6 unchanged sentences
Such statements involve known and unknown risks,
−Removed: uncertainties and other factors that may cause actual results, performance, or achievements of Renovaro Inc.
+Added: uncertainties and other factors that may cause actual results, performance, or achievements of Lunai Bioworks Inc.
and together with its subsidiaries, the “Company”, “we” or “us”) to be materially different from any
4 unchanged sentences
materially depending on a variety of factors, including, but not limited to, the risks and uncertainties discussed in Part I, Item 1A,
−Removed: “Risk Factors” in our Annual Report on Form 10-K/A as filed with the SEC on February 19, 2025.
+Added: “Risk Factors” in our Annual Report on Form 10-K as filed with the SEC on September 29, 2025.
The Company’s plans and
8 unchanged sentences
not be regarded as a representation by the Company or any other person that the objectives and plans of the Company will be achieved.
−Removed: operates through two subsidiaries, Renovaro Biosciences and Renovaro Cube.
−Removed: Renovaro Cube refers to Renovaro Cube Intl.
−Removed: known as GediCube Intl.
−Removed: Ltd.) and its wholly owned subsidiaries GediCube, B.V.
−Removed: and Grace Systems B.V., which were acquired on February
+Added: September 30, 2025, Lunai Bioworks Inc.
+Added: operates through two subsidiaries, Renovaro Biosciences and BioSymetrics.
+Added: BioSymetrics refers
+Added: to BioSymetrics Inc.
+Added: and its wholly owned subsidiary BioSymetrics Corp., which were acquired on April 8, 2025.
+Added: During the quarter ended
+Added: September 30, 2025, GediCube, B.V., acquired on February 13, 2024, filed for bankruptcy and ceased operations.
+Added: As a result, beginning
+Added: in the second quarter of 2026, the Company will no longer report on its operations.
Renovaro Biosciences Overview
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and potentially to treat or cure serious infectious diseases such as Human Immunodeficiency Virus (HIV) infections.
−Removed: As a result of our
−Removed: acquisition of GEDi Cube Intl Ltd.
−Removed: on February 13, 2024, we have shifted the Company’s primary focus and resources to the development
−Removed: of the Renovaro Cube technologies.
Therapeutic Technologies
56 unchanged sentences
immune response to viruses and other difficult to treat infections.
−Removed: Renovaro Cube Overview
−Removed: Renovaro Cube is an AI-driven healthcare
−Removed: technology company focusing on the earliest possible detection of cancer and its recurrence.
−Removed: Renovaro Cube has developed a proprietary
−Removed: AI platform that analyzes genetics using Explainable AI (as defined below) to provide earlier and more accurate cancer diagnosis.
−Removed: platform uses a multi-omics approach to search for individual biomarkers that are present even in asymptomatic patients.
−Removed: This approach
−Removed: is combined with differential molecular capabilities that are designed to identify, differentiate and pinpoint the exact source.
−Removed: Cube’s process also involves the mining of biomarker panels, which are integrated into a machine learning library referred to as
−Removed: “RenovaroCube” to further enhance diagnosis.
−Removed: Renovaro Cube also aims to utilize
−Removed: its proprietary AI platform in the development of commercial products to support clinical, research and pharmaceutical organizations that
−Removed: are trying to improve patient care through precision diagnosis, prediction of success of therapy, new drug discovery, treatment protocols
−Removed: or clinical trials.
−Removed: Specifically, Renovaro Cube is focused on developing products and services aimed at (i) early cancer characterization,
−Removed: (ii) personalized treatment selection, (iii) prediction and tracking response to therapies, (iv) recurrence detection and efficacy monitoring,
−Removed: and (v) ultimately, drug discovery.
−Removed: Renovaro Cube was initially incorporated
−Removed: as Grace Systems B.V.
−Removed: (“Grace Systems”) in 2013 under the laws of the Netherlands to develop unique data mining algorithms
−Removed: to enable banking, finance and government entities to extract business insights from data.
−Removed: Grace Systems began applying its algorithms
−Removed: to biological data in 2018 to uncover cancer-associated patterns.
−Removed: Beginning in 2018, Grace Systems pivoted its platform to focus only
−Removed: on healthcare.
−Removed: Renovaro Cube has focused on developing its AI technology for early cancer detection.
−Removed: Renovaro Cube has now focused on
−Removed: commercialization of its AI technology.
−Removed: Renovaro Cube believes that it has developed a unique approach to the early detection and diagnosis
−Removed: of cancer and its recurrence and, in time, other rare diseases through the systematic analysis of data using AI technologies, data mining
−Removed: procedures and algorithms for health technology.
−Removed: Renovaro Cube’s technology
−Removed: has been trained on complex heterogeneous cancer data and appears to find patterns associated with cancer in public and private data resources.
−Removed: With the help of Renovaro Cube’s algorithms, discovered patterns may be translated into biomarkers that can be used in a clinical
−Removed: setting to target various aspects of cancer diagnosis and treatment.
−Removed: Renovaro Cube’s Strategy
−Removed: Renovaro Cube’s product development
−Removed: focuses on four core areas:
−Removed: Early Detection.
−Removed: Multi-cancer early detection (“MCED”) blood tests are advanced diagnostic tools that analyze cell-derived molecules present in the bloodstream.
−Removed: These tests specifically look for abnormal genetic, epigenetic or proteomic patterns of these cell-derived molecules, which can indicate the presence of cancer cells.
−Removed: By examining the molecules shed from various cells, including cancer cells, MCED tests aim to detect cancer at an early stage.
−Removed: This approach holds promise for improving cancer detection and potentially saving lives.
−Removed: Recurrence of cancer .
−Removed: A recurrence refers to the return of cancer after a period of remission.
−Removed: A cancer recurrence happens because, in spite of the efforts to kill the cancer, some cells may remain, which grow and eventually cause symptoms.
−Removed: In rare instances, a patient may develop a new cancer that’s completely unrelated to the originally diagnosed cancer, which is referred to as a second primary cancer.
−Removed: An early warning system could help to identify a recurrence as early as possible, thereby helping to accelerate any treatment and diagnosis.
−Removed: The different types of recurrence include:
−Removed: Local recurrence, meaning that the cancer has returned in the same place it first started;
−Removed: Regional recurrence , meaning that the cancer has returned to the lymph nodes near the place it first started;
−Removed: Distant recurrence , meaning the cancer has returned in another part of the body.
−Removed: Response to treatment.
−Removed: At Renovaro Cube we aim to develop a new array of diagnostic products that can accurately identify patients that are going to respond or fail to a certain drug.
−Removed: In highly toxic therapies it will not only increase survival but will also reduce unnecessary exposure to chemotherapy.
−Removed: Furthermore, the costs for cancer drugs are usually very high.
−Removed: Providing the right therapy to the right patient will therefore significantly reduce the costs of medicine in cancer.
−Removed: Clinical trials .
−Removed: Clinical trials involve a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.
−Removed: People volunteer to take part in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioral treatments and preventive care.
−Removed: Clinical trials are carefully designed, reviewed and completed, and need to be approved before they can start.
−Removed: In response to these four core
−Removed: areas, the key components of Renovaro Cube’s product development are to build a software and hardware platform that:
−Removed: Uses data science to develop novel insights into the characterization of diseases such as cancer.
−Removed: Renovaro Cube intends to apply its proprietary technology to biological data from multiple sources to enable the typification (or classification) of disease entities and sub-entities to provide insights about the nature and behavior of diseases to payers, providers, pharmaceutical companies and patients.
−Removed: Enables more accurate diagnosis and earlier detection of cancer and other diseases with the goal of maximizing outcomes and minimizing the costs of treatment.
−Removed: Renovaro Cube intends to develop a system to understand the smallest fragments of cancer in the blood of the patient.
−Removed: Presently, Renovaro Cube is developing a product to analyze results from liquid biopsy run through an Oxford Nanopore Sequencer.
−Removed: We expect the Renovaro Cube product will subsequently identify, train and validate explainable biomarkers, panels and models on different molecular layers.
−Removed: Multiple models will be individually trained for optimal stratification through the entire health journey, ensuring the right accuracy for a therapeutic decision in every stage.
−Removed: Renovaro Cube will integrate different modalities and molecular data sources into a differential diagnostic report.
−Removed: Diagnostics and prognosis will be explainable with quality control reports and biomarker insights for different disciplines ensuring maximum trust and insight in medical decision making.
−Removed: Assists in clinical trials with patient cohort selection and response tracking, to be used by companies like Renovaro Biosciences in their patient cohort selection for their clinical trials, by looking at which patients are reacting positively, negatively and have no reaction.
−Removed: This data becomes more important through the progression of the different phases of drug development, as more and more patients are added.
−Removed: Renovaro Cube will provide multi-omic data analysis, looking for specific changes in the patients that might indicate a change in their molecular make-up.
−Removed: This can then be used for the next phase of a clinical trial to look for the specific molecular data that has showed a positive reaction in the previous phase.
−Removed: It also provides insights for more effective response tracking, which Renovaro Cube believes is important to the providers of care as well as the development and evaluation of new pharmaceuticals and immune therapies in clinical trials.
−Removed: Patient response to treatment can be used to focus the target audience for drugs in development and in subsequent clinical practice.
−Removed: As Renovaro Cube collects more data, longitudinal about treatment and response, it will have the ability to train prognostic models to give an insight in disease progression and treatment response, both critical for enrolling in clinical trials and eventually every treatment.
−Removed: Because Renovaro Cube consists of many independently trained and validated models, it will have the ability to assist in virtually every therapeutic decision, for different subtypes and groups (stratifications).
−Removed: The multi-omics and multi-modal pipelines could allow the use of multiple combinations of tissue samples and diagnostic platforms.
−Removed: The detailed diagnostic reports will allow and support insights for multiple disciplines such as cancer biology, genomics and pathology to look at underpinning biomarkers, pathways and clinical annotations.
−Removed: Provides insight into patients who have had cancer previously.
−Removed: These insights will provide for more effective recurrence monitoring, which Renovaro Cube believes is important to the providers of care and patients during follow-up monitoring of remissions.
−Removed: Renovaro Cube anticipates that payers want to detect and re-treat recurrences at the earliest possible stage to maximize patients’ outcomes in terms of time and cost and that, similarly, patients with a recurrence are keen to re-engage with effective treatment at the earliest opportunity.
−Removed: A key aspect of this will be taking blood from the patients, sequencing this blood and running it through the Renovaro Cube platform which will identify if the patient has any indication of the recurrence of the same or a new cancer.
−Removed: For recurrence monitoring, Renovaro Cube will focus on a highly sensitive combination of lab and information technology.
−Removed: Lab protocols, sequence post processing and machine learning will all be designed, trained and validated to get the best signal with the highest sensitivity to catch early signals of recurrence.
−Removed: This will be done on a regular basis allowing surveillance analysis over time.
−Removed: Includes biomarker panels that will be extended to include as many layers of genetic information (multi-omics) as possible including mutation, gene expression, methylation status, fragmentomics, nucleosome mapping, collectively named multi-omics, with the goal to reach the highest accuracy possible, both in terms of sensitivity and specificity of each individual biomarker panel.
−Removed: This provides a non-invasive alternative for the current complex, expensive and cumbersome procedures.
−Removed: Create value through advancing more sophisticated typification of diseases in an effort to address some of the pressing problems faced by modern healthcare, including healthcare costs, an aging population and developments in medical technology that produce a stream of increasingly sophisticated treatments requiring more precise targeting.
−Removed: One additional key focus of Renovaro
−Removed: Cube is its multi-modal, data analysis.
−Removed: Multi-modal data encompasses the whole aspect of data from a patient perspective, whether genomics,
−Removed: imaging, phenotypic or even wearable data, which can be cross analyzed to produce data that could not be previously produced.
−Removed: 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
−Removed: Renovaro Cube’s Technology
−Removed: and Techniques
−Removed: Renovaro Cube is dedicated to the
−Removed: development of early cancer detection blood tests and expects to develop partnerships with third-party laboratories across the United
−Removed: Kingdom, the Netherlands and the rest of Europe and will also expand to the United States.
−Removed: Renovaro Cube is focused on developing diagnostic
−Removed: tests and test kits that would analyze samples derived from non-invasive liquid biopsy samples and intends to perform these tests from
−Removed: Renovaro’s dedicated fully certified service laboratory and engage third-party laboratories to perform these tests for end-users.
−Removed: For this purpose, Renovaro Cube
−Removed: has developed an AI platform that aims to leverage expertise in both biological and computational sciences and to go beyond traditional
−Removed: tumor signals by detecting the body’s early warning signs of cancer.
−Removed: Renovaro Cube’s goal is to provide accurate and reliable
−Removed: tests that can aid in the early diagnosis and treatment of cancer.
−Removed: Renovaro Cube’s AI technology is created to detect a wide range
−Removed: of biological signs to enhance the accuracy and sensitivity of early cancer detection and, thereby, enable earlier intervention and potentially
−Removed: improved patient outcomes.
−Removed: Renovaro Cube’s AI technology
−Removed: aims to address three critical facets of medical needs within the domain of cancer diagnosis (as illustrated below):
−Removed: type-specific cancer detection;
−Removed: pan-cancer detection;
−Removed: patient stratification.
−Removed: Moreover, the versatility of Renovaro
−Removed: Cube’s AI technology extends to encompass the realm of rare cancers, including cases such as cancer of unknown primary.
−Removed: Leveraging DNA methylation data,
−Removed: Renovaro Cube has identified and validated biomarker panels tailored for the detection of a wide range of cancers, including bladder,
−Removed: breast, colon, prostate, thyroid, head and neck, liver, kidney and lung cancer.
−Removed: The foundational architecture of
−Removed: Renovaro Cube’s AI technology is engineered to facilitate comprehensive pan-cancer analysis through its extensive record of informative
−Removed: biomarkers discovered across a diverse array of cancer types.
−Removed: This comprehensive repository empowers Renovaro Cube’s AI technology
−Removed: to swiftly cross-reference biomarkers and explore molecular commonalities and distinctions that span multiple tumor categories.
−Removed: For example, the capabilities of
−Removed: Renovaro Cube’s AI technology have unearthed biomarkers capable of pinpointing a specific subgroup of thyroid cancer patients characterized
−Removed: by a distinct genomic alteration, the neurotrophic tyrosine receptor kinase (“NTRK”) gene fusion.
−Removed: Identification of these
−Removed: NTRK-positive patients provides an actionable therapeutic target.
−Removed: Uses of Renovaro Cube’s AI Technology
−Removed: Renovaro Cube has developed its AI platform to support:
−Removed: AI-assisted patient diagnostics;
−Removed: multi-omic data analysis;
−Removed: genome-wide or targeted analysis;
−Removed: pan-cancer analysis;
−Removed: different technology platforms (sequence or array);
−Removed: tracking of each sample;
−Removed: AI-guided biomarker discovery for single or multiple cancer types;
−Removed: logs of analysis steps and outcomes (data preparation, discovery, validation).
−Removed: Renovaro Cube’s AI platform
−Removed: is an enterprise software platform that is distinguished from its competitors’ technology by its core attributes encompassing AI-guided
−Removed: analysis and meticulous record-keeping of data handling procedures within audit trails, logs, and data discoveries.
−Removed: Renovaro Cube designed
−Removed: this technology to support and validate every phase of the process, from the initial handling of raw data to the creation of essential
−Removed: biomarker panels.
−Removed: Renovaro Cube’s AI platform also facilitates the integration of data originating from diverse sources, including
−Removed: public databases and collaborative partnership data.
−Removed: Illustrated below is the three-phase
−Removed: workflow behind Renovaro Cube’s AI platform for biomarker discovery using DNA methylation data.
−Removed: This workflow commences with the
−Removed: identification of pertinent single- and multi-omic data best suited to address the specific inquiries of Renovaro Cube’s clients,
−Removed: and the subsequent stages involve the meticulous pre-processing and loading of this data into the platform.
−Removed: This process culminates in
−Removed: the availability of a dashboard offering the client insights into the data’s characteristics, such as data quality, the technology
−Removed: employed, and associated metadata.
−Removed: Phase I of the workflow behind Renovaro Cube’s AI platform primarily centers on the pivotal process of biomarker discovery.
−Removed: This intricate procedure unfolds through the application of data mining algorithms and statistical methodologies integrated into the AI platform.
−Removed: The paramount objective of Phase I is to reduce the plethora of genomic features displaying variations across samples, which is accomplished by systematically eliminating extraneous or inconsequential features while preserving those features that exhibit the greatest potential for accurately detecting cancer.
−Removed: Phase II of the workflow builds upon the foundation of selected biomarkers by focusing on understanding the dynamic interplay among these chosen biomarkers, culminating in the creation of composite panels.
−Removed: The goal of Phase II is to pinpoint biomarker combinations that not only demonstrate robustness in detecting cancer but also maintain their efficacy across diverse contexts.
−Removed: Renovaro Cube believes that its AI algorithms are adept at uncovering multiple combinations across a spectrum of panels, which is supported by Renovaro Cube’s AI-guided panel mining, a proprietary combinatorial optimization technique used by Renovaro Cube’s AI technology.
−Removed: This approach, coupled with the capacity to explore numerous panels, significantly enhances the likelihood of discovering panels that align with specific metric criteria, such as sensitivity, specificity, precision, and recall and allows for tailoring criteria to align with clients’ unique needs, such as the number of biomarkers included per panel, or the inclusion of biomarkers associated with the expression of specific genes.
−Removed: The performance of the top-tier panels is further fine-tuned through the application of machine learning models.
−Removed: Subsequently, the efficacy of these biomarker panels in detecting cancer is validated through independent data sets.
−Removed: Phase III of the workflow involves Renovaro Cube’s collaboration with its clinical partners to validate the performance of the biomarker panels.
−Removed: Through this collaboration, Renovaro Cube can confirm the utility and accuracy of its biomarker panels in real-world clinical contexts.
−Removed: AI-Assisted Diagnostics
−Removed: The process of biomarker discovery
−Removed: facilitated by Renovaro Cube’s AI technology has yielded a set of data that enables scrutiny of the genomic distinctions and commonalities
−Removed: inherent in diverse cancer types.
−Removed: This data set can support the diagnosis of cancers when their type or origin remains unidentified.
−Removed: In addition to this role in biomarker
−Removed: discovery and the development of diagnostic tests, Renovaro Cube’s AI technology also integrates AI-guided molecular profiling of
−Removed: patient samples and furnishes diagnostic patient reports.
−Removed: These diagnostic reports reflect the outcomes of molecular profiling, coupled
−Removed: with interpretations provided by Renovaro Cube’s team, to facilitate the process of cancer diagnostics by a qualified healthcare
−Removed: provider, who can consider these reports in the context of a patient’s medical history, clinical signs, and symptoms, among other
−Removed: Quality Control Process
−Removed: Renovaro Cube undertakes post-processing
−Removed: of data generated from sequence and arrays to ensure accurate and meaningful results.
−Removed: These post-processing steps for omic data include:
−Removed: Quality Control :
−Removed: Quality control is performed to assess the overall data quality and to identify any technical issues or anomalies.
−Removed: Normalization :
−Removed: arrays can introduce various sources of technical variation, such as batch effects, intensity variations, and probe-specific biases.
−Removed: Quality Filtering :
−Removed: After genotype calling, additional quality filtering may be performed to remove low-quality SNPs based on criteria like call rates, minor allele frequency, Hardy-Weinberg equilibrium p-values, and linkage disequilibrium.
−Removed: Other post-processing steps may
−Removed: include genotype calling, population stratification and association analysis.
−Removed: Specific post-processing steps may vary depending on the
−Removed: type of array used, the study design, and the analytical goals.
−Removed: Planning for Commercialization
−Removed: Partnerships in Development
−Removed: To enhance multi-omic and multi-modal
−Removed: capacity, and to work to validate those capabilities with human samples including liquid-biopsy-based tests/test kits, Renovaro Cube is
−Removed: actively pursuing relationships with leading academic cancer centers, pathology and imagery centers in Europe, the USA and the Middle
−Removed: In certain cases, scopes of work are in process.
−Removed: This is a very attractive model for partners to be involved with Renovaro Cube
−Removed: to perform multi-omics genetic analysis using liquid biopsies.
−Removed: Renovaro Cube intends to hire additional
−Removed: staff to increase the speed and velocity of its organization, including the development of the AI platform and the opportunities to deploy
−Removed: the AI platform for research perspective and ultimately for clinical practice and into clinical trials.
−Removed: In addition, Renovaro Cube intends
−Removed: to build out its infrastructure by leasing space for storage, networking and hosting facilities.
−Removed: Target Market
−Removed: Renovaro Cube’s intended
−Removed: customers will be hospitals, clinics, insurance companies, pharmaceutical companies, biotech companies, research centers, physicians and
−Removed: individual patients.
−Removed: Renovaro Cube aims to utilize its
−Removed: AI technology to commercialize products and test kits for healthcare providers, hospitals, clinics and doctors that will expedite diagnosis
−Removed: and the selection of appropriate treatment for various types of cancer.
−Removed: Renovaro Cube intends to differentiate its products based on the
−Removed: following factors:
−Removed: Proprietary and unique panel mining algorithms to create multiple biomarker stratifications per cancer;
−Removed: Explainable AI, offering traceability between the prediction and the exact biomarkers, panels and genes;
−Removed: Differential diagnosis, inclusion and exclusion of cancer types based on facts;
−Removed: Precision diagnosis, with a high accuracy percentage with machine-learning tuning.
−Removed: The multi-omic design of Renovaro
−Removed: Cube’s AI platform enables the use of different molecular layers, such as epigenomics, transcriptomics, and metabolomics, together
−Removed: with genomics and clinical data.
−Removed: The unique panel mining technique
−Removed: in Renovaro Cube’s technology repeatedly investigates genes to identify relevant biomarkers.
−Removed: The proprietary technique in Renovaro
−Removed: Cube’s technology not only searches for individual biomarkers, but also integrates validated panels for different cancer types into
−Removed: the “RenovaroCube” machine learning library.
−Removed: This process enables precision diagnosis, by including one cancer and excluding
−Removed: others based on statistically, scientifically and clinically validated machine-learning panels.
−Removed: Panel mining is designed to combine
−Removed: biomarkers into panels in such a way that the final panel meets:
−Removed: performance metric criteria;
−Removed: technical criteria, such as a minimum or maximum number of biomarkers for the selected assay;
−Removed: biological criteria, non-annotated genes inclusion;
−Removed: stratification criteria.
−Removed: Explainable AI
−Removed: The term “Explainable AI”
−Removed: refers to the ability of an AI system or model to provide human-understandable explanations for its decision-making process or predictions.
−Removed: This feature aims to bridge the gap between the “black box” nature of many AI algorithms and the need for transparency, interpretability,
−Removed: and accountability in AI applications.
−Removed: In traditional machine learning
−Removed: approaches, such as deep neural networks, the internal workings of the model can be complex and difficult to interpret.
−Removed: This lack of interpretability
−Removed: poses challenges in critical domains where decisions have significant implications, such as healthcare.
−Removed: Renovaro Cube believes that Explainable
−Removed: AI is crucial for ensuring transparency, fairness, and accountability in AI systems.
−Removed: Renovaro Cube’s AI platform includes Explainable
−Removed: AI by design.
−Removed: All data points, calculations and results are traceable, and all calculations are verifiable and reproducible with the same
−Removed: Disease prognosis is one of the
−Removed: diagnostic capabilities of the Explainable AI feature of Renovaro Cube’s technology.
−Removed: Disease prognosis gives more insight for a
−Removed: specific patient that empowers healthcare providers, patients, and their families to make well-informed decisions about treatment, care,
−Removed: and future planning, thereby enhancing patient-centered care, optimizing resource utilization, and contributing to improved patient outcomes
−Removed: and quality of life.
−Removed: Differential Diagnosis
−Removed: Renovaro Cube’s AI platform
−Removed: offers differential diagnosis by design due to its approach with a multitude of models for different diseases and the ability to include
−Removed: and exclude diseases.
−Removed: Diseases like cancer are very homogenous,
−Removed: meaning that markers like TP53 or BRCA are expressed with multiple cancers.
−Removed: To address this homogeneity, differential diagnosis distinguishes
−Removed: between two or more conditions or diseases that share similar signs, symptoms or characteristics.
−Removed: The goal of differential diagnosis is
−Removed: to consider and evaluate all possible diagnoses for the patient’s symptoms to determine the most likely cause.
−Removed: Differential diagnosis
−Removed: therefore aims to identify the underlying condition accurately and guide appropriate treatment and management strategies.
+Added: BioSymetrics Overview
+Added: BioSymetrics is a biomedical artificial
+Added: intelligence company focused on integrating multimodal data sources, including genomics, imaging, electronic health records, and other
+Added: real-world evidence, to advance biomarker discovery, therapeutic development, and precision medicine.
+Added: BioSymetrics has developed proprietary
+Added: machine learning pipelines that harmonize and analyze complex, heterogeneous datasets to uncover clinically actionable insights.
+Added: insights are designed to support pharmaceutical research, early disease detection, and personalized treatment strategies.
+Added: BioSymetrics collaborates with
+Added: pharmaceutical companies, healthcare providers, and academic institutions to co-develop analytical tools and translational research programs.
+Added: Application areas of the BioSymetrics platform include:
+Added: (i) multi-omics integration for target identification and validation;
+Added: (ii) predictive
+Added: modeling of therapeutic efficacy and safety;
+Added: (iii) clinical trial optimization, including patient stratification and response monitoring;
+Added: and (iv) experimental screening of gene and small molecule effects for the purpose of identifying novel drug targets and therapeutics.
+Added: The key to the BioSymetrics approach
+Added: is Contingent AI.
+Added: In Contingent AI, any “settable” parameter for data processing, data integration, or feature selection is
+Added: permuted and the corresponding effects on the downstream predictive model measured.
+Added: This process is similar in nature to hyperparameter
+Added: tuning in machine learning, however instead of optimizing only the machine learning model, the entire data science pipeline (including
+Added: model selection) is subject to optimization.
+Added: We have applied this method extensively in drug discovery, producing marked improvements
+Added: in experiment interpretation and lead generation.
+Added: major component of BioSymetrics’ platform is the Phenograph.
+Added: The Phenograph TM is BioSymetrics’ proprietary knowledge
+Added: The purpose of the Phenograph TM is to map human genes and phenotypes to those of model systems, allowing virtual
+Added: phenotypic screening , target nomination, and active learning feedback.
+Added: The Phenograph TM contains 5,856 diseases associated
+Added: with one or more phenotypes in humans, and 16,676 human genes with one or more orthologous zebrafish genes.
+Added: Zebrafish genes are mapped
+Added: to phenotypic terms using over 300 individually-trained machine learning models, that fill in the gaps of known gene-phenotype associations.
+Added: Leveraging this platform, we can prioritize human genes on the basis of predicted experimental phenotype, reducing the number of required
+Added: experiments to produce human-informed in vivo disease models.
+Added: Finally, one important component of the BioSymetrics platform is that it couples AI-based prediction
+Added: with experimental validation.
+Added: BioSymetrics has designed deep learning-based computer vision software that automatically identifies and
+Added: characterizes organ systems relevant to neurological, cardiovascular, and muscle development ( Figure below ).
+Added: Additionally, BioSymetrics
+Added: has developed a proprietary light stimulus battery and characterized a small number of known CNS therapeutics and unknown compounds, providing
+Added: an initial basis for evaluation of chemical effects.
+Added: A large-scale behavioral profiling
+Added: platform for identification of neurotherapeutics.
+Added: (A) 96-well plate containing 8 zebrafish larvae per well, as used for behavioral
+Added: (B-C) Line plots showing activity over time for 48 replicate wells focusing in on a small (5 min) part of the behavioral profile.
+Added: Unlike control wells (B), drug-treated wells (C) show much higher activity levels.
+Added: (D-H) Example profiles for 5 different reference compounds
+Added: showing the average behavioral profiles for control and compound-treated wells (n= 4 wells;
+Added: orange and blue lines, respectively).
+Added: that each of the 5 compounds causes a distinct behavioral profile.
+Added: (I) Examples of morphological segmentation.
+Added: Colored micrographs of
+Added: laterally oriented zebrafish larvae show computer-vision-based organ segmentation using trained ML classifiers.
+Added: In prior work, we leveraged our
+Added: motion profiling capabilities to identify novel neuroactive compounds capable of resolving epilepsy-related phenotypes.
+Added: Specifically,
+Added: we screened 1400 compounds from a proprietary small molecule library both with and without addition of a chemical convulsant.
+Added: The experimental
+Added: component of this screen was completed by one technician in 10 days, giving us an approximate pace of 1,000 compounds screened per technician
+Added: This study resulted in identification of a hit compound that later showed efficacy in a mouse seizure model, now being further
+Added: progressed as a potential therapeutic by BioSymetrics.
+Added: Additionally, during the course of this study we screened approximately 100 known
+Added: neuroactives, including clinical anticonvulsants, antidepressants, antipsychotics, and dopaminergic signaling activators and inhibitors.
+Added: This study produced two key observations that are critical for this application.
+Added: The result is both an experimental platform and coupled
+Added: computational model that can identify both neurotherapeutics and neurotoxins, the former through direct experimental screening, and the
+Added: latter through machine-learning based prediction based on chemical structure.
+Added: We next examined the ability of
+Added: one of these compounds (BioS_831) to resolve seizures in a murine model using a previously established electroshock seizure assay.
+Added: after dosing each mouse with either BioS_831, negative control (vehicle), or positive control (Sodium Valproate), electroshock is delivered
+Added: transauricularly using stimulation at 50 Hz and 50 mA for 0.8 seconds with a pulse width of 10 milliseconds.
+Added: The total number of hind
+Added: limb flexes, hind limb extensions, and mortality rate is monitored for 60 seconds following electroshock, as are other adverse events.
+Added: 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
+Added: seizure induction and significantly reduced the number of observed tonic extension seizures, as compared to vehicle control.
+Added: unlike the ASM Sodium Valproate, BioS_831 did not cause sedation or ataxia.
+Added: Sodium Valproate (VPA) while effective in this model at this
+Added: concentration, results in high levels of neurotoxicity, and has been associated with multi-organ failure, underscoring the importance
+Added: of not observing negative neurological effects with our novel compound.
+Added: Post-study PK analysis showed good distribution of BioS_831 into
+Added: the brains of the test animals (average brain to plasma ratio 0.68).
+Added: Since the electroshock seizure model is not based on seizure induction
+Added: through hypofunction of KCC2, these findings suggest that our zebrafish epilepsy primary screening model is capable of identifying novel
+Added: compounds that show translation to mammalian generalized epilepsy models and suggest that BioS_831 could further be optimized as a potential
+Added: anti-epileptic therapeutic.
+Added: Additionally, during the course
+Added: of this study we screened approximately 100 known neuroactives in our zebrafish model including clinical anticonvulsants, antidepressants,
+Added: antipsychotics, and dopaminergic signaling activators and inhibitors.
+Added: The result is both an experimental platform and coupled computational
+Added: model that can identify both neurotherapeutics and neurotoxins, the former through direct experimental screening, and the latter through
+Added: machine-learning based prediction based on chemical structure.
+Added: BioSymetrics intends to expand the use of its platform
+Added: across the biopharmaceutical and healthcare markets.
+Added: The company is developing its technology in compliance with applicable healthcare
+Added: data privacy regulations, including HIPAA and GDPR, and is focused on building AI solutions that address the growing demand for robust,
+Added: transparent, and reliable applications of artificial intelligence in life sciences.
+Added: Our Intellectual Property
+Added: Patents and licenses are key to
+Added: our business.
+Added: Our strategy is to file patent applications to protect technology, inventions, and improvements to inventions that we consider
+Added: important for the development of our business.
+Added: We rely on a combination of patent, copyright, trademark, and trade secret laws, as well
+Added: as continuing technological innovations, proprietary knowledge, and various third-party agreements, including, without limitation, confidentiality
+Added: agreements, materials transfer agreements, research agreements, and licensing agreements, to establish and protect our proprietary rights.
+Added: 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
+Added: that we can fully exploit our innovations.
+Added: We also protect our proprietary
+Added: information by requiring our employees, consultants, contractors, and other advisors to execute nondisclosure and assignment of invention
+Added: agreements upon commencement of their respective employment or engagement.
Corporate History
10 unchanged sentences
subsidiary of Renovaro Inc.
+Added: On April 8, 2025, the Company acquired BioSymetrics, Inc.
+Added: and its subsidiary, as a wholly owned subsidiary.
+Added: On August 20, 2025, the Company changed its corporate name from Renovaro Inc.
+Added: to Lunai Bioworks Inc.
Going Concern and Management’s Plans
5 unchanged sentences
financing to fund operations.
−Removed: The Company incurred a net income (loss) of $189,176 and $(51,275,253) for the three and nine months ended
−Removed: March 31, 2025, respectively.
−Removed: As of March 31, 2025, the Company had cash and cash equivalents of $923,002 and an accumulated deficit of
−Removed: $383,730,334 and a working capital deficit of $25,173,586.
+Added: As of September 30, 2025, the Company had cash and cash equivalents of $624,808 and an accumulated deficit
+Added: of $507,643,549 and a working capital deficit of $18,922,114.
These conditions raise substantial doubt about the Company’s ability
21 unchanged sentences
working capital reserves.
−Removed: Results of Operations for the Three and Nine Months ended March 31,
−Removed: 2025 and 2024
+Added: Results of Operations for the Three Months ended September 30, 2025
The following table sets forth
−Removed: our revenues, expenses and net loss for the three and nine months ended March 31, 2025 and 2024.
−Removed: The financial information below is derived
−Removed: from our unaudited condensed consolidated financial statements.
+Added: our revenues, expenses and net income, loss for the three months ended September 30, 2025 and 2024.
+Added: The financial information below is
+Added: derived from our unaudited condensed consolidated financial statements.
For the Three Months Ended
−Removed: For the Nine Months Ended
−Removed: Increase/(Decrease)
+Added: September 30,
Increase/(Decrease)
1 unchanged sentence
General and administrative
−Removed: $ (3,427,789 )
−Removed: $ (5,680,018 )
Research and development
Goodwill impairment
−Removed: Intangible asset impairment
−Removed: (42,611,000 )
−Removed: (42,611,000 )
+Added: Long-lived asset impairment
Depreciation and amortization
Total Operating Expenses
−Removed: (47,218,348 )
LOSS FROM OPERATIONS
−Removed: (51,380,840 )
−Removed: (62,325,381 )
−Removed: (64,535,029 )
Other Income (Expenses)
1 unchanged sentence
Change in fair value of equity securities
+Added: Gain on bankruptcy of subsidiary
Loss on extinguishment of debt
Interest expense
−Removed: Interest and other income
+Added: Interest income and other income (expense)
Total Other Income (Expense)
NET INCOME (LOSS)
−Removed: $ (58,990,070 )
−Removed: $ (51,275,253 )
−Removed: $ (72,694,219 )
We are a pre-revenue, pre-clinical
2 unchanged sentences
since inception.
−Removed: We do not anticipate earning any revenue until our therapies or products are approved for marketing and sale.
−Removed: Our operating expenses for the
−Removed: three months ended March 31, 2025 and 2024, were $4,162,492 and $51,380,840 respectively, representing
−Removed: a decrease of $47,218,348 or approximately 92% .
−Removed: The decrease in operating expenses primarily relates to the decrease of intangible
−Removed: asset impairment of $42,611,000, general and administrative expenses of $3,427,789 and the decrease in research and development expenses
−Removed: of $1,181,229.
+Added: We do not anticipate earning any revenues until our therapies or products are approved for marketing and sale.
Our operating expenses for the
−Removed: nine months ended March 31, 2025 and 2024, were $62,047,361 and $64,535,029 respectively, representing
−Removed: a decrease of $2,487,668, or approximately 4% .
−Removed: The decrease in operating expenses primarily relates to the decrease in intangible
−Removed: asset impairment of $42,611,000, general and administrative expenses of $5,680,018 and research and development expenses of $1,817,121,
−Removed: partially offset by the increase in goodwill impairment of $47,614,729.
−Removed: General and administrative expenses
−Removed: for the three months ended March 31, 2025, and 2024, were $4,224,590 and $7,652,379, respectively, representing a decrease of $3,427,789
−Removed: or approximately 45%.
−Removed: The variance is related to decreases in legal expenses of $1,915,126, consulting fees expense of $453,294, non-cash
−Removed: stock-based compensation expense of $362,402, marketing expenses of $137,516, investor relations expenses of $109,831 and board of director
−Removed: compensation of $107,718.
−Removed: General and administrative expenses
−Removed: for the nine months ended March 31, 2025, and 2024, were $13,878,963 and $19,558,981, respectively, representing a decrease of $5,680,018
−Removed: or approximately 29%.
−Removed: The variance is related to decreases in legal expenses of $1,722,555, consulting fees expense of $2,552,211, non-cash
−Removed: stock-based compensation expense of $1,429,180, marketing expenses of $280,412, investor relations expenses of $186,646 and board of director
−Removed: compensation of $203,968, partially offset by an increase in compensation related expenses of $856,873.
−Removed: Research and development expenses
−Removed: for the three months ended March 31, 2025, and 2024, were $(94,073) and $1,087,156, respectively, representing a decrease of $1,181,229
+Added: three months ended September 30, 2025 and 2024, were $3,308,360 and $53,338,554, respectively, representing a decrease of $50,030,194,
or approximately 94%.
−Removed: The variance is primarily driven by decreases of $632,102 in collaborating partner expenses with
−Removed: CDMO and CROs, consulting expenses of $339,505 and consumables and reagents related expenses of $205,985.
+Added: The decrease in operating expenses primarily relates to the decrease in goodwill impairment of $47,614,729 and by
+Added: the decrease in general and administrative expenses of $2,890,735, partially offset by the impairment of fixed assets and right of
+Added: use assets of $831,915 due to no longer using assets.
+Added: and administrative expenses for the three months ended September 30, 2025, and 2024, were $2,410,516 and $5,301,251, respectively, representing
+Added: a decrease of $2,890,735 or approximately 55%.
+Added: The variance is primarily related to a decrease in consulting fees of $1,576,761, legal
+Added: expenses of $899,802 and compensation and related expenses of $205,381.
Research and development expenses
−Removed: for the nine months ended March 31, 2025, and 2024, were $457,200 and $2,274,321, respectively, representing a decrease of $1,817,121
+Added: for the three months ended September 30, 2025, and 2024, were $24,407 and $390,189, respectively, representing a decrease of $365,782
or approximately 94%.
−Removed: The variance is primarily driven by decreases of $1,130,193 in collaborating partner expenses with
−Removed: CDMO and CROs, consulting expenses of $446,938 and consumables and reagents related expenses of $231,281.
−Removed: The Company recorded other income
−Removed: of $4,351,668 for the three months ended March 31, 2025, compared to other expense of $7,609,230 for the three months ended March 31,
−Removed: 2024, representing an decrease in other expense of $11,960,898 or 157%.
−Removed: The variance is primarily due to the change in fair value of contingent
−Removed: consideration liability of $11,619,156.
−Removed: The Company recorded other income
−Removed: of $10,772,108 for the nine months ended March 31, 2025, compared to other expense of $8,159,190 for the nine months ended March 31, 2024,
−Removed: representing a decrease in other expense of $18,931,298 or 232%.
−Removed: The variance is primarily due to the change in fair value of contingent
−Removed: consideration liability of $18,279,156.
+Added: The variance is primarily driven by a decrease of $346,100 in consumables and reagents used in discontinued product
+Added: Company recorded other income of $6,127,381 for the three months ended September 30, 2025, compared to other income of $9,126,518 for
+Added: the three months ended September 30, 2024, representing a decrease in other income (expense) of $2,999,137 or 33%.
+Added: The variance is primarily
+Added: due to the decrease in fair value of contingent consideration of $8,880,000 and loss on extinguishment of debt of $6,329,592, partially
+Added: offset by the gain on the bankruptcy of Gedi Cube B.V.
+Added: of $12,019,227.
+Added: Net Income (Loss)
Net income (loss) for the three
−Removed: months ended March 31, 2025, and 2024, was $189,176 and $(58,990,070), respectively, representing a change in net income (loss) of $59,179,246
+Added: months ended September 30, 2025, and 2024, was $2,819,021 and $(44,212,036), respectively, representing a decrease in net loss of $47,031,057
or approximately 106%.
−Removed: The decrease in net loss was primarily due to a decrease in intangible asset impairment of $42,611,000 and the
−Removed: change in fair value of contingent consideration of $11,619,156.
−Removed: Net loss for the nine months ended
−Removed: March 31, 2025, and 2024, was $51,275,253 and $72,694,219, respectively, representing a decrease in net loss of $21,418,966 or approximately
−Removed: The decrease in net loss was primarily due to decreases in intangible asset impairment of $42,611,000, general and administrative
−Removed: expenses of $5,680,018, research development expenses of $1,817,121 and change in fair value of contingent consideration of $18,931,298,
−Removed: partially offset by the increase in goodwill impairment of $47,614,729.
+Added: The decrease in net loss was primarily due to the decrease in goodwill impairment of $47,614,729 in the prior period.
Liquidity and Capital Resources
7 unchanged sentences
As noted above under the heading
−Removed: “Going Concern and Management’s Plans,” through March 31, 2025, we have incurred substantial losses.
−Removed: We will need additional
−Removed: funds both in the next twelve months and beyond for (a) research and development, (b) increases in personnel, (c) the purchase of equipment,
−Removed: and investment in the development and validation of our technology.
−Removed: The availability of any required additional funding cannot be assured.
−Removed: In addition, an adverse outcome in legal or regulatory proceedings in which we are currently involved or in the future may be involved
−Removed: could adversely affect our liquidity and financial position.
−Removed: We may raise such funds from time to time through public or private sales
−Removed: of our equity or debt securities.
−Removed: Such financing may not be available on acceptable terms, or at all, and our failure to raise capital
−Removed: when needed could materially adversely affect our growth plans and our financial condition and results of operations.
−Removed: As of March 31, 2025, the Company
+Added: “Going Concern and Management’s Plans,” through September 30, 2025, we have incurred substantial losses.
+Added: additional funds both in the next twelve months and beyond for (a) research and development, (b) increases in personnel, (c) the purchase
+Added: of equipment, and investment in the development and validation of our technology.
+Added: The availability of any required additional funding
+Added: cannot be assured.
+Added: In addition, an adverse outcome in legal or regulatory proceedings in which we are currently involved or in the future
+Added: may be involved could adversely affect our liquidity and financial position.
+Added: We may raise such funds from time to time through public
+Added: or private sales of our equity or debt securities.
+Added: Such financing may not be available on acceptable terms, or at all, and our failure
+Added: to raise capital when needed could materially adversely affect our growth plans and our financial condition and results of operations.
+Added: As of September 30, 2025, the Company
had $624,808 in cash and working capital deficit of $18,922,114 as compared to $92,700 in cash and working capital deficit of $28,109,502
as of June 30, 2025, an increase of 574% and decrease of 33%, respectively.
−Removed: Total assets at March 31, 2025,
+Added: Total assets at September 30, 2025,
were $6,960,663 compared to $8,230,840 as of June 30, 2025.
−Removed: The decrease in assets is primarily due to goodwill impairment of $47,614,729
−Removed: in the current period.
−Removed: Total liabilities at March 31, 2025, were $29,339,269 compared to $31,152,306
−Removed: as of June 30, 2024.
−Removed: The decrease in total liabilities was primarily related to the decrease of $10,990,000 in contingent consideration
−Removed: liability, partially offset by an increases of $3,534,901 in notes payable – related parties, net, $2,277,375 in accounts payable
−Removed: and $3,000,000 in Stock subscription payable.
+Added: The decrease in assets is primarily due to the impairment of operating lease
+Added: right-of-use assets of $687,371, amortization of prepaid assets of $390,529, partially offset by the increase of cash of $532,108 in the
+Added: current period.
+Added: Total liabilities at September
+Added: 30, 2025, were $20,001,437 compared to $29,580,681 as of June 30, 2025.
+Added: The decrease in total liabilities was primarily related to the
+Added: decrease of $7,285,741 in notes payable – related parties, $974,383 in accrued expenses, $461,411 in accounts payable, $370,000
+Added: in contingent consideration liability and $306,853 in other current liabilities.
The following is a summary of the
Company’s cash flows (used in) or provided by operating, investing, and financing activities:
+Added: September 30,
+Added: September 30,
Net Cash Used in Operating Activities
−Removed: $ (6,063,511 )
−Removed: $ (8,557,649 )
−Removed: Net Cash Used in Investing Activities
+Added: Net Cash Provided by Investing Activities
Net Cash Provided by Financing Activities
1 unchanged sentence
Change in Cash and Cash Equivalents
−Removed: $ (1,561,783 )
The decrease in our cash used in
1 unchanged sentence
The change is primarily driven by our
−Removed: net loss offset by significant non-cash charges such as stock based compensation, impairments and change in fair value of contingent consideration.
−Removed: Additionally, our operating cash flow was positively impacted by changes in our operating assets and liabilities, primarily other receivables,
−Removed: prepaid expenses and accounts payable.
−Removed: Cash used in investing activities
−Removed: during the period related to the investment in equity securities of $1,464,389.
−Removed: Cash used in investing activities in the prior period primarily
−Removed: related to the issuance of notes receivable prior to the acquisition of Renovaro Cube totaling $1,206,806.
+Added: net income offset by significant non-cash charges such as stock-based compensation, impairments and change in fair value of contingent
+Added: consideration.
+Added: Additionally, our operating cash flow was positively impacted by changes in our operating assets and liabilities, primarily
+Added: other receivables, prepaid expenses and accounts payable.
+Added: Cash used provided by investing
+Added: activities during the period related to proceeds from the sale of equity securities of $544,700.
Cash provided by financing activities
−Removed: during the period primarily related to net proceeds of $3,527,822 from issuance of notes payable and $5,376,181 from private placements
−Removed: that were partially offset by $699,588 in repayment of a finance agreement.
+Added: during the period primarily related to net proceeds of $1,343,357 from issuance of $1,615,000, net of $18,495 placement costs, in notes
+Added: payable that were partially offset by $271,643 in repayment of a finance agreement.
Off-Balance Sheet Arrangements
15 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.