Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 6

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 6
---
=0.0096). 

During
2024, Melt reached an agreement with the FDA on a Special Protocol Assessment (“SPA”) for the MELT-300 Phase 3 study. FDA
agreed the study would “adequately address the objectives necessary to support a regulatory submission.” The SPA agreement
establishes a binding agreement on key elements to support a future marketing application. During 2025, we believe Melt intends to conduct
ancillary studies including a confirmatory pharmacokinetic, hepatic impairment, renal impairment and 28-day toxicity studies. Following
completion of those ancillary studies, in early 2026, we believe Melt intends to submit an NDA to the FDA for marketing approval of MELT-300.
A final decision regarding marketing approval will be based on the FDA’s review of the full MELT-300 submission package. Melt can
require ImprimisRx to cease compounding like products at the time of FDA approval of MELT-300. 

As of
December 31, 2024, we owned approximately 45% of Melt’s equity and voting interests issued and outstanding, along with a mid-single
digit royalty on future net sales of MELT-300.

Surface Ophthalmics,
Inc.

Surface
is a clinical-stage pharmaceutical company focused on development and commercialization of innovative therapeutics for ocular surface
diseases. Surface is developing four product candidates for certain ocular surface related indications.

We
own 3,500,000 shares of Surface common stock, which represented approximately 20% of Surface’s equity and voting interests as
of December 31, 2024. We own mid-single-digit royalty rights on future net sales of Surface’s drug candidates SURF-100,
SURF-200 and SURF-201.

 7 

Eton Pharmaceuticals,
Inc.

Eton
is an innovative pharmaceutical company focused on developing, acquiring, and commercializing treatments for rare diseases. Eton was
created and formed as a wholly-owned subsidiary of Harrow. In May 2017, we gave up our controlling interest in Eton. In April 2024, we
sold all of our remaining equity interests in Eton which was 1,982,000 shares of common stock in a block trade at a gross price of $3.00
per share. After deducting trading expenses and commissions of approximately $436,000, we received net proceeds of $5,510,000 and