Melt Pharmaceuticals Provides Corporate Update NASHVILLE, Tenn. (

Pharmaceuticals Provides Corporate Update

Tenn. (January 3, 2024) - Melt Pharmaceuticals, Inc. ("Melt"), a clinical-stage pharmaceutical company developing

novel approaches for procedural sedation, today provided a corporate update. The Company previously announced that MELT-300 achieved

the primary sedation endpoint in its Phase 2 Pivotal Efficacy and Safety Study in subjects undergoing cataract surgery. MELT-300, a non-IV,

non-opioid tablet that combines fixed doses of midazolam (3mg) and ketamine (50mg), is administered sublingually using Catalent Inc.'s

proprietary fast-dissolving Zydis delivery technology to rapidly dissolve the tablet for absorption across the

very thin sublingual mucosa.

Pharmaceuticals recently received a written response from the U.S. Food and Drug Administration (FDA) regarding its planned MELT-300

Phase 3 program. Based on the FDA's response, Melt Pharmaceuticals expects to begin Phase 3 program activities, which will consist

of a single pivotal study comparing MELT-300 to sublingual midazolam and placebo in subjects undergoing cataract surgery, in the first

Melt has now reached an agreement with and paid in full all the outstanding principal and accrued and unpaid interest under its loan

facility with Harrow, Inc. (Nasdaq: HROW), Melt's largest shareholder, through the issuance of shares of Melt's Series

B and Series B-1 Preferred Stock. Following this transaction, in addition to certain royalty rights, Harrow's equity ownership

percentage of Melt is approximately 47%.

are very pleased to have received a response from the FDA that supports the investment we are making in our proposed MELT-300 Phase 3

program," said Dr. Dillaha. "This was the last step needed to finalize our program design, paving the way for the commencement

of Phase 3 program activities in early 2024. Following the debt settlement with Harrow and our successful efforts to date to secure sufficient

funding to commence the Phase 3 program, we can now focus on the advancement of our non-IV, non-opioid MELT-300 product candidate, which

we believe has the potential to revolutionize short-duration procedural sedation for more than 100 million U.S. medical procedures, enhancing

the surgical patient experience by providing greater comfort and reducing reliance on opioids."

Melt Pharmaceuticals

Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing proprietary non-opioid, non-IV, sedation, and

analgesia therapeutics for human medical procedures in the hospital, outpatient, and in-office settings. Melt intends to seek regulatory

approval through the FDA's 505(b)(2) regulatory pathway for its proprietary, patented small-molecule product candidates, where

possible. Melt's core intellectual property is the subject of multiple granted patents in North America, Europe, Asia, and the

Middle East. Melt Pharmaceuticals, Inc. is a former subsidiary of Harrow, Inc. (Nasdaq: HROW) and was carved out as a separately managed

business in 2019. To learn more about Melt, please visit their website, www.meltpharma.com.