Lunai Bioworks Inc.

Our Business

As of June 30, 2026, Lunai Bioworks Inc. operated principally through two operating subsidiaries, Renovaro Biosciences and BioSymetrics; a third wholly owned subsidiary, Lunai Bioworks IP, Inc., holds the intellectual property acquired in the May 2026 Neurobridge acquisition, including the N2B intranasal drug delivery platform. BioSymetrics refers to BioSymetrics Inc. and its wholly owned subsidiary BioSymetrics Corp., which were acquired on April 8, 2025.

During the quarter ended September 30, 2025, GEDi Cube B.V. ("GEDi Cube"), acquired on February 13, 2024, filed for bankruptcy and ceased operations. Following GEDi Cube's bankruptcy and subsequent deconsolidation, the Company continued pursuing its AI-driven precision medicine and biomarker discovery strategy through BioSymetrics, which had been acquired prior to the bankruptcy. BioSymetrics' existing AI and machine-learning platform provided capabilities that overlapped with GEDi Cube's cancer diagnostics and biomarker discovery objectives while supporting a broader range of applications, including therapeutic development, central nervous system disorders, and biodefense. Using its independently developed technology, BioSymetrics continued pursuing cancer-related diagnostic and biomarker opportunities while expanding the Company's research and business development activities into additional therapeutic areas. Accordingly, GEDi Cube's bankruptcy did not represent a change in the Company's overall strategic direction, as its AI-driven biomedical research and development strategy continued and expanded through BioSymetrics. Following GEDi Cube's deconsolidation, the Company's consolidated operations consisted principally of Renovaro Biosciences' cell and gene therapy programs and BioSymetrics' AI-driven biotechnology platform.

Lunai Bioworks Inc. is an AI-driven biotechnology company focused on precision medicine, biomarker discovery, and therapeutic development for CNS disorders, biodefense, and other serious diseases with unmet medical need. Through its Renovaro Biosciences and BioSymetrics subsidiaries, the Company combines multimodal data analytics with experimental biology to generate predictive insights intended to accelerate research and development activities and improve the efficiency of therapeutic and chemical countermeasure discovery.

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, and potentially to treat or cure serious infectious diseases such as Human Immunodeficiency Virus (HIV) infections.

Therapeutic Technologies

Renovaro Biosciences 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., HIV and 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.

Gene Therapy

Renovaro Biosciences may also seek to explore various approaches for gene therapy design elements to potentially eliminate virus-infected or cancer cells by the modulation of the patient’s immune system. Upon injecting into the patients, these genetically engineered allogeneic cells have little to no risk of passing those modifications to the patient since they are terminally differentiated with locked functionality to activate the host immune system. Gene modified allogeneic cells are expected to be rejected naturally once they activate the patient’s immune system therefore will have a very short survival time.

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.

BioSymetrics Overview

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 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. The success of this program has enabled the initiation of two additional grant-supported programs. The first of these programs is for Alcohol Use Disorder (AUD), an area of high prevalence and substantial unmet medical need. Through funding obtained through the NIH’s STTR program, we initiated a therapeutic discovery program leveraging our zebrafish platform. The second program is for a rare pediatric epilepsy caused by mutation in the CDKL5 gene, and is supported by funding from the LouLou foundation. Here we are working in collaboration with a brain organoid company to test and develop novel therapeutics that are applicable not only for CDKL5-resultant epilepsies, but also for epilepsies of other origin.

Biodefense Initiative

Lunai Bioworks is applying the BioSymetrics platform’s toxicity and phenotypic screening capabilities to the identification and characterization of chemical and biological threats and the development of potential medical countermeasures. BioSymetrics’ zebrafish-based behavioral profiling and computer vision infrastructure, which has been used to characterize therapeutic candidates, can also be applied to characterize neurotoxic and other harmful compounds by comparing their phenotypic profiles against profiles of known threat agents and potential countermeasures.

In April 2026, the Company entered into its first commercial agreement in this area, a multi-year collaboration involving AI-powered chemical threat assessment. The Company is pursuing additional government-funded research and development opportunities in this area, including opportunities involving the Biomedical Advanced Research and Development Authority (“BARDA”) and the U.S. Department of Defense. There can be no assurance that the Company will receive any additional government award, contract or funding.

The Company has entered into memoranda of understanding (“MOUs”) with academic and research investigators affiliated with Harvard Medical School and Brigham and Women’s Hospital, the University of Utah, Purdue University, and the University of Colorado to support aspects of countermeasure research and development. These MOUs contemplate collaborative activities that may include in vivo validation, mechanism-of-action characterization and translational development of potential countermeasure candidates identified or evaluated using the Company’s platform. The MOUs are with the individual investigators and not with the institutions with which they are affiliated.

Neurobridge Nose-to-Brain (N2B) Delivery Platform

On May 1, 2026, Lunai Bioworks, through its wholly owned subsidiary Lunai Bioworks IP, Inc., acquired Neurobridge IP Holdings Incorporated, which held intellectual property relating to an intranasal drug delivery platform designed to facilitate delivery of therapeutic compounds to the central nervous system (the “N2B platform”), together with related intellectual property directed to a compound for the treatment of Alzheimer’s disease. The consideration for the acquisition consisted of shares of the Company’s Series B Convertible Preferred Stock.

The N2B platform was developed using intranasal apomorphine and has been evaluated in previously completed Phase I and Phase II clinical studies involving healthy volunteers and patients with Parkinson’s disease. These studies generated pharmacokinetic and other clinical data regarding intranasal administration of apomorphine, including data concerning systemic absorption and cerebrospinal fluid exposure.

Lunai’s rights to the N2B platform are limited to the fields of biodefense medical countermeasures and Alzheimer’s disease. Within those fields, Lunai intends to evaluate the potential use of the N2B platform for delivery of therapeutic compounds to the central nervous system.

In biodefense, the Company is evaluating whether the N2B platform could potentially support administration of medical countermeasures where rapid delivery and ease of administration may be important. Lunai is also evaluating applications of the platform in Alzheimer’s disease, where delivery of therapeutic compounds to the central nervous system represents a significant drug-development challenge. These programs remain subject to further research, development, regulatory review and, where applicable, clinical evaluation.

In connection with the acquisition, the Company entered into an agreement with Oncotelic Therapeutics, Inc., the originating developer of the N2B platform, pursuant to which Oncotelic provides certain intellectual property development and business development services relating to the platform. These activities include preparation and filing of additional patent applications, provision of technical and preclinical information, and support relating to potential government funding opportunities.

Lunai also intends to apply elements of the BioSymetrics platform, including its Contingent AI and Phenograph technologies described above, to support target identification, biomarker discovery and other research activities associated with its neurological programs.

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. The patent has a term of twenty years from its earliest effective filing date. The Company owns this patent through an assignment effective 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 application titled “Allogeneic T-Cell-Based HIV Vaccine to Induce Cellular and Humoral Immunity” (published as “US 2021/0030795 A1”), covering the composition and method of use concepts for RENB-HV-12, was filed. The Company owns this patent application through an assignment effective as of September 28, 2021.

In-Licensed Technology

The Company has historically in-licensed technology material to certain of its therapeutic programs under a Framework Agreement dated November 15, 2019 with G Tech Bio, LLC (“G Tech”) and G Health Research Foundation, doing business as Seraph Research Institute (“SRI”), and three related license arrangements described in Note 10 to the Financial Statements: (i) the HBV License Agreement, dated January 31, 2020, under which the Company acquired a perpetual, sublicensable, exclusive license to a treatment under development for Hepatitis B Virus infections; (ii) the Development License Agreement, effective as of April 18, 2021, entered into pursuant to the Framework Agreement, under which the Company acquired a perpetual, sublicensable, exclusive license to research, develop and commercialize certain formulations aimed at preventing and treating coronaviruses and influenza; and (iii) the ALC License Agreement, dated August 25, 2021, with Serhat Gümrükçü and SRI, under which the Company was granted an exclusive, worldwide, perpetual, fully paid-up, royalty-free license to certain patents for cell and gene therapy in the HIV field. The Company’s rights under these agreements are the subject of the litigation described in “Legal Proceedings” and Note 10. In that litigation, G Tech and SRI seek a declaration that the Framework Agreement, the HBV License Agreement and the Development License Agreement have been terminated and that the Company has no rights to any license under those agreements, which the Company disputes. In addition, as a result of the Neurobridge acquisition, the Company, through Lunai Bioworks IP, Inc., owns the intellectual property relating to the N2B intranasal drug delivery platform and a related Alzheimer’s disease compound.

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

Numerous competitors are pursuing cancer immunotherapies that are more advanced in development than Renovaro Biosciences’ program, and many have substantially greater financial, technical, clinical, manufacturing, regulatory and commercial resources. Competing therapies may demonstrate greater safety or efficacy, obtain regulatory approval sooner, be easier or less expensive to manufacture or administer, or achieve greater acceptance among patients, physicians and payors. We believe our approach differs from many conventional dendritic cell therapies through its use of healthy-donor-derived CD34+ cells and its incorporation of genetic modifications intended to enhance immune-cell activation, recruitment and activity in the tumor microenvironment. The use of an allogeneic source is also intended to support standardized manufacturing and the production and banking of cells for use across multiple patients. These potential advantages remain subject to further preclinical and clinical evaluation and have not been demonstrated in clinical trials. Our ability to compete will depend on, among other factors, our ability to successfully complete preclinical and clinical development, demonstrate the safety and efficacy of our product candidates, establish scalable and reproducible manufacturing processes, obtain regulatory approvals and intellectual property protection, and demonstrate meaningful advantages relative to existing and emerging cancer therapies.

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.

BioSymetrics develops artificial intelligence and machine learning-enabled technologies to support drug discovery and development, including the analysis of clinical and biological data to characterize patient populations, identify biomarkers and therapeutic targets, and inform preclinical and clinical development. BioSymetrics also uses experimental model systems, including automated zebrafish phenotyping and computer vision, to validate biological hypotheses and evaluate potential therapeutics. These activities operate within an evolving regulatory environment applicable to artificial intelligence, biomedical research, drug development, data privacy and security. Depending on the intended use and future development of particular technologies, products or biomarkers, certain applications may also become subject to regulatory requirements applicable to medical devices, clinical decision-support tools or companion diagnostics. BioSymetrics’ activities may therefore be subject to requirements and guidance from the U.S. Food and Drug Administration and other regulatory authorities, as well as applicable privacy and data-protection requirements, including HIPAA and GDPR where applicable. As regulatory frameworks governing artificial intelligence and its use in drug development and healthcare continue to evolve, compliance with applicable requirements relating to data integrity, validation, cybersecurity, privacy, quality systems and the use of AI-generated analyses may require additional resources and could affect the development, validation or commercialization of BioSymetrics’ technologies and programs.

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, 2026, we had 12 full-time employees. The Company has streamlined the organization to focus on its AI-driven precision medicine platform, therapeutic programs and biodefense initiatives, and has tailored its workforce to focus on these activities. 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. During the quarter ended September 30, 2025, GEDi Cube, B.V., filed for bankruptcy and ceased operations.

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.

On May 1, 2026, Lunai Bioworks Inc., through its wholly owned subsidiary, Lunai Bioworks IP, Inc., completed the acquisition of Neurobridge IP Holdings Incorporated through a merger pursuant to an Agreement and Plan of Merger dated April 27, 2026, with Lunai Bioworks IP, Inc. continuing as the surviving corporation. Lunai Bioworks IP, Inc. holds the intellectual property acquired in the Neurobridge transaction, including the N2B intranasal drug delivery platform.

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

Our website is http://www.lunaibioworks.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.