What changed in this filing

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Item 2. Management’s Discussion and Analysis

2022-05-13 compared with 2022-02-14 · 324 added, 331 removed, 78 unchanged (89% 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 September 24, 2021.

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 pre-clinical stage biotechnology company committed to using our genetically modified cell, gene, and immune therapy technologies

to potentially prevent or cure HIV, HBV, influenza and coronavirus infections, as well as to provide potentially long-term or life-long

cancer remission in some of the deadliest cancers.

Over the past several years,

Enochian Biosciences Inc.

has expanded the pipeline from a single potential cure for HIV (autologous transplantation with gene-modified

ENOB-HV-01) to three additional potential cures for HIV, a potential cure for Hepatitis B Virus (HBV), potential inhaled

treatment and prophylaxis/prevention of all variants of SARS-CoV-1 and -2 (the cause of the COVID-19 pandemic), and potential cures

for many solid tumors, beginning with pancreatic cancer.

Our integrated platforms

encompass innovative interventions in gene and immune therapies that provide hope for cures or life-long remissions for devastating

Our platforms can potentially streamline and accelerate pre-clinical, regulatory, clinical, and production pathways.

Because of the relative ease of administration, our potentially groundbreaking interventions could be used throughout the world.

Our novel approach

tricks the virus into sending suicide signals to the infected cell instead of turning the cell into a virus factory.

The technology

is delivered by vectors that would allow it to rapidly treat an infection, or to lay and wait in ambush until a cell becomes infected,

which would prevent (prophylaxis, similar to taking drugs to protect from becoming infected with malaria or HIV) future infections.

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 September 24, 2021.

The Company’s plans and

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

Assumptions relating to the foregoing

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

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

Although the Company

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

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

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

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

a pre-clinical stage biotechnology company committed to using our genetically modified cell, gene, and immune therapy technologies to

potentially prevent or cure HIV, HBV, influenza, SARS-CoV-1 and -2, and coronavirus infections, as well as to provide potentially long-term

or life-long cancer remission in some of the deadliest cancers.

Over the past several years, we

have expanded the pipeline from a single potential cure for HIV (autologous transplantation with gene-modified cells;

ENOB-HV-01) to three

additional potential cures for HIV, a potential cure for Hepatitis B Virus (HBV), potential inhaled treatment and prophylaxis/prevention

of all variants of SARS-CoV-1 and -2 (the cause of the COVID-19 pandemic) and potentially other coronaviruses, and potential cures for

many solid tumors, beginning with pancreatic cancer.

Our integrated platforms encompass

innovative interventions in gene and immune therapies that provide hope for cures or life-long remissions for devastating diseases.

platforms can potentially streamline and accelerate pre-clinical, regulatory, clinical, and production pathways.

Because of the relative

ease of administration, our potentially groundbreaking interventions could be used throughout the world.

Our novel approach tricks

the virus into sending suicide signals to the infected cell instead of turning the cell into a virus factory.

The technology is delivered

by vectors that would allow it to rapidly treat an infection, or to lay and wait in ambush until a cell becomes infected, which would

prevent (prophylaxis, similar to taking drugs to protect from becoming infected with malaria or HIV) future infections.

The delivery mechanism

can be adapted for aerosol (e.g., respiratory infections like the virus that causes COVID-19 and influenza), intravenous or other

delivery mechanisms (e.g.

can be adapted for aerosol (e.g., respiratory infections like the virus that causes COVID-19 and influenza), intravenous or other delivery

mechanisms (e.g.

for Hepatitis B Virus and HIV).

Allogeneic Cell

The human immune

system is designed to recognize “self” and destroy “otherness” or “non-self”, such as bacteria,

viruses and 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 hyperstimulate a person’s immune response to better attack a chronic infection (e.g.

HIV) or solid tumors.

In certain treatments (e.g.

HIV and cancer), cells taken from healthy donors are sometimes genetically modified

to further boost the immune system to seek and kill diseases.

In addition to

those platforms, Enochian Biosciences has an innovative approach to remove cells from a person living with HIV and genetically

modify them so they cannot be infected with HIV.

The unique innovation is an additional genetic alteration to increase the ability

of those cells to survive and expand when they are given back to the same person (autologous transplantation).

The human immune system

is designed to recognize “self” and destroy “otherness” or “non-self,” such as bacteria, viruses

and 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 tumors.

In certain treatments (e.g., HIV and cancer), cells taken from healthy donors are sometimes genetically modified to further boost the

immune system to seek and kill diseases.

In addition to those

platforms, we have an innovative approach to remove cells from a person living with HIV and genetically modify them so they cannot be

infected with HIV.

The unique innovation is an additional genetic alteration to increase the ability of those cells to survive and expand

when they are given back to the same person (autologous transplantation).

Respiratory Diseases

April 2021, Enochian Biosciences acquired the exclusive license to a potential pan-SARS-Cornavirus-1 and-2 (SARS-CoV) and pan-Influenza

inhaled treatment and prophylaxis.

2021, we acquired the exclusive license to a potential pan-SARS-Cornavirus-1 and-2 (SARS-CoV) and pan-Influenza inhaled treatment and

has caused the most devastating global pandemic in a century – COVID-19.

Using the Hijack RNA platform technology, in

vitro and in vivo results showing rapid killing of infected cells, but not uninfected cells were presented at the important

Conference on Retroviruses and Opportunistic Infections in March 2021.

Since that time, there has been substantial progress with

a Pre-IND (as defined below) submission expected in the near term.

Using the Hijack RNA platform technology, in vitro

and in vivo results showing rapid killing of infected cells, but not uninfected cells were presented at the important Conference

on Retroviruses and Opportunistic Infections in March 2021.

Since that time, there has been substantial progress with a Pre-IND (as defined

below) submission expected in the near term.

has caused dozens of major global pandemics;

the most notable in 1918 that killed 50 to 100 million people.

There was an H1N1 threat

as recently as 2009.

The Hijack RNA also has shown promising in vitro results that were presented at the Annual Conference

of the American Society of Gene and Cell Therapy (ASGCT) in May 2020.

leading scientist and public health expert serves on our Scientific Advisory Board focused on respiratory diseases.

There was an H1N1 threat as

recently as 2009.

The Hijack RNA also has shown promising in vitro results that were presented at the Annual Conference of the

American Society of Gene and Cell Therapy (ASGCT) in May 2020.

combining the SARS-CoV, and Influenza Hijack RNA has been designed.

scientist and public health expert serve on our Scientific Advisory Board focused on respiratory diseases.

Human Immunodeficiency

Virus (HIV), and Acquired Immunodeficiency Syndrome (AIDS)

attacks the human immune system, specifically killing off CD4+ cells, or T cells, which play a central, controlling role in the

immune system.

Left untreated, HIV dramatically reduces the number of T cells in the body, devastates the immune system, leading

to AIDS, a condition where the immune system cannot fight off life-threatening infections and cancers.

the human immune system, specifically killing off CD4+ cells, or T cells, which play a central, controlling role in the immune system.

Left untreated, HIV dramatically reduces the number of T cells in the body, devastates the immune system, leading to AIDS, a condition

where the immune system cannot fight off life-threatening infections and cancers.

there are over 30 antiretroviral drugs, or ART, approved by the U.S.

Food and Drug Administration (“FDA”) to treat

HIV but these drugs are expensive, require daily adherence, and can have significant side effects over time.

In addition, on a

global basis, as many as 1 million people, including persons in high-income countries, continue to die each year from HIV/AIDS

due to drug-resistant HIV or lack of access to treatment.

To date, there are no treatments that can eliminate the reservoir of

immune cells that are infected with HIV from the body.

Food and Drug Administration (“FDA”) to treat HIV but

these drugs are expensive, require daily adherence, and can have significant side effects over time.

In addition, on a global basis, as

many as 1 million people, including persons in high-income countries, continue to die each year from HIV/AIDS due to drug-resistant HIV

or lack of access to treatment.

To date, there are no treatments that can eliminate the reservoir of immune cells that are infected with

HIV from the body.

Consequently, treatment for HIV is life-long.

have been several efforts to cure HIV by re-engineering a person’s own T-cells so that these cells no longer express a special

protein (C-C chemokine co-receptor type 5 or CCR5), which HIV uses to gain entry to them.

A naturally occurring mutation that blocks

expression of CCR5 on T cells occurs in ~1% of persons living in or from Northern Europe with no known adverse effects.

patient”, and more recently the “London patient” were HIV-positive persons who developed cancer and were treated

with a bone marrow transplant with cells donated from persons with this naturally occurring mutation of CCR5.

The Berlin and London

patients seem to have been effectively cured from HIV providing proof-of-concept that HIV can be cured.

However, because the transplanted

cells come from another person, such transplants carry high risk and can result in death in a significant proportion of patients.

Given the success with these two patients, several researchers and companies have attempted to replicate this experience by genetically

modifying T cells of HIV-positive patients to render them unable to be infected by HIV and then returning them to the patient.

Because the transplanted cells are from the same person, the risks to the patient are much lower.

The uptake, or engraftment of

the modified T cells, however, has not been optimal, leading to failure to achieve a cure.

In addition, the transplant pre-treatment

that has been used is bone marrow-destroying chemotherapy, which wipes out the patient’s immune system and can have long-term

side effects including the risk of developing cancer.

have been several efforts to cure HIV by re-engineering a person’s own T-cells so that these cells no longer express a special protein

(C-C chemokine co-receptor type 5 or CCR5), which HIV uses to gain entry to them.

A naturally occurring mutation that blocks expression

of CCR5 on T cells occurs in ~1% of persons living in or from Northern Europe with no known adverse effects.

The “Berlin patient,”

and more recently the “London patient” were HIV-positive persons who developed cancer and were treated with a bone marrow

transplant with cells donated from persons with this naturally occurring mutation of CCR5.

The Berlin and London patients seem to have

been effectively cured from HIV providing proof-of-concept that HIV can be cured.

However, because the transplanted cells come from another

person, such transplants carry high risk and can result in death in a significant proportion of patients.

Given the success with these

two patients, several researchers and companies have attempted to replicate this experience by genetically modifying T cells of HIV-positive

patients to render them unable to be infected by HIV and then returning them to the patient.

Because the transplanted cells are from the

same person, the risks to the patient are much lower.

The uptake, or engraftment of the modified T cells, however, has not been optimal,

leading to failure to achieve a cure.

In addition, the transplant pre-treatment that has been used is bone marrow-destroying chemotherapy,

which wipes out the patient’s immune system and can have long-term side effects including the risk of developing cancer.

is a novel, proprietary approach with the potential to overcome the failures of recent efforts to develop a cure for HIV.

The intervention

provides gene-modified T cells with a competitive advantage over non-modified cells in the HIV-positive person, with the potential

to significantly increase engraftment;

and avoid the need for chemotherapy that substantially depletes the bone marrow and could

potentially be given as an outpatient treatment.

provides gene-modified T cells with a competitive advantage over non-modified cells in the HIV-positive person, with the potential to

significantly increase engraftment;

and avoid the need for chemotherapy that substantially depletes the bone marrow and could potentially

be given as an outpatient treatment.

The Company met with the FDA INTERACT team on June 2, 2020.

INTERACT is the first

available FDA interaction and is a key step in the process towards a potential Investigational New Drug Application (IND) to study

First-in-Human products potentially leading to marketing authorization via Biologics License Application (BLA).

The FDA Center

for Biologics Evaluation and Research (CBER) has numerous INTERACT requests and grants meetings that are deemed appropriate for

this early FDA engagement.

The Enochian management team considered the meeting to be successful with strong alignment between Enochian’s

approach to developing ENOB-HV-01 and the comments of the FDA reviewers.

INTERACT is the first available FDA interaction

and is a key step in the process towards a potential Investigational New Drug Application (IND) to study First-in-Human products potentially

leading to marketing authorization via Biologics License Application (BLA).

The FDA Center for Biologics Evaluation and Research (CBER)

has numerous INTERACT requests and grants meetings that are deemed appropriate for this early FDA engagement.

The Enochian BioSciences

management team considered the meeting to be successful with strong alignment between Enochian BioSciences’ approach to developing

ENOB-HV-01 and the comments of the FDA reviewers.

scientific findings from a mouse study on the ENOB-HV-01 approach were presented at the annual ASCGT conference in May 2020.

are also developing ENOB-HV-11 and ENOB-HV-12 that will utilize a novel cellular- and immunotherapy approach that could potentially

provide both preventative and therapeutic vaccines for HIV.

A non-human primate study is in process and on schedule.

results could potentially be available by the latter part of 2022.

Our co-founder and inventor,

Serhat Gümrükcü, who is also the Director of Seraph Research Institute (SRI), submitted Pre-IND for ENOB-HV-21,

an innovative treatment of Natural Killer (NK) and Gamma Delta T-Cells (GDT) collected from another person.

It is believed that

the GDT cells, a small subset of immune cells that can be infected with HIV, could be a key factor in controlling the virus.

initial scientific findings were presented during the ASCGT Conference this past May.

Enochian Biosciences has an exclusive license

to use the underlying patent to develop ENOB-HV-21 for the prevention, treatment, and/or amelioration of and/or therapy exclusively

for HIV in humans, and research and development exclusively relating to HIV in humans.

are in the development phase of additional product candidates related to our HIV pipeline.

ENOB-HV-31, which is an in vivo gene

therapy, and ENOB-HV-32, which is a peptide drug for packaging and distribution.

also developing ENOB-HV-12 that will utilize a novel cellular- and immunotherapy approach that could potentially provide both preventative

and therapeutic vaccines for HIV.

A non-human primate study is in process.

Preliminary results could potentially be available by the latter

part of 2022.

Our co-founder and inventor, Dr.

Serhat Gümrükcü, who is also the Director of Seraph Research Institute (SRI), submitted a Pre-IND for ENOB-HV-21, an innovative

treatment of Natural Killer (NK) and Gamma Delta T-Cells (GDT) collected from another person.

It is believed that the GDT cells, a small

subset of immune cells that can be infected with HIV, could be a key factor in controlling the virus.

The initial scientific findings

were presented during the ASCGT Conference in May 2021.

Enochian BioSciences has an exclusive license to use the underlying patent to

develop HV-21 for the prevention, treatment, and/or amelioration of and/or therapy exclusively for HIV in humans, and research and development

exclusively relating to HIV in humans.

On October 18, 2021, the Company

announced that FDA comments on an investigator-initiated Pre-IND were, from Management’s perspective, insightful and helpful with

an investigator-initiated IND submission possible in the near-term with the potential for human trial enrollment to begin in the near

to medium term in 2022.

in the development phase of additional product candidates related to our HIV pipeline.

ENOB-HV-31, which is in vivo gene therapy,

and ENOB-HV-32, which is a peptide drug for packaging and distribution.

Hepatitis B (HBV)

Despite the availability

of an effective vaccine and treatment that can control infection if it is taken daily for life, hepatitis B virus (HBV) is the

world’s most common serious liver infection.

While vaccines are increasingly required for children, many adults have not

been vaccinated.

Life-long treatment can be difficult for certain people and access can be limited.

In that regard, HBV remains

the leading cause of liver cancer and the second leading cause of cancer deaths in the world.

Two billion people have been infected

with HBV, approximately 350 million have chronic HBV infection, and nearly one million people die every year.

Current efforts to develop

novel treatment or cure largely focus on approaches to deplete the pool of a certain type of HBV DNA.

Enochian Biosciences has

collaborated with SRI to develop an innovative approach to co-opt HBV polymerase, a key expanding factor that the virus needs to

reproduce itself, to induce the death of liver cells infected with the virus.

On July 27, 2020, Enochian

Biosciences announced the creation of an HBV Scientific Advisory Board comprised of distinguished leaders in HBV disease, treatment

On August 23, 2021, we announced the addition of a third leading expert with substantial experience in HBV clinical trials.

On September 27, 2021, the

Company announced the completion of a Pre-Investigational New Drug (IND) process following receipt of written comments from the

Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies

(OTAT) for ENOB-HB-01.

The initial in vitro

and in vivo work was presented at the biannual HEP DART meeting in December of 2019, where it was selected as one of

the best new therapies/novel strategies.

Despite the availability of an

effective vaccine and treatment that can control infection if it is taken daily for life, hepatitis B virus (HBV) is the world’s

most common serious liver infection.

While vaccines are increasingly required for children, many adults have not been vaccinated.

treatment can be difficult for certain people and access can be limited.

In that regard, HBV remains the

leading cause of liver cancer and the second leading cause of cancer deaths in the world.

Two billion people have been infected with HBV,

approximately 350 million have chronic HBV infection, and nearly one million people die every year.

Current efforts to develop novel

treatment or cure largely focus on approaches to deplete the pool of a certain type of HBV DNA.

Enochian BioSciences has collaborated

with SRI to develop an innovative approach to co-opt HBV polymerase, a key expanding factor that the virus needs to reproduce itself,

to induce the death of liver cells infected with the virus.

On July 27, 2020, Enochian BioSciences

announced the creation of an HBV Scientific Advisory Board comprised of distinguished leaders in HBV disease, treatment, and cure.

August 23, 2021, we announced the addition of a third leading expert with substantial experience in HBV clinical trials.

On September 27, 2021, the Company

announced the completion of a Pre-Investigational New Drug (IND) process following receipt of written comments from the U.S.

Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) for ENOB-HB-01.

The initial in vitro and

in vivo work was presented at the biannual HEP DART meeting in December of 2019, where it was selected as one of the best new therapies/novel

Additional data was presented at the annual ASCGT conference in May 2020.

A proof-of-concept,

in vivo cure study is in advanced stages.

A proof-of-concept, in vivo cure study is

in advanced stages.

A Pre-IND request has been completed with productive comments and insights.

IND could potentially be submitted towards the end of 2022 with potential for enrollment in a clinical trial to begin by the end

of 2022 or in 2023.

Based 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 remissions from some of the deadliest solid tumors.

An IND could potentially be submitted

towards the end of 2022 with potential for enrollment in a clinical trial to begin by the end of 2022 or in 2023.

In March 2022, Enochian announced a profit-sharing

partnership with Caring Cross to use ENOB-HV-01’s “special sauce” to potentially improve the effectiveness and reduce

the cost and toxicity of a CAR-T approach to HIV Cure already in clinical trials.

Based 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

remissions from some of the deadliest solid tumors.

Initial preclinical in vitro studies have been encouraging.

We initially plan to target pancreatic cancer, triple-negative breast cancer, glioblastoma, and renal cell carcinoma.

might also allow for non-specific immune enhancement that could have impact against a broad array of solid tumors.

our approach would potentially allow for outpatient therapy without ablating or significantly impairing the patient’s immune

system, as many current approaches require.

Through a collaboration with a leader in the

field of pancreatic cancer, our first cancer-related therapeutic target, we are developing the pipeline with in vitro and

in vivo proof-of-concept studies to evaluate the potential to induce long-term remission or cure.

Results are expected in

first half 2022.

If the results are promising, a potential Pre-IND and an IND with potential for enrollment in a clinical trial

maybegin in 2022.

date, our operations have been funded by sales of our securities and the issuance of debt.

We have never generated any sales revenue,

and we expect this to continue until our therapies or products are approved for marketing in the United States and/or Europe.

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 initially plan

to target pancreatic cancer, triple-negative breast cancer, glioblastoma, and renal cell carcinoma.

The platform might also allow for

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

As with HIV, our approach would potentially

allow for outpatient therapy without ablating or significantly impairing the patient’s immune system, as many current approaches

Through a collaboration with a leader in the field

of pancreatic cancer, our first cancer-related therapeutic target, we are developing the pipeline with in vitro and in vivo

proof-of-concept studies to evaluate the potential to induce long-term remission or cure.

Results are expected in the second half

If the results are promising, a potential Pre-IND and an IND with potential for enrollment in a clinical trial may begin in 2022.

our operations have been funded by sales of our securities and the issuance of debt.

We have never generated any sales revenue, 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 profitable.

Corporate History

On February 16, 2018, we

completed our acquisition of Enochian Biopharma pursuant to an acquisition agreement, dated January 12, 2018, by and among the

Registrant, its wholly owned subsidiary DanDrit Acquisition Sub, Inc., Enochian Biopharma and Weird Science with Enochian Biopharma

surviving as a wholly owned subsidiary of the Registrant.

As consideration for the acquisition, the stockholders of Enochian Biopharma

received (i) 18,081,962 shares of Common Stock and (ii) the right to receive contingent shares pro rata upon the exercise or conversion

of warrants, which were outstanding at closing (see Note 7.)

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.

The COVID-19 pandemic continues

to evolve, and to date has led to the implementation of various mitigation responses, including government-imposed quarantines,

travel restrictions and other public health safety measures, as well as leading to reported adverse impacts on healthcare resources,

facilities and providers across the United States and in other countries.

to evolve, and to date has led to the implementation of various mitigation responses, including government-imposed quarantines, travel

restrictions and other public health safety measures, as well as leading to reported adverse impacts on healthcare resources, facilities,

and providers across the United States and in other countries.

COVID-19 may cause delays in our research activities.

To date, it has not materially affected our operations;

however it has caused delays in the conduct of experiments due to limitations

of various organizations, in particular those conducting experiments related to COVID-19.

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

Further quarantines, shelter-in-place or similar restrictions and other actions taken or imposed by foreign, federal,

state and local governments could adversely impact our or our partners’ clinical, research and development, regulatory and

manufacturing operations or timelines.

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.

the pandemic could result in significant and prolonged disruption of global financial markets, reducing our ability to access capital,

which could in the future negatively affect the financial resources available to us.

Results of Operations

for the three and six months ended December 31, 2021 compared to the three and six months ended December 31, 2020

The following table

sets forth our revenues, expenses and net loss for the three and six months ended December 31, 2021 and 2020.

The financial information

below is derived from our unaudited condensed consolidated financial statements.

To date, it has not

materially affected our operations;

however, it has caused delays in the conduct of experiments due to limitations of various organizations,

in particular those conducting experiments related to COVID-19.

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.

quarantines, shelter-in-place or similar restrictions and other actions taken or imposed by foreign, federal, state, and local governments

could adversely impact our or our partners’ clinical, research and development, regulatory and manufacturing operations, or timelines.

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.

In addition, the pandemic

could result in significant and prolonged disruption of global financial markets, reducing our ability to access capital, which could

in the future negatively affect the financial resources available to us.

Results of Operations for the

three and nine months ended March 31, 2022, compared to the three and nine months ended March 31, 2021

following table sets forth our revenues, expenses, and net loss for the three and nine months ended March 31, 2022, and 2021.

The financial

information below is derived from our unaudited condensed consolidated

For the Three Months Ended

For the Six Months Ended

For the Nine Months Ended

Increase/(Decrease)

11 unchanged sentences

$ (8,652,117 )

$ (7,671,491 )

Other Income (Expense)

19 unchanged sentences

We are a pre-revenue, pre-clinical biotechnology company.

never generated revenues and have incurred losses since inception.

We do not anticipate earning any revenues until our therapies

or products are approved for marketing and sale.

Our operating expenses for

the three months ended December 31, 2021, and December 31, 2020 were $6,330,791 and $3,305,216

respectively, representing an increase of $3,025,575, or approximately 92% .

The increase in operating expenses primarily

relate to general and administrative expenses.

Our operating expenses for

the six months ended December 31, 2021, and December 31, 2020, were $13,835,464 and $6,163,973, respectively, representing an increase

of $7,671,491 or approximately 124%.

The change is primarily related to the increase in general and administrative expenses of

$4,903,687, and an increase in R&D expenses of $2,747,984.

General and administrative

expenses for the three months ended December 31, 2021, and December 31, 2020, were $4,154,901 and $1,939,988, respectively, representing

an increase of $2,214,914 or approximately 114%.

The variance is primarily related to an increase in stock-based compensation of

$1,683,901, an increase in compensation and related expenses of $301,743, and an increase in lab expenses of $160,618.

General and administrative

expenses for the six months ended December 31, 2021, and December 31, 2020, were $8,621,598 and $3,717,911, respectively, representing

an increase of $4,903,687 or approximately 132%.

The largest contributors to the increase in general and administrative expenses

were the increases in stock-based compensation of $4,085,720, officer compensation of $436,062, salaries expense of $196,065, laboratory

expenses of $171,847, and recruiting expenses of $117,233, offset by a decrease in security expenses of $139,175.

Research and development

expenses for the three months ended December 31, 2021, and December 31, 2020, were $2,144,085 and $1,334,468, respectively, representing

a decrease of $809,617 or approximately 61%.

The variance is primarily driven by $684,939 contract development and manufacturing

company (“CDMO”) partner expenses related to CV-01, $75,000 related to COVID license payments that were not established

in prior year, and $33,000 in new contract research organization (“CRO”) payments.

All other R&D costs remained

relatively flat.

Research and development

expenses for the six months ended December 31, 2021, and December 31, 2020, were $5,150,328 and $2,384,844, respectively, representing

an increase of $2,765,484 or approximately 116%.

The largest contributors to the increase in research and development expenses

were the increases in license costs related to ENOB HB-01 of $1,500,000 for achievement of milestone, costs incurred for ENOB HV-21

of $600,000, newly incurred costs with CDMO and CRO partners totaling $765,939, new COVID license payments of $150,000, offset

by a reduction in license costs related to ENOB-HB-01 totaling $400,000 that were incurred in the prior period only.

The Company recorded other

(expense) of $252,150 for three months ended December 31, 2021, compared to other income of $370,762 for the three months ended

December 31, 2020, representing an increase in other (expense) of $622,912 or 168%.

The variance is primarily due to the change

in fair value of the contingent consideration liability expense of $660,666.

The Company recorded other

(expense) of $3,159,412 for the six months ended December 31, 2020, compared to other income of $710,155 for the six months ended

December 31, 2020, representing an increase in other (expense) of $3,869,567 or 545%.

The variance is primarily due to the change

in fair value of the contingent consideration liability expense of $3,912,708.

Net loss for the three months

ended December 31, 2021, and 2020, was $6,582,941 and $2,933,296, respectively, representing an increase in loss of $3,649,645

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 March 31, 2022, and March 31, 2021, were $4,034,556 and $3,053,930 respectively,

representing an increase of $980,626, or approximately 32% .

The increase in operating expenses primarily relates to an increase

in general and administrative expenses of $886,554.

Our operating expenses for the

nine months ended March 31, 2022, and March 31, 2021, were $17,870,020 and $9,217,903, respectively, representing an increase of $8,652,117

or approximately 94%.

The increase in net loss was primarily due to an increase in general and administrative expenses of $2,214,913,

an increase in research and development expenses of $809,617, and the change in the change in fair value of the contingent consideration

Net loss for the six months

ended December 31, 2021, and 2020, was $16,994,910 and $5,329,866, respectively, representing an increase in loss of $11,665,044

The change is primarily related to the increase in general and administrative expenses of $5,618,393, and an increase

in R&D expenses of $3,030,509.

General and administrative expenses

for the three months ended March 31, 2022, and March 31, 2021, were $2,790,456 and $1,903,902, respectively, representing an increase

of $886,554 or approximately 47%.

The variance is related to an increase in compensation and related expenses of $269,688, an increase

in legal expenses of $215,625, an increase in recruiting expenses of $133,007, an increase in stock-based compensation of $78,248, and

a net aggregate of immaterial increase variances of $189,985.

General and administrative expenses

for the nine months ended March 31, 2022, and March 31, 2021, were $11,169,724 and $5,551,331, respectively, representing an increase

of $5,618,393 or approximately 101%.

The largest contributors to the increase in general and administrative expenses were the increases

in stock-based compensation of $4,163,968, officer compensation of $558,770, salaries expense and related costs of $395,298, and recruiting

expenses of $250,240, and a net aggregate of immaterial increases of $250,118.

Research and development expenses

for the three months ended March 31, 2022, and March 31, 2021, were $1,212,380 and $1,119,203, respectively, representing an increase

of $93,177 or approximately 8%.

The variance is primarily driven by $74,470 in costs related to CV-01 and HV-12, and an increase of $56,000

in collaborating partner expenses, partially offset by a net aggregate of immaterial decreases of $37,293.

Research and development expenses

for the nine months ended March 31, 2022, and March 31, 2021, were $6,605,038 and $3,574,529, respectively, representing an increase of

$3,030,509 or approximately 85%.

The increase in net loss was primarily due to the increase in general and administrative expenses of $4,903,687,

an increase in research and development costs of $2,765,484, and an increase in expense related to the change in fair value of

the contingent consideration of $3,912,708.

The largest contributors to the increase in research and development expenses were the increases in license

costs related to ENOB HB-01 of $1,500,000 for achievement of a milestone, costs incurred for ENOB HV-21 of $600,000, newly incurred costs

with CDMO and CRO partners totaling $1,447,939 and, new COVID license payments of $150,000, partially offset by HBV costs and oncology

costs that were incurred in the prior period for a total of $785,000 that was not incurred in the current period.

The Company recorded other expense

of $2,166,909 for three months ended March 31, 2022, compared to other expense of $977,629 for the three months ended March 31, 2021,

representing an increase in other expense of $1,189,280 or 122%.

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

consideration liability expense of $1,196,496.

The Company recorded other expense

of $5,326,321 for the nine months ended March 31, 2022, compared to other expense of $267,474 for the nine months ended March 31, 2021,

representing an increase in other expense of $5,058,847 or 1,891%.

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

consideration liability expense of $5,109,204.

Net loss for the three months

ended March 31, 2022, and 2021, was $6,201,465 and $4,030,710, respectively, representing an increase in loss of $2,170,755 or approximately

The increase in net loss was primarily due to an increase in general and administrative expenses of $886,554, an increase in research

and development expenses of $93,177, and an increase in expense related to the change in fair value of contingent consideration of $1,196,496.

Net loss for the nine months ended

March 31, 2022, and 2021, was $23,196,375 and $9,360,576, respectively, representing an increase in loss of $13,835,799 or approximately

The increase in net loss was primarily due to the increase in general and administrative expenses of $5,618,393, an increase in

research and development costs of $3,030,509, and an increase in expense related to the change in fair value of contingent consideration

of $5,109,204.

Liquidity and Capital Resources

1 unchanged sentence

our capital and liquidity requirements through funding from shareholders, 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.

At this time, we believe

we have sufficient liquidity and access to committed funds to fund our operations for the next twelve months.

We may need additional

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

towards an Investigational New Drug Application (IND) following Pre-IND readouts from the FDA for ENOB-CV-01, ENOB-HB-01, ENOB-HV-01,

and ENOB-HV-21.

We will also require additional funding to continue our research and development of ENOB-HV-11/12, ENOB-DC-11,

ENOB-FL-01 and -11 and ENOB-CV-11, to fund the Coronavirus and Influenza Indications License Agreement in furtherance of treatment

related to all coronaviruses, and for possible future strategic acquisitions of businesses, products or technologies complementary

to our business.

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, 2021,

the Company had $13,707,907 in cash and working capital of $8,416,386 as compared to $20,664,410 in cash and working capital of

$19,013,100 as of June 30, 2021, a decrease of 34 % and 56%, respectively.

Total assets at December

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

At this time, we believe we have

sufficient liquidity and access to committed funds to fund our operations for the next twelve months.

We may need additional funds for

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

New Drug Application (IND) following Pre-IND readouts from the FDA for ENOB-CV-01, ENOB-HB-01, ENOB-HV-01, and ENOB-HV-21.

require additional funding to continue our research and development of ENOB-HV-11/12, ENOB-DC-11, ENOB-FL-01 and -11 and ENOB-CV-11, to

fund the Coronavirus and Influenza Indications License Agreement in furtherance of treatment related to all coronaviruses, and for possible

future strategic acquisitions of businesses, products, or technologies complementary to our business.

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 March 31, 2022, the Company

had $11,150,917 in cash and working capital of $4,184,007 as compared to $20,664,410 in cash and working capital of $19,013,100 as of

June 30, 2021, a decrease of 46% and 78%, respectively.

Total assets at March 31, 2022,

were $180,100,613 compared to $189,605,225 as of June 30, 2021.

The decrease in total assets was primarily due to the

decrease in cash of $6,956,503.

The change in cash is primarily attributed to $5,150,328 in research and development costs related

to the HBV license agreement, costs related to ENOB-CV-01 for related CDMO and CRO costs, and ENOB-HV-21 studies along with approximately

$3,710,286 in general and administrative expenses, net of non-cash items, offset by an increase in funding totaling $3,178,339

related to warrants exercised during the period and drawdowns from the LPC equity line.

Total liabilities at December

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

of $9,513,493.

The change in cash is primarily attributed to $6,605,038 in research and development costs related to the HBV license agreement,

costs related to ENOB-CV-01 for related CDMO and CRO costs, and ENOB-HV-21 studies along with approximately $5,820,781 in general and

administrative expenses, net of non-cash items, partially offset by an increase in funding totaling $3,630,039 related to drawdowns from

the LPC equity line and warrants exercised during the period.

Total liabilities at March 31,

2022, were $18,857,916 compared to $14,942,286 as of June 30, 2021.

The increase in total liabilities was primarily related

to an increase of $2,991,897 in the contingent consideration liability as a result of mark-to-market adjustment, and an increase

in other current liabilities of $409,273 related to a financing arrangement for a new insurance policy, partially offset by the

reduction in accrued expenses of $677,940, and the reduction of accounts payable of $153,809 due to timing.

The following is a summary

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

Ended December

The increase in total liabilities was primarily related to an increase

of $4,272,891 in the contingent consideration liability as a result of mark-to-market adjustment, an increase in other current liabilities

of $187,106 related to a financing arrangement for a new insurance policy and an increase in accounts payable of $166,457 due to timing,

partially offset by the reduction in accrued expenses of $715,999.

The following is a summary of

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

Net Cash (Used in) Operating Activities

$ (9,897,151 )

$ (5,251,828 )

Net Cash (Used in) Investing Activities

Net Cash Provided by Financing Activities

(Loss) Gain on Currency Translation

Effect of exchange rates on cash

Change in Cash and Cash Equivalents

$ (6,956,503 )

$ (5,271,311 )

Cash used in operating activities

for the six months ended December 31, 2021, and 2020 was ($9,897,151) and ($5,251,828), respectively.

for the nine months ended March 31, 2022, and 2021 was ($12,681,849) and ($7,582,676), respectively.

Cash used in operating activities

during the current period included $5,150,328 in research and development costs related to the HBV license agreement, costs related

to ENOB-CV-01 for related CDMO and CRO costs, and ENOB-HV-21 studies along with approximately $3,710,286 in general and administrative

expenses, net of non-cash items.

Cash provided by financing

activities for the six months ended December 31, 2021, was $2,950,741 as compared to cash used by financing activities of $40,408

during the six months ended December 31, 2020.

During the six months ended December 31, 2021, the Company received financing from

the drawdown of its LPC equity line of $3,048,339 and the exercise of warrants held by shareholders of $130,000.

during the current period included $6,605,038 in research and development costs related to the HBV license agreement, costs related to

ENOB-CV-01 for related CDMO and CRO costs, and ENOB-HV-21 studies along with approximately $5,820,781 in general and administrative expenses,

net of non-cash items.

Cash provided by financing activities

for the nine months ended March 31, 2022, was $3,180,274 as compared to cash provided by financing activities of $3,398,599 during the

nine months ended March 31, 2021.

During the nine months ended March 31, 2022, the Company received financing from the drawdown of its

LPC equity line of $3,500,039 and the exercise of warrants held by shareholders of $130,000.

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.

For a full explanation of

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

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.

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

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What changed 10-Q

Item 2. Management’s Discussion and Analysis