SteadyMed Raises Additional Capital from Key Institutional Shareholder
26 May 2017 - 10:42PM
SteadyMed Ltd. (Nasdaq:STDY), a specialty pharmaceutical company
focused on the development of drug product candidates to treat
orphan and high-value diseases with unmet parenteral delivery
needs, today announced that one of its largest institutional
shareholders has exercised warrants to purchase additional ordinary
shares of the Company received in conjunction with the first
tranche of SteadyMed’s third quarter 2016 private placement. As a
result of the exercise, SteadyMed has received additional proceeds
totaling approximately $5 million.
SteadyMed remains on track to submit a New Drug
Application (NDA), for Trevyent®, which is in development for the
treatment of Pulmonary Arterial Hypertension (PAH), in the second
quarter of 2017.
“This additional capital, which follows the
successful completion of a $30 million private placement in April,
provides us with greater financial resources as we increase our
pre-commercial and manufacturing initiatives to support an
impactful launch of Trevyent, subject to FDA approval, in
mid-2018,” said Jonathan Rigby, President & CEO of SteadyMed.
“These are exciting times for SteadyMed, and the exercise of these
warrants represents an important vote of confidence from one of our
largest healthcare-focused institutional investors. We are
confident that Trevyent, if approved, will take a meaningful share
of the PAH market and our growing body of high quality, diligent
investors who support our vision, is a testament to that.”
About SteadyMed
SteadyMed Ltd. is a specialty pharmaceutical
company focused on the development of drug products to treat orphan
and high value diseases with unmet parenteral delivery needs. The
company's lead drug product candidate is Trevyent, a development
stage drug product that combines SteadyMed's pre-filled, sterile,
single use, disposable, PatchPump® infusion system, with
treprostinil, a vasodilatory prostacyclin analogue to treat
pulmonary arterial hypertension (PAH). SteadyMed intends to
commercialize Trevyent in the U.S. and has signed an exclusive
license and supply agreement with Cardiome Pharma Corp. for the
commercialization of Trevyent in Europe, Canada and the Middle
East. SteadyMed has offices in San Ramon, California and Rehovot,
Israel. For additional information about SteadyMed please visit
www.steadymed.com.
Forward Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements include, among
others, statements about the company's ability to advance its
development-stage product candidates, including Trevyent.
Forward-looking statements reflect the company's current views with
respect to certain current and future events and are subject to
various risks, uncertainties and assumptions that could cause
actual results to differ materially. Risks and uncertainties
include, but are not limited to, the risk that Trevyent does not
demonstrate clinical superiority to existing parenteral
treprostinil products, that Trevyent is not approved for
commercialization by the FDA or approval is delayed by patent
litigation, that Trevyent is not granted orphan drug exclusivity,
the risk that drug development involves a lengthy and expensive
process with uncertain outcome, that the company will not satisfy
the milestone and other closing conditions to call the second
tranche of its July 2016 private placement, that the company will
continue to need additional funding, and that the company may be
unable to raise capital when needed, which would force the company
to delay, reduce or eliminate its product candidate development
programs and potentially cease operations. There can be no
assurance that the company will be able to complete the offering on
the terms described herein or in a timely manner, if at all. The
risks, uncertainties and assumptions referred to above are
discussed in detail in our reports filed with the Securities and
Exchange Commission, including our Quarterly Report on Form 10-Q
filed on May 12, 2017. The company does not undertake to publicly
update or revise any forward-looking statements to reflect events
or circumstances that may arise after the date hereof except as may
be required by law.
Contacts:
Marylyn Rigby
Senior Director, Investor Relations and Marketing
925-272-4999
mrigby@steadymed.com
The Ruth Group
Lee Roth
(646) 536-7012
lroth@theruthgroup.com
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