Lunai Bioworks Inc.

Our Business

Lunai Bioworks Inc. operates through three subsidiaries, Renovaro Biosciences, Renovaro Cube and BioSymetrics. Renovaro Cube refers to GediCube Intl. Ltd. and its wholly owned subsidiaries GediCube, B.V. and Grace Systems B.V., which were acquired on February 13, 2024. BioSymetrics refers to BioSymetrics Inc. and its wholly owned subsidiary BioSymetrics Corp., which were acquired on April 8, 2025.

Renovaro Biosciences Overview

Renovaro Biosciences is a biotechnology company intending, if the necessary funding is obtained, to develop advanced allogeneic cell and gene therapies to promote stronger immune system responses potentially for long-term or life-long cancer remission in some of the deadliest cancers. As a result of our acquisition of GEDi Cube Intl on February 13, 2024, we have shifted the Company’s primary focus and resources to the development of the GEDi Cube Intl technologies. This transition to focus more strongly on molecular diagnostics and oncology allows us to better align with market trends and streamline our efforts to indication areas where we see strong market fit.

Therapeutic Technologies

Renovaro Bioscience aims to train the immune system to allow a person to better fight diseases through allogeneic cell and/or gene therapy. Our vision is for a world with healthy longevity, and free from toxic chemotherapy, for those with cancer and other serious diseases. Renovaro Biosciences will seek to leverage general principles and advances in the knowledge of the immune response to engineer cells with enhanced attributes to promote the recognition and elimination of disease cells.

Allogeneic Cell Therapy

The strategic benefit of the allogeneic cell therapy technologies is to potentially allow for the manufacture of large, “off-the-shelf” banks of therapeutic cells that are readily available on demand by healthcare professionals, to potentially decrease the time between diagnosis and treatment.

In certain treatments (e.g., cancer), cells taken from healthy donors are engineered to introduce signaling molecules that are designed to enhance the ability of specific immune cells to recognize diseased cells, and to help recruit other cells that will destroy cancer or virus infected cells.

Renovaro Biosciences Focus Areas:

Oncology:

RENB-DC11: Genetically modified Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Product for Long-term Remission of Solid Tumors; specifically Pancreatic tumors

Allogeneic Cell Therapy Platform – Completed pre-IND, IND-enabling phase.

Based on learnings from our internal research, literature reviews of ongoing clinical development for solid tumors, and recent advances in immune modulation, we have designed an innovative therapeutic vaccination platform that could potentially be used to induce life-long remission from some of the deadliest solid tumors such as pancreatic, liver, triple negative breast and head & neck cancers.

The platform may one day enable broad immune enhancements that are combined with cancer specific antigens that could be applicable to a wide range of solid tumors. This approach allows us to quickly adapt our approach to any patient solid tumor using the same banked allogenic drug substance.

RENB-DC20: Genetically modified Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Treatment Product for Long-term Remission of Triple Negative Breast Cancer

Triple Negative Breast Cancer (TNBC) is a subtype of breast cancer that is negative for estrogens receptor (ER) negative, progesterone receptor (PR) negative and human epidermal growth factor receptor 2 (HER2). TNBC is characterized by its unique molecular profile, aggressive nature, and distinct metastatic patterns that lack targeted therapies. TNBC is well known for its aggressive behavior and is characterized by onset at a younger age, high mean tumor size, and higher-grade tumors.

Based upon our internal research, literature reviews of ongoing clinical development for solid tumors, and recent advances in immune modulation, we believe we may have the ability to design an innovative therapeutic vaccination platform that could potentially be used to treat some of the deadliest and hard-to-treat solid tumors that include triple negative breast cancer.

Renovaro Cube Overview

Renovaro Cube is an AI-driven healthcare technology company focusing on the earliest possible detection of cancer and its recurrence. Renovaro Cube has developed a proprietary AI platform that analyzes genetics using Explainable AI (as defined below) to provide earlier and more accurate cancer diagnosis. This platform uses a multi-omics approach to search for individual biomarkers that are present even in asymptomatic patients. This approach is combined with differential molecular capabilities that are designed to identify, differentiate and pinpoint the exact source. Renovaro Cube’s process also involves the mining of biomarker panels, which are integrated into a machine learning library referred to as “RenovaroCube” to further enhance diagnosis.

Renovaro Cube also aims to utilize its proprietary AI platform in the development of commercial products to support clinical, research and pharmaceutical organizations that are trying to improve patient care through precision diagnosis, prediction of success of therapy, new drug discovery, treatment protocols or clinical trials. Specifically, Renovaro Cube is focused on developing products and services aimed at (i) early cancer characterization, (ii) personalized treatment selection, (iii) prediction and tracking response to therapies, (iv) recurrence detection and efficacy monitoring, and (v) ultimately, drug discovery.

Renovaro Cube was initially incorporated as Grace Systems B.V. (“Grace Systems”) in 2013 under the laws of the Netherlands to develop unique data mining algorithms to enable banking, finance and government entities to extract business insights from data. Grace Systems began applying its algorithms to biological data in 2018 to uncover cancer-associated patterns. Beginning in 2018, Grace Systems pivoted its platform to focus only on healthcare. Renovaro Cube has focused on developing its AI technology for early cancer detection.

Renovaro Cube has now focused on commercialization of its AI technology. Renovaro Cube believes that it has developed a unique approach to the early detection and diagnosis of cancer and its recurrence and, in time, other rare diseases through the systematic analysis of data using AI technologies, data mining procedures and algorithms for health technology.

Renovaro Cube’s technology has been trained on complex heterogeneous cancer data and appears to find patterns associated with cancer in public and private data resources. With the help of Renovaro Cube’s algorithms, discovered patterns may be translated into biomarkers that can be used in a clinical setting to target various aspects of cancer diagnosis and treatment.

Renovaro Cube’s Strategy

Renovaro Cube’s product development focuses on four core areas:

In response to these four core areas, the key components of Renovaro Cube’s product development are to build a software and hardware platform that:

One additional key focus of Renovaro Cube is its multi-modal, data analysis. Multi-modal data encompasses the whole aspect of data from a patient perspective, whether genomics, imaging, phenotypic or even wearable data, which can be cross analyzed to produce data that could not be previously produced. Renovaro Cube intends to use multi-modal data to bring new insights to the clinical and research teams trying to understand what to do next with the patient.

Renovaro Cube’s Technology and Techniques

Renovaro Cube is dedicated to the development of early cancer detection blood tests and expects to develop partnerships with third-party laboratories across the United Kingdom, the Netherlands and the rest of Europe and will also expand to the United States. Renovaro Cube is focused on developing diagnostic tests and test kits that would analyze samples derived from non-invasive liquid biopsy samples and intends to perform these tests from a Renovaro’s dedicated fully certified service laboratory and engage third-party laboratories to perform these tests for end-users.

For this purpose, Renovaro Cube has developed an AI platform that aims to leverage expertise in both biological and computational sciences and to go beyond traditional tumor signals by detecting the body’s early warning signs of cancer. Renovaro Cube’s goal is to provide accurate and reliable tests that can aid in the early diagnosis and treatment of cancer. Renovaro Cube’s AI technology is created to detect a wide range of biological signs to enhance the accuracy and sensitivity of early cancer detection and, thereby, enable earlier intervention and potentially improved patient outcomes.

Renovaro Cube’s AI technology aims to address three critical facets of medical needs within the domain of cancer diagnosis (as illustrated below):

Moreover, the versatility of Renovaro Cube’s AI technology extends to encompass the realm of rare cancers, including cases such as cancer of unknown primary.

Leveraging DNA methylation data, Renovaro Cube has identified and validated biomarker panels tailored for the detection of a wide range of cancers, including bladder, breast, colon, prostate, thyroid, head and neck, liver, kidney and lung cancer.

The foundational architecture of Renovaro Cube’s AI technology is engineered to facilitate comprehensive pan-cancer analysis through its extensive record of informative biomarkers discovered across a diverse array of cancer types. This comprehensive repository empowers Renovaro Cube’s AI technology to swiftly cross-reference biomarkers and explore molecular commonalities and distinctions that span multiple tumor categories.

For example, the capabilities of Renovaro Cube’s AI technology have unearthed biomarkers capable of pinpointing a specific subgroup of thyroid cancer patients characterized by a distinct genomic alteration, the neurotrophic tyrosine receptor kinase (“NTRK”) gene fusion. Identification of these NTRK-positive patients provides an actionable therapeutic target.

Uses of Renovaro Cube’s AI Technology

Renovaro Cube has developed its AI platform to support:

Renovaro Cube’s AI platform is an enterprise software platform that is distinguished from its competitors’ technology by its core attributes encompassing AI-guided analysis and meticulous record-keeping of data handling procedures within audit trails, logs, and data discoveries. Renovaro Cube designed this technology to support and validate every phase of the process, from the initial handling of raw data to the creation of essential biomarker panels. Renovaro Cube’s AI platform also facilitates the integration of data originating from diverse sources, including public databases and collaborative partnership data.

Illustrated below is the three-phase workflow behind Renovaro Cube’s AI platform for biomarker discovery using DNA methylation data. This workflow commences with the identification of pertinent single- and multi-omic data best suited to address the specific inquiries of Renovaro Cube’s clients, and the subsequent stages involve the meticulous pre-processing and loading of this data into the platform. This process culminates in the availability of a dashboard offering the client insights into the data’s characteristics, such as data quality, the technology employed, and associated metadata.

AI-Assisted Diagnostics

The process of biomarker discovery facilitated by Renovaro Cube’s AI technology has yielded a set of data that enables scrutiny of the genomic distinctions and commonalities inherent in diverse cancer types. This data set can support the diagnosis of cancers when their type or origin remains unidentified.

In addition to this role in biomarker discovery and the development of diagnostic tests, Renovaro Cube’s AI technology also integrates AI-guided molecular profiling of patient samples and furnishes diagnostic patient reports. These diagnostic reports reflect the outcomes of molecular profiling, coupled with interpretations provided by Renovaro Cube’s team, to facilitate the process of cancer diagnostics by a qualified healthcare provider, who can consider these reports in the context of a patient’s medical history, clinical signs, and symptoms, among other factors.

Quality Control Process

Renovaro Cube undertakes post-processing of data generated from sequence and arrays to ensure accurate and meaningful results. These post-processing steps for omic data include:

Other post-processing steps may include genotype calling, population stratification and association analysis. Specific post-processing steps may vary depending on the type of array used, the study design, and the analytical goals.

Planning for Commercialization

Partnerships in Development

To enhance multi-omic and multi-modal capacity, and to work to validate those capabilities with human samples including liquid-biopsy-based tests/test kits, Renovaro Cube is actively pursuing relationships with leading academic cancer centers, pathology and imagery centers in Europe, the USA and the Middle East. In certain cases, scopes of work are in process. This is a very attractive model for partners to be involved with Renovaro Cube to perform multi-omics genetic analysis using liquid biopsies.

Resources

As of the year ended June 30, 2025, Renovaro Cube intends to hire additional staff to increase the speed and velocity of its organization, including the development of the AI platform and the opportunities to deploy the AI platform for research perspective and ultimately for clinical practice and into clinical trials. In addition, Renovaro Cube intends to build out its infrastructure by leasing space for storage, networking and hosting facilities.

Target Market

Renovaro Cube’s intended customers will be hospitals, clinics, insurance companies, pharmaceutical companies, biotech companies, research centers, physicians and individual patients.

Renovaro Cube aims to utilize its AI technology to commercialize products and test kits for healthcare providers, hospitals, clinics and doctors that will expedite diagnosis and the selection of appropriate treatment for various types of cancer. Renovaro Cube intends to differentiate its products based on the following factors:

The multi-omic design of Renovaro Cube’s AI platform enables the use of different molecular layers, such as epigenomics, transcriptomics, and metabolomics, together with genomics and clinical data.

Panel Mining

The unique panel mining technique in Renovaro Cube’s technology repeatedly investigates genes to identify relevant biomarkers. The proprietary technique in Renovaro Cube’s technology not only searches for individual biomarkers, but also integrates validated panels for different cancer types into the “RenovaroCube” machine learning library. This process enables precision diagnosis, by including one cancer and excluding others based on statistically, scientifically and clinically validated machine-learning panels.

Panel mining is designed to combine biomarkers into panels in such a way that the final panel meets:

Explainable AI

The term “Explainable AI” refers to the ability of an AI system or model to provide human-understandable explanations for its decision-making process or predictions. This feature aims to bridge the gap between the “black box” nature of many AI algorithms and the need for transparency, interpretability, and accountability in AI applications.

In traditional machine learning approaches, such as deep neural networks, the internal workings of the model can be complex and difficult to interpret. This lack of interpretability poses challenges in critical domains where decisions have significant implications, such as healthcare.

Renovaro Cube believes that Explainable AI is crucial for ensuring transparency, fairness, and accountability in AI systems. Renovaro Cube’s AI platform includes Explainable AI by design. All data points, calculations and results are traceable, and all calculations are verifiable and reproducible with the same result.

Disease prognosis is one of the diagnostic capabilities of the Explainable AI feature of Renovaro Cube’s technology. Disease prognosis gives more insight for a specific patient that empowers healthcare providers, patients, and their families to make well-informed decisions about treatment, care, and future planning, thereby enhancing patient-centered care, optimizing resource utilization, and contributing to improved patient outcomes and quality of life.

Differential Diagnosis

Renovaro Cube’s AI platform offers differential diagnosis by design due to its approach with a multitude of models for different diseases and the ability to include and exclude diseases.

Diseases like cancer are very homogenous, meaning that markers like TP53 or BRCA are expressed with multiple cancers. To address this homogeneity, differential diagnosis distinguishes between two or more conditions or diseases that share similar signs, symptoms or characteristics. The goal of differential diagnosis is to consider and evaluate all possible diagnoses for the patient’s symptoms to determine the most likely cause. Differential diagnosis therefore aims to identify the underlying condition accurately and guide appropriate treatment and management strategies.

Differential diagnosis is important for several reasons:

In summary, differential diagnosis is a critical process in healthcare that supports accurate identification of the underlying condition, tailored treatment plans, and improved patient outcomes.

Precision Diagnostics

Precision diagnostics and personalized care is about focusing on what is required for a specific patient, what are their individual needs, how can we understand more about them to be more precise when delivering care and identifying the right clinical pathway to move them through treatment. Renovaro Cube technology will bring a high level of detail with multi-omic data, allowing individual genes and different possible cancers under suspicion to be identified. Due to the structure of the data produced, Renovaro Cube can bring it into any format of user interface, documentation, or database. We expect to provide the flexibility to respond to the different requirements for delivering data to the right person at the right place at the right time. We will comply to user interface guidance and usability regulations (WC3C) to ensure that they meet the correct standards to enable the data to be displayed, read and understood. Personalized care is what we all in the healthcare system are striving for, we are one component that can make a huge difference.

Future Development

In driving towards future commercialization, Renovaro Cube intends to undertake or continue the following activities to enable the development of its AI platform, bolster the credibility of this platform and open up revenue opportunities:

Business Overview (BioSymetrics)

BioSymetrics is a biomedical artificial intelligence company focused on integrating multimodal data sources, including genomics, imaging, electronic health records, and other real-world evidence, to advance biomarker discovery, therapeutic development, and precision medicine. BioSymetrics has developed proprietary machine learning pipelines that harmonize and analyze complex, heterogeneous datasets to uncover clinically actionable insights. These insights are designed to support pharmaceutical research, early disease detection, and personalized treatment strategies.

BioSymetrics collaborates with pharmaceutical companies, healthcare providers, and academic institutions to co-develop analytical tools and translational research programs. Application areas of the BioSymetrics platform include: (i) multi-omics integration for target identification and validation; (ii) predictive modeling of therapeutic efficacy and safety; (iii) clinical trial optimization, including patient stratification and response monitoring; and (iv) experimental screening of gene and small molecule effects for the purpose of identifying novel drug targets and therapeutics.

The key to the BioSymetrics approach is Contingent AI. In Contingent AI, any “settable” parameter for data processing, data integration, or feature selection is permuted and the corresponding effects on the downstream predictive model measured. This process is similar in nature to hyperparameter tuning in machine learning, however instead of optimizing only the machine learning model, the entire data science pipeline (including model selection) is subject to optimization. We have applied this method extensively in drug discovery, producing marked improvements in experiment interpretation and lead generation.

Another major component of BioSymetrics’ platform is the Phenograph. The Phenograph TM is BioSymetrics’ proprietary knowledge graph. The purpose of the Phenograph TM is to map human genes and phenotypes to those of model systems, allowingvirtual phenotypic screening, target nomination, and active learning feedback. The Phenograph TM contains 5,856 diseases associated with one or more phenotypes in humans, and 16,676 human genes with one or more orthologous zebrafish genes. Zebrafish genes are mapped to phenotypic terms using over 300 individually-trained machine learning models, that fill in the gaps of known gene-phenotype associations. Leveraging this platform, we can prioritize human genes on the basis of predicted experimental phenotype, reducing the number of required experiments to produce human-informedin vivo disease models.

Finally, one important component of the BioSymetrics platform is that it couples AI-based prediction with experimental validation. BioSymetrics has designed deep learning-based computer vision software that automatically identifies and characterizes organ systems relevant to neurological, cardiovascular, and muscle development (Figure below). Additionally, BioSymetrics has developed a proprietary light stimulus battery and characterized a small number of known CNS therapeutics and unknown compounds, providing an initial basis for evaluation of chemical effects.

A large-scale behavioral profiling platform for identification of neurotherapeutics. (A) 96-well plate containing 8 zebrafish larvae per well, as used for behavioral profiling. (B-C) Line plots showing activity over time for 48 replicate wells focusing in on a small (5 min) part of the behavioral profile. Unlike control wells (B), drug-treated wells (C) show much higher activity levels. (D-H) Example profiles for 5 different reference compounds showing the average behavioral profiles for control and compound-treated wells (n= 4 wells; orange and blue lines, respectively). Note that each of the 5 compounds causes a distinct behavioral profile. (I) Examples of morphological segmentation. Colored micrographs of laterally oriented zebrafish larvae show computer-vision-based organ segmentation using trained ML classifiers.

In prior work, we leveraged our motion profiling capabilities to identify novel neuroactive compounds capable of resolving epilepsy-related phenotypes. Specifically, we screened 1400 compounds from a proprietary small molecule library both with and without addition of a chemical convulsant. The experimental component of this screen was completed by one technician in 10 days, giving us an approximate pace of 1,000 compounds screened per technician per week. This study resulted in identification of a hit compound that later showed efficacy in a mouse seizure model, now being further progressed as a potential therapeutic by BioSymetrics. Additionally, during the course of this study we screened approximately 100 known neuroactives, including clinical anticonvulsants, antidepressants, antipsychotics, and dopaminergic signaling activators and inhibitors. This study produced two key observations that are critical for this application. The result is both an experimental platform and coupled computational model that can identify both neurotherapeutics and neurotoxins, the former through direct experimental screening, and the latter through machine-learning based prediction based on chemical structure.

We next we examined the ability of one of these compounds (BioS_831) to resolve seizures in a murine model using a previously established electroshock seizure assay. Briefly, after dosing each mouse with either BioS_831, negative control (vehicle), or positive control (Sodium Valproate), electroshock is delivered transauricularly using stimulation at 50 Hz and 50 mA for 0.8 seconds with a pulse width of 10 milliseconds. The total number of hind limb flexes, hind limb extensions, and mortality rate is monitored for 60 seconds following electroshock, as are other adverse events. We screened BioS_831 at both a low and high dose and found that at 40 mg/kg of BioS_831 significantly increased latency time to tonic seizure induction and significantly reduced the number of observed tonic extension seizures, as compared to vehicle control. Notably, unlike the ASM Sodium Valproate, BioS_831 did not cause sedation or ataxia. Sodium Valproate (VPA) while effective in this model at this concentration, results in high levels of neurotoxicity, and has been associated with multi-organ failure, underscoring the importance of not observing negative neurological effects with our novel compound. Post-study PK analysis showed good distribution of BioS_831 into the brains of the test animals (average brain to plasma ratio 0.68). Since the electroshock seizure model is not based on seizure induction through hypofunction of KCC2, these findings suggest that our zebrafish epilepsy primary screening model is capable of identifying novel compounds that show translation to mammalian generalized epilepsy models and suggest that BioS_831 could further be optimized as a potential anti-epileptic therapeutic.

Additionally, during the course of this study we screened approximately 100 known neuroactives in our zebrafish model including clinical anticonvulsants, antidepressants, antipsychotics, and dopaminergic signaling activators and inhibitors. The result is both an experimental platform and coupled computational model that can identify both neurotherapeutics and neurotoxins, the former through direct experimental screening, and the latter through machine-learning based prediction based on chemical structure.

BioSymetrics intends to expand the use of its platform across the biopharmaceutical and healthcare markets. The company is developing its technology in compliance with applicable healthcare data privacy regulations, including HIPAA and GDPR, and is focused on building AI solutions that address the growing demand for robust, transparent, and reliable applications of artificial intelligence in life sciences.

Our Intellectual Property

Patents and licenses are key to our business. Our strategy is to file patent applications to protect technology, inventions, and improvements to inventions that we consider important for the development of our business. We rely on a combination of patent, copyright, trademark, and trade secret laws, as well as continuing technological innovations, proprietary knowledge, and various third-party agreements, including, without limitation, confidentiality agreements, materials transfer agreements, research agreements, and licensing agreements, to establish and protect our proprietary rights. We aim to take advantage of all of the intellectual property rights that are available to us and seek the protection of those rights so that we can fully exploit our innovations.

We also protect our proprietary information by requiring our employees, consultants, contractors, and other advisors to execute nondisclosure and assignment of invention agreements upon commencement of their respective employment or engagement.

Assigned Intellectual Property

On August 16, 2022, the USPTO issued U.S. Patent No. 11,413,338 B2, “Methods and Compositions Using Recombinant Dendritic Cells for Cancer Therapy”, pertaining to methods and compositions for treating cancer by eliciting an immune response by administering dendritic cells expressing heterologous proteins. This patent protects**RENB-DC11:Genetically modified Allogeneic Dendritic Cells as Potential Product for Long-term Remission of Solid Tumors – Starting with Pancreatic Cancer and potential future productsRENB-DC-12XX:**Genetically modified Allogeneic Dendritic Cells as Potential Product for Long-term Remission of Additional Indications for twenty years. The Company owns this patent application, through assignment as of July 15, 2019.

On July 5, 2022, the USPTO issued Patent No. US-11379757-B2, “Methods, systems, and frameworks for data analytics using machine learning”, pertaining to methods for pre-processing multi-modal data for biomedical applications. This patent protects our core Contingent AI technology, which allows us to simultaneously process multiple types of biomedical and experimental data, resulting in a unique method for the application of AI across therapeutic development. This method is applied in multiple components of the BioSymetrics platform and has been applied in projects with pharmaceutical partners.

On June 17, 2020, a patent titled “Allogeneic T-Cell-Based HIV Vaccine to Induce Cellular and Humoral Immunity”, US 2021/0030795 A1 for the composition and method of use concepts for RENB-HV-12. was filed. The Company owns this patent application, through assignment as of September 28, 2021.

In-Licensed Technology

Trade Secrets and Proprietary Know-How

In addition to intellectual property protected by patents and copyrights, we have trade secrets and proprietary know-how relating to our products, production processes, and future strategies.

Competition

Renovaro Cube operates in a highly competitive market with several companies developing AI-driven diagnostic platforms for early disease detection and personalized medicine. Key competitors include Grail, Freenome, and Owkin, each utilizing advanced AI and machine learning to analyze multi-omic data for cancer detection. While these companies focus primarily on specific diagnostic approaches, Renovaro Cube differentiates itself through its unique, disease-agnostic AI platform that integrates various molecular data sources for differential diagnosis. Our platform’s explainable AI system, capable of providing actionable insights and personalized treatment options, offers a distinct advantage. Despite the crowded landscape, Renovaro Cube’s scalable technology, multi-omics capabilities, and ability to process diverse biopsy sources position it as a versatile leader in precision diagnostics, allowing us to address a broader range of clinical and research needs.

BioSymetrics similarly operates in a highly competitive market with companies including Recursion Pharma and insitro also focused on phenotype-based profiling usingin vitro cellular profiling and AI. While similar in concept, Recursion and insitro’s models provide evidence on cellular, but not multicellular or multi-organ phenotypes, so we feel our platform is differentiated, specifically when investigating behavioral and neurological diseases. Similarly, while murine models are broadly accepted as being relevant for the study of neurological disorders, their experimental throughput is highly limited, and turnaround times for experimentation can be on the scale of months, resulting in a substantial experimental cost. The biggest difference is scale — mice cannot be used in large-scale chemical screens using multi-well plates. Therefore, BioSymetrics is targeting a market further upstream, for testing larger groups of candidate compounds in libraries too large for mice.

Government Regulation

FDA Review and Approval

Government authorities in the United States, at the federal, state, and local levels, and in other countries extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of therapeutic products such as those we are developing. Any products we develop are likely to require regulatory review and allowance to proceed prior to conducting clinical trials and additional regulatory approvals prior to commercialization. In the United States, the FDA regulates drugs under the Federal Food, Drug and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA) and their implementing regulations govern, among other things, biopharmaceutical testing, manufacturing, safety, efficacy, labeling, storage, recordkeeping, advertising, and other promotional practices.

Obtaining FDA approval is a costly and time-consuming process. FDA approval requires that preclinical studies be conducted in the laboratory and in animal model systems to gain preliminary information on efficacy and to identify any major safety concerns. The results of these studies are then submitted as a part of an IND, which the FDA must review and allow before human clinical trials can start. The IND includes a detailed description of the proposed clinical investigations. An independent Institutional Review Board (“IRB”) must also review and approve the clinical protocol and each clinical site.

A company must submit an IND for each investigational medical product and specific indication(s) and must conduct clinical studies to demonstrate the safety and efficacy of the product necessary to obtain FDA approval. The FDA receives reports on the progress of each phase of clinical testing and may require the modification, suspension, or termination of clinical trials if an unwarranted risk is observed in participants including patients.

Obtaining FDA approval prior to marketing a biopharmaceutical product in the United States typically requires multiple phases of clinical trials to demonstrate the safety and efficacy of the product candidate. Clinical trials are how experimental treatments are evaluated in humans and are conducted following preclinical testing. Clinical trials may be conducted within the United States or in foreign countries. If clinical trials are conducted in foreign countries, the products under development as well as the trials are subject to regulations of the FDA and/or its regulatory counterparts in the other countries. Upon successful completion of clinical trials, approval to market the treatment for a particular patient population may be requested from the FDA in the United States and/or its counterparts in other countries.

Applications submitted to the FDA are subject to an unpredictable and potentially prolonged approval process. Despite good-faith communication and collaboration between the applicant and the FDA during the development process, the FDA may decide, upon final review of the data, that the application does not satisfy its criteria for approval or requires additional product development or further preclinical or clinical studies. Even if FDA regulatory approval(s) are obtained, a marketed product is subject to continual review, and later discovery of previously unknown problems or failure to comply with the applicable regulatory requirements may result in restrictions on the marketing of a product or withdrawal of the product from the market as well as possible civil or criminal sanctions.

Sponsors of clinical trials are required to register, and report results for, all controlled, clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation. Trial registration may require public disclosure of certain confidential commercial development data.

The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval, may subject an applicant to administrative or judicial sanctions. FDA sanctions could include, among other actions, refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls or withdrawals from the market, product seizures, total or partial suspension of production or distribution injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on our business, financial condition, results of operations and cash flows.

Other Healthcare Laws and Compliance Regulations

Although we currently do not have any products on the market, we may also be subject to additional healthcare regulations and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which we conduct our business. In the United States, among other things, the research, manufacturing, distribution, sale and promotion of pharmaceutical and biological products are potentially subject to regulation and enforcement by various federal, state and local authorities in addition to the FDA, including the Centers for Medicare and Medicaid Services (“CMS”), other divisions of the United States Department of Health and Human Services (e.g., the Office of Inspector General), the Drug Enforcement Administration, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety and Health Administration, the Environmental Protection Agency, state Attorneys General and other state and local government agencies. Our current and future business activities, including for example, sales, marketing, and scientific/educational grant programs, must comply with health care regulatory laws, as applicable, including, without limitation:

If our operations are found to be in violation of any of such laws or any other governmental laws or regulations that apply, they may be subject to penalties, including, without limitation, civil and criminal penalties, damages, fines, disgorgement, the curtailment or restructuring of operations, exclusion from participation in federal and state healthcare programs, additional program integrity obligations, individual imprisonment, injunctions, recall or seizure of products, total or partial suspension of production, denial or withdrawal of product approvals, refusal to permit us to enter into supply contracts, including government contracts, contractual damages, reputational harm, administrative burdens, diminished profits, and future earnings, any of which could have a material adverse effect on our business, financial condition, result of operations, and cash flows. These additional healthcare regulations could affect our current and future arrangements with healthcare professionals, principal investigators, consultants, customers and third-party payors.

Moreover, the introduction of legislation, implementation of new regulations, or enforcement of existing regulations that have a negative impact on the commercial prospects for the types of products we are developing could negatively impact our share price and our ability to raise capital.

Coverage and Reimbursement

In the United States, third-party payors include federal and state healthcare programs, government authorities, private managed care providers, private health insurers and other organizations. Third-party payors are increasingly challenging the price, examining the medical necessity and reviewing the cost-effectiveness of medical drug products and medical services, in addition to questioning their safety and efficacy. Such payors may limit coverage to specific drug products on an approved list, also known as a formulary, which might not include all the FDA-approved drugs for a particular indication. Third-party payor coverage may be more limited than the purposes for which the FDA or foreign regulatory authorities approve the product. Further, one payor’s determination to provide coverage for a drug product does not assure that other payors will also provide coverage for the drug product.

Further, third-party payers are increasingly challenging the price of medical products and services, and there is increasing pressure on biotechnology companies to reduce healthcare costs. If purchasers or users of our products are not able to obtain adequate reimbursement for the cost of using our products, they may forgo or reduce their use. Significant uncertainty exists as to the reimbursement status of newly approved healthcare products, and whether adequate third-party coverage will be available. Our inability to promptly obtain coverage and profitable payment rates from both government funded and private payors for future products we develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize potential products, and our overall financial condition.

Healthcare Reform

In March 2010, former President Obama signed into law The Patient Protection and Affordable Care Act and the Health Care and Education Affordability Reconciliation Act of 2010 (collectively, the “Affordable Care Act”), which substantially changed the way healthcare is financed by both governmental and private insurers in the United States, and significantly affected the pharmaceutical industry. The Affordable Care Act contains a number of provisions, including those governing enrollments in federal healthcare programs, reimbursement adjustments and fraud and abuse changes. Additionally, the Affordable Care Act increases the minimum level of Medicaid rebates payable by manufacturers of brand name drugs; requires collection of rebates for drugs paid by Medicaid managed care organizations; requires manufacturers to participate in a coverage gap discount program, under which they must agree to offer point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; and imposes a non-deductible annual fee on pharmaceutical manufacturers or importers who sell “branded prescription drugs” to specified federal government programs.

Since its enactment, there have been judicial and Congressional challenges to certain aspects of the Affordable Care Act, and we expect there will be additional challenges and amendments to the Affordable Care Act in the future. Other legislative changes have been proposed and adopted since the Affordable Care Act was enacted, including aggregate reductions of Medicare payments to providers and reduced payments to several types of Medicare providers. Moreover, there has recently been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed bills designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. Individual states in the United States have also become increasingly active in implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, proposing to encourage importation from other countries and bulk purchasing. We cannot predict what healthcare reform initiatives may be adopted in the future.

We also are subject to various federal, state, and local laws, regulations, and recommendations relating to safe working conditions, laboratory and manufacturing practices, the experimental use of animals, and the use and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with our research. The extent of government regulation that might result from any future legislation or administrative action cannot be accurately predicted.

Renovaro Cube’sAI-guided diagnostic platform operates within a highly regulated environment, particularly as it involves health data and medical diagnostics. As a Software as a Medical Device (SaMD), the platform will require compliance with various regional regulations, including but not limited to the U.S. Food and Drug Administration (FDA) guidelines and European Union Medical Device Regulation (MDR). Our regulatory strategy involves a meticulous development process, adhering to international standards such as for quality management systems. Key elements include rigorous clinical validation, cybersecurity, data privacy (in compliance with HIPAA and GDPR), and quality control to ensure patient safety and diagnostic accuracy. Post-market surveillance and continuous improvement will be integral to maintaining compliance and effectiveness as we aim for global commercialization. Given the rapidly evolving regulatory landscape for AI-driven diagnostics, Renovaro Cube remains committed to working closely with regulatory bodies to navigate the approval processes and to address ethical considerations, ensuring that our products meet the highest standards of safety and efficacy.

Foreign Corrupt Practices Act

Our business activities may be subject to the Foreign Corrupt Practices Act, or FCPA, and similar anti-bribery or anti-corruption laws, regulations, or rules of other countries in which we operate. The FCPA generally prohibits offering, promising, giving, or authorizing others to give anything of value, either directly or indirectly, to a non-U.S. government official to influence official action, or otherwise obtain or retain business. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. Our business is heavily regulated and therefore involves significant interaction with public officials, including officials of non-U.S. governments. Additionally, in many other countries, the health care providers who prescribe pharmaceuticals are employed by their government, and the purchasers of pharmaceuticals are government entities; therefore, our dealings with these prescribers and purchasers are subject to regulation under the FCPA. There is no certainty that all of our employees,

agents, suppliers, manufacturers, contractors, or collaborators, or those of our affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws. Violations of these laws and regulations could result in fines, criminal sanctions against us, our officers, or our employees, the closing down of facilities, including those of our suppliers and manufacturers, requirements to obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs, and prohibitions on the conduct of our business. Any such violations could include prohibitions on our ability to offer our products in one or more countries as well as difficulties in manufacturing or continuing to develop our products, and could materially damage our reputation, our brand, our international expansion efforts, our ability to attract and retain employees, and our business, prospects, operating results, and financial condition.

Employees

As of June 30, 2025, we had 29 full-time employees. The Company has streamlined the organization to focus on its oncology therapeutic vaccine and artificial intelligence driven healthcare technology. The Company has tailored its workforce to focus on these therapies and technology. We believe that we have good relations with our employees.

Corporate Information

On February 13, 2024, Lunai Bioworks Inc. acquired Renovaro Cube Intl Ltd and its subsidiaries (“Renovaro Cube”), as a wholly owned subsidiary pursuant to a stock purchase agreement.

On April 8, 2025 Lunai Bioworks Inc. acquired BioSymetrics Inc. and its subsidiary BioSymetrics Corp., as a wholly owned subsidiary pursuant to a stock purchase agreement. The merger with BioSymetrics is designed to enhance Lunai’s data repository and biomarker discovery capabilities, as well as add in vivo validation and drug discovery to Lunai’s AI powered biomarker and diagnostic platform.

We trade on the NASDAQ Capital Market under the ticker “RENB.”

Our website is http://www.renovarogroup.com. We make available free of charge, on or through our website, our annual, quarterly, and current reports and any amendments to those reports filed or furnished pursuant to Section 13(a) of the Exchange Act as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. Information contained in our website is not part of, nor incorporated by reference into, this report.