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Renovaro Issues Shareholder Letter and Provides Corporate Update

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Renovaro Inc. (NASDAQ: RENB) released a shareholder letter from new CEO David Weinstein outlining the company's direction in cancer diagnostics and therapeutics. The company is developing two main verticals: a dendritic cancer cell vaccine (DCCV) for solid tumors, which showed promising preclinical results in pancreatic tumors, and RenovaroCube, an AI-powered multi-cancer early detection platform. The company has filed required SEC documents, dismissed a derivative class action lawsuit, and appointed new board members. A 100-day commercialization plan is being developed, focusing on advancing existing partnerships and leveraging synergies between both verticals.

Renovaro Inc. (NASDAQ: RENB) ha pubblicato una lettera agli azionisti del nuovo CEO David Weinstein, che delinea la direzione dell'azienda nella diagnostica e nella terapia del cancro. L'azienda sta sviluppando due principali aree: un vaccino a base di cellule dendritiche per il cancro (DCCV) per tumori solidi, che ha mostrato risultati preclinici promettenti nei tumori pancreatici, e RenovaroCube, una piattaforma di rilevamento precoce multi-cancro alimentata dall'intelligenza artificiale. L'azienda ha presentato i documenti richiesti alla SEC, ha respinto una class action derivativa e ha nominato nuovi membri del consiglio. Si sta sviluppando un piano di commercializzazione di 100 giorni, incentrato sul potenziamento delle partnership esistenti e sull'utilizzo delle sinergie tra i due settori.

Renovaro Inc. (NASDAQ: RENB) lanzó una carta a los accionistas del nuevo CEO David Weinstein que describe la dirección de la empresa en diagnósticos y terapias contra el cáncer. La empresa está desarrollando dos verticales principales: una vacuna de células dendríticas contra el cáncer (DCCV) para tumores sólidos, que mostró resultados preclínicos prometedores en tumores pancreáticos, y RenovaroCube, una plataforma de detección temprana de múltiples cánceres impulsada por inteligencia artificial. La empresa ha presentado los documentos requeridos a la SEC, desestimado una demanda colectiva derivativa y nombrado nuevos miembros de la junta. Se está desarrollando un plan de comercialización de 100 días, centrado en avanzar en las asociaciones existentes y aprovechar las sinergias entre ambas verticales.

Renovaro Inc. (NASDAQ: RENB)는 새로운 CEO David Weinstein의 주주 편지를 발표하였습니다. 이 편지에서는 암 진단 및 치료 분야에서 회사의 방향성을 설명하고 있습니다. 회사는 두 가지 주요 분야를 개발 중입니다: 고형 종양을 위한 수지상 세포 암 백신 (DCCV), 이는 췌장 종양에서 유망한 전임상 결과를 보였으며, RenovaroCube, 인공지능 기반의 다중 암 조기 발견 플랫폼입니다. 이 회사는 SEC에 필요한 문서를 제출하였고, 파생 집단 소송을 기각하였으며, 새로운 이사회를 임명하였습니다. 현재 기존 파트너십을 강화하고 두 분야 간의 시너지를 활용하는 데 중점을 둔 100일 상업화 계획이 개발 중입니다.

Renovaro Inc. (NASDAQ: RENB) a publié une lettre aux actionnaires de son nouveau PDG David Weinstein, décrivant l'orientation de l'entreprise dans les domaines du diagnostic et des thérapies contre le cancer. L'entreprise développe deux axes principaux : un vaccin contre le cancer à base de cellules dendritiques (DCCV) pour les tumeurs solides, qui a montré des résultats précliniques prometteurs dans les tumeurs du pancréas, et RenovaroCube, une plateforme d'alerte précoce multi-cancer alimentée par l'IA. La société a déposé les documents requis auprès de la SEC, a rejeté un recours collectif dérivé et a nommé de nouveaux membres au conseil d'administration. Un plan de commercialisation de 100 jours est en cours de développement, axé sur le développement des partenariats existants et l'exploitation des synergies entre les deux axes.

Renovaro Inc. (NASDAQ: RENB) veröffentlichte einen Brief an die Aktionäre des neuen CEO David Weinstein, in dem die Richtung des Unternehmens in der Krebsdiagnostik und -therapie umrissen wird. Das Unternehmen entwickelt zwei Hauptbereiche: einen Dendritischen Zellkrebsimpfstoff (DCCV) für solide Tumore, der vielversprechende präklinische Ergebnisse bei Pankreastumoren zeigte, und RenovaroCube, eine KI-gestützte Plattform zur frühzeitigen Erkennung mehrerer Krebsarten. Das Unternehmen hat die erforderlichen SEC-Dokumente eingereicht, eine derivative Sammelklage abgewiesen und neue Vorstandsmitglieder ernannt. Ein 100-tägiger Kommerzialisierungsplan wird entwickelt, der sich auf die Weiterentwicklung bestehender Partnerschaften und die Nutzung von Synergien zwischen beiden Bereichen konzentriert.

Positive
  • Promising preclinical results showing near complete elimination of pancreatic tumors in three weeks with DCCV
  • Successful dismissal of derivative class action lawsuit
  • New board appointed with expertise in Wall Street, biotechnology, AI, and corporate finance
  • Potential synergy between RenovaroCube and DCCV through biomarker analysis
Negative
  • DCCV still in preclinical stage, far from commercialization
  • Company needs to 'right the ship', suggesting current operational challenges

Insights

This shareholder letter reveals significant corporate restructuring at Renovaro, with new leadership and strategic focus on two key verticals: dendritic cancer cell vaccine (DCCV) and AI-powered multi-cancer early detection. The preclinical DCCV data showing near-complete elimination of pancreatic tumors in three weeks is particularly noteworthy, though still requiring extensive clinical validation. The company's AI platform, RenovaroCube, aims for 95% test accuracy in cancer detection, positioning it competitively against peers like Freenome.

The appointment of David Weinstein as CEO, with his 40-year Wall Street experience, along with a new board including the former CEO of Euronext Amsterdam, signals a shift from pure research to commercialization focus. The dismissal of derivative class action lawsuit and timely financial filings demonstrate improved corporate governance. However, the company remains in early stages with significant execution risks ahead.

The corporate restructuring signals a major transformation with the installation of an entirely new board bringing expertise in biotechnology, AI and public company finance. The swift completion of regulatory filings (10-K and 10-K/A) and dismissal of the derivative lawsuit indicate improved compliance and risk management. The emphasis on a structured 100-day plan and commitment to transparency suggests implementation of stronger governance frameworks. However, the company's small market cap of $87.3 million and early-stage status warrant careful monitoring of execution capabilities and cash management.

LOS ANGELES, Nov. 04, 2024 (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,

It is my honor to address you as the newly appointed CEO of Renovaro Inc. After careful consideration, I left a 40-year career on Wall Street to join Renovaro because I believe the Company has tremendous potential in its verticals, such as the dendritic cancer cell vaccine (DCCV) and AI powered multi-cancer early detection screening and therapeutics. It has been a busy two weeks since I arrived, managing to file our 10-K and 10-K/A on time and retain MZ Group for investor relationships and have had dismissed the derivative class action lawsuit. Now, our principal focus is conducting a comprehensive analysis of both businesses and developing a 100-day plan of action to commercialize our existing assets as soon as feasible. This includes an evaluation of previously announced MOUs and then determining how to advance these relationships. Additionally, we recognize the company’s strengths and are identifying areas where we can focus on business development. One key focus area is the cross pollination for both verticals. RenovaroCube can generate useful biomarkers analysis that could be used in trial design and cohort stratification for the DCCV clinical trials.

The future of multi-cancer early detection screening and recurrence testing reached an inflection point four years ago when the Nvidia-powered AI chips were introduced. RenovaroCube, Freenome, and other new entrants have the potential to set the standard because they are processing vast data sets with multiple biomarkers. Our moonshot is to achieve a test accuracy over 95% and, ultimately, to provide patients with rapid results from a simple blood draw taken when they have their physical exam. We are excited about the Company’s prospects and believe that over the next five years we will be part of the paradigm shift within the industry. Maurice van Tilberg, the Chairman of the Board (Director of the Dutch National Growth fund and former CEO of Euronext Amsterdam), remarked, “I am excited to be working with our CEO, David Weinstein. Together we are building a corporate culture that will support deliverables and timely execution upon solidifying our 100-day plan. This plan will prioritize commercializing our technologies.”

While chimeric antigen receptor (CAR)-T cell therapy has been successful in treating hematologic cancers, it has limited efficacy against solid tumors. While our Dendritic Cell Cancer Vaccine (DCCV) is still preclinical, it has the potential to treat solid tumors as a class. Preliminary preclinical in vitro data and the proof-of-concept data from the in vivo studies have been compelling, with near complete elimination of pancreatic tumors in three weeks.

Suffice it to say that both potential solutions represent billion-dollar opportunities. Yet, there remains much to be done to right the ship so we can extrapolate value from both verticals. Our goal is to advance from science to business. To accomplish this, I brought on an entirely new Board of Directors. They have both Wall Street experience and deep knowledge of biotechnology, AI, corporate governance, and public company finance.

Through the upcoming months, I will keep you informed and engaged in this journey. I am committed to solidifying our team and building the future. We are establishing proper corporate governance and transparency, which is important for all stakeholders.

You will hear from me in the next quarter about the progress would have made to that date. I am grateful for shareholders that have stayed with the company and will work hard to reward that loyalty.

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.

RenovaroCube has developed an award-winning AI platform that is committed to the early detection of cancer and its recurrence and monitoring subsequent treatments. RenovaroCube intervenes at a stage where potential therapy can be most effective. RenovaroCube is a molecular data science company with a background in FinTech and a 12-year history. It brings together proprietary artificial intelligence (AI) technology, multi-omics, multi-modal data, and the expertise of a carefully selected multidisciplinary team to radically accelerate precision medicine and enable breakthrough changes in disease agnostic decision support.

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 are the two main business verticals of Renovaro (RENB)?

Renovaro's two main verticals are the dendritic cancer cell vaccine (DCCV) for solid tumors and RenovaroCube, an AI-powered multi-cancer early detection screening platform.

What were the preclinical results of Renovaro's (RENB) DCCV in pancreatic tumors?

The preclinical in vivo studies showed promising results with near complete elimination of pancreatic tumors in three weeks.

What is RenovaroCube's target accuracy goal for cancer detection?

RenovaroCube aims to achieve a test accuracy of over 95% through blood-based testing during routine physical examinations.

Renovaro Inc.

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