What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-11-14 compared with 2023-05-12 · 288 added, 285 removed, 80 unchanged (88% of the section changed)

Management’s Discussion and Analysis of Financial

Condition and Results of Operations.

Management’s Discussion and Analysis of Financial Condition

and Results of Operations.

Forward-Looking Statement Notice

Certain statements made

in this Quarterly Report on Form 10-Q are “forward-looking statements” (within the meaning of the Private Securities

Litigation Reform Act of 1995) regarding the plans and objectives of management for future operations.

Such statements involve

known and unknown risks, uncertainties and other factors that may cause actual results, performance, or achievements of Enochian

Biosciences Inc.

(“Enochian,” and together with its subsidiaries, the “Company”, “we” or “us”)

to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.

The forward-looking statements included herein are based on current expectations that involve numerous risks and uncertainties.

Our actual future results and trends may differ materially depending on a variety of factors, including, but not limited to, the

risks and uncertainties discussed in Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K as filed with

the SEC on February 27, 2023.

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.

are a biotechnology company committed to developing advanced 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 potentially Hepatitis B virus (HBV) infection.

product development strategy 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,

Enochian BioSciences has evolved from a company with a single product candidate as a potential cure for HIV (ENOB-HV01), adding

two additional pipeline candidates for HIV (ENOB-HV12 and ENOB-HV21), a pipeline for HBV (ENOB-HB01), and with a significant expansion

into cancer immune therapies to address high unmet needs from difficult-to- treat solid tumors (ENOB-DC11.)

The oncology platform is

now at the forefront of our development activities, beginning with pancreatic cancer and potentially other solid tumors with poor

treatment and short life expectancy.

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, our potentially groundbreaking

interventions could have worldwide applicability.

The Company responds quickly

to new data and perceived development opportunities and risks 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.

Certain statements made in this

Quarterly Report on Form 10-Q are “forward-looking statements” (within the meaning of the Private Securities Litigation Reform

Act of 1995) regarding the plans and objectives of management for future operations.

Such statements involve known and unknown risks,

uncertainties and other factors that may cause actual results, performance, or achievements of Renovaro Biosciences Inc.

and together with its subsidiaries, the “Company”, “we” or “us”) to be materially different from any

future results, performance or achievements expressed or implied by such forward-looking statements.

The forward-looking statements included

herein are based on current expectations that involve numerous risks and uncertainties.

Our actual future results and trends may differ

materially depending on a variety of factors, including, but not limited to, the risks and uncertainties discussed in Part I, Item 1A,

“Risk Factors” in our Annual Report on Form 10-K as filed with the SEC on October 2, 2023.

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.

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

BioSciences 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.)

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

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.

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.

Therapeutic Platforms

The Company’s general

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

is leveraging general principles and advances in the knowledge of the immune response to genetically or otherwise engineered cells

with enhanced attributes to promote the recognition and elimination of diseased cells.

Advanced Allogeneic Cell

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

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.

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.

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

In addition to the platform

described above, Enochian BioSciences 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 benefit.

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

We have sublicensed under a profit-sharing agreement our technology to potentially increase engraftment for potential use

in CAR-T therapy as a potential cure for HIV.

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.

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.

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.

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 BioSciences 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 potential use in CAR-T therapy as a potential cure for

HBV Gene Therapy

Enochian BioSciences is

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

use of the allogenic cell model molecular mechanism that co-opts the virus’ machinery to induce the death of infected cells

rather than reproducing and causing more infection to exacerbate disease.

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

with Pancreatic Cancer

Allogeneic Cell Therapy

Platform –moderately 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.

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

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.

However, we intend to seek IND approval to include safety assessment in a wide range of solid tumors in

phase 1/2a, and narrow down to a few promising candidates such as pancreatic, triple negative breast, oral cancers, mesothelioma etc.,

based on early clinical signals.

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.

Enochian BioSciences 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 mimics the human immune

system in combination with implanted human cancer cells.

Early results show promising substantial tumor size reduction.

With reproducible

outcome in human pancreatic tumor animal studies, we are now fully committed to process development IND submission early/mid 2024.

If successful, clinical trials in humans could be possible by the first half of 2024.

ENOB-DC12--XX:

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

Genetically modified

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

Allogeneic Cell Therapy Platform

– 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.

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 BioSciences 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

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.

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 indications are being evaluated strategically to balance risk and opportunity to advance

therapeutic development quickly in cancer indications with few treatment options.

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.

Infectious Diseases:

1 unchanged sentence

Long-term Remission/Cure

Allogeneic Cell Therapy

Platform - Advanced Pre-Clinical Stage;

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 ENOB-HV12 that utilizes a novel cellular and

immunotherapy approach that could potentially provide therapeutic vaccines for HIV (ENOB-HV12).

A non-human primate study of the therapeutic

vaccine in primates at the Fred Hutchinson Cancer Research Center is ongoing.

Animals began receiving the first injections of the potential

therapeutic vaccine in August, 2022.

Preliminary results could potentially be available by mid-2023.

A Pre-IND request could be submitted

by late 2023 to early 2024 with IND submission and the beginning of Phase I clinical trials by mid- to late 2024.

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 primate study of the therapeutic vaccine in primates at the Fred Hutchinson Cancer Research Center is ongoing.

Animals 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.)

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 ENOB-HV01 at this time was deemed costly and a long-term undertaking.

While the 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., DC11).

a business decision was made to sub-license the ALDH gene modification.

ENOB-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

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

Immunotherapy with Allogeneic NK/GDT

Allogeneic Cell Therapy Platform -Pre-IND

conducted - Advanced Pre-Clinical with Human Data through a Collaboration

We are also exploring ENOB-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.

Enochian BioSciences has an exclusive license to use the

underlying patent to develop ENOB-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, Enochian BioSciences does not plan to pursue the IND

and potential clinical trial in the medium to long term.

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 Biosciences

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

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.

Renovaro BioSciences has 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

ENOB-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 first half of 2024.

However, our highest priority is currently

the oncology platform, beginning with pancreatic cancer.

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.

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.

Going Concern and Management’s Plans

The financial statements

included elsewhere herein for the period ended March 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

As of March 31, 2023, we had cash and cash equivalents of $2,948,042, an accumulated deficit of $220,831,001, and total

liabilities of $12,602,576.

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 September 30, 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 September 30, 2023, we had cash and cash equivalents of $523,474, an accumulated deficit of $253,204,281, and total liabilities

of $10,816,494.

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.

Management has reduced overhead

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

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, management has extended its $1.2 million

convertible notes 12 months out to be payable on February 28, 2024, and the Company was able to secure $2.7 million in additional

funding through a Private Placement and intends to attempt to secure additional required funding through equity or debt financing.

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

funding through equity or debt financing.

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

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.

1 unchanged sentence

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 fiscal 2023 is expected to be used to satisfy existing and future obligations and liabilities and working capital needs,

to support commercialization of our products and conduct the clinical and regulatory work to develop our product candidates, and

to begin building working capital reserves.

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

2023, compared to the three and nine months ended March 31, 2022

Funding that we may receive during

the fiscal year 2024 is expected to be used to satisfy existing and future obligations and liabilities and working capital needs, to support

commercialization of our products and conduct the clinical and regulatory work to develop our product candidates, and to begin building

working capital reserves.

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.)

Results of Operations for the three months ended September 30, 2023

The following table sets forth

our revenues, expenses, and net loss for the three and nine months ended March 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 months ended September 30, 2023 and 2022.

The financial information below is derived

from our unaudited condensed consolidated financial statements.

For the Three Months Ended

the Nine Months Ended

Increase/(Decrease)

September 30,

Increase/(Decrease)

and administrative

and development

and amortization

Operating Expenses

FROM OPERATIONS

Income (Expenses)

in fair value of contingent consideration

on extinguishment of contingent consideration

and other income (expense)

General and administrative

Research and development

Depreciation and amortization

Total Operating Expenses

LOSS FROM OPERATIONS

Other Income (Expenses)

Before Income Taxes

Tax (Provision) Benefit

Loss on extinguishment of debt

Loss on extinguishment of contingent consideration liability

Interest expense

Interest and other income

Total Other Income (Expenses)

Loss Before Income Taxes

Income Tax (Expense) Benefit

$ (9,175,028 )

$ (7,699,760 )

$ (1,475,268 )

We are a pre-revenue, pre-clinical

4 unchanged sentences

Our operating expenses for the

three months ended March 31, 2023, and 2022, were $4,063,436 and $4,034,556 respectively, representing an increase of $28,880, or approximately

The increase in operating expenses primarily relates to an increase in general and administrative expenses of $1,005,601 partially

offset by a decrease in research and development expenses of $973,243.

Our operating expenses for the

nine months ended March 31, 2023, and 2022, were $15,621,918 and $17,870,020, respectively, representing a decrease of $2,248,102 or approximately

The decrease in operating expenses primarily relates to a decrease in research and development expenses of $3,434,567, partially

offset by an increase in general and administrative expenses of $1,196,236.

General and administrative expenses

for the three months ended March 31, 2023, and 2022, were $3,796,057 and $2,790,456, respectively, representing an increase of $1,005,601

or approximately 36%.

The variance is primarily related to increases in accounting related expenses of $443,212, legal expenses of $378,421

and stock-based compensation of $498,529, partially offset by decreases in recruiting fees of $140,708.

three months ended September 30, 2023 and 2022, were $8,884,114 and $7,190,616 respectively, representing

an increase of $1,693,498, or approximately 24% .

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

and administrative expenses of $3,733,370 offset by the decrease in research and development expenses of $2,038,731.

General and administrative expenses

for the nine months ended March 31, 2023, and 2022, were $12,365,960 and $11,169,724, respectively, representing an increase of $1,196,236

for the three months ended September 30, 2023, and 2022, were $8,290,210 and $4,556,840, respectively, representing an increase of $3,733,370

or approximately 82%.

The variance primarily relates to increases in legal expenses of $2,611,749, accounting related expenses of $579,249,

and compensation and related expenses of $981,671, partially offset by a decrease in stock-based compensation of $2,426,777, security

costs of $405,000 and recruiting fees of $281,407.

Research and development expenses

for the three months ended March 31, 2023, and 2022, were $239,137 and $1,212,380, respectively, representing a decrease of $973,243 or

approximately 80%.

The variance is primarily driven by a decrease of $730,000 in collaboration expenses with CDMO and CRO partners, and

$219,500 R&D consulting expenses incurred in the prior period for abandoned product candidates.

The variance is related to an increase in non-cash consulting fees of $4,470,000, accounting fees of $196,426 and

insurance expenses of $118,311, partially offset by a decrease in compensation and related expenses of $617,340 and legal expenses of

Research and development expenses

for the nine months ended March 31, 2023, and 2022, were $3,170,471 and $6,605,038, respectively, representing a decrease of $3,434,567

for the three months ended September 30, 2023, and 2022, were $566,644 and $2,605,375, respectively, representing a decrease of $2,038,731

or approximately 78%.

The variance is primarily driven by a decrease of $2,578,754 in expenses related to collaboration partner expenses

for abandoned product candidates, $537,434 in R&D consulting expenses, and $228,185 in lab related expenses.

The Company recorded other expense

of $264,860 for the three months ended March 31, 2023, compared to other expense of $2,166,909 for the three months ended March 31, 2022,

representing a decrease in other expense of $1,902,049 or 88%.

The variance is primarily due to the change in fair value of the contingent

consideration liability expense of $2,078,994 incurred in the prior period.

The contingent consideration liability was settled in the

period ending September 30, 2022.

The variance is primarily driven by a decrease of $2,246,465 in collaborating partner expenses with

CDMO and CROs related to discontinued product candidates.

The Company recorded other expense

of $863,886 for the nine months ended March 31, 2023, compared to other expense of $5,326,321 for the nine months ended March 31, 2022,

of $290,914 for the three months ended September 30, 2023, compared to other expense of $509,144 for the three months ended September

30, 2022, representing a decrease in other expense of $218,230 or 43%.

The variance is primarily due to the change in fair value of the contingent

consideration liability expense of $5,070,891, in the prior period net of a loss of $419,182 related to the extinguishment of the contingent

consideration liability during the period ending September 30, 2022.

The variance is primarily due to the loss on extinguishment of

contingent consideration liability of 419,182 in the prior period, partially offset by the loss on extinguishment of debt of $120,018

in the current period.

Net loss for the three months ended

March 31, 2023, and 2022, was $4,328,296 and $6,201,465, respectively, representing a decrease in loss of $1,873,169 or approximately

The decrease in net loss was primarily due to a decrease in expense related to the change in fair value of contingent consideration

of $2,078,994.

Net loss for the nine months ended

March 31, 2023, and 2022, was $16,485,804 and $23,196,375, respectively, representing a decrease in loss of $6,710,571 or approximately

The decrease in net loss was primarily due to a decrease in research and development expenses of $3,434,567, and a decrease in expense

related to the change in fair value of contingent consideration of $5,070,891, partially offset by a loss of $419,182 related to the extinguishment

of the contingent consideration liability and an increase in general and administrative expenses of $1,196,236.

September 30, 2023, and 2022, was $9,175,028 and $7,699,760, respectively, representing an increase in net loss of $1,475,268 or approximately

The increase in net loss was primarily due to an increase in general and administrative expenses of $3,733,370, partially offset

by a decrease in research and development expenses of $2,038,73.

Liquidity and Capital Resources

7 unchanged sentences

As noted above under the heading

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

We will need 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 ENOB-DC11, ENOB-HV-12, ENOB-HV-01, ENOB-HV-21

and ENOB-HB-01.

“Going Concern and Management’s Plans,” through September 30, 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.

5 unchanged sentences

and our financial condition and results of operations.

As of March 31, 2023, the Company

As of September 30, 2023, the Company

had $523,474 in cash and working capital of $(8,189,378) as compared to $1,874,480 in cash and working capital of $(8,457,693) as of June

30, 2023, a decrease of 72% and 3%, respectively.

Total assets at March 31, 2023,

Total assets at September 30, 2023,

were $57,562,806 compared to $58,300,796 as of June 30, 2023.

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

The change in cash is primarily attributed to $3,170,471 in research and development costs related primarily to CDMO and CRO

costs, along with approximately $9,358,307 in general and administrative expenses, net of non-cash items, partially offset by an increase

in accounts payable of $3,069,487 due to the timing of cash payments, funding totaling $1,625,000 related to warrants exercised and $2,483,000

cash received from a private placement during the period.

Total liabilities at March 31,

Total liabilities at September

30, 2023, were $10,816,494 compared to $11,798,685 as of June 30, 2023.

The increase in total liabilities was primarily related to an increase

of $3,069,487 in accounts payable due to the timing of cash payments, partially offset by the reduction in the contingent consideration

liability of $2,343,318.

The decrease in total liabilities was primarily related to a decrease

of $1,714,960 in notes payable short term, net of discount partially offset by an increase of $752,741 in convertible notes payable short

term, net of discount.

The following is a summary of the

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

Cash Used in Operating Activities

September 30,

Net Cash Used in Operating Activities

$ (2,777,207 )

$ (2,653,674 )

Net Cash Used in Investing Activities

Net Cash Provided by Financing Activities

Effect of exchange rates on cash

Change in Cash and Cash Equivalents

$ (1,351,006 )

$ (1,200,224 )

Cash used in operating activities for the three months ended September 30, 2023,

and 2022 was ($2,777,207) and ($2,653,674), respectively.

Cash used in operating activities during the current period primarily related

to $566,644 in research and development expenses for CDMO and CRO costs, along with approximately $2,805,371 in general and administrative

expenses, net of non-cash items, partially offset by an increase in accounts payable of $124,303 due to the timing of cash payments and

a $411,352 increase in prepaid expenses.

Cash used in investing activities

Cash Provided by Financing Activities

of exchange rates on cash

in Cash and Cash Equivalents

Cash used in operating activities

for the nine months ended March 31, 2023, and 2022 was ($9,512,937) and ($12,681,849), respectively.

Cash used in operating activities

during the current period included $3,170,471 in research and development expenses for related CDMO and CRO costs, along with approximately

$9,358,307 in general and administrative expenses, net of non-cash items, partially offset by an increase in accounts payable of $3,069,487

due to the timing of cash payments.

Cash provided by financing activities

for the nine months ended March 31, 2023, was $3,267,008 as compared to cash provided by financing activities of $3,180,274 during the

nine months ended March 31, 2022.

During the nine months ended March 31, 2023, the Company received financing from the exercise of warrants

held by shareholders of $1,625,000 and $2,483,000 from a private placement that was partially offset by repayments of a financing agreement

for the three months ended September 30, 2023, and 2022 was ($1,057,875) and zero, respectively.

Cash used in investing activities during

the current period related to the issuance of notes receivable totaling $1,050,000 in principal and $7,875 of interest accrued as of September

30, 2023 (see Note 3.)

Cash provided by financing activities for the three months ended September 30,

2023, was $2,562,817 as compared to cash provided by financing activities of $1,458,375 during the three months ended September 30, 2022.

During the three months ended September 30, 2023, the Company received net proceeds of $2,750,000 from private placements that were partially

offset by $187,183 in repayment of a finance agreement.

Off-Balance Sheet Arrangements

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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