0001731122-23-001419.txt : 20230809 0001731122-23-001419.hdr.sgml : 20230809 20230809090550 ACCESSION NUMBER: 0001731122-23-001419 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20230809 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230809 DATE AS OF CHANGE: 20230809 FILER: COMPANY DATA: COMPANY CONFORMED NAME: RENOVARO BIOSCIENCES INC. CENTRAL INDEX KEY: 0001527728 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 452259340 STATE OF INCORPORATION: DE FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38758 FILM NUMBER: 231153582 BUSINESS ADDRESS: STREET 1: CENTURY CITY MEDICAL PLAZA STREET 2: 2080 CENTURY CITY EAST CITY: SUITE 906 LOS ANGELES STATE: CA ZIP: 90067 BUSINESS PHONE: 45 39179840 MAIL ADDRESS: STREET 1: CENTURY CITY MEDICAL PLAZA STREET 2: 2080 CENTURY CITY EAST CITY: SUITE 906 LOS ANGELES STATE: CA ZIP: 90067 FORMER COMPANY: FORMER CONFORMED NAME: Enochian Biosciences Inc. DATE OF NAME CHANGE: 20230804 FORMER COMPANY: FORMER CONFORMED NAME: Renovaro Biosciences Inc. DATE OF NAME CHANGE: 20230802 FORMER COMPANY: FORMER CONFORMED NAME: Enochian Biosciences Inc DATE OF NAME CHANGE: 20180306 8-K 1 e4918_8k.htm FORM 8-K
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): August 9, 2023

 

Renovaro Biosciences Inc.
(Exact name of registrant as specified in its charter)

 

Delaware   000-54478   45-2559340
(State or other jurisdiction   (Commission File Number)   (I.R.S. Employer
of incorporation)       Identification No.)

 

2080 Century Park East, Suite 906

Los Angeles, CA 90067

 

(Address of principal executive offices)

+1(305) 918-1980

 

(Registrant’s telephone number, including area code)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class   Trading Symbol   Name of Each Exchange on Which Registered
Common Stock, par value $0.0001 per share   RENB   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 
 

 

Item 7.01 Regulation FD Disclosure.

 

Signed LOI

 

On August 9, 2023, Renovaro Biosciences Inc. (“Renovaro”) announced it has signed a letter-of-intent (“LOI”) for a business combination with GEDi Cube Intl Ltd (“GEDi Cube”), a cutting-edge health AI company.

 

Under the terms of the LOI, GEDi Cube will merge with a subsidiary of Renovaro. A copy of the LOI, including a description of the binding provisions thereof, is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

Completion of the transaction with GEDi Cube is subject to, among other matters, the negotiation of a definitive agreement providing for the transaction, satisfaction of the conditions negotiated therein and approval of the transaction by the appropriate parties. There can be no assurance that a definitive agreement will be entered into or that the proposed transaction will be consummated on the terms or timeframe currently contemplated, or at all.

 

Press Release

 

On August 9, 2023, Renovaro issued a press release regarding the signing of the LOI. The contents of the press release are set forth below.

 

AI Company GEDi Cube and Renovaro Biosciences Announce a Binding, Exclusive Letter of Intent to Merge, Accelerating Fight Against Cancer

 

-Cutting-edge AI/machine learning technology with validation in humans for early diagnosis of lung cancer

 

oIn silico detection for 12 additional cancers, including pancreatic

 

oMore than 2,600 proprietary biomarker panels

 

oRapidly expanding to other cancers and diseases

 

-Innovative biotechnology firm with promising pancreatic cancer results projected to begin human studies for several challenging solid tumors by mid-2024

 

-Combination creates potential multiplier effect to accelerate earlier diagnosis, more effective therapy, and precision, in silico drug discovery

 

LOS ANGELES, Calif., August 9, 2023 - Renovaro BioSciences Inc. (NASDAQ:RENB) (formerly NASDAQ: ENOB), an advanced, pre-clinical biotechnology firm in cell, gene and immunotherapy focused on solid tumors with short life expectancy, has executed a binding, exclusive letter of intent to merge a subsidiary with the cutting-edge health AI company GEDi Cube Intl Ltd. The combined company would aim to accelerate diagnosis, enhance treatment effectiveness, discover new therapies, and expand access to life-saving technologies for cancer and other diseases.

 

“I have been privileged to lead life sciences groups at Intel, Oracle, and most recently, NVIDIA,” said Craig Rhodes, CEO of GEDi Cube Intl Ltd. “But GEDi Cube’s remarkably innovative technology developed over nearly a decade has already validated earlier diagnoses of lung cancer in humans at a leading university hospital and created the technology for 12 additional cancers, including pancreatic and breast cancer, which is very inspiring and exciting.”

 

“We are rapidly expanding our technologies to include other cancers and diseases,” Rhodes added. “I believe that uniting with Renovaro BioSciences’ potential solid tumor therapies is not merely synergistic. It could also create a multiplier effect to expedite diagnosis, improve treatment outcomes and discover, in silico, new therapies to improve many lives.”

 

 
 

 

“Renovaro, Latin for ‘renewal,’ represents our company’s mission,” Renovaro Biosciences CEO Dr. Mark Dybul said. ”Our advanced cell, gene and immunotherapy techniques are designed to reinvigorate the body’s natural tumor-fighting mechanisms. I believe joining forces with GEDi Cube could enhance the efficacy of our upcoming trials and speed up the discovery of novel treatment approaches, thereby extending our life-saving technology to more cancer patients and renewing hope for them and their families,” Dr. Dybul added.

 

While Renovaro’s current results focus on pancreatic cancer, it plans to include other solid tumors with short life-expectancy in the first in human Phase I/IIa studies that are in track to start by mid-2024. The rates of these cancers and other serious health conditions are rising rapidly as many populations are growing older. As a concrete example of a potential multiplier effect, GEDi Cube’s AI technology could potentially enable the combined Company to focus upcoming human trials on the cancers most likely to respond to therapy, expand the database of key markers for earlier diagnosis and disease progression and discover new generations of Renovaro’s treatment approach as well as entirely new therapies.

 

Dr. Anahid Jewett is a leading cancer immunotherapy researcher at UCLA who has conducted independent, pivotal studies with Renovaro’s technology in different animal models. She has consistently demonstrated 80% to 90% pancreatic tumor reduction in size and weight that was correlated with significant enhancement of key aspects of the immune response. “After decades as a scientist searching for the best ways to translate laboratory studies into life-saving treatments, I am very excited about the possibilities of uniting advanced AI with some of the most promising results we have seen in our pancreatic cancer models with Renovaro’s technology,” Dr. Jewett said. “To me, this is the future of medicine.”

 

FORWARD-LOOKING STATEMENT

 

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties, including but not limited to the success or efficacy of our pipeline. All statements other than historical facts are forward-looking statements, which can be identified by the use of forward-looking terminology such as “believes,” “plans,” “expects,” “aims,” “intends,” “potential,” or similar expressions. Actual events or results may differ materially from those projected in any of such statements due to various uncertainties, including as set forth in Renovaro BioSciences Inc. (NASDAQ: RENB) most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Renovaro Biosciences, Inc. undertakes no obligation to revise or update this shareholder letter to reflect events or circumstances after the date hereof.

 

For more information on Renovaro Biosciences Inc. go to their website at www.renovarobio.com.

 

For more information on GEDi Cube Intl LTD, go to their website at www.gedicube.com.

 

Press Contact:     IR@Renovarobio.com

IR@Gedicube.com

 

The information presented in Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, unless the Company specifically states that the information is to be considered “filed” under the Exchange Act or specifically incorporates it by reference into a filing under the Securities Act of 1933, as amended, or the Exchange Act.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Exhibit
99.1   Letter of Intent*
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)
* Certain exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company hereby undertakes to furnish copies of such omitted materials supplementally upon request by the U.S. Securities and Exchange Commission.

 

 
 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

RENOVARO BIOSCIENCES INC.  
   
By: /s/ Luisa Puche  
  Name: Luisa Puche  
  Title: Chief Financial Officer  

 

Date: August 9, 2023

 

 

 EX-99.1 2 e4918_ex99-1.htm EXHIBIT 99.1

 

 

 EXHIBIT 99.1

 

Letter of Intent

 

August 1, 2023

 

GEDi Cube Intl Ltd
71-75 Shelton Street, Covent Garden
London, WC2H 9JQ

 

Ladies and Gentlemen:

 

Following our recent discussions, this letter will confirm that Enochian BioSciences Inc., a Delaware corporation (“Enochian”) is interested in acquiring GEDi Cube Intl Ltd (the “Company”) (the “Potential Transaction”). In this letter, the Company and Enochian are referred to as “Party” or “Parties”.

 

The Company has novel, advanced life science Artificial Intelligence (AI)/Large Language Model (LLM) that could potentially be used to diagnosis diseases, predict responses to treatments and help design more effective therapies. Enochian is a cell- gene- immunotherapy company with a potential product to treat solid tumors starting with cancers with limited treatment options and a poor life expectancy. Enochian believes it could be at the human study phased by the mid- to late-2024. The combination of advanced AI/LLM with therapeutic research and development with access to data from humans could potentially accelerate the capabilities of the AI technology while potentially driving better diagnosis and treatment of cancers and other diseases.

 

1.            Material Terms. The material terms will be as set forth on the non-binding Term Sheet set forth as Annex A hereto.

 

The parties, intending to be legally bound, agree to the following legally enforceable paragraphs of this letter (the “Binding Provisions”).

 

2.            Access. Upon execution of this letter, each Party will afford the other Party, and each of their duly authorized representatives, immediate full and free access to the other Party, its personnel, properties, contracts, books and records, and all other documents and data necessary to complete due diligence, subject to the Confidential Disclosure Agreement entered into between the Company and Enochian on July 17, 2023 (the “NDA”).

 

3.            Exclusive Dealing

 

(a)For the period from the date of the Parties execution of this letter until the earlier to occur of (i) the Closing of the Potential Transaction or (ii) 120 days after the execution of this letter (the “Exclusivity Period”), the Company will not, directly or indirectly, through any representative or otherwise, solicit or entertain offers from, negotiate with or in any manner encourage, discuss, accept, or consider any proposal of any other person relating to a transaction similar to the Potential Transaction, in whole or in part, whether directly or indirectly, through purchase, merger, consolidation, or otherwise; and

 

(b)The Company will immediately notify Enochian regarding any contact between the Company, its shareholders, or their respective representatives, and any other person regarding any such offer or proposal or any related inquiry and, if made in writing, furnish a copy thereof.

 

1
 

 

4.           Conduct Of Business. Other than the payment of expenses necessary to consummate the Potential Transaction contemplated hereby, the Company shall operate in the ordinary course and refrain from any transactions outside the ordinary course of business.

 

5.           Confidentiality. Prior to the closing of the Potential Transaction, the Company will not, except as otherwise required by law, without the written consent of Enochian, make any announcement about the Potential Transaction to the Company’s customers, suppliers, or employees, or to any other person or entity, or otherwise disclose the existence of this letter, the existence of the discussions among the parties concerning the Potential Transaction or the specific terms of this letter. The parties will cooperate with one another in good faith in making a joint public announcement of the existence of the Potential Transaction, if legally necessary. Except as expressly modified herein, all other confidentiality agreements entered into between the Company and Enochian, including but not limited to the NDA, shall remain in full force and effect.

 

6.           Costs. Except as provided for in the Purchase Agreement, each Party will be responsible for and bear all of its respective costs and expenses incurred at any time in connection with pursuing or consummating the Potential Transaction.

 

7.           Termination. The Binding Provisions will automatically terminate upon the earliest of the following (the “Termination Date”): (i) expiration of the Exclusivity Period; (ii) execution of the Purchase Agreement by all parties thereto; or (iii) the mutual written agreement of Enochian and the Company; provided, however, that the termination of the Binding Provisions will not affect the liability of a Party for breach of any of the Binding Provisions prior to the termination. Upon termination of the Binding Provisions, the Parties will have no further obligations under this letter except that Paragraphs 5 and 9 will survive such termination.

 

8.            Effect of Letter. The Term Sheet attached to this letter is intended only as an expression of interest on behalf of Enochian, is not intended to be legally binding on any party, and is expressly subject to the negotiation and execution of an appropriate Purchase Agreement. In addition, nothing in this letter should be construed as an offer or commitment on the part of Enochian to submit a definitive proposal concerning the Potential Transaction. Except as expressly provided in Paragraphs 2 through 9 (or as expressly provided in any binding written agreement that the Parties may enter into in the future), no past or future action, course of conduct, or failure to act relating to the Potential Transaction, or relating to the negotiation of the terms of the Purchase Agreement, will give rise to or serve as a basis for any obligation or other liability on the part of the Parties.

 

9.           Miscellaneous.

 

(a)Entire Agreement. The Binding Provisions and the NDA supersede all prior agreements, whether written or oral, among the Parties with respect to their subject matter and constitute a complete and exclusive statement of the terms of the agreement between the Parties with respect to their subject matter.

 

(b)Modification. The letter may only be amended, supplemented, or otherwise modified by a writing executed by the Parties.

 

2
 

 

(c)Governing Law. All matters relating to or arising out of the Potential Transaction and the rights of the Parties (sounding in contract, tort, or otherwise) will be governed by and construed, and interpreted under the laws of the State of Delaware, U.S.A., without regard to conflicts of laws principles that would require the application of any other law.

 

(d)Jurisdiction; Service of Process. Any proceeding arising out of or relating to a Potential Transaction shall be brought in the federal or state courts of the State of Delaware, and each of the Parties irrevocably submits to the jurisdiction of such court in any such proceeding, waives any objection it may now or hereafter have to venue or to convenience of forum, agrees that all claims in respect of such proceeding shall be heard and determined only in any such court, and agrees not to bring any proceeding arising out of or relating to the Potential Transaction in any other court. Each Party acknowledges and agrees that this paragraph 9(d) constitutes a voluntary and bargained-for agreement between the Parties. Process in any proceeding may be served on any party anywhere in the world.

 

(e)Counterparts. This letter may be executed in one or more counterparts, each of which will be deemed to be an original copy and all of which, when taken together, will be deemed to constitute one and the same document and will be effective when counterparts have been signed by each of the parties and delivered to the other parties, including delivery by electronic means.

 

If you are in agreement with the foregoing, please sign and return one copy of this letter, which thereupon will constitute our understanding with respect to its subject matter and a binding agreement with respect to the Binding Provisions.

 

Very truly yours,

 

Enochian BioSciences Inc.  
     
By: /s/ Mark Dybul
Name: Mark Dybul, M.D.
Title: Chief Executive Officer

 

Accepted and agreed:

 

GEDi Cube Intl Ltd

 

By: /s/ Karen Brink  
Name: Karen Brink  
Title: Director  

 

3

 

 

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