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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 |
| o | In
silico
detection
for
12
additional
cancers,
including
pancreatic |
| o | More
than
2,600
proprietary
biomarker
panels
|
| o | Rapidly
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
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. |
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. |
| (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 |
|
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