Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 1140

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 1140
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 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 cover Renovaro Cube’s products and the amount it will reimburse for such products. Any determination
by a payor to cover and the amount it will reimburse for Renovaro Cube’s products would likely be made on an indication-by-indication basis.
For example, because Renovaro Cube intends to cover a broad asymptomatic population with its future products which could potentially generate
a significant number of false-positive results on an absolute basis, Renovaro Cube may face additional scrutiny in obtaining
reimbursement from third-party payors given the additional costs of further diagnostic workup. As a result, obtaining approvals
from third-party payors to cover Renovaro Cube’s products and establishing adequate coding recognition and reimbursement
levels is an unpredictable, challenging, time-consuming and costly process and Renovaro Cube may never be successful. If third-party payors
do not provide adequate coverage or reimbursement for Renovaro Cube’s products, Renovaro Cube’s ability to succeed commercially
will be limited.

Even
if Renovaro Cube