Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 1141

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 1141
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 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 circumstances, or
at what payment levels payors will cover or reimburse for its products. If Renovaro Cube fails to establish and maintain broad-based coverage
or reimbursement for its products, its ability to expand access to its products, generate increased revenue and grow its test volume and
customer base will be limited and its overall commercial success will be limited.

If
Renovaro Cube’s or BioSymetrics’ products, or the products of its competitors, directly or indirectly result in harm or injury
to patients, Renovaro Cube or BioSymetrics could be subject to significant reputational and liability risks, and its operating results,
reputation and business could suffer.

Renovaro
Cube’s and BioSymetrics’ success will depend on the market’s confidence that their developed products can provide reliable, high-quality results,
once such products are launched. Renovaro Cube and BioSymetrics believe that patients, physicians and regulators are likely to be particularly
sensitive to errors in the use of their products or failure of their products to perform as described, and there can be no guarantee that
their products will meet expectations. Renovaro Cube’s initial product is intended to be used to detect a cancer signal in patients,
but its results are not diagnostic. If a cancer signal is detected, the product would be used to localize the origin of the cancer signal.
A “cancer signal detected” test result would need to be followed up by appropriate diagnostic methods. Because this product
cannot detect all cancer signals, and may not detect signals for all cancer types,

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a negative test would not rule out the presence of
cancer. Additionally, a patient undergoing unnecessary diagnostic tests on the basis of a false-positive result or an erroneous
location of cancer signal result could expose Renovaro