```markdown [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) [Cautionary Language Regarding Forward-Looking Statements and Industry Data](index=4&type=section&id=Cautionary%20Language%20Regarding%20Forward-Looking%20Statements%20and%20Industry%20Data) The report contains forward-looking statements regarding future operations, market trends, and expectations, which are subject to known and unknown risks and uncertainties. Investors are cautioned not to place undue reliance on these statements, as they are not guarantees of future events and actual results may differ materially - Forward-looking statements are based on current assumptions and beliefs, but actual results may differ materially due to various risks and uncertainties[10](index=10&type=chunk)[12](index=12&type=chunk) - Key areas of forward-looking statements include the company's ability to continue as a going concern, incurrence of losses, need for additional capital, dependence on third parties, clinical trial outcomes, regulatory scrutiny of AI/gene therapies, competition, intellectual property disputes, and stock price volatility[11](index=11&type=chunk)[15](index=15&type=chunk) [Part I](index=6&type=section&id=Part%20I) [Business Overview](index=6&type=section&id=Item%201%20Business) Lunai Bioworks Inc. operates through three subsidiaries: Renovaro Biosciences (allogeneic cell and gene therapies for cancer), Renovaro Cube (AI-driven early cancer detection and recurrence), and BioSymetrics (AI for biomarker discovery, therapeutic development, and precision medicine). The company has shifted its primary focus to AI-driven diagnostics and oncology, protecting its innovations through patents, trade secrets, and strategic agreements - Lunai Bioworks Inc. operates through three subsidiaries: Renovaro Biosciences, Renovaro Cube, and BioSymetrics[18](index=18&type=chunk)[300](index=300&type=chunk) - The company's primary focus has shifted to the development of GEDi Cube Intl and BioSymetrics Inc. technologies following acquisitions in February 2024 and April 2025, respectively[19](index=19&type=chunk)[301](index=301&type=chunk) [Renovaro Biosciences Overview](index=6&type=section&id=Renovaro%20Biosciences%20Overview) 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 for solid tumors like pancreatic and triple-negative breast cancer - Renovaro Biosciences aims to develop allogeneic cell and gene therapies to train the immune system for long-term cancer remission[19](index=19&type=chunk)[20](index=20&type=chunk) - The company's focus areas include RENB-DC11 for solid tumors (e.g., pancreatic cancer) and RENB-DC20 for Triple Negative Breast Cancer (TNBC)[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 that analyzes multi-omics data for individual biomarkers. It aims to develop commercial products for precision diagnosis, treatment selection, therapy tracking, recurrence detection, and drug discovery - Renovaro Cube uses a proprietary AI platform with Explainable AI and a multi-omics approach for early and accurate cancer diagnosis and recurrence detection[28](index=28&type=chunk) - The company's product development focuses on early detection, recurrence of cancer, response to treatment, and clinical trials, aiming to provide insights into disease characterization and enable more accurate diagnosis[29](index=29&type=chunk)[33](index=33&type=chunk) - Renovaro Cube's technology has been trained on complex cancer data to identify patterns and translate them into biomarkers for clinical use, covering type-specific, pan-cancer detection, and patient stratification[32](index=32&type=chunk)[40](index=40&type=chunk)[43](index=43&type=chunk) [Business Overview (BioSymetrics)](index=16&type=section&id=Business%20Overview%20(BioSymetrics)) BioSymetrics is a biomedical AI company integrating multimodal data (genomics, imaging, EHR) to advance biomarker discovery, therapeutic development, and precision medicine. Its platform utilizes 'Contingent AI' for pipeline optimization and a proprietary 'Phenograph' knowledge graph for virtual phenotypic screening and target nomination, coupled with experimental validation - BioSymetrics integrates multimodal data using proprietary machine learning pipelines and 'Contingent AI' for biomarker discovery, therapeutic development, and precision medicine[70](index=70&type=chunk)[72](index=72&type=chunk) - The Phenograph, a proprietary knowledge graph, maps human genes and phenotypes to model systems for virtual phenotypic screening and target nomination[74](index=74&type=chunk) - BioSymetrics couples AI prediction with experimental validation, demonstrated by identifying novel neuroactive compounds for epilepsy-related phenotypes using zebrafish 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) Lunai Bioworks protects its intellectual property through patents, copyrights, trademarks, trade secrets, and third-party agreements. Key assigned patents include methods for cancer therapy using recombinant dendritic cells (RENB-DC11) and data analytics using machine learning (Contingent AI). The company also relies on in-licensed technology and proprietary know-how - The company's IP strategy involves filing patent applications and relying on a combination of patent, copyright, trademark, and trade secret laws[82](index=82&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 pre-processing using machine learning (Contingent AI)[84](index=84&type=chunk)[85](index=85&type=chunk) - Protection of trade secrets and proprietary know-how is maintained through non-disclosure and confidentiality agreements with employees, consultants, and collaborators[83](index=83&type=chunk)[87](index=87&type=chunk) [Competition](index=19&type=section&id=Competition) Lunai Bioworks operates in highly competitive markets for AI-driven diagnostics and therapeutic development. Renovaro Cube competes with companies like Grail, Freenome, and Owkin, differentiating itself with a disease-agnostic, multi-omics AI platform and explainable AI. BioSymetrics competes with Recursion Pharma and insitro, distinguishing its platform by focusing on multicellular/multi-organ phenotypes and large-scale chemical screening - Renovaro Cube competes in AI-driven diagnostics with companies like Grail, Freenome, and Owkin, differentiating through its disease-agnostic, multi-omics, and explainable AI platform[88](index=88&type=chunk) - BioSymetrics competes in phenotype-based profiling with Recursion Pharma and insitro, distinguishing its platform by focusing on multicellular/multi-organ phenotypes and high-throughput chemical screening[89](index=89&type=chunk) [Government Regulation](index=19&type=section&id=Government%20Regulation) The company's therapeutic products and AI-driven diagnostic platforms are subject to extensive government regulation in the US (FDA, HIPAA, False Claims Act) and internationally (EU MDR, GDPR). Obtaining regulatory approvals is costly, time-consuming, and uncertain, with potential for delays, restrictions, or withdrawal of products. The evolving regulatory landscape for AI, including concerns about bias, could also significantly impact operations - Therapeutic products require FDA review and approval, involving preclinical studies, IND submission, and multiple phases of clinical trials, a costly and time-consuming process[90](index=90&type=chunk)[91](index=91&type=chunk)[93](index=93&type=chunk) - AI-guided diagnostic platforms (SaMD) require compliance with regulations like FDA guidelines and EU Medical Device Regulation (MDR), emphasizing clinical validation, cybersecurity, data privacy (HIPAA, GDPR), and quality control[106](index=106&type=chunk) - The company is subject to various healthcare laws (anti-kickback, False Claims Act, HIPAA, Physician Payments Sunshine Act) and evolving AI regulations, which could lead to significant compliance costs, fines, or restrictions on business operations[97](index=97&type=chunk)[102](index=102&type=chunk)[165](index=165&type=chunk)[171](index=171&type=chunk) [Employees](index=23&type=section&id=Employees) As of June 30, 2025, Lunai Bioworks had 29 full-time employees, having streamlined its organization to focus on oncology therapeutic vaccines and AI-driven healthcare technology - As of June 30, 2025, the company had **29 full-time employees**, with a streamlined focus 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. (formerly Renovaro Inc. and Renovaro BioSciences Inc.) acquired Renovaro Cube Intl Ltd in February 2024 and BioSymetrics Inc. in April 2025. The company's common stock trades on the NASDAQ Capital Market under the ticker 'RENB.' - The company changed its name to Lunai Bioworks Inc. in August 2025, having previously been Renovaro Inc. and Renovaro BioSciences Inc[14](index=14&type=chunk)[390](index=390&type=chunk) - Key acquisitions include Renovaro Cube Intl Ltd (February 2024) and BioSymetrics Inc. (April 2025), enhancing data repository, biomarker discovery, in vivo validation, and drug discovery capabilities[110](index=110&type=chunk)[111](index=111&type=chunk)[395](index=395&type=chunk) - Lunai Bioworks Inc. common stock trades on the NASDAQ Capital Market under the ticker **'RENB.'**[4](index=4&type=chunk)[112](index=112&type=chunk)[294](index=294&type=chunk) [Risk Factors](index=23&type=section&id=Item%201A%20Risk%20Factors) The company faces significant risks including substantial and increasing losses, going concern doubts, need for additional financing (which may cause dilution), legal proceedings, negative publicity, limited operating history, unproven AI healthcare market, regulatory limitations on AI, uncertain clinical trial results, reliance on third parties, intellectual property issues, management turnover, and stock price volatility - The company has incurred substantial losses and faces significant doubt about its ability to continue as a going concern, requiring substantial additional financing[114](index=114&type=chunk) - Key risks include the unproven nature of the AI-based healthcare solutions market, potential regulatory limitations on AI, and the inherent uncertainty of preclinical and clinical trial results[115](index=115&type=chunk) - Legal proceedings, negative publicity, intellectual property infringement claims, and management turnover are also significant risks that could harm the business[115](index=115&type=chunk) [Risk Factor Summary](index=23&type=section&id=Risk%20Factor%20Summary) This section provides a summary of the key risks and uncertainties that could adversely affect the company's business, financial condition, and operating results, applicable across all subsidiaries - The company faces risks related to substantial losses, going concern doubts, need for additional financing, legal proceedings, negative publicity, limited operating history, and the unproven AI healthcare market[114](index=114&type=chunk)[115](index=115&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) Lunai Bioworks has incurred substantial and increasing net losses since inception, with an accumulated deficit of $510 million as of June 30, 2025. There is substantial doubt about its ability to continue as a going concern, necessitating significant additional financing, which could dilute existing stockholders or restrict operations - The company is a pre-clinical-stage biotechnology and AI-driven healthcare technology company with no approved products or product sales revenue to date[118](index=118&type=chunk)[119](index=119&type=chunk) | Metric | June 30, 2025 | June 30, 2024 | | :----- | :------------ | :------------ | | Net Loss | $(178,007,489) | $(88,425,828) | | Accumulated Deficit | $(510,000,000) | $(332,000,000) | - The company's cash and cash equivalents of **$92,700** as of June 30, 2025, are insufficient for the next twelve months, raising substantial doubt about its ability to continue as a going concern[121](index=121&type=chunk) [Risks Related to Our Limited Operating History](index=28&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History) Lunai Bioworks, as an early-stage biotechnology and AI-driven healthcare technology company, has a limited operating history and has not generated product revenue. Renovaro Cube and BioSymetrics also have limited histories in their current focus areas and have incurred net losses, making future performance difficult to predict. Commercial success depends on market acceptance, adequate reimbursement, and the ability to develop and commercialize new products, all of which are uncertain - Lunai Bioworks is an early-stage biotechnology company with no revenues to date and all product candidates in discovery or pre-clinical stages[131](index=131&type=chunk)[132](index=132&type=chunk)[314](index=314&type=chunk) - Renovaro Cube and BioSymetrics, while having some operational history, have limited experience in their current AI-driven healthcare focus and have incurred net losses, with Renovaro Cube never generating revenue from its cancer diagnostics AI platform[133](index=133&type=chunk)[134](index=134&type=chunk)[135](index=135&type=chunk) - Commercial success is highly dependent on market acceptance by consumers and healthcare providers, adequate coverage and reimbursement from third-party payors, and the ability to demonstrate clinical utility and differentiate products from competitors[138](index=138&type=chunk)[139](index=139&type=chunk)[140](index=140&type=chunk)[147](index=147&type=chunk)[148](index=148&type=chunk) [Risks Related to the Development of Our Product Candidates](index=35&type=section&id=Risks%20Related%20to%20the%20Development%20of%20Our%20Product%20Candidates) The development of the company's product candidates, including gene, cell, and immunotherapy, is highly uncertain, expensive, and time-consuming. Pre-clinical results are not predictive of clinical success, and novel approaches face heightened regulatory scrutiny. Competition is intense, and reliance on third parties for R&D and manufacturing poses risks of delays or failures. Changes in healthcare laws and reimbursement policies could also negatively impact revenue generation - Pre-clinical study results are not necessarily predictive of future clinical trial outcomes, and failure to demonstrate efficacy in future trials would materially adversely affect business prospects[172](index=172&type=chunk)[173](index=173&type=chunk) - Novel gene, cell, and immunotherapy product candidates face heightened regulatory scrutiny, potentially leading to delays in clinical development or approval[175](index=175&type=chunk) - The company operates in a highly competitive environment with rapid technological change, and competitors often have greater resources and longer drug development histories[177](index=177&type=chunk) - Reliance on third parties (e.g., university labs, CROs) for R&D and manufacturing means many aspects are out of direct control, risking delays or failures in completing studies[178](index=178&type=chunk) [Risks Related to Our Technology and Intellectual Property](index=39&type=section&id=Risks%20Related%20to%20Our%20Technology%20and%20Intellectual%20Property) The company's success relies on protecting its intellectual property (patents, trade secrets, licenses) and avoiding infringement claims. Licensing agreements are complex, and breaches could lead to loss of critical IP rights. The patentability and enforceability of biotechnology patents are uncertain, and third-party infringement claims could result in substantial costs, damages, or injunctions. The integration of AI into platforms introduces risks related to flawed algorithms, biased data, ethical concerns, and evolving regulations, which could lead to reputational harm or liability - The company relies on licensed intellectual property, and breaches of license agreements could lead to loss of important IP rights and adverse effects on business[186](index=186&type=chunk)[189](index=189&type=chunk) - Patentability, validity, and enforceability of biotechnology patents are uncertain, and third-party infringement claims could prevent or delay commercialization efforts, incurring substantial litigation expenses[191](index=191&type=chunk)[192](index=192&type=chunk)[200](index=200&type=chunk)[201](index=201&type=chunk) - AI integration in Renovaro Cube's and BioSymetrics' platforms carries risks of flawed algorithms, insufficient/biased data, ethical issues, and evolving regulations, potentially leading to competitive harm, legal liability, and reputational damage[203](index=203&type=chunk)[204](index=204&type=chunk)[206](index=206&type=chunk) [Risks Related to Employee Matters and Managing Growth](index=47&type=section&id=Risks%20Related%20to%20Employee%20Matters%20and%20Managing%20Growth) The company has limited corporate infrastructure and faces difficulties managing growth, including the need for additional managerial, scientific, and operational resources. Significant turnover in executive leadership and intense competition for highly skilled employees in AI, data science, and biomedical research create uncertainties and could harm business operations and growth prospects - The company has limited corporate infrastructure (**29 full-time employees** as of June 30, 2025) and relies on third-party contractors, which may lead to difficulties in managing growth and operational inefficiencies[226](index=226&type=chunk) - Significant turnover in executive leadership and management creates uncertainty, impacts execution, and can lead to loss of institutional knowledge[227](index=227&type=chunk)[229](index=229&type=chunk) - Attracting and retaining highly qualified personnel in AI, data science, and biomedical research is challenging due to intense competition, which could limit the ability to develop and commercialize products[228](index=228&type=chunk)[231](index=231&type=chunk)[232](index=232&type=chunk) [Risks Related To Our Business Operations](index=50&type=section&id=Risks%20Related%20To%20Our%20Business%20Operations) The company's business plan involves uncertain and risky activities, including product development programs that may be discontinued (as with prior pipelines) or modified based on competitive information. Serious adverse events or safety concerns from product candidates could delay clinical development, regulatory approval, or commercialization. International operations expose the company to economic, political, and regulatory risks, and product/professional liability claims could result in substantial liabilities - The business plan involves uncertain product development, with prior instances of discontinuing pipelines (e.g., pan-coronavirus and influenza) due to unfavorable results[242](index=242&type=chunk)[244](index=244&type=chunk) - Serious adverse events or undesirable side effects from product candidates could interrupt clinical trials, delay regulatory approval, or lead to market withdrawal and significant negative consequences[245](index=245&type=chunk)[246](index=246&type=chunk) - International operations expose the company to risks such as economic/political instability, changes in foreign laws, currency fluctuations, and difficulties in enforcing IP rights[247](index=247&type=chunk)[251](index=251&type=chunk) - The company faces substantial product or professional liability risks from potential errors in test results, manufacturing, design, or labeling of its products, which could lead to significant damages and reputational harm[249](index=249&type=chunk) [Risks Related to our Common Stock](index=52&type=section&id=Risks%20Related%20to%20our%20Common%20Stock) The company's stock price has been and is expected to remain volatile due to various factors, including negative publicity, competitive developments, regulatory actions, and financial performance. Substantial sales of common stock in the public market could cause the stock price to fall and dilute existing stockholders. As a public company, increased costs and management time are devoted to compliance. The company does not anticipate paying cash dividends, making capital appreciation the sole source of gain for stockholders. Anti-takeover provisions in charter documents and Delaware law could discourage acquisitions - The company's stock price has been volatile and may continue to be influenced by factors such as negative publicity, competitive success, regulatory actions, and financial results[250](index=250&type=chunk)[252](index=252&type=chunk)[255](index=255&type=chunk) - Sales of a substantial number of common stock shares in the public market could cause the stock price to fall and dilute existing stockholders[254](index=254&type=chunk)[259](index=259&type=chunk) - As a public company, the company incurs significant legal, accounting, and compliance costs, and management devotes substantial time to these programs[256](index=256&type=chunk)[257](index=257&type=chunk) - The company does not anticipate paying cash dividends, making capital appreciation the sole source of potential gain for stockholders[258](index=258&type=chunk) [Unresolved Staff Comments](index=55&type=section&id=Item%201B%20Unresolved%20Staff%20Comments) This item states that there are no unresolved staff comments applicable to the company - The company has no unresolved staff comments[263](index=263&type=chunk) [Cybersecurity Risk Management and Strategy](index=55&type=section&id=Item%201C%20Cybersecurity%20Risk%20Management%20and%20Strategy) Lunai has a comprehensive cybersecurity risk management program guided by NIST CSF 2.0, integrated with its broader enterprise risk management strategy. Key components include risk assessments, a dedicated security team, external service provider engagement, employee training, an incident response plan, and third-party risk management. The Board of Directors, through the Audit Committee, oversees cybersecurity risks - Lunai's cybersecurity risk management program is guided by NIST CSF 2.0 and integrated with its enterprise risk management strategy[264](index=264&type=chunk)[265](index=265&type=chunk)[266](index=266&type=chunk) - Key components include risk assessments, a dedicated security team, external evaluations, employee training, an incident response plan, and third-party risk management[268](index=268&type=chunk)[275](index=275&type=chunk) - Cybersecurity governance is a critical function of the Board of Directors, with the Audit Committee providing oversight and receiving regular updates from management[270](index=270&type=chunk)[271](index=271&type=chunk)[272](index=272&type=chunk) [Properties](index=56&type=section&id=Item%202%20Properties) The company leases its corporate headquarters in Los Angeles, CA (3,554 sq ft, 10-year lease from 2018) and an office in Boca Raton, FL (36-month operating lease from November 2024). Renovaro Cube previously leased an office in Amsterdam, Netherlands, which was terminated in April 2025 | Location | Use | Lease Term | Monthly Rent (Year 1-10) | | :------- | :-- | :--------- | :----------------------- | | 2080 Century Park East, Suite 906, Los Angeles, CA 90067 | Headquarters | 10 years (from June 19, 2018) | $17,770 - $23,186 | | 101 Plaza Real South, Suite 202, Boca Raton, FL 33432 | Lunai Bioworks Inc. Office | 36 months (from Nov 1, 2024) | Not specified | - Renovaro Cube's office lease in Amsterdam, Netherlands, which commenced on September 1, 2023, was mutually terminated on April 29, 2025[444](index=444&type=chunk) [Legal Proceedings](index=57&type=section&id=Item%203%20Legal%20Proceedings) The company is involved in several legal proceedings, including a pending Securities Class Action Litigation (settlement preliminarily approved Aug 2025), Federal Derivative Litigations (stayed), and State Derivative Litigation (stayed). The company also filed a complaint against a co-founder and others for alleged fraud related to misrepresented study results, and is involved in a dispute with Predictive Oncology, Inc. regarding a failed acquisition - A Securities Class Action Litigation (Chow Action) is pending, with a stipulation of settlement signed in September 2024 and preliminary approval granted in August 2025[276](index=276&type=chunk)[525](index=525&type=chunk) - Multiple Federal and State Derivative Litigations (Koenig, Solak, Midler Matters) are ongoing, naming a co-founder and current/former directors as defendants, alleging violations and breaches of fiduciary duty; these actions are currently stayed[277](index=277&type=chunk)[278](index=278&type=chunk)[280](index=280&type=chunk)[526](index=526&type=chunk)[527](index=527&type=chunk)[529](index=529&type=chunk) - The company filed a complaint against Serhat Gümrükcü and others, alleging a scheme to falsify and misrepresent study results for Hepatitis B and SARS-CoV-2/influenza pipelines, claiming approximately **$25 million** in damages[281](index=281&type=chunk)[530](index=530&type=chunk) - The company is also involved in a lawsuit against Predictive Oncology, Inc. for alleged breach of an acquisition agreement, seeking specific performance or money damages[291](index=291&type=chunk)[540](index=540&type=chunk) [Mine Safety Disclosures](index=59&type=section&id=Item%204%20Mine%20Safety%20Disclosures) This item states that there are no mine safety disclosures applicable to the company - The company has no mine safety disclosures[292](index=292&type=chunk) [Part II](index=60&type=section&id=Part%20II) [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=60&type=section&id=Item%205%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Lunai Bioworks' Common Stock trades on the Nasdaq Capital Market under 'RENB.' As of September 26, 2025, there were 231,802,470 shares outstanding and approximately 233 stockholders of record. The company has not declared or paid cash dividends and does not intend to in the foreseeable future - Common Stock trades on Nasdaq Capital Market under **'RENB.'**[294](index=294&type=chunk) | Metric | Value | | :----- | :---- | | Shares Outstanding | 231,802,470 | | Stockholders of Record | ~233 | - The company has not declared or paid cash dividends and does not intend to in the foreseeable future, with future earnings to be retained for business growth[298](index=298&type=chunk)[54](index=54&type=chunk) [Selected Financial Data](index=60&type=section&id=Item%206%20Selected%20Financial%20Data) This item is reserved and no information is provided [Management's Discussion and Analysis of Financial Condition and Results Of Operations](index=60&type=section&id=Item%207%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20Of%20Operations) This section provides an overview of Lunai Bioworks' business, recent developments, and financial performance. The company is pre-revenue and faces significant going concern doubts due to recurring losses. For FY2025, net loss increased to $178.0 million, driven by goodwill impairment, despite improved other income. Liquidity remains constrained, necessitating additional financing for R&D and operations [Our Business](index=60&type=section&id=Our%20Business) Lunai Bioworks Inc. operates through Renovaro Biosciences, Renovaro Cube, and BioSymetrics Inc., with a primary focus shifted to the AI-driven technologies of GEDi Cube Intl and BioSymetrics Inc. The company is pre-revenue and pre-clinical, relying on financing and not expecting sales revenue until product approval - Lunai Bioworks operates through three subsidiaries: Renovaro Biosciences, Renovaro Cube, and BioSymetrics Inc[300](index=300&type=chunk) - The company's primary focus has shifted to the development of GEDi Cube Intl and BioSymetrics Inc. technologies following acquisitions[301](index=301&type=chunk) - The company is a pre-revenue, pre-clinical biotechnology and AI-driven healthcare technology company, funded by securities sales and debt financing, with no current sales revenue and no expectation of profitability in the foreseeable future[302](index=302&type=chunk)[314](index=314&type=chunk) [Recent Developments](index=61&type=section&id=Recent%20Developments) Recent developments include the bankruptcy declaration of Gedi Cube B.V. (an indirect subsidiary) in September 2025, and several promissory note issuances and an exchange agreement in July-August 2025 to restructure debt. The exchange agreement converted $9.7 million in secured notes into $16.1 million in new convertible notes, which were then converted into 53.6 million shares of common stock, eliminating secured indebtedness without cash proceeds - Gedi Cube B.V., an indirect subsidiary, was declared bankrupt by the Court of Amsterdam on September 2, 2025, leading to a material impairment[303](index=303&type=chunk)[565](index=565&type=chunk) - In July-August 2025, the company issued promissory notes totaling **$1,695,000** with interest rates of **10-18%** and various maturity dates[304](index=304&type=chunk)[305](index=305&type=chunk)[566](index=566&type=chunk)[567](index=567&type=chunk) - An Exchange Agreement on July 7, 2025, restructured debt by converting **$9.7 million** in secured notes into **$16.1 million** in convertible notes (**65% premium**), which were immediately converted into **53.6 million shares** of common stock, eliminating secured debt without cash proceeds[306](index=306&type=chunk)[307](index=307&type=chunk)[308](index=308&type=chunk)[568](index=568&type=chunk)[569](index=569&type=chunk)[570](index=570&type=chunk) [Known Trends](index=61&type=section&id=Known%20Trends) The company's financial statements are prepared under a going concern assumption, but substantial recurring losses, cash usage in operations, and dependence on additional financing raise substantial doubt about its ability to continue. Management plans to reduce costs, streamline operations to focus on AI-driven cancer diagnostics, and seek additional equity or debt financing, but there's no assurance of obtaining funds on reasonable terms, which could lead to reduced operations or bankruptcy - Substantial recurring losses, cash usage in operations, and dependence on additional financing raise substantial doubt about the company's ability to continue as a going concern[309](index=309&type=chunk)[424](index=424&type=chunk) - Management plans to reduce overhead, streamline operations to focus on AI-driven cancer diagnostics, and secure additional funding through equity or debt financing[310](index=310&type=chunk)[425](index=425&type=chunk) - Failure to obtain additional funding could lead to material reduction or suspension of operations, significant dilution for stockholders, or even bankruptcy[310](index=310&type=chunk)[425](index=425&type=chunk) [Results of Operations](index=62&type=section&id=Results%20of%20Operations) The company reported a net loss of $178.0 million for the year ended June 30, 2025, a 101% increase from $88.4 million in 2024. Total operating expenses increased by 131% to $189.0 million, primarily due to a $158.8 million increase in goodwill impairment, partially offset by decreases in intangible asset impairment, general and administrative, and R&D expenses. Other income (expenses) significantly improved due to a positive change in contingent consideration fair value | Metric | 2025 | 2024 | Change ($) | Change (%) | | :-------------------------------- | :----------- | :----------- | :----------- | :--------- | | Net Loss | $(178,007,489) | $(88,425,828) | $(89,581,661) | 101% | | Total Operating Expenses | $188,966,002 | $81,639,296 | $107,326,706 | 131% | | Other Income (Expense) | $10,958,513 | $(6,786,532) | $17,745,045 | (261)% | [Revenues](index=63&type=section&id=Revenues) The company is a pre-revenue, pre-clinical biotechnology and AI-driven healthcare technology company and has not generated any revenues since inception. It does not anticipate earning revenues until its therapies or products are approved for marketing and sale - The company is a pre-revenue, pre-clinical biotechnology and AI-driven healthcare technology company[314](index=314&type=chunk) - No revenues have been generated since inception, and none are anticipated until product approval for marketing and sale[314](index=314&type=chunk) [Operating Expenses](index=63&type=section&id=Operating%20Expenses) Total operating expenses increased by $107.3 million (131%) to $189.0 million in FY2025, primarily driven by a $158.8 million increase in goodwill impairment. This was partially offset by decreases in intangible asset impairment ($42.6 million), general and administrative expenses ($6.7 million), and research and development expenses ($2.2 million) | Expense Category | 2025 | 2024 | Change ($) | Change (%) | | :----------------------- | :----------- | :----------- | :----------- | :--------- | | General and administrative | $17,880,050 | $24,557,608 | $(6,677,558) | (27)% | | Research and development | $537,428 | $2,708,829 | $(2,171,401) | (80)% | | Intangible asset impairment | $0 | $42,611,000 | $(42,611,000) | (100)% | | Goodwill impairment | $170,419,429 | $11,640,000 | $158,779,429 | 1,364% | | Depreciation and amortization | $129,095 | $121,859 | $7,236 | 6% | | **Total Operating Expenses** | **$188,966,002** | **$81,639,296** | **$107,326,706** | **131%** | - The significant increase in operating expenses was primarily due to a **1,364% increase** in non-cash goodwill impairment[315](index=315&type=chunk) - General and administrative expenses decreased by **27%** due to lower consulting, legal, stock-based compensation, sales tax, investor relations, advertising, and board member compensation, partially offset by increased compensation-related, rent, IT, and subscription expenses[316](index=316&type=chunk) - Research and development expenses decreased by **80%** due to reduced collaborating partner expenses (CDMO and CROs for discontinued product candidates), consulting expenses, and consumables[317](index=317&type=chunk) [Other Income (Expenses)](index=63&type=section&id=Other%20Income%20(Expenses)) Net other income (expenses) significantly improved from a $(6.8) million expense in FY2024 to a $11.0 million income in FY2025, a change of $17.7 million (261%). This was primarily driven by a positive change in the fair value of contingent consideration | Category | 2025 | 2024 | Change ($) | Change (%) | | :----------------------------------- | :----------- | :----------- | :----------- | :--------- | | Change in fair value of contingent consideration | $11,680,000 | $(3,048,183) | $14,728,183 | (483)% | | Loss on extinguishment of debt | $0 | $(1,303,578) | $1,303,578 | (100)% | | Change in fair value of equity securities | $(112,149) | $0 | $(112,149) | 100% | | Interest expense | $(725,684) | $(1,011,322) | $285,638 | (28)% | | Interest and other income (expense) | $116,346 | $(1,423,449) | $1,539,795 | (108)% | | **Total Other Income (Expense)** | **$10,958,513** | **$(6,786,532)** | **$17,745,045** | **(261)%** | - The primary driver for the increase in other income was a positive change of **$11,680,000** in the fair value of contingent consideration[318](index=318&type=chunk) [Net Loss](index=63&type=section&id=Net%20Loss) The net loss for the year ended June 30, 2025, increased by $89.6 million (101%) to $178.0 million, compared to $88.4 million in 2024. This increase was primarily due to a significant rise in goodwill impairment, partially offset by decreases in intangible asset impairment, general and administrative expenses, R&D expenses, and a favorable change in contingent consideration fair value | Metric | 2025 | 2024 | Change ($) | Change (%) | | :------- | :----------- | :----------- | :----------- | :--------- | | Net Loss | $(178,007,489) | $(88,425,828) | $(89,581,661) | 101% | - The increase in net loss was primarily driven by a **$158.8 million** increase in non-cash goodwill impairment[319](index=319&type=chunk) - Offsetting factors included a **$42.6 million** decrease in non-cash intangible asset impairment, a **$6.7 million** decrease in general and administrative expenses, a **$2.2 million** decrease in R&D expenses, and a **$14.7 million** favorable change in the fair value of contingent consideration[319](index=319&type=chunk) [Liquidity and Capital Resources](index=63&type=section&id=Liquidity%20and%20Capital%20Resources) The company relies on funding from stockholders, equity sales, and debt financing, as it has no sales revenue and expects this to continue until product approval. As of June 30, 2025, cash and cash equivalents were $92,700, and working capital was $(28.1) million, indicating a need for additional funds for R&D, personnel, equipment, and technology validation. Failure to secure additional funding could materially adversely affect growth plans and financial condition - The company has historically relied on stockholder funding, equity sales, and debt financing, with no sales revenue generated to date[320](index=320&type=chunk) | Metric | June 30, 2025 | June 30, 2024 | | :------------- | :------------ | :------------ | | Cash | $92,700 | $220,467 | | Working Capital | $(28,109,502) | $(28,312,274) | - Additional funds are needed for research and development, personnel increases, equipment purchases, and technology validation, with no assurance of availability on acceptable terms[321](index=321&type=chunk) [Equity](index=64&type=section&id=Equity) In FY2025, the company issued 15 million shares of Common Stock for the BioSymetrics acquisition ($6.06 million value) and several tranches of Common Stock for consulting services and executive compensation, totaling 3.16 million shares valued at $1.95 million - On April 8, 2025, **15,000,000 shares** of Common Stock were issued for the acquisition of BioSymetrics, Inc., valued at **$6,058,500**[323](index=323&type=chunk)[479](index=479&type=chunk) - Additional Common Stock issuances in FY2025 included **250,000 shares** to the Renovaro Cube CEO (**$177,500**), **160,000 shares** for consulting (**$118,400**), **500,000 shares** for consulting (**$275,000**), **250,000 shares** to the CEO (**$137,500**), and **2,000,000 shares** for consulting (**$1,400,000**)[323](index=323&type=chunk)[324](index=324&type=chunk)[325](index=325&type=chunk)[479](index=479&type=chunk)[480](index=480&type=chunk)[481](index=481&type=chunk)[483](index=483&type=chunk) [Debt](index=64&type=section&id=Debt) As of June 30, 2025, the company had $245,000 in convertible notes (12% interest, matured Dec 2024) and approximately $7.8 million in promissory notes. These promissory notes include bridge loans and other notes from related parties (Paseco ApS, Laksya Ventures Inc., Rene Sindlev, Yalla Yalla Limited), with interest rates of 10-12% and maturities ranging from December 2024 to December 2025. Most obligations, except Renovaro Cube's, are secured by a lien on all company assets | Debt Type | Principal Amount | Interest Rate | Maturity Date | | :---------------------- | :--------------- | :------------ | :------------ | | Convertible Notes Payable | $245,000 | 12% | Dec 29, 2024 | | Promissory Notes (Bridge Loans) | $3,450,000 | 10% | Dec 31, 2025 | | Promissory Notes (Paseco/Laksya) | $2,650,000 | 10% | Dec 2024 - Dec 2025 | | Promissory Notes (Renovaro Cube) | ~$490,000 | 10% | Dec 1, 2025 | | Promissory Note (Yalla Yalla) | ~$238,000 | 10% | Feb 24, 2025 | | Promissory Note (RS Bio/Sindlev) | $100,000 | 12% | Dec 31, 2024 | | Secured Promissory Note (RS Bio/Sindlev) | $105,263 | 12% | Dec 31, 2024 | | Secured Promissory Note (RS Bio/Sindlev) | $526,315 | 12% | Dec 31, 2024 | | Promissory Note (RS Bio/Sindlev) | $750,000 | 12% | Dec 31, 2024 | | Promissory Note (Paseco/Sindlev) | $831,497 | 12% | Nov 1, 2024 | - The company's obligations under most Promissory and Bridge Notes are secured by a Security Agreement, granting a lien on all company assets for the benefit of Paseco ApS, Rene Sindlev, and Laksya Ventures[339](index=339&type=chunk)[462](index=462&type=chunk) [Cash Flows](index=66&type=section&id=Cash%20Flows) For the year ended June 30, 2025, net cash used in operating activities decreased by $3.1 million to $7.9 million, while net cash used in investing activities decreased by $0.8 million to $0.5 million. Net cash provided by financing activities decreased by $2.1 million to $8.4 million. Overall, cash decreased by $127,767, resulting in an ending cash balance of $92,700 | Activity | 2025 | 2024 | Change ($) | | :------------------------------ | :----------- | :----------- | :----------- | | Net Cash Used in Operating Activities | $(7,874,647) | $(10,971,430) | $3,096,783 | | Net Cash Used in Investing Activities | $(500,000) | $(1,260,179) | $760,179 | | Net Cash Provided by Financing Activities | $8,382,772 | $10,517,455 | $(2,134,683) | | Effect of exchange rates on cash | $(135,892) | $60,141 | $(196,033) | | **Net Increase (Decrease) in Cash** | **$(127,767)** | **$(1,654,013)** | **$1,526,246** | | Cash, Beginning of Period | $220,467 | $1,874,480 | $(1,654,013) | | Cash, End of Period | $92,700 | $220,467 | $(127,767) | - The decrease in cash used in operating activities was primarily due to changes in operating assets and liabilities[342](index=342&type=chunk) - Financing activities were a primary source of cash, including proceeds from private placements and promissory notes, partially offset by repayments of finance agreements[344](index=344&type=chunk) [Off-Balance Sheet Arrangements](index=67&type=section&id=Off-Balance%20Sheet%20Arrangements) As of June 30, 2025, and 2024, the company had no off-balance sheet arrangements - The company had no off-balance sheet arrangements as of June 30, 2025, and 2024[345](index=345&type=chunk) [Significant Accounting Policies and Critical Accounting Estimates](index=67&type=section&id=Significant%20Accounting%20Policies%20and%20Critical%20Accounting%20Estimates) The preparation of financial statements requires significant estimates and assumptions, particularly for the fair value and impairment of intangible assets (patents, license agreements, goodwill), fair value of contingent consideration, and equity instruments. Goodwill and indefinite-life intangible assets are tested annually for impairment, with significant impairment losses recorded for goodwill in FY2025 and IPR&D in FY2024 - Significant accounting estimates include the fair value and potential impairment of intangible assets (definite and indefinite life), contingent consideration liability, and equity instruments[346](index=346&type=chunk)[396](index=396&type=chunk) - Goodwill and indefinite-life intangible assets (like IPR&D) are tested annually for impairment[350](index=350&type=chunk)[351](index=351&type=chunk)[406](index=406&type=chunk)[407](index=407&type=chunk)[409](index=409&type=chunk) | Asset Type | Year Ended June 30, 2025 | Year Ended June 30, 2024 | | :--------- | :----------------------- | :----------------------- | | Goodwill | $170,419,429 | $11,640,000 | | IPR&D | $0 | $42,611,000 | [Quantitative and Qualitative Disclosures About Market Risk](index=68&type=section&id=Item%207A%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Lunai Bioworks Inc. is not required to provide quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[362](index=362&type=chunk) [Financial Statements and Supplementary Data](index=68&type=section&id=Item%208%20Financial%20Statements%20and%20Supplementary%20Data) This section provides an index to the company's consolidated financial statements, including the Report of Independent Registered Public Accounting Firm, Consolidated Balance Sheets, Statements of Operations, Statements of Comprehensive Loss, Statement of Stockholders' Equity (Deficit), Statements of Cash Flows, and Notes to the Consolidated Financial Statements - The index lists all components of the consolidated financial statements, including the auditor's report, primary financial statements, and detailed notes[365](index=365&type=chunk) [Report of Independent Registered Public Accounting Firm](index=70&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Sadler, Gibb & Associates, LLC issued an unqualified opinion on Lunai Bioworks Inc.'s consolidated financial statements for the years ended June 30, 2025 and 2024, stating they are presented fairly in all material respects. However, an explanatory paragraph highlights substantial doubt about the company's ability to continue as a going concern due to recurring losses and dependence on additional financing. The critical audit matter identified was the goodwill impairment assessment due to significant management estimates - The independent auditor issued an unqualified opinion on the consolidated financial statements for FY2025 and FY2024[366](index=366&type=chunk) - An explanatory paragraph highlights substantial doubt about the company's ability to continue as a going concern due to recurring losses and dependence on additional financing[367](index=367&type=chunk) - The critical audit matter identified was the goodwill impairment assessment, which required significant auditor judgment due to management's estimates and assumptions[371](index=371&type=chunk)[372](index=372&type=chunk)[373](index=373&type=chunk) [Consolidated Financial Statements](index=72&type=section&id=Consolidated%20Financial%20Statements) This section presents the company's core consolidated financial statements, including the Balance Sheets, Statements of Operations, Statements of Comprehensive Loss, Statement of Stockholders' Equity (Deficit), and Statements of Cash Flows for the years ended June 30, 2025 and 2024 [Consolidated Balance Sheets](index=72&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets were $8.23 million, a significant decrease from $163.13 million in 2024, primarily due to a large goodwill impairment. Total liabilities decreased slightly to $29.58 million, while total stockholders' equity (deficit) shifted from a positive $131.98 million to a deficit of $(21.35) million | Metric | June 30, 2025 | June 30, 2024 | Change ($) | Change (%) | | :-------------------------- | :------------ | :------------ | :----------- | :--------- | | Total Assets | $8,230,840 | $163,129,450 | $(154,898,610) | (95)% | | Total Liabilities | $29,580,681 | $31,152,306 | $(1,571,625) | (5)% | | Total Stockholders' Equity (Deficit) | $(21,349,841) | $131,977,144 | $(153,326,985) | (116)% | - The substantial decrease in total assets was largely driven by the goodwill impairment recognized during the year[315](index=315&type=chunk)[372](index=372&type=chunk) - The company's stockholders' equity moved from a positive balance to a deficit, reflecting the significant net loss and impairment charges[376](index=376&type=chunk) [Consolidated Statements of Operations](index=74&type=section&id=Consolidated%20Statements%20of%20Operations) For the year ended June 30, 2025, the company reported a net loss of $178.0 million, a 101% increase from the $88.4 million loss in 2024. This was primarily due to a significant increase in goodwill impairment, partially offset by a favorable change in contingent consideration and reduced general & administrative and R&D expenses. Basic and diluted net loss per common share increased to $(1.08) from $(0.91) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :-------------------------------- | :----------- | :----------- | :----------- | :--------- | | Total Operating Expenses | $188,966,002 | $81,639,296 | $107,326,706 | 131% | | Loss from Operations | $(188,966,002) | $(81,639,296) | $(107,326,706) | 131% | | Total Other Income (Expense) | $10,958,513 | $(6,786,532) | $17,745,045 | (261)% | | Net Loss | $(178,007,489) | $(88,425,828) | $(89,581,661) | 101% | | Basic and Diluted Net Loss Per Common Share | $(1.08) | $(0.91) | $(0.17) | 18.7% | - The substantial increase in net loss was mainly driven by a **1,364% increase** in goodwill impairment[315](index=315&type=chunk)[319](index=319&type=chunk) - Other income (expense) saw a significant positive swing, primarily due to a favorable change in the fair value of contingent consideration[318](index=318&type=chunk) [Consolidated Statements of Comprehensive Loss](index=75&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) The comprehensive loss for the year ended June 30, 2025, was $(167.0) million, an 89% increase from $(88.6) million in 2024. This was primarily influenced by the net loss, partially offset by a positive foreign currency translation adjustment of $10.99 million in 2025, compared to a negative adjustment in 2024 | Metric | 2025 | 2024 | Change ($) | Change (%) | | :------------------------------ | :----------- | :----------- | :----------- | :--------- | | Net Loss | $(178,007,489) | $(88,425,828) | $(89,581,661) | 101% | | Foreign currency translation, net of taxes | $10,985,688 | $(140,964) | $11,126,652 | (7,893)% | | **Comprehensive Loss** | **$(167,021,801)** | **$(88,566,792)** | **$(78,455,009)** | **89%** | - A significant positive foreign currency translation adjustment in 2025 partially mitigated the impact of the net loss on comprehensive loss[381](index=381&type=chunk) [Consolidated Statement of Stockholders' Equity (Deficit)](index=76&type=section&id=Consolidated%20Statement%20of%20Stockholders'%20Equity%20(Deficit)) Total stockholders' equity shifted from a positive $131.98 million at June 30, 2024, to a deficit of $(21.35) million at June 30, 2025. This change was primarily driven by the net loss of $(178.0) million, partially offset by $6.06 million from common stock issued for acquisition, $2.38 million from private placement, $1.95 million from restricted shares, and a $10.99 million positive foreign currency translation adjustment | Metric | June 30, 2025 | June 30, 2024 | | :-------------------------- | :------------ | :------------ | | Common Stock (Amount) | $17,741 | $15,847 | | Additional Paid-In Capital | $478,280,146 | $464,587,224 | | Accumulated Deficit | $(510,462,570) | $(332,455,081) | | Accumulated Other Comprehensive (Loss) | $10,814,842 | $(170,846) | | **Total Stockholders' Equity (Deficit)** | **$(21,349,841)** | **$131,977,144** | - The significant decrease in equity was primarily due to the net loss of **$(178.0) million** for the year[385](index=385&type=chunk) - Common stock issuances included **15 million shares** for the BioSymetrics acquisition and **1.6 million shares** from private placement offerings[385](index=385&type=chunk) [Consolidated Statements of Cash Flows](index=78&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) For the year ended June 30, 2025, net cash used in operating activities was $(7.87) million, net cash used in investing activities was $(0.50) million, and net cash provided by financing activities was $8.38 million. The overall net decrease in cash was $(127,767), resulting in an ending cash balance of $92,700 | Activity | 2025 | 2024 | | :------------------------------ | :----------- | :----------- | | Net Cash Used in Operating Activities | $(7,874,647) | $(10,971,430) | | Net Cash Used in Investing Activities | $(500,000) | $(1,260,179) | | Net Cash Provided by Financing Activities | $8,382,772 | $10,517,455 | | Effect of exchange rates on cash | $(135,892) | $60,141 | | **Net Increase (Decrease) in Cash** | **$(127,767)** | **$(1,654,013)** | | Cash, End of Period | $92,700 | $220,467 | - The decrease in cash used in operating activities was primarily due to changes in operating assets and liabilities[342](index=342&type=chunk) - Financing activities were a primary source of cash, including proceeds from private placements and promissory notes, partially offset by repayments of finance agreements[344](index=344&type=chunk) [Notes to the Consolidated Financial Statements](index=80&type=section&id=Notes%20to%20the%20Consolidated%20Financial%20Statements) This section provides detailed notes to the consolidated financial statements, covering the company's organization, significant accounting policies, going concern status, fair value measurements, property and equipment, intangible assets and goodwill, leases, debt, income taxes, stockholders' equity, commitments and contingencies, related party transactions, acquisitions, segment reporting, and subsequent events [NOTE 1 — ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=80&type=section&id=NOTE%201%20%E2%80%94%20ORGANIZATION%20AND%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) Lunai Bioworks Inc. (formerly Renovaro Inc.) is an AI-driven platform for precision medicine, diagnostics, and biodefense, operating through wholly-owned subsidiaries Renovaro Biosciences, Renovaro Cube, and BioSymetrics. The financial statements are prepared under U.S. GAAP, with significant estimates for intangible assets, contingent consideration, and equity instruments. Functional currencies vary by subsidiary, with the U.S. Dollar as the reporting currency - Lunai Bioworks Inc. (formerly Renovaro Inc.) is an AI-driven platform for precision medicine, diagnostics, and biodefense, operating through Renovaro Biosciences, Renovaro Cube, and BioSymetrics[390](index=390&type=chunk) - The company's financial statements are prepared under U.S. GAAP, requiring significant estimates for fair value and impairment of intangible assets, contingent consideration, and equity instruments[391](index=391&type=chunk)[396](index=396&type=chunk) - Functional currencies for subsidiaries include Danish Kroner (Renovaro Denmark), Euro (Renovaro Cube), and Canadian Dollar (BioSymetrics Corp.), with the U.S. Dollar as the reporting currency[397](index=397&type=chunk) [NOTE 2 – GOING CONCERN](index=84&type=section&id=NOTE%202%20%E2%80%93%20GOING%20CONCERN) The company's financial statements are prepared assuming a going concern, but substantial recurring losses, cash usage, and dependence on additional financing raise significant doubt about its ability to continue operations for the next year. As of June 30, 2025, the company had $92,700 in cash and an accumulated deficit of $510.5 million. Management plans to reduce costs, streamline operations, and seek further funding, but there is no assurance of success, which could lead to reduced operations or bankruptcy - Substantial recurring losses, cash usage, and dependence on additional financing raise significant doubt about the company's ability to continue as a going concern[424](index=424&type=chunk) | Metric | Amount | | :---------------- | :----------- | | Net Loss (FY2025) | $(178,007,489) | | Cash and Cash Equivalents | $92,700 | | Accumulated Deficit | $(510,462,570) | | Working Capital Deficit | $(28,109,502) | - Management's plans include reducing overhead, streamlining operations to focus on AI-driven cancer diagnostics, and securing additional equity or debt financing[425](index=425&type=chunk) [NOTE 3 — FAIR VALUE MEASUREMENTS](index=84&type=section&id=NOTE%203%20%E2%80%94%20FAIR%20VALUE%20MEASUREMENTS) The company applies FASB ASC Topic 820 for fair value measurements, using a three-tier hierarchy. As of June 30, 2025, Level 1 assets included $387,851 in equity securities, and Level 3 liabilities included a contingent consideration liability of $630,000 related to the Renovaro Cube acquisition. The contingent consideration is valued using Black-Scholes and Monte-Carlo models, with volatility as a key unobservable input - Fair value measurements are categorized into a three-tier hierarchy (Level 1, 2, 3) based on input observability[427](index=427&type=chunk) | Category | Level 1 | Level 2 | Level 3 | | :-------------------------- | :------ | :------ | :------ | | Investment in equity securities | $387,851 | — | — | | Contingent consideration liability | — | — | $630,000 | - The contingent consideration liability, related to the Renovaro Cube acquisition, is valued using Black-Scholes and Monte-Carlo models, with volatility (**116%-141%**) being a key unobservable input[430](index=430&type=chunk)[431](index=431&type=chunk) - The fair value adjustment for contingent consideration resulted in a decrease of **$11,680,000** from June 30, 2024, to June 30, 2025[433](index=433&type=chunk) [NOTE 4 - PROPERTY AND EQUIPMENT](index=86&type=section&id=NOTE%204%20-%20PROPERTY%20AND%20EQUIPMENT) As of June 30, 2025, net property and equipment totaled $367,843, a decrease from $482,121 in 2024. This includes lab equipment, leasehold improvements, and furniture, fixtures, and equipment, depreciated on a straight-line basis over 4-10 years. Depreciation expense for FY2025 was $119,193 | Category | 2025 | 2024 | | :-------------------------- | :------- | :------- | | Lab equipment and instruments | $639,998 | $639,998 | | Leasehold improvements | $224,629 | $224,629 | | Furniture, fixtures, and equipment | $205,396 | $195,834 | | Total | $1,070,023 | $1,060,461 | | Less accumulated depreciation | $(702,180) | $(578,340) | | **Net Property and Equipment** | **$367,843** | **$482,121** | - Depreciation expense for the year ended June 30, 2025, was **$119,193**[434](index=434&type=chunk) [NOTE 5 — INTANGIBLE ASSETS AND GOODWILL](index=86&type=section&id=NOTE%205%20%E2%80%94%20INTANGIBLE%20ASSETS%20AND%20GOODWILL) As of June 30, 2025, net definite-life intangible assets (patents, software, trademarks) totaled $165,994, and goodwill was $5,963,000. The company recorded significant goodwill impairment losses of $47.6 million in Q1 FY2025 and $122.8 million in Q4 FY2025, totaling $170.4 million for the year, primarily due to a decline in the estimated fair value of the RENC reporting unit. IPR&D had a carrying value of zero in FY2025 after a $42.6 million impairment in FY2024 | Asset Type | Net Carrying Value | | :-------------------------- | :----------------- | | Definite-Life Intangible Assets (Patents, Software, Trademarks) | $165,994 | | Goodwill | $5,963,000 | | IPR&D | $0 | - Goodwill impairment losses totaled **$170,419,429** for the year ended June 30, 2025, including **$47,614,729** in Q1 and **$122,804,700** in Q4, driven by a decline in the RENC reporting unit's fair value due to inability to raise capital[372](index=372&type=chunk)[408](index=408&type=chunk)[441](index=441&type=chunk)[442](index=442&type=chunk) - IPR&D had a carrying value of **zero** as of June 30, 2025, following a **$42,611,000** impairment loss in the year ended June 30, 2024[352](index=352&type=chunk)[409](index=409&type=chunk)[410](index=410&type=chunk) - The acquisition of BioSymetrics Inc. on April 8, 2025, added **$5,963,500** in goodwill, **$143,000** in software, and **$8,000** in trademarks[439](index=439&type=chunk)[546](index=546&type=chunk) [NOTE 7 — LEASES](index=88&type=section&id=NOTE%207%20%E2%80%94%20LEASES) The company leases its Los Angeles headquarters (10-year term from 2018) and a Boca Raton office (36-month term from Nov 2024). Renovaro Cube's Amsterdam office lease was terminated in April 2025. Lease liabilities are calculated using an incremental borrowing rate (weighted-average 4.66% as of June 30, 2025) and a weighted-average remaining lease term of 1.95 years - The company leases its corporate headquarters in Los Angeles (10-year term from 2018) and an office in Boca Raton (36-month term from Nov 2024)[443](index=443&type=chunk)[445](index=445&type=chunk) - Renovaro Cube's Amsterdam office lease, which commenced in September 2023, was mutually terminated on April 29, 2025[444](index=444&type=chunk) - As of June 30, 2025, the weighted-average remaining lease term is **1.95 years**, and the weighted-average discount rate (incremental borrowing rate) is **4.66%**[445](index=445&type=chunk)[446](index=446&type=chunk) | Years Ending June 30 | Lease Expense | | :--- | :------------ | | 2026 | $363,999 | | 2027 | $358,326 | | Thereafter | $56,621 | | Less imputed interest | $(41,353) | | **Total** | **$737,593** | [NOTE 8 — DEBT](index=89&type=section&id=NOTE%208%20%E2%80%94%20DEBT) As of June 30, 2025, the company had $245,000 in convertible notes (12% interest, matured Dec 2024) and approximately $7.8 million in promissory notes. These promissory notes include bridge loans and other notes from related parties (Paseco ApS, Laksya Ventures Inc., Rene Sindlev, Yalla Yalla Limited), with interest rates of 10-12% and maturities ranging from December 2024 to December 2025. Most obligations, except Renovaro Cube's, are secured by a lien on all company assets. Total interest expense for FY2025 was $725,684 | Debt Type | Principal Amount | Interest Rate | Maturity Date | | :---------------------- | :--------------- | :------------ | :------------ | | Convertible Notes Payable | $245,000 | 12% | Dec 29, 2024 | | Promissory Notes (Bridge Loans) | $3,450,000 | 10% | Dec 31, 2025 | | Promissory Notes (Paseco/Laksya) | $2,650,000 | 10% | Dec 2024 - Dec 2025 | | Promissory Notes (Renovaro Cube) | ~$490,000 | 10% | Dec 1, 2025 | | Promissory Note (Yalla Yalla) | ~$238,000 | 10% | Feb 24, 2025 | | Promissory Note (RS Bio/Sindlev) | $100,000 | 12% | Dec 31, 2024 | | Secured Promissory Note (RS Bio/Sindlev) | $105,263 | 12% | Dec 31, 2024 | | Secured Promissory Note (RS Bio/Sindlev) | $526,315 | 12% | Dec 31, 2024 | | Promissory Note (RS Bio/Sindlev) | $750,000 | 12% | Dec 31, 2024 | | Promissory Note (Paseco/Sindlev) | $831,497 | 12% | Nov 1, 2024 | - Most promissory and bridge notes are secured by a lien on all company assets[462](index=462&type=chunk) - Total interest expense for the year ended June 30, 2025, was **$725,684**[464](index=464&type=chunk) [NOTE 9 — INCOME TAXES](index=91&type=section&id=NOTE%209%20%E2%80%94%20INCOME%20TAXES) The company accounts for income taxes using an asset and liability approach. As of June 30, 2025, it had net operating loss carryforwards of approximately $541.6 million, resulting in deferred tax assets of $76.3 million. However, a full valuation allowance of $83.7 million was recorded against these deferred tax assets, as management believes it is more likely than not that the company will not generate adequate net profits to utilize them - The company had net operating loss carryforwards of approximately **$541,603,425** as of June 30, 2025[466](index=466&type=chunk) | Metric | 2025 | 2024 | | :-------------------------- | :----------- | :----------- | | Deferred Tax Assets (from NOLs) | $76,296,814 | $148,832,041 | | Valuation Allowance | $(83,680,863) | $(170,988,308) | | **Total Deferred Tax Assets (Liabilities)** | **$0** | **$0** | - A full valuation allowance was recorded against deferred tax assets due to management's assessment that it is more likely than not the company will not generate adequate net profits to utilize them[468](index=468&type=chunk) [NOTE 10 — STOCKHOLDERS' EQUITY](index=92&type=section&id=NOTE%2010%20%E2%80%94%20STOCKHOLDERS'%20EQUITY) As of June 30, 2025, the company had 350 million authorized shares of Common Stock, with 177,392,907 shares issued and outstanding. There were no Preferred Stock shares outstanding. Stock-based compensation expense for FY2025 was $3.31 million. The company has various equity incentive plans (2014, 2019, 2023 Plans) and outstanding options and warrants | Metric | Value | | :-------------------------------- | :------------ | | Authorized Common Stock | 350,000,000 shares | | Issued & Outstanding Common Stock | 177,392,907 shares | | Authorized Preferred Stock | 10,000,000 shares | | Issued & Outstanding Preferred Stock | 0 shares | - Stock-based compensation expense for the year ended June 30, 2025, was **$3,313,291**[419](index=419&type=chunk)[499](index=499&type=chunk) - As of June 30, 2025, the company had **4,623,614 Plan Options** outst

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, 2025 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) Delaware 45-2259340 (State or other jurisdiction of (I. ...