Lunai Bioworks Inc. 10-Q

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations. Forward-Looking Statement Notice Certain statements made in this Quarterly Report on Form 10-Q are “forward-looking statements” (within the meaning of the Private Securities Litigation Reform Act of 1995) regarding the plans and objectives of management for future operations. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, or achievements of Lunai Bioworks Inc. (“Lunai,” and together with its subsidiaries, the “Company”, “we” or “us”) to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. The forward-looking statements included herein are based on current expectations that involve numerous risks and uncertainties. Our actual future results and trends may differ materially depending on a variety of factors, including, but not limited to, the risks and uncertainties discussed in Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K as filed with the SEC on September 29, 2025. The Company’s plans and objectives are based, in part, on assumptions involving the continued expansion of the business. Assumptions relating to the foregoing involve judgments with respect to, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the control of the Company. Although the Company believes its assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate and, therefore, there can be no assurance the forward-looking statements included in this Quarterly Report will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation by the Company or any other person that the objectives and plans of the Company will be achieved. Our Business As of September 30, 2025, Lunai Bioworks Inc. operates through two subsidiaries, Renovaro Biosciences and BioSymetrics. 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, GediCube, B.V., acquired on February 13, 2024, filed for bankruptcy and ceased operations. As a result, beginning in the second quarter of 2026, the Company will no longer report on its operations. 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. 25 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. Infectious Diseases: RENB-HV12: Genetically Modified Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Treatment Product for Long-term Remission of HIV; A Chronic Infectious Disease The oncology therapeutic vaccine technology could potentially be adapted to target infectious disease antigens and be a viable therapeutic approach in difficult to treat chronic infectious diseases. As described above, the engineered allogenic dendritic cell drug substance is thought to be able to be loaded with various cancer antigens for specific solid tumors but could or may be loaded with infectious disease antigens to elicit a more robust immune response to viruses and other difficult to treat infections. 26 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, allowing virtual 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-informed in vivo disease models. 27 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. 28 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. BioSymetrics intends to expand the use of its platform across the biopharmaceutical and healthcare markets. The company is developing its technology in compliance with applicable healthcare data privacy regulations, including HIPAA and GDPR, and is focused on building AI solutions that address the growing demand for robust, transparent, and reliable applications of artificial intelligence in life sciences. Our Intellectual Property Patents and licenses are key to our business. Our strategy is to file patent applications to protect technology, inventions, and improvements to inventions that we consider important for the development of our business. We rely on a combination of patent, copyright, trademark, and trade secret laws, as well as continuing technological innovations, proprietary knowledge, and various third-party agreements, including, without limitation, confidentiality agreements, materials transfer agreements, research agreements, and licensing agreements, to establish and protect our proprietary rights. We aim to take advantage of all of the intellectual property rights that are available to us and seek the protection of those rights so that we can fully exploit our innovations. We also protect our proprietary information by requiring our employees, consultants, contractors, and other advisors to execute nondisclosure and assignment of invention agreements upon commencement of their respective employment or engagement. 29 Corporate History We were incorporated under the laws of the State of Delaware on January 18, 2011, under the name Putnam Hills Corp. and in 2014 we merged with and changed our name to DanDrit Biotech USA, Inc. In 2018, we acquired Enochian Biopharma and changed our name to Enochian BioSciences Inc. In August 2023, the Company changed its corporate name to Renovaro Biosciences Inc. On February 13, 2024, the Company changed its corporate name to Renovaro Inc. On February 13, 2024, Renovaro Inc. acquired Renovaro Cube Intl Ltd and its subsidiaries, in which Renovaro Cube became a wholly-owned subsidiary of Renovaro Inc. On April 8, 2025, the Company acquired BioSymetrics, Inc. and its subsidiary, as a wholly owned subsidiary. On August 20, 2025, the Company changed its corporate name from Renovaro Inc. to Lunai Bioworks Inc. Going Concern and Management’s Plans The Company’s consolidated financial statements are prepared using the generally accepted accounting principles applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. However, the Company has incurred substantial recurring losses from continuing operations, has used cash in the Company’s continuing operations, and is dependent on additional financing to fund operations. As of September 30, 2025, the Company had cash and cash equivalents of $624,808 and an accumulated deficit of $507,643,549 and a working capital deficit of $18,922,114. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for one year after the date the financial statements are issued. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue in existence. Management has reduced overhead and administrative costs by streamlining the organization to focus around the development and validation of its AI-driven cancer diagnostics platform. The Company has tailored its workforce to focus on these activities. In addition, the Company intends to secure additional required funding through equity or debt financing. However, there can be no assurance that the Company will be able to obtain any sources of funding. Such additional funding may not be available or may not be available on reasonable terms, and, in the case of equity financing transactions, could result in significant additional dilution to our stockholders. If we do not obtain required additional equity or debt funding, our cash resources will be depleted and we could be required to materially reduce or suspend operations, which would likely have a material adverse effect on our business, stock price and our relationships with third parties with whom we have business relationships, at least until additional funding is obtained. If we do not have sufficient funds to continue operations, we could be required to seek bankruptcy protection or other alternatives that could result in our stockholders losing some or all of their investment in us. 30 Funding that we may receive during the fiscal year 2026 is expected to be used to satisfy existing and future obligations and liabilities and working capital needs, to support commercialization of our products, to conduct the clinical and regulatory work to develop our product candidates, and to begin building working capital reserves. Results of Operations for the Three Months ended September 30, 2025 and 2024 The following table sets forth our revenues, expenses and net income, loss for the three months ended September 30, 2025 and 2024. The financial information below is derived from our unaudited condensed consolidated financial statements. For the Three Months Ended September 30, Increase/(Decrease) 2025 2024 $ % Operating Expenses General and administrative $ 2,410,516 $ 5,301,251 $ (2,890,735 ) (55 )% Research and development 24,407 390,189 (365,782 ) (94 )% Goodwill impairment — 47,614,729 (47,614,729 ) (100 )% Long-lived asset impairment 831,915 — 831,915 100 % Depreciation and amortization 41,522 32,385 9,137 28 % Total Operating Expenses 3,308.360 53,338,554 (50,030,194 (94 )% LOSS FROM OPERATIONS (3,308,360 ) (53,338,554 ) 50,030,194 (94 )% Other Income (Expenses) Change in fair value of contingent consideration 370,000 9,250,000 (8,880,000 ) (96 )% Change in fair value of equity securities 156,849 — 156,849 100 % Gain on bankruptcy of subsidiary 12,019,227 — 12,019,227 100 % Loss on extinguishment of debt (6,329,592 ) — (6,329,592 ) (100 )% Interest expense (122,400 ) (250,080 ) 127,680 (51 )% Interest income and other income (expense) 33,297 126,598 (93,301 ) (74 )% Total Other Income (Expense) 6,127,381 9,126,518 (2,999,137 ) (33 )% NET INCOME (LOSS) $ 2,819,021 $ (44,212,036 ) $ 47,031,057 (106 )% Revenues We are a pre-revenue, pre-clinical biotechnology and artificial intelligence driven healthcare technology company. We have never generated revenues and have incurred losses since inception. We do not anticipate earning any revenues until our therapies or products are approved for marketing and sale. 31 Expenses Our operating expenses for the 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%. The decrease in operating expenses primarily relates to the decrease in goodwill impairment of $47,614,729 and by the decrease in general and administrative expenses of $2,890,735, partially offset by the impairment of fixed assets and right of use assets of $831,915 due to no longer using assets. General and administrative expenses for the three months ended September 30, 2025, and 2024, were $2,410,516 and $5,301,251, respectively, representing a decrease of $2,890,735 or approximately 55%. The variance is primarily related to a decrease in consulting fees of $1,576,761, legal expenses of $899,802 and compensation and related expenses of $205,381. Research and development expenses 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%. The variance is primarily driven by a decrease of $346,100 in consumables and reagents used in discontinued product candidates. The 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 the three months ended September 30, 2024, representing a decrease in other income (expense) of $2,999,137 or 33%. The variance is primarily 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 offset by the gain on the bankruptcy of Gedi Cube B.V. of $12,019,227. Net Income (Loss) Net income (loss) for the three 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%. The decrease in net loss was primarily due to the decrease in goodwill impairment of $47,614,729 in the prior period. 32 Liquidity and Capital Resources We have historically satisfied our capital and liquidity requirements through funding from stockholders, the sale of our Common Stock and warrants, and debt financing. We have never generated any sales revenue to support our operations, and we expect this to continue until our therapies or products are approved for marketing in the United States and/or Europe. Even if we are successful in having our therapies or products approved for sale in the United States and/or Europe, we cannot guarantee that a market for the therapies or products will develop. We may never be profitable. As noted above under the heading “Going Concern and Management’s Plans,” through September 30, 2025, we have incurred substantial losses. We will need additional funds both in the next twelve months and beyond for (a) research and development, (b) increases in personnel, (c) the purchase of equipment, and investment in the development and validation of our technology. The availability of any required additional funding cannot be assured. In addition, an adverse outcome in legal or regulatory proceedings in which we are currently involved or in the future may be involved could adversely affect our liquidity and financial position. We may raise such funds from time to time through public or private sales of our equity or debt securities. Such financing may not be available on acceptable terms, or at all, and our failure to raise capital when needed could materially adversely affect our growth plans and our financial condition and results of operations. 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. Assets Total assets at September 30, 2025, were $6,960,663 compared to $8,230,840 as of June 30, 2025. The decrease in assets is primarily due to the impairment of operating lease 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 current period. Liabilities Total liabilities at September 30, 2025, were $20,001,437 compared to $29,580,681 as of June 30, 2025. The decrease in total liabilities was primarily related to the decrease of $7,285,741 in notes payable – related parties, $974,383 in accrued expenses, $461,411 in accounts payable, $370,000 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: Three Months Ended September 30, 2025 Three Months Ended September 30, 2024 Net Cash Used in Operating Activities $ (1,349,110 ) $ (2,016,328 ) Net Cash Provided by Investing Activities 544,700 — Net Cash Provided by Financing Activities 1,343,357 2,029,183 Effect of exchange rates on cash (6,839 ) (12,751 ) Change in Cash and Cash Equivalents $ 532,108 $ 104 Cash Flows The decrease in our cash used in operating activities is primarily related to the changes in our operating assets and liabilities. The change is primarily driven by our net income offset by significant non-cash charges such as stock-based compensation, impairments and change in fair value of contingent consideration. Additionally, our operating cash flow was positively impacted by changes in our operating assets and liabilities, primarily other receivables, prepaid expenses and accounts payable. 33 Cash used provided by investing activities during the period related to proceeds from the sale of equity securities of $544,700. Cash provided by financing activities 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 payable that were partially offset by $271,643 in repayment of a finance agreement. Off-Balance Sheet Arrangements The Company does not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on the Company’s financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors. Significant Accounting Policies and Critical Accounting Estimates The methods, estimates, and judgments that we use in applying our accounting policies have a significant impact on the results that we report in our financial statements. Some of our accounting policies require us to make difficult and subjective judgments, often as a result of the need to make estimates regarding matters that are inherently uncertain. For a summary of our accounting policies, see Note 1 to the unaudited condensed consolidated financial statements. Item 3. Quantitative and Qualitative Disclosures About Market Risk. As a “smaller reporting company” as defined by Rule 12b-2 of the Securities Exchange Act of 1934, the Company is not required to provide the information required by this Item.