Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 23

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 23
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chanics. The FDA or other applicable regulatory authorities may ask for specific post-market requirements, and additional information
informing benefits or risks of our products may emerge at any time prior to or after regulatory approval.

We face significant competition
in an environment of rapid technological change and there is the possibility that our competitors may achieve regulatory approval before
us or develop therapies that are more advanced or effective than ours, which may adversely affect our financial condition and our ability
to successfully market or commercialize our product candidates. 

The development of treatments
in the fields of cancer and neurology is highly competitive and many pharmaceutical and biotechnology companies, academic institutions,
governmental agencies, and other public and private research organizations may pursue the research and development of technologies, drugs
or other therapeutic products for the treatment of some or all of the diseases we are targeting. Nearly all of our competitors have greater
capital resources, larger overall research and development staffs and facilities, and a longer history in drug discovery and development,
obtaining regulatory approval and pharmaceutical product manufacturing and marketing than we do. Techniques in gene, cell and immunotherapy
are subject to rapid technological change and development and are significantly affected by existing rival products and medical procedures,
new product introductions and the market activities of other participants. With additional resources, our competitors may be able to respond
to rapid and significant technological changes faster than we can. The future success of Renovaro Biosciences and BioSymetrics will depend
in large part on our ability to maintain a competitive position with respect to these technologies. We may also face competition from
products, which have already been approved and accepted by the medical community for the treatment of these same indications. If we are
unable to compete effectively with any existing products, new treatment methods and new technologies, we may be unable to commercialize
therapeutic products that we may develop in the future, which could adversely impact our potential revenues, results of operations and
financial condition or lead to abandonment of product candidates in our pipeline.

Our reliance on third parties,
such as university laboratories, contract manufacturing organizations and contract or clinical research organizations, may result in delays
in completing, or a failure to complete, non-clinical testing or clinical trials if they fail to perform under our agreements with them.

In the course of the development
of our pipeline, we have and expect to continue to engage university laboratories, non-profit organizations, independent contractors,
other biotechnology companies or clinical manufacturing organizations to conduct and manage research and development, pre-clinical and