Lunai Bioworks Inc 10-K for FY2025

Lunai Bioworks Inc. (LNAI)

10-K 2025-09-29 For: 2025-06-30

Added on April 07, 2026

About this 10-K

Lunai Bioworks Inc filed this 10-K on September 29, 2025, covering the fiscal year ended June 30, 2025 (FY2025).

Headline figures

Fiscal year ended June 30, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $178.01M; compared with a net loss of $88.43M a year earlier
Diluted EPS: -$1.08; compared with -$0.91 a year earlier

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Delaware		45-2259340
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

2080 Century Park East, Suite 906 Los Angeles, CA		90067
(Address of principal executive offices)		(Zip Code)

Title of Each Class		Trading Symbol		Name of Each Exchange on Which Registered
Common Stock, par value $0.0001 per share		RENB		The Nasdaq Stock Market LLC

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

		Page

	Forward-Looking Statements	ii

Part I		1

Item 1	Business	1

Item 1A	Risk Factors	18

Item 1B	Unresolved Staff Comments	50

Item 1C	Cybersecurity Risk Management and Strategy	50

Item 2	Properties	51

Item 3	Legal Proceedings	52

Item 4	Mine Safety Disclosures	54

Part II		55

Item 5	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	55

Item 6	Selected Financial Data	55

Item 7	Management’s Discussion and Analysis of Financial Condition and Results Of Operations	55

Item 7A	Quantitative and Qualitative Disclosures About Market Risk	63

Item 8	Financial Statements and Supplementary Data	63

Item 9	Changes In and Disagreements with Accountants on Accounting and Financial Disclosure	64

Item 9A	Controls and Procedures	64

Item 9B	Other Information	64

Part III		65

Item 10	Directors, Executive Officers and Corporate Governance	65

Item 11	Executive Compensation	65

Item 12	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	65

Item 13	Certain Relationships and Related Transactions and Director Independence	65

Item 14	Principal Accountant Fees and Services	65

Part IV		66

Item 15	Exhibits, Financial Statement Schedules	66

	Signatures and Certifications	69

	●	Our ability to continue as a going concern and ability to raise additional capital;

	●	Our continuous incurrence of losses as a pre-clinical-stage biotechnology company with no products that have achieved regulatory approval;

	●	Our ability to generate revenue if we fail to develop marketable product;

	●	Our dependence on substantial additional financing to support the research, development, licensing, manufacture, and marketing of product candidates and products, and the possibility that unforeseen operational costs will arise;

	●	The dilutive effect on stockholders’ ownership interests of the Company raising capital through an equity issuance in connection with future equity financing or equity debt agreements;

	●	Our dependence on the services of experts, including third parties to research and develop product candidates in cooperation with our employees and officers;

	●	The difficulty or impossibility of predicting future clinical trial results and regulatory outcomes of our products based upon our pre-clinical or earlier clinical trial performance;

	●	The application of heightened regulatory and commercial scrutiny to our AI-based technology, gene, cell, and immunotherapy products given their novel nature and concomitant potential for actual or perceived safety issues;

	●	Our ability to compete in rapidly developing fields, and the potential impact to our financial condition, product marketability, and operational capacities of a competitor receiving regulatory approval before us, or a competitor developing more advanced or efficacious products;

	●	Potential delays or total failures of third parties, such as universities, non-profits, and clinical research centers, to perform obligations on which our product research and development rely;

	●	The impact on our competitive position, business operations, and financial condition of implementation of amended healthcare laws and regulations;

	●	The dependence of certain of our pipelines on intellectual property licensed from licensors, and the severe adverse impact to our business operations of a disruption of one of our licensing relationships;

	●	The potential monetary costs of defending our intellectual property rights in a dispute, and the possibility that an intellectual property dispute will not be settled in our favor;

	●	The possibility that our patents and patent applications, even if unchallenged, will not sufficiently protect or provide exclusive use of our intellectual property, which could jeopardize our ability to commercialize our products and dissuade companies from subsequently collaborating with us;

	●	The negative impact to our competitive position and the value of our technology of our failure to protect trade secrets through the use of non-disclosure and confidentiality agreements, or the unavailability of adequate recourse for breach of such agreements;

	●	The fluctuation and volatility of the market price of our Common Stock due to its limited public market, and the possibility that these issues will compound and strain our stockholders’ ability to resell their Common Stock;

	●	Our significant dependence on sophisticated management with highly technical expertise to oversee business operations, and our ability to attract and retain qualified personnel to sustain growth;

	●	Our ability to adapt to future growth by training an expanding employee base and shifting away from reliance on third-party contractors;

	●	The risk of liability arising from claims of environmental damage, personal injury, and property damages in connection with our research and development activities, including those that involve the use of hazardous materials;

	●	The possibility that enforcement actions to suspend or severely restrict our business operations will be brought against the Company for our failure to comply with laws or regulations and the potential costs of defending against such actions;

	●	Our reliance on adequate maintenance of the security and integrity of our information technology systems to effectively operate our business; and

	●	Such other factors as discussed throughout Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations and in Part I, Item 1A. Risk Factors herein.

	●	Early Detection. Multi-cancer early detection (“MCED”) blood tests are advanced diagnostic tools that analyze cell-derived molecules present in the bloodstream. These tests specifically look for abnormal genetic, epigenetic or proteomic patterns of these cell-derived molecules, which can indicate the presence of cancer cells. By examining the molecules shed from various cells, including cancer cells, MCED tests aim to detect cancer at an early stage. This approach holds promise for improving cancer detection and potentially saving lives.

	●	Recurrence of cancer. A recurrence refers to the return of cancer after a period of remission. A cancer recurrence happens because, in spite of the efforts to kill the cancer, some cells may remain, which grow and eventually cause symptoms. In rare instances, a patient may develop a new cancer that’s completely unrelated to the originally diagnosed cancer, which is referred to as a second primary cancer. An early warning system could help to identify a recurrence as early as possible, thereby helping to accelerate any treatment and diagnosis. The different types of recurrence include:

	●	the federal anti-kickback statute, which is a criminal statute that makes it a felony for individuals or entities to knowingly and willfully offer or pay, or to solicit or receive, direct or indirect remuneration, in order to induce the purchase, order, lease, or recommending of items or services, or the referral of patients for services, that are reimbursed under a federal health care program, including Medicare and Medicaid;

	●	the federal False Claims Act, which prohibits, among other things, individuals and entities from knowingly submitting, or causing to be submitted, false or fraudulent claims for payment of government funds, with penalties that include three times the government’s damages plus civil penalties for each false claim; in addition, the False Claims Act permits a person with knowledge of fraud, referred to as a qui tam plaintiff, to file a lawsuit on behalf of the government against the person or business that committed the fraud, and, if the action is successful, the qui tam plaintiff is rewarded with a percentage of the recovery;

	●	federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

	●	the Health Insurance Portability and Accountability Act of 1996, or HIPAA, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information;

	●	the federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical suppliers to report annually to CMS information related to payments and other transfers of value to physicians, other healthcare professionals and teaching hospitals, and ownership and investment interests held by physicians and other healthcare professionals and their immediate family members; and

	●	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.

	●	The market for artificial intelligence -based (“AI”) healthcare solutions is new and unproven and may decline or experience limited growth, and concerns over the use of AI may hinder the adoption of AI technologies.

	●	Regulators and legislators may limit our ability to develop or implement our AI algorithms and may eliminate or restrict the confidentiality of our proprietary technology, which could have an adverse effect on our business, results of operations, reputation, and financial condition. Similarly, while yet there is no substantial regulation influencing the adoption and inclusion of large language models (LLMs) as part of a commercial offering, that may be subject to change, resulting in alterations to our platform offering and/or company productivity.

	●	Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.

	●	We use AI in our business, and challenges relating to the development and use of AI, including generative AI, could result in competitive harm, reputational harm, and legal liability, and adversely affect our results of operations.

	●	We have limited corporate infrastructure and may experience difficulties in managing growth.

	●	We have experienced and may continue to experience significant turnover in our management and executive leadership, which creates uncertainty and could harm our ability to operate our business effectively.

	●	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.

	●	Our stock price has been and will likely continue to be volatile and may decline regardless of our operating performance.

	●	the costs and payments associated with license agreements for our potential products and technologies;

	●	the costs of conducting pre-clinical and clinical studies and the costs of manufacturing our product candidates;

	●	the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates, if clinical studies are successful, including any costs from post-market requirements;

	●	the cost of commercialization activities for our product candidates, if any of these product candidates is approved for sale, including marketing, sales and distribution costs;

	●	our ability to establish and maintain strategic licensing or other arrangements and the financial terms of such agreements;

	●	the costs involved in preparing, filing, prosecuting, maintaining, expanding, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; and

	●	the timing, receipt and amount of sales of, or royalties on, our future products, if any.

	●	attract, hire, and retain qualified personnel;

	●	continue their research and development activities;

	●	initiate and conduct additional clinical validation to support the development and commercialization of products;

	●	expands their technological and operating capabilities and introduce laboratory capacity;

	●	seek regulatory approvals and any other marketing authorizations or clearances that may be necessary or desired for their products;

	●	establish sales, marketing and distribution infrastructure to commercialize products;

	●	acquire or in-license additional intellectual property and technologies;

	●	make milestone, royalty, or other payments due under any license or collaboration agreements;

	●	obtain, maintain, protect and enforce their intellectual property portfolio, including intellectual property obtained through license agreements;

	●	provide additional infrastructure to support continued research and development operations and any planned commercialization efforts in the future;

	●	as part of the combined company, meets the requirements and demands of being a public company; and

	●	defends against any product liability claims or other lawsuits related to its products.

	●	completing clinical development and additional validation of Renovaro Cube’s products and continuing to improve product performance and expand product features over time;

	●	seeking, obtaining and maintaining marketing approvals, clearances, licenses, or exemptions that may be necessary or desired for any future products that Renovaro Cube develops;

	●	establishing a sales force, marketing, medical affairs and distribution infrastructure or, alternatively, collaborating with a commercialization partner sufficient to launch and commercialize its products;

	●	obtaining market acceptance by consumers, including self-insured employers, integrated health systems, healthcare providers, patients and third-party payors;

	●	establishing and maintaining supply and manufacturing relationships with third parties that can timely and consistently provide adequate, in both amount and quality, products and services to support clinical development and the market demand for Renovaro Cube’s future products;

	●	achieving adequate coverage or reimbursement recognition from governments, health insurance organizations and other third-party payors for products that Renovaro Cube launches;

	●	addressing any technological and market developments, including competing products;

	●	negotiating favorable terms in any collaboration, licensing, or other arrangements into which Renovaro Cube may enter, and maintaining such existing or future arrangements;

	●	achieving general adoption and acceptance of Renovaro Cube’s products by the medical community;

	●	maintaining, protecting and expanding Renovaro Cube’s portfolio of intellectual property rights, including patents, trade secrets, know-how and trademarks;

	●	defending against third-party interference or infringement claims, if any; and

	●	attracting, hiring and retaining qualified personnel.

	●	the performance and clinical utility of its products as demonstrated in clinical validation and published in peer-reviewed journals;

	●	Renovaro Cube’s and BioSymetrics’ ability to demonstrate the clinical utility of its products and their potential advantages to the medical community;

	●	the ability of Renovaro Cube’s and BioSymetrics’ products to demonstrate the same performance in real-world intended use populations as in clinical validation;

	●	the willingness of consumers, including self-insured employers, integrated health systems, healthcare providers, patients and others in the medical community to utilize Renovaro Cube’s and BioSymetrics’ products;

	●	the willingness of commercial third-party payors and government payors to cover and reimburse for Renovaro Cube’s or BioSymetrics’ products, the scope and amount of which will likely affect an individual’s willingness or ability to pay for these products and likely heavily influence healthcare providers’ decisions to recommend these products;

	●	with respect to products under development that Renovaro Cube or BioSymetrics intends to launch for use in a broad asymptomatic population, the concern that such products could lead to over-diagnosis or a high false-positive rate and unnecessary medical procedures and costs;

	●	the introduction of competing products, including the expansion of the capabilities of existing products;

	●	the market acceptance of existing competitive products, including tests that are currently reimbursed;

	●	publicity concerning Renovaro Cube’s or BioSymetrics’ products or competing products; and

	●	the strength of Renovaro Cube’s and BioSymetrics’ marketing and distribution support.

	●	successfully commercialize its products;

	●	demonstrate compelling advantages in the performance and convenience of its products, including on a cost-competitive basis;

	●	achieve market acceptance of its products by consumers, including self-insured employers, integrated health systems, healthcare providers and patients;

	●	achieve adequate coverage or reimbursement by third-party payors for its products;

	●	differentiate its product from the other tests and products of current and potential competitors;

	●	attract qualified scientific, data science, clinical development, product development and commercial personnel;

	●	obtain, maintain, defend and enforce patents and other intellectual property rights and claims as necessary for its products;

	●	obtain and maintain any necessary or desirable clearance or approval from regulators in Europe, the United Kingdom, the United States and other jurisdictions;

	●	successfully collaborate with institutions in the discovery, development and commercialization of its products; and

	●	successfully expand its operations and implement a successful sales and marketing strategy to support commercialization.

	●	its inability to recruit and retain adequate numbers of effective sales, marketing, reimbursement, customer service, medical affairs and other support personnel;

	●	the inability of sales personnel to persuade adequate numbers of customers, including healthcare systems and healthcare providers, to use its products;

	●	the inability to price its products at a sufficient price point to ensure an adequate and attractive level of profitability;

	●	its inability to effectively market to, collaborate with, and secure coverage or reimbursement from third-party payors;

	●	its failure to comply with applicable regulatory requirements governing the sale, marketing, reimbursement and commercialization of its products; and

	●	unforeseen costs and expenses associated with creating an independent commercialization organization.

	●	the scope of rights granted under license agreements and other interpretation-related issues;

	●	payment obligations due to licensors under license agreements and other disputes related to the obligations for payment related to intellectual property protection;

	●	the extent to which our product candidates, technology and processes infringe on intellectual property of a licensor that is not subject to a licensing agreement;

	●	the sublicensing of patent and other rights under our collaborative development relationships;

	●	our diligence obligations under license agreements and what activities satisfy those diligence obligations;

	●	the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us; and

	●	the priority of invention of patented technology.

	●	identifying, recruiting, integrating, retaining and motivating additional employees;

	●	managing its internal development efforts effectively, including creating compliant programs and processes, and managing the regulatory requirements for its products, while complying with its contractual obligations to contractors and other third parties;

	●	expanding its operational, financial and management controls, reporting systems and procedures; and

	●	managing the increasing complexity associated with a larger organization and expanded operations.

	●	regulatory authorities may withdraw, suspend, or limit approvals of such products and require us to take them off the market;

	●	regulatory authorities may require the addition of labeling statements, specific warnings, a contraindication or field alerts to physicians and pharmacies;

	●	regulatory authorities may require a medication guide outlining the risks of such side effects for distribution to patients, or that we implement a REMS or REMS-like plan to ensure that the benefits of the product outweigh its risks;

	●	we may be required to change the way a product is distributed or administered, conduct additional clinical trials, or change the labeling of a product;

	●	we may be required to conduct additional post-marketing studies or surveillance;

	●	we may be subject to limitations on how we may promote the product;

	●	sales of the product may decrease significantly;

	●	we may be subject to regulatory investigations,

	●	we may be subject to government enforcement actions, litigation, or product liability claims; and

	●	our products may become less competitive, or our reputation may suffer.

	●	economic weakness, including inflation, or political instability in particular foreign economies and markets;

	●	challenges enforcing its contractual and intellectual property rights, especially in those foreign jurisdictions that do not respect and protect intellectual property rights to the same extent as the Netherlands;

	●	changes in foreign laws, regulations and customs, tariffs and trade barriers;

	●	changes in foreign currency exchange rates;

	●	changes in a specific countries or region’s political or economic environment;

	●	negative consequences from changes in tax laws;

	●	trade protection measures, import or export licensing requirements or other restrictive actions by the Netherlands or foreign governments;

	●	compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

	●	workforce uncertainty in countries where labor unrest is more common than in the Netherlands;

	●	difficulties associated with staffing and managing international operations, including differing labor relations; and

	●	business interruptions resulting from geo-political actions, including war and terrorism, pandemics, or natural disasters, including earthquakes, typhoons, floods and fires.

	●	negative publicity;

	●	our compliance with Nasdaq rules and regulations;

	●	the success of competitive products or technologies;

	●	regulatory actions with respect to our product candidates or products or our competitors’ product candidates or products;

	●	actual or anticipated changes in our growth rate relative to our competitors;

	●	announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations, or capital commitments;

	●	results of clinical studies of our product candidates or those of our competitors;

	●	regulatory or legal developments in the U.S. and other countries;

	●	developments or disputes concerning patent applications, issued patents or other proprietary rights;

	●	the recruitment or departure of key personnel;

	●	the level of expenses related to any of our product candidates or clinical development programs;

	●	the results of our efforts to in-license or acquire additional product candidates or products;

	●	actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;

	●	variations in our financial results or those of companies that are perceived to be similar to us;

	●	fluctuations in the valuation of companies perceived by investors to be comparable to us;

	●	inconsistent trading volume levels of our shares;

	●	announcement or expectation of additional financing efforts;

	●	sales of our Common Stock by us, our insiders or our other stockholders;

	●	market conditions in the pharmaceutical and biotechnology sectors;

	●	general economic, industry and market conditions; and

	●	the other risks described in this “Risk Factors” section.

	●	permit our Board of Directors to issue up to 10,000,000 shares of preferred stock, with any rights, preferences, and privileges as they may designate;

	●	provide that all vacancies on our Board of Directors, including as a result of newly created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum;

	●	provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide advance notice in writing, and also specify requirements as to the form and content of a stockholder’s notice; and

	●	do not provide for cumulative voting rights, thereby allowing the holders of a majority of the shares of Common Stock entitled to vote in any election of directors to elect all of the directors standing for election.

	●	Conducting risk assessments to pinpoint material cybersecurity threats to our critical systems, data, products, services, and overall IT infrastructure.

	●	A dedicated security team overseeing the risk assessment processes, maintenance of security controls, and coordination of responses to cybersecurity incidents.

	●	Engagement with external service providers to evaluate, enhance, or support our security measures.

	●	Comprehensive cybersecurity training programs for employees, incident responders, and senior management to foster a culture of security awareness.

	●	An incident response plan outlining specific procedures for managing cybersecurity incidents.

	●	A thorough third-party risk management process to evaluate and manage risks associated with service providers, suppliers, and vendors.

Location	Use	Terms
2080 Century Park East, Suite 906 Los Angeles, CA 90067	Headquarters	The Company entered into a Lease Agreement on June 19, 2018 for our corporate headquarters located at Century City Medical Plaza. We have a ten-year lease that was for approximately 2,453 square feet at this location. In February 2019, we extended our corporate headquarters to encompass the adjoining suite for approximately 1,101 square feet, bringing the total workspace to 3,554 square feet. The new base rent for this leased premises increases by 3% each year over the term, and ranges from $17,770 per month as of the date of the amendment until the end of the first year to $23,186 per month for the tenth year. The additional suite was in the form of an amendment to the original lease and will expire on the same date as the original lease. The Company was entitled to a total of $148,168 in contributions toward tenant improvements for both spaces.

101 Plaza Real South, Suite 202, Boca Raton, FL 33432	Lunai Bioworks Inc.	Lunai leases an office lease in Boca Raton, Florida, under a 36-month operating lease agreement commencing on November 1, 2024, with a maturity date of October 31, 2027. In determining lease asset values, the Company considers fixed and variable payment terms, prepayments, incentives, and options to extend, terminate or purchase.