Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 50

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 50
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 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 enforcing its contractual and intellectual property rights, especially in those foreign jurisdictions that do not respect and protect intellectual property rights to the same extent as the Netherlands;

    ●
    changes in foreign laws, regulations and customs, tariffs and trade barriers;

    ●
    changes in foreign currency exchange rates;

    ●
    changes in a specific countries or region’s political or economic environment;

    ●
    negative consequences from changes in tax laws;

    ●
    trade protection measures, import or export licensing requirements or other restrictive actions by the Netherlands or foreign governments;

    ●
    compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

    ●
    workforce uncertainty in