[Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) 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](index=10&type=chunk)[12](index=12&type=chunk) - 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](index=11&type=chunk) - 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](index=14&type=chunk) Part I [Item 1 Business](index=6&type=section&id=Item%201%20Business) Lunai Bioworks operates through three subsidiaries, focusing on advanced cell and gene therapies, AI-driven cancer detection, and biomarker discovery [Company Overview](index=6&type=section&id=Company%20Overview) 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](index=17&type=chunk)[18](index=18&type=chunk) [Renovaro Biosciences Overview](index=6&type=section&id=Renovaro%20Biosciences%20Overview) 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](index=19&type=chunk)[20](index=20&type=chunk) - 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](index=23&type=chunk)[26](index=26&type=chunk) [Renovaro Cube Overview](index=7&type=section&id=Renovaro%20Cube%20Overview) 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](index=28&type=chunk) - 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](index=29&type=chunk)[33](index=33&type=chunk) - 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](index=40&type=chunk)[41](index=41&type=chunk)[43](index=43&type=chunk) - 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](index=53&type=chunk)[54](index=54&type=chunk)[69](index=69&type=chunk) [Business Overview (BioSymetrics)](index=16&type=section&id=Business%20Overview%20(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](index=70&type=chunk) - 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](index=72&type=chunk)[74](index=74&type=chunk) - 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](index=75&type=chunk)[78](index=78&type=chunk)[79](index=79&type=chunk) [Our Intellectual Property](index=18&type=section&id=Our%20Intellectual%20Property) 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](index=82&type=chunk)[83](index=83&type=chunk) - 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](index=84&type=chunk)[85](index=85&type=chunk) [Competition](index=19&type=section&id=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](index=88&type=chunk) - 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](index=89&type=chunk) [Government Regulation](index=19&type=section&id=Government%20Regulation) 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](index=90&type=chunk) - 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](index=91&type=chunk)[93](index=93&type=chunk) - 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](index=97&type=chunk)[102](index=102&type=chunk)[107](index=107&type=chunk) - 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](index=106&type=chunk) [Employees](index=23&type=section&id=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](index=109&type=chunk) [Corporate Information](index=23&type=section&id=Corporate%20Information) 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](index=110&type=chunk)[111](index=111&type=chunk) - The company's common stock trades on the NASDAQ Capital Market under the ticker '**RENB**'[4](index=4&type=chunk) [Item 1A Risk Factors](index=23&type=section&id=Item%201A%20Risk%20Factors) The company faces substantial risks, including recurring losses, going concern doubts, financing needs, legal proceedings, and regulatory uncertainties [Risk Factor Summary](index=23&type=section&id=Risk%20Factor%20Summary) 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](index=114&type=chunk)[115](index=115&type=chunk) - 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](index=115&type=chunk) - 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](index=115&type=chunk)[120](index=120&type=chunk) [Risks Related to Our Financial Position and Capital Requirements](index=25&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Capital%20Requirements) 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](index=118&type=chunk) - There is substantial doubt about the company's ability to continue as a

Measure taken to Comply with Nasdaq Rule 5550(a)(2) Regarding Minimum Bid Price LOS ANGELES, CA / ACCESS Newswire / September 24, 2025 / Lunai Bioworks, Inc. (Nasdaq:RENB) ("Lunai Bioworks" or the "Company"), a pioneer in cancer diagnostics and therapeutics powered by artificial intelligence, today announced that the Company's Board of Directors has approved a 10:1 reverse stock split of the Company's issued and outstanding common stock, par value $0.0001 per share (the "Common Stock") to be effective 12:01 ...

BETHESDA, MD / ACCESS Newswire / September 11, 2025 / Lunai Bioworks Inc.'s (NASDAQ:RENB) wholly-owned subsidiary BioSymetrics Inc. today announced the award of a prestigious Small Business Technology Transfer (STTR) grant from the National Institutes of Health (NIH). The funding, awarded jointly to BioSymetrics and Brigham and Women's Hospital, will support the development of a novel platform that combines artificial intelligence and in vivo zebrafish screening to accelerate drug discovery for Alcohol Use ...

Proprietary safety intelligence creates dual value: faster therapeutic development and biodefense. LOS ANGELES, CALIFORNIA / ACCESS Newswire / September 9, 2025 / Lunai Bioworks Inc. (NASDAQ:RENB), an AI-powered drug discovery and biodefense company, today announced the launch of a transformer-based platform that embeds biological risk intelligence directly into large language model (LLM) pipelines. ...

Company remains committed to Europe with a streamlined, growth-focused approach. LOS ANGELES, CALIFORNIA / ACCESS Newswire / September 8, 2025 / Lunai Bioworks Inc. (Nasdaq:RENB), an AI-powered drug discovery and biodefense company, today reaffirmed its long-term commitment to European markets and partnerships while announcing the elimination of its legacy subsidiary, Gedi Cube B.V. ...

Group 1 - The proposed sale of Predictive Oncology Inc. to Renovaro Inc. involves a merger where Predictive Oncology shareholders will receive a newly created series of preferred stock in a 1:1 exchange for their existing common stock [1] - Kahn Swick & Foti, LLC is investigating whether the terms of the proposed sale adequately reflect the value of Predictive Oncology and the process leading to this transaction [1] - The investigation is led by former Louisiana Attorney General Charles C. Foti, Jr., indicating a legal scrutiny of the transaction [1][2] Group 2 - Kahn Swick & Foti, LLC is open to discussions regarding the legal rights of shareholders who believe the transaction undervalues Predictive Oncology [2] - Shareholders can contact KSF Managing Partner Lewis S. Kahn for more information about their rights related to the proposed sale [2]

Core Insights - Renovaro Inc. has received a Notice of Allowance for a new patent that enhances its AI and machine learning capabilities in drug discovery [1][2] - The patent focuses on integrating diverse biomedical data sources into a standardized framework for predictive modeling, addressing a critical need in the biopharma industry [2][4] - This development is seen as a strategic milestone for Renovaro, reinforcing its position in the growing market for data-driven therapeutics [3][4] Company Overview - Renovaro aims to accelerate precision and personalized medicine through AI and biotechnology platforms, focusing on early diagnosis and targeted treatments [5] - The company includes subsidiaries such as RenovaroBio, which specializes in cell-gene immunotherapy, and RenovaroCube, which leverages AI for multi-omic diagnostics [5] Patent Details - The new patent introduces methods for real-time, reproducible predictive analytics across distributed computing environments, essential for improving efficiency in biopharma [4][7] - This patent builds on a previously granted patent that protects machine learning pipeline optimization, enhancing Renovaro's foundational intellectual property [7] Market Implications - The patent addresses the integration of siloed and heterogeneous data, a significant challenge in pharmaceutical R&D and clinical practice [7] - It enhances Renovaro's commercial potential by enabling scalable biomedical analytics across various applications, including rare diseases and personalized medicine [7]

Core Viewpoint - Renovaro Inc. has initiated legal action against Predictive Oncology Inc. to enforce a merger agreement, alleging breaches of contract and seeking specific performance and damages [1][4]. Group 1: Legal Proceedings - Renovaro filed a lawsuit on May 9, 2025, in the Delaware Court of Chancery against Predictive Oncology to enforce a merger agreement executed on January 1, 2025 [1]. - The court has ruled to expedite the trial for this lawsuit, which is pending under Case No. 2025-0509 [4]. - Renovaro claims that Predictive Oncology breached the agreement by conducting a public offering of $545,000 in securities on February 19, 2025, and later attempted to unilaterally terminate the agreement on April 3, 2025 [3]. Group 2: Financial Impact - Following the public disclosure of the merger agreement on January 6, 2025, Predictive Oncology's stock price increased by over 50% [2]. - The litigation seeks specific performance, injunctive relief, and damages for the alleged breaches, indicating potential financial implications for both companies [4]. Group 3: Company Background - Renovaro Inc. focuses on next-generation diagnostics, drug discovery, and genetically enhanced cancer therapies, aiming to accelerate precision and personalized medicine [5]. - The company includes subsidiaries such as RenovaroBio, which specializes in advanced cell-gene immunotherapy, and RenovaroCube, leveraging AI for diagnostics and drug development [5].

Core Viewpoint - Renovaro Inc. has initiated legal action against Predictive Oncology Inc. to enforce a merger agreement, alleging breaches of contract and seeking specific performance and damages [1][4]. Group 1: Legal Proceedings - Renovaro filed a lawsuit on May 9, 2025, in the Delaware Court of Chancery against Predictive Oncology to enforce a merger agreement executed on January 1, 2025 [1]. - The court has ruled to expedite the trial for this lawsuit, which is pending under Case No. 2025-0509 [4]. - Renovaro claims that Predictive Oncology breached the agreement by conducting a public offering of $545,000 in securities on February 19, 2025, and later attempted to unilaterally terminate the agreement [3]. Group 2: Financial Impact - Following the public disclosure of the merger agreement on January 6, 2025, Predictive Oncology's stock price increased by over 50% [2]. - The litigation seeks specific performance, injunctive relief, and damages for the alleged breaches, indicating potential financial implications for both companies [4]. Group 3: Company Background - Renovaro Inc. focuses on next-generation diagnostics, drug discovery, and genetically enhanced cancer therapies, aiming to accelerate precision and personalized medicine [5]. - The company includes subsidiaries such as RenovaroBio, which specializes in advanced cell-gene immunotherapy, and RenovaroCube, leveraging AI for diagnostics and drug development [5].

Company Focus and Technology Development - Renovaro Inc. focuses on developing advanced allogeneic cell and gene therapies for long-term cancer remission and serious infectious diseases, contingent on obtaining necessary funding[126]. - The acquisition of GEDi Cube Intl. Ltd. on February 13, 2024, has shifted the company's primary focus to Renovaro Cube technologies[126]. - Renovaro Cube's AI platform utilizes a multi-omics approach to analyze genetics for early cancer detection, aiming to identify biomarkers even in asymptomatic patients[136]. - The company is developing multi-cancer early detection (MCED) blood tests to analyze cell-derived molecules for early-stage cancer detection[141]. - Renovaro Cube aims to assist in clinical trials by providing multi-omic data analysis to track patient responses and optimize patient cohort selection[142]. - The company plans to expand its diagnostic tests and test kits for non-invasive liquid biopsy samples across Europe and the United States[144]. - Renovaro Cube's technology is designed to enhance the accuracy and sensitivity of early cancer detection, potentially improving patient outcomes[145]. - The allogeneic cell therapy platform has completed the pre-IND and IND-enabling phase, focusing on long-term remission of solid tumors[131]. - Renovaro Biosciences is developing genetically modified dendritic cell therapeutic vaccines targeting pancreatic tumors and triple-negative breast cancer[133][134]. - The company aims to leverage AI technologies to provide insights into disease characterization and improve treatment protocols for cancer and other diseases[143]. - Renovaro Cube's AI technology focuses on cancer diagnosis, providing insights for effective recurrence monitoring and utilizing blood sequencing to detect cancer recurrence[146]. - The company aims to enhance biomarker panels by incorporating multi-omics data, targeting high accuracy in sensitivity and specificity for cancer detection[146]. - Renovaro Cube has identified biomarker panels for various cancers, including bladder, breast, and lung cancer, leveraging DNA methylation data[148]. - The AI platform supports comprehensive pan-cancer analysis, enabling swift cross-referencing of biomarkers across multiple tumor types[149]. Financial Performance and Concerns - The company has incurred a net loss of $51,275,253 for the nine months ended March 31, 2025, with an accumulated deficit of $383,730,334[173]. - As of March 31, 2025, Renovaro Cube had cash and cash equivalents of $923,002 and a working capital deficit of $25,173,586, raising concerns about its ability to continue as a going concern[173]. - Operating expenses for the three months ended March 31, 2025, decreased by $47,218,348 or approximately 92% compared to the same period in 2024, primarily due to a reduction in intangible asset impairment and general and administrative expenses[179]. - General and administrative expenses for the three months ended March 31, 2025, were $4,224,590, a decrease of $3,427,789 or approximately 45% from $7,652,379 in 2024[181]. - Research and development expenses for the three months ended March 31, 2025, were $(94,073), representing a decrease of $1,181,229 or approximately 109% compared to $1,087,156 in 2024[183]. - Net income for the three months ended March 31, 2025, was $189,176, a change of $59,179,246 or approximately 100% from a net loss of $(58,990,070) in 2024[187]. - Total assets as of March 31, 2025, were $117,726,120, a decrease from $163,129,450 as of June 30, 2024, primarily due to goodwill impairment of $47,614,729[192]. - Total liabilities as of March 31, 2025, were $29,339,269, a decrease from $31,152,306 as of June 30, 2024, mainly due to a reduction in contingent consideration liability[193]. - Cash used in operating activities for the nine months ended March 31, 2025, was $(6,063,511), compared to $(8,557,649) in 2024, indicating improved cash flow management[194]. - Cash provided by financing activities during the nine months ended March 31, 2025, was $8,204,415, primarily from the issuance of notes payable and private placements[197]. - The company had a working capital deficit of $25,173,586 as of March 31, 2025, compared to a deficit of $28,312,274 as of June 30, 2024, reflecting a decrease of 22%[191]. - The company has historically relied on funding from stockholders and debt financing, with no revenue generated to support operations until product approvals are obtained[189]. Future Plans and Partnerships - Renovaro Cube is actively pursuing partnerships with academic cancer centers and pathology centers to validate its multi-omic capabilities using liquid biopsies[157]. - The company plans to hire additional staff and build infrastructure to support the development and commercialization of its AI platform[160]. - Renovaro Cube's AI platform includes Explainable AI features, ensuring traceability and transparency in its diagnostic processes[168]. - The company intends to secure additional funding through equity or debt financing to support its operations and product commercialization[174].