LOS ANGELES, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Renovaro Biosciences Inc.
(Nasdaq: RENB)
Dear Shareholders,
Happy New Year.
I write to update you on our key developments towards precision medicine for
healthy longevity - starting with cancer - powered by mutually reinforcing AI
and biotechnology platforms for early diagnosis, better-targeted treatments, and
drug discovery towards our vision of a world with effective cancer treatments
free from toxic chemotherapy.
As we move from an exciting 2023, highlighted by:
- Signing a definitive agreement to combine with the European-based, cutting-
edge AI company GEDi Cube;
- GEDi Cube signed a partnership with NVIDIA to expand its multi-omic
capabilities to multi-modal and has progressed toward commercialization of
liquid biopsy test kits in 2024;
- Consistently achieving in pre-clinical studies what Dr. Anahid Jewett, an
oncological immunology scientist at UCLA, recently named among the top 3% of
researchers in the world by Stanford University, calls "The holy grail of cancer
research."
2024 is off to a promising start:
- The Company filed its definitive proxy statement for its shareholder meeting
scheduled for January 25, 2024, in order to vote on matters related to the
combination with GEDi Cube.
GEDi Cube has Promising AI advancements toward commercialization in 2024
In addition, since the last CEO letter, we have been advised by GEDi Cube that
its team has substantially accelerated its multi-omic health technology while
aggressively pursuing key partnerships to contribute to the commercialization of
potential products and lay a solid foundation for a client base for rapid uptake
when products become available.
In that regard, GEDi Cube became a formal Inception Partner of NVIDIA. This
partnership gives GEDi access to their resources for infrastructure and scaling,
and specific advice and guidance from their Inception Team to progress towards
moving from a multi-omic to a multi-modal approach by incorporating imaging
technology.
GEDi Cube also informed us that it 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 has progressed its efforts with a three-phase workflow for its AI
platform for biomarker discovery.
* Phase I of the workflow behind GEDi Cube's AI platform primarily centers on
the pivotal process of biomarker discovery. This intricate procedure unfolds
through the application of data mining algorithms and statistical
methodologies integrated into the AI platform. The paramount objective of
Phase I is to reduce the plethora of genomic features displaying variations
across samples, which is accomplished by systematically eliminating
extraneous or inconsequential features while preserving those features that
exhibit the greatest potential for accurately detecting cancer.
* Phase II of the workflow builds upon the foundation of selected biomarkers
by focusing on understanding the dynamic interplay among these chosen
biomarkers, culminating in the creation of composite panels. The goal of
Phase II is to pinpoint biomarker combinations that not only demonstrate
robustness in detecting cancer but also maintain their efficacy across
diverse contexts. GEDi Cube believes that its AI algorithms are adept at
uncovering multiple combinations across a spectrum of panels, which is
supported by GEDi Cube's AI-guided panel mining, a proprietary combinatorial
optimization technique used by GEDi Cube's AI technology. This approach,
coupled with the capacity to explore numerous panels, significantly enhances
the likelihood of discovering panels that align with specific metric
criteria, such as sensitivity, specificity, precision, and recall, and
allows for tailoring criteria to align with the client's unique needs, such
as the number of biomarkers included per panel or the inclusion of
biomarkers associated with the expression of specific genes. The performance
of the top-tier panels is further fine-tuned through the application of
machine learning models. Subsequently, the efficacy of these biomarker
panels in detecting cancer is validated through independent data sets.
* Phase III of the workflow involves GEDi Cube's collaboration with its
clinical partners to validate the performance of the biomarker panels.
Through this collaboration, GEDi Cube is able to confirm the utility and
accuracy of its biomarker panels in real-world clinical contexts.
While we await your decision on the business combination, the GEDi Cube and
Renovaro Biosciences teams have been actively planning for a potential
multiplier effect through the combined companies. We have jointly engaged to
design clinical studies that will collect blood and biopsy samples from leading
cancer centers in the USA and Holland to help accelerate the potential
commercialization of AI-powered products.
Advancing a Cancer Vaccine Toward Studies in Humans
Renovaro Biosciences has expanded the pre-clinical validation of the
effectiveness of the cancer vaccine RENB-DC11. Dr. Jewett dubbed the results
"the holy grail of cancer research" based on the highly reproducible results
obtained in 4 experiments of pancreatic cancer in humanized mice conducted by
UCLA, including:
- Rapid and significant tumor regression: an 80-90% decrease in tumor size;
- Effective tumor infiltration: significant infiltration of the tumor sack by
effector immune cells, indicating ongoing killing of cancer cells;
- Immune Cell activation predicted by the anticipated mechanism of action:
significant increases in the blood of effector immune cells and key markers of
cancer-killing immune activation, and;
- Aggressive cancer progression inhibition: no metastases.
Recently, a leading contract research organization conducted an additional
animal study that was designed to examine the effects of RENB-DC11 in a more
advanced stage of pancreatic cancer. In the treated group, there were no
metastases, and there was a significant reduction in tumor size - down to an
undetectable level. Compared with previous studies, half the dose and a non-
matched pancreas tumor line lysate, rather than matching it to the specific
cancer tissue biopsy, were used.
In addition, Dr. Jewett conducted a preliminary study in liver cancer with
promising results, showing a reduction in cancer progression, including
metastases, and apparently improved survival in mice treated with the vaccine
compared to the untreated group of animals.
While both studies are small and will be repeated, the results are encouraging
and consistent with the strong response observed in all previous studies.
In addition, we have made substantial progress toward manufacturing clinical-
grade material under Good Manufacturing Processes (GMP), enabling both safety
and toxicity studies required for the filing of an Investigational New Drug
(IND) application to initiate clinical trials.
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 32 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 sub-contractors who have already been identified rather than
outsourcing to a Clinical Research Organization. This should help ensure the
combined Phase 1 and 2 trial's quality and speed and reduce the estimated cost
by 50%.
Link to the deep-dive slide deck on the cancer platform:
https://renovarobio.com/events-and-presentations/default.aspx
Structured for Success
The structure envisioned for the combined Company, and as outlined in the Proxy,
is a Topco, for which I would serve as CEO, and two subsidiaries - Renovaro
Bioscience and GEDi Cube, with the intention to change the name to Renovaro AI
or another appropriate name. This approach is intended to allow each subsidiary
to advance its cutting-edge technologies without introducing cultural and
management challenges inherent in business combinations. However, as indicated,
we have already begun planning for a multiplier effect at the intersection of
the health tech and biotech platforms. This could lead to potentially numerous
"AI clones" and new therapies that could create the foundation for evergreen
business opportunities.
We firmly believe the winning combination of cutting-edge Health Tech and
Biotech offers an opportunity for an end-to-end approach to cancer - from early
diagnosis and detection of recurrence to prediction of treatment effectiveness
to the discovery of new therapies while advancing our existing therapeutic
vaccine towards our vision for living a long, healthy life free from toxic
chemotherapy.
Thank you for your support and for investing in the Company. As we turn the page
to a new year, we look forward to the opportunity to combine with GEDi Cube's
team of experts and award-winning AI.
Let's help define the future of medicine - together.
Forward-Looking Statements
This communication contains "forward-looking statements" within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. All statements, other than
statements of historical fact, included in this communication that address
activities, events, or developments that Renovaro or GEDi Cube expects,
believes, or anticipates will or may occur in the future are forward-looking
statements. Words such as "estimate," "project," "predict," "believe," "expect,"
"anticipate," "potential," "create," "intend," "could," "would," "may," "plan,"
"will," "guidance," "look," "goal," "future," "build," "focus," "continue,"
"strive," "allow" or the negative of such terms or other variations thereof and
words and terms of similar substance used in connection with any discussion of
future plans, actions, or events identify forward-looking statements. However,
the absence of these words does not mean that the statements are not forward-
looking. These forward-looking statements include but are not limited to,
statements regarding the proposed Transaction, the expected closing of the
proposed Transaction and the timing thereof, and as adjusted descriptions of the
post-transaction company and its operations, strategies and plans, integration,
debt levels and leverage ratio, capital expenditures, cash flows and anticipated
uses thereof, synergies, opportunities, and anticipated future performance.
Information adjusted for the proposed Transaction should not be considered a
forecast of future results. There are a number of risks and uncertainties that
could cause actual results to differ materially from the forward-looking
statements included in this communication. These include the risk that cost
savings, synergies and growth from the proposed Transaction may not be fully
realized or may take longer to realize than expected; the possibility that
shareholders of Renovaro may not approve the issuance of new shares of Renovaro
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; potential adverse reactions or
changes to business or employee relationships, including those resulting from
the announcement or completion of the proposed Transaction; the occurrence of
any other event, change or other circumstances that could give rise to the
termination of the stock purchase agreement relating to the proposed
Transaction; the risk that changes in Renovaro's capital structure and
governance could have adverse effects on the market value of its securities and
its ability to access the capital markets; the ability of Renovaro to retain its
Nasdaq listing; the ability of GEDi Cube to retain customers and retain and hire
key personnel and maintain relationships with their suppliers and customers and
on GEDi Cube's operating results and business generally; the risk the proposed
Transaction could distract management from ongoing business operations or cause
Renovaro and/or GEDi Cube to incur substantial costs; the risk that GEDi Cube
may be unable to reduce expenses; the impact of the COVID-19 pandemic, any
related economic downturn; the risk of changes in regulations effecting the
healthcare industry; and other important factors that could cause actual results
to differ materially from those projected. All such factors are difficult to
predict and are beyond Renovaro's or GEDi Cube's control, including those
detailed in Renovaro's Annual Reports on Form 10-K, Quarterly Reports on Form
10-Q and Current Reports on Form 8-K that are available on Renovaro's website at
www.renovarobio.com and on the website of the Securities and Exchange Commission
(the "SEC") at www.sec.gov. All forward-looking statements are based on
assumptions that Renovaro and GEDi Cube believe to be reasonable but that may
not prove to be accurate. Any forward-looking statement speaks only as of the
date on which such statement is made, and neither Renovaro nor GEDi Cube
undertakes any obligation to correct or update any forward-looking statement,
whether as a result of new information, future events or otherwise, except as
required by applicable law. Readers are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date hereof.
No Offer or Solicitation
This report is not intended to and shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to buy any
securities or a solicitation of any vote or approval, nor shall there be any
sale of securities in any jurisdiction in which such offer, solicitation or sale
would be unlawful prior to registration or qualification under the securities
laws of any such jurisdiction. No offer of securities shall be made except by
means of a prospectus meeting the requirements of Section 10 of the Securities
Act of 1933, as amended.
Important Additional Information Regarding the Merger Will Be Filed with the SEC
and Where to Find It
In connection with the proposed Transaction, Renovaro has filed relevant
materials with the SEC, including a proxy statement (the "proxy statement").
Promptly after filing the Proxy Statement with the SEC, Renovaro mailed the
Proxy Statement and a proxy card to each Renovaro stockholder entitled to vote
at the Special Meeting. This communication is not a substitute for the Proxy
Statement or for any other document that Renovaro may file with the SEC or send
to Renovaro's stockholders in connection with the proposed
Transaction. INVESTORS AND SECURITYHOLDERS OF RENOVARO ARE URGED TO CAREFULLY
AND THOROUGHLY READ THE PROXY STATEMENT, AS MAY BE AMENDED OR SUPPLEMENTED FROM
TIME TO TIME, AND OTHER RELEVANT DOCUMENTS FILED BY RENOVARO WITH THE SEC
BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT RENOVARO, GEDI CUBE AND
THE PROPOSED TRANSACTION, THE RISKS RELATED THERETO AND RELATED MATTERS.
The Proxy Statement was mailed on or about January 4, 2024, to Renovaro's
stockholders of record as of the close of business on December 29, 2023.
Investors and security holders are able to obtain free copies of the Proxy
Statement and other documents filed by Renovaro with the SEC at www.sec.gov.
Copies of documents filed with the SEC by Renovaro, including the proxy
statement are available free of charge from Renovaro's website at
www.renovarobio.com under the "Financials" tab.
Participants in the Solicitation
Renovaro and its directors and executive officers may be deemed to be
participants in the solicitation of proxies from the stockholders of Renovaro in
connection with the proposed Transaction. Information about Renovaro's directors
and executive officers is set forth in Renovaro's annual report on Form 10-K/A
filed with the SEC on October 30, 2023, and the Proxy Statement. Other
information regarding the interests of such individuals, as well as information
regarding other persons who may be deemed participants in the proposed
Transaction, is set forth in the proxy statement and other relevant materials to
be filed with the SEC. Stockholders of Renovaro, potential investors, and other
readers should read the Proxy Statement carefully when it becomes available
before making any voting or investment decisions.
ABOUT THE COMPANY
Renovaro has developed advanced cell, gene, and immunotherapy platforms designed
to renew the body's natural tumor-fighting capabilities against cancer and
infectious diseases. For more information on Renovaro, go to their website at
www.renovarobio.com (http://www.renovarobio.com).
Contact: ir@renovarobio.com (mailto:ir@renovarobio.com)
Source: Renovaro Biosciences Inc.
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