What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-02-14 compared with 2023-11-14 · 150 added, 108 removed, 260 unchanged (50% of the section changed)

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Such statements involve known and unknown risks,

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

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

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

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Over the past several years, Renovaro

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

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

pipeline candidates for HIV (RENB-HV12 and RENB-HV21), a pipeline for Hepatitis B Virus (HBV) (RENB-HB01), and with a significant expansion

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Advanced Allogeneic Cell Therapy

The strategic benefit of cell therapy

platforms is to potentially allow for manufacture of large, “off-the-shelf” banks of therapeutic cells that could be accessed

on demand by health care professionals to potentially decrease the time between diagnosis and treatment.

In addition, because we focus on

cells from donors, the strategy could potentially enhance the ability of the therapeutic candidates to induce a more robust response once

injected into patients.

The 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”

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virus infected cells.

The Company believes that the combination

of off-the-shelf allogeneic cells, combined with genetic modifications designed to enhance immune signaling, could potentially generate

therapeutic candidates that have unique attributes that will increase the likelihood of success.

The Company believes that the

combination of off-the-shelf allogeneic cells, combined with genetic modifications designed to enhance immune signaling, could potentially

generate therapeutic candidates that have unique attributes that will increase the likelihood of success.

Cell Therapy enabling technology

In addition to the platform described

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

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

therapeutic attributes.

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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

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

HBV Gene Therapy

Renovaro BioSciences is exploring

Renovaro Inc.

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

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current approaches require.

Renovaro BioSciences has initiated

Renovaro Inc.

has initiated

a collaboration with Dr.

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

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

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

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

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

BioSciences is developing RENB-HV12 that utilizes a novel cellular and immunotherapy approach that could potentially provide therapeutic

is developing RENB-HV12 that utilizes a novel cellular and immunotherapy approach that could potentially provide therapeutic

vaccines for HIV.

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

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

Preliminary results assessment may

potentially be available in the second half of 2023.

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

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

A non-human study of the therapeutic vaccine in primates at the Fred Hutchinson Cancer Research Center is ongoing.

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

Preliminary results assessment may potentially

be available in the second half of 2023.

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

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

Autologous Transplant with Genetically

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was made to sub-license the ALDH gene modification.

RENB-HV01 was sub-licensed to Caring

Cross with a profit share arrangement.

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

RENB-HV01 was sub-licensed to

Caring Cross with a profit share arrangement.

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

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

Immunotherapy with Allogeneic NK/GDT Cells

Immunotherapy with Allogeneic NK/GDT

Allogeneic Cell Therapy Platform - Pre-IND conducted

- Advanced Pre-Clinical with Human Data through a Collaboration

We are also exploring RENB-HV21,

an innovative treatment for HIV with allogeneic Natural Killer (NK) and Gamma Delta T-Cells (GDT).

It is believed that the GDT cells,

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

The initial scientific findings were presented during the American Society of Gene & Cell Therapy (ASCGT) Annual Meeting in 2021.

Renovaro BioSciences has an exclusive license to use the underlying patent to develop RENB-HV21 for potential treatment or cure of HIV.

We are also exploring RENB-HV21, an innovative treatment for HIV with allogeneic

Natural Killer (NK) and Gamma Delta T-Cells (GDT).

It is believed that the GDT cells, a small subset of immune cells that can be infected

with HIV, could both be infected by, and be a key factor in controlling the virus.

The initial scientific findings were presented during

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

Renovaro Inc.

has an exclusive license to use the underlying

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

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

However, due to a shift in priorities to the Oncology pipeline,

Renovaro BioSciences does not plan to pursue the IND and potential clinical trial in the medium- to long-term.

However, due to a shift in priorities to the Oncology pipeline, Renovaro does not plan to pursue the IND and potential clinical

trial in the medium- to long-term.

Potential Cure for

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Corporate History

We were incorporated under the

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

and in 2014 we merged with and changed our name to

DanDrit Biotech USA, Inc.

We were incorporated under

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

and in 2014 we merged with and changed

our name to DanDrit Biotech USA, Inc.

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

In August 2023, the

Company changed its corporate name from Enochian Biosciences Inc.

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

to Renovaro Biosciences Inc.

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

to Renovaro Inc.

Going Concern and Management’s Plans

The financial statements included

elsewhere herein for the period ended September 30, 2023, were prepared under the assumption that we would continue our operations as

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

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

of $10,816,494.

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

additional financing to fund operations.

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

one year after the date the financial statements are issued.

The financial statements included elsewhere herein do not include any adjustments

to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities

that may result from the outcome of this uncertainty.

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

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

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

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

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

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

These conditions raise substantial doubt about our ability to

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

The financial statements included elsewhere

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

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

Management has reduced overhead

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working capital reserves.

28, 2023, the Company, entered into a Stock Purchase Agreement (the “ Purchase Agreement ”) with GEDi Cube Intl Ltd.,

a private company formed under the laws of England and Wales (“ GEDi Cube ”).

Upon the terms and subject to the conditions

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

On September 28, 2023, the Company,

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

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

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

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

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

On September 28, 2023, the

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

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

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

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

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

The Company is working

with the GEDi Cube to close the transaction.

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

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

The following table sets forth

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

The financial information below is derived

from our unaudited condensed consolidated financial statements.

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

The financial information below is

derived from our unaudited condensed consolidated financial statements.

For the Three Months Ended

September 30,

For the Six Months Ended

Increase/(Decrease)

Operating Expenses

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LOSS FROM OPERATIONS

(13,154,189 )

(11,558,482 )

Other Income (Expenses)

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Total Other Income (Expenses)

Loss Before Income Taxes

Income Tax (Expense) Benefit

$ (4,529,121 )

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$ (13,704,149 )

$ (12,157,508 )

$ (1,546,641 )

We are a pre-revenue, pre-clinical

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Our operating expenses for the

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

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

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

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

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

Our operating expenses for the

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

an increase of $1,595,707, or approximately 14% .

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

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

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

General and administrative expenses

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

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

or approximately 10%.

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

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

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

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

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

General and administrative expenses

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

or approximately 39%.

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

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

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

Research and development expenses

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

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

or approximately 90%.

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

in consulting expenses related to regulatory and outsourced consultants.

Research and development expenses

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

or approximately 60%.

The variance is primarily driven by a decrease of $2,188,807 in collaborating partner expenses with

CDMO and CROs related to discontinued product candidates.

CDMO and CROs related to discontinued product candidates, partially offset by an increase in consumables of $239,619 and consulting expenses

The Company recorded other expense

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

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

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

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

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

The Company recorded other expense

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

representing a decrease in other expense of $49,066 or 8%.

The variance is primarily due to the loss on extinguishment of

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

in the current period.

Net loss for the three months ended

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

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

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

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

Net loss for the three months

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

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

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

Net loss for the six months ended

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

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

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As noted above under the heading

“Going Concern and Management’s Plans,” through September 30, 2023, we have incurred substantial losses.

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

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

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and our financial condition and results of operations.

As of September 30, 2023, the Company

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

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

Total assets at September 30, 2023,

As of December 31, 2023, the Company

had $243,980 in cash and working capital of $(11,355,216) as compared to $1,874,480 in cash and working capital of $(8,457,693) as of

June 30, 2023, a decrease of 87% and 34%, respectively.

Total assets at December 31, 2023,

were $58,018,120 compared to $58,300,796 as of June 30, 2023.

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

Total liabilities at September

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

Total liabilities at December

31, 2023, were $14,422,584 compared to $11,798,685 as of June 30, 2023.

The decrease in total liabilities was primarily related to a decrease

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

term, net of discount.

The following is a summary of the

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

September 30,

The increase in total liabilities was primarily related to increases

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

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

The following is a summary of

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

Net Cash Used in Operating Activities

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$ (5,053,246 )

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

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

Cash used in operating activities during the current period primarily related

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

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

a $411,352 increase in prepaid expenses.

Cash used in operating activities

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

Cash used in operating activities

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

costs, along with approximately $5,554,634 in general and administrative expenses, net of non-cash items, partially offset by an increase

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

Cash used in investing activities

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

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

Cash used in investing activities during

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

30, 2023 (see Note 3.)

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

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

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

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

December 31, 2023 (see Note 3.)

Cash provided by financing activities

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

six months ended December 31, 2022.

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

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

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

Off-Balance Sheet Arrangements

The Company does not have any off-balance

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

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

to investors.

The Company does not have any

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

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

that is material to investors.

Significant Accounting Policies and Critical Accounting

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About Market Risk.

As a “smaller reporting company”

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

As a “smaller reporting

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

required by this Item.

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