Full Press Release Details
Message from Renovaro Bioscience, Inc.'s CEO, The Hon.
Accelerating Healthcare With Award-Winning AI: Big Steps Forward
In 2023 And The Early Days Of 2024
LOS ANGELES, January 16, 2024 (GLOBE NEWSWIRE) -Renovaro Biosciences
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
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 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.
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.
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
-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
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