LOS ANGELES, Oct. 02, 2023 (GLOBE NEWSWIRE) -- Renovaro Biosciences Inc.
(Nasdaq: RENB)
Dear Shareholders,
I am writing to provide you with an update on our recent news of signing a
definitive agreement to combine with GEDiCube (GEDiCube Press Release
(https://www.businesswire.com/news/home/20230929767003/en/GEDi-Cube-and-
Renovaro-Biosciences-Sign-Definitive-Agreement-to-Combine)) (Renovaro Press
Release (https://renovarobio.com/news/news-details/2023/Renovaro-Biosciences-
and-AI-Health-Company-GEDi-Cube-Sign-Definitive-Agreement-to-
Combine/default.aspx)) and to share our vision for the promising future of our
newly combined company if you, as shareholders, approve the agreement. As we
embark on this next chapter, we want to express our appreciation for your
ongoing support and investment.
Renovaro Biosciences and GEDiCube strategically decided to combine our two
companies just months ago. We believe the combination will accelerate our shared
mission to transform medicine and promote healthy longevity through the
synergistic applications of advanced AI technology and pioneering
biotherapeutics.
The parties intend that I will serve as the CEO of the combined company. I am
humbled and honored to serve in that role. I firmly believe that we will achieve
far more together than either company could on its own. GEDiCube spent over a
decade developing a proprietary AI platform that has already shown accuracy in
detecting cancers earlier through analysis of complex molecular data. Renovaro
leveraged decades of collective immunology expertise to develop a robust
pipeline of novel immunotherapies.
By joining forces, our two technology divisions will collaborate to push new
boundaries in precision diagnostics and targeted treatments. At the same time,
we will maintain nimble independent operations, allowing each platform to
advance rapidly.
I am excited to lead this combined company alongside our esteemed leadership
team and board members, who offer unparalleled experience across AI, healthcare,
and biotechnology. We share an ambitious vision to leverage AI to improve
patient outcomes by detecting diseases sooner and matching treatments more
precisely to the individual. We believe that the coming months will be exciting
as we prepare to realize this combination's potential and deliver on our
commitment to shareholders.
In this letter, I'd like to provide an update on the combined company, our
shared vision, our plans for immediate revenue generation, and our
opportunities.
Background
GEDiCube and Renovaro Biosciences came together through a shared desire to
accelerate innovation in precision medicine. However, our crossing paths was not
coincidental. It resulted from a carefully considered strategy to combine
strengths and synergize work to elevate patient care by harnessing GEDiCube's AI
technology and its strategic partnerships, including with NVIDIA's inception
platform and Renovaro's biotechnology.
GEDiCube's founding mission was to enable earlier disease intervention through
AI-driven insights. Their proprietary platform using differential multi-omics
analysis was honed over a decade to pinpoint molecular patterns that can detect
cancer sooner than standard methods. GEDiCube won a prestigious medical
technology competition by using it to diagnose lung cancer with remarkable
accuracy.
Renovaro was founded to develop powerful new immunotherapies that retrain the
body's intrinsic capacity to fight cancer. Despite recent advances, many solid
tumors like pancreatic, liver, and triple-negative breast cancer have seen
limited improvement in survival rates. Renovaro aimed to change that paradigm
using genetically modified allogeneic dendritic cells to stimulate anti-tumor
immunity.
As we learned about each technology, it rapidly became apparent that combining
Renovaro's immunotherapies with GEDiCube's AI-driven early diagnostic
capabilities, its potential to help determine cancers to target for therapy, to
monitor the effectiveness of therapy, and even discovering new approaches to
treatment could lead to a powerful synergy. More lives could possibly be saved
by catching cancers sooner and matching patients with optimal treatments. At the
same time, using real-world data, GEDiCube's AI algorithms could guide and
accelerate Renovaro's therapy development. The knowledge Renovaro has about key
aspects of the immune system that relate to how cancers could respond to
treatment, its access to the databases of clinicians and large hospital systems,
and the results from its own future clinical trials could help strengthen
GEDiCube's AI technology.
This compelling strategic rationale drove our decision to join forces. Though
our platforms are distinct, together, we will collaborate to enhance the
productivity and performance of both. United, we believe we can achieve the
shared goal of delivering more effective, proactive, and personalized care to
the patients who need it.
Introducing The New Company
Our combined company brings together two innovative platforms in AI and
biotherapeutics to offer comprehensive solutions spanning early cancer
detection, diagnostic insights, and targeted immunotherapies.
GEDiCube contributes an award-winning AI technology that has already shown the
ability to detect lung cancer early with 95% accuracy by analyzing complex
molecular data. Their proprietary platform searches for patterns across
genomics, epigenomics, transcriptomics, and other omics layers to identify
informative biomarkers for over 12 cancers so far. With a strategic partnership
with NVIDIA to incorporate medical imaging, GEDiCube is pioneering multi-modal
AI to improve diagnostic accuracy further. GEDiCube intends to rebrand as
Renovaro.AI.
Renovaro's key strength is an advanced immunotherapy platform focused initially
on some of the deadliest solid tumor cancers that have seen only slightly
improved survival rates. A patented approach modifies allogeneic dendritic cells
to stimulate anti-tumor immunity specific to a patient's genetic profile. In
pancreatic cancer models, this personalized vaccine technology has shown an
80-90% reduction in tumor size. Renovaro expects to start human trials in the
second half of 2024.
Our combined company unites renowned leaders in AI and immunotherapy to deliver
transformative solutions across the cancer care continuum. I am honored to serve
as CEO, bringing decades of global health leadership experience, including
previously directing the U.S. President's Emergency Plan for AIDS Relief
(PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis, and Malaria. I am
joined by accomplished directors like Gregg Alton, former interim CEO of Gilead
Sciences, to help guide our strategy.
Visionary Craig Rhodes, CEO of GEDiCube, former head of Life Sciences for
Europe, the Middle East, and North Africa at NVIDIA, and before that, the leader
for the AI divisions of Intel and Oracle. His pioneering partnership brings AI
to frontline cancer diagnosis and treatment. Craig's team has already developed
proprietary, award-winning technology that can detect lung cancer early with
remarkable accuracy. He will lead Renovaro.AI.
Our combined company brings together renowned leaders across AI and
immunotherapy, including Dr. Anahid Jewett, Professor and Director of the tumor
immunology laboratory at UCLA. Dr. Jewett is nationally and internationally
recognized for her groundbreaking contributions to NK cell biology and cancer
immunotherapy. Her work developing methods to generate super-charged NK cells is
now being used in clinical trials with cancer patients. Dr. Jewett has also
conducted pivotal studies using our immunotherapy technology and demonstrated a
remarkable 80-90% reduction in pancreatic tumor size in models. Her expertise
and involvement are a tremendous asset as we prepare to enter human trials in
2024.
Together, we believe our leadership team offers the expertise to deliver
integrated AI solutions for earlier diagnosis and targeted immunotherapies that
match treatments more effectively to patients. Our combined capabilities are
structured to transform cancer care and detection across the continuum.
The Road Ahead
I am optimistic about the growth trajectory ahead for our combined company, with
multiple revenue-generating products expected to begin in 2024.
The AI division intends to launch commercial products for early cancer detection
and improved therapy selection in 2024. The rapidly expanding precision medicine
market - which is projected to reach $175 billion by 2030 - represents a
tremendous opportunity. We believe we are strategically positioned to capture a
substantial share of a largely untapped market.
The immunotherapy division plans to start Phase 1/2 trials of our lead asset in
the second half of 2024. I believe that this breakthrough approach could
possibly lead to emergency use authorization as soon as the end of 2027
following the results of a Phase 2 clinical trial, transforming treatment for
cancers with stagnant survival rates like pancreatic cancer.
We are also focused on supplementing our cash position through dilutive and non-
dilutive opportunities for pancreatic and other cancers, as well as for AI.
I am confident in our future, defined by life-saving advancements in diagnostic
insights and targeted immunotherapies for previously untreatable diseases.
Closing
I want to express my sincere appreciation for your support as shareholders in
getting our combined company to this point. Thanks to your ongoing investment,
we believe we have the potential to profoundly improve patient outcomes through
the intersection of AI and biotechnology.
Upon closing, we intend to leverage our synergistic capabilities and leadership
expertise to achieve what neither could alone. We are motivated every day by the
patients we can impact with more precise, effective cancer care.
Challenges will lie ahead, as with any company on the cutting edge. However, the
need has never been greater for transformative solutions like ours. We believe
that we have the vision, technology, and talent to transform how cancer is
detected and managed early on.
Together, we have the opportunity and responsibility to fundamentally transform
the lives of patients and families across the globe with healthy longevity, and
to define the future of medicine.
Cautionary Note Regarding 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 or that shareholders of Renovaro may
not approve 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.
About the Companies
GEDi Cube, Intl LTD is pioneering a multi-modal approach for the early detection
of cancer and its recurrence involving blood biopsies, imaging, and multiomic
analysis. The company has a strategic partnership with NVIDIA, the leader in
semiconductors for AI. For more information on GEDi Cube Intl LTD, go to their
website at www.gedicube.com
Renovaro Biosciences Inc. 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
Biosciences Inc., go to its website at www.renovarobio.com.
Contact: ir@renovarobio.com
Source: Renovaro Biosciences Inc.
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