Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 68

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 68
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 have a material
adverse effect on our business, results of operations, financial condition and prospects.

 40 

We may depend on the success of our drug candidates,
and those we have royalty rights to, which have not yet demonstrated efficacy for their target or any other indications. If we are unable
to generate revenues from our drug candidates, our ability to create stockholder value may be limited. 

Our drug candidates are in various
stages of clinical development. There is no guarantee that our clinical trials will be successful or that we will continue clinical development
in support of an approval from the FDA or comparable foreign regulatory authorities for any indication. We note that most drug candidates
never reach the clinical development stage and even those that do commence clinical development have only a small chance of successfully
completing clinical development and gaining regulatory approval. Therefore, aspects of our business depend on the successful development,
regulatory approval and commercialization of our drug candidates, which may never occur.

If we are not able to obtain required regulatory
approvals for a drug candidate, we will not be able to commercialize such drug candidate and our ability to generate revenues will be
limited. 

We must successfully complete
clinical trials for our drug candidates before we can apply for marketing approval. Even if we complete our clinical trials, it does
not assure marketing approval. Our clinical trials may be unsuccessful, which would materially harm our business. Even if our initial
clinical trials are successful, we are required to conduct additional clinical trials to establish our drug candidates’ safety
and efficacy, before an NDA or Biologics License Application (“BLA”), or their foreign equivalents can be filed with the
FDA or comparable foreign regulatory authorities for marketing approval of our drug candidates.

Clinical testing is expensive,
is difficult to design and implement, can take many years to complete and is uncertain as to outcome. Success in early phases of pre-clinical
and clinical trials does not ensure that later clinical trials will be successful, and interim results of a clinical trial do not necessarily
predict final results. A failure of one or more of our clinical trials can occur at any stage of testing. We may experience numerous
unforeseen events during, or as a result of, the clinical trial process that could delay or prevent our ability to receive regulatory
approval or commercialize our drug candidates. The research, testing, manufacturing, labeling, packaging, storage, approval, sale, marketing,
advertising and promotion, pricing, export, import and distribution of drug products are subject