LNAI 10-K & 10-Q changes, risk factors and insider trading
Lunai Bioworks Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1527728 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
Largest changes
As and to the extent demand increases beyond Renovaro Cube’s or BioSymetrics’ expectations following the launch of each’s platform, Renovarosee in full comparisonCube’sCubeplatform,andRenovaro CubeBioSymetrics will likely need to start to ramp up operating capacity.Renovaro CubeWe will need to implement new infrastructure, data processing capabilities, customer service, billing and systems processes, and expandRenovaro Cube’sinternal quality assurance program and technologytechnologyto support operations on a larger scale.Renovaro CubeWe 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.Renovaro CubeWe may face difficulties increasing the scale ofitsoperations, including implementing changes in infrastructure or programs or acquiring additional equipment or personnel. AsRenovaroweCuberefinerefines itsour products anddevelopsdevelop 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.
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 Cubesee in full comparisonhasand BioSymetrics have invested significant financial resources in research and development activities, including to developitstheirtechnologytechnologies and investigationalproducts and plan for commercial launch of its AI platform.products. The amount ofRenovaroeachCube’scompany’s future net losses will depend, in part, on the level ofRenovaro Cube’sfuture expenditures anditstheir ability to generate revenue following the commercialization ofitstheir AI platform. Moreover,Renovaro Cube’snet losses may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison ofRenovaro Cube’sresults of operations may not be a good indication ofRenovaro Cube’sfuture performance.
Renovaro Cube’s and BioSymetrics’ success depends onsee in full comparisonitsour ability to develop and commercializeitsour technology without infringing, misappropriating, or otherwise violating the intellectual property of third parties. Third parties may initiate legal proceedings alleging that Renovaro CubeCubeor BioSymetrics is infringing their intellectual property rights, and if they prevail, could block sales of Renovaro Cube’s or BioSymetrics’ products and forceRenovaro Cubeus to make large damages and/or royalty payments, which could have a material adverse effect on the success ofitsour business.
Renovaro Cubesee in full comparisonisandanBioSymetrics are artificial intelligence (“AI”)-driven healthcare technologycompanycompanies operating in a rapidly evolving fieldandwithhasa limited operating history, which makes it difficult to evaluateRenovaro Cube’stheir current business and predict Renovaro Cube’s future performance.
Renovaro Cubesee in full comparisonisand BioSymetrics are highly dependent onitstheir key personnel. If Renovaro Cube or BioSymetrics is not successful in attracting, motivating and retaining highly qualified personnel,itthey may not be able to successfully implementitstheir business strategy.
“The market price of our Common Stock could decline as a result of substantial sales of our Common Stock in the public market, or the perception that such sales could occur. Because the majority of our outstanding shares of Common Stock are registered and unrestricted, they may be sold in the public market at any time. Any such sales, or the availability of those shares for sale, could adversely affect the trading price of our Common Stock and make it more difficult for us to raise capital through future equity offerings. …”see in full comparison
Full comparison: every changed paragraph (86)
The following is a summary of the risks and uncertainties that could cause our business, financial condition or operating results to be harmed. We encourage you to carefully review the full risk factors contained in this report in their entirety for additional information regarding these risks and uncertainties. These risk factors should be considered applicable across all subsidiaries.
RenovaroLunai 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, 2024,2025, and 2023, 2024,
respectively, we reported a net loss of $80,650,172$178,007,489 and $39,684,056.
$88,425,828. We had an accumulated deficit of $325$510 million and $244$332 million as
of June 30, 20242025 and 2023,2024, respectively.
From time to time, we may be subject
to claims, lawsuits, government investigations, and other proceedings involving intellectual property, privacy, securities, tax, labor
and employment, and other matters that could adversely affect our business operations and financial condition. Recently, we have seen
a rise in the number and significance of these disputes and inquiries. The arrestarrest, indictment and indictmentconviction of Serhat Gümrükcü,
a a
co-founder of the Company, has, and could in the future, subject us to regulatory proceedings and litigation by governance agencies
and and
private litigants brought against us, that regardless of their merits, could harm our reputation, divert management’s attention
from our operations and result in substantial legal fees and other costs. Additionally, we have in the past been subject to intense media
scrutiny, which exposes us to increasing regulation, government investigations, legal actions, and penalties.
Our business and reputation have
been negatively affected by negative publicity resulting from the arrestarrest, indictment and indictmentconviction of Serhat Gümrükcü,
a co-founder
of the Company and an inventor of some of the Company’s intellectual property. If we are unable to rebuild the trust
of our collaborators,
research institutions and investors, and if further negative publicity continues, we could experience a substantial
negative impact on
our business. We have experienced claims and litigation as a consequence of these matters, including stockholder class
actions in connection
with a decline in our stock price and litigation with Mr. Gümrükcü. Related legal expenses of defending
these claims have
negatively impacted our operating results. Continuing higher legal fees, potential new claims, liabilities from existing
cases and continuing
negative publicity could continue to have a negative impact on our operating results.
RenovaroLunai BiosciencesBioworks is a pre-clinical
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.
RenovaroLunai BiosciencesBioworks 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 HIV,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.
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.
Renovaro
Cube isand anBioSymetrics are artificial intelligence (“AI”)-driven healthcare technology companycompanies operating in a rapidly evolving
field andwith has
a limited operating history, which makes it difficult to evaluate Renovaro Cube’stheir current business and predict Renovaro Cube’s
future performance.
Renovaro
Cube isand anBioSymetrics are AI-driven healthcare technology companycompanies operating in a rapidly evolving field and, having commenced operations
in 2013,
has2013 and 2017, respectively, have a limited operating history. Renovaro Cube shifted its business from the financial technology
(or FinTech) industry to cancer diagnostics
in 2018.2018 Weand currently dodoes not have a commercial product for sale. WeIt havehas never generated any revenue
relating to ourits 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.
Renovaro
Cube hasand BioSymetrics have a history of net losses and anticipates that itthey may continue to incur net losses for the foreseeable future.
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 hasand BioSymetrics have invested significant financial resources in research and development
activities, including to
develop itstheir technologytechnologies and investigational products and plan for commercial launch of its AI platform.products. The amount of Renovaroeach Cube’s
company’s future net losses
will depend, in part, on the level of Renovaro Cube’s future expenditures and itstheir ability to generate revenue
following the commercialization of its their
AI platform. Moreover, Renovaro Cube’s net losses may fluctuate significantly from quarter
to quarter and year to year, such that a period-to-period comparison
of Renovaro Cube’s results of operations may not
be a good indication of Renovaro Cube’s future performance.
Renovaro
Cube expectsand BioSymetrics expect to continue to incur significant expenses and operating losses for the foreseeable future if, and as, itthey:
Renovaro
Cube’s ability to generate revenue from product sales and maintain
profitability in the future depends on its ability to commercialize
its products. While Renovaro Cube plans to commercially launch its
AI platform in the European Union and United Kingdom in 2024, 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:
Even
if we commercially launch Renovaro Cube’s or BioSymetrics’ AI platformplatforms and other products, they may fail to achieve the degree
of market acceptance
necessary for commercial success.
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 Renovaro Cube’sthese products will depend on a number of factors, including:
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.
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 Renovaro Cube’sthese products and positive reimbursement or coverage
decisions for Renovaro
Cube’sthese 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 Renovaro Cube’sour ability to derive
sufficient revenues from any
of its products that are developed using data from a clinical study.
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.
Renovaro Cube and BioSymetrics may be unable to develop and commercialize new products.
Renovaro
Cube continuesand BioSymetrics continue to expand itstheir research and development efforts to use itstheir proprietary AI platformplatforms to develop new products,
including in
disease areas beyond cancer.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.
Renovaro
Cube and BioSymetrics also cannot assure you that itthey will be able to reduce itstheir expenditures sufficiently, generate sufficient revenue
from products that
it they successfully commercializescommercialize or otherwise mitigate the risks associated with itstheir 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 Renovaro Cube’stheir ability to implement
its their strategy and grow itstheir business.
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.
Renovaro
Cube’s and BioSymetrics’ success will depend on the market’s confidence that itstheir developed products can provide reliable, high-quality results,
once such products are launched. Renovaro Cube believesand BioSymetrics believe that patients, physicians and regulators are likely to be particularly
sensitive sensitive
to errors in the use of itstheir products or failure of itstheir products to perform as described, and there can be no guarantee that its
their products
will meet their expectations. Renovaro Cube’s initial product is intended to be used to detect a cancer signal in patients,
but 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, 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.
BioSymetrics does not currently have a similar diagnostic product, but if developing a similar product the same risks would apply.
If Renovaro Cube’s
or BioSymetrics’ facilities or those of its third-party collaborators become inoperable, Renovaro Cube’stheir ability to provide its
products products
will be significantly impaired and its business will be harmed.
Renovaro
Cube reliesand BioSymetrics rely on its 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,Cube or BioSymetrics, which may adversely impact itstheir operations and financial condition.
Renovaro Cube’s and BioSymetrics’ business and results of operations will suffer if it fails to compete effectively.
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. RenovaroSimilarly, Cube’sthere 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. Renovaro Cube’sThese 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 Cube anticipates.anticipated.
Renovaro
Cube’s and BioSymetrics’ ability to compete successfully will depend largely on itsthe ability of each to:
Renovaro
Cube and BioSymetrics may not be able to compete effectively if Renovarothey Cube isare unable to accomplish one or more of these or similar objectives.
If
Renovaro Cube or BioSymetrics cannot enter new collaborations in a timely manner and on acceptable terms, itstheir efforts to develop and
commercialize its
their products could be delayed or adversely affected.
From
time time
to time, Renovaro Cube expectsand 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,Cube or BioSymetrics, could result in adverse speculation about Renovaroeither, Cube, itstheir products
or its technology, resulting in harm to itstheir reputation
and its business. In addition, establishing collaborations is difficult and time-consuming and
may require Renovaro Cube’s
significant financial investment. Potential collaborators may elect not to work with Renovaro Cube or BioSymetrics based on
their assessment of itstheir 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 itstheir products or technology.
If
Renovaro Cube or BioSymetrics is unable to establish sales and marketing capabilities, itthey may not be successful in commercializing Renovaro Cube’stheir
products.
Renovaro
Cube hasand 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 isand BioSymetrics are rapidly hiring
additional personnel in Renovaro Cube’s
sales and marketing organization.marketing.
Factors that may inhibit
Renovaro Cube’s or BioSymetrics’ efforts to each commercialize any of itstheir respective products include:
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 its 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 Renovaro Cube’s 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 Renovaro Cube’s future products,
which may negatively affect its ability to obtain or maintain FDA
or comparable regulatory approval of its products, if required.
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.
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.
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.
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 Renovaro Cube’s operating expenses, which could adversely affect its either’s
business, financial
condition and results of operations.
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, 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,Cube or BioSymetrics, and could adversely affect itseither’s business, operations and financial
condition.
Success in pre-clinical studies
does not ensure that later clinical studies will generate adequate data to demonstrate the efficacy and safety of an investigational drug.
Currently, several of our product candidates, including RENB-DC-11, our genetically-modified allogeneic dendritic therapeutic vaccination
platform for solid tumors, and RENB-HV-12,BioS_831, our therapeuticsmall HIVmolecule vaccine,compound being developed for epilepsy, are currently in various stages of pre-clinical
development with
ongoing and planned pre-clinical studies in conjunction with research institutions and third parties. Despite preliminary
data we believe
is positive, this does not guarantee that any of these products will proceed to the clinical stage or to approval for
commercial use.
A number of companies in the pharmaceutical and biotechnology industries, including those with greater resources and experience
than us,
have suffered significant setbacks in clinical studies, even after seeing promising results in earlier preclinical or clinical
studies.
The development of treatments
in in
the fields of cancer and HIVneurology is highly competitive and many pharmaceutical and biotechnology companies, academic institutions,
governmental governmental
agencies, and other public and private research organizations may pursue the research and development of technologies, drugs
or other
therapeutic products for the treatment of some or all of the diseases we are targeting. Nearly all of our competitors have greater
capital capital
resources, larger overall research and development staffs and facilities, and a longer history in drug discovery and development,
obtaining obtaining
regulatory approval and pharmaceutical product manufacturing and marketing than we do. Techniques in gene, cell and immunotherapy
are are
subject to rapid technological change and development and are significantly affected by existing rival products and medical procedures,
new product introductions and the market activities of other participants. With additional resources, our competitors may be able to respond
to rapid and significant technological changes faster than we can. The future success of Renovaro Biosciences and BioSymetrics will depend
in large part
on our ability to maintain a competitive position with respect to these technologies. We may also face competition from
products, which
have already been approved and accepted by the medical community for the treatment of these same indications. If we are
unable to compete
effectively with any existing products, new treatment methods and new technologies, we may be unable to commercialize
therapeutic products
that we may develop in the future, which could adversely impact our potential revenues, results of operations and
financial condition
or lead to abandonment of product candidates in our pipeline.
AI is
integrated into Renovaro Cube’s platformand BioSymetrics’ platforms and is a significant element of itseach 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 aimsBioSymetrics aim to develop and use AI responsibly and attemptsattempt to identify and mitigate ethical and legal issues presented by its
its use, Renovaro Cube and BioSymetrics may be unsuccessful in identifying or resolving issues before they arise. If Renovaro Cube usesor BioSymetrics
use AI as part of its
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 itstheir 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.
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 Renovaro Cube’stheir ability to process its data, develop products, or provide test results,
and harm itstheir business and results of operations.
The design,
development, maintenance and operation of Renovaro Cube’s technologyand 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 Renovaroeither’s Cube’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, Renovaro Cubewe may be unable to provide, or its customers
may stop using, itsour products.
Real or perceived errors,
failures, or bugs in Renovaro Cube’s or BioSymetrics’ platform and future products could adversely affect itstheir business,
results of operations, financial
condition, and growth prospects.
Renovaro Cube’s platformand BioSymetrics’
is,platforms are, and itstheir future products will be, complex, and therefore, undetected errors, failures, bugs, or defects may be present
in such platform
or products or occur in the future in itstheir platform or products, itstheir technology or software or the technology or software
they Renovaro Cube
licenseslicense from third parties, including open source software, especially when updates or new products are released. Such software and
technology technology
is used in information technology (“IT”) environments with different operating systems, system management software,
devices, devices,
databases, servers, storage, middleware, custom and third-party applications, and equipment and networking configurations, which
may cause
errors, failures, bugs, or defects in the IT environment into which such software and technology is deployed. This diversity
increases increases
the likelihood of errors, failures, bugs, or defects in those IT environments. Some of the features in Renovaro Cube’s
and platform
BioSymetrics’ platforms are powered by machine learning and AI, which depend on datasets and algorithms that could be flawed,
including through inaccurate,
insufficient, outdated, or biased data. Despite testing by Renovaro Cube,Cube and BioSymetrics, real or perceived
errors, failures, bugs, or defects may not
be found until Renovaro Cube’s customers use itstheir products. Real or perceived errors, failures, bugs, or defects
in Renovaro Cube’s
or BioSymetrics’ products could result in negative publicity, loss of or delay in market acceptance of
their its platformplatforms or future products and harm to its
their brand, loss of investor confidence, weakening of itsour competitive position, claims
by customers for losses sustained by them, or failure
to meet the stated service level commitments in its customer agreements. In such an
event, Renovaro Cube or BioSymetrics may be required, or may choose,
for customer relations or other reasons, to expend significant additional
resources in order to help correct the problem. Any real or
perceived errors, failures, bugs, or defects in Renovaro Cube’s or BioSymetrics’
products could also impair itstheir ability to attract new customers,
retain existing customers, or expand their use of its products, which
would adversely affect Renovaro Cube’s or BioSymetrics’ business, results of
operations and financial condition.
Renovaro Cube and BioSymetrics may also be subject to liability claims for damages related to real or perceived errors, failures, bugs, or defects in its platform or future products. A material liability claim or other occurrence that harms Renovaro Cube’s or BioSymetrics’ reputation or decreases market acceptance of its platform or future products may harm its business and results of operations. Finally, since some of Renovaro Cube’s or BioSymetrics’ customers use its products for compliance reasons, any errors, failures, bugs, defects, disruptions in service or other performance problems with Renovaro Cube’s or BioSymetrics’ products may damage its customers’ businesses and could hurt its reputation.
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.
Despite
the implementation of security and back-up measures, Renovaro Cube’s or BioSymetrics’ internal computer, server
and other information technology
systems as well as those of its third-party collaborators, consultants, contractors, suppliers
and service providers, may be
vulnerable to damage from physical or electronic break-ins, computer viruses, malware, ransomware,
denial of service and other cyber-attacks or
disruptive incidents that could result in unauthorized access to, use or disclosure
of, corruption of, or loss of sensitive and/or proprietary
data, including personal and health information, and could subject Renovaro
Cube Cubeor BioSymetrics to significant liabilities, regulatory and enforcement
actions and reputational damage. For example, the loss of
clinical study data from future clinical studies could result in delays in any
regulatory clearance or approval efforts and significantly
increase Renovaro Cube’s or BioSymetrics’ costs to recover or reproduce the data, and
subsequently commercialize its future
products. If Renovaro CubeCube, BioSymetrics’ or itseither’s third-party collaborators, consultants, contractors, suppliers
suppliers or service providers were to suffer an attack or breach, for example, that resulted in the unauthorized access to or use or disclosure
disclosure of personal or health information, Renovaro Cube or BioSymetrics may have to notify physicians, patients, partners, collaborators, government
authorities and the media, and may be subject to investigations, civil penalties, administrative and enforcement actions and litigation,
any of which could harm Renovaro Cube’stheir business and reputation. Likewise, Renovaro Cube reliesand BioSymetrics rely on its third-party research institution
institution collaborators and other third parties to conduct clinical validation, and similar events relating to their computer systems
could also
have a material adverse effect on Renovaro Cube’s or BioSymetrics’ business. To the extent that any disruption or security
breach were
to result in a loss of, or damage to, Renovaro Cube’s or BioSymetrics’ data or systems, or inappropriate or unauthorized
access to or disclosure
or use of confidential, proprietary, or other sensitive, personal, or health information, Renovaro Cube or BioSymetrics
could incur liability and suffer
reputational harm, and the development and commercialization of its products could be delayed.
Renovaro Cube’s or BioSymetrics’ insurance policies may not be adequate to compensate it for the potential losses arising from such disruptions, failure, or security breach. In addition, such insurance may not be available to Renovaro Cube or BioSymetrics in the future on economically reasonable terms, or at all. Further, Renovaro Cube’s or BioSymetrics’ insurance may not cover all claims made against it and defending a suit, regardless of its merit, could be costly, divert management attention and harm Renovaro Cube’s or BioSymetrics’ reputation.
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.
Renovaro
Cube reliesand BioSymetrics rely on trade secrets and confidentiality agreements to protect itstheir know-how, technology, data and other
proprietary information
and to maintain itsa competitive position. Trade secrets and know-how can be difficult to protect. Renovaro
Cube expectsand its
BioSymetrics expect trade secrets and know-how to, over time, be disseminated within the industry through independent
development, the publication
of journal articles describing the methodology and the movement of personnel from academic to industry scientific
positions.
Renovaro
Cube and BioSymetrics each seeks to protect these trade secrets and other proprietary technology, in part, by entering into non-disclosure and
confidentiality confidentiality
agreements with parties who have access to them, such as Renovaro Cube’s and BioSymetrics’ employees, directors,
corporate collaborators, outside
scientific collaborators, contract research organizations (“CROs”), contract manufacturers,
suppliers, service providers,
consultants, advisors and other third parties. Renovaro Cube and BioSymetrics also entersenter into confidentiality
and invention or patent assignment agreements
with its employees and consultants, and reminds departing employees when they leave their
employment of their continuing confidentiality
obligations. Renovaro Cube and BioSymetrics cannot guarantee that itthey hashave entered into
such agreements with each party that may have, or have had, access
to Renovaro Cube’s trade secrets or proprietary technology and processes. Despite Renovaro
Cube’s Cube’sand BioSymetrics’ efforts, any of these parties
may breach the agreements and disclose Renovaro Cube’sour proprietary information,
including Renovaro Cube’s trade secrets, and
Renovaro Cubewe may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally
disclosed or misappropriated
a trade secret is difficult, expensive, and time-consuming, and the outcome is unpredictable. Some
courts outside Thethe Netherlands
respective jurisdictions of BioSymetrics and Renovaro Cube are less willing or unwilling to protect trade secrets.
For example, in China, claims regarding infringement or misappropriation of trade
secrets are difficult to prove, and consequently plaintiffs
are rarely successful in bringing these claims. If any of Renovaro Cube’s
or BioSymetrics’ trade secrets were to be lawfully
obtained or independently developed by a competitor or other third party, Renovaro Cube and BioSymetrics would have no
right to prevent
them from using that technology or information to compete with Renovaro Cube.us. If any of Renovaro Cube’s or BioSymetrics’ trade secrets
were to be misappropriated by, disclosed to, or independently developed by a competitor or other third party, Renovaro Cube’s or
BioSymetrics’ competitive
position could be materially and adversely harmed.
Renovaro
Cube hasand BioSymetrics have and may enter into collaboration, license, contract research and/or manufacturing relationships with contract
organizations that
operate in certain countries that are at heightened risk of theft of technology,
data and intellectual
property through direct intrusion by private parties or foreign actors, including those affiliated with or controlled
by state actors.
Accordingly, Renovaro Cube’s and BioSymetrics’ efforts to protect and enforce Renovaro Cube’stheir intellectual property
rights around the world
may be inadequate to obtain a significant commercial advantage from the intellectual property that Renovaro Cube
and BioSymetrics develops or licenses,
and Renovaro Cubewe may be at heightened risk of losing its proprietary intellectual property rights around the
world, including outside
of such countries, to the extent such theft or intrusion destroys the proprietary nature of its intellectual
property.
Renovaro
Cube’s and BioSymetrics’ success depends on itsour ability to develop and commercialize itsour technology without infringing, misappropriating,
or otherwise
violating the intellectual property of third parties. Third parties may initiate legal proceedings alleging that Renovaro
Cube Cubeor BioSymetrics is infringing
their intellectual property rights, and if they prevail, could block sales of Renovaro Cube’s
or BioSymetrics’ products and force Renovaro Cubeus to
make large damages and/or royalty payments, which could have a material adverse effect
on the success of itsour business.
Renovaro
Cube’s and BioSymetrics’ commercial success in part depends upon itsour ability, and the ability of itsour collaborators, to market,
sell and distribute
Renovaro Cube’sour products and use Renovaro Cube’sour proprietary technologies without infringing, misappropriating or otherwise
violating the
proprietary rights of third parties. There is considerable intellectual property litigation in the medical technology, biotechnology,
diagnostic and pharmaceutical industries. Renovaro Cube or BioSymetrics may become party to, or threatened with, future adversarial proceedings
or litigation
regarding intellectual property rights with respect to its products, including interference proceedings before the United
Kingdom Intellectual
Property Office, the European Patent Office, the United States
Patent and Trademark Office and similar bodies in other jurisdictions.
Third parties may assert infringement claims against Renovaro Cube
or BioSymetrics based on existing patents or patents that may be issued in the future.
If Renovaro
Cube or BioSymetrics is found to infringe, misappropriate, or otherwise violate a third party’s intellectual property rights, it
could be required
to obtain a license from such third party to continue developing, marketing, selling and distributing Renovaro Cube’sour products,
or to cease using the infringing technology. However, Renovaro Cubewe may not be able to obtain any required license on commercially reasonable terms
terms or at all. Even if Renovaro Cubewe were able to obtain a license, it could be non-exclusive, thereby giving Renovaroour Cube’s
competitors access to the
same technologies licensed to Renovaro Cube.us. In addition, Renovaro CubeWe could be found liable for monetary damages,
including treble damages if it is found
to have willfully infringed a patent and attorneys’ fees if the court finds the case to
be exceptional. A finding of infringement,
misappropriation, or other violation could prevent Renovaro Cubeus from commercializing itsour products
or force Renovaro Cubeus to cease some of itsour operations, which
could materially harm itsour business. Claims that Renovaro Cube or BioSymetrics has misappropriated
the confidential information or trade
secrets of third parties could have a similar negative impact on Renovaro Cube’sour business.
Even
if if
resolved in Renovaro Cube’sour favor, litigation or other legal proceedings relating to intellectual property claims may cause Renovaro
Cubeus to incur significant
expenses and could distract Renovaro Cube’sour personnel from their normal responsibilities. Such litigation
or proceedings could substantially increase Renovaro Cube’s
our operating losses and reduce the resources available for development
activities or any future sales, marketing, or distribution activities. Renovaro Cube
We may not have sufficient financial or other resources
to conduct such litigation or proceedings adequately. Some of Renovaro Cube’sour competitors
may be able to sustain the costs of such
litigation or proceedings more effectively than Renovaro Cubewe can because of their greater financial resources
and more mature and developed
intellectual property portfolios. Uncertainties resulting from the initiation and continuation of patent
litigation or other proceedings
could have a material adverse effect on Renovaro Cube’sour ability to compete in the market place.marketplace.
Renovaro
Cube’s and BioSymetrics’ use of open-source software could subject Renovaro Cube’sour proprietary technology to unwanted open-source license
conditions that could negatively impact its business.
Management's Discussion & Analysis (MD&A)
Removed heading “Warrant Exercises”
Largest changes
“On September 2, 2025, the Court of Amsterdam (the “Court”) declared bankrupt Gedi Cube B.V. (“Gedi”), an indirect subsidiary of Lunai Bioworks, Inc. (“Lunai”), and appointed Mr. M.M. Dellebeke as the receiver in the bankruptcy. Gedi filed a voluntary petition seeking a declaration of bankruptcy due to its inability to make payments as they became due. As a result of this, the Company determined that a material impairment of Gedi had occurred (see Note 6 to the financial statements).”see in full comparison
Our operating expenses for the years ended June 30,see in full comparison20242025 and20232024 were$81,639,296$188,966,002 and$38,556,891,$81,639,296, respectively, representing an increase of$43,082,405$107,326,706 or112%.131%. TheThelargest contributors to the increase in operating expenses for the year ended June 30,2024,2025, were the increase in the non-cashintangiblegoodwillassetimpairment of$23,651,000 (see Note 5 to the Financial Statements), increase in the non-cash goodwill impairment of $11,640,000 and the increase in general and administrative expenses of $9,239,410$158,779,429 partially offset by thedecreasedecreases in the non-cash intangible asset impairment of $42,611,000, general and administrative expenses of $6,677,558 and in research and development expenses of$1,456,368$2,171,401 compared to the year ended June 30,2023.2024.
Net loss for the years ended June 30,see in full comparison20242025 and June 30,20232024 was$80,650,172$178,007,489 and$39,684,056,$88,425,828, respectively, representing an increase in net loss of$40,966,116$89,581,661 or103%.101%. The increase in net loss was primarily due to the increase of non-cash goodwill impairment of $158,779,429, offset by the decrease in non-cash intangible asset impairment of$23,651,000,$42,611,000,thedecreasenon-cash goodwill impairment of $11,640,000 and the increasein general and administrative expenses of$9,239,410$6,677,558,offsetdecrease in research and development expenses of $2,171,401 and by the change in fair value of contingent consideration of$4,727,473 and by the $1,456,368 decrease in research and development expenses.$14,728,183.
“The 2023 Notes — Between September 5, 2023, and October 5, 2023, the Company entered into Subscription Agreements with five investors to purchase 5% Original Issue Discount Convertible Promissory Notes (the “2023 Notes”) for an aggregate principal amount of $2,105,263. The Company received a total of $2,000,000 in gross proceeds from the private placement, after taking into account the 5% original issue discount. The discount of $105,263 was to be accreted over the life of the 2023 Notes. …”see in full comparison
“The Company intends to use the net proceeds from the Private Placement for general corporate purposes. Each Subscription Agreement contains customary representations and warranties of the Company and of each Investor, including that all Investors purchasing the Securities are not “U.S. persons” as defined by Rule 902 of Regulation S. The Private Placement was made directly by the Company and no underwriter or placement agent was engaged by the Company. …”see in full comparison
On January 2, 2024, the Company entered into an agreement with RS Bio to issue a 5% Original Issue Discount Secured Promissory Note for the principal amount ofsee in full comparison$526,315 (the “January 2024 Note”).$526,315. The Company received a total of $500,000 in gross proceeds after taking into account the 5% original issue discount. TheJanuary 2024 Notenote bears an interest rate of 12% per annum and matured onMarch 1, 2024 and was extended toDecember 31, 2024.TheOnCompanyFebruaryis24,required2025 RS Bio assigned its ownership rights topayRene Sindlevinterest onwiththeallmaturitytermsdate.remaining unchanged. TheJanuary 2024 Note will be accounted for under ASC 470-20, and all proceeds received from the issuance will be recognized as a liability on the balance sheet net of discount. For the year ended June 30, 2024, discount amortization of $26,315 was charged to interest expense. As of June 30, 2024, the Company accrued $31,579 of interest expense that is included in accrued expenses on the balance sheet. The Notenote balance, net of discount at June 30,20242025 was$526,315.$526,315In connection with the entry into the January 2024 Note, the Company and Paseco ApS agreed to amend and restate a Security Agreement to add the Company’s obligations under the November 2023(see Noteand the January 2024 Note8 to theSecured Obligations (as defined in the Amended and Restated Security AgreementFinancial Statements).
Full comparison: every changed paragraph (74)
RenovaroLunai
Bioworks Inc. operates through twothree subsidiaries, Renovaro BiosciencesBiosciences,
Renovaro Cube and RenovaroBioSymetrics Cube.Inc. Renovaro Cube refers to GediCube Intl. Ltd. and its wholly
owned subsidiarysubsidiaries GediCube, B.V. and Grace
Systems B.V., which were acquired on February 13, 2024. BioSymetrics Inc. refers to BioSymetrics Inc. and its wholly owned subsidiary
BioSymetrics Corp., which were acquired on April 8, 2025.
Renovaro
Biosciences is a biotechnology company intending, if the necessary funding
is obtained, to develop advanced allogeneic cell and gene therapies
to promote stronger immune system responses potentially for long-term
or life-long cancer remission in some of the deadliest cancers, and potentially to treat or cure serious infectious diseases such as Humancancers.
Immunodeficiency Virus (HIV) infections. As a result of our acquisition of GEDi Cube Intl on February 13, 2024,2024 and BioSymetrics Inc. on April 8, 2025, we have shifted the Company’s
primary focus and resources to the development of the GEDi Cube Intl and BioSymetrics Inc. technologies.
On September 2, 2025, the Court of Amsterdam (the “Court”) declared bankrupt Gedi Cube B.V. (“Gedi”), an indirect subsidiary of Lunai Bioworks, Inc. (“Lunai”), and appointed Mr. M.M. Dellebeke as the receiver in the bankruptcy. Gedi filed a voluntary petition seeking a declaration of bankruptcy due to its inability to make payments as they became due. As a result of this, the Company determined that a material impairment of Gedi had occurred (see Note 6 to the financial statements).
On August 18, 2025, the Company issued Promissory Notes in the aggregate principal amount of $1,000,000. The Notes bear an interest rate of 18% per annum and mature on the 6-month anniversary of the Issue Date., (the “Maturity Date”). The Company is required to pay principal and interest on the Maturity Date.
From July 3, 2025, to August 19, 2025, the Company issued Promissory Notes in the aggregate principal amount of $695,000. The Notes bear an interest rate of 10% per annum and mature on June 30, 2026, (the “Maturity Date”). The Company is required to pay principal and interest on the Maturity Date.
On July 7, 2025, Renovaro Inc. (“Renovaro”) entered into an Exchange Agreement (the “Exchange Agreement”) with certain accredited investors (the “Investors”), all of whom are existing shareholders of the Company. Pursuant to the Exchange Agreement, the Investors agreed to exchange an aggregate of $9.7 million in outstanding secured promissory notes (the “Secured Notes”) for $16.1 million in new convertible promissory notes (the “Convertible Notes”), representing a 65% premium to the principal and interest amount of the Secured Notes. The Convertible Notes mature on July 31, 2025, and do not bear any interest. The exchange was completed to restructure the Company’s debt obligations and provide additional flexibility to support strategic initiatives.
Immediately following the issuance of the Convertible Notes on July 7, 2025, the Investors elected to convert the entire $16.1 million principal amount into an aggregate of 53.6 million shares of common stock (the “Conversion Shares”), based on the stated $0.30 per share conversion price. The $0.30 per share conversion price of the Convertible Notes represented a premium to the closing price of the Company’s common stock on July 7, 2025, the date of execution and conversion. As a result, the issuance of the 53.6 million shares of common stock upon conversion of the Convertible Notes did not constitute a “below market” issuance under applicable Nasdaq listing rules and did not trigger stockholder approval requirements under Nasdaq Listing Rule 5635(d). The shares were issued without any additional consideration from the Investors.
As a result of the foregoing transactions, the Company (i) eliminated $9.7 million of secured indebtedness, (ii) issued $16.1 million in Convertible Notes to the same holders, and (iii) issued 53.6 million shares of common stock upon full conversion of such Convertible Notes. The shares of common stock will be issued on or before July 11, 2025, and no cash will be issued for any fractional shares. The transactions did not involve any cash proceeds to the Company.
Known Trends
On June 14, 2024, the Company closed a private placement of the Company’s
Units, each such Unit consisting of (i) one share of the Company’s common stock, $0.0001 par value per share and (ii) one common
stock purchase warrant to purchase one-tenth of a share of Common Stock, with certain investors. The Warrants are exercisable for five
years from the date of issuance and have an exercise price of $1.4726 and $1.4765 per share, payable in cash.
The Private Placement was completed
pursuant to Regulation S promulgated under the Securities Act of 1933, as amended (“Regulation S”). In connection with the
Private Placement, each Investor executed a subscription agreement (each, a “Subscription Agreement”) in the form of Exhibit
10.1 attached hereto.
In the Private Placement, the Company sold 3,939,299 Units at a price per
Unit equal to $1.4726 to a certain investor who settled debt and paid in cash an aggregate amount of $5,801,012 in consideration for the
Units. As of June 30, 2024, the Company issued 2,325,869 shares of Common Stock, $0.0001 par value,
at $1.4726 per share for aggregate proceeds to the Company of $3,425,075 in cash and settlement of debt.
Subsequently related to the
June 14, 2024, Private Placement, the Company sold 1,423,456 Units at a price per Unit equal to $1.4726 to a certain investor who paid
in cash and settled debt an aggregate amount of $2,096,181 in consideration for the Units.
The Company intends to use
the net proceeds from the Private Placement for general corporate purposes. Each Subscription Agreement contains customary representations
and warranties of the Company and of each Investor, including that all Investors purchasing the Securities are not “U.S. persons”
as defined by Rule 902 of Regulation S. The Private Placement was made directly by the Company and no underwriter or placement agent was
engaged by the Company. The Company did not engage in general solicitation or advertising and did not offer the Securities to the public
in connection with the Private Placement.
Our operating expenses for the
years ended June 30, 20242025 and 20232024 were $81,639,296$188,966,002 and $38,556,891,$81,639,296, respectively, representing an increase of $43,082,405$107,326,706 or 112%.131%.
The The
largest contributors to the increase in operating expenses for the year ended June 30, 2024,2025, were the increase in the non-cash intangiblegoodwill
asset impairment of $23,651,000 (see Note 5 to the Financial Statements), increase in the non-cash goodwill impairment of $11,640,000
and the increase in general and administrative expenses of $9,239,410$158,779,429 partially offset by the decreasedecreases in the non-cash intangible asset impairment of $42,611,000, general and administrative
expenses of $6,677,558 and in research and development expenses
of $1,456,368$2,171,401 compared to the year ended June 30, 2023.2024.
General and administrative expenses
for the years ended June 30, 20242025 and 2023,2024, were $24,557,608$17,880,050 and $15,318,198,$24,557,608, respectively, representing ana increasedecrease of $9,239,410,$6,677,558, or
60%.27%. The increasedecrease in general and administrative expenses is primarily related to increasesdecreases in non-cash consulting fees of $4,664,190,
accrued expenses related to the GEDi Cube acquisition of $812,775, legal expenses of $1,360,761,$2,783,367, legal
expenses of $2,260,485, stock based compensation expense of $1,359,838, sales tax expense of $717,744, investor relations expenses of
$526,229, $882,534,
consultingadvertising expenses of $661,998,$247,491, marketingboard member compensation of $238,855, partially offset by an increase in compensation related
expenses of $303,730 and$986,127, rent expenses of $413,802,$174,590, partiallyinformation offsettechnology byexpenses aof decrease$145,199 inand compensation
andsubscription related expenses of $781,467.$112,738.
Research and development expenses
for the years ended June 30, 2024,2025, and 2023,2024, were $2,708,829$537,428 and $4,165,197,$2,708,829, respectively, representing a decrease of $1,456,368$2,171,401 or 35%.80%.
The decrease in research and development expenses is primarily related to $2,090,957decreases in collaborating partner expenses of $1,351,135 with
CDMO CDMO
and CROs related to discontinued product candidates, partiallydecreases offsetin byconsulting anexpenses increaseof $534,564, and decreases in consumables of $238,862 and consulting expenses
of $333,894.$241,982.
Net other income (expenses) for
the years ended June 30, 20242025 and 20232024 was
$989,124 $10,958,513 and $(1,127,1656,786,532), respectively, representing ana increasechange of $2,116,289$17,745,045 or 188%.261%. The
increase in other income was due primarily
to the change in the fair value of the contingent consideration in the amount of $4,727,473, $11,680,000,
which resulted from the mark to market adjustment
on the remaining contingent consideration liability in the year ended June 30, 2024, 2025,
offset by a loss on extinguishment of debt in the
amount of $1,303,578 and interest and other expense of $1,423,449.$725,684.
Net loss for the years ended June
30, 20242025 and June 30, 20232024 was $80,650,172
$178,007,489 and $39,684,056,$88,425,828, respectively, representing an increase in net loss of $40,966,116$89,581,661 or 103%. 101%.
The increase in net loss was primarily due
to the increase of non-cash goodwill impairment of $158,779,429, offset by the decrease in
non-cash intangible asset impairment of $23,651,000,$42,611,000, thedecrease non-cash goodwill impairment of $11,640,000 and the increase
in general and administrative expenses of $9,239,410$6,677,558, offsetdecrease in research
and development expenses of $2,171,401 and by the change in fair value of contingent consideration of $4,727,473 and
by the $1,456,368 decrease in research and development expenses.$14,728,183.
As of June 30, 2024,2025, the Company
had $220,467 in cash and working capital
of $(28,312,274) as compared to $1,874,480$92,700 in cash and working capital of $(8,457,69328,109,502) as compared to $220,467 in cash and working capital of $(28,312,274) as of June
30, 2023.2024. The decrease in cash of $1,654,013
$127,767 is primarily due to the cost of operations of $10,971,430,$7,874,647, notesinvestment receivablein priorequity to acquisitionsecurities of $1,255,600
$500,000 and repayments of finance
agreement of $870,073,$971,231, partially offset by funding totaling $11,387,528 $9,354,003
related to private placements,
placements and proceeds from note payables and the exercise of warrants during the period.
On February 15, 2024, the Company
closed a private placement of 344,827 shares of Common Stock, $0.0001 par value, at $2.90 per share for aggregate proceeds
to the Company of $1,000,000 in cash (see Note 9 to the Financial Statements).
On August 1, 2023, the Company
closed a private placement of 280,505 units (the “Units”), each consisting of (i) one share of the Company’s
Series A Convertible Preferred Stock, (the “Preferred Stock”) and (ii) one common stock purchase warrant (each, a “Warrant”,
and together with the Units and the shares of Preferred Stock, the “Securities”) to purchase five shares of the Company’s
common stock, at a price per Unit equal to $7.13 for aggregate proceeds to the Company of $2,000,000 in cash. In addition, the
Company issued 280,505 Units in connection with the conversion of $2,000,000 of the Promissory Note (see
Note 9 to the Financial Statements).
The Company issued an aggregate
of 561,010 shares of Preferred Stock, which were initially convertible into an aggregate of 5,610,100 shares
of common stock. In connection with the Private Placement, the Company sold Warrants to purchase an aggregate of 2,805,050 shares
of common stock. The Warrants are exercisable for five years from the date of issuance and have an exercise price of $0.65 per share,
payable in cash (see Note 9 to the Financial Statements).
Warrant Exercises
On
April December8, 4, 2023,2025, the Company issued 525,94515,000,000 shares
of Common Stock valued at $6,058,500 pursuant to warrantsthe exercisedStock forPurchase cash proceedsAgreement of $341,865Biosymetrics,
Inc. (see Note 910 to the
Financial Statements).
On January 21, 2025, the Company issued 250,000 shares of Common Stock to its Chief Executive Officer of Renovaro Cube valued at $177,500 (see Note 10 to the Financial Statements).
On October 17, 2024, the Company issued 160,000 shares of Common Stock for consulting services valued at $118,400 (see Note 10 to the Financial Statements).
On October 14, 2024, the Company issued 500,000 shares of Common Stock for consulting services valued at $275,000 (see Note 10 to the Financial Statements).
On October 14, 2024, the Company issued 250,000 shares of Common Stock to its Chief Executive Officer valued at $137,500 (see Note 10 to the Financial Statements).
On August 1, 2024, the Company issued 2,000,000 shares of Common Stock for consulting services valued at $1,400,000 (see Note 10 to the Financial Statements).
On February 20, 2024, 2,953,700
warrants outstanding were exercised at prices ranging from $0.53 to $0.65 per share and the aggregate $1,750,000 of a promissory note
held by the holder was applied to the exercise price of the warrants (see Note 9 to the Financial
Statements).
On February 20, 2024, 471,699 warrants outstanding were exercised at $0.53
per share valued at $250,000. A promissory note held by the holder was applied to the exercise price of the warrants in lieu of cash proceeds
(see Note 9 to the Financial Statements).
MarchThe January 2024 Note —
On MarchJanuary 14,12, 2024, the Company entered into a Subscription AgreementAgreements with an investor to issue a Convertible Promissory Note infor thean aggregate
principal amount
of $500,000$125,000 (the “MarchJanuary 2024 Note”). The MarchCompany received a total of $125,000 in gross proceeds. The
January 2024 Note hadbears an interest rate of 10%12% per annum and was due to maturematured on March
15,December 2025.29, 2024. The Company wasis required to pay interest quarterly,
in arrears, in cash, on the first day of each quarter of each year following
the issue date prior to the maturity of the MarchJanuary 2024
Note. Notwithstanding the immediately foregoing, at the option of the holder, interest
could accrue on this note on a quarterly basis. The MarchJanuary 2024 Note wasis convertible either at the option of the holder afteror aautomatically qualifiedupon offering.
Ifmaturity nointo qualifiedshares offering occurs prior toof the maturityCompany’s
Common date,Stock at the March 2024 Note wasConversion toPrice beof repaid in cash.$3.38.
On June 14, 2024, the Company
sold 344,966 of the Company’s units, each such unit consisting of (i) one share of the Company’s common stock, $0.0001 par
value per share and (ii) one common stock purchase warrant to purchase one-tenth of a share of Common Stock (a “Unit”), to
the holder of the March 2024 Note in consideration for the total $512,361 in principal amount and interest accrued under the March 2024
Note. The warrants are exercisable for five years from the date of issuance and have an exercise price of $1.4726 per share, payable in
cash (see Note 7 to the Financial Statements).
The 2024 Notes —
On January 11, 2024, the Company entered into a Subscription Agreement with an investor to issue a Convertible Promissory Note (the “January
2024 Note I”) in the amount of $460,000. The January 2024 Note I had an interest rate of 12% per annum and was due to mature on
January 11, 2025. The Company was required to pay interest quarterly, in arrears, in cash, on the first day of each quarter of each year
following the issue date prior to the maturity of the notes. Notwithstanding the immediately foregoing, at the option of the holder, interest
could accrue on this note on a quarterly basis. The January 2024 Note I was convertible either at the option of the holder or automatically
upon maturity into shares of the Company’s Common Stock at the conversion price of $3.38. On January 12, 2024, the Company entered
into Subscription Agreements with an investor to issue a Convertible Promissory Note for an aggregate principal amount of $125,000 (the
“January 2024 Note II”, and collectively with the January 2024 Note I, the “January 2024 Notes”). The Company
received a total of $125,000 in gross proceeds. The January 2024 Note II bears an interest rate of 12% per annum and shall mature
on December 29, 2024. The Company is required to pay interest quarterly, in arrears, in cash, on the first day of each quarter of each
year following the issue date prior to the maturity of the January 2024 Note II. The January 2024 Note II is convertible either at the
option of the holder or automatically upon maturity into shares of the Company’s Common Stock at the Note Conversion Price of $3.38.
On June 14, 2024, the Company sold
325,508 of the Company’s Units, each such Unit consisting of (i) one share of the Company’s common stock, $0.0001 par value
per share and (ii) one common stock purchase warrant to purchase one-tenth of a share of Common Stock, to the holder of the January 2024
Note I in consideration for the total $483,460 in principal amount and interest accrued under the January 2024 Note I. The warrants are
exercisable for five years from the date of issuance and have an exercise price of $1.4726 per share, payable in cash The January 2024
Notes principal balance at June 30, 2024, is $125,000 (see Note 7 to the Financial Statements).
December 2023 Notes —
BetweenOn December 1, 2023, and December 29,20, 2023, the Company entered into Subscription
Agreements with two investors to purchase Convertible Promissory Notes for an aggregate
principal amount of $560,000$120,000 (the “December
2023 Notes”). The Company received a total of $560,000 in gross proceeds, consisting of $440,000 and $100,000$120,000 from the private placement
prior to the end of the quarter endingbetween December 31, 2023,2023 and $20,000 received in January 2024. The December 2023 Notes bear an interest
rate of 12% per annum and shall maturematured one year after
their respective dates of issuance (the “Maturity Date”). The Company
is required to pay interest quarterly, in arrears, in
cash, on the first day of each quarter of each year following the issue date prior
to the maturity of the December 2023 Notes. Notwithstanding
the immediately foregoing, at the option of the holder, interest may accrue on
the December Notes on a quarterly basis. The December 2023
Notes are convertible into shares of the Company’s Common Stock in whole or
in part at any time and from time to time, after the
original issue date and prior to the Maturity Date, at a conversion price of $3.38
per share. The December Notes will be accounted for under ASC 470-20.
The January 2024 Note and December 2023 Notes balance at June 30, 2025 was $245,000 (see Note 8 to the Financial Statements).
On June 14, 2024, in a private
placement the Company sold 317,715 Units to an investor who surrendered and terminated $440,000 in aggregate principal amount and $28,453
of interest accrued on the December Notes and paid in cash an aggregate amount of $66,000 to the Company in consideration for the Units,
each such Unit consisting of (i) one share of the Company’s common stock, $0.0001 par value per share and (ii) one common stock
purchase warrant to purchase one-tenth of a share of Common Stock. The warrants are exercisable for five years from the date of issuance
and have an exercise price of $1.4726 per share, payable in cash. The December Notes principal balance at June 30, 2024, is $120,000 (see
Note 7 to the Financial Statements).
The 2023 Notes — Between
September 5, 2023, and October 5, 2023, the Company entered into Subscription Agreements with five investors to purchase 5% Original Issue
Discount Convertible Promissory Notes (the “2023 Notes”) for an aggregate principal amount of $2,105,263. The Company received
a total of $2,000,000 in gross proceeds from the private placement, after taking into account the 5% original issue discount. The
discount of $105,263 was to be accreted over the life of the 2023 Notes. The 2023 Notes had an interest rate of 12% per annum and were
due to mature on September 5, 2024 (the “Maturity Date”). The Company was required to pay interest quarterly, in arrears,
in cash, on the first day of each quarter of each year following the issue date prior to the maturity of the 2023 Notes. Notwithstanding
the immediately foregoing, at the option of the holder, interest could accrue on the notes on a quarterly basis. The 2023 Notes were convertible
into shares of the Company’s Common Stock upon the occurrence of a Qualified Offering (as defined below) or upon the Maturity Date.
The 2023 Notes were subject to
mandatory conversion (“Mandatory Conversion”) in the event the Company closed an offering of its Common Stock and received
gross proceeds of not less than $10,000,000 (a “Qualified Offering”). The conversion price per share of Common Stock in the
case of a Mandatory Conversion was to be 95% of the offering price per share in the Qualified Offering, subject to a floor of $4.50 per
share. In addition, if no Qualified Offering occurred prior to the Maturity Date, the 2023 Notes were to automatically convert into
shares of Common Stock on the Maturity Date at a conversion price per share equal to the closing sale price of the Common Stock on the
Maturity Date, subject to a floor of $4.50 per share.
On January 11, 2024, the Company
entered into an amendment with one of the investors of the 2023 Notes whereas the conversion terms were amended to provide for optional
conversion at a conversion price of $3.38 per share. All other terms of the Promissory Note remained the same. The Company treated this
as a modification for accounting purposes.
On June 14, 2024, the Company sold 1,546,449 Units to the holders of the 2023
Notes who surrendered and terminated $2,293,825 in aggregate principal amount and interest accrued thereon of the 2023 Notes and paid
in cash an aggregate amount of $443,575 (of which $318,063 was applied against the Company’s Promissory Notes), to the Company in
consideration for the Units, each such Unit consisting of (i) one share of the Company’s common stock, $0.0001 par value per share
and (ii) one common stock purchase warrant to purchase one-tenth of a share of Common Stock. The warrants are exercisable for five years
from the date of issuance and have an exercise price of $1.4726 and $1.4765 per share, payable in cash. The 2023 Notes principal balance
at June 30, 2024, is zero.
For the year ended
June 30, 2024, discount amortization of $78,567 was charged to interest expense and $26,696 of discount amortization was charged to other
income and expense due to the early termination of the notes, respectively. In the year ended June 30, 2024, the Company recorded interest
expense of $189,614 related to the 2023 Notes. The 2023 Notes balance, net of discount at June 30, 2024 is zero (see
Note 7 to the Financial Statements).
The Convertible Notes —
On February 6, 2020, the Company issued two Convertible Notes (the “Convertible Notes”) to Paseco ApS (the “Holder”),
a Danish limited company and an existing stockholder of the Company, each with a face value amount of $600,000, convertible into shares
of Common Stock. The outstanding principal amount of the Convertible Notes was due and payable on February 6, 2023. Interest on the Convertible
Notes commenced accruing on the date of issuance at six percent (6%) per annum, computed on the basis of twelve 30-day months, and was
compounded monthly on the final day of each calendar month based upon the principal and all accrued and unpaid interest outstanding as
of such compound date. The interest was payable in cash on a semi-annual basis.
The
conversion price was equal to $12.00 per
share of Common Stock. The Holder did not exercise its conversion feature that expired on February 6, 2021. The Company evaluated the
Convertible Notes in accordance with ASC 470-20 and identified that they each contain an embedded conversion feature that shall not be
bifurcated from the host document (i.e., the Convertible Notes) as they are not deemed to be readily convertible into cash.
Effective December 30, 2022 (the
“Effective Date”), the Company amended and restated the Convertible Notes (the “Amended and Restated Secured Notes”).
Pursuant to the Amended and Restated Secured Notes, the due date was extended to February 28, 2024. The Amended and Restated Secured Notes
were convertible by the Holder if the Company consummated a public offering or private placement of Common Stock or securities convertible
into Common Stock. The conversion price was to be the price being paid by the investors in such offering. The interest rate was increased
to twelve percent (12%) per annum, which was prepaid by the Company in full on the date of amendment through the issuance of 198,439 shares
of the Company’s Common Stock: 29,419 shares for accrued interest up to the Effective Date and 169,020 shares related to the prepayment
of interest through the extension date of the Amended and Restated Secured Notes using the Common Stock closing market price on the Effective
Date, of $1.03. The obligations of the Company under the Amended and Restated Secured Notes were secured by a security agreement (the
“Security Agreement”). The Company evaluated the Amended and Restated Secured Notes and conversion feature to determine the
appropriate accounting treatment based on the terms of the agreement. In accordance with ASC 480 - Distinguishing Liabilities from Equity,
the Company determined that the Amended and Restated Secured Notes embody an obligation that may require the Company to settle with the
issuance of a variable number of shares, where the monetary value of the obligation is based predominantly on a fixed monetary amount
of $1,200,000 known at inception. Accordingly, the Company recorded the Amended and Restated Secured Notes as share settled debt. The
total value of the shares issued was $204,392 which included $174,090 of prepaid interest and $30,302 for accrued interest as of December
30, 2022. On June 26, 2023, the Holder notified the Company that it wished to elect to exercise
its conversion right triggered by a private placement. Therefore, all outstanding $1,200,000 Amended and Restated Secured Notes were converted
into 2,264,150 shares of Common Stock and warrants to purchase 1,132,075 shares of Common Stock. There were no Amended and Restated Secured
Notes outstanding after the foregoing conversion.
Bridge Loans — From June 4, 2025 to June 14, 2025, the Company entered into agreements with Paseco ApS, a Danish entity controlled by a shareholder (“Paseco ApS”) and Laksya Ventures Inc. to issue Promissory Notes for the principal amount of $1,725,000 to each note holder. The Company received $3,450,000 in gross proceeds. The notes bear an interest rate of 10% per annum and mature on December 31, 2025. The notes balance at June 30, 2025, was $3,450,000 with Paseco ApS and Laksya Ventures Inc. each holding $1,725,000 (see Note 8 to the Financial Statements).
From October 21, 2024 to January 24, 2025, the Company entered into agreements with Paseco ApS, a Danish entity controlled by a shareholder (“Paseco ApS”), to issue Promissory Notes for the principal amount of $2,650,000. The Company received $2,650,000 in gross proceeds. The notes bear an interest rate of 10% per annum and mature from December 31, 2024 to December 31, 2025. Approximately $700,000 matured on December 31, 2024, $900,000 matured on December 31, 2025 and $1,050,000 matured on January 31, 2025. On February 24, 2025, Paseco ApS assigned 50% of its ownership rights to Laksya Ventures Inc. with all terms remaining unchanged. The note balance at June 30, 2025, was $2,650,000 with Paseco ApS and Laksya Ventures Inc. each holding $1,325,000 (see Note 8 to the Financial Statements).
From November 12, 2024 to December 3, 2024, Renovaro Cube entered into an agreement with Paseco ApS, a Danish entity controlled by a shareholder (“Paseco ApS”), to issue Promissory Notes for the principal amount of €450,000. The note bears an interest rate of 10% per annum and matures on December 1, 2025. On February 24, 2025 Paseco ApS assigned 50% of its ownership rights to Laksya Ventures Inc. with all terms remaining unchanged. The note balance at June 30, 2025 was approximately $530,000 with Paseco ApS and Laksya Ventures Inc. each holding approximately $265,000 (see Note 8 to the Financial Statements).
On November 1, 2024, Renovaro Cube entered into an agreement with Yalla Yalla Limited, an investor to issue a Promissory Note for the amount of approximately €225,000. The note bears an interest rate of 10% per annum and matured on February 24, 2025. The note balance at June 30, 2025 was approximately $238,000 (see Note 8 to the Financial Statements).
On September 16, 2024, the Company entered into an agreement with RS Bio ApS, a Danish entity controlled by a shareholder (“RS Bio”), to issue a Promissory Note for the principal amount of $100,000 (the “September 2024 Note”). The Company received $100,000 in gross proceeds. The note bears an interest rate of 12% per annum and matured on December 31, 2024. On February 24, 2025 RS Bio assigned its ownership rights to Rene Sindlev with all terms remaining unchanged. The note balance at June 30, 2025 was $100,000 (see Note 8 to the Financial Statements).
On September 6, 2024, Renovaro Cube entered into an agreement with Paseco ApS, a Danish entity controlled by a shareholder (“Paseco ApS”), to issue a Promissory Note for the principal amount of €50,000. The note bears an interest rate of 12% per annum and matures on September 9, 2025. On February 24, 2025 Paseco ApS assigned 50% of its ownership rights to Laksya Ventures Inc. with all terms remaining unchanged. The note balance at June 30, 2025 was approximately $59,000 with Paseco ApS and Laksya Ventures Inc. each holding approximately $30,000 (see Note 8 to the Financial Statements).
Bridge
Loans — Between March 26, 2024 and June 4, 2024 the Company issued Paseco ApS promissory notes (the “Notes”)
in the aggregate principal and interest accrued amount of $2,098,252. The Notes had an interest rate of 10% per annum and were to mature
between May 1, 2024, and August 1, 2024. The Notes were accounted for under ASC 470-20, and all proceeds received from the issuance was
recognized as a liability on the balance sheet. On June 14, 2024, the Company sold 1,424,862 Units at a price per Unit equal to $1.4726
to settle the bridge loan aggregate amount of $2,098,252. As of June 30, 2024 the Notes balance is zero.
On
February 5, 2024, the Company
entered into an agreement with RS Bio ApS,
a Danish entity controlled by the Company’s Chairman, Rene Sindlev (“RS Bio”) to issue a 5% Original Issue Discount
Secured Promissory Note for the principal amount of $105,263.$105,263
(the “February 2024 Note”). The Company received $100,000 in gross proceeds after taking into account
the 5% original issue
discount. The note bears an interest rate of 12% per annum and matured on MarchDecember 1, 2024 and was extended to December
31, 2024. TheOn obligationsFebruary under24, this2025 noteRS areBio securedassigned byits
ownership the Amended and Restated Security Agreement. The Company is requiredrights to payRene interest
onSindlev the maturity date. The note is accounted for under ASC 470-20, andwith all proceedsterms receivedremaining fromunchanged. the issuance will be recognized as a
liability on the balance sheet net of discount. For the year ended June 30, 2024, discount amortization of $5,263 was charged to interest
expense. As of June 30, 2024, the Company accrued $6,316 of interest expense that is included in accrued expenses on the balance sheet.
The note balance, net of discount at June 30, 20242025 was $105,263.$105,263 (see
Note 8 to the Financial Statements).
On
January 2, 2024, the Company
entered into an agreement with RS Bio to issue
a 5% Original Issue Discount Secured Promissory Note for the principal amount of $526,315 (the “January 2024 Note”). $526,315.
The Company
received a total of $500,000 in gross proceeds after taking into account the 5% original issue discount. The January 2024 Notenote bears
an interest rate of 12% per annum and matured on March 1, 2024 and was extended to December 31, 2024. TheOn CompanyFebruary is24, required2025 RS Bio assigned its ownership rights to payRene
Sindlev interest
onwith theall maturityterms date.remaining unchanged. The January 2024 Note will be accounted for under ASC 470-20, and all proceeds received from the issuance will be
recognized as a liability on the balance sheet net of discount. For the year ended June 30, 2024, discount amortization of $26,315 was
charged to interest expense. As of June 30, 2024, the Company accrued $31,579 of interest expense that is included in accrued expenses
on the balance sheet. The Notenote balance, net of discount at June 30, 20242025 was $526,315.$526,315 In connection with the entry into the January 2024
Note, the Company and Paseco ApS agreed to amend and restate a Security Agreement to add the Company’s obligations under the November
2023(see Note and the January 2024 Note8 to the Secured Obligations (as defined in the Amended and Restated Security AgreementFinancial
Statements).
On
November 22, 2023, Renovaro Cube entered into a loan agreement where the holder agreed to loan the Company up to £500,000 (approximately
$624,000 USD). The note had a repayment date occurring the first business day after the first anniversary of the draw down of the loan.
The first draw down of £250,000 occurred on November 27, 2023, and the second draw down of approximately £250,000 occurred
on December 13, 2023. The Company paid interest on the loan at the rate of 10% per annum. Interest was accrued quarterly in arrears on
the last business day of March, June, September, and December and was payable on the repayment date. On June 14, 2024 the Company sold
454,708 Units to the holder and terminated $665,387 in aggregate principal amount and accrued interest and received in cash an aggregate
amount of $100,400 in consideration for the Units which was applied against the loan. For the year ended June 30, 2024, the Company recorded
$36,388 of interest expense related to this loan. The total amount of the loan at June 30, 2024, is zero (see
Note 7 to the Financial Statements).
On
November 3, 2023, the Company
entered into an agreement with RS Bio to
issue a 5% Original Issue Discount Promissory Note for the principal amount of $1,000,000 (the “November 2023 Note”).$1,000,000. The
Company received a total of $950,000 in gross proceeds after taking into account the 5% original issue discount. The discount of
$50,000 will be accreted over the life of the Note.note. The November 2023 Notenote bears an interest rate of 12% per annum and wasmatured due to mature
on January 1, 2024 (the “Maturity Date”). On January 1, 2024, the Company entered into an amendment with RS Bio for the November
2023 Note to extend the maturity date to March 1, 2024 and was extended to December 31, 2024. The Company is required to pay interest
on the maturity date. The November 2023 Note will be accounted for under ASC 470-20, and all proceeds received from the issuance will
be recognized as a liability on the balance sheet net of discount. On February 16,24, 2024,2025 theRS CompanyBio receivedassigned noticeits fromownership the holder to
exercise 471,699 warrants outstanding at $0.53 per share and apply $250,000 of the note balancerights to theRene exerciseSindlev pricewith ofall theterms warrants.
Forremaining the year ended June 30, 2024, discount amortization of $50,000 was charged to interest expense. As of June 30, 2024, the Company accrued
$69,083 of interest expense that is included in accrued expenses on the balance sheet.unchanged. The November 2023 Notenote balance, net of
discount discount
at June 30, 20242025 iswas $750,000 (see Note 78 to the Financial Statements).
Promissory Note — On March 30, 2020 (the “Issuance Date”), the Company issued a Promissory Note in the principal amount of $5,000,000 (the “Promissory Note”) to Paseco ApS. There have been eight amendments to the Promissory Note since the issuance date, the most recent of which is dated August 1, 2024. The principal amount of the Promissory Note, as amended, was payable and matured on November 1, 2024 (the “Maturity Date”). The Promissory Note, as amended, bears interest at a fixed rate of 12% per annum. On February 24, 2025 Paseco ApS assigned its ownership rights to Rene Sindlev with all terms remaining unchanged. The Promissory Note balance at June 30, 2025 is $831,497.
Promissory Note — On
March 30, 2020 (the “Issuance Date”), the Company issued a Promissory Note in the principal amount of $5,000,000 (the “Promissory
Note”) to the Holder. The principal amount of the Promissory Note was originally payable on November 30, 2021 (the “Maturity
Date”). The Promissory Note bore interest at a fixed rate of 6% per annum, computed based on the number of days between the Issuance
Date and the Maturity Date, and the interest was prepaid by the Company in full on the Issuance Date through the issuance of 188,485 shares
of the Company’s Common Stock based on the closing market price on that date for a total value of $501,370. The Company evaluated
the Promissory Note and PIK interest in accordance with ASC 470-Debt and ASC 835-Interest, respectively. Pursuant to ASC 470-20, proceeds
received from the issuance are to be recognized at their relative fair value, thus the liability is shown net of the corresponding discount
of $493,192, which is the relative fair value of the shares issued for the PIK interest on the closing date using the effective interest
method. The discount of $493,192 will be accreted over the life of the Promissory Note.
What changed in the latest 10-Q
Risk Factors
As a “smaller reporting company” as defined by Rule 12b-2 of the Securities Exchange Act of 1934, the Company is not required to provide the information required by this Item.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
Largest changes
As ofsee in full comparisonDecemberMarch 31,2025,2026, Lunai Bioworks Inc.operatesoperated through two subsidiaries, Renovaro Biosciences and BioSymetrics. BioSymetrics refers to BioSymetricsBioSymetricsInc. and its wholly owned subsidiary BioSymetrics Corp., which were acquired on April 8, 2025. During the quarter ended September 30,30,2025, GediCube, B.V., acquired on February 13, 2024, filed for bankruptcy and ceased operations.As a result, beginning inFollowing thesecond quarterdeconsolidation of2026,GediCube B.V.,theconsolidatedCompanyoperationswillnownoconsistlongerofreportRenovaroonBiosciencesitscelloperations.and gene therapy programs and BioSymetrics AI platform.
Our operating expenses for thesee in full comparisonsixthree months endedDecemberMarch 31,20252026 and2024,2025, were$5,131,774$1,448,202 and$57,884,869$4,162,492 respectively, representing a decrease of$52,753,095,$2,714,290 or approximately91%.65%. The decrease in operating expenses primarily relates to the decrease in general and administrative expenses of $2,803,335 and research and development expenses of $110,019 Our operating expenses for the nine months ended March 31, 2026 and 2025, were $6,579,977 and $62,047,361 respectively, representing a decrease of $55,467,384, or approximately 89%. The decrease in operating expenses primarily relates to the decrease in goodwill impairment of $47,614,729, general and administrative expenses of$5,477,647,$8,280,982, research and development expenses of$480,994,$370,974, partially offset by the increase in intangible asset impairment of $831,915.
“Lunai Bioworks Inc. is an AI-driven biotechnology company focused on precision medicine, biomarker discovery, and therapeutic development for CNS disorders, biodefence, and other serious diseases with unmet medical need. The Company, through the Renovaro Biosciences and BioSymetrics subsidiaries, combines multimodal data analytics with experimental biology to generate predictive insights intended to accelerate research and development activities and improve the efficiency of therapeutic and chemical countermeasure discovery.”see in full comparison
Net loss for the three months ended March 31, 2026 was $2,571,394, compared to Net Income of $189,176 for the three months endedsee in full comparisonDecemberMarch 31, 2025,and 2024, was $1,799,404 and $7,252,394, respectively,, representing andecreaseincrease in net loss of$5,452,990$2,760,570 or approximately75%.1,459%. The decrease in net loss was primarily due to a decrease in the change in fair value of contingent consideration of$2,730,000,$4,260,000, a decrease in general and administrative expenses of$2,586,913$2,803,335 and adecreaselossinonresearchtheandextinguishment ofdevelopment expensesdebt of$115,212.$1,086,116.
General and administrative expenses for thesee in full comparisonsixnine months endedDecemberMarch 31,2025,2026, and2024,2025, were$4,176,726$5,597,980 and$9,654,373,$13,878,963, respectively, representing a decrease of$5,477,647$8,280,982 or approximately57%.60%. The variance is related to a decrease in consulting fees expense of$1,960,495,$2,016,801, legal expenses of$1,616,069,$1,885,606, compensation and relates expenses of$797,019,non-cash$1,436,178, non-cash stock-based compensation expense of$606,148,$1,936,354, rent expense and related office expenses of $403,761, travel and related expenses of$108,772$141,479 and information technology expenses of$76,669.$124,976.
We are asee in full comparisonpre-revenue,pre-clinicalpre-clinicalbiotechnology and artificial intelligence driven healthcare technology company.WeOur therapeutic and core diagnostic product candidates remain pre-clinical and havenevernot generatedrevenuesany product revenue. During the three and nine months ended March 31, 2026, we recognized $20,942 of service revenue from a single research-services customer (Kapoose Creek Bio Inc.); the Company had no revenues from continuing operations in prior periods. We have incurred losses since inception. We do not anticipate earninganymaterial product revenues until our therapies or products are approved for marketing and sale.
Full comparison: every changed paragraph (22)
As of
DecemberMarch 31, 2025,2026, Lunai Bioworks Inc. operatesoperated through two subsidiaries, Renovaro Biosciences and BioSymetrics. BioSymetrics refers to BioSymetrics
BioSymetrics Inc. and its wholly owned subsidiary BioSymetrics Corp., which were acquired on April 8, 2025. During the quarter ended September 30,
30, 2025, GediCube, B.V., acquired on February 13, 2024, filed for bankruptcy and ceased operations. As a result, beginning inFollowing the second
quarterdeconsolidation of 2026,GediCube
B.V., theconsolidated Companyoperations willnow noconsist longerof reportRenovaro onBiosciences itscell operations.and gene therapy programs and BioSymetrics AI platform.
Lunai Bioworks Inc. is an AI-driven biotechnology company focused on precision medicine, biomarker discovery, and therapeutic development for CNS disorders, biodefence, and other serious diseases with unmet medical need. The Company, through the Renovaro Biosciences and BioSymetrics subsidiaries, combines multimodal data analytics with experimental biology to generate predictive insights intended to accelerate research and development activities and improve the efficiency of therapeutic and chemical countermeasure discovery.
The Company’s consolidated
financial statements are prepared using the generally accepted accounting principles applicable to a going concern, which contemplates
the realization of assets and liquidation of liabilities in the normal course of business. However, the Company has incurred substantial
recurring losses from continuing operations, has used cash in the Company’s continuing operations, and is dependent on additional
financing to fund operations. As of DecemberMarch 31, 2025,2026, the Company had cash and cash equivalents of $491,645,$3,155,272, an accumulated deficit of
$509,442,953$512,014,347 and a working capital deficit of $19,487,088.$15,550,002. These conditions raise substantial doubt about the Company’s ability to
to continue as a going concern for one year after the date the financial statements are issued. The consolidated financial statements do
do not include any adjustments relating to the recoverability and classification of recorded asset amounts and classification of liabilities
that might be necessary should the Company be unable to continue in existence.
Results of Operations for the Three and SixNine Months ended DecemberMarch 31,
20252026 and 20242025
The following table sets forth
our revenues, expenses and net income, loss for the three and sixnine months ended DecemberMarch 31, 20252026 and 2024.2025. The financial information below
is derived from our unaudited condensed consolidated financial statements.
We
are a pre-revenue,pre-clinical pre-clinical
biotechnology and artificial intelligence driven healthcare technology company. WeOur therapeutic and core diagnostic
product candidates remain pre-clinical and have nevernot generated revenuesany product revenue. During the three and nine months ended March 31, 2026,
we recognized $20,942 of service revenue from a single research-services customer (Kapoose Creek Bio Inc.); the Company had no revenues
from continuing operations in prior periods. We have incurred losses
since inception. We do not anticipate earning anymaterial product revenues
until our therapies or products are approved for marketing and sale.
Our operating expenses for the three months ended December 31, 2025 and 2024,
were $1,823,414 and $4,546,316 respectively, representing a decrease of $2,722,902 or approximately
60%. The decrease in operating expenses primarily relates to the decrease in general and administrative expenses of $2,586,913
and research and development expenses of $115,212.
Our operating expenses for the
sixthree months ended DecemberMarch 31, 20252026 and 2024,2025, were $5,131,774$1,448,202 and $57,884,869$4,162,492 respectively, representing
a decrease of $52,753,095,$2,714,290 or approximately 91%.65%. The decrease in operating expenses primarily relates to the decrease in general
and administrative expenses of $2,803,335 and research and development expenses of $110,019 Our operating expenses for the
nine months ended March 31, 2026 and 2025, were $6,579,977 and $62,047,361 respectively, representing
a decrease of $55,467,384, or approximately 89%. The decrease in operating expenses primarily relates to the decrease in goodwill
impairment of $47,614,729, general and administrative expenses of $5,477,647,$8,280,982, research and development expenses of $480,994,$370,974, partially
offset by the increase in intangible asset impairment of $831,915.
General and administrative expenses
for the three months ended DecemberMarch 31, 2025,2026, and 2024,2025, were $1,766,210$1,421,255 and $4,353,123,$4,224,590, respectively, representing a decrease of $2,586,913$2,803,335
or approximately 59%.66%. The variance is primarily related to a decrease in legal expenses of $717,092,$269,536, compensation and related expenses
of $591,638,$587,535, consulting fees expense of $383,735,$56,306, non-cash stock-based compensation expense of $429,812$1,330,206 and rent expense of $136,365,
investor relation expenses of $86,243 and accounting related expense of $77,120.$125,722.
General and administrative expenses
for the sixnine months ended DecemberMarch 31, 2025,2026, and 2024,2025, were $4,176,726$5,597,980 and $9,654,373,$13,878,963, respectively, representing a decrease of $5,477,647$8,280,982
or approximately 57%.60%. The variance is related to a decrease in consulting fees expense of $1,960,495,$2,016,801, legal expenses of $1,616,069,$1,885,606, compensation
and relates expenses of $797,019,non-cash$1,436,178, non-cash stock-based compensation expense of $606,148,$1,936,354, rent expense and related office expenses
of $403,761, travel and related expenses of $108,772$141,479 and information
technology expenses of $76,669.$124,976.
Research and development expenses
for the three months ended DecemberMarch 31, 2025,2026, and 2024,2025, were $45,872$15,946 and $161,084,$(94,073), respectively, representing aan decreaseincrease of $115,212$110,019 or
approximately 72%.117%. The variance is primarily driven by aan decreaseincrease of $121,511$111,803 in consulting expenses and outside services related to
pre-clinical pre-clinical
testing.
Research and development expenses
for the sixnine months ended DecemberMarch 31, 2025,2026, and 2024,2025, were $70,279$86,226 and $551,273,$457,200, respectively, representing a decrease of $480,994$370,974 or approximately
approximately 87%.81%. The variance is primarily driven by a decrease of $344,382$345,627 in consumables and reagents, and $143,777$24,865 in consulting
expenses.
The Company recorded other incomeexpense
of $24,010$(1,144,134) for the three months ended DecemberMarch 31, 2025,2026, compared to other expenseincome of $2,706,078$4,351,668 for the three months ended DecemberMarch 31,
2024,2025, representing aan decrease in other expense of $2,730,088$5,495,802 or 101%.126%. The variance is primarily due to a decrease of $2,730,000$4,260,000 in the
change in fair value of contingent consideration in the current period.period and the loss on the exchange of debt of $1,086,116.
The Company recorded other income
of $6,151,391$5,007,257 for the sixnine months ended DecemberMarch 31, 2025,2026, compared to other income of $6,420,440$10,772,108 for the sixnine months ended DecemberMarch 31, 2025,
2023, representing a decrease in other expense of $269,049$5,764,851or or 4%.54%. The variance is primarily due to the change in fair value of contingent
consideration liability of $6,150,000$10,410,000 in the current period, loss on extinguishment of debt of $6,329,592$7,415,708 in the current period, partially
offset by the gain on bankruptcy of subsidiary in the amount of $12,019,227.
Net loss for the three months
ended March 31, 2026 was $2,571,394, compared to Net Income of $189,176 for the three months ended
December March 31, 2025, and 2024, was $1,799,404 and $7,252,394, respectively,, representing an decrease increase
in net loss of $5,452,990$2,760,570 or approximately
75%. 1,459%. The decrease in net loss was primarily due to a decrease in the change in fair value
of contingent consideration of $2,730,000,$4,260,000, a
decrease in general and administrative expenses of $2,586,913$2,803,335 and a decreaseloss inon researchthe andextinguishment
of development expensesdebt of $115,212.$1,086,116.
Net income (loss) for the sixnine months ended
ended DecemberMarch 31, 2025,2026, and 2024,2025, was $1,019,617$1,551,778 and $(51,464,429) 51,275,253 respectively, representing a decrease in net loss of $52,484,046$49,723,475 or approximately
approximately 102%.97%. The decrease in net loss was primarily due to decrease in goodwill impairment of $47,614,729, gain on bankruptcy of
subsidiary of
12,019,227 and a decrease in general and administrative expenses of $5,477,647.$8,280,982, decrease in the change in fair value of contingent consideration
of $10,410,000 and loss on the extinguishment of debt of $7,415,708.
We
have historically satisfied
our capital and liquidity requirements through funding from stockholders, the sale of our Common Stock and
warrants, and debt financing.
We haveAlthough neverwe generatedrecognized any$20,942 salesof service revenue from a single research-services customer during the three
and nine months ended March 31, 2026 under the Kapoose Creek Bio Inc. agreement described in Note 1, this revenue is not sufficient to
support our operations, and we expectdo thisnot anticipate generating revenues sufficient to continuesupport operations until our therapies or core diagnostic
products are
approved for marketing in the United States and/or Europe. Even if we are successful in having our therapies or products
approved for
sale in the United States and/or Europe, we cannot guarantee that a market for the therapies or products will develop. We
may never be
profitable.
As
noted above under the heading
“Going Concern and Management’s Plans,” through DecemberMarch 31, 2025,2026, we have incurred substantial
losses. We will need
additional funds both in the next twelve months and beyond for (a) research and development, (b) increases in personnel,
(c) the purchase
of equipment, and investment in the development and validation of our technology. The availability of any required
additional funding
cannot be assured. In addition, an adverse outcome in legal or regulatory proceedings in which we are currently involved
or in the future
may be involved could adversely affect our liquidity and financial position. We may raise such funds from time to time
through public
or private sales of our equity or debt securities. Such financing may not be available on acceptable terms, or at all,
and our failure
to raise capital when needed could materially adversely affect our growth plans and our financial condition and results
of operations.
As of DecemberMarch 31, 2025,2026, the Company
had $491,645$3,155,272 in cash and working capital deficit of $19,487,088$15,550,002 as compared to $92,700 in cash and working capital deficit of $28,109,502
as of June 30, 2025, an increase of 430%3,304% and decrease of 31%,45%, respectively.
Total assets at DecemberMarch 31, 2025,2026,
were $6,666,446$9,860,540 compared to $8,230,840 as of June 30, 2025. The decreaseincrease in assets of $1,629,700 is primarily due to the increase in cash
and cash equivalents of $3,062,572 offset by the impairment of operating lease
right-of-use assets of $687,371, amortization of prepaid
assets of $543,237,$11,297 and a decrease of investment in equity securities of $387,851,
partially offset by the increase of cash of $398,945 in the current period.$387,851.
Total liabilities at DecemberMarch 31,
2025,2026, were $20,215,234$19,413,968 compared to $29,580,681 as of June 30, 2025. The decrease in total liabilities of $10,166,713 was primarily related
to the decrease
of $7,045,741$8,319,236 in notes payable – related parties, $915,595, $930,319 in accrued expenses, $216,220 in accounts payable, $510,000$580,000 in contingent consideration
consideration liability and $303,937$319,958 in other current liabilities.
Cash provided by financing activities
during the period
primarily related to proceeds of $750,000$4,499,551 from an ATM offering, net of issuance costs $191,439, proceeds from Notes Payable of $2,323,000
and proceeds from a private placement, $1,815,000, netplacement of $58,495 placement costs, in notes
payable that were partially offset by $271,643 in repayment of a finance agreement.$750,000.
LNAI insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
No Form 4 stock transactions in this period.
Well-known investors holding LNAI (13F)
None of the 59 investors we track reported a position in their latest 13F.