Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-K/A
Source: 0001731122-25-000252
Chunk: 42

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-K/A
Chunk 42
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 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 to develop and commercialize new products could have a material adverse effect on Renovaro Cube’s ability to implement
its strategy and grow its business.

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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 test out-of-pocket, which
could dissuade physicians from ordering Renovaro Cube’s products and, if ordered, could result in delay in, or decreased likelihood
of, Renovaro Cube’s collection of payment. Renovaro Cube believes its revenue and revenue growth will depend on its success in achieving
broad coverage and adequate reimbursement for its products from third-party payors.

Coverage
and reimbursement by a third-party payor may depend on a number of factors, including a payor’s determination that a product
is appropriate, medically necessary and cost-effective. Each payor will make its own decision as to whether to establish a policy
or enter into a contract to