Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-K/A
Source: 0001731122-25-000252
Chunk: 51

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-K/A
Chunk 51
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Our novel gene, cell and immunotherapy product candidates and new therapeutic approaches could result in heightened regulatory scrutiny, delays in clinical development or delays in our ability to achieve regulatory approval or commercialization of 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 HIV 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 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