• A Binding LOI has been executed: GEDiCube will acquire 75% of Cyclomics at Closing.
• Expected breakthroughs by combining technologies in (early) cancer detection and recurrence of cancer with a single vial of blood.
• Cyclomics’ 4th generation liquid biopsy genomics platform is a truly “Omni-Omic” blood test ready for AI application
• GEDiCube’s award-winning AI is developing high-performance biomarker panels for 13 different cancers.
• GEDiCube’s partnership with NVIDIA’s Inception program will help expand to multi-modal capabilities by adding imaging.

The combined Companies aim to Disrupt Cancer Diagnosis and treatment through early disease and recurrence detection, prediction of response to treatment, and personalized therapy.

LOS ANGELES, Feb. 13, 2024 (GLOBE NEWSWIRE) -- GEDi Cube Intl Ltd., a London and Netherlands-based advanced AI company and a wholly owned subsidiary of Renovaro Inc. (NASDAQ: RENB), announces it has executed a binding Letter of Intent (LOI) to acquire 75% of Cyclomics, a Dutch Company. Under the terms of the LOI, the parties have agreed to work in good faith on the drafting of a definitive agreement.

Cyclomics has developed a groundbreaking diagnostic method for monitoring early cancer recurrence named “CyclomicsSeq”- a novel ctDNA (circulating tumor DNA is tumor-derived fragmented DNA in the bloodstream that is not associated with cells) detection assay based on Oxford Nanopore sequencing which delivers fast, low-cost, and point-of-care sequencing. In contrast to available ctDNA-based methods, “CyclomicsSeq” ensures that even a single ctDNA molecule in the blood can be detected at very high accuracy. This solution consists of a new diagnostic kit (CyclomicsSeq), which has been licensed to Oxford Nanopore (LON: ONT), an RNA/DNA next-generation sequencing platform company.

Cyclomics’ Omni-Omic 4th generation technology, we believe, will disrupt the cancer diagnostics market and clinical practice by enabling fast and reliable results and delivering superior performance to standard radiological and physical examination alone. The platform is expected to enable reliable, fast, and ultra-sensitive early/recurrence detection of cancer using the next-generation whole genome sequencing. That is achieved by detecting ctDNA, a reliable biomarker for determining the presence or absence of cancer, which can be non-invasively obtained from a blood sample (liquid biopsy). The novel approach to cancer detection is based on a single vial of blood and multi-dimensional profiling. Cyclomics applies a wide multi-signal/multi-omics approach to a very low amount of tumor ctDNA. The Omni-Omic approach is critical for early cancer detection with high accuracy.

Radiological imaging is the current standard in detecting tumor recurrence, but it suffers from low sensitivity and specificity, very often revealing relapsed cancer when it has progressed too far for effective treatment strategies. Fast non-invasive treatment response monitoring is critical for cancer patients to timely adjust drug doses or change drug choices.

Cyclomics has already developed an early detection technology called “CyclomicsSeq TP53”, an in vitro diagnostic (IVD) kit integrating an innovative sequencing methodology and state-of-the-art analysis software. Ninety percent of Head Neck Cancer (HNC) patients carry specific oncogenic DNA mutations in the gene TP53. There are 150,000 new cases every year in the EU and nearly 70,000 in the USA. The Cyclomics solution can be applied to other cancer types harboring TP53, such as small-cell lung cancer, squamous cell lung cancer, triple-negative breast cancer, and high-grade serous ovarian cancer, and can be expanded to almost all cancer types.

GEDiCube’s platform technology deploys next-generation AI running on NVIDIA's latest chips and stacks genetic and protein expression on top of DNA mutation for accuracy in cancer detection. GEDiCube is focused on developing advanced diagnostic and monitoring tests that use multi-omics, integrating data from each stage of genetic expression, including genomics, epigenomics, transcriptomics, proteomics, fragmentomics and metabolomics. As a member of the Nvidia Inception Program, the company will integrate medical imaging into its AI engine.

Upon closing, the combined companies will aim to accelerate entry into the cancer monitoring market and gain access to integrating whole genome data into GEDiCube’s AI/Machine Learning platform.

“We are very excited about this new opportunity,” said Alessio Marcozzi, PhD, co-founder of Cyclomics. “Our Omni-Omic technology was developed to help empower AI platforms and thereby transform non-invasive healthcare solutions to detect cancers and other diseases as early as possible. GEDiCube’s innovative deep learning algorithms have created robust multi-omics panels that perform remarkably well. Together, I believe we will change the field.” Coenraad van Kalken, MD, PhD, the CEO of GEDiCube, commented, “There is enormous power in applying AI to multiple omics data layers that can be detected from a vial of blood from every patient with cancer. I believe that integrating Cyclomics into GEDiCube will allow us to gain greater accuracy and widespread Omni-omic measurements through next-generation sequencing and enter the cancer monitoring market this year. I consider that to be a significant step towards bringing early detection of cancer to its inflection point.”

About Cyclomics

Cyclomics is a Dutch company founded in 2018, winner of the Health Holland Venture Challenge (startup of the year) by scientists of the UMC Utrecht. Its ambition is to transform cancer care by enabling faster and more reliable diagnoses, particularly in the context of cancer recurrence, thanks to its proprietary circulating tumor DNA (ctDNA) detection technology.

About GEDiCube

At GEDiCube, we are committed to the early detection of cancer, to intervene at a stage where treatment can be most effective. We have developed an award-winning AI Technology that significantly accelerates early cancer detection and diagnosis at an early stage and its recurrence via liquid biopsy. Our platform, “ The Cube,” brings together proprietary artificial intelligence (AI/ML) technology and algorithms, multi-omics, multi-modal data, and the expertise of a carefully selected multidisciplinary team to accelerate precision medicine and enable breakthrough changes in cancer care. As of this morning GEDiCube will operate under its new name, RenovaroCube.

About Renovaro

Renovaro aims to accelerate precision, personalized medicine for longevity powered by mutually reinforcing AI and biotechnology platforms for early diagnosis, better-targeted treatments, and drug discovery. Renovaro includes RenovaroCube and Renovaro Biosciences.

Renovaro Biosciences is an advanced cell-gene-immunotherapy company. Its lead candidate product is a therapeutic vaccine targeting cancers which are difficult to treat including pancreatic and potentially HNC, triple-negative breast cancer, and advanced liver cancer. However, the vaccine could potentially work for all solid tumors and chronic infectious diseases such as HIV and Hepatitis B Virus.

FORWARD-LOOKING STATEMENTS

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’s most recent Annual Report on Form 10-K and its definitive proxy statement related to the acqusition of GEDi Cube Intl Ltd. 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 Inc. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

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