Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 13

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 13
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ization 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 United States and similar programs in other countries,
for the types of early detection and post-diagnosis service tests that Renovaro Cube provides can be limited and uncertain. Healthcare
providers may not order Renovaro Cube’s products unless third-party payors cover or provide adequate reimbursement for
a substantial portion of the price of Renovaro Cube’s products. If Renovaro Cube is not able to obtain adequate coverage or an acceptable
level of reimbursement for its products from third-party payors, there could be a greater co-insurance or co-payment obligation
for any individual for whom a test is ordered. The individual may be forced to pay the entire cost of a