AI algorithms and the need

for transparency, interpretability, and accountability in AI applications.

RenCube believes that Explainable

AI is crucial for ensuring transparency, fairness, and accountability in AI systems.

RenCube’s AI platform includes Explainable

AI by design.

All data points, calculations and results are traceable, and all calculations are verifiable and reproducible with the same

Differential Diagnosis

Diseases like cancer are very homogenous,

meaning that markers like TP53 or BRCA are expressed with multiple cancers.

To address this homogeneity, differential diagnosis distinguishes

between two or more conditions or diseases that share similar signs, symptoms or characteristics.

The goal of differential diagnosis is

to consider and evaluate all possible diagnoses for the patient’s symptoms to determine the most likely cause.

Differential diagnosis

therefore aims to identify the underlying condition accurately and guide appropriate treatment and management strategies.

Corporate History

We were incorporated under

the laws of the State of Delaware on January 18, 2011, under the name Putnam Hills Corp.

and in 2014 we merged with and changed

our name to DanDrit Biotech USA, Inc.

We were incorporated under the

laws of the State of Delaware on January 18, 2011, under the name Putnam Hills Corp.

and in 2014 we merged with and changed our name to

DanDrit Biotech USA, Inc.

In 2018, we acquired Enochian Biopharma and changed our name to Enochian BioSciences Inc.

In August 2023, the Company changed its corporate name from Enochian Biosciences Inc.

to Renovaro Biosciences Inc.

13, 2024, the Company changed its corporate name from Renovaro Biosciences Inc.

to Renovaro Inc.

In August 2023, the

Company changed its corporate name to Renovaro Biosciences Inc.

On February 13, 2024, the Company changed its corporate name to Renovaro

On February 13, 2024, Renovaro Inc.

acquired Renovaro Cube Intl Ltd and its subsidiaries, in which Renovaro Cube became a wholly-owned

subsidiary of Renovaro Inc.

Going Concern and Management’s Plans

The financial statements included

elsewhere herein for the period ended December 31, 2023, were prepared under the assumption that we would continue our operations as a

going concern, which contemplates the realization of assets and the satisfaction of liabilities during the normal course of business.

As of December 31, 2023, we had cash and cash equivalents of $243,980, an accumulated deficit of $257,733,402 and a working capital deficit

of $11,355,216 and total liabilities of $14,422,584.

We have incurred losses from continuing operations, have used cash in our continuing

operations, and are dependent on additional financing to fund operations.

These conditions raise substantial doubt about our ability to

continue as a going concern for one year after the date the financial statements are issued.

The financial statements included elsewhere

herein do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the

amounts and classification of liabilities that may result from the outcome of this uncertainty.

The financial statements included elsewhere herein for the period ended March

31, 2024, were prepared under the assumption that we would continue our operations as a going concern, which contemplates the realization

of assets and the satisfaction of liabilities during the normal course of business.

As of March 31, 2024, we had cash and cash equivalents

of $312,697, an accumulated deficit of $274,757,816 and a working capital deficit of $19,654,098 and total liabilities of $43,683,784.

We have incurred significant losses from continuing operations, have used cash in our continuing operations, and are dependent on additional

financing to fund operations.

These conditions raise substantial doubt about our ability to continue as a going concern for one year after

the date the financial statements are issued.

The financial statements included elsewhere herein do not include any adjustments to reflect

the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may

result from the outcome of this uncertainty.

Management has reduced overhead

and administrative costs by streamlining the organization to focus around two of its therapies (oncology and a HIV therapeutic vaccine)

The Company has tailored its workforce to focus on these therapies.

In addition, the Company intends to attempt to secure additional required

funding through equity or debt financing.

and investment in the development and validation of our AI driven cancer diagnostics platform.

The Company has tailored its workforce

to focus on these therapies.

In addition, the Company intends to attempt to secure additional required funding through equity or debt

However, there can be no assurance that the Company will be able to obtain any sources of funding.

Such additional funding may not be available or may not be available on reasonable terms, and, in the case of equity financing transactions,

could result in significant additional dilution to our stockholders.

If we do not obtain required additional equity or debt funding, our

cash resources will be depleted and we could be required to materially reduce or suspend operations, which would likely have a material

adverse effect on our business, stock price and our relationships with third parties with whom we have business relationships, at least

until additional funding is obtained.

If we do not have sufficient funds to continue operations, we could be required to seek bankruptcy

protection or other alternatives that could result in our stockholders losing some or all of their investment in us.

Such additional funding

may not be available or may not be available on reasonable terms, and, in the case of equity financing transactions, could result in significant

additional dilution to our stockholders.

If we do not obtain required additional equity or debt funding, our cash resources will be depleted

and we could be required to materially reduce or suspend operations, which would likely have a material adverse effect on our business,

stock price and our relationships with third parties with whom we have business relationships, at least until additional funding is obtained.

If we do not have sufficient funds to continue operations, we could be required to seek bankruptcy protection or other alternatives that

could result in our stockholders losing some or all of their investment in us.

Funding that we may receive during

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working capital reserves.

On September 28, 2023, the Company,

entered into a Stock Purchase Agreement (the “ Purchase Agreement ”) with GEDi Cube Intl Ltd., a private company formed

under the laws of England and Wales (“ GEDi Cube ”).

Upon the terms and subject to the conditions set forth in the Purchase

Agreement, the Company will acquire 100% of the equity interests of GEDi Cube from its equity holders (the “ Sellers ”)

and GEDi Cube will become a wholly-owned subsidiary of the Company (the “ Transaction ”).

On September 28, 2023, the

board of directors of the Company, and the board of managers of GEDi Cube unanimously approved the Purchase Agreement (see Note 9.) On

January 25, 2024, the Company held a Special Shareholders’ Meeting, during which the shareholders approved the issuance of the Company’s

common stock to the Sekkers and the requisite increase in the amount of the Company’s authorized common stock.

The Company is working

with the GEDi Cube to close the transaction.

Results of Operations for the three and six months ended December 31,

2023, compared to the three and six months ended December 31, 2022

Results of Operations for the three and nine months ended March 31,

2024, compared to the three and nine months ended March 31, 2023

The following table sets forth

our revenues, expenses and net loss for the three and six months ended December 31, 2023 and 2022.

The financial information below is

derived from our unaudited condensed consolidated financial statements.

our revenues, expenses and net loss for the three and nine months ended March 31, 2024 and 2023.

The financial information below is derived

from our unaudited condensed consolidated financial statements.

For the Three Months Ended

For the Six Months Ended

For the Nine Months Ended

Increase/(Decrease)

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Research and development

Intangible assets impairment

Depreciation and amortization

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(13,127,404 )

(30,345,029 )

(15,621,918 )

(15,299,606 )

Other Income (Expenses)

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Loss on extinguishment of contingent consideration liability

Change in fair value of contingent consideration

Interest expense

Interest and other income

Total Other Income (Expenses)

Interest and other income (expense)

Total Other Income (Expense)

$ (17,024,414 )

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$ (16,485,804 )

We are a pre-revenue, pre-clinical

biotechnology company.

We have never generated revenues and have incurred losses since inception.

We do not anticipate earning any revenues

until our therapies or products are approved for marketing and sale.

$ (14,242,759 )

We are a pre-revenue,

pre-clinical biotechnology and artificial intelligence driven healthcare technology company.

We have never generated revenues and

have incurred losses since inception.

We do not anticipate earning any revenues until our therapies or products are approved for

marketing and sale.

Our operating expenses for the

three months ended December 31, 2023 and 2022, were $4,270,075 and $4,367,866 respectively, representing

a decrease of $97,791 or approximately 2% .

The decrease in operating expenses primarily relates to the decrease in general

and administrative expenses of $396,671 partially offset by the increase in research and development expenses of $294,562.

three months ended March 31, 2024 and 2023, were $17,190,840 and $4,063,436 respectively, representing

an increase of $13,127,404 or approximately 323% .

The increase in operating expenses primarily relates to the increase in general

and administrative expenses of $3,856,322, the increase in research and development expenses of $848,019 and an indefinite life intangible

assets impairment charge of $8,421,000.

Our operating expenses for the

six months ended December 31, 2023 and 2022, were $13,154,189 and $11,558,482 respectively, representing

nine months ended March 31, 2024 and 2023, were $30,345,029 and $15,621,918 respectively, representing

an increase of $14,723,111, or approximately 94% .

The increase in operating expenses primarily relates to the increase in general

and administrative expenses of $3,336,699 partially offset by the decrease in research and development expenses of $1,744,169.

and administrative expenses of $7,193,021, and the indefinite life intangible assets impairment charge of $8,421,000, partially offset

by the decrease in research and development expenses of $896,150.

General and administrative expenses

for the three months ended December 31, 2023, and 2022, were $3,616,392 and $4,013,063, respectively, representing a decrease of $396,671

for the three months ended March 31 2024, and 2023, were $7,652,379 and $3,796,057, respectively, representing an increase of $3,856,322

or approximately 102%.

The variance is related to a decrease in legal expenses of $453,934, compensation and related expenses of $353,309,

and accounting fees of $133,819, partially offset by an increase in investor relations expenses of $142,183, marketing expenses of $100,183,

filing fees of $62,243 and insurance expenses of $60,525.

The variance is related to an increase in legal expenses of $1,552,970, non-cash stock-based compensation of $785,396,

non-cash consulting fees of $544,657, accrued expenses related to the GEDi Cube acquisition of $797,203, investor relations expenses of

$264,344, marketing expenses of $148,827, and compensation and related expenses of $97,528, partially offset by a decrease in accounting

fees of $466,145.

General and administrative expenses

for the six months ended December 31, 2023, and 2022, were $11,906,602 and $8,569,903, respectively, representing an increase of $3,336,699

for the nine months ended March 31, 2024, and 2023, were $19,558,981 and $12,365,960, respectively, representing an increase of $7,193,021

or approximately 58%.

The variance is related to an increase in non-cash consulting fees of $4,470,000, investor relations expenses of

$241,051, insurance expenses of $178,836, and marketing expenses of $121,183, partially offset by a decrease in compensation and related

expenses of $970,649 and legal expenses of $859,497.

The variance is related to an increase in non-cash consulting fees of $4,570,000, non-cash stock-based compensation

of $922,492, accrued expenses related to the GEDi Cube acquisition of $797,203, legal expenses of $693,473, investor relations expenses

of $505,395, consulting expenses of $447,407, marketing expenses of $270,010, rent expenses of $156,626, and insurance expenses of $127,628,

partially offset by a decrease in accounting fees of $403,538.

Research and development expenses

for the three months ended December 31, 2023, and 2022, were $620,521 and $325,959, respectively, representing an increase of $294,562

for the three months ended March 31, 2024, and 2023, were $1,087,156 and $239,137, respectively, representing an increase of $848,019

or approximately 355%.

The variance is primarily driven by an increase of $129,990 in consumables related to pre-clinical testing and $104,628

in consulting expenses related to regulatory and outsourced consultants.

The variance is primarily driven by an increase of $584,912 in collaborating partner expenses with

CDMO and CROs, $115,616 in consumables related to pre-clinical testing and $150,811 in consulting expenses related to regulatory

and outsourced consultants.

Research and development expenses

for the six months ended December 31, 2023, and 2022, were $1,187,165 and $2,931,334, respectively, representing a decrease of $1,744,169

for the nine months ended March 31, 2024, and 2023, were $2,274,321 and $3,170,471, respectively, representing a decrease of $896,150

or approximately 28%.

1 unchanged sentence

CDMO and CROs related to discontinued product candidates, partially offset by an increase in consumables of $355,235 and consulting expenses

The Company recorded other expense

of $259,046 for the three months ended December 31, 2023, compared to other expense of $89,882 for the three months ended December 31,

2022, representing an increase in other expense of $169,164 or 188%.

The variance is primarily due to an increase of $182,092 in interest

expense related to the convertible promissory notes and other notes entered into in the current period.

Intangible assets impairment expense

for the three and nine months ended March 31, 2024, was $8,421,000.

This was due to the termination

of the HV-01 license agreement in which the Company abandoned the development of a technology included in its IPR&D and recorded an

impairment of $8,421,000 in the period ended March 31, 2024.

The Company recorded other income

of $166,426 for the three months ended March 31, 2024, compared to other expense of $264,860 for the three months ended March 31, 2023,

representing a decrease in other expense of $431,286 or 163%.

The variance is primarily due to an increase of $486,500 in change in fair

value of contingent consideration following the acquisition of GEDi Cube.

The Company recorded other expense

of $549,960 for the six months ended December 31, 2023, compared to other expense of $599,026 for the six months ended December 31, 2022,

of $383,534 for the nine months ended March 31, 2024, compared to other expense of $863,886 for the nine months ended March 31, 2023,

representing a decrease in other expense of $480,352 or 56%.

The variance is primarily due to the loss on extinguishment of contingent consideration

liability of 419,182 in the prior period, partially offset by an increase of $265,778 in interest expense and by the loss on extinguishment

of debt of $120,018 in the current period.

The variance is primarily due to the loss on extinguishment of contingent

consideration liability of $419,182 in the prior period, and an increase of $486,500 in change in fair value of contingent consideration

in the current period, partially offset by an increase of $447,291 in interest expense in the current period.

Net loss for the three months

ended December 31, 2023, and 2022, was $4,529,121 and $4,457,748, respectively, representing an increase in net loss of $71,373 or approximately

The increase in net loss was primarily due to a decrease in general and administrative expenses of $396,671, partially offset by an

increase in research and development expenses of $294,562 and $182,092 of additional interest expense.

Net loss for the six months ended

December 31, 2023, and 2022, was $13,704,149 and $12,157,508, respectively, representing an increase in net loss of $1,546,641 or approximately

The increase in net loss was primarily due to an increase in general and administrative expenses of $3,336,699, partially offset

by a decrease in research and development expenses of $1,744,169.

ended March 31, 2024, and 2023, was $17,024,414 and $4,328,296, respectively, representing an increase in net loss of $12,696,118 or approximately

The increase in net loss was primarily due to the indefinite life intangible assets impairment charge of $8,421,000 and an increase

in general and administrative expenses of $3,856,322.

Net loss for the nine months ended

March 31, 2024, and 2023, was $30,728,563 and $16,485,804, respectively, representing an increase in net loss of $14,242,759 or approximately

The increase in net loss was primarily due to the indefinite life intangible assets impairment charge of $8,421,000 and an increase

in general and administrative expenses of $7,193,021.

Liquidity and Capital Resources

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As noted above under the heading

“Going Concern and Management’s Plans,” through December 31, 2023, we have incurred substantial losses.

additional funds for (a) research and development, (b) increases in personnel, and (c) the purchase of equipment, specifically to advance

towards an Investigational New Drug Application (IND) following Pre-IND readouts from the FDA for RENB-DC11, RENB-HV12, RENB-HV01, RENB-HV21

and RENB-HB01.

The availability of any required additional funding cannot be assured.

In addition, an adverse outcome in legal or regulatory

proceedings in which we are currently involved or in the future may be involved could adversely affect our liquidity and financial position.

We may raise such funds from time to time through public or private sales of our equity or debt securities.

Such financing may not be

available on acceptable terms, or at all, and our failure to raise capital when needed could materially adversely affect our growth plans

and our financial condition and results of operations.

As of December 31, 2023, the Company

“Going Concern and Management’s Plans,” through March 31, 2024, we have incurred substantial losses.

We will need additional

funds for (a) research and development, (b) increases in personnel, (c) the purchase of equipment, specifically to advance towards an

Investigational New Drug Application (IND) following Pre-IND readouts from the FDA for RENB-DC11, RENB-HV12, RENB-HV21 and RENB-HB01 and

(d) investment in the development and validation of our AI driven cancer diagnostics platform.

The availability of any required additional

funding cannot be assured.

In addition, an adverse outcome in legal or regulatory proceedings in which we are currently involved or in

the future may be involved could adversely affect our liquidity and financial position.

We may raise such funds from time to time through

public or private sales of our equity or debt securities.

Such financing may not be available on acceptable terms, or at all, and our

failure to raise capital when needed could materially adversely affect our growth plans and our financial condition and results of operations.

As of March 31, 2024, the Company

had $312,697 in cash and working capital of $(19,654,098) as compared to $1,874,480 in cash and working capital of $(8,457,693) as of

June 30, 2023, a decrease of 83% and 132%, respectively.

Total assets at December 31, 2023,

Total assets at March 31, 2024,

were $212,279,340 compared to $58,300,796 as of June 30, 2023.

The decrease in total assets was primarily due to the decrease in cash of

$1,630,500, partially offset by increases in notes receivable of $1,073,625 and prepaids and other assets of $394,620.

Total liabilities at December

The increase in total assets was primarily due to the increase in goodwill

of $152,546,852 from the acquisition of Renovaro Cube.

Total liabilities at March 31,

2024, were $43,683,784 compared to $11,798,685 as of June 30, 2023.

The increase in total liabilities was primarily related to increases

of $2,569,379 in convertible notes payable, net of discount, $484,651 in other current liabilities and $281,095 in accounts payable, partially

offset by a decrease of $684,947 in notes payable, net of discount.

The following is a summary of

the Company’s cash flows (used in) or provided by operating, investing, and financing activities:

of $20,071,000 in contingent consideration liability, $3,031,803 in accrued expenses, $2,693,808 in accounts payable, $3,700,694 in convertible

notes payable, net of discount and $2,774,856 in deferred tax liability offset by a decrease of $1,206,326 in notes payable, net of discount.

The following is a summary of the

Company’s cash flows (used in) or provided by operating, investing, and financing activities:

Net Cash Used in Operating Activities

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Cash used in operating activities

for the six months ended December 31, 2023, and 2022 was ($5,923,830) and ($6,205,145), respectively.

for the nine months ended March 31, 2024, and 2023 was ($8,557,649) and ($9,512,937), respectively.

Cash used in operating activities

during the current period primarily related to the next loss including $1,187,165 in research and development expenses for CDMO and CRO

during the current period primarily related to the net loss including $2,274,321 in research and development expenses for CDMO and CRO

costs, along with approximately $10,477,101 in general and administrative expenses, net of non-cash items, partially offset by an increase

in accounts payable of $281,095 due to the timing of cash payments and a $516,296 increase in prepaid expenses.

in accounts payable of $2,693,808 and accrued expenses of $3,031,803 due to the timing of cash payments and a $216,293 increase in prepaid

Cash used in investing activities

for the six months ended December 31, 2023, and 2022 was ($1,115,209) and ($23,633), respectively.

for the nine months ended March 31, 2024, and 2023 was ($1,206,806) and ($23,633), respectively.

Cash used in investing activities during

the current period related to the issuance of notes receivable totaling $1,050,000 in principal and $23,625 of interest accrued as of

December 31, 2023 (see Note 3.)

the current period primarily related to the issuance of notes receivable prior to the acquisition of Renovaro Cube totaling $1,193,000

in principal and $32,779 of interest accrued as of February 13, 2024.

Cash provided by financing activities

for the six months ended December 31, 2023, was $5,409,682 as compared to cash provided by financing activities of $1,158,375 during the

six months ended December 31, 2022.

During the six months ended December 31, 2023, the Company received net proceeds of $3,490,000 from

issuance of promissory notes, $2,000,000 from a private placement and $341,865 from Common Stock warrants exercised, that were partially

offset by $422,183 in repayment of a finance agreement.

for the nine months ended March 31, 2024, was $8,050,737 as compared to cash provided by financing activities of $3,267,008 during the

nine months ended March 31, 2023.

During the nine months ended March 31, 2024, the Company received net proceeds of $5,355,000 from issuance

of notes payable, $3,000,000 from private placements and $341,865 from Common Stock warrants exercised, that were partially offset by

$646,128 in repayment of a finance agreement.

Off-Balance Sheet Arrangements

The Company does not have any

off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on the Company’s financial

condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources

that is material to investors.

The Company does not have any off-balance

sheet arrangements that have or are reasonably likely to have a current or future effect on the Company’s financial condition, changes

in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material

to investors.

Significant Accounting Policies and Critical Accounting

7 unchanged sentences

About Market Risk.

As a “smaller reporting

company” as defined by Rule 12b-2 of the Securities Exchange Act of 1934, the Company is not required to provide the information

required by this Item.

As a “smaller reporting company”

as defined by Rule 12b-2 of the Securities Exchange Act of 1934, the Company is not required to provide the information required by this

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis