SEC Form DEFM14A filed by Enochian Biosciences Inc.

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

SCHEDULE 14A 

Proxy Statement Pursuant to Section 14(a) of the

Securities Exchange Act of 1934

Filed by the Registrant ☒

Filed by a Party other than the Registrant ☐

Check the appropriate box:

☐ Preliminary Proxy Statement
☐ Confidential, For Use of the Commission Only (As Permitted by Rule 14a-6(e)(2))
☒ Definitive Proxy Statement
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RENOVARO BIOSCIENCES INC. 

(Name of Registrant as Specified In Its Charter)

(Name of Person(s) Filing Proxy Statement, if
other than the Registrant)

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☐ Fee computed on table in exhibit required by Item 25(b) per Exchange Act Rules 14a-6(i)(1) and 0-11.

RENOVARO BIOSCIENCES INC.

2080 Century Park East, Suite 906

Los Angeles, CA 90067

NOTICE OF SPECIAL MEETING OF STOCKHOLDERS

TO BE HELD ON JANUARY 25, 2024

Dear Stockholder:

You are invited to attend a special meeting of the stockholders of Renovaro Biosciences Inc., a Delaware corporation (“Renovaro”), which will be held on Thursday, January 25, 2024, at 12:00 p.m., Eastern Standard Time (the “Special Meeting”), at K&L Gates LLP, 200 S Biscayne Blvd., Suite 3900, Miami, FL 33131, unless postponed or adjourned to a later date. The Special Meeting is an important meeting that will impact your investment in Renovaro.

On September 28, 2023, Renovaro entered into a Stock Purchase Agreement, dated September 28, 2023, as amended on December 20, 2023 (the “Stock Purchase Agreement”), with GEDi Cube Intl Ltd., a private company formed under the laws of England and Wales (“GEDi Cube”), the other sellers party thereto (together with the other shareholders of GEDi Cube who deliver to Renovaro a joinder to the Stock Purchase Agreement, the “Sellers” and each, a “Seller”), and Yalla Yalla Ltd., a private limited liability company registered and incorporated under the laws of Malta, in its capacity as the representative of the Sellers (the “Sellers’ Representative”), pursuant to which Renovaro will acquire all of the issued and outstanding shares and other equity interests of GEDi Cube from the Sellers after which GEDi Cube will become a wholly-owned subsidiary of Renovaro (the “Transaction”).

Under the terms of the Stock Purchase Agreement, at the effective time of the Transaction (the “Effective Time”), the Sellers will sell and transfer to Renovaro all of the equity interests of GEDi Cube (each, a “GEDi Cube Share”) owned by Sellers that are issued and outstanding as of immediately prior to the Effective Time in exchange for (i) an aggregate number of shares of common stock, par value $0.0001 per share, of Renovaro (“Common Stock”) equal to a specified percentage of the shares of Common Stock issued and outstanding as of the Effective Time (minus (a) 1 million shares of Common Stock issued to a consultant assisting with the Transaction and (b) 1 million shares of Common Stock issued to Avram Miller prior to the Closing pursuant to his Advisory Agreement, dated October 11, 2023, by and between Mr. Miller and Renovaro (the “Miller Consulting Agreement”)), which percentage shall be a ratio of the aggregate number of GEDi Cube Shares owned by the Sellers divided by the aggregate number of GEDi Cube Shares issued and outstanding, in each case, as of the Effective Time (the “Closing Consideration”), and (ii) the right to receive earn-out shares of Common Stock to be issued pro rata to the Sellers upon the exercise or conversion of any of Renovaro’s derivative securities (subject to certain exceptions) which are outstanding at the Effective Time (the “Earnout Shares”). For a complete description of how the Closing Consideration and Earnout Shares will be determined, see “The Stock Purchase Agreement—Exchange Consideration” in the accompanying proxy statement. Based on the number of shares of Common Stock outstanding as of December 29, 2023 and the terms of the Stock Purchase Agreement governing the determination of the Closing Consideration, Renovaro estimates that, immediately following the closing of the Transaction, the Sellers will own approximately 49% of the issued and outstanding shares of Common Stock (before giving effect to the issuance of the Earnout Shares). In addition, following the closing of the Transaction, Renovaro will change its name to “Renovaro AI,” or such other name as mutually agreed by Renovaro and GEDi Cube.

At the Effective Time of the Transaction, the Board of Directors of Renovaro (the “Renovaro Board”) is expected to include Mark R. Dybul, as Chief Executive Officer of Renovaro, four of the other existing directors of Renovaro, three of whom must qualify as independent directors under the rules of The Nasdaq Stock Market (“Nasdaq”), and four persons designated by GEDi Cube, two of whom shall qualify as independent directors under the Nasdaq rules.

The Common Stock is currently listed on Nasdaq under the symbol “RENB.” After the closing of the Transaction, Renovaro expects that its Common Stock will continue trading on Nasdaq under the symbol “RENB.”

At the Special Meeting, the stockholders of Renovaro will be asked to consider and vote on the following matters, as more fully described in the accompanying proxy statement:

After careful consideration, the Renovaro Board unanimously approved the Stock Purchase Agreement, the Transaction and each of the proposals referred to above, and has determined that they are advisable, fair and in the best interests of Renovaro’s stockholders. Accordingly, the Renovaro Board unanimously recommends that Renovaro’s stockholders vote “FOR” the Share Issuance Proposal, “FOR” the Authorized Share Proposal, “FOR” the Repricing Proposal, “FOR” the 2023 Plan Amendment Proposal and “FOR” the Adjournment Proposal.

More information about Renovaro, GEDi Cube, the Stock Purchase Agreement, the Transaction and the proposals referred to above is contained in the accompanying proxy statement. Renovaro urges you to read the accompanying proxy statement carefully and in its entirety. IN PARTICULAR, YOU SHOULD CAREFULLY CONSIDER THE MATTERS DISCUSSED UNDER “RISK FACTORS” BEGINNING ON PAGE 22.

The Renovaro Board fixed December 29, 2023, as the record date (the “Record Date”) for the Special Meeting. Only holders of record of shares of Common Stock and shares of Series A Convertible Preferred Stock, par value $0.0001 per share, of Renovaro (“Series A Preferred Stock”) at the close of business on the Record Date are entitled to notice of, and to vote at, the Special Meeting. At the close of business on the Record Date, Renovaro had 67,224,089 shares of Common Stock outstanding and entitled to vote at the Special Meeting and 561,010 shares of Series A Preferred Stock outstanding and entitled to vote at the Special Meeting. Each holder of record of shares of Common Stock on the Record Date will be entitled to one vote for each share held on all matters to be voted upon at the Special Meeting. Each holder of record of shares of Series A Preferred Stock on the Record Date will be entitled to ten (10) votes for each share held on all matters to be voted upon at the Special Meeting.

Whether or not you plan to attend the Special Meeting, Renovaro encourages you to vote as soon as possible to ensure that your shares are represented at the Special Meeting. The accompanying proxy statement explains more about proxy voting, so please read it carefully. Please complete, date, sign and return the accompanying proxy card in the enclosed envelope or vote online or by telephone using the instructions included on the proxy card, to ensure the presence of a quorum at the Special Meeting. Even if you have voted by proxy, and you attend the Special Meeting, you may, if you prefer, revoke your proxy and vote your shares in person. Please note, however, that if your shares are held of record by a broker, bank or other nominee and you wish to vote at the Special Meeting, you will not be permitted to vote in person at the Special Meeting unless you first obtain a legal proxy issued in your name from the record holder.

The proxy statement is dated January 3, 2024 and is expected to be first mailed to stockholders of Renovaro on or about January 4, 2024. The proxy statement is available at http://www.viewproxy.com/Renovaro/2024.

Renovaro is excited about the opportunities that the Transaction brings to Renovaro’s stockholders and thanks you for your consideration and continued support.

January 3, 2024

TABLE OF CONTENTS

RENOVARO BIOSCIENCES INC.

PROXY STATEMENT FOR THE
SPECIAL MEETING OF STOCKHOLDERS

TO BE HELD ON JANUARY 25, 2024

Renovaro Biosciences Inc. (“we,” “us,” “our,” “Renovaro,” or the “Company”) is providing these proxy materials in connection with the special meeting of Renovaro stockholders to be held on Thursday, January 25, 2024, at 12:00 p.m., Eastern Standard Time (the “Special Meeting”), at K&L Gates LLP, 200 S Biscayne Blvd., Suite 3900, Miami, FL 33131, unless postponed or adjourned to a later date. This proxy statement contains important information for you to consider when deciding how to vote on the matters to be brought before the Special Meeting. The following section provides answers to frequently asked questions about the Special Meeting and the Transaction (as defined below). This section, however, only provides summary information. For a more complete response to these questions and for additional information, please refer to the cross-referenced sections. Renovaro urges its stockholders to read this document in its entirety prior to making any decision.

QUESTIONS AND ANSWERS ABOUT THE SPECIAL MEETING AND THE TRANSACTION

The approval of Proposals 1 and 2 is a condition to the consummation of the Transaction pursuant to the Stock Purchase Agreement.

Pursuant to the terms of the Series A Preferred Stock, the holders of Series A Preferred Stock will vote together with the holders of Common Stock, as a single class, on all matters to be presented to the Renovaro stockholders at the Special Meeting.

For each of the Proposals 1, 2, 3, 4 and 5, broker non-votes, if any, and a properly marked “ABSTAIN” with respect to any such matter will not be voted “for” or “against,” and will not be counted as a vote cast for purposes of determining the number of votes cast with respect to such proposals. Accordingly, broker non-votes and abstentions will not be considered as a vote cast with respect to such matters.

If you are a registered holder:

MARKET PRICE AND DIVIDEND INFORMATION

The Common Stock trades on Nasdaq under the symbol “RENB”. GEDi Cube is a private company and its GEDi Cube Shares are not publicly traded.

As of September 27, 2023, the last full trading day immediately preceding the public announcement of the signing of the Stock Purchase Agreement, the closing price of the Common Stock as reported on Nasdaq was $3.80 per share. Because the market price of the Common Stock is subject to fluctuation, the market value of the shares of the Common Stock that the Sellers will be entitled to receive in the Transaction may increase or decrease after the Effective Time.

As of December 29, 2023, the Record Date for the Special Meeting, there were approximately 189 holders of record of the Common Stock. The number of record holders was determined from the records of our transfer agent and does not include beneficial owners of our Common Stock whose shares are held in the names of various banks, brokers or other nominees.

Assuming approval of the Share Issuance Proposal, the Authorized Share Proposal and the Repricing Proposal and following the consummation of the Transaction, the Common Stock is expected to continue trading on Nasdaq under the symbol “RENB.”

Dividends

Renovaro has not declared or paid any cash dividends on the Common Stock and does not intend to declare or pay any cash dividends in the foreseeable future. The payment of dividends, if any, is within the discretion of the Renovaro Board and will depend on Renovaro’s earnings, if any, its capital requirements and financial condition and such other factors as the Renovaro Board may consider.

RISK FACTORS

In addition to the other information contained in this proxy statement, you should carefully consider the material risks described below before deciding how to vote your shares of Common Stock. You should also read and consider the risks associated with the business of Renovaro because these risks may also affect the combined company—these risks can be found in the Renovaro 2023 Form 10-K and the Renovaro First Quarter 2024 Form 10-Q, copies of which were delivered with this proxy statement, and are incorporated by reference herein. You should also read and consider the other information in this proxy statement and the other documents incorporated by reference into this proxy statement. Please see the section titled “Where You Can Find More Information” on page 178 of this proxy statement.

Summary of Risk Factors

Risks Related to the Transaction

Risks Related to Renovaro

Please refer to the section titled “Item 1A. Risk Factors” set forth in the Renovaro 2023 Form 10-K and the section titled “Item 1A. Risk Factors” set forth in the Renovaro First Quarter 2024 Form 10-Q.

Risks Related to GEDi Cube

Risks Related to the Transaction

If the proposed Transaction with GEDi Cube is not consummated, Renovaro’s business could suffer materially and the price of the Common Stock could decline.

The consummation of the Transaction with GEDi Cube is subject to the satisfaction of a number of closing conditions, including the receipt of Renovaro stockholder approval on Proposals 1 and 2; the occurrence of the Special Meeting; all of the holders of GEDi Cube Shares becoming a party to the Stock Purchase Agreement; and other closing conditions. For a more detailed discussion of these and other closing conditions, see the section titled “The Stock Purchase Agreement—Conditions to Completion of the Transaction.” Renovaro expects the Transaction to close during the first half of 2024, subject to satisfying certain closing conditions.

If the Transaction is not consummated, Renovaro may be subject to a number of material risks, and its business and stock price could be adversely affected, as follows:

The market price of the Common Stock may decline as a result of the Transaction.

The market price of the Common Stock may decline as a result of the Transaction for a number of reasons including if:

The Transaction may be completed even though material adverse changes may occur prior to the Closing.

In general, either party can refuse to complete the Transaction if there is a material adverse change affecting the other party between the date of the Stock Purchase Agreement and the Closing. However, some types of changes do not permit either party to refuse to complete the Transaction, even if such changes would have a material adverse effect on Renovaro or GEDi Cube, to the extent they resulted from the following:

If adverse changes occur but Renovaro and GEDi Cube must still complete the Transaction, the combined company’s stock price may suffer.

Renovaro’s stockholders will have a reduced ownership and voting interest in, and will exercise less influence over the management of, Renovaro following the Closing as compared to their current ownership and voting interest in Renovaro.

After the completion of the Transaction, the stockholders of Renovaro before the Effective Time of the Transaction will own a smaller percentage of the combined company than their ownership in Renovaro prior to the Transaction. Consequently, the stockholders of Renovaro will not be able to exercise the same degree of influence over the management and policies of the combined company following the Closing.

Renovaro’s stockholders may not realize a benefit from the Transaction commensurate with the ownership dilution they will experience in connection with the Transaction.

If the combined company is unable to realize the strategic and financial benefits currently anticipated from the Transaction, Renovaro’s stockholders will have experienced substantial dilution of their ownership interest without receiving any commensurate benefit. Significant management attention and resources will be required to integrate the two companies. Delays in this process could adversely affect the combined company’s business, financial results, financial condition and stock price following the Closing. Even if the combined company is able to integrate the business operations successfully, there can be no assurance that this integration will result in the realization of the full benefits of synergies, innovation and operational efficiencies that may be possible from this integration and that these benefits will be achieved within a reasonable period of time.

Certain provisions of the Stock Purchase Agreement may discourage third parties from submitting competing proposals, including proposals that may be superior to the transactions contemplated by the Stock Purchase Agreement. During the pendency of the Transaction, Renovaro may not be able to pursue alternatives to the Transaction or enter into a business combination or acquisition transaction with another party on more favorable terms because of restrictions in the Stock Purchase Agreement, which could adversely affect its business prospects.

The terms of the Stock Purchase Agreement generally prohibit each of Renovaro and GEDi Cube from soliciting competing acquisition proposals or discussing or negotiating with, or furnishing information to, persons making unsolicited acquisition proposals, except in limited circumstances. Covenants in the Stock Purchase Agreement impede the ability of each of Renovaro and GEDi Cube to engage in certain transactions involving the acquisition of each company’s business during the pendency of the Transaction, subject to specified exceptions. As a result, if the Transaction is not completed, the parties may be at a disadvantage to their competitors during that period. In addition, while the Stock Purchase Agreement is in effect, each party is generally prohibited from soliciting, assisting, initiating, or facilitating the making, submission or announcement of, or intentionally encouraging any acquisition proposal or inquiry or engaging or participating in discussions or negotiations with respect to or that could reasonably be expected to lead to any acquisition proposal or inquiry, including a merger, sale of assets or other business combination, subject to specified exceptions. Any such transactions could be favorable to such party’s securityholders, but the parties may be unable to pursue them. For more information, see the section titled “The Stock Purchase Agreement—Exclusivity” beginning on page 70 of this proxy statement.

Because the lack of a public market for the GEDi Cube Shares makes it difficult to evaluate the fairness of the Transaction, the Sellers may receive consideration in the Transaction that is greater than or less than the fair market value of the GEDi Cube Shares.

The outstanding shares and other equity interests in GEDi Cube are privately held and are not traded in any public market. The lack of a public market makes it extremely difficult to determine the fair market value of GEDi Cube. Since the percentage of Renovaro’s Common Stock to be issued to the Sellers was determined based on negotiations between the parties, it is possible that the value of the Common Stock to be issued in connection with the Transaction will be greater than the fair market value of GEDi Cube. Alternatively, it is possible that the value of the shares of Common Stock to be issued in connection with the Transaction will be less than the fair market value of GEDi Cube.

The combined company will incur significant transaction costs as a result of the Transaction, including investment banking, legal and accounting fees. In addition, the combined company will incur significant consolidation and integration expenses which cannot be accurately estimated at this time. Actual transaction costs may substantially exceed estimates and may have an adverse effect on the combined company’s financial condition and operating results.

Renovaro and GEDi Cube may become involved in securities litigation or stockholder derivative litigation in connection with the Transaction in the future, and this could divert the attention of Renovaro and GEDi Cube management and harm the combined company’s business, and insurance coverage may not be sufficient to cover all related costs and damages.

Securities litigation or stockholder derivative litigation frequently follows the announcement of certain significant business transactions, such as the sale of a business division or the announcement of a business combination transaction. Renovaro and GEDi Cube may become involved in this type of litigation in connection with the Transaction, and the combined company may become involved in this type of litigation in the future. Litigation often is expensive and diverts management’s attention and resources, which could adversely affect the business of Renovaro, GEDi Cube and the combined company, and insurance coverage may not be sufficient to cover all related costs and damages.

If the conditions of the Transaction are not met or waived, the Transaction will not occur.

Even if the Share Issuance Proposal and the Authorized Share Proposal, as described in this proxy statement, are approved by the Renovaro stockholders, specified conditions set forth in the Stock Purchase Agreement must be satisfied or waived to complete the Transaction. These conditions are described in the section titled “The Stock Purchase Agreement—Conditions to Completion of the Transaction” beginning on page 71 of this proxy statement. Renovaro cannot assure you that all of the conditions to the consummation of the Transaction will be satisfied or waived. If the conditions are not satisfied or waived, the Transaction may not occur or the Closing may be delayed, and Renovaro and GEDi Cube each may lose some or all of the intended benefits of the Transaction.

The unaudited pro forma financial information included in this proxy statement may not be representative of the combined company’s results following the Closing.

The unaudited pro forma financial information included in this proxy statement has been presented for informational purposes only and is not necessarily indicative of the financial position or results of operations that actually would have occurred had the Transaction been completed as of the date indicated, nor is it indicative of the combined company’s future operating results or financial position. The pro forma financial statements have been derived from the historical financial statements of Renovaro and GEDi Cube and adjustments and assumptions have been made regarding the combined company after giving effect to the Transaction. The information upon which these adjustments and assumptions have been made is preliminary, and these kinds of adjustments and assumptions are difficult to make with accuracy. Moreover, the pro forma financial statements do not reflect all costs that are expected to be incurred by the combined company in connection with the Transaction. As a result, the actual financial condition of the combined company following the Closing may not be consistent with, or evident from, these pro forma financial statements. The assumptions used in preparing the pro forma financial information may not prove to be accurate, and other factors may affect the combined company’s financial condition following the Closing.

Following the Closing, the combined company may be unable to integrate successfully the businesses of Renovaro and GEDi Cube and realize the anticipated benefits of the Transaction.

The Transaction involves the combination of two companies which currently operate as independent companies. Following the Closing, the combined company will be required to devote significant management attention and resources to integrating its business practices and operations. The combined company may fail to realize some or all of the anticipated benefits of the Transaction if the integration process takes longer than expected or is more costly than expected. Some of the potential difficulties the combined company may encounter in the integration process include the following:

In addition, Renovaro and GEDi Cube have operated and, until the completion of the Transaction will continue to operate, independently. It is possible that the integration process also could result in the diversion of each company’s management’s attention, the disruption or interruption of, or the loss of momentum in, each company’s ongoing businesses or inconsistencies in standards, controls, procedures and policies, any of which could adversely affect the combined company’s ability to maintain its business relationships or the ability to achieve the anticipated benefits of the Transaction, or could otherwise adversely affect the business and financial results of the combined company.

Risks Related to Renovaro

For risks related to the business of Renovaro, please refer to the section titled “Item 1A. Risk Factors” set forth in the Renovaro 2023 Form 10-K and the section titled “Item 1A. Risk Factors” set forth in the Renovaro First Quarter 2024 Form 10-Q, each of which is incorporated by reference herein.

Risks Related to GEDi Cube

Risks Related to GEDi Cube’s Limited Operating History, Financial Position and Capital Requirements

GEDi Cube is an artificial intelligence (“AI”)-driven healthcare technology company operating in a rapidly evolving field and has a limited operating history, which makes it difficult to evaluate GEDi Cube’s current business and predict GEDi Cube’s future performance.

GEDi Cube is an AI-driven healthcare technology company operating in a rapidly evolving field and, having commenced operations in 2013, has a limited operating history. GEDi Cube shifted its business from the financial technology (or FinTech) industry to cancer diagnostics only in 2018. GEDi Cube does not currently have a commercial product for sale. GEDi Cube has never generated any revenue relating to its cancer diagnostics AI platform. GEDi Cube’s short operating history as a company makes any assessment of its current business or future success and viability subject to significant uncertainty. GEDi Cube expects to encounter risks and difficulties, including those frequently experienced by early-stage companies in rapidly evolving fields. If GEDi Cube does not address these risks and difficulties successfully, its business will suffer.

GEDi Cube has a history of net losses and anticipates that it may continue to incur net losses for the foreseeable future.

Grace Systems (GEDi Cube’s predecessor) has primarily incurred net losses since its inception in 2013 and has never generated any revenue relating to its cancer diagnostics AI platform. GEDi Cube anticipates that it may continue to incur primarily net losses in the foreseeable future. GEDi Cube has invested significant financial resources in research and development activities, including to develop its technology and investigational products and plan for commercial launch of its AI platform. The amount of GEDi Cube’s future net losses will depend, in part, on the level of GEDi Cube’s future expenditures and its ability to generate revenue following the commercialization of its AI platform. Moreover, GEDi Cube’s net losses may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of GEDi Cube’s results of operations may not be a good indication of GEDi Cube’s future performance.

GEDi Cube expects to continue to incur significant expenses and operating losses for the foreseeable future if, and as, it:

GEDi Cube has never generated revenue from its cancer diagnostics AI platform, and does not expect any near-term revenue to offset GEDi Cube’s ongoing operating expenses, and may never be able to maintain profitability.

GEDi Cube’s ability to generate revenue from product sales and maintain profitability in the future depends on its ability to commercialize its products. While GEDi Cube plans to commercially launch its AI platform in the European Union and United Kingdom in 2024, GEDi Cube cannot assure you that it will successfully be able to do so as planned, if at all, and GEDi Cube’s failure to do so would prevent GEDi Cube from generating revenue. Furthermore, even if GEDi Cube is able to launch its AI platform or other products in a timely manner, GEDi Cube may not be able to generate sufficient revenue to offset its costs and maintain profitability. GEDi Cube’s ability to generate future revenue from product sales depends heavily on its success in:

GEDi Cube anticipates incurring substantial costs to commercialize GEDi Cube’s products. GEDi Cube’s expenses could increase beyond expectations if it is required by the U.S. Food and Drug Administration (the “FDA”), the European Medicines Agency (the “EMA”), the Medicines and Healthcare products Regulatory Agency (“MHRA”) or other regulatory agencies to delay its launch, narrow or change its intended use or product claims, modify or expand its clinical validation, perform future additional clinical validation, either pre- or post-approval, or conduct clinical trials. Even if GEDi Cube is able to generate revenue from the sale of any products, GEDi Cube may not become profitable and may need to obtain additional funding to continue its operations.

GEDi Cube will require additional financing in order to start its commercialization efforts and develop additional products.

To date, GEDi Cube has financed its operations primarily through the sale of its equity securities and cash flow from consulting services previously provided by GEDi Cube. GEDi Cube’s product development and clinical validation activities are expensive, and GEDi Cube expects to start to spend substantial amounts as it prepares for the launch and commercialization of its AI platform, continues to enhance its AI platform, broadens the applications of its AI platform and develops new products. In addition, obtaining any necessary or desirable regulatory approvals and clearances from the FDA, the MHRA, or the EMA for GEDi Cube’s products will require substantial additional funding.

GEDi Cube will require additional capital for the development of its AI platform and future products. GEDi Cube’s future capital requirements depend on many additional factors, including:

Risks Related to GEDi Cube’s Business Operations, Products and Industry

GEDi Cube’s products may not perform as expected, which could materially and adversely affect GEDi Cube’s business, financial condition, results of operations and growth prospects.

GEDi Cube does not currently have a commercial product. GEDi Cube’s success depends on the market’s confidence that it can provide reliable, high-quality products. Assuming successful launch, GEDi Cube’s products may not perform as expected. If this were to occur, GEDi Cube’s business, financial condition, results of operations and growth prospects would suffer.

GEDi Cube’s AI platform requires a number of complex and sophisticated biochemical and bioinformatics processes, many of which are highly sensitive to external factors. An operational or technological failure in one of these complex processes or fluctuations in external variables may result in sensitivity and specificity rates that are lower than GEDi Cube anticipates or that vary between test runs or in a higher than anticipated number of tests that fail to produce consistent results. In addition, GEDi Cube regularly evaluates and refines its algorithms and other processes under development. These refinements may inadvertently result in unanticipated issues that may reduce GEDi Cube’s sensitivity and specificity rates or otherwise adversely affect the performance of the tests supported by GEDi Cube’s AI platform and the results of such tests.

Further, GEDi Cube plans to iterate and improve, enhancing product performance, offerings, scalability and/or cost of goods. However, GEDi Cube may not be successful in transitioning its AI platform to a new or enhanced version or iteration. Product development involves a lengthy and complex process and GEDi Cube may be unable to commercialize, validate, or improve performance of any of its AI platform or products on a timely basis, or at all. GEDi Cube’s failure to successfully develop new and/or improved products (including new versions of its existing platform and other products) on a timely basis could have a material adverse effect on GEDi Cube’s results of operations and business.

Even if GEDi Cube commercially launches its AI platform and other products, they may fail to achieve the degree of market acceptance necessary for commercial success.

The commercial success of GEDi Cube’s AI platform and other future products will depend upon the degree of market acceptance by consumers, including self-insured employers, integrated health systems, healthcare providers, patients and, over the long-term, third-party payors. The degree of market acceptance of GEDi Cube’s products will depend on a number of factors, including:

The failure of GEDi Cube’s AI platform, once introduced, to be listed in physician guidelines or of any future clinical validation to produce favorable results or to be published in peer-reviewed journals could limit the adoption of its AI platform. In addition, healthcare providers and third-party payors, including Medicare, may rely on physician guidelines issued by industry groups, medical societies and other key organizations, such as the U.S. Preventive Services Task Force, before utilizing or reimbursing the cost of any diagnostic or screening test. Although GEDi Cube has conducted prior clinical validation of its AI platform, this platform is not yet, and may never be, listed in any such guidelines.

Further, if GEDi Cube’s products and the technology underlying them do not receive sufficient favorable exposure in peer-reviewed publications, the rate of physician and market acceptance of GEDi Cube’s products and positive reimbursement or coverage decisions for GEDi Cube’s products could be negatively affected. The publication of clinical data in peer-reviewed journals is a crucial step in commercializing and obtaining reimbursement or coverage for GEDi Cube’s products, and GEDi Cube’s inability to control when, if ever, results are published may delay or limit GEDi Cube’s ability to derive sufficient revenues from any of its products that is developed using data from a clinical study.

Failure to achieve broad market acceptance of GEDi Cube’s products, once launched, would materially harm GEDi Cube’s business, financial condition and results of operations.

GEDi Cube may be unable to develop and commercialize new products.

GEDi Cube continues to expand its research and development efforts to use its proprietary AI platform to develop new products, including in disease areas beyond cancer. The commercialization of any new products will require the completion of certain clinical development activities, regulatory activities and the expenditure of additional cash resources. GEDi Cube cannot assure you that it can successfully complete the clinical development of any such products.

GEDi Cube also cannot assure you that it will be able to reduce its expenditures sufficiently, generate sufficient revenue from products that it successfully commercializes or otherwise mitigate the risks associated with its business to raise enough capital to develop and commercialize new products. In addition, once GEDi Cube’s development efforts for a product are completed, commercialization efforts, including allocation of resources necessary to comply with applicable laws and regulations, will require significant expenditures. Any failure by GEDi Cube to develop and commercialize new products could have a material adverse effect on GEDi Cube’s ability to implement its strategy and grow its business.

One of the key elements of GEDi Cube’s strategy is to expand access to its tests by pursuing reimbursement and/or coverage from third-party payors. If GEDi Cube’s products do not receive adequate coverage or reimbursement from third-party payors, its ability to expand access to its tests beyond its initial sales channels and its overall commercial success will be limited.

GEDi Cube anticipates that it will not have broad-based coverage or reimbursement at the initial commercial launch. However, a key element to GEDi Cube’s strategy is to expand access to its tests by pursuing coverage and/or reimbursement by third-party payors, including government payors. Coverage and reimbursement by third-party payors, including managed care organizations, private health insurers and government healthcare programs, such as Medicare and Medicaid in the United States and similar programs in other countries, for the types of early detection and post-diagnosis service tests that GEDi Cube provides can be limited and uncertain. Healthcare providers may not order GEDi Cube’s products unless third-party payors cover or provide adequate reimbursement for a substantial portion of the price of GEDi Cube’s products. If GEDi Cube is not able to obtain adequate coverage or an acceptable level of reimbursement for its products from third-party payors, there could be a greater co-insurance or co-payment obligation for any individual for whom a test is ordered. The individual may be forced to pay the entire cost of a test out-of-pocket, which could dissuade physicians from ordering GEDi Cube’s products and, if ordered, could result in delay in, or decreased likelihood of, GEDi Cube’s collection of payment. GEDi Cube believes its revenue and revenue growth will depend on its success in achieving broad coverage and adequate reimbursement for its products from third-party payors.

Coverage and reimbursement by a third-party payor may depend on a number of factors, including a payor’s determination that a product is appropriate, medically necessary and cost-effective. Each payor will make its own decision as to whether to establish a policy or enter into a contract to cover GEDi Cube’s products and the amount it will reimburse for such products. Any determination by a payor to cover and the amount it will reimburse for GEDi Cube’s products would likely be made on an indication-by-indication basis. For example, because GEDi Cube intends to cover a broad asymptomatic population with its future products which could potentially generate a significant number of false-positive results on an absolute basis, GEDi Cube may face additional scrutiny in obtaining reimbursement from third-party payors given the additional costs of further diagnostic workup. As a result, obtaining approvals from third-party payors to cover GEDi Cube’s products and establishing adequate coding recognition and reimbursement levels is an unpredictable, challenging, time-consuming and costly process and GEDi Cube may never be successful. If third-party payors do not provide adequate coverage or reimbursement for GEDi Cube’s products, GEDi Cube’s ability to succeed commercially will be limited.

Even if GEDi Cube establishes relationships with payors to provide its products at negotiated rates, such agreements would not obligate any healthcare providers to order its products or guarantee that it would receive reimbursement for its products from these or any other payors at adequate levels. Thus, these payor relationships, or any similar relationships, may not result in acceptable levels of coverage or reimbursement for GEDi Cube’s products or meaningful increases in the number of billable tests it sells to healthcare providers. GEDi Cube believes it may take several years to achieve coverage or adequate reimbursement with a majority of third-party payors, including with those payors offering negotiated rates. In addition, GEDi Cube cannot predict whether, under what circumstances, or at what payment levels payors will cover or reimburse for its products. If GEDi Cube fails to establish and maintain broad-based coverage or reimbursement for its products, its ability to expand access to its products, generate increased revenue and grow its test volume and customer base will be limited and its overall commercial success will be limited.

If GEDi Cube’s products, or the products of its competitors, directly or indirectly result in harm or injury to patients, GEDi Cube could be subject to significant reputational and liability risks, and its operating results, reputation and business could suffer.

GEDi Cube’s success will depend on the market’s confidence that its developed products can provide reliable, high-quality results, once such products are launched. GEDi Cube believes that patients, physicians and regulators are likely to be particularly sensitive to errors in the use of its products or failure of its products to perform as described, and there can be no guarantee that its products will meet their expectations. GEDi Cube’s initial product is intended to be used to detect a cancer signal in patients, but its results are not diagnostic. If a cancer signal is detected, the product would be used to localize the origin of the cancer signal. A “cancer signal detected” test result would need to be followed up by appropriate diagnostic methods. Because this product cannot detect all cancer signals, and may not detect signals for all cancer types, a negative test would not rule out the presence of cancer. Additionally, a patient undergoing unnecessary diagnostic tests on the basis of a false-positive result or an erroneous location of cancer signal result could expose GEDi Cube to significant liability and reputational risks notwithstanding the emotional and mental health effects to which the patient may be exposed. Similarly, a patient who receives a cancer diagnosis shortly following a “no cancer signal detected” test result may create negative publicity about GEDi Cube’s product, which would discourage adoption. Performance failures could establish a negative perception of GEDi Cube’s products among physicians, patients and regulators, jeopardize GEDi Cube’s ability to successfully commercialize its products, impair GEDi Cube’s ability to obtain regulatory approvals or secure favorable coverage or reimbursement, or otherwise result in reputational harm. In addition, GEDi Cube may be subject to legal claims arising from any errors in the use, manufacture, design, labelling or performance of its products, including any false-positive or false-negative results.

In addition, other companies are developing competing cancer detection tests and technologies focused on improving cancer care with cancer detection tests and post-diagnostic products. If any tests marketed or being developed by GEDi Cube’s competitors that are similar to its products do not perform in accordance with expectations or cause harm or injury to patients, such failure to perform, harm or injury may result in lower confidence in early disease detection and post-diagnosis tests in general, which could potentially adversely affect confidence in GEDi Cube’s products and result in an adverse impact on its operating results and reputation.

If GEDi Cube’s facilities or those of its third-party collaborators become inoperable, GEDi Cube’s ability to provide its products will be significantly impaired and its business will be harmed.

GEDi Cube relies on its third-party collaborators, consultants, contractors, vendors, suppliers and service providers. The facilities of these partners could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods, tornadoes, hurricanes, fires, extreme weather conditions, medical epidemics, pandemics, global conflict, war and other natural or man-made disasters or business interruptions. In addition, they may be affected by government shutdowns, changes to applicable laws, regulations and policies, or withdrawn funding. The occurrence of any of these business disruptions could seriously harm their ability to complete their contracted services to GEDi Cube, which may adversely impact its operations and financial condition.

GEDi Cube’s business and results of operations will suffer if it fails to compete effectively.

The testing and diagnostic products industry is intensely competitive. GEDi Cube has competitors both in Europe and abroad, including Grail, Inc., Exact Sciences Corporation, Freenome, Inc. and Thrive Earlier Detection Corp., that have stated that they are developing tests designed to detect cancer. GEDi Cube’s competitors have, or may have, substantially greater financial, technical and other resources, such as larger research and development staff and well-established marketing and sales forces, and they may operate in jurisdictions where lower standards of evidence are required to bring products to market. GEDi Cube’s competitors may succeed in developing, acquiring, or licensing, on an exclusive basis or otherwise, tests or services that are more effective or less costly than GEDi Cube’s products. In addition, established medical technology, biotechnology, or pharmaceutical companies may invest heavily to accelerate the discovery and development of tests that could make GEDi Cube’s products less competitive than GEDi Cube anticipates.

GEDi Cube’s ability to compete successfully will depend largely on its ability to:

GEDi Cube may not be able to compete effectively if GEDi Cube is unable to accomplish one or more of these or similar objectives.

If GEDi Cube cannot enter new collaborations in a timely manner and on acceptable terms, its efforts to develop and commercialize its products could be delayed or adversely affected.

From time to time, GEDi Cube expects to engage in discussions with potential development and/or commercial collaborators that may or may not lead to collaborations. However, GEDi Cube cannot guarantee that any discussions will result in development or commercial collaborations. Further, once news of discussions regarding possible collaborations are known in the general public, regardless of whether the news is accurate, failure to announce a collaboration agreement, or the entity’s announcement of a collaboration with an entity other than GEDi Cube, could result in adverse speculation about GEDi Cube, its products or its technology, resulting in harm to its reputation and its business. In addition, establishing collaborations is difficult and time-consuming and may require GEDi Cube’s significant financial investment. Potential collaborators may elect not to work with GEDi Cube based on their assessment of its financial, regulatory, or intellectual property position. Even if GEDi Cube establishes new collaborations, they may not result in the successful development or commercialization of its products or technology.

If GEDi Cube is unable to establish sales and marketing capabilities, it may not be successful in commercializing GEDi Cube’s products.

GEDi Cube has only limited sales and marketing infrastructures and no experience as a company in the sale, marketing and distribution of screening or diagnostic tests. In preparation of a commercial launch, GEDi Cube is rapidly hiring additional personnel in GEDi Cube’s sales and marketing organization.

Factors that may inhibit GEDi Cube’s efforts to commercialize any of its products include:

GEDi Cube’s business is subject to economic, political, regulatory and other risks associated with international operations.

GEDi Cube’s business is subject to risks associated with conducting business internationally. For example, some of GEDi Cube’s suppliers and parties with whom it has collaborative relationships are located outside of the Netherlands, including in the United Kingdom and Israel. Accordingly, GEDi Cube’s future results could be harmed by a variety of factors, including:

Risks Related to GEDi Cube’s Employee Matters and Managing Growth

GEDi Cube is highly dependent on its key personnel. If GEDi Cube is not successful in attracting, motivating and retaining highly qualified personnel, it may not be able to successfully implement its business strategy.

GEDi Cube’s ability to compete in the highly competitive biotechnology industry depends upon its ability to attract, motivate and retain highly qualified personnel. GEDi Cube is highly dependent on its executive management team and its scientific, medical, technological and engineering personnel, all of whom have been working together as a group for only a limited period of time. The loss of the services provided by any of GEDi Cube’s executive officers, other key employees and other scientific and medical advisors, and GEDi Cube’s inability to find suitable replacements as needed, could result in delays in commercialization of its products and harm its business. GEDi Cube does not maintain “key person” insurance policies on the lives of these individuals or the lives of any of its other employees.

GEDi Cube is headquartered in Amsterdam, the Netherlands, a region in which many other healthcare companies, technology companies and academic and research institutions are headquartered. Competition for personnel is intense and the turnover rate can be high, which may limit GEDi Cube’s ability to hire and retain highly qualified personnel on acceptable terms or at all. GEDi Cube expects that it may need to recruit talent from outside of its region, and doing so may be costly and difficult. If GEDi Cube is unable to attract and retain highly qualified personnel, its ability to develop and commercialize its products may be limited.

If GEDi Cube is unable to scale its operations successfully to support demand for its products following the launch of its platform, its business could suffer.

As and to the extent demand increases beyond GEDi Cube’s expectations following the launch of GEDi Cube’s platform, GEDi Cube will likely need to start to ramp up operating capacity. GEDi Cube will need to implement new infrastructure, data processing capabilities, customer service, billing and systems processes, and expand GEDi Cube’s internal quality assurance program and technology to support operations on a larger scale. GEDi Cube will also need collaboration arrangements with third-party laboratories to process its physical tests or, if processing of such tests is not fully outsourced to support demand, will need to obtain equipment and certified and licensed laboratory personnel to process these physical tests internally. GEDi Cube may face difficulties increasing the scale of its operations, including implementing changes in infrastructure or programs or acquiring additional equipment or personnel. As GEDi Cube refines its products and develops additional products, GEDi Cube may need to introduce new equipment, implement new systems, technology, controls and procedures, and hire personnel with different qualifications, licenses or certifications.

The value of GEDi Cube’s products will depend, in part, on GEDi Cube’s ability to perform tests, whether through a licensed provider or internally, and return results to providers on a timely basis and at an appropriate quality standard, and on GEDi Cube’s reputation for such timeliness and quality. Failure to establish necessary arrangements with licensed providers, to implement necessary procedures, to transition to new equipment or processes, or to hire the appropriately qualified personnel could result in higher costs of processing, longer turnaround times or an inability to meet market demand. There can be no assurance that GEDi Cube or any such licensed provider will be able to perform tests on a timely basis at a level consistent with demand, that GEDi Cube will be able to maintain the quality of its test results as GEDi Cube scales its commercial operations, or that GEDi Cube will be successful in responding to the potential growing complexity of its operations, including the related data analysis requirements.

In addition, GEDi Cube’s growth may place a significant strain on its management, operating and financial systems, research and development, and its sales, marketing, and administrative resources. As a result of GEDi Cube’s growth, its operating costs may escalate even faster than planned, and some of its internal systems may need to be enhanced or replaced. If GEDi Cube cannot effectively manage its expanding operations and its costs, GEDi Cube may not be able to grow successfully or it may grow at a slower pace, and its business could be adversely affected.

GEDi Cube will need to grow the size and capabilities of its organization, and it may experience difficulties in managing this growth.

As of December 20, 2023, GEDi Cube had 11 full-time employees and four independent contractors, including two full-time. As GEDi Cube’s growth plan and strategies develop, it must add a significant number of additional managerial, operational, financial and other personnel. Future growth will impose significant added responsibilities on members of management, including:

GEDi Cube’s future financial performance and its ability to commercialize its products will depend, in part, on its ability to effectively manage any future growth. GEDi Cube’s management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to manage these growth activities. GEDi Cube’s ability to successfully manage its expected growth is uncertain given the fact that GEDi Cube has been in full operation as an independent company focusing on cancer diagnostics AI only since 2018. GEDi Cube’s executive management team’s lack of long-term experience working together may adversely impact their ability to effectively manage its business and growth.

If GEDi Cube is not able to effectively expand its organization by hiring new employees, it may not be able to successfully implement the tasks necessary to commercialize its products, which would have a negative impact on GEDi Cube’s business and result of operations.

Risks Related to GEDi Cube’s Legal Compliance and Litigation

Changes in funding or disruptions at the EMA, the MRHA, and other government agencies caused by funding shortages or global health concerns could hinder GEDi Cube’s ability to hire and retain key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, or otherwise prevent those agencies from performing normal business functions on which the operation of GEDi Cube’s business may rely, which could negatively impact its business.

The ability of the EMA, the MRHA, and, in the future, the FDA and other government agencies to review and clear or approve new products or changes to existing products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory and policy changes, the agency’s ability to hire and retain key personnel and accept the payment of user fees, government shutdowns and other events that may otherwise affect the agency’s ability to perform routine functions. For example, average review times at the FDA have fluctuated in recent years as a result of such factors. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the EMA, the MRHA, and, in the future, the FDA and other agencies may also slow the time necessary for new medical devices or modifications to cleared or approved medical devices to be reviewed and/or approved by necessary government agencies, which would adversely affect GEDi Cube’s business.

If GEDi Cube is sued for product or professional liability, it could face substantial liabilities that exceed its resources.

GEDi Cube’s business depends upon its ability to obtain reliable and accurate test results that incorporate rapidly evolving understanding of how to interpret minute signals detected by GEDi Cube’s assays as indications of potential presence of disease. Actual or perceived errors resulting from laboratory or reporting errors, false positive or false negative test results, or the manufacture, design, or labelling of GEDi Cube’s products, could subject GEDi Cube to product liability or professional liability claims. A product liability or professional liability claim against GEDi Cube could result in substantial damages and be costly and time-consuming to defend. Any liability claim brought against GEDi Cube, with or without merit, could increase its insurance rates or prevent it from securing insurance coverage in the future. Additionally, any liability lawsuit could damage GEDi Cube’s reputation or force it to delay or suspend sales of its products. The occurrence of any of these events could have a material adverse effect on GEDi Cube’s business, results of operations, financial condition and prospects.

GEDi Cube’s employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

GEDi Cube is exposed to the risk of fraud, misconduct, or other illegal activity by its employees, independent contractors, consultants, commercial partners and vendors. Misconduct by these parties could include intentional, reckless and negligent conduct that fails to comply with the rules and regulations of the Centers for Medicare & Medicaid Services (the “CMS”), the FDA, the EMA, the MRHA and other comparable regulatory authorities; provide true, complete and accurate information to such regulatory authorities; comply with manufacturing and clinical laboratory standards; comply with healthcare fraud and abuse laws in the United Kingdom, Europe and, in the future, the United States and similar fraudulent misconduct laws; or report financial information or data accurately or to disclose unauthorized activities to GEDi Cube. When GEDi Cube begins commercializing its products in the United Kingdom and Europe and, in the future,

the United States, its potential exposure under such laws will increase significantly, and its costs associated with compliance with such laws are also likely to increase. In particular, research, sales, marketing, education and other business arrangements in the healthcare industry are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices, as well as off-label product promotion. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, educating, marketing and promotion, sales and commission, certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of clinical validation, which could result in regulatory sanctions and cause serious harm to GEDi Cube’s reputation. GEDi Cube has adopted a code of business conduct and ethics, but it is not always possible to identify and deter misconduct by employees and third parties, and the precautions GEDi Cube takes to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting GEDi Cube from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws. If any such actions are instituted against GEDi Cube, and GEDi Cube is not successful in defending itself or asserting its rights, those actions could have a significant impact on GEDi Cube’s business, including the imposition of significant fines or other sanctions. Even if it is later determined after an action is instituted against GEDi Cube that GEDi Cube was not in violation of these laws, GEDi Cube may be faced with negative publicity, incur significant expenses defending its actions and have to divert significant management resources from other matters.

GEDi Cube’s products, if used for the diagnosis of disease, could be subject to government regulation, and the regulatory approval and maintenance process for such products may be expensive, time-consuming, and uncertain both in timing and in outcome.

GEDi Cube’s products are not subject to FDA or other government regulatory clearance or approval if they are not intended to be used for the diagnosis, treatment or prevention of disease. However, as GEDi Cube expands its product line to encompass products that are intended to be used for the diagnosis of disease, certain of its products will become subject to regulation by the FDA, or comparable international agencies, including requirements for regulatory clearance or approval of such products before they can be marketed. Such regulatory approval processes or clearances may be expensive, time-consuming, and uncertain, and GEDi Cube’s failure to obtain or comply with such approvals and clearances could have an adverse effect on its business, financial condition, or operating results. In addition, changes to the current regulatory framework, including the imposition of additional or new regulations, could arise at any time during the development or marketing of GEDi Cube’s future products, which may negatively affect its ability to obtain or maintain FDA or comparable regulatory approval of its products, if required.

Diagnostic products are regulated as medical devices by the FDA and comparable international agencies and may require either clearance from the FDA or such other comparable agencies following the 510(k) pre-market notification process or pre-market approval from the FDA, in each case prior to marketing. Obtaining the requisite regulatory approvals can be expensive and may involve considerable delay. If GEDi Cube fails to obtain, or experiences significant delays in obtaining, regulatory approvals for diagnostic products that it develops in the future, GEDi Cube may not be able to launch or successfully commercialize such products in a timely manner, or at all.

In addition, if GEDi Cube’s products labelled as “For Research Use Only. Not for use in diagnostic procedures,” or RUO, are used, or could be used, for the diagnosis of disease, the regulatory requirements related to marketing, selling, and supporting such products could change or be uncertain, even if such use by GEDi Cube’s customers is without its consent. If the FDA or other regulatory agencies assert that any of GEDi Cube’s RUO products are subject to regulatory clearance or approval, GEDi Cube’s business, financial condition, or results of operations could be adversely affected.

Regulatory and legislative developments on the use of AI and machine learning could adversely affect GEDi Cube’s use of such technologies in its platform and other products.

As the regulatory framework for machine learning technology and AI evolves, GEDi Cube’s business, financial condition, and results of operations may be adversely affected. The regulatory framework for machine learning technology, AI and automated decision-making is evolving. It is possible that new laws and regulations will be adopted in the United Kingdom, the European Union, the United States and/or other foreign jurisdictions, or that existing laws and regulations may be interpreted in ways that would affect the operation of GEDi Cube’s AI platform and data analytics and the way in which GEDi Cube uses AI and machine learning technology. Further, the cost to comply with such laws or regulations could be significant and would increase GEDi Cube’s operating expenses, which could adversely affect its business, financial condition and results of operations.

For example, in Europe, on April 21, 2021, the European Commission proposed a regulation seeking to establish a comprehensive, risk-based governance framework for AI in the European Union market. The proposed legislation is intended to apply to companies that develop, use and/ or provide AI in the European Union and includes requirements around transparency, conformity assessments and monitoring, risk assessments, human oversight, security and accuracy, and proposes fines for breach of up to 6% of worldwide annual turnover. In addition, on September 28, 2022, the European Commission proposed the AI Liability Directive and the revised Product Liability Directive seeking to establish a harmonized civil liability regime for AI in the European Union in order to facilitate civil claims in respect of harm caused by AI and to include AI-enabled products within the scope of the European Union’s existing product liability regime. If enacted, this regulatory framework is expected to have a material impact on the way AI is regulated in the European Union, and together with developing guidance and/or decisions in this area, may affect GEDi Cube’s use of AI and its ability to provide and to improve its services, require additional compliance measures and changes to its operations and processes, result in increased compliance costs and potential increases in civil claims against GEDi Cube, and could adversely affect its business, operations and financial condition.

Risks Related to GEDi Cube’s Technology and Intellectual Property

Issues in the development and use of AI, including machine learning and computer vision, in GEDi Cube’s AI platform may result in reputational harm or liability.

AI is integrated into GEDi Cube’s platform and is a significant element of its business offerings going forward. As with many developing technologies, AI presents risks, challenges and unintended consequences that could affect its further development, adoption, and use, and therefore GEDi Cube’s business. AI algorithms and training methodologies may be flawed. Data sets may be insufficient, of poor quality, or contain biased information. Inappropriate or controversial data practices by data scientists, engineers, and end-users of GEDi Cube’s systems could impair the acceptance of AI solutions. If the analyses that AI applications assist in producing are deficient or inaccurate, GEDi Cube could be subjected to competitive harm, potential legal liability, and brand or reputational harm. Some uses of AI present ethical issues, and GEDi Cube’s judgment as to the ethical concerns may not be perceived as accurate. While GEDi Cube aims to develop and use AI responsibly and attempts to identify and mitigate ethical and legal issues presented by its use, GEDi Cube may be unsuccessful in identifying or resolving issues before they arise. If GEDi Cube uses AI as part of its platform in a manner that is controversial or perceived as unethical, this may lead to adverse results for GEDi Cube’s financial condition and operations or the financial condition and operations of its collaborators or vendors, which may further lead to GEDi Cube experiencing competitive harm, legal liability and brand or reputational harm. In addition, AI-related issues, deficiencies and/or failures could give rise to legal and/or regulatory action, including with respect to proposed legislation regulating AI in jurisdictions such as the European Union and others, and as a result of new applications of existing data protection, privacy, intellectual property, and other laws.

Failure of, or defects in, GEDi Cube’s machine learning and cloud-based computing infrastructure, or increased regulation in the machine learning space, could impair GEDi Cube’s ability to process its data, develop products, or provide test results, and harm its business and results of operations.

The design, development, maintenance and operation of GEDi Cube’s technology over time is expensive and complex, and may involve unforeseen difficulties including material performance problems, undetected defects or errors. Overcoming technical obstacles and correcting defects or errors could prove to be impossible or impracticable, and the costs incurred may be substantial and adversely affect GEDi Cube’s results of operations. Additionally, regulation in the machine learning space is constantly evolving and may make it difficult for GEDi Cube to continue using its machine learning approach. If GEDi Cube’s technology does not function reliably, fails to meet expectations in terms of performance, or cannot be fully utilized due to increasing regulation, GEDi Cube may be unable to provide, or its customers may stop using, its products.

GEDi Cube currently hosts all of its data on, and conducts its data analysis through, local hosting facilities. Any technical problems or outages that may arise in connection with these hosting facilities could result in the loss of GEDi Cube’s data or delayed or ineffective data processing. A variety of factors, including infrastructure changes, human or software errors, viruses, malware, security attacks, fraud, spikes in customer usage, or denial of service issues could cause interruptions in GEDi Cube’s service. Such service interruptions may reduce or inhibit GEDi Cube’s ability to provide its products, delay any further clinical validation and any future clinical studies, and damage its relationships with its customers. GEDi Cube could also be exposed to potential lawsuits, liability claims or regulatory actions, if, for example, GEDi Cube’s local servers experienced a data privacy breach. If GEDi Cube was required to transfer its data to an alternative hosting provider, the transfer and acclimation to the new provider could result in significant business delays and require additional resources.

Real or perceived errors, failures, or bugs in GEDi Cube’s platform and future products could adversely affect its business, results of operations, financial condition, and growth prospects.

GEDi Cube’s platform is, and its future products will be, complex, and therefore, undetected errors, failures, bugs, or defects may be present in such platform or products or occur in the future in its platform or products, its technology or software or the technology or software GEDi Cube licenses from third parties, including open source software, especially when updates or new products are released. Such software and technology is used in information technology (“IT”) environments with different operating systems, system management software, devices, databases, servers, storage, middleware, custom and third-party applications, and equipment and networking configurations, which may cause errors, failures, bugs, or defects in the IT environment into which such software and technology is deployed. This diversity increases the likelihood of errors, failures, bugs, or defects in those IT environments. Some of the features in GEDi Cube’s platform are powered by machine learning and AI, which depend on datasets and algorithms that could be flawed, including through inaccurate, insufficient, outdated, or biased data. Despite testing by GEDi Cube, real or perceived errors, failures, bugs, or defects may not be found until GEDi Cube’s customers use its products. Real or perceived errors, failures, bugs, or defects in GEDi Cube’s products could result in negative publicity, loss of or delay in market acceptance of its platform or future products and harm to its brand, loss of investor confidence, weakening of its competitive position, claims by customers for losses sustained by them, or failure to meet the stated service level commitments in its customer agreements. In such an event, GEDi Cube may be required, or may choose, for customer relations or other reasons, to expend significant additional resources in order to help correct the problem. Any real or perceived errors, failures, bugs, or defects in GEDi Cube’s products could also impair its ability to attract new customers, retain existing customers, or expand their use of its products, which would adversely affect GEDi Cube’s business, results of operations and financial condition.

GEDi Cube may also be subject to liability claims for damages related to real or perceived errors, failures, bugs, or defects in its platform or future products. A material liability claim or other occurrence that harms GEDi Cube’s reputation or decreases market acceptance of its platform or future products may harm its business and results of operations. Finally, since some of GEDi Cube’s customers use its products for compliance reasons, any errors, failures, bugs, defects, disruptions in service or other performance problems with GEDi Cube’s products may damage its customers’ businesses and could hurt its reputation.

GEDi Cube’s internal computer systems, or those expected to be used by its third-party research institution collaborators or other contractors or consultants, may fail or suffer security breaches.

Despite the implementation of security and back-up measures, GEDi Cube’s internal computer, server and other information technology systems as well as those of its third-party collaborators, consultants, contractors, suppliers and service providers, may be vulnerable to damage from physical or electronic break-ins, computer viruses, malware, ransomware, denial of service and other cyber-attacks or disruptive incidents that could result in unauthorized access to, use or disclosure of, corruption of, or loss of sensitive and/or proprietary data, including personal and health information, and could subject GEDi Cube to significant liabilities, regulatory and enforcement actions and reputational damage. For example, the loss of clinical study data from future clinical studies could result in delays in any regulatory clearance or approval efforts and significantly increase GEDi Cube’s costs to recover or reproduce the data, and subsequently commercialize its future products. If GEDi Cube or its third-party collaborators, consultants,

contractors, suppliers or service providers were to suffer an attack or breach, for example, that resulted in the unauthorized access to or use or disclosure of personal or health information, GEDi Cube may have to notify physicians, patients, partners, collaborators, government authorities and the media, and may be subject to investigations, civil penalties, administrative and enforcement actions and litigation, any of which could harm GEDi Cube’s business and reputation. Likewise, GEDi Cube relies on its third-party research institution collaborators and other third parties to conduct clinical validation, and similar events relating to their computer systems could also have a material adverse effect on GEDi Cube’s business. To the extent that any disruption or security breach were to result in a loss of, or damage to, GEDi Cube’s data or systems, or inappropriate or unauthorized access to or disclosure or use of confidential, proprietary, or other sensitive, personal, or health information, GEDi Cube could incur liability and suffer reputational harm, and the development and commercialization of its products could be delayed.

GEDi Cube’s insurance policies may not be adequate to compensate it for the potential losses arising from such disruptions, failure, or security breach. In addition, such insurance may not be available to GEDi Cube in the future on economically reasonable terms, or at all. Further, GEDi Cube’s insurance may not cover all claims made against it and defending a suit, regardless of its merit, could be costly, divert management attention and harm GEDi Cube’s reputation.

If GEDi Cube is unable to protect the confidentiality of its trade secrets, GEDi Cube’s business and competitive position would be harmed.

GEDi Cube relies on trade secrets and confidentiality agreements to protect its know-how, technology, data and other proprietary information and to maintain its competitive position. Trade secrets and know-how can be difficult to protect. GEDi Cube expects its trade secrets and know-how to, over time, be disseminated within the industry through independent development, the publication of journal articles describing the methodology and the movement of personnel from academic to industry scientific positions.

GEDi Cube seeks to protect these trade secrets and other proprietary technology, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as GEDi Cube’s employees, directors, corporate collaborators, outside scientific collaborators, contract research organizations (“CROs”), contract manufacturers, suppliers, service providers, consultants, advisors and other third parties. GEDi Cube also enters into confidentiality and invention or patent assignment agreements with its employees and consultants, and reminds departing employees when they leave their employment of their continuing confidentiality obligations. GEDi Cube cannot guarantee that it has entered into such agreements with each party that may have, or have had, access to GEDi Cube’s trade secrets or proprietary technology and processes. Despite GEDi Cube’s efforts, any of these parties may breach the agreements and disclose GEDi Cube’s proprietary information, including GEDi Cube’s trade secrets, and GEDi Cube may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive, and time-consuming, and the outcome is unpredictable. Some courts outside The Netherlands are less willing or unwilling to protect trade secrets. For example, in China, claims regarding infringement or misappropriation of trade secrets are difficult to prove, and consequently plaintiffs are rarely successful in bringing these claims. If any of GEDi Cube’s trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, GEDi Cube would have no right to prevent them from using that technology or information to compete with GEDi Cube. If any of GEDi Cube’s trade secrets were to be misappropriated by, disclosed to, or independently developed by a competitor or other third party, GEDi Cube’s competitive position could be materially and adversely harmed.

GEDi Cube has and may enter into collaboration, license, contract research and/or manufacturing relationships with contract organizations that operate in certain countries that are at heightened risk of theft of technology, data and intellectual property through direct intrusion by private parties or foreign actors, including those affiliated with or controlled by state actors. Accordingly, GEDi Cube’s efforts to protect and enforce GEDi Cube’s intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that GEDi Cube develops or licenses, and GEDi Cube may be at heightened risk of losing its proprietary intellectual property rights around the world, including outside of such countries, to the extent such theft or intrusion destroys the proprietary nature of its intellectual property.

GEDi Cube depends on its information technology and telecommunications systems and those of third parties, the failure or disruption of which could harm its business.

GEDi Cube depends on information technology and telecommunications systems, including those provided by third parties and their vendors, for significant elements of its operations, such as its information management systems, research and development, scientific and medical data analysis and general administrative activities. In addition, GEDi Cube’s third-party service providers depend upon technology and telecommunications systems provided by outside vendors. Following the Closing, GEDi Cube expects that the combined company will expand and strengthen a number of enterprise software systems that affect a broad range of business processes and functions, including, for example, systems handling human resources, financial controls and reporting, customer relationship management, regulatory compliance, security controls and other infrastructure operations. These expansions may prove more difficult than GEDi Cube expects and could cause disruptions in its operations or additional expense.

Information technology and telecommunications systems are vulnerable to damage from a variety of sources, including telecommunications or network failures, malicious human acts and natural disasters. Moreover, despite network security and back-up measures, some of GEDi Cube’s servers are potentially vulnerable to physical or electronic break-ins, computer viruses and similar disruptive events. Despite the precautionary measures GEDi Cube has taken to detect and prevent or solve problems that could affect its information technology and telecommunications systems, failures or significant downtime of these systems or those used by its third-party service providers and their vendors could prevent GEDi Cube from conducting tests, preparing and providing reports to future customers, billing payors, conducting research and development activities, maintaining its financial controls and other reporting functions, and managing the administrative aspects of its business. Any disruption or loss of information technology or telecommunications systems on which critical aspects of GEDi Cube’s operations depend could have an adverse effect on its business.

If GEDi Cube’s trademarks and trade names are not adequately protected, GEDi Cube may not be able to build name recognition in its markets of interest and its business may be adversely affected.

GEDi Cube uses certain unregistered trademarks and trade names in its business. These trademarks or trade names may be challenged, infringed or declared generic or determined to be infringing on other marks. GEDi Cube may not be able to protect its rights to these trademarks and trade names in the future, which GEDi Cube views as valuable to building name recognition among potential partners and customers in its markets of interest. At times, competitors or other third parties have adopted or may adopt trade names or trademarks similar to GEDi Cube’s trade names and/or trademarks, thereby impeding its ability to build brand identity and possibly leading to market confusion and/or litigation. In addition, there could be potential trade name or trademark infringement claims brought by owners of registered trademarks or trademarks that incorporate variations of GEDi Cube’s unregistered trademarks or trade names. Over the long term, if GEDi Cube is unable to establish name recognition based on its trademarks and trade names, then GEDi Cube may not be able to compete effectively and GEDi Cube’s business may be adversely affected. GEDi Cube’s efforts to enforce, protect or defend its proprietary rights related to trademarks and trade names may be ineffective and could result in substantial costs and diversion of resources and could adversely affect GEDi Cube’s business, financial condition, results of operations and prospects.

Intellectual property litigation may lead to unfavorable publicity that harms GEDi Cube’s reputation.

During the course of any intellectual property litigation, there could be public announcements of the initiation of the litigation as well as results of hearings, rulings on motions and other interim proceedings in the litigation. Such announcements could harm GEDi Cube’s reputation, the perceived value of GEDi Cube’s intellectual property or the potential market for its products, which could have a material adverse effect on its business.

GEDi Cube’s success depends on its ability to develop and commercialize its technology without infringing, misappropriating, or otherwise violating the intellectual property of third parties. Third parties may initiate legal proceedings alleging that GEDi Cube is infringing their intellectual property rights, and if they prevail, could block sales of GEDi Cube’s products and force GEDi Cube to make large damages and/or royalty payments, which could have a material adverse effect on the success of its business.

GEDi Cube’s commercial success in part depends upon its ability, and the ability of its collaborators, to market, sell and distribute GEDi Cube’s products and use GEDi Cube’s proprietary technologies without infringing, misappropriating or otherwise violating the proprietary rights of third parties. There is considerable intellectual property litigation in the medical technology, biotechnology, diagnostic and pharmaceutical industries. GEDi Cube may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to its products, including interference proceedings before the United Kingdom Intellectual Property Office, the European Patent Office, the United States Patent and Trademark Office and similar bodies in other jurisdictions. Third parties may assert infringement claims against GEDi Cube based on existing patents or patents that may be issued in the future.

If GEDi Cube is found to infringe, misappropriate, or otherwise violate a third party’s intellectual property rights, it could be required to obtain a license from such third party to continue developing, marketing, selling and distributing GEDi Cube’s products, or to cease using the infringing technology. However, GEDi Cube may not be able to obtain any required license on commercially reasonable terms or at all. Even if GEDi Cube were able to obtain a license, it could be non-exclusive, thereby giving GEDi Cube’s competitors access to the same technologies licensed to GEDi Cube. In addition, GEDi Cube could be found liable for monetary damages, including treble damages if it is found to have willfully infringed a patent and attorneys’ fees if the court finds the case to be exceptional. A finding of infringement, misappropriation, or other violation could prevent GEDi Cube from commercializing its products or force GEDi Cube to cease some of its operations, which could materially harm its business. Claims that GEDi Cube has misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on GEDi Cube’s business.

Even if resolved in GEDi Cube’s favor, litigation or other legal proceedings relating to intellectual property claims may cause GEDi Cube to incur significant expenses and could distract GEDi Cube’s personnel from their normal responsibilities. Such litigation or proceedings could substantially increase GEDi Cube’s operating losses and reduce the resources available for development activities or any future sales, marketing, or distribution activities. GEDi Cube may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of GEDi Cube’s competitors may be able to sustain the costs of such litigation or proceedings more effectively than GEDi Cube can because of their greater financial resources and more mature and developed intellectual property portfolios. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on GEDi Cube’s ability to compete in the market place.

GEDi Cube’s use of open-source software could subject GEDi Cube’s proprietary technology to unwanted open-source license conditions that could negatively impact its business.

A portion of GEDi Cube’s technology capabilities incorporates open-source software, and GEDi Cube may incorporate open-source software into other offerings or products in the future. If an author or other third party that distributed such open-source software to GEDi Cube were to allege that GEDi Cube had not complied with the conditions of one or more of these licenses, GEDi Cube could be required to incur significant legal expenses defending against such allegations. Further, the outcome of such litigation may be particularly uncertain in some cases, because there is little legal precedent governing the interpretation of certain terms of common open source licenses. In addition, if GEDi Cube combines its proprietary software with open-source software in a certain manner and makes it available to others, under some open-source licenses, it could be required to license or make available the source code of its proprietary software, which could substantially help its competitors develop products that are similar to or better than GEDi Cube’s and harm its business.

The success and growth of GEDi Cube’s business depends upon its ability to continuously innovate and develop new products and technologies.

GEDi Cube’s solution is a technology-driven platform that relies on innovation to remain competitive. The process of developing new technologies and products is complex, and GEDi Cube has built and seeks to further develop its own technology using the latest in AI and machine learning, cloud-based technologies and other tools to differentiate GEDi Cube’s products and technologies. In addition, GEDi Cube’s dedication to incorporating technological advancements into its AI platform requires significant financial and personnel resources and talent. GEDi Cube’s development efforts with respect to these initiatives could distract management from current operations and could divert capital and other resources from other growth initiatives important to GEDi Cube’s business. GEDi Cube operates in an industry experiencing rapid technological change and frequent product introductions. GEDi Cube may not be able to make technological improvements as quickly as demanded by its customers, or GEDi Cube may not be able to accurately predict the demand or growth of its technological investments, which could harm its ability to attract customers and have a material and adverse effect on its business, results of operations, financial condition and future prospects. In addition, GEDi Cube may not be able to effectively implement new technology-driven products and services as quickly as its competitors or be successful in marketing these products and services to potential customers. If GEDi Cube is unable to successfully and timely innovate, GEDi Cube could experience reputational damage and decreased demand for its AI platform and other products and technologies and its growth, business, results of operations, financial condition and future prospects could be materially and adversely affected.

GEDi Cube’s AI platform and other related products may become obsolete due to fast growing technological innovations or the entry of competitors with more financial and brand power.

AI is a fast growing industry and GEDi Cube must successfully adapt and manage technological advancements in AI and AI-related markets, as well as effectively compete with the emergence of additional competitors in the AI industry in order to maintain and grow GEDi Cube’s AI business and products. Thus, the success of GEDi Cube’s AI platform, other products and business depends in large part on its ability to keep pace with rapid technological changes in the development and implementation of AI products. For example, the development of groundbreaking technological innovations in AI, or innovations that would render AI obsolete, would harm GEDi Cube’s business and make its platform or other products less durable. Further, the entry of competitors into the AI market that have more financial and brand power could cause GEDi Cube’s share of the market to be significantly reduced thereby negatively affecting its business, operating results and financial condition.

Risks Related to the Combined Company

The combined company does not expect to pay dividends in the foreseeable future. Any return on investment may be limited to the value of its Common Stock.

The current expectation is that the combined company will retain its future earnings to fund the development and growth of its business and, as such, that it will not pay cash dividends on the Common Stock in the foreseeable future. The payment of dividends on the Common Stock will depend on earnings, financial condition and other business and economic factors affecting it at such time as the combined company’s board of directors may consider relevant. As a result, capital appreciation, if any, of the shares of the combined company’s Common Stock will be your sole source of gain, if any, for the foreseeable future.

The financial and operational projections that GEDi Cube or the combined company has made or may make from time to time are subject to inherent risks.

The projections of GEDi Cube provided herein or that, following the Closing, the management of the combined company may provide from time to time (including, but not limited to, those relating to potential clinical and regulatory timelines, production and supply matters, commercial launch dates, potential sales amounts and other financial or operational matters) reflect numerous assumptions made by GEDi Cube’s or the combined company’s management, as applicable, including assumptions with respect to its specific as well as general business, regulatory, economic, market and financial conditions and other matters, all of which are difficult to predict and many of which are beyond GEDi Cube’s or the combined company’s control. Accordingly, there is a risk that the assumptions made in preparing the projections, or the projections themselves, will prove inaccurate. There may be differences between actual and projected results, and actual results may be materially different from those contained in the projections.

If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about the combined company’s business, the stock price and trading volume of the combined company’s Common Stock could decline.

The trading market for the Common Stock of the combined company following the Closing will depend in part on the research and reports that securities or industry analysts publish about the combined company and its business. Securities and industry analysts do not currently, and may never, publish research on the combined company. If no or only very few securities analysts commence coverage, or if industry analysts cease coverage, of the combined company, the trading price for the combined company’s Common Stock would be negatively affected. If one or more of the analysts who cover the combined company downgrade the Common Stock or publish inaccurate or unfavorable research about the combined company’s business, the Common Stock price would likely decline. If one or more of these analysts cease coverage of the combined company or fail to publish reports on the combined company regularly, demand for the Common Stock could decrease, which might cause the price and trading volume of the Common Stock to decline.

The combined company’s quarterly results of operations may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause the combined company’s stock price to fluctuate or decline.

Following the Closing, it is expected that the combined company’s results of operations will be subject to quarterly fluctuations. The combined company’s net loss and other operating results will be affected by numerous factors, including:

If, following the Closing, the combined company’s quarterly results of operations fall below the expectations of investors or securities analysts, the value of the Common Stock could decline substantially. Furthermore, any quarterly fluctuations in the combined company’s results of operations may, in turn, cause the value of the Common Stock to fluctuate substantially. Accordingly, quarterly comparisons of the combined company’s financial results are not necessarily meaningful and should not be relied upon as an indication of its future performance.

Acquisitions or other strategic transactions may increase the combined company’s capital requirements, dilute its stockholders, cause it to incur debt or assume contingent liabilities, and subject it to other risks.

Following the Closing, the combined company may engage in various additional acquisitions and strategic partnerships in the future, including licensing or acquiring complementary intellectual property rights, technologies, or businesses. Any acquisition or strategic partnership may entail numerous risks, including:

In addition, as GEDi Cube and Renovaro integrate and the combined company’s strategy evolves, the combined company may opt to discontinue, deprioritize, or dispose of assets, technologies, or acquired businesses.

The combined company’s business activities are subject to the Foreign Corrupt Practices Act (the “FCPA”) and similar anti-bribery and anti-corruption laws.

Following the Closing, the combined company’s business activities will be subject to the FCPA and similar anti-bribery or anti-corruption laws, regulations, or rules of other countries in which the combined company will operate, including the U.K. Bribery Act. The FCPA generally prohibits offering, promising, giving, or authorizing others to give anything of value, either directly or indirectly, to a non-U.S. government official in order to influence official action, or otherwise obtain or retain business. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. GEDi Cube’s and Renovaro’s respective businesses are, and the combined company’s business will be, heavily regulated and, therefore, do and will involve significant interaction with public officials, including officials of foreign governments. Additionally, in many other countries, the healthcare providers who administer diagnostic tests are employed by their government, and the purchasers of diagnostics tests are government entities. Therefore, the combined company’s dealings with these providers and purchasers will be subject to regulation under the FCPA. The SEC and United States Department of Justice (the “DOJ”) have increased their FCPA enforcement activities with respect to biotechnology and pharmaceutical companies. There is no certainty that all of the combined company’s employees, agents, contractors, or collaborators, or those of its affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws. Violations of these laws and regulations could result in fines, criminal sanctions against the combined company and its officers and employees, the closing down of the combined company’s facility, requirements to obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs, and prohibitions on the conduct of the combined company’s business. Any such violations could include prohibitions on the combined company’s ability to offer its products in one or more countries and could materially damage the combined company’s reputation, brand, international expansion efforts, ability to attract and retain employees, business, prospects, operating results and financial condition.

FORWARD-LOOKING STATEMENTS

This proxy statement contains “forward-looking statements” (including within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 27A of the Securities Act), relating to Renovaro, GEDi Cube, the Transaction and the other proposed transactions contemplated by the Stock Purchase Agreement. These forward-looking statements include express or implied statements relating to Renovaro’s or GEDi Cube’s expectations, hopes, beliefs, intentions or strategies regarding the future, including the future business and results of operations of the combined company. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Renovaro or GEDi Cube, as well as assumptions made by, and information currently available to, management. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “approximate,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Renovaro, GEDi Cube, the combined company after the Transaction, or the proposed Transaction will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Renovaro’s and GEDi Cube’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Factors that might cause these differences include, but are not limited to, those described in this proxy statement under the heading “Risk Factors,” and the following factors:

The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere in this proxy statement. Many of the important factors that will determine these results are beyond Renovaro’s and GEDi Cube’s ability to control or predict. Should one or more of these risks or uncertainties materialize, or should any of Renovaro’s assumptions prove incorrect, actual results of Renovaro, GEDi Cube or the combined company could differ materially from the forward-looking statements. There may be additional risks that Renovaro considers immaterial or that are unknown. It is not possible to predict or identify all such risks. Forward-looking statements only speak as of the date they are made, and neither Renovaro nor GEDi Cube undertake any obligation to (and expressly disclaims any such obligation to) update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable laws.

For a discussion of the factors that may cause Renovaro’s, GEDi Cube’s or the combined company’s actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied in such forward-looking statements, or for a discussion of risks associated with the ability of Renovaro and GEDi Cube to complete the Transaction and the effect of the Transaction on the business of Renovaro, GEDi Cube and the combined company, please see the section titled “Risk Factors” beginning on page 22 of this proxy statement. Additional factors that could cause actual results to differ materially from those expressed in the forward-looking statements are also discussed in reports filed with the SEC by Renovaro.

THE SPECIAL MEETING OF RENOVARO STOCKHOLDERS

General

The special meeting of the Renovaro stockholders, or the Special Meeting, will be held on Thursday, January 25, 2024, at 12:00 p.m., Eastern Standard Time, at K&L Gates LLP, 200 S Biscayne Blvd., Suite 3900, Miami, FL 33131, unless postponed or adjourned to a later date.

This proxy statement, together with copies of the Renovaro 2023 Form 10-K and the Renovaro First Quarter 2024 Form 10-Q, is expected to be first mailed to stockholders of Renovaro on or about January 4, 2024.

Record Date and Shares Outstanding

Stockholders of record at the close of business on December 29, 2023, the Record Date, are entitled to notice of the Special Meeting. At the Record Date, 67,224,089 shares of Common Stock and 561,010 shares of Series A Preferred Stock were outstanding and entitled to vote at the Special Meeting.

Voting Rights

Only holders of Common Stock and Series A Preferred Stock at the close of business on the Record Date are entitled to notice of, and to vote at, the Special Meeting. Each share of Common Stock is entitled to one vote on all matters to be voted on at the Special Meeting, and each share of Series A Preferred Stock is entitled to ten (10) votes on all matters to be voted on at the Special Meeting. The presence in person or by proxy of at least one-third (¹/₃) of the issued and outstanding shares of Common Stock and Series A Preferred Stock entitled to vote at the Special Meeting constitutes a quorum.

Broker Non-Votes

If you do not give instructions to your broker or other nominee on how to vote, your nominee may vote your shares on matters that are considered to be “routine” under applicable stock exchange rules, but will not be permitted to vote your shares with respect to “non-routine” items. We believe that, under the applicable stock exchange rules, the Share Issuance Proposal, the Authorized Share Proposal, the Repricing Proposal, the 2023 Plan Amendment Proposal and the Adjournment Proposal are non-routine matters. A “broker non-vote” occurs when a broker, bank or other nominee that is a holder of record holding shares for a beneficial owner properly executes and returns a proxy without voting on a particular proposal because such holder of record does not have discretionary voting power for that particular item. Broker non-votes will not be counted as votes “FOR” or “AGAINST” any proposal to be considered at the Special Meeting but will be counted in determining whether there is a quorum for the Special Meeting. We strongly encourage you to submit your voting instructions and exercise your right to vote as a stockholder.

Purposes of the Special Meeting

The purposes of the Special Meeting are:

If Renovaro is to complete the Transaction with GEDi Cube, stockholders must approve Proposals 1 and 2. The approval of Proposals 3, 4 and/or 5 is not a condition to the completion of the Transaction.

As of the date of this proxy statement, the Renovaro Board does not know of any business to be presented at the Special Meeting other than as set forth in the notice accompanying this proxy statement. If any other matters should properly come before the Special Meeting, it is intended that the shares represented by proxies will be voted with respect to such matters in accordance with the judgment of the persons voting the proxies.

Recommendation of the Renovaro Board

After careful consideration, the Renovaro Board has unanimously approved the Stock Purchase Agreement, the Transaction and each of the proposals referred to above, and has determined that they are advisable, fair and in the best interests of Renovaro’s stockholders. Accordingly, the Renovaro Board unanimously recommends that Renovaro’s stockholders vote “FOR” the Share Issuance Proposal, “FOR” the Authorized Share Proposal, “FOR” the Repricing Proposal, “FOR” the 2023 Plan Amendment Proposal and “FOR” the Adjournment Proposal.

Voting and Revocation of Proxies

The proxy accompanying this proxy statement is solicited on behalf of the Renovaro Board for use at the Special Meeting and any adjournments or postponements of the Special Meeting.

If you are a stockholder of record of Renovaro as of the Record Date, you may vote:

Whether or not you plan to attend the Special Meeting, Renovaro urges you to vote by proxy to ensure your vote is counted. You may still attend the Special Meeting and vote in person if you have already voted by proxy. If you vote by proxy, your vote must be received by 11:59 p.m., Eastern Standard Time, on January 24, 2024 to be counted.

If your shares are held in the name of a bank, broker, trustee or other nominee holder of record (i.e., in “street name”), you may vote by following the voting instructions provided to you by your bank or broker.

All properly executed proxies that are not revoked will be voted at the Special Meeting and at any adjournment or postponement of the Special Meeting in accordance with the voting instructions contained in the proxy. If a holder of Common Stock or Series A Preferred Stock executes and returns a proxy or otherwise votes without marking voting selections, the shares represented by that proxy will be voted “FOR” the Share Issuance Proposal, the Authorized Share Proposal, the Repricing Proposal, the 2023 Plan Amendment Proposal and the Adjournment Proposal.

A stockholder of record as of the Record Date who has submitted a proxy may change or revoke the proxy. You may change your vote or revoke your proxy at any time prior to the taking of the vote at the Special Meeting as follows:

For all methods of voting, the last vote cast will supersede all previous votes. Attendance at the Special Meeting alone will not have the effect of revoking a proxy. The method by which you vote by proxy will in no way limit your right to vote at the Special Meeting if you decide to attend the Special Meeting.

If your shares are held in the name of a broker or other nominee, you may change or revoke your vote by following the specific directions provided to you by your broker or other nominee.

Required Vote

The presence at the Special Meeting, in person or by proxy, of the holders of one-third (¹/₃) of the issued and outstanding shares of Common Stock and Series A Preferred Stock entitled to vote at the Special Meeting will constitute a quorum. At the close of business on the Record Date, Renovaro had 67,224,089 shares of Common Stock outstanding and entitled to vote at the Special Meeting and 561,010 shares of Series A Preferred Stock outstanding and entitled to vote at the Special Meeting. Abstentions and broker non-votes will be counted for purposes of determining whether a quorum is present at the Special Meeting.

Each of Proposals 1 and 2 must be approved by the affirmative vote of a majority of the votes cast in person or by proxy at the Special Meeting, as required by Nasdaq Listing Rule 5635.

Each of Proposal 3 and Proposal 4 must be approved by the affirmative vote of a majority of the votes cast in person or by proxy at the Special Meeting, as required by the General Corporation Law of the State of Delaware.

Proposal 5 must be approved by the affirmative vote of a majority of the votes cast in person or by proxy at the Special Meeting, as required by the By-laws.

For these proposals, broker non-votes, if any, and a properly marked “ABSTAIN” with respect to any such matter will not be voted for or against a proposal and will not be counted as a vote cast for or against a proposal for purposes of determining the number of votes cast with respect to such proposals.

Appraisal Rights

Renovaro’s stockholders are not entitled to appraisal rights in connection with the Transaction.

Solicitation of Proxies

In addition to solicitation by mail, the directors, officers, employees and agents of Renovaro may solicit proxies from Renovaro stockholders by telephone, letter, email or in person without compensation. Renovaro will reimburse banks, brokerage firms and other custodians, nominees, and fiduciaries for their reasonable out-of-pocket expenses for sending proxy materials to stockholders and obtaining their votes.

THE TRANSACTION

This section and the section titled “The Stock Purchase Agreement” beginning on page 64 of this proxy statement describe the material aspects of the Transaction, including the Stock Purchase Agreement. While Renovaro believes that this description covers the material terms of the Transaction and the Stock Purchase Agreement, it may not contain all of the information that is important to you. You should carefully read this entire proxy statement, including the Stock Purchase Agreement, which is attached as Annex A-I to this proxy statement, including the First Amendment to Stock Purchase Agreement attached as Annex A-II to this proxy statement, and the other documents to which Renovaro has referred or which have been incorporated by reference herein. For a more detailed description of where you can find those other documents, please see the section titled “Where You Can Find More Information” beginning on page 178 of this proxy statement.

Background of the Transaction

The following chronology summarizes the key meetings and events that led to the signing of the Stock Purchase Agreement. The following chronology does not purport to catalogue every conversation among the Renovaro Board, the Transaction Committee (as defined below), members of Renovaro management or Renovaro’s representatives and other parties.

During the second quarter of 2023, Renovaro’s management began actively exploring options to strengthen Renovaro’s ability to advance its existing product pipeline and enhance stockholder value. These options included licensing or acquiring rights to other product candidates, or acquisitions of, or mergers with, other companies with other products, product candidates or technologies. Management had regular conversations with various Renovaro Board members, including Rene Sindlev and Gregg Alton, about market competition and opportunities. In April 2023, Nina Storms, an advisor to GEDi Cube, spoke with René Sindlev, Chairman of Renovaro, regarding a potential business relationship. On May 17, 2023, Mr. Sindlev met with Ms. Storms regarding GEDi Cube and the possible benefits of a transaction. Mr. Sindlev conducted multiple calls and in-person meetings with Ms. Storms in the weeks that followed, including a meeting with Frank Van Asch, the inventor of the GEDi Cube technology.

On June 8, 2023, Renovaro announced it had received FDA comments on pre-Investigational New Drug Application (“IND”) for pancreatic cancer therapy, RENB-DC11: Genetically modified Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Product for Long-term Remission of Solid Tumors (“RENB-DC11”). Renovaro considered the comments to be thorough and highly informative setting a clear pathway for IND. Renovaro developed extensive pre-clinical and clinical plans to achieve IND and conduct Phase 1 and 2 clinical trials. Ongoing pre-clinical studies in animal models conducted through Dr. Anahid Jewett at UCLA continued to demonstrate promising results. Renovaro projected IND submission and commencement of human trials for the second half of 2024, with the potential for approval for human use by the end of 2025 or early 2026.

On June 9, 2023, the Renovaro Board held a special meeting at which members of Renovaro management and representatives of K&L Gates LLP (“K&L”), Renovaro’s outside legal counsel, were present. At this meeting, the Renovaro management discussed the strategic, financial and operational challenges of operating Renovaro’s business in the then-current environment, including the macro-economic, industry and market conditions negatively impacting pre-clinical-stage cell and gene therapy companies such as Renovaro. The Renovaro Board discussed the need for significant capital investment to complete Renovaro’s pre-clinical and clinical trials of RENB-DC11 and its other therapeutic platforms in development, support the filing of an IND application for RENB-DC11, fund its manufacturing network, fund its innovative research and development efforts, hire the appropriate personnel necessary to execute on those priorities, retain critical talent, and operate generally as a public company, as well as the risks and uncertainties associated with conducting pre-clinical and clinical trials for RENB-DC11, pursuing related regulatory approvals and, if successful, launching and commercializing RENB-DC11. The Renovaro Board also discussed the risks and uncertainties associated with Renovaro’s cash requirements, which had severely negatively impacted Renovaro’s stock price and its ability to raise sufficient capital through equity financings. The Renovaro Board further discussed Renovaro’s current cash position, its near-term priorities and related cash requirements, and the lack of attractive financing alternatives given then-current market conditions. The Renovaro Board further discussed changing the Company’s name to Renovaro, a variant of the Latin verb “to renew”.

Throughout June, Ms. Storms and Mr. Sindlev continued to have discussions regarding a possible transaction. On June 19, 2023, Ms. Storms sent an email to Mr. Sindlev with information regarding GEDi Cube.

On June 20, 2023, Mr. Sindlev forwarded the information provided by Ms. Storms concerning GEDi Cube to Dr. Mark Dybul, the Chief Executive Officer of Renovaro, and other representatives of Renovaro.

Additional, preliminary and high-level exploratory communications followed between representatives of Renovaro, including Dr. Dybul, Mr. Sindlev, Ms. Luisa Puche, Renovaro’s Chief Financial Officer and Francois Binette, Renovaro’s Chief Operating Officer, and representatives of GEDi Cube, including Ms. Storms, GEDi Cube representatives including incoming Chief Executive Officer, and Rhys Tombling, GEDi Cube’s Finance Director throughout late June 2023 and early July 2023.

During late June 2023 and early July 2023, Dr. Dybul had discussions with the senior management of a biotech company (“Party A”) with, among other assets, advanced pre-clinical potential mRNA vaccines for two infectious diseases with sizeable potential commercial markets. Party A was in the midst of a sale process and was looking to sell, license or otherwise partner these products to Renovaro. Because of the market size and complementarity to Renovaro’s pipeline, on July 6, 2023, management began working on strategies to secure funding of Renovaro’s acquisition of Party A and discussions were held with potential investor relations consultants regarding such strategies.

During early July 2023, there were many discussions among Renovaro management, Mr. Sindlev, Gregg Alton, a member of the Renovaro Board and K&L regarding Party A and the ability to finance the acquisition of the specified pipelines.

On July 10, 2023, Dr. Dybul wrote to representatives of GEDi Cube to request certain additional information regarding GEDi Cube. Ms. Storms provided a response to that request via email on July 10, 2023, which included discussions of the preparation of a confidentiality agreement and a preliminary term sheet for a possible business combination.

On July 15, 2023, Mr. Sindlev had a further communication with Ms. Storms regarding the terms of the potential business combination.

On July 16, 2023, members of Renovaro’s management had communications with the K&L team to discuss matters related to the structure of the potential business combination and due diligence of GEDi Cube.

Renovaro and GEDi Cube entered into a mutual confidentiality disclosure agreement, effective as of July 17, 2023 (the “NDA”), to enable the parties to engage in confidential discussions in respect of a potential negotiated business arrangement between the parties. The NDA did not contain standstill obligations.

On July 20, 2023, Renovaro provided a draft of a non-binding letter of intent to representatives of GEDi Cube (the “LOI”). The LOI proposed to combine Renovaro and GEDi Cube in an all-stock transaction. Among other terms, the LOI offered consideration of Renovaro Common Stock for each outstanding ordinary share of GEDi Cube such that GEDi Cube shareholders immediately prior to consummation of the proposed transaction would own approximately 50% of the combined company immediately following closing of the proposed transaction. The LOI also proposed a 120-day exclusivity period and that GEDi Cube would receive board representation on the combined company’s board of directors.

On July 20, 2023, Dr, Dybul, Ms. Storms and Mr. Tombling had a call to discuss the LOI in which they requested the clarification that the 50% ownership was on a fully-diluted basis.

On July 21, 2023 Renovaro management sent the Renovaro Board the draft letter of intent, including the request for the 50% ownership on a fully diluted basis, and a presentation prepared by GEDi Cube about the company and called a meeting of the Renovaro Board on July 25, 2023 to discuss.

On July 25, 2023, the Renovaro Board had a telephonic board meeting at which members of Renovaro management and representatives of K&L were present. Dr. Dybul updated the Renovaro Board on the potential strategic opportunities for Renovaro. Dr. Dybul informed the Renovaro Board that Renovaro had been deemed ineligible for a grant Renovaro had been pursuing because of its limited cash reserves and other issues. Dr. Dybul advised the Renovaro Board on the discussions with Party A and that management had not yet been able to identify financing to proceed with the acquisition of Party A’s pipelines. Dr. Dybul also advised the Renovaro Board on the potential opportunity with GEDi Cube, including GEDi Cube’s technology, senior management, possible synergies, strategic rationale and considerations in evaluating a potential business combination transaction. The Renovaro Board and management also discussed the terms of the LOI. A representative of K&L provided the Renovaro Board with an overview of the terms of the LOI. Following discussion, the Renovaro Board directed management to continue negotiations on the July LOI with GEDi Cube on the terms previously reviewed by and discussed with the Renovaro Board at the meeting. In addition, the Renovaro Board approved the change in the Company’s name to Renovaro Biosciences Inc.

On July 26, 2023, there was a joint meeting of the senior scientific consultants and management of Renovaro and GEDi Cube to explore areas of synergy. The Renovaro team was impressed with the depth of experience and knowledge of the GEDi Cube team and identified clear areas to mutually reinforce each of Renovaro’s platforms as well as areas for collaboration to develop novel approaches across the companies. There were additional post-meeting interactions between senior members of each team to discuss further.

On July 28, 2023, the Renovaro Board had a telephonic meeting at which Dr. Dybul informed of the additional diligence conversations that had taken place with GEDi Cube management and that GEDi Cube had expressed an interest in executing the LOI previously presented to the Renovaro Board. The Renovaro Board authorized Dr. Dybul to execute the LOI.

On August 1st, Dr. Dybul and Karen Brink, a director of GEDi Cube, executed the LOI.

Between August 1, 2023 and August 6, 2023, representatives of Renovaro and GEDi Cube, along with input from a third-party publication relations firm, discussed the contents of the public announcement of the entry into the LOI.

On August 8, 2023 and August 9, 2023, Dr. Dybul, Mr. Sindlev, representatives from K&L, Ms. Storms, Mr. Rhodes and Mr. Tombling met in person in Cannes, France where the parties discussed the status of the parties’ confirmatory diligence, negotiation of the definitive agreement, and the expected communications regarding announcement of the execution of the LOI and the proposed transaction as well as the short-term working capital needs of GEDi Cube and the possibility of Renovaro lending funds to GEDi Cube to meet those needs. On August 9, 2023, Renovaro issued a press release announcing the entry into the LOI.

On August 10, 2023, Dr. Dybul circulated to the Renovaro Board a written consent for the approval of a loan of up to $1.1 million to GEDi Cube for its short-term working capital needs. On August 10th, the Renovaro Board approved a loan of up to $1.1 million to GEDi Cube. On August 11th, Renovaro loaned GEDi Cube $550,000, as evidenced by a six-month promissory note, and on August 18th, Renovaro loaned GEDi Cube $500,000, evidenced by a second six-month promissory note.

Between August 11, 2023 and August 20, 2023, Dr. Dybul, Mr. Sindlev and representatives from K&L had various discussions on the confirmatory due diligence process and the expected timeline for the execution of a definitive agreement. On August 22, 2023, the Renovaro Board held a telephonic board meeting at which they discussed the Transaction and formed a transaction committee of Mr. Alton, Jayne McNicol, a Renovaro Board member, and Mr. Sindlev (the “Transaction Committee”).

On August 29, 2023, K&L sent Greenberg Traurig, P.A. (“Greenberg”), counsel to GEDi Cube, an initial draft of a definitive agreement. Among other things, the draft Stock Purchase Agreement provided for (i) representations and warranties and interim operating covenants customary for transactions of this type, (ii) largely reciprocal non-solicitation restrictions prohibiting either party from soliciting or engaging in discussions with competing bidders, and (iii) a termination right, exercisable by either party, if the Transaction had not closed by February 28, 2024. K&L also provided a draft of the Stock Purchase Agreement to the Transaction Committee and received comments from the Transaction Committee thereon.

During the period from August 30, 2023 through September 28, 2023, representatives and advisors of Renovaro and GEDi Cube reviewed due diligence materials provided by the other party and engaged in business, financial and legal due diligence discussions with representatives and advisors of the other party and submitted a number of requests for supplemental due diligence information. The mutual diligence was focused on assessing potential synergies and risks for the combined company, legal and compliance matters, intellectual property matters and accounting matters.

On September 10, 2023, Renovaro management received a due diligence report it had independently contracted for from an AI expert on the GEDi Cube technology (the “Due Diligence Report”).

On September 11, 2023, Greenberg sent a revised draft of the Stock Purchase Agreement to K&L, which, among other things, (i) provided for reciprocal representations and warranties, interim operating covenants, closing conditions and indemnification obligations of Renovaro, and (ii) added an expense reimbursement obligation of Renovaro for the cost of the completion of the GEDi Cube audit of its 2022 financial statements.

From September 11, 2023, through September 28, 2023, representatives of K&L, with input from the Renovaro Transaction Committee and Renovaro management, and GEDi Cube’s representatives and representatives of Greenberg exchanged drafts and participated in discussions regarding the terms of the definitive agreement, the registration rights agreement and related documents.

On September 27, 2023, the Renovaro Board held a meeting at which members of Renovaro management and representatives of K&L were present. Representatives from K&L reviewed with members of the Renovaro Board the status of due diligence and the status of the negotiations on the definitive agreement, including the probability that less than 100% of the shareholders of GEDi Cube would sign the definitive agreement, but that the Stock Purchase Agreement would contain a condition to closing that 100% of the stockholders sign joinders prior to closing. The Renovaro Board asked questions and provided feedback and direction to Renovaro management on these matters. Dr. Dybul provided a summary to the Renovaro Board of the information contained in a valuation report which GEDi Cube obtained on the valuation of itself as well as a summary of the conclusions of the Due Diligence Report. The Renovaro Board asked questions of Dr. Dybul regarding these diligence matters. Representatives of K&L then discussed, in response to questions from the Renovaro Board, certain financial terms of the Stock Purchase Agreement (including the 50%/50% split of the ownership of the post-closing combined entity and the possible change in the Renovaro stock price between signing of the LOI and closing). After discussion, the Renovaro Board directed management to continue negotiation of the Stock Purchase Agreement and that the Renovaro Board would reconvene to consider the revised definitive agreement.

On September 28, 2023, the Renovaro Board held a meeting at which members of Renovaro management and representatives of K&L were present. Representatives from K&L reviewed with members of the Renovaro Board the status of the negotiations on the definitive agreement. After discussion and consideration of the definitive agreement, the members of the Renovaro Board present at the meeting unanimously approved the terms of the Stock Purchase Agreement and the other transactions contemplated by the Stock Purchase Agreement and directed Renovaro management to execute the Stock Purchase Agreement.

In the evening of September 28, 2023, Renovaro, GEDi Cube and GEDi Cube shareholders holding 77.5% of the outstanding GEDi Cube Shares executed the Stock Purchase Agreement.

On September 29, 2023, Renovaro and GEDi Cube issued a joint press release announcing the parties’ entry into the Stock Purchase Agreement.

On November 17, 2023, Renovaro received an executed joinder by a GEDi Cube shareholder who owns 16.7% of the outstanding GEDi Cube Shares.

On December 20, 2023, Renovaro, GEDi Cube and the shareholders party to the Stock Purchase Agreement executed a First Amendment to Stock Purchase Agreement, which is attached as Annex A-II to this proxy statement, pursuant to which the parties agreed that the 1 million shares of Common Stock issued to Avram Miller pursuant to the Miller Consulting Agreement would not be counted for the calculation of the Closing Consideration as well as to correct the definition of “Shareholder Approval”.

Reasons for the Transaction

At a meeting held on September 28, 2023, among other things, the Renovaro Board unanimously (i) determined that the Transaction and the other transactions contemplated by the Stock Purchase Agreement are fair to, advisable and in the best interests of Renovaro and its stockholders, (ii) approved and declared advisable the Stock Purchase Agreement and the transactions contemplated thereby, including the issuance of shares of Common Stock to the Sellers, and (iii) determined to recommend, upon the terms and subject to the conditions set forth in the Stock Purchase Agreement, that the stockholders approve the Share Issuance Proposal and the Authorized Share Proposal, each of which is required to consummate the Transaction.

In reaching its decision to approve the Stock Purchase Agreement and the transactions contemplated thereby, including the Transaction, the Renovaro Board considered a number of factors that it viewed as supporting this decision, including:

The Renovaro Board also reviewed the terms and conditions of the Stock Purchase Agreement and concluded that such terms and conditions were reasonable under the circumstances:

In the course of its deliberations and in addition to the analyses and recommendation of the Renovaro Board, the Renovaro Board also considered a variety of risks and other countervailing factors related to entering into the Transaction, including:

After evaluating the proposed Transaction and taking into account all of the factors previously discussed and considered by the Renovaro Board, the Renovaro Board unanimously approved the Transaction and authorized management to negotiate and enter into definitive agreements on terms consistent in material respects with the terms presented to the Renovaro Board. In making its determination, the Renovaro Board considered the range of percentages of the combined company that would be held by Renovaro stockholders, the existing business and future business prospects of GEDi Cube, the overall structure of the Transaction, the terms of the Stock Purchase Agreement and the factors and considerations described above.

The foregoing information and factors considered by the Renovaro Board are not intended to be exhaustive but are believed to include the material factors considered by the Renovaro Board in its decision to approve the Stock Purchase Agreement and the transactions contemplated thereby. The Renovaro Board viewed its recommendation to approve the Transaction as being based upon its business judgment in light of Renovaro’s financial position and the totality of the information presented and considered, and the overall effect of the Transaction on the stockholders of Renovaro compared to other alternatives. In view of the wide variety of factors considered in connection with its evaluation of the Transaction and the complexity of these matters, the Renovaro Board did not find it useful, and did not attempt, to quantify, rank or otherwise assign relative weights to these factors. In considering the factors described above, individual members of the Renovaro Board may have given different weight to different factors. The Renovaro Board conducted an overall consideration of the factors described above, including discussions with, and questioning of, Renovaro’s management and Renovaro’s legal advisors, and considered the factors overall to be favorable to, and to support, its determination.

Interests of the Renovaro Directors and Executive Officers in the Transaction

In considering the recommendation of the Renovaro Board with respect to the Share Issuance Proposal and the other matters to be acted upon by the Renovaro stockholders at the Special Meeting, the Renovaro stockholders should be aware that certain members of the Renovaro Board, and certain executive officers of Renovaro, have interests in the Transaction that may be different from, or in addition to, the interests of the Renovaro stockholders. Members of the Renovaro Board were aware of and considered these interests, among other matters, in evaluating and negotiating the Stock Purchase Agreement and the Transaction, and in recommending to Renovaro’s stockholders to vote in favor of the proposals outlined herein.

These interests relate to or arise from, among other things:

See “Proposal 3: Approval of the Repricing of Outstanding Stock Options Granted under the Enochian BioSciences Inc. 2019 Equity Incentive Plan and the Renovaro Biosciences Inc. 2023 Equity Incentive Plan—Eligible Option Holders” for additional information regarding the Eligible Options (as defined below) held by Renovaro’s executive officers that may be subject to the Option Repricing.

Ownership Interests

As of December 29, 2023, Renovaro’s current directors and executive officers held, in the aggregate, approximately 21.00% of the outstanding shares of Renovaro’s capital stock and 20.18% of the outstanding shares of Common Stock (in each case, which excludes any shares of Common Stock issuable upon exercise or settlement of outstanding stock options or restricted stock units under the Plans and outstanding warrants held by such individuals).

Executive Officers Following the Closing

The current executive officers of Renovaro are expected to continue as executive officers of the combined company following the Closing, which includes the following individuals:

Director Positions Following the Closing

Mark R. Dybul, M.D., currently the Chief Executive Officer of Renovaro and a member of the Renovaro Board, will continue as the Chief Executive Officer and a director of the combined company after the Closing. In addition, pursuant to the Stock Purchase Agreement, the board of directors of the combined company effective as of the Closing will include, of the nine total directors serving thereon, four persons designated by Renovaro (at least three of whom must qualify as an “independent director” under Nasdaq Listing Rules). Accordingly, it is expected that certain of Renovaro’s current directors will continue to serve on the board of directors of the combined company following the Closing.

Indemnification and Insurance

Under the terms of the Stock Purchase Agreement, at or prior to the Closing, Renovaro must provide to each director appointed to service on the board of directors of the combined company following the Closing a customary director indemnification agreement, in form and substance reasonably acceptable to such director, to be effective upon the later of the Closing or the date of such director’s appointment.

For a discussion of the indemnification and insurance provisions related to the Renovaro directors and officers under the Stock Purchase Agreement, please see the section titled “The Stock Purchase Agreement—Indemnification” beginning on page 73 below.

Federal Securities Law Consequences

The issuance of Common Stock in the Transaction to Renovaro stockholders will be effected by means of a private placement, which is exempt from registration under the Securities Act, in reliance on Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D or Regulation S promulgated thereunder, and such shares will be “restricted securities.” The shares issued in connection with the Transaction will not be registered under the Securities Act upon issuance and will not be freely transferable. Holders of such shares may not sell their respective shares unless the shares are registered under the Securities Act or an exemption is available under the Securities Act. Upon the consummation of the Transaction, Renovaro will enter into a registration rights agreement with each Seller granting to each such Seller certain customary registration rights with respect to such Seller’s shares of Common Stock acquired in the Transaction, as described in further detail under “Agreements Related to the Transaction—Registration Rights Agreement” beginning on page 76 of this proxy statement.

Material U.S. Federal Income Tax Consequences of the Transaction

Regardless of whether the Transaction will qualify for U.S. federal income tax purposes as a reorganization within the meaning of Section 368(a) of the Code, the Transaction will not result in any taxable gain or loss for U.S. federal income tax purposes to Renovaro, GEDi Cube or any Renovaro stockholder in his, her or its capacity as a Renovaro stockholder.

The foregoing discussion is for general information purposes only and is not intended to be a complete analysis or description of all potential U.S. federal income tax consequences of the Transaction. In addition, the discussion does not address tax consequences that may vary with, or are contingent on, your individual circumstances. Moreover, the discussion does not address any non-income tax or any non-U.S., state or local tax consequences of the Transaction. Accordingly, you are strongly encouraged to consult with your own tax advisor as to the tax consequences of the Transaction in your particular circumstances, including the applicability and effect of the alternative minimum tax and any state, local or non-U.S. and other tax laws and of changes in those laws.

Regulatory Approvals

Renovaro must comply with applicable federal and state securities laws and the rules and regulations of Nasdaq in connection with the issuance of shares of the Common Stock in the Transaction and the filing of this proxy statement with the SEC. Renovaro does not intend to seek any regulatory approval from antitrust authorities to consummate the Transaction.

Anticipated Accounting Treatment

Renovaro will apply the acquisition method of accounting for business combinations in accordance with U.S. GAAP to the Transaction. Under the acquisition method of accounting, Renovaro will record the acquisition based on the fair value of the consideration given, which includes the market value of its shares of Common Stock issued in connection with the Transaction (based on the closing price of the Common Stock as reported on Nasdaq on the effective date of the Closing). Renovaro will allocate the purchase price to the identifiable assets acquired and liabilities assumed based on their respective fair values at the date of the Closing. Any excess of the value of consideration paid over the aggregate fair value of those net assets will be recorded as goodwill.

Appraisal Rights

Under the General Corporation Law of the State of Delaware, Renovaro stockholders are not entitled to appraisal rights in connection with the Transaction.

THE STOCK PURCHASE AGREEMENT

The following is a summary of selected provisions of the Stock Purchase Agreement. While Renovaro believes that this description covers the material terms of the Stock Purchase Agreement, it may not contain all of the information that is important to you. The Stock Purchase Agreement and the First Amendment to Stock Purchase Agreement have been attached as Annexes A-I and A-II to this proxy statement to provide you with information regarding the terms of the Stock Purchase Agreement. They are not intended to provide any other factual information about Renovaro, GEDi Cube or the Sellers. The following description does not purport to be complete and is qualified in its entirety by reference to the Stock Purchase Agreement, including the First Amendment to Stock Purchase Agreement. You should refer to the full text of the Stock Purchase Agreement, including the First Amendment to Stock Purchase Agreement, for details of the Transaction and the terms and conditions thereof.

The Stock Purchase Agreement contains representations and warranties that Renovaro, on the one hand, and GEDi Cube and the Sellers, on the other hand, have made to one another as of specific dates. These representations and warranties have been made for the benefit of the other parties to the Stock Purchase Agreement and may be intended not as statements of fact but rather as a way of allocating certain risks to one of the parties if those statements prove to be incorrect. In addition, the assertions embodied in the representations and warranties are qualified by information in confidential disclosure schedules exchanged by the parties in connection with signing the Stock Purchase Agreement. While Renovaro does not believe that these disclosure schedules contain information required to be publicly disclosed under applicable securities laws, other than information that has already been so disclosed, the disclosure schedules do contain information that modifies, qualifies and creates exceptions to the representations and warranties set forth in the Stock Purchase Agreement. Accordingly, you should not rely on the representations and warranties as current characterizations of factual information about Renovaro, GEDi Cube or the Sellers, because they were made as of specific dates, may be intended merely as a risk allocation mechanism between Renovaro, on the one hand, and GEDi Cube and the Sellers, on the other hand, and are modified by the disclosure schedules.

The Transaction and Effective Time of the Transaction

The Stock Purchase Agreement provides that, at the Effective Time, the Sellers will sell and transfer to Renovaro, and Renovaro will purchase and acquire from the Sellers, all of the GEDi Cube Shares owned by the Sellers that are issued and outstanding as of immediately prior to the Effective Time in exchange for the Exchange Consideration, as described below. The Closing will occur as soon as practicable but no later than three (3) business days after the satisfaction or waiver of the last to be fulfilled of the closing conditions set forth in the Stock Purchase Agreement, or at such other date and place as Renovaro, GEDi Cube and the Sellers may agree to in writing. The Transaction will be deemed effective as of the closing of business on the Closing Date (which is referred to herein as the “Effective Time”). Renovaro expects that the Closing will take place during the first half of 2024, subject to satisfying the closing conditions set forth in the Stock Purchase Agreement, including the approval by Renovaro’s stockholders of the Share Issuance Proposal and the Authorized Share Proposal. Because the Closing is subject to such conditions, Renovaro cannot predict if or exactly when the Closing will occur.

Exchange Consideration

If the Transaction is consummated, in exchange for the sale and transfer of the issued and outstanding GEDi Cube Shares to Renovaro, the Sellers shall become entitled to receive from Renovaro (i) an aggregate number of shares of Common Stock equal to a specified percentage of the shares of Common Stock issued and outstanding as of the Effective Time (minus (a) 1 million shares of Common Stock issued to a consultant assisting with the Transaction and (b) 1 million shares of Common Stock issued to Avram Miller prior to the Closing pursuant to the Miller Consulting Agreement), which percentage shall be a ratio of the aggregate number of GEDi Cube Shares owned by the Sellers divided by the aggregate number of GEDi Cube Shares issued and outstanding, in each case, as of the Effective Time (which is referred to herein as the “Closing Consideration”), and (ii) earn-out shares of Common Stock to be issued pro rata to the Sellers upon the exercise or conversion of any of Renovaro’s derivative securities (subject to certain exceptions) which are outstanding at the Effective Time (which is referred to herein as the “Earnout Shares” and, together with the Closing Consideration, the “Exchange Consideration”). The aggregate number of Earnout Shares to be issued to the Sellers will be equal to a percentage of the shares of Common Stock issued upon exercise or conversion of Renovaro’s derivative securities, which percentage shall be a ratio of the aggregate number of GEDi Cube Shares owned by the Sellers divided by the aggregate number of GEDi Cube Shares issued and outstanding, in each case, as of the Effective Time. Each Seller will receive its pro rata portion of the Exchange Consideration based on such Seller’s pro rata ownership of the GEDi Cube Shares transferred to Renovaro.

Immediately following the Closing, the Sellers are expected to own approximately 49% of the issued and outstanding shares of Common Stock (before giving effect to the issuance of the Earnout Shares).

Fractional Shares

No fractional shares of Common Stock will be issued in connection with the Transaction, and no cash will be paid for fractional shares. Any fractional shares of Common Stock that a Seller would otherwise be entitled to receive will be rounded down to the nearest whole share.

Renovaro Stock Approval; Increase in Authorized Shares

The Stock Purchase Agreement provides that it is a condition to the parties’ obligation to consummate the Transaction that the Renovaro stockholders have approved, at the Special Meeting, the Share Issuance Proposal and the Authorized Share Proposal, as described in this proxy statement. Upon approval by the Renovaro stockholders of the amendment to the Certificate of Incorporation effecting the increase in the number of authorized shares of Common Stock, Renovaro will file such amendment to its Certificate of Incorporation with the Secretary of State of the State of Delaware to be effective upon the Effective Time. Pursuant to the terms of the Stock Purchase Agreement, Renovaro will also amend its Certificate of Incorporation, effective as of the Effective Time, to change its name to “Renovaro AI” and to provide for the changes to the size and structure of the post-Closing board of directors of Renovaro as contemplated by the Stock Purchase Agreement (discussed in further detail below under “—Board of Directors and Officers of the Combined Company”).

Surrender of GEDi Cube Shares

At the Closing, each Seller will deliver to Renovaro an executed share transfer form in respect of the GEDi Cube Shares to be transferred to Renovaro and the certificate(s) representing such shares. In the event that any such certificate is lost, stolen or destroyed, in lieu of delivery thereof to Renovaro, the Seller may instead deliver to Renovaro a statutory declaration of lost certificate and an indemnity of loss in form and substance reasonably acceptable to Renovaro and GEDi Cube, which may, in the reasonable discretion of Renovaro, include a requirement that such Seller deliver a bond in such sum as Renovaro may reasonably direct as indemnity against a claim that may be made against Renovaro or GEDi Cube with respect to the GEDi Cube Shares represented by the lost, stolen or destroyed certificate.

Board of Directors and Officers of the Combined Company

The Stock Purchase Agreement obligates the parties to take all necessary action so that, effective as of the Closing, the combined company’s board of directors will consist of nine (9) individuals, including the Chief Executive Officer of Renovaro, four (4) additional persons designated by Renovaro (at least three (3) of whom must qualify as an “independent director” under Nasdaq Listing Rules) and four (4) additional persons designated by GEDi Cube (at least two (2) of whom must qualify as an “independent director” under Nasdaq Listing Rules); provided that the combined company’s board of directors as so composed must meet all diversity and other requirements under applicable law and Nasdaq Listing Rules. The board of directors of GEDi Cube immediately after the Closing shall be composed of the same individuals as the combined company’s board of directors as of the Closing.

The Stock Purchase Agreement does not address the composition of the combined company’s executive officers following the Closing. Renovaro expects that the current executive officers of Renovaro will continue, immediately following the Closing, as the executive officers of the combined company, including Mark R. Dybul, M.D. as Chief Executive Officer, Luisa Puche as Chief Financial Officer and Corporate Secretary and François Binette as Chief Operating Officer and Executive Vice President for Research & Development.

Representations and Warranties

The Stock Purchase Agreement contains generally similar representations and warranties of Renovaro with respect to Renovaro and of GEDi Cube and the Sellers with respect to GEDi Cube regarding:

In addition, the Stock Purchase Agreement contains further representations and warranties of Renovaro as to, among other things:

In addition, each Seller represents and warrants as to the following matters with respect to such Seller:

The representations and warranties have been made solely for the benefit of the parties in connection with the Stock Purchase Agreement and are not intended to be relied upon by any other person, including the stockholders of Renovaro. In addition, the representations and warranties are qualified by specific disclosures made to the other parties in connection with the Stock Purchase Agreement and should not be relied upon by any other person as current characterizations of factual information about Renovaro, GEDi Cube or the Sellers. Moreover, many of the representations and warranties are subject to materiality and knowledge qualifications contained in the Stock Purchase Agreement and are made only as of the date of the Stock Purchase Agreement or such other date as is specified in the Stock Purchase Agreement.

Covenants; Conduct of Business Pending the Transaction

Under the Stock Purchase Agreement, each of Renovaro and GEDi Cube has agreed, during the period from the date of the Stock Purchase Agreement and continuing until the earlier of the termination of the Stock Purchase Agreement or the Closing (the “Interim Period”), except as set forth in the Stock Purchase Agreement or unless the other party consents in advance in writing, to carry on its business in the ordinary course consistent with past practice, continue to observe its obligations to comply with applicable legal and regulatory requirements, and use commercially reasonable efforts to, subject to certain exceptions:

In addition, each of Renovaro and GEDi Cube has agreed, during the Interim Period, except as set forth in the Stock Purchase Agreement or unless the other party consents in advance in writing, not to take any of the following actions, among others:

In addition, GEDi Cube has further agreed, during the Interim Period, except as set forth in the Stock Purchase Agreement or unless Renovaro consents in advance in writing, not to issue, grant, sell, dispose of or propose to do any of the foregoing with respect to any equity interests, other securities or rights to acquire or sell any equity interests or other securities of GEDi Cube or engage in any hedging transactions with respect to such securities.

In addition, each Seller has agreed that, during the Interim Period, such Seller will not sell, transfer or dispose of any GEDi Cube Shares owned by such Seller unless the transferee thereof becomes a party to the Stock Purchase Agreement as a Seller and executes and delivers each document required to be delivered by such transferee as a Seller under the Stock Purchase Agreement.

Renovaro and GEDi Cube also agreed to (i) confer with the other party (and, in the case of GEDi Cube, the Sellers) and its representatives about operations and integration matters to the extent permitted by law, (ii) notify the other party in writing promptly after becoming aware of any event that would cause or constitute a material breach of any of the representations and warranties of such party and use commercially reasonable efforts to remedy such breach; (iii) promptly notify the other party if it fails to comply with or satisfy any of its covenants in the Stock Purchase Agreement in any material respect; (iv) promptly notify the other party of any change in the normal course of any business, operations or financial condition of such party or its respective assets or properties or any emergency related to the same; and (v) afford the other party (and, in the case of GEDi Cube, the Sellers) and its representatives reasonable access during normal business hours during the Interim Period to all information concerning the business, properties and personnel of such party, as may be requested by the other party to complete the Transaction and prepare for post-closing transition of GEDi Cube’s business.

Additional Agreements

Each of Renovaro and GEDi Cube has agreed to use its commercially reasonable efforts to (i) apply for or otherwise seek, or obtain the consents (if any) of, or provide notice to, a third party or governmental entity required to be obtained or provided in connection with the Transaction (including, with respect to Renovaro, the approval by the Renovaro stockholders of the Share Issuance Proposal and the Authorized Share Proposal); (ii) make any filings required with respect to the consummation of the Transaction; (iii) effect the Transaction and fulfill or cause to be fulfilled the conditions to Closing under the Stock Purchase Agreement; and (iv) defend against any proceedings challenging the Stock Purchase Agreement and the consummation of the Transaction, seeking to have any preliminary injunction, temporary restraining order, stay or other legal restraint or prohibition entered or imposed by any court or other governmental entity that is not yet final and nonappealable, vacated or reversed.

GEDi Cube and the Sellers further agreed that:

Exclusivity

Each of Renovaro, on the one hand, and GEDi Cube and the Sellers, on the other hand, agreed to not, and to cause their respective representatives to not, subject to certain exceptions under the Stock Purchase Agreement, during the Interim Period:

Each of Renovaro, on the one hand, and GEDi Cube and the Sellers, on the other hand, agreed to notify the other parties or party as promptly as practicable (but in any event within three (3) business days) in writing of the receipt of (i) any bona fide inquiries, proposals or offers, requests for information or requests for discussions or negotiations regarding or constituting any Acquisition Proposal or any bona fide inquiries, proposals or offers, requests for information or requests for discussions or negotiations that could be expected to result in an Acquisition Proposal and (ii) any request for non-public information relating to Renovaro or GEDi Cube, as applicable, or its affiliates in connection with any Acquisition Proposal.

For purposes of the Stock Purchase Agreement, an “Acquisition Proposal” means any inquiry, proposal or offer or any indication of interest in making an offer or proposal from any person or group at any time relating to any of the following, as applicable:

Renovaro Special Meeting and Proxy Statement

Renovaro is obligated under the Stock Purchase Agreement to use its reasonable best efforts to obtain approval of its stockholders at the Special Meeting, and to take all action necessary or advisable to secure the required vote or consent of its stockholders to approve the Share Issuance Proposal and the Authorized Share Proposal. For such purpose, Renovaro was required to prepare and file with the SEC a notice of meeting and this proxy statement relating to the Special Meeting. If the Authorized Share Proposal is approved, Renovaro is further obligated to amend its Certificate of Incorporation promptly after the Special Meeting and prior to the Closing to reflect the amendment so approved by its stockholders.

Indemnification and Insurance of Directors and Officers

The Stock Purchase Agreement provides that all rights to exculpation, indemnification and advancement of expenses existing in favor of any current or former directors and officers of Renovaro or GEDi Cube and each person who served as a director, officer, member, trustee or fiduciary of another corporation, partnership, joint venture, trust, pension or other employee benefit plan or enterprise at the request of Renovaro or GEDi Cube (collectively, the “D&O Indemnified Persons”) as provided in their respective organizational documents or under any indemnification, employment or similar agreements between any such D&O Indemnified Person and Renovaro or GEDi Cube, as applicable, in each case as in effect on the date of the Stock Purchase Agreement, shall survive the Closing and continue in full force and effect in accordance with their terms to the extent permitted by applicable law. Each of Renovaro and GEDi Cube agree to cause their respective organizational documents to contain, for a period of six (6) years following the Closing, provisions no less favorable with respect to exculpation and indemnification of and advancement of expenses to D&O Indemnified Persons than are set forth in their respective organizational documents as of the date of the Stock Purchase Agreement to the extent permitted by applicable law. The Stock Purchase Agreement further provides that Renovaro will amend its directors’ and officers’ insurance policy in form reasonably satisfactory to GEDi Cube to provide to the members of the combined company’s board of directors and any new officers of Renovaro appointed after the date of the Stock Purchase Agreement with at least as favorable terms and scope of coverage as its directors’ and officers’ insurance policy in existence as of the date of the Stock Purchase Agreement.

Conditions to Completion of the Transaction

The obligation of Renovaro, on the one hand, and the Sellers and GEDi Cube, on the other hand, to consummate the Transaction is subject to certain customary conditions, unless otherwise waived, including the following:

In addition, the obligation of Renovaro to consummate the Transaction is subject to the following additional conditions, unless waived by Renovaro:

In addition, the obligation of GEDi Cube and the Sellers to consummate the Transaction is subject to the following additional conditions, unless waived by GEDi Cube:

Indemnification

The Stock Purchase Agreement provides that each Seller will indemnify Renovaro and its respective officers, directors, agents, consultants, advisors, representatives and equity holders (each, a “Buyer Indemnified Person” and, collectively, “Buyer Indemnified Persons”) from all documented and out-of-pocket costs, expenses, losses or damages incurred by Buyer Indemnified Persons arising out of, relating to or resulting from:

Each Seller shall only be liable to Buyer Indemnified Persons for indemnification with respect to breaches of representations and warranties or claims under the third matter identified above with respect to claims by third parties in proportion to such Seller’s pro rata portion such losses based on such Seller’s pro rata ownership of the GEDi Cube Shares to be transferred to Renovaro. No Seller shall have any liability to a Buyer Indemnified Person with respect to a breach of representation, warranty or covenant under the Stock Purchase Agreement to the extent that Renovaro knew of such breach as of the Closing.

The Stock Purchase Agreement provides that Renovaro will indemnify each Seller and its respective officers, directors, agents, consultants, advisors, representatives and equity holders, and successors and assigns (each, a “Seller Indemnified Person” and, collectively, “Seller Indemnified Persons”) from all documented and out-of-pocket costs, expenses, losses or damages incurred by Seller Indemnified Persons arising out of, relating to or resulting from:

Renovaro shall have no liability to a Seller Indemnified Person with respect to a breach of representation, warranty or covenant under the Stock Purchase Agreement to the extent that the Sellers knew of such breach as of the Closing.

The Stock Purchase Agreement provides for customary survival periods and limitations on the parties’ respective indemnification obligations, including the following (subject, in all cases, to fraud by the indemnifying party and the other exceptions described below):

Termination

The Stock Purchase Agreement may be terminated by Renovaro or by GEDi Cube or the Sellers’ Representative upon written notice by such party under certain circumstances, including, among others:

In the event of termination, the Stock Purchase Agreement (other than certain provisions as set forth in the Stock Purchase Agreement) will become void and of no effect with no liability or obligation on the part of any party to the Stock Purchase Agreement or any of its officers or directors, except that no party will be relieved of any liability or damages arising from fraud or willful breach by such party of its representations, warranties or covenants in the Stock Purchase Agreement.

Fees and Expenses

Generally, each party will pay its own fees and expenses incurred in connection with the Stock Purchase Agreement, whether or not the Transaction is completed. However, the Stock Purchase Agreement provides that Renovaro will pay for all costs of GEDi Cube in connection with the preparation and audit of the consolidated financial statements of GEDi Cube included in this proxy statement.

AGREEMENTS RELATED TO THE TRANSACTION

Registration Rights Agreement

The Stock Purchase Agreement contemplates that, at the Closing, Renovaro and each of the Sellers will enter into a Registration Rights Agreement, pursuant to which, among other matters, Renovaro will agree to undertake certain shelf registration obligations in accordance with the Securities Act and each Seller will be granted customary demand and piggyback registration rights with respect to its shares of Common Stock acquired in the Transaction. The Registration Rights Agreement also provides that Renovaro will pay certain expenses related to such registrations and will indemnify the Sellers against certain liabilities arising from such registrations.

Under the Registration Rights Agreement, Renovaro further agrees to take such action as the Sellers may reasonably request, and to the extent required from time to time, to (i) enable such Sellers to sell their shares of Common Stock acquired in the Transaction without registration under the Securities Act within the limitation of the exemptions provided by Rule 144 under the Securities Act and, (ii) within two (2) business days of receipt of written notice from any Seller wishing to transfer or sell any of such Seller’s shares without registration under the Securities Act within the limitation of the exemption provided by Rule 144, provide, execute or deliver, as applicable, all notifications, certifications, legal opinions, instruction letters, and any other documents or instruments reasonably requested by such Seller or Renovaro’s transfer agent for such Seller to be able to sell or transfer such shares within the limitation of the exemption provided by Rule 144.

Promissory Notes

On August 11, 2023, and August 18, 2023, Renovaro entered into two Promissory Notes (the “Notes”) in the amounts $550,000 and $500,000, respectively, to lend a total of $1.05 million to GEDi Cube to further develop GEDi Cube’s intellectual property and technology, which will become part of the combined company following the Closing. Pursuant to the Notes, GEDi Cube promised to pay Renovaro the outstanding principal and related accrued interest at a rate of 6% per annum on the applicable maturity date, February 11 and February 18, 2024, respectively. The outstanding aggregate balance of the Notes at September 30, 2023, was $1,057,875.

MATTERS BEING SUBMITTED TO A VOTE OF RENOVARO’S STOCKHOLDERS

PROPOSAL 1:

Approval of the Issuance of Common Stock in the Transaction Nasdaq Listing Rule 5635

At the Special Meeting, Renovaro stockholders will be asked to approve the issuance of shares of Common Stock as the Exchange Consideration to the Sellers pursuant to the Stock Purchase Agreement. Based on the number of shares of Common Stock outstanding as of December 29, 2023 and the terms of the Stock Purchase Agreement governing the determination of the Closing Consideration, Renovaro estimates that, immediately following the Closing, the Sellers will own approximately 49% of the issued and outstanding shares of Common Stock (before giving effect to the issuance of the Earnout Shares). This percentage is subject to certain assumptions and may change prior to the Closing, including as a result of future changes in the number of shares of Common Stock outstanding prior to the Closing, the securityholders of GEDi Cube who become a party to the Stock Purchase Agreement and the Effective Time of the Transaction, see “The Stock Purchase Agreement—Exchange Consideration.” As a result, the stockholders of Renovaro and the securityholders of GEDi Cube immediately before the Effective Time of the Transaction could own a greater, or lesser, percentage amount of the outstanding shares of the combined company immediately after the Effective Time of the Transaction.

The terms of, reasons for, and other aspects of the Stock Purchase Agreement, the Transaction, and the issuance of the Exchange Consideration to the Sellers pursuant to the Stock Purchase Agreement, are described in detail in other sections of this proxy statement.

Reasons for Stockholder Approval

The Common Stock is listed on Nasdaq, and, as such, Renovaro is subject to the applicable Nasdaq Listing Rules, including Nasdaq Listing Rule 5635. In order to comply with the Nasdaq Listing Rules and to satisfy conditions under the Stock Purchase Agreement, Renovaro is seeking stockholder approval of this Proposal 1. Nasdaq Listing Rule 5635 requires stockholder approval in connection with the acquisition of the stock or assets of another company if, due to the present or potential issuance of common stock, the common stock of the issuer has or will have upon issuance voting power equal to or in excess of 20% of the voting power outstanding before the issuance of stock or securities convertible into or exercisable for common stock of the issuer.

Renovaro is seeking stockholder approval of the Share Issuance Proposal in order to satisfy the requirements of Nasdaq Listing Rule 5635 with respect to the issuance of the Common Stock in the Transaction in excess of the 20% of the voting power outstanding before the issuance.

The Stock Purchase Agreement requires Renovaro to submit this Proposal 1 to its stockholders at the Special Meeting. Approval of this Proposal 1 will constitute approval pursuant to the Nasdaq Listing Rules.

Dilution

If this Proposal 1 is approved, existing Renovaro stockholders will suffer significant dilution in ownership interests and voting rights as a result of the issuance of shares of Common Stock in the Transaction. In the case of the Transaction, the number of shares of Common Stock to be issued will be based on the number of issued and outstanding shares of Common Stock as of the Effective Time and the number of securityholders of GEDi Cube who join as Sellers under the Stock Purchase Agreement. This number would not give effect to any other future issuances of Common Stock. The sale into the public market of these shares could also materially and adversely affect the market price of the Common Stock.

Vote Required; Recommendation of the Renovaro Board

The affirmative vote of a majority of the votes cast in person or by proxy at the Special Meeting is required for approval of Proposal 1. A failure to submit a proxy card or vote at the Special Meeting, or an abstention for Proposal 1 will have no effect on the outcome of Proposal 1.

THE RENOVARO BOARD UNANIMOUSLY RECOMMENDS THAT RENOVARO’S STOCKHOLDERS VOTE “FOR” PROPOSAL 1 TO APPROVE THE ISSUANCE OF THE COMMON STOCK PURSUANT TO THE STOCK PURCHASE AGREEMENT UNDER THE NASDAQ LISTING RULES. THE APPROVAL OF EACH OF PROPOSALS 1 AND 2 IS REQUIRED TO CONSUMMATE THE TRANSACTION.

PROPOSAL 2:

Approval of Amendment to Renovaro’s Certificate of Incorporation to Increase the Number of Authorized Common Shares of Renovaro

On December 21, 2023, the Renovaro Board approved and declared advisable, subject to stockholder approval, an amendment to the Certificate of Incorporation to increase the total number of authorized shares of capital stock of Renovaro from one hundred ten million (110,000,000) to three hundred sixty million (360,000,000) and to increase the total number of authorized shares of Common Stock from one hundred million (100,000,000) to three hundred fifty million (350,000,000). The Certificate of Incorporation currently authorizes one hundred ten million (110,000,000) shares of capital stock of Renovaro, including one hundred million (100,000,000) shares of Common Stock and ten million (10,000,000) shares of preferred stock, par value $0.0001 per share (“Preferred Stock”). As of December 29, 2023, out of the authorized shares of Common Stock, 9,696,664 remained available for future issuance and 90,303,336 shares were issued or issuable, as follows:

For a description of the Convertible Notes, see Note 7 to Renovaro’s unaudited condensed consolidated financial statements for the quarter ended September 30, 2023, which are included in the First Quarter 2024 Form 10-Q.

As described in greater detail in the Share Issuance Proposal, Renovaro will be required to reserve approximately 82,389,720 shares of Common Stock for issuance as Exchange Consideration in connection with the Transaction pursuant to the terms of the Stock Purchase Agreement. As a result, even if Renovaro’s stockholders approve the Share Issuance Proposal, Renovaro will not have sufficient authorized shares of Common Stock for issuance of the Exchange Consideration, and the Transaction may not be completed unless this Proposal 2 is approved. In addition, approval of this Proposal 2 by the Renovaro stockholders is required to consummate the Transaction, unless waived by GEDi Cube. The proposed amendment to the Certificate of Incorporation would not increase or otherwise affect Renovaro’s authorized Preferred Stock. As of September 30, 2023, there were 561,010 shares of Series A Preferred Stock issued and outstanding.

The Common Stock is all of a single class, with equal voting, distribution, liquidation and other rights. The additional Common Stock to be authorized by adoption of the proposed amendment to the Certificate of Incorporation would have rights identical to Renovaro’s currently outstanding Common Stock. A copy of the amendment to the Certificate of Incorporation is attached as Annex B to this proxy statement. If Renovaro’s stockholders approve this Proposal 2, subject to the discretion of the Renovaro Board, Renovaro intends to file the amendment to the Certificate of Incorporation with the Secretary of State of the State of Delaware immediately prior to the Effective Time of the Transaction.

Purpose

After consideration and consultation with its senior management and its financial and legal advisors, the Renovaro Board determined that the Stock Purchase Agreement and the Transaction are advisable and in the best interests of Renovaro and its stockholders. The Renovaro Board considered various reasons to reach its determination, as discussed elsewhere in this proxy statement. The amendment to the Certificate of Incorporation as described in this Proposal 2 is necessary for Renovaro to have sufficient authorized shares of Common Stock to issue the Exchange Consideration to the Sellers under the Stock Purchase Agreement and stockholder approval of this Proposal 2 is a condition to the Sellers’ and GEDi Cube’s obligation to consummate the Transaction. At this time, Renovaro does not have any plans, commitments, arrangements, understandings or agreements regarding the issuance of Common Stock following the increase of its authorized shares, except as described in this Proposal 2.

Possible Effects of the Amendment

If the amendment to the Certificate of Incorporation to effect the increase in number of authorized shares of Common Stock is adopted and filed with the Secretary of State of the State of Delaware, the additional authorized shares of Common Stock would be available for issuance at the discretion of the Renovaro Board and without further stockholder approval, except as may be required by law or the rules of Nasdaq on which the Common Stock is listed. The additional authorized shares of Common Stock would have the same rights and privileges as the shares of Common Stock currently issued and outstanding. Holders of Common Stock have no preemptive rights. The issuance of additional shares of Common Stock is likely to, among other things, have a dilutive effect on earnings per share and on stockholders’ equity and voting rights. Furthermore, future sales of substantial amounts of Common Stock, or the perception that these sales might occur, could adversely affect the prevailing market price of the Common Stock or limit Renovaro’s ability to raise additional capital.

Vote Required; Recommendation of the Renovaro Board

The affirmative vote of a majority of the votes cast in person or by proxy at the Special Meeting is required for approval of Proposal 2. A failure to submit a proxy card or vote at the Special Meeting, or an abstention for Proposal 2 will have no effect on the outcome of Proposal 2.

THE RENOVARO BOARD UNANIMOUSLY RECOMMENDS A VOTE “FOR” THE APPROVAL OF THE AMENDMENT TO THE CERTIFICATE OF INCORPORATION OF RENOVARO TO INCREASE THE NUMBER OF AUTHORIZED SHARES OF COMMON STOCK. THE APPROVAL OF EACH OF PROPOSALS 1 AND 2 IS REQUIRED TO CONSUMMATE THE TRANSACTION.

PROPOSAL 3:

Approval of the Repricing of Outstanding Stock Options Granted under the Enochian BioSciences Inc. 2019 Equity Incentive Plan and the Renovaro Biosciences Inc. 2023 Equity Incentive Plan

Renovaro is seeking stockholder approval of a decrease in the exercise price (the “Option Repricing”) of outstanding stock options held by employees and consultants of Renovaro (“Eligible Participants”) covering up to an aggregate of 3,931,430 shares of Common Stock granted under the Plans, which currently have exercise prices above the closing price of the Common Stock as reported on Nasdaq (the “Reported Price”) on the date of the Closing (the “Repricing Date”). To qualify for the Option Repricing,

Eligible Participants must hold as of the Repricing Date options that: (i) were issued pursuant to the 2019 Plan or 2023 Plan, (ii) have a per share exercise price that is in excess of the Reported Price, and (iii) are outstanding and unexercised (the “Eligible Options”). Options held by Eligible Participants that have a per share exercise price that is in excess of the Reported Price will not be considered Eligible Options and will not be impacted by the Option Repricing in any manner.

On December 21, 2023, the Renovaro Board approved, upon the recommendation of the Compensation Committee of Renovaro, subject to the approval of the stockholders at the Special Meeting, the repricing of the Eligible Options, as of the Repricing Date to the Reported Price (the “Repriced Exercise Price”). In approving the Option Repricing, the Renovaro Board considered the impact of the current exercise prices of the stock options on the incentives provided to Renovaro’s employees and consultants, the lack of retention value provided by the current stock options, and the impact of such options on the capital structure of Renovaro. On December 21, 2023, the date on which the Renovaro Board approved the Option Repricing, the closing price of the Common Stock on Nasdaq was $3.34 per share.

There will be no other changes to the stock options outstanding under the Plans. The Renovaro Board has determined that the Option Repricing is in the best interest of Renovaro and its stockholders.

Specifics of the Option Repricing

Under the Option Repricing, on the Repricing Date, the Eligible Options held by Eligible Participants as of the Repricing Date will automatically be repriced to the Repriced Exercise Price without any action on the part of the Eligible Participants. If any holder of an Eligible Option ceases to be an employee or consultant, as applicable, with Renovaro before the Repricing Date, the holder’s Eligible Options will not be repriced on the Repricing Date. The following table provides information, as of December 29, 2023, regarding the Eligible Options eligible for the Option Repricing:

Option Repricing

The Renovaro Board has determined that adverse changes in the market price of the Common Stock since the Eligible Options were granted could materially interfere with Renovaro’s efforts to retain the service of employees and consultants. Therefore, the Renovaro Board recommends the Option Repricing to encourage an increasing alignment of employees’ and consultants’ interests with those of Renovaro’s stockholders and increased stake of Renovaro’s employees and consultants in the long-term performance and success of Renovaro. When the market price for the Common Stock is significantly below the applicable exercise price of a stock option (often referred to as “underwater” or “out-of-the-money” option), for example, the Renovaro Board believes that the option holder is not likely to exercise that stock option and will not have the desired incentive that the stock option was intended to provide.

Alternatives Considered

The Renovaro Board considered several alternatives in arriving at this Proposal 3, namely:

Eligible Option Holders

The Option Repricing, if approved, would benefit 62% of Renovaro’s employees, including Renovaro’s executive officers and one consultant. The following table lists, for each of our named executive officers, all of our current executive officers as a group, and all of our employees (other than our executive officers) as a group, the following information as of December 29, 2023: (i) the number of shares of Common Stock subject to Eligible Options and (ii) the per share weighted average exercise prices of the Eligible Options. Each holder of an Eligible Option must continue to be an employee or consultant of Renovaro, as applicable, through the Repricing Date in order to participate in the Option Repricing, and any such holder that terminates service with Renovaro before the Repricing Date will not have the holder’s Eligible Options repriced under the Option Repricing.

Accounting Treatment of the Option Repricing

Under Financial Accounting Standards Codification Topic 718, Renovaro will recognize any incremental compensation cost of the Eligible Options subject to the Option Repricing. Renovaro believes that the incremental compensation cost will be measured on the Repricing Date, if any, of the fair value of the repriced Eligible Options immediately following the Option Repricing over the fair value of the Eligible Options immediately prior to the Option Repricing.

Certain U.S. Federal Income Tax Consequences

Under U.S. federal tax laws, the repricing of an Eligible Option is treated as a new option granted as of the Repricing Date, including with respect to the incentive stock option rules. The rules concerning the federal income tax consequences with respect to options granted pursuant to the Plans are quite technical. Moreover, the applicable statutory provisions are subject to change, as are their interpretations and applications, which may vary in individual circumstances. Therefore, the following is designed to provide a general understanding of the U.S. federal income tax consequences with respect to such grants. In addition, the following discussion does not set forth any gift, estate, social security or state or local tax consequences that may be applicable and is limited to the U.S. federal income tax consequences to individuals who are citizens or residents of the United States, other than those individuals who are taxed on a residence basis in a non-U.S. country.

Incentive Stock Options

No taxable income is reportable when an incentive stock option is granted or exercised, although the exercise may subject the optionee to the alternative minimum tax or may affect the determination of the optionee’s alternative minimum tax (unless the shares are sold or otherwise disposed of in the same year). If the optionee exercises the option and then later sells or otherwise disposes of the shares acquired more than two years after the grant date and more than one year after the exercise date, the difference between the sale price and the exercise price will be taxed as capital gain or loss. If the optionee exercises the option and then later sells or otherwise disposes of the shares before the end of the two- or one-year holding periods described above, he or she generally will have ordinary income at the time of the sale equal to the fair market value of the shares on the exercise date (or the sale price, if less) minus the exercise price of the option. For purposes of the alternative minimum tax, the difference between the option exercise price and the fair market value of the shares on the exercise date is treated as an adjustment item in computing the optionee’s alternative minimum taxable income in the year of exercise. In addition, special alternative minimum tax rules may apply to certain subsequent disqualifying dispositions of the shares or provide certain basis adjustments or tax credits for alternative minimum tax purposes.

Nonqualified Stock Options

No taxable income is reportable when a nonstatutory stock option with a per share exercise price at least equal to the fair market value of a share of the underlying stock on the date of grant is granted to an optionee. Upon exercise, the optionee will recognize ordinary income in an amount equal to the excess of the fair market value (on the exercise date) of the shares purchased over the exercise price of the exercised shares subject to the option. Any taxable income recognized in connection with an option exercise by an employee is subject to tax withholding by Renovaro. Any additional gain or loss recognized upon any later disposition of the shares would be capital gain or loss to the optionee.

Tax Effect for Renovaro

Renovaro generally will be entitled to a tax deduction in connection with the repriced Eligible Options in an amount equal to the ordinary income realized by the holder at the time the holder recognizes such income (for example, the exercise of a nonstatutory stock option). Special rules limit the deductibility of compensation paid to Renovaro’s Chief Executive Officer and other “covered employees” within the meaning of Code Section 162(m). Under Code Section 162(m), the annual compensation paid to any of these specified employees will be deductible only to the extent that it does not exceed $1,000,000.

Vote Required; Recommendation of the Renovaro Board

The affirmative vote of a majority of the votes cast in person or by proxy at the Special Meeting is required for approval of Proposal 3. A failure to submit a proxy card or vote at the Special Meeting, or an abstention for Proposal 3 will have no effect on the outcome of Proposal 3.

THE RENOVARO BOARD UNANIMOUSLY RECOMMENDS A VOTE “FOR” APPROVAL OF THE Repricing of Outstanding Stock Options Granted under the Enochian BioSciences Inc. 2019 Equity Incentive Plan and the Renovaro Biosciences Inc. 2023 Equity Incentive Plan.

PROPOSAL 4:

Approval of Amendment to the Renovaro Biosciences Inc. 2023 Equity Incentive Plan to Authorize 5,000,000 Additional Shares

At the 2023 annual meeting of stockholders of Renovaro held on July 21, 2023 (the “2023 Annual Meeting”), the stockholders approved the 2023 Plan, including approval of a reserve of 4,000,000 shares of Common Stock available for the grant of awards under the 2023 Plan. Following the consummation of the Transaction, it is expected that the officers, employees and certain consultants and advisors of GEDi Cube will be eligible to receive awards under the 2023 Plan. With the expansion of the potential recipients under the 2023 Plan, Renovaro is requesting that its stockholders approve an amendment to increase the reserve of shares of Common Stock available for the grant of awards under the 2023 Plan to enable the Renovaro Board to continue to make grants to eligible officers, employees, consultants, advisors and non-employee directors of the combined company and its affiliates following the consummation of the Transaction. If Renovaro’s stockholders approve the amendment proposed under this Proposal 4 at the Special Meeting, it will become effective on the date of the Special Meeting. The effectiveness of this amendment is not subject to approval of any other proposals at the Special Meeting or consummation of the Transaction.

On December 21, 2023, upon the recommendation of the Compensation Committee of the Renovaro Board, the Renovaro Board unanimously adopted, subject to approval by Renovaro’s stockholders, an amendment to the 2023 Plan authorizing five million (5,000,000) additional shares of Common Stock for delivery in connection with awards under the 2023 Plan, increasing the total number of shares of Common Stock available for the grant of awards under the 2023 Plan to nine million (9,000,000) (subject to adjustment under the terms of the 2023 Plan), plus the number of shares of Common Stock available for the grant of awards under the 2019 Plan as of July 21, 2023. A copy of the 2023 Plan, as proposed to be amended, is attached as Annex C to this proxy statement. With 2,205,489 shares of Common Stock remaining available for the grant of awards under the 2019 Plan as of July 21, 2023 (the date of the 2023 Annual Meeting at which the 2023 Plan was approved) and 291,873 shares of Common Stock already subject to outstanding awards, or having already been issued in connection with awards, under the 2023 Plan as of December 29, 2023, the total number of shares of Common Stock available for the grant of awards under the 2023 Plan would be 10,913,616 shares of Common Stock if the amendment proposed under this Proposal 4 is approved at the Special Meeting. No additional changes to the 2023 Plan are proposed for consideration by the Renovaro stockholders at the Special Meeting.

The purposes of the 2023 Plan are to enhance Renovaro’s ability to attract and retain highly qualified officers, non-employee directors, key employees and consultants, and to motivate those service providers to serve Renovaro and to expend maximum effort to improve Renovaro’s business results and earnings, by providing to those service providers an opportunity to acquire or increase a direct proprietary interest in Renovaro’s operations and future success of Renovaro. Renovaro believes that, following the consummation of the Transaction, the increase in the number of shares of Common Stock available for future grants to eligible individuals under the 2023 Plan is vital to the combined company’s ability to continue offering competitive equity-based compensation to further the purposes of the 2023 Plan.

The following is a summary of the material terms of the 2023 Plan. The only change proposed under the 2023 Plan Amendment Proposal is to increase the number of shares available for the grant of awards under the 2023 Plan by five million (5,000,000) shares. The summary is not intended to be a complete description of the 2023 Plan and is qualified in its entirety by the actual text of the 2023 Plan, as proposed to be amended, which is attached as Annex C to this proxy statement.

Description of the 2023 Plan

Eligibility and Participation. Awards may be granted under the 2023 Plan to officers, employees, consultants, advisors and non-employee directors of Renovaro and its affiliates. Incentive stock options may be granted only to employees of Renovaro or its subsidiaries. As of December 29, 2023, approximately 24 individuals were eligible to receive awards under the 2023 Plan, including three named executive officers, ten other employees, nine non-employee directors and two non-employee scientific advisors.

Plan Administration. The Renovaro Board has the power and authority to administer the 2023 Plan as is consistent with the Certificate of Incorporation and the By-laws, and applicable law. Pursuant to the 2023 Plan, the Renovaro Board has the authority to delegate such power and authority to administer the 2023 Plan to a committee of two or more non-employee directors.

Type of Awards. The following types of awards are available for grant under the 2023 Plan: stock options, stock appreciation rights (“SARs”), restricted shares, restricted stock units (“RSUs”), other stock-based awards and cash awards.

Number of Authorized Shares. Under the 2023 Plan, as proposed to be amended, and subject to adjustment as provided by the terms of the 2023 Plan, the maximum number of shares of Common Stock with respect to which awards may be granted under the 2023 Plan is 9,000,000 shares, plus the number of shares of Common Stock available for the grant of awards under the 2019 Plan as of July 21, 2023. Of this maximum amount, as of December 29, 2023, approximately 291,873 shares of Common Stock are already subject to outstanding awards, or have already been issued in connection with awards, under the 2023 Plan. All such shares may be granted as Incentive Stock Options (“ISOs”). In addition, any shares subject to outstanding awards under the 2019 Plan or the 2023 Plan that subsequently expire, terminate, or are surrendered or forfeited for any reason without issuance of shares will automatically become available for issuance under the 2023 Plan. The shares of Common Stock issuable under the 2023 Plan will consist of authorized and unissued shares, treasury shares, or shares purchased on the open market or otherwise.

Share Counting

Each share granted in connection with an award is counted as one share against the number of shares available.

Share Recycling. If any award is surrendered, terminates, expires or lapses for any reason prior to the issuance of shares, or if shares are issued under the 2023 Plan and thereafter are forfeited to Renovaro, the shares subject to such awards and the forfeited shares will again be available for grant under the 2023 Plan. In addition, any issued shares that are repurchased by Renovaro at no more than cost will again be available for grant under the 2023 Plan.

The following items will not count against the aggregate number of shares of Common Stock available for grant under the 2023 Plan: (i) any award that is settled in cash rather than by issuance of shares of Common Stock, or (ii) awards granted in assumption of or in substitution for awards previously granted. Shares tendered or withheld to pay the exercise price for an option or tax withholding for any type of award will continue to count against the aggregate number of shares of Common Stock available for grant under the 2023 Plan. In addition, the total number of shares covering stock-settled SARs or net-settled options will be counted against the pool of available shares, not just the net shares issued upon exercise.

Stand-Alone, Additional, Tandem, and Substitute Awards

The Renovaro Board may grant awards either alone, in addition to, in tandem with, or in substitution or exchange for (i) any other award, (ii) any award granted under another plan or (iii) any other right to receive payment from Renovaro.

Stock Options

Option Price. The Renovaro Board may grant either ISOs, which must comply with Section 422 of the Code, or nonstatutory stock options (“NSOs”) (together “options”). Options confer on the grantee a right to purchase a specified number of shares of Common Stock at a specified price (the “option price”) subject to the terms and conditions of the award agreement. The option price per share will be at least 100% of the fair market value of a share of Common Stock on the grant date. In the case of a grant of an option intended to qualify as an ISO to a grantee that owns more than 10% of the total combined voting power of Renovaro (a “10% Stockholder”), the option price will not be less than 110% of the fair market value of a share of Common Stock on the grant date.

Vesting and Exercise. The Renovaro Board will determine the terms and conditions under which an option will become exercisable. No option may be exercised for a fraction of a share. The Renovaro Board will establish the terms, conditions, and method of exercise. An option may be exercised by delivery of a notice of exercise to Renovaro, setting forth the number of shares with respect to which the option is to be exercised, accompanied by full payment for the shares.

Special Limitations on ISOs. An option will constitute an ISO only (i) if the grantee is an employee of Renovaro or a subsidiary of Renovaro, (ii) to the extent the option is specifically designated as an ISO in the related award agreement, and (iii) to the extent that the aggregate fair market value (determined at the time the option is granted) of the shares of Common Stock with respect to which all ISOs held by the grantee become exercisable for the first time during any calendar year (under the 2023 Plan, the 2019 Plan and all other plans of the grantee’s employer and its affiliates) does not exceed $100,000.

Expiration. Options will expire no more than 10 years from its grant date, or in the case of an ISO held by a 10% Stockholder, not more than five years from its grant date.

Stock Appreciation Rights

SAR Exercise Price. A SAR will confer on the grantee a right to receive, upon exercise, a payment of the excess of (i) the fair market value of one share of Common Stock on the date of exercise over (ii) the SAR exercise price, which will be determined by the Renovaro Board (the “SAR exercise price”). The SAR exercise price will be fixed at no less than the fair market value of a share of Common Stock on the grant date and will be specified in the award agreement. SARs granted in tandem with an outstanding option following the grant date of such option will have a SAR exercise price that is equal to the option price, except that the SAR’s exercise price may not be less than the fair market value of a share of Common Stock on the grant date of the SAR.

Vesting and Exercise. The Renovaro Board will determine the terms and conditions under which a SAR will become exercisable.

Expiration. SARs will expire no more than 10 years from their grant date.

Restricted Shares and RSUs

Restricted Shares. At the time a grant of restricted shares is made, the Renovaro Board may establish an applicable “restricted period” during which all or any portion of the shares will be forfeited if the grantee terminates service during the period and prescribes other restrictions, including the satisfaction of corporate or individual performance objectives, which will be specified in the award agreement. Unless the Renovaro Board otherwise provides in an award agreement, holders of restricted shares will have the right to vote and the right to receive any dividends declared or paid with respect to the stock subject to the awards. All distributions, if any, received by a grantee with respect to restricted stock as a result of any stock split, stock dividend, combination of shares, or other similar transaction will be subject to the restrictions applicable to the original grant.

RSUs. An RSU is a bookkeeping entry representing the right to receive cash or shares of Common Stock in the future. At the time a grant of RSUs is made, the Renovaro Board will establish the events upon which the RSUs will become vested and payable, including either service-based vesting conditions or performance-based vesting conditions based on the satisfaction of corporate or individual performance objectives, which will be specified in the award agreement. RSUs will not confer stockholder rights to grantees. A grantee of RSUs shall have no rights other than those of a general creditor of Renovaro.

Neither restricted shares nor RSUs can be sold, transferred, assigned, pledged, or otherwise encumbered or disposed of during the restricted period, prior to vesting and settlement, or before satisfaction of any other applicable restrictions.

Other Stock-Based Awards

The Renovaro Board may, in its discretion, grant other stock-based awards, valued in whole or in part by reference to, or otherwise based upon, Common Stock. The terms of other stock-based awards will be set forth in the applicable award agreements.

Performance Awards

The Renovaro Board may condition the grant, exercise, vesting, or settlement of any award on performance conditions as it may specify. The Renovaro Board may select corporate or individual performance objectives as it deems appropriate.

Effect of Certain Transactions

Adjustments for Changes in Capitalization. If changes in Renovaro’s Common Stock occur by reason of any recapitalization, reclassification, stock split, reverse split, combination of shares, exchange of shares, stock dividend or other distribution payable in stock, or other increase or decrease without receipt of consideration by Renovaro, or if there occurs any spin-off, split-up, extraordinary cash dividend or other distribution of assets by Renovaro, the number and kind of securities for which grants of awards may be made or settled under the 2023 Plan will be equitably adjusted by Renovaro. In addition, if there occurs any spin-off, split-up, extraordinary cash dividend or other distribution of assets by Renovaro, the number and kind of securities subject to any outstanding awards and the exercise price of any outstanding options or SARs will be equitably adjusted by Renovaro.

Adjustments for Certain Transactions. Except as otherwise provided in an award agreement, in the event of a recapitalization, reorganization, merger, consolidation, combination, exchange, consolidation, sale of all or substantially all of Renovaro’s assets, or the acquisition of assets or stock of another entity by Renovaro, or other corporate transaction involving Renovaro (a “transaction”), the 2023 Plan and the awards issued pursuant to the 2023 Plan will continue in effect in accordance with their respective terms, except that following a transaction either (i) each outstanding award will be treated as provided for in the agreement entered into in connection with the transaction or (ii) if not so provided in the agreement, each grantee will be entitled to receive in respect of each share of our Common Stock subject to any outstanding awards, upon exercise or payment or transfer in respect of any award, the same number and kind of stock, securities, cash, property or other consideration that each holder of a share of Common Stock was entitled to receive in the transaction in respect of a share of Common Stock, except that, unless otherwise determined by the Renovaro Board, such stock, securities, cash, property or other consideration will remain subject to all of the terms and conditions (including performance criteria) which were applicable to the awards prior to the transaction. The treatment of outstanding options and SARs in connection with a transaction in which the consideration paid or distributed to our stockholders is not entirely shares of Common Stock of the acquiring or resulting corporation may include the cancellation of outstanding options and SARs upon consummation of the transaction as long as, at the election of the Renovaro Board, (i) the holders of affected options and SARs have been given a period of at least 15 days prior to the date of the consummation of the transaction to exercise the options or SARs (to the extent otherwise exercisable) or (ii) the holders of the affected options and SARs are paid (in cash or cash equivalents) in respect of each share covered by the option or SAR being canceled an amount equal to the excess, if any, of the per share price paid or distributed to Renovaro’s stockholders in the transaction (the value of any non-cash consideration to be determined by the Renovaro Board in its sole discretion) over the option or SAR exercise price, as applicable.

Change in Control. Under the 2023 Plan, the Renovaro Board will determine how outstanding shares will be treated in the event of a change in control. The Renovaro Board may provide that:

Term of 2023 Plan. Unless terminated earlier by the Renovaro Board, the authority to make grants under the 2023 Plan will terminate on July 21, 2033.

Amendment and Termination. The Renovaro Board may, at any time and from time to time, amend, suspend, or terminate the 2023 Plan as to any shares of Common Stock as to which awards have not been made. An amendment will be contingent on approval of Renovaro’s stockholders to the extent stated by the Renovaro Board, required by applicable law or required by applicable stock exchange listing requirements. No awards will be made after termination of the 2023 Plan. No amendment, suspension, or termination of the 2023 Plan will, without the consent of the grantee, materially impair rights or obligations under any award theretofore awarded under the 2023 Plan.

No Repricing. Stockholder approval will be required if any modification to an award would result in repricing of the award.

Clawback Policy. All awards received or outstanding under the 2023 Plan shall be subject to clawback, cancellation, recoupment, rescission, payback, reduction, or other similar action in accordance with any Company clawback or similar policy or any applicable law related to such actions. In addition, a grantee may be required to repay Renovaro previously paid compensation, whether provided pursuant to the 2023 Plan or an award agreement in accordance with Renovaro’s clawback policy. A grantee’s acceptance of an award constitutes the grantee’s acknowledgement of and consent to Renovaro’s clawback or similar policy or any applicable law related to such actions and the grantee’s agreement that Renovaro may take any actions that may be necessary to effectuate any such policy or applicable law, without further consideration or action.

Separation from Service for Cause. Renovaro may annul an award if the grantee is terminated from Renovaro’s employment for cause.

Deferral Arrangement. The Renovaro Board may permit or require the deferral of any award payment into a deferred compensation arrangement, subject to rules and procedures as Renovaro may establish and in accordance with Code Section 409A.

Transferability. Awards are not transferable other than by will or the laws of descent, except that in certain instances transfers may be made to or for the benefit of designated family members of the grantee for no value.

New Plan Benefits. The participants to be granted awards and the amount and nature of awards to be granted to a particular participant under the 2023 Plan are within the discretion of the Renovaro Board and, therefore, cannot be determined at this time.

Aggregate Past Grants. The following table provides information, as of June 30, 2023, regarding the number of shares of Common Stock that may be issued under Renovaro’s 2014 Equity Incentive Plan (the “2014 Plan”) and the 2019 Plan:

(1) On February 6, 2014, the Renovaro Board adopted the 2014 Plan, and Renovaro had reserved 1,206,000 shares of Common Stock for issuance in accordance with the terms of the 2014 Plan. On October 30, 2019, the Renovaro Board approved, and on October 31, 2019, Renovaro’s stockholders adopted the 2019 Plan, which became effective on December 12, 2019 (the “Plan Effective Date”) and replaced the 2014 Plan. The 2019 Plan included a reserve of (i) 6,000,000 new shares of Common Stock, (ii) the number of shares of Common Stock available under the 2014 Plan for the grant of awards as of the Plan Effective Date, and (iii) shares of Common Stock underlying outstanding awards granted under the 2014 Plan that, after the Plan Effective Date, expire or are terminated, surrendered, or forfeited for any reason without the issuance of shares. The remaining shares of Common Stock available for grant related to the 2014 Plan was 655,769. As of the Plan Effective Date, this amount, along with the new 6,000,000 shares of Common Stock, totaled 6,655,769 shares of Common Stock available for grant immediately after the Plan Effective Date. After June 30, 2023, the Renovaro Board and Renovaro’s stockholders approved the 2023 Plan.

Federal Tax Consequences

The following is a brief summary of the U.S. federal income tax consequences of the 2023 Plan generally applicable to Renovaro and to grantees in the 2023 Plan who are subject to U.S. federal taxes. The summary is based on the Code, applicable Treasury Regulations, and administrative and judicial interpretations thereof, each as in effect on the date of this proxy statement, and is, therefore, subject to future changes in the law, possibly with retroactive effect.

THE FOLLOWING INFORMATION IS ONLY A SUMMARY OF THE TAX CONSEQUENCES OF THE AWARDS AND IS NOT INTENDED TO COVER ALL TAX CONSEQUENCES NOR IS IT INTENDED TO BE USED BY ANY TAXPAYER TO AVOID PENALTIES WHICH MAY BE IMPOSED. WE ENCOURAGE GRANTEES TO CONSULT WITH THEIR OWN TAX ADVISORS WITH RESPECT TO THE TAX CONSEQUENCES INHERENT IN THE OWNERSHIP, EXERCISE, VESTING OR SETTLEMENT OF THEIR AWARDS, AND THE OWNERSHIP AND DISPOSITION OF ANY UNDERLYING SECURITIES. TAX CONSEQUENCES FOR ANY PARTICULAR INDIVIDUAL OR UNDER STATE OR NON-U.S. TAX LAWS MAY BE DIFFERENT.

Nonqualified Stock Options. A grantee generally will not recognize taxable income upon the grant or vesting of a nonqualified stock option with an exercise price that is at least equal to the fair market value of Common Stock on the date of grant and that does not otherwise provide for the deferral of compensation. Upon the exercise of a nonqualified stock option, a grantee generally will recognize compensation taxable as ordinary income in an amount equal to the difference between the fair market value of the shares underlying the stock option on the date of exercise and the exercise price of the stock option. When a grantee sells the shares, the grantee will have short-term or long-term capital gain or loss, as the case may be, equal to the difference between the amount the grantee received from the sale and the tax basis of the shares sold. The tax basis of the shares generally will be equal to the greater of the fair market value of the shares on the exercise date or the exercise price of the stock option.

Incentive Stock Options. A grantee generally will not recognize taxable income upon the grant of an incentive stock option. If a grantee exercises an incentive stock option during employment or within three months after employment ends (12 months in the case of permanent and total disability), the grantee will not recognize taxable income at the time of exercise for regular U.S. federal income tax purposes (although the grantee generally will have taxable income for alternative minimum tax purposes at that time as if the stock option were a nonqualified stock option). If a grantee sells or otherwise disposes of the shares acquired upon exercise of an incentive stock option after the later of (i) one year from the date the grantee exercised the option and (ii) two years from the grant date of the stock option, the grantee generally will recognize long-term capital gain or loss equal to the difference between the amount the grantee received in the disposition and the exercise price of the stock option. If a grantee sells or otherwise disposes of shares acquired upon exercise of an incentive stock option before these holding period requirements are satisfied, the disposition will constitute a “disqualifying disposition,” and the grantee generally will recognize taxable ordinary income in the year of disposition equal to the excess of the fair market value of the shares on the date of exercise over the exercise price of the stock option (or, if less, the excess of the amount realized on the disposition of the shares over the exercise price of the stock option). The balance of the grantee’s gain on a disqualifying disposition, if any, will be taxed as short-term or long-term capital gain, as the case may be.

With respect to both nonqualified stock options and incentive stock options, special rules apply if a grantee uses shares of Common Stock already held by the grantee to pay the exercise price or if the shares received upon exercise of the stock option are subject to a substantial risk of forfeiture by the grantee.

Stock Appreciation Rights. A grantee generally will not recognize taxable income upon the grant or vesting of a SAR with a grant price at least equal to the fair market value of our Common Stock on the date of grant and that does not otherwise provide for the deferral of compensation. Upon the exercise of a SAR, a grantee generally will recognize compensation taxable as ordinary income in an amount equal to the difference between the fair market value of the shares underlying the SAR on the date of exercise and the grant price of the SAR.

Restricted Share Awards, RSUs, and Performance Awards. A grantee generally will not have taxable income upon the grant of restricted shares, restricted stock units or performance awards. Instead, the grantee will recognize ordinary income at the time of vesting or payout equal to the fair market value (on the vesting or payout date) of the shares or cash received minus any amount paid. For restricted shares only, a grantee may instead elect to be taxed at the time of grant.

Other Stock-Based Awards. The U.S. federal income tax consequences of other stock or cash-based awards will depend on the specific terms of each award.

Tax Consequences to Renovaro. In the foregoing cases, Renovaro generally will be entitled to a deduction at the same time, and in the same amount, as a grantee recognizes ordinary income, subject to certain limitations imposed under the Code.

Section 409A. Renovaro intends that awards granted under the 2023 Plan comply with, or otherwise be exempt from, Code Section 409A, but make no representation or warranty to that effect.

Tax Withholding. Renovaro is authorized to deduct or withhold from any award granted or payment due under the 2023 Plan, or require a grantee to remit, the amount of any withholding taxes due in respect of the award or payment and to take such other action as may be necessary to satisfy all obligations for the payment of applicable withholding taxes. Renovaro is not required to issue any shares of Common Stock or otherwise settle an award under the 2023 Plan until all tax withholding obligations are satisfied.

Vote Required; Recommendation of the Renovaro Board

The affirmative vote of a majority of the votes cast virtually or by proxy at the virtual Special Meeting is required for approval of Proposal 4. A failure to submit a proxy card or vote at the Special Meeting, or an abstention for Proposal 4 will have no effect on the outcome of Proposal 4.

THE RENOVARO BOARD UNANIMOUSLY RECOMMENDS A VOTE “FOR” APPROVAL OF THE proposed amendment to the 2023 plan to Increase the number of shares of Common Stock available for awards BY FIVE MILLION (5,000,000) SHARES.

PROPOSAL 5:

Approval of Possible Adjournment of the Special Meeting, if Necessary, to Solicit Additional Proxies

General

The Renovaro Board believes that if there are insufficient votes to constitute a quorum, or if Renovaro fails to receive a sufficient number of votes to approve Proposals 1, 2, 3 and/or 4, it is in the best interests of the stockholders to enable the Renovaro Board to continue to seek to obtain a sufficient number of additional affirmative votes to approve such proposals, and as a result our proxy holders may move to adjourn the Special Meeting, for a period of not more than sixty (60) days, for the purpose of soliciting additional proxies to approve such proposals. Renovaro currently does not intend to propose adjournment at the Special Meeting if there are sufficient votes to approve Proposals 1, 2, 3 and 4. If a quorum is present, the affirmative vote of a majority of votes cast in person or in person on the proposal (not counting “abstentions” or “broker non-votes” as votes cast) at the Special Meeting is required to approve the adjournment of the Special Meeting for the purpose of soliciting additional proxies to approve Proposals 1, 2, 3 and/or 4.

In this Proposal 5, Renovaro is asking its stockholders to authorize the holder of any proxy solicited by the Renovaro Board to vote in favor of adjourning the Special Meeting to another time and place, if necessary, to solicit additional proxies in the event there are not sufficient votes to approve Proposals 1, 2, 3 and/or 4. If the Renovaro stockholders approve this Proposal 5, Renovaro could adjourn the Special Meeting and any adjourned or postponed session of the Special Meeting and use the additional time to solicit additional proxies, including the solicitation of proxies from the Renovaro stockholders that have previously voted. Among other things, approval of this Proposal 5 could mean that, even if Renovaro had received proxies representing a sufficient number of votes to defeat Proposal 1, 2, 3 or 4, we could adjourn the Special Meeting without a vote on such proposal to solicit additional proxies and votes in favor of such proposal.

If it is necessary to adjourn the Special Meeting, except as may be required by applicable law or SEC regulations, no notice of the adjourned meeting is required to be given to Renovaro’s stockholders, other than an announcement at the Special Meeting of the date, time and place to which the Special Meeting is adjourned, and the means of remote communication, if any, by which stockholders may participate in the meeting, so long as the meeting is adjourned for 30 days or less and no new record date is fixed for the adjourned meeting. At the adjourned meeting, Renovaro may transact any business which might have been transacted at the original meeting.

Vote Required; Recommendation of the Renovaro Board

The affirmative vote of a majority of the votes cast in person or by proxy at the Special Meeting is required for approval of Proposal 5. A failure to submit a proxy card or vote at the Special Meeting, or an abstention for Proposal 5 will have no effect on the outcome of Proposal 5.

THE RENOVARO BOARD UNANIMOUSLY RECOMMENDS A VOTE “FOR” APPROVAL OF THE PROPOSAL TO ADJOURN THE SPECIAL MEETING, IF NECESSARY, TO SOLICIT ADDITIONAL PROXIES IF THERE ARE NOT SUFFICIENT VOTES IN FAVOR OF PROPOSALS 1, 2, 3 and/or 4.

RENOVARO’S BUSINESS

In addition to the information set forth below, please refer to the Renovaro 2023 Form 10-K, the Renovaro First Quarter 2024 Form 10-Q, and the other documents filed with the SEC and incorporated by reference into this proxy statement for additional information regarding Renovaro’s business.

Unless otherwise indicated or the context otherwise requires, all references in this section to “we,” “us,” “our,” or “Renovaro” are to Renovaro Biosciences Inc., a Delaware corporation together with its wholly owned subsidiaries, Renovaro Biopharma, Inc., a Delaware corporation (“Renovaro Biopharma”), Renovaro BioSciences Denmark ApS, a Danish limited company, organized under the Danish Act on Limited Companies of the Kingdom of Denmark, and Renovaro Technologies, Inc., a Nevada corporation (“Renovaro Technologies”).

Our Business

We 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.

Our 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, Renovaro has evolved from a company with a single product candidate as a potential cure for HIV, adding two additional pipeline candidates for HIV, a pipeline for HBV, and with a significant expansion into cancer immune therapies to address high unmet needs from difficult-to-treat solid tumors.

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.

Renovaro responds quickly to new data and perceived development opportunities and risk assessments. Based on the maturation of our pipelines, Renovaro makes business decisions to prioritize the programs that could move more rapidly through development and commercial processes.

Therapeutic Areas of focus

Solid Tumors

Cancer is caused by an uncontrolled proliferation of abnormal cells. The immune system plays a key role in identifying and destroying those abnormal cells. In the past 10 years, there has been significant investment in research and development to retrain the immune system in people with cancer to restore the effectiveness of that immune response – so called “immune-therapy”. Immune-therapies have made substantial advances to treat various types of blood cell-derived cancers. However, solid tumors still represent a key challenge for long-term remission or cure. Certain solid tumors have evolved mechanisms that can either hide from normal immune control and immune-therapies or release certain signaling factors that can block attempts by the immune system to recognize and destroy cancer cells.

Renovaro is developing innovative, proprietary approaches that involve gene- and/or cell-therapy to promote cancer fighting cells that are designed to potentially overcome those mechanisms and enhance the ability of a person living with a solid tumor to more easily recognize cancer cells and mount a much more robust and effective immune reaction to destroy them.

Pancreatic cancer remains a very deadly disease with only 5-10 percent of patients surviving 5 years. Initial preclinical in vitro and proof of concept in vivo studies of our immune-therapeutic approach for pancreatic cancer have demonstrated promising results.

The flexibility provided by the platform technology for quick adaptations during research and development and manufacturing processes could accelerate the development of potential products for other solid tumors beyond pancreatic cancer. For example, triple-negative breast cancer, glioblastoma and renal cell carcinoma are all solid tumors with poor survival rates and limited treatment options. The platform might also allow for non-specific immune enhancement that could have impact against a broad array of solid tumors. As currently conceived, our approach could potentially allow for outpatient therapy without significant impairment of the patient’s immune system, as many current approaches require.

Because many types of solid tumors do not have adequate therapies, are difficult to treat and have relatively low survival rates, there is a large market potential.

Infectious Diseases

Infectious diseases such as HIV and HBV cause disease and death in hundreds of millions of people every year. In a similar way to solid tumors, those viruses escape from natural immune response by hiding inside of human cells, creating sanctuaries or reservoirs of infection that can evade the immune system. Advances in anti-viral drugs have made a huge impact on the ability to extend and improve the quality of life for many, but are often associated with side effects and can be very expensive.

Through its advanced cell- and gene- therapy platforms, Renovaro is developing unique tools potentially to enhance a person’s ability to both recognize and fight infections. Because those mechanisms aim to eliminate the cells that serve as a reservoir for viral replication, our therapy could potentially either cure or at least provide long term remission to people living with chronic infections.

HIV

HIV attacks the human immune system, specifically killing off CD4+ T-cells, a central part of a person’s ability to control other infections and certain cancers. Left untreated, over time, the number of CD4+ T-cells drops to such low levels that people die from those infections and cancers.

Thanks to scientific advances, there are over 30 antiretroviral drugs, or ARVs, approved by the FDA to treat HIV that allow many people to live almost as long as people without HIV. But, as mentioned, the drugs are expensive, require taking pills every day, and can have significant side effects over time.

According to the World Health Organization, more than 30 million people are living with HIV. In addition, as many as 1 million people, including people in high-income countries, continue to die each year from HIV due to the ability of the virus to evolve to evade the effects of the drugs, in particular in people who have been taking various drugs for many years. 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.

HBV

Despite the availability of an effective vaccine and treatment that can control infection if it is taken daily for life, HBV is the world’s most common serious liver infection. According to the Hepatitis B Foundation, two billion people have been infected with HBV, approximately 300 million have chronic HBV infection, and nearly one million people die every year around the world. HBV remains the leading cause of liver cancer and the second leading cause of cancer deaths in the world.

While vaccines are increasingly required for children, many adults have not been vaccinated. Life-long treatment access can be limited and also can be difficult for certain people to follow due to its side effects.

Current efforts to develop novel treatments or cure largely focus on approaches to deplete the pool of the covalently closed circular DNA (cccDNA), a type of HBV DNA that is the root cause of HBV chronicity. Renovaro is exploring the development of an innovative gene therapy approach to co-opt HBV polymerase, a key factor that the virus needs to reproduce itself and to induce the death of liver cells infected with the virus.

Therapeutic Platforms

Renovaro’s general approach with gene- and/or cell-therapy is to enhance the immune system to allow a person to better fight diseases. Our vision is for a world free from toxic chemotherapy and healthy longevity for those with cancer and other diseases. Renovaro is leveraging general principles and advances in the knowledge of the immune response to engineer cells with enhanced attributes to promote the recognition and elimination of diseased cells.

Advanced Allogeneic Cell Therapy

The strategic benefit of cell therapy platforms is to potentially allow for manufacture of large, “off-the-shelf” banks of therapeutic cells that could be accessed on demand by health care professionals to potentially decrease the time between diagnosis and treatment.

In addition, because we focus on cells from donors, the strategy could potentially enhance the ability of the therapeutic candidates to induce a more robust response once injected into patients. The human immune system is designed to recognize and distinguish “self” from “non-self” and destroy “otherness” such as bacteria, viruses, and damaged or diseased cells such as cancer cells. Alloreactivity (reacting against another person’s cells) is the most powerful response the immune system generates. Several of our technologies take advantage of the alloreactivity to hyper stimulate a person’s immune response to better attack a chronic infection (e.g., HIV) or solid tumor.

In certain treatments (e.g., HIV and cancer), cells taken from healthy donors are sometimes genetically modified to introduce signaling molecules that are designed to enhance the ability of specific immune cells to recognize diseased cells, and to help recruit other cells that will destroy cancer or virus infected cells.

Renovaro 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 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 uptake. We have sublicensed under a profit-sharing agreement our technology to potentially increase engraftment for potential use in CAR-T therapy as a potential cure for HIV.

HBV Gene Therapy

Renovaro 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 and exacerbate disease.

Our Product Candidates

Oncology:

RENB-DC11: Genetically modified Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Product for Long-term Remission of Solid Tumors – Starting with Pancreatic Cancer

Allogeneic Cell Therapy Platform – Advanced Pre-Clinical

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 remission from some of the deadliest solid tumors. The survival rate in pancreatic cancer is currently only 5 to 10 percent at 5 years.

Initial preclinical in vitro and proof of concept in vivo studies have been compelling. The platform might also allow for non-specific immune enhancement that could have impact against a broad array of solid tumors. We initially plan to target pancreatic cancer. Other potential targets for later development could include triple-negative breast cancer, liver or mesothelioma. As with HIV, our approach would potentially allow for outpatient therapy without wiping out or significantly impairing the patient’s immune system, as many current approaches require.

Renovaro has initiated a collaboration with Dr. Anahid Jewett, a leading cancer immunology researcher recently identified by Stanford University as being among the top 3% of researchers in the world, from UCLA to study further the in vitro and in vivo effectiveness of the approach in pancreatic cancer. Dr. Jewett created an innovative pancreatic cancer mouse model that comprises the human immune system repertoire in combination with implanted human cancer cells. Reproducible results from four independently conducted studies show promising substantial tumor size reduction, significant infiltration of the tumor sack by effector immune cells, indicating ongoing killing of cancer cells, markers of significant immune activation and, in a recent study with our most refined technology, no metastases. Multiple experiments in different humanized mouse models are consistently showing with only one cycle of therapy – in humans five to ten are likely - what Dr. Jewett calls “the Holy Grail of cancer research”:

Recently, a leading research and product development company conducted a study of the effects of the therapeutic vaccine in more advanced pancreatic cancer. In the treated group, there were no metastases, and there was a significant reduction in tumor size – perhaps even elimination – despite using approximately half as many gene-modified immune cells and using a general tumor lysate rather than matching it to the specific cancer compared with previous studies. In addition, Dr. Jewett conducted a study in liver cancer with promising results, including no metastases in mice treated with the vaccine compared to metastases in all the animals that received no treatment.

Finally, we have finalized the design of the clinical protocol and have identified the principal investigator from the Department of Oncology at UCLA to conduct the first in-human studies, which is projected to be at the end of 2024. Because our Senior Vice President for Clinical Operations has 35 years of experience at Pfizer, including creating and leading teams that managed human trials of cancer cell and gene therapies, we will retain complete control of the study with subcontractors who have already been identified rather than outsourcing to a clinical research organization, which we expect will support the combined Phase 1 and 2 trial’s quality and speed and reduce the estimated cost by 50% or greater.

The confirming reproducibility and robustness of the therapeutic response in an aggressive form of human pancreatic cancer in several models is promising. We received FDA input from pre-IND interactions, which helped solidify our IND-enabling plan as well as our investigational plan. We are now fully committed to process development/improvements and IND-enabling activities. We believe that we can complete IND-enabling activities in the second half of 2024, which, if successful, would enable the start of clinical trials in humans during the second half of 2024. The investigational plan discussed with the FDA includes phase 1 safety testing broadly in all solid tumor types, followed by a phase 2a focusing on a few solid tumor types that are difficult to treat and have poor life expectancy, for example triple negative breast, second-line liver, head and neck cancers. Phase 2b would expand cohorts in cancers with the strongest response in phase 2a.

RENB-DC-12--XX: Genetically 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 cancer vaccine designs are being evaluated strategically to balance risk and opportunity to advance therapeutic development quickly in cancer indications with few treatment options.

Infectious Diseases:

HIV:

RENB-HV 12: 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.

Renovaro 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.

RENB-HV-01: 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 Renovaro’s experimental plan. Although in vitro and in vivo studies have demonstrated promising results, further development of RENB-HV01 at this time was deemed costly and a long-term undertaking. While Renovaro plans to return to full development of the approach when resources are available, it has become less attractive and been deprioritized for business reasons, while pipelines that could move more quickly have been prioritized (e.g., RENB-DC11). Therefore, a business decision was made to sub-license the ALDH gene modification.

RENB-HV01 was sub-licensed to Caring Cross with a profit share arrangement. Caring Cross is developing a CAR-T approach that they believe, when combined with Renovaro ALDH gene modification, could enhance engraftment of their CAR-T cell therapy and enhance their likelihood of success.

RENB-HV-21: Immunotherapy with Allogeneic NK/GDT Cells

Allogeneic Cell Therapy Platform -Pre-IND conducted - Advanced Pre-Clinical with Human Data through a Collaboration

We are also exploring RENB-HV21, an innovative treatment for HIV with allogeneic Natural Killer (NK) and Gamma Delta T-Cells (GDT). It is believed that the GDT cells, a small subset of immune cells that can be infected with HIV, could both be infected by, and be a key factor in controlling, the virus. The initial scientific findings were presented during the American Society of Gene & Cell Therapy (ASCGT) Annual Meeting in 2021. Renovaro has an exclusive license to use the underlying patent to develop RENB-HV21 for potential treatment or cure of HIV. A successful investigator-initiated Pre-IND was completed in October 2021. However, due to a shift in priorities to the Oncology pipeline, Renovaro does not plan to pursue the IND and potential clinical trial in the medium- to long-term.

HBV:

RENB-HB-01: Potential Cure for HBV

HBV Gene Therapy - Pre-Clinical

RENB-HB01 is in an early pre-clinical phase as we explore various approaches for gene therapy design elements. If those explorations are successful, it is possible we could begin the regulatory process at the earliest in the second half of 2024. However, our highest priority is currently the oncology platform, beginning with pancreatic cancer and other solid tumors with poor life expectancy.

Collaborations

We have established strategic partnerships with leading scientists and research centers, such as the University of California, Los Angeles, Fred Hutchinson Cancer Research Center, and Caring Cross for some of our programs. We will continue to pursue partnerships and collaborations when appropriate with selected philanthropic, pharmaceutical and biotechnology companies to fund internal research and development activities, and to assist in product development and commercialization. We are applying our technology platform to several potential commercial applications in which our products provide us and our strategic partners and collaborators with potential technical, competitive and economic advantages.

Our Intellectual Property

Patents and licenses are key to our business. Our strategy is to file for patent applications to protect technology, inventions and improvements to inventions that we consider important for the development of our business. We rely on a combination of patent, copyright, trademark and trade secret laws, as well as continuing technological innovations, proprietary knowledge and various third-party agreements, including, without limitation, confidentiality agreements, materials transfer agreements, research agreements and licensing agreements to establish and protect our proprietary rights. We aim to take advantage of all of the intellectual property rights that are available to us and seek the protection of those rights so that we can fully exploit our innovations.

We also protect our proprietary information by requiring our employees, consultants, contractors and other advisors to execute nondisclosure and assignment of invention agreements upon commencement of their respective employment or engagement. Our patent filings are discussed briefly below.

Internally Developed Intellectual Property

Protocol for generating dendritic cells (2005 DK, 2008 PCT)

This patent family is directed to the generation of dendritic cells based on a blood sample by culturing monocytes at reduced temperatures. Dendritic cells exposed to tumor antigens followed by treatment with T(h) 1-polarizing differentiation signals have paved the way for the development of dendritic cell-based cancer vaccines. Issued claims are directed to a method of generating immature dendritic cells under certain temperature settings, which by further activation has been shown to give a high yield of homogeneous and fully matured dendritic cells. The patent expiration date is December 2026 subject to any applicable patent term extension, patent term adjustment, or supplementary protection certificates that may be available in a country or jurisdiction. This patent has been issued in the USA, Canada, China, Eurasia, Russia, Europe, Israel, Mexico, Malaysia and New Zealand. This patent is owned by Renovaro and was not licensed from third parties.

Assigned Intellectual Property

On August 16, 2022, the USPTO issued U.S. Patent No. 11,413,338 B2, “Methods and Compositions Using Recombinant Dendritic Cells for Cancer Therapy,” pertaining to methods and compositions for treating cancer by eliciting an immune response by administering dendritic cells expressing heterologous proteins. This patent protects RENB-DC-11: Genetically modified Allogeneic Dendritic Cells as Potential Product for Long-term Remission of Solid Tumors – Starting with Pancreatic Cancer and potential future products RENB-DC-12-XX: Genetically modified Allogeneic Dendritic Cells as Potential Product for Long-term Remission of Additional Indications for twenty years. This patent is owned by Renovaro through assignment as of July 15, 2019.

On June 17, 2020, a patent application was filed entitled “Allogeneic T-Cell-Based HIV Vaccine to Induce Cellular and Humoral Immunity,” US 2021/0030795 A1, for the composition and method of use concepts for HV-12. This patent application is owned by Renovaro through assignment as of September 28, 2021.

In-Licensed Technology

On February 16, 2018, Renovaro Biopharma, Renovaro’s wholly owned subsidiary, entered into a License Agreement (the “HIV License Agreement”) with Weird Science, LLC (“Weird Science”). The License Agreement contains, among other things, the following terms: (a) a perpetual, fully paid-up, royalty-free, sublicensable, and exclusive (including to the exclusion of Weird Science) worldwide license from Weird Science to Renovaro Biopharma to use Weird Science’s intellectual property and technology for the prevention, treatment, and/or amelioration of and/or therapy for HIV in humans, and research and development exclusively relating to HIV in humans (the “Field”) worldwide; (b) a nonexclusive, royalty-free, sublicensable license from Renovaro Biopharma to Weird Science to use the Renovaro technology to commercialize products outside of the Field worldwide; (c) a nonexclusive, royalty-free license from Renovaro Biopharma to Weird Science to use the results of a study with syngeneic and humanized mice models outside the Field and, at Weird Science’s own expense, to prosecute patents relating to the results of the study, which Weird Science will own, and (d) a perpetual, fully paid-up, royalty-free, sublicensable, and sole and exclusive (including to the exclusion of Weird Science) worldwide license from Weird Science to Renovaro Biopharma (which will be part of the license described in (a) above) to use patent applications and patents related to the study results disclosed in (d) above solely in the Field, and to make, have made, use, sell, offer to sell and import inventions claimed in such patent applications and patents solely in the Field. Our current product candidates covered by this license include RENB-HV-01: Autologous Transplant with Genetically Modified Cells.

On January 31, 2020, Renovaro entered into a Statement of Work and License Agreement (the “HBV License Agreement”) by and among Renovaro, G Tech Bio, LLC (“G-Tech”), and Seraph Research Institute (“SRI”) (formerly G Health Research Foundation), and, a not for profit entity organized under the laws of California doing business as Seraph Research Institute (“SRI”), whereby Renovaro acquired a perpetual, sublicensable, exclusive license (the “HBV License”) for a treatment under development (aimed to treat HBV infections in accordance with its agreement in principle with G-Tech and SRI announced by Renovaro on November 25, 2019. The HBV License Agreement states that in consideration for the HBV License, Renovaro would provide cash funding for research costs and equipment and certain other in-kind funding related to the licensed treatment over a 24-month period. Renovaro paid an upfront payment of $1.2 million on February 6, 2020. Our current product candidate under this license is RENB-HB-01 HBV Gene Therapy (see Note 9 to the consolidated financial statements included in the Renovaro 2023 Form 10-K and to the condensed consolidated financial statements included in the Renovaro First Quarter 2024 Form 10-Q).

On August 25, 2021, Renovaro entered into an ALC Patent License and Research Funding Agreement in the HIV Field (the “ALC License Agreement”) with SRI whereby Renovaro was granted an exclusive, worldwide, perpetual, fully paid-up, royalty-free license (the “ALC License”), with the right to sublicense, the proprietary technology subject to a U.S. patent application, to make, use, offer to sell, sell or import products for use solely for the prevention, treatment, amelioration of or therapy exclusively for HIV in humans, and research and development exclusively relating to HIV in humans; provided the licensor retained the right to conduct HIV research in the HIV Field. Pursuant to the ALC License Agreement, Renovaro granted a non-exclusive license back to licensor, under any patents or other intellectual property owned or controlled by Renovaro, to the extent arising from the ALC License, to make, use, offer to sell, sell or import products for use in the diagnosis, prevention, treatment, amelioration or therapy of any (i) HIV comorbidities and (ii) any other diseases or conditions outside the HIV Field. Renovaro made an initial payment to SRI of $600,000 and agreed to fund future HIV research, as mutually agreed to by the parties. Our current product candidate under this license is RENB-HV-21: HIV Natural Killer and Gamma Delta T Cell Treatment or Cure (see Note 9 to the consolidated financial statements included in the Renovaro 2023 Form 10-K and to the condensed consolidated financial statements included in the Renovaro First Quarter 2024 Form 10-Q).

Trade Secrets and Proprietary Know-How

In addition to intellectual property protected by patents and copyrights, we have trade secrets and proprietary know-how relating to our products, production processes and future strategies.

Competition

The biotechnology and pharmaceutical industries, including in the field of gene therapy, are characterized by rapidly advancing technologies, intense competition and a strong emphasis on intellectual property. While we believe that our technology platforms, strong intellectual property portfolio and scientific expertise in the gene therapy field provide us with competitive advantages, we face potential competition from many different sources, including larger and better-funded pharmaceutical and biotechnology companies, new market entrants and new technologies.

 We are aware of several companies focused on other methods for editing genes and regulating their expression, and a limited number of commercial and academic groups pursuing the development of gene regulation and genome editing technology. The field of applied gene regulation and genome editing is highly competitive, and we expect competition to persist and intensify in the future from several different sources, including pharmaceutical and biotechnology companies, academic and research institutions and government agencies.

Accordingly, our competitors may succeed in obtaining patent protection, receiving FDA approval or commercializing competitive products before us. If we commence commercial product sales, we may be competing against companies with greater marketing and manufacturing capabilities, areas in which we have limited or no experience. In addition, any product candidate that we successfully develop may compete with existing products that have long histories of safe and effective use.

The competitive landscape that we are facing is as follows:

Gene therapy companies developing gene-based products in clinical trials. uniQure N.V.’s product for lipoprotein lipase deficiency and GlaxoSmithKline plc, or GSK’s, product for severe combined immunodeficiency due to adenosine deaminase deficiency are approved in Europe. No other gene therapy products have yet been approved. Our competitors in this category may include, but not be limited to, Sangamo Therapeutics, Inc., uniQure N.V., bluebird bio, Inc., Regenxbio Inc., Shire, Pfizer Pharmaceutical, and GSK.

Cell therapy companies developing cell-based products. Our competitors in this category may include Novartis AG, Adaptimmune Therapeutics PLC, Atara Biotherapeutics, Inc., bluebird bio, Inc., Cellectis S.A., Juno Therapeutics, Inc., Kite Pharma, and Iovance Biotechnologies, Inc.

For RENB-DC-11, the competitive landscape is more complex.

Immunotherapy is an active area of research and a number of immune-related products have been identified in recent years that are alleged to modulate the immune system. Many of these products utilize dendritic cells, a form of immune cell that presents cancer target peptides to T cells and that can in turn result in T cell activation. More recently, bi-specific antibodies and checkpoint inhibitors (for instance PD-1/PD-L1 antibodies) have been identified as having utility in the treatment of cancer. Bi-specific antibodies commonly target both the cancer peptide and the T cell receptors (“TCR”), thus bringing both cancer cells and T cells into close proximity to maximize the chance of TCR binding and hence an immune response to the cancer cells. Checkpoint inhibitors on the other hand work by targeting receptors that inhibit T cell effectiveness and proliferation and essentially activate T cells. Other immunotherapies that are being actively investigated include antibody-drug complexes, TCR-mimic antibodies, oncolytic viruses and cancer vaccines. A variety of cell-based autologous and allogeneic approaches are also being researched and developed.

CAR-T in solid tumors

In addition to hematological malignancies, a growing number of pharmaceutical, biotechnology, and academic institutions are researching and developing autologous and allogeneic chimeric antigen receptor T cell (“CAR-T”) therapies in the solid tumor setting. These CAR-T cell therapies are at a variety of stages of preclinical and clinical development, as well as directed towards a broad target spectrum. Four CAR-T therapies have been approved for treatment of leukemia.

TCR T cells

Competitors are developing TCR T cells (including affinity engineered T cells) that are directed towards a multitude of targets. Juno Therapeutics has developed an engineered TCR therapeutic candidate where the end TCR is purported to have enhanced affinity through stem-cell selection.

Other cell-based approaches

In addition to all the adoptive cell therapy approaches above, our competitors are also investigating the potential of Gamma Delta T cell, Chimeric Antigen Receptor - Natural Killer (CAR-NK) cell, Natural Killer (NK) cell, (NKT) cell and Cytotoxic T-cells (CTLs) either in a preclinical or clinical setting (both hematologic malignancies and solid tumors). In addition, Bristol Myers Squibb’s Abraxane is used for pancreatic cancer.

For RENB-HV-12, we are aware of a few biotech companies developing an HIV vaccine such as Geovax, Biosantech SA, and FIT Biotech, among a few others.

For RENB-HV-01, we are aware of two companies developing a gene therapy for HIV/AIDS: Sangamo and American Gene Technology.

For RENB-HB-01, there is an approved vaccine to prevent HBV infection. In addition, several approved combination antivirals can suppress replication, but do not cure HBV. Several companies are pursuing cures, mostly targeting the depletion of ccc-DNA.

Manufacturing

Our intent is to rely on contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), to help develop processes and manufacture our product candidates in accordance with FDA and EMA mandated regulations, also known as current good manufacturing practices, (“cGMPs”). We employ a technical operations staff in the areas of process development, analytical development, quality control, quality assurance, project management and manufacturing, which will facilitate appropriate oversight of our CMOs, support of our regulatory filings and execution of clinical trials.

Government Regulation

FDA Review and Approval

Government authorities in the United States, at the federal, state, and local levels, and in other countries extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of products such as those we are developing. Any products we develop will require regulatory review and allowance to proceed prior to conducting clinical trials and additional regulatory approvals prior to commercialization. In the United States, the FDA regulates drugs under the Federal Food, Drug and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA) and their implementing regulations govern, among other things, biopharmaceutical testing, manufacturing, safety, efficacy, labeling, storage, recordkeeping, advertising, and other promotional practices.

Obtaining FDA approval is a costly and time-consuming process. Generally, FDA approval requires that preclinical studies be conducted in the laboratory and in animal model systems to gain preliminary information on efficacy and to identify any major safety concerns. The results of these studies are then submitted as a part of an IND, which the FDA must review and allow before human clinical trials can start. The IND includes a detailed description of the proposed clinical investigations. An independent Institutional Review Board (“IRB”) must also review and approve the clinical protocol and each clinical site.

A company must submit an IND for each investigational medical product and specific indication(s) and must conduct clinical studies to demonstrate the safety and efficacy of the product necessary to obtain FDA approval. The FDA receives reports on the progress of each phase of clinical testing and may require the modification, suspension or termination of clinical trials if an unwarranted risk is presented to participants including patients.

Obtaining FDA approval prior to marketing a biopharmaceutical product in the United States typically requires several phases of clinical trials to demonstrate the safety and efficacy of the product candidate. Clinical trials are the means by which experimental treatments are tested in humans and are conducted following preclinical testing. Clinical trials may be conducted within the United States or in foreign countries. If clinical trials are conducted in foreign countries, the products under development as well as the trials are subject to regulations of the FDA and/or its regulatory counterparts in the other countries. Upon successful completion of clinical trials, approval to market the treatment for a particular patient population may be requested from the FDA in the United States and/or its counterparts in other countries.

Clinical trials for therapeutic products are normally conducted in three phases. Phase 1 clinical trials are typically conducted with a small number of subjects/patients to evaluate the safety, determine a safe dosage range, identify side effects and, if possible, gain early evidence of effectiveness. Phase 2 clinical trials are conducted with a larger group of patients to evaluate the effectiveness of an investigational product for a defined patient population and to determine common short-term side effects and risks associated with the drug. Phase 3 clinical trials involve large scale, multi-center, comparative trials that are conducted to evaluate the overall benefit-risk relationship of the investigational product and to provide an adequate basis for product labeling. In some special cases where the efficacy testing of a product may present a special challenge to testing in humans, such as in the case of a vaccine to protect healthy humans from a life-threatening disease that is not a naturally occurring threat, effectiveness testing may be required in animals. For certain advanced therapies that meet eligibility criteria for expedited program designations, clinical development may be accelerated.

Clinical trials involve the administration of the treatment/drug product candidate to healthy volunteers or patients under the supervision of qualified investigators who generally are physicians not employed by, or under, the control of the trial sponsor. Clinical trials are conducted under written study protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria and the parameters to be used to monitor subject safety, including stopping rules that assure a clinical trial will be stopped if certain adverse events should occur. Each protocol and any amendments to the protocol must be submitted to the FDA as part of the IND. Clinical trials must be conducted and monitored in accordance with the FDA’s regulations comprising the Good Clinical Practice (“GCP”) requirements, and any additional requirements for the protection of human research subjects and their health information including the requirement that all research subjects provide informed consent.

Further, each clinical trial must be reviewed and approved by an IRB at or servicing each institution at which the clinical trial will be conducted. An IRB is charged with protecting the welfare and rights of trial participants and considers items such as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the form and content of the informed consent that must be signed by each clinical trial subject, or their legal representative, reviews and approves the study protocol, and must monitor the clinical trial until completed. Clinical trials involving recombinant DNA also must be reviewed by an institutional biosafety committee, or IBC, a local institutional committee that reviews and oversees basic and clinical research that utilizes recombinant DNA at that institution. The IBC assesses the safety of the research and identifies any potential risk to public health or the environment.

After completion of clinical trials of a new product, FDA marketing approval must be obtained. If the product is regulated as a biologic, a Biologics License Application, or BLA, is required. If the product is classified as a new drug, a New Drug Application, or NDA is required. The NDA or BLA must include results of product development activities, preclinical studies and clinical trials in addition to detailed chemistry, manufacturing and control information.

Applications submitted to the FDA are subject to an unpredictable and potentially prolonged approval process. Despite good-faith communication and collaboration between the applicant and the FDA during the development process, the FDA may ultimately decide, upon final review of the data, that the application does not satisfy its criteria for approval or requires additional product development or further preclinical or clinical studies. Even if FDA regulatory approval(s) are obtained, a marketed product is subject to continual review, and later discovery of previously unknown problems or failure to comply with the applicable regulatory requirements may result in restrictions on the marketing of a product or withdrawal of the product from the market as well as possible civil or criminal sanctions.

Before marketing approval can be secured for a product, the facility in which the product is manufactured must be inspected by the FDA and must comply with the FDA’s cGMP regulations. In addition, after marketing approval is secured, the manufacturing facility must be inspected periodically for cGMP compliance by FDA inspectors, and, if the facility is located in California, by inspectors from the Food and Drug Branch of the California Department of Health Services. As of the date of this proxy statement, we have made substantial progress toward demonstrating cGMP compliance and Chemistry, Manufacturing and Controls Management (CMC) required for FDA regulatory approval.

Sponsors of clinical trials are required to register, and report results for, all controlled, clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation. Trial registration may require public disclosure of certain confidential commercial development data.

The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval, may subject an applicant to administrative or judicial sanctions. FDA sanctions could include, among other actions, refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls or withdrawals from the market, product seizures, total or partial suspension of production or distribution injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on our business, financial condition, results of operations and cash flows.

The FDA offers several programs to expedite the development of products that treat serious or life-threatening illnesses and that provide meaningful therapeutic benefits to patients over existing treatments.

RMAT designation:

A drug is eligible for designation as an RMAT if: the drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product or any combination product using such therapies or products, except for those regulated solely under certain other sections; the drug is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition; and preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition. Some of our current and future products may be eligible for RMAT designation.

Orphan designation:

Under the Orphan Drug Act, the FDA may grant orphan designation to a product intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making a product available for this type of disease or condition will be recovered from sales of the product. Orphan designation must be requested before submitting an NDA or BLA. Orphan designation does not convey any advantage in or shorten the duration of the regulatory review and approval process. If a product that has orphan designation subsequently receives the first FDA approval for such product for the disease or condition for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications to market a product containing the same active moiety for the same use or indication for seven years,

except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity. A product is clinically superior if it is safer, more effective or makes a major contribution to patient care. Any claims of clinical superiority could require a head-to-head clinical trial between such drugs. Competitors may receive approval of different products for the indication for which the orphan product has exclusivity or obtain approval for the same product but for a different indication for which the orphan product has exclusivity. If a product designated as an orphan product receives marketing approval for an indication broader than what is designated, it may not be entitled to orphan product exclusivity.

Other Healthcare Laws and Compliance Regulations

Although we currently do not have any products on the market, we may also be subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which we conduct our business. In the United States, among other things, the research, manufacturing, distribution, sale and promotion of pharmaceutical and biological products are potentially subject to regulation and enforcement by various federal, state and local authorities in addition to the FDA, including the CMS, other divisions of the United States Department of Health and Human Services (e.g., the Office of Inspector General), the Drug Enforcement Administration, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety and Health Administration, the Environmental Protection Agency, state Attorneys General and other state and local government agencies. Our current and future business activities, including for example, sales, marketing, and scientific/educational grant programs, must comply with health care regulatory laws, as applicable, including, without limitation:

If our operations are found to be in violation of any of such laws or any other governmental laws or regulations that apply, they may be subject to penalties, including, without limitation, civil and criminal penalties, damages, fines, disgorgement, the curtailment or restructuring of operations, exclusion from participation in federal and state healthcare programs, additional program integrity obligations, individual imprisonment, injunctions, recall or seizure of products, total or partial suspension of production, denial or withdrawal of product approvals, refusal to permit us to enter into supply contracts, including government contracts, contractual damages, reputational harm, administrative burdens, diminished profits, and future earnings, any of which could have a material adverse effect on our business, financial condition, result of operations and cash flows. These additional healthcare regulations could affect our current and future arrangements with healthcare professionals, principal investigators, consultants, customers and third-party payors.

Moreover, the introduction of legislation, implementation of new regulations, or enforcement of existing regulations that have a negative impact on the commercial prospects for the types of products we are developing could negatively impact our share price and our ability to raise capital.

Coverage and Reimbursement

Significant uncertainty exists as to the coverage and reimbursement status of any product candidate that receives regulatory approval. In the United States and markets in other countries, sales of our product candidates, if approved, will depend, in part, on the extent to which third-party payors provide coverage and establish adequate reimbursement levels.

In the United States, third-party payors include federal and state healthcare programs, government authorities, private managed care providers, private health insurers and other organizations. Third-party payors are increasingly challenging the price, examining the medical necessity and reviewing the cost-effectiveness of medical drug products and medical services, in addition to questioning their safety and efficacy. Such payors may limit coverage to specific drug products on an approved list, also known as a formulary, which might not include all the FDA-approved drugs for a particular indication. Third-party payor coverage may be more limited than the purposes for which the product is approved by the FDA or foreign regulatory authorities. Further, one payor’s determination to provide coverage for a drug product does not assure that other payors will also provide coverage for the drug product.

Moreover, the process for determining whether a third-party payor will provide coverage for a drug product may be separate from the process for setting the price of a drug product or for establishing the reimbursement rate that such a payor will pay for the drug product. A payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved or that the product will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution. There may be significant delays in obtaining reimbursement for approved products, and reimbursement rates may fluctuate over time or vary according to the use of the product or clinical setting in which a product is used. Net prices for products may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of products from countries where they may be sold at lower prices than in the United States.

Further, third-party payers are increasingly challenging the price of medical products and services, and there is increasing pressure on biotechnology companies to reduce healthcare costs. If purchasers or users of our products are not able to obtain adequate reimbursement for the cost of using our products, they may forgo or reduce their use. Significant uncertainty exists as to the reimbursement status of newly approved healthcare products, and whether adequate third-party coverage will be available. Our inability to promptly obtain coverage and profitable payment rates from both government funded and private payors for future products we develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize potential products, and our overall financial condition.

Healthcare Reform

In March 2010, former President Obama signed into law The Patient Protection and Affordable Care Act and the Health Care and Education Affordability Reconciliation Act of 2010 (collectively, the “Affordable Care Act”), which substantially changed the way healthcare is financed by both governmental and private insurers in the United States and significantly affected the pharmaceutical industry. The Affordable Care Act contains a number of provisions, including those governing enrollments in federal healthcare programs, reimbursement adjustments and fraud and abuse changes. Additionally, the Affordable Care Act increases the minimum level of Medicaid rebates payable by manufacturers of brand name drugs; requires collection of rebates for drugs paid by Medicaid managed care organizations; requires manufacturers to participate in a coverage gap discount program, under which they must agree to offer point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; and imposes a non-deductible annual fee on pharmaceutical manufacturers or importers who sell “branded prescription drugs” to specified federal government programs.

Since its enactment, there have been judicial and Congressional challenges to certain aspects of the Affordable Care Act, and we expect there will be additional challenges and amendments to the Affordable Care Act in the future. Other legislative changes have been proposed and adopted since the Affordable Care Act was enacted, including aggregate reductions of Medicare payments to providers and reduced payments to several types of Medicare providers. Moreover, there has recently been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed bills designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. Individual states in the United States have also become increasingly active in implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, proposing to encourage importation from other countries and bulk purchasing. We cannot predict what healthcare reform initiatives may be adopted in the future.

We also are subject to various federal, state and local laws, regulations, and recommendations relating to safe working conditions, laboratory and manufacturing practices, the experimental use of animals and the use and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with our research. The extent of government regulation that might result from any future legislation or administrative action cannot be accurately predicted.

Foreign Corrupt Practices Act

Our business activities may be subject to the FCPA and similar anti-bribery or anti-corruption laws, regulations, or rules of other countries in which we operate. The FCPA generally prohibits offering, promising, giving, or authorizing others to give anything of value, either directly or indirectly, to a non-U.S. government official in order to influence official action, or otherwise obtain or retain business. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. Our business is heavily regulated and therefore involves significant interaction with public officials, including officials of non-U.S. governments. Additionally, in many other countries, the health care providers who prescribe pharmaceuticals are employed by their government, and the purchasers of pharmaceuticals are government entities; therefore, our dealings with these prescribers and purchasers are subject to regulation under the FCPA. There is no certainty that all of our employees, agents, suppliers, manufacturers, contractors, or collaborators, or those of our affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws. Violations of these laws and regulations could result in fines, criminal sanctions against us, our officers, or our employees, the closing down of facilities, including those of our suppliers and manufacturers, requirements to obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs, and prohibitions on the conduct of our business. Any such violations could include prohibitions on our ability to offer our products in one or more countries as well as difficulties in manufacturing or continuing to develop our products, and could materially damage our reputation, our brand, our international expansion efforts, our ability to attract and retain employees, and our business, prospects, operating results, and financial condition.

Employees

As of November 30, 2023, we had 13 full-time employees. In July 2022, Renovaro began to streamline the organization to focus around two of its therapies (oncology and HIV therapeutic vaccine). Renovaro has tailored its workforce to focus on these therapies. We believe that we have good relations with our employees.

Corporate Information

On September 28, 2023, Renovaro entered into the Stock Purchase Agreement with GEDi Cube. Upon the terms and subject to the conditions set forth in the Stock Purchase Agreement, Renovaro will acquire 100% of the GEDi Cube Shares from the Sellers and GEDi Cube will become a wholly-owned subsidiary of Renovaro. On September 28, 2023, the Renovaro Board and the board of managers of GEDi Cube unanimously approved the Stock Purchase Agreement. The completion of the Transaction is subject to the satisfaction or waiver of customary closing conditions. The Stock Purchase Agreement contains certain termination rights for both Renovaro and GEDi Cube described herein.

There can be no assurance that the Transaction will be fully realized or may take longer to realize than expected; the possibility that stockholders of Renovaro may not approve the issuance of new shares of Common Stock in the proposed Transaction; the risk that a condition to closing of the proposed Transaction may not be satisfied, that either party may terminate the Transaction Agreement or that the Closing of the proposed Transaction might be delayed or not occur at all.

We trade on Nasdaq under the ticker “RENB.”

Our website is http://www.renovarobio.com. We make available free of charge, on or through our website, our annual, quarterly, and current reports and any amendments to those reports filed or furnished pursuant to Section 13(a) of the Exchange Act as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. Information contained in our website is not part of, nor incorporated by reference into, this proxy statement.

Legal Proceedings

For a description of material legal proceedings to which Renovaro is a party, please refer to the section titled “Item 3. Legal Proceedings” set forth in the Renovaro 2023 Form 10-K and the section titled “Item 1. Legal Proceedings” set forth in the Renovaro First Quarter 2024 Form 10-Q, each of which is incorporated by reference herein.

Property

For a description of Renovaro’s property, please refer to the section titled “Item 2. Properties” set forth in the Renovaro 2023 Form 10-K, which is incorporated by reference herein.

GEDI CUBE’S BUSINESS

Overview

GEDi Cube is an AI-driven healthcare technology company focusing on the earliest possible detection of cancer and its recurrence. GEDi Cube has developed a proprietary AI platform that analyzes genetics using Explainable AI (as defined below) to provide earlier and more accurate cancer diagnosis. This platform uses a multi-omics approach to search for individual biomarkers that are present even in asymptomatic patients. This approach is combined with differential molecular capabilities that are designed to identify, differentiate and pinpoint the exact source. GEDi Cube’s process also involves the mining of biomarker panels, which are integrated into a machine learning library referred to as “GEDiCube” to further enhance diagnosis.

GEDi Cube also aims to utilize its proprietary AI platform in the development of commercial products to support clinical, research and pharmaceutical organizations that are trying to improve patient care through precision diagnosis, prediction of success of therapy, new drug discovery, treatment protocols or clinical trials. Specifically, GEDi Cube specializes in developing products and services aimed at (i) early cancer characterization, (ii) personalized treatment selection, (iii) prediction and tracking response to therapies, (iv) recurrence detection and efficacy monitoring, and (v) ultimately, drug discovery.

GEDi Cube was initially incorporated as Grace Systems B.V. (“Grace Systems”) in 2013 under the laws of the Netherlands to develop unique data mining algorithms to enable banking, finance and government entities to extract business insights from data. Grace Systems began applying its algorithms to biological data in 2018 to uncover cancer-associated patterns. Beginning in 2018, Grace Systems pivoted its platform to focus only on healthcare. On August 22, 2023, GEDi Cube Intl. Ltd. (formerly known as GEDi Health Group Ltd.), initially incorporated in June 2023, acquired 100% of the shares of Grace Systems. Since this acquisition, GEDi Cube has focused on developing its AI technology for early cancer detection and its recurrence and has developed a pipeline of in silico validated biomarker panels for 13 types of cancer.

GEDi Cube has now focused on commercialization of its AI technology. GEDi Cube believes that it has developed a unique approach to the early detection and diagnosis of cancer and its recurrence and, in time, other rare diseases through the systematic analysis of data using AI technologies, data mining procedures and algorithms for health technology.

GEDi Cube’s technology has also been applied to complex heterogeneous cancer data and has been shown to find patterns associated with cancer in public and private data resources. With the help of GEDi Cube’s algorithms, discovered patterns may be translated into biomarkers that can be used in a clinical setting to target various aspects of cancer diagnosis and treatment.

Cancer is a complex set of diseases. The abnormalities that cause cancer and drive its progression can often be observed at multiple molecular layers, including genome, transcriptome, proteome, and even microbiome. The growing prominence of large multi-omics datasets resulting from research studies give GEDi Cube the opportunity to integrate wide-spread molecular alterations underlying cancer and gain actionable knowledge in a precision medicine framework. However, the heterogeneous nature of cancer makes data highly divergent from patient to patient, which makes it difficult to extract meaningful patterns that can be utilized in a clinical setting. GEDi Cube hopes to address the need for more powerful tools to extract information from big data and augment the ability of clinicians to identify cancer quickly and accurately.

GEDi Cube’s Strategy

GEDi Cube’s product development focuses on four core areas:

In response to these four core areas, the key components of GEDi Cube’s product development are to build a software and hardware platform that:

One additional key focus of GEDi Cube is its multi-modal data analysis. Multi-modal data encompasses the whole aspect of data from a patient perspective, whether genomics, imaging, phenotypic or even wearable data, which can be cross-analyzed to produce data that could not be previously produced. GEDi Cube intends to use multi-modal data to bring new insights to the clinical and research teams trying to understand what to do next with the patient.

GEDi Cube’s Technology and Techniques

GEDi Cube is dedicated to the development of early cancer detection blood tests and expects to develop partnerships with third-party laboratories across the United Kingdom, the Netherlands, elsewhere in Europe and the United States and others, as needed. In particular, GEDi Cube is focused on developing tests and test kits that would analyze samples derived from non-invasive liquid biopsy samples and intends to engage third-party laboratories to perform these tests for end-users.

For this purpose, GEDi Cube has developed an AI platform that aims to leverage expertise in both biological and computational sciences and to go beyond traditional tumor signals by detecting the body’s early warning signs of cancer. GEDi Cube’s goal is to provide accurate and reliable tests that can aid in the early diagnosis and treatment of cancer. GEDi Cube’s AI technology is created to detect a wide range of biological signs to enhance the accuracy and sensitivity of early cancer detection and, thereby, enable earlier intervention and potentially improved patient outcomes.

GEDi Cube’s AI technology aims to address three critical facets of medical needs within the domain of cancer diagnosis (as illustrated in below):

Moreover, the versatility of GEDi Cube’s AI technology extends to encompass the realm of rare cancers, including cases such as cancer of unknown primary.

Leveraging DNA methylation data, GEDi Cube has identified and validated biomarker panels tailored for the detection of a wide range of cancers, including bladder, breast, colon, prostate, thyroid, head and neck, liver, kidney and lung cancer.

The foundational architecture of GEDi Cube’s AI technology is engineered to facilitate comprehensive pan-cancer analysis through its extensive record of informative biomarkers discovered across a diverse array of cancer types. This comprehensive repository empowers GEDi Cube’s AI technology to swiftly cross-reference biomarkers and explore molecular commonalities and distinctions that span multiple tumor categories.

For example, the capabilities of GEDi Cube’s AI technology have unearthed biomarkers capable of pinpointing a specific subgroup of thyroid cancer patients characterized by a distinct genomic alteration, the neurotrophic tyrosine receptor kinase (“NTRK”) gene fusion. Identification of these NTRK-positive patients provides an actionable therapeutic target.

Uses of GEDi Cube’s AI Technology

GEDi Cube has developed its AI platform to support: