Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 1176

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 1176
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 indications. The drug-related side effects could affect patient recruitment
or the ability of enrolled patients to complete the trial or result in potential product liability claims.

Additionally, if any of our product
candidates receives marketing approval and we or others later identify undesirable or unacceptable side effects or safety concerns caused
by these product candidates, a number of potentially significant negative consequences could result, including:

    ●
    regulatory authorities may withdraw, suspend, or limit approvals of such products and require us to take them off the market;

    ●
    regulatory authorities may require the addition of labeling statements, specific warnings, a contraindication or field alerts to physicians and pharmacies;

    ●
    regulatory authorities may require a medication guide outlining the risks of such side effects for distribution to patients, or that we implement a REMS or REMS-like plan to ensure that the benefits of the product outweigh its risks;

    ●
    we may be required to change the way a product is distributed or administered, conduct additional clinical trials, or change the labeling of a product;

    ●
    we may be required to conduct additional post-marketing studies or surveillance;

    ●
    we may be subject to limitations on how we may promote the product;

    ●
    sales of the product may decrease significantly;

    ●
    we may be subject to regulatory investigations,

    ●
    we may be subject to government enforcement actions, litigation, or product liability claims; and

    ●
    our products may become less competitive, or our reputation may suffer.

Any of these events could prevent
us or any collaborators from achieving or maintaining market acceptance of our product candidates or could substantially increase commercialization
costs and expenses, which in turn could delay or prevent us from generating revenue from the sale of our product candidates.

Renovaro
Cube’s and BioSymetrics’ business is subject to economic, political, regulatory and other risks associated with international
operations.

Renovaro
Cube’s and BioSymetrics’ business is subject to risks associated with conducting business internationally. For example, some
of Renovaro Cube’s and BioSymetrics’ suppliers and parties with whom they have collaborative relationships are located outside
of the United States, including in Canada, the United Kingdom, and Israel. Accordingly, Renovaro Cube’s and BioSymetrics’
future results could be harmed by a variety of factors, including:

46

    ●
    economic weakness, including inflation, or political instability in particular foreign economies and markets;

    ●
    challenges