Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 15

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 15
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 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 Cube to significant liability and reputational risks notwithstanding the emotional
and mental health effects to which the patient may be exposed. Similarly, a patient who receives a cancer diagnosis shortly following
a “no cancer signal detected” test result may create negative publicity about Renovaro Cube’s product, which would discourage
adoption. Performance failures could establish a negative perception of Renovaro Cube’s products among physicians, patients and
regulators, jeopardize Renovaro Cube’s ability to successfully commercialize its products, impair Renovaro Cube’s ability
to obtain regulatory approvals or secure favorable coverage or reimbursement, or otherwise result in reputational harm. In addition, Renovaro
Cube may be subject to legal claims arising