Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 22

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 22
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 safety.

Success in pre-clinical studies
does not ensure that later clinical studies will generate adequate data to demonstrate the efficacy and safety of an investigational drug.
Currently, several of our product candidates, including RENB-DC-11, our genetically-modified allogeneic dendritic therapeutic vaccination
platform for solid tumors, and BioS_831, our small molecule compound being developed for epilepsy, are in various stages of pre-clinical
development with ongoing and planned pre-clinical studies in conjunction with research institutions and third parties. Despite preliminary
data we believe is positive, this does not guarantee that any of these products will proceed to the clinical stage or to approval for
commercial use. A number of companies in the pharmaceutical and biotechnology industries, including those with greater resources and experience
than us, have suffered significant setbacks in clinical studies, even after seeing promising results in earlier preclinical or clinical
studies.

Regulatory agencies evaluate non-clinical
data carefully before they will approve clinical testing in humans. If certain non-clinical data reveals potential safety issues or the
results are inconsistent with an expectation of the potential product candidates’ efficacy in humans, the regulatory agencies may
require additional more rigorous testing before allowing human clinical trials. This additional testing will increase program expenses
and extend timelines. We may decide to suspend further testing on our potential products or abandon the product lines altogether if, in
the judgment of our management and advisors, the pre-clinical test results do not support further development, as we did with our pan-coronavirus
and influenza product lines.

31

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
me