Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 247

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 247
---
 our drug candidates and generate revenue. Adverse regulatory action,
whether pre- or post-approval, can also potentially lead to product liability claims and increase our product liability exposure.

Delays in the completion of, or the termination
of, any clinical or non-clinical trials for any drug candidates for which we may seek FDA approval could adversely affect our business.

Clinical trials are very expensive,
time consuming, unpredictable and difficult to design and implement. The results of clinical trials may be unfavorable, they may continue
for several years, and they may take significantly longer to complete and involve significantly more costs than expected. Delays in the
commencement or completion of clinical testing could significantly affect product development costs and plans with respect to any drug
candidate for which we seek FDA approval. The commencement and completion of clinical trials can be delayed and experience difficulties
for a number of reasons, including delays and difficulties caused by circumstances over which we may have no control. For instance, approvals
of the scope, design or trial site may not be obtained from the FDA and other required bodies in a timely manner or at all, agreements
with acceptable terms may not be reached in a timely manner or at all with CROs to conduct the trials, a sufficient number of subjects
may not be recruited and enrolled in the trials, and third-party manufacturers of the materials for use in the trials may encounter delays
and problems in the manufacturing process, including failure to produce materials in sufficient quantities or of an acceptable quality
to complete the trials. If we were to experience delays in the commencement or completion of, or if we were to terminate, any clinical
or non-clinical trials we pursue in the future, the commercial prospects for the applicable drug candidates may be limited or eliminated,
which may prevent us from recouping our investment in research and development efforts for the drug candidate and would 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