Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 14

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 14
---
 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 establishes relationships with payors to provide its products at negotiated rates, such agreements would not obligate
any healthcare providers to order its products or guarantee that it would receive reimbursement for its products from these or any other
payors at adequate levels. Thus, these payor relationships, or any similar relationships, may not result in acceptable levels of coverage
or reimbursement for Renovaro Cube’s products or meaningful increases in the number of billable tests it sells to healthcare providers.
Renovaro Cube believes it may take several years to achieve coverage or adequate reimbursement with a majority of third-party payors,
including with those payors offering negotiated rates. In addition, Renovaro Cube cannot predict whether, under what