Raised $28.2 Million in Net Proceeds in a
Private Placement
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 provided a corporate update and reported financial
results for the first quarter ended March 31, 2017.
First Quarter 2017 and Recent
Corporate Highlights Include:
- SteadyMed is on-track to file a New Drug Application (NDA) for
Trevyent for the treatment of PAH by the end of the second quarter
of 2017.
- In April, SteadyMed successfully raised $28.2 million in net
proceeds in a private placement led by institutional healthcare
investors Adage Capital, OrbiMed, Deerfield Management and Kingdon
Capital Management. This additional capital is expected to
fund pre-launch commercial activities, distribution network
establishment and manufacture of commercial Trevyent inventory
aimed at a 2018 commercial launch in the U.S. (subject to NDA
approval), as well as working capital and general corporate
purposes. The Company now has sufficient capital to fund operations
into late 2018.
- In late March, SteadyMed received a favorable ruling from the
Patent Trial and Appeal Board (PTAB) of the United States Patent
and Trademark Office (USPTO) in the Inter Partes Review (IPR)
proceeding against United Therapeutics’ (Nasdaq: UTHR) '393 patent.
The PTAB ruled that all 22 claims in the '393 patent were
unpatentable and cancelled them, rendering the patent
invalid. The '393 patent claimed a product made by a process
to further purify prostacyclin derivatives, such as treprostinil.
Treprostinil is the active pharmaceutical ingredient used in United
Therapeutics' Remodulin® and SteadyMed's lead drug candidate,
Trevyent, which is in development for the treatment of
PAH.
- In April, SteadyMed announced the successful completion of a
clinical study for Trevyent to provide clinical validation of
usability over the 48 hour, per unit, intended use. This study
enrolled 60 healthy adult volunteers in an in-clinic setting, and
was intended to provide clinical validation of the performance of
the Trevyent product. The results indicate that the PatchPump®
devices performed as intended in all categories of
evaluation.
- SteadyMed received a Notice of Allowance from the USPTO for
patent application number 14/384,152, related to its PatchPump
infusion system for injectable drugs. The grant of this patent
potentially protects not only Trevyent, but SteadyMed’s proprietary
PatchPump, prefilled, preprogrammed, sterile and disposable
infusion system. This is another potential US FDA Orange Book
listable patent, added to SteadyMed’s robust intellectual property
portfolio that is expected to further protect its anticipated
position in the PAH market and more broadly its expansion into
other, high value disease states for which there are unmet
parenteral delivery needs.
“The first several months of 2017 have been
one of the most significant periods in SteadyMed’s history, and set
the stage for additional milestones in the months and years ahead.
In parallel with our strong progress, we believe the competitive
landscape in the PAH market is changing in a manner that favors
SteadyMed, and our recent financing which included additional high
quality diligent investors, is testament to that fact,” said
Jonathan Rigby, President and Chief Executive Officer of SteadyMed.
“We finished the first quarter with a cash position of $14.6
million, further strengthened by the additional $28.2 million
raised in our recent private placement, plus the potential for an
additional $10.7 million from the second tranche of our 2016
financing in Q3 of this year. At this point, we are sufficiently
capitalized to execute on our core strategic objectives, and
increase our pre-commercial activities in preparation for the
potential 2018 U.S. launch of Trevyent.”
First Quarter 2017 Financial
Results:
SteadyMed recorded licensing revenues of
$315,000 in the first quarter of 2017, compared to $375,000
revenues in the first quarter of 2016. The decrease in
recorded revenues was attributable to the adjustment to the
estimated performance obligations period.
For the first quarter ended March 31, 2017,
SteadyMed reported a net loss of $18.6 million, or $0.92 per share,
compared to a net loss of $6.3 million, or $0.46 per share for the
first quarter ended March 31, 2016. The net loss of $18.6
million included $12.7 million of noncash financial expenses as
further detailed below.
Total operating expenses for the first
quarter ended March 31, 2017 were $6 million, compared to $6.6
million for the quarter ended March 31, 2016. The decrease in total
operating expenses was primarily attributable to a decrease in
Research and Development (R&D) expenses of $0.9 million and a
decrease in General and Administrative (G&A) expenses of $0.1
million offset by an increase in Sales and Marketing (S&M)
expenses of $0.4 million.
R&D expenses for the first quarter of
2017 were $4.1 million, compared to $4.9 million for the first
quarter of 2016. The decrease in R&D expenses was
primarily due to a decrease of $0.9 million in subcontractors and
materials.
G&A expenses for the first quarter of
2017 were $1.3 million, compared to $1.4 million for the first
quarter of 2016. The decrease in G&A expenses was primarily due
to a decrease of $0.1 million in consulting expenses.
S&M expenses for the first quarter of
2017 were $0.6 million, compared to $0.2 million for the first
quarter of 2016. The increase was primarily due to an increase of
$0.2 million in consulting expenses related to the
pre-commercialization plan for Trevyent and an increase of $0.1
million in salary expenses mainly due to increase in headcount.
Financial expenses, net, amounted to
$12.7 million during the first quarter of 2017 mainly due to
an expense of $12.7 million from revaluation of fair value of the
warrants to purchase Ordinary Shares due to significant increase in
the company's share price from December 31, 2016 to March 31, 2017.
Financial income, net, amounted to $0.07 million during the
first quarter of 2016, mainly due to a $0.05 million gain from
foreign currency translation adjustments.
As of March 31, 2017, SteadyMed had cash and
cash equivalents of $14.6 million. On April 21, 2017, the Company
completed a private placement in which it received net proceeds of
$28.2 million.
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.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSS |
U.S. dollars in thousands (except
share data) |
|
|
|
Three months ended March
31, |
|
|
2017 |
|
|
|
2016 |
|
|
|
Unaudited |
Revenues |
|
$ |
315 |
|
|
$ |
375 |
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
Research and
development |
|
$ |
4,101 |
|
|
$ |
4,965 |
|
Sales and
marketing |
|
588 |
|
|
|
212 |
|
General and
administrative |
|
1,316 |
|
|
|
1,433 |
|
|
|
|
|
|
Total operating
expenses |
|
6,005 |
|
|
|
6,610 |
|
|
|
|
|
|
Total operating
loss |
|
5,690 |
|
|
|
6,235 |
|
|
|
|
|
|
Financial expenses
(income), net |
|
12,721 |
|
|
|
(69 |
) |
|
|
|
|
|
Loss before taxes on
income |
|
18,411 |
|
|
|
6,166 |
|
|
|
|
|
|
Taxes on income |
|
148 |
|
|
|
108 |
|
|
|
|
|
|
Net loss |
|
$ |
18,559 |
|
|
$ |
6,274 |
|
Net loss per
share: |
|
|
|
|
Basic and diluted net
loss per Ordinary Share |
|
$ |
(0.92 |
) |
|
$ |
(0.46 |
) |
Weighted-average number
of Ordinary Shares used to compute basic and diluted net loss per
share |
|
|
20,139,826 |
|
|
|
13,585,810 |
|
CONSOLIDATED BALANCE SHEETS |
U.S. dollars in thousands |
|
|
|
March 31, |
|
December 31, |
|
|
2017 |
|
2016 |
|
|
Unaudited |
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
14,579 |
|
|
$ |
23,215 |
Other
assets |
|
|
5,429 |
|
|
|
4,943 |
|
|
|
|
|
Total
assets |
|
$ |
20,008 |
|
|
$ |
28,158 |
|
|
|
|
|
Liabilities and shareholders' equity
(deficit): |
|
|
|
|
|
|
|
|
|
Current
liabilities |
|
$ |
3,785 |
|
|
$ |
6,357 |
Non-current
liabilities |
|
|
20,226 |
|
|
|
7,490 |
Shareholders' equity (deficit) |
|
|
(4,003 |
) |
|
|
14,311 |
|
|
|
|
|
Total
liabilities and shareholders' equity |
|
$ |
20,008 |
|
|
$ |
28,158 |
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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