Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-K/A
Source: 0001731122-25-000252
Chunk: 43

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-K/A
Chunk 43
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 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 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.

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

Renovaro
Cube’s success will depend on the market’s confidence that its developed products can provide reliable, high-quality results,