Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-K/A
Source: 0001731122-25-000252
Chunk: 44

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-K/A
Chunk 44
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once such products are launched. Renovaro Cube believes that patients, physicians and regulators are likely to be particularly sensitive
to errors in the use of its products or failure of its products to perform as described, and there can be no guarantee that its products
will meet their 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, 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 from any errors in the use, manufacture, design, labelling or performance of its products,
including any false-positive or false-negative results.

In addition,
other companies are developing competing cancer detection tests and technologies focused on improving cancer care with cancer detection
tests and post-diagnostic products. If any tests marketed or being developed by Renovaro Cube’s competitors that are similar
to its products do not perform in accordance with expectations or cause harm or injury to patients, such failure to perform, harm or injury
may result in lower confidence in early disease detection and post-diagnosis tests in general, which could potentially adversely
affect confidence in Renovaro Cube’s products and result in an adverse impact on its operating results and reputation.

If Renovaro Cube’s facilities or those of its third-party collaborators become inoperable, Renovaro Cube’s ability to provide its products will be