Renovaro Biosciences (RENB) - 2025 Q4 - Annual Report

Forward-Looking Statements This section cautions investors on forward-looking statements, which are based on current assumptions and involve inherent risks - This section contains cautionary language regarding forward-looking statements, based on current assumptions and expectations, involving known and unknown risks and uncertainties, where actual results may differ materially[10][12] - Key forward-looking statements address the company's going concern ability, continuous losses, need for additional capital, product development, third-party dependence, and unpredictable clinical trial results and regulatory outcomes[11] - The company changed its corporate name from Renovaro BioSciences Inc. to Renovaro Inc. in February 2024, and then to Lunai Bioworks Inc. in August 2025[14] Part I Item 1 Business Lunai Bioworks operates through three subsidiaries, focusing on advanced cell and gene therapies, AI-driven cancer detection, and biomarker discovery Company Overview Lunai Bioworks Inc. operates through three wholly-owned subsidiaries, focusing on biotechnology and AI-driven healthcare technologies - Lunai Bioworks Inc. operates through three wholly-owned subsidiaries: Renovaro Biosciences, Renovaro Cube (acquired February 13, 2024), and BioSymetrics (acquired April 8, 2025)[17][18] Renovaro Biosciences Overview Renovaro Biosciences develops advanced allogeneic cell and gene therapies to enhance immune responses for long-term cancer remission - Renovaro Biosciences is a biotechnology company focused on developing advanced allogeneic cell and gene therapies to enhance immune responses for long-term cancer remission, particularly in deadly cancers[19][20] - The company's primary focus areas include RENB-DC11 for solid tumors (e.g., pancreatic cancer) and RENB-DC20 for Triple Negative Breast Cancer (TNBC), leveraging an allogeneic cell therapy platform[23][26] Renovaro Cube Overview Renovaro Cube is an AI-driven healthcare technology company specializing in early cancer detection and recurrence using a proprietary Explainable AI platform - Renovaro Cube is an AI-driven healthcare technology company focused on early cancer detection and recurrence using a proprietary Explainable AI platform that analyzes genetics with a multi-omics approach[28] - The company's strategy includes developing products for early cancer characterization, personalized treatment selection, therapy response prediction and tracking, recurrence detection, efficacy monitoring, and drug discovery[29][33] - Renovaro Cube's AI technology supports type-specific cancer detection, pan-cancer analysis, and patient stratification, leveraging DNA methylation data to identify biomarkers for various cancers[40][41][43] - Commercialization plans involve partnerships with academic cancer centers and pathology/imagery centers, hiring additional staff, building infrastructure, and establishing certified service laboratories in EMEA and the US for liquid biopsy analysis[53][54][69] Business Overview (BioSymetrics) BioSymetrics is a biomedical AI company integrating multimodal data to advance biomarker discovery, therapeutic development, and precision medicine - BioSymetrics is a biomedical AI company integrating multimodal data (genomics, imaging, EHR) to advance biomarker discovery, therapeutic development, and precision medicine[70] - Its platform utilizes 'Contingent AI' to optimize the entire data science pipeline and features a proprietary 'Phenograph' knowledge graph to map human genes and phenotypes for virtual phenotypic screening and target nomination[72][74] - BioSymetrics couples AI prediction with experimental validation, demonstrated by identifying a novel neuroactive compound (BioS_831) effective in a mouse seizure model, showing translation to mammalian epilepsy models[75][78][79] Our Intellectual Property The company protects its intellectual property through patents, copyrights, trademarks, and trade secrets, secured via filings and agreements - The company's intellectual property strategy relies on patents, copyrights, trademarks, and trade secrets, protected through filings and agreements[82][83] - Key assigned patents include U.S. Patent No. 11,413,338 B2 for cancer therapy using recombinant dendritic cells (RENB-DC11) and Patent No. US-11379757-B2 for multi-modal data analytics using machine learning (Contingent AI)[84][85] Competition The company faces intense competition in AI-driven diagnostics and phenotype-based profiling, differentiating through its unique AI platforms - Renovaro Cube faces intense competition in AI-driven diagnostics from companies like Grail, Freenome, and Owkin, differentiating itself with a disease-agnostic, multi-omics, explainable AI platform[88] - BioSymetrics competes with Recursion Pharma and insitro in phenotype-based profiling, distinguishing its platform by providing multicellular/multi-organ phenotypes and higher throughput for large chemical screens than murine models[89] Government Regulation The company's products are subject to extensive government regulation, including FDA approval processes and various healthcare laws - The company's products are subject to extensive regulation by government authorities, including the FDA in the U.S. and comparable international agencies, covering research, development, testing, manufacturing, and commercialization[90] - Obtaining regulatory approval is a costly and time-consuming process, requiring preclinical studies, IND submissions, and multiple phases of clinical trials to demonstrate safety and efficacy[91][93] - Compliance with various healthcare laws (e.g., federal anti-kickback statute, False Claims Act, HIPAA) and foreign corrupt practices acts (FCPA) is critical, with potential for significant penalties for non-compliance[97][102][107] - Renovaro Cube's AI-guided diagnostic platform, as a Software as a Medical Device (SaMD), will require compliance with FDA guidelines and EU Medical Device Regulation (MDR), emphasizing rigorous clinical validation, cybersecurity, and data privacy[106] Employees As of June 30, 2025, the company had 29 full-time employees, focusing on oncology therapeutic vaccines and AI-driven healthcare technology - As of June 30, 2025, the company had 29 full-time employees, with a streamlined organization focused on oncology therapeutic vaccines and AI-driven healthcare technology[109] Corporate Information Lunai Bioworks Inc. acquired Renovaro Cube and BioSymetrics to enhance its data capabilities, with its common stock trading on NASDAQ - Lunai Bioworks Inc. acquired Renovaro Cube Intl Ltd on February 13, 2024, and BioSymetrics Inc. on April 8, 2025, to enhance its data repository, biomarker discovery, and in vivo validation capabilities[110][111] - The company's common stock trades on the NASDAQ Capital Market under the ticker 'RENB'[4] Item 1A Risk Factors The company faces substantial risks, including recurring losses, going concern doubts, financing needs, legal proceedings, and regulatory uncertainties Risk Factor Summary Key risks include substantial losses, going concern doubts, financing needs, legal proceedings, and operational challenges with unproven AI solutions - Key risks include substantial and increasing losses, substantial doubt about going concern, need for significant additional financing (which may cause dilution), legal proceedings and regulatory investigations, and negative publicity[114][115] - Operational risks involve the unproven market for AI-based healthcare solutions, potential regulatory limits on AI algorithms, unpredictability of preclinical/clinical trial results, reliance on third parties, and limited experience in drug development[115] - Intellectual property risks include dependence on licensed IP, inability to obtain/maintain sufficient protection, and third-party infringement claims; other risks relate to corporate infrastructure, management turnover, and stock price volatility[115][120] Risks Related to Our Financial Position and Capital Requirements The company faces significant financial risks, including substantial losses, going concern doubts, and the need for additional financing amid ongoing legal proceedings - The company has incurred substantial losses since inception, with a net loss of $178,007,489 in FY2025 and $88,425,828 in FY2024, and an accumulated deficit of $510 million as of June 30, 2025[118] - There is substantial doubt about the company's ability to continue as a