Melt Pharmaceuticals, Inc., an affiliated company of Harrow Health,
Inc. (NASDAQ: HROW), today announced it has entered into definitive
stock purchase agreements with accredited and institutional
investors to raise proceeds of approximately $11 million in a
private placement sale of its Series A preferred stock at $5 per
share. Proceeds from the Series A financing will advance the
development of MELT-100, Melt’s patented flagship 505(b)(2) drug
candidate. Melt Pharmaceuticals will be located in Boston,
MA.
Concurrent with the financing, Greg Madison has
been hired as CEO of Melt Pharmaceuticals. Most recently, Mr.
Madison was CEO of Keryx Biopharmaceuticals where he led the
company’s transformation from development stage to a fully
integrated 200+ employee commercial organization and drove
impressive revenue growth by expanding the label for the company’s
lead product. Before Keryx, he was Chief Commercial Officer
at specialty pharma company AMAG Pharmaceuticals and spent 12 years
at Genzyme/Sanofi, ending as Vice-President and General Manager of
the Renal division.
Mr. Madison commented, “I am excited to lead the
Melt Pharmaceuticals team as we embark upon our mission to bring to
market innovative therapies used for conscious sedation and pain
that are non-opioid and non-IV. The market opportunity for a
sublingual formulation for use in conscious sedation and pain is
large, as there are numerous procedures where this technology could
be a potential alternative to traditional IV-based therapies.
Our initial focus will be in use prior to cataract surgeries, of
which there are approximately 4.4 million procedures in the U.S.
each year. As a non-opioid alternative, this formulation
could help tackle one of the biggest issues today, with citizens,
physicians, and lawmakers in the U.S. concerned about opioid
addiction and overdoses. We have assembled an excellent Board
of Directors and clinical advisory team to help guide us as we
bring MELT-100 and the relevant data to FDA with the goal of
ultimately supplying physicians and patients with a much-needed
alternative, or supplement to, IV sedation.”
Madison concluded, “Two weeks ago, we met with
FDA in a planned Pre-IND meeting to discuss our clinical program
for MELT-100. We are pleased with the dialogue with FDA and
outcome of the meeting. We believe this Series A capital may
be sufficient to take us to Phase 3 activities for the MELT-100
program. We look forward to executing the next phases of our
clinical program for MELT-100, with the expectation of having our
IND application for MELT-100 submitted during 2020 along with
starting patient enrollment in our clinical studies
thereafter.”
Following this close of the Series A financing,
Melt Pharmaceuticals will be deconsolidated from Harrow Health and
Harrow will hold approximately 44% of the ownership interests in
Melt, consisting of 3,500,000 shares of common stock. Harrow
also owns a mid-single digit percent royalty on sales of all
current drug assets owned by Melt (including MELT-100).
Harrow Health CEO, Mark L. Baum, added, “This
marks the third time we’ve successfully taken Harrow Health drug
formulations, know-how and other IP, founded a new company, hired
an experienced and focused management team, and brought in third
party capital to fund the development of drug candidates for FDA
approval. Also, at $5 per share, the value of Harrow’s
ownership stake in Melt is greater in value than what we retained
after the Series A financings of either Eton or Surface, our two
previous spin-outs. I am highly confident that through Greg’s
leadership and execution of the MELT-100 development program,
Harrow’s equity holdings and royalties in Melt could create
significant value for Harrow shareholders for many years to
come. With Harrow and Melt shareholders now positioned for
success, we look forward to completing work on our two other drug
development subsidiaries, Mayfield Pharmaceuticals and Radley
Pharmaceuticals.”
Lake Street Capital Markets was the exclusive
placement agent for the financing.
This press release shall not constitute an offer
to sell or the solicitation of an offer to buy any securities
described herein, nor shall there be any sale of any such
securities in any jurisdiction in which such offer, solicitation or
sale would be unlawful prior to the registration or qualification
under the securities laws of any such jurisdiction.
ABOUT MELT PHARMACEUTICALS
Melt Pharmaceuticals, Inc., is a development
stage pharmaceutical company focused on the development and
commercialization of patented non-opioid and non-intravenous (or
non-IV) sedation and anesthesia therapeutics for human medical
procedures in hospital, outpatient, and in-office settings. Melt
intends to seek regulatory approval through the U.S. Food and Drug
Administration’s 505(b)(2) regulatory pathway for these proprietary
technologies. Melt’s core technology is a series of combination
non-opioid sedation drug formulations that may replace or
supplement current sedation modalities for more than 100 million
medical procedures in the United States.
Melt Pharmaceuticals’ vision is to be the
leading provider of non-opioid, non-intravenous conscious sedation
and analgesia pharmaceuticals used for human medical procedures in
hospital, outpatient, and in-office settings.
ABOUT MELT-100
MELT-100 is the patented lead drug candidate of
Melt Pharmaceuticals, Inc. and was developed as a means for
providing moderate conscious sedation without an IV or opioids for
patients undergoing cataract surgery and other in-office,
out-patient and hospital-based procedures. The MELT-100 drug
candidate is designed to be administered sublingually, whereby the
medication dissolves under the tongue for absorption into the
bloodstream.
ABOUT HARROW HEALTH
Harrow Health, Inc. (NASDAQ: HROW) owns a
portfolio of healthcare businesses, including the nation’s leading
ophthalmology pharmaceutical compounding business,
ImprimisRx. The company holds large equity positions in Eton
Pharmaceuticals, Surface Pharmaceuticals, Melt Pharmaceuticals,
Mayfield Pharmaceuticals and Radley Pharmaceuticals, all companies
founded as subsidiaries of Harrow Health. The Company also
owns royalty rights in certain 505(b)(2) drug candidates being
developed by Eton, Surface, Melt, Mayfield and Radley. Harrow
intends to create, invest in and grow paradigm shifting healthcare
businesses that put patients first. For more information
about Harrow Health, please visit the Investor Relations section of
the corporate website by clicking here.
ABOUT LAKE STREET CAPITAL
MARKETS
Lake Street Capital Markets is a full-service
investment bank based in Minneapolis, MN. Lake Street
provides Investment Banking, Research, Trading, and Sales services
to clients. Lake Street was founded on the premise that a
clear focus and a collaborative approach with both investors and
corporations is the best strategy for creating value for
clients.
SAFE HARBOR
This press release contains forward-looking
statements within the meaning of the U.S. Private Securities
Litigation Reform Act of 1995. Any statements in this release that
are not historical facts may be considered 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
predicted include our ability to make commercially available our
compounded formulations and technologies in a timely manner or at
all; physician interest in prescribing our formulations; risks
related to our compounding pharmacy operations; our ability to
enter into other strategic alliances, including arrangements 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 expenses and cash burn, and raise
additional funds when necessary; risks related to research and
development activities; the projected size of the potential market
for our technologies and formulations; unexpected new data, safety
and technical issues; regulatory and market developments impacting
compounding pharmacies, outsourcing facilities and the
pharmaceutical industry; competition; and market conditions. These
and additional risks and uncertainties are more fully described in
Harrow Health’s filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K and its
Quarterly Reports on Form 10-Q. Such documents may be read free of
charge on the SEC's web site at www.sec.gov. Undue reliance should
not be placed on forward-looking statements, which speak only as of
the date they are made. Except as required by law, Harrow Health
undertakes no obligation to update any forward-looking statements
to reflect new information, events or circumstances after the date
they are made, or to reflect the occurrence of unanticipated
events.
CONTACTS
Investor Contact for Melt:Greg
Madisongmadison@meltpharma.com
Investor Contact for Harrow
Health:Jon Pattonjpatton@harrowinc.com858-704-4587
Source: Harrow Health, Inc.; Melt
Pharmaceuticals, Inc.
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