NASHVILLE, Tennessee – (COMMERCIAL THREAD) – Harrow Health, Inc. (Nasdaq: HROW), an ophthalmology-focused healthcare company, and Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing first-class drugs for sedation and l analgesia, announced today that Harrow Health has provided a $ 13.5 million senior secured loan to Melt Pharmaceuticals.
Melt Pharmaceuticals plans to use the sale product to conduct its pivotal Phase 2 efficacy study for the Company’s lead drug candidate, MELT-300, a patented combination of midazolam and ketamine in a rapidly dissolving sublingual tablet. to provide sedation and analgesia to patients undergoing cataract surgery. Melt’s intravenous, opioid-free approach aims to replace the current practice of intravenous sedation and analgesia, including the use of intraoperative fentanyl and other opioids prescribed for postoperative pain. Melt plans to assay its first patient in September 2021 and publish the first clinical results in spring 2022. Pending the results of the phase 2 clinical study, Melt Pharmaceuticals plans to start a phase 3 clinical study, which compares MELT- 300 to a placebo, in the second half of 2022. Melt also plans to file with the United States Food and Drug Administration (FDA) two New Drug Investigation (IND) applications for its MELT-210 and MELT-400 programs. during the latter part of 2021.
“We are delighted to have secured this non-dilutive funding which allows us to complete our Phase 2 clinical study of MELT-300 and execute our overall clinical strategy, which should generate data to ultimately support a new drug demand (NDA ) with the FDA, âsaid Larry Dillaha, MD, CEO of Melt Pharmaceuticals. “Recent estimates indicate that up to 50% of the more than four million annual cataract surgeries in the United States involve patients exposed to opioids in the perioperative period. If approved by the FDA, MELT-300 will be a new surgical protocol that is expected to virtually eliminate opioid exposure during cataract surgery, ameliorating, in part, the devastating public health effects of the opioid crisis in the USA. With this funding, we will now also be able to advance our goal of exploiting our patented technology in other short-term procedures in medical fields such as pediatrics, dermatology, plastics and women’s health.
Mark L. Baum, CEO of Harrow Health, added: âAs the major shareholder of Melt Pharmaceuticals, owner of the royalty rights to potential sales of MELT-300 and given our expertise in the commercialization of ophthalmic surgical pharmaceuticals, Harrow is delighted to provide capital for the flagship program. Melt’s MELT-300 and to advance other Melt Development programs. Dr Dillaha has an impressive 505 (b) (2) drug approval record, and we strongly believe in his team’s strategy with the MELT-300 program. For Harrow, I can think of a few short-term events that could deliver the magnitude of value that MELT-300, a multi-patent drug development candidate with a billion dollar annual revenue opportunity in the market. growing in ophthalmic surgery. I am very excited about what this potential paradigm shift a way opioids and IVs could mean clinically for patients and ophthalmologists and financially for Harrow shareholders. ”
The senior secured loan, funded with approximately $ 12.5 million in new cash and approximately $ 1 million in existing amounts owed to Harrow Health, has a term of one year with no principal repayment until maturity and without penalty for early repayment. The loan carries an annual interest rate of 12.5%, which can be paid in kind in the form of an additional principal balance. The loan is secured by substantially all of Melt’s assets, including all issued patents in the United States, Australia, Japan and South Korea related to Melt’s platform technologies. Along with the completion of the loan agreement, Harrow Health was also offered a five-year right of first refusal option tied to third-party marketing rights for Melt’s drug candidates.
Harrow Health owns approximately 44% of the interests in Melt Pharmaceuticals as well as a 5% royalty interest on sales of MELT-300.
About Melt Pharmaceuticals
Melt Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on the development and commercialization of patented non-intravenous, non-opioid sedation and analgesia drugs for acute outpatient and office medical procedures. Melt’s core technology is a series of combination formulations of non-opioid sedative drugs that can replace or supplement current sedation modalities for more than 100 million medical procedures in the United States. To learn more about Melt, please visit their website, www.meltpharma.com.
About Harrow Health
Harrow Health, Inc. (NASDAQ: HROW) is an ophthalmology-focused healthcare company. The Company owns and operates ImprimisRx, one of the country’s leading ophthalmology-focused pharmaceutical companies, and Visionology, a direct-to-consumer eye care subsidiary focused on chronic eye care. Harrow Health also owns non-controlling interests in Eton Pharmaceuticals, Surface Ophthalmics and Melt Pharmaceuticals, all of which started as subsidiaries of Harrow Health, and holds royalty rights to four clinical-stage drug candidates developed by Surface Ophthalmics. and Melt Pharmaceuticals. For more information on Harrow Health, please visit the Investors section of the company’s website, www.harrowinc.com.
This press release contains “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not historical facts may be deemed to be such “forward-looking statements”. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those expected include the impact of the COVID-19 pandemic and any future health outbreaks on our financial condition, liquidity and operating results. ; our ability to make our formulations and compound technologies commercially available on time or not at all; the market acceptance of the Company’s formulations and the challenges associated with the commercialization of the Company’s formulations; risks associated with our compounding pharmacy operations; our ability to enter into other strategic alliances, including agreements with pharmacies, physicians and healthcare organizations for the development and distribution of our formulations; our ability to obtain intellectual property protection for our assets; our ability to accurately estimate our spending and cash usage, and to raise additional funds as needed; risks related to research and development activities; the projected size of the potential market for our technologies and formulations; unexpected new data, security issues and technical issues; regulatory and market developments affecting dispensing pharmacies, outsourcing facilities and the pharmaceutical industry; competetion; and market conditions. These and other risks and uncertainties are described in more detail in documents filed by Harrow Health with the Securities and Exchange Commission, including its annual report on Form 10-K and quarterly reports on Form 10-Q. . These documents can be read free of charge on the SEC’s website at www.sec.gov. You should not place undue reliance on forward-looking statements, which speak only as of the date on which they are made. Except as required by law, Harrow Health assumes no obligation to update forward-looking statements to reflect new information, events or circumstances after the date on which they are made, or to reflect the occurrence of unforeseen events.