Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 1139

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 1139
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 inability to control when, if ever, results are published may delay or limit our ability to derive
sufficient revenues from any of its products that are developed using data from a clinical study.

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 and BioSymetrics continue to expand their research and development efforts to use their proprietary AI platforms to develop new products,
including in disease areas beyond cancer and neurology. The commercialization of any new products will require the completion of certain
clinical development activities, regulatory activities and the expenditure of additional cash resources. Renovaro Cube and BioSymetrics
cannot assure you that it can successfully complete the clinical development of any such products.

Renovaro
Cube and BioSymetrics also cannot assure you that they will be able to reduce their expenditures sufficiently, generate sufficient revenue
from products that they successfully commercialize or otherwise mitigate the risks associated with their business to raise enough capital
to develop and commercialize new products. In addition, once Renovaro Cube’s and BioSymetrics’ development efforts for a product
are completed, commercialization efforts, including allocation of resources necessary to comply with applicable laws and regulations,
will require significant expenditures. Any failure by Renovaro Cube or BioSymetrics to develop and commercialize new products could have
a material adverse effect on their ability to implement their strategy and grow their business.

26

One
of the key elements of Renovaro Cube’s strategy is to expand access to its tests by pursuing reimbursement and/or coverage from third-party payors.
If Renovaro Cube’s products do not receive adequate coverage or reimbursement from third-party payors, its ability to
expand access to its tests beyond its initial sales channels and its overall commercial success will be limited.

Renovaro
Cube anticipates that it will not have broad-based coverage or reimbursement at the initial commercial launch. However, a key
element to Renovaro Cube’s strategy is to expand access to its tests by pursuing coverage and/or reimbursement by third-party payors,
including government payors. Coverage and reimbursement by third-party payors, including managed care organizations, private
health insurers and government healthcare programs, such as Medicare and Medicaid in the