Renovaro Issues Shareholder Letter and Provides Corporate Update

Rhea-AI Summary

Renovaro Inc. (NASDAQ: RENB) has issued a corporate update highlighting recent developments and 2025 plans. The company has signed a binding letter of intent to acquire Predictive Oncology, which will provide access to a vast database including 150,000 frozen tumor samples and 20 years of drug response data. The acquisition aims to strengthen Renovaro's core programs in cancer diagnostics and therapeutics.

The company has formed a strategic collaboration with Nebul to access advanced computing capabilities for their AI-powered cancer detection tests. Through the Lumina project, they will receive 300 samples for non-small cell lung cancer analysis. Additionally, Maurice van Tilburg has transitioned to full-time CEO of the AL/ML subsidiary, GEDiCube, and Nathen Fuentes has joined as CFO. The company has regained good standing with NASDAQ and plans an international roadshow in January 2025.

Positive

• Signed binding LOI to acquire Predictive Oncology, gaining access to extensive tumor database and CLIA laboratory
• Strategic collaboration with Nebul providing advanced computing capabilities
• Access to 300 NSCLC samples through Lumina project for test development
• Regained NASDAQ compliance
• Strengthened management team with new full-time subsidiary CEO and CFO appointments

Negative

• None.

Insights

Market Research Analyst

The shareholder letter reveals several significant strategic developments for Renovaro, primarily centered on their planned acquisition of Predictive Oncology. The binding LOI provides access to a substantial database of 150,000 frozen tumor samples and extensive drug response data, significantly enhancing their AI-driven cancer diagnostics capabilities. This database acquisition addresses a critical business need and could accelerate their product development timeline.

The strategic collaboration with Nebul for superpod computing power, combined with access to 300 NSCLC samples through the Lumina project, positions Renovaro to advance their AI-powered cancer detection platform. The company's dual focus on AI cancer detection and cancer vaccines shows promising synergistic potential, though monetization remains a key challenge.

While the company has resolved its NASDAQ compliance issues, investors should note that with a market cap of $160.3 million, successful execution of these initiatives is important for future growth. The upcoming international roadshow suggests active pursuit of additional capital or strategic partnerships.

Medical Research Analyst

The integration of Predictive Oncology's PEDAL platform with Renovaro's existing capabilities represents a significant technological advancement in personalized cancer treatment. The combination of AI technology with extensive biological samples (40,000 FFPE blocks, 200,000 pathology slides) creates a robust foundation for developing precision oncology solutions.

The development of their Dendritic Cancer Cell Vaccine (DCCV) platform, enhanced by AI/ML analysis for gene discovery, shows promise for creating cancer-specific treatments. The potential evolution from personalized vaccines to off-the-shelf solutions could dramatically improve treatment accessibility and effectiveness. The planned presentation at AACR in April 2025 will be a important milestone for validating their approach to the scientific community.

Company to Host International Roadshow the Week of January 13, 2025

LOS ANGELES, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Renovaro Inc. (NASDAQ: RENB), a pioneer in cancer diagnostics and therapeutics powered by artificial intelligence, today issued a letter to shareholders from Chief Executive Officer David Weinstein.

Dear Shareholders,

As we enter the new year, I wanted to update you on the progress we have made in the last two months and further define our trajectory for 2025. Our comprehensive analysis of both businesses and development of a 100-day plan of action has already turned up some hidden value in both businesses and is helping us understand key areas of the business we need to fortify. We have identified three areas as mission critical for building the point of care cancer detection, personalized therapy and vaccine business are: we need to acquire large amounts of data, build the business of clinical decision support for oncologists, and monetize our AI though building and licensing predictive models for drug repurposing and our cancer vaccine. We are meeting these three challenges through the acquisition of Predictive Oncology.

We recently signed a binding letter of intent to acquire Predictive Oncology (NASDAQ: POAI) that will provide us with a tremendous company-owned database consisting of 150,000 frozen / live tumor samples, 20 years of drug response data, 40,000 FFPE tissue blocks, 200,000 pathology slides and digital library, and a fully certified CLIA laboratory. We plan to commercialize Predictive’s clinical support test that assists oncologists in selecting the best therapy for their patients, and deploy their multi-omic AI system for drug discovery known as PEDAL (Patient-centric Discovery by Active Learning), a platform that combines AI technology, drug response data, and a large biobank of tumor samples to predict how different tumors will respond to various drugs. These capabilities strengthen all of our core programs at Renovaro.

When Renovaro Biosciences acquired GEDiCube, the rationale was that these two business segments were synergistic. This remains a core value proposition but for synergies to materialize requires structured collaboration between the two verticals: AI cancer detection and genetically enhanced cancer vaccines. Since my arrival at Renovaro we have prioritized this collaboration and have identified an array of joint initiatives. There are two business developments that we are pursuing.

1) Identifying a whole genome sequencer that can serve as the front end of our point of care cancer detection platform. Given our wet lab in California, this is where the initial testing will take place.
2) GEDiCube to deploy its AI/ML analysis to discover more genes and factors that can be deployed in our Dendritic Cancer Cell Vaccine (DCCV). Incorporating these new discoveries into our patent filings will build shareholder value by ringfencing our DCCV platform and providing us the ability to partner or license specific cancer applications. This has the potential to enhance the core three elements we infuse into our DCCV now, allowing it to become specific for cancer types, and ultimately be available as an off the shelf solution. In the future this could facilitate early cancer detection in a doctor’s office followed by the treatment of a patient with our vaccine. To gain exposure for our DCCV and generate business development we will be attending the American Association for Cancer Research (AACR), the first and largest cancer research organization, Annual Meeting in April 2025.

To make our AI/ML powered early cancer detection tests a reality, Renovaro requires two vital components: the latest superpods to achieve the speed necessary to run trillions of calculations, and critical data and sample sets. We announced in late December 2024 that we have formed a strategic collaboration with Nebul (www.nebul.com) that will provide us with that power. Additionally, Nebul is focused on healthcare and is ISO certified. The company has received a grant for the Lumina project that aims to deliver an advanced Minimal Residual Disease (MRD) detection platform for non-small cell lung cancer (NSCLC). This project provides us with 100 samples for immediate analysis followed by an additional 200 samples as they are generated and provides us with the critical data we need to develop our test. Over the next several months we will be acquiring the necessary data and samples to advance our programs.

I am delighted to announce that our Maurice van Tilburg, our Chairman, has decided to join us full time as the CEO of our AL/ML subsidiary, GEDiCube. Renovaro management, including Mr. van Tilburg, will be hosting investor meetings the week of January 13, 2025, in Amsterdam, Stockholm, Copenhagen, Monaco, Riyadh and Abu Dhabi. To schedule a meeting, please reach out to our investor relations firm, MZ Group, at RENB@mzgroup.us.

Further strengthening our management team, we have brought Nathen Fuentes on board as our CFO. On the corporate front, NASDAQ notified us that the company is now in good standing. We are now in full have taken critical steps in building a point of care cancer detection and vaccine company and will continue to update you regularly on our progress.

Sincerely,

David Weinstein
CEO
Renovaro Inc.

About Renovaro

Renovaro https://renovarogroup.com/ aims to accelerate precision and personalized medicine for longevity powered by mutually reinforcing AI and biotechnology platforms for early diagnosis, better-targeted treatments, and drug discovery. Renovaro Inc. includes RenovaroBio with its advanced cell-gene immunotherapy company and RenovaroCube.

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, platform and fundraising. 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 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.

Investor Relations

Chris Tyson
Executive Vice President
MZ Group - MZ North America
949-491-8235
RENB@mzgroup.us
www.mzgroup.us

For media inquiries, please contact:

karen@renovarocube.com and STarsh@Renovarogroup.com

FAQ

What is the significance of Renovaro's (RENB) acquisition of Predictive Oncology?

The acquisition provides Renovaro access to a vast database of 150,000 frozen tumor samples, 20 years of drug response data, and a CLIA laboratory, enhancing their cancer diagnostics and therapeutics capabilities.

How will the Nebul collaboration benefit Renovaro's (RENB) cancer detection program?

The collaboration provides Renovaro with necessary computing power through superpods and access to 300 NSCLC samples for analysis, essential for developing their AI-powered cancer detection tests.

What are the three core mission-critical areas identified by Renovaro (RENB) for 2025?

The three areas are: acquiring large amounts of data, building clinical decision support for oncologists, and monetizing AI through predictive models for drug repurposing and cancer vaccines.

When will Renovaro (RENB) conduct its international roadshow in 2025?

Renovaro will conduct its international roadshow the week of January 13, 2025, visiting Amsterdam, Stockholm, Copenhagen, Monaco, Riyadh, and Abu Dhabi.

What recent management changes has Renovaro (RENB) implemented?

Maurice van Tilburg has become full-time CEO of the AL/ML subsidiary GEDiCube, and Nathen Fuentes has joined as CFO.