SteadyMed Raises $30 Million in Private Placement
21 April 2017 - 10:10PM
SteadyMed prepares to file New Drug Application
(NDA) for Trevyent® in Q2 2017
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 it has entered into a definitive
agreement to sell its ordinary shares and warrants to purchase its
ordinary shares for aggregate gross proceeds of approximately $30
million in a private placement. The financing was led by Adage
Capital Management, OrbiMed, Deerfield Management and Kingdon
Capital Management.
“We recently achieved several significant
milestones, having received a favorable ruling by the Patent Trial
and Appeal Board of the U.S. Patent and Trademark Office (USPTO) in
our Inter Partes Review (IPR) that invalidated all of the claims in
the United Therapeutics’ ‘393 patent and completed the clinical
validation study of our lead drug product candidate Trevyent, that
is in development to treat Pulmonary Arterial Hypertension (PAH),”
said Jonathan Rigby, President & CEO of SteadyMed. “We are on
track to submit our NDA for Trevyent in this calendar quarter and
continue executing on our pre-commercialization strategy, leading
to the launch of Trevyent in the U.S. in 2018, if approved by the
FDA. We are delighted with the strong support of our existing
investors and pleased to have several new, high quality
institutional healthcare funds that support our belief that
Trevyent has the potential to capture substantial share of the PAH
market.”
JMP Securities served as lead placement agent
for the offering. H.C. Wainwright & Co. acted as co-placement
agent for the offering.
About the Private
PlacementAccording to the terms of the definitive
agreement, SteadyMed will sell approximately 5.0 million ordinary
shares and warrants to purchase approximately 2.5 million ordinary
shares for aggregate gross proceeds of $30.0 million in the private
placement. The price to be paid for the ordinary shares, $5.90 per
share (“Original Issue Price”), is equal to the consolidated
closing bid price on the Nasdaq Global Market on the day of
pricing, April 20, 2017. The purchase price for each whole warrant
will be $0.125 per ordinary share subject to such warrants. The
warrants are exercisable at a price of $6.785 per share and expire
five years from the date of issuance. The transaction is expected
to close on or about April 25, 2017, subject to customary closing
conditions. Proceeds from the private placement will be used
primarily to fund the NDA submission for Trevyent approval for sale
in the U.S., as well as pre-launch commercial activities,
distribution network establishment and manufacture of commercial
Trevyent inventory aimed at a 2018 U.S. commercial launch subject
to NDA approval, and other general corporate purposes.
The securities being sold in the private
placement have not been registered under the Securities Act of
1933, as amended, or state securities laws and may not be offered
or sold in the United States absent registration with the
Securities and Exchange Commission (“SEC”) or an applicable
exemption from such registration requirements. SteadyMed has agreed
to file a registration statement with the SEC covering the resale
of the ordinary shares issuable in connection with the private
placement.
This press release shall not constitute
an offer to sell or the solicitation of an offer to buy these
securities, nor shall there be any sale of these 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 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 Annual Report on form 10-K filed
on March 29, 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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