Company Structure and Subsidiaries - Renovaro Inc. operates through two subsidiaries: Renovaro Biosciences and Renovaro Cube, with Renovaro Cube acquired on February 13, 2024[14] - The company acquired Renovaro Cube Intl Ltd and its subsidiaries on February 13, 2024, as a wholly owned subsidiary[101] Renovaro Biosciences' Therapeutic Focus - Renovaro Biosciences focuses on developing allogeneic cell and gene therapies for cancer remission and infectious diseases like HIV, with a shift in focus to GEDi Cube Intl technologies post-acquisition[15] - Renovaro Biosciences' allogeneic cell therapy aims to create "off-the-shelf" therapeutic cells for faster treatment availability[16] - Renovaro Biosciences' gene therapy approach involves genetically engineered allogeneic cells to modulate the immune system, with short survival time post-activation[18] - Renovaro Biosciences' oncology focus includes RENB-DC11, a therapeutic vaccine for solid tumors like pancreatic cancer, currently in pre-IND and IND-enabling phases[19] - Renovaro Biosciences is developing RENB-DC20, a therapeutic vaccine for Triple Negative Breast Cancer (TNBC), targeting its aggressive and hard-to-treat nature[21] - Renovaro Biosciences is exploring RENB-HV12, a therapeutic vaccine for HIV, leveraging its oncology vaccine technology for infectious diseases[23] Renovaro Cube's AI and Diagnostic Technologies - Renovaro Cube utilizes AI for early cancer detection, focusing on multi-omics approaches and biomarker panels to enhance diagnosis accuracy[25] - Renovaro Cube's AI platform aims to support clinical and pharmaceutical organizations in precision diagnosis, treatment selection, and drug discovery[26] - Renovaro Cube's strategy includes developing multi-cancer early detection (MCED) blood tests to identify cancer at early stages through genetic and proteomic patterns[30] - Renovaro Cube is developing a system to detect cancer recurrence through highly sensitive lab and IT protocols, focusing on early signals of recurrence with regular surveillance analysis[37] - The company is working on a product to analyze liquid biopsy results using an Oxford Nanopore Sequencer, aiming to identify and validate biomarkers for accurate cancer diagnosis[35] - Renovaro Cube's AI platform leverages multi-omic data analysis, including genomics, imaging, and wearable data, to provide new insights for clinical and research teams[39] - The company has identified and validated biomarker panels for detecting cancers such as bladder, breast, colon, prostate, thyroid, and lung, using DNA methylation data[43] - Renovaro Cube's AI technology aims to achieve >98% sensitivity and specificity for high-performance biomarker panels, validated through independent data sets[48] - Renovaro Cube's panel mining technique integrates validated panels for different cancer types into its machine learning library, enabling precision diagnosis by including one cancer and excluding others based on statistically, scientifically, and clinically validated machine-learning panels[61] - Renovaro Cube's Explainable AI feature ensures transparency, fairness, and accountability by making all data points, calculations, and results traceable, verifiable, and reproducible[62] - Renovaro Cube's AI platform provides differential diagnosis by using multiple models for different diseases, addressing the homogeneity of diseases like cancer and enabling accurate identification of underlying conditions[64] - Renovaro Cube's AI platform supports pan-cancer analysis, patient stratification, and AI-guided biomarker discovery, with a focus on rare cancers and cancer of unknown primary[42][45] Renovaro Cube's Commercialization and Partnerships - Renovaro Cube plans to expand partnerships with academic cancer centers and pathology labs in Europe, the USA, and the Middle East to validate multi-omic capabilities[56] - Renovaro Cube intends to commercialize AI-driven diagnostic products and test kits for hospitals, clinics, and healthcare providers, focusing on precision and explainable AI[58] - Renovaro Cube plans to establish state-of-the-art certified service laboratories for liquid biopsies using a multi-omic approach, aiming to generate immediate revenue and expand data for system improvements[71] - Renovaro Cube intends to expand its team with biomedical scientists, data scientists, machine-learning engineers, specialized medical doctors, and high-performance computer engineers to support its AI platform development[70] - Renovaro Cube plans to deploy a sequencing lab in the EMEA region to control sample preparation and medical device processes, enabling faster commercialization and quality control[70] - The company aims to develop long-term strategic partnerships with clinical organizations, research centers, and pharmaceutical companies to advance multi-modal analysis and open revenue streams[70] - Renovaro Cube plans to commercially launch its AI platform in the European Union and United Kingdom in 2024[135] - Renovaro Cube's strategy includes expanding access to its tests by pursuing reimbursement and coverage from third-party payors[147] Regulatory and Compliance Challenges - The company is subject to extensive FDA regulations, requiring costly and time-consuming preclinical studies and clinical trials to obtain approval for its products[81][82] - The company is subject to various healthcare regulations, including the federal anti-kickback statute, False Claims Act, HIPAA, and the Physician Payments Sunshine Act, which govern its business activities and compliance requirements[88][89] - Violations of healthcare laws could result in severe penalties, including fines, criminal sanctions, exclusion from federal programs, and reputational harm, potentially impacting the company's financial condition and operations[90] - Renovaro Cube's AI-guided diagnostic platform, Renovaro Cube, must comply with FDA guidelines, EU Medical Device Regulation (MDR), and international standards for quality management, cybersecurity, and data privacy[98] - The company's business activities are subject to the Foreign Corrupt Practices Act (FCPA) and similar anti-bribery laws, with potential penalties including fines, criminal sanctions, and restrictions on international operations[99] - Regulatory approval for diagnostic products could be expensive, time-consuming, and uncertain, potentially delaying commercialization[164][165] - AI and machine learning regulations in the EU and US could increase compliance costs and restrict Renovaro Cube's use of these technologies[169][170][171] Financial and Operational Risks - The company has incurred substantial losses and anticipates continued losses, raising concerns about its ability to continue as a going concern[102] - The company relies on third parties for drug development and clinical trials, which could lead to delays or failures in completing these activities[105] - The company faces risks related to intellectual property protection, including potential breaches of license agreements and third-party infringement claims[106] - The company's stock price is volatile and may decline due to factors such as future sales of common stock and dilution from equity incentive plans[107][108] - Company reported a net loss of $80,650,172 for the year ended June 30, 2024, compared to $39,684,056 in 2023[112] - Accumulated deficit increased to $325 million as of June 30, 2024, from $244 million in 2023[112] - Cash and cash equivalents stood at $220,467 as of June 30, 2024, insufficient for the next twelve months[114] - Company anticipates continued significant expenses and operating losses for the foreseeable future[113] - Company expects to expend substantial resources on pre-clinical development of cell, gene, and immunotherapy product candidates[116] - Company faces substantial doubt about its ability to continue as a going concern[114] - Company may need to raise additional capital through equity offerings, debt financings, or other arrangements[119] - Renovaro Cube, an AI-driven healthcare technology company, has never generated revenue and anticipates continued net losses[131] - Company's future capital requirements depend on factors such as clinical study costs, regulatory approvals, and commercialization activities[117] - Renovaro Cube has never generated revenue from its cancer diagnostics AI platform and does not expect near-term revenue to offset ongoing operating expenses[135] - Renovaro Cube anticipates incurring substantial costs to commercialize its products, with potential delays or changes required by regulatory agencies[138] - Renovaro Cube's ability to generate future revenue depends on completing clinical development, obtaining regulatory approvals, and establishing a sales and distribution infrastructure[135] - Renovaro Cube may face challenges in achieving broad market acceptance and reimbursement for its products, particularly in asymptomatic populations[149] - Renovaro Cube's products may face competition from established companies with greater financial and technical resources[156] - Renovaro Cube's business could suffer if its products result in harm or injury to patients, leading to reputational and liability risks[152] - Renovaro Cube relies on third-party collaborators, and any disruptions to their operations could adversely impact its business[155] - Renovaro Cube's ability to compete depends on successful product commercialization, market acceptance, and differentiation from competitors[158] - Renovaro Cube may face delays or adverse effects if it cannot establish new collaborations on acceptable terms[159] - Renovaro Cube has limited sales and marketing infrastructure and is rapidly hiring personnel to prepare for commercial launch[161] - Pre-clinical study success does not guarantee clinical trial efficacy, and failure could materially impact Renovaro Cube's business prospects[175][176] - Renovaro Cube faces significant competition in cancer and HIV treatment development, with competitors having greater resources and experience[180] - Reliance on third parties for research and development may result in delays or failures in completing clinical trials[182][183] - Changes in healthcare laws and reimbursement policies could negatively impact Renovaro Cube's ability to generate revenue[185] - Renovaro Cube's limited experience in drug development poses a risk to its ability to successfully develop and commercialize products[186] - The company has never successfully developed a new drug and brought it to market, and its ability to achieve revenues and profitability depends on successful product development, regulatory approvals, and third-party manufacturing and sales arrangements[187] - Disruptions at the FDA and other government agencies due to funding shortages or global health concerns could hinder the company's ability to develop, approve, or commercialize new products in a timely manner[188] - The company's gene therapy product candidates are still in development and will require extensive clinical testing before submitting applications for marketing approval, with clinical trials estimated to take at least several years to complete[190][191] - Delays or failures in patient enrollment or retention for clinical trials could result in increased costs, program delays, or render further development impossible, impacting the company's ability to develop gene therapy product candidates[193] - The company relies on licensed intellectual property from licensors, and any breach of license agreements or disruptions to business relationships could result in the loss of critical intellectual property rights[195][196] - Disputes over intellectual property licenses could narrow the scope of the company's rights or increase financial obligations, potentially impacting the development and commercialization of product candidates[198] - The company's ability to commercialize product candidates successfully depends on obtaining and maintaining sufficient intellectual property protection, with uncertainties in patentability and enforceability in the biotechnology field[201][203] - The company may be unaware of prior art that could invalidate issued patents or prevent pending patent applications from issuing, potentially impacting patent protection for product candidates[204] - Even if patents are issued, third parties may challenge their validity, enforceability, or scope, which could result in patents being narrowed, invalidated, or held unenforceable[205] Legal and Reputational Risks - The company has been named in several lawsuits related to its co-founder, Serhat Gümrükcü, impacting its reputation and financial condition[123] Intellectual Property and Patents - The company holds key patents, including U.S. Patent No. 11,413,338 B2 for cancer therapy using recombinant dendritic cells, protecting its potential products for long-term remission of solid tumors[76]

AMSTERDAM, Sept. 13, 2024 (GLOBE NEWSWIRE) -- (NASDAQ: RENB) RenovaroCube (Cube, the Company), a leading AI-driven innovator using multi-omics technology for cancer profiling, is pleased to announce two scientific presentations at a leading cancer conference – the European Society for Medical Oncology (ESMO) Congress – on September 15, 2024. "Combined, the findings that will be showcased represent key steps along the developmental pathway of Cube's "go-to-market" strategy for its open-source AI platform as ...

AMSTERDAM, Sept. 11, 2024 (GLOBE NEWSWIRE) -- (NASDAQ: RENB) The Board of Renovaro, Inc (RENB) intends to seek strategic investors to acquire up to 20% of RenovaroCube (Cube), currently a wholly owned subsidiary. This opportunity will be available to all potential investors including current shareholders of RENB. Cube is a molecular data science company with a background in FinTech and a 10-year history. It brings together proprietary artificial intelligence (AI) technology for multi-omics and multi-modal d ...

"We appreciate confidence in the Company demonstrated by the investors," said the Hon. Mark Dybul, MD, CEO. "We believe this is only the beginning. We are hopeful to be able to secure additional financing such as, but not limited to, long-term loans, grants and subsidies from various US and European institutions for which the Company is eligible – potentially worth tens of millions of dollars." Statements in this press release that are not strictly historical in nature are forward-looking statements. These ...

"We appreciate confidence in the Company demonstrated by the investors," said the Hon. Mark Dybul, MD, CEO. "We believe this is only the beginning. We are hopeful to be able to secure additional financing such as, but not limited to, long-term loans, grants and subsidies from various US and European institutions for which the Company is eligible – potentially worth tens of millions of dollars." Statements in this press release that are not strictly historical in nature are forward-looking statements. These ...

This collaboration would bring together Renovaro's proprietary cancer vaccine technology and the Cancer Center's expertise in several ancillary immunomodulatory technologies, towards innovative advancements in cancer treatment. LOS ANGELES and AMSTERDAM, May 24, 2024 (GLOBE NEWSWIRE) -- Renovaro Inc. (NASDAQ: RENB) and the Amsterdam UMC Cancer Center today announced an intended partnership and therefore signed an MoU to establish a joint company based in the Netherlands aimed at pioneering the next generati ...

U.S. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission file number 001-38758 Renovaro Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I.R.S. Employer incorp ...

U.S. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission file number 001-38758 Renovaro Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I.R.S. Employer inc ...

U.S. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification Number) Delaware 45-2559340 2080 Century Park East, Suite 906 Los Angeles, CA (Address of principal executive offices) (Zip Code) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES E ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2023 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from Commission file number 001-38758 RENOVARO BIOSCIENCES INC. (Name of registrant in its charter) | Delaware | | 45-2559340 | | --- | --- | --- | | (State or other jurisdiction of | | (I.R.S. Empl ...