Company: HROW
Filing Date: 2025-08-11
Form Type: 10-Q
Source: 0001641172-25-022980
Chunk: 111

Company: HARROW, INC.
Filing Date: 2025-08-11
Form: 10-Q
Item: Item 1A
Chunk 111
---
In
addition to the other information contained in this Quarterly Report you should consider the risk factors and the other information in
our Annual Report on Form 10-K for the year ended December 31, 2024, including our audited financial statements and the related notes
and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” If any such risks actually
occur, our business, financial condition, results of operations and future growth prospects would likely be materially and adversely
affected. In these circumstances, the market price of our common stock would likely decline and you may lose all or part of your investment.
Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.

Below
we provide in supplemental form the material changes to our risk factors that occurred during the past quarter. Our risk factors disclosed
in Part I, Item 1A, of our Annual Report on Form 10-K for the year ended December 31, 2024, provide additional disclosure for these supplemental
risks and are incorporated herein by reference.

The
federal government could pursue enforcement actions against us to the extent we are unable to demonstrate compliance with cGMPs and other
required regulations, the effects of which could be costly to us and could result in adverse consequences to our business.

In August
2017, the FDA issued a MedWatch notification regarding a curcumin emulsion and two adverse events that had been associated with the use
of these emulsions by prescribing physicians. We issued a press release on August 7, 2017, clarifying certain facts regarding the notice
which outlined our belief that the adverse events associated with the two patients occurred due to an allergic reaction caused by the
products being inappropriately administered and obtained by the prescribing physician, and our use of curcumin and excipients in our curcumin
emulsion formulation met regulatory standards required for dispensing of the curcumin emulsion. In September 2017, the FDA released a
letter confirming that the alleged misuse of certain ingredients in our curcumin emulsions was due to mislabeling by the underlying supplier
and not of our own misdoing. We no longer compound curcumin emulsion products.

Separately,
in December 2017, we were issued a warning letter from the FDA alleging that, in its interpretation of our public communications, we had
made false or misleading claims and omitted risk and side effect information regarding certain of our o