Melt Pharmaceuticals Provides Corporate Update

Rhea-AI Summary

Melt Pharmaceuticals, Inc. (Melt) provided a corporate update, announcing the success of MELT-300 in its Phase 2 Pivotal Efficacy and Safety Study for procedural sedation in cataract surgery. The non-IV, non-opioid tablet, using Catalent Inc.'s fast-dissolving Zydis® delivery technology, is expected to begin Phase 3 program activities in the first quarter of 2024. Additionally, Melt settled its debt with its largest shareholder, Harrow, Inc. (Nasdaq: HROW), and secured funding for the Phase 3 program.

Financial Analyst

The strategic financial moves by Melt Pharmaceuticals, particularly the settlement of debt through the issuance of Series B and Series B-1 Preferred Stock, indicate a pivotal shift in the company's capital structure. The conversion of debt to equity, especially with Harrow Inc. as the largest shareholder now holding approximately 47% equity stake, may dilute existing shareholders but also alleviates short-term cash outflow pressures. This transaction potentially improves the balance sheet and may be seen favorably by investors who prefer companies with lower debt levels. The impact on the stock market could hinge on investor perception of this equity increase as either a positive step towards financial stability or a concern for share dilution.

Medical Research Analyst

The advancement of Melt Pharmaceuticals' MELT-300 into Phase 3 clinical trials is a critical milestone in drug development, signaling a positive response from the FDA and a higher likelihood of eventual market approval. The focus on non-IV, non-opioid procedural sedation addresses a significant market need for alternative sedation methods, which could disrupt the current reliance on opioids and IV sedation. This has the potential to not only provide a new option for over 100 million U.S. medical procedures but also to reduce the risks associated with opioid use. The successful completion and favorable results of the Phase 3 trial could significantly enhance the company's valuation and attractiveness to investors, given the high demand for innovative and safer medical treatments.

Market Research Analyst

From a market perspective, the development of MELT-300 by Melt Pharmaceuticals taps into the growing demand for opioid alternatives and advancements in drug delivery technology. The use of Catalent Inc.'s Zydis® fast-dissolving delivery system for sublingual administration could offer a competitive edge by improving patient compliance and experience. The potential market impact of MELT-300, should it gain FDA approval, extends beyond the company's financials, as it may catalyze a shift in procedural sedation practices. Market adoption rates, however, will depend on the drug's efficacy, safety profile and cost-effectiveness compared to existing sedation methods. If successful, Melt Pharmaceuticals could capture a significant share of the procedural sedation market, influencing both the pharmaceutical industry and stock market valuations in this sector.

NASHVILLE, Tenn.--(BUSINESS WIRE)-- 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.

Melt 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 quarter of 2024.

Additionally, 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%.

“We 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.”

About Melt Pharmaceuticals

Melt 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240103707106/en/

Investor Contact:

Larry Dillaha, M.D.

Chief Executive Officer

ldillaha@meltpharma.com

Media Contact:

Deb Holliday

Holliday Communications, Inc.

deb@hollidaycommunications.net

412-877-4519

Source: Melt Pharmaceuticals, Inc.

What is the latest update from Melt Pharmaceuticals, Inc. (Melt)?

Melt Pharmaceuticals, Inc. (Melt) announced the success of MELT-300 in its Phase 2 Pivotal Efficacy and Safety Study for procedural sedation in cataract surgery.

What is MELT-300 and its expected Phase 3 program activities?

MELT-300 is a non-IV, non-opioid tablet using fast-dissolving Zydis® delivery technology, expected to begin Phase 3 program activities in the first quarter of 2024.

What is the recent agreement and settlement made by Melt Pharmaceuticals, Inc. (Melt)?

Melt Pharmaceuticals, Inc. (Melt) settled its debt with its largest shareholder, Harrow, Inc. (Nasdaq: HROW), and secured funding for the Phase 3 program.