(Note: Melt Pharmaceuticals, Inc. withdrew its IPO plans in an SEC filing dated Jan. 4, 2023.)

Melt is a clinical stage pharmaceutical company focused on the development and commercialization of proprietary non-opioid, non-IV, sedation and anesthesia therapeutics for human medical procedures in hospital, outpatient and in-office settings. We intend to seek regulatory approval through the FDA’s 505(b)(2) regulatory pathway for these proprietary, patented small-molecule product candidates, where possible. The core intellectual property we own is a patented series of combination non-opioid sedation drug formulations that we believe have multiple clinical applications for potential indications of use.

Melt was formed as a wholly owned subsidiary of Harrow Health, Inc. f/k/a Imprimis Pharmaceuticals, Inc. (“Harrow”) in 2018. Following the completion of an offering of our Series A Preferred Stock in 2019, Harrow lost its controlling interest in Melt, and we are no longer considered a subsidiary of Harrow.

We have compiled a unique pipeline of product candidates in various stages of development. Our lead product candidate, MELT-300, was acquired from Harrow, and our other two product candidates, MELT-210 and MELT-400, were developed internally. We may look to grow our pipeline of product candidates through value-creating business development activities and through further internal research and development. All of our product candidates use the proprietary Zydis® drug delivery technology of Catalent, Inc. (“Catalent”), our manufacturing partner. 

Our product candidate pipeline consists of:

MELT-300 combines fixed doses of midazolam (3mg) and ketamine (50mg) in one dissolvable tablet that is administered sublingually for procedural sedation and analgesia during cataract surgery. This product candidate utilizes Catalent’s proprietary fast-dissolving Zydis® delivery technology to rapidly dissolve the tablet for absorption across the very thin sublingual mucosa.