What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2023-03-07 compared with 2022-05-13 · 350 added, 362 removed, 40 unchanged (95% 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.

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.

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 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

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.

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.

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)

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.

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.

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.

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 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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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

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.

Infectious Diseases:

HIV Therapeutic Vaccines for Potential

Long-term Remission/Cure

Allogeneic Cell Therapy

Platform - Advanced Pre-Clinical Stage;

Non-Human Primate Studies Ongoing.

In persons living with HIV

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

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

BioSciences is developing ENOB-HV-12 that utilizes a novel cellular and immunotherapy approach that could potentially provide therapeutic

vaccines for HIV (ENOB-HV-12).

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

Center is ongoing.

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

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.)

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.

A successful investigator-initiated Pre-IND was completed in October

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.

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.

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.

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 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.

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.

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 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

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.

The financial information below

is derived from our unaudited condensed consolidated financial statements.

For the Three Months Ended

For the Nine Months Ended

Increase/(Decrease)

September 30,

Increase/(Decrease)

Operating Expenses

General and administrative expenses

Research and development expenses

General and administrative

Research and development

Depreciation and amortization

Total Operating Expense

Total Operating Expenses

LOSS FROM OPERATIONS

$ (4,034,556 )

$ (3,053,930 )

$ (17,870,020 )

$ (9,217,903 )

$ (8,652,117 )

Other Income (Expense)

Other Income (Expenses)

extinguishment of contingent consideration liability

Change in fair value of contingent consideration

Interest expense

Gain (Loss) on currency transactions

Interest income

Total Other (expense) income

Gain on currency transactions

Interest and other income

Total Other Income (Expenses)

Loss Before Income Taxes

(10,411,935 )

$ (4,031,559 )

$ (2,169,906 )

$ (23,196,341 )

$ (9,485,377 )

$ (13,710,964 )

Income Tax Benefit

$ (6,201,465 )

$ (4,030,710 )

$ (2,170,755 )

$ (23,196,375 )

Income Tax (Expense) Benefit

$ (7,699,760 )

$ (10,411,969 )

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

We have never

generated revenues and have incurred losses since inception.

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

are approved for marketing and sale.

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 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.

We are a pre-revenue, pre-clinical

biotechnology company.

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

We do not anticipate earning

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

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

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

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 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 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 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 .

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.

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

30, 2021, representing a decrease in other expense of $2,398,118 or 82%.

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.

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.

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.

Liquidity and Capital Resources

We have historically satisfied

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.

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,

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.

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,

2022, were $83,070,556 compared to $84,632,663 as of June 30, 2022.

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,

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

during the period.

Total liabilities at September

30, 2022, were $12,745,714 compared to $12,013,815 as of June 30, 2022.

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:

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,

Net Cash Used in Operating Activities

$ (2,820,299 )

$ (5,276,687 )

Net Cash Used in Investing Activities

2 unchanged sentences

Change in Cash and Cash Equivalents

Cash used in operating activities

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

$ (1,200,224 )

$ (5,287,360 )

Cash used in operating activities

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.

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.

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

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.

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 summary of our accounting

6 unchanged sentences

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