Harrow completes Melt Pharmaceuticals acquisition with approximately $4.3 million paid at closing

Harrow, Inc. said in a Form 8-K filed Nov 18, 2025, that it completed its acquisition of Melt Pharmaceuticals, Inc. on Nov 17, 2025. At closing, Harrow paid about $4.3 million in cash as initial consideration for the remaining equity interests in Melt. The merger was effective that day under an Agreement and Plan of Merger dated Sept 24, 2025. The parties to that agreement are Harrow, Harrow Acquisition Sub, Inc., Melt and a stockholder representative.

The 8-K says the material terms of the merger agreement and a related milestone payment agreement were described in Harrow's Sept 26, 2025, 8-K. The contingent regulatory and commercial milestone payments described there remain unchanged. Harrow says all closing conditions were satisfied or waived. The filing does not restate the amount or timing of those milestone payments, so readers have to go back to the September filing for them.

Under Item 3.02, Harrow said it could issue more common stock later in connection with the deal. Any such shares would be issued under the exemption from registration in Section 4(a)(2) of the Securities Act. The 8-K does not say how many shares that could be.

What Melt brings

Harrow describes Melt as a clinical-stage pharmaceutical company developing non-opioid, non-IV therapies for sedation in hospital, outpatient and office settings. Its product candidates are MELT-210, MELT-300 and MELT-400, all built on the Zydis orally dissolving tablet platform. MELT-300 is the lead candidate. The company describes it as a patented, sublingual fixed-dose combination of midazolam (3mg) and ketamine (50mg), designed to give sedation without intravenous access.

Harrow says the MELT-300 Phase 2 and Phase 3 programs "previously demonstrated statistical superiority to midazolam alone." The same release says a Special Protocol Assessment confirmed that the completed Phase 3 design, statistical approach and endpoints adequately support a future regulatory submission. A Special Protocol Assessment is a review of study design, not a finding of efficacy or an approval. The release does not give the trial's effect size, its p-values or its patient counts, so the superiority claim cannot be checked against the figures.

Harrow links MELT-300 to MKO Melt, a compounded sublingual sedation product sold by its ImprimisRx subsidiary and administered by more than 800 U.S. ophthalmic institutions, mainly for cataract surgery. Harrow calls MELT-300 a potential FDA-approved successor to that product, but the filing does not say whether any MELT-300 approval would require the company to stop selling the compounded version.

The NDA timetable

The release lists the steps still ahead. Harrow will start one non-clinical animal study and three pharmacokinetic studies to generate the rest of the data for a new drug application. It plans to submit the NDA in the first half of 2027 and expects potential approval in the first half of 2028. Commercial launch preparations are scheduled for the second half of 2028. Each of those dates depends on FDA review, which the release does not describe in detail.

The studies named in the release are still to be run. The release reports no results from them.

Harrow's own finances

Harrow's 10-K for 2024, filed March 27, 2025, carries a going-concern warning that is tied to its debt. The filing says $107,500,000 of principal under the Oaktree Loan becomes due in January 2026. It says that maturity, without a refinancing, could raise substantial doubt about the company's ability to continue as a going concern. The same report lists two senior note issues on Nasdaq, the 8.625% notes due 2026 and the 11.875% notes due 2027.

The 10-K also says Harrow may need additional capital to keep operating and to pursue acquisitions, and that such funding may not be available on acceptable terms. The milestone payments are contingent, but the 8-K does not say how Harrow will fund them or refinance the Oaktree debt.

Harrow describes itself as a leading provider of ophthalmic disease management products in North America. The Melt purchase adds candidates that have not been approved.

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