Lunai Bioworks Inc.
For the period ended Jun 30, 2026. Filed Oct 13, 2026.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2026 · Filed Oct 13, 2026
LNAI$0.16-30.2%Stored close · as of Oct 29, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-K
Period ended 2025-06-30; filed 2025-09-29.
0001731122-25-001316
Item 1A. Risk FactorsCurrent report: 10-K
Period ended 2026-06-30; filed 2026-10-13.
0001731122-26-001339
Item 1A. Risk FactorsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 181 previous paragraphs and 164 current paragraphs.
79 unchanged; 76 reworded; 9 added; 26 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 38 previous and 38 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
For example, the European Union’s Artificial Intelligence Act (Regulation (EU) 2024/1689) entered into force in August 2024 and establishes a comprehensive, risk-based governance framework for AI in the European Union, applying to companies that develop, provide or use AI systems in the European Union. Its obligations phase in over time, including prohibitions on certain AI practices (which began to apply in February 2025), obligations for general-purpose AI models (which began to apply in August 2025) and requirements for high-risk AI systems — a category that may include certain AI systems used in medical and healthcare applications — which generally apply beginning in August 2026, with certain high-risk obligations extending into 2027. These requirements address, among other things, transparency, conformity assessments, risk management, data governance, human oversight, security and accuracy, and noncompliance can result in fines of up to the greater of €35 million or 7% of worldwide annual turnover for prohibited practices, with lower tiers for other violations. In addition, the revised EU Product Liability Directive (Directive (EU) 2024/2853), which entered into force in December 2024 and must be implemented by member states by December 2026, extends strict’ product liability to software and AI systems; the separately proposed AI Liability Directive was withdrawn by the European Commission in 2025. This regulatory framework is expected to have a material impact on the way AI is regulated in the European Union,
Current report
In the United States, the federal approach to AI regulation has shifted substantially. The October 2023 Executive Order on the Safe, Secure and Trustworthy Development and Use of AI (Executive Order 14110) was rescinded in January 2025, and Executive Order 14179 (Removing Barriers to American Leadership in Artificial Intelligence) now directs federal agencies to identify and roll back regulatory measures viewed as barriers to AI innovation, reflecting a policy emphasis on reduced federal AI oversight. At the same time, a growing patchwork of state AI laws — including comprehensive state legislation regulating high-risk and consumer-facing AI systems — has begun to take effect, and subsequent federal actions have sought to promote a uniform national AI policy framework, creating uncertainty as to the scope of state AI regulation that will ultimately apply to our business. Federal agencies, including the U.S. Food and Drug Administration with respect to AI-enabled medical technologies, continue to develop guidance applicable to AI in healthcare. This evolving and uncertain regulatory landscape may increase our compliance costs or render the development or deployment of our AI-based technologies more challenging.
Current report
We are also actively pursuing non-dilutive funding and contractual opportunities with U.S. and Canadian government agencies in support of our therapeutic programs and biodefense applications. Government funding and procurement priorities may change as a result of budgetary constraints, changes in administration, policy priorities, geopolitical developments or other factors outside our control, which could delay, reduce or eliminate potential funding or contracting opportunities. In addition, our participation in government-funded or defense-related programs could expose us to reputational or investor-perception risks, including differing views regarding government policies, defense activities or the use of technologies developed through such programs. Any such developments could adversely affect our ability to obtain funding, enter into partnerships or maintain support among certain investors or other stakeholders.
Current report
We may be unable to maintain compliance with the continued listing requirements of The Nasdaq Capital Market, and our Common Stock could be delisted.
Current report
Our Common Stock is listed on The Nasdaq Capital Market, which imposes continued listing requirements, including a minimum bid price of $1.00 per share, minimum stockholders’ equity or market value requirements, and corporate governance standards. We have previously received deficiency notices from Nasdaq, and we effected reverse stock splits of our Common Stock in September 2025 and May 2026 in part to regain and maintain compliance with the minimum bid price requirement. We are currently subject to a one-year Mandatory Panel Monitor under Nasdaq Listing Rule 5815(d)(4)(B), and if we again fail to satisfy the Bid Price Rule during the monitoring period, the Listing Qualifications Department will issue a delist determination rather than a new compliance period. As of June 30, 2026, we had a stockholders’ deficit of $9,024,946, which is below the $2,500,000 minimum stockholders’ equity requirement of Nasdaq Listing Rule 5550(b)(1). If Nasdaq determines that we do not satisfy that requirement or one of the alternative continued listing standards under Nasdaq Listing Rule 5550(b), we could receive a deficiency notice or a delisting determination. There can be no assurance that we will maintain compliance with the applicable continued listing requirements. If our Common Stock were delisted, the liquidity and market price of our Common Stock would likely be materially adversely affected, our ability to raise capital would be impaired, and our Common Stock could become subject to the “penny stock” rules, which could further limit trading in our Common Stock.
Current report
The conversion of our Series B Convertible Preferred Stock would result in substantial dilution to our existing stockholders, and the Series B Preferred Stock ranks senior to our Common Stock upon liquidation.
Current report
In connection with the Neurobridge acquisition, we issued eight shares of Series B Convertible Preferred Stock with an aggregate stated value of $20.0 million. The Series B Preferred Stock is not convertible unless and until the Company obtains the stockholder approval required under Nasdaq Listing Rules 5635(a) and 5635(d) in connection with the Neurobridge acquisition and the potential issuance upon conversion of shares representing 20% or more of the Company’s pre-transaction outstanding Common Stock. Following receipt of such approval, the Series B Preferred Stock will be convertible into up to 1,666,666 shares of Common Stock at a conversion price of $12.00 per share — reflecting the proportionate adjustment of the original $1.50 conversion price and 13,333,333-share maximum required by the Series B Certificate of Designation for the May 2026 Reverse Stock Split — subject to a 4.99% beneficial ownership limitation (increasable to 9.99% upon 61 days’ notice). Based on 4,615,503 shares of Common Stock outstanding as of June 30, 2026, full conversion would represent an increase of approximately 36% in our outstanding shares and would substantially dilute the ownership and voting power of our existing stockholders, and sales of the shares issued upon conversion (or the perception that such sales may occur) could depress the market price of our Common Stock. In addition, the Series B Preferred Stock has a liquidation preference equal to its aggregate stated value and ranks senior to our Common Stock with respect to distributions upon liquidation, dissolution or winding up. The aggregate liquidation preference of the Series B Preferred Stock is $20.0 million, which substantially exceeds the $1.84 million at which the Series B Preferred Stock is recorded in our consolidated financial statements. The recorded amount reflects the estimated fair value of the Series B Preferred Stock at issuance for accounting purposes and does not limit the amount payable to the holders in a liquidation. In any liquidation, dissolution or winding up of the Company, holders of Series B Preferred Stock would be entitled to receive the full $20.0 million preference before any distribution to holders of our Common Stock and, because our total stockholders’ deficit was $9,024,946 at June 30, 2026, holders of Common Stock would likely receive nothing. If the required stockholder approval is not obtained, the Series B Preferred Stock will remain outstanding with such preference. There can be no assurance as to whether or when stockholder approval will be obtained.
Current report
We have identified a material weakness in our internal control over financial reporting. If we fail to remediate the material weakness, or otherwise fail to maintain effective internal control over financial reporting, our ability to report our financial results accurately and timely could be adversely affected.
Current report
As described in Part II, Item 9A of this Annual Report, management concluded that our disclosure controls and procedures and our internal control over financial reporting were not effective as of June 30, 2026, due to a material weakness attributable to the Company not having adequate resources to address complex accounting matters. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. Until remediated, this material weakness could result in errors in our financial statements, cause us to fail to meet our reporting obligations on a timely basis, and lead to a loss of investor confidence and a decline in the market price of our Common Stock. Remediation will require financial and personnel resources that we may not have, and there can be no assurance that our remediation efforts will be successful or that we will be able to maintain effective internal control over financial reporting in the future.
Removed paragraphs (26)
Previous report
Renovaro Cube has never generated revenue from its cancer diagnostics AI platform, and does not expect any near-term revenue to offset Renovaro Cube’s ongoing operating expenses, and may never be able to maintain profitability.
Previous report
Renovaro Cube’s ability to generate revenue from product sales and maintain profitability in the future depends on its ability to commercialize its products. Renovaro Cube cannot be certain that it will be able to do so successfully as planned, if at all, and Renovaro Cube’s failure to do so would prevent Renovaro Cube from generating revenue. Furthermore, even if Renovaro Cube is able to launch its AI platform or other products in a timely manner, Renovaro Cube may not be able to generate sufficient revenue to offset its costs and maintain profitability. Renovaro Cube’s ability to generate future revenue from product sales depends heavily on its success in:
Previous report
Renovaro Cube anticipates incurring substantial costs to commercialize Renovaro Cube’s products. Renovaro Cube’s expenses could increase beyond expectations if it is required by the U.S. Food and Drug Administration (the “FDA”), the European Medicines Agency (the “EMA”), the Medicines and Healthcare products Regulatory Agency (“MHRA”) or other regulatory agencies to delay its launch, narrow or change its intended use or product claims, modify or expand its clinical validation, perform future additional clinical validation, either pre- or post-approval, or conduct clinical trials. Even if Renovaro Cube is able to generate revenue from the sale of any products, Renovaro Cube may not become profitable and may need to continue to obtain additional funding to continue its operations.
Previous report
The failure of Renovaro Cube’s or BioSymetrics’ AI platform, once introduced, to be listed in physician guidelines or any future clinical validation to produce favorable results or to be published in peer-reviewed journals could limit the adoption of its AI platform. In addition, healthcare providers and third-party payors, including Medicare, may rely on physician guidelines issued by industry groups, medical societies and other key organizations, such as the U.S. Preventive Services Task Force, before utilizing or reimbursing the cost of any diagnostic or screening test. Although Renovaro Cube has conducted prior clinical validation of its AI platform, this platform is not yet, and may never be, listed in any such guidelines.
Previous report
Further, if Renovaro Cube’s or BioSymetrics’ products and the technology underlying them do not receive sufficient favorable exposure in peer-reviewed publications, the rate of physician and market acceptance of these products and positive reimbursement or coverage decisions for these products could be negatively affected. The publication of clinical data in peer-reviewed journals is a crucial step in commercializing and obtaining reimbursement or coverage for Renovaro Cube’s or BioSymetrics’ products, and Renovaro Cube’s and BioSymetrics’ inability to control when, if ever, results are published may delay or limit our ability to derive sufficient revenues from any of its products that are developed using data from a clinical study.
Previous report
One of the key elements of Renovaro Cube’s strategy is to expand access to its tests by pursuing reimbursement and/or coverage from third-party payors. If Renovaro Cube’s products do not receive adequate coverage or reimbursement from third-party payors, its ability to expand access to its tests beyond its initial sales channels and its overall commercial success will be limited.
Previous report
Renovaro Cube anticipates that it will not have broad-based coverage or reimbursement at the initial commercial launch. However, a key element to Renovaro Cube’s strategy is to expand access to its tests by pursuing coverage and/or reimbursement by third-party payors, including government payors. Coverage and reimbursement by third-party payors, including managed care organizations, private health insurers and government healthcare programs, such as Medicare and Medicaid in the United States and similar programs in other countries, for the types of early detection and post-diagnosis service tests that Renovaro Cube provides can be limited and uncertain. Healthcare providers may not order Renovaro Cube’s products unless third-party payors cover or provide adequate reimbursement for a substantial portion of the price of Renovaro Cube’s products. If Renovaro Cube is not able to obtain adequate coverage or an acceptable level of reimbursement for its products from third-party payors, there could be a greater co-insurance or co-payment obligation for any individual for whom a test is ordered. The individual may be forced to pay the entire cost of a test out-of-pocket, which could dissuade physicians from ordering Renovaro Cube’s products and, if ordered, could result in delay in, or decreased likelihood of, Renovaro Cube’s collection of payment. Renovaro Cube believes its revenue and revenue growth will depend on its success in achieving broad coverage and adequate reimbursement for its products from third-party payors.
Previous report
Coverage and reimbursement by a third-party payor may depend on a number of factors, including a payor’s determination that a product is appropriate, medically necessary and cost-effective. Each payor will make its own decision as to whether to establish a policy or enter into a contract to cover Renovaro Cube’s products and the amount it will reimburse for such products. Any determination by a payor to cover and the amount it will reimburse for Renovaro Cube’s products would likely be made on an indication-by-indication basis. For example, because Renovaro Cube intends to cover a broad asymptomatic population with its future products which could potentially generate a significant number of false-positive results on an absolute basis, Renovaro Cube may face additional scrutiny in obtaining reimbursement from third-party payors given the additional costs of further diagnostic workup. As a result, obtaining approvals from third-party payors to cover Renovaro Cube’s products and establishing adequate coding recognition and reimbursement levels is an unpredictable, challenging, time-consuming and costly process and Renovaro Cube may never be successful. If third-party payors do not provide adequate coverage or reimbursement for Renovaro Cube’s products, Renovaro Cube’s ability to succeed commercially will be limited.
Previous report
Even if Renovaro Cube establishes relationships with payors to provide its products at negotiated rates, such agreements would not obligate any healthcare providers to order its products or guarantee that it would receive reimbursement for its products from these or any other payors at adequate levels. Thus, these payor relationships, or any similar relationships, may not result in acceptable levels of coverage or reimbursement for Renovaro Cube’s products or meaningful increases in the number of billable tests it sells to healthcare providers. Renovaro Cube believes it may take several years to achieve coverage or adequate reimbursement with a majority of third-party payors, including with those payors offering negotiated rates. In addition, Renovaro Cube cannot predict whether, under what circumstances, or at what payment levels payors will cover or reimburse for its products. If Renovaro Cube fails to establish and maintain broad-based coverage or reimbursement for its products, its ability to expand access to its products, generate increased revenue and grow its test volume and customer base will be limited and its overall commercial success will be limited.
Previous report
a negative test would not rule out the presence of cancer. Additionally, a patient undergoing unnecessary diagnostic tests on the basis of a false-positive result or an erroneous location of cancer signal result could expose Renovaro Cube to significant liability and reputational risks notwithstanding the emotional and mental health effects to which the patient may be exposed. Similarly, a patient who receives a cancer diagnosis shortly following a “no cancer signal detected” test result may create negative publicity about Renovaro Cube’s product, which would discourage adoption. Performance failures could establish a negative perception of Renovaro Cube’s products among physicians, patients and regulators, jeopardize Renovaro Cube’s ability to successfully commercialize its products, impair Renovaro Cube’s ability to obtain regulatory approvals or secure favorable coverage or reimbursement, or otherwise result in reputational harm. In addition, Renovaro Cube may be subject to legal claims arising from any errors in the use, manufacture, design, labelling or performance of its products, including any false-positive or false-negative results.
Previous report
In addition, other companies are developing competing cancer detection tests and technologies focused on improving cancer care with cancer detection tests and post-diagnostic products. If any tests marketed or being developed by Renovaro Cube’s competitors that are similar to its products do not perform in accordance with expectations or cause harm or injury to patients, such failure to perform, harm or injury may result in lower confidence in early disease detection and post-diagnosis tests in general, which could potentially adversely affect confidence in Renovaro Cube’s products and result in an adverse impact on its operating results and reputation.
Previous report
BioSymetrics does not currently have a similar diagnostic product, but if developing a similar product the same risks would apply.
Previous report
Renovaro Cube and BioSymetrics have only limited sales and marketing infrastructures and no experience as a company in the sale, marketing and distribution of screening or diagnostic tests. In preparation of a commercial launch, Renovaro Cube and BioSymetrics are rapidly hiring additional personnel in sales and marketing.
Previous report
For example, in Europe, on April 21, 2021, the European Commission proposed a regulation seeking to establish a comprehensive, risk-based governance framework for AI in the European Union market. The proposed legislation is intended to apply to companies that develop, use and/ or provide AI in the European Union and includes requirements around transparency, conformity assessments and monitoring, risk assessments, human oversight, security and accuracy, and proposes fines for breach of up to 6% of worldwide annual turnover. In addition, on September 28, 2022, the European Commission proposed the AI Liability Directive and the revised Product Liability Directive seeking to establish a harmonized civil liability regime for AI in the European Union in order to facilitate civil claims in respect of harm caused by AI and to include AI-enabled products within the scope of the European Union’s existing product liability regime. If enacted, this regulatory framework is expected to have a material impact on the way AI is regulated in the European Union,
Previous report
On October 30, 2023, the Biden administration issued an Executive Order on the Safe, Secure and Trustworthy Development and Use of AI, emphasizing the need for transparency, accountability, and fairness in the development and use of AI, including in the healthcare industry. The order seeks to balance fostering innovation with addressing risks associated with AI by providing eight guiding principles and priorities, such as ensuring that consumers are protected from fraud, discrimination, and privacy risks related to AI. The order also calls for future regulations from various agencies, such as the Department of Commerce (to draft guidance for detecting and authenticating AI content) and the Federal Trade Commission (to ensure fair competition and reduce consumer harm). In alignment with the order, other agencies have published guidance. Other jurisdictions may decide to adopt similar or more restrictive legislation that may render the use of such technologies challenging.
Previous report
Renovaro Cube currently hosts all of its data on, and conducts its data analysis through, local hosting facilities. Any technical problems or outages that may arise in connection with these hosting facilities could result in the loss of Renovaro Cube’s data or delayed or ineffective data processing. A variety of factors, including infrastructure changes, human or software errors, viruses, malware, security attacks, fraud, spikes in customer usage, or denial of service issues could cause interruptions in Renovaro Cube’s service. Such service interruptions may reduce or inhibit Renovaro Cube’s ability to provide its products, delay any further clinical validation and any future clinical studies, and damage its relationships with its customers. Renovaro Cube could also be exposed to potential lawsuits, liability claims or regulatory actions, if, for example, Renovaro Cube’s local servers experienced a data privacy breach. If Renovaro Cube was required to transfer its data to an alternative hosting provider, the transfer and acclimation to the new provider could result in significant business delays and require additional resources.
Previous report
Renovaro Cube is headquartered in Amsterdam, the Netherlands, a region in which many other healthcare companies, technology companies and academic and research institutions are headquartered. Competition for personnel is intense and the turnover rate can be high, which may limit Renovaro Cube’s ability to hire and retain highly qualified personnel on acceptable terms or at all. Renovaro Cube expects that it may need to recruit talent from outside of its region, and doing so may be costly and difficult. If Renovaro Cube is unable to attract and retain highly qualified personnel, its ability to develop and commercialize its products may be limited.
Previous report
If Renovaro Cube or BioSymetrics is unable to scale its operations successfully to support demand for its products following the launch of its platform, its business could suffer.
Previous report
As and to the extent demand increases beyond Renovaro Cube’s or BioSymetrics’ expectations following the launch of each’s platform, Renovaro Cube and BioSymetrics will likely need to start to ramp up operating capacity. We will need to implement new infrastructure, data processing capabilities, customer service, billing and systems processes, and expand internal quality assurance program and technology to support operations on a larger scale. We will also need collaboration arrangements with third-party laboratories to process its physical tests or, if processing of such tests is not fully outsourced to support demand, will need to obtain equipment and certified and licensed laboratory personnel to process these physical tests internally. We may face difficulties increasing the scale of operations, including implementing changes in infrastructure or programs or acquiring additional equipment or personnel. As we refine our products and develop additional products, Renovaro Cube and BioSymetrics may need to introduce new equipment, implement new systems, technology, controls and procedures, and hire personnel with different qualifications, licenses or certifications.
Previous report
The value of Renovaro Cube’s and BioSymetrics’ products will depend, in part, on our ability to perform tests, whether through a licensed provider or internally, and return results to providers on a timely basis and at an appropriate quality standard, and on our reputation for such timeliness and quality. Failure to establish necessary arrangements with licensed providers, to implement necessary procedures, to transition to new equipment or processes, or to hire the appropriately qualified personnel could result in higher costs of processing, longer turnaround times or an inability to meet market demand. There can be no assurance that Renovaro Cube, BioSymetrics, or any such licensed provider will be able to perform tests on a timely basis at a level consistent with demand, that we will be able to maintain the quality of our test results as we scale our commercial operations, or that we will be successful in responding to the potential growing complexity of its operations, including the related data analysis requirements.
Previous report
In addition, Renovaro Cube’s and BioSymetrics’ growth may place a significant strain on its management, operating and financial systems, research and development, and its sales, marketing, and administrative resources. As a result of growth, our operating costs may escalate even faster than planned, and some of its internal systems may need to be enhanced or replaced. If Renovaro Cube or BioSymetrics cannot effectively manage expanding operations and costs, Renovaro Cube or BioSymetrics may not be able to grow successfully or it may grow at a slower pace, and its business could be adversely affected.
Previous report
If we are sued for product or professional liability, we could face substantial liabilities that exceed our resources.
Previous report
Renovaro Cube’s business depends upon its ability to obtain reliable and accurate test results that incorporate rapidly evolving understanding of how to interpret minute signals detected by Renovaro Cube’s assays as indications of potential presence of disease. Actual or perceived errors resulting from laboratory or reporting errors, false positive or false negative test results, or the manufacture, design, or labelling of Renovaro Cube’s products, could subject Renovaro Cube to product liability or professional liability claims. A product liability or professional liability claim against Renovaro Cube could result in substantial damage and be costly and time-consuming to defend. Any liability claim brought against Renovaro Cube, with or without merit, could increase its insurance rates or prevent it from securing insurance coverage in the future. Additionally, any liability lawsuit could damage Renovaro Cube’s reputation or force it to delay or suspend sales of its products. The occurrence of any of these events could have a material adverse effect on Renovaro Cube’s business, results of operations, financial condition and prospects. The same would apply to products of BioSymetrics.
Reworded paragraphs (76)
Previous wording
Lunai is a pre-clinical-stage biotechnology company and AI-driven healthcare technology company. Investment in biotechnology related to genetically modified cells is highly speculative because it entails substantial upfront capital expenditures and significant risk that a product candidate will fail to prove effective, gain regulatory approval or become commercially viable. We do not have any products approved by regulatory authorities and have not generated any revenues from product sales or otherwise to date, and have incurred significant research, development and other expenses related to our ongoing operations and expect to continue to incur such expenses. As a result, we have not been profitable and have incurred significant operating losses in every reporting period since our inception. For the years ended June 30, 2025, and 2024, respectively, we reported a net loss of $178,007,489 and $88,425,828. We had an accumulated deficit of $510 million and $332 million as of June 30, 2025 and 2024, respectively.
Current wording
Lunai, through its wholly owned subsidiaries BioSymetrics Inc. and Renovaro Biosciences, is an AI-driven precision medicine platform company, with a pre-clinical portfolio focused on central nervous system disorders and oncology. Investment in preclinical biotechnology is highly speculative because it entails substantial upfront capital expenditures and significant risk that a product candidate will fail to prove effective, gain regulatory approval or become commercially viable. We do not have any products approved by regulatory authorities and have not generated any revenue from product sales to date (during fiscal 2026 we recognized $51,992 of service revenue from a single research services customer), and have incurred significant research, development and other expenses related to our ongoing operations and expect to continue to incur such expenses. As a result, we have not been profitable and have incurred significant operating losses in every reporting period since our inception. For the years ended June 30, 2026, and 2025, respectively, we reported a net loss of $3,562,479 and $178,007,489. We had an accumulated deficit of $514,025,049 and $510,462,570 as of June 30, 2026 and 2025, respectively.
Previous wording
We do not expect to generate revenues for the foreseeable future. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate these losses to increase as we continue to research, develop, and seek regulatory approvals for our product candidates and any additional product candidates we may acquire, in-license or develop, and potentially begin to commercialize product candidates that may achieve regulatory approval. We may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues. If any of our product candidates fails in clinical studies or does not gain regulatory approval, or if approved, fails to achieve market acceptance, we may never become profitable. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods. We anticipate that our expenses will increase in the future as we continue to invest in research and development of our existing product candidates, investigate and potentially acquire new product candidates and expand our manufacturing and commercialization activities.
Current wording
We do not expect to generate material product revenues for the foreseeable future. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate these losses to increase as we continue to research, develop, and seek regulatory approvals for our product candidates and any additional product candidates we may acquire, in-license or develop, and potentially begin to commercialize product candidates that may achieve regulatory approval. We may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues. If any of our product candidates fails in clinical studies or does not gain regulatory approval, or if approved, fails to achieve market acceptance, we may never become profitable. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods. We anticipate that our expenses will increase in the future as we continue to invest in research and development of our existing product candidates, investigate and potentially acquire new product candidates and expand our manufacturing and commercialization activities.
Previous wording
Our consolidated financial statements as of June 30, 2025, have been prepared under the assumption that we will continue as a going concern for the next twelve months. As of June 30, 2025, we had cash and cash equivalents of $92,700 and an accumulated deficit of $510 million. We do not believe that our cash and cash equivalents are sufficient for the next twelve months. As a result of our financial condition and other factors described herein, there is substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern will depend on our ability to obtain additional funding, as to which no assurances can be given. We continue to analyze various alternatives, including potentially obtaining debt or equity financings or other arrangements. Our future success depends on our ability to raise capital. We cannot be certain that raising additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to us or, if available, will be on terms acceptable to us. If we issue additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of our Common Stock, and our current shareholders may experience dilution. If we are unable to obtain funds when needed or on acceptable terms, we may be required to curtail our current development programs, cut operating costs, forgo future development and other opportunities, or even terminate our operations.
Current wording
Our consolidated financial statements as of June 30, 2026, have been prepared under the assumption that we will continue as a going concern for the next twelve months. As of June 30, 2026, we had cash and cash equivalents of $1,713,653 and an accumulated deficit of $514,025,049. We do not believe that our cash and cash equivalents are sufficient for the next twelve months. As a result of our financial condition and other factors described herein, there is substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern will depend on our ability to obtain additional funding, as to which no assurances can be given. We continue to analyze various alternatives, including potentially obtaining debt or equity financings or other arrangements. Our future success depends on our ability to raise capital. We cannot be certain that raising additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to us or, if available, will be on terms acceptable to us. If we issue additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of our Common Stock, and our current shareholders may experience dilution. If we are unable to obtain funds when needed or on acceptable terms, we may be required to curtail our current development programs, cut operating costs, forgo future development and other opportunities, or even terminate our operations.
Previous wording
Litigation, regulatory proceedings, such as the investigations described above, as well as the related class action claims and lawsuits, and securities matters that we are currently facing or could face, can be protracted and expensive, and have results that are difficult to predict. Certain of these matters include speculative claims for substantial or indeterminate amounts of damages and include claims for injunctive relief. Additionally, our legal costs for any of these matters, either alone or in the aggregate, could be significant. Adverse outcomes with respect to any of these legal or regulatory proceedings may result in significant settlement costs or judgments, penalties, and fines. Even if these proceedings are resolved in our favor, the time and resources necessary to resolve them could divert the resources of our management and require significant expenditures. SeeNote 11 - Commitments and Contingencies in the Notes to our Consolidated Financial Statements in Part II, Item 8 of this Annual Report on Form 10-K and the section titled “Legal Proceedings” in Part I, Item 3 of this Annual Report on Form 10-K.
Current wording
Litigation, regulatory proceedings, such as the investigations described above, as well as the related class action claims and lawsuits, and securities matters that we are currently facing or could face, can be protracted and expensive, and have results that are difficult to predict. Certain of these matters include speculative claims for substantial or indeterminate amounts of damages and include claims for injunctive relief. Additionally, our legal costs for any of these matters, either alone or in the aggregate, could be significant. Adverse outcomes with respect to any of these legal or regulatory proceedings may result in significant settlement costs or judgments, penalties, and fines. Even if these proceedings are resolved in our favor, the time and resources necessary to resolve them could divert the resources of our management and require significant expenditures. SeeNote 10 - Commitments and Contingencies in the Notes to our Consolidated Financial Statements in Part II, Item 8 of this Annual Report on Form 10-K and the section titled “Legal Proceedings” in Part I, Item 3 of this Annual Report on Form 10-K.
Previous wording
Lunai Bioworks is a pre-clinical biotechnology company and may never be able to successfully develop marketable products or generate any revenue. We have a very limited relevant operating history upon which an evaluation of our performance and prospects can be made. There is no assurance that our future operations will result in profits. If we cannot generate sufficient revenues, we may suspend or cease operations.
Current wording
Lunai Bioworks is a pre-clinical biotechnology company and may never be able to successfully develop marketable products or generate any material product revenue. We have a very limited relevant operating history upon which an evaluation of our performance and prospects can be made. There is no assurance that our future operations will result in profits. If we cannot generate sufficient revenues, we may suspend or cease operations.
Previous wording
Lunai Bioworks is an early-stage biotechnology company and has not generated any revenues to date. All of our product candidates are in the discovery stage or pre-clinical development stage. Moreover, we cannot be certain that our research and development efforts will be successful or, if successful, that our potential treatments will ever be approved for sale to generate commercial revenues. Our therapeutic pipeline includes cell, gene and immunotherapy involving genetically modified cells targeted to treat cancer, and we rely on third parties under contract in the development of product candidates in our pipeline. There is no guarantee that we will be able to manage and fund the development of a pipeline with multiple target conditions, nor that third parties will meet their obligations to us in connection with our research and development. We and certain third parties, on which we rely, have no relevant operating history upon which an evaluation of our performance and prospects can be made. We are subject to all of the business risks associated with a new enterprise, including, but not limited to, risks of unforeseen capital requirements, failure of treatments either in non-clinical testing or in clinical trials, failure to establish business relationships, failure of our third parties to meet their obligations to us and competitive disadvantages against larger and more established companies. If we fail to become profitable, we may suspend or cease operations.
Current wording
Lunai Bioworks is an early-stage biotechnology company and has not generated any revenue from product sales to date (during fiscal 2026, the Company recognized $51,992 of service revenue). All of our product candidates are in the discovery stage or pre-clinical development stage. Moreover, we cannot be certain that our research and development efforts will be successful or, if successful, that our potential treatments will ever be approved for sale to generate commercial revenues. Our therapeutic pipeline includes cell, gene and immunotherapy involving genetically modified cells targeted to treat cancer, and we rely on third parties under contract in the development of product candidates in our pipeline. There is no guarantee that we will be able to manage and fund the development of a pipeline with multiple target conditions, nor that third parties will meet their obligations to us in connection with our research and development. We and certain third parties, on which we rely, have no relevant operating history upon which an evaluation of our performance and prospects can be made. We are subject to all of the business risks associated with a new enterprise, including, but not limited to, risks of unforeseen capital requirements, failure of treatments either in non-clinical testing or in clinical trials, failure to establish business relationships, failure of our third parties to meet their obligations to us and competitive disadvantages against larger and more established companies. If we fail to become profitable, we may suspend or cease operations.
Previous wording
Renovaro Cube and BioSymetrics are artificial intelligence (“AI”)-driven healthcare technology companies operating in a rapidly evolving field with a limited operating history, which makes it difficult to evaluate their current business and predict Renovaro Cube’s future performance.
Current wording
BioSymetrics is an artificial intelligence (“AI”)-driven healthcare technology company operating in a rapidly evolving field with a limited operating history, which makes it difficult to evaluate its current business and predict future performance.
Previous wording
Renovaro Cube and BioSymetrics are AI-driven healthcare technology companies operating in a rapidly evolving field and, having commenced operations in 2013 and 2017, respectively, have a limited operating history. Renovaro Cube shifted its business from the financial technology (or FinTech) industry to cancer diagnostics in 2018 and does not have a commercial product for sale. It has never generated any revenue relating to its cancer diagnostics AI platform. Renovaro Cube’s short operating history makes any assessment of its current business or future success and viability subject to significant uncertainty. BioSymetrics does have a history of deployment of a commercial AI-based biotechnology platform and has had previous revenue generation, however the same risk regarding future performance applies. We expect to encounter risks and difficulties, including those frequently experienced by early-stage companies in rapidly evolving fields. If we do not address these risks and difficulties successfully, our business will suffer.
Current wording
BioSymetrics is an AI-driven healthcare technology company operating in a rapidly evolving field and, having commenced operations in 2017, has a limited operating history. BioSymetrics has a history of deployment of a commercial AI-based biotechnology platform and has had previous, as well as current revenue generation and other non-dilutive funding, however its short operating history makes any assessment of its current business or future success and viability subject to uncertainty. We expect to encounter risks and difficulties, including those frequently experienced by early-stage companies in rapidly evolving fields. If we do not address these risks and difficulties successfully, our business will suffer.
Previous wording
Renovaro Cube and BioSymetrics have a history of net losses and anticipates that they may continue to incur net losses for the foreseeable future.
Current wording
BioSymetrics has a history of net losses and anticipates that it may continue to incur net losses for the foreseeable future.
Previous wording
Grace Systems (Renovaro Cube’s predecessor) has primarily incurred net losses since its inception in 2013 and has never generated any revenue relating to its cancer diagnostics AI platform. Renovaro Cube anticipates that it may continue to incur primarily net losses in the foreseeable future. Similarly, while BioSymetrics has a history of revenue generation since its inception in 2017, these revenues have been inconsistent. Both Renovaro Cube and BioSymetrics have invested significant financial resources in research and development activities, including to develop their technologies and investigational products. The amount of each company’s future net losses will depend, in part, on the level of future expenditures and their ability to generate revenue following the commercialization of their AI platform. Moreover, net losses may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of results of operations may not be a good indication of future performance.
Current wording
While BioSymetrics has a history of revenue generation and success in obtaining other non-dilutive funding since its inception in 2017, these revenues have been inconsistent. BioSymetrics has invested significant financial resources in research and development activities, including to develop their technologies and investigational products. The amount of future net losses will depend, in part, on the level of future expenditures and its ability to generate revenue through its AI platform and programs. Moreover, net losses may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of results of operations may not be a good indication of future performance.
Previous wording
Renovaro Cube and BioSymetrics expect to continue to incur significant expenses and operating losses for the foreseeable future if, and as, they:
Current wording
BioSymetrics expects to continue to incur significant expenses and operating losses for the foreseeable future if, and as, BioSymetrics:
Previous wording
Even if we commercially launch Renovaro Cube’s or BioSymetrics’ AI platforms and other products, they may fail to achieve the degree of market acceptance necessary for commercial success.
Current wording
BioSymetrics’ AI platform and other products may fail to achieve the degree of market acceptance necessary for commercial success.
Previous wording
The commercial success of Renovaro Cube’s or BioSymetrics’ AI platform and other future products will depend upon the degree of market acceptance by consumers, including self-insured employers, integrated health systems, healthcare providers, patients and, over the long-term, third-party payors. The degree of market acceptance of these products will depend on a number of factors, including:
Current wording
The commercial success of BioSymetrics’ AI platform and other future products will depend upon the degree of market acceptance by pharmaceutical companies, consumers, including self-insured employers, integrated health systems, healthcare providers. The degree of market acceptance of these products will depend on a number of factors, including:
Previous wording
Failure to achieve broad market acceptance of Renovaro Cube’s or BioSymetrics’ products, once launched, would materially harm Renovaro Cube’s and BioSymetrics’ business, financial condition and results of operations.
Current wording
Failure to achieve broad market acceptance of BioSymetrics’ products, once launched, would materially harm BioSymetrics’ business, financial condition and results of operations.
Previous wording
Renovaro Cube and BioSymetrics may be unable to develop and commercialize new products.
Current wording
BioSymetrics may be unable to develop and commercialize new products.
Previous wording
Renovaro Cube and BioSymetrics continue to expand their research and development efforts to use their proprietary AI platforms to develop new products, including in disease areas beyond cancer and neurology. The commercialization of any new products will require the completion of certain clinical development activities, regulatory activities and the expenditure of additional cash resources. Renovaro Cube and BioSymetrics cannot assure you that it can successfully complete the clinical development of any such products.
Current wording
BioSymetrics continues to expand its research and development efforts to use their proprietary AI platform to develop new products, including in disease areas beyond cancer and neurology. The commercialization of any new products will require the completion of certain clinical development activities, regulatory activities and the expenditure of additional cash resources. BioSymetrics cannot assure you that it can successfully complete the clinical development of any such products.
Previous wording
Renovaro Cube and BioSymetrics also cannot assure you that they will be able to reduce their expenditures sufficiently, generate sufficient revenue from products that they successfully commercialize or otherwise mitigate the risks associated with their business to raise enough capital to develop and commercialize new products. In addition, once Renovaro Cube’s and BioSymetrics’ development efforts for a product are completed, commercialization efforts, including allocation of resources necessary to comply with applicable laws and regulations, will require significant expenditures. Any failure by Renovaro Cube or BioSymetrics to develop and commercialize new products could have a material adverse effect on their ability to implement their strategy and grow their business.
Current wording
BioSymetrics also cannot assure you that they will be able to reduce their expenditures sufficiently, generate sufficient revenue from products that they successfully commercialize or otherwise mitigate the risks associated with their business to raise enough capital to develop and commercialize new products. In addition, once BioSymetrics’ development efforts for a product are completed, commercialization efforts, including potentially the allocation of resources necessary to comply with applicable laws and regulations, will require significant expenditures. Any failure by BioSymetrics to develop and commercialize new products could have a material adverse effect on their ability to implement their strategy and grow their business.
Previous wording
If Renovaro Cube’s or BioSymetrics’ products, or the products of its competitors, directly or indirectly result in harm or injury to patients, Renovaro Cube or BioSymetrics could be subject to significant reputational and liability risks, and its operating results, reputation and business could suffer.
Current wording
If BioSymetrics’ products, or the products of its competitors, directly or indirectly result in harm or injury to patients, BioSymetrics could be subject to significant reputational and liability risks, and its operating results, reputation and business could suffer.
Previous wording
Renovaro Cube’s and BioSymetrics’ success will depend on the market’s confidence that their developed products can provide reliable, high-quality results, once such products are launched. Renovaro Cube and BioSymetrics believe that patients, physicians and regulators are likely to be particularly sensitive to errors in the use of their products or failure of their products to perform as described, and there can be no guarantee that their products will meet expectations. Renovaro Cube’s initial product is intended to be used to detect a cancer signal in patients, but its results are not diagnostic. If a cancer signal is detected, the product would be used to localize the origin of the cancer signal. A “cancer signal detected” test result would need to be followed up by appropriate diagnostic methods. Because this product cannot detect all cancer signals, and may not detect signals for all cancer types,
Current wording
BioSymetrics’ success will depend on the market’s confidence that their developed products can provide reliable, high-quality results, once such products are launched. BioSymetrics believes that patients, physicians and regulators are likely to be particularly sensitive to errors in the use of their products or failure of their products to perform as described, and there can be no guarantee that their products will meet expectations.
Previous wording
If Renovaro Cube’s or BioSymetrics’ facilities or those of its third-party collaborators become inoperable, their ability to provide its products will be significantly impaired and its business will be harmed.
Current wording
If BioSymetrics’ facilities or those of its third-party collaborators become inoperable, their ability to provide its products will be significantly impaired and its business will be harmed.
Previous wording
Renovaro Cube and BioSymetrics rely on third-party collaborators, consultants, contractors, vendors, suppliers and service providers. The facilities of these partners could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods, tornadoes, hurricanes, fires, extreme weather conditions, medical epidemics, pandemics, global conflict, war and other natural or man-made disasters or business interruptions. In addition, they may be affected by government shutdowns, changes to applicable laws, regulations and policies, or withdrawn funding. The occurrence of any of these business disruptions could seriously harm their ability to complete their contracted services to Renovaro Cube or BioSymetrics, which may adversely impact their operations and financial condition.
Current wording
BioSymetrics relies on third-party collaborators, consultants, contractors, vendors, suppliers and service providers. The facilities of these partners could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods, tornadoes, hurricanes, fires, extreme weather conditions, medical epidemics, pandemics, global conflict, war and other natural or man-made disasters or business interruptions. In addition, they may be affected by government shutdowns, changes to applicable laws, regulations and policies, or withdrawn funding. The occurrence of any of these business disruptions could seriously harm their ability to complete their contracted services to BioSymetrics, which may adversely impact their operations and financial condition.
Previous wording
Renovaro Cube’s and BioSymetrics’ business and results of operations will suffer if it fails to compete effectively.
Current wording
BioSymetrics’ business and results of operations will suffer if it fails to compete effectively.
Previous wording
The testing and diagnostic products industry is intensely competitive. Renovaro Cube has competitors both in Europe and abroad, including Grail, Inc., Exact Sciences Corporation, Freenome, Inc. and Thrive Earlier Detection Corp., that have stated that they are developing tests designed to detect cancer. Similarly, there are companies with comparable and possibly competing offerings to BioSymetrics, including Recursion Pharma, insitro, and In Silico Medicine. Each of these potential competitors have, or may have, substantially greater financial, technical and other resources, such as larger research and development staff and well-established marketing and sales forces, and they may operate in jurisdictions where lower standards of evidence are required to bring products to market. These competitors may succeed in developing, acquiring, or licensing, on an exclusive basis or otherwise, tests or services that are more effective or less costly than Renovaro Cube’s or BioSymetrics’ products. In addition, established medical technology, biotechnology, or pharmaceutical companies may invest heavily to accelerate the discovery and development of tests that could make Renovaro Cube’s or BioSymetrics’ products less competitive than Renovaro anticipated.
Current wording
There are companies with comparable and possibly competing offerings to BioSymetrics, including Recursion Pharma, insitro, and In Silico Medicine. Each of these potential competitors have, or may have, substantially greater financial, technical and other resources, such as larger research and development staff and well-established marketing and sales forces, and they may operate in jurisdictions where lower standards of evidence are required to bring products to market. These competitors may succeed in developing, acquiring, or licensing, on an exclusive basis or otherwise, tests or services that are more effective or less costly than BioSymetrics’ products. In addition, established medical technology, biotechnology, or pharmaceutical companies may invest heavily to accelerate the discovery and development of products that could make BioSymetrics’ products less competitive than anticipated.
Previous wording
Renovaro Cube’s and BioSymetrics’ ability to compete successfully will depend largely on the ability of each to:
Current wording
BioSymetrics’ ability to compete successfully will depend largely on the ability of each to:
Previous wording
Renovaro Cube and BioSymetrics may not be able to compete effectively if they are unable to accomplish one or more of these or similar objectives.
Current wording
BioSymetrics may not be able to compete effectively if it is unable to accomplish one or more of these or similar objectives.
Previous wording
If Renovaro Cube or BioSymetrics cannot enter new collaborations in a timely manner and on acceptable terms, their efforts to develop and commercialize their products could be delayed or adversely affected.
Current wording
If BioSymetrics cannot enter new collaborations in a timely manner and on acceptable terms, its efforts to develop and commercialize its products could be delayed or adversely affected.
Previous wording
From time to time, Renovaro Cube and BioSymetrics expect to engage in discussions with potential development and/or commercial collaborators that may or may not lead to collaborations. However, Renovaro Cube and BioSymetrics cannot guarantee that any discussions will result in development or commercial collaborations. Further, once news of discussions regarding possible collaborations are known in the general public, regardless of whether the news is accurate, failure to announce a collaboration agreement, or the entity’s announcement of a collaboration with an entity other than Renovaro Cube or BioSymetrics, could result in adverse speculation about either, their products or technology, resulting in harm to their reputation and business. In addition, establishing collaborations is difficult and time-consuming and may require significant financial investment. Potential collaborators may elect not to work with Renovaro Cube or BioSymetrics based on their assessment of their financial, regulatory, or intellectual property position. Even if Renovaro Cube or BioSymetrics establishes new collaborations, they may not result in the successful development or commercialization of their products or technology.
Current wording
From time to time, BioSymetrics expects to engage in discussions with potential development and/or commercial collaborators that may or may not lead to collaborations. However, BioSymetrics cannot guarantee that any discussions will result in development or commercial collaborations. Further, once news of discussions regarding possible collaborations are known in the general public, regardless of whether the news is accurate, failure to announce a collaboration agreement, or the entity’s announcement of a collaboration with an entity other than BioSymetrics, could result in adverse speculation about either their products or technology, resulting in harm to their reputation and business. In addition, establishing collaborations is difficult and time-consuming and may require significant financial investment. Potential collaborators may elect not to work with BioSymetrics based on their assessment of their financial, regulatory, or intellectual property position. Even if BioSymetrics establishes new collaborations, they may not result in the successful development or commercialization of products or technology.
Previous wording
If Renovaro Cube or BioSymetrics is unable to establish sales and marketing capabilities, they may not be successful in commercializing their products.
Current wording
If BioSymetrics is unable to establish sales and marketing capabilities, they may not be successful in commercializing their products.
Previous wording
Factors that may inhibit Renovaro Cube’s or BioSymetrics’ efforts to each commercialize any of their respective products include:
Current wording
BioSymetrics has only limited sales and marketing infrastructure. Factors that may inhibit BioSymetrics’ efforts to commercialize any of its products include:
Previous wording
Renovaro Cube’s and BioSymetrics’ products are not subject to FDA or other government regulatory clearance or approval if they are not intended to be used for the diagnosis, treatment or prevention of disease. However, as Renovaro Cube and BioSymetrics expands their product line to encompass products that are intended to be used for the diagnosis of disease, certain of its products will become subject to regulation by the FDA, or comparable international agencies, including requirements for regulatory clearance or approval of such products before they can be marketed. Such regulatory approval processes or clearances may be expensive, time-consuming, and uncertain, and failure to obtain or comply with such approvals and clearances could have an adverse effect on its business, financial condition, and operating results. In addition, changes to the current regulatory framework, including the imposition of additional or new regulations, could arise at any time during the development or marketing of future products, which may negatively affect its ability to obtain or maintain FDA or comparable regulatory approval of its products, if required.
Current wording
BioSymetrics’ products are not subject to FDA or other government regulatory clearance or approval if they are not intended to be used for the diagnosis, treatment or prevention of disease. However, if BioSymetrics expands its product line to encompass products that are intended to be used for the diagnosis of disease, certain of its products will become subject to regulation by the FDA, or comparable international agencies, including requirements for regulatory clearance or approval of such products before they can be marketed. Such regulatory approval processes or clearances may be expensive, time-consuming, and uncertain, and failure to obtain or comply with such approvals and clearances could have an adverse effect on its business, financial condition, and operating results. In addition, changes to the current regulatory framework, including the imposition of additional or new regulations, could arise at any time during the development or marketing of future products, which may negatively affect its ability to obtain or maintain FDA or comparable regulatory approval of its products, if required.
Previous wording
Diagnostic products are regulated as medical devices by the FDA and comparable international agencies and may require either clearance from the FDA or such other comparable agencies following the 510(k) pre-market notification process or pre-market approval from the FDA, in each case prior to marketing. Obtaining the requisite regulatory approvals can be expensive and may involve considerable delay. If Renovaro Cube or BioSymetrics fails to obtain, or experiences significant delays in obtaining, regulatory approvals for diagnostic products that it develops in the future, Renovaro Cube and BioSymetrics may not be able to launch or successfully commercialize such products in a timely manner, or at all.
Current wording
Diagnostic products are regulated as medical devices by the FDA and comparable international agencies and may require either clearance from the FDA or such other comparable agencies following the 510(k) pre-market notification process or pre-market approval from the FDA, in each case prior to marketing. Obtaining the requisite regulatory approvals can be expensive and may involve considerable delay. If BioSymetrics fails to obtain, or experiences significant delays in obtaining, regulatory approvals for diagnostic products that it develops in the future, BioSymetrics may not be able to launch or successfully commercialize such products in a timely manner, or at all.
Previous wording
In addition, if Renovaro Cube’s and BioSymetrics’ products labelled as “For Research Use Only. Not for use in diagnostic procedures,” or RUO, are used, or could be used, for the diagnosis of disease, the regulatory requirements related to marketing, selling, and supporting such products could change or be uncertain, even if such use by Renovaro Cube’s or BioSymetrics’ customers is without its consent. If the FDA or other regulatory agencies assert that any of Renovaro Cube’s or BioSymetrics’ RUO products are subject to regulatory clearance or approval, Renovaro Cube’s or BioSymetrics’ business, financial condition, and results of operations could be adversely affected.
Current wording
In addition, if BioSymetrics’ products labelled as “For Research Use Only. Not for use in diagnostic procedures,” or RUO, are used, or could be used, for the diagnosis of disease, the regulatory requirements related to marketing, selling, and supporting such products could change or be uncertain, even if such use by BioSymetrics’ customers is without its consent. If the FDA or other regulatory agencies assert that any of BioSymetrics’ RUO products are subject to regulatory clearance or approval, BioSymetrics’ business, financial condition, and results of operations could be adversely affected.
Previous wording
Regulatory and legislative developments on the use of AI and machine learning could adversely affect Renovaro Cube’s or BioSymetrics’ use of such technologies in its platform and other products.
Current wording
Regulatory and legislative developments on the use of AI and machine learning could adversely affect BioSymetrics’ use of such technologies in its platform and other products.
Previous wording
As with many technological innovations, artificial intelligence presents risks and challenges that could affect its adoption, and therefore our business. Uncertainty in the legal regulatory regime relating to AI may require significant resources to modify and maintain business practices to comply with U.S. and non-U.S. laws, the nature of which cannot be determined at this time. It is possible that new laws and regulations will be adopted in the United Kingdom, the European Union, the United States and/or other foreign jurisdictions, or that existing laws and regulations may be interpreted in ways that would affect the operation of Renovaro Cube’s or BioSymetrics’ AI platform and data analytics and the way in which Renovaro Cube or BioSymetrics uses AI and machine learning technology. Further, the cost to comply with such laws or regulations could be significant and would increase operating expenses, which could adversely affect either’s business, financial condition and results of operations.
Current wording
As with many technological innovations, artificial intelligence presents risks and challenges that could affect its adoption, and therefore our business. Uncertainty in the legal regulatory regime relating to AI may require significant resources to modify and maintain business practices to comply with U.S. and non-U.S. laws, the nature of which cannot be determined at this time. It is possible that new laws and regulations will be adopted in the United Kingdom, the European Union, the United States and/or other foreign jurisdictions, or that existing laws and regulations may be interpreted in ways that would affect the operation of BioSymetrics’ AI platform and data analytics and the way in which BioSymetrics uses AI and machine learning technology. Further, the cost to comply with such laws or regulations could be significant and would increase operating expenses, which could adversely affect either’s business, financial condition and results of operations.
Previous wording
and together with developing guidance and/or decisions in this area, may affect Renovaro Cube’s or BioSymetrics’ use of AI and its ability to provide and to improve its services, require additional compliance measures and changes to its operations and processes, result in increased compliance costs and potential increases in civil claims against Renovaro Cube or BioSymetrics, and could adversely affect either’s business, operations and financial condition.
Current wording
and together with developing guidance and/or decisions in this area, may affect BioSymetrics’ use of AI and its ability to provide and to improve its services, require additional compliance measures and changes to its operations and processes, result in increased compliance costs and potential increases in civil claims against BioSymetrics, and could adversely affect their business, operations and financial condition.
Previous wording
Renovaro Biosciences’ future success is dependent on the successful development of novel gene, cell and immunotherapy product candidates. Because these programs, particularly our pipeline of allogeneic T-cell product candidates that are bioengineered from healthy donor cells, represent a new approach to immunotherapy for the treatment of cancer and other diseases, developing and commercializing our product candidates subject us to a number of challenges.
Current wording
Renovaro Biosciences’ future success is dependent on the successful development of novel gene, cell and immunotherapy product candidates. Because these programs, particularly our pipeline of allogeneic product candidates that are bioengineered from healthy donor cells, represent a new approach to immunotherapy for the treatment of cancer and other diseases, developing and commercializing our product candidates subject us to a number of challenges.
Previous wording
Issues in the development and use of AI, including machine learning and computer vision, in Renovaro Cube’s AI platform may result in reputational harm or liability.
Current wording
Issues in the development and use of AI, including machine learning and computer vision, in BioSymetrics’ AI platform may result in reputational harm or liability.
Previous wording
AI is integrated into Renovaro Cube’s and BioSymetrics’ platforms and is a significant element of each of their business offerings going forward. As with many developing technologies, AI presents risks, challenges and unintended consequences that could affect its further development, adoption, and use, and therefore Renovaro Cube’s and BioSymetrics’ business. AI algorithms and training methodologies may be flawed. Data sets may be insufficient, of poor quality, or contain biased information. Inappropriate or controversial data practices by data scientists, engineers, and end-users of Renovaro Cube’s or BioSymetrics’ systems could impair the acceptance of AI solutions. If the analyses that AI applications assist in producing are deficient or inaccurate, Renovaro Cube or BioSymetrics could be subjected to competitive harm, potential legal liability, and brand or reputational harm. Some uses of AI present ethical issues, and Renovaro Cube’s or BioSymetrics’ judgment as to the ethical concerns may not be perceived as accurate. While Renovaro Cube and BioSymetrics aim to develop and use AI responsibly and attempt to identify and mitigate ethical and legal issues presented by its use, Renovaro Cube and BioSymetrics may be unsuccessful in identifying or resolving issues before they arise. If Renovaro Cube or BioSymetrics use AI as part of their platform in a manner that is controversial or perceived as unethical, this may lead to adverse results for Renovaro Cube’s or BioSymetrics’ financial condition and operations or the financial condition and operations of their collaborators or vendors, which may further lead to Renovaro Cube or BioSymetrics experiencing competitive harm, legal liability and brand or reputational harm. In addition, AI-related issues, deficiencies and/or failures could give rise to legal and/or regulatory action, including with respect to proposed legislation regulating AI in jurisdictions such as the European Union and others, and as a result of new applications of existing data protection, privacy, intellectual property, and other laws.
Current wording
AI is integrated into BioSymetrics’ platform and is a significant element of its business offering going forward. As with many developing technologies, AI presents risks, challenges and unintended consequences that could affect its further development, adoption, and use, and therefore BioSymetrics’ business. AI algorithms and training methodologies may be flawed. Data sets may be insufficient, of poor quality, or contain biased information. Inappropriate or controversial data practices by data scientists, engineers, and end-users of BioSymetrics’ systems could impair the acceptance of AI solutions. If the analyses that AI applications assist in producing are deficient or inaccurate, BioSymetrics could be subjected to competitive harm, potential legal liability, and brand or reputational harm. Some uses of AI present ethical issues, and BioSymetrics’ judgment as to the ethical concerns may not be perceived as accurate. While BioSymetrics aims to develop and use AI responsibly and attempt to identify and mitigate ethical and legal issues presented by its use, BioSymetrics may be unsuccessful in identifying or resolving issues before they arise. If BioSymetrics uses AI as part of its platform in a manner that is controversial or perceived as unethical, this may lead to adverse results for BioSymetrics’ financial condition and operations or the financial condition and operations of its collaborators or vendors, which may further lead to BioSymetrics experiencing competitive harm, legal liability and brand or reputational harm. In addition, AI-related issues, deficiencies and/or failures could give rise to legal and/or regulatory action, including with respect to proposed legislation regulating AI in jurisdictions such as the European Union and others, and as a result of new applications of existing data protection, privacy, intellectual property, and other laws.
Previous wording
Failure of, or defects in, Renovaro Cube’s or BioSymetrics’ machine learning and cloud-based computing infrastructure, or increased regulation in the machine learning space, could impair their ability to process data, develop products, or provide test results, and harm their business and results of operations.
Current wording
Failure of, or defects in, BioSymetrics’ machine learning and cloud-based computing infrastructure, or increased regulation in the machine learning space, could impair its ability to process data, develop products, or provide test results, and harm its business and results of operations.
Previous wording
The design, development, maintenance and operation of Renovaro Cube’s and BioSymetrics’ technologies over time is expensive and complex, and may involve unforeseen difficulties including material performance problems, undetected defects or errors. Overcoming technical obstacles and correcting defects or errors could prove to be impossible or impracticable, and the costs incurred may be substantial and adversely affect either’s results of operations. Additionally, regulation in the machine learning space is constantly evolving and may make it difficult for Renovaro Cube or BioSymetrics to continue using its machine learning approach. If Renovaro Cube’s or BioSymetrics’ technology does not function reliably, fails to meet expectations in terms of performance, or cannot be fully utilized due to increasing regulation, we may be unable to provide, or its customers may stop using, our products.
Current wording
The design, development, maintenance and operation of BioSymetrics’ technologies over time is expensive and complex, and may involve unforeseen difficulties including material performance problems, undetected defects or errors. Overcoming technical obstacles and correcting defects or errors could prove to be impossible or impracticable, and the costs incurred may be substantial and adversely affect either’s results of operations. Additionally, regulation in the machine learning space is constantly evolving and may make it difficult for BioSymetrics to continue using its machine learning approach. If BioSymetrics’ technology does not function reliably, fails to meet expectations in terms of performance, or cannot be fully utilized due to increasing regulation, we may be unable to provide, or its customers may stop using, our products.
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