Melt Pharmaceuticals Closes $24 Million Series B Preferred Stock Financing

Rhea-AI Summary

Melt Pharmaceuticals, Inc. completes a Series B Preferred Stock financing of $24 million, increasing pre-money valuation by 150%. The funding will support the development of MELT-300, a non-IV, non-opioid tablet for procedural sedation. The Phase 3 program started in Q1 2024, with topline results expected in Q4 2024.

Pharmaceutical Industry Analyst

The completion of Melt Pharmaceuticals' Series B financing marks a significant milestone in the company's journey to bring MELT-300 to market. The substantial increase in pre-money valuation suggests strong investor confidence in the product's market potential. MELT-300's non-invasive delivery mechanism, which leverages Catalent's Zydis technology, addresses a current gap in procedural sedation, particularly for cataract surgeries, a common procedure with over 4.5 million occurrences annually in the U.S. alone.

Investors and stakeholders should note the potential market disruption if MELT-300 gains FDA approval. The shift towards non-opioid alternatives is a response to the opioid crisis and Melt's focus on a needle-free solution could significantly enhance patient comfort and safety. This product could see rapid adoption, given the current trend towards minimizing opioid use across healthcare settings.

However, the success of MELT-300 hinges not only on clinical efficacy but also on its safety profile, cost-effectiveness and the company's ability to navigate the regulatory landscape. As the Phase 3 trial progresses, data will be critical in determining the viability of MELT-300 and its impact on Melt Pharmaceuticals' financials and stock performance.

Healthcare Market Research Analyst

The procedural sedation market is poised for innovation, with MELT-300 positioned as a potential disruptor. The product's design caters to a wide range of short-duration medical procedures, which exceed 100 million annually in the U.S. The adoption of MELT-300 could streamline operational efficiencies in healthcare facilities by reducing the need for intravenous setups and opioid-based sedation protocols, potentially leading to cost savings and improved throughput.

Market penetration will depend on factors such as the ease of integration into existing procedural workflows, reimbursement landscape and clinician training. Melt Pharmaceuticals' partnership with Catalent for the Zydis fast-dissolving technology could provide a competitive edge in terms of user experience and speed of onset, which are important in time-sensitive clinical environments.

Long-term, the success of MELT-300 could catalyze further investments in non-IV and non-opioid sedation solutions, reshaping the standard of care in procedural sedation. The financial implications for Melt Pharmaceuticals and its investors could be substantial, provided the product demonstrates a favorable balance between efficacy, safety and cost.

Biotech Investment Analyst

The recent Series B financing for Melt Pharmaceuticals signifies a strong investor interest, which could be indicative of the company's growth trajectory and the perceived potential of MELT-300. The nearly 150% increase in pre-money valuation since the Series A round reflects optimism about the company's strategic direction and its ability to execute on its clinical development plan.

From an investment perspective, the projected Q4 2024 topline readout date for the Phase 3 program will be a critical juncture. Positive trial results could lead to significant value creation, while any setbacks might pose risks to the investment thesis. Investors should monitor enrollment progress, interim data and peer comparisons to gauge the likelihood of clinical and regulatory success.

It is important for investors to consider the broader implications of MELT-300's market entry, such as potential shifts in prescribing habits, competitive responses and the evolving regulatory environment for non-opioid sedatives. Given the current focus on opioid-sparing strategies in healthcare, MELT-300 may benefit from favorable policy tailwinds that could enhance its commercial prospects.

MELT-300 Pivotal Phase 3 Program Topline Readout Expected in Q4 2024

NASHVILLE, Tenn.--(BUSINESS WIRE)-- Melt Pharmaceuticals, Inc. (“Melt”), a clinical‑stage pharmaceutical company developing novel approaches for procedural sedation, today announced the completion of its Series B Preferred Stock financing of approximately $24 million from new and existing investors at a pre‑money valuation that increased nearly 150% from the pre-money valuation for Melt’s Series A Preferred Stock financing in 2019. The capital raised will primarily support the further development of MELT-300, including the MELT-300 Phase 3 program. 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. The MELT-300 Phase 3 program commenced in the first quarter of 2024, with first patient dosing expected in the second quarter of 2024 and a topline readout expected in the fourth quarter of 2024.

“Melt is seeking to drive a paradigm shift in procedural sedation, fulfilling an unmet need to provide a needle- and opioid-free alternative for procedural sedation, especially in cataract surgeries, which are estimated at over 4.5 million procedures in the U.S. As we continue to develop our patented technologies, we believe we can also impact the more than 100 million short-duration medical procedures nationwide,” said Dr. Larry Dillaha, Chief Executive Officer of Melt. “If approved, we expect MELT-300 will enhance the patient’s experience in all sites of care by offering greater comfort without a needle stick and by reducing exposure to opioids.

“With this round of financing, we’ve obtained the funding to further the development of MELT-300, including conducting our recently commenced Phase 3 program. We are grateful for the ongoing support from our current investors and are pleased to welcome new investors to our company. Their shared belief in the vision of MELT-300 and their confidence in its potential to revolutionize short-duration procedural sedation is incredibly valuable to us.”

Newbridge Securities Corporation acted as the exclusive placement agent for the Series B Preferred Stock Offering.

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/20240402844928/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 funding amount for Melt Pharmaceuticals' Series B Preferred Stock financing?

Melt Pharmaceuticals raised approximately $24 million in its Series B Preferred Stock financing.

What is the purpose of the funding raised by Melt Pharmaceuticals?

The capital raised will primarily support the further development of MELT-300, including the MELT-300 Phase 3 program.

What is MELT-300 developed by Melt Pharmaceuticals?

MELT-300 is a non-IV, non-opioid tablet that combines fixed doses of midazolam (3mg) and ketamine (50mg) for procedural sedation.

When did the MELT-300 Phase 3 program start?

The MELT-300 Phase 3 program commenced in the first quarter of 2024.

When are the topline results of the MELT-300 Phase 3 program expected?

The topline readout for the MELT-300 Phase 3 program is expected in the fourth quarter of 2024.