Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 1149

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 1149
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 our product candidates.

Renovaro Biosciences’ future
success is dependent on the successful development of novel gene, cell and immunotherapy product candidates. Because these programs, particularly
our pipeline of allogeneic T-cell product candidates that are bioengineered from healthy donor cells, represent a new approach to immunotherapy
for the treatment of cancer and other diseases, developing and commercializing our product candidates subject us to a number of challenges.

Moreover, actual or perceived
safety issues, including adoption of new therapeutics or novel approaches to treatment, may adversely influence the willingness of subjects
to participate in clinical studies, or if approved by applicable regulatory authorities, of physicians to subscribe to the novel treatment
mechanics. 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 commercial