Lunai Bioworks (LNAI) FY2026 10-K Risk Factors: 3 New, 7 Dropped

What the changes say

Nasdaq compliance is a prominent new risk: stockholders’ deficit was $9.0 million versus Nasdaq’s $2.5 million equity requirement.
New financing and controls risks involve potential dilution from $20.0 million of Series B Preferred Stock and a material accounting weakness.
The risk section now focuses on BioSymetrics, with Renovaro Cube-specific commercialization, scaling, liability, and cybersecurity disclosures removed.

What changed since the prior 10-K

New

NewRisks Related to our Common Stock
We may be unable to maintain compliance with the continued listing requirements of The Nasdaq Capital Market, and our Common Stock could be delisted
Nasdaq could delist the Common Stock because of bid-price, equity, governance, or monitoring-period failures, including the $9.0 million stockholders’ deficit.
NewRisks Related to our Common Stock
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
After required Nasdaq approval, Series B Preferred Stock could convert into up to 1,666,666 shares at $12, diluting holders and ranking senior in liquidation.
NewRisks Related to our Common Stock
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
Inadequate resources for complex accounting have caused a material weakness that could produce reporting errors, delays, investor distrust, or remediation costs.

Dropped

DroppedRisks Related to Our Limited Operating History
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
DroppedRisks Related to Employee Matters and Managing Growth
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
DroppedRisks Related To Our Business Operations
If we are sued for product or professional liability, we could face substantial liabilities that exceed our resources
DroppedRisks Related to our Common Stock
1C. Cybersecurity Risk Management and Strategy
DroppedRisks Related to our Common Stock
Our cybersecurity framework is seamlessly integrated broader enterprise risk management strategy, sharing methodologies, reporting mechanisms, and governance structures with other risk domains including legal, compliance, strategic, operational, and financial risks
DroppedRisks Related to our Common Stock
To date, we have not identified any cybersecurity threats or past incidents that have had, or are likely to have, a material impact on our company’s operations, business strategy, financial performance, or results of operations
DroppedRisks Related to our Common Stock
Our Board is actively involved in our cybersecurity oversight, receiving detailed briefings from internal technology teams or external cybersecurity experts. These sessions are part of the Board’s commitment to continuous learning and staying informed about issues critical to public companies, including cybersecurity

Reworded

87% rewrittenRisks Related to Our Limited Operating History
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
The risk shifts from combined companies’ product reliability and cancer-signal follow-up to BioSymetrics products potentially harming patients and creating liability and reputational damage.
Was: 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
85% rewrittenRisks Related to Our Limited Operating History
BioSymetrics may be unable to develop and commercialize new products
The risk now covers only BioSymetrics; Renovaro Cube is removed, while clinical, regulatory, spending, revenue, and financing challenges remain.
Was: Renovaro Cube and BioSymetrics may be unable to develop and commercialize new products
76% rewrittenRisks Related to Our Limited Operating History
BioSymetrics’ AI platform and other products may fail to achieve the degree of market acceptance necessary for commercial success
The market-acceptance risk now names pharmaceutical companies as customers and focuses solely on BioSymetrics, rather than both companies and Renovaro Cube’s platform.
Was: 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
68% rewrittenRisks Related to Our Limited Operating History
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
The discussion now covers only BioSymetrics and notes current revenue and non-dilutive funding, while adding broader early-stage execution risks.
Was: 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
67% rewrittenRisks Related to Our Technology and Intellectual Property
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
The risk is narrowed to BioSymetrics and adds that unreliable performance, unmet expectations, or regulation could cause customers to stop using products.
Was: 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
66% rewrittenRisks Related to Our Limited Operating History
If BioSymetrics is unable to establish sales and marketing capabilities, they may not be successful in commercializing their products
The risk now covers only BioSymetrics, removes several named commercialization functions and healthcare-system references, and expressly adds regulatory-compliance failures.
Was: If Renovaro Cube or BioSymetrics is unable to establish sales and marketing capabilities, they may not be successful in commercializing their products
49% rewrittenRisks Related to Employee Matters and Managing Growth
Renovaro Biosciences and BioSymetrics are highly dependent on their key personnel. If Renovaro Biosciences or BioSymetrics are not successful in attracting, motivating and retaining highly qualified personnel, they may not be able to successfully implement their business strategy
Renovaro Cube is replaced with Renovaro Biosciences; the dependence on executives, scientific and technical personnel, and lack of key-person insurance is otherwise unchanged.
Was: Renovaro Cube and BioSymetrics are highly dependent on their key personnel. If Renovaro Cube or BioSymetrics is not successful in attracting, motivating and retaining highly qualified personnel, they may not be able to successfully implement their business strategy
47% rewrittenRisks Related to the Development of Our Product Candidates
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
The risk is narrowed from both companies to BioSymetrics, while the potential impact of U.S., U.K., EU, and other AI regulation remains.
Was: 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
45% rewrittenRisks Related to Employee Matters and Managing Growth
BioSymetrics will need to grow the size and capabilities of its organizations, and may experience difficulties in managing this growth
Was: Renovaro Cube and BioSymetrics will need to grow the size and capabilities of their organizations, and may experience difficulties in managing this growth
45% rewrittenRisks Related to Our Limited Operating History
BioSymetrics’ business and results of operations will suffer if it fails to compete effectively
Was: Renovaro Cube’s and BioSymetrics’ business and results of operations will suffer if it fails to compete effectively
44% rewrittenRisks Related to Our Limited Operating History
BioSymetrics has a history of net losses and anticipates that it may continue to incur net losses for the foreseeable future
Was: Renovaro Cube and BioSymetrics have a history of net losses and anticipates that they may continue to incur net losses for the foreseeable future
43% rewrittenRisks Related to Our Technology and Intellectual Property
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
Was: 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
38% rewritten
If serious adverse events or other undesirable side effects or safety concerns attributable to our product candidates occur, they may adversely affect or delay our clinical development and commercialization of some or all of our product candidates
38% rewrittenRisks Related to Our Financial Position and Capital Requirements
We have incurred substantial losses since our inception and anticipate that we will continue to incur substantial and increasing losses for the foreseeable future
35% rewrittenRisks Related to Our Technology and Intellectual Property
Real or perceived errors, failures, or bugs in BioSymetrics’ platform and future products could adversely affect its business, results of operations, financial condition, and growth prospects
Was: Real or perceived errors, failures, or bugs in Renovaro Cube’s or BioSymetrics’ platform and future products could adversely affect their business, results of operations, financial condition, and growth prospects
34% rewrittenRisks Related to Our Limited Operating History
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
Was: 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
34% rewrittenRisks Related to Our Technology and Intellectual Property
If BioSymetrics or Renovaro Biosciences are unable to protect the confidentiality of their trade secrets, BioSymetrics’ or Renovaro Biosciences’ business and competitive position would be harmed
Was: If Renovaro Cube or BioSymetrics is unable to protect the confidentiality of its trade secrets, Renovaro Cube’s or BioSymetrics’ business and competitive position would be harmed
31% rewrittenRisks Related to Our Technology and Intellectual Property
BioSymetrics’ internal computer systems, or those expected to be used by its third-party research institution collaborators or other contractors or consultants, may fail or suffer security breaches
Was: Renovaro Cube’s or BioSymetrics’ internal computer systems, or those expected to be used by its third-party research institution collaborators or other contractors or consultants, may fail or suffer security breaches
30% rewrittenRisks Related to Our Technology and Intellectual Property
BioSymetrics’ AI platform and other related products may become obsolete due to fast growing technological innovations or the entry of competitors with more financial and brand power
Was: Renovaro Cube’s and BioSymetrics’ AI platform and other related products may become obsolete due to fast growing technological innovations or the entry of competitors with more financial and brand power
27% rewrittenRisks Related To Our Business Operations
Renovaro Biosciences’ and BioSymetrics’ business is subject to economic, political, regulatory and other risks associated with international operations
Was: Renovaro Cube’s and BioSymetrics’ business is subject to economic, political, regulatory and other risks associated with international operations
25% rewrittenRisks Related to Employee Matters and Managing Growth
Renovaro Biosciences’ or BioSymetrics’ employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
Was: Renovaro Cube’s or BioSymetrics’ employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements

All 56 risk factors

Headings as the filing states them, in filing order.

Other

01If serious adverse events or other undesirable side effects or safety concerns attributable to our product candidates occur, they may adversely affect or delay our clinical development and commercialization of some or all of our product candidates38% rewritten

Risks Related to Our Financial Position and Capital Requirements

02We have incurred substantial losses since our inception and anticipate that we will continue to incur substantial and increasing losses for the foreseeable future38% rewritten
03There is substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing
04We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts
05Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies
06From time to time, we may be subject to legal proceedings, regulatory investigations or disputes, and governmental inquiries that could cause us to incur significant expenses, divert our management’s attention, and materially harm our business, financial condition, and operating results
07Negative publicity has had and may continue to have a negative impact on our business and may have a long-term effect on our relationships with our customers, partners and collaborators

Risks Related to Our Limited Operating History

08Lunai Bioworks is a pre-clinical biotechnology company and may never be able to successfully develop marketable products or generate any material product revenue
09BioSymetrics 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 performance68% rewritten
10BioSymetrics has a history of net losses and anticipates that it may continue to incur net losses for the foreseeable future44% rewritten
11BioSymetrics’ AI platform and other products may fail to achieve the degree of market acceptance necessary for commercial success76% rewritten
12BioSymetrics may be unable to develop and commercialize new products85% rewritten
13If 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 suffer87% rewritten
14If 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
15BioSymetrics’ business and results of operations will suffer if it fails to compete effectively45% rewritten
16If 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 affected34% rewritten
17If BioSymetrics is unable to establish sales and marketing capabilities, they may not be successful in commercializing their products66% rewritten

Risks Related to the Development of Our Product Candidates

18Regulatory and legislative developments on the use of AI and machine learning could adversely affect BioSymetrics’ use of such technologies in its platform and other products47% rewritten
19Our novel gene, cell and immunotherapy product candidates and new therapeutic approaches could result in heightened regulatory scrutiny, delays in clinical development or delays in our ability to achieve regulatory approval or commercialization of our product candidates
20Our reliance on third parties, such as university laboratories, contract manufacturing organizations and contract or clinical research organizations, may result in delays in completing, or a failure to complete, non-clinical testing or clinical trials if they fail to perform under our agreements with them
21Changes in healthcare law and implementing regulations, including government restrictions on pricing and reimbursement, as well as healthcare policy, may negatively impact our ability to generate revenues
22We have limited experience in drug development and may not be able to successfully develop any drugs, which would cause us to cease operations
23Clinical trials are expensive, time-consuming, difficult to design and implement, and involve an uncertain outcome
24Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control

Risks Related to Our Technology and Intellectual Property

25We have licensed a portion of our intellectual property from our licensors
26In addition, the agreements under which we currently license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations
27If we are unable to obtain and maintain sufficient intellectual property protection for our product candidates, or if the scope of the intellectual property protection is not sufficiently broad, our ability to commercialize our product candidates successfully and to compete effectively may be adversely affected
28Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts
29Issues in the development and use of AI, including machine learning and computer vision, in BioSymetrics’ AI platform may result in reputational harm or liability43% rewritten
30Failure 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 operations67% rewritten
31Real or perceived errors, failures, or bugs in BioSymetrics’ platform and future products could adversely affect its business, results of operations, financial condition, and growth prospects35% rewritten
32BioSymetrics’ internal computer systems, or those expected to be used by its third-party research institution collaborators or other contractors or consultants, may fail or suffer security breaches31% rewritten
33If BioSymetrics or Renovaro Biosciences are unable to protect the confidentiality of their trade secrets, BioSymetrics’ or Renovaro Biosciences’ business and competitive position would be harmed34% rewritten
34We depend on our information technology and telecommunications systems and those of third parties, the failure or disruption of which could harm our business
35Intellectual property litigation may lead to unfavorable publicity that harms our reputation
36BioSymetrics’ use of open-source software could subject our proprietary technology to unwanted open-source license conditions that could negatively impact its business
37The success and growth of BioSymetrics’ business depends upon their ability to continuously innovate and develop new products and technologies
38BioSymetrics’ AI platform and other related products may become obsolete due to fast growing technological innovations or the entry of competitors with more financial and brand power30% rewritten
39We may not be able to protect our intellectual property rights throughout the world

Risks Related to Employee Matters and Managing Growth

40We have limited corporate infrastructure and may experience difficulties in managing growth
41Management and employee turnover creates uncertainties and could harm our business
42Renovaro Biosciences and BioSymetrics are highly dependent on their key personnel. If Renovaro Biosciences or BioSymetrics are not successful in attracting, motivating and retaining highly qualified personnel, they may not be able to successfully implement their business strategy49% rewritten
43BioSymetrics will need to grow the size and capabilities of its organizations, and may experience difficulties in managing this growth45% rewritten
44Renovaro Biosciences’ or BioSymetrics’ employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements25% rewritten

Risks Related To Our Business Operations

45Our business plan may lead to the initiation of one or more product development programs, the discontinuation of one or more development programs, or the execution of one or more transactions that investors do not agree with or that investors do not perceive as favorable to their investment in our Common Stock
46Renovaro Biosciences’ and BioSymetrics’ business is subject to economic, political, regulatory and other risks associated with international operations27% rewritten

Risks Related to our Common Stock

47Our stock price has been and will likely continue to be volatile and may decline regardless of our operating performance
48We may be unable to maintain compliance with the continued listing requirements of The Nasdaq Capital Market, and our Common Stock could be delistedNew
49The 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 liquidationNew
50Sales of a substantial number of shares of our Common Stock in the public market could cause our stock price to fall
51We have incurred and will continue to incur increased costs as a result of being a public company and our management expects to devote substantial time to public company compliance programs
52We 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 affectedNew
53Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be the sole source of potential gain for our stockholders
54Future sales and issuances of our Common Stock or rights to purchase Common Stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall
55Some terms of our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders and may prevent attempts by our stockholders to replace or remove our current management
56Any of the factors listed above may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our Board of Directors, who are responsible for appointing the members of our management

Other Lunai Bioworks 10-Ks

FY2025 10-K risk factors
59 risks2 new1 dropped21 reworded
Expansion of risk disclosures to jointly cover BioSymetrics alongside Renovaro Cube following integration.
Filed Sep 29, 2025
FY2024 10-K risk factors
58 risks
This pre-clinical biotech and AI healthcare company faces severe going concern doubts with only $220,467 in cash as of June 30, 2024, and an accumulated deficit of $325 million. The risk profile is dominated by the heavy capital requirements for unproven gene, cell, and immunotherapy candidates and AI diagnostics. Reputation and business operations have been harmed by the arrest and indictment of co-founder Serhat Gümrükcü.
Filed Oct 10, 2024

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The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.