Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-K/A
Source: 0001731122-25-000252
Chunk: 50

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-K/A
Chunk 50
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 our end-users, including patients, clinicians, and healthcare institutions, and
it is not guaranteed that regulators will agree with our approach to limiting these risks or to our compliance more generally. Any of
these factors could adversely affect our business, financial condition, and results of operations.

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The results of pre-clinical studies or earlier clinical studies are not necessarily predictive of future results, and if we fail to demonstrate efficacy in our pre-clinical studies and/or clinical trials in the future our future business prospects, financial condition and operating results will be materially adversely affected.

The success of our therapeutic
research and development efforts will depend upon our ability to demonstrate the efficacy of the treatments in our pipeline in pre-clinical
studies, as well as in clinical trials following IND approval by the FDA. Pre-clinical studies involve testing potential product candidates
in appropriate non-human disease models to demonstrate efficacy and 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 RENB-HV-12, our therapeutic HIV vaccine, are currently 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.