What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-03-09 compared with 2023-03-07 · 340 added, 326 removed, 64 unchanged (91% 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 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.

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-HV-01), adding

two additional pipeline candidates for HIV (ENOB-HV-12 and ENOB-HV-21), a pipeline for Hepatitis B Virus (HBV) (ENOB-HB-01), and

with a significant expansion into cancer immune therapies to address high unmet needs from difficult-to- treat solid tumors (ENOB-DC-11.)

The oncology platform is

now at the forefront of our development activities, beginning with pancreatic cancer.

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 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 Enochian 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 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.

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, Enochian

BioSciences has evolved from a company with a single product candidate as a potential cure for HIV (ENOB-HV-01), adding two additional

pipeline candidates for HIV (ENOB-HV-12 and ENOB-HV-21), a pipeline for Hepatitis B Virus (HBV) (ENOB-HB-01), and with a significant

expansion into cancer immune therapies to address high unmet needs from difficult-to- treat solid tumors (ENOB-DC-11.)

The oncology platform is now at

the forefront of our development activities, beginning with pancreatic cancer.

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 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.

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 principals 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

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 enhance the immune system to allow a person to better fight diseases.

The Company is leveraging

general principals 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, 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

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

HBV Gene Therapy

Enochian 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 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.

Enochian 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

–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.

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

Other potential targets for later development could include triple-negative breast cancer, glioblastoma, or renal cell

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.

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, glioblastoma, or renal cell carcinoma.

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.

now fully committed to process development/improvements and hope to have confirmatory in vivo data by early 2023 with potential

Pre-IND submission early/mid 2023.

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

We are now fully committed to process

development/improvements and hope to have confirmatory in vivo data by early 2023 with potential Pre-IND submission early/mid

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

ENOB-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 indications 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.

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-HV-12 that utilizes a novel cellular and immunotherapy approach that could potentially provide therapeutic

3 unchanged sentences

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

results could potentially be available in the first half of 2023.

A Pre-IND request could be submitted by mid-2023, with IND submission and

the beginning of Phase I clinical trials by mid- to end-2024.

Preliminary results

could potentially be available in the first half of 2023.

A Pre-IND request could be submitted by mid-2023, with IND submission and the

beginning of Phase I clinical trials by mid- to end-2024.

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-HV-01 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., DC-11).

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

ENOB-HV-01 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

Allogeneic Cell Therapy Platform -Pre-IND

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

are also exploring ENOB-HV-21, 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-HV-21 for potential treatment or cure of HIV.

Although in vitro and in vivo studies have

demonstrated promising results, further development of ENOB-HV-01 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., DC-11).

Therefore, a business decision

was made to sub-license the ALDH gene modification.

ENOB-HV-01 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 of success.

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-HV-21,

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-HV-21 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 near to medium-term.

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 near to medium-term.

Potential Cure

HBV Gene Therapy -Pre-Clinical

ENOB-HB-01 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.

ENOB-HB-01 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.

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.

Regaining Compliance with Nasdaq Listing Requirements

On each of October 17, 2022,

November 23, 2022, and February 16, 2022, we received a notice, or the Notices, from the Listing Qualifications Department of Nasdaq

stating that we were not in compliance with Nasdaq Listing Rule 5250(c)(1), or the “Rule”, because we did not timely

file our Form 10-K for the period ended June 30, 2022 and our Forms 10-Q for the periods ended September 30, 2022 and December 31,

2022 with the SEC.

The Rule requires listed companies to timely file all required periodic financial reports with the SEC.

27, 2023, we filed our Form 10-K.

Today we filed our Form 10-Q for the period ended September 30, 2022 but have not yet filed our

Form 10-Q for the period ended December 31, 2022, and therefore we have not regained compliance with the Rule.

We were unable to

file the Annual Report on Form 10-K for the period ended June 30, 2022 and the Quarterly Report on Form 10-Q for the periods ended

September 30, 2022 and December 31, 2022 by their initial deadlines, due to the reasons described in the Notifications of Late

Filing on Form 12b-25, filed with the SEC on September 29, 2022 and November 15, 2022.

While we were able to file the Annual Report

on Form 10-K for the period ended June 30, 2022 and the Quarterly Report on Form 10-Q for the period ended September 30, 2022 within

the extension period provided pursuant to Nasdaq rules, we have not yet filed the Form 10-Q for the period ended December 31, 2022,

and there can be no assurance that we will be able to remain in compliance with the Rule or with other Nasdaq listing requirements

in the future.

If we are unable to regain

compliance with the Rule or with any of the other continued listing requirements, Nasdaq may take steps to delist our securities,

which could have adverse consequences, including a limited availability of market quotations for our securities, reduced liquidity

for our securities, a limited amount of news and analyst coverage and a decreased ability to issue additional securities or obtain

additional financing in the future.

On each of October 17, 2022, November

23, 2022, and February 16, 2022, we received a notice, or the Notices, from the Listing Qualifications Department of Nasdaq stating that

we were not in compliance with Nasdaq Listing Rule 5250(c)(1), or the “Rule”, because we did not timely file our Form 10-K

for the period ended June 30, 2022 and our Forms 10-Q for the periods ended September 30, 2022 and December 31, 2022 with the SEC.

Rule requires listed companies to timely file all required periodic financial reports with the SEC.

On February 27, 2023, we filed our

On March 7, 2023 we filed our Form 10-Q for the period ended September 30, 2022 but have not yet filed our Form 10-Q for the

period ended December 31, 2022, and therefore we have not regained compliance with the Rule.

We were unable to file the Annual Report

on Form 10-K for the period ended June 30, 2022 and the Quarterly Report on Form 10-Q for the periods ended September 30, 2022 and December

31, 2022 by their initial deadlines, due to the reasons described in the Notifications of Late Filing on Form 12b-25, filed with the

SEC on September 29, 2022 and November 15, 2022.

If we are unable to maintain compliance

with the Rule or with any of the other continued listing requirements, Nasdaq may take steps to delist our securities, which could have

adverse consequences, including a limited availability of market quotations for our securities, reduced liquidity for our securities,

a limited amount of news and analyst coverage and a decreased ability to issue additional securities or obtain additional financing in

Going Concern and Management’s Plans

The financial statements

included elsewhere herein for the period ended September 30, 2022, 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, 2022, we had cash and cash equivalents of $7,971,918, an accumulated deficit of $212,044,957,

and total liabilities of $12,745,714.

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 vaccine).

The financial statements included

elsewhere herein for the period ended December 31, 2022, 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, 2022, we had cash and cash equivalents of $4,118,896, an accumulated deficit of $216,502,705, and total liabilities

of $13,374,307.

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 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 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 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 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.

In addition, management has extended its $1.2 million convertible

notes 12 months out to be payable on February 28, 2024, and 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 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

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

The COVID-19 pandemic continues

COVID-19 may cause delays in our research activities.

To date, the COVID-19 pandemic has not materially affected

our operations.

However, it has caused delays in the conduct of experiments due to limitations in resources and supply chain issues,

in particular for those conducting experiments.

There have also been increases in the cost to conduct animal studies due to staffing

and other limitations.

The full extent to which

the COVID-19 pandemic may impact our business and operations is subject to future developments, which are uncertain and difficult

We continue to monitor the

impact of the COVID-19 pandemic on our business and operations and will seek to adjust our activities as appropriate.

Results of Operations

for the three months ended September 30, 2022 and 2021

The following table sets

forth our revenues, expenses and net loss for the three months ended September 30, 2022 and 2021.

To date, the COVID-19 pandemic has not materially affected our operations.

However, it has caused delays in the conduct of experiments due to limitations in resources and supply chain issues, in particular for

those conducting experiments.

There have also been increases in the cost to conduct animal studies due to staffing and other limitations.

The full extent to which the COVID-19

pandemic may impact our business and operations is subject to future developments, which are uncertain and difficult to predict.

We continue to monitor the impact

of the COVID-19 pandemic on our business and operations and will seek to adjust our activities as appropriate.

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

2022, compared to the three and six months ended December 31, 2021

The following table sets forth

our revenues, expenses, and net loss for the three and six months ended December 31, 2022, and 2021.

The financial information below

1 unchanged sentence

For the Three Months Ended

September 30,

the Six Months Ended

Increase/(Decrease)

and administrative

and development

and amortization

Operating Expenses

General and administrative

Research and development

Depreciation and amortization

Total Operating Expenses

LOSS FROM OPERATIONS

$ (1,962,925 )

$ (2,276,982 )

FROM OPERATIONS

$ (4,367,866 )

$ (6,330,791 )

$ (1,962,925 )

$ (11,558,482 )

$ (13,835,464 )

Income (Expenses)

in fair value of contingent consideration

on extinguishment of contingent consideration liability

(Loss) on currency transactions

and other income

Other Income (Expenses)

extinguishment of contingent consideration liability

Change in fair value of contingent consideration

Interest expense

Gain on currency transactions

Interest and other income

Total Other Income (Expenses)

Loss Before Income Taxes

Before Income Taxes

$ (4,457,748 )

Income Tax (Expense) Benefit

$ (6,582,941 )

$ (12,157,508 )

$ (16,994,876 )

$ (4,837,368 )

Tax (Expense) Benefit

$ (4,457,748 )

$ (6,582,941 )

$ (2,125,193 )

$ (12,157,508 )

$ (16,994,910 )

We are a pre-revenue, pre-clinical

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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 September 30, 2022, and September 30, 2021, were $7,190,616 and $7,504,673

respectively, representing a decrease of $314,057, or approximately 4% .

The decrease in operating expenses primarily relates

to the decrease in research and development expenses of $450,060 offset by the increase in general and administrative expenses

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, 2022, and 2021, were $4,367,866 and $6,330,791 respectively, representing a decrease of $1,962,925, or

approximately 31%.

The decrease in operating expenses primarily relates to a decrease in research and development expenses of $2,011,263

partially offset by an increase in general and administrative expenses of $51,299.

Our operating expenses for the

six months ended December 31, 2022, and 2021, were $11,558,482 and $13,835,464, respectively, representing a decrease of $2,276,982 or

approximately 16%.

The decrease in operating expenses primarily relates to a decrease in research and development expenses of $2,461,324,

partially offset by an increase in general and administrative expenses of $190,635.

General and administrative expenses

for the three months ended September 30, 2022, and September 30, 2021, were $4,556,840 and $4,417,505, respectively, representing an increase

of $139,335 or approximately 3%.

The variance is related to an increase in legal expenses of $1,278,351, compensation and related expenses

of $662,380, offset by a decrease in stock-based compensation of $1,701,968.

Research and development

expenses for the three months ended September 30, 2022, and September 30, 2021, were $2,605,375 and $3,055,435, respectively, representing

a decrease of $450,060 or approximately 15%.

The variance is primarily driven by a decrease of $2,683,500 in expenses related to payments made to a related party for abandoned product candidate ENOB-CV-01, offset by an increase of $2,303,615 in

collaborating partner expenses with CDMO and CRO partners .

for the three months ended December 31, 2022, and 2021, were $4,013,063 and $3,961,764, respectively, representing an increase of $51,299

or approximately 1%.

The variance is related to an increase in legal expenses of $1,115,456 and compensation and related expenses of

$243,919, partially offset by a decrease in stock-based compensation of $1,223,337.

General and administrative expenses

for the six months ended December 31, 2022, and 2021, were $8,569,903 and $8,379,268, respectively, representing an increase of $190,635

or approximately 2%.

The variance primarily relates to an increase in legal expenses of $2,393,807 and compensation and related expenses

of $906,299, partially offset by a decrease in stock-based compensation of $2,925,304.

Research and development expenses

for the three months ended December 31, 2022, and 2021, were $325,959 and $2,337,222, respectively, representing a decrease of $2,011,263

or approximately 86%.

The variance is primarily driven by a decrease of $508,500 in expenses related to payments made to a related party

for an abandoned product candidate, and $1,273,343 in collaborating partner expenses with CDMO and CRO partners incurred in the prior

Research and development expenses

for the six months ended December 31, 2022, and 2021, were $2,931,334 and $5,392,658, respectively, representing a decrease of $2,461,324

or approximately 46%.

The variance is primarily driven by a decrease of $3,117,000 in expenses related to payments made to a related

party for an abandoned product candidate, $381,986 in consulting expenses, and $226,562 in lab related expenses partially offset by an

increase of $1,365,557 in collaborating partner expenses with CDMO and CRO partners.

The Company recorded other expense

of $509,144 for the three months ended September 30, 2022, compared to other expense of $2,907,262 for the three months ended September

of $89,882 for the three months ended December 31, 2022, compared to other expense of $252,150 for the three months ended December 31,

2021, representing a decrease in other expense of $162,268 or 64%.

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

the contingent consideration liability expense of $2,824,624 offset by the loss on extinguishment of contingent consideration liability

As of September 30, 2022, the contingent consideration liability has been settled.

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

consideration liability expense of $167,255 incurred in the prior period.

The contingent consideration liability was settled in the period

ending September 30, 2022.

The Company recorded other expense

of $599,026 for the six months ended December 31, 2022, compared to other expense of $3,159,412 for the six months ended December 31,

2021, representing a decrease in other expense of $2,560,386 or 81%.

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

contingent consideration liability expense of $2,991,897, 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.

Net loss for the three months

ended September 30, 2022, and 2021, was $7,699,760 and $10,411,969, respectively, representing a decrease in net loss of $2,712,209

or approximately 26%.

The decrease in net loss was primarily due to a decrease in research and development expenses of $450,060, a

decrease in expense related to the change in fair value of contingent consideration of $2,824,642, offset by loss on extinguishment

of contingent consideration liability of 419,182 and offset by an increase in general and administrative expenses of $139,335.

ended December 31, 2022, and 2021, was $4,457,748 and $6,582,941, respectively, representing a decrease in loss of $2,125,193 or approximately

The decrease in net loss was primarily due to a decrease in research and development expenses of $2,011,263 and a decrease in expense

related to the change in fair value of contingent consideration of $167,255.

Net loss for the six months ended

December 31, 2022, and 2021, was $12,157,508 and $16,994,910, respectively, representing a decrease in loss of $4,837,402 or approximately

The decrease in net loss was primarily due to a decrease in research and development expenses of $2,461,324, and a decrease in expense

related to the change in fair value of contingent consideration of $2,991,897.

Liquidity and Capital Resources

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our capital and liquidity requirements through funding from stockholders, the sale of our Common Stock and warrants, and debt financing.

We have never generated any sales revenue to support our operations and we expect this to continue until our therapies or products

are approved for marketing in the United States and/or Europe.

Even if we are successful in having our therapies or products approved

for sale in the United States and/or Europe, we cannot guarantee that a market for the therapies or products will develop.

never be profitable.

As noted above under the

heading “Going Concern and Management’s Plans,” through September 30, 2022, 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.

We have never generated any sales revenue to support our operations and we expect this to continue until our therapies or products are

approved for marketing in the United States and/or Europe.

Even if we are successful in having our therapies or products approved for

sale in the United States and/or Europe, we cannot guarantee that a market for the therapies or products will develop.

We may never be

As noted above under the heading

“Going Concern and Management’s Plans,” through December 31, 2022, 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 ENOB-DC11, ENOB-HV-12, ENOB-HV-01,

ENOB-HV-21 and ENOB-HB-01.

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.

If additional funds are required, 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 September 30, 2022,

the Company had $7,971,918 in cash and working capital of $973,463 as compared to $9,172,142 in cash and working capital of $3,114,170

as of June 30, 2022, a decrease of 13% and 69%, respectively.

Total assets at September 30,

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.

If additional funds are required, 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, 2022, the Company

had $4,118,896 in cash and working capital of $(5,902,533) as compared to $9,172,142 in cash and working capital of $3,114,170 as of

June 30, 2022, a decrease of 55% and 290%, respectively.

Total assets at December 31, 2022,

were $80,273,663 compared to $84,632,663 as of June 30, 2022.

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

cash of $1,200,224.

The change in cash is primarily attributed to $2,605,375 in research and development costs related primarily to CDMO

and CRO costs, along with approximately $3,502,431 in general and administrative expenses, net of non-cash items, partially offset by

an increase in accounts payable of $3,280,878 due to the timing of cash payments and funding totaling $1,625,000 related to warrants exercised

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

of $5,053,246.

The change in cash is primarily attributed to $2,931,334 in research and development costs related primarily to CDMO and

CRO costs, along with approximately $6,666,695 in general and administrative expenses, net of non-cash items, partially offset by an

increase in accounts payable of $3,153,358 due to the timing of cash payments and funding totaling $1,625,000 related to warrants exercised

during the period.

Total liabilities at September

Total liabilities at December

31, 2022, were $13,374,307 compared to $12,013,815 as of June 30, 2022.

The increase in total liabilities was primarily related

to an increase of $3,280,878 in accounts payable due to timing, offset by a decrease in other current liabilities of $185,145 related

to a financing arrangement for an insurance policy and the reduction in the contingent consideration liability of $2,343,318.

The following is a summary

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

September 30,

The increase in total liabilities was primarily related to an

increase of $3,153,358 in accounts payable due to timing of cash payments and $654,730 in other current liabilities related to a financing

arrangement for an insurance policy partially offset by the reduction in the contingent consideration liability of $2,343,318.

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

$ (2,820,299 )

$ (5,276,687 )

Net Cash Used in Investing Activities

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Change in Cash and Cash Equivalents

$ (1,200,224 )

$ (5,287,360 )

Cash used in operating activities

for the three months ended September 30, 2022, and 2021 was ($2,820,299) and ($5,276,687), respectively.

Cash used in operating

activities during the current period included $2,605,375 in research and development for related CDMO and CRO costs, along with

approximately $3,502,431 in general and administrative expenses, net of non-cash items, partially offset by an increase in accounts

payable of $3,280,878 due to the timing of cash payments.

Cash provided by financing

activities for the three months ended September 30, 2022, was $1,625,000 as compared to cash provided by financing activities of

zero during the three months ended September 30, 2021.

During the three months ended September 30, 2022, the Company received financing

from the exercise of warrants held by shareholders of $1,625,000.

for the six months ended December 31, 2022, and 2021 was ($6,205,145) and ($9,897,151), respectively.

Cash used in operating activities

during the current period included $2,931,334 in research and development expenses for related CDMO and CRO costs, along with approximately

$6,666,695 in general and administrative expenses, net of non-cash items, partially offset by an increase in accounts payable of $3,153,358

due to the timing of cash payments.

Cash provided by financing activities

for the six months ended December 31, 2022, was $1,158,375 as compared to cash provided by financing activities of $2,950,741 during

the six months ended December 31, 2021.

During the six months ended December 31, 2022, the Company received financing from the exercise

of warrants held by shareholders of $1,625,000 that was partially offset by repayments of a financing agreement of $466,625.

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.

Significant Accounting Policies and Critical

Accounting Estimates

The methods, estimates,

and judgments that we use in applying our accounting policies have a significant impact on the results that we report in our financial

Some of our accounting policies require us to make difficult and subjective judgments, often as a result of the need

to make estimates regarding matters that are inherently uncertain.

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

The methods, estimates, and judgments

that we use in applying our accounting policies have a significant impact on the results that we report in our financial statements.

Some of our accounting policies require us to make difficult and subjective judgments, often as a result of the need to make estimates

regarding matters that are inherently uncertain.

For a summary of our accounting

policies, see Note 1 to the unaudited condensed consolidated financial statements.

Quantitative and Qualitative Disclosures

About Market Risk.

and Qualitative Disclosures About Market Risk.

As a “smaller reporting

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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